WorldWideScience

Sample records for radiation regulatory agencies

  1. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    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...

  2. REGULATORY AGENCIES, CONSUMER AND ENVIROMENT

    Directory of Open Access Journals (Sweden)

    Giseli Valezi Raymundo

    2011-03-01

    Full Text Available The aim of this paper is to present the analysis on the insertion of the consumer in the current model of State in Brazil, considering the nowaday legal system. It is wished to be shown, moreover, the already existing reality on the theme, even if modest, so to in a way to question the responsibility of the consumer, according to its consuming habits and its inertia, takes in today’s technological society. To such proposal, the most effective research method, and, for this reason had been used in this paper, is the extensive bibliography research and legislation consultation. Through it, it had been found that the State model has changed over the past decades in order to delegate the execution of various activities of State ownership to private enterprise, in view of the existence of a minimal State and governor. In this sense, there were created the Regulatory Agencies, which are indirect public administration entities, with the ultimate objective of regulating and supervising the execution of those legal activities, performed by the private sector. The consumer, inserted in this reality, is the direct recipient of the action of the mentioned entities, questioning the legislative and sanction legitimacy of the regulatory entities as well as the possibility of judicial review on the merits of administrative actions of these entities and the applicability of the Brazilian Code of Defense of the Consumer (CDC to the execution of public services, a discipline that affects the administrative law rights. Notwithstanding the above analysis in context, all these social workers, consumers and regulatory agencies are immersed in changing habits, due to the optimization of actions, aimed at preserving the environment, the prospect of achieving sustainable development. Based on this perspective, the results brought by the survey showed that the application of the Brazilian Code of Defense of the Consumer in relations between consumers does not preclude

  3. The Political Communication of Independent Regulatory Agencies

    National Research Council Canada - National Science Library

    Puppis, Manuel; Maggetti, Martino; Gilardi, Fabrizio; Biela, Jan; Papadopoulos, Yannis

    2014-01-01

    .... In this context, public communication plays an important role. On the one hand, regulatory agencies might try to use communication to raise their accountability and thereby to mitigate their democratic deficit...

  4. Environmental Protection Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... for the environment, Administrator Jackson has outlined seven themes to focus the work of EPA. These... Radiation, C439-01, Research Triangle Park, NC 27711 Phone: 919 541-5426 Email: eddinger.jim@epamail.epa.gov..., Environmental Protection Agency, Air and Radiation, C439-01, Research Triangle Park, NC 27711 Phone: 919...

  5. The role of veterinary medicine regulatory agencies.

    Science.gov (United States)

    Smith, M V

    2013-08-01

    An effective animal medicine regulatory programme includes a systematic, evidence-based means of documenting the safety and effectiveness of products before they are produced, marketed or used in a particular country or region. The programme must also include adequate monitoring and controls over the use of these substances. It is clearthat such programmes provide veterinarians, farmers and other animal medicine users with greater assurance that veterinary drugs and biologicals will be safe and effective in preventing and mitigating disease. It is important that these regulatory controls include programmes to ensure that human food obtained from treated animals is safe and that all potential toxicological and microbiological hazards that may be associated with the use of veterinary medicines have been adequately evaluated. There is a great need worldwide for veterinary medicines that provide needed therapies for vast numbers of animals and animal species and, in the case of food-producing animals, for medicinal products that enhance the productivity and efficiency of food production and ensure food safety when they are used in accordance with their approval specifications. The public health mission of regulatory agencies succeeds when they are able to put into the hands of the user an approved, safe and effective, well-manufactured and appropriately labelled medicine, and when there are adequate controls in place to assure proper compliance.

  6. 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...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1990-12-31

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

  8. Radiation Enhances Regulatory T Cell Representation

    Energy Technology Data Exchange (ETDEWEB)

    Kachikwu, Evelyn L.; Iwamoto, Keisuke S.; Liao, Yu-Pei; DeMarco, John J.; Agazaryan, Nzhde [Department of Radiation Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA (United States); Economou, James S. [Department of Surgical Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA (United States); McBride, William H. [Department of Radiation Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA (United States); Schaue, Doerthe, E-mail: dschaue@mednet.ucla.edu [Department of Radiation Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA (United States)

    2011-11-15

    Purpose: Immunotherapy could be a useful adjunct to standard cytotoxic therapies such as radiation in patients with micrometastatic disease, although successful integration of immunotherapy into treatment protocols will require further understanding of how standard therapies affect the generation of antitumor immune responses. This study was undertaken to evaluate the impact of radiation therapy (RT) on immunosuppressive T regulatory (Treg) cells. Methods and Materials: Treg cells were identified as a CD4{sup +}CD25{sup hi}Foxp3{sup +} lymphocyte subset, and their fate was followed in a murine TRAMP C1 model of prostate cancer in mice with and without RT. Results: CD4{sup +}CD25{sup hi}Foxp3{sup +} Treg cells increased in immune organs after local leg or whole-body radiation. A large part, but not all, of this increase after leg-only irradiation could be ascribed to radiation scatter and Treg cells being intrinsically more radiation resistant than other lymphocyte subpopulations, resulting in their selection. Their functional activity on a per-cell basis was not affected by radiation exposure. Similar findings were made with mice receiving local RT to murine prostate tumors growing in the leg. The importance of the Treg cell population in the response to RT was shown by systemic elimination of Treg cells, which greatly enhanced radiation-induced tumor regression. Conclusions: We conclude that Treg cells are more resistant to radiation than other lymphocytes, resulting in their preferential increase. Treg cells may form an important homeostatic mechanism for tissues injured by radiation, and in a tumor context, they may assist in immune evasion during therapy. Targeting this population may allow enhancement of radiotherapeutic benefit through immune modulation.

