Regulatory T-Cell-Associated Cytokines in Systemic Lupus Erythematosus

Directory of Open Access Journals (Sweden)

Akiko Okamoto

2011-01-01

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

Proteomic analysis reveals metabolic and regulatory systems involved the syntrophic and axenic lifestyle of Syntrophomonas wolfei.

Directory of Open Access Journals (Sweden)

Jessica Rhea Sieber

2015-02-01

Full Text Available Microbial syntrophy is a vital metabolic interaction necessary for the complete oxidation of organic biomass to methane in all-anaerobic ecosystems. However, this process is thermodynamically constrained and represents an ecosystem-level metabolic bottleneck. To gain insight into the physiology of this process, a shotgun proteomic approach was used to quantify the protein landscape of the model syntrophic metabolizer, Syntrophomonas wolfei, grown axenically and syntrophically with Methanospirillum hungatei. Remarkably, the abundance of most proteins as represented by normalized spectral abundance factor (NSAF value changed very little between the pure and coculture growth conditions. Among the most abundant proteins detected were GroEL and GroES chaperonins, a small heat shock protein, and proteins involved in electron transfer, beta-oxidation, and ATP synthesis. Several putative energy conservation enzyme systems that utilize NADH and ferredoxin were present. The abundance of an EtfAB2 and the membrane-bound iron-sulfur oxidoreductase (Swol_0698 gene product delineated a potential conduit for electron transfer between acyl-CoA dehydrogenases and membrane redox carriers. Proteins detected only when S. wolfei was grown with M. hungatei included a zinc-dependent dehydrogenase with a GroES domain, whose gene is present in genomes in many organisms capable of syntrophy, and transcriptional regulators responsive to environmental stimuli or the physiological status of the cell. The proteomic analysis revealed an emphasis macromolecular stability and energy metabolism to S. wolfei and presence of regulatory mechanisms responsive to external stimuli and cellular physiological status.

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

International Nuclear Information System (INIS)

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

2009-01-01

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

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

Steady-State-Preserving Simulation of Genetic Regulatory Systems

Directory of Open Access Journals (Sweden)

Ruqiang Zhang

2017-01-01

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

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

Directory of Open Access Journals (Sweden)

Heath Murray

2014-10-01

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

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

Science.gov (United States)

Murray, Heath; Koh, Alan

2014-01-01

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

Regulatory systems-based licensing guidance documentation

International Nuclear Information System (INIS)

Delligatti, M.S.

1991-01-01

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

SACE_5599, a putative regulatory protein, is involved in morphological differentiation and erythromycin production in Saccharopolyspora erythraea.

Science.gov (United States)

Kirm, Benjamin; Magdevska, Vasilka; Tome, Miha; Horvat, Marinka; Karničar, Katarina; Petek, Marko; Vidmar, Robert; Baebler, Spela; Jamnik, Polona; Fujs, Štefan; Horvat, Jaka; Fonovič, Marko; Turk, Boris; Gruden, Kristina; Petković, Hrvoje; Kosec, Gregor

2013-12-17

Erythromycin is a medically important antibiotic, biosynthesized by the actinomycete Saccharopolyspora erythraea. Genes encoding erythromycin biosynthesis are organized in a gene cluster, spanning over 60 kbp of DNA. Most often, gene clusters encoding biosynthesis of secondary metabolites contain regulatory genes. In contrast, the erythromycin gene cluster does not contain regulatory genes and regulation of its biosynthesis has therefore remained poorly understood, which has for a long time limited genetic engineering approaches for erythromycin yield improvement. We used a comparative proteomic approach to screen for potential regulatory proteins involved in erythromycin biosynthesis. We have identified a putative regulatory protein SACE_5599 which shows significantly higher levels of expression in an erythromycin high-producing strain, compared to the wild type S. erythraea strain. SACE_5599 is a member of an uncharacterized family of putative regulatory genes, located in several actinomycete biosynthetic gene clusters. Importantly, increased expression of SACE_5599 was observed in the complex fermentation medium and at controlled bioprocess conditions, simulating a high-yield industrial fermentation process in the bioreactor. Inactivation of SACE_5599 in the high-producing strain significantly reduced erythromycin yield, in addition to drastically decreasing sporulation intensity of the SACE_5599-inactivated strains when cultivated on ABSM4 agar medium. In contrast, constitutive overexpression of SACE_5599 in the wild type NRRL23338 strain resulted in an increase of erythromycin yield by 32%. Similar yield increase was also observed when we overexpressed the bldD gene, a previously identified regulator of erythromycin biosynthesis, thereby for the first time revealing its potential for improving erythromycin biosynthesis. SACE_5599 is the second putative regulatory gene to be identified in S. erythraea which has positive influence on erythromycin yield. Like bld

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.

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

International Nuclear Information System (INIS)

Rashidi Othman; Fatimah Azzahra Mohd Zaifuddin; Norazian Mohd Hassan

2015-01-01

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

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

International Nuclear Information System (INIS)

2015-01-01

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

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

International Nuclear Information System (INIS)

Dahll, Gustav; Liwang, Bo; Wainwright, Norman

2006-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2006-07-01

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

Environment, safety, and health regulatory implementation plan

International Nuclear Information System (INIS)

1993-01-01

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

Access to the decision-making process: opportunities for public involvement in the facility decommissioning process of the United States Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Cameron, F.X.

1996-01-01

This paper discusses recent initiatives taken by the United States Nuclear Regulatory Commission NRC) to effectively involve the public in decommissioning decisions. Initiatives discussed include the Commission's rulemaking to establish the radiological criteria for decommissioning, as well as public involvement methods that have been used on a site-by-site basis. As un example of public involvement, the NRC is currently in the process of developing generic rules on the radiological criteria for the decontamination and decommissioning of NRC-licensed sites. Not only was this proposed rule developed through an extensive and novel approach for public involvement, but it also establishes the basic provisions that will govern public involvement in future NRC decisions on the decommissioning of individual sites. The aim is to provide the public with timely information about all phases of the NRC staff to express concerns and make recommendations. Th NRC recognizes the value and the necessity of effective public involvement in its regulatory activities and has initiated a number of changes to its regulatory program to accomplish this. From the NRC's perspective, it is much easier and less costly to incorporate these mechanisms for public involvement into the regulatory program early in the process, rather than try to add them after considerable public controversy on an action has already been generated. The historical antecedents for initiatives mentioned, as well as 'lessons learned' from prior experience are also discussed. (author)

What Are the Molecules Involved in Regulatory T-Cells Induction by Dendritic Cells in Cancer?

Directory of Open Access Journals (Sweden)

Rodrigo Nalio Ramos

2013-01-01

Full Text Available Dendritic cells (DCs are essential for the maintenance of homeostasis in the organism, and they do that by modulating lymphocyte priming, expansion, and response patterns according to signals they receive from the environment. The induction of suppressive lymphocytes by DCs is essential to hinder the development of autoimmune diseases but can be reverted against homeostasis when in the context of neoplasia. In this setting, the induction of suppressive or regulatory T cells contributes to the establishment of a state of tolerance towards the tumor, allowing it to grow unchecked by an otherwise functional immune system. Besides affecting its local environment, tumor also has been described as potent sources of anti-inflammatory/suppressive factors, which may act systemically, generating defects in the differentiation and maturation of immune cells, far beyond the immediate vicinity of the tumor mass. Cytokines, as IL-10 and TGF-beta, as well as cell surface molecules like PD-L1 and ICOS seem to be significantly involved in the redirection of DCs towards tolerance induction, and recent data suggest that tumor cells may, indeed, modulate distinct DCs subpopulations through the involvement of these molecules. It is to be expected that the identification of such molecules should provide molecular targets for more effective immunotherapeutic approaches to cancer.

Stakeholder involvement in the evaluation of a multipurpose canister system

International Nuclear Information System (INIS)

Williams, J.R.; Kane, D.; Smith, T.B. Jr.

1994-01-01

The U.S. Department of Energy (DOE), Office of Civilian Radioactive Waste Management (OCRWM), began evaluating a multipurpose canister (MPC) concept in October of 1992. This followed recommendations by the Nuclear Waste Technical Review Board (NWTRB) and the U.S. Nuclear Regulatory Commission (NRC) that DOE develop a nuclear waste management system that achieves system integration, standardization, and reduced fuel-handling operations. Industry organizations such as Edison Electric Institute (EEI) and Electric Power Research Institute (EPRI) had conducted earlier studies that concluded advantages to the nuclear waste management system may be offered by such a concept. The MPC concept involves a metal canister which would contain multiple spent nuclear fuel assemblies. The canister would be sealed at the nuclear power plant and would not be reopened. The MPC would then be placed inside separate casks or overpacks for storage, transportation, and disposal. An important factor in DOE's evaluation of the MPC concept was the involvement of external parties. This paper describes that involvement process for the OCRWM's MPC implementation program. External parties who have an interest or stake in the program are referred to as stakeholders

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

International Nuclear Information System (INIS)

2001-09-01

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

RING E3 ligases: key regulatory elements are involved in abiotic stress responses in plants.

Science.gov (United States)

Cho, Seok Keun; Ryu, Moon Young; Kim, Jong Hum; Hong, Jeong Soo; Oh, Tae Rin; Kim, Woo Taek; Yang, Seong Wook

2017-08-01

Plants are constantly exposed to a variety of abiotic stresses, such as drought, heat, cold, flood, and salinity. To survive under such unfavorable conditions, plants have evolutionarily developed their own resistant-mechanisms. For several decades, many studies have clarified specific stress response pathways of plants through various molecular and genetic studies. In particular, it was recently discovered that ubiquitin proteasome system (UPS), a regulatory mechanism for protein turn over, is greatly involved in the stress responsive pathways. In the UPS, many E3 ligases play key roles in recognizing and tethering poly-ubiquitins on target proteins for subsequent degradation by the 26S proteasome. Here we discuss the roles of RING ligases that have been defined in related to abiotic stress responses in plants. [BMB Reports 2017; 50(8): 393-400].

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

Science.gov (United States)

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

2015-01-01

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

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 and Stakeholder Involvement is Key to Successful Project Completion

International Nuclear Information System (INIS)

Ballinger, K. S.; Coleman, S. J.; Shoemake, J. M.; Olds, T. E.

2006-01-01

Public involvement participation is an integral and effective component of the U.S. Department of Energy's (DOE) activities that ensures crucial decisions are made with the benefit and consideration of public perspectives. This component brings a broad range of diverse viewpoints and values into DOE's decision-making processes before end decision points are reached. Early involvement enables DOE to make more informed decisions, improve quality through collaborative efforts, and helps to build mutual understanding and trust between DOE and the public it serves. During the cold war, the production of thousands of nuclear warheads was an outstanding engineering achievement that created materials and technologies that were vital to national interest and security; however, it also created a legacy of perplexing toxic nuclear waste. The significant challenges presented by the liquid and solid nuclear wastes stored at the Hanford Site, were formally acknowledged by the U.S. Congress when it directed DOE to establish the Office of River Protection (ORP). The office was assigned the single, dedicated mission of retrieving, treating, and disposing of all waste contained in 177 huge underground storage tanks at the Hanford Site in Southeastern Washington State. As part of this on-going mission of cleanup, the Office of River Protection must make sound decisions that uphold not only the Department of Energy's interests, but more importantly, the interests of the state of Washington. Public participation is an open, ongoing, two-way communication, both formal and informal, between DOE and its stakeholders, regulatory agencies and Tribal governments. Similarly, public information is a means to keep the public informed of progress or to status ongoing activities and/or issues. Another facet of this process is that various laws and regulations govern public participation and information when it comes to Hanford cleanup, including the Hanford Federal Facility Agreement and Consent

National Strategy for Modernizing the Regulatory System for Biotechnology Products

Science.gov (United States)

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

Review of regulatory requirements for digital I and C systems

Energy Technology Data Exchange (ETDEWEB)

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

2001-11-01

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

Review of regulatory requirements for digital I and C systems

International Nuclear Information System (INIS)

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

2001-11-01

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

A transcriptome-wide study on the microRNA- and the Argonaute 1-enriched small RNA-mediated regulatory networks involved in plant leaf senescence.

Science.gov (United States)

Qin, J; Ma, X; Yi, Z; Tang, Z; Meng, Y

2016-03-01

Leaf senescence is an important physiological process during the plant life cycle. However, systemic studies on the impact of microRNAs (miRNAs) on the expression of senescence-associated genes (SAGs) are lacking. Besides, whether other Argonaute 1 (AGO1)-enriched small RNAs (sRNAs) play regulatory roles in leaf senescence remains unclear. In this study, a total of 5,123 and 1,399 AGO1-enriched sRNAs, excluding miRNAs, were identified in Arabidopsis thaliana and rice (Oryza sativa), respectively. After retrieving SAGs from the Leaf Senescence Database, all of the AGO1-enriched sRNAs and the miRBase-registered miRNAs of these two plants were included for target identification. Supported by degradome signatures, 200 regulatory pairs involving 120 AGO1-enriched sRNAs and 40 SAGs, and 266 regulatory pairs involving 64 miRNAs and 42 SAGs were discovered in Arabidopsis. Moreover, 13 genes predicted to interact with some of the above-identified target genes at protein level were validated as regulated by 17 AGO1-enriched sRNAs and ten miRNAs in Arabidopsis. In rice, only one SAG was targeted by three AGO1-enriched sRNAs, and one SAG was targeted by miR395. However, five AGO1-enriched sRNAs were conserved between Arabidopsis and rice. Target genes conserved between the two plants were identified for three of the above five sRNAs, pointing to the conserved roles of these regulatory pairs in leaf senescence or other developmental procedures. Novel targets were discovered for three of the five AGO1-enriched sRNAs in rice, indicating species-specific functions of these sRNA-target pairs. These results could advance our understanding of the sRNA-involved molecular processes modulating leaf senescence. © 2015 German Botanical Society and The Royal Botanical Society of the Netherlands.

What is a comprehensive system of regulatory governance?

International Nuclear Information System (INIS)

Real diaz, F. J.

2011-01-01

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

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

International Nuclear Information System (INIS)

2008-01-01

policies, the regulatory framework and activities identified by the IRRS team were: Both BMU and UM BW have high quality and experienced staff, which are supported by experienced and competent technical support organizations. Both organizations have a high commitment to learning and self improvement; The team has also made recommendations and suggestions related to areas where the regulatory system as a whole could be improved. Examples include: There is room for improving information exchange and communication between the Federal and State regulatory bodies. Such enhanced communication would also lead to increased mutual trust and public confidence. In order to fulfill their regulatory responsibilities, BMU and UM BW should be staffed appropriately and develop a plan for a succession planning strategy. It could be very beneficial for the regulatory system, and helpful for worldwide learning, if all German 'Laender' (states) with nuclear power plants also took the opportunity to benefit from the experience of an IRRS mission, including making self- assessments against international best practice. The peer review consisted of an analysis of technical regulatory information, interviews, and discussions with key personnel at BMU and UM BW, as well as with regulatory inspectors at Neckarwestheim-1 Nuclear Power Plant to witness a regulatory inspection. Regulatory aspects were also discussed with Federal Minister Sigmar Gabriel and Minister Tanja Goenner of Baden-Wuerttemberg. Other organisations such as the Federal Office for Radiation Protection (BFS), the Reactor Safety Commission (RSK), the technical support organisation Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS), and the Nuclear Safety Standards Commission (ILK) were also involved. (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.

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.

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

International Nuclear Information System (INIS)

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

2004-01-01

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

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

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

NARCIS (Netherlands)

Van der Heijden, J.J.

2009-01-01

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

Regulatory Control of Radiation Sources. Safety Guide

International Nuclear Information System (INIS)

2009-01-01

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

Systemic Risk and Optimal Regulatory Architecture

NARCIS (Netherlands)

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

2011-01-01

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

Hydrogen mitigation systems - a Canadian regulatory perspective

International Nuclear Information System (INIS)

Khosla, J.K.; Rizk, M.

1997-01-01

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

Regulatory T Cells in Peripheral Blood and Cerebrospinal Fluid of Syphilis Patients with and without Neurological Involvement

Science.gov (United States)

Li, Kang; Wang, Cuini; Lu, Haikong; Gu, Xin; Guan, Zhifang; Zhou, Pingyu

2013-01-01

Background Syphilis, a sexually transmitted disease caused by spirochetal bacterium Treponema pallidum, can progress to affect the central nervous system, causing neurosyphilis. Accumulating evidence suggest that regulatory T cells (Tregs) may play an important role in the pathogenesis of syphilis. However, little is known about Treg response in neurosyphilis. Methodology/Principal Findings We analyzed Treg frequencies and Transforming Growth Factor-β (TGF-β) levels in the blood and CSF of 431 syphilis patients without neurological involvement, 100 neurosyphilis patients and 100 healthy donors. Suppressive function of Tregs in peripheral blood was also assessed. Among syphilis patients without neurological involvement, we found that secondary and serofast patients had increased Treg percentages, suppressive function and TGF-β levels in peripheral blood compared to healthy donors. Serum Rapid Plasma Reagin (RPR) titers were positively correlated with Treg numbers in these patients. Compared to these syphilis patients without neurological involvement, neurosyphilis patients had higher Treg frequency in peripheral blood. In the central nervous system, neurosyphilis patients had higher numbers of leukocytes in CSF compared to syphilis patients without neurological involvement. CD4+ T cells were the predominant cell type in the inflammatory infiltrates in CSF of neurosyphilis patients. Interestingly, among these neurosyphilis patients, a significant decrease in CSF CD4+ CD25high Treg percentage and number was observed in symptomatic neurosyphilis patients compared to those of asymptomatic neurosyphilis patients, which may be associated with low CSF TGF-β levels. Conclusions Our findings suggest that Tregs might play an important role in both bacterial persistence and neurologic compromise in the pathogenesis of syphilis. PMID:24244772

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

International Nuclear Information System (INIS)

2011-01-01

improving its regulatory activities at federal and at state level. The IRRS team observed that this high-level clarification of duties has led to improved cooperation between the Federal and Leander regulators, a noteworthy and positive change since the 2008 IRRS mission. A number of the findings identified in the 2008 report have been effectively addressed and therefore can be considered closed. However, further important steps need to be made to address recommendations and suggestion that are still open. In addition, the IRRS team noted the following strengths and improvements, examples include: The UM BW demonstrated commitment to continuous improvement as evidenced by its responsiveness to the recommendations and suggestions from the 2008 IRRS mission; The BMU has implemented a comprehensive IT knowledge management approach to support the activities of the regulatory body and its stakeholders. The availability of this up-to-date online information to all involved parties has contributed to mutual trust and shared understanding among all stakeholders; and The prompt and coordinated incident response activities of the BMU and UM BW to the Fukushima accident are commendable. The environmental radiation monitoring programme and the communication to the public and interested parties were carried out in an exemplary manner. Gustavo Caruso, the IRRS Team Coordinator said, ''Important changes have been made in the German regulatory system which resulted in the redefinition of responsibilities and roles among the federal and the states regulatory bodies and this is also contributing to a better understanding and cooperation among them.'' The mission should lead to increased governmental support for regulatory activities with a consequential strengthening of the nuclear safety regulation in the country. The IRRS team also made recommendations and suggestions to further strengthen the German regulatory system. Examples include: BMU should ensure its ability to carry out work in

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

International Nuclear Information System (INIS)

2011-01-01

Full text: An international team of senior nuclear safety experts concluded today a two-week mission to review the regulatory framework for nuclear safety in the Republic of Korea. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Korea, while the final report will be submitted by the end of summer 2011. At the request of the Korean Government, the IAEA assembled a team of 16 senior regulatory experts from 14 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Korean Ministry for Education, Science and Technology (MEST) and the Korean Institute for Nuclear Safety (KINS). The mission is a peer-review based on the IAEA Safety Standards. ''This was the first IRRS mission organized after Japan's Fukushima Daiichi nuclear accident and it included a review of the regulatory implications of that event,' explains Denis Flory, IAEA Deputy Director General and Head of the Department of Nuclear Safety and Security. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission and Team Leader of this mission commended the Korean authorities for their openness and commitment to sharing their experience with the world's nuclear safety community. ''IRRS missions such as the one that was just concluded here in the Republic of Korea are crucial to the enhancement of nuclear safety worldwide,'' he said. The IRRS team reviewed Korea's current regulatory framework while acknowledging the fact that the country's Government has already decided to establish, as of October 2011, a new independent regulatory body to be called Nuclear Safety Commission (NSC). As a consequence, KINS role will be as a regulatory expert organization reporting to the NSC, while MEST's role will be restricted to promoting the utilization of nuclear energy. The IRRS team identified particular strengths in the Korean regulatory system

In silico analysis of cis-acting regulatory elements in 5' regulatory regions of sucrose transporter gene families in rice (Oryza sativa Japonica) and Arabidopsis thaliana.

Science.gov (United States)

Ibraheem, Omodele; Botha, Christiaan E J; Bradley, Graeme

2010-12-01

The regulation of gene expression involves a multifarious regulatory system. Each gene contains a unique combination of cis-acting regulatory sequence elements in the 5' regulatory region that determines its temporal and spatial expression. Cis-acting regulatory elements are essential transcriptional gene regulatory units; they control many biological processes and stress responses. Thus a full understanding of the transcriptional gene regulation system will depend on successful functional analyses of cis-acting elements. Cis-acting regulatory elements present within the 5' regulatory region of the sucrose transporter gene families in rice (Oryza sativa Japonica cultivar-group) and Arabidopsis thaliana, were identified using a bioinformatics approach. The possible cis-acting regulatory elements were predicted by scanning 1.5kbp of 5' regulatory regions of the sucrose transporter genes translational start sites, using Plant CARE, PLACE and Genomatix Matinspector professional databases. Several cis-acting regulatory elements that are associated with plant development, plant hormonal regulation and stress response were identified, and were present in varying frequencies within the 1.5kbp of 5' regulatory region, among which are; A-box, RY, CAT, Pyrimidine-box, Sucrose-box, ABRE, ARF, ERE, GARE, Me-JA, ARE, DRE, GA-motif, GATA, GT-1, MYC, MYB, W-box, and I-box. This result reveals the probable cis-acting regulatory elements that possibly are involved in the expression and regulation of sucrose transporter gene families in rice and Arabidopsis thaliana during cellular development or environmental stress conditions. Copyright © 2010 Elsevier Ltd. All rights reserved.

RNA-Binding Proteins in Trichomonas vaginalis: Atypical Multifunctional Proteins Involved in a Posttranscriptional Iron Regulatory Mechanism

Science.gov (United States)

Figueroa-Angulo, Elisa E.; Calla-Choque, Jaeson S.; Mancilla-Olea, Maria Inocente; Arroyo, Rossana

2015-01-01

Iron homeostasis is highly regulated in vertebrates through a regulatory system mediated by RNA-protein interactions between the iron regulatory proteins (IRPs) that interact with an iron responsive element (IRE) located in certain mRNAs, dubbed the IRE-IRP regulatory system. Trichomonas vaginalis, the causal agent of trichomoniasis, presents high iron dependency to regulate its growth, metabolism, and virulence properties. Although T. vaginalis lacks IRPs or proteins with aconitase activity, possesses gene expression mechanisms of iron regulation at the transcriptional and posttranscriptional levels. However, only one gene with iron regulation at the transcriptional level has been described. Recently, our research group described an iron posttranscriptional regulatory mechanism in the T. vaginalis tvcp4 and tvcp12 cysteine proteinase mRNAs. The tvcp4 and tvcp12 mRNAs have a stem-loop structure in the 5'-coding region or in the 3'-UTR, respectively that interacts with T. vaginalis multifunctional proteins HSP70, α-Actinin, and Actin under iron starvation condition, causing translation inhibition or mRNA stabilization similar to the previously characterized IRE-IRP system in eukaryotes. Herein, we summarize recent progress and shed some light on atypical RNA-binding proteins that may participate in the iron posttranscriptional regulation in T. vaginalis. PMID:26703754

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...

USNRC regulatory guidance for engineered safety feature air cleaning systems

International Nuclear Information System (INIS)

Bellamy, R.R.

1991-01-01

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

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...

Modernizing the Regulatory System for Biotechnology Products

Science.gov (United States)

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

Integration of a complex regulatory cascade involving the SirA/BarA and Csr global regulatory systems that controls expression of the Salmonella SPI-1 and SPI-2 virulence regulons through HilD.

Science.gov (United States)

Martínez, Luary C; Yakhnin, Helen; Camacho, Martha I; Georgellis, Dimitris; Babitzke, Paul; Puente, José L; Bustamante, Víctor H

2011-06-01

Salmonella pathogenicity islands 1 and 2 (SPI-1 and SPI-2) play key roles in the pathogenesis of Salmonella enterica. Previously, we showed that when Salmonella grows in Luria-Bertani medium, HilD, encoded in SPI-1, first induces the expression of hilA, located in SPI-1, and subsequently of the ssrAB operon, located in SPI-2. These genes code for HilA and the SsrA/B two-component system, the positive regulators of the SPI-1 and SPI-2 regulons respectively. In this study, we demonstrate that CsrA, a global regulatory RNA binding protein, post-transcriptionally regulates hilD expression by directly binding near the Shine-Dalgarno and translation initiation codon sequences of the hilD mRNA, preventing its translation and leading to its accelerated turnover. Negative regulation is counteracted by the global SirA/BarA two-component system, which directly activates the expression of CsrB and CsrC, two non-coding regulatory RNAs that sequester CsrA, thereby preventing it from binding to its target mRNAs. Our results illustrate the integration of global and specific regulators into a multifactorial regulatory cascade controlling the expression of virulence genes acquired by horizontal transfer events. © 2011 Blackwell Publishing Ltd.

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

Energy Technology Data Exchange (ETDEWEB)

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

2012-05-15

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

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

International Nuclear Information System (INIS)

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

2004-01-01

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

Regulatory control analysis and design for sewer systems

DEFF Research Database (Denmark)

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

2015-01-01

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

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

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

Energy Technology Data Exchange (ETDEWEB)

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

1997-09-01

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

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

International Nuclear Information System (INIS)

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

1997-01-01

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

Accountability feedback assessments for improving efficiency of nuclear regulatory institutions

International Nuclear Information System (INIS)

Lavarenne, Jean; Shwageraus, Eugene; Weightman, Michael

2016-01-01

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

Regulatory RNAs in the Less Studied Streptococcal Species: from Nomenclature to Identification

Directory of Open Access Journals (Sweden)

Mohamed Amine Zorgani

2016-07-01

Full Text Available Streptococcal species are Gram-positive bacteria involved in severe and invasive diseases in humans and animals. Although this group includes different pathogenic species involved in life-threatening infections for humans, it also includes beneficial species, such as Streptococcus thermophilus, which is used in yogurt production. In bacteria virulence factors are controlled by various regulatory networks including regulatory RNAs. For clearness and to develop logical thinking, we start this review with a revision of regulatory RNAs nomenclature. Previous reviews are mostly dealing with Streptococcus pyogenes and Streptococcus pneumoniae regulatory RNAs. We especially focused our analysis on regulatory RNAs in Streptococcus agalactiae, Streptococcus mutans, Streptococcus thermophilus and other less studied Streptococcus species. Although S. agalactiae RNome remains largely unknown, sRNAs (small RNAs are supposed to mediate regulation during environmental adaptation and host infection. In the case of S. mutans, sRNAs are suggested to be involved in competence regulation, carbohydrate metabolism and Toxin-Antitoxin systems. A new category of miRNA-size small RNAs (msRNAs was also identified for the first time in this species. The analysis of S. thermophilus sRNome shows that many sRNAs are associated to the bacterial immune system known as CRISPR-Cas system. Only few of the other different Streptococcus species have been the subject of studies pointed toward the characterization of regulatory RNAs. Finally, understanding bacterial sRNome can constitute one step forward to the elaboration of new strategies in therapy such as substitution of antibiotics in the management of S. agalactiae neonatal infections, prevention of S. mutans dental caries or use of S. thermophilus CRISPR-Cas system in genome editing applications.

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

International Nuclear Information System (INIS)

2012-01-01

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

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

Science.gov (United States)

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

2014-12-06

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

Contribution of a fuzzy expert system to regulatory impact analysis

Directory of Open Access Journals (Sweden)

Marco Antônio da Cunha

2015-09-01

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

Development of regulatory guidance for risk-informing digital system reviews

International Nuclear Information System (INIS)

Arndt, S. A.

2006-01-01

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

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

International Nuclear Information System (INIS)

2016-01-01

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

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

International Nuclear Information System (INIS)

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

2008-01-01

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

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

International Nuclear Information System (INIS)

Tanabe, Tomoyuki; Suzuki, Tatsujiro

2003-01-01

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

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)

Infant Distress and Regulatory Behaviors Vary as a Function of Attachment Security Regardless of Emotion Context and Maternal Involvement

Science.gov (United States)

Leerkes, Esther M.; Wong, Maria S.

2012-01-01

Differences in infant distress and regulatory behaviors based on the quality of attachment to mother, emotion context (frustration versus fear), and whether or not mothers were actively involved in the emotion-eliciting tasks were examined in a sample of ninety-eight 16-month-old infants and their mothers. Dyads participated in the Strange…

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

International Nuclear Information System (INIS)

2011-01-01

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

Regulatory System of Radiation Protection in Taiwan

International Nuclear Information System (INIS)

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

2004-01-01

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

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

Science.gov (United States)

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

2016-05-01

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

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.

Nuclear knowledge management system in the regulatory activity

International Nuclear Information System (INIS)

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

2010-01-01

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

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

Science.gov (United States)

Pérez-Morales, Deyanira; Bustamante, Víctor H

2016-02-01

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

Reconstruction of the gene regulatory network involved in the sonic hedgehog pathway with a potential role in early development of the mouse brain.

