WorldWideScience

Sample records for strict regulatory requirements

  1. Internationalization of regulatory requirements.

    Science.gov (United States)

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  2. [Regulatory requirements for topical preparations].

    Science.gov (United States)

    Wohlrab, J; Klauck, D; Savtcheva, E

    2014-03-01

    Professional use of topical treatment in dermatological practice requires not only knowledge about the pharmacological properties, efficacy, safety and pharmaceutical quality of a preparation, but also about its regulatory classification. The latter essentially determines the physician's prescription practice and therapeutic freedom. The regulatory framework with which one is confronted unfortunately lacks transparency. It regulates not only the prescribability and reimbursability of proprietary medicinal products and extemporaneous preparations, but also the obligation to give information as well as the details of liability of both the prescriber (physician) and the manufacturer (pharmaceutical company or pharmacist). The prescriber needs to be aware of to what extent the pharmacist has the possibility and even obligation to change the prescribed preparation. In some cases this can directly affect the therapeutic concept of the physician and even impair the effectiveness and safety of the chosen therapy.

  3. A non-permselective membrane reactor for chemical processes normally requiring strict stoichiometric feed rates of reactants

    NARCIS (Netherlands)

    Sloot, H.J.; Versteeg, Geert; van Swaaij, Willibrordus Petrus Maria

    1990-01-01

    A novel type of membrane reactor with separated feeding of the reactants is presented for chemical processes normally requiring strict stoichiometric feed rates of premixed reactants. The reactants are fed in the reactor to the different sides of a porous membrane which is impregnated with a

  4. Regulatory requirements for radiation protection

    International Nuclear Information System (INIS)

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

    1977-01-01

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

  5. Grand Gulf-prioritization of regulatory requirements

    International Nuclear Information System (INIS)

    Meisner, M.J.

    1993-01-01

    As cost pressures mount, Grand Gulf nuclear station (GGNS) is relying increasingly on various prioritization approaches to implement, modify, eliminate, or defer regulatory requirements. Regulatory requirements can be prioritized through the use of three measures: (1) safety (or risk) significance; (2) cost; and (3) public policy (or political) significance. This paper summarizes GGNS' efforts to implement solutions to regulatory issues using these three prioritization schemes to preserve a balance between cost and safety benefit

  6. Methodological developments vs. regulatory requirements.

    Science.gov (United States)

    Bauer, Peter

    2006-08-01

    This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill, 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.

  7. Pseudouridine synthase 1: a site-specific synthase without strict sequence recognition requirements

    Science.gov (United States)

    Sibert, Bryan S.; Patton, Jeffrey R.

    2012-01-01

    Pseudouridine synthase 1 (Pus1p) is an unusual site-specific modification enzyme in that it can modify a number of positions in tRNAs and can recognize several other types of RNA. No consensus recognition sequence or structure has been identified for Pus1p. Human Pus1p was used to determine which structural or sequence elements of human tRNASer are necessary for pseudouridine (Ψ) formation at position 28 in the anticodon stem-loop (ASL). Some point mutations in the ASL stem of tRNASer had significant effects on the levels of modification and compensatory mutation, to reform the base pair, restored a wild-type level of Ψ formation. Deletion analysis showed that the tRNASer TΨC stem-loop was a determinant for modification in the ASL. A mini-substrate composed of the ASL and TΨC stem-loop exhibited significant Ψ formation at position 28 and a number of mutants were tested. Substantial base pairing in the ASL stem (3 out of 5 bp) is required, but the sequence of the TΨC loop is not required for modification. When all nucleotides in the ASL stem other than U28 were changed in a single mutant, but base pairing was retained, a near wild-type level of modification was observed. PMID:22102571

  8. The LHC Continuous Cryostat Interconnections The Organization of a Logistically Complex Worksite Requiring Strict Quality Standards and High Output

    CERN Document Server

    Fessia, P; Bozzini, D; Cruikshank, P; Jacquemod, A; Maan, W; Musso, A; Oberli, L; Poncet, A; Russenschuck, Stephan; Savary, F; Struik, M; Tock, J Ph; Tommasini, D; Völlinger, C; Kotarba, A; Olek, S; Sulek, Z; Grimaud, A; Vaudaux, L

    2008-01-01

    The interconnections of the Large Hadron Collider (LHC) continuous cryostat have been completed in fall 2007: 1695 interconnections magnet to magnet and 224 interconnections between the continuous cryostat and the cryogenic distribution line have been executed along the 27 km of the LHC. The very tight schedule, the complexity of the interconnection sequence, the strict quality standards applied have required the creation of an ad hoc organization in order to steer and coordinate the activities on the worksite dispersed along the whole accelerator ring. The concatenation of construction and test phases carried out by CERN staff, CERN collaborating institutes and contractors have led to the necessity of a common approach and of a very effective information flow. In this paper, after having recalled the main technical challenges, we review the organizational choices that have been taken and we briefly analyze the development of the worksite in term of allocated resources and production.

  9. Regulatory capital requirements and bail in mechanisms

    NARCIS (Netherlands)

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

    2015-01-01

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

  10. 12 CFR 567.2 - Minimum regulatory capital requirement.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Minimum regulatory capital requirement. 567.2... Regulatory Capital Requirements § 567.2 Minimum regulatory capital requirement. (a) To meet its regulatory capital requirement a savings association must satisfy each of the following capital standards: (1) Risk...

  11. Use of prioritization in meeting regulatory requirements

    Energy Technology Data Exchange (ETDEWEB)

    Bowling, M.L.; Sommers, D.A.; Girvin, L.M. (Virginia Power, Glen Allen, VA (United States))

    1993-01-01

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

  12. Use of prioritization in meeting regulatory requirements

    International Nuclear Information System (INIS)

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

    1993-01-01

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

  13. International regulatory requirements for skin sensitization testing.

    Science.gov (United States)

    Daniel, Amber B; Strickland, Judy; Allen, David; Casati, Silvia; Zuang, Valérie; Barroso, João; Whelan, Maurice; Régimbald-Krnel, M J; Kojima, Hajime; Nishikawa, Akiyoshi; Park, Hye-Kyung; Lee, Jong Kwon; Kim, Tae Sung; Delgado, Isabella; Rios, Ludmila; Yang, Ying; Wang, Gangli; Kleinstreuer, Nicole

    2018-03-05

    Skin sensitization test data are required or considered by chemical regulation authorities around the world. These data are used to develop product hazard labeling for the protection of consumers or workers and to assess risks from exposure to skin-sensitizing chemicals. To identify opportunities for regulatory uses of non-animal replacements for skin sensitization tests, the needs and uses for skin sensitization test data must first be clarified. Thus, we reviewed skin sensitization testing requirements for seven countries or regions that are represented in the International Cooperation on Alternative Test Methods (ICATM). We noted the type of skin sensitization data required for each chemical sector and whether these data were used in a hazard classification, potency classification, or risk assessment context; the preferred tests; and whether alternative non-animal tests were acceptable. An understanding of national and regional regulatory requirements for skin sensitization testing will inform the development of ICATM's international strategy for the acceptance and implementation of non-animal alternatives to assess the health hazards and risks associated with potential skin sensitizers. Copyright © 2018. Published by Elsevier Inc.

  14. Species Protection in the European Union : How Strict is Strict?

    NARCIS (Netherlands)

    Schoukens, Hendrik; Bastmeijer, Kees; Born et al., Charles-Hubert

    2015-01-01

    European Union law to protect wild species of plants and animals is generally considered as ‘strict’. Opponents of nature conservation law often pick the species protection components of the EU Bird Directive and Habitat Directive as a prime example of an unnecessary strict regulatory scheme that

  15. 12 CFR 562.1 - Regulatory reporting requirements.

    Science.gov (United States)

    2010-01-01

    ... REPORTING STANDARDS § 562.1 Regulatory reporting requirements. (a) Authority and scope. This part is issued... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Regulatory reporting requirements. 562.1... regulatory reports submitted to the OTS and financial reports prepared in accordance with GAAP. The records...

  16. Public consultation: regulatory requirement or business principle?

    International Nuclear Information System (INIS)

    Seeley, R.

    1999-01-01

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

  17. 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

  18. Regulatory Safety Requirements for Operating Nuclear Installations

    International Nuclear Information System (INIS)

    Gubela, W.

    2017-01-01

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

  19. Regulatory history of educational requirements for nuclear power plant staff

    International Nuclear Information System (INIS)

    Persensky, J.J.; Goodman, C.

    1985-01-01

    The purpose of the paper is to describe the history of educational qualifications requirements considered by the US Nuclear Regulatory Commission (NRC) since 1980 and to discuss the current NRC position on educational qualifications

  20. Strict confluent drawing

    Directory of Open Access Journals (Sweden)

    David Eppstein

    2016-01-01

    Full Text Available We define strict confluent drawing, a form of confluent drawing in which the existence of an edge is indicated by the presence of a smooth path through a system of arcs and junctions (without crossings, and in which such a path, if it exists, must be unique. We prove that it is NP-complete to determine whether a given graph has a strict confluent drawing but polynomial to determine whether it has an outerplanar strict confluent drawing with a fixed vertex ordering (a drawing within a disk, with the vertices placed in a given order on the boundary.

  1. Soil quality assessment under emerging regulatory requirements.

    Science.gov (United States)

    Bone, James; Head, Martin; Barraclough, Declan; Archer, Michael; Scheib, Catherine; Flight, Dee; Voulvoulis, Nikolaos

    2010-08-01

    New and emerging policies that aim to set standards for protection and sustainable use of soil are likely to require identification of geographical risk/priority areas. Soil degradation can be seen as the change or disturbance in soil quality and it is therefore crucial that soil and soil quality are well understood to protect soils and to meet legislative requirements. To increase this understanding a review of the soil quality definition evaluated its development, with a formal scientific approach to assessment beginning in the 1970s, followed by a period of discussion and refinement. A number of reservations about soil quality assessment expressed in the literature are summarised. Taking concerns into account, a definition of soil quality incorporating soil's ability to meet multifunctional requirements, to provide ecosystem services, and the potential for soils to affect other environmental media is described. Assessment using this definition requires a large number of soil function dependent indicators that can be expensive, laborious, prone to error, and problematic in comparison. Findings demonstrate the need for a method that is not function dependent, but uses a number of cross-functional indicators instead. This method to systematically prioritise areas where detailed investigation is required, using a ranking based against a desired level of action, could be relatively quick, easy and cost effective. As such this has potential to fill in gaps and compliment existing monitoring programs and assist in development and implementation of current and future soil protection legislation. Copyright 2010 Elsevier Ltd. All rights reserved.

  2. 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

  3. Regulatory requirements for marketing fixed dose combinations

    Directory of Open Access Journals (Sweden)

    B G Jayasheel

    2010-01-01

    Full Text Available The development of fixed-dose combinations (FDCs is becoming increasingly important from a public health perspective. FDCs have advantages when there is an identifiable patient population for whom treatment with a particular combination of actives in a fixed ratio is safe and effective and when all of the actives contribute to the overall therapeutic effect. Such combinations of drugs are particularly useful in the management of chronic diseases. In addition, there can be real clinical benefits in the form of increased efficacy and/or a reduced incidence of adverse effects. Additional advantages of FDCs are potentially lower costs of manufacturing compared to the costs of producing separate products administered concurrently, simpler logistics of distribution and reduced development of resistance in the case of antimicrobials. Above all, FDC therapy reduces pill burden and improves medication compliance. Although, FDCs seem to be ideal under certain pre-defined circumstances, if a dosing adjustment is warranted, there may not be an FDC available in the most appropriate strength for the patient and if an adverse drug reaction occurs from using an FDC, it may be difficult to identify the active ingredient responsible for causing the reaction. Appendix VI of Schedule Y (Drugs & Cosmetics Rules 1945, India states the requirements for marketing approval of various types of FDCs. The same is further elaborated in this article to provide a detailed guidance including the clinical trial requirements. However, the heterogeneity of the therapeutic field makes it difficult to develop a standard guidance document.

  4. Regulatory requirements for desalination plant coupled with nuclear reactor plant

    International Nuclear Information System (INIS)

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

    2005-01-01

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

  5. Strictly convex renormings

    Czech Academy of Sciences Publication Activity Database

    Moltó, A.; Orihuela, J.; Troyanski, S.; Zizler, Václav

    2007-01-01

    Roč. 75, č. 3 (2007), s. 647-658 ISSN 0024-6107 R&D Projects: GA AV ČR IAA100190502 Institutional research plan: CEZ:AV0Z10190503 Keywords : strictly convex norms * lattice norm * quasi-diagonal sets Subject RIV: BA - General Mathematics Impact factor: 0.733, year: 2007

  6. Quine's "Strictly Vegetarian" Analyticity

    NARCIS (Netherlands)

    Decock, L.B.

    2017-01-01

    I analyze Quine’s later writings on analyticity from a linguistic point of view. In Word and Object Quine made room for a “strictly vegetarian” notion of analyticity. In later years, he developed this notion into two more precise notions, which I have coined “stimulus analyticity” and “behaviorist

  7. 10 CFR 51.21 - Criteria for and identification of licensing and regulatory actions requiring environmental...

    Science.gov (United States)

    2010-01-01

    ... COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY... § 51.21 Criteria for and identification of licensing and regulatory actions requiring environmental assessments. All licensing and regulatory actions subject to this subpart require an environmental assessment...

  8. 10 CFR 51.20 - Criteria for and identification of licensing and regulatory actions requiring environmental...

    Science.gov (United States)

    2010-01-01

    ... COMMISSION (CONTINUED) ENVIRONMENTAL PROTECTION REGULATIONS FOR DOMESTIC LICENSING AND RELATED REGULATORY... § 51.20 Criteria for and identification of licensing and regulatory actions requiring environmental impact statements. (a) Licensing and regulatory actions requiring an environmental impact statement shall...

  9. Economic analysis requirements in support of orbital debris regulatory policy

    Science.gov (United States)

    Greenberg, Joel S.

    1996-10-01

    As the number of Earth orbiting objects increases so does the potential for generating orbital debris with the consequent increase in the likelihood of impacting and damaging operating satellites. Various debris remediation approaches are being considered that encompass both in-orbit and return-to-Earth schema and have varying degrees of operations, cost, international competitiveness, and safety implications. Because of the diversity of issues, concerns and long-term impacts, there is a clear need for the setting of government policies that will lead to an orderly abatement of the potential orbital debris hazards. These policies may require the establishment of a supportive regulatory regime. The Department of Transportation is likely to have regulatory responsibilities relating to orbital debris stemming from its charge to protect the public health and safety, safety of property, and national security interests and foreign policy interests of the United States. This paper describes DOT's potential regulatory role relating to orbital debris remediation, the myriad of issues concerning the need for establishing government policies relating to orbital debris remediation and their regulatory implications, the proposed technological solutions and their economic and safety implications. Particular emphasis is placed upon addressing cost-effectiveness and economic analyses as they relate to economic impact analysis in support of regulatory impact analysis.

  10. Regulatory requirement of the Juragua nuclear Power Plant PSA

    International Nuclear Information System (INIS)

    Valhuerdi Debesa, C.

    1996-01-01

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

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

    Science.gov (United States)

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

    2009-01-08

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

  12. 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)

  13. Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements.

    Science.gov (United States)

    Cilurzo, Francesco; Musazzi, Umberto M; Franzé, Silvia; Selmin, Francesca; Minghetti, Paola

    2018-02-01

    Orodispersible dosage forms have a growing presence in the pharmaceutical market because their administration can improve the bioavailability of some drugs and their prescription can ameliorate patient adherence and/or compliance. Here, we review the main features of orodispersible tablets, including oral lyophilisates, and orodispersible films along with their main production technologies. We summarize the bioavailability data and critically discussed their potential to improve patient adherence and/or compliance. We revisit this information in light of both the European Union (EU) and US regulatory frameworks, focusing on the differences in the definitions of such dosage forms and the requirements for marketing authorization. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Michalis Barkoulas

    2016-09-01

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

  15. Development Approach of General Regulatory Requirements for SFR in Korea

    International Nuclear Information System (INIS)

    Yune, Young Gill; Song, Jae Ho; Huh, Chang Wook; Jin, Chang Yong; Bae, Moo Hoon; Kim, Kyun Tae

    2011-01-01

    The Atomic Energy Commission of Korea established a long-term R and D plan for future reactor systems including sodium-cooled fast reactor (SFR) in Dec. 2008. According to the plan, an application for the design approval of an SFR demonstration reactor is scheduled in 2017. A project to develop the SFR was launched in 2010 to implement the long-term R and D plan. Korea Institute of Nuclear Safety (KINS) also started to develop general regulatory requirements (GRRs) for SFR for the preparation of the licensing application of the SFR. In this paper, the development approach of KINS was introduced. The GRRs for SFR are developed based on the current GRRs for LWR, 'Regulations on Technical Standards for Nuclear Reactor Facilities, Etc.'. And design characteristics of SFRs are reflected in the current GRRs. Also, the following items are considered: strengthening of safety by the IAEA, foreign regulatory requirements for SFR, risk-informed regulations, and the lessons learned from Hukushima accident

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

    International Nuclear Information System (INIS)

    Husarcek, J.

    2003-01-01

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

  17. 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

  18. WIPP Waste Characterization: Implementing Regulatory Requirements in the Real World

    International Nuclear Information System (INIS)

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

    1999-01-01

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

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

    International Nuclear Information System (INIS)

    1987-01-01

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

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

    International Nuclear Information System (INIS)

    Williams, C.R.

    1999-01-01

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

  1. Regulatory requirements and quality assurance of radiation monitoring instruments

    International Nuclear Information System (INIS)

    Narasimharao, K.L.; Sharma, Ranjit

    2005-01-01

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

  2. Efficient Strictness Analysis of Haskell

    DEFF Research Database (Denmark)

    Jensen, Kristian Damm; Hjæresen, Peter; Rosendahl, Mads

    1994-01-01

    Strictness analysis has been a living field of investigation since Mycroft's original work in 1980, and is getting increasingly significant with the still wider use of lazy functional programming languages. This paper focuses on an actual implementation of a strictness analyser for Haskell...

  3. Legislative framework and regulatory requirements for the introduction of nuclear power

    International Nuclear Information System (INIS)

    Ha-Vinh, Phuong

    1975-01-01

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

  4. Regulatory requirements for the transport of radioactive materials in Canada

    International Nuclear Information System (INIS)

    Garg, R.

    2004-01-01

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

  5. Regulatory requirements for the transport of radioactive materials in Canada

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-07-01

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

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

    International Nuclear Information System (INIS)

    Goicea, Lucian

    2012-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-03-15

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

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

    International Nuclear Information System (INIS)

    Mourlon, Sophie

    2014-01-01

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

  9. Regulatory Requirements to Combat Illicit Trafficking of Hazardous Materials

    International Nuclear Information System (INIS)

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

    2011-01-01

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

  10. Regulatory requirements and administrative practice in safety of nuclear installations

    International Nuclear Information System (INIS)

    Servant, J.

    1977-01-01

    This paper reviews the current situation of the France regulatory rules and procedures dealing with the safety of the main nuclear facilities and, more broadly, the nuclear security. First, the author outlines the policy of the French administration which requires that the licensee responsible for an installation has to demonstrate that all possible measures are taken to ensure a sufficient level of safety, from the early stage of the project to the end of the operation of the plant. Thus, the administration performs the assessment on a case-by-case basis, of the safety of each installation before granting a nuclear license. On the other hand, the administration settles overall safety requirements for specific categories of installations or components, which determine the ultimate safety performances, but avoid, as far as possible, to detail the technical specifications to be applied in order to comply with these goals. This approach, which allows the designers and the licensees to rely upon sound codes and standards, gains the advantage of a great flexibility without imparing the nuclear safety. The author outlines the licensing progress for the main categories of installations: nuclear power plants of the PWR type, fast breeders, uranium isotope separation plants, and irradiated fuel processing plants. Emphasis is placed on the most noteworthy points: standardization of projects, specific risks of each site, problems of advanced type reactors, etc... The development of the technical regulations is presented with emphasis on the importance of an internationally concerned action within the nuclear international community. The second part of this paper describes the France operating experience of nuclear installations from the safety point of view. Especially, the author examines the technical and administrative utilization of data from safety significant incidents in reactors and plants, and the results of the control performed by the nuclear installations

  11. Defining regulatory requirements for water supply systems in Vietnam

    Directory of Open Access Journals (Sweden)

    Deryushev Leonid Georgiyevich

    2014-01-01

    Full Text Available In the article the authors offer their suggestions for improving the reliability of the standardization requirements for water supply facilities in Vietnam, as an analog of building regulations of Russia 31.13330.2012. In Russia and other advanced countries the reliability of the designed water supply systems is usual to assess quantitatively. Guidelines on the reliability assessment of water supply systems and facilities have been offered by many researchers, but these proposals are not officially approved. Some methods for assessing the reliability of water supply facilities are informally used in practice when describing their quality. These evaluation methods are simple and useful. However, the given estimations defy common sense and regulatory requirements used by all the organizations, ministries and departments, for example, of Russia, in the process of allowances for restoration and repair of water supply facilities. Inadequacy of the water supply facilities assessment is shown on the example of assessing the reliability of pipeline system. If we take MTBF of specific length of the pipeline as reliability index for a pipeline system, for example, 5 km, a pipeline of the similar gauge, material and working conditions with the length of 5 m, according to the estimation on the basis of non-official approach, must have a value of MTBF 1000 times greater than with the length of 5 km. This conclusion runs counter to common sense, for the reason that all the pipes in the area of 5 km are identical, have the same load and rate of wear (corrosion, fouling, deformation, etc.. It was theoretically and practically proved that products of the same type in the same operating conditions (excluding determined impact of a person, work as an entity, which MTBF is equal to the average lifetime. It is proposed to take the average service life as a reliability indicator of a pipeline. Durability, but not failsafety of the pipe guarantees pipeline functioning

  12. Regulatory requirements for groundwater monitoring networks at hazardous waste sites

    International Nuclear Information System (INIS)

    Keller, J.F.

    1989-10-01

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

  13. Regulatory science requirements of labeling of genetically modified food.

    Science.gov (United States)

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

    2018-05-01

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

  14. Regulatory requirements related to risk-based inspection and maintenance

    International Nuclear Information System (INIS)

    Schroeder, H.C.; Kauer, R.

    2003-01-01

    By asking the question why new inspection and maintenance strategies have to be developed one can often be made aware that there is always a continue demand for cost reduction and optimisation. In this framework, general trends involving staff reduction, outsourcing, benchmarking etc. can often be observed nearly everywhere. Since inspection and maintenance are amongst the few cost factors, which could be actively influenced in the short term, and in combination with the recent regulatory fundamental changes (e.g. PED) yielding to considerably greater responsibilities for the operator of a plant, also the demand for documentation and comprehensibility of measures will increase. (orig.)

  15. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements

    International Nuclear Information System (INIS)

    Briand, S.

    2008-03-01

    The radiopharmaceuticals devoted to the biomedical research were the object of the directive 2001/20/C.E. transposition that defined again the conditions of implementation of biomedical research using drugs at human use, whom authorization is delivered by A.f.s.s.a.p.s.. In an other hand the law 2006-686 of the 13. june 2006 ( called law T.S.N.) has modified the regulatory dispositions relative to the radiation protection norms. These new dispositions allow to the health facilities to realize their research projects without difficulties for experimental drugs supply. (N.C.)

  16. Regulatory and administrative requirements for practice of nuclear medicine in India

    International Nuclear Information System (INIS)

    Tandon, Pankaj

    1998-01-01

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

  17. Strictness Analysis for Attribute Grammars

    DEFF Research Database (Denmark)

    Rosendahl, Mads

    1992-01-01

    interpretation of attribute grammars. The framework is used to construct a strictness analysis for attribute grammars. Results of the analysis enable us to transform an attribute grammar such that attributes are evaluated during parsing, if possible. The analysis is proved correct by relating it to a fixpoint...... semantics for attribute grammars. An implementation of the analysis is discussed and some extensions to the analysis are mentioned....

  18. Issues and regulatory requirements for the connection of wind generation

    Energy Technology Data Exchange (ETDEWEB)

    Gimenez Alvarez, J.M. [National University of San Juan (Argentina)], E-mail: jgimenez@unsj.edu.ar; Gomez Targarona, J.C. [National University of Rio Cuarto, Cordoba (Argentina). Electric Power Systems Protection Institute (IPSEP)], E-mail: jcgomez@ing.unrc.edu.ar

    2009-07-01

    Pollution problems such as greenhouse effect as well as the high value and volatility of fuel prices have forced and accelerated the development and use of renewable energy sources. In this work a complete revision of wind generation is presented. In the first part a brief history of the wind energy developments is detailed. Next, some commentaries related to the present and future state are made. Then, a revision of the modern structures of wind generation is realized. In fourth place it is included a brief comparison between small and big size turbines. Then, different types of energy storage are mentioned. Finally regulatory aspects are discussed, respect to the treatment of the technical problems. (author)

  19. Chapter 27. Seed testing requirements and regulatory laws

    Science.gov (United States)

    Richard Stevens; Kent R. Jorgensen

    2004-01-01

    Federal and State seed laws require that seed used on range and wildland sites be officially tested and appropriately labeled or tagged. It is the responsibility of the seed distributor (who may be the producer, collector, or broker) toward the end user to properly tag each container of seed to comply with these laws. An analysis tag is always required. If seed has...

  20. Flexible or Strict Taxonomic Organization?

    DEFF Research Database (Denmark)

    Glückstad, Fumiko Kano; Mørup, Morten

    2012-01-01

    This work compares methods for constructing feature-based ontologies that are supposed to be used for culturally-specific knowledge transfer. The methods to be compared are the Terminological Ontology (TO) [1], a method of constructing ontology based on strict principles and rules, and the Infinite...... Relational Model (IRM) [2], a novel unsupervised machine learning method that learns multi-dimensional relations among concepts and features from loosely structured datasets. These methods are combined with a novel cognitive model, the Bayesian Model of Generalization (BMG) [3] that maps culturally...

  1. 30 CFR 938.16 - Required regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ... Section 938.16 Mineral Resources OFFICE OF SURFACE MINING RECLAMATION AND ENFORCEMENT, DEPARTMENT OF THE INTERIOR PROGRAMS FOR THE CONDUCT OF SURFACE MINING OPERATIONS WITHIN EACH STATE PENNSYLVANIA § 938.16... consistent with section 510(d) of SMCRA by requiring that the restoration of prime farmland soil productivity...

  2. Regulatory requirements for radiopharmaceutical radiochemistry and radiation dosimetry

    International Nuclear Information System (INIS)

    Bonnyman, J.

    1985-01-01

    The Australian Department of Health is responsible for ensuring that radiopharmaceuticals are safe and effective and that their use does not result in unnecessary radiation exposure. Section B1 requirements of New Drug Form 4 (NDF4) fall into the following sections - manufacture, product specifications, quality assurance testing, stability studies and expiry dating. It covers ready to inject pharmaceuticals, radioactive formulations used to prepare a radiopharmaceutical, generators and cold kits

  3. REGULATORY REQUIREMENTS FOR REGISTRATION OF GENERIC DRUGS IN "BRICS" COUNTRIES

    OpenAIRE

    G.Ravi Kiran* , M.V.Nagabhushanam, Brahmaiah Bonthagarala, D.Nagarjuna Reddy

    2017-01-01

    The purpose of the study was to compare generic drug registration process and to find out the differences, lacunae among the guidelines. Brazil, Russia, India, China and South Africa are typically rendered as "the BRICS" or "the BRICS economies". The registration process for Brazil and Russia are completely different. Even though India, China and South Africa follow the CTD format the requirements for Module 1 are different. It can be concluded that the world pharmaceutical economy, the faste...

  4. Regulatory requirements of radiation protection for veterinary nuclear medicine

    International Nuclear Information System (INIS)

    Ernst-Elz, Andreas

    2010-01-01

    The application of radionuclides for diagnostic and therapy in veterinary medicine requires permission by terms of German radiation protection ordinance. Conditions for granting this licence are described. Preconditions are the requisite qualification of the veterinarian and the structural conditions of radiation protection. It is necessary to consider the possible exposure of the public by radioactive waste and by animals after their discharge from treatment. (orig.)

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

    International Nuclear Information System (INIS)

    MULKEY, C.H.

    1999-01-01

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

  6. Investigating electronic records management and compliance with regulatory requirements in a South African university

    OpenAIRE

    M.E. Kyobe; P. Molai; T. Salie

    2009-01-01

    This study investigated the extent to which academics and students at a leading University in South Africa managed electronic records in accordance with good practices and regulatory requirements. Literature on electronic records management (ERM) and regulatory compliance was synthesised to create a framework for effective records management. A survey was then conducted to test this framework with 17 academics, 97 students and two technical staff from five faculties. The results revealed seve...

  7. 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...

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

    Science.gov (United States)

    2016-01-01

    Purpose The purpose of this study is to compare and contrast the contents of each state’s occupational therapy (OT) regulatory board requirements regarding licensees’ acquisition of continuing education units in the United States of America. Methods Data related to continuing education requirements from each OT regulatory board of all 50 states and the District of Columbia in the United States were reviewed and categorized by two reviewers. Analysis was conducted based on the categorization of the continuing education requirements and activities required, allowed, and not allowed/not mentioned for continuing education units. Results Findings revealed non-uniformity and inconsistency of continuing education requirements for licensure renewal between OT regulatory boards and was coupled with lack of specific criteria for various continuing education activities. Continuing education requirements were not tailored to meet the needs of individual licensee’s current and anticipated professional role and job responsibilities, with a negative bias towards presentation and publication allowed for continuing education units. Few boards mandated continuing education topics on ethics related to OT practice within each renewal cycle. Conclusion OT regulatory boards should move towards unifying the reporting format of continuing education requirements across all states to reduce ambiguity and to ensure licensees are equipped to provide ethical and competent practice. Efforts could be made to enact continuing education requirements specific to the primary role of a particular licensee. Finally, assigning the amount of continuing education credits to be awarded for different activities should be based on research evidence rather than arbitrary determination. PMID:27780351

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

    Science.gov (United States)

    Hall, Savannah R; Crifasi, Kristen A; Marinelli, Christina M; Yuen, Hon K

    2016-01-01

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

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

    International Nuclear Information System (INIS)

    2016-01-01

    This publication establishes requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered. A review of Safety Requirements publications was commenced in 2011 following the accident in the Fukushima Daiichi nuclear power plant in Japan. The review revealed no significant areas of weakness and resulted in just a small set of amendments to strengthen the requirements and facilitate their implementation, which are contained in the present publication.

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

    International Nuclear Information System (INIS)

    2016-01-01

    This publication establishes requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered. A review of Safety Requirements publications was commenced in 2011 following the accident in the Fukushima Daiichi nuclear power plant in Japan. The review revealed no significant areas of weakness and resulted in just a small set of amendments to strengthen the requirements and facilitate their implementation, which are contained in the present publication

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

    International Nuclear Information System (INIS)

    Erp, J.B. van

    1978-01-01

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

  13. Analysis of regulatory requirement for beyond design basis events of SMART

    International Nuclear Information System (INIS)

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

    2000-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    MULKEY, C.H.

    1999-07-06

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

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

    International Nuclear Information System (INIS)

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

    1992-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-01

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

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

    International Nuclear Information System (INIS)

    2000-01-01

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

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

    International Nuclear Information System (INIS)

    Roberts, J.K.

    1976-01-01

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

  19. Regulatory and backfit analysis: Unresolved safety issue A-45, shutdown decay heat removal requirements

    International Nuclear Information System (INIS)

    1988-11-01

    All light water reactors require decay heat to be removed subsequent to reactor shutdown. Interruption of the decay heat removal function could lead to severe consequences. Concerns about the reliability of the systems and components that assist in the decay heat removal process and the potentially severe consequences of a complete loss of decay heat removal resulted in establishing the requirements for decay heat removal as an unresolved safety issue (USI) designated USI A-45, ''Shutdown Decay Heat Removal Requirements.'' This report presents the regulatory analysis for USI A-45. It includes (1) a summary of the issue, (2) the proposed technical resolution, (3) alternative resolutions considered by the Nuclear Regulatory Commission, (4) an assessment of the benefits and costs of all alternatives considered, and (5) the decision rationale. 23 refs., 9 figs., 39 tabs

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

    International Nuclear Information System (INIS)

    Dory, A.B.

    1981-10-01

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

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

    International Nuclear Information System (INIS)

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

    1988-01-01

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

  2. CD4+ regulatory T cells require CTLA-4 for the maintenance of systemic tolerance.

    Science.gov (United States)

    Friedline, Randall H; Brown, David S; Nguyen, Hai; Kornfeld, Hardy; Lee, Jinhee; Zhang, Yi; Appleby, Mark; Der, Sandy D; Kang, Joonsoo; Chambers, Cynthia A

    2009-02-16

    Cytotoxic T lymphocyte antigen-4 (CTLA-4) plays a critical role in negatively regulating T cell responses and has also been implicated in the development and function of natural FOXP3(+) regulatory T cells. CTLA-4-deficient mice develop fatal, early onset lymphoproliferative disease. However, chimeric mice containing both CTLA-4-deficient and -sufficient bone marrow (BM)-derived cells do not develop disease, indicating that CTLA-4 can act in trans to maintain T cell self-tolerance. Using genetically mixed blastocyst and BM chimaeras as well as in vivo T cell transfer systems, we demonstrate that in vivo regulation of Ctla4(-/-) T cells in trans by CTLA-4-sufficient T cells is a reversible process that requires the persistent presence of FOXP3(+) regulatory T cells with a diverse TCR repertoire. Based on gene expression studies, the regulatory T cells do not appear to act directly on T cells, suggesting they may instead modulate the stimulatory activities of antigen-presenting cells. These results demonstrate that CTLA-4 is absolutely required for FOXP3(+) regulatory T cell function in vivo.

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

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

    International Nuclear Information System (INIS)

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

    2006-01-01

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

  5. Extremely strict ideals in Banach spaces

    Indian Academy of Sciences (India)

    Motivated by the notion of an ideal introduced by Godefroy {\\it et al.} ({\\it Studia Math.} {\\bf 104} (1993) 13–59), in this article, we introduce and study the notion of an extremely strict ideal. For a Poulsen simplex K , we show that the space of affine continuous functions on K is an extremely strict ideal in the space of continuous ...

  6. Hyperbolic spaces are of strictly negative type

    DEFF Research Database (Denmark)

    Hjorth, Poul G.; Kokkendorff, Simon L.; Markvorsen, Steen

    2002-01-01

    We study finite metric spaces with elements picked from, and distances consistent with, ambient Riemannian manifolds. The concepts of negative type and strictly negative type are reviewed, and the conjecture that hyperbolic spaces are of strictly negative type is settled, in the affirmative...

  7. Extremely strict ideals in Banach spaces

    Indian Academy of Sciences (India)

    Abstract. Motivated by the notion of an ideal introduced by Godefroy et al. (Stu- dia Math. 104 (1993) 13–59), in this article, we introduce and study the notion of an extremely strict ideal. For a Poulsen simplex K, we show that the space of affine contin- uous functions on K is an extremely strict ideal in the space of continuous ...

  8. 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.

  9. 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

  10. Finite Metric Spaces of Strictly negative Type

    DEFF Research Database (Denmark)

    Hjorth, Poul G.

    If a finite metric space is of strictly negative type then its transfinite diameter is uniquely realized by an infinite extent (“load vector''). Finite metric spaces that have this property include all trees, and all finite subspaces of Euclidean and Hyperbolic spaces. We prove that if the distance...... matrix of a finite metric space is both hypermetric and regular, then it is of strictly negative type. We show that the strictly negative type finite subspaces of spheres are precisely those which do not contain two pairs of antipodal points....

  11. Modeling regulatory policies associated with offshore structure removal requirements in the Gulf of Mexico

    Energy Technology Data Exchange (ETDEWEB)

    Kaiser, Mark J. [Center for Energy Studies, Louisiana State University, Energy Coast and Environment Building, Baton Rouge, LA (United States)

    2008-07-15

    Federal regulations require that a lease in the Outer Continental Shelf of the Gulf of Mexico be cleared of all structures within one year after production on the lease ceases, but in recent years, the Minerals Management Service has begun to encourage operators to remove idle (non-producing) structures on producing leases that are no longer ''economically viable''. At the end of 2003, there were 2175 producing structures, 898 idle (non-producing) structures, and 440 auxiliary (never-producing) structures on 1356 active leases; and 329 idle structures and 65 auxiliary structures on 273 inactive leases. The purpose of this paper is to model the impact of alternative regulatory policies on the removal trends of structures and the inventory of idle iron, and to provide first-order estimates of the cost of each regulatory option. A description of the modeling framework and implementation results is presented. (author)

  12. Hyperbolic spaces are of strictly negative type

    DEFF Research Database (Denmark)

    Hjorth, Poul G.; Kokkendorff, Simon L.; Markvorsen, Steen

    2002-01-01

    We study finite metric spaces with elements picked from, and distances consistent with, ambient Riemannian manifolds. The concepts of negative type and strictly negative type are reviewed, and the conjecture that hyperbolic spaces are of strictly negative type is settled, in the affirmative....... The technique of the proof is subsequently applied to show that every compact manifold of negative type must have trivial fundamental group, and to obtain a necessary criterion for product manifolds to be of negative type....

  13. 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)

  14. A regulatory gene (ECO-orf4) required for ECO-0501 biosynthesis in Amycolatopsis orientalis.

    Science.gov (United States)

    Shen, Yang; Huang, He; Zhu, Li; Luo, Minyu; Chen, Daijie

    2014-02-01

    ECO-0501 is a novel linear polyene antibiotic, which was discovered from Amycolatopsis orientalis. Recent study of ECO-0501 biosynthesis pathway revealed the presence of regulatory gene: ECO-orf4. The A. orientalis ECO-orf4 gene from the ECO-0501 biosynthesis cluster was analyzed, and its deduced protein (ECO-orf4) was found to have amino acid sequence homology with large ATP-binding regulators of the LuxR (LAL) family regulators. Database comparison revealed two hypothetical domains, a LuxR-type helix-turn-helix (HTH) DNA binding motif near the C-terminal and an N-terminal nucleotide triphosphate (NTP) binding motif included. Deletion of the corresponding gene (ECO-orf4) resulted in complete loss of ECO-0501 production. Complementation by one copy of intact ECO-orf4 restored the polyene biosynthesis demonstrating that ECO-orf4 is required for ECO-0501 biosynthesis. The results of overexpression ECO-orf4 on ECO-0501 production indicated that it is a positive regulatory gene. Gene expression analysis by reverse transcription PCR of the ECO-0501 gene cluster showed that the transcription of ECO-orf4 correlates with that of genes involved in polyketide biosynthesis. These results demonstrated that ECO-orf4 is a pathway-specific positive regulatory gene that is essential for ECO-0501 biosynthesis. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

    International Nuclear Information System (INIS)

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

    2004-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Giannakou C

    2016-06-01

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

  17. Investigating electronic records management and compliance with regulatory requirements in a South African university

    Directory of Open Access Journals (Sweden)

    M.E. Kyobe

    2009-02-01

    Full Text Available This study investigated the extent to which academics and students at a leading University in South Africa managed electronic records in accordance with good practices and regulatory requirements. Literature on electronic records management (ERM and regulatory compliance was synthesised to create a framework for effective records management. A survey was then conducted to test this framework with 17 academics, 97 students and two technical staff from five faculties. The results revealed several incidents of poor records management and lack of compliance with regulations. Many academics and students were unaware of legislative requirements and penalties. They did not backup or archive records regularly and where this was done, there were no standard procedures followed, which resulted in the adoption of distinct approaches to record keeping. Furthermore, appropriate programmes for educating users on ERM did not exist and academics had not established collaborative initiatives with other nonacademics (e.g. internal auditors and legal experts to ensure effective ERM. It was also surprising to find that non-computing academics and students managed system security risks better than their computing counterparts. Useful recommendations and the way forward are provided.

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

    International Nuclear Information System (INIS)

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

    1989-06-01

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

  19. Strictly convex functions on complete Finsler manifolds

    Indian Academy of Sciences (India)

    ... Refresher Courses · Symposia · Live Streaming. Home; Journals; Proceedings – Mathematical Sciences; Volume 126; Issue 4. Strictly convex functions on complete Finsler manifolds. YOE ITOKAWA KATSUHIRO SHIOHAMA BANKTESHWAR TIWARI. Research Article Volume 126 Issue 4 October 2016 pp 623-627 ...

  20. Finite Metric Spaces of Strictly Negative Type

    DEFF Research Database (Denmark)

    Hjorth, Poul; Lisonek, P.; Markvorsen, Steen

    1998-01-01

    We prove that, if a finite metric space is of strictly negative type, then its transfinite diameter is uniquely realized by the infinite extender (load vector). Finite metric spaces that have this property include all spaces on two, three, or four points, all trees, and all finite subspaces of Eu...

  1. Requirements for efficient cell-type proportioning: regulatory timescales, stochasticity and lateral inhibition

    Science.gov (United States)

    Pfeuty, B.; Kaneko, K.

    2016-04-01

    The proper functioning of multicellular organisms requires the robust establishment of precise proportions between distinct cell types. This developmental differentiation process typically involves intracellular regulatory and stochastic mechanisms to generate cell-fate diversity as well as intercellular signaling mechanisms to coordinate cell-fate decisions at tissue level. We thus surmise that key insights about the developmental regulation of cell-type proportion can be captured by the modeling study of clustering dynamics in population of inhibitory-coupled noisy bistable systems. This general class of dynamical system is shown to exhibit a very stable two-cluster state, but also metastability, collective oscillations or noise-induced state hopping, which can prevent from timely and reliably reaching a robust and well-proportioned clustered state. To circumvent these obstacles or to avoid fine-tuning, we highlight a general strategy based on dual-time positive feedback loops, such as mediated through transcriptional versus epigenetic mechanisms, which improves proportion regulation by coordinating early and flexible lineage priming with late and firm commitment. This result sheds new light on the respective and cooperative roles of multiple regulatory feedback, stochasticity and lateral inhibition in developmental dynamics.

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

    Science.gov (United States)

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

    2010-01-01

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

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

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

    International Nuclear Information System (INIS)

    LeClair, J.; Ashley, F.

    2006-01-01

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

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

    Science.gov (United States)

    Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

    2007-09-01

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

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

    International Nuclear Information System (INIS)

    Horvath, C.L.