  9. The Role of Regulatory Agencies and Intellectual Property: Part I.

    Science.gov (United States)

    Noonan, Kevin E

    2015-03-16

    The patent and regulatory regimes of different agencies of the federal government are not always in agreement, and although the concept of the "unified executive" holds that the executive branch speaks with one voice, that is not always the case.(1) Some agencies, like the Food and Drug Administration, tend toward cooperation with government patent policies, whereas others, notably the Federal Trade Commission, are often at odds with the Patent Office, the patent system, or both. These skirmishes, when they arise, eventually come before federal courts and ultimately the Supreme Court, where balancing the differing policy objectives, as well as the will of Congress as embodied in its statutes, is subject to the vagaries of the politics of how the issues are framed by the courts, and the judges' and justices' own predilections and prejudices. Examples of these situations were prevalent in 2013 and the circumstances surrounding them illustrative of the tensions inherent between the various federal agencies.

  10. Protection of people and environment from radiation risk through good regulatory practice

    Science.gov (United States)

    Jais, Azlina Mohammad; Hassan, Najwa

    2017-01-01

    The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

  11. Re-evaluation of Non-regulatory Asbestos Group Minerals for Regulatory Agencies

    Science.gov (United States)

    Dogan, M.; Dogan, A.

    2013-05-01

    Agencies should oversea "positive" identification guidelines followed closely for non-regulatory asbestos group minerals.

  12. Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

    Science.gov (United States)

    Hojo, Taisuke

    2017-01-01

     Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

  13. Radiation and the regulatory landscape of neo2-Darwinism.

    Science.gov (United States)

    Rollo, C David

    2006-05-11

    Several recently revealed features of eukaryotic genomes were not predicted by earlier evolutionary paradigms, including the relatively small number of genes, the very large amounts of non-functional code and its quarantine in heterochromatin, the remarkable conservation of many functionally important genes across relatively enormous phylogenetic distances, and the prevalence of extra-genomic information associated with chromatin structure and histone proteins. All of these emphasize a paramount role for regulatory evolution, which is further reinforced by recent perspectives highlighting even higher-order regulation governing epigenetics and development (EVO-DEVO). Modern neo2-Darwinism, with its emphasis on regulatory mechanisms and regulatory evolution provides new vision for understanding radiation biology, particularly because free radicals and redox states are central to many regulatory mechanisms and free radicals generated by radiation mimic and amplify endogenous signalling. This paper explores some of these aspects and their implications for low-dose radiation biology.

  14. Quantitative Characterization Guidelines of Erionite Series Minerals for Regulatory Agencies

    Science.gov (United States)

    Dogan, A.; Dogan, M.

    2013-05-01

    Erionite is a major health problem where contaminates an environment, which human population exists. Erionite - mesothelioma relationship was first observed in Turkey in 1980's and now the problem is emerging in other places in the world including Mexico. In the past, there have been in vivo or in vitro biological experiments performed using "not correctly characterized" erionite minerals. In addition, in 1997, the erionite was elevated to series status and new erionite minerals - erionite-Na, -K, -Ca - have been proposed. In 2008, erionite characterization guidelines have been proposed (Dogan and Dogan, 2008) and using these criteria, published data was re-evaluated and re-classified; and new mean chemical formula of erionite-Na, -K, -Ca was proposed. If data do not pass the E% and Mg-tests, then any reference to them in the literature is proposed to be disregarded. In some cases, different results have been reported for erionites from the same location by different authors. In these cases, if data do pass both tests but are characterized as from more than one type of erionite, then the mineral should be classified as "undifferentiated" until further clarification. Therefore, we propose (i) Erionite should be correctly characterized using proposed "positive" identification guidelines. (ii) Erionite species (whether it is -Na or -K or -Ca) should be correctly identified. (iii) There should be a close collaboration between medical community researchers and mineralogists in this field so that animal and cell experiments should be performed only with minerals that have passed "positive" identification tests. (iv) An international data bank should be established at one of the mineralogical societies and new data must be evaluated rigorously before being accepted. (v) Regulatory Agencies should ensure that the proposed guidelines for "positive" identification of erionite series minerals, both for a single fiber and a bulk mineral, are followed closely. (vi) Finally, the

  15. Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents.

    Science.gov (United States)

    Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

    2014-01-01

    The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

  16. LEGAL ASPECTS OF THE REGULATORY FRAMEWORK FOR CREDIT RATING AGENCIES

    Directory of Open Access Journals (Sweden)

    Oana Mihaela MARIOARA (ORHEIAN

    2014-06-01

    Full Text Available This article makes an analysis of the main regulations used by the credit rating agencies on the financial market. The article describes the main specific legislation on credit rating agencies existing on the market. Credit rating agencies are issuing independent opinions on the reliability of an entity, of a debt, of financial obligations, or of a certain financial instrument. The credit ratings issued by the credit rating agencies established in the European Union are analysed by investors, debtors, issuers and governments, helping all these entities in making any decisions on investments and financing. These ratings may also serve as reference for determining their own funds, necessary to ensure the solvency or reference helping the investors in assessing any risks related to their investment activities. Rating agencies and the products they offer on the international capital market are subject of various researches, which mainly refer to market structure and organization, to the architecture of agencies` s rating systems, to the rating functions, to the controversies concerning rating activity, the role of rating agencies and rating quality.

  17. Formal independence of regulatory agencies and Varieties of Capitalism

    DEFF Research Database (Denmark)

    Guardiancich, Igor; Guidi, Mattia

    2016-01-01

    The Varieties of Capitalism literature posits that national economic institutions reflect the mode of coordination of a country’s market actors. Despite the importance of this claim and a rich literature on the emergence of regulatory capitalism, few studies test such prediction for Independent...