Directory of Open Access Journals (Sweden)

Jinhua Liu

2014-10-01

Full Text Available The Sonic hedgehog (Shh signaling pathway is crucial for pattern formation in early central nervous system development. By systematically analyzing high-throughput in situ hybridization data of E11.5 mouse brain, we found that Shh and its receptor Ptch1 define two adjacent mutually exclusive gene expression domains: Shh+Ptch1- and Shh-Ptch1+. These two domains are associated respectively with Foxa2 and Gata3, two transcription factors that play key roles in specifying them. Gata3 ChIP-seq experiments and RNA-seq assays on Gata3-knockdown cells revealed that Gata3 up-regulates the genes that are enriched in the Shh-Ptch1+ domain. Important Gata3 targets include Slit2 and Slit3, which are involved in the process of axon guidance, as well as Slc18a1, Th and Qdpr, which are associated with neurotransmitter synthesis and release. By contrast, Foxa2 both up-regulates the genes expressed in the Shh+Ptch1- domain and down-regulates the genes characteristic of the Shh-Ptch1+ domain. From these and other data, we were able to reconstruct a gene regulatory network governing both domains. Our work provides the first genome-wide characterization of the gene regulatory network involved in the Shh pathway that underlies pattern formation in the early mouse brain.

Transcriptome landscape of Lactococcus lactis reveals many novel RNAs including a small regulatory RNA involved in carbon uptake and metabolism.

Science.gov (United States)

van der Meulen, Sjoerd B; de Jong, Anne; Kok, Jan

2016-01-01

RNA sequencing has revolutionized genome-wide transcriptome analyses, and the identification of non-coding regulatory RNAs in bacteria has thus increased concurrently. Here we reveal the transcriptome map of the lactic acid bacterial paradigm Lactococcus lactis MG1363 by employing differential RNA sequencing (dRNA-seq) and a combination of manual and automated transcriptome mining. This resulted in a high-resolution genome annotation of L. lactis and the identification of 60 cis-encoded antisense RNAs (asRNAs), 186 trans-encoded putative regulatory RNAs (sRNAs) and 134 novel small ORFs. Based on the putative targets of asRNAs, a novel classification is proposed. Several transcription factor DNA binding motifs were identified in the promoter sequences of (a)sRNAs, providing insight in the interplay between lactococcal regulatory RNAs and transcription factors. The presence and lengths of 14 putative sRNAs were experimentally confirmed by differential Northern hybridization, including the abundant RNA 6S that is differentially expressed depending on the available carbon source. For another sRNA, LLMGnc_147, functional analysis revealed that it is involved in carbon uptake and metabolism. L. lactis contains 13% leaderless mRNAs (lmRNAs) that, from an analysis of overrepresentation in GO classes, seem predominantly involved in nucleotide metabolism and DNA/RNA binding. Moreover, an A-rich sequence motif immediately following the start codon was uncovered, which could provide novel insight in the translation of lmRNAs. Altogether, this first experimental genome-wide assessment of the transcriptome landscape of L. lactis and subsequent sRNA studies provide an extensive basis for the investigation of regulatory RNAs in L. lactis and related lactococcal species.

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

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

Science.gov (United States)

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

2013-06-01

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

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

International Nuclear Information System (INIS)

Romine, D.T.

1989-01-01

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

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

International Nuclear Information System (INIS)

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

1996-01-01

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

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

Science.gov (United States)

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

2015-12-01

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

Technical Support Organization Knowledge Management for Nuclear Regulatory Support

International Nuclear Information System (INIS)

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

2016-01-01

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

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

Directory of Open Access Journals (Sweden)

Reinhold Eisner

2017-04-01

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

The regulatory and waste safety infrastructure of Bangladesh: Present status and future direction

International Nuclear Information System (INIS)

Kazi, O.A.

2001-01-01

Although nuclear energy and ionizing radiation exist as this planet earth exists, the history of human use of these energies is only a little over hundred years old. Nuclear and radiological practices are of immense benefit to society. But, like all other practices, nuclear and radiological practices also involve risks of a special type and nature. People and media are particularly sensitive to the use as well as to any accident or emergency involving the practices. Necessary laws and regulatory bodies have existed in many countries for a long time to control and keep the risks within acceptable limits. Nonetheless, accidents do occur and emergencies arise, which leads to the questioning of such regulatory systems' effectiveness. International interaction and co-operation are essential to addressing societal concerns appropriately. Bangladesh, though late, has also enacted laws and established a regulatory system to control the practices. This paper focuses on the country's regulatory status, hurdles being faced in implementing the legal requirements, and future thinking to increase effectiveness and efficiency. (author)

Preparation of safety regulatory requirements for new technology like digital system

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

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

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.

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

2012-01-01

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

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

International Nuclear Information System (INIS)

2010-01-01

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

Nuclear Regulatory Infrastructure in the Philippines

International Nuclear Information System (INIS)

Leonin, Teofilo V. Jr.

2015-01-01

Regulating the use of radioactive materials in the Philippines involves the adherence to legislation, regulations, standards and regulatory guides. It is based on a detailed review and assessment of the radiation safety program of owners and users of these materials and associated equipment against safety requirements and on additional verification of the operating practices and procedures. Republic Acts 5207 and 2067, both as amended, are implemented through the regulations which are titled Code of PNRI Regulations or CPRs are developed and issued together with supporting regulatory guides, Bulletins and other documents detailing the safety requirements. These issuance adhere to internationally accepted requirements on radiation protection, and nuclear safety and security, as well as safeguards. Design documents and technical Specifications of important radioactive materials, equipment and components are required to be submitted and reviewed by the PNRI before the issuance of an authorization in the form of a license Verification of adherence to regulations and safety requirements are periodically checked through the implementation of an inspection and enforcement program. The ISO certified regulatory management system of PNRI is documented in a QMS manual that provides guidance on all work processes. It involves systematic planning and evaluation of activities, multiple means of getting feedback on the work processes, and continuous efforts to improve its effectiveness. Efforts are implemented in order to strengthen the transparency openness, independence, technical competence and effectiveness of the regulatory body. (author)

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

Science.gov (United States)

2010-04-01

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

Chemokines involved in protection from colitis by CD4+CD25+ regulatory T cells

DEFF Research Database (Denmark)

Kristensen, Nanna Ny; Brudzewsky, Dan; Gad, Monika

2006-01-01

/chemokine receptor-specific gene expression profiling system of 67 genes, the authors have determined the expression profile of chemokine and chemokine receptor genes in the rectum of colitic mice and in mice that have been protected fromcolitis by CD4CD25 regulatory T cells. In mice protected from colitis......, the authors found down regulation of the mRNA expression of the inflammatory chemokine receptors CCR1 and CXCR3 and their ligands CXCL9, CXCL10, CCL5, and CCL7. Also the transcripts for CCR9, CCL25, CCL17, and CXCL1 are found down regulated in protected compared with colitic animals. In addition, the authors......' results suggest that CCL20 is used by CCR6 regulatory T cells in the complex process of controlling colitis because transcripts for this chemokine were expressed to a higher level in protected animals. The chemokine pathways identified in the present study may be of importance for the development of new...

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

International Nuclear Information System (INIS)

Izquierdo, J.M.

1979-01-01

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

[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.

Risk undermined in the bilateral pharmaceutical regulatory system in Taiwan.

Science.gov (United States)

Wang, Hui-Po; Wang, Chun-Li

2018-04-01

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

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)

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

Directory of Open Access Journals (Sweden)

Lan Chung-Yu

2008-09-01

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

The regulatory system for diabetes mellitus: Modeling rates of glucose infusions and insulin injections

Science.gov (United States)

Yang, Jin; Tang, Sanyi; Cheke, Robert A.

2016-08-01

Novel mathematical models with open and closed-loop control for type 1 or type 2 diabetes mellitus were developed to improve understanding of the glucose-insulin regulatory system. A hybrid impulsive glucose-insulin model with different frequencies of glucose infusions and insulin injections was analyzed, and the existence and uniqueness of the positive periodic solution for type 1 diabetes, which is globally asymptotically stable, was studied analytically. Moreover, permanence of the system for type 2 diabetes was demonstrated which showed that the glucose concentration level is uniformly bounded above and below. To investigate how to prevent hyperinsulinemia and hyperglycemia being caused by this system, we developed a model involving periodic intakes of glucose with insulin injections applied only when the blood glucose level reached a given critical glucose threshold. In addition, our numerical analysis revealed that the period, the frequency and the dose of glucose infusions and insulin injections are crucial for insulin therapies, and the results provide clinical strategies for insulin-administration practices.

Security of material: Preventing criminal activities involving nuclear and other radioactive materials

International Nuclear Information System (INIS)

Nilsson, A.

2001-01-01

The report emphasizes the need for national regulatory authorities to include in the regulatory systems, measures to control and protect nuclear materials from being used in illegal activities, as well as aspects of relevance for detecting and responding to illegal activities involving nuclear and other radioactive materials. The report will give an overview of the international treaties and agreements that underpin the establishment of a regulatory structure necessary for States to meet their non-proliferation policy and undertakings. Ongoing work to strengthen the protection of nuclear material and to detect and respond to illegal activities involving nuclear and other radioactive material will be included. The focus of the paper is on the need for standards and national regulation in the nuclear security area. (author)

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

Science.gov (United States)

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

2010-12-01

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

Regulatory T-cells and autoimmunity.

LENUS (Irish Health Repository)

Ni Choileain, Niamh

2012-02-03

Approximately 20% of the population is affected by autoimmune or inflammatory diseases mediated by an abnormal immune response. A characteristic feature of autoimmune disease is the selective targeting of a single cell type, organ or tissue by certain populations of autoreactive T-cells. Examples of such diseases include rheumatoid arthritis, insulin-dependent diabetes mellitus, and systemic lupus erythematosus (SLE), all of which are characterized by chronic inflammation, tissue destruction and target organ malfunction. Although strong evidence links most autoimmune diseases to specific genes, considerable controversy prevails regarding the role of regulatory T-cell populations in the disease process. These cells are now also believed to play a key role in mediating transplantation tolerance and inhibiting the induction of tumor immunity. Though the concept of therapeutic immune regulation aimed at treating autoimmune pathology has been validated in many animal models, the development of strategies for the treatment of human autoimmune disorders remains in its infancy. The main obstacles to this include the conflicting findings of different model systems, as well as the contrasting functions of regulatory T-cells and cytokines involved in the development of such disorders. This review examines the role of regulatory T-cells in the pathogenesis of autoimmunity and describes the therapeutic potential of these cells for the prevention of immune-mediated pathologies in the future. Although much remains to be learned about such pathologies, a clearer understanding of the mechanisms by which regulatory T-cells function will undoubtedly lead to exciting new possibilities for immunotherapeutics.

Improvement of the regulatory system by implementation new safety demands

International Nuclear Information System (INIS)

Iglesias, R.; Alfonso, C.

1996-01-01

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

Transportation of radioactive materials: the legislative and regulatory information system

International Nuclear Information System (INIS)

Fore, C.S.

1982-03-01

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

Transportation of radioactive materials: the legislative and regulatory information system

Energy Technology Data Exchange (ETDEWEB)

Fore, C.S.

1982-03-01

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

Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

International Nuclear Information System (INIS)

Illizastigui, P.F.

2016-01-01

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

Regulatory inspection of nuclear power plants in NEA member countries

International Nuclear Information System (INIS)

Gronow, W.S.; Ilani, O.

1977-01-01

The increasing use of nuclear power and public interest in the safety controls led to the proposal by the sub-Committe on Licensing of the NEA Committee on the Safety of Nuclear Installations for a specialist meeting on regulatory inspection practices. This report which was prepared at the request of the sub-Committee to assist in the exchange of views and experience at the meeting reviews the response to a questionnaire on the systems employed, the scope and objectives and the effort involved in regulatory inspection throughout all stages of the life of a nuclear power plant. Other aspects of regulatory inspection activities are discussed including documentation, procedures for changes in technical specification and modifications to plant, powers and duties of regulatory inspection personnel and actions to be taken in the event of an accident or emergency. The report concludes with some comments on those aspects of regulatory inspection practices where further information and an exchange of experience might prove to be beneficial to Member countries. (author)

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

OpenAIRE

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

2010-01-01

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

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...

Involvement of the iron regulatory protein from Eisenia andrei earthworms in the regulation of cellular iron homeostasis.

Directory of Open Access Journals (Sweden)

Petra Procházková

Full Text Available Iron homeostasis in cells is regulated by iron regulatory proteins (IRPs that exist in different organisms. IRPs are cytosolic proteins that bind to iron-responsive elements (IREs of the 5'- or 3'-untranslated regions (UTR of mRNAs that encode many proteins involved in iron metabolism. In this study, we have cloned and described a new regulatory protein belonging to the family of IRPs from the earthworm Eisenia andrei (EaIRP. The earthworm IRE site in 5'-UTR of ferritin mRNA most likely folds into a secondary structure that differs from the conventional IRE structures of ferritin due to the absence of a typically unpaired cytosine that participates in protein binding. Prepared recombinant EaIRP and proteins from mammalian liver extracts are able to bind both mammalian and Eisenia IRE structures of ferritin mRNA, although the affinity of the rEaIRP/Eisenia IRE structure is rather low. This result suggests the possible contribution of a conventional IRE structure. When IRP is supplemented with a Fe-S cluster, it can function as a cytosolic aconitase. Cellular cytosolic and mitochondrial fractions, as well as recombinant EaIRP, exhibit aconitase activity that can be abolished by the action of oxygen radicals. The highest expression of EaIRP was detected in parts of the digestive tract. We can assume that earthworms may possess an IRE/IRP regulatory network as a potential mechanism for maintaining cellular iron homeostasis, although the aconitase function of EaIRP is most likely more relevant.

Involvement of the Iron Regulatory Protein from Eisenia andrei Earthworms in the Regulation of Cellular Iron Homeostasis

Science.gov (United States)

Procházková, Petra; Škanta, František; Roubalová, Radka; Šilerová, Marcela; Dvořák, Jiří; Bilej, Martin

2014-01-01

Iron homeostasis in cells is regulated by iron regulatory proteins (IRPs) that exist in different organisms. IRPs are cytosolic proteins that bind to iron-responsive elements (IREs) of the 5′- or 3′-untranslated regions (UTR) of mRNAs that encode many proteins involved in iron metabolism. In this study, we have cloned and described a new regulatory protein belonging to the family of IRPs from the earthworm Eisenia andrei (EaIRP). The earthworm IRE site in 5′-UTR of ferritin mRNA most likely folds into a secondary structure that differs from the conventional IRE structures of ferritin due to the absence of a typically unpaired cytosine that participates in protein binding. Prepared recombinant EaIRP and proteins from mammalian liver extracts are able to bind both mammalian and Eisenia IRE structures of ferritin mRNA, although the affinity of the rEaIRP/Eisenia IRE structure is rather low. This result suggests the possible contribution of a conventional IRE structure. When IRP is supplemented with a Fe-S cluster, it can function as a cytosolic aconitase. Cellular cytosolic and mitochondrial fractions, as well as recombinant EaIRP, exhibit aconitase activity that can be abolished by the action of oxygen radicals. The highest expression of EaIRP was detected in parts of the digestive tract. We can assume that earthworms may possess an IRE/IRP regulatory network as a potential mechanism for maintaining cellular iron homeostasis, although the aconitase function of EaIRP is most likely more relevant. PMID:25279857

Quorum Sensing: A Transcriptional Regulatory System Involved in the Pathogenicity of Burkholderia mallei

National Research Council Canada - National Science Library

Ulrich, Ricky L; DeShazer, David; Hines, Harry B; Jeddeloh, Jeffrey A

2004-01-01

.... To determine if QS is involved in the virulence of B. mallei, we generated mutations in each putative luxIR homologue and tested the pathogenicities of the derivative strains in aerosol BALB/c mouse and intraperitoneal hamster models...

Quorum Sensing: A transcriptional Regulatory System Involved in the Pathogenicity of Burkholderia mallei

National Research Council Canada - National Science Library

Ulrich, Ricky

2004-01-01

.... To determine if QS is involved in the virulence of B. mallei, we generated mutations in each putative luxIR homologue and tested the pathogenicities of the derivative strains in aerosol BALB/c mouse and intraperitoneal hamster models...

Through the regulatory hoop

International Nuclear Information System (INIS)

Kirner, N.P.

1985-01-01

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

ENSI’s regulatory framework strategy

International Nuclear Information System (INIS)

2015-03-01

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

Facing regulatory challenges of on-line hemodiafiltration.

Science.gov (United States)

Kümmerle, Wolfgang

2011-01-01

On-line hemodiafiltration (on-line HDF) is the result of a vision that triggered multifarious changes in very different areas. Driven by the idea to offer better medical treatment for renal patients, technological innovations were developed and established that also constituted new challenges in the field of regulatory affairs. The existing regulations predominantly addressed the quality and safety of those products needed to perform dialysis treatment which were supplied by industrial manufacturers. However, the complexity of treatment system required for the provision of on-line fluids demanded a holistic approach encompassing all components involved. Hence, focus was placed not only on single products, but much more on their interfacing, and the clinical infrastructure, in particular, had to undergo substantial changes. The overall understanding of the interaction between such factors, quite different in their nature, was crucial to overcome the arising regulatory obstacles. This essay describes the evolution of the on-line HDF procedure from the regulatory point of view. A simplified diagram demonstrates the path taken from the former regulatory understanding to the realization of necessary changes. That achievement was only possible through 'management of preview' and consequent promotion of technical and medical innovations as well as regulatory re-evaluations. Copyright © 2011 S. Karger AG, Basel.

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.

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

Ito, Juichiro; Takita, Masami

2011-01-01

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

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

International Nuclear Information System (INIS)

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

2002-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2006-07-01

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

Toxin-antitoxin systems and regulatory mechanisms in Mycobacterium tuberculosis.

Science.gov (United States)

Slayden, Richard A; Dawson, Clinton C; Cummings, Jason E

2018-06-01

There has been a significant reduction in annual tuberculosis incidence since the World Health Organization declared tuberculosis a global health threat. However, treatment of M. tuberculosis infections requires lengthy multidrug therapeutic regimens to achieve a durable cure. The development of new drugs that are active against resistant strains and phenotypically diverse organisms continues to present the greatest challenge in the future. Numerous phylogenomic analyses have revealed that the Mtb genome encodes a significantly expanded repertoire of toxin-antitoxin (TA) loci that makes up the Mtb TA system. A TA loci is a two-gene operon encoding a 'toxin' protein that inhibits bacterial growth and an interacting 'antitoxin' partner that neutralizes the inhibitory activity of the toxin. The presence of multiple chromosomally encoded TA loci in Mtb raises important questions in regard to expansion, regulation and function. Thus, the functional roles of TA loci in Mtb pathogenesis have received considerable attention over the last decade. The cumulative results indicate that they are involved in regulating adaptive responses to stresses associated with the host environment and drug treatment. Here we review the TA families encoded in Mtb, discuss the duplication of TA loci in Mtb, regulatory mechanism of TA loci, and phenotypic heterogeneity and pathogenesis.

Plant-based oral tolerance to hemophilia therapy employs a complex immune regulatory response including LAP+CD4+ T cells

OpenAIRE

Wang, Xiaomei; Su, Jin; Sherman, Alexandra; Rogers, Geoffrey L.; Liao, Gongxian; Hoffman, Brad E.; Leong, Kam W.; Terhorst, Cox; Daniell, Henry; Herzog, Roland W.

2015-01-01

Coadministering FIX orally and systemically induces tolerance via complex immune regulation, involving tolerogenic dendritic and T-cell subsets.Induced CD4+CD25−LAP+ regulatory T cells with increased IL-10 and TGF-β expression and CD4+CD25+ regulatory T cells suppress antibody formation against FIX.

Predictors of justice system involvement: Maltreatment and education.

Science.gov (United States)

Robertson, Angela A; Walker, Courtney S

2018-02-01

Decades of research have established that experience of abuse and/or neglect in childhood is related to negative outcomes, such as juvenile delinquency. Existing research has shown that involvement in child welfare services is also related to juvenile delinquency, particularly for children who are victims of neglect. Research has also identified educational factors such as chronic absenteeism as significant predictors of involvement in the juvenile justice system. However, little research has investigated the combined influence of educational factors, child abuse, and involvement in child protective services on justice system involvement. The current study examined the influence of educational factors and involvement in child protective services on justice system involvement. The study utilized records from an educational database of children who attended a school within a county of Mississippi in any year from 2003 through 2013. Cases were then matched with records from the county Youth Court, Law Enforcement agencies, and Child Protection Services. A multivariate logistic regression controlling for gender, race, current age, and time at risk was conducted to involvement in the justice system. In general, educational factors were stronger predictors of justice system involvement than allegations of maltreatment. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Regulatory Inspection of Nuclear Power Plants in NEA Member Countries

International Nuclear Information System (INIS)

1978-01-01

Based on the replies to a questionnaire, this report gives a description and comparative evaluation of the regulatory inspection activities in several NEA Member countries. The questionnaire which was circulated to all Member countries requested details on the organisation, system, scope and objectives of nuclear regulatory inspection and the effort required throughout all stages of the life of a nuclear plant including the use of independent bodies or consultants. Additional information was requested on the documentation concerned with regulatory inspections, incident and accident reporting procedures, and the duties, powers and bases for recruitment of regulatory personnel with the object of covering all related aspects. However, because of the differences in national practices and perhaps in the interpretation of the questionnaire, it proved to be extremely difficult to make an evaluation and comparison of inspection activities and effort involved in these Member countries. This report, which includes a section on the nuclear power programme in Member countries, should therefore only be regarded as an initial review but it provides a useful contribution to the exchange of experience and views on regulatory inspection practices

Learning from nuclear regulatory self-assessment. International peer review of the CSN report on lessons learnt from the essential service water system degradation event at the Vandellos nuclear power plant

International Nuclear Information System (INIS)

2006-01-01

Nuclear regulatory self-assessment together with the benchmarking of regulatory practices against those of other countries operating nuclear power plants are key elements in maintaining a high level of nuclear safety. In that light, the Spanish Consejo de Seguridad Nuclear (CSN) formally asked the OECD Nuclear Energy Agency (NEA) to establish an international peer review team to assess the CSN report on the lessons learnt as a result of the 2004 Vandellos II event involving essential service water system degradation. The International Review Team considers the CSN report prepared in follow-up to the Vandellos event to be a commendable effort in regulatory self-assessment. The report, complemented by this international peer review, should enable the CSN to take appropriate action to ensure that its regulatory supervision is in line with best international practice. (authors)

Factors associated with regulatory action involving investigation of illnesses associated with Shiga toxin-producing Escherichia coli in products regulated by the Food Safety and Inspection Service.

Science.gov (United States)

Green, Alice L; Seys, Scott; Douris, Aphrodite; Levine, Jeoff; Robertson, Kis

2014-07-01

We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information.

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

Science.gov (United States)

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

2015-09-01

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

microRNA involvement in developmental and functional aspects of the nervous system and in neurological diseases

DEFF Research Database (Denmark)

Christensen, Mette; Schratt, Gerhard M

2009-01-01

microRNAs, small non-coding RNAs that regulate gene expression at the post-transcriptional level, are emerging as important regulatory molecules involved in the fine-tuning of gene expression during neuronal development and function. microRNAs have roles during neuronal stem cell commitment...... and early differentiation as well as in later stages of neuronal development, such as dendritogenesis and synaptic plasticity. A link between microRNAs and neurological diseases, such as neurodegeneration or synaptic dysfunction, is becoming increasingly clear. This review summarizes the current knowledge...... of the function of microRNAs in the developing and adult nervous system and their potential contribution to the etiology of neurological diseases....

Nuclear Regulatory Systems in Africa: Improving Safety and Security Culture Through Education and Training

International Nuclear Information System (INIS)

Kazadi Kabuya, F.

2016-01-01

The purpose of this paper is to address the important issue of supporting safety and security culture through an educational and training course program designed both for regulatory staff and licensees. Enhancing the safety and security of nuclear facilities may involve assessing the overall effectiveness of the organization's safety culture. Safety Culture implies steps such as identifying and targeting areas requiring attention, putting emphasis on organizational strengths and weaknesses, human attitudes and behaviours that may positively impact an organization's safety culture, resulting in improving workplace safety and developing and maintaining a high level of awareness within these facilities. Following the terrorist attacks of September 11, 2001, international efforts were made towards achieving such goals. This was realized through meetings, summits and training courses events, with main aim to enhance security at facilities whose activities, if attacked, could impact public health and safety. During regulatory oversight inspections undertaken on some licensee's premises, violations of security requirements were identified. They mostly involved inadequate management oversight of security, lack of a questioning attitude, complacency and mostly inadequate training in both security and safety issues. Using training and education approach as a support to raise awareness on safety and security issues in the framework of improving safety and security culture, a tentative training program in nuclear and radiological safety was started in 2002 with the main aim of vulgarizing the regulatory framework. Real first needs for a training course program were identified among radiographers and radiologists with established working experience but with limited knowledge in radiation safety. In the field of industrial uses of radiation the triggering events for introducing and implementing a training program were: the loss of a radioactive source in a mining

A genomic approach to identify regulatory nodes in the transcriptional network of systemic acquired resistance in plants.

Directory of Open Access Journals (Sweden)

Dong Wang

2006-11-01

Full Text Available Many biological processes are controlled by intricate networks of transcriptional regulators. With the development of microarray technology, transcriptional changes can be examined at the whole-genome level. However, such analysis often lacks information on the hierarchical relationship between components of a given system. Systemic acquired resistance (SAR is an inducible plant defense response involving a cascade of transcriptional events induced by salicylic acid through the transcription cofactor NPR1. To identify additional regulatory nodes in the SAR network, we performed microarray analysis on Arabidopsis plants expressing the NPR1-GR (glucocorticoid receptor fusion protein. Since nuclear translocation of NPR1-GR requires dexamethasone, we were able to control NPR1-dependent transcription and identify direct transcriptional targets of NPR1. We show that NPR1 directly upregulates the expression of eight WRKY transcription factor genes. This large family of 74 transcription factors has been implicated in various defense responses, but no specific WRKY factor has been placed in the SAR network. Identification of NPR1-regulated WRKY factors allowed us to perform in-depth genetic analysis on a small number of WRKY factors and test well-defined phenotypes of single and double mutants associated with NPR1. Among these WRKY factors we found both positive and negative regulators of SAR. This genomics-directed approach unambiguously positioned five WRKY factors in the complex transcriptional regulatory network of SAR. Our work not only discovered new transcription regulatory components in the signaling network of SAR but also demonstrated that functional studies of large gene families have to take into consideration sequence similarity as well as the expression patterns of the candidates.

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

Directory of Open Access Journals (Sweden)

Lawrie Savage

2015-09-01

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

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

Directory of Open Access Journals (Sweden)

Lawrie Savage

2014-05-01

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

Two negative regulatory systems of root nodule symbiosis - how are symbiotic benefits and costs balanced?

Science.gov (United States)

Nishida, Hanna; Suzaki, Takuya

2018-05-30

Root nodule symbiosis is one of the best-characterized mutualistic relationships between plants-microbes symbiosis, where mainly leguminous species can obtain nitrogen sources fixed by nitrogen-fixing rhizobia through the formation of symbiotic organs root nodules. In order to drive this symbiotic process, plants need to provide carbon sources that should be used for their growth. Therefore, a balance between the benefits of obtaining nitrogen sources and the costs of losing carbon sources needs to be maintained during root nodule symbiosis. Plants have developed at least two negative regulatory systems of root nodule symbiosis. One strategy involves the regulation of nodule number in response to rhizobial infection. For this regulation, a systemic long-range signaling between roots and shoots called autoregulation of nodulation has a pivotal role. Another strategy involves the regulation of root nodule symbiosis in response to nitrate, the most abundant form of nitrogen nutrients in the soil. Recent studies indicate that a long-distance signaling is shared between the two strategies, where NIN and NRSYM1, two paralogous RWP-RK transcription factors, can activate the production of nodulation-related CLE peptides in response to different inputs. Here, we give an overview of such progress in our understanding of molecular mechanisms relevant to the control of the symbiotic balance, including their biological significance.

Legitimacy challenges of intermediary gatekeeping in the Chinese internet regulatory system

NARCIS (Netherlands)

Wei, Lulu

2018-01-01

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

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

International Nuclear Information System (INIS)

Bergren, C.L.

1992-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

1995-09-01

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

Regulatory issues on using programmable logic device in nuclear power plants

International Nuclear Information System (INIS)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H.

2012-01-01

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards

Regulatory issues on using programmable logic device in nuclear power plants

Energy Technology Data Exchange (ETDEWEB)

Park, G. Y.; Yu, Y. J.; Kim, H. T.; Kwon, Y. I.; Park, H. S.; Jeong, C. H. [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2012-10-15

For replacing obsolete analog equipment in nuclear power plant, the Programmable Logic Devices (PLDs) using Hardware Description Language (HDL) have been widely adopted in digitalized Instrumentation and Control (I and C) systems because of its flexibility. For safety reviews on Nuclear Power Plants (NPPs,) qualifying digitalized safety I and C system using PLDs is an important issue. As an effort to provide regulatory position on using PLDs in safety I and C system, there is a research project to provide the regulatory positions against emerging issues involved with digitalisation of I and C system including using PLDs. Therefore, this paper addresses the important considerations for using PLDs in safety I and C systems such as diversity, independence and qualification, etc. In this point, this study focuses on technical reports for Field Programmable Gate Array (FPGA) from EPRI,. U.S. NRC, and relevant technical standards.