    1991-01-01

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

  7. Extremely strict ideals in Banach spaces

    Indian Academy of Sciences (India)

    the space of regular Borel measures, it is easy to see that with respect to the projection μ → μ|(0, 1), M is an extremely strict ideal in C([0, 1]) but as the Lebesgue measure is non-atomic, M. ∗. 1 is not the norm closed ..... (Grenoble) 28 (1978) 35–65. [10] Rao T S S R K, On ideals in Banach spaces, Rocky Mountain J. Math.

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

    Science.gov (United States)

    Giannakou, Christina; Park, Margriet Vdz; de Jong, Wim H; van Loveren, Henk; Vandebriel, Rob J; Geertsma, Robert E

    2016-01-01

    Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome activation, and hypersensitivity, are not readily detected by using current testing guidelines. Immunotoxicity of NMPs would be more accurately evaluated by an expanded testing strategy that is equipped to stratify applicable testing for the various types of NMPs.

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

    International Nuclear Information System (INIS)

    Dverstorp, B.

    2010-01-01

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

  10. A guide to ventilation requirements for uranium mines and mills. Regulatory guide G-221

    International Nuclear Information System (INIS)

    2003-06-01

    The purpose of G-221 is to help persons address the requirements for the submission of ventilation-related information when applying for a Canadian Nuclear Safety Commission (CNSC) licence to site and construct, operate or decommission a uranium mine or mill. This guide is also intended to help applicants for a uranium mine or mill licence understand their operational and maintenance obligations with respect to ventilation systems, and to help CNSC staff evaluate the adequacy of applications for uranium mine and mill licences. This guide is relevant to any application for a CNSC licence to prepare a site for and construct, operate or decommission a uranium mine or mill. In addition to summarizing the ventilation-related obligations or uranium mine and mill licensee, the guide describes and discusses the ventilation-related information that licence applicants should typically submit to meet regulatory requirements. The guide pertains to any ventilation of uranium mines and mills for the purpose of assuring the radiation safety of workers and on-site personnel. This ventilation may be associated with any underground or surface area or premise that is licensable by the CNSC as part of a uranium mine or mill. These areas and premises typically include mine workings, mill buildings, and other areas or premises involving or potentially affected by radiation or radioactive materials. Some examples of the latter include offices, effluent treatment plants, cafeterias, lunch rooms and personnel change-rooms. (author)

  11. More strictly protected areas are not necessarily more protective: evidence from Bolivia, Costa Rica, Indonesia, and Thailand

    International Nuclear Information System (INIS)

    Ferraro, Paul J; Hanauer, Merlin M; Miteva, Daniela A; Pattanayak, Subhrendu K; Canavire-Bacarreza, Gustavo Javier; Sims, Katharine R E

    2013-01-01

    National parks and other protected areas are at the forefront of global efforts to protect biodiversity and ecosystem services. However, not all protection is equal. Some areas are assigned strict legal protection that permits few extractive human uses. Other protected area designations permit a wider range of uses. Whether strictly protected areas are more effective in achieving environmental objectives is an empirical question: although strictly protected areas legally permit less anthropogenic disturbance, the social conflicts associated with assigning strict protection may lead politicians to assign strict protection to less-threatened areas and may lead citizens or enforcement agents to ignore the strict legal restrictions. We contrast the impacts of strictly and less strictly protected areas in four countries using IUCN designations to measure de jure strictness, data on deforestation to measure outcomes, and a quasi-experimental design to estimate impacts. On average, stricter protection reduced deforestation rates more than less strict protection, but the additional impact was not always large and sometimes arose because of where stricter protection was assigned rather than regulatory strictness per se. We also show that, in protected area studies contrasting y management regimes, there are y 2 policy-relevant impacts, rather than only y, as earlier studies have implied. (letter)

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

    International Nuclear Information System (INIS)

    Dory, A.B.

    1981-10-01

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

  13. Strictness Analysis and Denotational Abstract Interpretation

    DEFF Research Database (Denmark)

    Nielson, Flemming

    1988-01-01

    there and this sufices to make the framework applicable to strictness analysis for the lambda-calculus. This shows the possibility of a general theory for the analysis of functional programs and it gives more insight into the relative precision of the various analyses. In particular it is shown that a collecting (static......A theory of abstract interpretation () is developed for a typed lambda-calculus. The typed lambda-calculus may be viewed as the ''static'' part of a two-level denotational metalanguage for which abstract interpretation was developed by ). The present development relaxes a condition imposed...

  14. 7 CFR 28.441 - Strict Middling Yellow Stained Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Middling Yellow Stained Color. 28.441 Section... Strict Middling Yellow Stained Color. Strict Middling Yellow Stained Color is color which is deeper than that of Strict Middling Tinged Color. [57 FR 34498, Aug. 5, 1992] ...

  15. 7 CFR 28.412 - Strict Middling Light Spotted Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Middling Light Spotted Color. 28.412 Section 28... Light Spotted Color. Strict Middling Light Spotted Color is color which in spot or color, or both, is between Strict Middling Color and Strict Middling Spotted Color. ...

  16. Accident analyses in fulfillment of the requirements of the National Environmental Policy Act and their relationship to the packaging and testing requirements of the Nuclear Regulatory Commission

    Energy Technology Data Exchange (ETDEWEB)

    Darrough, M. [US Dept. of Energy, Forrestal Building, Washington, DC (United States); McSweeney, T. [Battelle Columbus Div., OH (United States); Rothman, R. [US Dept. of Energy, Argonne, IL (United States)

    1990-10-01

    This paper presents a proposed approach to assess transportation accidents in OCRWM`s fulfillment of NEPA requirements. This proposed approach builds on the methodology used in the NRC assessments of transportation accidents, frequently called the Modal Study. The authors demonstrate compatibility between the two regulatory perspectives.

  17. Regulatory requirements and tools for environmental assessment of hazardous wastes: understanding tribal and stakeholder concerns using Department of Energy sites.

    Science.gov (United States)

    Burger, Joanna; Powers, Charles; Gochfeld, Michael

    2010-12-01

    Many US governmental and Tribal Nation agencies, as well as state and local entities, deal with hazardous wastes within regulatory frameworks that require specific environmental assessments. In this paper we use Department of Energy (DOE) sites as examples to examine the relationship between regulatory requirements and environmental assessments for hazardous waste sites and give special attention to how assessment tools differ. We consider federal laws associated with environmental protection include the National Environmental Policy Act (NEPA), the Resource Conservation and Recovery Act (RCRA), the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), as well as regulations promulgated by the Nuclear Regulatory Commission, Tribal Nations and state agencies. These regulatory regimes require different types of environmental assessments and remedial investigations, dose assessments and contaminant pathways. The DOE case studies illustrate the following points: 1) there is often understandable confusion about what regulatory requirements apply to the site resources, and what environmental assessments are required by each, 2) the messages sent on site safety issued by different regulatory agencies are sometimes contradictory or confusing (e.g. Oak Ridge Reservation), 3) the regulatory frameworks being used to examine the same question can be different, leading to different conclusions (e.g. Brookhaven National Laboratory), 4) computer models used in support of groundwater models or risk assessments are not necessarily successful in convincing Native Americans and others that there is no possibility of risk from contaminants (e.g. Amchitka Island), 5) when given the opportunity to choose between relying on a screening risk assessments or waiting for a full site-specific analysis of contaminants in biota, the screening risk assessment option is rarely selected (e.g. Amchitka, Hanford Site), and finally, 6) there needs to be agreement on whether

  18. PRMT1 mediated methylation of TAF15 is required for its positive gene regulatory function

    Energy Technology Data Exchange (ETDEWEB)

    Jobert, Laure; Argentini, Manuela [Institut de Genetique et de Biologie Moleculaire et Cellulaire (IGBMC), CNRS UMR 7104, INSERM U 596, Universite Louis Pasteur de Strasbourg, BP 10142 - 67404 Illkirch Cedex, CU de Strasbourg (France); Tora, Laszlo, E-mail: laszlo@igbmc.u-strasbg.fr [Institut de Genetique et de Biologie Moleculaire et Cellulaire (IGBMC), CNRS UMR 7104, INSERM U 596, Universite Louis Pasteur de Strasbourg, BP 10142 - 67404 Illkirch Cedex, CU de Strasbourg (France)

    2009-04-15

    TAF15 (formerly TAF{sub II}68) is a nuclear RNA-binding protein that is associated with a distinct population of TFIID and RNA polymerase II complexes. TAF15 harbours an N-terminal activation domain, an RNA recognition motif (RRM) and many Arg-Gly-Gly (RGG) repeats at its C-terminal end. The N-terminus of TAF15 serves as an essential transforming domain in the fusion oncoprotein created by chromosomal translocation in certain human chondrosarcomas. Post-transcriptional modifications (PTMs) of proteins are known to regulate their activity, however, nothing is known on how PTMs affect TAF15 function. Here we demonstrate that endogenous human TAF15 is methylated in vivo at its numerous RGG repeats. Furthermore, we identify protein arginine N-methyltransferase 1 (PRMT1) as a TAF15 interactor and the major PRMT responsible for its methylation. In addition, the RGG repeat-containing C-terminus of TAF15 is responsible for the shuttling between the nucleus and the cytoplasm and the methylation of RGG repeats affects the subcellular localization of TAF15. The methylation of TAF15 by PRMT1 is required for the ability of TAF15 to positively regulate the expression of the studied endogenous TAF15-target genes. Our findings demonstrate that arginine methylation of TAF15 by PRMT1 is a crucial event determining its proper localization and gene regulatory function.

  19. [Requirements for drug approval and additional benefits assessment: Regulatory aspects and experiences].

    Science.gov (United States)

    Broich, K; Löbker, W; Schulte, A; Beinlich, P; Müller, T

    2016-04-01

    The early assessment of benefits of newly approved drugs with novel active substances or new applications, which came into force on 1 January 2011 still represents a challenge to all parties involved. This article highlights the definitions, regulatory requirements and interaction between drug marketing approval and early assessment of benefits in Germany. The constellation of an extensively harmonized European and even international drug authorization process with a predominantly national regulation of drug reimbursement situation inevitably causes friction, which could be markedly reduced through early joint advisory discussions during the planning phase for pivotal clinical trials. During the year 2015 the Federal Institute for Drugs and Medical Devices (BfArM) carried out 300 scientific advice procedures of which 34 were concerned with applications in the field of indications for the central nervous system (CNS). In comparison 98 advisory meetings were held by the Federal Joint Committee (G-BA) of which the BfArM provided advice in 12 instances and in 2 cases on CNS indications. Study design, endpoints and appropriate comparative therapies are the key issues in exchanges and discussions between the BfArM, the G‑BA and applicants. Under these aspects the BfArM and G‑BA promote an early and consistent involvement in early advice procedures regarding the prerequisites for drug approval and assessment of additional benefits.

  20. Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

    Science.gov (United States)

    Trows, Sabrina; Wuchner, Klaus; Spycher, Rene; Steckel, Hartwig

    2014-01-01

    Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD), plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results. PMID:24732068

  1. Regulatory Requirements for Pollution Prevention for the Salt Waste Processing Facility at Savannah River Site

    International Nuclear Information System (INIS)

    Malik, N.P.

    1999-01-01

    Savannah River Site (SRS) is a Department of Energy facility for production of nuclear materials located near Aiken, South Carolina that is operated by the Westinghouse Savannah River Company. Waste sludges and salts generated from the processing of nuclear materials have been stored in underground storage tanks since operations began in the 1950s. These sludges and salts contain high levels of long-lived and short-lived radionuclides. To ensure the long-term protection of human health and the environment, some tanks that do not comply with current regulatory requirements are to be emptied and closed per the SRS Federal Facilities Agreement . Sludge generated from these tanks is being immobilized in borosilicate glass through vitrification at the Defense Waste Processing Facility (DWPF) at SRS. The remaining radioactive liquids have a high concentration of salts. For economic and practical purposes, the approach for processing salts is to separate the radionuclides from the non-radioactive salts and incidental wastes. The radionuclides are processed at the DWPF, while the salts and incidental wastes are disposed of as low level waste

  2. Basic regulatory policy requirements for a liberalised natural gas market; Ordnungspolitische Grunderfordernisse fuer den liberalisierten Gasmarkt

    Energy Technology Data Exchange (ETDEWEB)

    Geisel, K.H. [BEB Erdgas und Erdoel GmbH, Hannover (Germany)

    1997-08-01

    Whether worldwide, on the European Continent, or at national level, natural gas is coming to the front everywhere. In Latin America or South-East Asia, the natural gas industry is booming. However, the regional constraints of natural gas should not be forgotten. ``et`` interviewed a representative of the BEB company about the prospects of the natural business at large and the primary energy source no. 2 in the German energy market, where natural gas ranks second after mineral oil. The topics reported refer to basic regulatory policy requirements in order to safeguard a smooth functioning of the gas market, as well as suitable environmental policy instruments and strategies for management re-orientation to cope with the expected changes in the competitive situation. (Orig.) [Deutsch] Ob weltweit, kontinentaleuropaeisch oder national betrachtet - das Erdgas ist dort wie hier auf dem Vormarsch. In Lateinamerika und Suedostasien kann man regelrecht von einem Erdgasboom sprechen. Allerdings sollte man die regionale Gebundenheit der Erdgasnutzung nicht aus den Augen verlieren. `et` sprach mit dem `Unternehmen Erdgas` BEB ueber die Perspektiven des - nach dem Mineraloel - Primaerenergietraegers Nr. 2 auf dem deutschen Markt. Neben der Auslotung von ordnungspolitischen Grunderfordernissen fuer einen funktionierenden Gasmarkt und geeigneten Instrumenten fuer den Umweltschutz geht es um die Strategien fuer eine unternehmerische Neuausrichtung fuer den verschaerften Wettbewerb. (orig.)

  3. Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

    Directory of Open Access Journals (Sweden)

    Sabrina Trows

    2014-04-01

    Full Text Available Nasal drug delivery can be assessed by a variety of means and regulatory agencies, e.g., the Food and Drug Administration (FDA and the European Medicines Agency (EMA have published a set of guidelines and regulations proposing in vitro test methods for the characterization of nasal drug products. This article gives a summary of the FDA and EMA requirements regarding the determination of droplet size distribution (DSD, plume geometry, spray pattern and shot weights of solution nasal sprays and discusses the analytical challenges that can occur when performing these measurements. In order to support findings from the literature, studies were performed using a standard nasal spray pump and aqueous model formulations. The aim was to identify possible method-, device- and formulation-dependent influencing factors. The literature review, as well as the results from the studies show that DSD, plume geometry and spray pattern are influenced by, e.g., the viscosity of the solution, the design of the device and the actuation parameters, particularly the stroke length, actuation velocity and actuation force. The dominant factor influencing shot weights, however, is the adjustment of the actuation parameters, especially stroke length and actuation velocity. Consequently, for routine measurements assuring, e.g., the quality of a solution nasal spray or, for in vitro bioequivalence studies, the critical parameters, have to be identified and considered in method development in order to obtain reproducible and reliable results.

  4. 78 FR 76757 - Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become...

    Science.gov (United States)

    2013-12-19

    ... Service of Drivers Rest Break Requirement; Drivers Who Become Ineligible for the ``Short-Haul'' Exception... guidance. SUMMARY: This regulatory guidance addresses application of the 30- minute break rule to... exempt from the break rule, but who occasionally exceed the short haul distance or time limits. Such...

  5. Disabled-2 is a FOXP3 target gene required for regulatory T cell function

    OpenAIRE

    Jain, N; Nguyen, H; Friedline, RH; Malhotra, N; Brehm, M; Koyonagi, M; Bix, M; Cooper, JA; Chambers, CA; Kang, J

    2009-01-01

    FOXP3 expressing regulatory T cells are vital for maintaining peripheral T cell tolerance and homeostasis. The mechanisms by which FOXP3 target genes orchestrate context-dependent Treg cell function are largely unknown. Here we show that in mouse peripheral lymphocytes, the Drosophila Disabled-2 (Dab2) homolog, a gene that is involved in enhancing TGFβ responses, is exclusively expressed in FOXP3+ regulatory T cells. Dab2 is a direct target of FOXP3 and regulatory T cells lacking DAB2 are fun...

  6. Impact of regulatory requirements on medicine registration in African countries - perceptions and experiences of pharmaceutical companies in South Africa.

    Science.gov (United States)

    Narsai, Kirti; Williams, Abeda; Mantel-Teeuwisse, Aukje Kaija

    2012-07-01

    Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of

  7. A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

    Science.gov (United States)

    Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

    2015-01-01

    Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

  8. Geometrical optimization for strictly localized structures

    Science.gov (United States)

    Mo, Yirong

    2003-07-01

    Recently we proposed the block localized wavefunction (BLW) approach which takes the advantages of valence bond theory and molecular orbital theory and defines the wavefunctions for resonance structures based on the assumption that all electrons and orbitals are partitioned into a few subgroups. In this work, we implement the geometrical optimization of the BLW method based on the algorithm proposed by Gianinetti and coworkers. Thus, we can study the conjugation effect on not only the molecular stability, but also the molecular geometry. With this capability, the π conjugation effect in trans-polyenes C2nH2n+2 (n=2-5) as well as in formamide and its analogs are studied by optimizing their delocalized and strictly localized forms with the 6-31G(d) and 6-311+G(d,p) basis sets. Although it has been well presumed that the π resonance shortens the single bonds and lengthens the double bonds with the delocalization of π electrons across the whole line in polyenes, our optimization of the strictly localized structures quantitatively shows that when the conjugation effect is "turned off," the double bond lengths will be identical to the CC bond length in ethylene and the single Csp2-Csp2 bond length will be about 1.513-1.517 Å. In agreement with the classical Hückel theory, the resonance energies in polyenes are approximately in proportion to the number of double bonds. Similarly, resonance is responsible not only for the planarity of formamide, thioformamide, and selenoformamide, but also for the lengthening of the CX (X=O,S,Se) double bond and the shortening of the CN bonds. Although it is assumed that the CX bond polarization decreases in the order of O>S>Se, the π electronic delocalization increases in the opposite order, i.e., formamide

  9. Cutting edge: Dab2 is a FOXP3 target gene required for regulatory T cell function.

    Science.gov (United States)

    Jain, Nitya; Nguyen, Hai; Friedline, Randall H; Malhotra, Nidhi; Brehm, Michael; Koyanagi, Madoka; Bix, Mark; Cooper, Jonathan A; Chambers, Cynthia A; Kang, Joonsoo

    2009-10-01

    FOXP3-expressing regulatory T (Treg) cells are vital for maintaining peripheral T cell tolerance and homeostasis. The mechanisms by which FOXP3 target genes orchestrate context-dependent Treg cell function are largely unknown. In this study we show that in mouse peripheral lymphocytes the Drosophila Disabled-2 (Dab2) homolog, a gene that is involved in enhancing TGFbeta responses, is exclusively expressed in FOXP3+ regulatory T cells. Dab2 is a direct target of FOXP3, and regulatory T cells lacking DAB2 are functionally impaired in vitro and in vivo. However, not all aspects of Treg cell function are perturbed, and DAB2 appears to be dispensable for Treg cell function in maintaining naive T cell homeostasis.

  10. Disabled-2 is a FOXP3 target gene required for regulatory T cell function

    Science.gov (United States)

    Jain, N; Nguyen, H; Friedline, RH; Malhotra, N; Brehm, M; Koyonagi, M; Bix, M; Cooper, JA; Chambers, CA; Kang, J

    2010-01-01

    FOXP3 expressing regulatory T cells are vital for maintaining peripheral T cell tolerance and homeostasis. The mechanisms by which FOXP3 target genes orchestrate context-dependent Treg cell function are largely unknown. Here we show that in mouse peripheral lymphocytes, the Drosophila Disabled-2 (Dab2) homolog, a gene that is involved in enhancing TGFβ responses, is exclusively expressed in FOXP3+ regulatory T cells. Dab2 is a direct target of FOXP3 and regulatory T cells lacking DAB2 are functionally impaired in vitro and in vivo. However, not all aspects of Treg cell function are perturbed and DAB2 appears dispensable for Treg cell function in maintaining naïve T cell homeostasis. PMID:19767570

  11. Evaluation of research reactor fuel reliability in support of regulatory requirements

    International Nuclear Information System (INIS)

    Sokolov, Eugene N.

    2005-01-01

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

  12. From Regular to Strictly Locally Testable Languages

    Directory of Open Access Journals (Sweden)

    Stefano Crespi Reghizzi

    2011-08-01

    Full Text Available A classical result (often credited to Y. Medvedev states that every language recognized by a finite automaton is the homomorphic image of a local language, over a much larger so-called local alphabet, namely the alphabet of the edges of the transition graph. Local languages are characterized by the value k=2 of the sliding window width in the McNaughton and Papert's infinite hierarchy of strictly locally testable languages (k-slt. We generalize Medvedev's result in a new direction, studying the relationship between the width and the alphabetic ratio telling how much larger the local alphabet is. We prove that every regular language is the image of a k-slt language on an alphabet of doubled size, where the width logarithmically depends on the automaton size, and we exhibit regular languages for which any smaller alphabetic ratio is insufficient. More generally, we express the trade-off between alphabetic ratio and width as a mathematical relation derived from a careful encoding of the states. At last we mention some directions for theoretical development and application.

  13. 7 CFR 28.404 - Strict Low Middling Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Low Middling Color. 28.404 Section 28.404... for the Color Grade of American Upland Cotton § 28.404 Strict Low Middling Color. Strict Low Middling Color is color which is within the range represented by a set of samples in the custody of the United...

  14. 7 CFR 28.406 - Strict Good Ordinary Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Good Ordinary Color. 28.406 Section 28.406... for the Color Grade of American Upland Cotton § 28.406 Strict Good Ordinary Color. Strict Good Ordinary Color is color which is within the range represented by a set of samples in the custody of the...

  15. 7 CFR 28.402 - Strict Middling Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Middling Color. 28.402 Section 28.402... for the Color Grade of American Upland Cotton § 28.402 Strict Middling Color. Strict Middling Color is color which is within the range represented by a set of samples in the custody of the United States...

  16. Franchise Values, Regulatory Monitoring, and Capital Requirements in Optimal Bank Regulation

    DEFF Research Database (Denmark)

    Andersen, Thomas Barnebeck; Harr, Thomas

    2008-01-01

    This paper demonstrates that financial deregulation is likely to make standard prudential regulatory instruments less effective in curbing excessive risk-taking incentives among banks. This has interesting implications for optimal bank regulation. When there is an increase in competition, the opt...

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

    International Nuclear Information System (INIS)

    Ritterbusch, S.E.

    2000-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Ritterbusch, S.E.

    2000-08-01

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

  19. Mammalian evolution may not be strictly bifurcating.

    Science.gov (United States)

    Hallström, Björn M; Janke, Axel

    2010-12-01

    The massive amount of genomic sequence data that is now available for analyzing evolutionary relationships among 31 placental mammals reduces the stochastic error in phylogenetic analyses to virtually zero. One would expect that this would make it possible to finally resolve controversial branches in the placental mammalian tree. We analyzed a 2,863,797 nucleotide-long alignment (3,364 genes) from 31 placental mammals for reconstructing their evolution. Most placental mammalian relationships were resolved, and a consensus of their evolution is emerging. However, certain branches remain difficult or virtually impossible to resolve. These branches are characterized by short divergence times in the order of 1-4 million years. Computer simulations based on parameters from the real data show that as little as about 12,500 amino acid sites could be sufficient to confidently resolve short branches as old as about 90 million years ago (Ma). Thus, the amount of sequence data should no longer be a limiting factor in resolving the relationships among placental mammals. The timing of the early radiation of placental mammals coincides with a period of climate warming some 100-80 Ma and with continental fragmentation. These global processes may have triggered the rapid diversification of placental mammals. However, the rapid radiations of certain mammalian groups complicate phylogenetic analyses, possibly due to incomplete lineage sorting and introgression. These speciation-related processes led to a mosaic genome and conflicting phylogenetic signals. Split network methods are ideal for visualizing these problematic branches and can therefore depict data conflict and possibly the true evolutionary history better than strictly bifurcating trees. Given the timing of tectonics, of placental mammalian divergences, and the fossil record, a Laurasian rather than Gondwanan origin of placental mammals seems the most parsimonious explanation.

  20. Semaphorin 4C Protects against Allergic Inflammation: Requirement of Regulatory CD138+ Plasma Cells.

    Science.gov (United States)

    Xue, Di; Kaufman, Gabriel N; Dembele, Marieme; Beland, Marianne; Massoud, Amir H; Mindt, Barbara C; Fiter, Ryan; Fixman, Elizabeth D; Martin, James G; Friedel, Roland H; Divangahi, Maziar; Fritz, Jörg H; Mazer, Bruce D

    2017-01-01

    The regulatory properties of B cells have been studied in autoimmune diseases; however, their role in allergic diseases is poorly understood. We demonstrate that Semaphorin 4C (Sema4C), an axonal guidance molecule, plays a crucial role in B cell regulatory function. Mice deficient in Sema4C exhibited increased airway inflammation after allergen exposure, with massive eosinophilic lung infiltrates and increased Th2 cytokines. This phenotype was reproduced by mixed bone marrow chimeric mice with Sema4C deficient only in B cells, indicating that B lymphocytes were the key cells affected by the absence of Sema4C expression in allergic inflammation. We determined that Sema4C-deficient CD19 + CD138 + cells exhibited decreased IL-10 and increased IL-4 expression in vivo and in vitro. Adoptive transfer of Sema4c -/- CD19 + CD138 + cells induced marked pulmonary inflammation, eosinophilia, and increased bronchoalveolar lavage fluid IL-4 and IL-5, whereas adoptive transfer of wild-type CD19 + CD138 + IL-10 + cells dramatically decreased allergic airway inflammation in wild-type and Sema4c -/- mice. This study identifies a novel pathway by which Th2-mediated immune responses are regulated. It highlights the importance of plasma cells as regulatory cells in allergic inflammation and suggests that CD138 + B cells contribute to cytokine balance and are important for maintenance of immune homeostasis in allergic airways disease. Furthermore, we demonstrate that Sema4C is critical for optimal regulatory cytokine production in CD138 + B cells. Copyright © 2016 by The American Association of Immunologists, Inc.

  1. Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER)

    International Nuclear Information System (INIS)

    Petti, D.A.; Haire, J.C.

    1993-12-01

    The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project

  2. Sucrose-induced anthocyanin accumulation in vegetative tissue of Petunia plants requires anthocyanin regulatory transcription factors.

    Science.gov (United States)

    Ai, Trinh Ngoc; Naing, Aung Htay; Arun, Muthukrishnan; Lim, Sun-Hyung; Kim, Chang Kil

    2016-11-01

    The effects of three different sucrose concentrations on plant growth and anthocyanin accumulation were examined in non-transgenic (NT) and transgenic (T 2 ) specimens of the Petunia hybrida cultivar 'Mirage rose' that carried the anthocyanin regulatory transcription factors B-Peru+mPAP1 or RsMYB1. Anthocyanin accumulation was not observed in NT plants in any treatments, whereas a range of anthocyanin accumulation was observed in transgenic plants. The anthocyanin content detected in transgenic plants expressing the anthocyanin regulatory transcription factors (B-Peru+mPAP1 or RsMYB1) was higher than that in NT plants. In addition, increasing sucrose concentration strongly enhanced anthocyanin content as shown by quantitative real-time polymerase chain reaction (qRT-PCR) analysis, wherein increased concentrations of sucrose enhanced transcript levels of the transcription factors that are responsible for the induction of biosynthetic genes involved in anthocyanin synthesis; this pattern was not observed in NT plants. In addition, sucrose affected plant growth, although the effects were different between NT and transgenic plants. Taken together, the application of sucrose could enhance anthocyanin production in vegetative tissue of transgenic Petunia carrying anthocyanin regulatory transcription factors, and this study provides insights about interactive effects of sucrose and transcription factors in anthocyanin biosynthesis in the transgenic plant. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  3. Managing Hanford Site solid waste through strict acceptance criteria

    International Nuclear Information System (INIS)

    Jasen, W.G.; Pierce, R.D.; Willis, N.P.

    1993-02-01

    Various types of waste have been generated during the 50-year history of the Hanford Site. Regulatory changes in the last 20 years have provided the emphasis for better management of these wastes. Interpretations of the Atomic Energy Act of 1954 (AEA) and the Resource Conservation and Recovery Act of 1976 (RCRA) have led to the definition of a group of wastes called radioactive mixed wastes (RMW). As a result of the radioactive and hazardous properties of these wastes, strict management programs have been implemented for the management of these wastes. Solid waste management is accomplished through a systems performance approach to waste management that used best-demonstrated available technology (BDAT) and best management practices. The solid waste program at the Hanford Site strives to integrate all aspects of management relative to the treatment, storage and disposal (TSD) of solid waste. Often there are many competing and important needs. It is a difficult task to balance these needs in a manner that is both equitable and productive. Management science is used to help the process of making decisions. Tools used to support the decision making process include five-year planning, cost estimating, resource allocation, performance assessment, waste volume forecasts, input/output models, and waste acceptance criteria. The purpose of this document is to describe how one of these tools, waste acceptance criteria, has helped the Hanford Site manage solid wastes

  4. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

  5. Understanding how to maintain compliance in the current regulatory climate

    International Nuclear Information System (INIS)

    Bignell, D.T.; Burns, R.

    1995-01-01

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

  6. Rebirth of U.S. nuclear power option requires radical regulatory reform

    International Nuclear Information System (INIS)

    Green, H.P.

    1979-01-01

    It has been clear for some years the nuclear power industry is in serious trouble and on a steadily downward course. Three Mile Island was only one major event in a series that has shaken the industry, and only a part of the deterioriation process that has been underway for years. Nevertheless, TMI has considerable symbolic significance. It can be the last nail in the coffin of nuclear power or it can be the opportunity for the rebirth of a vigorous, living nuclear power option. This opportunity cannot, however, be grasped without a firm commitment by the nuclear establishment--industry and government--for a radical restructuring of the regulatory process

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

    International Nuclear Information System (INIS)

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

    1985-08-01

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

  8. Classification and disposal of radioactive wastes: History and legal and regulatory requirements

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1990-01-01

    This document discusses the laws and regulations in the United States addressing classification of radioactive wastes and the requirements for disposal of different waste classes. This review emphasizes the relationship between waste classification and the requirements for permanent disposal

  9. Regulatory requirements on accident management and emergency preparedness - concept of nuclear and radiation safety during beyond-design-basis accidents

    International Nuclear Information System (INIS)

    Yanke, R.

    2002-01-01

    Actual practice the and proposals for further activities in the field of Accident Management (AM) in the member countries of the Co-operation Forum of WWER regulators and in Western countries have been assessed. Further the results of the last working group on AM , the overview of interactions of severe accident research and the regulatory positions in various countries, IAEA reports, practice in Switzerland and Finland, were taken into consideration. From this information, the working group derived recommendations on Accident Management. The general proposals correspond to the present state of the art on AM. They do not describe the whole spectra of recommendations on AM for NPPs with WWER reactors. A basis for the implementation of an AM program is given, which could be extended in a follow-up working group. The developments and research concerning AM have to be continued. The positions of various countries with regard to the 'Interactions of severe accident research and the regulatory positions' are given. On the basis of the working group proposals, the WWER regulators could set regulatory requirements and support further developments of AM strategies, making use of the benefits of common features of NPPs with WWER reactors. Concerted actions in the field of AM between the WWER regulators would bundle the development of a unified concept of recommendations and speed up the implementation of AM measures in order to minimise the risks involved in nuclear power generation

  10. Situation of the medical physics in the Republic of Argentina. Regulatory problem linked to the requirement of physic specialists

    International Nuclear Information System (INIS)

    Arbor Gonzalez, A.; Larcher, A.; Blanco, S.

    2001-01-01

    This paper provides up-to-date data on the participation of medical physicists in current staffs for radiotherapy, nuclear medicine and diagnostic radiology in Argentina, and it presents projections on the academic education of specialists in the next five years. At the same time, the regulatory framework including the requirements for physicists staffing levels in medical practices is presented. This panorama permits to stick out the important role of the professional associations and the academic institutions in the development of Medical Physics in the country. (author)

  11. 76 FR 50537 - Regulatory Guidance Concerning Household Goods Carriers Requiring Shippers To Sign Blank or...

    Science.gov (United States)

    2011-08-15

    ... Concerning Household Goods Carriers Requiring Shippers To Sign Blank or Incomplete Documents AGENCY: Federal... sign incomplete, but not blank, documents so long as the omitted information is limited to: (1) The... in transit. This guidance also clarifies that carriers may not require shippers to sign ``Revised...

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

    International Nuclear Information System (INIS)

    Bobaly, P.

    2001-01-01

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

  13. Chromatin reader L(3)mbt requires the Myb-MuvB/DREAM transcriptional regulatory complex for chromosomal recruitment.

    Science.gov (United States)

    Blanchard, Daniel P; Georlette, Daphne; Antoszewski, Lisa; Botchan, Michael R

    2014-10-07

    Lethal malignant brain tumors (lmbt) result from the loss of the conserved transcriptional repressor l(3)mbt, in Drosophila melanogaster. Similar mutations in the human homolog L3MBTL1 correlate with some cancers. The protein's C-terminal MBT repeats bind mono and dimethylated histones in vitro, which could influence recruitment of L3MBTL1 to its target sites. The L(3)mbt chromatin targeting mechanism, however, is controversial and several studies suggest insufficiency or a minor role for histone methylation in determining the site specificity for recruitment. We report that L(3)mbt colocalizes with core members of the Myb-MuvB/DREAM (MMB/DREAM) transcriptional regulatory complex genome-wide, and that L(3)mbt-mediated repression requires this complex in salivary glands and larval brains. Loss of l(3)mbt or of MMB components through mutation cause similar spurious expression of genes, including the transposon regulatory gene piwi, in terminally differentiated cells. The DNA-binding MMB core component Mip120 (Lin54) is required for L(3)mbt recruitment to chromosomes, whereas Mip130 (Lin9) (an MMB core protein) and E2f2 (an MMB transcriptional repressor) are not, but are essential for repression. Cytolocalization experiments suggest the presence of site-specific differential composition of MMB in polytene chromosomes where some loci were bound by a Myb-containing or alternatively, an E2f2 and L(3)mbt form of the complex.

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

    International Nuclear Information System (INIS)

    1997-01-01

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

  15. Modal Inclusion Logic: Being Lax is Simpler than Being Strict

    DEFF Research Database (Denmark)

    Hella, Lauri; Kuusisto, Antti Johannes; Meier, Arne

    2015-01-01

    We investigate the computational complexity of the satisfiability problem of modal inclusion logic. We distinguish two variants of the problem: one for strict and another one for lax semantics. The complexity of the lax version turns out to be complete for EXPTIME, whereas with strict semantics...

  16. 7 CFR 28.431 - Strict Middling Tinged Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Middling Tinged Color. 28.431 Section 28.431 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards... Color. Strict Middling Tinged Color is color which is better than Middling Tinged Color. ...

  17. 7 CFR 28.433 - Strict Low Middling Tinged Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Low Middling Tinged Color. 28.433 Section 28.433 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards... Tinged Color. Strict Low Middling Tinged Color is color which is within the range represented by a set of...

  18. 7 CFR 28.424 - Strict Low Middling Spotted Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Low Middling Spotted Color. 28.424 Section 28.424 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards... Spotted Color. Strict Low Middling Spotted Color is color which is within the range represented by a set...

  19. 7 CFR 28.426 - Strict Good Ordinary Spotted Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Good Ordinary Spotted Color. 28.426 Section 28.426 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards... Spotted Color. Strict Good Ordinary Spotted Color is color which is within the range represented by a set...

  20. 7 CFR 28.422 - Strict Middling Spotted Color.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Strict Middling Spotted Color. 28.422 Section 28.422 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards... Color. Strict Middling Spotted Color is color which is within the range represented by a set of samples...

  1. Strictly-regular number system and data structures

    DEFF Research Database (Denmark)

    Elmasry, Amr Ahmed Abd Elmoneim; Jensen, Claus; Katajainen, Jyrki

    2010-01-01

    We introduce a new number system that we call the strictly-regular system, which efficiently supports the operations: digit-increment, digit-decrement, cut, concatenate, and add. Compared to other number systems, the strictly-regular system has distinguishable properties. It is superior to the re...

  2. U.S. regulatory requirements for nuclear plant license renewal: The B and W Owners Group License Renewal Program

    International Nuclear Information System (INIS)

    Staudinger, Deborah K.

    2004-01-01

    This paper discusses the current U.S. Regulatory Requirements for License Renewal and describes the Babcock and Wilcox Owners Group (B and WOG) Generic License Renewal Program (GLRP). The B and W owners, recognizing the need to obtain the maximum life for their nuclear generating units, embarked on a program to renew the licenses of the seven reactors in accordance with the requirements of the Atomic Energy Act of 1954 and further defined by Title 10 of the Code of Federal Regulation Part 54 (10 CFR 54). These reactors, owned by five separate utilities, are Pressurized Water Reactors (PWR) ranging in net rated capacity from approximately 800 to 900 MW. The plants, predominately constructed in the 70s, have USNRC Operating Licenses that expire between 2013 to 2017. (author)

  3. Sources, classification, and disposal of radioactive wastes: History and legal and regulatory requirements

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1991-01-01

    This report discusses the following topics: (1) early definitions of different types (classes) of radioactive waste developed prior to definitions in laws and regulations; (2) sources of different classes of radioactive waste; (3) current laws and regulations addressing classification of radioactive wastes; and requirements for disposal of different waste classes. Relationship between waste classification and requirements for permanent disposal is emphasized; (4) federal and state responsibilities for radioactive wastes; and (5) distinctions between radioactive wastes produced in civilian and defense sectors

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

    Directory of Open Access Journals (Sweden)

    Vivian Lin

    2009-02-01

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

  5. A comparison of the different regulatory requirements of NPP in vertical ground motion

    International Nuclear Information System (INIS)

    Hou Chunlin; Pan Rong; Yang Yu; Wang Shuguo; Li Xiaojun

    2015-01-01

    Based on the importance of vertical motion in the nuclear power plants (NPPs) and equipment identification of seismic test, we summarize the existing laws and regulations cited by China's NPPs in the vertical seismic ground motion of the regulations. Then, according to the interpretation of various laws and regulations content, we may identified four vertical earthquake response spectrums. Finally, combined with the seismic safety requirements of China NPPs evaluation and the vertical seismic design of M310, EPR, AP1000 and CAP1400 pressurized water reactor, we explain that the vertical seismic ground motion selection should distinguish the effects between near field and far field earthquake, the existing regulations and specifications that China used are still required to further improve on the selection of vertical ground motion. The results of this study can provide reference for seismic design of China's nuclear power plant and nuclear safety review. (authors)

  6. The Histone H2B Monoubiquitination Regulatory Pathway Is Required for Differentiation of Multipotent Stem Cells

    DEFF Research Database (Denmark)

    Karpiuk, Oleksandra; Najafova, Zeynab; Kramer, Frank

    2012-01-01

    Extensive changes in posttranslational histone modifications accompany the rewiring of the transcriptional program during stem cell differentiation. However, the mechanisms controlling the changes in specific chromatin modifications and their function during differentiation remain only poorly...... understood. We show that histone H2B monoubiquitination (H2Bub1) significantly increases during differentiation of human mesenchymal stem cells (hMSCs) and various lineage-committed precursor cells and in diverse organisms. Furthermore, the H2B ubiquitin ligase RNF40 is required for the induction...... during the transition from an inactive to an active chromatin conformation. Thus, these data indicate that H2Bub1 is required for maintaining multipotency of hMSCs and plays a central role in controlling stem cell differentiation....

  7. Review of Regulatory Quality Assurance Requirements for the Operation of Nuclear R and D Facilities

    International Nuclear Information System (INIS)

    Kwon, Hyuk Il; Lim, Nam Jin

    2005-01-01

    Korea Atomic Energy Research Institute (KAERI) has many R and D facilities in operation, including HANARO research reactor, radioactive waste treatment facility (RWTF), post-irradiation examination facility (PIEF) and irradiated material test facility (IMEF). Recently, nation-wide interest is focused on the safety and security of major industrial facilities. Safe operation of nuclear facilities is imperative because of the consequence of public disaster by radiological release/ contamination, in case of an accident. Recently, Ministry of Science and Technology (MOST) of the Korean government announced amendments of Atomic Energy laws to enforce requirements of the physical protection and radiological emergency. In this paper, the context of amended Atomic Energy laws were reviewed to confirm quality assurance measures and identify additional QA activities, if any, that is required by the amendment

  8. Strategy and Aspects of Monitoring / Control Strictly in Coordinated Subsystems

    Directory of Open Access Journals (Sweden)

    William José Borges

    2012-06-01

    Full Text Available This paper aims to discuss the approach structures of the strictly coordinated theoretical framework developed by Zylbersztajn and Farina (1999 as an expanded perspective of the firm, taking into account the food supply chains as an extension of the nexus of contracts proposed by Coase (1937 and taken up by Williamson (1985. The structures stand out as strictly coordinated. Zylbersztajn and Farina (1999 turn to identifying points of common interests that encourage firms to promote contracts between themselves in a strictly coordinated way, considering the degree of asset specificity involved in the transaction and the competitive forces that determine the search for strategic positioning organizations to achieve sustainable superior results.

  9. Requirement Management between Regulatory Framework and Dismantling Activities for Decommissioning of a Nuclear Facility

    International Nuclear Information System (INIS)

    Park, H.S.; Jin, H.G.; Hong, Y.J.; Choi, J.W.; Park, S.

    2016-01-01

    Full text: The decommissioning and environmental remediation (D&ER) projects require stepwise long-term research and development (R&D) such as a shutdown, transition, decontamination and decommissioning (D&D) activities, radioactive waste management, and site restoration. During each step of the D&ER projects, a significant amount of information and knowledge such as experimental data, databases, design drawings, technical reports, guidelines, operation manuals, and modeling and simulation reports are produced. Knowledge based on experiences by staff members participating in each step of the D&ER project are also very important. Such knowledge based on experiences may disappear with the retirement of staff members if there are no effective and systematic approaches for its acquisition and storage. Therefore, to perform the D&ER project successfully, it is necessary to preserve written theses and experiences systematically. The integrated knowledge management system (KMS) for the D&ER projects have never been developed. Therefore, the establishment of an integrated KMS is necessary for the effective performance of D&ER projects. This study introduces a decommissioning procedure requirement management system as a part of the KMS related to the D&ER projects. (author

  10. Strict finitism and the logic of mathematical applications

    CERN Document Server

    Ye, Feng

    2011-01-01

    Exploring the logic behind applied mathematics to the physical world, this volume illustrates how radical naturalism, nominalism and strict finitism can account for the applications of classical mathematics in current theories about natural phenomena.