  18. Role of regulatory agencies in translating pharmacogenetics to the clinics

    OpenAIRE

    Prasad, Krishna

    2009-01-01

    Overall, the regulators (here the term is used in the broad sense including competent authorities, the national departments of health and the European commission) have a significant role in translating pharmacogenomics into clinical practice. The first objective is to establish the role of the genomic information that is available, and this should be data driven. Conduct of robust clinical trials that are sound both scientifically and from a regulatory perspective should be encouraged. Signif...

  19. Analysis of Necessity of Transforming Electrical Grid Access Training and Examination Regulatory Agency Mode

    Institute of Scientific and Technical Information of China (English)

    JI Tuo; SUN Qi; ZHOU Wan-lan

    2016-01-01

    There are numerous electricians, but only a few of them have obtained certificate. Training and examination agencies provide services relating to training, examination, and certificate application and so on. Thus, training resources are not rationally utilized, and the increased training demand cannot be fully satisfied. Under such circumstances, it is recommended to transform the regulatory agency mode by establishing a scientific management process, and put forward a new mode of electrical grid access training and examination to better meet related demands. Under the coordination of examination center regulatory agency, uniform training program, training materials, charging standard, examination and certificate can be guaranteed. This project is carried out as an effort to improve the quality of electronic-engineering training and examination, so that electricity accident rate can be reduced, and the security of electrical grid operation can be guaranteed to boost the rapidly developing economy.

  20. Scientific foundation of regulating ionizing radiation: application of metrics for evaluation of regulatory science information.

    Science.gov (United States)

    Moghissi, A Alan; Gerraa, Vikrham Kumar; McBride, Dennis K; Swetnam, Michael

    2014-11-01

    This paper starts by describing the historical evolution of assessment of biologic effects of ionizing radiation leading to the linear non-threshold (LNT) system currently used to regulate exposure to ionizing radiation. The paper describes briefly the concept of Best Available Science (BAS) and Metrics for Evaluation of Scientific Claims (MESC) derived for BAS. It identifies three phases of regulatory science consisting of the initial phase, when the regulators had to develop regulations without having the needed scientific information; the exploratory phase, when relevant tools were developed; and the standard operating phase, when the tools were applied to regulations. Subsequently, an attempt is made to apply the BAS/MESC system to various stages of LNT. This paper then compares the exposure limits imposed by regulatory agencies and also compares them with naturally occurring radiation at several cities. Controversies about LNT are addressed, including judgments of the U.S. National Academies and their French counterpart. The paper concludes that, based on the BAS/MESC system, there is no disagreement between the two academies on the scientific foundation of LNT; instead, the disagreement is based on their judgment or speculation.

  1. PERFORMANCE OF REGULATORY AGENCIES IN ROAD CONCESSIONS IN BRAZIL: IMPLICATIONS OF THE AGENT-PRINCIPAL PROBLEM

    Directory of Open Access Journals (Sweden)

    Graciela Aparecida Profeta

    2016-05-01

    Full Text Available Public infrastructure services have been offered by private companies with state participation through sectoral regulatory agencies. However, due the existence of typical problems of Agent-Principal relationship that sign these arrangements, there are questions related to efficient performance of these agencies. In this sense, the objective was to present and discuss the intrinsic characteristics of the performance of the regulatory agencies, and how they are susceptible to political influence and capture problems. It was concluded that despite authorities with financial and administrative independence, there are important points of laxity in the agencies acting regime, especially those ones linked to the nomination / appointment of certain directors from their government and to budget subordination. These aspects indicate the possibility of capture and political influence, which can affect the efficiency in the sector. However, despite lack of reformulation and law enforcement, the performance of the agencies is important for ensuring efficiency because the highway concessions sector in Brazil is concentrated and this may allow the opportunistic behavior of firms and governments at the time of bidding.

  2. Measuring Cross-Sectorial Law Enforcement Capacity of Regulatory Agencies in Hungary

    Directory of Open Access Journals (Sweden)

    György GAJDUSCHEK

    2015-02-01

    Full Text Available The paper analyses the effectiveness of law enforcement by regulatory agencies in Hungary. Empirical data were collected from such diverse felds as consumer rights protection, construc-tion, road safety, labor regulation, etc. The data were analyzed using a simplifed rational choice model, looking for evidence of whether adminis-trative practices were effective in preventing ra-tional actors from breaking the law. The analysis robustly proves the ineffectiveness of regulatory activity, as the breaking of laws may yield, in a conservative estimate, 10 to 100,000 times more income than the expected monetary value of the fne. In brief, the government of Hungary is gen-erally unable to enforce its own laws. Though the paper makes use of data solely from Hungary, it aims to provide a methodology for measuring regulatory capacity more generally.

  3. What Can We Learn About Regulatory Agencies and Regulated Parties from the Empirical Study of Judicial Review of Regulatory Agencies’ Decisions? The Case of Croatia

    Directory of Open Access Journals (Sweden)

    Bajakić Ivana

    2016-05-01

    Full Text Available The purpose of this paper is to examine regulatory agencies and regulated parties in an empirical study of administrative disputes initiated against the decisions of regulatory agencies in Croatia. We first aim to provide an overview of the status and trend estimates regarding these disputes; second, to answer the question how well does the system work from the perspectives of both the plaintiffs and the regulatory agencies; third, to identify the problem areas and to compare these with problem areas identified by the authors studying the broader area of administrative judiciary in Croatia, and finally to compare efficiency level of regulatory agencies to other public authorities in confirming the legality of their decisions and actions. Data on all administrative disputes against 12 Croatian regulatory agencies’ decisions in the 17-year period between 1995 and 2011 are used to identify the main characteristics and trends relating to these disputes. Data for 2012 to 2013 was also examined to identify initial changes and emerging trends in the new administrative judiciary system resulting from fundamental legal reform as part of Croatia’s process of accession to the European Union in 2013. The results show these administrative disputes to be often costly and timely with modest outcome for the plaintiff and impressive success rate for the most of regulatory agencies.