Managing Regulatory Body Competence

International Nuclear Information System (INIS)

2013-01-01

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

Nuclear regulatory decision making

International Nuclear Information System (INIS)

Wieland, Patricia; Almeida, Ivan Pedro Salati de

2011-01-01

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

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

Science.gov (United States)

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

2010-05-18

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

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

International Nuclear Information System (INIS)

Stade, R.E.

1978-01-01

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

Regulatory systems for the control of land remediation processes

Energy Technology Data Exchange (ETDEWEB)

Lowe, J.; Vijgen, J.; Summersgill, M.

2003-07-01

One of the recurring themes in looking at land remediation over the last decade has been identifying and overcoming barriers to the use of innovative, sustainable technologies, whilst still ensuring that there are no adverse environmental impacts from their use. In parallel with this, the regeneration of brownfield sites has increasingly needed effective and economic solutions that leave the site without the stigma of being associated with contamination and waste disposal. Regulatory controls are often identified as one of the main barriers to both of these objectives. Previously, the focus of attention in the study of regulatory controls relating to land contamination has largely been on regimes that trigger the need for clean-up. These may be pollution control legislation or land-use planning controls. However, the focus of this paper will be on the controls on the selection and implementation of the remediation technologies and processes themselves. It will look in particular at the European-wide controls on waste management, pollution prevention and environmental impact assessment. The UK work is being carried out by a working group involving: landowners; developers; public sector regeneration agencies; house-builders; industry; insurers; technology providers; professional advisers; local government authorities; and national government regulators and policy-makers. This multi-stakeholder approach has facilitated the identification of practical, legal, financial and administrative issues to assist in developing new solutions. (orig.)

[Central nervous system involvement in systemic lupus erythematosus - diagnosis and therapy].

Science.gov (United States)

Szmyrka, Magdalena

Nervous system involvement in lupus belongs to its severe complications and significantly impacts its prognosis. Neuropsychiatric lupus includes 19 disease manifestations concerning both central and peripheral nervous system. This paper presents clinical aspects of central nervous system involvement in lupus. It reviews its epidemiology, risk factors and principles of diagnosis and therapy.

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

Energy Technology Data Exchange (ETDEWEB)

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

2014-05-01

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

Sequence-based model of gap gene regulatory network.

Science.gov (United States)

Kozlov, Konstantin; Gursky, Vitaly; Kulakovskiy, Ivan; Samsonova, Maria

2014-01-01

The detailed analysis of transcriptional regulation is crucially important for understanding biological processes. The gap gene network in Drosophila attracts large interest among researches studying mechanisms of transcriptional regulation. It implements the most upstream regulatory layer of the segmentation gene network. The knowledge of molecular mechanisms involved in gap gene regulation is far less complete than that of genetics of the system. Mathematical modeling goes beyond insights gained by genetics and molecular approaches. It allows us to reconstruct wild-type gene expression patterns in silico, infer underlying regulatory mechanism and prove its sufficiency. We developed a new model that provides a dynamical description of gap gene regulatory systems, using detailed DNA-based information, as well as spatial transcription factor concentration data at varying time points. We showed that this model correctly reproduces gap gene expression patterns in wild type embryos and is able to predict gap expression patterns in Kr mutants and four reporter constructs. We used four-fold cross validation test and fitting to random dataset to validate the model and proof its sufficiency in data description. The identifiability analysis showed that most model parameters are well identifiable. We reconstructed the gap gene network topology and studied the impact of individual transcription factor binding sites on the model output. We measured this impact by calculating the site regulatory weight as a normalized difference between the residual sum of squares error for the set of all annotated sites and for the set with the site of interest excluded. The reconstructed topology of the gap gene network is in agreement with previous modeling results and data from literature. We showed that 1) the regulatory weights of transcription factor binding sites show very weak correlation with their PWM score; 2) sites with low regulatory weight are important for the model output; 3

A novel processing system of sterol regulatory element-binding protein-1c regulated by polyunsaturated fatty acid.

Science.gov (United States)

Nakakuki, Masanori; Kawano, Hiroyuki; Notsu, Tatsuto; Imada, Kazunori; Mizuguchi, Kiyoshi; Shimano, Hitoshi

2014-05-01

The proteolytic cascade is the key step in transactivation of sterol regulatory element-binding proteins (SREBPs), a transcriptional factor of lipid synthesis. Proteolysis of SREBP-2 is strictly regulated by sterols, but that of SREBP-1c was not strongly sterol-regulated, but inhibited by polyunsaturated fatty acids (PUFAs). In this study, the proteolytic processing of SREBP-1 and -2 was examined by transfection studies of cDNA-encoding mutants in which all the known cleavage sites were disrupted. In cultured cells, sterol-regulated SREBP-2 processing was completely eliminated by mutation of cleavage sites. In contrast, the corresponding SREBP-1c mutants as well as wild type exhibited large amounts of cleaved products in the nuclear extracts from culture cells and murine liver in vivo. The nuclear form of the mutant SREBP-1c was induced by delipidated condition and suppressed by eicosapentaenoic acid, an n-3 PUFA, but not by sterols. This novel processing mechanism was affected by neither SREBP cleavage-activating protein (SCAP) nor insulin-induced gene (Insig)-1, unlike SREBP-2, but abolished by a serine protease inhibitor. Through analysis of deletion mutant, a site-2 protease recognition sequence (DRSR) was identified to be involved in this novel processing. These findings suggest that SREBP-1c cleavage could be subjected to a novel PUFA-regulated cleavage system in addition to the sterol-regulatory SCAP/Insig system.

In silico transcriptional regulatory networks involved in tomato fruit ripening

Directory of Open Access Journals (Sweden)

Stilianos Arhondakis

2016-08-01

Full Text Available ABSTRACTTomato fruit ripening is a complex developmental programme partly mediated by transcriptional regulatory networks. Several transcription factors (TFs which are members of gene families such as MADS-box and ERF were shown to play a significant role in ripening through interconnections into an intricate network. The accumulation of large datasets of expression profiles corresponding to different stages of tomato fruit ripening and the availability of bioinformatics tools for their analysis provide an opportunity to identify TFs which might regulate gene clusters with similar co-expression patterns. We identified two TFs, a SlWRKY22-like and a SlER24 transcriptional activator which were shown to regulate modules by using the LeMoNe algorithm for the analysis of our microarray datasets representing four stages of fruit ripening, breaker, turning, pink and red ripe. The WRKY22-like module comprised a subgroup of six various calcium sensing transcripts with similar to the TF expression patterns according to real time PCR validation. A promoter motif search identified a cis acting element, the W-box, recognized by WRKY TFs that was present in the promoter region of all six calcium sensing genes. Moreover, publicly available microarray datasets of similar ripening stages were also analyzed with LeMoNe resulting in TFs such as SlERF.E1, SlERF.C1, SlERF.B2, SLERF.A2, SlWRKY24, SLWRKY37 and MADS-box/TM29 which might also play an important role in regulation of ripening. These results suggest that the SlWRKY22-like might be involved in the coordinated regulation of expression of the six calcium sensing genes. Conclusively the LeMoNe tool might lead to the identification of putative TF targets for further physiological analysis as regulators of tomato fruit ripening.

Selected legal and regulatory concerns affecting domestic energy transportation systems

International Nuclear Information System (INIS)

Schuller, C.R.

1979-07-01

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

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)

The regulatory infrastructure for radiation protection, the safety of radiation sources and security of radioactive materials in Ethiopia

International Nuclear Information System (INIS)

Gebeyehu Wolde, G.

2003-01-01

The application of Nuclear Techniques in Ethiopia started in the early sixties in the medical field and through time has gradually expanded to other areas. Following this growth the practice of Radiation Protection in Ethiopia dates back over 15 years. Radiation Protection Legislation 79/1993 was promulgated in December 1993, which has established an Autonomous Regulatory Authority to control and supervise the introduction and conduct of any practice involving ionizing radiation. Since 1998 the National Radiation Protection Authority has made a remarkable progress in terms of building a National Radiation Protection Infrastructure and is in a full swing transformation process towards a dynamic credible and competent regulatory Authority. The regulatory activities are designed in line with the main regulatory instruments, Notification, Authorization, Inspection and Enforcement. NRPA has a national inventory system and fully implemented the Regulatory Authority Information System (RAIS), which provides a systemic integration and will be instrumental to enhance the effectiveness of the regulatory system. A substantial progress has been made in the development and provision of support and technical services in the areas of Metrology and Calibration Services, Instrument Maintenance Service, Individual Monitoring of Personnel, Environmental and Food Monitoring and Interim Storage Facility for spent sources. Development of a national system for emergency preparedness and response is the current top agenda of NRPA. Towards ensuring an effective radiation protection and regulatory programme, NRPA is also making a proactive involvement in, expanding its outreach, information dissemination, awareness promotion and development of key human resources. In the last four years Ethiopia has been actively co-operating with IAEA in the framework of the Regional Model Projects RAF/9/024, RAF/9/028 and RAF/9/029. The inputs received through the project framework coupled with the

Legal and regulatory issues affecting compressed air energy storage

Energy Technology Data Exchange (ETDEWEB)

Hendrickson, P.L.

1981-07-01

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

Boundaries of regulatory fit: Is it the thought that counts?

DEFF Research Database (Denmark)

Leikas, S.; Lindeman, M.; Roininen, K.

2009-01-01

The feeling of regulatory fit is thought to arise from the right kind of goal pursuit, but some studies imply that it may be evoked even by lesser involvement in the right kind of strategies. The present experiment explored the minimum of involvement necessary to evoke regulatory fit. Participants...... the same information. Participants in promotion focus reported more positive attitudes in the rich information condition, whereas prevention-focused participants reported more positive attitudes in the accurate information condition. The results showed that regulatory fit can be evoked through mere thought...

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

Energy Technology Data Exchange (ETDEWEB)

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

2002-10-01

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

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

International Nuclear Information System (INIS)

2009-01-01

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

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

International Nuclear Information System (INIS)

Pelin, H.

2016-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

Real diaz, F. J.

2011-07-01

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

KH-type splicing regulatory protein is involved in esophageal squamous cell carcinoma progression.

Science.gov (United States)

Fujita, Yuji; Masuda, Kiyoshi; Hamada, Junichi; Shoda, Katsutoshi; Naruto, Takuya; Hamada, Satoshi; Miyakami, Yuko; Kohmoto, Tomohiro; Watanabe, Miki; Takahashi, Rizu; Tange, Shoichiro; Saito, Masako; Kudo, Yasusei; Fujiwara, Hitoshi; Ichikawa, Daisuke; Tangoku, Akira; Otsuji, Eigo; Imoto, Issei

2017-11-24

KH-type splicing regulatory protein (KHSRP) is a multifunctional RNA-binding protein, which is involved in several post-transcriptional aspects of RNA metabolism, including microRNA (miRNA) biogenesis. It affects distinct cell functions in different tissues and can have an impact on various pathological conditions. In the present study, we investigated the oncogenic functions of KHSRP and their underlying mechanisms in the pathogenesis of esophageal squamous cell carcinoma (ESCC). KHSRP expression levels were elevated in ESCC tumors when compared with those in non-tumorous tissues by immunohistochemistry, and cytoplasmic KHSRP overexpression was found to be an independent prognosticator for worse overall survival in a cohort of 104 patients with ESCC. KHSRP knockdown inhibited growth, migration, and invasion of ESCC cells. KHSRP knockdown also inhibited the maturation of cancer-associated miRNAs, such as miR-21, miR-130b, and miR-301, and induced the expression of their target mRNAs, such as BMP6, PDCD4, and TIMP3, resulting in the inhibition of epithelial-to-mesenchymal transition. Our findings uncover a novel oncogenic function of KHSRP in esophageal tumorigenesis and implicate its use as a marker for prognostic evaluation and as a putative therapeutic target in ESCC.

Identifying Cis-Regulatory Changes Involved in the Evolution of Aerobic Fermentation in Yeasts

Science.gov (United States)

Lin, Zhenguo; Wang, Tzi-Yuan; Tsai, Bing-Shi; Wu, Fang-Ting; Yu, Fu-Jung; Tseng, Yu-Jung; Sung, Huang-Mo; Li, Wen-Hsiung

2013-01-01

Gene regulation change has long been recognized as an important mechanism for phenotypic evolution. We used the evolution of yeast aerobic fermentation as a model to explore how gene regulation has evolved and how this process has contributed to phenotypic evolution and adaptation. Most eukaryotes fully oxidize glucose to CO2 and H2O in mitochondria to maximize energy yield, whereas some yeasts, such as Saccharomyces cerevisiae and its relatives, predominantly ferment glucose into ethanol even in the presence of oxygen, a phenomenon known as aerobic fermentation. We examined the genome-wide gene expression levels among 12 different yeasts and found that a group of genes involved in the mitochondrial respiration process showed the largest reduction in gene expression level during the evolution of aerobic fermentation. Our analysis revealed that the downregulation of these genes was significantly associated with massive loss of binding motifs of Cbf1p in the fermentative yeasts. Our experimental assays confirmed the binding of Cbf1p to the predicted motif and the activator role of Cbf1p. In summary, our study laid a foundation to unravel the long-time mystery about the genetic basis of evolution of aerobic fermentation, providing new insights into understanding the role of cis-regulatory changes in phenotypic evolution. PMID:23650209

Regulatory control of radiation sources in the Philippines

Energy Technology Data Exchange (ETDEWEB)

Daroy, Rosita R

1996-12-31

This paper is concerned with the radiation protection and safety infrastructure providing emphasis on the regulation and control of radiation sources in the Philippines. It deals with the experiences of the Philippine Nuclear Research Institute, as a regulatory body, in the regulation and control of radioactive materials in radiotherapy, nuclear medicine, industrial radiography, industrial gauges, industrial irradiators, and well logging. This paper includes an inventory of the sources and types of devices/equipment used by licensed users of radioactive materials in the Philippines as a contribution to the data base being prepared by the IAEA. The problems encountered by the regulatory body in the licensing and enforcement process, as well as the lessons learned from incidents involving radioactive materials are discussed. Plans for improving compliance to the regulations and enhancing the effectiveness of PNRI`s regulatory functions are presented. (author). Paper presented during the IAEA Regional (RCA) Workshop on System of Notification, Registration, Licensing, and Control of Radiation Sources and Installations, Jakarta, Indonesia, 24-28 April 1995. 6 refs., 2 figs., 12 tabs.

Eucalyptus ESTs involved in the production of 9-cis epoxycarotenoid dioxygenase, a regulatory enzyme of abscisic acid production

Directory of Open Access Journals (Sweden)

Iraê A. Guerrini

2005-01-01

Full Text Available Abscisic acid (ABA regulates stress responses in plants, and genomic tools can help us to understand the mechanisms involved in that process. FAPESP, a Brazilian research foundation, in association with four private forestry companies, has established the FORESTs database (https://forests.esalq.usp.br. A search was carried out in the Eucalyptus expressed sequence tag database to find ESTs involved with 9-cis epoxycarotenoid dioxygenase (NCED, the regulatory enzyme for ABA biosynthesis, using the basic local BLAST alignment tool. We found four clusters (EGEZLV2206B11.g, EGJMWD2252H08.g, EGBFRT3107F10.g, and EGEQFB1200H10.g, which represent similar sequences of the gene that produces NCED. Data showed that the EGBFRT3107F10.g cluster was similar to the maize (Zea mays NCED enzyme, while EGEZLV2206B11.g and EGJMWD2252H08.g clusters were similar to the avocado (Persea americana NCED enzyme. All Eucalyptus clusters were expressed in several tissues, especially in flower buds, where ABA has a special participation during the floral development process.

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

International Nuclear Information System (INIS)

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

2010-01-01

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

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

International Nuclear Information System (INIS)

Kim, B.R.

1995-01-01

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

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

International Nuclear Information System (INIS)

Chiramal, M.

1993-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

2014-11-01

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

Promoting and assessment of safety culture within regulatory body

International Nuclear Information System (INIS)

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

2015-01-01

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

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

International Nuclear Information System (INIS)

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

1987-05-01

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

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...

Long-range regulatory interactions at the 4q25 atrial fibrillation risk locus involve PITX2c and ENPEP.

Science.gov (United States)

Aguirre, Luis A; Alonso, M Eva; Badía-Careaga, Claudio; Rollán, Isabel; Arias, Cristina; Fernández-Miñán, Ana; López-Jiménez, Elena; Aránega, Amelia; Gómez-Skarmeta, José Luis; Franco, Diego; Manzanares, Miguel

2015-04-17

Recent genome-wide association studies have uncovered genomic loci that underlie an increased risk for atrial fibrillation, the major cardiac arrhythmia in humans. The most significant locus is located in a gene desert at 4q25, approximately 170 kilobases upstream of PITX2, which codes for a transcription factor involved in embryonic left-right asymmetry and cardiac development. However, how this genomic region functionally and structurally relates to PITX2 and atrial fibrillation is unknown. To characterise its function, we tested genomic fragments from 4q25 for transcriptional activity in a mouse atrial cardiomyocyte cell line and in transgenic mouse embryos, identifying a non-tissue-specific potentiator regulatory element. Chromosome conformation capture revealed that this region physically interacts with the promoter of the cardiac specific isoform of Pitx2. Surprisingly, this regulatory region also interacts with the promoter of the next neighbouring gene, Enpep, which we show to be expressed in regions of the developing mouse heart essential for cardiac electrical activity. Our data suggest that de-regulation of both PITX2 and ENPEP could contribute to an increased risk of atrial fibrillation in carriers of disease-associated variants, and show the challenges that we face in the functional analysis of genome-wide disease associations.

International conference on safe decommissioning for nuclear activities: Assuring the safe termination of practices involving radioactive materials. Contributed papers

Energy Technology Data Exchange (ETDEWEB)

NONE

2002-07-01

Thousands of operations involving the use of radioactive substances will end during the current century. While there is considerable regulatory experience in the 'front end' of the regulatory system for practices, the experience at the back end is more limited as fewer practices have actually been terminated. When a practice is terminated because the facility has reached the end of its useful life, action has to betaken to ensure the safe shutdown of the facility and allow the removal of regulatory controls. There are many issues involved in the safe termination of practices. These include setting criteria for the release of material and sites from regulatory control; determining the suitability of the various options for decommissioning nuclear facilities, managing the waste and material released from control (recycling, reuse or disposal), and the eventual remediation of the site. Some countries have put in place regulatory infrastructures and have developed programmes to manage the associated decommissioning and remediation activities. Other countries are at the stage of assessing what is involved in terminating such practices. The purpose of this Conference is to foster an information exchange on the safe an orderly termination of practices that involve the use of radioactive substances, including both decommissioning and environmental remediation, and to promote improved coherence internationally on strategies and criteria for the safe termination of practices.

International conference on safe decommissioning for nuclear activities: Assuring the safe termination of practices involving radioactive materials. Contributed papers

International Nuclear Information System (INIS)

2002-01-01

Thousands of operations involving the use of radioactive substances will end during the current century. While there is considerable regulatory experience in the 'front end' of the regulatory system for practices, the experience at the back end is more limited as fewer practices have actually been terminated. When a practice is terminated because the facility has reached the end of its useful life, action has to betaken to ensure the safe shutdown of the facility and allow the removal of regulatory controls. There are many issues involved in the safe termination of practices. These include setting criteria for the release of material and sites from regulatory control; determining the suitability of the various options for decommissioning nuclear facilities, managing the waste and material released from control (recycling, reuse or disposal), and the eventual remediation of the site. Some countries have put in place regulatory infrastructures and have developed programmes to manage the associated decommissioning and remediation activities. Other countries are at the stage of assessing what is involved in terminating such practices. The purpose of this Conference is to foster an information exchange on the safe an orderly termination of practices that involve the use of radioactive substances, including both decommissioning and environmental remediation, and to promote improved coherence internationally on strategies and criteria for the safe termination of practices

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

Directory of Open Access Journals (Sweden)

Kaznessis Yiannis N

2007-01-01

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

Transcriptional regulatory programs underlying barley germination and regulatory functions of Gibberellin and abscisic acid

Science.gov (United States)

2011-01-01

Background Seed germination is a complex multi-stage developmental process, and mainly accomplished through concerted activities of many gene products and biological pathways that are often subjected to strict developmental regulation. Gibberellins (GA) and abscisic acid (ABA) are two key phytohormones regulating seed germination and seedling growth. However, transcriptional regulatory networks underlying seed germination and its associated biological pathways are largely unknown. Results The studies examined transcriptomes of barley representing six distinct and well characterized germination stages and revealed that the transcriptional regulatory program underlying barley germination was composed of early, late, and post-germination phases. Each phase was accompanied with transcriptional up-regulation of distinct biological pathways. Cell wall synthesis and regulatory components including transcription factors, signaling and post-translational modification components were specifically and transiently up-regulated in early germination phase while histone families and many metabolic pathways were up-regulated in late germination phase. Photosynthesis and seed reserve mobilization pathways were up-regulated in post-germination phase. However, stress related pathways and seed storage proteins were suppressed through the entire course of germination. A set of genes were transiently up-regulated within three hours of imbibition, and might play roles in initiating biological pathways involved in seed germination. However, highly abundant transcripts in dry barley and Arabidopsis seeds were significantly conserved. Comparison with transcriptomes of barley aleurone in response to GA and ABA identified three sets of germination responsive genes that were regulated coordinately by GA, antagonistically by ABA, and coordinately by GA but antagonistically by ABA. Major CHO metabolism, cell wall degradation and protein degradation pathways were up-regulated by both GA and seed

Transcriptional regulatory programs underlying barley germination and regulatory functions of Gibberellin and abscisic acid

Directory of Open Access Journals (Sweden)

Lin Li

2011-06-01

Full Text Available Abstract Background Seed germination is a complex multi-stage developmental process, and mainly accomplished through concerted activities of many gene products and biological pathways that are often subjected to strict developmental regulation. Gibberellins (GA and abscisic acid (ABA are two key phytohormones regulating seed germination and seedling growth. However, transcriptional regulatory networks underlying seed germination and its associated biological pathways are largely unknown. Results The studies examined transcriptomes of barley representing six distinct and well characterized germination stages and revealed that the transcriptional regulatory program underlying barley germination was composed of early, late, and post-germination phases. Each phase was accompanied with transcriptional up-regulation of distinct biological pathways. Cell wall synthesis and regulatory components including transcription factors, signaling and post-translational modification components were specifically and transiently up-regulated in early germination phase while histone families and many metabolic pathways were up-regulated in late germination phase. Photosynthesis and seed reserve mobilization pathways were up-regulated in post-germination phase. However, stress related pathways and seed storage proteins were suppressed through the entire course of germination. A set of genes were transiently up-regulated within three hours of imbibition, and might play roles in initiating biological pathways involved in seed germination. However, highly abundant transcripts in dry barley and Arabidopsis seeds were significantly conserved. Comparison with transcriptomes of barley aleurone in response to GA and ABA identified three sets of germination responsive genes that were regulated coordinately by GA, antagonistically by ABA, and coordinately by GA but antagonistically by ABA. Major CHO metabolism, cell wall degradation and protein degradation pathways were up

47 CFR 1.1159 - Filing locations and receipts for regulatory fees.

Science.gov (United States)

2010-10-01

... fees. 1.1159 Section 1.1159 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... for regulatory fees. (a) Regulatory fee payments must be directed to the location and address set forth in §§ 1.1152 through 1.1156 for the specific category of fee involved. Any regulatory fee required...

Systems Biology Approach to the Dissection of the Complexity of Regulatory Networks in the S. scrofa Cardiocirculatory System

Directory of Open Access Journals (Sweden)

Paolo Martini

2013-11-01

Full Text Available Genome-wide experiments are routinely used to increase the understanding of the biological processes involved in the development and maintenance of a variety of pathologies. Although the technical feasibility of this type of experiment has improved in recent years, data analysis remains challenging. In this context, gene set analysis has emerged as a fundamental tool for the interpretation of the results. Here, we review strategies used in the gene set approach, and using datasets for the pig cardiocirculatory system as a case study, we demonstrate how the use of a combination of these strategies can enhance the interpretation of results. Gene set analyses are able to distinguish vessels from the heart and arteries from veins in a manner that is consistent with the different cellular composition of smooth muscle cells. By integrating microRNA elements in the regulatory circuits identified, we find that vessel specificity is maintained through specific miRNAs, such as miR-133a and miR-143, which show anti-correlated expression with their mRNA targets.

Use of PRA in the nuclear regulatory field in South Africa

International Nuclear Information System (INIS)

Hill, T.F.

1994-01-01

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

Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis

DEFF Research Database (Denmark)

Avouac, Jerome; Walker, Ulrich; Tyndall, Alan

2010-01-01

To determine the prevalence of and independent factors associated with joint involvement in a large population of patients with systemic sclerosis (SSc).......To determine the prevalence of and independent factors associated with joint involvement in a large population of patients with systemic sclerosis (SSc)....

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

International Nuclear Information System (INIS)

Birkholz, W.

2000-01-01

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

Genomic regulatory landscapes and chromosomal rearrangements

DEFF Research Database (Denmark)

Ladegaard, Elisabete L Engenheiro

2008-01-01

The main objectives of the PhD study are to identify and characterise chromosomal rearrangements within evolutionarily conserved regulatory landscapes around genes involved in the regulation of transcription and/or development (trans-dev genes). A frequent feature of trans-dev genes is that they ......The main objectives of the PhD study are to identify and characterise chromosomal rearrangements within evolutionarily conserved regulatory landscapes around genes involved in the regulation of transcription and/or development (trans-dev genes). A frequent feature of trans-dev genes...... the complex spatio-temporal expression of the associated trans-dev gene. Rare chromosomal breakpoints that disrupt the integrity of these regulatory landscapes may be used as a tool, not only to make genotype-phenotype associations, but also to link the associated phenotype with the position and tissue...... specificity of the individual CNEs. In this PhD study I have studied several chromosomal rearrangements with breakpoints in the vicinity of trans-dev genes. This included chromosomal rearrangements compatible with known phenotype-genotype associations (Rieger syndrome-PITX2, Mowat-Wilson syndrome-ZEB2...

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

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

International Nuclear Information System (INIS)

2015-03-01

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

Bladder involvement in systemic lupus erythematosus

Directory of Open Access Journals (Sweden)

Eric Roger Wroclawski

2009-12-01

Full Text Available Objective: To study bladder involvement in systemic lupus erythematosus patients through clinical and laboratorial evaluation, ultrasonography, radiological and endoscopic examination. Methods: Thirty-nine patients, either outpatients or inpatients at the Department of Rheumatology of Hospital das Clínicas da Faculdade de Medicina from Universidade de São Paulo were evaluated as to clinical and laboratorial data. All patients were submitted to ultrasonographic evaluation of the upper urinary tract, radiological and endoscopic examinations of the middle and lower urinary tracts. Rresults: Mean age of patients varied between 13 and 62 years (median = 29 years. Thirty-six were females and three were males. The disease varied from 6 months to 22 years (median three years and one month. Clinical and laboratory activity of the disease was present in 30 patients. Twenty-two patients had the diagnosis of lupus established for three years or more. Twenty-five patients were asymptomatic and all had received corticosteroids for treatment at least once. Twenty-three received antimalarial drugs; ten received cytostatics, and seven patients received non-steroid anti-inflammatory drugs. Upper urinary tract ultrasonography was normal in all cases but one with staghorn calculus associated with neurogenic bladder secondary to neurological involvement by the disease. Vesicoureteral reflux was observed in two cases. Other two patients had significant post-voiding residual urine, both with neurogenic bladder secondary to nervous system involvement by lupus. The average bladder maximum capacity in an awaken patient was 342 mL, and was decreased in 18.9% of cases. This subgroup of patients presented a greater frequency of urinary symptoms and greater use of cytostatic drugs (Z > Z5%. A pathognomonic cystoscopic pattern of bladder involvement in systemic lupus erythematosus could not be established. Cystoscopic aspects similar to those seen in the initial or minor

Rho family GTP binding proteins are involved in the regulatory volume decrease process in NIH3T3 mouse fibroblasts

DEFF Research Database (Denmark)

Pedersen, Stine F; Beisner, Kristine H; Willumsen, Berthe M

2002-01-01

The role of Rho GTPases in the regulatory volume decrease (RVD) process following osmotic cell swelling is controversial and has so far only been investigated for the swelling-activated Cl- efflux. We investigated the involvement of RhoA in the RVD process in NIH3T3 mouse fibroblasts, using wild......-type cells and three clones expressing constitutively active RhoA (RhoAV14). RhoAV14 expression resulted in an up to fourfold increase in the rate of RVD, measured by large-angle light scattering. The increase in RVD rate correlated with RhoAV14 expression. RVD in wild-type cells was unaffected by the Rho...

Two regulatory RNA elements affect TisB-dependent depolarization and persister formation.

Science.gov (United States)

Berghoff, Bork A; Hoekzema, Mirthe; Aulbach, Lena; Wagner, E Gerhart H

2017-03-01

Bacterial survival strategies involve phenotypic diversity which is generated by regulatory factors and noisy expression of effector proteins. The question of how bacteria exploit regulatory RNAs to make decisions between phenotypes is central to a general understanding of these universal regulators. We investigated the TisB/IstR-1 toxin-antitoxin system of Escherichia coli to appreciate the role of the RNA antitoxin IstR-1 in TisB-dependent depolarization of the inner membrane and persister formation. Persisters are phenotypic variants that have become transiently drug-tolerant by arresting growth. The RNA antitoxin IstR-1 sets a threshold for TisB-dependent depolarization under DNA-damaging conditions, resulting in two sub-populations: polarized and depolarized cells. Furthermore, our data indicate that an inhibitory 5' UTR structure in the tisB mRNA serves as a regulatory RNA element that delays TisB translation to avoid inappropriate depolarization when DNA damage is low. Investigation of the persister sub-population further revealed that both regulatory RNA elements affect persister levels as well as persistence time. This work provides an intriguing example of how bacteria exploit regulatory RNAs to control phenotypic heterogeneity. © 2016 John Wiley & Sons Ltd.