  11. Strict monotonicity and unique continuation of the biharmonic operator

    Directory of Open Access Journals (Sweden)

    Najib Tsouli

    2012-01-01

    Full Text Available In this paper, we will show that the strict monotonicity of the eigenvalues of the biharmonic operator holds if and only if some unique continuation property is satisfied by the corresponding eigenfunctions.

  12. Advantages and disadvantages of a risk - based regulatory requirement (the experience in Argentina)

    International Nuclear Information System (INIS)

    Baron, Jorge

    2006-01-01

    Argentina has its own nuclear regulations, which include a risk-based criterion curve for the licensing of nuclear installations. This requirement, established in the early '70s, must be fulfilled with a PSA study. It has been applied to several installations, and the advantages and disadvantages of this approach are discussed in the paper through several examples. The main disadvantage is a somehow large amount of PSA work that needs to be performed for the licensing of a nuclear installation. The main advantage is the effective risk reduction that can be achieved by retrofitting the risk-based lessons learned into the design teams (not only for design of systems and components, but also for design of operation, testing and maintenance schemes). (author)

  13. Two examples of non strictly convex large deviations

    OpenAIRE

    De Marco, Stefano; Jacquier, Antoine; Roome, Patrick

    2016-01-01

    We present two examples of a large deviations principle where the rate function is not strictly convex. This is motivated by a model used in mathematical finance (the Heston model), and adds a new item to the zoology of non strictly convex large deviations. For one of these examples, we show that the rate function of the Cramer-type of large deviations coincides with that of the Freidlin-Wentzell when contraction principles are applied.

  14. Comparison and Analysis of Regulatory and Derived Requirements for Certain DOE Spent Nuclear Fuel Shipments; Lessons Learned for Future Spent Fuel Transportation Campaigns

    International Nuclear Information System (INIS)

    Kramer, George L.; Fawcett, Rick L.; Rieke, Philip C.

    2003-01-01

    Radioactive materials transportation is stringently regulated by the Department of Transportation and the Nuclear Regulatory Commission to protect the public and the environment. As a Federal agency, however, the U.S. Department of Energy (DOE) must seek State, Tribal and local input on safety issues for certain transportation activities. This interaction has invariably resulted in the imposition of extra-regulatory requirements, greatly increasing transportation costs and delaying schedules while not significantly enhancing the level of safety. This paper discusses the results an analysis of the regulatory and negotiated requirements established for a July 1998 shipment of spent nuclear fuel from foreign countries through the west coast to the Idaho National Engineering and Environmental Laboratory (INEEL). Staff from the INEEL Nuclear Materials Engineering and Disposition Department undertook the analysis in partnership with HMTC, to discover if there were instances where requirements derived from stakeholder interactions duplicate, contradict, or otherwise overlap with regulatory requirements. The study exhaustively lists and classifies applicable Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) regulations. These are then compared with a similarly classified list of requirements from the Environmental Impact Statements (EIS) and those developed during stakeholder negotiations. Comparison and analysis reveals numerous attempts to reduce transportation risk by imposing more stringent safety measures than those required by DOT and NRC. These usually took the form of additional inspection, notification and planning requirements. There are also many instances of overlap with, and duplication of regulations. Participants will gain a greater appreciation for the need to understand the risk-oriented basis of the radioactive materials regulations and their effectiveness in ensuring safety when negotiating extra-regulatory requirements

  15. Strictly contractive quantum channels and physically realizable quantum computers

    International Nuclear Information System (INIS)

    Raginsky, Maxim

    2002-01-01

    We study the robustness of quantum computers under the influence of errors modeled by strictly contractive channels. A channel T is defined to be strictly contractive if, for any pair of density operators ρ, σ in its domain, parallel Tρ-Tσ parallel 1 ≤k parallel ρ-σ parallel 1 for some 0≤k 1 denotes the trace norm). In other words, strictly contractive channels render the states of the computer less distinguishable in the sense of quantum detection theory. Starting from the premise that all experimental procedures can be carried out with finite precision, we argue that there exists a physically meaningful connection between strictly contractive channels and errors in physically realizable quantum computers. We show that, in the absence of error correction, sensitivity of quantum memories and computers to strictly contractive errors grows exponentially with storage time and computation time, respectively, and depends only on the constant k and the measurement precision. We prove that strict contractivity rules out the possibility of perfect error correction, and give an argument that approximate error correction, which covers previous work on fault-tolerant quantum computation as a special case, is possible

  16. The Microtubule Regulatory Protein Stathmin Is Required to Maintain the Integrity of Axonal Microtubules in Drosophila.

    Directory of Open Access Journals (Sweden)

    Jason E Duncan

    Full Text Available Axonal transport, a form of long-distance, bi-directional intracellular transport that occurs between the cell body and synaptic terminal, is critical in maintaining the function and viability of neurons. We have identified a requirement for the stathmin (stai gene in the maintenance of axonal microtubules and regulation of axonal transport in Drosophila. The stai gene encodes a cytosolic phosphoprotein that regulates microtubule dynamics by partitioning tubulin dimers between pools of soluble tubulin and polymerized microtubules, and by directly binding to microtubules and promoting depolymerization. Analysis of stai function in Drosophila, which has a single stai gene, circumvents potential complications with studies performed in vertebrate systems in which mutant phenotypes may be compensated by genetic redundancy of other members of the stai gene family. This has allowed us to identify an essential function for stai in the maintenance of the integrity of axonal microtubules. In addition to the severe disruption in the abundance and architecture of microtubules in the axons of stai mutant Drosophila, we also observe additional neurological phenotypes associated with loss of stai function including a posterior paralysis and tail-flip phenotype in third instar larvae, aberrant accumulation of transported membranous organelles in stai deficient axons, a progressive bang-sensitive response to mechanical stimulation reminiscent of the class of Drosophila mutants used to model human epileptic seizures, and a reduced adult lifespan. Reductions in the levels of Kinesin-1, the primary anterograde motor in axonal transport, enhance these phenotypes. Collectively, our results indicate that stai has an important role in neuronal function, likely through the maintenance of microtubule integrity in the axons of nerves of the peripheral nervous system necessary to support and sustain long-distance axonal transport.

  17. The Microtubule Regulatory Protein Stathmin Is Required to Maintain the Integrity of Axonal Microtubules in Drosophila

    Science.gov (United States)

    Duncan, Jason E.; Lytle, Nikki K.; Zuniga, Alfredo; Goldstein, Lawrence S. B.

    2013-01-01

    Axonal transport, a form of long-distance, bi-directional intracellular transport that occurs between the cell body and synaptic terminal, is critical in maintaining the function and viability of neurons. We have identified a requirement for the stathmin (stai) gene in the maintenance of axonal microtubules and regulation of axonal transport in Drosophila . The stai gene encodes a cytosolic phosphoprotein that regulates microtubule dynamics by partitioning tubulin dimers between pools of soluble tubulin and polymerized microtubules, and by directly binding to microtubules and promoting depolymerization. Analysis of stai function in Drosophila , which has a single stai gene, circumvents potential complications with studies performed in vertebrate systems in which mutant phenotypes may be compensated by genetic redundancy of other members of the stai gene family. This has allowed us to identify an essential function for stai in the maintenance of the integrity of axonal microtubules. In addition to the severe disruption in the abundance and architecture of microtubules in the axons of stai mutant Drosophila , we also observe additional neurological phenotypes associated with loss of stai function including a posterior paralysis and tail-flip phenotype in third instar larvae, aberrant accumulation of transported membranous organelles in stai deficient axons, a progressive bang-sensitive response to mechanical stimulation reminiscent of the class of Drosophila mutants used to model human epileptic seizures, and a reduced adult lifespan. Reductions in the levels of Kinesin-1, the primary anterograde motor in axonal transport, enhance these phenotypes. Collectively, our results indicate that stai has an important role in neuronal function, likely through the maintenance of microtubule integrity in the axons of nerves of the peripheral nervous system necessary to support and sustain long-distance axonal transport. PMID:23840848

  18. Ongoing regulatory compliance required.

    Science.gov (United States)

    Harris, Peter

    2005-06-01

    New regulations concerning the management of asbestos in non-residential properties came into force in May last year, and this 'Duty to Manage' legislation means that duty holders should be managing their asbestos adequately by fulfilling certain criteria. Inadequate management of asbestos could lead to heavy fines. Special report by Peter Harris, client services manager, Redhill Analysts.

  19. Convergence theorems for strictly hemi-contractive maps

    International Nuclear Information System (INIS)

    Chidume, C.E.; Osilike, M.O.

    1992-04-01

    It is proved that each of two well-known fixed point iteration methods (the Mann and the Ishikawa iteration methods) converges strongly to the fixed point of strictly hemi-contractive map in real Banach spaces with property (U, λ, m+1,m), λ is an element of R, m is an element of IN. The class of strictly hemi-contractive maps includes all strictly pseudo-contractive maps with nonempty fixed point sets; and Banach spaces with property (U, λ, m+1, m), λ is an element of R, m is an element of IN include the L p (or l p ) spaces, p≥2. Our theorems generalize important known results. (author). 22 refs

  20. Granzyme A Is Required for Regulatory T-Cell Mediated Prevention of Gastrointestinal Graft-versus-Host Disease.

    Directory of Open Access Journals (Sweden)

    Sarvari Velaga

    Full Text Available In our previous work we could identify defects in human regulatory T cells (Tregs likely favoring the development of graft-versus-host disease (GvHD following allogeneic stem cell transplantation (SCT. Treg transcriptome analyses comparing GvHD and immune tolerant patients uncovered regulated gene transcripts highly relevant for Treg cell function. Moreover, granzyme A (GZMA also showed a significant lower expression at the protein level in Tregs of GvHD patients. GZMA induces cytolysis in a perforin-dependent, FAS-FASL independent manner and represents a cell-contact dependent mechanism for Tregs to control immune responses. We therefore analyzed the functional role of GZMA in a murine standard model for GvHD. For this purpose, adoptively transferred CD4+CD25+ Tregs from gzmA-/- mice were analyzed in comparison to their wild type counterparts for their capability to prevent murine GvHD. GzmA-/- Tregs home efficiently to secondary lymphoid organs and do not show phenotypic alterations with respect to activation and migration properties to inflammatory sites. Whereas gzmA-/- Tregs are highly suppressive in vitro, Tregs require GZMA to rescue hosts from murine GvHD, especially regarding gastrointestinal target organ damage. We herewith identify GZMA as critical effector molecule of human Treg function for gastrointestinal immune response in an experimental GvHD model.

  1. Donor hematopoiesis in mice following total lymphoid irradiation requires host T-regulatory cells for durable engraftment

    Science.gov (United States)

    Müller, Antonia M. S.; Poyser, Jessica; Küpper, Natascha J.; Burnett, Cassandra; Ko, Rose M.; Kohrt, Holbrook E.K.; Florek, Mareike; Zhang, Pei; Negrin, Robert S.

    2014-01-01

    Total lymphoid irradiation (TLI) with antithymocyte globulin (ATG) is a unique regimen that prepares recipients for allogeneic hematopoietic cell transplantation by targeting lymph nodes, while sparing large areas of the bone marrow. TLI is reported to increase the frequency of CD4+CD25+FoxP3+ T-regulatory cells (Treg) relative to conventional T cells. In this study, barriers to hematopoietic stem cell (HSC) engraftment following this nonmyeloablative conditioning were evaluated. TLI/ATG resulted in profound lymphoablation but endogenous host HSC remained. Initial donor HSC engraftment occurred only in radiation exposed marrow sites, but gradually distributed to bone marrow outside the radiation field. Sustained donor engraftment required host lymphoid cells insofar as lymphocyte deficient Rag2γc−/− recipients had unstable engraftment compared with wild-type. TLI/ATG treated wild-type recipients had increased proportions of Treg that were associated with increased HSC frequency and proliferation. In contrast, Rag2γc−/− recipients who lacked Treg did not. Adoptive transfer of Treg into Rag2γc−/− recipients resulted in increased cell cycling of endogenous HSC. Thus, we hypothesize that Treg influence donor engraftment post-TLI/ATG by increasing HSC cell cycling, thereby promoting the exit of host HSC from the marrow niche. Our study highlights the unique dynamics of donor hematopoiesis following TLI/ATG, and the effect of Treg on HSC activity. PMID:24591203

  2. Two-component regulatory system ActS/ActR is required for Sinorhizobium meliloti adaptation to oxidative stress.

    Science.gov (United States)

    Tang, Guirong; Wang, Sunjun; Lu, Dawei; Huang, Leqi; Li, Ningning; Luo, Li

    2017-05-01

    The two-component system ActS/ActR plays important roles in bacterial adaptation to abiotic stress, including acid tolerance and oxidant resistance. However, the underlying regulatory mechanism is not clear. In this study, we found that the ActS/ActR system is required for adaptation to oxidative stress by regulating the transcription of the genes actR, katB, gshA and gshB1. The actS and actR mutants were sensitive to low pH and oxidants such as H 2 O 2 , oxidized glutathione (GSSG) and sodium nitroprusside (SNP). The expression of actR by using a plasmid rescued the defect of SNP sensitivity for all actS and actR mutants. The expression of actS and actR were suppressed by treatment with H 2 O 2 . The expression of actS, actR, oxyR, katA and katB was required for ActS and ActR under normal conditions. The induction of katB, gshA and gshB1 depended on ActS and ActR during treatment with H 2 O 2 and SNP. Our findings revealed that the ActS/ActR system is a key redox regulator in S. meliltoi and provides a new cue to understanding Rhizobium-legume symbiosis. Copyright © 2017 The Authors. Published by Elsevier GmbH.. All rights reserved.

  3. Mann iteration with errors for strictly pseudo-contractive mappings ...

    African Journals Online (AJOL)

    It is well known that any fixed point of a Lipschitzian strictly pseudo-contractive self mapping of a nonempty closed convex and bounded subset K of a Banach space X is unique [6] and may be norm approximated by an iterative procedure. In this paper, we show that Mann iteration with errors can be used to approximate the ...

  4. Dominated operators, absolutely summing operators and the strict ...

    African Journals Online (AJOL)

    b(X;E) be the space of all E-valued bounded continuous functions on X, equipped with the strict topology β. We study dominated and absolutely summing operators T : Cb(X;E) → F. We derive that if X is a locally compact Hausdorff space and E ...

  5. Convergence of GAOR Iterative Method with Strictly Diagonally Dominant Matrices

    Directory of Open Access Journals (Sweden)

    Guangbin Wang

    2011-01-01

    Full Text Available We discuss the convergence of GAOR method for linear systems with strictly diagonally dominant matrices. Moreover, we show that our results are better than ones of Darvishi and Hessari (2006, Tian et al. (2008 by using three numerical examples.

  6. Runaway selection for cooperation and strict-and-severe punishment.

    Science.gov (United States)

    Nakamaru, Mayuko; Dieckmann, Ulf

    2009-03-07

    Punishing defectors is an important means of stabilizing cooperation. When levels of cooperation and punishment are continuous, individuals must employ suitable social standards for defining defectors and for determining punishment levels. Here we investigate the evolution of a social reaction norm, or psychological response function, for determining the punishment level meted out by individuals in dependence on the cooperation level exhibited by their neighbors in a lattice-structured population. We find that (1) cooperation and punishment can undergo runaway selection, with evolution towards enhanced cooperation and an ever more demanding punishment reaction norm mutually reinforcing each other; (2) this mechanism works best when punishment is strict, so that ambiguities in defining defectors are small; (3) when the strictness of punishment can adapt jointly with the threshold and severity of punishment, evolution favors the strict-and-severe punishment of individuals who offer slightly less than average cooperation levels; (4) strict-and-severe punishment naturally evolves and leads to much enhanced cooperation when cooperation without punishment would be weak and neither cooperation nor punishment are too costly; and (5) such evolutionary dynamics enable the bootstrapping of cooperation and punishment, through which defectors who never punish gradually and steadily evolve into cooperators who punish those they define as defectors.

  7. Dominance on Strict Triangular Norms and Mulholland Inequality

    Czech Academy of Sciences Publication Activity Database

    Petrík, Milan

    2018-01-01

    Roč. 335, 15 March (2018), s. 3-17 ISSN 0165-0114 R&D Projects: GA ČR GJ15-07724Y Institutional support: RVO:67985807 Keywords : dominance relation * Mulholland inequality * strict triangular norm * transitivity Subject RIV: BA - General Mathematics Impact factor: 2.718, year: 2016

  8. The regulatory requirements, design bases, researches and assessments in the field of Ukrainian NPP's seismic safety

    Energy Technology Data Exchange (ETDEWEB)

    Mykolaychuk, O.; Mayboroda, O.; Krytskyy, V.; Karnaukhov, O. [Ministry of Environment and Natural Resources, (Ukraine)

    2001-07-01

    State Nuclear Regulatory Authority of Ukraine (SNRA) pays large attention to problem of nuclear installations seismic stability. As a result the seismic design regulatory guides is revised, additional seismic researches of NPP sites are conducted, seismic reassessment of NPP designs were begun. The experts involved address all seismic related factors under close contact with the staff of NPP, design institutes and research organizations. This document takes stock on the situation and the research programs. (author)

  9. A study for good regulatin of the CANDU's in Korea. Development of safety regulatory requirement for CANDU nuclear power plants

    International Nuclear Information System (INIS)

    Oh, Se Ki; Shin, Y. K.; Kim, J. S.; Yu, Y. J.; Lee, Y. J.

    2001-03-01

    The objective of project is to derive the policy recommendations to improve the efficiency of CANDU plants regulation. These policy recommendations will eventually contribute to the upgrading of Korean nuclear regulatory system and safety enhancement. During the first phase of this 2 years study, following research activities were done. On-site survey and analysis on CANDU plants regulation. Review on CANDU plants regulating experiences and current constraints. Review and analysis on the new Canadian regulatory approach

  10. Allocation of distinct organ fates from a precursor field requires a shift in expression and function of gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Sneha Palliyil

    2018-01-01

    Full Text Available A common occurrence in metazoan development is the rise of multiple tissues/organs from a single uniform precursor field. One example is the anterior forebrain of vertebrates, which produces the eyes, hypothalamus, diencephalon, and telencephalon. Another instance is the Drosophila wing disc, which generates the adult wing blade, the hinge, and the thorax. Gene regulatory networks (GRNs that are comprised of signaling pathways and batteries of transcription factors parcel the undifferentiated field into discrete territories. This simple model is challenged by two observations. First, many GRN members that are thought to control the fate of one organ are actually expressed throughout the entire precursor field at earlier points in development. Second, each GRN can simultaneously promote one of the possible fates choices while repressing the other alternatives. It is therefore unclear how GRNs function to allocate tissue fates if their members are uniformly expressed and competing with each other within the same populations of cells. We address this paradigm by studying fate specification in the Drosophila eye-antennal disc. The disc, which begins its development as a homogeneous precursor field, produces a number of adult structures including the compound eyes, the ocelli, the antennae, the maxillary palps, and the surrounding head epidermis. Several selector genes that control the fates of the eye and antenna, respectively, are first expressed throughout the entire eye-antennal disc. We show that during early stages, these genes are tasked with promoting the growth of the entire field. Upon segregation to distinct territories within the disc, each GRN continues to promote growth while taking on the additional roles of promoting distinct primary fates and repressing alternate fates. The timing of both expression pattern restriction and expansion of functional duties is an elemental requirement for allocating fates within a single field.

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

    Energy Technology Data Exchange (ETDEWEB)

    Pope, R.B. [Oak Ridge National Lab., TN (United States). Transportation Technologies Group; Easton, E.P.; Cook, J.R. [Nuclear Regulatory Commission, Washington, DC (United States). Spent Fuel Project Office; Boyle, R.W. [Dept. of Transportation, Washington, DC (United States). Research and Special Programs Administration

    1997-10-01

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

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

    International Nuclear Information System (INIS)

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

    1997-01-01

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

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

    International Nuclear Information System (INIS)

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

    1994-01-01

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

  14. Heterologous expression of the pneumococcal serotype 14 polysaccharide in Lactococcus lactis requires lactococcal epsABC regulatory genes

    NARCIS (Netherlands)

    Nierop Groot, M.N.; Godefrooij, J.; Kleerebezem, M.

    2008-01-01

    The pneumococcal serotype 14 polysaccharide was produced in Lactococcus lactis by coexpressing pneumococcal polysaccharide type 14-specific genes (cpsFGHIJKL(14)) with the lactococcal regulatory and priming glucosyltransferase-encoding genes specific for B40 polysaccharide (epsABCD(B40)). The

  15. Relaxation Methods for Strictly Convex Regularizations of Piecewise Linear Programs

    International Nuclear Information System (INIS)

    Kiwiel, K. C.

    1998-01-01

    We give an algorithm for minimizing the sum of a strictly convex function and a convex piecewise linear function. It extends several dual coordinate ascent methods for large-scale linearly constrained problems that occur in entropy maximization, quadratic programming, and network flows. In particular, it may solve exact penalty versions of such (possibly inconsistent) problems, and subproblems of bundle methods for nondifferentiable optimization. It is simple, can exploit sparsity, and in certain cases is highly parallelizable. Its global convergence is established in the recent framework of B -functions (generalized Bregman functions)

  16. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 2. Evaluation of seismic designs: a review of seismic design requirements for Nuclear Power Plant Piping

    Energy Technology Data Exchange (ETDEWEB)

    1985-04-01

    This document reports the position and recommendations of the NRC Piping Review Committee, Task Group on Seismic Design. The Task Group considered overlapping conservation in the various steps of seismic design, the effects of using two levels of earthquake as a design criterion, and current industry practices. Issues such as damping values, spectra modification, multiple response spectra methods, nozzle and support design, design margins, inelastic piping response, and the use of snubbers are addressed. Effects of current regulatory requirements for piping design are evaluated, and recommendations for immediate licensing action, changes in existing requirements, and research programs are presented. Additional background information and suggestions given by consultants are also presented.

  17. Frequency effect on p-nitrophenol degradation under conditions of strict acoustic and electric control

    Directory of Open Access Journals (Sweden)

    Chang-ping Zhu

    2011-03-01

    Full Text Available The process of decomposing p-nitrophenol (PNP with power ultrasound requires strict control of acoustic and electric conditions. In this study, the conditions, including acoustic power and acoustic intensity, but not ultrasonic frequency, were controlled strictly at constant levels. The absorbency and the COD concentrations of the samples were measured in order to show the variation of the sample concentration. The results show significant differences in the trend of the solution degradation rate as acoustic power increases after the PNP solution (with a concentration of 114 mg/L and a pH value of 5.4 is irradiated for 60 min with ultrasonic frequencies of 530.8 kHz, 610.6 kHz, 855.0 kHz, and 1 130.0 kHz. The degradation rate of the solution increases with time and acoustic power (acoustic intensity. On the other hand, the degradation rate of the solution is distinctly dependent on frequency when the acoustic power and intensity are strictly controlled and maintained at constant levels. The degradation rate of the PNP solution declines with ultrasonic frequencies of 530.8 kHz, 610.6 kHz, 855.0 kHz, and 1 130.0 kHz; the COD concentration, on the contrary, increase.

  18. Non-strictly black body spectrum from the tunnelling mechanism

    International Nuclear Information System (INIS)

    Corda, Christian

    2013-01-01

    The tunnelling mechanism is widely used to explain Hawking radiation. However, in many cases the analysis used to obtain the Hawking temperature only involves comparing the emission probability for an outgoing particle with the Boltzmann factor. Banerjee and Majhi improved this approach by explicitly finding a black body spectrum associated with black holes. Their result, obtained using a reformulation of the tunnelling mechanism, is in contrast to that of Parikh and Wilczek, who found an emission probability that is compatible with a non-strictly thermal spectrum. Using the recently identified effective state for a black hole, we solve this contradiction via a slight modification of the analysis by Banerjee and Majhi. The final result is a non-strictly black body spectrum from the tunnelling mechanism. We also show that for an effective temperature, we can express the corresponding effective metric using Hawking’s periodicity arguments. Potential important implications for the black hole information puzzle are discussed. -- Highlights: •We review an important result by Banerjee and Majhi on the tunnelling mechanism in the framework of Hawking radiation. •This result is in contrast to another result reported by Parikh and Wilczek. •We introduce the effective state of a black hole. •We explain the contrast via a slight modification of the analysis by Banerjee and Majhi. •We discuss potential important implications for the black hole information puzzle

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-05-01

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

  20. Effects of a strict cutoff on Quantum Field Theory

    International Nuclear Information System (INIS)

    Sturnfield, J.F.

    1987-01-01

    Standard Quantum Field Theory has a number of integrals which are infinite. Although these are eliminated for some cases by renormalization, this aspect of the theory is not fully satisfactory. A number of theories with fundamental lengths have been introduced as alternatives and it would be useful to be able to distinguish between them. In particular, the effects that a strict cutoff would have on Quantum Field Theory is studied. It is noted that care must be taken in the method used to apply a strict cutoff. This lead to considering a theory where the cutoffs are defined by restricting each internal line. This theory is only piece-wise analytic. The resulting scattering matrix is frame dependent, yet the theory still satisfies the special relativity view that all frames are subjectively identical. The renormalization of this theory is finite. The change in mass from the electron self-energy will be a spinor operator. The main distinctions of this theory from standard theory will occur at super high energies. New poles and resonances which arise from new endpoint singularities will be found. The locations of these singularities will be frame dependent. Some of these singularities will correspond to creations or interactions of the normal particles with tachyons. It will be shown that for the one loop diagram, the form of the cutoff singularities are closely related to the standard singularities. When there is more than one loop, there can appear some new type of behavior. In particular, a cube root type of behavior in the two loop self-energy diagram will be found. Also the asymptotic behavior of the ladder diagram is studied

  1. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

    LENUS (Irish Health Repository)

    Kubiak, Christine

    2009-10-16

    Abstract Background Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. Methods In order to summarise the current situation in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching an agreement on a common classification was the initial step in the development of the survey. Results The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant from both the regulatory and the scientific points of view, and correspond to congruent definitions in all countries: clinical trials on medicinal products; clinical trials on medical devices; other therapeutic trials (including surgery trials, transplantation trials, transfusion trials, trials with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification was essential to develop a survey focused on protocol submission to ethics committees and competent authorities, procedures for amendments, requirements for sponsor and insurance, and adverse event reporting following five main phases: drafting, consensus, data collection, validation, and finalising. Conclusion The list of clinical research categories as used for the survey could serve as a contribution to the, much needed, task of harmonisation and simplification of the

  2. Shielding requirements for diagnostic and therapeutic X-ray apparatus in South Australia: regulatory requirements, specifications and assessment of X-ray rooms

    International Nuclear Information System (INIS)

    Bibbo, G.

    1988-01-01

    In South Australia the shielding requirements for diagnostic and therapeutic x-ray apparatus depend on the maximum power output of the equipment regardless of workload, usage or occupancy. The method of calculating the required shielding is discussed and the procedure for assessing the degree of radiation protection of the x-ray room once the apparatus has been installed is outlined

  3. Independent Verification and Validation Of SAPHIRE 8 Software Requirements Project Number: N6423 U.S. Nuclear Regulatory Commission

    Energy Technology Data Exchange (ETDEWEB)

    Kent Norris

    2009-09-01

    The purpose of the Independent Verification and Validation (IV&V) role in the evaluation of the SAPHIRE requirements definition is to assess the activities that results in the specification, documentation, and review of the requirements that the software product must satisfy, including functionality, performance, design constraints, attributes and external interfaces. The IV&V team began this endeavor after the software engineering and software development of SAPHIRE had already been in production. IV&V reviewed the requirements specified in the NRC Form 189s to verify these requirements were included in SAPHIRE’s Software Verification and Validation Plan (SVVP).

  4. 7 CFR 28.414 - Strict Low Middling Light Spotted Color.

    Science.gov (United States)

    2010-01-01

    ... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Standards Light Spotted Cotton § 28.414 Strict Low Middling Light Spotted Color. Strict Low Middling Light Spotted Color is color which in spot or...

  5. On N. Chomsky’s strict subcategorization of verbs

    Directory of Open Access Journals (Sweden)

    Janez Orešnik

    1966-12-01

    Full Text Available This paper studies the so-called strict subcategorization rules, and the theory associated with them, in the transformational grammar of. Erigl·ish as proposed by Noarn Chomsky in his Aspects. The syntactic component of English transformational grammar consists of two mutually ordered parts, viz., the base and the transformational subcomponents. The initial part of the base are the so-called categorial rules, which are of almost exclusive interest to us here. Their primary task is to generate what are usually called basic sentence patterns, and will here, with Chomsky (Aspects, p.ll3, be designated with the expression, frames of category symbols.- The rules of the transformational subcomponent modify, in various ways, the frames generated by the base. For several reasons - one of them being that the correct work of the transformational subcomponent quite often depends on the kind of lexical items with which the syntactic positions in the frames of category symbols have been filled, the lexical items must be introduced from the lexicon into the empty positions in the frames before the rules of the transformational subcomponent can be allowed to modify the frames.

  6. Effects of strict prolonged bed rest on cardiorespiratory fitness

    DEFF Research Database (Denmark)

    Ried-Larsen, Mathias; Aarts, Hugo M; Joyner, Michael J

    2017-01-01

    with larger declines in V̇o2max). Furthermore, the systematic review revealed a gap in the knowledge about the cardiovascular response to extreme physical inactivity, particularly in older subjects and women of any age group. In addition to its relevance to spaceflight, this lack of data has significant....... Since 1949, 80 studies with a total of 949 participants (>90% men) have been published with data on strict bed rest and V̇o2max The studies were conducted mainly in young participants [median age (interquartile range) 24.5 (22.4-34.0) yr]. The duration of bed rest ranged from 1 to 90 days. V̇o2max...... declined linearly across bed rest duration. No statistical difference in the decline among studies reporting V̇o2max as l/min (-0.3% per day) compared with studies reporting V̇o2max normalized to body weight (ml·kg-1·min-1; -0.43% per day) was observed. Although both total body weight and lean body mass...

  7. Fixed point iterations for strictly hemi-contractive maps in uniformly smooth Banach spaces

    International Nuclear Information System (INIS)

    Chidume, C.E.; Osilike, M.O.

    1993-05-01

    It is proved that the Mann iteration process converges strongly to the fixed point of a strictly hemi-contractive map in real uniformly smooth Banach spaces. The class of strictly hemi-contractive maps includes all strictly pseudo-contractive maps with nonempty fixed point sets. A related result deals with the Ishikawa iteration scheme when the mapping is Lipschitzian and strictly hemi-contractive. Our theorems generalize important known results. (author). 29 refs

  8. Development of safety and regulatory requirements for Korean next generation reactor - Development of human factors design review guidelines (II)

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Oh, In Suk; Lee, Hyun Chul; Cheon, Se Woo [Korea Atomic Energy Research Institute, Taejon (Korea)

    1999-02-01

    The objective of this study is to develop human factors engineering program review guidelines and alarm system review guidelines in order to resolve the two major technical issues: '25. Human Factors Engineering Program Review Model' and '26. Review Criteria for Human Factors Aspects of Advanced Controls and Instrumentation', which are related to the development of human factors safety regulation guides being performed by KINS. For the development of human factors program review guidelines, we made a Korean version of NUREG-0711 and added our comments by considering Korean regulatory situation and the characteristics of the KNGR design, and reviewing the reference documents of NURGE-0711. We also computerized the Korean version of NUREG-0711, additional comments, and selected portion of the reference documents for the developer of safety regulation guides at KINS to see the contents comparatively at a glance and use them easily. For the development of alarm system design review guidelines, we made a Korean version of NUREG/CR-6105, which was published by NRC in 1994 as a guideline document for the human factors review of alarm systems. Then we updated the guidelines by reviewing the literature related to alarm design that published after 1994. 12 refs., 11 figs., 2 tabs. (Author)

  9. Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment.

    Science.gov (United States)

    Djuris, Jelena; Djuric, Zorica

    2017-11-30

    Mathematical models can be used as an integral part of the quality by design (QbD) concept throughout the product lifecycle for variety of purposes, including appointment of the design space and control strategy, continual improvement and risk assessment. Examples of different mathematical modeling techniques (mechanistic, empirical and hybrid) in the pharmaceutical development and process monitoring or control are provided in the presented review. In the QbD context, mathematical models are predominantly used to support design space and/or control strategies. Considering their impact to the final product quality, models can be divided into the following categories: high, medium and low impact models. Although there are regulatory guidelines on the topic of modeling applications, review of QbD-based submission containing modeling elements revealed concerns regarding the scale-dependency of design spaces and verification of models predictions at commercial scale of manufacturing, especially regarding real-time release (RTR) models. Authors provide critical overview on the good modeling practices and introduce concepts of multiple-unit, adaptive and dynamic design space, multivariate specifications and methods for process uncertainty analysis. RTR specification with mathematical model and different approaches to multivariate statistical process control supporting process analytical technologies are also presented. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. Use of FPGA and CPLD in nuclear reactor safety systems and its regulatory review requirements for reactor safety

    International Nuclear Information System (INIS)

    Roy, Suvadip; Biswas, Animesh; Pradhan, S.K.

    2015-01-01

    Field Programmable Gate Arrays (FPGA) and Complex Programmable Logic Devices (CPLD) is being used widely in safety critical and safety related systems in nuclear power plans like in trip logic units, Engineered Safety Feature (ESF) actuation decision logic and neutronic signal processing for their reprogrammability feature and compact design. These HDL Programmable devices (HPD) are complex devices consisting of both hardware and software which is used to implement the logic on the FPGA. It is observed that these Programmable devices suffer from various modes of failure and the major failures in these devices are due to Single Event Upset (SEU), where a highly energetic ionizing radiation may lead to device failure which can even occur in radiologically benign environment. Other failures can occur during steps of developing the hardware using software tools like during Synthesis and placement and routing of the desired hardware. Here a study on use of such devices in Nuclear Reactors, study on mode of failures of these devices, way to tackle such failure and development of review guidelines for review of such devices used in safety critical and safety related systems with special emphasis on choice of software tools, way to mitigate effects of SEU and simulation and hardware testing results to be reviewed by regulatory body during design safety review is done. (author)

  11. Effects of growth temperature and strictly anaerobic recovery on the survival of Listeria monocytogenes during pasteurization.

    Science.gov (United States)

    Knabel, S J; Walker, H W; Hartman, P A; Mendonca, A F

    1990-02-01

    Listeria monocytogenes F5069 was suspended in either Trypticase soy broth-0.6% yeast extract (TSBYE) or sterile, whole milk and heated at 62.8 degrees C in sealed thermal death time tubes. Severely heat-injured cells were recovered in TSBYE within sealed thermal death time tubes because of the formation of reduced conditions in the depths of the TSBYE. Also, the use of strictly anaerobic Hungate techniques significantly increased recovery in TSBYE containing 1.5% agar compared with aerobically incubated controls. The exogenous addition of catalase, but not superoxide dismutase, slightly increased the recovery of heat-injured cells in TSBYE containing 1.5% agar incubated aerobically. Growth of cells at 43 degrees C caused a greater increase in heat resistance as compared with cells heat shocked at 43 degrees C or cells grown at lower temperatures. Growth of L. monocytogenes at 43 degrees C and enumeration by the use of strictly anaerobic Hungate techniques resulted in D62.8 degrees C values that were at least sixfold greater than those previously obtained by using cells grown at 37 degrees C and aerobic plating. Results indicate that, under the conditions of the present study, high levels of L. monocytogenes would survive the minimum low-temperature, long-time treatment required by the U.S. Food and Drug Administration for pasteurizing milk. The possible survival of low levels of L. monocytogenes during high-temperature, short-time pasteurization and enumeration of injured cells by recovery on selective media under strictly anaerobic conditions are discussed.

  12. An overview of some basic design features of Koeberg Nuclear Power Station highlighting how regulatory requirements can influence design

    International Nuclear Information System (INIS)

    Morrison, A.R.

    1985-01-01

    The paper attempts to show that licensing requirements significantly influence the design of nuclear power plants. The French designed Pressurised Water Reactor system adopted by Escom at Koeberg has its origins in the General Design Criteria set out in the American Code of Federal Regulations document 10CFR50. Three of the General Design Criteria have been selected for illustrating how the requirements have influenced Koeberg in terms of design, both from a hardware and software view point. The requirements of the criteria on quality standard and records are to a certain extent reflected in the Licensing Branch Guide developed by the Atomic Energy Corporation to address quality assurance. The criterion on containment design sets requirements in respect of containment design which are incorporated in the Koeberg design. The criterion on electric power systems sets many of the basic design requirements for the electrical power supply systems inside and outside the station. The existence of the criterion led Escom to introduce changes in the transmission network to meet the requirements in respect of the independent criteria for the grid connections

  13. Ecologically justified regulatory provisions for riverine hydroelectric power plants and minimum instream flow requirements in diverted streams; Oekologisch begruendete, dynamische Mindestwasserregelungen bei Ausleitungskraftwerken

    Energy Technology Data Exchange (ETDEWEB)

    Jorde, K.

    1997-12-31

    The study was intended to develop a model versatile enough to permit quantification of various water demand scenarios in connection with operation of riverine hydroelectric power plants. Specific emphasis was to be placed on defining the minimum instream flow to be maintained in river segments because of the elementary significance to flowing water biocinoses. Based on fictitious minimum water requirements, various scenarious were simulated for flow regimes depending on power plant operation, so as to establish a system for comparative analysis and evaluation of resulting economic effects on power plant efficiency on the one hand, and the ecologic effects on the aquatic habitat. The information derived was to serve as a basis for decision-making for regulatory purposes. For this study, the temporal and spatial variability of the flow regime at the river bed in a river segment was examined for the first time. Based on this information, complemented by information obtained from habitat simulations, a method was derived for determination of ecologic requirements and their incorporation into regulatory water management provisions. The field measurements were carried out with the FST hemisphere as a proven and most efficient and reliable method of assessing flow regimes at river beds. Evaluation of the measured instream flow data characterising three morphologically different segments of diverted rivers was done with the CASIMIR computer code. The ASS models derived were used for comparative assessment of existing regulatory provisions and recommended amendments determining required minimum instream flow in diverted rivers. The requirements were defined taking as a basis data obtained for three different years. (orig./CB) [Deutsch] Ziel der Arbeit war die Entwicklung eines Modellverfahrens, das flexibel die Quantifizierung unterschiedlicher Nutzansprueche an Laufwasserkraftanlagen ermoeglicht. Insbesondere der Erhalt einer gewissen Dynamik, die fuer

  14. Strict or graduated punishment? Effect of punishment strictness on the evolution of cooperation in continuous public goods games.

    Directory of Open Access Journals (Sweden)

    Hajime Shimao

    Full Text Available Whether costly punishment encourages cooperation is one of the principal questions in studies on the evolution of cooperation and social sciences. In society, punishment helps deter people from flouting rules in institutions. Specifically, graduated punishment is a design principle for long-enduring common-pool resource institutions. In this study, we investigate whether graduated punishment can promote a higher cooperation level when each individual plays the public goods game and has the opportunity to punish others whose cooperation levels fall below the punisher's threshold. We then examine how spatial structure affects evolutionary dynamics when each individual dies inversely proportional to the game score resulting from the social interaction and another player is randomly chosen from the population to produce offspring to fill the empty site created after a player's death. Our evolutionary simulation outcomes demonstrate that stricter punishment promotes increased cooperation more than graduated punishment in a spatially structured population, whereas graduated punishment increases cooperation more than strict punishment when players interact with randomly chosen opponents from the population. The mathematical analysis also supports the results.

  15. Strict or Graduated Punishment? Effect of Punishment Strictness on the Evolution of Cooperation in Continuous Public Goods Games

    Science.gov (United States)

    Shimao, Hajime; Nakamaru, Mayuko

    2013-01-01

    Whether costly punishment encourages cooperation is one of the principal questions in studies on the evolution of cooperation and social sciences. In society, punishment helps deter people from flouting rules in institutions. Specifically, graduated punishment is a design principle for long-enduring common-pool resource institutions. In this study, we investigate whether graduated punishment can promote a higher cooperation level when each individual plays the public goods game and has the opportunity to punish others whose cooperation levels fall below the punisher’s threshold. We then examine how spatial structure affects evolutionary dynamics when each individual dies inversely proportional to the game score resulting from the social interaction and another player is randomly chosen from the population to produce offspring to fill the empty site created after a player’s death. Our evolutionary simulation outcomes demonstrate that stricter punishment promotes increased cooperation more than graduated punishment in a spatially structured population, whereas graduated punishment increases cooperation more than strict punishment when players interact with randomly chosen opponents from the population. The mathematical analysis also supports the results. PMID:23555826

  16. Evaluation of New Chemical Entities as Substrates of Liver Transporters in the Pharmaceutical Industry: Response to Regulatory Requirements and Future Steps.

    Science.gov (United States)

    Okudaira, Noriko

    2017-09-01

    This article discusses the evaluation of drug candidates as hepatic transporter substrates. Recently, research on the applications of hepatic transporters in the pharmaceutical industry has improved to meet the requirements of the regulatory guidelines for the evaluation of drug interactions. To identify the risk of transporter-mediated drug-drug interactions at an early stage of drug development, we used a strategy of reviewing the in vivo animal pharmacokinetics and tissue distribution data obtained in the discovery stage together with the in vitro data obtained for regulatory submission. In the context of nonclinical evaluation of new chemical entities as medicines, we believe that transporter studies are emerging as a key strategy to predict their pharmacological and toxicological effects. In combination with the recent progress in systems approaches, the estimation of effective concentrations in the target tissues, by using mathematical models to describe the transporter-mediated distribution and elimination, has enabled us to identify promising compounds for clinical development at the discovery stage. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  17. Regulatory requirements of radiation protection for veterinary nuclear medicine; Strahlenschutzrechtliche Voraussetzungen fuer die Nuklearmedizin in der Tierheilkunde

    Energy Technology Data Exchange (ETDEWEB)

    Ernst-Elz, Andreas [Referat Strahlenschutz, Ministerium fuer Justiz, Gleichstellung und Integration des Landes Schleswig-Holstein, Kiel (Germany)

    2010-03-15

    The application of radionuclides for diagnostic and therapy in veterinary medicine requires permission by terms of German radiation protection ordinance. Conditions for granting this licence are described. Preconditions are the requisite qualification of the veterinarian and the structural conditions of radiation protection. It is necessary to consider the possible exposure of the public by radioactive waste and by animals after their discharge from treatment. (orig.)

  18. Public Notice of Nuclear Regulatory Authority of the Slovak Republic No. 57/2006 Coll. which constitutes the details about requirements in the transport of radioactive material

    International Nuclear Information System (INIS)

    Konecny, L.; Vaclav, J.