  4. NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

    Science.gov (United States)

    Duda, Kristen; Scroggins. Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. 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 several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross-Agency

  5. 77 FR 41417 - Regulatory Science Considerations for Medical Countermeasure Radiation Biodosimetry Devices

    Science.gov (United States)

    2012-07-13

    ... performance evaluation challenges identified by FDA, (3) specific technology considerations in radiation... radiation biodosimeter be assessed? G. What challenges does the use of novel technologies bring to radiation... Radiation Biodosimetry Devices AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

  6. [Financial capital versus medical-industrial complex: challenges for the regulatory agencies].

    Science.gov (United States)

    Iriart, Celia

    2008-01-01

    This article presents the structural processes that consolidated under the hegemony of the financial capital in the 90s; the dispute between the financial capital operating in the health sector and the medical-industrial complex; the strategies used by the medical-industrial complex for regaining positions; and the challenges all these processes pose for the regulatory agencies. The problems the regulatory agencies are facing lie in two central processes: 1) the hegemony the financial capital reached in the 90s in the health sector through reforms aimed at deregulating the sector in order to facilitate its entrance; and 2) the repositioning of the medical-industrial complex since the mid 90s by radicalizing medicalization. This article is based on several studies conducted by the author using qualitative methods and quantitative secondary data for understanding the historical-situational context. The theoretical approach was based on Marx, Gramsci, Benasayag, Badiou, Testa and Merhy. The analyses of the most recent reforms induced by the medical-industrial complex were the result of a bibliographic and document review.

  7. Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies

    Science.gov (United States)

    Lehoux, Pascale; Miller, Fiona A.; Daudelin, Geneviève; Denis, Jean-Louis

    2017-01-01

    Background: New technologies constitute an important cost-driver in healthcare, but the dynamics that lead to their emergence remains poorly understood from a health policy standpoint. The goal of this paper is to clarify how entrepreneurs, investors, and regulatory agencies influence the value of emerging health technologies. Methods: Our 5-year qualitative research program examined the processes through which new health technologies were envisioned, financed, developed and commercialized by entrepreneurial clinical teams operating in Quebec’s (Canada) publicly funded healthcare system. Results: Entrepreneurs have a direct influence over a new technology’s value proposition, but investors actively transform this value. Investors support a technology that can find a market, no matter its intrinsic value for clinical practice or healthcare systems. Regulatory agencies reinforce the "double" value of a new technology—as a health intervention and as an economic commodity—and provide economic worth to the venture that is bringing the technology to market. Conclusion: Policy-oriented initiatives such as early health technology assessment (HTA) and coverage with evidence may provide technology developers with useful input regarding the decisions they make at an early stage. But to foster technologies that bring more value to healthcare systems, policy-makers must actively support the consideration of health policy issues in innovation policy.

  8. Access to regulatory data from the European Medicines Agency: the times they are a-changing.

    Science.gov (United States)

    Wieseler, Beate; McGauran, Natalie; Kerekes, Michaela F; Kaiser, Thomas

    2012-10-30

    Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs) to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed. In the case of the inhaled insulin Exubera, the manufacturer refused to cooperate and in 2007 we asked the European Medicines Agency (EMA) to provide the relevant CSRs, but EMA denied access. Other researchers have reported similar experiences.In 2010 EMA introduced a new policy on access to regulatory documents, including CSRs, and has also undertaken further steps. The new policy has already borne fruit: in 2011, by providing additional sections of relevant CSRs, EMA made an important contribution to a review of oseltamivir (Tamiflu).Unfortunately, speedy implementation of the new policy may be endangered. We define a CSR following the International Conference on Harmonisation (ICH) E3 guideline. Although this guideline requires individual patient data listings, it does not necessarily require that these listings be made available in a computer-readable format, as proposed by some regulators from EMA and other agencies. However, access to raw data in a computer-readable format poses additional problems; merging this issue with that of access to CSRs could hamper the relatively simple implementation of the EMA policy. Moreover, EMA plans to release CSRs only on request; we suggest making these documents routinely available on the EMA website.Public access to regulatory data also carries potential risks. In our view, the issue of patient confidentiality has been largely resolved by current European legislation. The risk of other problems, such as conflicts of interest (CoIs) of independent researchers or quality issues can be reduced by

  9. Access to regulatory data from the European Medicines Agency: the times they are a-changing

    Directory of Open Access Journals (Sweden)