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

International Nuclear Information System (INIS)

Oedewald, P.; Väisäsvaara, J.

2016-01-01

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

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.

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

International Nuclear Information System (INIS)

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

2008-01-01

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

Inflammatory gene regulatory networks in amnion cells following cytokine stimulation: translational systems approach to modeling human parturition.

Directory of Open Access Journals (Sweden)

Ruth Li

Full Text Available A majority of the studies examining the molecular regulation of human labor have been conducted using single gene approaches. While the technology to produce multi-dimensional datasets is readily available, the means for facile analysis of such data are limited. The objective of this study was to develop a systems approach to infer regulatory mechanisms governing global gene expression in cytokine-challenged cells in vitro, and to apply these methods to predict gene regulatory networks (GRNs in intrauterine tissues during term parturition. To this end, microarray analysis was applied to human amnion mesenchymal cells (AMCs stimulated with interleukin-1β, and differentially expressed transcripts were subjected to hierarchical clustering, temporal expression profiling, and motif enrichment analysis, from which a GRN was constructed. These methods were then applied to fetal membrane specimens collected in the absence or presence of spontaneous term labor. Analysis of cytokine-responsive genes in AMCs revealed a sterile immune response signature, with promoters enriched in response elements for several inflammation-associated transcription factors. In comparison to the fetal membrane dataset, there were 34 genes commonly upregulated, many of which were part of an acute inflammation gene expression signature. Binding motifs for nuclear factor-κB were prominent in the gene interaction and regulatory networks for both datasets; however, we found little evidence to support the utilization of pathogen-associated molecular pattern (PAMP signaling. The tissue specimens were also enriched for transcripts governed by hypoxia-inducible factor. The approach presented here provides an uncomplicated means to infer global relationships among gene clusters involved in cellular responses to labor-associated signals.

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

International Nuclear Information System (INIS)

Loy, J.; Colgan, P.

2001-01-01

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

A comparative analysis between France and Japan on local governments' involvement in nuclear safety governance

International Nuclear Information System (INIS)

Sugawara, Shin-etsu; Shiroyama, Hideaki

2011-01-01

This paper shows a comparative analysis between France and Japan on the way of the local governments' involvement in nuclear safety governance through some interviews. In France, a law came into force that requires related local governments to establish 'Commision Locale d'Information' (CLI), which means the local governments officially involve in nuclear regulatory activity. Meanwhile, in Japan, related local governments substantially involve in the operation of nuclear facilities through the 'safety agreements' in spite of the lack of legal authority. As a result of comparative analysis, we can point out some institutional input from French cases as follows: to clarify the local governments' roles in the nuclear regulation system, to establish the official channels of communication among nuclear utilities, national regulatory authorities and local governments, and to stipulate explicitly the transparency as a purpose of safety regulation. (author)

Adaptation of Regulatory Systems in Schoolchildren, Residing in Industrial Area

Directory of Open Access Journals (Sweden)

Aiman E. Konkabaeva

2013-01-01

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

Central nervous system involvement by multiple myeloma

DEFF Research Database (Denmark)

Jurczyszyn, Artur; Grzasko, Norbert; Gozzetti, Alessandro

2016-01-01

The multicenter retrospective study conducted in 38 centers from 20 countries including 172 adult patients with CNS MM aimed to describe the clinical and pathological characteristics and outcomes of patients with multiple myeloma (MM) involving the central nervous system (CNS). Univariate......, 97% patients received initial therapy for CNS disease, of which 76% received systemic therapy, 36% radiotherapy and 32% intrathecal therapy. After a median follow-up of 3.5 years, the median overall survival (OS) from the onset of CNS involvement for the entire group was 7 months. Untreated...... untreated patients and patients with favorable cytogenetic profile might be prolonged due to systemic treatment and/or radiotherapy. This article is protected by copyright. All rights reserved....

Environmental regulatory reform in Poland: lessons for industrializing economies

Energy Technology Data Exchange (ETDEWEB)

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

2000-09-01

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

EROP-Moscow: specialized data bank for endogenous regulatory oligopeptides.

Science.gov (United States)

Zamyatnin, A A

1991-07-01

At present we are familiar with several hundred endogenous oligopeptides involved in the functioning of the nervous, immune and endocrine systems. The information on their structures and functions is contained in a specially created data bank. Data on 865 regulatory oligopeptides with a total of 17,723 amino acid residues have been collected. Most molecules have about 10 amino acid residues, although the range chosen was from 2 to 50. The results obtained permitted us to define the difference between oligo- and polypeptides.

Safety system upgrades to a research reactor: A regulatory perspective

International Nuclear Information System (INIS)

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

2003-01-01

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

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

The post-transcriptional regulatory system CSR controls the balance of metabolic pools in upper glycolysis of Escherichia coli.

Science.gov (United States)

Morin, Manon; Ropers, Delphine; Letisse, Fabien; Laguerre, Sandrine; Portais, Jean-Charles; Cocaign-Bousquet, Muriel; Enjalbert, Brice

2016-05-01

Metabolic control in Escherichia coli is a complex process involving multilevel regulatory systems but the involvement of post-transcriptional regulation is uncertain. The post-transcriptional factor CsrA is stated as being the only regulator essential for the use of glycolytic substrates. A dozen enzymes in the central carbon metabolism (CCM) have been reported as potentially controlled by CsrA, but its impact on the CCM functioning has not been demonstrated. Here, a multiscale analysis was performed in a wild-type strain and its isogenic mutant attenuated for CsrA (including growth parameters, gene expression levels, metabolite pools, abundance of enzymes and fluxes). Data integration and regulation analysis showed a coordinated control of the expression of glycolytic enzymes. This also revealed the imbalance of metabolite pools in the csrA mutant upper glycolysis, before the phosphofructokinase PfkA step. This imbalance is associated with a glucose-phosphate stress. Restoring PfkA activity in the csrA mutant strain suppressed this stress and increased the mutant growth rate on glucose. Thus, the carbon storage regulator system is essential for the effective functioning of the upper glycolysis mainly through its control of PfkA. This work demonstrates the pivotal role of post-transcriptional regulation to shape the carbon metabolism. © 2016 John Wiley & Sons Ltd.

The transcriptional regulatory network of Corynebacterium jeikeium K411 and its interaction with metabolic routes contributing to human body odor formation.

Science.gov (United States)

Barzantny, Helena; Schröder, Jasmin; Strotmeier, Jasmin; Fredrich, Eugenie; Brune, Iris; Tauch, Andreas

2012-06-15

Lipophilic corynebacteria are involved in the generation of volatile odorous products in the process of human body odor formation by degrading skin lipids and specific odor precursors. Therefore, these bacteria represent appropriate model systems for the cosmetic industry to examine axillary malodor formation on the molecular level. To understand the transcriptional control of metabolic pathways involved in this process, the transcriptional regulatory network of the lipophilic axilla isolate Corynebacterium jeikeium K411 was reconstructed from the complete genome sequence. This bioinformatic approach detected a gene-regulatory repertoire of 83 candidate proteins, including 56 DNA-binding transcriptional regulators, nine two-component systems, nine sigma factors, and nine regulators with diverse physiological functions. Furthermore, a cross-genome comparison among selected corynebacterial species of the taxonomic cluster 3 revealed a common gene-regulatory repertoire of 44 transcriptional regulators, including the MarR-like regulator Jk0257, which is exclusively encoded in the genomes of this taxonomical subline. The current network reconstruction comprises 48 transcriptional regulators and 674 gene-regulatory interactions that were assigned to five interconnected functional modules. Most genes involved in lipid degradation are under the combined control of the global cAMP-sensing transcriptional regulator GlxR and the LuxR-family regulator RamA, probably reflecting the essential role of lipid degradation in C. jeikeium. This study provides the first genome-scale in silico analysis of the transcriptional regulation of metabolism in a lipophilic bacterium involved in the formation of human body odor. Copyright © 2012 Elsevier B.V. All rights reserved.

Regulatory requirements for replacement of analog systems with digital upgrades

International Nuclear Information System (INIS)

Loeser, P.J.

1993-01-01

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

Regulatory compliance issues related to the White Oak Creek Embayment time-critical removal action

International Nuclear Information System (INIS)

Leslie, M.; Kimmel, B.L.

1992-01-01

In September 1990, Martin Marietta Energy Systems (Energy Systems) discovered high levels of Cesium-137 present in surface sediments at the mouth of White Oak Creek (WOC) Embayment. WOC receives the majority of surface water drainage from Oak Ridge National Laboratory. Following this discovery, the Department of Energy (DOE) and Energy Systems pursued stabilizing sediment migration under provisions of the National Contingency Plan (NCP) Section 300.400 et. seq. as a time-critical removal action. However, significant uncertainty exists concerning the applicability of NCP procedural requirements designed for conducting US EPA-led, Superfund-financed response actions, because NCP Subpart K dealing with response actions at federal facilities has not been promulgated. In addition, relatively new guidance exists from DOE concerning National Environmental Policy Act documentation requirements for categorical exclusions associated with conducting removal actions at DOE facilities. A proactive approach was taken to identify issues and involve appropriate state and federal regulatory agencies. This approach required achieving consensus among all involved parties and identification of all applicable or relevant and appropriate regulatory requirements related to the removal action. As a result, this project forms a framework for conducting future time-critical removal actions at federal facilities

ENSI’s regulatory framework strategy; Regelwerksstrategie des ENSI -- Stratégie réglementaire de l’IFSN -- ENSI’s regulatory framework strategy

Energy Technology Data Exchange (ETDEWEB)

NONE

2015-03-15

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

Enabling legislation and regulatory determinations for a nuclear power programme

International Nuclear Information System (INIS)

Ha-Vinh, Phuong

1975-01-01

Broad definition of the scope of enabling legislation, identification of branches of laws involved in the licensing and regulatory control, overview of some typical licensing practices and provisions, some specific legislative or regulatory requirements including financial security to over nuclear liability. (HP) [de

Regulatory Circuits Linking Energy Status to Growth

NARCIS (Netherlands)

Jansen, W.M.

2017-01-01

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

Sjogrens Syndrome Presenting with Central Nervous System Involvement

Directory of Open Access Journals (Sweden)

Tülay Terzi

2012-01-01

Full Text Available Sjogren’s syndrome is a slowly progressive autoimmune disease. Neurological involvement occurs in approximately 20-25% cases in Sjogren’s syndrome. 87% of the neurological involvement is peripheral nervous system, almost 13% in the form of central nervous system involvement. Affected central nervous system may show similar clinical and radiological findings as in multiple sclerosis (MS. In this paper, a 43-year-old patient is discussed who was referred with the complaint of dizziness, there was MS- like lesions in brain imaging studies and was diagnosed with Sjogren’s syndrome. MS- like clinical and radiologic tables can be seen, albeit rarely in Sjogren’s syndrome. In these cases, early diagnosis and early treatment for the sjögren has a great importance for the prognosis of the disease.

The Political Economy of Regulatory Risk

OpenAIRE

Strausz, Roland

2009-01-01

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

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

Science.gov (United States)

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

2018-05-01

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

A primer on thermodynamic-based models for deciphering transcriptional regulatory logic.

Science.gov (United States)

Dresch, Jacqueline M; Richards, Megan; Ay, Ahmet

2013-09-01

A rigorous analysis of transcriptional regulation at the DNA level is crucial to the understanding of many biological systems. Mathematical modeling has offered researchers a new approach to understanding this central process. In particular, thermodynamic-based modeling represents the most biophysically informed approach aimed at connecting DNA level regulatory sequences to the expression of specific genes. The goal of this review is to give biologists a thorough description of the steps involved in building, analyzing, and implementing a thermodynamic-based model of transcriptional regulation. The data requirements for this modeling approach are described, the derivation for a specific regulatory region is shown, and the challenges and future directions for the quantitative modeling of gene regulation are discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

[Neuronal and hormonal regulatory mechanisms of tears production and secretion].

Science.gov (United States)

Mrugacz, Małgorzata; Zywalewska, Nella; Bakunowicz-Lazarczyk, Alina

2005-01-01

The ocular surface, tear film, lacrimal glands act as a functional unit to preserve the quality of the refractive surface of the eye, and to resist injury and protect the eye against bodily and environmental conditions. Homeostasis of this functional unit involves neuronal and hormonal regulatory mechanisms. The eye appears to be a target organ for sex hormones particulary the androgen, as they modulate the immune system and trophic functions of the lacrimal and Meibomian glands.

Legal principles of regulatory administration and nuclear safety regulation

Energy Technology Data Exchange (ETDEWEB)

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

2000-12-15

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

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

International Nuclear Information System (INIS)

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

1975-01-01

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

Lmx1b-targeted cis-regulatory modules involved in limb dorsalization.

Science.gov (United States)

Haro, Endika; Watson, Billy A; Feenstra, Jennifer M; Tegeler, Luke; Pira, Charmaine U; Mohan, Subburaman; Oberg, Kerby C

2017-06-01

Lmx1b is a homeodomain transcription factor responsible for limb dorsalization. Despite striking double-ventral (loss-of-function) and double-dorsal (gain-of-function) limb phenotypes, no direct gene targets in the limb have been confirmed. To determine direct targets, we performed a chromatin immunoprecipitation against Lmx1b in mouse limbs at embryonic day 12.5 followed by next-generation sequencing (ChIP-seq). Nearly 84% ( n =617) of the Lmx1b-bound genomic intervals (LBIs) identified overlap with chromatin regulatory marks indicative of potential cis -regulatory modules (PCRMs). In addition, 73 LBIs mapped to CRMs that are known to be active during limb development. We compared Lmx1b-bound PCRMs with genes regulated by Lmx1b and found 292 PCRMs within 1 Mb of 254 Lmx1b-regulated genes. Gene ontological analysis suggests that Lmx1b targets extracellular matrix production, bone/joint formation, axonal guidance, vascular development, cell proliferation and cell movement. We validated the functional activity of a PCRM associated with joint-related Gdf5 that provides a mechanism for Lmx1b-mediated joint modification and a PCRM associated with Lmx1b that suggests a role in autoregulation. This is the first report to describe genome-wide Lmx1b binding during limb development, directly linking Lmx1b to targets that accomplish limb dorsalization. © 2017. Published by The Company of Biologists Ltd.

78 FR 4186 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2013-01-18

... securities offered or sold pursuant to crowdfunding.\\5\\ Intermediaries in transactions involving the offer or sale of securities for the account of others pursuant to the crowdfunding exemption must, among other...- regulatory organization.\\7\\ \\4\\ Public Law 112-106, 126 Stat. 306 (2012). \\5\\ In general, crowdfunding refers...

Annual Report 2010. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

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

Annual Report 2011. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

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

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.

Improving nuclear regulatory effectiveness

International Nuclear Information System (INIS)

2001-01-01

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

Regulatory T Cells: Potential Target in Anticancer Immunotherapy

Directory of Open Access Journals (Sweden)

Chi-Mou Juang

2007-09-01

Full Text Available The concept of regulatory T cells was first described in the early 1970s, and regulatory T cells were called suppressive T cells at that time. Studies that followed have demonstrated that these suppressive T cells negatively regulated tumor immunity and contributed to tumor growth in mice. Despite the importance of these studies, there was extensive skepticism about the existence of these cells, and the concept of suppressive T cells left the center stage of immunologic research for decades. Interleukin-2 receptor α-chain, CD25, was first demonstrated in 1995 to serve as a phenotypic marker for CD4+ regulatory cells. Henceforth, research of regulatory T cells boomed. Regulatory T cells are involved in the pathogenesis of cancer, autoimmune disease, transplantation immunology, and immune tolerance in pregnancy. Recent evidence has demonstrated that regulatory T cellmediated immunosuppression is one of the crucial tumor immune evasion mechanisms and the main obstacle of successful cancer immunotherapy. The mechanism and the potential clinical application of regulatory T cells in cancer immunotherapy are discussed.

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

International Nuclear Information System (INIS)

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

2006-01-01

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

Nuclear regulatory communication with the public: 10 years of progress

International Nuclear Information System (INIS)

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

2008-01-01

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

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

International Nuclear Information System (INIS)

2015-01-01

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

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

Science.gov (United States)

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

2015-09-21

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

Regulatory framework for nuclear power plant operation

International Nuclear Information System (INIS)

Perez Alcaniz, T.; Esteban Barriendos, M.

1995-01-01

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

Evolving Regulatory Processes Used by Students and Experts in the Acquiring of Improvisational Skills: A Qualitative Study

Science.gov (United States)

de Bruin, Leon R.

2018-01-01

The way an improviser practices is a vital and significant aspect to a musician's means and capacities of expression. Expert music performers utilize extensive self-regulatory processes involving planning, strategic development, and systemized approaches to learning and reflective practice. Scholars posit that these processes are constructivist…

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)

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

OpenAIRE

Suzuki, Kazushi; 鈴木, 一史

2007-01-01

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

Regulatory Competition in Global Financial Markets

DEFF Research Database (Denmark)

Ringe, Georg

2015-01-01

competition are a reality in today’s global financial market, and the financial sector is different from their traditional fields of application: the ease of arbitrage, the fragility of banking and the risks involved are exceptional. Most importantly, regulatory arbitrage does not or only rarely occurs......The decades-long discussion on the merits of regulatory competition appears in a new light on the global financial market. There are a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of shifting trading abroad or else relocating activities...

Development of regulatory procedures for the disposal of solid radioactive waste in deep, continental formations

International Nuclear Information System (INIS)

1980-01-01

For the disposal of radioactive waste, and in particular, of the high-level and alpha-bearing waste from the nuclear fuel cycle, the most favoured solution in most countries is disposal in deep, continental geological formations. Commitment to this disposal method involves a number of issues related to the various stages of the disposal programme which must be addressed through some reasoned decision-making process. Most countries are opting for regulating such a programme through licensing actions by a body whose purpose is to review, certify and ensure the safety of all the stages of the disposal programme. This regulatory body may either be one single national authority or a system of authorities designated by the government. The key to such regulation is the set of procedures, determined in advance, for the actions of the implementing organization, the review by the regulatory body and the involvement of other parties. This document concerns itself with the procedures which could logically be followed in reaching a set of rational decisions by the regulatory body. Care in the preparation and application of such procedures is an important element in the acceptability of the concept, the site and the other aspects of the disposal programme. The intention of this document is to give guidance as to what issues should be addressed in the licensing review, what decision points are important, and what guidance should be given to the applicant by the regulatory body in the course of the licensing actions. The procedures are keyed to be designed according to the logical steps involved in the development and operation of the repository. However, the document does not pretend to give guidance regarding the optimal interactions between the implementing organization and the regulatory body. This document is oriented to the disposal of solid radioactive waste in deep, continental geological formations using mining techniques

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

Science.gov (United States)

2013-11-20

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

Regulatory Proteolysis in Arabidopsis-Pathogen Interactions.

Science.gov (United States)

Pogány, Miklós; Dankó, Tamás; Kámán-Tóth, Evelin; Schwarczinger, Ildikó; Bozsó, Zoltán

2015-09-24

Approximately two and a half percent of protein coding genes in Arabidopsis encode enzymes with known or putative proteolytic activity. Proteases possess not only common housekeeping functions by recycling nonfunctional proteins. By irreversibly cleaving other proteins, they regulate crucial developmental processes and control responses to environmental changes. Regulatory proteolysis is also indispensable in interactions between plants and their microbial pathogens. Proteolytic cleavage is simultaneously used both by plant cells, to recognize and inactivate invading pathogens, and by microbes, to overcome the immune system of the plant and successfully colonize host cells. In this review, we present available results on the group of proteases in the model plant Arabidopsis thaliana whose functions in microbial pathogenesis were confirmed. Pathogen-derived proteolytic factors are also discussed when they are involved in the cleavage of host metabolites. Considering the wealth of review papers available in the field of the ubiquitin-26S proteasome system results on the ubiquitin cascade are not presented. Arabidopsis and its pathogens are conferred with abundant sets of proteases. This review compiles a list of those that are apparently involved in an interaction between the plant and its pathogens, also presenting their molecular partners when available.

Expression of Genes Involved in Bacteriocin Production and Self-Resistance in Lactobacillus brevis 174A Is Mediated by Two Regulatory Proteins.

Science.gov (United States)

Noda, Masafumi; Miyauchi, Rumi; Danshiitsoodol, Narandalai; Matoba, Yasuyuki; Kumagai, Takanori; Sugiyama, Masanori

2018-04-01

We have previously shown that the lactic acid bacterium Lactobacillus brevis 174A, isolated from Citrus iyo fruit, produces a bacteriocin designated brevicin 174A, which is comprised of two antibacterial polypeptides (designated brevicins 174A-β and 174A-γ). We have also found a gene cluster, composed of eight open reading frames (ORFs), that contains genes for the biosynthesis of brevicin 174A, self-resistance to its own bacteriocin, and two transcriptional regulatory proteins. Some lactic acid bacterial strains have a system to start the production of bacteriocin at an adequate stage of growth. Generally, the system consists of a membrane-bound histidine protein kinase (HPK) that senses a specific environmental stimulus and a corresponding response regulator (RR) that mediates the cellular response. We have previously shown that although the HPK- and RR-encoding genes are not found on the brevicin 174A biosynthetic gene cluster in the 174A strain, two putative regulatory genes, designated breD and breG , are in the gene cluster. In the present study, we demonstrate that the expression of brevicin 174A production and self-resistance is positively controlled by two transcriptional regulatory proteins, designated BreD and BreG. BreD is expressed together with BreE as the self-resistance determinant of L. brevis 174A. DNase I footprinting analysis and a promoter assay demonstrated that BreD binds to the breED promoter as a positive autoregulator. The present study also demonstrates that BreG, carrying a transmembrane domain, binds to the common promoter of breB and breC , encoding brevicins 174A-β and 174A-γ, respectively, for positive regulation. IMPORTANCE The problem of the appearance of bacteria that are resistant to practical antibiotics and the increasing demand for safe foods have increased interest in replacing conventional antibiotics with bacteriocin produced by the lactic acid bacteria. This antibacterial substance can inhibit the growth of pathogenic

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

Science.gov (United States)

Yoshida, Saishu; Kato, Takako; Kato, Yukio

2016-01-01

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

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

Directory of Open Access Journals (Sweden)

Saishu Yoshida

2016-01-01

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

Structure reveals regulatory mechanisms of a MaoC-like hydratase from Phytophthora capsici involved in biosynthesis of polyhydroxyalkanoates (PHAs).

Science.gov (United States)

Wang, Huizheng; Zhang, Kai; Zhu, Jie; Song, Weiwei; Zhao, Li; Zhang, Xiuguo

2013-01-01

Polyhydroxyalkanoates (PHAs) have attracted increasing attention as "green plastic" due to their biodegradable, biocompatible, thermoplastic, and mechanical properties, and considerable research has been undertaken to develop low cost/high efficiency processes for the production of PHAs. MaoC-like hydratase (MaoC), which belongs to (R)-hydratase involved in linking the β-oxidation and the PHA biosynthetic pathways, has been identified recently. Understanding the regulatory mechanisms of (R)-hydratase catalysis is critical for efficient production of PHAs that promise synthesis an environment-friendly plastic. We have determined the crystal structure of a new MaoC recognized from Phytophthora capsici. The crystal structure of the enzyme was solved at 2.00 Å resolution. The structure shows that MaoC has a canonical (R)-hydratase fold with an N-domain and a C-domain. Supporting its dimerization observed in structure, MaoC forms a stable homodimer in solution. Mutations that disrupt the dimeric MaoC result in a complete loss of activity toward crotonyl-CoA, indicating that dimerization is required for the enzymatic activity of MaoC. Importantly, structure comparison reveals that a loop unique to MaoC interacts with an α-helix that harbors the catalytic residues of MaoC. Deletion of the loop enhances the enzymatic activity of MaoC, suggesting its inhibitory role in regulating the activity of MaoC. The data in our study reveal the regulatory mechanism of an (R)-hydratase, providing information on enzyme engineering to produce low cost PHAs.

A case for increased private sector involvement in Ireland's national animal health services.

Science.gov (United States)

More, Simon J

2008-02-01

Non-regulatory animal health issues, such as Johne's disease, infectious bovine rhinotracheitis (IBR) and mastitis will become increasing important, with ongoing globalisation of markets in animals and animal products. In response, Ireland may need to broaden the scope of its national animal health services. However, there have been concerns about the respective roles and responsibilities (both financial and otherwise) of government and industry in any such moves. This paper argues the case for increased private sector involvement in Ireland's national animal health services, based both on theoretical considerations and country case studies (the Netherlands and Australia). The Dutch and Australian case studies present examples of successful partnerships between government and industry, including systems and processes to address non-regulatory animal health issues. In each case, the roles and responsibilities of government are clear, as are the principles underpinning government involvement. Furthermore, the roles and responsibilities (financial and otherwise) of the Dutch and Australian industry are determined through enabling legislation, providing both legitimacy and accountability. There are constraints on the use of EU and national government funds to support non-regulatory animal health services in EU member states (such as Ireland and the Netherlands).

A case for increased private sector involvement in ireland's national animal health services

Directory of Open Access Journals (Sweden)

More Simon J

2008-02-01

Full Text Available Abstract Non-regulatory animal health issues, such as Johne's disease, infectious bovine rhinotracheitis (IBR and mastitis will become increasing important, with ongoing globalisation of markets in animals and animal products. In response, Ireland may need to broaden the scope of its national animal health services. However, there have been concerns about the respective roles and responsibilities (both financial and otherwise of government and industry in any such moves. This paper argues the case for increased private sector involvement in Ireland's national animal health services, based both on theoretical considerations and country case studies (the Netherlands and Australia. The Dutch and Australian case studies present examples of successful partnerships between government and industry, including systems and processes to address non-regulatory animal health issues. In each case, the roles and responsibilities of government are clear, as are the principles underpinning government involvement. Furthermore, the roles and responsibilities (financial and otherwise of the Dutch and Australian industry are determined through enabling legislation, providing both legitimacy and accountability. There are constraints on the use of EU and national government funds to support non-regulatory animal health services in EU member states (such as Ireland and the Netherlands.

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

Science.gov (United States)

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

2012-01-01

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

Nuclear energy - some regulatory aspects

International Nuclear Information System (INIS)

Jennekens, Jon.

1980-03-01

The nuclear industry is often perceived by the public as being uniquely hazardous. As a consequence, the demands placed upon a nuclear regulatory agency invariably include sorting out the valid from the invalid. As the public becomes better informed, more time should become available for regulating the industry. The Canadian nuclear safety philosophy relies upon fundamental principle and basic criteria which licensees must show they are meeting at all stages in the development of a nuclear facility. In reactors, the concept of defence in depth involves the use of well-qualified personnel, compliance with national and international engineering codes and standards, the separation of process and safety systems, frequent testing of safety systems, redundancy in monitoring, control and initiation systems, multiple barriers against fission product release, and strict enforcement of compliance measurements. The Atomic Energy Control Board is writing a set of licensing guides to cover the whole nuclear fuel cycle; however, these will not lead to the impsition of a 'design by regulation' approach in Canada. (LL)

XcisClique: analysis of regulatory bicliques

Directory of Open Access Journals (Sweden)

Grene Ruth

2006-04-01

Full Text Available Abstract Background Modeling of cis-elements or regulatory motifs in promoter (upstream regions of genes is a challenging computational problem. In this work, set of regulatory motifs simultaneously present in the promoters of a set of genes is modeled as a biclique in a suitably defined bipartite graph. A biologically meaningful co-occurrence of multiple cis-elements in a gene promoter is assessed by the combined analysis of genomic and gene expression data. Greater statistical significance is associated with a set of genes that shares a common set of regulatory motifs, while simultaneously exhibiting highly correlated gene expression under given experimental conditions. Methods XcisClique, the system developed in this work, is a comprehensive infrastructure that associates annotated genome and gene expression data, models known cis-elements as regular expressions, identifies maximal bicliques in a bipartite gene-motif graph; and ranks bicliques based on their computed statistical significance. Significance is a function of the probability of occurrence of those motifs in a biclique (a hypergeometric distribution, and on the new sum of absolute values statistic (SAV that uses Spearman correlations of gene expression vectors. SAV is a statistic well-suited for this purpose as described in the discussion. Results XcisClique identifies new motif and gene combinations that might indicate as yet unidentified involvement of sets of genes in biological functions and processes. It currently supports Arabidopsis thaliana and can be adapted to other organisms, assuming the existence of annotated genomic sequences, suitable gene expression data, and identified regulatory motifs. A subset of Xcis Clique functionalities, including the motif visualization component MotifSee, source code, and supplementary material are available at https://bioinformatics.cs.vt.edu/xcisclique/.