    2006-01-01

    The Public Notice has constituted the details about requirements in the transport of radioactive material. The Public Notice has replaced the previous Public Notice of the Nuclear Regulatory Authority of the Slovak Republic No. 284/1999 Coll. about the details of transport of the nuclear material. The Public Notice has elaborated in the detailed form rights and duties of subjects participating in transport of the nuclear material as well as the technical terms for facilities used for transport. Recommendations of the International Agency for the Nuclear energy were included into the Public Notice. These recommendations are mentioned in its safety standard 'Regulations for the Safe Transport of Radioactive Material', edition 2003. Only those recommendations have been taken on which concern the transport of nuclear material, radioactive waste and nuclear fuel burnt-up. These recommendations have been created by the international group of experts under IAEA organisation. The group regularly updates the recommendations in accordance with the newest knowledge

  19. Common definition for categories of clinical research: a prerequisite for a survey on regulatory requirements by the European Clinical Research Infrastructures Network (ECRIN)

    DEFF Research Database (Denmark)

    Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang

    2009-01-01

    BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation...... in relation to the wide spectrum of clinical research, the European Clinical Research Infrastructures Network (ECRIN) developed a multinational survey in ten European countries. However a lack of common classification framework for major categories of clinical research was identified, and therefore reaching...... an agreement on a common classification was the initial step in the development of the survey. RESULTS: The ECRIN transnational working group on regulation, composed of experts in the field of clinical research from ten European countries, defined seven major categories of clinical research that seem relevant...

  20. 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...

  1. The pioneer factor OCT4 requires the chromatin remodeller BRG1 to support gene regulatory element function in mouse embryonic stem cells.

    Science.gov (United States)

    King, Hamish W; Klose, Robert J

    2017-03-13

    Pioneer transcription factors recognise and bind their target sequences in inaccessible chromatin to establish new transcriptional networks throughout development and cellular reprogramming. During this process, pioneer factors establish an accessible chromatin state to facilitate additional transcription factor binding, yet it remains unclear how different pioneer factors achieve this. Here, we discover that the pluripotency-associated pioneer factor OCT4 binds chromatin to shape accessibility, transcription factor co-binding, and regulatory element function in mouse embryonic stem cells. Chromatin accessibility at OCT4-bound sites requires the chromatin remodeller BRG1, which is recruited to these sites by OCT4 to support additional transcription factor binding and expression of the pluripotency-associated transcriptome. Furthermore, the requirement for BRG1 in shaping OCT4 binding reflects how these target sites are used during cellular reprogramming and early mouse development. Together this reveals a distinct requirement for a chromatin remodeller in promoting the activity of the pioneer factor OCT4 and regulating the pluripotency network.

  2. French regulatory requirements for the occupational radiation protection in severe accident situations and post-accident recovery

    International Nuclear Information System (INIS)

    Couasnon, Olivier

    2014-01-01

    -accident), intervention personnel receive radiation protection granted to exposed workers. ASN will have to take into account two major sources of implementation of the occupational radiation protection during an emergency situation: the transposition of Council Directive 2013/59/EURATOM of 5 December 2013 and the requirements following the complementary safety assessments of the nuclear power plants in the light of the accident that occurred on the nuclear power plant at Fukushima Daiichi. Indeed, member States shall bring into force the laws, regulations and administrative provisions necessary to comply with the Directive. For example, in the French regulation, the end of the emergency situation and the transition from emergency phase to the recovery phase are not mentioned and will have to be integrated in the French legal framework. Concerning the complementary safety assessments, they require a 'hard core' of material and organizational measures designed to ensure control of basic safety functions in extreme situations (comprising operational dosimetry resources for workers) and in addition that the operator (EDF) gradually deploy its proposed national 'Nuclear rapid response force (FARN)' comprising specialist crews and equipment able to take over from the personnel on a site affected by an accident. (author)

  3. Improvements related with the safety required by the Argentine Regulatory Authority to the Atucha I Nuclear Central

    International Nuclear Information System (INIS)

    Calvo, J.; Michelin, C.; Navarro, R.; Waldman, R.

    2006-01-01

    The Argentinean Nuclear Regulation Authority (ARN) verified the existence of changes in the state of some internal components of the reactor of the Atucha I Nuclear Power station that, of continuing in the time, it could take to an inconvenient degradation for the safety operation of the installation. In consequence, to the effects of preventing that reach this situation, at the end of 1999, the ARN required to the Responsible Entity for the operation of this power station the implementation of an important improvements program in the internal components of the reactor. Additionally, and based on the results of the Probabilistic Safety analysis, it was added the one mentioned improvements program the implementation of an alternative cooling system of the reactor core denominated Second Drain of Heat, due to it was determined that, for some accidental sequences, their performance would reduce considerably the probability of damage to the core. The concretion of the improvements program implied to the Responsible Entity the realization of an important quantity of engineering studies, tests and specific inspections that allowed to carry out changes on the control bars of the reactor and its guide tubes; the coolant channels; the sensors of neutron flow; and diverse components of the primary and moderator systems. On the other hand also it was implemented the system Second Drain of Heat, what represents a considerable effort to make compatible the instrumentation and control of last generation, with the instrumentation and existent control systems in the power station. Also, it was requested to be carried out an integrity of the pressure recipient for to demonstrate the existence of an acceptable margin for the difference among the acceptable limit temperatures and of ductile/fragile transition of the material for all the possible accidental scenarios during the useful life of the reactor. (Author)

  4. The Success Rate of Initial {sup 131I} Ablation in Differentiated Thyroid Cancer: Comparison Between Less strict and Very Strict Low Iodine Diets

    Energy Technology Data Exchange (ETDEWEB)

    Yoo, Ik Dong; Kim, Sung Hoon; Seo, Ye Young; Oh, Jin Kyoung; O, Joo Hyun; Chung, Soo Kyo [The Catholic Univ. of Korea, Seoul (Korea, Republic of)

    2012-03-15

    To decrease the risk of recurrence or metastasis in differentiated thyroid cancer (DTC), selected patients receive radioactive iodine ablation of remnant thyroid tissue or tumor. A low iodine diet can enhance uptake of radioactive iodine. We compared the success rates of radioactive iodine ablation therapy in patients who followed two different low iodine diets (LIDs). The success rates of postsurgical radioactive iodine ablation in DTC patients receiving empiric doses of 150 mCi were retrospectively reviewed. First-time radioactive iodine ablation therapy was done in 71 patients following less strict LID. Less strict LID restricted seafood, iodized salt, egg yolk, dairy products, processed meat, instant prepared meals, and multivitamins. Very strict LID additionally restricted rice, freshwater fish, spinach, and soybean products. Radioactive iodine ablation therapy was considered successful when follow up {sup 123I} whole body scan was negative and stimulated serum thyroglobulin level was less than 2.0 ng/mL. The success rate of patients following less strict LID was 80.3% and for very strict LID 75.6%. There was no statistically significant difference in the success rates between the two LID groups (P=0.48). Very strict LID may not contribute to improving the success rate of initial radioactive iodine ablation therapy at the cost of great inconvenience to the patient.

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

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2000-01-01

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

  6. Selvester scoring in patients with strict LBBB using the QUARESS software.

    Science.gov (United States)

    Xia, Xiaojuan; Chaudhry, Uzma; Wieslander, Björn; Borgquist, Rasmus; Wagner, Galen S; Strauss, David G; Platonov, Pyotr; Ugander, Martin; Couderc, Jean-Philippe

    2015-01-01

    Estimation of the infarct size from body-surface ECGs in post-myocardial infarction patients has become possible using the Selvester scoring method. Automation of this scoring has been proposed in order to speed-up the measurement of the score and improving the inter-observer variability in computing a score that requires strong expertise in electrocardiography. In this work, we evaluated the quality of the QuAReSS software for delivering correct Selvester scoring in a set of standard 12-lead ECGs. Standard 12-lead ECGs were recorded in 105 post-MI patients prescribed implantation of an implantable cardiodefibrillator (ICD). Amongst the 105 patients with standard clinical left bundle branch block (LBBB) patterns, 67 had a LBBB pattern meeting the strict criteria. The QuAReSS software was applied to these 67 tracings by two independent groups of cardiologists (from a clinical group and an ECG core laboratory) to measure the Selvester score semi-automatically. Using various level of agreement metrics, we compared the scores between groups and when automatically measured by the software. The average of the absolute difference in Selvester scores measured by the two independent groups was 1.4±1.5 score points, whereas the difference between automatic method and the two manual adjudications were 1.2±1.2 and 1.3±1.2 points. Eighty-two percent score agreement was observed between the two independent measurements when the difference of score was within two point ranges, while 90% and 84% score agreements were reached using the automatic method compared to the two manual adjudications. The study confirms that the QuAReSS software provides valid measurements of the Selvester score in patients with strict LBBB with minimal correction from cardiologists. Copyright © 2015 Elsevier Inc. All rights reserved.

  7. Validation of an automatic diagnosis of strict left bundle branch block criteria using 12-lead electrocardiograms

    DEFF Research Database (Denmark)

    Xia, Xiaojuan; Ruwald, Anne-Christine; Ruwald, Martin H

    2017-01-01

    AIMS: Strict left bundle branch block (LBBB) criteria were recently proposed to identify LBBB patients to benefit most from cardiac resynchronization therapy (CRT). The aim of our study was to automate identification of strict LBBB in order to facilitate its broader application. METHODS: We devel...

  8. 7 CFR 28.416 - Strict Good Ordinary Light Spotted Color.

    Science.gov (United States)

    2010-01-01

    ... CONTAINER REGULATIONS COTTON CLASSING, TESTING, AND STANDARDS Standards Light Spotted Cotton § 28.416 Strict Good Ordinary Light Spotted Color. Strict Good Ordinary Light Spotted Color is color which in spot or... Cotton Source: 57 FR 34498, Aug. 5, 1992, unless otherwise noted. ...

  9. The translation regulatory subunit eIF3f controls the kinase-dependent mTOR signaling required for muscle differentiation and hypertrophy in mouse.

    Directory of Open Access Journals (Sweden)

    Alfredo Csibi

    2010-02-01

    Full Text Available The mTORC1 pathway is required for both the terminal muscle differentiation and hypertrophy by controlling the mammalian translational machinery via phosphorylation of S6K1 and 4E-BP1. mTOR and S6K1 are connected by interacting with the eIF3 initiation complex. The regulatory subunit eIF3f plays a major role in muscle hypertrophy and is a key target that accounts for MAFbx function during atrophy. Here we present evidence that in MAFbx-induced atrophy the degradation of eIF3f suppresses S6K1 activation by mTOR, whereas an eIF3f mutant insensitive to MAFbx polyubiquitination maintained persistent phosphorylation of S6K1 and rpS6. During terminal muscle differentiation a conserved TOS motif in eIF3f connects mTOR/raptor complex, which phosphorylates S6K1 and regulates downstream effectors of mTOR and Cap-dependent translation initiation. Thus eIF3f plays a major role for proper activity of mTORC1 to regulate skeletal muscle size.

  10. Differentiation of type 1 T regulatory cells (Tr1) by tolerogenic DC-10 requires the IL-10-dependent ILT4/HLA-G pathway.

    Science.gov (United States)

    Gregori, Silvia; Tomasoni, Daniela; Pacciani, Valentina; Scirpoli, Miriam; Battaglia, Manuela; Magnani, Chiara Francesca; Hauben, Ehud; Roncarolo, Maria-Grazia

    2010-08-12

    Type 1 T regulatory (Tr1) cells suppress immune responses in vivo and in vitro and play a key role in maintaining tolerance to self- and non-self-antigens. Interleukin-10 (IL-10) is the crucial driving factor for Tr1 cell differentiation, but the molecular mechanisms underlying this induction remain unknown. We identified and characterized a subset of IL-10-producing human dendritic cells (DCs), termed DC-10, which are present in vivo and can be induced in vitro in the presence of IL-10. DC-10 are CD14(+), CD16(+), CD11c(+), CD11b(+), HLA-DR(+), CD83(+), CD1a(-), CD1c(-), express the Ig-like transcripts (ILTs) ILT2, ILT3, ILT4, and HLA-G antigen, display high levels of CD40 and CD86, and up-regulate CD80 after differentiation in vitro. DC-10 isolated from peripheral blood or generated in vitro are potent inducers of antigen-specific IL-10-producing Tr1 cells. Induction of Tr1 cells by DC-10 is IL-10-dependent and requires the ILT4/HLA-G signaling pathway. Our data indicate that DC-10 represents a novel subset of tolerogenic DCs, which secrete high levels of IL-10, express ILT4 and HLA-G, and have the specific function to induce Tr1 cells.

  11. 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

  12. Synchronization control of cross-strict feedback hyperchaotic system based on cross active backstepping design

    International Nuclear Information System (INIS)

    Wang Jing; Gao Jinfeng; Ma Xikui

    2007-01-01

    This Letter presents a novel cross active backstepping design method for synchronization control of cross-strict feedback hyperchaotic system, in which the ordinary backstepping design is unavailable. The proposed control method, combining backstepping design and active control approach, extends the application of backstepping technique in chaos control. Based on this method, different combinations of controllers can be designed to meet the needs of different applications. The proposed method is applied to achieve chaos synchronization of two identical cross-strict feedback hyperchaotic systems. Also it is used to implement synchronization between cross-strict feedback hyperchaotic system and Roessler hyperchaotic system. Numerical examples illustrate the validity of the control method

  13. The Rts1 regulatory subunit of protein phosphatase 2A is required for control of G1 cyclin transcription and nutrient modulation of cell size.

    Directory of Open Access Journals (Sweden)

    Karen Artiles

    2009-11-01

    Full Text Available The key molecular event that marks entry into the cell cycle is transcription of G1 cyclins, which bind and activate cyclin-dependent kinases. In yeast cells, initiation of G1 cyclin transcription is linked to achievement of a critical cell size, which contributes to cell-size homeostasis. The critical cell size is modulated by nutrients, such that cells growing in poor nutrients are smaller than cells growing in rich nutrients. Nutrient modulation of cell size does not work through known critical regulators of G1 cyclin transcription and is therefore thought to work through a distinct pathway. Here, we report that Rts1, a highly conserved regulatory subunit of protein phosphatase 2A (PP2A, is required for normal control of G1 cyclin transcription. Loss of Rts1 caused delayed initiation of bud growth and delayed and reduced accumulation of G1 cyclins. Expression of the G1 cyclin CLN2 from an inducible promoter rescued the delayed bud growth in rts1Delta cells, indicating that Rts1 acts at the level of transcription. Moreover, loss of Rts1 caused altered regulation of Swi6, a key component of the SBF transcription factor that controls G1 cyclin transcription. Epistasis analysis revealed that Rts1 does not work solely through several known critical upstream regulators of G1 cyclin transcription. Cells lacking Rts1 failed to undergo nutrient modulation of cell size. Together, these observations demonstrate that Rts1 is a key player in pathways that link nutrient availability, cell size, and G1 cyclin transcription. Since Rts1 is highly conserved, it may function in similar pathways in vertebrates.

  14. Protection of Mice from Acute Graft-versus-Host Disease Requires CD28 Co-stimulation on Donor CD4+ Foxp3+ Regulatory T Cells

    Directory of Open Access Journals (Sweden)

    Anna Uri

    2017-06-01

    Full Text Available Acute graft-versus-host disease (aGvHD is a major cause of morbidity and mortality after allogeneic hematopoietic stem cell plus T cell transplantation (allo-HSCT. In this study, we investigated the requirement for CD28 co-stimulation of donor CD4+ conventional (CD4+CD25−Foxp3−, Tconv and regulatory (CD4+CD25+Foxp3+, Treg T cells in aGvHD using tamoxifen-inducible CD28 knockout (iCD28KO or wild-type (wt littermates as donors of CD4+ Tconv and Treg. In the highly inflammatory C57BL/6 into BALB/c allo-HSCT transplantation model, CD28 depletion on donor CD4+ Tconv reduced clinical signs of aGvHD, but did not significantly prolong survival of the recipient mice. Selective depletion of CD28 on donor Treg did not abrogate protection of recipient mice from aGvHD until about day 20 after allo-HSCT. Later, however, the pool of CD28-depleted Treg drastically declined as compared to wt Treg. Consequently, only wt, but not CD28-deficient, Treg were able to continuously suppress aGvHD and induce long-term survival of the recipient mice. To our knowledge, this is the first study that specifically evaluates the impact of CD28 expression on donor Treg in aGvHD. Moreover, the delayed kinetics of aGvHD lethality after transplantation of iCD28KO Treg provides a novel animal model for similar disease courses found in patients after allo-HSCT.

  15. 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

  16. Strictly hyperbolic models of co-current three-phase flow withgravity

    Energy Technology Data Exchange (ETDEWEB)

    Juanes, Ruben; Patzek, Tadeusz W.

    2002-11-18

    We study the character of the equations in the traditional formulation of one-dimensional immiscible three-phase flow with gravity, in the limit of negligible capillarity. We restrict our analysis to co-current flow required for a displacement process; in cases of mixed co-current and counter-current flow, capillarity effects cannot be dropped from the formulation. The model makes use of the classical multiphase extension of Darcy's equation. It is well known that, if relative permeabilities are taken as fixed functions of saturations, the model yields regions in the saturation space where the system of equations is locally elliptic. We regard elliptic behavior as a nonphysical artifact of an incomplete formulation, and derive conditions on the relative permeabilities that ensure strict hyperbolicity of the governing equations. The key point is to acknowledge that a Darcy-type formulation is insufficient to capture all the physics of three-phase flow and that, consequently, the relative permeabilities are functionals that depend on the fluid viscosity ratio and the gravity number. The derived conditions are consistent with the type of displacements that take place in porous media. By means of an illustrative example, we show how elliptic behavior can be removed, even when using simplistic relative permeability models.

  17. The Effect of Strict Segregation on Pseudomonas aeruginosa in Cystic Fibrosis Patients

    NARCIS (Netherlands)

    van Mansfeld, Rosa; de Vrankrijker, Angelica; Brimicombe, Roland; Heijerman, Harry; Teding van Berkhout, Ferdinand; Spitoni, Cristian|info:eu-repo/dai/nl/304625957; Grave, Sanne; van der Ent, Cornelis; Wolfs, Tom; Willems, Rob; Bonten, Marc

    2016-01-01

    INTRODUCTION: Segregation of patients with cystic fibrosis (CF) was implemented to prevent chronic infection with epidemic Pseudomonas aeruginosa strains with presumed detrimental clinical effects, but its effectiveness has not been carefully evaluated. METHODS: The effect of strict segregation on

  18. Strict deformation quantization for actions of a class of symplectic lie groups

    International Nuclear Information System (INIS)

    Bieliavsky, Pierre; Massar, Marc

    2002-01-01

    We present explicit universal strict deformation quantization formulae for actions of Iwasawa subgroups AN of SN(1, n). This answers a question raised by Rieffel in [Contemp. Math. 228 (1998), 315]. (author)

  19. Strict optical orthogonal codes for purely asynchronous code-division multiple-access applications

    Science.gov (United States)

    Zhang, Jian-Guo

    1996-12-01

    Strict optical orthogonal codes are presented for purely asynchronous optical code-division multiple-access (CDMA) applications. The proposed code can strictly guarantee the peaks of its cross-correlation functions and the sidelobes of any of its autocorrelation functions to have a value of 1 in purely asynchronous data communications. The basic theory of the proposed codes is given. An experiment on optical CDMA systems is also demonstrated to verify the characteristics of the proposed code.

  20. Plant use in the medicinal practices known as "strict diets" in Chazuta valley (Peruvian Amazon).

    Science.gov (United States)

    Sanz-Biset, Jaume; Cañigueral, Salvador

    2011-09-01

    Strict diets are traditional medicinal practices where plant remedies are consumed with nearly fasting and with some sort of social seclusion. The aim of this work was to describe these practices of Chazuta and the use of plants within, as well as to analyse the possible functions of the last. The information was obtained through interviews to the 6.3% of the district rural adult population (140 individuals, 75% of which was considered Quechua). In total, 122 strict diets were recorded and 106 different plant species were reported to be used. Strict diets present a characteristic structure and plant use. The main effects reported in strict diets were antinflammatory, antiinfective, brain function alteration and depuration. Strict diets are well structured traditional medicinal practices, also with a symbolic significance in the life cycle of chazutian men. Plants used in strict diets can contribute to the main effects through antinflammation, antiinfective actions, psychoactivity and depurative related activities. The correlation between literature evidence of activity of most used plants and effects reported for the correspondent diet (i.e. in which the plant was used) are 36% for antinflammatory activity, 29% for antimicrobial activity, 18% for psychoactivity and 5% for depurative related activities. The percentages go to 77%, 64%, 73% and 32%, respectively, when literature evidences on related taxa are also considered. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  1. New Materials Developed To Meet Regulatory And Technical Requirements Associated With In-Situ Decommissioning Of Nuclear Reactors And Associated Facilities

    International Nuclear Information System (INIS)

    Blankenship, J.; Langton, C.; Musall, J.; Griffin, W.

    2012-01-01

    For the 2010 ANS Embedded Topical Meeting on Decommissioning, Decontamination and Reutilization and Technology, Savannah River National Laboratory's Mike Serrato reported initial information on the newly developed specialty grout materials necessary to satisfy all requirements associated with in-situ decommissioning of P-Reactor and R-Reactor at the U.S. Department of Energy's Savannah River Site. Since that report, both projects have been successfully completed and extensive test data on both fresh properties and cured properties has been gathered and analyzed for a total of almost 191,150 m 3 (250,000 yd 3 ) of new materials placed. The focus of this paper is to describe the (1) special grout mix for filling the P-Reactor vessel (RV) and (2) the new flowable structural fill materials used to fill the below grade portions of the facilities. With a wealth of data now in hand, this paper also captures the test results and reports on the performance of these new materials. Both reactors were constructed and entered service in the early 1950s, producing weapons grade materials for the nation's defense nuclear program. R-Reactor was shut down in 1964 and the P-Reactor in 1991. In-situ decommissioning (ISD) was selected for both facilities and performed as Comprehensive Environmental Response, Compensations and Liability Act actions (an early action for P-Reactor and a removal action for R-Reactor), beginning in October 2009. The U.S. Department of Energy concept for ISD is to physically stabilize and isolate intact, structurally robust facilities that are no longer needed for their original purpose of producing (reactor facilities), processing (isotope separation facilities), or storing radioactive materials. Funding for accelerated decommissioning was provided under the American Recovery and Reinvestment Act. Decommissioning of both facilities was completed in September 2011. ISD objectives for these CERCLA actions included: (1) Prevent industrial worker exposure to

  2. Agonist-Driven Development of CD4+CD25+Foxp3+Regulatory T Cells Requires a Second Signal Mediated by Stat6

    DEFF Research Database (Denmark)

    Sanchez-Guajardo, Vanesa Maria; Tanshot, C.; O'Malley, J.T.

    2007-01-01

    The factors that induce Foxp3 expression and regulatory T (Treg) cell development remain unknown. In this study, we investigated the role of STAT4 and STAT6 in agonist-driven generation of Ag-specific Foxp3-expressing Treg cells. Our findings indicate that fully efficient induction of Foxp3...

  3. Strict Criteria for Selection of Laparoscopy for Women with Adnexal Mass

    Science.gov (United States)

    Sallum, Luis Felipe; Sarian, Luis Otávio; Bastos, Joana Fróes Bragança; Derchain, Sophie

    2014-01-01

    Objectives: We compared the indication of laparoscopy for treatment of adnexal masses based on the risk scores and tumor diameters with the indication based on gynecology-oncologists' experience. Methods: This was a prospective study of 174 women who underwent surgery for adnexal tumors (116 laparotomies, 58 laparoscopies). The surgeries begun and completed by laparoscopy, with benign pathologic diagnosis, were considered successful. Laparoscopic surgeries that required conversion to laparotomy, led to a malignant diagnosis, or facilitated cyst rupture were considered failures. Two groups were defined for laparoscopy indication: (1) absence of American College of Obstetrics and Gynecology (ACOG) guideline for referral of high-risk adnexal masses criteria (ACOG negative) associated with 3 different tumor sizes (10, 12, and 14 cm); and (2) Index of Risk of Malignancy (IRM) with cutoffs at 100, 200, and 300, associated with the same 3 tumor sizes. Both groups were compared with the indication based on the surgeon's experience to verify whether the selection based on strict rules would improve the rate of successful laparoscopy. Results: ACOG-negative and tumors ≤10 cm and IRM with a cutoff at 300 points and tumors ≤10cm resulted in the same best performance (78% success = 38/49 laparoscopies). However, compared with the results of the gynecology-oncologists' experience, those were not statistically significant. Discussion: The selection of patients with adnexal mass to laparoscopy by the use of the ACOG guideline or IRM associated with tumor diameter had similar performance as the experience of gynecology-oncologists. Both methods are reproducible and easy to apply to all women with adnexal masses and could be used by general gynecologists to select women for laparoscopic surgery; however, referral to a gynecology-oncologist is advisable when there is any doubt. PMID:25392617

  4. Actions of a separately strict cpo-monoid on pointed directed complete posets

    Directory of Open Access Journals (Sweden)

    Halimeh Moghbeli Damaneh

    2015-07-01

    Full Text Available ‎ In the present article‎, ‎we study some categorical properties of the category {$bf‎ Cpo_{Sep}$-$S$} of all {separately strict $S$-cpo's}; cpo's equipped with‎ a compatible right action of a separately strict cpo-monoid $S$ which is‎ strict continuous in each component‎. ‎In particular‎, we show that this category is reflective and coreflective in the‎ category of $S$-cpo's‎, ‎find the free and cofree functors‎, characterize products and coproducts‎. ‎Furthermore‎, ‎epimorphisms and‎  monomorphisms in {$bf Cpo_{Sep}$-$S$} are studied‎, ‎and show that‎ {$bf Cpo_{Sep}$-$S$} is not cartesian closed‎.

  5. The photon is no strict particle and nonlocality is far from being proven

    Energy Technology Data Exchange (ETDEWEB)

    Greulich, Karl Otto [Fritz Lipmann Institut, Jena (Germany)

    2010-07-01

    Two aspects of philosophical discussions on physics are the wave particle dualism and non locality including entanglement. However the strict particle aspect of the photon, in the common sense view, has never been proven. The accumulation time argument, the only experimental verification of a strictly particle like photon, has so far not yet been satisfied. Also, experiments thought to prove nonlocality have loophole which have so far not yet been safely closed, and now an even more serious loophole emerges. Thus, also nonlocality cannot be seen as proven. This demands some fine tuning of philosophical discussions on critical experiments in physics.

  6. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

    Science.gov (United States)

    Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

    2009-01-01

    The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

  7. Induction of Foxp3-expressing regulatory T-cells by donor blood transfusion is required for tolerance to rat liver allografts.

    Directory of Open Access Journals (Sweden)

    Yuta Abe

    Full Text Available BACKGROUND: Donor-specific blood transfusion (DST prior to solid organ transplantation has been shown to induce long-term allograft survival in the absence of immunosuppressive therapy. Although the mechanisms underlying DST-induced allograft tolerance are not well defined, there is evidence to suggest DST induces one or more populations of antigen-specific regulatory cells that suppress allograft rejection. However, neither the identity nor the regulatory properties of these tolerogenic lymphocytes have been reported. Therefore, the objective of this study was to define the kinetics, phenotype and suppressive function of the regulatory cells induced by DST alone or in combination with liver allograft transplantation (LTx. METHODOLOGY/PRINCIPAL FINDINGS: Tolerance to Dark Agouti (DA; RT1(a rat liver allografts was induced by injection (iv of 1 ml of heparinized DA blood to naïve Lewis (LEW; RT1(l rats once per week for 4 weeks prior to LTx. We found that preoperative DST alone generates CD4(+ T-cells that when transferred into naïve LEW recipients are capable of suppressing DA liver allograft rejection and promoting long-term survival of the graft and recipient. However, these DST-generated T-cells did not express the regulatory T-cell (Treg transcription factor Foxp3 nor did they suppress alloantigen (DA-induced activation of LEW T-cells in vitro suggesting that these lymphocytes are not fully functional regulatory Tregs. We did observe that DST+LTx (but not DST alone induced the time-dependent formation of CD4(+Foxp3(+ Tregs that potently suppressed alloantigen-induced activation of naïve LEW T-cells in vitro and liver allograft rejection in vivo. Finally, we present data demonstrating that virtually all of the Foxp3-expressing Tregs reside within the CD4(+CD45RC(- population whereas in which approximately 50% of these Tregs express CD25. CONCLUSIONS/SIGNIFICANCE: We conclude that preoperative DST, in the absence of liver allograft

  8. Regulation of stability studies to enhance the efficiency of drug registrations to regulatory authorities

    Directory of Open Access Journals (Sweden)

    Mohammad Sajjad Khan

    2015-01-01

    Full Text Available Stability testing is an important tool to assess the quality of drug substances and products which may vary with time under influence of variety of factors such as temperature, humidity, and light. Stability studies of drugs are designed according to the climatic zones to establish a retest period for active drug substance or a shelf life for the finished product as well as to recommend the storage conditions. The strict regulatory requirements on designing, performing evaluating stability study to claim the expiry date, and shelf life of drug products are based on a series of regulatory requirements and advisory guidelines that have been developed by regulatory authorities of US, Europe, and Japan which; were harmonized through the development of the International Conference on Harmonization (ICH procedures. To assess the stability of drug substances and products, the design and conduct of stability studies, defining relevant thresholds for impurities testing is required with a current good manufacturing practice-based risk management approach to achieve a robust stability of pharmaceutical dosage forms. There are relevant requirements that cover new drug substances and products as well as new dosage forms containing existing active ingredients and vice versa.

  9. Comments on regulatory reform

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1982-01-01

    Nuclear regulatory reform is divided into two parts. The first part contains all those matters for which new legislation is required. The second part concerns all those matters that are within the power of the Commission under existing statutes. Recommendations are presented

  10. Strict Monotonicity and Unique Continuation for the Third-Order Spectrum of Biharmonic Operator

    Directory of Open Access Journals (Sweden)

    Khalil Ben Haddouch

    2012-01-01

    Full Text Available We will study the spectrum for the biharmonic operator involving the laplacian and the gradient of the laplacian with weight, which we call third-order spectrum. We will show that the strict monotonicity of the eigenvalues of the operator , where , holds if some unique continuation property is satisfied by the corresponding eigenfunctions.

  11. "Let the Master Respond": Should Schools Be Strictly Liable When Employees Sexually Abuse Children?

    Science.gov (United States)

    Fossey, Richard; DeMitchell, Todd

    Although sexual abuse against children is a problem in the public schools, school officials have generally not acted aggressively to stop it. This paper argues for a strict liability standard--the assessment of liability without fault--against a school district in cases of student sexual abuse by a school employee. Part 1 explores the principle of…

  12. Detection of low numbers of microplastics in North Sea fish using strict quality assurance criteria

    NARCIS (Netherlands)

    Hermsen, E.; Pompe, R.; Besseling, E.; Koelmans, A.A.

    2017-01-01

    We investigated 400 individual fish of four North Sea species: Atlantic Herring, Sprat, Common Dab, and Whiting on ingestion of > 20 μm microplastic. Strict quality assurance criteria were followed in order to control contamination during the study. Two plastic particles were found in only 1 (a

  13. History, administration, goals, values, and long-term data of Russia's strictly protected scientific nature reserves

    Science.gov (United States)

    Martin A. Spetich; Anna E. Kvashnina; Y.D. Nukhimovskya; Olin E. Jr. Rhodes

    2009-01-01

    One of the most comprehensive attempts at biodiversity conservation in Russia and the former Soviet Union has been the establishment of an extensive network of protected natural areas. Among all types of protected areas in Russia, zapovedniks (strictly protected scientific preserve) have been the most effective in protecting biodiversity at the ecosystem scale. Russia...

  14. The Preventive Effect of Strict Gun Control Laws on Suicide and Homicide.

    Science.gov (United States)

    Lester, David; Murrell, Mary E.

    1982-01-01

    Examined state gun control laws and used a multidimensional scaling technique to study the relationship of strictness and death rates. Results showed states with stricter laws had lower suicide rates by firearms but higher rates by other means. No effect on homicide was found. (JAC)

  15. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    , legal and cultural, on a global scale. Against this background, this special issue sets out to explore the multifaceted meaning, potential and impact as well as the social praxis of regulatory governance. Under the notions rules, resistance and responsibility the special issue pins out three overall......Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2017-11-15

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

  17. Resident Bacteria-Stimulated Interleukin-10-Secreting B Cells Ameliorate T-Cell-Mediated Colitis by Inducing T-Regulatory-1 Cells That Require Interleukin-27 SignalingSummary

    Directory of Open Access Journals (Sweden)

    Yoshiyuki Mishima

    2015-05-01

    Full Text Available Background & Aims: The regulatory roles of interleukin-10 (IL10-producing B cells in colitis are not fully understood, so we explored the molecular mechanisms by which these cells modulate mucosal homeostasis. Methods: CD4+ T cells from wild-type (WT, Il10−/−, or Il27ra−/− mice were cotransferred with B cells from specific pathogen-free (SPF or germ-free (GF WT or Il10−/− mice into Rag2−/−Il10−/−(double-knockout mice, and the severity of colitis and intestinal regulatory T-cell populations were characterized. In vitro, WT or Il10−/− B cells were cocultured with unfractionated, naïve or regulatory T cells plus Il10−/− antigen-presenting cells and stimulated with cecal bacterial lysate (CBL with or without IL27 or anti-IL10R blockade. Gene expressions, cytokines in the supernatant and cell populations were assessed. Results: WT but not Il10−/− B cells attenuated T helper cell TH1/TH17-mediated colitis in double-knockout mice that also received WT but not Il10−/− T cells. In vitro, CBL-stimulated WT B cells secrete abundant IL10 and suppress interferon-γ (IFNγ and IL17a-production by T cells without requiring cell contact. Although both WT and Il10−/− B cells induced Foxp3+CD4+ T-regulatory cells, only WT B cells induced IL10-producing (Foxp3-negative T regulatory-1 (Tr-1 cells both in vivo and in vitro. However, IL10-producing B cells did not attenuate colitis or induce Tr-1 cells in the absence of T cell IL27 signaling in vivo. WT B cell-dependent Tr-1 induction and concomitant decreased IFNγ-secretion were also mediated by T-cell IL27-signaling in vitro. Conclusions: IL10-secreting B cells activated by physiologically relevant bacteria ameliorate T-cell-mediated colitis and contribute to intestinal homeostasis by suppressing effector T cells and inducing Tr-1 cells via IL27-signaling on T cells. Keywords: Experimental

  18. Iterative algorithms for the input and state recovery from the approximate inverse of strictly proper multivariable systems

    Science.gov (United States)

    Chen, Liwen; Xu, Qiang

    2018-02-01

    This paper proposes new iterative algorithms for the unknown input and state recovery from the system outputs using an approximate inverse of the strictly proper linear time-invariant (LTI) multivariable system. One of the unique advantages from previous system inverse algorithms is that the output differentiation is not required. The approximate system inverse is stable due to the systematic optimal design of a dummy feedthrough D matrix in the state-space model via the feedback stabilization. The optimal design procedure avoids trial and error to identify such a D matrix which saves tremendous amount of efforts. From the derived and proved convergence criteria, such an optimal D matrix also guarantees the convergence of algorithms. Illustrative examples show significant improvement of the reference input signal tracking by the algorithms and optimal D design over non-iterative counterparts on controllable or stabilizable LTI systems, respectively. Case studies of two Boeing-767 aircraft aerodynamic models further demonstrate the capability of the proposed methods.

  19. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    , legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  20. Veterinary applications of ionising radiation HERCA Task Force on Veterinary Applications. Main results of the Questionnaire 'National regulatory requirements with regard to veterinary medical applications of ionising radiation' and conclusions of the TF

    International Nuclear Information System (INIS)

    Van Bladel, Lodewijk; Berlamont, Jolien; Michalczak, Herbert; Balogh, Lajos; Peremans, Kathelijne

    2013-11-01

    In the fall of 2012, the subject of radiation protection in veterinary medicine was raised during the meeting of the HERCA Board. Issues with regard to this subject had been brought to the attention of HERCA by the European College of Veterinary Diagnostic Imaging (ECVDI). In October 2012, the Board decided to charge a small Task Force (TF) to further explore the issues in this field. This TF drew up a questionnaire which looked at the general radiation protection regulatory requirements in veterinary medicine applications of ionizing radiation. The results of this study showed large differences in the requirements applicable in the HERCA member countries. The TF also noticed the increasing use of more complex imaging procedures and of different radio-therapeutic modalities, which may imply greater risks of exposure of humans to ionising radiation. These results were presented during the HERCA Board meeting in Berlin, Germany and on which the Board decided to establish a Working Group on veterinary applications of ionising radiations (WG Vet). The main results of the Questionnaire 'National regulatory requirements with regard to veterinary medicine applications of ionising radiation' is attached in Appendix

  1. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

    Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders

  2. The NF-κB transcription factor RelA is required for the tolerogenic function of Foxp3(+) regulatory T cells.

    Science.gov (United States)

    Messina, Nicole; Fulford, Thomas; O'Reilly, Lorraine; Loh, Wen Xian; Motyer, Jessica M; Ellis, Darcy; McLean, Catriona; Naeem, Haroon; Lin, Ann; Gugasyan, Raffi; Slattery, Robyn M; Grumont, Raelene J; Gerondakis, Steve

    2016-06-01

    The properties of CD4(+) regulatory T cell (Treg) subsets are dictated by distinct patterns of gene expression determined by FOXP3 and different combinations of various transcription factors. Here we show the NF-κB transcription factor RelA is constitutively active in naïve and effector Tregs. The conditional inactivation of Rela in murine FOXP3(+) cells induces a rapid onset, multi-focal autoimmune disease that depends on RelA being expressed in conventional T cells. In addition to promoting Treg lineage stability, RelA determines the size of the effector Treg population, a function influenced by the presence or absence of RelA in conventional T cells. These findings showing that RelA controls Treg stability and promotes the competitive fitness of effector Tregs highlight the importance of RelA activity in peripheral Treg induced tolerance. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. A Criterium for the Strict Positivity of the Density of the Law of a Poisson Process

    Directory of Open Access Journals (Sweden)

    Léandre Rémi

    2011-01-01

    Full Text Available We translate in semigroup theory our result (Léandre, 1990 giving a necessary condition so that the law of a Markov process with jumps could have a strictly positive density. This result express, that we have to jump in a finite number of jumps in a "submersive" way from the starting point to the end point if the density of the jump process is strictly positive in . We use the Malliavin Calculus of Bismut type of (Léandre, (2008;2010 translated in semi-group theory as a tool, and the interpretation in semi-group theory of some classical results of the stochastic analysis for Poisson process as, for instance, the formula giving the law of a compound Poisson process.

  4. The effect of 8 days of strict bed rest on the incretin effect in healthy volunteers

    DEFF Research Database (Denmark)

    Nielsen, Signe Tellerup; Harder-Lauridsen, Nina Majlund; Benatti, Fabiana Braga

    2016-01-01

    in the levels of GLP-1 and Glucagon. Bed rest led to a mean loss of 2.4 kg of fat-free mass, and induced insulin resistance evaluated by the Matsuda index, but did not affect the incretin effect (P = 0.6). In conclusion, 8 days of bed rest induces insulin resistance, but we did not see evidence of an associated......Bed rest and physical inactivity are the consequences of hospital admission for many patients. Physical inactivity induces changes in glucose metabolism, but its effect on the incretin effect, which is reduced in, e.g., Type 2 diabetes, is unknown. To investigate how 8 days of strict bed rest...... affects the incretin effect, 10 healthy nonobese male volunteers underwent 8 days of strict bed rest. Before and after the intervention, all volunteers underwent an oral glucose tolerance test (OGTT) followed by an intravenous glucose infusion (IVGI) on the following day to mimic the blood glucose profile...

  5. Detection of low numbers of microplastics in North Sea fish using strict quality assurance criteria.

    Science.gov (United States)

    Hermsen, Enya; Pompe, Renske; Besseling, Ellen; Koelmans, Albert A

    2017-09-15

    We investigated 400 individual fish of four North Sea species: Atlantic Herring, Sprat, Common Dab, and Whiting on ingestion of >20μm microplastic. Strict quality assurance criteria were followed in order to control contamination during the study. Two plastic particles were found in only 1 (a Sprat) out of 400 individuals (0.25%, with a 95% confidence interval of 0.09-1.1%). The particles were identified to consist of polymethylmethacrylate (PMMA) through FTIR spectroscopy. No contamination occurred during the study, showing the method applied to be suitable for microplastic ingestion studies in biota. We discuss the low particle count for North Sea fish with those in other studies and suggest a relation between reported particle count and degree of quality assurance applied. Microplastic ingestion by fish may be less common than thought initially, with low incidence shown in this study, and other studies adhering to strict quality assurance criteria. Copyright © 2017 Elsevier Ltd. All rights reserved.

  6. A strict anaerobic extreme thermophilic hydrogen-producing culture enriched from digested household waste

    DEFF Research Database (Denmark)

    Karakashev, Dimitar Borisov; Kotay, Shireen Meher; Trably, Eric

    2009-01-01

    sources. Growth on glucose produced acetate, H-2 and carbon dioxide. Maximal H-2 production rate on glucose was 1.1 mmol l(-1) h(-1) with a maximum H-2 yield of 1.9 mole H-2 per mole glucose. 16S ribosomal DNA clone library analyses showed that the culture members were phylogenetically affiliated......The aim of this study was to enrich, characterize and identify strict anaerobic extreme thermophilic hydrogen (H-2) producers from digested household solid wastes. A strict anaerobic extreme thermophilic H-2 producing bacterial culture was enriched from a lab-scale digester treating household...... wastes at 70 degrees C. The enriched mixed culture consisted of two rod-shaped bacterial members growing at an optimal temperature of 80 degrees C and an optimal pH 8.1. The culture was able to utilize glucose, galactose, mannose, xylose, arabinose, maltose, sucrose, pyruvate and glycerol as carbon...

  7. A Hybrid P2P Overlay Network for Non-strictly Hierarchically Categorized Content

    Science.gov (United States)

    Wan, Yi; Asaka, Takuya; Takahashi, Tatsuro

    In P2P content distribution systems, there are many cases in which the content can be classified into hierarchically organized categories. In this paper, we propose a hybrid overlay network design suitable for such content called Pastry/NSHCC (Pastry for Non-Strictly Hierarchically Categorized Content). The semantic information of classification hierarchies of the content can be utilized regardless of whether they are in a strict tree structure or not. By doing so, the search scope can be restrained to any granularity, and the number of query messages also decreases while maintaining keyword searching availability. Through simulation, we showed that the proposed method provides better performance and lower overhead than unstructured overlays exploiting the same semantic information.