    Wieseler Beate

    2012-10-01

    Full Text Available Abstract Systematic reviewers are increasingly trying to obtain regulatory clinical study reports (CSRs to correct for publication bias. For instance, our organization, the Institute for Quality and Efficiency in Health Care, routinely asks drug manufacturers to provide full CSRs of studies considered in health technology assessments. However, since cooperation is voluntary, CSRs are available only for a subset of studies analysed. In the case of the inhaled insulin Exubera, the manufacturer refused to cooperate and in 2007 we asked the European Medicines Agency (EMA to provide the relevant CSRs, but EMA denied access. Other researchers have reported similar experiences. In 2010 EMA introduced a new policy on access to regulatory documents, including CSRs, and has also undertaken further steps. The new policy has already borne fruit: in 2011, by providing additional sections of relevant CSRs, EMA made an important contribution to a review of oseltamivir (Tamiflu. Unfortunately, speedy implementation of the new policy may be endangered. We define a CSR following the International Conference on Harmonisation (ICH E3 guideline. Although this guideline requires individual patient data listings, it does not necessarily require that these listings be made available in a computer-readable format, as proposed by some regulators from EMA and other agencies. However, access to raw data in a computer-readable format poses additional problems; merging this issue with that of access to CSRs could hamper the relatively simple implementation of the EMA policy. Moreover, EMA plans to release CSRs only on request; we suggest making these documents routinely available on the EMA website. Public access to regulatory data also carries potential risks. In our view, the issue of patient confidentiality has been largely resolved by current European legislation. The risk of other problems, such as conflicts of interest (CoIs of independent researchers or quality issues

  10. Radiation and the regulatory landscape of neo{sup 2}-Darwinism

    Energy Technology Data Exchange (ETDEWEB)

    Rollo, C. David [Department of Biology, Life Sciences Building, 1280 Main St. West, Hamilton, Ont., Canada L8S 4K1 (Canada)]. E-mail: rollocd@mcmaster.ca

    2006-05-11

    Several recently revealed features of eukaryotic genomes were not predicted by earlier evolutionary paradigms, including the relatively small number of genes, the very large amounts of non-functional code and its quarantine in heterochromatin, the remarkable conservation of many functionally important genes across relatively enormous phylogenetic distances, and the prevalence of extra-genomic information associated with chromatin structure and histone proteins. All of these emphasize a paramount role for regulatory evolution, which is further reinforced by recent perspectives highlighting even higher-order regulation governing epigenetics and development (EVO-DEVO). Modern neo{sup 2}-Darwinism, with its emphasis on regulatory mechanisms and regulatory evolution provides new vision for understanding radiation biology, particularly because free radicals and redox states are central to many regulatory mechanisms and free radicals generated by radiation mimic and amplify endogenous signalling. This paper explores some of these aspects and their implications for low-dose radiation biology.

  11. An abuse of risk assessment: how regulatory agencies improperly adopted LNT for cancer risk assessment.

    Science.gov (United States)

    Calabrese, Edward J

    2015-04-01

    The Genetics Panel of the National Academy of Sciences' Committee on Biological Effects of Atomic Radiation (BEAR) recommended the adoption of the linear dose-response model in 1956, abandoning the threshold dose-response for genetic risk assessments. This recommendation was quickly generalized to include somatic cells for cancer risk assessment and later was instrumental in the adoption of linearity for carcinogen risk assessment by the Environmental Protection Agency. The Genetics Panel failed to provide any scientific assessment to support this recommendation and refused to do so when later challenged by other leading scientists. Thus, the linearity model used in cancer risk assessment was based on ideology rather than science and originated with the recommendation of the NAS BEAR Committee Genetics Panel. Historical documentation in support of these conclusions is provided in the transcripts of the Panel meetings and in previously unexamined correspondence among Panel members.

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

    NARCIS (Netherlands)

    W. Schultz; P. Valcke; K. Irion

    2014-01-01

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

  13. Dismantlement of nuclear facilities decommissioned from the Russian navy: Enhancing regulatory supervision of nuclear and radiation safety

    Energy Technology Data Exchange (ETDEWEB)

    Sneve, M.K.

    2013-03-01

    The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)

  14. U.S. Environmental Protection Agency's activities to prepare for regulatory and risk assessment applications of genomics information.

    Science.gov (United States)

    Benson, William H; Gallagher, Kathryn; McClintock, J Thomas

    2007-06-01

    Genomics is expected to have significant implications for risk assessment and regulatory decision making. Since 2002, the U.S. Environmental Protection Agency (EPA) has undertaken a number of cross-agency activities to further prepare itself to receive, interpret, and apply genomics information for risk assessment and regulatory purposes. These activities include: (1) the issuance of an Interim Genomics Policy on the use of genomics information in risk assessments and decision making, (2) the release of the 2004 Genomics White Paper, which outlines potential applications and implications of genomics for EPA, and (3) the recent release of the external review draft of the Interim Guidance on Microarray-Based Assays, which outlines data submission, quality, analysis, management, and training considerations for such data. This manuscript discusses these activities and more recent follow-up activities with the aim of further communicating these efforts to the broader scientific and stakeholder community.

  15. Status of contamination monitoring in radiation activities of National Atomic Energy Agency (NAEA) in Indonesia

    Energy Technology Data Exchange (ETDEWEB)

    Suhariyono, Gatot [National Atomic Energy Agency, Jakarta (Indonesia)

    1997-06-01

    National Atomic Energy Agency (NAEA) or Badan Tenaga Atom Nasional (BATAN) is a non departmental governmental agency, headed by a Director General who is directly responsible to the President. Center for Standardization and Radiation Safety Research (CSRSR) is one of the research centers within the deputy for the assessment of nuclear science and technology of the NAEA. The main task of the CSRSR is to implement research and development program, development and services in the field of radiation safety, standardization, dosimetry, radiation health as well as the application of nuclear techniques in medicine, according to the policy confirmed by the director general of BATAN. Task of radiation protection division is to set up programs and to develop radiation protection, personal monitoring system and radiation level of the working areas and their surroundings as well as dose limitation system, to carry out technical up grading of radiation protection officials skill and to help coping with radiation accident. The key factor on contamination monitoring is to reduce human error and mechanical failures. These problems can be achieved to the highest degree by developing knowledge and skill of staffs via trainings or courses on contamination and decontamination, so that they are hoped to become trained and qualified staffs. (G.K.)