The bacterial two-hybrid system uncovers the involvement of acetylation in regulating of Lrp activity in Salmonella Typhimurium

Directory of Open Access Journals (Sweden)

Ran Qin

2016-11-01

Full Text Available Nε-lysine acetylation is an abundant and important Post-translational modification in bacteria. We used the bacterial two-hybrid system to screen the genome library of the Salmonella Typhimurium to identify potential proteins involved in acetyltransferase Pat - or deacetylase CobB-mediated acetylation. Then, the in vitro (deacetylation assays were used to validate the potential targets, such as STM14_1074, NrdF, RhaR. Lrp, a leucine-responsive regulatory protein and global regulator, was shown to interact with Pat. We further demonstrate that Lrp could be acetylated by Pat and deacetylated by NAD+-dependent CobB in vitro. Specifically, the conserved lysine residue 36 (K36 in helix-turn-helix (HTH DNA-binding domain of Lrp was acetylated. Acetylation of K36 impaired the function of Lrp through altering the affinity with the target promoter. The mutation of K36 in chromosome mimicking acetylation enhanced the transcriptional level of itself and attenuated the mRNA levels of Lrp-regulated genes including fimA, which was confirmed by yeast agglutination assay. These findings demonstrate that the acetylation regulates the DNA-binding activity of Lrp, suggesting that acetylation modification of transcription factors is a conserved regulatory manner to modulate gene expression in bacteria and eukaryotes.

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

Energy Technology Data Exchange (ETDEWEB)

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

2016-10-15

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

The small nucleoid protein Fis is involved in Vibrio cholerae quorum sensing.

Science.gov (United States)

Lenz, Derrick H; Bassler, Bonnie L

2007-02-01

Quorum sensing is a process of cell-cell communication that bacteria use to relay information to one another about the cell density and species composition of the bacterial community. Quorum sensing involves the production, secretion and population-wide detection of small signalling molecules called autoinducers. This process allows bacteria to synchronize group behaviours and act as multicellular units. The human pathogen, Vibrio cholerae, uses quorum sensing to co-ordinate such complex behaviours as pathogenicity and biofilm formation. The quorum-sensing circuit of V. cholerae consists of two autoinducer/sensor systems, CAI-1/CqsS and AI-2/LuxPQ, and the VarS/A-CsrA/BCD growth-phase regulatory system. Genetic analysis suggests that an additional regulatory arm involved in quorum sensing exists in V. cholerae. All of these systems channel information into the histidine phosphotransfer protein, LuxU, and/or the response regulator, LuxO. LuxO, when phosphorylated, activates the expression of four genes encoding the Qrr (quorum regulatory RNAs) small RNAs (sRNAs). The Qrr sRNAs destabilize the hapR transcript encoding the master regulator of quorum sensing, HapR. Here we identify the nucleoid protein Fis as playing a major role in the V. cholerae quorum-sensing circuit. Fis fulfils the predictions required to be the putative additional component that inputs information into the cascade: its expression is regulated in a growth phase-dependent manner; it requires LuxO but acts independently of LuxU, and it regulates all four qrr genes and, in turn, HapR by directly binding to the qrr gene promoters and modulating their expression.

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

Regulatory point of view of SAT application

International Nuclear Information System (INIS)

Juhasz, L.

2002-01-01

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

Meeting the regulatory information needs of users of radioactive materials

International Nuclear Information System (INIS)

MacDurmon, G.W.

1996-01-01

The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff

Meeting the regulatory information needs of users of radioactive materials

Energy Technology Data Exchange (ETDEWEB)

MacDurmon, G.W. [American Cyanamid Company, Princeton, NJ (United States)

1996-10-01

The use of radioactive materials is one of the most regulated areas of research. Researchers face ever increasing regulatory requirements and issues involving the disposal of radioactive material, while meeting the demands of higher productivity. Radiation safety programs must maximize regulatory compliance, minimize barriers, provide services and solutions, and effectively communicate with users of radioactive materials. This talk will discuss methods by which a radiation safety program can meet the needs of both the research staff and regulatory compliance staff.

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

Energy Technology Data Exchange (ETDEWEB)

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

2001-03-15

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

Romanian regulatory requirements on nuclear field specific education needs

International Nuclear Information System (INIS)

Biro, L.; Velicu, O.

2004-01-01

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

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

Science.gov (United States)

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

2006-07-01

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

Biochemical markers predictive for bone marrow involvement in systemic mastocytosis

NARCIS (Netherlands)

Donker, Marjolein L.; van Doormaal, Jasper J.; van Doormaal, Frederiek F.; Kluin, Philip M.; van der Veer, Eveline; de Monchy, Jan G. R.; Kema, Ido P.; Kluin-Nelemans, Hanneke C.

Systemic mastocytosis is characterized by bone marrow involvement, which requires a bone marrow biopsy for diagnostic work-up. We questioned whether bone marrow involvement could be predicted using biochemical markers. We selected patients with various symptoms suggestive of indolent systemic

Regulatory aspects of the radioactive waste management in Argentina

International Nuclear Information System (INIS)

Siraky, Graciela

2000-01-01

This paper describes briefly the legislative and regulatory framework in which the radioactive waste management is carried out in Argentina. The activities of the Nuclear Regulatory Authority (NRA) and the applied approaches in relation to inspection of facilities, safety assessments of associated systems and collaboration in the matter with international agencies are also exposed. The 'National Law of the Nuclear Activity' (No. 24804), in force since April 1997, assigns to NRA the following functions: to regulate and to inspect nuclear activities regarding radiological and nuclear safety, physical protection of nuclear materials, in order to verify that such materials are used exclusively with peaceful purposes and also, to advise the National Executive Power in matters of its competence. For the fulfilment of these functions the Law grants to NRA the necessary legal competence to develop, to establish and to apply a regulatory system to all nuclear activities carried out in Argentina. The activity of NRA is carried out in the framework of a regulatory system whose fundamental aspect in the approach adopted to establish the requirements of safety, which is know as 'of performance'. This system has a group of rules known as 'AR Standards' (AR: abbreviation of Regulatory Authority) that, among other requirements, establish that the construction, operation and decommissioning of a nuclear installation can not start without the corresponding construction, operation or decommissioning license. In that sense, besides having the legal competence in the topic, NRA has developed its necessary technical competence to evaluate, with own criteria, all radiological and nuclear safety aspects involved in the grant of licenses and to guarantee an appropriate level of control in the facilities. In relation to the radioactive waste management, NRA has developed some basic criteria. These criteria underline the requirements put to the 'Responsible Entity' that generates or manages

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

International Nuclear Information System (INIS)

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

2001-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2001-05-01

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

A feedback regulatory loop involving microRNA-9 and nuclear receptor TLX in neural stem cell fate determination.

Science.gov (United States)

Zhao, Chunnian; Sun, GuoQiang; Li, Shengxiu; Shi, Yanhong

2009-04-01

MicroRNAs have been implicated as having important roles in stem cell biology. MicroRNA-9 (miR-9) is expressed specifically in neurogenic areas of the brain and may be involved in neural stem cell self-renewal and differentiation. We showed previously that the nuclear receptor TLX is an essential regulator of neural stem cell self-renewal. Here we show that miR-9 suppresses TLX expression to negatively regulate neural stem cell proliferation and accelerate neural differentiation. Introducing a TLX expression vector that is not prone to miR-9 regulation rescued miR-9-induced proliferation deficiency and inhibited precocious differentiation. In utero electroporation of miR-9 in embryonic brains led to premature differentiation and outward migration of the transfected neural stem cells. Moreover, TLX represses expression of the miR-9 pri-miRNA. By forming a negative regulatory loop with TLX, miR-9 provides a model for controlling the balance between neural stem cell proliferation and differentiation.

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

Science.gov (United States)

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

2017-06-01

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

Evolutionary conservation of regulatory elements in vertebrate HOX gene clusters

Energy Technology Data Exchange (ETDEWEB)

Santini, Simona; Boore, Jeffrey L.; Meyer, Axel

2003-12-31

Due to their high degree of conservation, comparisons of DNA sequences among evolutionarily distantly-related genomes permit to identify functional regions in noncoding DNA. Hox genes are optimal candidate sequences for comparative genome analyses, because they are extremely conserved in vertebrates and occur in clusters. We aligned (Pipmaker) the nucleotide sequences of HoxA clusters of tilapia, pufferfish, striped bass, zebrafish, horn shark, human and mouse (over 500 million years of evolutionary distance). We identified several highly conserved intergenic sequences, likely to be important in gene regulation. Only a few of these putative regulatory elements have been previously described as being involved in the regulation of Hox genes, while several others are new elements that might have regulatory functions. The majority of these newly identified putative regulatory elements contain short fragments that are almost completely conserved and are identical to known binding sites for regulatory proteins (Transfac). The conserved intergenic regions located between the most rostrally expressed genes in the developing embryo are longer and better retained through evolution. We document that presumed regulatory sequences are retained differentially in either A or A clusters resulting from a genome duplication in the fish lineage. This observation supports both the hypothesis that the conserved elements are involved in gene regulation and the Duplication-Deletion-Complementation model.

Lung involvement in systemic connective tissue diseases

Directory of Open Access Journals (Sweden)

Plavec Goran

2008-01-01

Full Text Available Background/Aim. Systemic connective tissue diseases (SCTD are chronic inflammatory autoimmune disorders of unknown cause that can involve different organs and systems. Their course and prognosis are different. All of them can, more or less, involve the respiratory system. The aim of this study was to find out the frequency of respiratory symptoms, lung function disorders, radiography and high-resolution computerized tomography (HRCT abnormalities, and their correlation with the duration of the disease and the applied treatment. Methods. In 47 non-randomized consecutive patients standard chest radiography, HRCT, and lung function tests were done. Results. Hypoxemia was present in nine of the patients with respiratory symptoms (20%. In all of them chest radiography was normal. In five of these patients lung fibrosis was established using HRCT. Half of all the patients with SCTD had symptoms of lung involvement. Lung function tests disorders of various degrees were found in 40% of the patients. The outcome and the degree of lung function disorders were neither in correlation with the duration of SCTD nor with therapy used (p > 0.05 Spearmans Ro. Conclusion. Pulmonary fibrosis occurs in about 10% of the patients with SCTD, and possibly not due to the applied treatment regimens. Hypoxemia could be a sing of existing pulmonary fibrosis in the absence of disorders on standard chest radiography.

Annual Report 2008. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2009-01-01

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

Annual Report 2007. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2008-01-01

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

Langerhans cell histiocytosis involving central nervous system: a case report

Energy Technology Data Exchange (ETDEWEB)

Moon, Won Jin; Park, Dong Woo; Lee, Seung Ro; Hahm, Chang Kok; Ju, Kyung Bin [Hanyang University College of Medicine, Seoul (Korea, Republic of); Kim, Sung Tae [Ulsan University College of Medicine, Seoul (Korea, Republic of)

1997-01-01

Langerhans cell histiocytosis(LCH) is a systemic disorder characterized by idiopathic proliferation of histiocytes in the reticuloendothelial system; CNS involvement outside the hypothalamus or pituitary gland is uncommon. We present a case of LCH involving the brainstem, cerebellum, and temporal lobes, and also showing hypothalamic involvement. The lesions were isointense or hypointense on T1WI and hyperintense on T2WI, and showed multifocal enhancing nodules on post-contrast CT and Gd-enhanced MRI.

Nuclear Magnetic Resonance structural studies of peptides and proteins from the vaso-regulatory System

International Nuclear Information System (INIS)

Sizun, Philippe

1991-01-01

The aim of the present work is to show how Nuclear Magnetic Resonance (NMR) allows to determine the 3D structure of peptides and proteins in solution. A comparative study of peptides involved in the vaso-regulatory System (form small hormonal peptide to the 65 amido-acid protein hirudin) has allowed to design most efficient NMR 1D and 2D strategies. It rapidly appeared that the size of the peptide plays a key role in the structuration of the molecule, smallest peptides being weakly structured owing to the lack of cooperative effects. As the molecular size increases or if conformational locks are present (disulfide bridges) the probability of stable secondary structure increases. For the protein hirudin, a combination of ail available NMR parameters deduced form dedicated experiments (chemical shifts, coupling constants, overhauser effects, accessibility of amide protons) and molecular modelling under constraints allows a clear 3D structure to be proposed for this protein in solution. Finally, a comparative study of the experimental structures and of those deduced form prediction rules has shed light on the concept of structural predisposition, the latter being of high value for a better understanding of structure-activity relationships. (author) [fr

Regulatory frameworks for Natural Gas DSM in Canada : exploring design options, influences and characteristics of success

International Nuclear Information System (INIS)

Simon, J.

2005-11-01

There are 6 natural gas distribution companies in Canada with formal, ratepayer-funded demand side management (DSM) programs. However, the general characteristics and regulatory environment of these companies varies greatly. With the exception of Enbridge Gas and Union Gas, each company is located in a different province, which means that companies face different energy regulations and energy efficiency policies. An introduction to DSM and its regulation in Canada was presented, as well as an overview of common models in Canada, and the general considerations involved in designing a regulatory framework were discussed. Regulatory design options for natural gas demand-side management regulatory frameworks were evaluated. The major factors that influence the frameworks were analyzed, and the characteristics of a successful DSM program were outlined. The research methodology for this paper consisted of telephone interviews with policy-makers, regulators, non-governmental organizations and regulatory affairs personnel from local distribution companies. Results indicated the importance of a clear policy framework that provides direction for DSM designers. The common elements for a successful regulatory framework were considered to be a systems approach to the definition of DSM; clear regulatory rules; a long-term predictable source and level of DSM funding that reflected the maturity of the DSM market; an alignment of government energy policies and DSM regulatory frameworks; and recognition and capturing of the broad range of DSM benefits

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

Science.gov (United States)

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

2018-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

Heckman, R.A.

1977-12-06

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

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

International Nuclear Information System (INIS)

Heckman, R.A.

1977-01-01

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

Structure reveals regulatory mechanisms of a MaoC-like hydratase from Phytophthora capsici involved in biosynthesis of polyhydroxyalkanoates (PHAs.

Directory of Open Access Journals (Sweden)

Huizheng Wang

Full Text Available Polyhydroxyalkanoates (PHAs have attracted increasing attention as "green plastic" due to their biodegradable, biocompatible, thermoplastic, and mechanical properties, and considerable research has been undertaken to develop low cost/high efficiency processes for the production of PHAs. MaoC-like hydratase (MaoC, which belongs to (R-hydratase involved in linking the β-oxidation and the PHA biosynthetic pathways, has been identified recently. Understanding the regulatory mechanisms of (R-hydratase catalysis is critical for efficient production of PHAs that promise synthesis an environment-friendly plastic.We have determined the crystal structure of a new MaoC recognized from Phytophthora capsici. The crystal structure of the enzyme was solved at 2.00 Å resolution. The structure shows that MaoC has a canonical (R-hydratase fold with an N-domain and a C-domain. Supporting its dimerization observed in structure, MaoC forms a stable homodimer in solution. Mutations that disrupt the dimeric MaoC result in a complete loss of activity toward crotonyl-CoA, indicating that dimerization is required for the enzymatic activity of MaoC. Importantly, structure comparison reveals that a loop unique to MaoC interacts with an α-helix that harbors the catalytic residues of MaoC. Deletion of the loop enhances the enzymatic activity of MaoC, suggesting its inhibitory role in regulating the activity of MaoC.The data in our study reveal the regulatory mechanism of an (R-hydratase, providing information on enzyme engineering to produce low cost PHAs.

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

International Nuclear Information System (INIS)

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

2016-01-01

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

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.

Transportation of radioactive materials: legislative and regulatory information system

International Nuclear Information System (INIS)

Fore, C.S.; Heiskell, M.M.

1980-01-01

The transportation of radioactive materials, as well as hazardous materials in general, has been an issue of ever-increasing concern and an object of numerous regulations and legislative actions worldwide. The Transportation Technology Center of the US Department of Energy's Sandia Laboratories in Albuquerque, New Mexico, is currently involved in developing a national program to assure the safe shipment of radioactive materials. At Oak Ridge National Laboratory (ORNL), Oak Ridge, Tennessee, this overall effort is being supported in a specialized manner. As part of the Logistics Modeling program at ORNL, the Ecological Sciences Information Center has developed comprehensive data bases containing legislative and regulatory actions relevant to the transportation of hazardous materials. The data bases are separated according to status level of the legislation. The Current Legislation Data Base includes all new legislative actions introduced during the present year (1980) or those bills carried over from the previous year's sessions. The second data file, Historical Legislation Data Base, consists of all legislative actions since 1976 that have passed and become public laws, as well as those actions that were unsuccessful and were classified as denied by law. Currently the data bases include state-, local-, and federal, level legislation, with emphasis on the transportation of radioactive materials. Because of their relevance to the transportation issues, actions involving related subject areas such as, disposal and storage of radioactive wastes, moratoriums on power plant construction, and remedial actions studies, special agencies to regulate shipment of radioactive materials, and requirements of advanced notification, permits and escorts are also included in the data bases

The regulatory function in radioactive waste management

International Nuclear Information System (INIS)

Duncan, A.; Pescatore, C.

2008-01-01

Allan Duncan, expert to NEA and former Chief Inspector for Pollution (United Kingdom), elaborated on the regulatory function in the domain of radioactive waste management. The preparation of a document and a brochure on the subject has been one of the main tasks of the Regulators' Forum since its creation in 2001. He stressed that management of NORM waste was generally subject to different standards than similar radioactive waste from a nuclear source, for no obvious reason than that of public perception. He also pointed out the large number of 'regulatory bodies' involved in the regulation of radioactive waste management facilities and particularly geological disposal facilities, and their links to the Government. He gave the example of the United Kingdom. He stressed the fact that, since there will not be continuous control, licensing of geological disposal is an act of trust in the regulatory system. A. Duncan gave the position of two Commissions in England on deep geological disposal. The UK Sustainable Development Commission says, 'it is impossible to guarantee safety over long-term disposal of (nuclear) waste' which implies that nuclear fission power should be shut down; CoRWM, the Committee on Radioactive Waste Management, recommends instead geological disposal for existing wastes as a broadly acceptable solution. As a concluding remark A. Duncan focused the attention on the general question of what current society needs to do in order to meet its obligations to future generations with respect to disposal of long-lived wastes. (authors)

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)

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

NARCIS (Netherlands)

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

2014-01-01

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

Regulatory framework and business models for charging plug-in electric vehicles: Infrastructure, agents, and commercial relationships

Energy Technology Data Exchange (ETDEWEB)

Gomez San Roman, Tomas [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain); Momber, Ilan, E-mail: ilan.momber@iit.upcomillas.es [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain); Rivier Abbad, Michel; Sanchez Miralles, Alvaro [Instituto de Investigacion Tecnologica, Universidad Pontificia Comillas, Madrid (Spain)

2011-10-15

Electric vehicles (EVs) present efficiency and environmental advantages over conventional transportation. It is expected that in the next decade this technology will progressively penetrate the market. The integration of plug-in electric vehicles in electric power systems poses new challenges in terms of regulation and business models. This paper proposes a conceptual regulatory framework for charging EVs. Two new electricity market agents, the EV charging manager and the EV aggregator, in charge of developing charging infrastructure and providing charging services are introduced. According to that, several charging modes such as EV home charging, public charging on streets, and dedicated charging stations are formulated. Involved market agents and their commercial relationships are analysed in detail. The paper elaborates the opportunities to formulate more sophisticated business models for vehicle-to-grid applications under which the storage capability of EV batteries is used for providing peak power or frequency regulation to support the power system operation. Finally penetration phase dependent policy and regulatory recommendations are given concerning time-of-use pricing, smart meter deployment, stable and simple regulation for reselling energy on private property, roll-out of public charging infrastructure as well as reviewing of grid codes and operational system procedures for interactions between network operators and vehicle aggregators. - Highlights: > A conceptual regulatory framework for charging EVs is proposed. > 2 new agents, EV charging point manager, EV aggregator and their functions are introduced. > Depending on private or public access of charging points, contractual relations change. > A classification of charging scenarios alludes implications on regulatory topics. > EV penetration phase dependent policy and regulatory recommendations are given.

Regulatory network analysis of Epstein-Barr virus identifies functional modules and hub genes involved in infectious mononucleosis.

Science.gov (United States)

Poorebrahim, Mansour; Salarian, Ali; Najafi, Saeideh; Abazari, Mohammad Foad; Aleagha, Maryam Nouri; Dadras, Mohammad Nasr; Jazayeri, Seyed Mohammad; Ataei, Atousa; Poortahmasebi, Vahdat

2017-05-01

Epstein-Barr virus (EBV) is the most common cause of infectious mononucleosis (IM) and establishes lifetime infection associated with a variety of cancers and autoimmune diseases. The aim of this study was to develop an integrative gene regulatory network (GRN) approach and overlying gene expression data to identify the representative subnetworks for IM and EBV latent infection (LI). After identifying differentially expressed genes (DEGs) in both IM and LI gene expression profiles, functional annotations were applied using gene ontology (GO) and BiNGO tools, and construction of GRNs, topological analysis and identification of modules were carried out using several plugins of Cytoscape. In parallel, a human-EBV GRN was generated using the Hu-Vir database for further analyses. Our analysis revealed that the majority of DEGs in both IM and LI were involved in cell-cycle and DNA repair processes. However, these genes showed a significant negative correlation in the IM and LI states. Furthermore, cyclin-dependent kinase 2 (CDK2) - a hub gene with the highest centrality score - appeared to be the key player in cell cycle regulation in IM disease. The most significant functional modules in the IM and LI states were involved in the regulation of the cell cycle and apoptosis, respectively. Human-EBV network analysis revealed several direct targets of EBV proteins during IM disease. Our study provides an important first report on the response to IM/LI EBV infection in humans. An important aspect of our data was the upregulation of genes associated with cell cycle progression and proliferation.

Regulatory reform in Mexico's natural gas sector

International Nuclear Information System (INIS)

1996-01-01

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

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

Science.gov (United States)

Belackova, Vendula; Shanahan, Marian; Ritter, Alison

2017-05-30

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

Annual Report 2009. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

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

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

Regulatory Guidance for Lightning Protection in Nuclear Power Plants

International Nuclear Information System (INIS)

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

2006-01-01

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

Innate immunity and effector and regulatory mechanisms involved in allergic contact dermatitis.

Science.gov (United States)

Silvestre, Marilene Chaves; Sato, Maria Notomi; Reis, Vitor Manoel Silva Dos

2018-03-01

Skin's innate immunity is the initial activator of immune response mechanisms, influencing the development of adaptive immunity. Some contact allergens are detected by Toll-like receptors (TLRs) and inflammasome NLR3. Keratinocytes participate in innate immunity and, in addition to functioning as an anatomical barrier, secrete cytokines, such as TNF, IL-1β, and IL-18, contributing to the development of Allergic Contact Dermatitis. Dendritic cells recognize and process antigenic peptides into T cells. Neutrophils cause pro-inflammatory reactions, mast cells induce migration/maturation of skin DCs, the natural killer cells have natural cytotoxic capacity, the γδ T cells favor contact with hapten during the sensitization phase, and the innate lymphoid cells act in the early stages by secreting cytokines, as well as act in inflammation and tissue homeostasis. The antigen-specific inflammation is mediated by T cells, and each subtype of T cells (Th1/Tc1, Th2/Tc2, and Th17/Tc17) activates resident skin cells, thus contributing to inflammation. Skin's regulatory T cells have a strong ability to inhibit the proliferation of hapten-specific T cells, acting at the end of the Allergic Contact Dermatitis response and in the control of systemic immune responses. In this review, we report how cutaneous innate immunity is the first line of defense and focus its role in the activation of the adaptive immune response, with effector response induction and its regulation.

Innate immunity and effector and regulatory mechanisms involved in allergic contact dermatitis*

Science.gov (United States)

Silvestre, Marilene Chaves; Sato, Maria Notomi; dos Reis, Vitor Manoel Silva

2018-01-01

Skin's innate immunity is the initial activator of immune response mechanisms, influencing the development of adaptive immunity. Some contact allergens are detected by Toll-like receptors (TLRs) and inflammasome NLR3. Keratinocytes participate in innate immunity and, in addition to functioning as an anatomical barrier, secrete cytokines, such as TNF, IL-1β, and IL-18, contributing to the development of Allergic Contact Dermatitis. Dendritic cells recognize and process antigenic peptides into T cells. Neutrophils cause pro-inflammatory reactions, mast cells induce migration/maturation of skin DCs, the natural killer cells have natural cytotoxic capacity, the γδ T cells favor contact with hapten during the sensitization phase, and the innate lymphoid cells act in the early stages by secreting cytokines, as well as act in inflammation and tissue homeostasis. The antigen-specific inflammation is mediated by T cells, and each subtype of T cells (Th1/Tc1, Th2/Tc2, and Th17/Tc17) activates resident skin cells, thus contributing to inflammation. Skin's regulatory T cells have a strong ability to inhibit the proliferation of hapten-specific T cells, acting at the end of the Allergic Contact Dermatitis response and in the control of systemic immune responses. In this review, we report how cutaneous innate immunity is the first line of defense and focus its role in the activation of the adaptive immune response, with effector response induction and its regulation. PMID:29723367

A flexible regulatory framework

International Nuclear Information System (INIS)

Silvennoinen, T.

2000-01-01

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

Food irradiation regulatory development in the U.S

International Nuclear Information System (INIS)

Miller, S.A.; Coleman, E.C.

1985-01-01

The Food and Drug Administration's involvement in food irradiation dates back more than thirty years. The agency has been involved with the wholesomeness testing of the irradiated foods from both nutritional and toxicological standpoints. Knowledge about the nutritional and toxicological aspects of irradiated foods is fundamental in the development of a regulatory strategy for assuring the safe use of such foods. (author)

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

Directory of Open Access Journals (Sweden)

Marcelo Barros da Cunha

2016-05-01

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

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

International Nuclear Information System (INIS)

Ilizastegui Perez, F.

1998-01-01

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

Ancient duplications and functional divergence in the interferon regulatory factors of vertebrates provide insights into the evolution of vertebrate immune systems.

Science.gov (United States)

Du, Kang; Zhong, Zaixuan; Fang, Chengchi; Dai, Wei; Shen, Yanjun; Gan, Xiaoni; He, Shunping

2018-04-01

Interferon regulatory factors (IRFs) were first discovered as transcription factors that regulate the transcription of human interferon (IFN)-β. Increasing evidence shows that they might be important players involved in Adaptive immune system (AIS) evolution. Although numbers of IRFs have been identified in chordates, the evolutionary history and functional diversity of this gene family during the early evolution of vertebrates have remained obscure. Using IRF HMM profile and HMMER searches, we identified 148 IRFs in 11 vertebrates and 4 protochordates. For them, we reconstructed the phylogenetic relationships, determined the synteny conservation, investigated the profile of natural selection, and analyzed the expression patterns in four "living fossil" vertebrates: lamprey, elephant shark, coelacanth and bichir. The results from phylogeny and synteny analysis imply that vertebrate IRFs evolved from three predecessors, instead of four as suggested in a previous study, as results from an ancient duplication followed by special expansions and lost during the vertebrate evolution. The profile of natural selection and expression reveals functional dynamics during the process. Together, they suggest that the 2nd whole-genome duplication (2WGD) provided raw materials for innovation in the IRF family, and that the birth of type-I IFN might be an important factor inducing the establishment of IRF-mediated immune networks. As a member involved in the AIS evolution, IRF provide insights into the process and mechanism involved in the complexity and novelties of vertebrate immune systems. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Gene ercA, encoding a putative iron-containing alcohol dehydrogenase, is involved in regulation of ethanol utilization in Pseudomonas aeruginosa.

Science.gov (United States)

Hempel, Niels; Görisch, Helmut; Mern, Demissew S

2013-09-01

Several two-component regulatory systems are known to be involved in the signal transduction pathway of the ethanol oxidation system in Pseudomonas aeruginosa ATCC 17933. These sensor kinases and response regulators are organized in a hierarchical manner. In addition, a cytoplasmic putative iron-containing alcohol dehydrogenase (Fe-ADH) encoded by ercA (PA1991) has been identified to play an essential role in this regulatory network. The gene ercA (PA1991) is located next to ercS, which encodes a sensor kinase. Inactivation of ercA (PA1991) by insertion of a kanamycin resistance cassette created mutant NH1. NH1 showed poor growth on various alcohols. On ethanol, NH1 grew only with an extremely extended lag phase. During the induction period on ethanol, transcription of structural genes exa and pqqABCDEH, encoding components of initial ethanol oxidation in P. aeruginosa, was drastically reduced in NH1, which indicates the regulatory function of ercA (PA1991). However, transcription in the extremely delayed logarithmic growth phase was comparable to that in the wild type. To date, the involvement of an Fe-ADH in signal transduction processes has not been reported.

Regulatory elements involved in tax-mediated transactivation of the HTLV-I LTR.

Science.gov (United States)

Seeler, J S; Muchardt, C; Podar, M; Gaynor, R B

1993-10-01

HTLV-I is the etiologic agent of adult T-cell leukemia. In this study, we investigated the regulatory elements and cellular transcription factors which function in modulating HTLV-I gene expression in response to the viral transactivator protein, tax. Transfection experiments into Jurkat cells of a variety of site-directed mutants in the HTLV-1 LTR indicated that each of the three motifs A, B, and C within the 21-bp repeats, the binding sites for the Ets family of proteins, and the TATA box all influenced the degree of tax-mediated activation. Tax is also able to activate gene expression of other viral and cellular promoters. Tax activation of the IL-2 receptor and the HIV-1 LTR is mediated through NF-kappa B motifs. Interestingly, sequences in the 21-bp repeat B and C motifs contain significant homology with NF-kappa B regulatory elements. We demonstrated that an NF-kappa B binding protein, PRDII-BF1, but not the rel protein, bound to the B and C motifs in the 21-bp repeat. PRDII-BF1 was also able to stimulate activation of HTLV-I gene expression by tax. The role of the Ets proteins on modulating tax activation was also studied. Ets 1 but not Ets 2 was capable of increasing the degree of tax activation of the HTLV-I LTR. These results suggest that tax activates gene expression by either direct or indirect interaction with several cellular transcription factors that bind to the HTLV-I LTR.