  8. Weak asymptotic solution for a non-strictly hyperbolic system of conservation laws-II

    Directory of Open Access Journals (Sweden)

    Manas Ranjan Sahoo

    2016-04-01

    Full Text Available In this article we introduce a concept of entropy weak asymptotic solution for a system of conservation laws and construct the same for a prolonged system of conservation laws which is highly non-strictly hyperbolic. This is first done for Riemann type initial data by introducing $\\delta,\\delta',\\delta''$ waves along a discontinuity curve and then for general initial data by piecing together the Riemann solutions.

  9. Multiple-Set Split Feasibility Problems for κ-Strictly Pseudononspreading Mapping in Hilbert Spaces

    Directory of Open Access Journals (Sweden)

    Jing Quan

    2013-01-01

    Full Text Available The purpose of this paper is to prove some weak and strong convergence theorems for solving the multiple-set split feasibility problems for κ-strictly pseudononspreading mapping in infinite-dimensional Hilbert spaces by using the proposed iterative method. The main results presented in this paper extend and improve the corresponding results of Xu et al. (2006, of Osilike et al. (2011, and of many other authors.

  10. Multiobjective Optimization for the Forecasting Models on the Base of the Strictly Binary Trees

    OpenAIRE

    Nadezhda Astakhova; Liliya Demidova; Evgeny Nikulchev

    2016-01-01

    The optimization problem dealing with the development of the forecasting models on the base of strictly binary trees has been considered. The aim of paper is the comparative analysis of two optimization variants which are applied for the development of the forecasting models. Herewith the first optimization variant assumes the application of one quality indicator of the forecasting model named as the affinity indicator and the second variant realizes the application of two quality indicators ...

  11. Cannabis legalization with strict regulation, the overall superior policy option for public health.

    Science.gov (United States)

    Rehm, J; Fischer, B

    2015-06-01

    Cannabis is the most prevalently used drug globally, with many jurisdictions considering varying reform options to current policies to deal with this substance and associated harm. Three policy options are available: prohibition, decriminalization, and legalization, with prohibition currently the dominant model globally. This contribution gives reasons why legalization with strict regulation should be considered superior to other options with respect to public health in high income countries in North America. © 2015 ASCPT.

  12. 12 CFR 562.2 - Regulatory reports.

    Science.gov (United States)

    2010-01-01

    ... not limited to the minimum requirements under generally accepted accounting principles (GAAP) because... condition and operation of savings associations. The Report of Examination and the Thrift Financial Report (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting...

  13. Examination of the PCICE method in the nearly incompressible, as well as strictly incompressible, limits

    International Nuclear Information System (INIS)

    Berry, Ray A.; Martineau, Richard C.

    2007-01-01

    The conservative-form, pressure-based PCICE numerical method (Martineau and Berry, 2004) (Berry, 2006), recently developed for computing transient fluid flows of all speeds from very low to very high (with strong shocks), is simplified and generalized. Though the method automatically treats a continuous transition of compressibility, three distinct, limiting compressibility regimes are formally defined for purposes of discussion and comparison with traditional methods - the strictly incompressible limit, the nearly incompressible limit, and the fully compressible limit. The PCICE method's behavior is examined in each limiting regime. In the strictly incompressible limit the PCICE algorithm reduces to the traditional MAC-type method with velocity divergence driving the pressure Poisson equation. In the nearly incompressible limit the PCICE algorithm is found to reduce to a generalization of traditional incompressible methods, i.e. to one in which not only the velocity divergence effect, but also the density gradient effect is included as a driving function in the pressure Poisson equation. This nearly incompressible regime has received little attention, and it appears that in the past, strictly incompressible methods may have been conveniently applied to flows in this regime at the expense of ignoring a potentially important coupling mechanism. This could be significant in many important flows; for example, in natural convection flows resulting from high heat flux. In the fully compressible limit or regime, the algorithm is found to reduce to an expression equivalent to density-based methods for high-speed flow. (author)

  14. TESTING STRICT HYDROSTATIC EQUILIBRIUM IN SIMULATED CLUSTERS OF GALAXIES: IMPLICATIONS FOR A1689

    International Nuclear Information System (INIS)

    Molnar, S. M.; Umetsu, K.; Chiu, I.-N.; Chen, P.; Hearn, N.; Broadhurst, T.; Bryan, G.; Shang, C.

    2010-01-01

    Accurate mass determination of clusters of galaxies is crucial if they are to be used as cosmological probes. However, there are some discrepancies between cluster masses determined based on gravitational lensing and X-ray observations assuming strict hydrostatic equilibrium (i.e., the equilibrium gas pressure is provided entirely by thermal pressure). Cosmological simulations suggest that turbulent gas motions remaining from hierarchical structure formation may provide a significant contribution to the equilibrium pressure in clusters. We analyze a sample of massive clusters of galaxies drawn from high-resolution cosmological simulations and find a significant contribution (20%-45%) from non-thermal pressure near the center of relaxed clusters, and, in accord with previous studies, a minimum contribution at about 0.1 R vir , growing to about 30%-45% at the virial radius, R vir . Our results strongly suggest that relaxed clusters should have significant non-thermal support in their core region. As an example, we test the validity of strict hydrostatic equilibrium in the well-studied massive galaxy cluster A1689 using the latest high-resolution gravitational lensing and X-ray observations. We find a contribution of about 40% from non-thermal pressure within the core region of A1689, suggesting an alternate explanation for the mass discrepancy: the strict hydrostatic equilibrium is not valid in this region.

  15. Temporary Strict Maternal Avoidance of Cow’s Milk and Infantile Colic

    Directory of Open Access Journals (Sweden)

    Firoozeh Sajedi

    2009-12-01

    Full Text Available Infant colic is a common problem characterized by excessive crying and fussing. We examined whether colic symptoms of exclusively breast-milk-fed infants would be improved by temporary strict maternal avoidance of cows milk. This study is analytic and experimental. Sixty-six subjects were recruited during winter of 2006 from a clinic in Isfahan, Iran. Breast-milk-fed in-fants with "colic", age 3-6 months and to be in otherwise good health were referred by pediatri-cians. The intervention was 1 week period of strict maternal avoidance of cows milk while they continued exclusive breast-milk-feeding. All infants showed improvement in distressed behavior (crying and fussing during intervention. The total recorded crying and fussing time was reduced by an average of 31%. A significant difference was found in cry and fuss time between first and last 2 days of intervention (P = 0.000. Cows milk proteins may play an etiologic role in colic. We propose that a brief intervention with strict maternal avoidance of cows milk may be an effective treatment for colic in some breast-milk-fed infants.

  16. Deposit Insurance and Risk Shifting in a Strong Regulatory Environment

    DEFF Research Database (Denmark)

    Bartholdy, Jan; Justesen, Lene Gilje

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

  17. Private Equity and Regulatory Capital

    NARCIS (Netherlands)

    Bongaerts, D.; Charlier, E.

    2008-01-01

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

  18. Na+/H+ exchange regulatory factor 1 is required for ROMK1 K+ channel expression in the surface membrane of cultured M-1 cortical collecting duct cells.

    Science.gov (United States)

    Suzuki, Takashi; Nakamura, Kazuyoshi; Mayanagi, Taira; Sobue, Kenji; Kubokawa, Manabu

    2017-07-22

    The ROMK1 K + channel, a member of the ROMK channel family, is the major candidate for the K + secretion pathway in the renal cortical collecting duct (CCD). ROMK1 possesses a PDZ domain-binding motif at its C-terminus that is considered a modulator of ROMK1 expression via interaction with Na + /H + exchange regulatory factor (NHERF) 1 and NHERF2 scaffold protein. Although NHERF1 is a potential binding partner of the ROMK1 K + channel, the interaction between NHERF1 and K + channel activity remains unclear. Therefore, in this study, we knocked down NHERF1 in cultured M-1 cells derived from mouse CCD and investigated the surface expression and K + channel current in these cells after exogenous transfection with EGFP-ROMK1. NHERF1 knockdown resulted in reduced surface expression of ROMK1 as indicated by a cell biotinylation assay. Using the patch-clamp technique, we further found that the number of active channels per patched membrane and the Ba 2+ -sensitive whole-cell K + current were decreased in the knockdown cells, suggesting that reduced K + current was accompanied by decreased surface expression of ROMK1 in the NHERF1 knockdown cells. Our results provide evidence that NHERF1 mediates K + current activity through acceleration of the surface expression of ROMK1 K + channels in M-1 cells. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. CCDC39 is required for assembly of inner dynein arms and the dynein regulatory complex and for normal ciliary motility in humans and dogs.

    Science.gov (United States)

    Merveille, Anne-Christine; Davis, Erica E; Becker-Heck, Anita; Legendre, Marie; Amirav, Israel; Bataille, Géraldine; Belmont, John; Beydon, Nicole; Billen, Frédéric; Clément, Annick; Clercx, Cécile; Coste, André; Crosbie, Rachelle; de Blic, Jacques; Deleuze, Stephane; Duquesnoy, Philippe; Escalier, Denise; Escudier, Estelle; Fliegauf, Manfred; Horvath, Judith; Hill, Kent; Jorissen, Mark; Just, Jocelyne; Kispert, Andreas; Lathrop, Mark; Loges, Niki Tomas; Marthin, June K; Momozawa, Yukihide; Montantin, Guy; Nielsen, Kim G; Olbrich, Heike; Papon, Jean-François; Rayet, Isabelle; Roger, Gilles; Schmidts, Miriam; Tenreiro, Henrique; Towbin, Jeffrey A; Zelenika, Diana; Zentgraf, Hanswalter; Georges, Michel; Lequarré, Anne-Sophie; Katsanis, Nicholas; Omran, Heymut; Amselem, Serge

    2011-01-01

    Primary ciliary dyskinesia (PCD) is an inherited disorder characterized by recurrent infections of the upper and lower respiratory tract, reduced fertility in males and situs inversus in about 50% of affected individuals (Kartagener syndrome). It is caused by motility defects in the respiratory cilia that are responsible for airway clearance, the flagella that propel sperm cells and the nodal monocilia that determine left-right asymmetry. Recessive mutations that cause PCD have been identified in genes encoding components of the outer dynein arms, radial spokes and cytoplasmic pre-assembly factors of axonemal dyneins, but these mutations account for only about 50% of cases of PCD. We exploited the unique properties of dog populations to positionally clone a new PCD gene, CCDC39. We found that loss-of-function mutations in the human ortholog underlie a substantial fraction of PCD cases with axonemal disorganization and abnormal ciliary beating. Functional analyses indicated that CCDC39 localizes to ciliary axonemes and is essential for assembly of inner dynein arms and the dynein regulatory complex.

  20. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

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

  1. Balanced Integrated Regulatory Oversight

    International Nuclear Information System (INIS)

    Borchardt, R.W.

    2010-01-01

    Reactor safety, protecting the public health and safety, and protecting the environment must always be the nuclear regulator's top priorities. Enabling the use of nuclear power for the benefit of society, while protecting the public and the environment requires the regulator to balance many factors. In addition, the regulator is only one part of the overall government that must consider many factors as it carries out its societal responsibilities. Some of the factors that must be balanced and the practical impacts on how the regulator carries out its responsibilities will be addressed. The first International Conference on Effective Regulatory Systems, held in Moscow, Russian Federation, in 2006, focused on safety and security challenges with a goal of improving regulatory effectiveness through cooperation and sharing of information and best practices. The challenge of meeting both safety and security objectives is one example of potentially competing programmes that must be balanced. Other balances that must be evaluated include the benefits of safety improvements compared to the cost of implementation, the use of deterministic and probabilistic approaches, communication openness balanced with the protection of information that could be used for detrimental purposes, and timeliness of regulatory decision making balanced with the need to perform quality work in support of oversight responsibilities. A balanced and integrated approach to regulatory oversight is vital to ensuring that the regulatory body remains effective in its mission to enable the use of nuclear power while protecting the public and the environment. This concept is applicable to nations beginning a nuclear programme as well as established and experienced regulatory bodies. (author)

  2. 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.

  3. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-07-01

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

  4. Virginia Power's regulatory reduction program

    International Nuclear Information System (INIS)

    Miller, G.D.

    1996-01-01

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

  5. Rate Control Efficacy in Permanent Atrial Fibrillation : Successful and Failed Strict Rate Control Against a Background of Lenient Rate Control

    NARCIS (Netherlands)

    Groenveld, Hessel F.; Tijssen, Jan G. P.; Crijns, Harry J. G. M.; Van den Berg, Maarten P.; Hillege, Hans L.; Alings, Marco; Van Veldhuisen, Dirk J.; Van Gelder, Isabelle C.

    2013-01-01

    Objectives This study sought to investigate differences in outcome between patients treated with successful strict, failed strict, and lenient rate control. Background The RACE II (Rate Control Efficacy in Permanent Atrial Fibrillation) study showed no difference in outcome between lenient and

  6. Host defense and recruitment of Foxp3⁺ T regulatory cells to the lungs in chronic Mycobacterium tuberculosis infection requires toll-like receptor 2.

    Directory of Open Access Journals (Sweden)

    Amanda McBride

    Full Text Available Acute resistance to low dose M. tuberculosis (Mtb infection is not dependent on Toll-like receptor (TLR 2. However, whether TLR2 contributes to resistance in chronic Mtb infection has remained uncertain. Here we report that, following low dose aerosol infection with Mtb, mice lacking TLR2 (TLR2KO, in comparison with wild type (WT mice, exhibit enhanced cellular infiltration and inflammation in the lungs, and fail to stably control bacterial burden during chronic infection. IFNγ and IL-17 was expressed at equivalent levels in the two groups; however, the characteristic accumulation of Foxp3⁺ T regulatory cells (Tregs in pulmonary granulomas was significantly reduced in TLR2KO mice. Nonetheless, this reduction in Tregs was independent of whether Tregs expressed TLR2 or not. To directly link the reduced number of Tregs to the increased inflammation present in the TLR2KO mice, we used a macrophage adoptive transfer model. At seven weeks post-Mtb infection, TLR2KO mice, which were adoptively transferred with WT macrophages, displayed enhanced accumulation of Tregs in the lungs and a concomitant reduction in inflammation in contrast with control mice that received TLR2KO macrophages. However, the pulmonary bacterial burden between the two groups remained similar indicating that TLR2's role in modulating immunopathology is functionally distinct from its role in restricting Mtb growth in chronic infection. Together, these findings unequivocally demonstrate that TLR2 contributes to host resistance against chronic Mtb infection and reveal a novel role for TLR2 in mediating the recruitment of Foxp3⁺ Tregs to the lungs to control inflammation.

  7. Strict versus liberal insulin therapy in the cardiac surgery patient: An evidence-based practice development, implementation and evaluation project.

    Science.gov (United States)

    Gordon, Jacqueline M; Lauver, Lori S; Buck, Harleah G

    2018-02-01

    Hyperglycemia post-cardiac surgery is associated with poor clinical outcomes. Recent studies suggest maintaining liberal glycemic control (liberal CII protocol. Retrospective review of 144 strict CII patient records and 147 liberal CII patient records. Mean blood glucose was 159.8mg/dL (liberal CII) compared to 143.3mg/dL (strict CII) (p≤0.001). No surgical site infections occurred in either group. Mean ICU length of stay was 4.5days (liberal) versus 4.4days (strict) (p=0.74). Two 30-day mortalities occurred for the liberal cohort compared to no deaths in the strict group (p=0.49). Hypoglycemia incidence within 24h after surgery was 0.1% (liberal) compared to 0.3% (strict) compared to (p=0.16). Use of a nurse managed liberal CII resulted in similar outcomes with fewer incidents of hypoglycemia. Copyright © 2017. Published by Elsevier Inc.

  8. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants (Cooperative Agreement DE-FC03-99SF21902, Am. M004) Final Technical Report

    Energy Technology Data Exchange (ETDEWEB)

    Stanley E. Ritterbusch, et. al.

    2003-01-29

    '' were evaluated. It is expected that design basis accidents would be an inherent part of the Probabilistic Safety Assessment for the plant and their evaluation would be probabilistic. Other first year accomplishments include (1) the conversion of an NRC database for cross-referencing NRC criteria and industry codes and standards to Microsoft 2000 software, (2) an assessment of the NRC's hearing process which concluded that the normal cross-examination during public hearings is not actually required by the U.S. Administrative Procedures Act, (3) the identification and listing of reliability data sources, and (4) interfacing with other industry groups (e.g., NEI and IAEA) and NRC at workshops for risk-informing regulations. The major accomplishments during the second year consisted of (1) issuance of the final report for Subtask 1.1, ''Identify Current Applicable Regulatory Requirements [and Industry Standards],'' (2) issuance of the final report for Subtask 1.2,'' Identify Structures, Systems, and Components and Their Associate d Costs for a Typical Plant,'' (3) extension of the new, highly risk-informed design and regulatory framework to non-light-water-reactor technology, (4) completion of more detailed thermal-hydraulic and probabilistic analyses of advanced conceptual reactor system/component designs, (6) initial evaluation and recommendations for improvement of the NRC design review process, and (7) initial development of the software format, procedures and statistical routines needed to store, analyze and retrieve the available reliability data. Final reports for Subtasks 1.1 (regulatory and design criteria) and 1.2 (costs for structures, systems, and components) were prepared and issued. A final report for Subtask 1.3 (Regulatory Framework) was drafted with the aim to issue it in Phase 3 (Year 3). One technical report was produced for Subtask 1.4 (methods development) and two technical reports were produced for Subtask

  9. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants (Cooperative Agreement DE-FC03-99SF21902, Am. M004) Final Technical Report

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2003-01-01

    accidents would be an inherent part of the Probabilistic Safety Assessment for the plant and their evaluation would be probabilistic. Other first year accomplishments include (1) the conversion of an NRC database for cross-referencing NRC criteria and industry codes and standards to Microsoft 2000 software, (2) an assessment of the NRC's hearing process which concluded that the normal cross-examination during public hearings is not actually required by the U.S. Administrative Procedures Act, (3) the identification and listing of reliability data sources, and (4) interfacing with other industry groups (e.g., NEI and IAEA) and NRC at workshops for risk-informing regulations. The major accomplishments during the second year consisted of (1) issuance of the final report for Subtask 1.1, ''Identify Current Applicable Regulatory Requirements [and Industry Standards],'' (2) issuance of the final report for Subtask 1.2,'' Identify Structures, Systems, and Components and Their Associate d Costs for a Typical Plant,'' (3) extension of the new, highly risk-informed design and regulatory framework to non-light-water-reactor technology, (4) completion of more detailed thermal-hydraulic and probabilistic analyses of advanced conceptual reactor system/component designs, (6) initial evaluation and recommendations for improvement of the NRC design review process, and (7) initial development of the software format, procedures and statistical routines needed to store, analyze and retrieve the available reliability data. Final reports for Subtasks 1.1 (regulatory and design criteria) and 1.2 (costs for structures, systems, and components) were prepared and issued. A final report for Subtask 1.3 (Regulatory Framework) was drafted with the aim to issue it in Phase 3 (Year 3). One technical report was produced for Subtask 1.4 (methods development) and two technical reports were produced for Subtask 1.6 (sample problem analysis). An interim report on the NRC design review process (Subtask 1.7) was

  10. RelTime Rates Collapse to a Strict Clock When Estimating the Timeline of Animal Diversification.

    Science.gov (United States)

    Lozano-Fernandez, Jesus; Dos Reis, Mario; Donoghue, Philip C J; Pisani, Davide

    2017-05-01

    Establishing an accurate timescale for the history of life is crucial to understand evolutionary processes. For this purpose, relaxed molecular clock models implemented in a Bayesian MCMC framework are generally used. However, these methods are time consuming. RelTime, a non-Bayesian method implementing a fast, ad hoc, algorithm for relative dating, was developed to overcome the computational inefficiencies of Bayesian software. RelTime was recently used to investigate the timing of origin of animals, yielding results consistent with early strict clock studies from the 1980s and 1990s, estimating metazoans to have a Mesoproterozoic origin-over a billion years ago. RelTime results are unexpected and disagree with the largest majority of modern, relaxed, Bayesian molecular clock analyses, which suggest animals originated in the Tonian-Cryogenian (less that 850 million years ago). Here, we demonstrate that RelTime-inferred divergence times for the origin of animals are spurious, a consequence of the inability of RelTime to relax the clock along the internal branches of the animal phylogeny. RelTime-inferred divergence times are comparable to strict-clock estimates because they are essentially inferred under a strict clock. Our results warn us of the danger of using ad hoc algorithms making implicit assumptions about rate changes along a tree. Our study roundly rejects a Mesoproterozoic origin of animals; metazoans emerged in the Tonian-Cryogenian, and diversified in the Ediacaran, in the immediate prelude to the routine fossilization of animals in the Cambrian associated with the emergence of readily preserved skeletons. © The Author 2017. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  11. Effect of cryopreservation and lyophilization on viability and growth of strict anaerobic human gut microbes.

    Science.gov (United States)

    Bircher, Lea; Geirnaert, Annelies; Hammes, Frederik; Lacroix, Christophe; Schwab, Clarissa

    2018-04-17

    Strict anaerobic gut microbes have been suggested as 'next-generation probiotics' for treating several intestinal disorders. The development of preservation techniques is of major importance for therapeutic application. This study investigated cryopreservation (-80°C) and lyophilization survival and storage stability (4°C for 3 months) of the strict anaerobic gut microbes Bacteroides thetaiotaomicron, Faecalibacterium prausnitzii, Roseburia intestinalis, Anaerostipes caccae, Eubacterium hallii and Blautia obeum. To improve preservation survival, protectants sucrose and inulin (both 5% w/v) were added for lyophilization and were also combined with glycerol (15% v/v) for cryopreservation. Bacterial fitness, evaluated by maximum growth rate and lag phase, viability and membrane integrity were determined using a standardized growth assay and by flow cytometry as markers for preservation resistance. Lyophilization was more detrimental to viability and fitness than cryopreservation, but led to better storage stability. Adding sucrose and inulin enhanced viability and the proportion of intact cells during lyophilization of all strains. Viability of protectant-free B. thetaiotaomicron, A. caccae and F. prausnitzii was above 50% after cryopreservation and storage and increased to above 80% if protectants were present. The addition of glycerol, sucrose and inulin strongly enhanced the viability of B. obeum, E. hallii and R. intestinalis from 0.03-2% in protectant-free cultures to 11-37%. This is the first study that quantitatively compared the effect of cryopreservation and lyophilization and the addition of selected protectants on viability and fitness of six strict anaerobic gut microbes. Our results suggest that efficiency of protectants is process- and species-specific. © 2018 The Authors. Microbial Biotechnology published by John Wiley & Sons Ltd and Society for Applied Microbiology.

  12. Effects of growth temperature and strictly anaerobic recovery on the survival of Listeria monocytogenes during pasteurization.

    OpenAIRE

    Knabel, S J; Walker, H W; Hartman, P A; Mendonca, A F

    1990-01-01

    Listeria monocytogenes F5069 was suspended in either Trypticase soy broth-0.6% yeast extract (TSBYE) or sterile, whole milk and heated at 62.8 degrees C in sealed thermal death time tubes. Severely heat-injured cells were recovered in TSBYE within sealed thermal death time tubes because of the formation of reduced conditions in the depths of the TSBYE. Also, the use of strictly anaerobic Hungate techniques significantly increased recovery in TSBYE containing 1.5% agar compared with aerobicall...

  13. The Dirichlet problem for the Monge-Ampere equation in convex (but not strictly convex domains

    Directory of Open Access Journals (Sweden)

    David Hartenstine

    2006-10-01

    Full Text Available It is well-known that the Dirichlet problem for the Monge-Amp`ere equation $det D^2 u = mu$ in a bounded strictly convex domain $Omega$ in $mathbb{R}^n$ has a weak solution (in the sense of Aleksandrov for any finite Borel measure $mu$ on $Omega$ and for any continuous boundary data. We consider the Dirichlet problem when $Omega$ is only assumed to be convex, and give a necessary and sufficient condition on the boundary data for solvability.

  14. Selections of the metric projection operator and strict solarity of sets with continuous metric projection

    Science.gov (United States)

    Alimov, A. R.

    2017-07-01

    In a broad class of finite-dimensional Banach spaces, we show that a closed set with lower semicontinuous metric projection is a strict sun, admits a continuous selection of the metric projection operator onto it, has contractible intersections with balls, and its (nonempty) intersection with any closed ball is a retract of this ball. For sets with continuous metric projection, a number of new results relating the solarity of such sets to the stability of the operator of best approximation are obtained. Bibliography 25 titles.

  15. Transplanting Diseases from Organ Donors in Western Europe: Fault Liability or Strict Liability?

    Science.gov (United States)

    Broeckx, Nils; Verhoeven, Dimitri

    2015-06-01

    This article will examine the problem of disease transmission through organ transplantation from a civil liability perspective. Both fault liability and strict product liability might be possible. These two types of liability will be compared, while applying them to the actions of the central parties involved in organ donation and transplantation, namely the physician/hospital, the donor and the organ exchange organisation. While product liability is generally an easier way to obtain compensation than fault liability, it might nevertheless place too heavy a burden on the transplant professionals.

  16. Single molecule experiments challenge the strict wave-particle dualism of light.

    Science.gov (United States)

    Greulich, Karl Otto

    2010-01-21

    Single molecule techniques improve our understanding of the photon and light. If the single photon double slit experiment is performed at the "single photon limit" of a multi-atom light source, faint light pulses with more than one photon hamper the interpretation. Single molecules, quantum dots or defect centres in crystals should be used as light source. "Single photon detectors" do not meet their promise-only "photon number resolving single photon detectors" do so. Particularly, the accumulation time argument, the only safe basis for the postulate of a strictly particle like photon, has so far not yet been verified.

  17. Single Molecule Experiments Challenge the Strict Wave-Particle Dualism of Light

    Directory of Open Access Journals (Sweden)

    Karl Otto Greulich

    2010-01-01

    Full Text Available Single molecule techniques improve our understanding of the photon and light. If the single photon double slit experiment is performed at the “single photon limit” of a multi-atom light source, faint light pulses with more than one photon hamper the interpretation. Single molecules, quantum dots or defect centres in crystals should be used as light source. “Single photon detectors” do not meet their promise―only “photon number resolving single photon detectors” do so. Particularly, the accumulation time argument, the only safe basis for the postulate of a strictly particle like photon, has so far not yet been verified.

  18. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    1999-06-01

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

  19. Molecular mechanism of strict substrate specificity of an extradiol dioxygenase, DesB, derived from Sphingobium sp. SYK-6.

    Directory of Open Access Journals (Sweden)

    Keisuke Sugimoto

    Full Text Available DesB, which is derived from Sphingobium sp. SYK-6, is a type II extradiol dioxygenase that catalyzes a ring opening reaction of gallate. While typical extradiol dioxygenases show broad substrate specificity, DesB has strict substrate specificity for gallate. The substrate specificity of DesB seems to be required for the efficient growth of S. sp. SYK-6 using lignin-derived aromatic compounds. Since direct coordination of hydroxyl groups of the substrate to the non-heme iron in the active site is a critical step for the catalytic reaction of the extradiol dioxygenases, the mechanism of the substrate recognition and coordination of DesB was analyzed by biochemical and crystallographic methods. Our study demonstrated that the direct coordination between the non-heme iron and hydroxyl groups of the substrate requires a large shift of the Fe (II ion in the active site. Mutational analysis revealed that His124 and His192 in the active site are essential to the catalytic reaction of DesB. His124, which interacts with OH (4 of the bound gallate, seems to contribute to proper positioning of the substrate in the active site. His192, which is located close to OH (3 of the gallate, is likely to serve as the catalytic base. Glu377' interacts with OH (5 of the gallate and seems to play a critical role in the substrate specificity. Our biochemical and structural study showed the substrate recognition and catalytic mechanisms of DesB.

  20. Dsc E3 ligase localization to the Golgi requires the ATPase Cdc48 and cofactor Ufd1 for activation of sterol regulatory element-binding protein in fission yeast.

    Science.gov (United States)

    Burr, Risa; Ribbens, Diedre; Raychaudhuri, Sumana; Stewart, Emerson V; Ho, Jason; Espenshade, Peter J

    2017-09-29

    Sterol regulatory element-binding proteins (SREBPs) in the fission yeast Schizosaccharomyces pombe regulate lipid homeostasis and the hypoxic response under conditions of low sterol or oxygen availability. SREBPs are cleaved in the Golgi through the combined action of the Dsc E3 ligase complex, the rhomboid protease Rbd2, and the essential ATPases associated with diverse cellular activities (AAA + ) ATPase Cdc48. The soluble SREBP N-terminal transcription factor domain is then released into the cytosol to enter the nucleus and regulate gene expression. Previously, we reported that Cdc48 binding to Rbd2 is required for Rbd2-mediated SREBP cleavage. Here, using affinity chromatography and mass spectrometry experiments, we identified Cdc48-binding proteins in S. pombe , generating a list of many previously unknown potential Cdc48-binding partners. We show that the established Cdc48 cofactor Ufd1 is required for SREBP cleavage but does not interact with the Cdc48-Rbd2 complex. Cdc48-Ufd1 is instead required at a step prior to Rbd2 function, during Golgi localization of the Dsc E3 ligase complex. Together, these findings demonstrate that two distinct Cdc48 complexes, Cdc48-Ufd1 and Cdc48-Rbd2, are required for SREBP activation and low-oxygen adaptation in S. pombe . © 2017 by The American Society for Biochemistry and Molecular Biology, Inc.

  1. [Regulatory science researches of nanomedicines].

    Science.gov (United States)

    Sakai-Kato, Kumiko; Goda, Yukihiro

    2014-01-01

    Recently, the development of nanomedicines is progressing. These are designed to ensure high stability and to optimize the pharmacokinetics in vivo. The polymeric micelles and lipid nanoparticles are typical such examples. Because the unique size-specific interaction with biological systems or biodistribution may have significant impacts on the efficacy and safety of nanomedicines, regulatory science researches of nanomedicines are required. In this review, the authors introduce our initiatives of the regulatory science researches of nanomedicines.

  2. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

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

    1994-02-28

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

  3. Fuzzy Adaptive Decentralized Optimal Control for Strict Feedback Nonlinear Large-Scale Systems.

    Science.gov (United States)

    Sun, Kangkang; Sui, Shuai; Tong, Shaocheng

    2018-04-01

    This paper considers the optimal decentralized fuzzy adaptive control design problem for a class of interconnected large-scale nonlinear systems in strict feedback form and with unknown nonlinear functions. The fuzzy logic systems are introduced to learn the unknown dynamics and cost functions, respectively, and a state estimator is developed. By applying the state estimator and the backstepping recursive design algorithm, a decentralized feedforward controller is established. By using the backstepping decentralized feedforward control scheme, the considered interconnected large-scale nonlinear system in strict feedback form is changed into an equivalent affine large-scale nonlinear system. Subsequently, an optimal decentralized fuzzy adaptive control scheme is constructed. The whole optimal decentralized fuzzy adaptive controller is composed of a decentralized feedforward control and an optimal decentralized control. It is proved that the developed optimal decentralized controller can ensure that all the variables of the control system are uniformly ultimately bounded, and the cost functions are the smallest. Two simulation examples are provided to illustrate the validity of the developed optimal decentralized fuzzy adaptive control scheme.

  4. What's an ARAR?exclamation point: Regulatory requirements for CERCLA remedial activities at D ampersand D sites on the Oak Ridge Reservation

    International Nuclear Information System (INIS)

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

    1994-01-01

    Many government-owned facilities that supported early nuclear energy research and defense programs have no current use and have been retired. Some of these facilities have residual radioactive or chemical contamination that require remediation. The Department of Energy (DOE) Decontamination and Decommissioning (D ampersand D) Program is responsible for managing these surplus facilities. Remedial activities for contaminated environs and inactive land-based units (e.g., landfills, surface impoundments) at the Oak Ridge Reservation (ORR) are conducted under the direction of the Environmental Restoration (ER) Program

  5. 76 FR 37384 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

    Science.gov (United States)

    2011-06-27

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and... Recording and Reporting Requirements June 21, 2011. Pursuant to Section 19(b)(1) of the Securities Exchange..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  6. 75 FR 17806 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

    Science.gov (United States)

    2010-04-07

    ... commenter raised the following issues related to the proposed 30-second reporting requirement.\\22\\ First...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Amendment No. 2... Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  7. Regulatory Physiology

    Science.gov (United States)

    Lane, Helen W.; Whitson, Peggy A.; Putcha, Lakshmi; Baker, Ellen; Smith, Scott M.; Stewart, Karen; Gretebeck, Randall; Nimmagudda, R. R.; Schoeller, Dale A.; Davis-Street, Janis

    1999-01-01

    As noted elsewhere in this report, a central goal of the Extended Duration Orbiter Medical Project (EDOMP) was to ensure that cardiovascular and muscle function were adequate to perform an emergency egress after 16 days of spaceflight. The goals of the Regulatory Physiology component of the EDOMP were to identify and subsequently ameliorate those biochemical and nutritional factors that deplete physiological reserves or increase risk for disease, and to facilitate the development of effective muscle, exercise, and cardiovascular countermeasures. The component investigations designed to meet these goals focused on biochemical and physiological aspects of nutrition and metabolism, the risk of renal (kidney) stone formation, gastrointestinal function, and sleep in space. Investigations involved both ground-based protocols to validate proposed methods and flight studies to test those methods. Two hardware tests were also completed.

  8. Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology.

    Science.gov (United States)

    Fikes, James D; Patrick, Daniel J; Francke, Sabine; Frazier, Kendall S; Reindel, James F; Romeike, Annette; Spaet, Robert H; Tomlinson, Lindsay; Schafer, Kenneth A

    2015-10-01

    In 2014, the Organisation for Economic Co-operation and Development (OECD) issued guidance no. 16, Guidance on the GLP Requirements for Peer Review of Histopathology. The stated purpose of the guidance document is "to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented, and reported in order to meet Good Laboratory Practice (GLP) expectations and requirements." On behalf of and in collaboration with the global societies of toxicologic pathology, the Society of Toxicologic Pathology initiated a review of OECD guidance no. 16. The objectives of this review are to provide a unified interpretation of the guidance, to recommend compliant processes for organizations to implement, and to avoid inconsistent process adaptations across the industry. This review of the guidance document is the product of a global collaboration with other societies of toxicologic pathology and provides a section-by-section international consensus view and interpretation of the OECD guidance on peer review. © 2015 by The Author(s).

  9. Capital Requirements and Banks' Leniency

    DEFF Research Database (Denmark)

    Dietrich, J. Kimball; Wihlborg, Clas

    2003-01-01

    We investigate the effect of changes in capital regulation on the strictness(leniency) of loan terms using a simple model of bank capital requirements andasset quality examinations. Banks offer different levels of `leniency' in the senseof willingness to offer automatic extensions of loans...... rates. As capital requirements increase thedifference between initial capital levels and between interest rates of strict andlenient banks decrease. Thus, higher capital requirements in recessions tend toreduce the interest rate premium paid for leniency. If a recession is interpreted asan increase...... in the required return, the interest rate premium paid for leniency isincreased in recession at a given level of required capital....

  10. 77 FR 8072 - Semiannual Regulatory Flexibility Agenda

    Science.gov (United States)

    2012-02-13

    ... pledged; and certain other elements including a strategic analysis of the company's plans for maintaining... Expects Further Action........ 01/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact... Action........ 12/00/11 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Dena Milligan...

  11. Study on Environment Performance Evaluation and Regional Differences of Strictly-Environmental-Monitored Cities in China

    Directory of Open Access Journals (Sweden)

    Ji Guo

    2017-12-01

    Full Text Available With the rapid economic growth and development, the problem of environmental pollution in China’s cities is becoming increasingly serious, and environmental pollution takes on a regional difference. There is, however, little comprehensive evaluation on the environmental performance and the regional difference of strictly-environmental-monitored cities in China. In this paper, the environmental performance of 109 strictly-environmental-monitored cities in China is evaluated in terms of natural performance, management performance, and scale performance by Data Envelopment Analysis (DEA, incorporating PM2.5 and PM10 as undesirable outputs. The empirical results show that: (1 At present, the natural performance is quite high, while the management performance is noticeably low for most cities. (2 The gap between the level of economic development and environmental protection among cities in China is large, and the scale efficiency of big cities is better than that of smaller cities. The efficiency value of large-scale cities such as Beijing, Shanghai, Guangzhou, Shenzhen, etc. is high, equaling 1; the value of smaller cities such as Sanmenxia, Baoding, Mudanjiang, and Pingdingshan is low, close to 0, indicating that big cities are characterized by high environmental efficiency. (3 From the perspective of region, the level of environmental performance in China is very uneven. For example, the environmental efficiency level of the Pan-Pearl River Delta region is superior to that of the Pan-Yangtze River region and the Bahia Rim region, whose values of environmental efficiency are 0.858, 0.658, and 0.622 respectively. The average efficiency of the Southern Coastal Economic Zone, Eastern Coastal Comprehensive Economic Zone, and the Comprehensive Economic Zone in the middle reaches of the Yangtze River is higher than that of other regions. Finally, corresponding countermeasures and suggestions are put forward. The method used in this paper is applicable

  12. Disordered strictly jammed binary sphere packings attain an anomalously large range of densities

    Science.gov (United States)

    Hopkins, Adam B.; Stillinger, Frank H.; Torquato, Salvatore

    2013-08-01

    Previous attempts to simulate disordered binary sphere packings have been limited in producing mechanically stable, isostatic packings across a broad spectrum of packing fractions. Here we report that disordered strictly jammed binary packings (packings that remain mechanically stable under general shear deformations and compressions) can be produced with an anomalously large range of average packing fractions 0.634≤ϕ≤0.829 for small to large sphere radius ratios α restricted to α≥0.100. Surprisingly, this range of average packing fractions is obtained for packings containing a subset of spheres (called the backbone) that are exactly strictly jammed, exactly isostatic, and also generated from random initial conditions. Additionally, the average packing fractions of these packings at certain α and small sphere relative number concentrations x approach those of the corresponding densest known ordered packings. These findings suggest for entropic reasons that these high-density disordered packings should be good glass formers and that they may be easy to prepare experimentally. We also identify an unusual feature of the packing fraction of jammed backbones (packings with rattlers excluded). The backbone packing fraction is about 0.624 over the majority of the α-x plane, even when large numbers of small spheres are present in the backbone. Over the (relatively small) area of the α-x plane where the backbone is not roughly constant, we find that backbone packing fractions range from about 0.606 to 0.829, with the volume of rattler spheres comprising between 1.6% and 26.9% of total sphere volume. To generate isostatic strictly jammed packings, we use an implementation of the Torquato-Jiao sequential linear programming algorithm [Phys. Rev. EPLEEE81539-375510.1103/PhysRevE.82.061302 82, 061302 (2010)], which is an efficient producer of inherent structures (mechanically stable configurations at the local maxima in the density landscape). The identification and

  13. Disordered strictly jammed binary sphere packings attain an anomalously large range of densities.

    Science.gov (United States)

    Hopkins, Adam B; Stillinger, Frank H; Torquato, Salvatore

    2013-08-01

    Previous attempts to simulate disordered binary sphere packings have been limited in producing mechanically stable, isostatic packings across a broad spectrum of packing fractions. Here we report that disordered strictly jammed binary packings (packings that remain mechanically stable under general shear deformations and compressions) can be produced with an anomalously large range of average packing fractions 0.634≤φ≤0.829 for small to large sphere radius ratios α restricted to α≥0.100. Surprisingly, this range of average packing fractions is obtained for packings containing a subset of spheres (called the backbone) that are exactly strictly jammed, exactly isostatic, and also generated from random initial conditions. Additionally, the average packing fractions of these packings at certain α and small sphere relative number concentrations x approach those of the corresponding densest known ordered packings. These findings suggest for entropic reasons that these high-density disordered packings should be good glass formers and that they may be easy to prepare experimentally. We also identify an unusual feature of the packing fraction of jammed backbones (packings with rattlers excluded). The backbone packing fraction is about 0.624 over the majority of the α-x plane, even when large numbers of small spheres are present in the backbone. Over the (relatively small) area of the α-x plane where the backbone is not roughly constant, we find that backbone packing fractions range from about 0.606 to 0.829, with the volume of rattler spheres comprising between 1.6% and 26.9% of total sphere volume. To generate isostatic strictly jammed packings, we use an implementation of the Torquato-Jiao sequential linear programming algorithm [Phys. Rev. E 82, 061302 (2010)], which is an efficient producer of inherent structures (mechanically stable configurations at the local maxima in the density landscape). The identification and explicit construction of binary packings

  14. 75 FR 79873 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... Act Subcontract Reporting Procedures 9000-AL63 494 FAR Case 2008-039, Reporting Executive Compensation... Analysis Required: Yes Agency Contact: Karlos Morgan, Procurement Analyst, General Services Administration... Regulatory Flexibility Analysis Required: Yes Agency Contact: Karlos Morgan, Procurement Analyst, General...

  15. Nutritionally recommended food for semi- to strict vegetarian diets based on large-scale nutrient composition data.

    Science.gov (United States)

    Kim, Seunghyeon; Fenech, Michael F; Kim, Pan-Jun

    2018-03-12

    Diet design for vegetarian health is challenging due to the limited food repertoire of vegetarians. This challenge can be partially overcome by quantitative, data-driven approaches that utilise massive nutritional information collected for many different foods. Based on large-scale data of foods' nutrient compositions, the recent concept of nutritional fitness helps quantify a nutrient balance within each food with regard to satisfying daily nutritional requirements. Nutritional fitness offers prioritisation of recommended foods using the foods' occurrence in nutritionally adequate food combinations. Here, we systematically identify nutritionally recommendable foods for semi- to strict vegetarian diets through the computation of nutritional fitness. Along with commonly recommendable foods across different diets, our analysis reveals favourable foods specific to each diet, such as immature lima beans for a vegan diet as an amino acid and choline source, and mushrooms for ovo-lacto vegetarian and vegan diets as a vitamin D source. Furthermore, we find that selenium and other essential micronutrients can be subject to deficiency in plant-based diets, and suggest nutritionally-desirable dietary patterns. We extend our analysis to two hypothetical scenarios of highly personalised, plant-based methionine-restricted diets. Our nutrient-profiling approach may provide a useful guide for designing different types of personalised vegetarian diets.