  16. Aflatoxin control--how a regulatory agency managed risk from an unavoidable natural toxicant in food and feed.

    Science.gov (United States)

    Park, D L; Stoloff, L

    1989-04-01

    The control by the Food and Drug Administration (FDA) of aflatoxin, a relatively recently discovered, unavoidable natural contaminant produced by specific molds that invade a number of basic food and feedstuffs, provides an example of the varying forces that affect risk assessment and management by a regulatory Agency. This is the story of how the FDA responded to the initial discovery of a potential carcinogenic hazard to humans in a domestic commodity, to the developing information concerning the nature of the hazard, to the economic and political pressures that are created by the impact of natural forces on regulatory controls, and to the restraints of laws within which the Agency must work. This story covers four periods: the years of discovery and action decisions on the basis of meager knowledge and the fear of cancer; the years of tinkering on paper with the regulatory process, the years of digestion of the accumulating knowledge, and the application of that knowledge to actions forced by natural events; and an audit of the current status of knowledge about the hazard from aflatoxin, and proposals for regulatory control based on that knowledge.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-06-15

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

  18. NASA's Agency-Wide Strategy for Environmental Regulatory Risk Analysis and Communication

    Science.gov (United States)

    Scroggins, Sharon; Duda, Kristen

    2008-01-01

    This viewgraph presentation gives an overview of NASA's risk analysis communication programs associated with changing environmental policies. The topics include: 1) NASA Program Transition; 2) Principal Center for Regulatory Risk Analysis and Communication (RRAC PC); and 3) Regulatory Tracking and Communication Process.

  19. Multi-agency radiation survey and site investigation manual (MARSIM). Final report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-01

    The MARSSIM provides information on planning, conducting, evaluating, and documenting building surface and surface soil final status radiological surveys for demonstrating compliance with dose or risk-based regulations or standards. The MARSSIM is a multi-agency consensus document that was developed collaboratively by four Federal agencies having authority and control over radioactive materials: Department of Defense (DOD), Department of Energy (DOE), Environmental Protection Agency (EPA), and Nuclear Regulatory Commission (NRC). The MARSSIM`s objective is to describe a consistent approach for planning, performing, and assessing building surface and surface soil final status surveys to meet established dose or risk-based release criteria, while at the same time encouraging an effective use of resources.

  20. Agency rivalry in a shared regulatory space and its impact on social welfare

    DEFF Research Database (Denmark)

    Gedefaw Abate, Tenaw; Nielsen, Rasmus; Nielsen, Max

    2017-01-01

    powerful agency dictates policies in favor of its own agenda, even when such policies may not necessarily lead to optimal social welfare. In the case of aquaculture, higher relative power of a pro-environment agency leads to underdevelopment of the sector, as is the case in developed countries, whereas...

  1. The accountability of the brazilian regulatory agencies: the experience of the National Petroleum Agency; O controle externo das agencias reguladoras: o caso da Agencia Nacional do Petroleo

    Energy Technology Data Exchange (ETDEWEB)

    Pinto Junior, Helder Queiroz; Borges, Heloisa Lopes [Universidade Federal do Rio de Janeiro (UFRJ), RJ (Brazil). Inst. de Economia. Grupo de Economia da Energia

    2004-07-01

    During the reform process for which passed the Brazilian Oil and Gas Industry, the academic debate was centered mostly in the sectorial restructuring process, in the contract designs and regulatory environment for the industries in change, particularly the desired attributes of its institutions. The debate tends, in the present, to converge towards the existence of different possible combinations between market structures and institutional structures (the regulators among them) that would lead to a desirable result. Thus, the various characteristics and configurations, originally appointed as necessary conditions for the success of any reform, are not dealt with such great deference anymore. The hypothesis that the existence of a independent regulator is a determinant choice for the success of structural and institutional reforms was relaxed as general rule, but there are still strong economic reasons to justify the option, adopted in Brazil. The creation of the Oil National Agency (ANP), the Brazilian regulator for the Oil and Gas Industry is a recent phenomenon. And few studies specifically approach the issue of its accountability, institutional role that in Brazil is delegated mostly, but not exclusively, to the National Court of Accounts (Tribunal de Contas da Uniao). Therefore, the objective of this work will be to discuss the different possibilities of accountability over the ANP, evaluating the paper and the functions of the TCU and the forms of external control on the Agency, pointing out the possibilities, the impediments and the challenges, as well as the economic consequences to the Natural Gas Industry of the current configuration. (author)

  2. Upgrading of data acquisition software for centralized radiation monitoring system in Malaysian Nuclear Agency

    Science.gov (United States)

    Yussup, F.; Ibrahim, M. M.; Haris, M. F.; Soh, S. C.; Hasim, H.; Azman, A.; Razalim, F. A. A.; Yapp, R.; Ramli, A. A. M.

    2016-01-01

    With the growth of technology, many devices and equipments can be connected to the network and internet to enable online data acquisition for real-time data monitoring and control from monitoring devices located at remote sites. Centralized radiation monitoring system (CRMS) is a system that enables area radiation level at various locations in Malaysian Nuclear Agency (Nuklear Malaysia) to be monitored centrally by using a web browser. The Local Area Network (LAN) in Nuclear Malaysia is utilized in CRMS as a communication media for data acquisition of the area radiation levels from radiation detectors. The development of the system involves device configuration, wiring, network and hardware installation, software and web development. This paper describes the software upgrading on the system server that is responsible to acquire and record the area radiation readings from the detectors. The recorded readings are called in a web programming to be displayed on a website. Besides the main feature which is acquiring the area radiation levels in Nuclear Malaysia centrally, the upgrading involves new features such as uniform time interval for data recording and exporting, warning system and dose triggering.