Support in the development of Regulatory Procedures for licensing Lepse Waste Management Operations

International Nuclear Information System (INIS)

2001-05-01

This report describes a project intended to assist Gosatomnadzor of Russia develop a set of documents defining the regulatory requirements for information to be submitted to Gosatomnadzor in support of any application for a licence relating to the removal of spent nuclear fuel from the depot ship Lepse. The project resulted in the development of three regulatory documents covering the documentation required in support of a licence application, the requirements for quality assurance arrangements and the safety analysis report. The working method adopted involved staged development of draft material and review at workshops involving a wide variety of relevant Russian and western organizations. The input and output of the workshops was fully documented to provide an audit trail for the document development and the rationale for what has been included and what is excluded and why. The availability of the regulatory documents in English should significantly assist in the use of the documents by western partners in the actual industrial project. Important experience and information was exchanged among participants in the project. The developing understanding is an important element in providing confidence, from a western perspective, that appropriate regulatory supervision can be applied to industrial projects supported by organizations such as the European Commission and national agencies. The same working methods could be used in the next phase of Lepse regulatory support, i.e., support in development of the procedures for the regulatory review of licence applications, and, subsequently, support in the application of the regulatory inspection process to ensure licence conditions are being complied with. Similarly, these working methods could be used in providing regulatory support for nuclear and radiation safety related to other industrial projects involving radioactive waste management. The participants in this sub-project described in this report were Norwegian

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)

Stakeholders in nursing education: their role and involvement.

Science.gov (United States)

Virgolesi, M; Marchetti, A; Piredda, M; Pulimeno, A M L; Rocco, G; Stievano, A; De Marinis, M G

2014-01-01

In literature, there is evidence that all stakeholders need to be involved in the curricula building process to make sure that health professionals are "educated" to meet the stakeholders' "demands". In Italy, the involvement of stakeholders in the definition of university curricula is ratified by various regulations. To describe the major experiences of stakeholder involvement in nursing education, identify the main stakeholders for nursing education, and the processes in which they are involved. The search strategy included an electronic exploration of the relevant databases. The search terms were: Stakeholders, Curriculum, Nursing Education combined with Boolean operators. The references of the retrieved articles were hand searched for additional related studies. Most of the studies identified were from the United Kingdom, Australia, and the USA. In Italy, no relevant studies were found. The most frequently identified stakeholders were: students, clinicians, educators, nurse managers. They were mainly involved during profound changes in the curricula and the implementation of new educational approaches. Stakeholders are mostly involved in countries with a private funding system for universities. Such funding systems have probably developed in the academia a greater propensity to involve stakeholders, to provide recognition of success when starting new programs, and are perceived more as marketing research. This seems contrary to the spirit of the Italian and European regulatory interventions, which instead, provide a structured commitment to consolidating and expanding the collaboration among universities, users, and the world of labor. This latter collaboration should facilitate internship activities, lifelong learning, and employability of the newly-graduated professionals.

Risk acceptance criteria of the Nuclear Regulatory Authority

International Nuclear Information System (INIS)

Felizia, Eduardo R.

2005-01-01

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

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

DEFF Research Database (Denmark)

Ropenus, Stephanie; Skytte, Klaus

2005-01-01

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

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.

Systematic identification and characterization of regulatory elements derived from human endogenous retroviruses.

Directory of Open Access Journals (Sweden)

Jumpei Ito

2017-07-01

Full Text Available Human endogenous retroviruses (HERVs and other long terminal repeat (LTR-type retrotransposons (HERV/LTRs have regulatory elements that possibly influence the transcription of host genes. We systematically identified and characterized these regulatory elements based on publicly available datasets of ChIP-Seq of 97 transcription factors (TFs provided by ENCODE and Roadmap Epigenomics projects. We determined transcription factor-binding sites (TFBSs using the ChIP-Seq datasets and identified TFBSs observed on HERV/LTR sequences (HERV-TFBSs. Overall, 794,972 HERV-TFBSs were identified. Subsequently, we identified "HERV/LTR-shared regulatory element (HSRE," defined as a TF-binding motif in HERV-TFBSs, shared within a substantial fraction of a HERV/LTR type. HSREs could be an indication that the regulatory elements of HERV/LTRs are present before their insertions. We identified 2,201 HSREs, comprising specific associations of 354 HERV/LTRs and 84 TFs. Clustering analysis showed that HERV/LTRs can be grouped according to the TF binding patterns; HERV/LTR groups bounded to pluripotent TFs (e.g., SOX2, POU5F1, and NANOG, embryonic endoderm/mesendoderm TFs (e.g., GATA4/6, SOX17, and FOXA1/2, hematopoietic TFs (e.g., SPI1 (PU1, GATA1/2, and TAL1, and CTCF were identified. Regulatory elements of HERV/LTRs tended to locate nearby and/or interact three-dimensionally with the genes involved in immune responses, indicating that the regulatory elements play an important role in controlling the immune regulatory network. Further, we demonstrated subgroup-specific TF binding within LTR7, LTR5B, and LTR5_Hs, indicating that gains or losses of the regulatory elements occurred during genomic invasions of the HERV/LTRs. Finally, we constructed dbHERV-REs, an interactive database of HERV/LTR regulatory elements (http://herv-tfbs.com/. This study provides fundamental information in understanding the impact of HERV/LTRs on host transcription, and offers insights into

Argentine influence on regulatory activities in Latin America

International Nuclear Information System (INIS)

Palacios, Elias

1998-01-01

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

SELANSI: a toolbox for simulation of stochastic gene regulatory networks.

Science.gov (United States)

Pájaro, Manuel; Otero-Muras, Irene; Vázquez, Carlos; Alonso, Antonio A

2018-03-01

Gene regulation is inherently stochastic. In many applications concerning Systems and Synthetic Biology such as the reverse engineering and the de novo design of genetic circuits, stochastic effects (yet potentially crucial) are often neglected due to the high computational cost of stochastic simulations. With advances in these fields there is an increasing need of tools providing accurate approximations of the stochastic dynamics of gene regulatory networks (GRNs) with reduced computational effort. This work presents SELANSI (SEmi-LAgrangian SImulation of GRNs), a software toolbox for the simulation of stochastic multidimensional gene regulatory networks. SELANSI exploits intrinsic structural properties of gene regulatory networks to accurately approximate the corresponding Chemical Master Equation with a partial integral differential equation that is solved by a semi-lagrangian method with high efficiency. Networks under consideration might involve multiple genes with self and cross regulations, in which genes can be regulated by different transcription factors. Moreover, the validity of the method is not restricted to a particular type of kinetics. The tool offers total flexibility regarding network topology, kinetics and parameterization, as well as simulation options. SELANSI runs under the MATLAB environment, and is available under GPLv3 license at https://sites.google.com/view/selansi. antonio@iim.csic.es. © The Author(s) 2017. Published by Oxford University Press.

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

International Nuclear Information System (INIS)

Hauser-Kronberger, C.

1992-01-01

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

A Review on Regulatory Enforcement Policy

International Nuclear Information System (INIS)

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

2017-01-01

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

Systemic involvement in localized scleroderma/morphea.

Science.gov (United States)

Gorkiewicz-Petkow, Anna; Kalinska-Bienias, Agnieszka

2015-01-01

Localized scleroderma (LoSc), also known as morphea, is a rare fibrosing disorder of the skin and underlying tissues. Sclerosis is mainly limited to the skin, but subcutaneous tissue, fascia, and underlying muscles and bone may also be involved. In some cases, systemic manifestation with visceral abnormalities may occur. Several publications have focused on significant aspects of LoSc: genetics, immunity, epidemiology, scoring systems, and unification of classifications. Clinical studies featuring large cohorts with the disease published by various international study groups have been of great value in furthering the diagnostic and therapeutic management of LoSc. Copyright © 2015 Elsevier Inc. All rights reserved.

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

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

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

Regulatory framework and business models for charging plug-in electric vehicles: Infrastructure, agents, and commercial relationships

International Nuclear Information System (INIS)

Gomez San Roman, Tomas; Momber, Ilan; Rivier Abbad, Michel; Sanchez Miralles, Alvaro

2011-01-01

Electric vehicles (EVs) present efficiency and environmental advantages over conventional transportation. It is expected that in the next decade this technology will progressively penetrate the market. The integration of plug-in electric vehicles in electric power systems poses new challenges in terms of regulation and business models. This paper proposes a conceptual regulatory framework for charging EVs. Two new electricity market agents, the EV charging manager and the EV aggregator, in charge of developing charging infrastructure and providing charging services are introduced. According to that, several charging modes such as EV home charging, public charging on streets, and dedicated charging stations are formulated. Involved market agents and their commercial relationships are analysed in detail. The paper elaborates the opportunities to formulate more sophisticated business models for vehicle-to-grid applications under which the storage capability of EV batteries is used for providing peak power or frequency regulation to support the power system operation. Finally penetration phase dependent policy and regulatory recommendations are given concerning time-of-use pricing, smart meter deployment, stable and simple regulation for reselling energy on private property, roll-out of public charging infrastructure as well as reviewing of grid codes and operational system procedures for interactions between network operators and vehicle aggregators. - Highlights: → A conceptual regulatory framework for charging EVs is proposed. → 2 new agents, EV charging point manager, EV aggregator and their functions are introduced. → Depending on private or public access of charging points, contractual relations change. → A classification of charging scenarios alludes implications on regulatory topics. → EV penetration phase dependent policy and regulatory recommendations are given.

Experience Transformed into Nuclear Regulatory Improvements in Russia

International Nuclear Information System (INIS)

Sapozhnikov, A.

2016-01-01

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

Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria

International Nuclear Information System (INIS)

Acevedo Lozada, D. J.; Rivas, I.; Davila, L.; Flores, Y.

2013-01-01

The present work shows the need to identify, in the Venezuelan oil industry, the existence of exposure to natural sources of radiation should be considered as occupational. As Regulatory Authority in the area of ionizing radiation the need for regulatory processes and ensure radiation protection of personnel involved in these practices arises, as well as personal and environmental monitoring. NORM identifying an installation of the Venezuelan oil industry to establish regulatory processes and take steps to ensure occupational radiation protection. (Author)

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

International Nuclear Information System (INIS)

Polo, Rolando

1996-01-01

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

The Tumorigenic Roles of the Cellular REDOX Regulatory Systems

Directory of Open Access Journals (Sweden)

Stéphanie Anaís Castaldo

2016-01-01

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

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

International Nuclear Information System (INIS)

2012-01-01

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

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)

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.

A Regulatory Circuit Composed of a Transcription Factor, IscR, and a Regulatory RNA, RyhB, Controls Fe-S Cluster Delivery.

Science.gov (United States)

Mandin, Pierre; Chareyre, Sylvia; Barras, Frédéric

2016-09-20

Fe-S clusters are cofactors conserved through all domains of life. Once assembled by dedicated ISC and/or SUF scaffolds, Fe-S clusters are conveyed to their apo-targets via A-type carrier proteins (ATCs). Escherichia coli possesses four such ATCs. ErpA is the only ATC essential under aerobiosis. Recent studies reported a possible regulation of the erpA mRNA by the small RNA (sRNA) RyhB, which controls the expression of many genes under iron starvation. Surprisingly, erpA has not been identified in recent transcriptomic analysis of the iron starvation response, thus bringing into question the actual physiological significance of the putative regulation of erpA by RyhB. Using an sRNA library, we show that among 26 sRNAs, only RyhB represses the expression of an erpA-lacZ translational fusion. We further demonstrate that this repression occurs during iron starvation. Using mutational analysis, we show that RyhB base pairs to the erpA mRNA, inducing its disappearance. In addition, IscR, the master regulator of Fe-S homeostasis, represses expression of erpA at the transcriptional level when iron is abundant, but depleting iron from the medium alleviates this repression. The conjunction of transcriptional derepression by IscR and posttranscriptional repression by RyhB under Fe-limiting conditions is best described as an incoherent regulatory circuit. This double regulation allows full expression of erpA at iron concentrations for which Fe-S biogenesis switches from the ISC to the SUF system. We further provide evidence that this regulatory circuit coordinates ATC usage to iron availability. Regulatory small RNAs (sRNAs) have emerged as major actors in the control of gene expression in the last few decades. Relatively little is known about how these regulators interact with classical transcription factors to coordinate genetic responses. We show here how an sRNA, RyhB, and a transcription factor, IscR, regulate expression of an essential gene, erpA, in the bacterium E

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.

Ion Channels Involved in Cell Volume Regulation

DEFF Research Database (Denmark)

Hoffmann, Else Kay

2011-01-01

regulatory ion channels involved, and the mechanisms (cellular signalling pathways) that regulate these channels. Finally, I shall also briefly review current investigations in these two cell lines that focuses on how changes in cell volume can regulate cell functions such as cell migration, proliferation......This mini review outlines studies of cell volume regulation in two closely related mammalian cell lines: nonadherent Ehrlich ascites tumour cells (EATC) and adherent Ehrlich Lettre ascites (ELA) cells. Focus is on the regulatory volume decrease (RVD) that occurs after cell swelling, the volume...

Stakeholder Involvement Throughout the Life Cycle of Nuclear Facilities

International Nuclear Information System (INIS)

2011-01-01

This report demonstrates the importance of stakeholder involvement throughout the life cycle of all nuclear facilities; including operating reactors, temporary spent fuel storage facilities and final radioactive waste repositories and follows what is defined in the IAEA Safety Standards GS-R-3 where the stakeholders' expectations (identified as 'interested parties' in GS-R-3) shall be taken into consideration 'in the activities and interactions in the processes of the management system, with the aim of enhancing the satisfaction of interested parties while at the same time ensuring that safety is not compromised'. This report explains how involving stakeholders in decision making processes, even for those stakeholder groups that do not have a direct role in making those decisions, can enhance public confidence in the application of nuclear science and technology. In addition, this report presents general guidance on stakeholder involvement. It does not provide detailed procedures for developing and implementing stakeholder involvement programmes, and specifics regarding stakeholder involvement for particular types of nuclear facilities. However, this publication references reports that provide such details. This publication provides assistance to those responsible for planning, designing, constructing, operating or decommissioning a nuclear facility. In addition, regulatory organizations and other authorities overseeing nuclear activities or managing nuclear facility licensing processes are often seen as the main source of independent information for the general public; therefore, stakeholder involvement can demonstrate capability and trustworthiness of regulatory organizations as well. The role of stakeholder involvement at different stages of a facility's life cycle is discussed, with suggestions on developing the components of a comprehensive stakeholder involvement plan. Included is guidance on focusing communication with certain stakeholders, applying various

Rate of cardiovascular system involvement and gender distribution in Behcets disease

Directory of Open Access Journals (Sweden)

Yalcin Bas

2011-06-01

Full Text Available Behcets disease is a systemic vasculitis affecting arteries and veins. According to the International Working Group on diagnostic criteria, a clinical description of other non-recurrent oral ulceration, at least two of findings of their examinations; genital ulceration, eye lesions, skin lesions and pathergy test positivity to be accompanied. Vascular involvement is very important symptom in determining the prognosis of the disease that is commonly observed. In this study, 581 Behcets patients who were treated between 1993-2009 were reviewed. 52 patients with cardiovascular involvement retrospectively reviewed. Total cardiovascular system involvements were found to be 9% in Behcets disease patients. 41 thrombophlebit, 11 deep venous thrombosis, 4 aneurysm cases were found. Pulmonary artery aneurysms in 2 of them, 1 in the abdominal aorta, 1 of which was found in the femoral artery. All of aneurysm and deep vein thrombosis and 77% of thrombophlebitis were male. As a result, together with common skin and mucosal involvement severe systemic symptoms such as the cardiovascular system involvement were significantly found in Behcets disease. Moreover, a high percentage of these findings is seen in men have been identified. [J Contemp Med 2011; 1(2.000: 46-49

Regulatory factors governing adenosine-to-inosine (A-to-I) RNA editing.

Science.gov (United States)

Hong, HuiQi; Lin, Jaymie Siqi; Chen, Leilei

2015-03-31

Adenosine-to-inosine (A-to-I) RNA editing, the most prevalent mode of transcript modification in higher eukaryotes, is catalysed by the adenosine deaminases acting on RNA (ADARs). A-to-I editing imposes an additional layer of gene regulation as it dictates various aspects of RNA metabolism, including RNA folding, processing, localization and degradation. Furthermore, editing events in exonic regions contribute to proteome diversity as translational machinery decodes inosine as guanosine. Although it has been demonstrated that dysregulated A-to-I editing contributes to various diseases, the precise regulatory mechanisms governing this critical cellular process have yet to be fully elucidated. However, integration of previous studies revealed that regulation of A-to-I editing is multifaceted, weaving an intricate network of auto- and transregulations, including the involvement of virus-originated factors like adenovirus-associated RNA. Taken together, it is apparent that tipping of any regulatory components will have profound effects on A-to-I editing, which in turn contributes to both normal and aberrant physiological conditions. A complete understanding of this intricate regulatory network may ultimately be translated into new therapeutic strategies against diseases driven by perturbed RNA editing events. Herein, we review the current state of knowledge on the regulatory mechanisms governing A-to-I editing and propose the role of other co-factors that may be involved in this complex regulatory process.

Implementation of a Quality Management System in regulatory inspection activities

International Nuclear Information System (INIS)

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

2005-01-01

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

Conservatism in effective dose calculations for accident events involving fuel reprocessing waste tanks.

Science.gov (United States)

Bevelacqua, J J

2011-07-01

Conservatism in the calculation of the effective dose following an airborne release from an accident involving a fuel reprocessing waste tank is examined. Within the regulatory constraints at the Hanford Site, deterministic effective dose calculations are conservative by at least an order of magnitude. Deterministic calculations should be used with caution in reaching decisions associated with required safety systems and mitigation philosophy related to the accidental release of airborne radioactive material to the environment.

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

[TNF-α, diabetes type 1 and regulatory T cells].

Science.gov (United States)

Ryba, Monika; Myśliwska, Jolanta

2010-01-01

Recent studies on animal models of diabetes as well as human regulatory T cells have shown that α impairs the ability of these cells to prevent the disease. NOD mice treated with α had decreased frequency of regulatory T cells, whereas anti-TNF administration induced the increase in the number of these cells and disease prevention. The action of α also influenced the suppressive potential of Tregs. Increased susceptibility of Tregs to the modulatory effects of α involves signaling through TNFR2 that is expressed on the surface of this cell population. It seems that α neutralization may rescue regulatory T cells and restore their function in several autoimmune and inflammatory diseases. This review describes recent data concerning regulatory T cells in the context of inflammation that is present during diabetes type 1. It describes how TNF contributes to the pathogenesis of type 1 diabetes, what is the impact of this cytokine on regulatory T cell population and therapeutic effects that result from its neutralization in several inflammatory and autoimmune diseases.

Regulatory research for waste disposal - Objectives and international approaches

International Nuclear Information System (INIS)

Wanner, Hans; Fischer-Appelt, Klaus; Pescatore, Claudio

2011-01-01

The question of active involvement of nuclear regulatory and supervisory bodies in research and development (R and D) projects has become a topic of increasing interest in recent years. The way in which research is included in regulatory activities varies from country to country, ranging from countries with no regulatory R and D activities to countries with extensive activities which are often carried out by independent research organisations acting on behalf of the regulatory body. The present report outlines (part 1) the potential merits of R and D work carried out by the regulator, and summarizes (part 2) the results of a questionnaire that was circulated among the members of the Regulators' Forum of NEA's Radioactive Waste Management Committee in 2009. Part 3 presents the conclusions of discussions within the RWMC-RF. The detailed answers to the questionnaire are also provided

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

Science.gov (United States)

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

2017-05-01

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

Excessive crying in infants with regulatory disorders.

Science.gov (United States)

Maldonado-Duran, M; Sauceda-Garcia, J M

1996-01-01

The authors point out a correlation between regulatory disorders in infants and the problem of excessive crying. The literature describes other behavioral problems involving excessive crying in very young children, but with little emphasis on this association. The recognition and diagnosis of regulatory disorders in infants who cry excessively can help practitioners design appropriate treatment interventions. Understanding these conditions can also help parents tailor their caretaking style, so that they provide appropriate soothing and stimulation to their child. In so doing, they will be better able to develop and preserve a satisfactory parent-child relationship, as well as to maintain their own sense of competence and self-esteem as parents.

Gene regulatory and signaling networks exhibit distinct topological distributions of motifs

Science.gov (United States)

Ferreira, Gustavo Rodrigues; Nakaya, Helder Imoto; Costa, Luciano da Fontoura

2018-04-01

The biological processes of cellular decision making and differentiation involve a plethora of signaling pathways and gene regulatory circuits. These networks in turn exhibit a multitude of motifs playing crucial parts in regulating network activity. Here we compare the topological placement of motifs in gene regulatory and signaling networks and observe that it suggests different evolutionary strategies in motif distribution for distinct cellular subnetworks.

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

International Nuclear Information System (INIS)

Basdekas, D.L.

1989-05-01

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

Clinical and biological features of multiple myeloma involving the gastrointestinal system.

Science.gov (United States)

Talamo, Giampaolo; Cavallo, Federica; Zangari, Maurizio; Barlogie, Bart; Lee, Choon-Kee; Pineda-Roman, Mauricio; Kiwan, Elias; Krishna, Somashekar; Tricot, Guido

2006-07-01

We report 24 cases of multiple myeloma (MM) with involvement of the gastrointestinal (GI) system. We found a strong association with high A lactate dehydrogenase levels, plasmablastic morphology, and A unfavorable karyotype. GI involvement at the time of initial diagnosis was much rarer than later in the course of the disease. The A median survival after diagnosis of GI involvement was 7 months. Among 13 patients treated with stem cell transplantation, the response rate was 92%, and median progression-free survival was 4 months. We conclude that MM involving the GI system is associated with adverse biological features and with short-lasting remissions, even after A high-dose chemotherapy.

CoryneRegNet: an ontology-based data warehouse of corynebacterial transcription factors and regulatory networks.

Science.gov (United States)

Baumbach, Jan; Brinkrolf, Karina; Czaja, Lisa F; Rahmann, Sven; Tauch, Andreas

2006-02-14

The application of DNA microarray technology in post-genomic analysis of bacterial genome sequences has allowed the generation of huge amounts of data related to regulatory networks. This data along with literature-derived knowledge on regulation of gene expression has opened the way for genome-wide reconstruction of transcriptional regulatory networks. These large-scale reconstructions can be converted into in silico models of bacterial cells that allow a systematic analysis of network behavior in response to changing environmental conditions. CoryneRegNet was designed to facilitate the genome-wide reconstruction of transcriptional regulatory networks of corynebacteria relevant in biotechnology and human medicine. During the import and integration process of data derived from experimental studies or literature knowledge CoryneRegNet generates links to genome annotations, to identified transcription factors and to the corresponding cis-regulatory elements. CoryneRegNet is based on a multi-layered, hierarchical and modular concept of transcriptional regulation and was implemented by using the relational database management system MySQL and an ontology-based data structure. Reconstructed regulatory networks can be visualized by using the yFiles JAVA graph library. As an application example of CoryneRegNet, we have reconstructed the global transcriptional regulation of a cellular module involved in SOS and stress response of corynebacteria. CoryneRegNet is an ontology-based data warehouse that allows a pertinent data management of regulatory interactions along with the genome-scale reconstruction of transcriptional regulatory networks. These models can further be combined with metabolic networks to build integrated models of cellular function including both metabolism and its transcriptional regulation.

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

International Nuclear Information System (INIS)

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

1995-01-01

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

Recent Experiments Involving Few-Nucleon Systems

Science.gov (United States)

Tornow, W.

2014-08-01

Recent experimental results are presented for reactions involving A = 3 to A = 6 nuclear systems. The emphasis is on unique data obtained at new experimental facilities. It is shown that the inertial confinement fusion facilities OMEGA and NIF provide a largely unexpected opportunity for experimental few-body physics to both obtain data of unprecedented quality and extend previous measurements to energies not accessible in the past. Whenever possible, data are compared to state-of-the-art theoretical calculations.

Recent Experiments Involving Few-Nucleon Systems

International Nuclear Information System (INIS)

Tornow, W.

2014-01-01

Recent experimental results are presented for reactions involving A = 3 to A = 6 nuclear systems. The emphasis is on unique data obtained at new experimental facilities. It is shown that the inertial confinement fusion facilities OMEGA and NIF provide a largely unexpected opportunity for experimental few-body physics to both obtain data of unprecedented quality and extend previous measurements to energies not accessible in the past. Whenever possible, data are compared to state-of-the-art theoretical calculations. (author)

Regulatory role of melatonin and BMP-4 in prolactin production by rat pituitary lactotrope GH3 cells.

Science.gov (United States)

Ogura-Ochi, Kanako; Fujisawa, Satoshi; Iwata, Nahoko; Komatsubara, Motoshi; Nishiyama, Yuki; Tsukamoto-Yamauchi, Naoko; Inagaki, Kenichi; Wada, Jun; Otsuka, Fumio

2017-08-01

The effects of melatonin on prolactin production and its regulatory mechanism remain uncertain. We investigated the regulatory role of melatonin in prolactin production using rat pituitary lactotrope GH3 cells by focusing on the bone morphogenetic protein (BMP) system. Melatonin receptor activation, induced by melatonin and its receptor agonist ramelteon, significantly suppressed basal and forskolin-induced prolactin secretion and prolactin mRNA expression in GH3 cells. The melatonin MT2 receptor was predominantly expressed in GH3 cells, and the inhibitory effects of melatonin on prolactin production were reversed by treatment with the receptor antagonist luzindole, suggesting functional involvement of MT2 action in the suppression of prolactin release. Melatonin receptor activation also suppressed BMP-4-induced prolactin expression by inhibiting phosphorylation of Smad and transcription of the BMP-target gene Id-1, while BMP-4 treatment upregulated MT2 expression. Melatonin receptor activation suppressed basal, BMP-4-induced and forskolin-induced cAMP synthesis; however, BtcAMP-induced prolactin mRNA expression was not affected by melatonin or ramelteon, suggesting that MT2 activation leads to inhibition of prolactin production through the suppression of Smad signaling and cAMP synthesis. Experiments using intracellular signal inhibitors revealed that the ERK pathway is, at least in part, involved in prolactin induction by GH3 cells. Thus, a new regulatory role of melatonin involving BMP-4 in prolactin secretion was uncovered in lactotrope GH3 cells. Copyright © 2017 Elsevier Inc. All rights reserved.

Stakeholder Involvement in Brazil. Appendix IX.4

International Nuclear Information System (INIS)

2016-01-01

In response to public concerns about mining projects, mechanisms for stakeholder involvement in decisions concerning the licensing process of mining operations have been established. The most popular ones are the public hearings. The environmental regulatory body, Brazilian Institute of the Environment and Renewable Natural Resources (Instituto Brasileiro do Meio Ambiente e dos Recursos Naturais Renováveis, IBAMA), makes use of these events to inform the local community about impacts on the economic, physical and social issues caused by the operation of a mining project. However, by legislation, a uranium mining and processing plant is not regulated solely by the environmental regulator at the state and federal level. The Brazilian National Nuclear Energy Commission (Comissão Nacional de Energia Nuclear, CNEN) plays the key role as the nuclear regulatory body, and in many situations, it is perceived by local communities, where uranium mining projects are developed, as the main responsible party responding to regulatory issues regarding this type of operation. The situation gets even more complicated when it is seen that uranium mining and processing operations are state owned activities and the independency of the regulatory body (mainly the nuclear regulatory authority) is questioned, or at least put under scrutiny. It is not common for an ‘independent’ organization to be requested to provide regulatory oversight and this undermines the trust the communities may have on the regulatory process carried on regarding that specific operation

Annual Report 2013. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across seven parts and eight annexes the activities developed by the organism during 2013. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.

Energy Projects, Social Licence, Public Acceptance and Regulatory Systems in Canada: A White Paper

Directory of Open Access Journals (Sweden)

John Colton

2016-05-01

Full Text Available It has become increasingly difficult in Canada to gain and sustain public acceptance of energy projects. Increased levels of protest, combined with traditional media and social media coverage of opposition, combine to suggest decreased public acceptance of energy projects. Decision-makers have responded accordingly, and a variety of energy projects have either been delayed or put on hold indefinitely. This is true for both conventional and renewable energy projects and in many different regions across the country. A number of proposed energy projects have recently faced opposition from various stakeholder groups. For instance, the decision of the Joint Review Panel for the Northern Gateway Pipeline is being challenged in Canada’s court system. First Nations groups have issued an ultimatum to the Federal Government that it must choose between Site C (a proposed hydro dam and liquefied natural gas development in B.C. Rapid expansion of wind energy projects in Ontario has engendered lengthy and costly appeals and the rise of an anti-wind social movement. In Nova Scotia, tidal energy development is being positioned as a new renewable energy option; gaining public acceptance is critical in light of recent opposition to wind energy development. As these experiences suggest, not only has the regulatory process become more contentious, but also an apparently new concept — social licence — has had popular appeal. This white paper reports on the results of a year-long interdisciplinary collaboration aimed at identifying and summarizing extant research regarding social licence and related concepts, with a particular emphasis on understanding its implications for public acceptance of energy projects in Canada, and their related regulatory processes. In particular, this research addressed the following questions: 1. What is the history and scope of the term ‘social licence’, both in the context of energy project development and more generally? What

Information management systems for integrating the technical data and regulatory requirements of environmental restoration activities

International Nuclear Information System (INIS)

Geffen, C.A.; Garrett, B.A.; Walter, M.B.