  16. Lyme Neuroborreliosis: Preliminary Results from an Urban Referral Center Employing Strict CDC Criteria for Case Selection

    Directory of Open Access Journals (Sweden)

    David S. Younger

    2010-01-01

    Full Text Available Lyme neuroborreliosis or “neurological Lyme disease” was evidenced in 2 of 23 patients submitted to strict criteria for case selection of the Centers for Disease Control and Prevention employing a two-tier test to detect antibodies to Borrelia burgdorferi at a single institution. One patient had symptomatic polyradiculoneuritis, dysautonomia, and serological evidence of early infection; and another had symptomatic small fiber sensory neuropathy, distal polyneuropathy, dysautonomia, and serological evidence of late infection. In the remaining patients symptoms initially ascribed to Lyme disease were probably unrelated to B. burgdorferi infection. Our findings suggest early susceptibility and protracted involvement of the nervous system most likely due to the immunological effects of B. burgdorferi infection, although the exact mechanisms remain uncertain.

  17. On The Integral Representation of Strictly Continuous Set-Valued Maps

    Directory of Open Access Journals (Sweden)

    Anaté K. Lakmon

    2015-11-01

    Full Text Available Let T be a completely regular topological space and C(T be the space of bounded, continuous real-valued functions on T. C(T is endowed with the strict topology (the topology generated by seminorms determined by continuous functions vanishing at in_nity. R. Giles ([13], p. 472, Theorem 4.6 proved in 1971 that the dual of C(T can be identi_ed with the space of regular Borel measures on T. We prove this result for positive, additive set-valued maps with values in the space of convex weakly compact non-empty subsets of a Banach space and we deduce from this result the theorem of R. Giles ([13], theorem 4.6, p.473.

  18. A Total Variation Model Based on the Strictly Convex Modification for Image Denoising

    Directory of Open Access Journals (Sweden)

    Boying Wu

    2014-01-01

    Full Text Available We propose a strictly convex functional in which the regular term consists of the total variation term and an adaptive logarithm based convex modification term. We prove the existence and uniqueness of the minimizer for the proposed variational problem. The existence, uniqueness, and long-time behavior of the solution of the associated evolution system is also established. Finally, we present experimental results to illustrate the effectiveness of the model in noise reduction, and a comparison is made in relation to the more classical methods of the traditional total variation (TV, the Perona-Malik (PM, and the more recent D-α-PM method. Additional distinction from the other methods is that the parameters, for manual manipulation, in the proposed algorithm are reduced to basically only one.

  19. Residual diffeomorphisms and symplectic soft hairs: The need to refine strict statement of equivalence principle

    Science.gov (United States)

    Sheikh-Jabbari, M. M.

    2016-09-01

    General covariance is the cornerstone of Einstein’s general relativity (GR) and implies that any two metrics related by diffeomorphisms are physically equivalent. There are, however, many examples pointing to the fact that this strict statement of general covariance needs refinement. There are a very special (measure-zero) subset of diffeomorphisms, the residual diffeomorphisms, to which one can associate well-defined conserved charges. This would hence render these diffeomorphic geometries physically distinct. We discuss that these symmetries may be appropriately called “symplectic symmetries”. Existence of residual diffeomorphisms and symplectic symmetries can be a quite general feature and not limited to the examples discussed so far in the literature. We propose that, in the context of black holes, these diffeomorphic, but distinct, geometries may be viewed as “symplectic soft hair” on black holes. We comment on how this may remedy black hole microstate problem, which in this context are dubbed as “horizon fluffs”.

  20. Reactions to terror attacks in ultra-orthodox jews: the cost of maintaining strict identity.

    Science.gov (United States)

    Ankri, Yael L E; Bachar, Eytan; Shalev, Arieh Y

    2010-01-01

    Traumatic events can shatter faith and beliefs. The responses of Ultra-Orthodox survivors of deadly terrorist attacks illustrate an effort to reconcile dreadful experiences with deeply embedded beliefs. Qualified clinicians prospectively evaluated self-reported and interviewer-generated posttraumatic stress disorder (PTSD) symptoms and cognitive appraisal in Ultra-Orthodox (n = 20) and non-Ultra-Orthodox (n = 33) survivors of suicide bus-bombing incidents in Jerusalem. Ultra-Orthodox survivors reported higher levels of PTSD symptoms and more personal guilt. Their narratives reflected an unshaken belief in Just Providence, within which being a victim of terror was perceived as a Just retribution for known or unknown wrongdoing. Survivors' reactions to trauma often reflect an effort to reconcile incongruous experiences with previously held beliefs. When treating strict believers, helpers should be sensitive to the identity-preserving function of posttraumatic cognitions.

  1. On a class of adjustable rate mortgage loans subject to a strict balance principle

    DEFF Research Database (Denmark)

    Astrup Jensen, Bjarne

    We describe the background and the basic funding mechanisms for the type of adjustable rate mortgageloans that were introduced in the Danish market in 1996. Each loan is funded separately by tap issuingpass-through mortgage bonds (`strict balance principle'). The novelty is a funding mechanism...... that usesa roll-over strategy, where long term loans are funded by sequentially issuing short term pass-throughbonds, and the first issuer of these loans obtained a patent on the funding principles in 1999. Publiclyavailable descriptions of the principles leave an impression of very complicated numerical...... algorithms.The algorithms described here show that the essentials can be reduced to a `back of an envelope' complexity.Keywords: Adjustable rate mortgages, balance principle, patent, yield curve riding...

  2. Strict Liability Versus Policy and Regulation for Environmental Protection and Agricultural Waste Management in Malaysia

    Directory of Open Access Journals (Sweden)

    Mohd Bakri Ishak

    2010-01-01

    Full Text Available Basically, strict liability is part of the mechanism for expressing judgment or sentence by using direct evidence. This principle is very useful in order to obtain remedies from any damage either directly or indirectly. The principle in Rylands v Fletcher is responsible on imposing strict liability where if something brought onto land or collected there escapes liability under this rule can include not only the owner of land but also those who control or occupation on it. However, as a matter of fact, policy and regulation are also important in taking any action against any party who are responsible for environmental pollution or damage, which may include mismanagement of waste or industrial waste or agricultural waste. There are certain policies and regulations on environmental protection such as the National Environmental Policy, certain Acts and several regulations under the Environmental Quality Act 1974 (Act 127, which are very useful for agricultural waste management inter alia: Waters Act 1920 (Act 418, Environmental Quality (Prescribed Premises (Crude Palm Oil Regulations 1977, Environmental Quality (Prescribed Premises (Raw Natural Rubber Regulations 1978, Environmental Quality (Sewage and Industrial Effluents Regulations 1979, and Environmental Quality (Compounding of Offences Rules 1978. As a matter of fact, we should realize that time is of an essence for any parties which are involved in court cases and especially in avoiding the element of externality, which is commonly suffered by the government. In making this paper, therefore, some element of comparison with certain developed jurisdiction such as in the United Kingdom and Japan could not be avoided in order to obtain better outcome and to be more practical for the purpose of environmental protection and agricultural waste management.

  3. The Effect of Strict Segregation on Pseudomonas aeruginosa in Cystic Fibrosis Patients.

    Directory of Open Access Journals (Sweden)

    Rosa van Mansfeld

    Full Text Available Segregation of patients with cystic fibrosis (CF was implemented to prevent chronic infection with epidemic Pseudomonas aeruginosa strains with presumed detrimental clinical effects, but its effectiveness has not been carefully evaluated.The effect of strict segregation on the incidence of P. aeruginosa infection in CF patients was investigated through longitudinal protocolized follow-up of respiratory tract infection before and after segregation. In two nested cross-sectional studies in 2007 and 2011 the P. aeruginosa population structure was investigated and clinical parameters were determined in patients with and without infection with the Dutch epidemic P. aeruginosa clone (ST406.Of 784 included patients 315 and 382 were at risk for acquiring chronic P. aeruginosa infection before and after segregation. Acquisition rates were, respectively, 0.14 and 0.05 per 1,000 days at risk (HR: 0.66, 95% CI [0.2548-1.541]; p = 0.28. An exploratory subgroup analysis indicated lower acquisition after segregation in children < 15 years of age (HR: 0.43, 95% CI[0.21-0.95]; p = 0.04. P. aeruginosa population structure did not change after segregation and ST406 was not associated with lung function decline, death or lung transplantation.Strict segregation was not associated with a statistically significant lower acquisition of chronic P. aeruginosa infection and ST406 was not associated with adverse clinical outcome. After segregation there were no new acquisitions of ST406. In an unplanned exploratory analysis chronic acquisition of P. aeruginosa was lower after implementation of segregation in patients under 15 years of age.

  4. Weight of fitness deviation governs strict physical chaos in replicator dynamics

    Science.gov (United States)

    Pandit, Varun; Mukhopadhyay, Archan; Chakraborty, Sagar

    2018-03-01

    Replicator equation—a paradigm equation in evolutionary game dynamics—mathematizes the frequency dependent selection of competing strategies vying to enhance their fitness (quantified by the average payoffs) with respect to the average fitnesses of the evolving population under consideration. In this paper, we deal with two discrete versions of the replicator equation employed to study evolution in a population where any two players' interaction is modelled by a two-strategy symmetric normal-form game. There are twelve distinct classes of such games, each typified by a particular ordinal relationship among the elements of the corresponding payoff matrix. Here, we find the sufficient conditions for the existence of asymptotic solutions of the replicator equations such that the solutions—fixed points, periodic orbits, and chaotic trajectories—are all strictly physical, meaning that the frequency of any strategy lies inside the closed interval zero to one at all times. Thus, we elaborate on which of the twelve types of games are capable of showing meaningful physical solutions and for which of the two types of replicator equation. Subsequently, we introduce the concept of the weight of fitness deviation that is the scaling factor in a positive affine transformation connecting two payoff matrices such that the corresponding one-shot games have exactly same Nash equilibria and evolutionary stable states. The weight also quantifies how much the excess of fitness of a strategy over the average fitness of the population affects the per capita change in the frequency of the strategy. Intriguingly, the weight's variation is capable of making the Nash equilibria and the evolutionary stable states, useless by introducing strict physical chaos in the replicator dynamics based on the normal-form game.

  5. Strict stoichiometric homeostasis of Cryptomonas pyrenoidifera (Cryptophyceae in relation to N:P supply ratios

    Directory of Open Access Journals (Sweden)

    Eloísa Ramos Rodríguez

    2016-11-01

    Full Text Available A common freshwater cryptophyte, Cryptomonas pyrenoidifera, was cultivated in batch-cultures to analyze intraspecific variation in elemental stoichiometry along a broad gradient of pulsed phosphorus (P enrichment during the early acclimation period and to determine the immediate homeostatic capacity of the nitrogen-to-phosphorus (N:P ratio of this alga when nutrients are at saturating levels. Experimental results revealed that nitrogen (N and P cell quotas significantly increased with increasing P concentration. However, despite the wide range of N:P ratios in the medium, Cryptomonas N:P ratios were highly stable at higher P-level treatments, indicating a highly conservative behavior and suggesting strict elemental homeostasis when nutrients are at saturating levels. The strictly homeostatic N:P ratio appears to be attributable to their high potential for a fast luxury consumption of both N and P after a brief and intense episode of increased resource availability and to physiological limits on their nutrient storage capacity. Most importantly, the N:P biomass ratio at nutrient saturating levels converged around 11:1, which was the observed ratio of maximum internal cell quotas for N and P (i.e. Qmax,N:Qmax,P under the prevailing experimental conditions. This value is particularly informative for C. pyrenoidifera because it represents cell storage quotients and may be a taxon-specific evolutionary optimum, providing a reference point to infer the grade of nutrient-limitation. The experimental data give ranges of variation in C. pyrenoidifera elemental composition permitting, among others, proper parameterization of cryptophyte stoichiometry models.

  6. Strict follow-up programme including CT and (18) F-FDG-PET after curative surgery for colorectal cancer

    DEFF Research Database (Denmark)

    Sørensen, N F; Jensen, A B; Wille-Jørgensen, P

    2010-01-01

    Aim  The risk of local recurrence following curative surgery for colorectal cancer (CRC) is up to 50%. A rigorous follow-up program may increase survival. Guidelines on suitable methods for scheduled follow up examinations are needed. This study evaluates a strict follow-up program including...... supported a strict follow-up program following curative surgery for colorectal cancer. FDG-PET combined with CT should be included in control programs....

  7. Alloantigen-specific CD4(+) regulatory T cells induced in vivo by ultraviolet irradiation after alloantigen immunization require interleukin-10 for their induction and activation, and flexibly mediate bystander immunosuppression of allograft rejection.

    Science.gov (United States)

    Hori, Tomohide; Kuribayashi, Kagemasa; Saito, Kanako; Wang, Linan; Torii, Mie; Uemoto, Shinji; Kato, Takuma

    2015-06-01

    Ultraviolet (UV) irradiation prior to antigen immunization is employed to induce antigen-specific regulatory T cells (Tregs). UV-induced Tregs demonstrate unique bystander suppression, although antigen-specific activation is required initially. We previously reported the phenotype of alloantigen-specific transferable Tregs induced by UV-B irradiation after immunization was the same as T regulatory type 1-like CD4(+) T cells, with antigen-specific interleukin (IL)-10 production. Here, by using semi-allogeneic transplantation models in vivo, we investigated the role of IL-10 in the induction and activation of these Tregs, and the possibility of bystander suppression of third-party allograft rejection. Naïve mice (H-2(b)) were immunized with alloantigen (H-2(b/d)), and received UV-B irradiation (40 kJ/m(2)) 1 week later. Four weeks afterwards, splenic CD4(+) T cells were purified from the UV-irradiated immunized mice, and were transferred into naïve mice (H-2(b)). Allografts expressing the same alloantigen as T-cell donors were immunized against (H-2(b/d)) or an irrelevant alloantigen (H-2(b/k)) were transplanted to CD4(+) T-cell-transferred mice, and an alloantigen-specific prolongation of allograft survival observed. Experiments where IL-10 was neutralized by monoclonal antibody in the induction or effector phase revealed that IL-10 is critical, not only for induction but also for immunosuppressive function of CD4(+) Tregs induced by UV irradiation after alloantigen immunization. Third-party allografts (H-2(d/k)) were transplanted to CD4(+) T-cell-transferred mice, and graft survival was also prolonged. Even a graft only partially compatible with immunized alloantigen worked well in vivo to activate CD4(+) Tregs induced by UV irradiation after alloantigen immunization, which resulted in the bystander suppression of third-party allograft rejection. Copyright © 2015 Elsevier B.V. All rights reserved.

  8. Strengthening Regulatory Competence in Pakistan

    International Nuclear Information System (INIS)

    Sadiq, M.

    2016-01-01

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

  9. Assessing the Land Subsidence Governance in Ningbo City: By a Close Study of the Building Collapse at the Strictly Protected Land Subsidence Area

    Science.gov (United States)

    Yu, Xia

    2016-04-01

    Ningbo is a coastal city in East China, its land subsidence problem was noticed in the 1960s. However, scientific management was insufficient at that time, so with the fast city development from the 1980s, groundwater was used by a large amount of small factories, and tall buildings were built on the land. It was in 2008, scientists predicted that if without doing anything to prevent the land from subsiding, the city will be covered by the East Sea in 2030. From then on, the local government implied several policies, such as shut down most of the groundwater pumping wells, set up a new authority to enhance the cooperation among different administration departments, and also set up a land subsidence monitoring center for the city. Recently, it is declared that a Stereo regulatory system of land subsidence governance has been achieved. However, in 2012, a 23-years old building in the city center collapsed. According to the City Planning 2009, this building is located just in the strictly protected land subsidence area. The experts, however, think that land subsidence is not the main reason, since there are many illegal changes to the building during the past 23 years. The aim of my research is to assess the land subsidence governance in Ningbo city. I studied the collapsed building, how it was built, what has changed after building, how the environment changed in this area, and how this area became the strictly protected land subsidence area, and what kind of protections have been made. Actually, during the case study I discuss the land subsidence governance design of Ningbo, and to see what practices and lessons we can learn from this case.

  10. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

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

  11. 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)

  12. REQUIREMENTS FOR STORAGE AND TRANSPORT OF BIOTECHNOLOGICAL MEDICAL PRODUCTS IN ACCORDANCE WITH THE REGULATORY FRAMEWORK OF MINISTRY OF PUBLIC HEALTH OF UKRAINE AND DETECTION OF VIOLATIONS IN THE MEDICAL AND PHARMACEUTICAL INSTITUTIONS

    Directory of Open Access Journals (Sweden)

    Shukaeva O.

    2015-05-01

    Full Text Available Introduction. The rapid development of the pharmaceutical industry and the expansion of the range of biotech drugs require special conditions to ensure the quality, storage and transport through out the entire chain: manufacturer - distributor - pharmacy - hospital - the patient.We analyzed the current legislative frame work of Ministry of Public Health of Ukraine and conducted a study to identify and analyze of typical violations in the medical and pharmaceutical institutions. The aim of the investigation was to investigate and analyze inspection acts under storage and transport of biological medical products and identify major violations during the performance requirements for storage and transportation of drugs, level of awareness about medical products which are requiring special storage requirement. Methods: systemic, logistical, structural, marketing, regulatory. Results & discussion. According to the data presented in the report «Assessing biosimilar uptake and competition in European markets» of «IMS Health», sales of medical products with biological nature - biological medicinal products and biosymilyars is about 27% of total sales of drugs in the EU. This segment of the pharmaceutical market is characterized by faster growth compared to the pharmaceutical marketas a whole. Thus, in 2012-2013 years sales of biological medical products in the EU countries increased by 5.5% compared to 1.5% increase in total sales of drugs. It is important that in Europe, according to the 2013 preparations, the market share in value terms, with eight to prepare biological products, the term of patent protection that are either already expired or will expireby 2020, and therefore they can be competitors with biosymilars. In creasing the number of medications on the market requires a careful approach of storing and preserving the quality of distribution during throughout the life of the medical products in the chain: manufacturer - distributor

  13. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, Final report

    International Nuclear Information System (INIS)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1988), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the '978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ''green field'' condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities

  14. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  15. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N. [Pacific Northwest Lab., Richland, WA (United States)

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1988), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the {prime}978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  16. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    International Nuclear Information System (INIS)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ''green field'' condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities

  17. Regulatory and Safety Requirements for Food Cultures.

    Science.gov (United States)

    Laulund, Svend; Wind, Anette; Derkx, Patrick M F; Zuliani, Véronique

    2017-05-23

    The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product.

  18. Regulatory and Safety Requirements for Food Cultures

    Directory of Open Access Journals (Sweden)

    Svend Laulund

    2017-05-01

    Full Text Available The increased use of food cultures to ferment perishable raw materials has potentiated the need for regulations to assess and assure the safety of food cultures and their uses. These regulations differ from country to country, all aimed at assuring the safe use of food cultures which has to be guaranteed by the food culture supplier. Here we highlight national differences in regulations and review a list of methods and methodologies to assess the safety of food cultures at strain level, at production, and in the final product.

  19. Immediate effect of instrumentation on the subgingival microflora in deep inflamed pockets under strict plaque control.

    Science.gov (United States)

    Rhemrev, G E; Timmerman, M F; Veldkamp, I; Van Winkelhoff, A J; Van der Velden, U

    2006-01-01

    To investigate (1) reduction in the number of microorganisms obtained directly after subgingival instrumentation, (2) rate of bacterial re-colonization during 2 weeks, under supragingival plaque-free conditions. Effects of subgingival instrumentation were measured at one deep pocket in 22 patients (11 smokers and 11 non-smokers). Immediately after initial therapy, experimental sites, under strict plaque control, were instrumented subgingivally. Microbiological evaluation was performed at pre-instrumentation, immediate post-instrumentation and 1 and 2 weeks post-instrumentation. Mean total anaerobic colony forming units (CFUs) dropped from 3.9 x 10(6) before to 0.09 x 10(6) immediately following instrumentation. Significant reductions were found for Tannerella forsythia, Micromonas micros, Fusobacterium nucleatum and spirochetes. Significant reductions were not observed for Actinobacillus actinomycetemcomitans, Porphyromonas gingivalis, Prevotella intermedia and Campylobacter rectus. Except for spirochetes, no reduction in prevalence of specific periodontal bacteria was found immediately after instrumentation. During follow-up, mean total CFU tended to increase. Prevalence of periodontal bacteria further reduced. No effect of smoking was found. Results indicate that subgingival mechanical cleaning in itself, has a limited effect, in actually removing bacteria. The subsequent reduction in prevalence of specific periodontal bacteria shows that it is apparently difficult for these species to survive in treated pockets.

  20. Magnetic resonance imaging quantitation of changes in muscle volume during 7 days of strict bed rest.

    Science.gov (United States)

    Ferrando, A A; Stuart, C A; Brunder, D G; Hillman, G R

    1995-10-01

    Prolonged bed rest results in a loss of leg lean body mass. Previous studies using bed rest as a model for microgravity have shown decreases in leg mass after 12 and 14 d, 5 and 17 wk. As magnetic resonance imaging (MRI) can provide a precise and non-invasive means of determining muscle volume, we sought to determine if changes in leg muscle volume could be detected in bed rest periods as short as 7 d. Five young, healthy, male volunteers were subjected to 7 d of absolute bed rest. Each subject underwent MRI quantitation of segmental muscle volumes of the calves and thighs before and after bed rest. Eleven (calf) and nine (thigh) contiguous 1-cm thick transaxial images were generated over prescribed regions using a Technicare MRI imager with a 0.6T superconducting magnet and body coil. Image processing was performed using a generalized 8-bit medical image analysis package developed at University of Texas Medical Branch. Images were analyzed for muscle and non-muscle volumes (including fat, blood vessel, and bone marrow volumes). The MRI quantitation demonstrated bed rest-induced significant decreases in segmental thigh muscle (approximately 3.0%, p image analysis of MRI images provides a sensitive tool capable of detecting leg volume changes of as little as 3.0% over a 7-d period of strict bed rest.

  1. Managing curriculum transformation within strict university governance structures: an example from Damascus University Medical School.

    Science.gov (United States)

    Kayyal, Mohammad; Gibbs, Trevor

    2012-01-01

    As the world of medical education moves forward, it becomes increasingly clear that the transformative process is not as easy a process for all. Across the globe, there appears to be many barriers that obstruct or threaten innovation and change, most of which cause almost insurmountable problems to many schools. If transformative education is to result in an equitable raising of standards across such an unlevel playing field, schools have to find ways in overcoming these barriers. One seemingly common barrier to development occurs when medical schools are trapped within strict University governance structures; rules and regulations which are frequently inappropriate and obstructive to the transformation that must occur in today's medical educational paradigm. The Faculty of Medicine at Damascus University, one of the oldest and foremost medical schools in the Middle East, is one such school where rigid rules and regulations and traditional values are obstructing transformative change. This paper describes the problems, which the authors believe to be common to many, and explores how attempts have been made to overcome them and move the school into the twenty-first century. It is the ultimate purpose of this paper to raise awareness of the issue, share the lessons learned in order to assist others who are experiencing similar problems and possibly create opportunities for dialogue between schools.

  2. On a holomorphic Lefschetz formula in strictly pseudoconvex subdomains of complex manifolds

    International Nuclear Information System (INIS)

    Kytmanov, A M; Myslivets, S G; Tarkhanov, N N

    2004-01-01

    The classical Lefschetz formula expresses the number of fixed points of a continuous map f:M→M in terms of the transformation induced by f on the cohomology of M. In 1966, Atiyah and Bott extended this formula to elliptic complexes over a compact closed manifold. In particular, they obtained a holomorphic Lefschetz formula on compact complex manifolds without boundary. Brenner and Shubin (1981, 1991) extended the Atiyah-Bott theory to compact manifolds with boundary. On compact complex manifolds with boundary the Dolbeault complex is not elliptic, therefore the Atiyah-Bott theory is not applicable. Bypassing difficulties related to the boundary behaviour of Dolbeault cohomology, Donnelly and Fefferman (1986) obtained a formula for the number of fixed points in terms of the Bergman metric. The aim of this paper is to obtain a Lefschetz formula on relatively compact strictly pseudoconvex subdomains of complex manifolds X with smooth boundary, that is, to find the total Lefschetz number for a holomorphic endomorphism f * of the Dolbeault complex and to express it in terms of local invariants of the fixed points of f.

  3. Divergent changes in serum sterols during a strict uncooked vegan diet in patients with rheumatoid arthritis.

    Science.gov (United States)

    Agren, J J; Tvrzicka, E; Nenonen, M T; Helve, T; Hänninen, O

    2001-02-01

    The effects of a strict uncooked vegan diet on serum lipid and sterol concentrations were studied in patients with rheumatoid arthritis. The subjects were randomized into a vegan diet group (n 16), who consumed a vegan diet for 2-3 months, or into a control group (n 13), who continued their usual omnivorous diets. Serum total and LDL-cholesterol and -phospholipid concentrations were significantly decreased by the vegan diet. The levels of serum cholestanol and lathosterol also decreased, but serum cholestanol:total cholesterol and lathosterol:total cholesterol did not change. The effect of a vegan diet on serum plant sterols was divergent as the concentration of campesterol decreased while that of sitosterol increased. This effect resulted in a significantly greater sitosterol:campesterol value in the vegan diet group than in the control group (1.48 (SD 0.39) v. 0.72 (SD 0.14); P vegan diet changes the relative absorption rates of these sterols and/or their biliary clearance.

  4. Model-Based Adaptive Event-Triggered Control of Strict-Feedback Nonlinear Systems.

    Science.gov (United States)

    Li, Yuan-Xin; Yang, Guang-Hong

    2018-04-01

    This paper is concerned with the adaptive event-triggered control problem of nonlinear continuous-time systems in strict-feedback form. By using the event-sampled neural network (NN) to approximate the unknown nonlinear function, an adaptive model and an associated event-triggered controller are designed by exploiting the backstepping method. In the proposed method, the feedback signals and the NN weights are aperiodically updated only when the event-triggered condition is violated. A positive lower bound on the minimum intersample time is guaranteed to avoid accumulation point. The closed-loop stability of the resulting nonlinear impulsive dynamical system is rigorously proved via Lyapunov analysis under an adaptive event sampling condition. In comparing with the traditional adaptive backstepping design with a fixed sample period, the event-triggered method samples the state and updates the NN weights only when it is necessary. Therefore, the number of transmissions can be significantly reduced. Finally, two simulation examples are presented to show the effectiveness of the proposed control method.

  5. DNA remodelling by Strict Partial Endoreplication in orchids, an original process in the plant kingdom.

    Science.gov (United States)

    Brown, Spencer C; Bourge, Mickaël; Maunoury, Nicolas; Wong, Maurice; Bianchi, Michele Wolfe; Lepers-Andrzejewski, Sandra; Besse, Pascale; Siljak-Yakovlev, Sonja; Dron, Michel; Satiat-Jeunemaître, Béatrice

    2017-04-13

    DNA remodelling during endoreplication appears to be a strong developmental characteristic in orchids. In this study, we analysed DNA content and nuclei in 41 species of orchids to further map the genome evolution in this plant family. We demonstrate that the DNA remodelling observed in 36 out of 41 orchids studied corresponds to strict partial endoreplication. Such process is developmentally regulated in each wild species studied. Cytometry data analyses allowed us to propose a model where nuclear states 2C, 4E, 8E, etc. form a series comprising a fixed proportion, the euploid genome 2C, plus 2 to 32 additional copies of a complementary part of the genome. The fixed proportion ranged from 89% of the genome in Vanilla mexicana down to 19% in V. pompona, the lowest value for all 148 orchids reported. Insterspecific hybridisation did not suppress this phenomenon. Interestingly, this process was not observed in mass-produced epiphytes. Nucleolar volumes grow with the number of endocopies present, coherent with high transcription activity in endoreplicated nuclei. Our analyses suggest species-specific chromatin rearrangement. Towards understanding endoreplication, V. planifolia constitutes a tractable system for isolating the genomic sequences that confer an advantage via endoreplication from those that apparently suffice at diploid level. © The Author(s) 2017. Published by Oxford University Press on behalf of the Society for Molecular Biology and Evolution.

  6. Clinical impact of strict criteria for selectivity and lateralization in adrenal vein sampling.

    Science.gov (United States)

    Gasparetto, Alessandro; Angle, John F; Darvishi, Pasha; Freeman, Colbey W; Norby, Ray G; Carey, Robert M

    2015-04-01

    Selectivity index (SI) and lateralization index (LI) thresholds determine the adequacy of adrenal vein sampling (AVS) and the degree of lateralization. The purpose of this study was investigate the clinical outcome of patients whose adrenal vein sampling was interpreted using "strict criteria" (SC) (SIpre-stimuli≥3, SIpost-stimuli≥5 and LIpre-stimuli≥4, LIpost-stimuli≥4). A retrospective review of 73 consecutive AVS procedures was performed and 67 were technically successful. Forty-three patients showed lateralization and underwent surgery, while 24 did not lateralize and were managed conservatively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), kalemia (K(+)), and the change in number of blood pressure (BP) medications were recorded for each patient before and after AVS and potential surgery were performed. In the surgery group, BP and K(+) changed respectively from 160±5.3/100±2.0 mmHg to 127±3.3/80±1.9 (p blood pressure medications were six (14.0%) in the lateralized group and 22 (91.7%) in the non-lateralized group (p <0.001). AVS interpretation with SC leads to significant clinical improvement in both patients who underwent surgery and those managed conservatively.

  7. Generalized mechanical pain sensitivity over nerve tissues in patients with strictly unilateral migraine.

    Science.gov (United States)

    Fernández-de-las-Peñas, César; Arendt-Nielsen, Lars; Cuadrado, María Luz; Pareja, Juan A

    2009-06-01

    No study has previously analyzed pressure pain sensitivity of nerve trunks in migraine. This study aimed to examine the differences in mechanical pain sensitivity over specific nerves between patients with unilateral migraine and healthy controls. Blinded investigators assessed pressure pain thresholds (PPT) over the supra-orbital nerves (V1) and peripheral nerve trunks of both upper extremities (median, radial, and ulnar nerves) in 20 patients with strictly unilateral migraine and 20 healthy matched controls. Pain intensity after palpation over both supra-orbital nerves was also assessed. A pressure algometer was used to quantify PPT, whereas a 10-point numerical pain rate scale was used to evaluate pain to palpation over the supra-orbital nerve. The analysis of covariance revealed that pain to palpation over the supra-orbital nerve was significantly higher (P0.6). In patients with unilateral migraine, we found increased mechano-sensitivity of the supra-orbital nerve on the symptomatic side of the head. Outside the head, the same patients showed increased mechano-sensitivity of the main peripheral nerves of both upper limbs, without asymmetries. Such diffuse hypersensitivity of the peripheral nerves lends further evidence to the presence of a state of hyperexcitability of the central nervous system in patients with unilateral migraine.

  8. 77 FR 63763 - Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and...

    Science.gov (United States)

    2012-10-17

    ... 324 RIN 3064-AD96 Regulatory Capital Rules: Standardized Approach for Risk-Weighted Assets; Market Discipline and Disclosure Requirements; Initial Regulatory Flexibility Analysis AGENCY: Federal Deposit Insurance Corporation. ACTION: Initial regulatory flexibility analysis. SUMMARY: On August 30, 2012, the...

  9. USI A-43 regulatory analysis. Revision 1

    International Nuclear Information System (INIS)

    1985-10-01

    This report consists of: (1) the regulatory analysis for Unresolved Safety Issue (USI) A-43, ''Containment Emergency Sump Performance''; (2) the proposed resolution; (3) a summary of public comments received and action taken; (4) the Committee to Review Generic Requirements (CRGR) minutes related to this USI; and (5) appendices that summarize assumptions, calculational methods, consequence analyses, and cost estimates used in this regulatory analysis

  10. Environment, safety, and health regulatory implementation plan

    Energy Technology Data Exchange (ETDEWEB)

    1993-10-21

    To identify, document, and maintain the Uranium Mill Tailings Remedial Action (UMTRA) Project`s environment, safety, and health (ES&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&H regulatory requirements, analyze applicability to the UMTRA Project, and evaluate UMTRA Project compliance status.

  11. 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

  12. Government Regulatory

    Science.gov (United States)

    Becker, Katie

    Government regulation of food products, food processing, and food preparation is imperative in bringing an unadulterated, nonmisleading, and safe food product to market and is relevant to all areas of food science, including engineering, processing, chemistry, and microbiology. The liability associated with providing consumers with an adulterated or substandard product cannot only tarnish a company's name and reputation, but also impose substantial financial repercussions on the company and those individuals who play an active role in the violation. In order for a company to fully comply with the relevant food laws (both federal and state), an intimate knowledge of food science is required. Individuals knowledgeable in food science play an integral role not only in implementing and counseling food companies/processors to ensure compliance with government regulations, but these individuals are also necessary to the state and federal governments that make and enforce the relevant laws and regulators.

  13. Strict Host-Symbiont Cospeciation and Reductive Genome Evolution in Insect Gut Bacteria

    Science.gov (United States)

    Hosokawa, Takahiro; Kikuchi, Yoshitomo; Nikoh, Naruo; Shimada, Masakazu; Fukatsu, Takema

    2006-01-01

    Host-symbiont cospeciation and reductive genome evolution have been identified in obligate endocellular insect symbionts, but no such example has been identified from extracellular ones. Here we first report such a case in stinkbugs of the family Plataspidae, wherein a specific gut bacterium is vertically transmitted via “symbiont capsule.” In all of the plataspid species, females produced symbiont capsules upon oviposition and their gut exhibited specialized traits for capsule production. Phylogenetic analysis showed that the plataspid symbionts constituted a distinct group in the γ-Proteobacteria, whose sister group was the aphid obligate endocellular symbionts Buchnera. Removal of the symbionts resulted in retarded growth, mortality, and sterility of the insects. The host phylogeny perfectly agreed with the symbiont phylogeny, indicating strict host-symbiont cospeciation despite the extracellular association. The symbionts exhibited AT-biased nucleotide composition, accelerated molecular evolution, and reduced genome size, as has been observed in obligate endocellular insect symbionts. These findings suggest that not the endocellular conditions themselves but the population genetic attributes of the vertically transmitted symbionts are probably responsible for the peculiar genetic traits of these insect symbionts. We proposed the designation “Candidatus Ishikawaella capsulata” for the plataspid symbionts. The plataspid stinkbugs, wherein the host-symbiont associations can be easily manipulated, provide a novel system that enables experimental approaches to previously untouched aspects of the insect-microbe mutualism. Furthermore, comparative analyses of the sister groups, the endocellular Buchnera and the extracellular Ishikawaella, would lead to insights into how the different symbiotic lifestyles have affected their genomic evolution. PMID:17032065

  14. A study of bacterial gene regulatory mechanisms

    DEFF Research Database (Denmark)

    Hansen, Sabine

    the different regulatory mechanisms affect system dynamics. We have designed a synthetic gene regulatory network (GRN) in bacterial cells that enables us to study the dynamics of GRNs. The results presented in this PhD thesis show that model equations based on the established mechanisms of action of each...... of a particular type of regulatory mechanism. The synthetic system presented in this thesis is, to our knowledge, the first of its kind to allow a direct comparison of the dynamic behaviors of gene regulatory networks that employ different mechanisms of regulation. In addition to studying the dynamic behavior...... switch off the expression of unfavorable proteins. This dynamic regulation requires a coordinated effort by a network of regulatory factors. The regulatory mechanisms employed by bacterial cell to regulate their protein expression have been extensively studied. However, little is known about how...

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

    Science.gov (United States)

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

    2017-03-01

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

  16. Analyses des discours non strictement mathematiques accompagnant des cours de mathematiques (Analysis of Not Strictly Mathematical Discourse in Mathematics Classes).

    Science.gov (United States)

    Robert, Aline

    1995-01-01

    Examines discourse, not strictly mathematical, that teachers might adopt in a mathematics class and presents three major functions of such discourse: communication; structuring and labeling; and reflection. Develops lines for further inquiry, notably on the third function, the most likely focus for specific preparation by the teacher. (13…

  17. Properties of N-person axiomatic bargaining solutions if the Pareto frontier is twice differentiable and strictly concave

    NARCIS (Netherlands)

    Douven, R.C.M.H.; Engwerda, J.C.

    1995-01-01

    In this paper we discuss properties of N-person axiomatic bargaining problems, where the Pareto frontier of S can be described by a strictly concave and twice differentiable function. These type of problems are characteristic for the empirical policy coordination literature. In that literature the

  18. Convergence of Implicit and Explicit Schemes for an Asymptotically Nonexpansive Mapping in -Uniformly Smooth and Strictly Convex Banach Spaces

    Directory of Open Access Journals (Sweden)

    Meng Wen

    2012-01-01

    Full Text Available We introduce a new iterative scheme with Meir-Keeler contractions for an asymptotically nonexpansive mapping in -uniformly smooth and strictly convex Banach spaces. We also proved the strong convergence theorems of implicit and explicit schemes. The results obtained in this paper extend and improve many recent ones announced by many others.

  19. Strict Fathers, Competing Culture(s), and Racialized Poverty: White South African Teachers' Conceptions of Themselves as Racialized Actors

    Science.gov (United States)

    Casey, Zachary A.

    2016-01-01

    This article focuses in particular on four white South African female practicing P-12 teachers' narratives about their own racialized understanding of their classroom practice(s) and their (racio-cultural) self-identity. Each of the four participants reported growing up with what they described as "strict fathers" and shared ways in…

  20. 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)

  1. Compliance. Regulatory policy P-211

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    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)

  2. The US uranium industry: Regulatory and policy impediments

    International Nuclear Information System (INIS)

    Drennen, T.E.; Glicken, J.

    1995-06-01

    The Energy Policy Act of 1992 required the DOE to develop recommendations and implement government programs to assist the domestic uranium industry in increasing export opportunities. In 1993, as part of that effort, the Office of Nuclear Energy identified several key factors that could (or have) significantly impact(ed) export opportunities for domestic uranium. This report addresses one of these factors: regulatory and policy impediments to the flow of uranium products between the US and other countries. It speaks primarily to the uranium market for civil nuclear power. Changes in the world political and economic order have changed US national security requirements, and the US uranium industry has found itself without the protected market it once enjoyed. An unlevel playing field for US uranium producers has resulted from a combination of geology, history, and a general US political philosophy of nonintervention that precludes the type of industrial policy practiced in other uranium-exporting countries. The US has also been hampered in its efforts to support the domestic uranium-producing industry by its own commitment to free and open global markets and by international agreements such as GATT and NAFTA. Several US policies, including the imposition of NRC fees and licensing costs and Harbor Maintenance fees, directly harm the competitiveness of the domestic uranium industry. Finally, requirements under US law, such as those in the 1979 Nuclear Nonproliferation Act, place very strict limits on the use of US-origin uranium, limitations not imposed by other uranium-producing countries. Export promotion and coordination are two areas in which the US can help the domestic uranium industry without violating existing trade agreements or other legal or policy constraints

  3. The US uranium industry: Regulatory and policy impediments

    Energy Technology Data Exchange (ETDEWEB)

    Drennen, T.E.; Glicken, J.

    1995-06-01

    The Energy Policy Act of 1992 required the DOE to develop recommendations and implement government programs to assist the domestic uranium industry in increasing export opportunities. In 1993, as part of that effort, the Office of Nuclear Energy identified several key factors that could (or have) significantly impact(ed) export opportunities for domestic uranium. This report addresses one of these factors: regulatory and policy impediments to the flow of uranium products between the US and other countries. It speaks primarily to the uranium market for civil nuclear power. Changes in the world political and economic order have changed US national security requirements, and the US uranium industry has found itself without the protected market it once enjoyed. An unlevel playing field for US uranium producers has resulted from a combination of geology, history, and a general US political philosophy of nonintervention that precludes the type of industrial policy practiced in other uranium-exporting countries. The US has also been hampered in its efforts to support the domestic uranium-producing industry by its own commitment to free and open global markets and by international agreements such as GATT and NAFTA. Several US policies, including the imposition of NRC fees and licensing costs and Harbor Maintenance fees, directly harm the competitiveness of the domestic uranium industry. Finally, requirements under US law, such as those in the 1979 Nuclear Nonproliferation Act, place very strict limits on the use of US-origin uranium, limitations not imposed by other uranium-producing countries. Export promotion and coordination are two areas in which the US can help the domestic uranium industry without violating existing trade agreements or other legal or policy constraints.

  4. Nuclear Regulatory Commission: more aggressive leadership needed

    International Nuclear Information System (INIS)

    Staats, E.B.

    1980-01-01

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

  5. Regulatory actions post - Fukushima

    International Nuclear Information System (INIS)

    Ciurea Ercau, C.

    2013-01-01

    The paper presents the results of the safety reviews performed in Romania after the Fukushima accident and the resulting actions for improving the safety. The actions taken by the National Commission for Nuclear Activities Control (CNCAN) to improve the regulatory framework include the development of new regulations and the enhancement of inspection practices, taking account of the lessons learned from the Fukushima accident. A regulation on the response to transients, accidents and emergency situations at nuclear power plants has been developed, which includes requirements on transient and accident scenarios that have to be covered by the Emergency Operating Procedures (EOPs), accident scenarios to be covered by the Severe Accident Management Guidelines (SAMGs), emergency situations to be covered by the on-site emergency response plan and emergency response procedures. (authors)

  6. 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)

  7. Regulatory perspectives of concept assessment

    International Nuclear Information System (INIS)

    Flavelle, Peter A.

    1987-09-01

    The Atomic Energy Control Board is the head agency for the regulatory review of the Assessment of the Canadian Concept for Nuclear Fuel Waste Disposal being done by Atomic Energy of Canada Limited and Ontario Hydro. This paper describes the regulatory perspective of how the Concept Assessment could demonstrate the feasibility of a disposal conforming to regulatory requirements. The long-term aspects of Concept Assessment encourage the use of various predictive techniques for different time scales. Each technique will have a different potential for establishing confidence in the predictions. The predicted performance of a facility during operation should have a very high confidence, as it can be based on standard engineering calculations and the predictions can be validated later by monitoring during operation. The predictions of the transient period following closure of the facility should achieve a medium level of confidence, since they can be based on extrapolations of predictions of operational performance, using models that can be calibrated with monitoring data and with averaged input data derived from natural analog studies. Predictions based on fundamental processes will have a medium level of confidence when made to intermediate times after closure. Long-term predictions using generic or typical input data or Monte Carlo calculations of simplified models will have the least confidence and yet they can still contribute to the confidence that the disposal concept will conform to regulatory requirements

  8. Identité stricte ou partielle et identification dans les phrases à copule. Comment les identifier ?

    Directory of Open Access Journals (Sweden)

    Amary-Coudreau Valérie

    2014-07-01

    éristiques propres à l’identité, ainsi que celles propres à la spécification et à l’identification, pour lesquelles X et Y ont des degrés de référentialité et/ou de prédicativité différents. Enfin, cette hypothèse nous amène à distinguer l’identité de l’identification, sur la base de tests qui, à l’inverse de Larreya (2003, différencient l’identité stricte de l’identité partielle.