  3. Upgrading of data acquisition software for centralized radiation monitoring system in Malaysian Nuclear Agency

    Energy Technology Data Exchange (ETDEWEB)

    Yussup, F., E-mail: nolida@nm.gov.my; Ibrahim, M. M., E-mail: maslina-i@nm.gov.my; Soh, S. C.; Hasim, H. [Instrumentation and Automation Centre, Technical Support Division, Malaysian Nuclear Agency, Bangi, 43000 Kajang. Selangor (Malaysia); Haris, M. F. [Information Technology Centre, Technical Support Division, Malaysian Nuclear Agency, Bangi, 43000 Kajang. Selangor (Malaysia); Azman, A. [Prototype and Development Centre, Technical Support Division, Malaysian Nuclear Agency, Bangi, 43000 Kajang. Selangor (Malaysia); Razalim, F. A. A.; Yapp, R. [Health Physics Group, Radiation Safety and Health Division, Malaysian Nuclear Agency, Bangi, 43000 Kajang. Selangor (Malaysia); Ramli, A. A. M. [Technical Support Division, Malaysian Nuclear Agency, Bangi, 43000 Kajang. Selangor (Malaysia)

    2016-01-22

    With the growth of technology, many devices and equipments can be connected to the network and internet to enable online data acquisition for real-time data monitoring and control from monitoring devices located at remote sites. Centralized radiation monitoring system (CRMS) is a system that enables area radiation level at various locations in Malaysian Nuclear Agency (Nuklear Malaysia) to be monitored centrally by using a web browser. The Local Area Network (LAN) in Nuclear Malaysia is utilized in CRMS as a communication media for data acquisition of the area radiation levels from radiation detectors. The development of the system involves device configuration, wiring, network and hardware installation, software and web development. This paper describes the software upgrading on the system server that is responsible to acquire and record the area radiation readings from the detectors. The recorded readings are called in a web programming to be displayed on a website. Besides the main feature which is acquiring the area radiation levels in Nuclear Malaysia centrally, the upgrading involves new features such as uniform time interval for data recording and exporting, warning system and dose triggering.

  4. The regulatory effects of low-dose ionizing radiation on Ikaros-autotaxin interaction

    Energy Technology Data Exchange (ETDEWEB)

    Kang, Hana; Cho, Seong Jun; Kim, Sung Jin; Nam, Seon Young; Yang, Kwang Hee [KHNP Radiation Health Institute, Korea Hydro and Nuclear Power Co, Seoul (Korea, Republic of)

    2016-11-15

    Ikaros, a transcription factor containing zinc-finger motif, has known as a critical regulator of hematopoiesis in immune system. Ikaros protein modulates the transcription of target genes via binding to the regulatory elements of the genes promoters. However the regulatory function of Ikaros in other organelle except nuclear remains to be determined. This study explored radiation-induced modulatory function of Ikaros in cytoplasm. The results showed that Ikaros protein lost its DNA binding ability after LDIR (low-dose ionizing radiation) exposure. Cell fractionation and Western blot analysis showed that Ikaros protein was translocated into cytoplasm from nuclear by LDIR. This was confirmed by immunofluorescence assay. We identified Autotaxin as a novel protein which potentially interacts with Ikaros through in vitro protein-binding screening. Co-immunoprecipitation assay revealed that Ikaros and Autotaxin are able to bind each other. Autotaxin is a crucial enzyme generating lysophosphatidic acid (LPA), a phospholipid mediator, which has potential regulatory effects on immune cell growth and motility. Our results indicate that LDIR potentially regulates immune system via protein-protein interaction of Ikaros and Autotaxin.

  5. Ionizing radiation selectively reduces skin regulatory T cells and alters immune function.

    Directory of Open Access Journals (Sweden)

    Yu Zhou

    Full Text Available The skin serves multiple functions that are critical for life. The protection from pathogens is achieved by a complicated interaction between aggressive effectors and controlling functions that limit damage. Inhomogeneous radiation with limited penetration is used in certain types of therapeutics and is experienced with exposure to solar particle events outside the protection of the Earth's magnetic field. This study explores the effect of ionizing radiation on skin immune function. We demonstrate that radiation, both homogeneous and inhomogeneous, induces inflammation with resultant specific loss of regulatory T cells from the skin. This results in a hyper-responsive state with increased delayed type hypersensitivity in vivo and CD4+ T cell proliferation in vitro. The effects of inhomogeneous radiation to the skin of astronauts or as part of a therapeutic approach could result in an unexpected enhancement in skin immune function. The effects of this need to be considered in the design of radiation therapy protocols and in the development of countermeasures for extended space travel.

  6. Ionizing Radiation Selectively Reduces Skin Regulatory T Cells and Alters Immune Function

    Science.gov (United States)

    Zhou, Yu; Ni, Houping; Balint, Klara; Sanzari, Jenine K.; Dentchev, Tzvete; Diffenderfer, Eric S.; Wilson, Jolaine M.; Cengel, Keith A.; Weissman, Drew

    2014-01-01

    The skin serves multiple functions that are critical for life. The protection from pathogens is achieved by a complicated interaction between aggressive effectors and controlling functions that limit damage. Inhomogeneous radiation with limited penetration is used in certain types of therapeutics and is experienced with exposure to solar particle events outside the protection of the Earth’s magnetic field. This study explores the effect of ionizing radiation on skin immune function. We demonstrate that radiation, both homogeneous and inhomogeneous, induces inflammation with resultant specific loss of regulatory T cells from the skin. This results in a hyper-responsive state with increased delayed type hypersensitivity in vivo and CD4+ T cell proliferation in vitro. The effects of inhomogeneous radiation to the skin of astronauts or as part of a therapeutic approach could result in an unexpected enhancement in skin immune function. The effects of this need to be considered in the design of radiation therapy protocols and in the development of countermeasures for extended space travel. PMID:24959865