1990-03-01

Current environmental regulations require that comprehensive planning be conducted before remediating a hazardous waste site to characterize the nature and extent of site contamination, calculate the risk to the public, and assess the effectiveness of various remediation technologies. Remediation of Department of Energy (DOE) sites contaminated with hazardous or mixed wastes will require the effective integration of scientific and engineering data with regulatory and institutional requirements. The information management challenge presented by waste site cleanup activities goes beyond merely dealing with the large quantity of data that will be generated. The information must be stored, managed, and presented in a way that provides some consistency in approach across sites, avoids duplication of effort, and facilitates responses to requests for information from the regulators and the public. This paper provides background information on the regulatory requirements for data gathering and analysis for environmental restoration activities, and outlines the data and information management requirements for completing the pre-remediation phases of an environmental restoration project. Information management systems for integrating the regulatory and institutional requirements of the environmental restoration process with the technical data and analysis requirements are also described. 7 refs

Integration Host Factor (IHF binds to the promoter region of the phtD operon involved in phaseolotoxin synthesis in P. syringae pv. phaseolicola NPS3121

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Álvarez-Morales Ariel

2011-05-01

Full Text Available Abstract Background Pseudomonas syringae pv. phaseolicola, the causal agent of halo blight disease in beans, produces a toxin known as phaseolotoxin, in whose synthesis participate a group of genes organized within the genome in a region known as the "Pht cluster". This region, which is thought to have been acquired by horizontal gene transfer, includes 5 transcriptional units, two monocistronic (argK, phtL and three polycistronic (phtA, phtD, phtM, whose expression is temperature dependent. So far, the regulatory mechanisms involved in phaseolotoxin synthesis have not been elucidated and the only well-established fact is the requirement of low temperatures for its synthesis. In this work, we searched for regulatory proteins that could be involved in phaseolotoxin synthesis, focusing on the regulation of the phtD operon. Results In this study we identified the global regulator IHF (Integration Host Factor, which binds to the promoter region of the phtD operon, exerting a negative effect on the expression of this operon. This is the first regulatory protein identified as part of the phaseolotoxin synthesis system. Our findings suggest that the Pht cluster was similarly regulated in the ancestral cluster by IHF or similar protein, and integrated into the global regulatory mechanism of P. syringae pv. phaseolicola, after the horizontal gene transfer event by using the host IHF protein. Conclusion This study identifies the IHF protein as one element involved in the regulation of phaseolotoxin synthesis in P. syringae pv. phaseolicola NPS3121 and provides new insights into the regulatory mechanisms involved in phaseolotoxin production.

Smart grids and power systems efficiency: regulatory tools and demand-side management impacts

International Nuclear Information System (INIS)

Bergaentzle, Claire

2015-01-01

The physical architecture of electricity grids and the organizational structure of power systems implemented after the reforms have traditionally be achieved according to the characteristics of the transmission infrastructures and power mixes. However, the new challenges related to energy transition favor a greater participation of decentralized generation and final consumers to system exploitation and competitive markets. This latter participation is made possible thanks to recent innovations in the fields of communication and remote control technologies. Significant evolutions are expected in power industries that share common characteristics. First, these evolutions suppose massive capital investments to modernize and adapt current power distribution grids. Second, it is expected the activation of distribution grids and final consumers will unleash substantial unexploited economic efficiency gains as well as impose new constraints. Taking these simple facts as a starting point, the objective of the thesis is twofold. In the first place, we provide a theoretical analysis of the regulatory instruments that monitor the system operators' expenses. Relying on the literature, we aim at characterizing what regulatory tools and incitation are suitable for investing in smart grids technologies. Since it is necessary to compare theoretical formulation to facts, we use an empirical approach that allows us to designate key benefits pursued by the development of smart grids and to compare our theoretical results with practical regulatory applications. Our findings eventually allow us to formulate recommendations. In the second place, the thesis focuses on the impacts of demand-side management during peak periods. We structure our approach around two general observations. Large benefits should be generated in lowering substantially peak demand. However, such situation also creates losses of profit for generators. We provide an estimation of efficiency gains and revenue losses

REGULATORY T-CELLS IN CHRONIC LYMPHOCYTIC LEUKEMIA

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Giovanni D'arena

2012-08-01

Full Text Available Regulatory T-cells (Tregs constitute a small subset of cells that are actively involved in maintaining self-tolerance, in immune homeostasis and in antitumor immunity. They are thought to play a significant role in the progression of cancer and are generally increased in patient with chronic lymphocytic leukemia (CLL. Their number correlates with more aggressive disease status and is predictive of the time to treatment, as well. Moreover, it is now clear that dysregulation in Tregs cell frequency and/or function may result in a plethora of autoimmune diseases, including multiple sclerosis, type 1 diabetes mellitus, myasthenia gravis, systemic lupus erythematosis, autoimmune lymphoproliferative disorders, rheumatoid arthritis, and psoriasis. Efforts are made aiming to develop approaches to deplete Tregs or inhibit their function in either cancer and autoimmune disorders.

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

Science.gov (United States)

Gorini, Giuseppe

2011-01-01

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

Regulatory issues in the maintenance of Argentine nuclear power plants

International Nuclear Information System (INIS)

Castro, E.; Caruso, G.

1997-01-01

The influence of maintenance activities upon nuclear safety and their relevance as means to detect and prevent aging make them play an outstanding role among the fields of interest of the Argentine nuclear regulatory body (ENREN). Such interest is reinforced by the fact that the data obtained during maintenance are used - among other - as inputs in the Probabilistic Safety Analyses required for those nuclear power plants. This paper provides a brief description of the original requirements by the regulatory body concerning maintenance, of the factors that led to review the criteria involved in such requirements and of the key items identified during the reviewing process. The latter shall be taken into account in the maintenance regulatory policy, for the consequent issue of new requirements from the utilities and for the eventual publication of a specific regulatory standard. (author)

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)

Cardio-pulmonary involvement in systemic sclerosis: A study at a tertiary care center

Directory of Open Access Journals (Sweden)

Geetakiran Arakkal

2017-01-01

Conclusions: In our patients, pulmonary involvement was more common than cardiac involvement. Interstitial lung disease and cardiac involvement were more commonly seen in diffuse systemic sclerosis whereas pulmonary hypertension was more frequent in limited systemic sclerosis. Hence, it is important to screen the patients for cardiopulmonary involvement for early diagnosis and treatment and a better prognostic outcome.

ResDE Two-Component Regulatory System Mediates Oxygen Limitation-Induced Biofilm Formation by Bacillus amyloliquefaciens SQR9.

Science.gov (United States)

Zhou, Xuan; Zhang, Nan; Xia, Liming; Li, Qing; Shao, Jiahui; Shen, Qirong; Zhang, Ruifu

2018-04-15

Efficient biofilm formation and root colonization capabilities facilitate the ability of beneficial plant rhizobacteria to promote plant growth and antagonize soilborne pathogens. Biofilm formation by plant-beneficial Bacillus strains is triggered by environmental cues, including oxygen deficiency, but the pathways that sense these environmental signals and regulate biofilm formation have not been thoroughly elucidated. In this study, we showed that the ResDE two-component regulatory system in the plant growth-promoting rhizobacterium Bacillus amyloliquefaciens strain SQR9 senses the oxygen deficiency signal and regulates biofilm formation. ResE is activated by sensing the oxygen limitation-induced reduction of the NAD + /NADH pool through its PAS domain, stimulating its kinase activity, and resulting in the transfer of a phosphoryl group to ResD. The phosphorylated ResD directly binds to the promoter regions of the qoxABCD and ctaCDEF operons to improve the biosynthesis of terminal oxidases, which can interact with KinB to activate biofilm formation. These results not only revealed the novel regulatory function of the ResDE two-component system but also contributed to the understanding of the complicated regulatory network governing Bacillus biofilm formation. This research may help to enhance the root colonization and the plant-beneficial efficiency of SQR9 and other Bacillus rhizobacteria used in agriculture. IMPORTANCE Bacillus spp. are widely used as bioinoculants for plant growth promotion and disease suppression. The exertion of their plant-beneficial functions is largely dependent on their root colonization, which is closely related to their biofilm formation capabilities. On the other hand, Bacillus is the model bacterium for biofilm study, and the process and molecular network of biofilm formation are well characterized (B. Mielich-Süss and D. Lopez, Environ Microbiol 17:555-565, 2015, https://doi.org/10.1111/1462-2920.12527; L. S. Cairns, L. Hobley, and

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

International Nuclear Information System (INIS)

2013-01-01

development or improvement of nuclear security systems and measures for the detection of criminal or unauthorized acts with nuclear security implications involving nuclear and other radioactive material out of regulatory control. The preparation of this publication benefitted from the model guidelines document for nuclear detection architectures developed within the framework of the Global Initiative to Combat Nuclear Terrorism (GICNT). The work undertaken by the GICNT in this endeavour is gratefully acknowledged.

Regulatory control of radiation sources in the Philippines

International Nuclear Information System (INIS)

Daroy, Rosita R.

1995-01-01

This paper is concerned with the radiation protection and safety infrastructure providing emphasis on the regulation and control of radiation sources in the Philippines. It deals with the experiences of the Philippine Nuclear Research Institute, as a regulatory body, in the regulation and control of radioactive materials in radiotherapy, nuclear medicine, industrial radiography, industrial gauges, industrial irradiators, and well logging. This paper includes an inventory of the sources and types of devices/equipment used by licensed users of radioactive materials in the Philippines as a contribution to the data base being prepared by the IAEA. The problems encountered by the regulatory body in the licensing and enforcement process, as well as the lessons learned from incidents involving radioactive materials are discussed. Plans for improving compliance to the regulations and enhancing the effectiveness of PNRI's regulatory functions are presented. (author)

A Research Framework for Understanding the Practical Impact of Family Involvement in the Juvenile Justice System: The Juvenile Justice Family Involvement Model.

Science.gov (United States)

Walker, Sarah Cusworth; Bishop, Asia S; Pullmann, Michael D; Bauer, Grace

2015-12-01

Family involvement is recognized as a critical element of service planning for children's mental health, welfare and education. For the juvenile justice system, however, parents' roles in this system are complex due to youths' legal rights, public safety, a process which can legally position parents as plaintiffs, and a historical legacy of blaming parents for youth indiscretions. Three recent national surveys of juvenile justice-involved parents reveal that the current paradigm elicits feelings of stress, shame and distrust among parents and is likely leading to worse outcomes for youth, families and communities. While research on the impact of family involvement in the justice system is starting to emerge, the field currently has no organizing framework to guide a research agenda, interpret outcomes or translate findings for practitioners. We propose a research framework for family involvement that is informed by a comprehensive review and content analysis of current, published arguments for family involvement in juvenile justice along with a synthesis of family involvement efforts in other child-serving systems. In this model, family involvement is presented as an ascending, ordinal concept beginning with (1) exclusion, and moving toward climates characterized by (2) information-giving, (3) information-eliciting and (4) full, decision-making partnerships. Specific examples of how courts and facilities might align with these levels are described. Further, the model makes predictions for how involvement will impact outcomes at multiple levels with applications for other child-serving systems.

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

Science.gov (United States)

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

2016-06-01

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

DnaA protein DNA-binding domain binds to Hda protein to promote inter-AAA+ domain interaction involved in regulatory inactivation of DnaA.

Science.gov (United States)

Keyamura, Kenji; Katayama, Tsutomu

2011-08-19

Chromosomal replication is initiated from the replication origin oriC in Escherichia coli by the active ATP-bound form of DnaA protein. The regulatory inactivation of DnaA (RIDA) system, a complex of the ADP-bound Hda and the DNA-loaded replicase clamp, represses extra initiations by facilitating DnaA-bound ATP hydrolysis, yielding the inactive ADP-bound form of DnaA. However, the mechanisms involved in promoting the DnaA-Hda interaction have not been determined except for the involvement of an interaction between the AAA+ domains of the two. This study revealed that DnaA Leu-422 and Pro-423 residues within DnaA domain IV, including a typical DNA-binding HTH motif, are specifically required for RIDA-dependent ATP hydrolysis in vitro and that these residues support efficient interaction with the DNA-loaded clamp·Hda complex and with Hda in vitro. Consistently, substitutions of these residues caused accumulation of ATP-bound DnaA in vivo and oriC-dependent inhibition of cell growth. Leu-422 plays a more important role in these activities than Pro-423. By contrast, neither of these residues is crucial for DNA replication from oriC, although they are highly conserved in DnaA orthologues. Structural analysis of a DnaA·Hda complex model suggested that these residues make contact with residues in the vicinity of the Hda AAA+ sensor I that participates in formation of a nucleotide-interacting surface. Together, the results show that functional DnaA-Hda interactions require a second interaction site within DnaA domain IV in addition to the AAA+ domain and suggest that these interactions are crucial for the formation of RIDA complexes that are active for DnaA-ATP hydrolysis.

DnaA Protein DNA-binding Domain Binds to Hda Protein to Promote Inter-AAA+ Domain Interaction Involved in Regulatory Inactivation of DnaA*

Science.gov (United States)

Keyamura, Kenji; Katayama, Tsutomu

2011-01-01

Chromosomal replication is initiated from the replication origin oriC in Escherichia coli by the active ATP-bound form of DnaA protein. The regulatory inactivation of DnaA (RIDA) system, a complex of the ADP-bound Hda and the DNA-loaded replicase clamp, represses extra initiations by facilitating DnaA-bound ATP hydrolysis, yielding the inactive ADP-bound form of DnaA. However, the mechanisms involved in promoting the DnaA-Hda interaction have not been determined except for the involvement of an interaction between the AAA+ domains of the two. This study revealed that DnaA Leu-422 and Pro-423 residues within DnaA domain IV, including a typical DNA-binding HTH motif, are specifically required for RIDA-dependent ATP hydrolysis in vitro and that these residues support efficient interaction with the DNA-loaded clamp·Hda complex and with Hda in vitro. Consistently, substitutions of these residues caused accumulation of ATP-bound DnaA in vivo and oriC-dependent inhibition of cell growth. Leu-422 plays a more important role in these activities than Pro-423. By contrast, neither of these residues is crucial for DNA replication from oriC, although they are highly conserved in DnaA orthologues. Structural analysis of a DnaA·Hda complex model suggested that these residues make contact with residues in the vicinity of the Hda AAA+ sensor I that participates in formation of a nucleotide-interacting surface. Together, the results show that functional DnaA-Hda interactions require a second interaction site within DnaA domain IV in addition to the AAA+ domain and suggest that these interactions are crucial for the formation of RIDA complexes that are active for DnaA-ATP hydrolysis. PMID:21708944

Stakeholders involvement in the decommissioning processes in Italy

International Nuclear Information System (INIS)

Dionisi, Mario

2006-01-01

The aim of this paper is to present the situation about stakeholders involvement in Italy in the framework of the decommissioning process of the Italian nuclear installations, and in particular the specific experience of the Italian Regulatory Body APAT. Specific aspects and APAT initiatives for building confidence of stakeholders in the process of the release of solid material from the regulatory control are presented. Content: Decommissioning activities in Italy, Decommissioning licensing procedures (Site and material release, APAT - ARPA Partnership approach in the clearance process)

A complex regulatory network controls aerobic ethanol oxidation in Pseudomonas aeruginosa: indication of four levels of sensor kinases and response regulators.

Science.gov (United States)

Mern, Demissew S; Ha, Seung-Wook; Khodaverdi, Viola; Gliese, Nicole; Görisch, Helmut

2010-05-01

In addition to the known response regulator ErbR (former AgmR) and the two-component regulatory system EraSR (former ExaDE), three additional regulatory proteins have been identified as being involved in controlling transcription of the aerobic ethanol oxidation system in Pseudomonas aeruginosa. Two putative sensor kinases, ErcS and ErcS', and a response regulator, ErdR, were found, all of which show significant similarity to the two-component flhSR system that controls methanol and formaldehyde metabolism in Paracoccus denitrificans. All three identified response regulators, EraR (formerly ExaE), ErbR (formerly AgmR) and ErdR, are members of the luxR family. The three sensor kinases EraS (formerly ExaD), ErcS and ErcS' do not contain a membrane domain. Apparently, they are localized in the cytoplasm and recognize cytoplasmic signals. Inactivation of gene ercS caused an extended lag phase on ethanol. Inactivation of both genes, ercS and ercS', resulted in no growth at all on ethanol, as did inactivation of erdR. Of the three sensor kinases and three response regulators identified thus far, only the EraSR (formerly ExaDE) system forms a corresponding kinase/regulator pair. Using reporter gene constructs of all identified regulatory genes in different mutants allowed the hierarchy of a hypothetical complex regulatory network to be established. Probably, two additional sensor kinases and two additional response regulators, which are hidden among the numerous regulatory genes annotated in the genome of P. aeruginosa, remain to be identified.

Manufacturing of biodrugs: need for harmonization in regulatory standards.

Science.gov (United States)

Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

2009-01-01

Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

US Nuclear Regulatory Commission, 1984 annual report. Volume 1

International Nuclear Information System (INIS)

1985-01-01

This is the 10th annual report of the US Nuclear Regulatory Commission (NRC). This report covers the major activities, events, decisions and planning that took place during fiscal year 1984 (October 1983 through September 1984) within the NRC or involving the NRC. Information is presented concerning 1984 highlights and planning for 1985; reactor regulation; cleanup at Three Mile Island Unit 2; operational experience; nuclear materials; safeguards; waste management; inspection, enforcement, quality assurance, and emergency preparedness; cooperation with the States; international programs; nuclear regulatory research; proceedings and litigation; and management and communication

Informational analysis involving application of complex information system

Science.gov (United States)

Ciupak, Clébia; Vanti, Adolfo Alberto; Balloni, Antonio José; Espin, Rafael

The aim of the present research is performing an informal analysis for internal audit involving the application of complex information system based on fuzzy logic. The same has been applied in internal audit involving the integration of the accounting field into the information systems field. The technological advancements can provide improvements to the work performed by the internal audit. Thus we aim to find, in the complex information systems, priorities for the work of internal audit of a high importance Private Institution of Higher Education. The applied method is quali-quantitative, as from the definition of strategic linguistic variables it was possible to transform them into quantitative with the matrix intersection. By means of a case study, where data were collected via interview with the Administrative Pro-Rector, who takes part at the elaboration of the strategic planning of the institution, it was possible to infer analysis concerning points which must be prioritized at the internal audit work. We emphasize that the priorities were identified when processed in a system (of academic use). From the study we can conclude that, starting from these information systems, audit can identify priorities on its work program. Along with plans and strategic objectives of the enterprise, the internal auditor can define operational procedures to work in favor of the attainment of the objectives of the organization.

Quality Management System at the Nuclear Regulatory Authority of the Slovak Republic

International Nuclear Information System (INIS)

Husarcek, J.; Novak, S.

2008-01-01

The process-oriented quality management system (QMS) implemented at the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in compliance with the EN ISO 9001:2001 standard is described. The history of the establishment and development of the QMS is given. The main, managerial and supporting processes with respect to defined activities are specified, and a scheme of their interactions is presented. The contents of the Quality Manual content and the structure of the system documentation are briefly described. The responsibilities for the operation and improvements of the QMS are described along with the methods applied (internal and external audits, self-assessment - Common Assessment Framework (CAF)). Examples of established quality objectives and indicators for some processes are provided. A future development of the QMS is expected in accordance with the relevant ISO Standard and IAEA recommendations and based on evaluation of the effectiveness of the critical system. (orig.)

Involving Extension in Urban Food Systems: An Example from California

Directory of Open Access Journals (Sweden)

Lucy Diekmann

2017-06-01

Full Text Available Nationwide, Extension is increasingly involved in local food system work. In cities, initiatives to improve the local food system often include urban agriculture, which has attracted the attention of diverse stakeholders for its many potential social, health, economic, and environmental impacts. This article illustrates how Extension in the San Francisco Bay Area is developing urban agriculture programming and engaging in food-system-related partnerships. It also shares lessons learned from these efforts. In this metropolitan region, Extension practice aligns well with research findings on Extension involvement in local food systems, particularly with the emphasis on providing educational opportunities and resources adapted to unique needs of city residents and working collaboratively with community and government partners to facilitate broader food system change. The results of this case study will be useful for Extension personnel in designing and implementing programs related to urban food systems.

Strategic Regulatory Evaluation and Endorsement of the Hollow Fiber Tuberculosis System as a Novel Drug Development Tool.

Science.gov (United States)

Romero, Klaus; Clay, Robert; Hanna, Debra

2015-08-15

The first nonclinical drug development tool (DDT) advanced by the Critical Path to TB Drug Regimens (CPTR) Initiative through a regulatory review process has been endorsed by leading global regulatory authorities. DDTs with demonstrated predictive accuracy for clinical and microbiological outcomes are needed to support decision making. Regulatory endorsement of these DDTs is critical for drug developers, as it promotes confidence in their use in Investigational New Drug and New Drug Application filings. The in vitro hollow fiber system model of tuberculosis (HFS-TB) is able to recapitulate concentration-time profiles (exposure) observed in patients for single drugs and combinations, by evaluating exposure measures for the ability to kill tuberculosis in different physiologic conditions. Monte Carlo simulations make this quantitative output useful to inform susceptibility breakpoints, dosage, and optimal combination regimens in patients, and to design nonclinical experiments in animal models. The Pre-Clinical and Clinical Sciences Working Group within CPTR executed an evidence-based evaluation of the HFS-TB for predictive accuracy. This extensive effort was enabled through the collaboration of subject matter experts representing the pharmaceutical industry, academia, product development partnerships, and regulatory authorities including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A comprehensive analysis plan following the regulatory guidance documents for DDT qualification was developed, followed by individual discussions with the FDA and the EMA. The results from the quantitative analyses were submitted to both agencies, pursuing regulatory DDT endorsement. The EMA Qualification Opinion for the HFS-TB DDT was published 26 January 2015 (available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000319.jsp). © The Author 2015. Published by Oxford University Press on behalf of the

Pathogenic adaptation of intracellular bacteria by rewiring a cis-regulatory input function.

Science.gov (United States)

Osborne, Suzanne E; Walthers, Don; Tomljenovic, Ana M; Mulder, David T; Silphaduang, Uma; Duong, Nancy; Lowden, Michael J; Wickham, Mark E; Waller, Ross F; Kenney, Linda J; Coombes, Brian K

2009-03-10

The acquisition of DNA by horizontal gene transfer enables bacteria to adapt to previously unexploited ecological niches. Although horizontal gene transfer and mutation of protein-coding sequences are well-recognized forms of pathogen evolution, the evolutionary significance of cis-regulatory mutations in creating phenotypic diversity through altered transcriptional outputs is not known. We show the significance of regulatory mutation for pathogen evolution by mapping and then rewiring a cis-regulatory module controlling a gene required for murine typhoid. Acquisition of a binding site for the Salmonella pathogenicity island-2 regulator, SsrB, enabled the srfN gene, ancestral to the Salmonella genus, to play a role in pathoadaptation of S. typhimurium to a host animal. We identified the evolved cis-regulatory module and quantified the fitness gain that this regulatory output accrues for the bacterium using competitive infections of host animals. Our findings highlight a mechanism of pathogen evolution involving regulatory mutation that is selected because of the fitness advantage the new regulatory output provides the incipient clones.

Gastrointestinal system involvement in systemic lupus erythematosus.

Science.gov (United States)

Li, Z; Xu, D; Wang, Z; Wang, Y; Zhang, S; Li, M; Zeng, X

2017-10-01

Systemic lupus erythematosus (SLE) is a multisystem disorder which can affect the gastrointestinal (GI) system. Although GI symptoms can manifest in 50% of patients with SLE, these have barely been reviewed due to difficulty in identifying different causes. This study aims to clarify clinical characteristics, diagnosis and treatment of the four major SLE-related GI system complications: protein-losing enteropathy (PLE), intestinal pseudo-obstruction (IPO), hepatic involvement and pancreatitis. It is a systematic review using MEDLINE and EMBASE databases and the major search terms were SLE, PLE, IPO, hepatitis and pancreatitis. A total of 125 articles were chosen for our study. SLE-related PLE was characterized by edema and hypoalbuminemia, with Technetium 99m labeled human albumin scintigraphy ( 99m Tc HAS) and alpha-1-antitrypsin fecal clearance test commonly used as diagnostic test. The most common site of protein leakage was the small intestine and the least common site was the stomach. More than half of SLE-related IPO patients had ureterohydronephrosis, and sometimes they manifested as interstitial cystitis and hepatobiliary dilatation. Lupus hepatitis and SLE accompanied by autoimmune hepatitis (SLE-AIH overlap) shared similar clinical manifestations but had different autoantibodies and histopathological features, and positive anti-ribosome P antibody highly indicated the diagnosis of lupus hepatitis. Lupus pancreatitis was usually accompanied by high SLE activity with a relatively high mortality rate. Early diagnosis and timely intervention were crucial, and administration of corticosteroids and immunosuppressants was effective for most of the patients.

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…

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

The Rose (Rosa hybrida) NAC Transcription Factor 3 Gene, RhNAC3, Involved in ABA Signaling Pathway Both in Rose and Arabidopsis

OpenAIRE

Jiang, Guimei; Jiang, Xinqiang; Lü, Peitao; Liu, Jitao; Gao, Junping; Zhang, Changqing

2014-01-01

Plant transcription factors involved in stress responses are generally classified by their involvement in either the abscisic acid (ABA)-dependent or the ABA-independent regulatory pathways. A stress-associated NAC gene from rose (Rosa hybrida), RhNAC3, was previously found to increase dehydration tolerance in both rose and Arabidopsis. However, the regulatory mechanism involved in RhNAC3 action is still not fully understood. In this study, we isolated and analyzed the upstream regulatory seq...

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.

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

International Nuclear Information System (INIS)

Dalheimer, A.; Henrichs, K.

1996-01-01

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

Co-suppression of sterol-regulatory element binding protein ...

African Journals Online (AJOL)

Administrator

2011-06-22

Jun 22, 2011 ... In Arabidopsis,. At5g35220 gene being sterol regulatory element-binding protein site 2, protease and metalloendopeptidase activity were required for chloroplast development and play a role in regulation of endodermal plastid size and number that are involved in ethylene-dependent gravitropism of light-.

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

Octopamine and Tyramine Contribute Separately to the Counter-Regulatory Response to Sugar Deficit in Drosophila

Directory of Open Access Journals (Sweden)

Christine Damrau

2018-01-01

Full Text Available All animals constantly negotiate external with internal demands before and during action selection. Energy homeostasis is a major internal factor biasing action selection. For instance, in addition to physiologically regulating carbohydrate mobilization, starvation-induced sugar shortage also biases action selection toward food-seeking and food consumption behaviors (the counter-regulatory response. Biogenic amines are often involved when such widespread behavioral biases need to be orchestrated. In mammals, norepinephrine (noradrenalin is involved in the counterregulatory response to starvation-induced drops in glucose levels. The invertebrate homolog of noradrenalin, octopamine (OA and its precursor tyramine (TA are neuromodulators operating in many different neuronal and physiological processes. Tyrosine-ß-hydroxylase (tßh mutants are unable to convert TA into OA. We hypothesized that tßh mutant flies may be aberrant in some or all of the counter-regulatory responses to starvation and that techniques restoring gene function or amine signaling may elucidate potential mechanisms and sites of action. Corroborating our hypothesis, starved mutants show a reduced sugar response and their hemolymph sugar concentration is elevated compared to control flies. When starved, they survive longer. Temporally controlled rescue experiments revealed an action of the OA/TA-system during the sugar response, while spatially controlled rescue experiments suggest actions also outside of the nervous system. Additionally, the analysis of two OA- and four TA-receptor mutants suggests an involvement of both receptor types in the animals' physiological and neuronal response to starvation. These results complement the investigations in Apis mellifera described in our companion paper (Buckemüller et al., 2017.

CoryneRegNet: An ontology-based data warehouse of corynebacterial transcription factors and regulatory networks

Directory of Open Access Journals (Sweden)

Czaja Lisa F

2006-02-01

Full Text Available Abstract Background The application of DNA microarray technology in post-genomic analysis of bacterial genome sequences has allowed the generation of huge amounts of data related to regulatory networks. This data along with literature-derived knowledge on regulation of gene expression has opened the way for genome-wide reconstruction of transcriptional regulatory networks. These large-scale reconstructions can be converted into in silico models of bacterial cells that allow a systematic analysis of network behavior in response to changing environmental conditions. Description CoryneRegNet was designed to facilitate the genome-wide reconstruction of transcriptional regulatory networks of corynebacteria relevant in biotechnology and human medicine. During the import and integration process of data derived from experimental studies or literature knowledge CoryneRegNet generates links to genome annotations, to identified transcription factors and to the corresponding cis-regulatory elements. CoryneRegNet is based on a multi-layered, hierarchical and modular concept of transcriptional regulation and was implemented by using the relational database management system MySQL and an ontology-based data structure. Reconstructed regulatory networks can be visualized by using the yFiles JAVA graph library. As an application example of CoryneRegNet, we have reconstructed the global transcriptional regulation of a cellular module involved in SOS and stress response of corynebacteria. Conclusion CoryneRegNet is an ontology-based data warehouse that allows a pertinent data management of regulatory interactions along with the genome-scale reconstruction of transcriptional regulatory networks. These models can further be combined with metabolic networks to build integrated models of cellular function including both metabolism and its transcriptional regulation.

Integration of Bacterial Small RNAs in Regulatory Networks.