  9. The Strictly Conserved Arg-321 Residue in the Active Site of Escherichia coli Topoisomerase I Plays a Critical Role in DNA Rejoining*

    Science.gov (United States)

    Narula, Gagandeep; Annamalai, Thirunavukkarasu; Aedo, Sandra; Cheng, Bokun; Sorokin, Elena; Wong, Agnes; Tse-Dinh, Yuk-Ching

    2011-01-01

    The strictly conserved arginine residue proximal to the active site tyrosine of type IA topoisomerases is required for the relaxation of supercoiled DNA and was hypothesized to be required for positioning of the scissile phosphate for DNA cleavage to take place. Mutants of recombinant Yersinia pestis topoisomerase I with hydrophobic substitutions at this position were found in genetic screening to exhibit a dominant lethal phenotype, resulting in drastic loss in Escherichia coli viability when overexpressed. In depth biochemical analysis of E. coli topoisomerase I with the corresponding Arg-321 mutation showed that DNA cleavage can still take place in the absence of this arginine function if Mg2+ is present to enhance the interaction of the enzyme with the scissile phosphate. However, DNA rejoining is inhibited in the absence of this conserved arginine, resulting in accumulation of the cleaved covalent intermediate and loss of relaxation activity. These new experimental results demonstrate that catalysis of DNA rejoining by type IA topoisomerases has a more stringent requirement than DNA cleavage. In addition to the divalent metal ions, the side chain of this arginine residue is required for the precise positioning of the phosphotyrosine linkage for nucleophilic attack by the 3′-OH end to result in DNA rejoining. Small molecules that can interfere or distort the enzyme-DNA interactions required for DNA rejoining by bacterial type IA topoisomerases could be developed into novel antibacterial drugs. PMID:21478161

  10. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-06-15

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

  11. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2003-06-15

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

  12. Regulatory analysis technical evaluation handbook. Final report

    International Nuclear Information System (INIS)

    1997-01-01

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

  13. Regulatory analysis technical evaluation handbook. Final report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-01-01

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

  14. 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.

  15. Strict liability as a legal mechanism protecting the aggrieved parties' interests within the nuclear liability regime

    International Nuclear Information System (INIS)

    Novotna, Marianna

    2016-01-01

    The no-fault liability principle of nuclear liability regime, its compensation schemes, sociological and legal grounds of its construction as well as liberation grounds are analysed. The simple existence of causation of damage and nuclear accident without necessity of proving negligence or any other type of fault on the part of the operator as an adequate basis for the operator’s strict liability is highlighted thus simplifying the litigation process eliminating potential obstacles, especially such as might exist with the burden of proof. The question of weighing the interests of society in the development of nuclear industry, the necessary extent of protection of victims of nuclear accidents and the interests of operators of nuclear facilities as main determinants of the strict nature of nuclear liability is also described. (orig.)

  16. Virtual private networks application in Nuclear Regulatory Authority of Argentina

    International Nuclear Information System (INIS)

    Glidewell, Donnie D.; Smartt, Heidi A.; Caskey, Susan A.; Bonino, Anibal D.; Perez, Adrian C.; Pardo, German R.; Vigile, Rodolfo S.; Krimer, Mario

    2004-01-01

    As the result of the existence of several regional delegations all over the country, a requirement was made to conform a secure data interchange structure. This would make possible the interconnection of these facilities and their communication with the Autoridad Regulatoria Nuclear (ARN) headquarters. The records these parts exchange are often of classified nature, including sensitive data by the local safeguards inspectors. On the other hand, the establishment of this network should simplify the access of authorized nuclear and radioactive materials users to the ARN databases, from remote sites and with significant trust levels. These requirements called for a network that should be not only private but also secure, providing data centralization and integrity assurance with a strict user control. The first proposal was to implement a point to point link between the installations. This proposal was deemed as economically not viable, and it had the disadvantage of not being easily reconfigurable. The availability of new technologies, and the accomplishment of the Action Sheet 11 under an agreement between Argentine Nuclear Regulatory Authority and the United States Department of Energy (DOE), opened a new path towards the resolution of this problem. By application of updated tunneling security protocols it was possible to project a manageable and secure network through the use of Virtual Private Networking (VPN) hardware. A first trial installation of this technology was implemented between ARN headquarters at Buenos Aires and the Southern Region Office at Bariloche, Argentina. This private net is at the moment under test, and it is planned to expand to more sites in this country, reaching for example to nuclear power plants. The Bariloche installation had some interesting peculiarities. The solutions proposed to them revealed to be very useful during the development of the network expansion plans, as they showed how to adapt the VPN technical requisites to the

  17. Principles of regulatory policy design

    OpenAIRE

    Sappington, David E.M.; DEC

    1994-01-01

    The author contrasts command-and-control regulation (tight control of water purification, for example) with more flexible forms, including incentive regulation (such as price cap regulation), potential regulation (providing for closer scrutiny if enough customers complain), and reactive rather than proactive policies (the firm proposing actions, the regulatory saying yes or no). He contrasts informing regulation (for example, requiring that consumers be informed about ingredients in a product...

  18. The impact of Sleep Time-Related Information and Communication Technology (STRICT) on sleep patterns and daytime functioning in American adolescents.

    Science.gov (United States)

    Polos, Peter G; Bhat, Sushanth; Gupta, Divya; O'Malley, Richard J; DeBari, Vincent A; Upadhyay, Hinesh; Chaudhry, Saqib; Nimma, Anitha; Pinto-Zipp, Genevieve; Chokroverty, Sudhansu

    2015-10-01

    This cross-sectional study explored the extent and impact of mobile device-based Sleep Time-Related Information and Communication Technology (STRICT) use among American adolescents (N = 3139, 49.3% female, mean age = 13.3 years). Nearly 62% used STRICT after bedtime, 56.7% texted/tweeted/messaged in bed, and 20.8% awoke to texts. STRICT use was associated with insomnia, daytime sleepiness, eveningness, academic underperformance, later bedtimes and shorter sleep duration. Moderation analysis demonstrated that the association between STRICT use and insomnia increased with age, the association between STRICT use and daytime sleepiness decreased with age, and the association between STRICT use and shorter sleep duration decreased with age and was stronger in girls. Insomnia and daytime sleepiness partially mediated the relationship between STRICT use and academic underperformance. Our results illustrate the adverse interactions between adolescent STRICT use and sleep, with deleterious effects on daytime functioning. These worrisome findings suggest that placing reasonable limitations on adolescent STRICT use may be appropriate. Copyright © 2015 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

  19. Regulation No. 56/2006 Coll. of the Nuclear Regulatory Authority of the Slovak Republic dated as of January 12, 2006 on details concerning requirements for quality system documentation of authorisation holder, as well as details concerning quality requirements for nuclear installations, details concerning quality requirements for classified equipment and details concerning the scope of their approval

    International Nuclear Information System (INIS)

    2006-01-01

    This Regulation provides details of the requirements for quality system documentation holder, details of the quality requirements for nuclear installations, details concerning quality requirements for classified equipment and details of the scope of their approval. This Regulation came into force on March 1, 2006.

  20. Strict versus liberal target range for perioperative glucose in patients undergoing coronary artery bypass grafting: a prospective randomized controlled trial.

    Science.gov (United States)

    Desai, Shalin P; Henry, Linda L; Holmes, Sari D; Hunt, Sharon L; Martin, Chidima T; Hebsur, Shrinivas; Ad, Niv

    2012-02-01

    The purpose of this study was to test the hypothesis that a liberal blood glucose strategy (121-180 mg/dL) is not inferior to a strict blood glucose strategy (90-120 mg/dL) for outcomes in patients after first-time isolated coronary artery bypass grafting and is superior for glucose control and target blood glucose management. A total of 189 patients undergoing coronary artery bypass grafting were investigated in this prospective randomized study to compare 2 glucose control strategies on patient perioperative outcomes. Three methods of analyses (intention to treat, completer, and per protocol) were conducted. Observed power was robust (>80%) for significant results. The groups were similar on preoperative hemoglobin A(1c) and number of diabetic patients. The liberal group was found to be noninferior to the strict group for perioperative complications and superior on glucose control and target range management. The liberal group had significantly fewer patients with hypoglycemic events (liberal range after coronary artery bypass grafting led to similar outcomes compared with a strict target range and was superior in glucose control and target range management. On the basis of the results of this study, a target blood glucose range of 121 to 180 mg/dL is recommended for patients after coronary artery bypass grafting as advocated by the Society of Thoracic Surgeons. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  1. Regulatory considerations for biosimilars

    Directory of Open Access Journals (Sweden)

    Ranjani Nellore

    2010-01-01

    Full Text Available Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  2. Genomics in the land of regulatory science.

    Science.gov (United States)

    Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

    2015-06-01

    Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making. Published by Elsevier Inc.

  3. Regulatory RNAs in Planarians.

    Science.gov (United States)

    Pawlicka, Kamila; Perrigue, Patrick M; Barciszewski, Jan

    2016-01-01

    The full scope of regulatory RNA evolution and function in epigenetic processes is still not well understood. The development of planarian flatworms to be used as a simple model organism for research has shown a great potential to address gaps in the knowledge in this field of study. The genomes of planarians encode a wide array of regulatory RNAs that function in gene regulation. Here, we review planarians as a suitable model organism for the identification and function of regulatory RNAs.

  4. Regulatory control of nuclear power plants

    International Nuclear Information System (INIS)

    2002-01-01

    consultants meeting at the end of 2001 by adding updates on the Nuclear Safety Convention and US regulatory practices. The main purpose of the book is to provide written background material to the participants and to support lecturers of the training courses on Regulatory Control of Nuclear Power Plants. The idea is to present general practices recommended by the IAEA in its safety guidance as well as country specific examples of how these general principles and requirements have been implemented in various countries. The examples selected are representative, showing existing and functional practices, and also provide a good selection of different practices adopted by different regulatory organizations. They reflect practices in large and small countries and regulatory bodies. They do not follow any particular regulatory practice but try to offer several alternatives to be useful for many inspectors coming from different types of organizations. The textbook has been compiled from the presentations provided during the training courses on Regulatory Control of Nuclear Power Plants from 1997 to 2001

  5. Mission Risk Reduction Regulatory Change Management

    Science.gov (United States)

    Scroggins, Sharon

    2007-01-01

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

  6. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    Science.gov (United States)

    Galli, Maria Cristina

    2016-01-01

    This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

  7. Regulatory issues in accreditation of toxicology laboratories.

    Science.gov (United States)

    Bissell, Michael G

    2012-09-01

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

  8. 77 FR 8028 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2012-02-13

    ... Compensation and First- Tier Subcontract Awards. 485 FAR Case 2011-004, 9000-AL88 Socioeconomic Program Parity... Analysis Required: Yes. Agency Contact: Karlos Morgan, Procurement Analyst, DOD/GSA/NASA (FAR), 1275 First... Regulatory Flexibility Analysis Required: Yes. Agency Contact: William Clark, Procurement Analyst, DOD/GSA...

  9. 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

  10. Effectiveness of strict vs. multiple use protected areas in reducing tropical forest fires: a global analysis using matching methods.

    Directory of Open Access Journals (Sweden)

    Andrew Nelson

    Full Text Available Protected areas (PAs cover a quarter of the tropical forest estate. Yet there is debate over the effectiveness of PAs in reducing deforestation, especially when local people have rights to use the forest. A key analytic problem is the likely placement of PAs on marginal lands with low pressure for deforestation, biasing comparisons between protected and unprotected areas. Using matching techniques to control for this bias, this paper analyzes the global tropical forest biome using forest fires as a high resolution proxy for deforestation; disaggregates impacts by remoteness, a proxy for deforestation pressure; and compares strictly protected vs. multiple use PAs vs indigenous areas. Fire activity was overlaid on a 1 km map of tropical forest extent in 2000; land use change was inferred for any point experiencing one or more fires. Sampled points in pre-2000 PAs were matched with randomly selected never-protected points in the same country. Matching criteria included distance to road network, distance to major cities, elevation and slope, and rainfall. In Latin America and Asia, strict PAs substantially reduced fire incidence, but multi-use PAs were even more effective. In Latin America, where there is data on indigenous areas, these areas reduce forest fire incidence by 16 percentage points, over two and a half times as much as naïve (unmatched comparison with unprotected areas would suggest. In Africa, more recently established strict PAs appear to be effective, but multi-use tropical forest protected areas yield few sample points, and their impacts are not robustly estimated. These results suggest that forest protection can contribute both to biodiversity conservation and CO2 mitigation goals, with particular relevance to the REDD agenda. Encouragingly, indigenous areas and multi-use protected areas can help to accomplish these goals, suggesting some compatibility between global environmental goals and support for local livelihoods.

  11. Hydroxycinnamic acids used as external acceptors of electrons: an energetic advantage for strictly heterofermentative lactic acid bacteria.

    Science.gov (United States)

    Filannino, Pasquale; Gobbetti, Marco; De Angelis, Maria; Di Cagno, Raffaella

    2014-12-01

    The metabolism of hydroxycinnamic acids by strictly heterofermentative lactic acid bacteria (19 strains) was investigated as a potential alternative energy route. Lactobacillus curvatus PE5 was the most tolerant to hydroxycinnamic acids, followed by strains of Weissella spp., Lactobacillus brevis, Lactobacillus fermentum, and Leuconostoc mesenteroides, for which the MIC values were the same. The highest sensitivity was found for Lactobacillus rossiae strains. During growth in MRS broth, lactic acid bacteria reduced caffeic, p-coumaric, and ferulic acids into dihydrocaffeic, phloretic, and dihydroferulic acids, respectively, or decarboxylated hydroxycinnamic acids into the corresponding vinyl derivatives and then reduced the latter compounds to ethyl compounds. Reductase activities mainly emerged, and the activities of selected strains were further investigated in chemically defined basal medium (CDM) under anaerobic conditions. The end products of carbon metabolism were quantified, as were the levels of intracellular ATP and the NAD(+)/NADH ratio. Electron and carbon balances and theoretical ATP/glucose yields were also estimated. When CDM was supplemented with hydroxycinnamic acids, the synthesis of ethanol decreased and the concentration of acetic acid increased. The levels of these metabolites reflected on the alcohol dehydrogenase and acetate kinase activities. Overall, some biochemical traits distinguished the common metabolism of strictly heterofermentative strains: main reductase activity toward hydroxycinnamic acids, a shift from alcohol dehydrogenase to acetate kinase activities, an increase in the NAD(+)/NADH ratio, and the accumulation of supplementary intracellular ATP. Taken together, the above-described metabolic responses suggest that strictly heterofermentative lactic acid bacteria mainly use hydroxycinnamic acids as external acceptors of electrons. Copyright © 2014, American Society for Microbiology. All Rights Reserved.

  12. REGULATORY T CELLS AND VASECTOMY

    Science.gov (United States)

    Rival, Claudia; Wheeler, Karen; Jeffrey, Sarah; Qiao, Hui; Luu, Brian; Tewalt, Eric F; Engelhard, Victor H; Tardif, Stephen; Hardy, Daniel; del Rio, Roxana; Teuscher, Cory; Tung, Kenneth

    2013-01-01

    CD4+CD25+ regulatory T cells (Tregs) strongly influence the early and late autoimmune responses to meiotic germ cell antigens (MGCA) and the gonadal immunopathology in vasectomized mice. This is supported by the published and recently acquired information presented here. Within 24 hours of unilateral vasectomy (uni-vx) the ipsilateral epididymis undergoes epithelial cell apoptosis followed by necrosis, severe inflammation, and granuloma formation. Unexpectedly, vasectomy alone induced MGCA-specific tolerance. In contrast, uni-vx plus simultaneous Treg depletion resulted in MGCA-specific autoimmune response and bilateral autoimmune orchitis. Both tolerance and autoimmunity were strictly linked to the early epididymal injury. We now discovered that testicular autoimmunity in uni-vx mice did not occur when Treg depletion was delayed by one week. Remarkably, this delayed Treg depletion also prevented tolerance induction. Therefore, tolerance depends on a rapid de novo Treg response to MGCA exposed after vasectomy. Moreover, tolerance was blunted in mice genetically deficient in PD-1 ligand, suggesting the involvement of induced Treg. We conclude that pre-existing natural Treg prevents post-vasectomy autoimmunity, whereas vasectomy-induced Treg maintains post-vasectomy tolerance. We further discovered that vasectomized mice were still resistant to autoimmune orchitis induction for at least 12–16 months; thus, tolerance is long-lasting. Although significant sperm autoantibodies of low titers became detectable in uni-vx mice at seven months, the antibody titers fluctuated over time, suggesting a dynamic “balance” between the autoimmune and tolerance states. Finally, we observed severe epididymal fibrosis and hypo-spermatogenesis at 12 months after uni-vx: findings of highly critical clinical significance. PMID:24080233

  13. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... Departments and Agencies For well over two decades, the Office of Information and Regulatory Affairs (OIRA) at... opportunities and security. While recognizing the expertise and authority of executive branch departments and... as a means of promoting regulatory goals. The fundamental principles and structures governing...

  14. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-10-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  15. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-08-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  16. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1991-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  17. Nuclear Regulatory legislation

    International Nuclear Information System (INIS)

    1984-06-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 97th Congress, 2nd Session, has been prepared by the Office of the Executive Legal Director, U.S. Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document

  18. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-04-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  19. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-01-01

    The NRC Regulatory Agenda is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  20. Scurvy in the present times: vitamin C allergy leading to strict fast food diet.

    Science.gov (United States)

    Shaath, Tarek; Fischer, Ryan; Goeser, Megan; Rajpara, Anand; Aires, Daniel

    2016-01-15

    Scurvy results from a deficiency of vitamin C, a nutrient otherwise known as ascorbic acid. Today, scurvy is rare yet emerges in select patients. The patient reported herein developed scurvy secondary to deliberate avoidance of vitamin C-rich foods. Classic cutaneous manifestations of scurvy include follicular hyperkeratosis and perifollicular hemorrhage encompassing coiled "corkscrew" hairs and hairs bent into "swan-neck" deformities. Ecchymoses, purpura, and petechiae are also characteristically prominent. Classic oral abnormalities include erythematous, swollen gingivae that hemorrhage from subtle microtrauma.Subungual linear splinter hemorrhages may also manifest as a sign of the disease. To establish the diagnosis requirements include characteristic physical exam findings, evidence of inadequate dietary intake, and rapid reversal of symptoms upon supplementation. Although unnecessary for diagnosis, histological findings demonstrate perifollicular inflammation and hemorrhage, fibrosis, and hyperkeratosis, amongst dilated hair follicles and keratin plugging. Although citrus fruit allergies have been historically documented, ascorbic acid has not been previously reported as an allergen. Although lacking absolute certainty, this report suggests a presumed case of ascorbic acid allergy based on patient history and favorable response to ascorbic acid desensitization therapy.

  1. Fermentative Degradation of Polyethylene Glycol by a Strictly Anaerobic, Gram-Negative, Nonsporeforming Bacterium, Pelobacter venetianus sp. nov

    OpenAIRE

    1983-01-01

    The synthetic polyether polyethylene glycol (PEG) with a molecular weight of 20,000 was anaerobically degraded in enrichment cultures inoculated with mud of limnic and marine origins. Three strains (Gra PEG 1, Gra PEG 2, and Ko PEG 2) of rod-shaped, gram-negative, nonsporeforming, strictly anaerobic bacteria were isolated in mineral medium with PEG as the sole source of carbon and energy. All strains degraded dimers, oligomers, and polymers of PEG up to a molecular weight of 20,000 completely...

  2. An Iterative Algorithm Combining Viscosity Method with Parallel Method for a Generalized Equilibrium Problem and Strict Pseudocontractions

    Directory of Open Access Journals (Sweden)

    2009-03-01

    Full Text Available We introduce a new approximation scheme combining the viscosity method with parallel method for finding a common element of the set of solutions of a generalized equilibrium problem and the set of fixed points of a family of finitely strict pseudocontractions. We obtain a strong convergence theorem for the sequences generated by these processes in Hilbert spaces. Based on this result, we also get some new and interesting results. The results in this paper extend and improve some well-known results in the literature.

  3. The evaluation of drug regulation - economic approaches into the valuation and evaluation of the drug regulatory framework

    NARCIS (Netherlands)

    Bouvy, J.C.

    2013-01-01

    The European pharmaceutical market is strictly regulated. Sufficient levels of quality, safety, and efficacy will have to be demonstrated before a pharmaceutical is allowed to enter the market. There is little evidence, however, that the current drug regulatory framework is achieving its goals of

  4. Maintenance of Taste Organs Is Strictly Dependent on Epithelial Hedgehog/GLI Signaling.

    Science.gov (United States)

    Ermilov, Alexandre N; Kumari, Archana; Li, Libo; Joiner, Ariell M; Grachtchouk, Marina A; Allen, Benjamin L; Dlugosz, Andrzej A; Mistretta, Charlotte M

    2016-11-01

    For homeostasis, lingual taste papilla organs require regulation of epithelial cell survival and renewal, with sustained innervation and stromal interactions. To investigate a role for Hedgehog/GLI signaling in adult taste organs we used a panel of conditional mouse models to manipulate GLI activity within epithelial cells of the fungiform and circumvallate papillae. Hedgehog signaling suppression rapidly led to taste bud loss, papilla disruption, and decreased proliferation in domains of papilla epithelium that contribute to taste cells. Hedgehog responding cells were eliminated from the epithelium but retained in the papilla stromal core. Despite papilla disruption and loss of taste buds that are a major source of Hedgehog ligand, innervation to taste papillae was maintained, and not misdirected, even after prolonged GLI blockade. Further, vimentin-positive fibroblasts remained in the papilla core. However, retained innervation and stromal cells were not sufficient to maintain taste bud cells in the context of compromised epithelial Hedgehog signaling. Importantly taste organ disruption after GLI blockade was reversible in papillae that retained some taste bud cell remnants where reactivation of Hedgehog signaling led to regeneration of papilla epithelium and taste buds. Therefore, taste bud progenitors were either retained during epithelial GLI blockade or readily repopulated during recovery, and were poised to regenerate taste buds once Hedgehog signaling was restored, with innervation and papilla connective tissue elements in place. Our data argue that Hedgehog signaling is essential for adult tongue tissue maintenance and that taste papilla epithelial cells represent the key targets for physiologic Hedgehog-dependent regulation of taste organ homeostasis. Because disruption of GLI transcriptional activity in taste papilla epithelium is sufficient to drive taste organ loss, similar to pharmacologic Hedgehog pathway inhibition, the findings suggest that taste

  5. Regulatory aspects of criticality control in Australia

    International Nuclear Information System (INIS)

    Zimin, Sergei

    2003-01-01

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

  6. Adaptive terminal sliding mode control for hypersonic flight vehicles with strictly lower convex function based nonlinear disturbance observer.

    Science.gov (United States)

    Wu, Yun-Jie; Zuo, Jing-Xing; Sun, Liang-Hua

    2017-11-01

    In this paper, the altitude and velocity tracking control of a generic hypersonic flight vehicle (HFV) is considered. A novel adaptive terminal sliding mode controller (ATSMC) with strictly lower convex function based nonlinear disturbance observer (SDOB) is proposed for the longitudinal dynamics of HFV in presence of both parametric uncertainties and external disturbances. First, for the sake of enhancing the anti-interference capability, SDOB is presented to estimate and compensate the equivalent disturbances by introducing a strictly lower convex function. Next, the SDOB based ATSMC (SDOB-ATSMC) is proposed to guarantee the system outputs track the reference trajectory. Then, stability of the proposed control scheme is analyzed by the Lyapunov function method. Compared with other HFV control approaches, key novelties of SDOB-ATSMC are that a novel SDOB is proposed and drawn into the (virtual) control laws to compensate the disturbances and that several adaptive laws are used to deal with the differential explosion problem. Finally, it is illustrated by the simulation results that the new method exhibits an excellent robustness and a better disturbance rejection performance than the convention approach. Copyright © 2017 ISA. Published by Elsevier Ltd. All rights reserved.

  7. Strictly monolayer large continuous MoS{sub 2} films on diverse substrates and their luminescence properties

    Energy Technology Data Exchange (ETDEWEB)

    Mohapatra, P. K.; Deb, S.; Singh, B. P.; Vasa, P.; Dhar, S., E-mail: dhar@phy.iitb.ac.in [Department of Physics, Indian Institute of Technology Bombay, Mumbai 400076 (India)

    2016-01-25

    Despite a tremendous interest on molybdenum disulfide as a thinnest direct band gap semiconductor, single step synthesis of a large area purely monolayer MoS{sub 2} film has not yet been reported. Here, we report a CVD route to synthesize a continuous film of strictly monolayer MoS{sub 2} covering an area as large as a few cm{sup 2} on a variety of different substrates without using any seeding material or any elaborate pretreatment of the substrate. This is achieved by allowing the growth to take place in the naturally formed gap between a piece of SiO{sub 2} coated Si wafer and the substrate, when the latter is placed on top of the former inside a CVD reactor. We propose a qualitative model to explain why the MoS{sub 2} films are always strictly monolayer in this method. The photoluminescence study of these monolayers shows the characteristic excitonic and trionic features associated with monolayer MoS{sub 2}. In addition, a broad defect related luminescence band appears at ∼1.7 eV. As temperature decreases, the intensity of this broad feature increases, while the band edge luminescence reduces.

  8. Event-Sampled Direct Adaptive NN Output- and State-Feedback Control of Uncertain Strict-Feedback System.

    Science.gov (United States)

    Szanto, Nathan; Narayanan, Vignesh; Jagannathan, Sarangapani

    2017-04-12

    In this paper, a novel event-triggered implementation of a tracking controller for an uncertain strict-feedback system is presented. Neural networks (NNs) are utilized in the backstepping approach to design a control input by approximating unknown dynamics of the strict-feedback nonlinear system with event-sampled inputs. The system state vector is assumed to be unknown and an NN observer is used to estimate the state vector. By using the estimated state vector and backstepping design approach, an event-sampled controller is introduced. As part of the controller design, first, input-to-state-like stability for a continuously sampled controller that has been injected with bounded measurement errors is demonstrated, and subsequently, an event-execution control law is derived, such that the measurement errors are guaranteed to remain bounded. Lyapunov theory is used to demonstrate that the tracking errors, the observer estimation errors, and the NN weight estimation errors for each NN are locally uniformly ultimately bounded in the presence bounded disturbances, NN reconstruction errors, as well as errors introduced by event sampling. Simulation results are provided to illustrate the effectiveness of the proposed controllers.

  9. Regulatory viewpoint on nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    Tripp, L.E.

    1976-01-01

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

  10. Major gene-regulatory mechanisms operating in ribosomally synthesized and post-translationally modified peptide (RiPP) biosynthesis.

    Science.gov (United States)

    Bartholomae, Maike; Buivydas, Andrius; Viel, Jakob H; Montalbán-López, Manuel; Kuipers, Oscar P

    2017-10-01

    Post-translationally modified peptides commonly display antimicrobial activity, but can also aid the development of bacterial colonies, giving a competitive advantage in the ecological niche. The production of post-translationally modified peptides by bacteria is a complex and energetically costly process that is strictly orchestrated in the cell. The onset of peptide production is linked to the different enzymes that take part during maturation, the transporters and the immunity determinants (if required). Thus, the population can make optimal use of available resources and obtain the benefits of production at an advantageous moment during growth, avoiding toxicity to itself. The timing and level of expression of the different operons is controlled by diverse (complex) regulatory pathways in response to environmental changes, stress or master regulators during specific growth transition phases. In this review, we highlight the basic principles and mechanisms of regulation of expression of post-translationally modified peptides and the relationship with the overall culture developmental processes and/or cellular differentiation. We also discuss the biotechnological consequences derived from the understanding of regulatory networks involved in the biosynthesis of these natural products. © 2017 John Wiley & Sons Ltd.

  11. 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

  12. Safety Committees for Argentinean Research Reactor - Regulatory Issues

    International Nuclear Information System (INIS)

    Perrin, Carlos D.

    2009-01-01

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

  13. Advances in Canadian regulatory practice

    International Nuclear Information System (INIS)

    Waddington, J.G.

    1993-03-01

    The new General Amendments to the Regulations, new recommendations on dose limits, developments in techniques and safety thinking, and aging of plant are all contributing to the need for a significant number of new regulatory document on a wide range of topics. this paper highlights a number of initiatives taken in response to these pressures, giving a brief background to the initiative and, where possible, outlining some of the ideas in the document licensing guides on new dose limits, dosimetry, safety analysis, reliability, fault tree analysis, reporting requirements, human factors, software, the ALARA principle, backfitting and the licensing process. (Author) 29 refs., fig., 4 tabs

  14. Regulatory guidance for license renewal

    International Nuclear Information System (INIS)

    Thoma, John A.

    1991-01-01

    The proposed 10 CFR Part 54 rule proceduralizes the process for license renewal by identifying both the administrative and technical requirements for a renewal application. To amplify and support this regulation, written guidance has been provided in the form of a draft Regulatory Guide (DG 1009) and a draft Standard Review Plan for License Renewal (NUREG 1299). This guidance is scheduled to be finalized in 1992. Similar guidance will be provided for the proposed revisions to 10 CFR Part 51 concerning the environmental aspects of license renewal. (author)

  15. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  16. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  17. Closure requirements

    International Nuclear Information System (INIS)

    Hutchinson, I.P.G.; Ellison, R.D.

    1992-01-01

    Closure of a waste management unit can be either permanent or temporary. Permanent closure may be due to: economic factors which make it uneconomical to mine the remaining minerals; depletion of mineral resources; physical site constraints that preclude further mining and beneficiation; environmental, regulatory or other requirements that make it uneconomical to continue to develop the resources. Temporary closure can occur for a period of several months to several years, and may be caused by factors such as: periods of high rainfall or snowfall which prevent mining and waste disposal; economic circumstances which temporarily make it uneconomical to mine the target mineral; labor problems requiring a cessation of operations for a period of time; construction activities that are required to upgrade project components such as the process facilities and waste management units; and mine or process plant failures that require extensive repairs. Permanent closure of a mine waste management unit involves the provision of durable surface containment features to protect the waters of the State in the long-term. Temporary closure may involve activities that range from ongoing maintenance of the existing facilities to the installation of several permanent closure features in order to reduce ongoing maintenance. This paper deals with the permanent closure features

  18. 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)

  19. Strict fibonacci heaps

    DEFF Research Database (Denmark)

    Brodal, Gerth Stølting; Lagogiannis, George; Tarjan, Robert E.

    2012-01-01

    We present the first pointer-based heap implementation with time bounds matching those of Fibonacci heaps in the worst case. We support make-heap, insert, find-min, meld and decrease-key in worst-case O(1) time, and delete and delete-min in worst-case O(lg n) time, where n is the size of the heap...... of the smaller heap when doing a meld. We use the pigeonhole principle in place of the redundant counter mechanism. We present the first pointer-based heap implementation with time bounds matching those of Fibonacci heaps in the worst case. We support make-heap, insert, find-min, meld and decrease-key in worst...

  20. Online Recorded Data-Based Composite Neural Control of Strict-Feedback Systems With Application to Hypersonic Flight Dynamics.

    Science.gov (United States)

    Xu, Bin; Yang, Daipeng; Shi, Zhongke; Pan, Yongping; Chen, Badong; Sun, Fuchun

    2017-09-25

    This paper investigates the online recorded data-based composite neural control of uncertain strict-feedback systems using the backstepping framework. In each step of the virtual control design, neural network (NN) is employed for uncertainty approximation. In previous works, most designs are directly toward system stability ignoring the fact how the NN is working as an approximator. In this paper, to enhance the learning ability, a novel prediction error signal is constructed to provide additional correction information for NN weight update using online recorded data. In this way, the neural approximation precision is highly improved, and the convergence speed can be faster. Furthermore, the sliding mode differentiator is employed to approximate the derivative of the virtual control signal, and thus, the complex analysis of the backstepping design can be avoided. The closed-loop stability is rigorously established, and the boundedness of the tracking error can be guaranteed. Through simulation of hypersonic flight dynamics, the proposed approach exhibits better tracking performance.

  1. Global neural dynamic surface tracking control of strict-feedback systems with application to hypersonic flight vehicle.

    Science.gov (United States)

    Xu, Bin; Yang, Chenguang; Pan, Yongping

    2015-10-01

    This paper studies both indirect and direct global neural control of strict-feedback systems in the presence of unknown dynamics, using the dynamic surface control (DSC) technique in a novel manner. A new switching mechanism is designed to combine an adaptive neural controller in the neural approximation domain, together with the robust controller that pulls the transient states back into the neural approximation domain from the outside. In comparison with the conventional control techniques, which could only achieve semiglobally uniformly ultimately bounded stability, the proposed control scheme guarantees all the signals in the closed-loop system are globally uniformly ultimately bounded, such that the conventional constraints on initial conditions of the neural control system can be relaxed. The simulation studies of hypersonic flight vehicle (HFV) are performed to demonstrate the effectiveness of the proposed global neural DSC design.

  2. Monolithic InP strictly non-blocking 8×8 switch for high-speed WDM optical interconnection.

    Science.gov (United States)

    Kwack, Myung-Joon; Tanemura, Takuo; Higo, Akio; Nakano, Yoshiaki

    2012-12-17

    A strictly non-blocking 8 × 8 switch for high-speed WDM optical interconnection is realized on InP by using the phased-array scheme for the first time. The matrix switch architecture consists of over 200 functional devices such as star couplers, phase-shifters and so on without any waveguide cross-section. We demonstrate ultra-broad optical bandwidth covering the entire C-band through several Input/Output ports combination with extinction ratio performance of more than 20dB. Also, nanoseconds reconfiguration time was successfully achieved by dynamic switching experiment. Error-free transmission was verified for 40-Gbps (10-Gbps × 4ch) WDM signal.

  3. Analysis of strictly bound modes in photonic crystal fibers by use of a source-model technique.

    Science.gov (United States)

    Hochman, Amit; Leviatan, Yehuda

    2004-06-01

    We describe a source-model technique for the analysis of the strictly bound modes propagating in photonic crystal fibers that have a finite photonic bandgap crystal cladding and are surrounded by an air jacket. In this model the field is simulated by a superposition of fields of fictitious electric and magnetic current filaments, suitably placed near the media interfaces of the fiber. A simple point-matching procedure is subsequently used to enforce the continuity conditions across the interfaces, leading to a homogeneous matrix equation. Nontrivial solutions to this equation yield the mode field patterns and propagation constants. As an example, we analyze a hollow-core photonic crystal fiber. Symmetry characteristics of the modes are discussed and exploited to reduce the computational burden.

  4. Development of a PCR assay based on the 16S-23S rDNA internal transcribed spacer for identification of strictly anaerobic bacterium Zymophilus

    Czech Academy of Sciences Publication Activity Database

    Felsberg, Jürgen; Jelínková, Markéta; Kubizniaková, P.; Matoulková, D.

    2015-01-01

    Roč. 33, June (2015), s. 85-89 ISSN 1075-9964 Institutional support: RVO:61388971 Keywords : Brewing microbiology * Strictly anaerobic bacteria * Yeast contamination Subject RIV: GM - Food Processing Impact factor: 2.424, year: 2015

  5. Strict blood glucose control by an artificial endocrine pancreas during hepatectomy may prevent postoperative acute kidney injury.

    Science.gov (United States)

    Mita, Naoji; Kawahito, Shinji; Soga, Tomohiro; Takaishi, Kazumi; Kitahata, Hiroshi; Matsuhisa, Munehide; Shimada, Mitsuo; Kinoshita, Hiroyuki; Tsutsumi, Yasuo M; Tanaka, Katsuya

    2017-03-01

    The aim of the present study was to evaluate the usefulness of a closed-loop system (STG-55; Nikkiso, Tokyo, Japan), a type of artificial endocrine pancreas for the continuous monitoring and control of intraoperative blood glucose, for preventing postoperative acute kidney injury (AKI) in patients undergoing hepatectomy. Thirty-eight patients were enrolled in this study. Glucose concentrations were controlled with either a manual injection of insulin based on a commonly used sliding scale (manual insulin group, n = 19) or the programmed infusion of insulin determined by the control algorithm of the artificial endocrine pancreas (programmed insulin group, n = 19). After the induction of anesthesia, a 20-G intravenous catheter was inserted into the peripheral forearm vein of patients in the programmed insulin group and connected to an artificial endocrine pancreas (STG-55). The target range for glucose concentrations was set to 100-150 mg/dL. The mean serum creatinine concentrations of preoperative, postoperative 24 and 48 h were 0.72, 0.78, and 0.79 mg/dL in the programmed insulin group, and 0.81, 0.95, and 1.03 mg/dL in the manual insulin group, respectively. Elevations in serum creatinine concentrations postoperative 48 h were significantly suppressed in the programmed insulin group. The STG-55 closed-loop system was effective for maintaining strict blood glucose control during hepatectomy with minimal variability in blood glucose concentrations and for suppressing elevations in serum creatinine concentrations. Strict blood glucose control by an artificial endocrine pancreas during hepatectomy may prevent postoperative AKI.

  6. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

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

  7. Structure and drafting of safeguards regulatory documents

    International Nuclear Information System (INIS)

    Cole, R.J.; Bennett, C.A.; Edelhertz, H.; Wood, M.T.; Brown, R.J.; Roberts, F.P.

    1977-09-01

    This study develops hypothesis about the relation between the structure and drafting of safeguards regulatory documents and the ability of document users to understand and implement them in a way that reflects the intent and requirements of the NRC. Four decisions are needed to improve communication: (1) Should improvement of safeguards regulatory documents as communication instruments be an explicit NRC program. (2) What specific methods of communication should be the focus of improvement efforts. (3) What actions to improve communications are feasible and desirable. (4) How should the NRC divide its available effort and resources among desirable actions in order to provide the most effective communication through regulatory documents. This volume contains: introduction, conceptual bases, legal requirements, targets, choice of documents, preparation of documents, readability, and further study of recommended changes in structure and drafting

  8. 75 FR 54921 - Withdrawal of Regulatory Guides 1.38, 1.94, and 1.116

    Science.gov (United States)

    2010-09-09

    ... Guide 1.38, ``Quality Assurance Requirements for Packaging, Shipping, Receiving, Storage, and Handling....116, ``Quality Assurance Requirements for Installation, Inspection, and Testing of Mechanical... Development Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory...

  9. Regulatory Issues Surrounding Merchant Interconnection

    International Nuclear Information System (INIS)

    Kuijlaars, Kees-Jan; Zwart, Gijsbert

    2003-11-01

    We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections

  10. 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.

  11. Safeguards inventory and process monitoring regulatory comparison

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-06-27

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

  12. Federal Reserve System Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... [The Regulatory Plan and Unified Agenda of Federal Regulatory and Deregulatory Actions] [Federal Reserve System Semiannual Regulatory Agenda ] Part XXI Federal Reserve System Semiannual Regulatory Agenda... Flexibility Agenda AGENCY: Board of Governors of the Federal Reserve System. ACTION: Semiannual regulatory...

  13. Structure and drafting of safeguards regulatory documents

    International Nuclear Information System (INIS)

    Cole, R.J.; Bennett, C.A.; Edelhertz, H.; Wood, M.T.; Brown, R.J.; Roberts, F.P.

    1977-09-01

    Improving communication of NRU's requirements is the subject of this study. This summary is organized in terms of four decisions on whether safeguards regulatory documents as communication instruments should be an explicit NRC program, what communication methods should be focused on, what actions are feasible and desirable, and how should the NRC divide its effort and resources among desirable actions

  14. 7 CFR 1717.304 - State regulatory authority rate jurisdiction.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 11 2010-01-01 2010-01-01 false State regulatory authority rate jurisdiction. 1717.304 Section 1717.304 Agriculture Regulations of the Department of Agriculture (Continued) RURAL....304 State regulatory authority rate jurisdiction. (a) In the event that rate revisions required by the...

  15. 30 CFR 229.120 - Obtaining regulatory and policy guidance.

    Science.gov (United States)

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Obtaining regulatory and policy guidance. 229.120 Section 229.120 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT OF THE INTERIOR MINERALS REVENUE MANAGEMENT DELEGATION TO STATES Oil and Gas, Onshore Delegation Requirements § 229.120 Obtaining regulatory and policy guidance. All...

  16. Identification of Ser-543 as the major regulatory phosphorylation site in spinach leaf nitrate reductase

    Science.gov (United States)

    Bachmann, M.; Shiraishi, N.; Campbell, W. H.; Yoo, B. C.; Harmon, A. C.; Huber, S. C.; Davies, E. (Principal Investigator)

    1996-01-01

    Spinach leaf NADH:nitrate reductase (NR) responds to light/dark signals and photosynthetic activity in part as a result of rapid regulation by reversible protein phosphorylation. We have identified the major regulatory phosphorylation site as Ser-543, which is located in the hinge 1 region connecting the cytochrome b domain with the molybdenum-pterin cofactor binding domain of NR, using recombinant NR fragments containing or lacking the phosphorylation site sequence. Studies with NR partial reactions indicated that the block in electron flow caused by phosphorylation also could be localized to the hinge 1 region. A synthetic peptide (NR6) based on the phosphorylation site sequence was phosphorylated readily by NR kinase (NRk) in vitro. NR6 kinase activity tracked the ATP-dependent inactivation of NR during several chromatographic steps and completely inhibited inactivation/phosphorylation of native NR in vitro. Two forms of NRk were resolved by using anion exchange chromatography. Studies with synthetic peptide analogs indicated that both forms of NRk had similar specificity determinants, requiring a basic residue at P-3 (i.e., three amino acids N-terminal to the phosphorylated serine) and a hydrophobic residue at P-5. Both forms are strictly calcium dependent but belong to distinct families of protein kinases because they are distinct immunochemically.

  17. 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)

  18. Regulatory Risk Management of Advanced Nuclear Power Plants

    International Nuclear Information System (INIS)

    George, Glenn R.

    2002-01-01

    Regulatory risk reflects both the likelihood of adverse outcomes during regulatory interactions and the severity of those outcomes. In the arena of advanced nuclear power plant licensing and construction, such adverse outcomes may include, for example, required design changes and construction delays. These, in turn, could significantly affect the economics of the plant and the generation portfolio in which it will operate. In this paper, the author addresses these issues through the lens of risk management. The paper considers various tools and techniques of regulatory risk management, including design diversity and hedging strategies. The effectiveness of alternate approaches is weighed and recommendations are made in several regulatory contexts. (author)

  19. Regulation for continuous improvements - the new regulatory strategy of SKI

    International Nuclear Information System (INIS)

    Hoegberg, L.; Svensson, G.; Viktorsson, C.

    1998-01-01

    This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)

  20. Systematic Assessment of Regulatory Competences (SARCON) V18a

    International Nuclear Information System (INIS)

    Zimmermann, Moritz

    2014-01-01

    Why Competence Management? • Arrangements for competence management is a key factor to: • Support the implementation of article 8 of CNS (Convention on Nuclear Safety – “regulatory body with adequate competence and human resources”); • Support the implementation of Modules 3 and 4 of the IRRS and other IAEA Safety Standards (Module 3: “Responsibilities and functions of the regulatory body”, Module 4: “Management system of the regulatory body”); • Identify gaps between regulatory required competences and the existing resources; • Develop and implement tools and programmes to fill the gaps; • Review periodically the competence needs and training programmes

  1. Three cis-Regulatory Motifs, AuxRE, MYCRS1 and MYCRS2, are Required for Modulating the Auxin- and Mycorrhiza-Responsive Expression of a Tomato GH3 Gene.

    Science.gov (United States)

    Chen, Xiao; Liao, Dehua; Yang, Xiaofeng; Ji, Minjie; Wang, Shuangshuang; Gu, Mian; Chen, Aiqun; Xu, Guohua

    2017-04-01

    Auxin is well known to be a key regulator that acts in almost all physiological processes during plant growth, and in interactions between plants and microbes. However, to date, the regulatory mechanisms underlying auxin-mediated plant-arbuscular mycorrhizal (AM) fungi symbiosis have not been well deciphered. Previously we identified a GH3 gene, SlGH3.4, strongly responsive to both auxin induction and mycorrhizal symbiosis. Here, we reported a refined dissection of the SlGH3.4 promoter activity using the β-glucuronidase (GUS) reporter. The SlGH3.4 promoter could drive GUS expression strongly in mycorrhizal roots of soybean and rice plants, and in IAA-treated soybean roots, but not in IAA-treated rice roots. A promoter deletion assay revealed three cis-acting motifs, i.e. the auxin-responsive element, AuxRE, and two newly identified motifs named MYCRS1 and MYCRS2, involved in the activation of auxin- and AM-mediated expression of SlGH3.4. Deletion of the AuxRE from the SlGH3.4 promoter caused almost complete abolition of GUS staining in response to external IAA induction. Seven repeats of AuxRE fused to the Cauliflower mosaic virus (CaMV) 35S minimal promoter could direct GUS expression in both IAA-treated and AM fungal-colonized roots of tobacco plants. Four repeats of MYCRS1 or MYCRS2 fused to the CaMV35S minimal promoter was sufficient to drive GUS expression in arbuscule-containing cells, but not in IAA-treated tobacco roots. In summary, our results offer new insights into the molecular mechanisms underlying the potential cross-talk between the auxin and the AM regulatory pathways in modulating the expression of AM-responsive GH3 genes in diverse mycorrhizal plants. © The Author 2017. Published by Oxford University Press on behalf of Japanese Society of Plant Physiologists. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  2. Analysis of safety-related regulatory actions by Japan's pharmaceutical regulatory agency.

    Science.gov (United States)

    Ishiguro, Chieko; Misu, Takashi; Iwasa, Eiko; Izawa, Tadashi

    2017-11-01

    To evaluate the safety-related regulatory actions implemented by Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in 2012. We analyzed serious safety issues appended to drug package inserts (PIs) in Japan in 2012. The issues were characterized according to drug class, adverse event, years since drug approval, initiator of regulatory actions, revised section of PI, and evidence source. We also quantified the durations from signal detection to tentative decision and from tentative decision to regulatory action. We identified 144 serious safety issues during the study period, and the majority of evidence originated from spontaneous reports (83.5%). The PMDA initiated regulatory actions for half of all safety issues, and the median duration from drug approval to regulatory action was 8 years (interquartile range [IQR], 3-26.5 years). The median duration was 49 days (IQR, 0-362 days) from signal detection to tentative decision and 84 days (IQR, 63-136 days) from tentative decision to regulatory action. Several safety issues involving older drugs and multiple products had protracted decision-making durations. Most safety issues led to prompt regulatory actions predominantly based on spontaneous reports. Some safety issues that were not easily detected by the spontaneous reporting system were identified years after approval. In addition, several safety issues required assessments of multiple drug products, which prolonged the decision-making process. Copyright © 2017 John Wiley & Sons, Ltd.

  3. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

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

  4. Organization of nuclear regulatory activities

    International Nuclear Information System (INIS)

    Blidaru, Valentin

    2008-01-01

    The paper presents the structure, missions and organizational aspects of the CNCAN, the National Commission for the control of nuclear activities in Romania. The paper addresses the following main issues: 1.General aspects; 2.Organizational structure of the NRA in Romania; 3.General description of the Division for Nuclear Safety Assessments; 4.Specific activities; 5.Regulatory approaches and practices. Under the title of 'General aspects' the following three basic statements are highlighted: 1.CNCAN is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and the licensing of nuclear facilities; 2.CNCAN is the national authority competent in exercising the regulatory activity, authorization and control in the nuclear field provided by the law No. 111/ 1996 republished in 1998; 3.The Commission exercises its functions independently of the ministries and other authorities of the public control administration being subordinated to the Romanian Government. The organizational structure is as follows: - President, the Managerial Council and the Advisory Council coordinating the four General Divisions that are responsible for: - Nuclear Safety with Division of Nuclear Safety Assessment and Division of Nuclear Objectives Surveillance; - Radiological Safety with Division of Radiological Safety Assessment and Division of Operational Radiation Protection; - Surveillance of Environmental Radioactivity with Division of Assessment and Analysis and Division of National Network; - Development and Resource with the Division of Economy and Division of Human Resources. In addition under direct coordination of the President operate the Division of Radiation Protection, Transport and Radioactive Waste and the Division of International Cooperation and Communication. Specific activities are listed describing among others the issues of: - Safety of nuclear installation; - Evaluation relating to licensing of nuclear

  5. Intra-Genomic Heterogeneity in 16S rRNA Genes in Strictly Anaerobic Clinical Isolates from Periodontal Abscesses

    Science.gov (United States)

    Chen, Jiazhen; Miao, Xinyu; Xu, Meng; He, Junlin; Xie, Yi; Wu, Xingwen; Chen, Gang; Yu, Liying; Zhang, Wenhong

    2015-01-01

    Background Members of the genera Prevotella, Veillonella and Fusobacterium are the predominant culturable obligate anaerobic bacteria isolated from periodontal abscesses. When determining the cumulative number of clinical anaerobic isolates from periodontal abscesses, ambiguous or overlapping signals were frequently encountered in 16S rRNA gene sequencing chromatograms, resulting in ambiguous identifications. With the exception of the genus Veillonella, the high intra-chromosomal heterogeneity of rrs genes has not been reported. Methods The 16S rRNA genes of 138 clinical, strictly anaerobic isolates and one reference strain were directly sequenced, and the chromatograms were carefully examined. Gene cloning was performed for 22 typical isolates with doublet sequencing signals for the 16S rRNA genes, and four copies of the rrs-ITS genes of 9 Prevotella intermedia isolates were separately amplified by PCR, sequenced and compared. Five conserved housekeeping genes, hsp60, recA, dnaJ, gyrB1 and rpoB from 89 clinical isolates of Prevotella were also amplified by PCR and sequenced for identification and phylogenetic analysis along with 18 Prevotella reference strains. Results Heterogeneity of 16S rRNA genes was apparent in clinical, strictly anaerobic oral bacteria, particularly in the genera Prevotella and Veillonella. One hundred out of 138 anaerobic strains (72%) had intragenomic nucleotide polymorphisms (SNPs) in multiple locations, and 13 strains (9.4%) had intragenomic insertions or deletions in the 16S rRNA gene. In the genera Prevotella and Veillonella, 75% (67/89) and 100% (19/19) of the strains had SNPs in the 16S rRNA gene, respectively. Gene cloning and separate amplifications of four copies of the rrs-ITS genes confirmed that 2 to 4 heterogeneous 16S rRNA copies existed. Conclusion Sequence alignment of five housekeeping genes revealed that intra-species nucleotide similarities were very high in the genera Prevotella, ranging from 94.3–100%. However, the

  6. Wetlands: The changing regulatory landscape

    International Nuclear Information System (INIS)

    Glick, R.M.

    1993-01-01

    Protection of wetlands became a national issue in 1988 when President George Bush pledged no net loss of wetlands in the US under his open-quotes environmental presidency.close quotes As wetlands became a national issue, the job of protecting them became an obligation for many groups, including hydro-power developers. Now, when a site selected for development includes an area that may be classified as a wetland, the developer quickly discovers the importance of recognizing and protecting these natural habitats. Federal legislation severely limits development of wetland, and most states increase the restrictions with their own wetlands regulations. The difficulty of defining wetlands complicates federal and state enforcement. Land that appears to be dry may in fact be classified as a wetland. So, even if a site appears dry, potential hydro developers must confirm whether or not any jurisdictional wetlands are present. Regulated lands include much more than marshes and swamps. Further complicating the definition of wetlands, a recent court decision found that even artificially created wetlands, such as man-made ponds, may be subject to regulation. Hydro developers must be aware of current regulatory requirements before they consider development of any site that may contain wetlands. To be certain that a site is open-quotes buildableclose quotes from the standpoint of wetlands regulation, a developer must verify (with the help of state agencies) that the property does not contain any jurisdictional wetlands. If it does, the regulatory process before development becomes much more complicated. For the short term, uncertainty abounds and extreme caution is in order. Because the regulatory process has become so complex and an agreeable definition of wetlands so elusive, the trend among the Corps and collaborating agencies is to constrict nationwide permits in favor of narrowing the jurisdictional definition of wetlands

  7. Fermentative degradation of polyethylene glycol by a strictly anaerobic, gram-negative, nonsporeforming bacterium, Pelobacter venetianus sp. nov.

    Science.gov (United States)

    Schink, B; Stieb, M

    1983-06-01

    The synthetic polyether polyethylene glycol (PEG) with a molecular weight of 20,000 was anaerobically degraded in enrichment cultures inoculated with mud of limnic and marine origins. Three strains (Gra PEG 1, Gra PEG 2, and Ko PEG 2) of rod-shaped, gram-negative, nonsporeforming, strictly anaerobic bacteria were isolated in mineral medium with PEG as the sole source of carbon and energy. All strains degraded dimers, oligomers, and polymers of PEG up to a molecular weight of 20,000 completely by fermentation to nearly equal amounts of acetate and ethanol. The monomer ethylene glycol was not degraded. An ethylene glycol-fermenting anaerobe (strain Gra EG 12) isolated from the same enrichments was identified as Acetobacterium woodii. The PEG-fermenting strains did not excrete extracellular depolymerizing enzymes and were inhibited by ethylene glycol, probably owing to a blocking of the cellular uptake system. PEG, some PEG-containing nonionic detergents, 1,2-propanediol, 1,2-butanediol, glycerol, and acetoin were the only growth substrates utilized of a broad variety of sugars, organic acids, and alcohols. The isolates did not reduce sulfate, sulfur, thiosulfate, or nitrate and were independent of growth factors. In coculture with A. woodii or Methanospirillum hungatei, PEGs and ethanol were completely fermented to acetate (and methane). A marine isolate is described as the type strain of a new species, Pelobacter venetianus sp. nov. Its physiology and ecological significance, as well as the importance and possible mechanism of anaerobic polyether degradation, are discussed.

  8. Effect of nonsurgical periodontal therapy and strict plaque control on preterm/low birth weight: a randomized controlled clinical trial.

    Science.gov (United States)

    Weidlich, Patricia; Moreira, Carlos Heitor C; Fiorini, Tiago; Musskopf, Marta L; da Rocha, José M; Oppermann, Maria Lucia R; Aass, Anne M; Gjermo, Per; Susin, Cristiano; Rösing, Cassiano K; Oppermann, Rui V

    2013-01-01

    This randomized controlled clinical trial was carried out to assess the effect of comprehensive nonsurgical periodontal treatment and strict plaque control performed during pregnancy on the reduction of preterm and/or low birth weight rates (PTLBW). Three hundred and three women were randomly allocated to receive periodontal treatment either during pregnancy (n = 147, test group) or after delivery (n = 156, control group). During pregnancy, the control group received only one session of supragingival scaling and oral hygiene instruction. In contrast, the test group received comprehensive periodontal treatment including multiple sessions of scaling and root planing, oral hygiene instructions, and frequent maintenance visits. At baseline, periodontal inflammation was observed in approximately 50% of sites and attachment loss affected controls, women in the test group had significant reductions in the percentage of sites with plaque (48.5% vs. 10.3%, p control significantly improved periodontal health; however, no reduction of PTLBW rates was observed. Thus, remaining periodontal inflammation posttreatment cannot explain the lack of effect of periodontal treatment on PTLBW. Clinical relevance This study demonstrated that periodontal diseases may be successfully treated during pregnancy. Our results do not support a potential beneficial effect of periodontal treatment on PTLBW.

  9. Lack of evidence for phase-only control of retinal photoisomerization in the strict one-photon limit

    Science.gov (United States)

    Liebel, M.; Kukura, P.

    2017-01-01

    The concept of shaping electric fields to steer light-induced processes coherently has fascinated scientists for decades. Despite early theoretical considerations that ruled out one-photon coherent control (CC), several experimental studies reported that molecular responses are sensitive to the shape of the excitation field in the weak-field limit. These observations were largely attributed to the presence of rapid-decay channels, but experimental verification is lacking. Here, we test this hypothesis by investigating the degree of achievable control over the photoisomerization of the retinal protonated Schiff-base in bacteriorhodopsin, isorhodopsin and rhodopsin, all of which exhibit similar chromophores but different isomerization yields and excited-state lifetimes. Irrespective of the system studied, we find no evidence for dissipation-dependent behaviour, nor for any CC in the strict one-photon limit. Our results question the extent to which a photochemical process at ambient conditions can be controlled at the amplitude level, and how the underlying molecular potential-energy surfaces and dynamics may influence this controllability.

  10. Effect of strict metabolic control on regulation of subcutaneous blood flow in insulin-dependent diabetic patients

    DEFF Research Database (Denmark)

    Kastrup, J; Mathiesen, E R; Saurbrey, Nina

    1987-01-01

    washout technique. Mean arterial blood pressure was reduced by a maximum of 23 mmHg by elevating the limb above heart level and elevated to a maximum of 65 mmHg by head-up tilt; in the latter position venous pressure was kept constantly low by activation of the leg muscle vein pump (heel raising......The effect of 10 weeks of improved metabolic control on the impaired autoregulation of the subcutaneous blood flow was studied at the level of the lateral malleolus in eight long-term insulin-dependent diabetic patients with clinical microangiopathy. Blood flow was measured by the local 133-Xenon......). Improved metabolic control was achieved using either continuous subcutaneous insulin infusion or multiple insulin injections. The blood glucose concentration declined from (median) 12.7 to 6.8 mmol/l and the HbA1C level from 10.1 to 7.5% during strict metabolic control (p less than 0.01 and p less than 0...

  11. Regulatory stability and credibility

    International Nuclear Information System (INIS)

    Lee, B. Jr.

    1988-01-01

    The author discusses programs within the nuclear industry dedicated to enhancing the utilities' role in achieving operational excellence. The activities of the Nuclear Management and Resources Council (NUMARC), INPO, and EPRI are described. NRC regulations are addressed. The author identifies and focuses on the importance of a stable and credible regulatory process for the achievement of operational excellence

  12. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1989-07-01

    This document is a compilation of all rules on which the NRC has proposed or is considering action and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  13. Developing regulatory approaches

    International Nuclear Information System (INIS)

    Axelsson, Lars

    2012-01-01

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

  14. OAR Regulatory Reform

    Science.gov (United States)

    The U.S. EPA's Office of Air and Radiation is hosting a public teleconference to solicit input on specific air and radiation actions that should be considered for “repeal, replacement, or modification” to reduce regulatory burden consistent with EO 13777.

  15. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-02-01

    This document is a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considered action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  16. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1992-07-01

    This document compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rule making which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  17. Prediction of regulatory elements

    DEFF Research Database (Denmark)

    Sandelin, Albin

    2008-01-01

    Finding the regulatory mechanisms responsible for gene expression remains one of the most important challenges for biomedical research. A major focus in cellular biology is to find functional transcription factor binding sites (TFBS) responsible for the regulation of a downstream gene. As wet-lab...

  18. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1992-11-01

    This document provides a compilation of all rules on which the NRC has recently completed action, or has proposed action, or is considering action, and all petitions for rulemaking which have been received by the Commission and are pending disposition by the Commission. The Regulatory Agenda is updated and issued each quarter

  19. Type 2 innate lymphoid cell suppression by regulatory T cells attenuates airway hyperreactivity and requires inducible T-cell costimulator-inducible T-cell costimulator ligand interaction.

    Science.gov (United States)

    Rigas, Diamanda; Lewis, Gavin; Aron, Jennifer L; Wang, Bowen; Banie, Homayon; Sankaranarayanan, Ishwarya; Galle-Treger, Lauriane; Maazi, Hadi; Lo, Richard; Freeman, Gordon J; Sharpe, Arlene H; Soroosh, Pejman; Akbari, Omid

    2017-05-01

    Atopic diseases, including asthma, exacerbate type 2 immune responses and involve a number of immune cell types, including regulatory T (Treg) cells and the emerging type 2 innate lymphoid cells (ILC2s). Although ILC2s are potent producers of type 2 cytokines, the regulation of ILC2 activation and function is not well understood. In the present study, for the first time, we evaluate how Treg cells interact with pulmonary ILC2s and control their function. ILC2s and Treg cells were evaluated by using in vitro suppression assays, cell-contact assays, and gene expression panels. Also, human ILC2s and Treg cells were adoptively transferred into NOD SCID γC-deficient mice, which were given isotype or anti-inducible T-cell costimulator ligand (ICOSL) antibodies and then challenged with IL-33 and assessed for airway hyperreactivity. We show that induced Treg cells, but not natural Treg cells, effectively suppress the production of the ILC2-driven proinflammatory cytokines IL-5 and IL-13 both in vitro and in vivo. Mechanistically, our data reveal the necessity of inducible T-cell costimulator (ICOS)-ICOS ligand cell contact for Treg cell-mediated ILC2 suppression alongside the suppressive cytokines TGF-β and IL-10. Using a translational approach, we then demonstrate that human induced Treg cells suppress syngeneic human ILC2s through ICOSL to control airway inflammation in a humanized ILC2 mouse model. These findings suggest that peripheral expansion of induced Treg cells can serve as a promising therapeutic target against ILC2-dependent asthma. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  20. Pollution prevention: A regulatory update

    International Nuclear Information System (INIS)

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

    1993-01-01

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

  1. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2015-01-01

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

  2. Agronomic traits and deoxynivalenol contamination of two tetraploid wheat species (Triticum turgidum spp. durum, Triticum turgidum spp. turanicum grown strictly under low input conditions

    Directory of Open Access Journals (Sweden)

    Giovanni Dinelli

    2014-09-01

    Full Text Available An evaluation of the agronomic performance of two tetraploid wheat varieties (Triticum turgidum spp. durum, Claudio; Triticum turgidum spp. turanicum, Kamut® grown strictly under low input conditions was carried out over three consecutive cropping years. The study reported grain yield values ranging from 1.8 to 2.6 t ha-1. Productivity showed to be primarily affected by environmental conditions, while no differences were observed between the two genotypes. The study of the yield components highlighted that the durum wheat variety had a higher plant density than Kamut®, but this discrepancy was offset by a greater number of kernels per spike and the kernel weight of khorasan wheat. The investigated wheat genotypes were also analysed to assess the mycotoxin (DON levels of wholegrain semolina and the efficiency of cleaning treatments to reduce contamination. Results showed that both wheat varieties had a good hygienic and sanitary quality with a DON content ranging from 0.35 to 1.31 mg kg-1, which was lower than the maximum acceptable level set by the European regulation at 1.75 mg kg-1. In addition, our research work investigated the effects of premilling cleaning procedures, such as water washing and brushing, on mycotoxin levels, which yielded interesting results in terms of decontamination efficiency. These methods were particularly efficient with Kamut® semolina (46-93% DON reduction, suggesting that mycotoxins accumulate in this variety at more superficial levels than in the durum wheat variety. On the whole, our study provided additional knowledge on the traits to be further improved to respond to low input requirements and to enhance the potential adaptability of wheat genotypes to organic agriculture. Our results emphasized the need to develop wheat varieties that can provide adequate performance without high levels of nitrogen inputs by selecting specific traits, such as kernel weight, spike length and kernel/spike. This may help

  3. South African Regulatory Framework for Nuclear Power Plant Life Management

    International Nuclear Information System (INIS)

    Mbebe, B.Z.

    2012-01-01

    The paper presents the regulatory approach to plant life management (PLiM) adopted by the National Nuclear Regulator (NNR) in South Africa, the licensing basis and regulatory requirements for Koeberg Nuclear Power Station (KNPS),operational programmes ensuring continued safe operation, issues related to the ageing of the plant, and the requirements for spent fuel as well as radioactive waste management. The paper will further present insights from the Periodic Safety Review (PSR) and Long Term Asset Management. (author)

  4. Licensing and regulatory control of nuclear power plants in Canada

    International Nuclear Information System (INIS)

    Atchison, R.J.

    1975-01-01

    The paper discusses the safety philosophy adopted in Canada, the safety criteria and regulatory requirements necessary for the application of this philosophy to reactor design and operation, and finally the means by which compliance with Board requirements is effected. It is emphasized that the effectiveness of regulatory control depends not only on the underlying philosophy but also on the detailed way in which it is applied. (orig./HP) [de

  5. Gene function analysis in environmental isolates: The nif regulon of the strict iron oxidizing bacterium Leptospirillum ferrooxidans

    Science.gov (United States)

    Parro, Víctor; Moreno-Paz, Mercedes

    2003-01-01

    A random genomic library from an environmental isolate of the Gram-negative bacterium Leptospirillum ferrooxidans has been printed on a microarray. Gene expression analysis was carried out with total RNA extracted from L. ferrooxidans cultures in the presence or absence of ammonium as nitrogen source under aerobic conditions. Although practically nothing is known about the genome sequence of this bacterium, this approach allowed us the selection and sequencing of only those clones bearing genes that showed an altered expression pattern. By sequence comparison, we have identified most of the genes of nitrogen fixation regulon in L. ferrooxidans, like the nifHDKENX operon, encoding the structural components of Mo-Fe nitrogenase; nifSU-hesB-hscBA-fdx operon, for Fe-S cluster assembly; the amtB gene (ammonium transporter); modA (molybdenum ABC type transporter); some regulatory genes like ntrC, nifA (the specific activator of nif genes); or two glnB-like genes (encoding the PII regulatory protein). Our results show that shotgun DNA microarrays are very powerful tools to accomplish gene expression studies with environmental bacteria whose genome sequence is still unknown, avoiding the time and effort necessary for whole genome sequencing projects. PMID:12808145

  6. A novel strictly anaerobic recovery and enrichment system incorporating lithium for detection of heat-injured Listeria monocytogenes in pasteurized milk containing background microflora.

    Science.gov (United States)

    Mendonca, A F; Knabel, S J

    1994-11-01

    Heat-injured cells of Listeria monocytogenes were recovered from heated raw milk containing noninjured Enterococcus faecium by combining a simple method for obtaining strict anaerobiosis with a novel enrichment broth, Penn State University broth (PSU broth). Strictly anaerobic conditions were rapidly achieved by adding 0.5 g of filter-sterilized cysteine per liter to PSU broth and then purging the preparation with N2 gas. Little resuscitation or growth occurred in strictly anaerobic PSU broth without lithium chloride because of overgrowth by E. faecium. The growth of E. faecium decreased dramatically with increasing LiCl concentration; LiCl concentrations of 8 and 10 g/liter were completely bacteriostatic. The mechanism of inhibition by LiCl appeared to involve competition with the divalent cations Ca2+ and Mg2+. Heat-injured L. monocytogenes consistently recovered and grew rapidly in strictly anaerobic PSU broth containing 4, 6, or 7 g of LiCl per liter. The use of strictly anaerobic PSU broth containing 7 g of LiCl per liter permitted detection of severely heat-injured L. monocytogenes in one simple recovery-enrichment step by eliminating oxygen toxicity and inhibiting the growth of background microflora, without preventing the resuscitation and subsequent growth of heat-injured L. monocytogenes. L. monocytogenes heated in raw milk at 62.8 degrees C for 10, 15, and 20 min could be consistently recovered from strictly anaerobic PSU broth enrichment cultures at 30 degrees C after 48, 96, and 144 h, respectively, and hence, use of PSU broth may result in better recovery of both injured and noninjured cells from foods than currently used U.S. Department of Agriculture and Food and Drug Administration preenrichment procedures.

  7. 77 FR 61463 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2012-10-09

    ... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule...

  8. 75 FR 4635 - Risk-Based Capital Guidelines; Capital Adequacy Guidelines; Capital Maintenance: Regulatory...

    Science.gov (United States)

    2010-01-28

    ... would have on regulatory capital, the appropriateness of adjusting the risk-based capital treatment of... agencies' risk-based capital and leverage rules would increase regulatory capital requirements for banking... measure risk and allay the agencies' concerns regarding regulatory capital arbitrage (that is, the...

  9. 77 FR 61449 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2012-10-09

    ..., regulatory and other risks of this business activity. These controls include financial risk management... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...

  10. Novel microsatellite DNA markers indicate strict parthenogenesis and few genotypes in the invasive willow sawfly Nematus oligospilus.

    Science.gov (United States)

    Caron, V; Norgate, M; Ede, F J; Nyman, T; Sunnucks, P

    2013-02-01

    Invasive organisms can have major impacts on the environment. Some invasive organisms are parthenogenetic in their invasive range and, therefore, exist as a number of asexual lineages (=clones). Determining the reproductive mode of invasive species has important implications for understanding the evolutionary genetics of such species, more especially, for management-relevant traits. The willow sawfly Nematus oligospilus Förster (Hymenoptera: Tenthredinidae) has been introduced unintentionally into several countries in the Southern Hemisphere where it has subsequently become invasive. To assess the population expansion, reproductive mode and host-plant relationships of this insect, microsatellite markers were developed and applied to natural populations sampled from the native and expanded range, along with sequencing of the cytochrome-oxidase I mitochondrial DNA (mtDNA) region. Other tenthredinids across a spectrum of taxonomic similarity to N. oligospilus and having a range of life strategies were also tested. Strict parthenogenesis was apparent within invasive N. oligospilus populations throughout the Southern Hemisphere, which comprised only a small number of genotypes. Sequences of mtDNA were identical for all individuals tested in the invasive range. The microsatellite markers were used successfully in several sawfly species, especially Nematus spp. and other genera of the Nematini tribe, with the degree of success inversely related to genetic divergence as estimated from COI sequences. The confirmation of parthenogenetic reproduction in N. oligospilus and the fact that it has a very limited pool of genotypes have important implications for understanding and managing this species and its biology, including in terms of phenotypic diversity, host relationships, implications for spread and future adaptive change. It would appear to be an excellent model study system for understanding evolution of invasive parthenogens that diverge without sexual reproduction and

  11. Sporothrix schenckii (sensu strict S. globosa) mating type 1-2 (MAT1-2) gene.

    Science.gov (United States)

    Kano, Rui; Anzawa, Kazushi; Mochizuki, Takashi; Nishimoto, Katsutaro; Hiruma, Masataro; Kamata, Hiroshi; Hasegawa, Atsuhiko

    2013-09-01

    Sporotix schenckii is a pathogenic fungus that causes human and animal sporotrichosis, and based on morphology of the sessile conidia and molecular analysis, it was recently recognized as a species complex comprising at least the following six sibling species: S. albicans, S. brasiliensis, S. globosa, S. luriei, S. mexicana and S. schenckii. However, apart from S. schenckii sensu strict, only S. brasiliensis, S. globosa and S. luriei are associated with human and animal infection. S. globosa has been most commonly isolated in Asia, Europe and the USA; therefore, molecular epidemiological study for S. globosa is important in relation to human sporotrichosis in Japan. To the best of our knowledge, this is the first study to determine the mating type 1-2 (MAT1-2) gene of Sporothrix schenckii with the aim of understanding the taxonomy of the genus Sporothrix. The MAT1-2 gene (1618 bp) encodes a protein sequence of 198 amino acids. Reverse transcription polymerase chain reaction analysis also detected MAT1-2 gene mRNA expression in all of the S. schenckii strains examined, indicating that this gene is expressed in S. schenckii cells. Phylogenetic analysis of the MAT1-2 gene fragments of Ophiostoma himal-ulmi, O. novo-ulmi, O. ulmi and S. schenckii indicated that these isolates could be classified into four clusters. MAT1-1 gene-specific polymerase chain reaction was positive in 15 isolates, but negative in four human isolates and one feline isolate. © 2013 Japanese Dermatological Association.

  12. Changes in Frequency Intake of Foods in Patients Undergoing Sleeve Gastrectomy and Following a Strict Dietary Control.

    Science.gov (United States)

    Ruiz-Tovar, Jaime; Bozhychko, Maryana; Del-Campo, Jone Miren; Boix, Evangelina; Zubiaga, Lorea; Muñoz, Jose Luis; Llavero, Carolina

    2017-12-17

    Dietary intake and food preferences change after bariatric surgery, secondary to gastrointestinal symptoms and dietitian counseling. The aim of this study was to evaluate the changes in the frequency intake of different foods in patients undergoing sleeve gastrectomy and following a strict dietary control. A prospective observational study of all the morbidly obese patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure between 2007 and 2012 was performed. Dietary assessment was performed using the Alimentary Frequency Questionnaire 1991-2002, developed and validated by the Department of Epidemiology of Miguel Hernandez University (Elche, Alicante Spain). Ninety-three patients were included for analysis, 73 females and 20 males, with a mean preoperative BMI of 46.4 ± 7.9 kg/m 2 . One year after surgery, excess weight loss was 81.1 ± 8.3% and 5 years after surgery, 79.9 ± 6.4%. Total weight loss at 1 year was 38.8 ± 5.3% and at 5 years, 35.4 ± 4.9%. Postoperatively, a reduction in the intake of dairy products, red meat, deli meat products, shellfish, fried potatoes, sweets, rice, pasta, beer, and processed foods was observed. Vegetables, fruits, and legumes intake increased after surgery. In the first postoperative year, there was a slight intolerance to red meat, fruits, vegetables and legumes, dairy products, pasta, and rice that mostly disappeared 5 years after surgery. One year after sleeve gastrectomy, calibrated with a 50-French bougie, there are not important problems in the intake of foods a priori difficult to digest. These problems mostly disappeared 5 years after surgery. The decrease intake of other unhealthy foods is mostly based on the dietary counseling.

  13. Functional footprinting of regulatory DNA.

    Science.gov (United States)

    Vierstra, Jeff; Reik, Andreas; Chang, Kai-Hsin; Stehling-Sun, Sandra; Zhou, Yuanyue; Hinkley, Sarah J; Paschon, David E; Zhang, Lei; Psatha, Nikoletta; Bendana, Yuri R; O'Neil, Colleen M; Song, Alexander H; Mich, Andrea K; Liu, Pei-Qi; Lee, Gary; Bauer, Daniel E; Holmes, Michael C; Orkin, Stuart H; Papayannopoulou, Thalia; Stamatoyannopoulos, George; Rebar, Edward J; Gregory, Philip D; Urnov, Fyodor D; Stamatoyannopoulos, John A

    2015-10-01

    Regulatory regions harbor multiple transcription factor (TF) recognition sites; however, the contribution of individual sites to regulatory function remains challenging to define. We describe an approach that exploits the error-prone nature of genome editing-induced double-strand break repair to map functional elements within regulatory DNA at nucleotide resolution. We demonstrate the approach on a human erythroid enhancer, revealing single TF recognition sites that gate the majority of downstream regulatory function.

  14. Consistent Regulatory Policy under Uncertainty

    OpenAIRE

    Michael J. Brennan; Eduardo S. Schwartz

    1982-01-01

    This article is concerned with the effects of regulation on the risk and value of the regulated firm in a dynamic context. Current regulatory practice is shown to be logically deficient, since it ignores the effect of regulatory policy on the cost of capital and therefore on the appropriate allowed rate of return. A notion of consistency in regulatory policy is developed, and it is shown how consistent regulatory policies may be implemented once the valuation problem is solved.

  15. Nuclear Regulatory Commission information digest

    Energy Technology Data Exchange (ETDEWEB)

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  16. REQUIREMENTS FOR STORAGE AND TRANSPORT OF BIOTECHNOLOGICAL MEDICAL PRODUCTS IN ACCORDANCE WITH THE REGULATORY FRAMEWORK OF MINISTRY OF PUBLIC HEALTH OF UKRAINE AND DETECTION OF VIOLATIONS IN THE MEDICAL AND PHARMACEUTICAL INSTITUTIONS

    OpenAIRE

    Shukaeva O.

    2015-01-01

    Introduction. The rapid development of the pharmaceutical industry and the expansion of the range of biotech drugs require special conditions to ensure the quality, storage and transport through out the entire chain: manufacturer - distributor - pharmacy - hospital - the patient.We analyzed the current legislative frame work of Ministry of Public Health of Ukraine and conducted a study to identify and analyze of typical violations in the medical and pharmaceutical inst...

  17. 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

  18. 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

  19. Essays in Regulatory Economics

    OpenAIRE

    Guerrero, Santiago

    2011-01-01

    This dissertation consists of three essays. The objective of the essays is to study the impacts of different regulations on the behavior of regulated agents. The first two essays focus on the analysis of non-traditional regulatory policies that complement traditional regulations consisting of inspections and fines for plants that violate regulations. The third essay studies the impacts of the Minimum Legal Drinking Age regulation on alcohol and marijuana consumption. The first essay of this d...

  20. 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)

  1. 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

  2. 75 FR 21955 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... Part XXI National Credit Union Administration ###Semiannual Regulatory Agenda### [[Page 21956... Regulatory Agenda AGENCY: National Credit Union Administration (NCUA). ACTION: Semiannual regulatory agenda... included in the Unified Agenda of Federal Regulatory and Deregulatory Actions. DATES: This information is...

  3. Optimization of an effective growth medium for culturing probiotic bacteria for applications in strict vegetarian food products

    Directory of Open Access Journals (Sweden)

    Manju Pathak

    2012-10-01

    Full Text Available Background: This study aimed to modify de Man Rogosa Sharpe culture medium (termed MRS for selective cultivation of probiotics strain for the consumption by the strictly vegetarian human population. Vegetarian probiotic foods by definition must be free from all animal-derived ingredients. This not only includes the product ingredients but the probiotic inoculum as well. Probiotic starter cultures are traditionally grown and stored in media containing milk or meatderived ingredients. The presence of these ingredients makes the probiotic cell concentrates unsuitable for use in vegetarian products and thus creates the need for a growth medium which isfree from animal-derived ingredients. Present study investigated the growth of a strain of Lactobacillus lactis in MRS. The present invention relates in general to a bacterial culture media,and more specifically a complex microbial culture media, based on plant seed powder extract in place of animal extract for probiotic bacterial growth.Methods: Lactobacillus lactis, a probiotic, was grown in standard MRS culture medium as well as in our various test media (TM containing various vegetal source in place of beef extract, yeast extract and peptone as in case of MRS. The inoculated culture mediums were incubated at 37C for 72 hours and growth of probiotic is recorded at regular intervals. The growth was recorded as Colony Forming Units (CFUs.Results: The best growth of probiotic is observed in TM 2. TM 2 is the leguminous seed extract. Starter culture mediums for probiotics or other bacteria primarily contain protein from animal source. The possibility of using vegetal protein from TM 2 extract in place of peptones and meat extract for the nitrogen supplementation of culture media for the growth of lactic acid bacteria has been demonstrated.Functional Foods in Health and Disease 2012, 2(10:369-378 Conclusion: The absolute vegetarian culture medium containing TM 2 is better than standard MRS for the

  4. Lenient vs. strict rate control in patients with atrial fibrillation and heart failure: a post-hoc analysis of the RACE II study

    NARCIS (Netherlands)

    Mulder, Bart A.; van Veldhuisen, Dirk J.; Crijns, Harry J. G. M.; Tijssen, Jan G. P.; Hillege, Hans L.; Alings, Marco; Rienstra, Michiel; Groenveld, Hessel F.; van den Berg, Maarten P.; van Gelder, Isabelle C.

    2013-01-01

    It is unknown whether lenient rate control is an acceptable strategy in patients with AF and heart failure. We evaluated differences in outcome in patients with AF and heart failure treated with lenient or strict rate control. This post-hoc analysis of the RACE II trial included patients with an

  5. A Banach-Dieudonné theorem for the space of bounded continuous functions on a separable metric space with the strict topology

    NARCIS (Netherlands)

    Kraaij, R.C.

    2016-01-01

    Let X be a separable metric space and let β be the strict topology on the space of bounded continuous functions on X, which has the space of τ-additive Borel measures as a continuous dual space. We prove a Banach-Dieudonné type result for the space of bounded continuous functions equipped with β:

  6. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure - main report. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J.; McDuffie, P.N.

    1996-07-01

    The NRC staff is in need of updated bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System`s Washington Nuclear Plant Two (WNP-2), which is a boiling water reactor (BWR), located at Richland, Washington, including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a {open_quotes}green field{close_quotes} condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low- level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities. Sensitivity of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances is also examined.

  7. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure - appendices. Final report

    International Nuclear Information System (INIS)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J.; McDuffie, P.N.

    1996-07-01

    The NRC staff is in need of decommissioning bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System's Washington Nuclear Plant Two (WNP-2) located at Richland, Washington, including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clear structures on the site and to restore the site to a open-quotes green fieldclose quotes condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities. Sensitivity of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances is also examined

  8. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure - appendices. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J.; McDuffie, P.N.

    1996-07-01

    The NRC staff is in need of decommissioning bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System`s Washington Nuclear Plant Two (WNP-2) located at Richland, Washington, including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clear structures on the site and to restore the site to a {open_quotes}green field{close_quotes} condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities. Sensitivity of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances is also examined.

  9. Nuclear Regulatory Commission Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... material by adding specific requirements for licensing of and reporting by distributors of products and... applicable constraints of the exemptions. In addition, the amounts of source material allowed under the... of the Chief Financial Officer, Washington, DC 20555-0001 Phone: 301 415-7126 Email: rebecca.ericson...

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

    International Nuclear Information System (INIS)

    Wennerberg, Linda

    1992-01-01

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

  11. Establishing exemption and clearance criteria by the regulatory authority

    International Nuclear Information System (INIS)

    Salih, A.E.A.

    2012-04-01

    This Project work discusses the relationship between the concepts of exemption and clearance, and their practical use in the overall scheme of regulatory control of practices. It also discusses how exemptions and clearance is established and the scope of its applications for regulatory control. The concept of general clearance levels for any type of material and any possible pathway of disposal is also introduced in this work. Guidance of the Group of Experts establishing scenarios for general clearance, parameter values, and a nuclide-specific list of calculated clearance levels is also presented. Regulatory authorities are required to develop guidance on exemption and clearance levels to assist licensees and registrants to know which practices and sources within practices are exempted from regulatory control and those to be cleared from further controls. Exemption and clearance levels are tools for assisting the Regulatory Authority to optimize the use of resources. (author)

  12. 78 FR 1698 - Semiannual Regulatory Flexibility Agenda

    Science.gov (United States)

    2013-01-08

    ...: Regulatory Capital, Implementation of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, and...--Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory Capital Ratios... Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for More Resilient Banks and Banking Systems...

  13. A waste package strategy for regulatory compliance

    International Nuclear Information System (INIS)

    Stahl, D.; Cloninger, M.O.

    1990-01-01

    This paper summarizes the strategy given in the Site Characterization Plan for demonstrating compliance with the post closure performance objectives for the waste package and the Engineered Barrier System contained in the Code of Federal Regulations. The strategy consists of the development of a conservative waste package design that will meet the regulatory requirements with sufficient margin for uncertainty using a multi-barrier approach that takes advantage of the unsaturated nature of the Yucca Mountain site. 7 refs., 1 fig

  14. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2013-01-01

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

  15. 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...

  16. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

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

  17. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

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

    2017-09-01

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

  18. Assessment of regulatory effectiveness. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1999-09-01

    This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

  19. The "high solubility" definition of the current FDA Guidance on Biopharmaceutical Classification System may be too strict for acidic drugs.

    Science.gov (United States)

    Yazdanian, Mehran; Briggs, Katherine; Jankovsky, Corinne; Hawi, Amale

    2004-02-01

    The purpose of this study was to assess if the definition of high solubility as proposed in the FDA Guidance on Biopharmaceutical Classification System (BCS) is too strict for highly permeable acidic drugs. The solubility and permeability values of 20 (18 acidic and 2 non-acidic) nonsteroidal anti-inflammatory drugs (NSAID) were determined. The NSAIDs were grouped into three different sets having acetic acid, propionic acid, or other acidic moieties such as fenamate, oxicam, and salicylate. Two nonacidic NSAIDs (celecoxib and rofecoxib) were also included for comparison purposes. Equilibrium solubility values were determined at pH 1.2, 5.0, 7.4, and in biorelevant media simulating fed intestinal fluid at pH 5.0. For a select number of acids, we also measured solubility values in media simulating gastric and fasted intestinal fluids. Permeability classification was established relative to that of reference drugs in the Caco-2 cell permeability model. Permeability coefficients for all drugs were measured at concentrations corresponding to the lowest and highest marketed dose strengths dissolved in 250 ml volume, and their potential interaction with cellular efflux pumps was investigated. All NSAIDs with different acidic functional groups were classified as highly permeable based on their Caco-2 cell permeability. Only ketorolac appeared to have a potential for interaction with cellular efflux pumps. Solubility classification was based on comparison of equilibrium solubility at pH 1.2, 5.0. and 7.4 relative to marketed dose strengths in 250 ml. The pKa values for the acidic NSAIDs studied were between 3.5 and 5.1. and, as expected, their solubility increased dramatically at pH 7.4 compared to pH 1.2. Only three NSAIDs, ketorolac, ketoprofen. and acetyl salicylic acid, meet the current criteria for high solubility over the entire pH range. However, with the exception of ibuprofen, oxaprozin, and mefenamic acid, the remaining compounds can be classified as Class I drugs

  20. 78 FR 14306 - International Cooperation on Harmonisation of Technical Requirements for Registration of...

    Science.gov (United States)

    2013-03-05

    ...]; (Formerly Docket No. 00D-1631)] International Cooperation on Harmonisation of Technical Requirements for... for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for... regulatory authorities and industry associations to promote the international harmonization of regulatory...