Science.gov (United States)

Nitzan, Mor; Rehani, Rotem; Margalit, Hanah

2017-05-22

Small RNAs (sRNAs) are central regulators of gene expression in bacteria, controlling target genes posttranscriptionally by base pairing with their mRNAs. sRNAs are involved in many cellular processes and have unique regulatory characteristics. In this review, we discuss the properties of regulation by sRNAs and how it differs from and combines with transcriptional regulation. We describe the global characteristics of the sRNA-target networks in bacteria using graph-theoretic approaches and review the local integration of sRNAs in mixed regulatory circuits, including feed-forward loops and their combinations, feedback loops, and circuits made of an sRNA and another regulator, both derived from the same transcript. Finally, we discuss the competition effects in posttranscriptional regulatory networks that may arise over shared targets, shared regulators, and shared resources and how they may lead to signal propagation across the network.

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.

Efficient Reverse-Engineering of a Developmental Gene Regulatory Network

Science.gov (United States)

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

2012-01-01

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

The capacity for multistability in small gene regulatory networks

Directory of Open Access Journals (Sweden)

Grotewold Erich

2009-09-01

Full Text Available Abstract Background Recent years have seen a dramatic increase in the use of mathematical modeling to gain insight into gene regulatory network behavior across many different organisms. In particular, there has been considerable interest in using mathematical tools to understand how multistable regulatory networks may contribute to developmental processes such as cell fate determination. Indeed, such a network may subserve the formation of unicellular leaf hairs (trichomes in the model plant Arabidopsis thaliana. Results In order to investigate the capacity of small gene regulatory networks to generate multiple equilibria, we present a chemical reaction network (CRN-based modeling formalism and describe a number of methods for CRN analysis in a parameter-free context. These methods are compared and applied to a full set of one-component subnetworks, as well as a large random sample from 40,680 similarly constructed two-component subnetworks. We find that positive feedback and cooperativity mediated by transcription factor (TF dimerization is a requirement for one-component subnetwork bistability. For subnetworks with two components, the presence of these processes increases the probability that a randomly sampled subnetwork will exhibit multiple equilibria, although we find several examples of bistable two-component subnetworks that do not involve cooperative TF-promoter binding. In the specific case of epidermal differentiation in Arabidopsis, dimerization of the GL3-GL1 complex and cooperative sequential binding of GL3-GL1 to the CPC promoter are each independently sufficient for bistability. Conclusion Computational methods utilizing CRN-specific theorems to rule out bistability in small gene regulatory networks are far superior to techniques generally applicable to deterministic ODE systems. Using these methods to conduct an unbiased survey of parameter-free deterministic models of small networks, and the Arabidopsis epidermal cell

Involving stakeholders in evaluating environmental restoration technologies

International Nuclear Information System (INIS)

McCabe, G.H.; Serie, P.J.

1993-02-01

Involving citizens, interest groups, and regulators in environmental restoration and waste management programs is a challenge for government agencies and the organizations that support them. To be effective, such involvement activities must identify all individuals and groups who have a stake in the cleanup. Their participation must be early, substantive, and meaningful. Stockholders must be able to see how their input was considered and used, and feel that a good- faith effort was made to reconcile conflicting objectives. The Integrated Demonstration for Cleanup of Volatile Organic Compounds at Arid Sites (VOC-Arid ID) is a Department of Energy Office of Technology Development project located at Hanford. Along with technical evaluation of innovative cleanup technologies, the program is conducting an institutional assessment of regulatory and public acceptance of new technologies. Through a series of interviews and workshops, and use of a computerized information management tool, stakeholders are having a voice in the evaluation. Public and regulatory reaction has been positive

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

OpenAIRE

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

2017-01-01

Abstract Previous neuroimaging work has shown that increased reward-related activity following exposure to food cues is predictive of self-control failure. The balance model suggests that self-regulation failures result from an imbalance in reward and executive control mechanisms. However, an open question is whether the relative balance of activity in brain systems associated with executive control (vs reward) supports self-regulatory outcomes when people encounter tempting cues in daily lif...

Regulatory analysis for resolution of USI A-17

International Nuclear Information System (INIS)

Thatcher, D.F.

1989-08-01

This report presents a summary of the regulatory analysis conducted by the NRC staff to evaluate the value and impact of potential alternatives for the resolution of Unresolved Safety Issue (USI) A-17, ''Systems Interactions in Nuclear Power Plants.'' The NRC staff's proposed resolution offered in this report is based on this analysis. The staff's technical finding regarding interactions can be found in NUREG-1174. Adverse systems interactions (ASIs) involve subtle and often very complicated plant-specific dependencies between components and systems, possible compounded by inducing erroneous human intervention. The staff has identified actions to be taken by licensees and the NRC to resolve USI A-17; the staff has also made the judgment that these actions, together with other ongoing activities, would reduce the risk from adverse systems interactions. As discussed further in this report, the staff judgment that the actions are sufficient is not based on the assertion that all systems interactions have been identified, but rather that the A-17 actions, plus other activities by the licensees and staff, will identify precursors to potentially risk-significant interactions so that the action can be taken if deemed necessary

Involvement of serotonin system in bullimia

International Nuclear Information System (INIS)

Marazziti, D.; Macchi, E.; Rotondo, A.; Placidi, G.F.; Cassano, G.B.

1988-01-01

Platelet 3 H-imipramine binding was investigated in 8 patients affected by bulimia according to DSM III criteria, and in 7 health volunteers. The Bmax /+ -/SD (fmol/mg protein) was 356 /+ -/ 53 in patients, and 1144 /+ -/ 134 in controls. The Kd /+ -/ SD (nM) was 1.35 /+ -/ 0.44 in patients, and 1.90 /+ -/ 0.72 in controls. There was a significant difference in Bmax values in the two groups, whereas no significant difference was observed in Kd values. This study suggests the possible involvement of the indoleamine system in bullimia

Involvement of serotonin system in bullimia

Energy Technology Data Exchange (ETDEWEB)

Marazziti, D.; Macchi, E.; Rotondo, A.; Placidi, G.F.; Cassano, G.B.

1988-01-01

Platelet /sup 3/H-imipramine binding was investigated in 8 patients affected by bulimia according to DSM III criteria, and in 7 health volunteers. The Bmax /+ -/SD (fmol/mg protein) was 356 /+ -/ 53 in patients, and 1144 /+ -/ 134 in controls. The Kd /+ -/ SD (nM) was 1.35 /+ -/ 0.44 in patients, and 1.90 /+ -/ 0.72 in controls. There was a significant difference in Bmax values in the two groups, whereas no significant difference was observed in Kd values. This study suggests the possible involvement of the indoleamine system in bullimia.

Fisheries regulatory regimes and resilience to climate change.

Science.gov (United States)

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

2017-05-01

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

Involvement of central nervous system in the schistosomiasis

Directory of Open Access Journals (Sweden)

Teresa Cristina de Abreu Ferrari

2004-08-01

Full Text Available The involvement of the central nervous system (CNS by schistosomes may or may not determine clinical manifestations. When symptomatic, neuroschistosomiasis (NS is one of the most severe presentations of schistosomal infection. Considering the symptomatic form, cerebral involvement is almost always due to Schistosoma japonicum and the spinal cord disease, caused by S. mansoni or S. haematobium. Available evidence suggests that NS depends basically on the presence of parasite eggs in the nervous tissue and on the host immune response. The patients with cerebral NS usually have the clinical manifestations of increased intracranial pressure associated with focal neurological signs; and those with schistosomal myeloradiculopathy (SMR present rapidly progressing symptoms of myelitis involving the lower cord, usually in association with the involvement of the cauda esquina roots. The diagnosis of cerebral NS is established by biopsy of the nervous tissue and SMR is usually diagnosed according to a clinical criterion. Antischistosomal drugs, corticosteroids and surgery are the resourses available for treating NS. The outcome is variable and is better in cerebral disease.

Regulatory surveillance of safety related maintenance at nuclear power plants. Report of a technical committee meeting

International Nuclear Information System (INIS)

1997-08-01

The operational safety and reliability of a nuclear power plant as well as its availability for electricity generation depend on, among other things, its maintenance programme. Regulatory bodies therefore have considerable interest in maintenance activities. There are several approaches to maintenance, i.e. reliability centered maintenance or risk focused maintenance, aimed at optimizing maintenance by focusing on important components or systems. These approaches may result in significant changes to maintenance activities and therefore have to be considered for regulatory acceptance. In order to review and discuss the status of maintenance regulation in participating countries, the IAEA convened a Technical Committee Meeting on Regulatory Oversight of Maintenance Activities at Nuclear Power Plants in Vienna from 9 to 13 October 1995. The meeting was attended by 16 experts from 11 countries. In addition to the consideration of papers that were presented and which are reproduced here, extensive group and panel discussions took place during the meeting. These covered three main topics: general features and basic characteristics of maintenance regulation, regulatory acceptance of maintenance optimization and use of PSA for maintenance optimization. The discussion are summarized in Section 2. Section 3 discusses the following three additional topics: regulatory involvement in the maintenance programme, modifications to the maintenance programme and personnel related aspects of maintenance. The conclusions are presented in Section 4. Figs, tabs

Regulatory requirements related to maintenance and compliance monitoring

International Nuclear Information System (INIS)

Ling, A.K.H.

1997-01-01

The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

The Role of Involvement in Learning Management System Success

Science.gov (United States)

Klobas, Jane E.; McGill, Tanya J.

2010-01-01

Learning management systems (LMS) have been adopted by the majority of higher education institutions and research that explores the factors that influence the success of LMS is needed. This paper investigates the roles of student and instructor involvement in LMS success, using the DeLone and McLean (2003) model of information systems success as a…

Comparison of regulatory framework among bench marking countries for improving regulatory effectiveness in Malaysia

International Nuclear Information System (INIS)

Khairuddin, Nik Mohd Faiz Bin; Choi, Kwang Sik

2010-01-01

Nowadays some of developing countries in Asian region are announcing their planning to embark the nuclear power program. This progression are rising due to four factor: increasing political instabilities in fossil-fuel exporting countries; declining domestic natural energy resources; growing concerns about greenhouse gas emissions; and increasing demand for electricity. This paper gives a study on the comparison between Canada, Republic of South Korea and Malaysia regarding to their regulatory framework as well as the licensing procedures in controlling the nuclear power plants establishment. Canada and Korea were selected to study because of both of the countries have different system in controlling the nuclear power plants in terms of its regulatory framework as well as the licensing process. The idea is to compare these countries along with the guidelines by the IAEA and to find out what Malaysia could be learn to start the nuclear power program and find out the best practice in nuclear licensing. Factors taken into consideration are the regulatory framework, especially the nature of the licensing authority, the licensing process and enforcement actions. Together, these give a way to evaluate the effectiveness of the regulatory body due to the licensing authorization of nuclear power plant

Comparison of regulatory framework among bench marking countries for improving regulatory effectiveness in Malaysia

Energy Technology Data Exchange (ETDEWEB)

Khairuddin, Nik Mohd Faiz Bin [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2010-05-15

Nowadays some of developing countries in Asian region are announcing their planning to embark the nuclear power program. This progression are rising due to four factor: increasing political instabilities in fossil-fuel exporting countries; declining domestic natural energy resources; growing concerns about greenhouse gas emissions; and increasing demand for electricity. This paper gives a study on the comparison between Canada, Republic of South Korea and Malaysia regarding to their regulatory framework as well as the licensing procedures in controlling the nuclear power plants establishment. Canada and Korea were selected to study because of both of the countries have different system in controlling the nuclear power plants in terms of its regulatory framework as well as the licensing process. The idea is to compare these countries along with the guidelines by the IAEA and to find out what Malaysia could be learn to start the nuclear power program and find out the best practice in nuclear licensing. Factors taken into consideration are the regulatory framework, especially the nature of the licensing authority, the licensing process and enforcement actions. Together, these give a way to evaluate the effectiveness of the regulatory body due to the licensing authorization of nuclear power plant

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

Science.gov (United States)

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

2014-11-01

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

Sequence analysis of the MYC oncogene involved in the t(8;14)(q24;q11) chromosome translocation in a human leukemia T-cell line indicates that putative regulatory regions are not altered

International Nuclear Information System (INIS)

Finver, S.N.; Nishikura, K.; Finger, L.R.; Haluska, F.G.; Finan, J.; Nowell, P.C.; Croce, C.M.

1988-01-01

The authors cloned the translocation-associated and homologous normal MYC alleles from SKW-3, a leukemia T-cell line with the t(8; 14)(q24; q11) translocation, and determined the sequence of the MYC oncogene first exon and flanking 5' putative regulatory regions. S1 nuclease protection experiments utilizing a MYC first exon probe demonstrated transcriptional deregulation of the MYC gene associated with the T-cell receptor α locus on the 8q + chromosome of SKW-3 cells. Nucleotide sequence analysis of the translocation-associated (8q +) MYC allele identified a single base substitution within the upstream flanking region; the homologous nontranslocated allele contained an additional substitution and a two-base deletion. None of the deletions or substitutions localized to putative 5' regulatory regions. The MYC first exon sequence was germ line in both alleles. These results demonstrate that alterations within the putative 5' MYC regulatory regions are not necessarily involved in MYC deregulation in T-cell leukemias, and they show that juxtaposition of the T-cell receptor α locus to a germ-line MYC oncogene results in MYC deregulation

Antioxidant and Ex Vivo Immune System Regulatory Properties of Boswellia serrata Extracts

Directory of Open Access Journals (Sweden)

Daniela Beghelli

2017-01-01

Full Text Available Boswellia serrata (BS is an important traditional medicinal plant that currently represents an interesting topic for pharmaceutical research since it possesses several pharmacological properties (e.g., anti-inflammatory, antimicrobial, and antitumour. The safety and versatility of this dietary supplement should allow for its use in numerous pathological conditions; however the quality of the extracts needs to be standardized to increase the clinical success rate resulting from its use. In the present study, different commercially available B. serrata extracts were employed to compare their AKBA content and in vitro antioxidant power. Furthermore, their ability to modulate the immune system regulatory properties was investigated. Our results showed that the AKBA content varied from 3.83±0.10 to 0.03±0.004%, with one sample in which it was not detectable. The highest antioxidant power and phenolic content were shown by the same extract, which also exhibited the highest AKBA concentration. Finally, the BS extracts showed the ability to influence the regulatory and effector T-cell compartments. Our results suggest that frankincense should be further investigated for its promising potentiality to modulate not only inflammation/oxidative stress but also immune dysregulation, but attention should be paid to the composition of the commercial extracts.

Nuclear regulatory organisations: Learning from stakeholders to enhance communication

International Nuclear Information System (INIS)

Lorin, Aurelie

2015-01-01

Since its creation 15 years ago, the NEA Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) has been addressing a broad range of communication issues, with two reports recently issued on Nuclear Regulatory Organisations, the Internet and Social Media: The What, How and Why of Their Use as Communication Tools and on Nuclear Regulatory Organisations and Communication Strategies. After the Fukushima Daiichi nuclear power plant accident in 2011, nuclear regulatory organisations around the world reaffirmed the need to strengthen stakeholder outreach and communication, and to create more robust avenues for stakeholder involvement in regulatory matters. The WGPC proposed a means for stakeholders to play a more active role in the group by holding one-day workshops in conjunction with regular meetings. These workshops offer a platform for stakeholder exchange with communication experts from nuclear regulatory organisations (NROs). The objective is to stimulate co-operation and improve communication by better understanding stakeholder perceptions, needs and expectations, and by discussing how to use traditional and social media more effectively. While nuclear regulatory organisations may have a common willingness to improve their communication methods and to build constructive relationships with stakeholders, every country has its own practices and cultural background, and thus its own challenges. Following the first workshop in Paris, which brought together European stakeholders, and the second in North America, the NEA is now organising a third workshop in Asia (Japan) to be held in April 2016. This third workshop will enable the NEA to gather stakeholder views from a third continent. A report on the workshops' findings will be issued after the completion of this third workshop, thus giving a broader idea of how to improve the overall communication methods of nuclear regulatory

Structural studies of bacterial transcriptional regulatory proteins by multidimensional heteronuclear NMR

Energy Technology Data Exchange (ETDEWEB)

Volkman, Brian Finley [Univ. of California, Berkeley, CA (United States)

1995-02-01

Nuclear magnetic resonance spectroscopy was used to elucidate detailed structural information for peptide and protein molecules. A small peptide was designed and synthesized, and its three-dimensional structure was calculated using distance information derived from two-dimensional NMR measurements. The peptide was used to induce antibodies in mice, and the cross-reactivity of the antibodies with a related protein was analyzed with enzyme-linked immunosorbent assays. Two proteins which are involved in regulation of transcription in bacteria were also studied. The ferric uptake regulation (Fur) protein is a metal-dependent repressor which controls iron uptake in bacteria. Two- and three-dimensional NMR techniques, coupled with uniform and selective isotope labeling allowed the nearly complete assignment of the resonances of the metal-binding domain of the Fur protein. NTRC is a transcriptional enhancer binding protein whose N-terminal domain is a "receiver domain" in the family of "two-component" regulatory systems. Phosphorylation of the N-terminal domain of NTRC activates the initiation of transcription of aeries encoding proteins involved in nitrogen regulation. Three- and four-dimensional NMR spectroscopy methods have been used to complete the resonance assignments and determine the solution structure of the N-terminal receiver domain of the NTRC protein. Comparison of the solution structure of the NTRC receiver domain with the crystal structures of the homologous protein CheY reveals a very similar fold, with the only significant difference being the position of helix 4 relative to the rest of the protein. The determination of the structure of the NTRC receiver domain is the first step toward understanding a mechanism of signal transduction which is common to many bacterial regulatory systems.

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...

Regulatory criteria for final disposal of radioactive wastes

International Nuclear Information System (INIS)

Petraitis, E.; Ciallella, N.; Siraky, G.

1998-01-01

This paper describes briefly the legislative and regulatory framework in which the final disposal of radioactive wastes is carried out in Argentina. It also presents the criteria developed by the Nuclear Regulatory Authority (ARN) to assess the long-term safety of final disposal systems for high level radioactive wastes. (author)

Promoting Regulatory Reform: The African Health Profession Regulatory Collaborative (ARC) for Nursing and Midwifery Year 4 Evaluation.

Science.gov (United States)

Kelley, Maureen A; Spangler, Sydney A; Tison, Laura I; Johnson, Carla M; Callahan, Tegan L; Iliffe, Jill; Hepburn, Kenneth W; Gross, Jessica M

2017-10-01

As countries across sub-Saharan Africa work towards universal health coverage and HIV epidemic control, investments seek to bolster the quality and relevance of the health workforce. The African Health Profession Regulatory Collaborative (ARC) partnered with 17 countries across East, Central, and Southern Africa to ensure nurses and midwives were authorized and equipped to provide essential HIV services to pregnant women and children with HIV. Through ARC, nursing leadership teams representing each country identify a priority regulatory function and develop a proposal to strengthen that regulation over a 1-year period. Each year culminates with a summative congress meeting, involving all ARC countries, where teams present their projects and share lessons learned with their colleagues. During a recent ARC Summative Congress, a group survey was administered to 11 country teams that received ARC Year 4 grants to measure advancements in regulatory function using the five-stage Regulatory Function Framework, and a group questionnaire was administered to 16 country teams to measure improvements in national nursing capacity (February 2011-2016). In ARC Year 4, eight countries implemented continuing professional development projects, Botswana revised their scope of practice, Mozambique piloted a licensing examination to assess HIV-related competencies, and South Africa developed accreditation standards for HIV/tuberculosis specialty nurses. Countries reported improvements in national nursing leaders' teamwork, collaborations with national organizations, regional networking with nursing leaders, and the ability to garner additional resources. ARC provides an effective, collaborative model to rapidly strengthen national regulatory frameworks, which other health professional cadres or regions may consider using to ensure a relevant health workforce, authorized and equipped to meet the emerging demand for health services.

The regulatory roles of B cell subsets in transplantation.

Science.gov (United States)

Chu, Zhulang; Zou, Weilong; Xu, Yanan; Sun, Qiquan; Zhao, Yong

2018-02-01

B cells mediate allograft rejection through antigen presentation, and production of cytokines and antibodies. More and more immunosuppressive agents specifically targeting B cells and plasma cells have been applied in clinical transplantation. However, recent studies have indicated the regulatory roles of B cells. Therefore, it is vital to clarify the different effects of B cell subsets in organ transplantation so that we can completely understand the diverse functions of B cells in transplantation. Areas covered: This review focuses on the regulatory roles of B cells in transplantation. B cell subsets with immune modulation and factors mediating immunosuppressive functions of regulatory B (Breg) cells were analyzed. Therapies targeting B cells and the application of B cells for transplant tolerance induction were discussed. Expert commentary: Besides involving rejection, B cells could also play regulatory roles in transplantation. Breg cells and the related markers may be used to predict the immune tolerant state in transplant recipients. New therapeutic strategies targeting B cells should be explored to promote tolerance induction with less impact on the host's protective immunity in organ transplanted patients.

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

Compliance. Regulatory policy P-211

International Nuclear Information System (INIS)

2001-05-01

This regulatory policy describes the basic principles and directives for establishing and conducting the Canadian Nuclear Safety Commission (CNSC) Compliance Program. The program is aimed at securing compliance by regulated persons with regulatory requirements made under the Nuclear Safety and Control Act ('the Act'). The policy applies to persons who are regulated by the CNSC through the Act, regulations and licences, as well as by decisions and orders made under the Act. The policy applies to officers and employees of the CNSC, and its authorized representatives or agents, who are involved in developing and carrying out compliance activities. Compliance, in the context of this policy, means conformity by regulated persons with the legally binding requirements of the Act, and the CNSC regulations, licences, decisions, and orders made under the Act. Compliance activities are CNSC measures of promotion, verification and enforcement aimed at securing compliance by regulated person with the applicable legally binding requirements. (author)

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

Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

International Nuclear Information System (INIS)

Yun, Y. C.; Lee, J. H.; Lee, H. C.; Lee, J. S.

2000-01-01

In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage

Information Management system of the safety regulatory requirements and guidance for the Korea next generation reactors

Energy Technology Data Exchange (ETDEWEB)

Yun, Y. C. [LG-EDS Systems, Seoul (Korea, Republic of); Lee, J. H.; Lee, H. C.; Lee, J. S. [Korea Institute of Nuclear Safety, Taejon (Korea, Republic of)

2000-05-01

In order to achieve the safety of the Korea Next Generation Reactors (KNGR), the Korea Institute of Nuclear Safety has carried out the Safety and Regulatory Requirements and Guidance (SRRG) development program from 1992 such as establishment of the SRRG hierarchy, development of technical requirements and guidance, and consideration of new licensing system. The SRRG hierarchy for the KNGR was consisted of five tiers; Safety Objectives, Safety Principles, General Safety Criteria, Specific Safety Requirements and Safety Regulatory Guides. The developed SRRG have been compared the criteria in 10CFR and Reg. Guide in the U.S.A and the IAEA documents for assuring internationally acceptable level of the SRRG. To improve the efficiency and accuracy of SRRG development, the construction of database system was required in the course of development. Therefore, the Information Management System of SRRG for the KNGR has been developed which enables developers to quickly and accurately seek and systematically manage whole contexts of the SRRG, reference requirements, and current atomic energy regulation rules. Moreover, through homepage whose URL is 'http://kngr.kins.re.kr', the concerned persons and public can acquire the information related with SRRG and KNGR project, and post his/her thought to the opinion forum in the homepage.

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

Genes involved in complex adaptive processes tend to have highly conserved upstream regions in mammalian genomes

Directory of Open Access Journals (Sweden)

Kohane Isaac

2005-11-01

Full Text Available Abstract Background Recent advances in genome sequencing suggest a remarkable conservation in gene content of mammalian organisms. The similarity in gene repertoire present in different organisms has increased interest in studying regulatory mechanisms of gene expression aimed at elucidating the differences in phenotypes. In particular, a proximal promoter region contains a large number of regulatory elements that control the expression of its downstream gene. Although many studies have focused on identification of these elements, a broader picture on the complexity of transcriptional regulation of different biological processes has not been addressed in mammals. The regulatory complexity may strongly correlate with gene function, as different evolutionary forces must act on the regulatory systems under different biological conditions. We investigate this hypothesis by comparing the conservation of promoters upstream of genes classified in different functional categories. Results By conducting a rank correlation analysis between functional annotation and upstream sequence alignment scores obtained by human-mouse and human-dog comparison, we found a significantly greater conservation of the upstream sequence of genes involved in development, cell communication, neural functions and signaling processes than those involved in more basic processes shared with unicellular organisms such as metabolism and ribosomal function. This observation persists after controlling for G+C content. Considering conservation as a functional signature, we hypothesize a higher density of cis-regulatory elements upstream of genes participating in complex and adaptive processes. Conclusion We identified a class of functions that are associated with either high or low promoter conservation in mammals. We detected a significant tendency that points to complex and adaptive processes were associated with higher promoter conservation, despite the fact that they have emerged

78 FR 10538 - Protections for Subjects in Human Research Involving Pesticides

Science.gov (United States)

2013-02-14

... involving intentional exposure of children or of pregnant or nursing women, unless relying on the data is crucial to a decision that would impose a more stringent regulatory restriction that would improve... itself to conduct or support any research involving intentional exposure of pregnant or nursing women or...

Regulatory risks associated with nuclear safety legislation after Fukushima Daiichi Nuclear Accident in Japan. Focus on legal structure of the nuclear reactor regulation act

International Nuclear Information System (INIS)

Tanabe, Tomoyuki; Maruyama, Masahiro

2016-01-01

Nuclear safety regulations enforced after Fukushima Daiichi Nuclear Accident under the Nuclear Reactor Regulation Act face the following regulatory problems that involve potential risk factors for nuclear businesses; 1) 'entity based regulation' unable to cope with business cessation or bankruptcy of the entity subject of regulation, 2) potential risk of the Nuclear Regulation Authority's inappropriate involvement in nuclear industry policy beyond their duty, and 3) compliance of backfits under vague regulations. In order to alleviate them, this report, through analyzing these regulatory problems from the view point of sound development of the nuclear industry, proposes the following regulatory reforms; (1) To clarify the rule for industry policy in nuclear regulations and enable the authority, Ministry of Economy, Trade and Industry, to choose most appropriate industrial policy measure. (2) Through establishing safety goals as measures to promote continuous improvement of nuclear safety regulations, to stimulate timely adjustments of the regulations, and to introduce a legal mechanism into the nuclear regulation systems under which validity of administrative law and its application can be checked. (author)

MicroRNA involvement in glioblastoma pathogenesis

International Nuclear Information System (INIS)

Novakova, Jana; Slaby, Ondrej; Vyzula, Rostislav; Michalek, Jaroslav

2009-01-01

MicroRNAs are endogenously expressed regulatory noncoding RNAs. Altered expression levels of several microRNAs have been observed in glioblastomas. Functions and direct mRNA targets for these microRNAs have been relatively well studied over the last years. According to these data, it is now evident, that impairment of microRNA regulatory network is one of the key mechanisms in glioblastoma pathogenesis. MicroRNA deregulation is involved in processes such as cell proliferation, apoptosis, cell cycle regulation, invasion, glioma stem cell behavior, and angiogenesis. In this review, we summarize the current knowledge of miRNA functions in glioblastoma with an emphasis on its significance in glioblastoma oncogenic signaling and its potential to serve as a disease biomarker and a novel therapeutic target in oncology.

Regulatory, administrative and financial problems raised by radioactive waste disposal

International Nuclear Information System (INIS)

Reyners, P.

1980-03-01

This paper analyses the salient aspects of the non-technical problems involved in radioactive waste disposal: the division of operational, regulatory and administrative responsibilities, the usefulness of providing a form of institutional control of the waste disposed of, and the question of the length of time for such mechanisms, both of which are closely linked to the preceding point. A description follows of the R and D financing mechanisms in the field and of the surveillance systems to be set up. Finally, mention is made of the legal and practical difficulties encountered in the application of the third party liability and insurance regime to long-term waste management and the international dimension of all these questions. (NEA) [fr

Analysis of a Plant Transcriptional Regulatory Network Using Transient Expression Systems.

Science.gov (United States)

Díaz-Triviño, Sara; Long, Yuchen; Scheres, Ben; Blilou, Ikram

2017-01-01

In plant biology, transient expression systems have become valuable approaches used routinely to rapidly study protein expression, subcellular localization, protein-protein interactions, and transcriptional activity prior to in vivo studies. When studying transcriptional regulation, luciferase reporter assays offer a sensitive readout for assaying promoter behavior in response to different regulators or environmental contexts and to confirm and assess the functional relevance of predicted binding sites in target promoters. This chapter aims to provide detailed methods for using luciferase reporter system as a rapid, efficient, and versatile assay to analyze transcriptional regulation of target genes by transcriptional regulators. We describe a series of optimized transient expression systems consisting of Arabidopsis thaliana protoplasts, infiltrated Nicotiana benthamiana leaves, and human HeLa cells to study the transcriptional regulations of two well-characterized transcriptional regulators SCARECROW (SCR) and SHORT-ROOT (SHR) on one of their targets, CYCLIN D6 (CYCD6).Here, we illustrate similarities and differences in outcomes when using different systems. The plant-based systems revealed that the SCR-SHR complex enhances CYCD6 transcription, while analysis in HeLa cells showed that the complex is not sufficient to strongly induce CYCD6 transcription, suggesting that additional, plant-specific regulators are required for full activation. These results highlight the importance of the system and suggest that including heterologous systems, such as HeLa cells, can provide a more comprehensive analysis of a complex gene regulatory network.