  7. Mapping knowledge investments in the aftermath of Hurricane Katrina: a new approach for assessing regulatory agency responses to environmental disaster

    Energy Technology Data Exchange (ETDEWEB)

    Frickel, Scott [Department of Sociology, 213 Wilson Hall, Washington State University, Pullman, WA 99164-4020 (United States)], E-mail: frickel@wsu.edu; Campanella, Richard [Center for Bioenvironmental Research, Alcee Fortier Hall, Tulane University, New Orleans, LA 70118 (United States); Vincent, M. Bess [Department of Sociology, 220 Newcomb Hall, Tulane University, New Orleans, LA 70118 (United States)

    2009-04-15

    In the aftermath of large-scale disasters, the public's dependency on federal and state agencies for information about public safety and environmental risk is acute. While formal rules and procedures are in place to guide policy decisions in environmental risk assessment of spatially concentrated hazards such as regulated waste sites or vacant city lots, standard procedures for risk assessment seem potentially less well-suited for urban-scale disaster zones where environmental hazards may be widely dispersed and widely varying. In this paper we offer a new approach for the social assessment of regulatory science in response to large-scale disaster, illustrating our methodology through a socio-spatial analysis of the U.S. Environmental Protection Agency's (EPA) hazard assessment in New Orleans, Louisiana, following Hurricane Katrina in 2005. We find that the agency's commitment of epistemic resources or 'knowledge investments' varied considerably across the flood-impacted portion of the city, concentrating in poorer and disproportionately African American neighborhoods previously known to be heavily contaminated. We address some of the study's social and policy implications, noting the multidimensionality and interactive nature of knowledge investments and the prospects for deepening and extending this approach through comparative research.

  8. Desenho e funcionamento dos mecanismos de controle e accountability das agências reguladoras brasileiras: semelhanças e diferenças Design and operation of the Brazilian regulatory agencies' control and accountability mechanisms: similarities and differences

    National Research Council Canada - National Science Library

    Marcos Vinicius Pó; Fernando Luiz Abrucio

    2006-01-01

    ... agências reguladoras provoca na accountability do Estado brasileiro.This article studies the design and operation of the regulatory agencies' control and accountability mechanisms, underlining...

  9. The planning, construction, and operation of a radioactive waste storage facility for an Australian state radiation regulatory authority

    Energy Technology Data Exchange (ETDEWEB)

    Wallace, J.D.; Kleinschmidt, R.; Veevers, P. [Radiation Health, Queensland (Australia)

    1995-12-31

    Radiation regulatory authorities have a responsibility for the management of radioactive waste. This, more often than not, includes the collection and safe storage of radioactive sources in disused radiation devices and devices seized by the regulatory authority following an accident, abandonment or unauthorised use. The public aversion to all things radioactive, regardless of the safety controls, together with the Not In My Back Yard (NIMBY) syndrome combine to make the establishment of a radioactive materials store a near impossible task, despite the fact that such a facility is a fundamental tool for regulatory authorities to provide for the radiation safety of the public. In Queensland the successful completion and operational use of such a storage facility has taken a total of 8 years of concerted effort by the staff of the regulatory authority, the expenditure of over $2 million (AUS) not including regulatory staff costs and the cost of construction of an earlier separate facility. This paper is a summary of the major developments in the planning, construction and eventual operation of the facility including technical and administrative details, together with the lessons learned from the perspective of the overall project.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2002-05-31

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

  11. Review of the International Atomic Energy Agency International database on reactor pressure vessel materials and US Nuclear Regulatory Commission/Oak Ridge National Laboratory embrittlement data base

    Energy Technology Data Exchange (ETDEWEB)

    Wang, J.A.; Kam, F.B.K.

    1998-02-01

    The International Atomic Energy Agency (IAEA) has supported neutron radiation effects information exchange through meetings and conferences since the mid-1960s. Through an International Working Group on Reliability of Reactor Pressure Components, information exchange and research activities were fostered through the Coordinated Research Program (CRP) sponsored by the IAEA. The final CRP meeting was held in November 1993, where it was recommended that the IAEA coordinate the development of an International Database on Reactor Pressure Vessel Material (IDRPVM) as the first step in generating an International Database on Aging Management. The purpose of this study was to provide special technical assistance to the NRC in monitoring and evaluating the IAEA activities in developing the IAEA IDRPVM, and to compare the IDRPVM with the Nuclear Regulatory Commission (NRC) - Oak Ridge National Laboratory (ORNL) Power Reactor Embrittlement Data Base (PR-EDB) and provide recommendations for improving the PR-EDB. A first test version of the IDRPVM was distributed at the First Meeting of Liaison Officers to the IAEA IDRPVM, in November 1996. No power reactor surveillance data were included in this version; the testing data were mainly from CRP Phase III data. Therefore, because of insufficient data and a lack of power reactor surveillance data received from the IAEA IDRPVM, the comparison is made based only on the structure of the IDRPVM. In general, the IDRPVM and the EDB have very similar data structure and data format. One anticipates that because the IDRPVM data will be collected from so many different sources, quality assurance of the data will be a difficult task. The consistency of experimental test results will be an important issue. A very wide spectrum of material characteristics of RPV steels and irradiation environments exists among the various countries. Hence the development of embrittlement prediction models will be a formidable task. 4 refs., 2 figs., 4 tabs.

  12. The science of value: Economic expertise and the valuation of human life in US federal regulatory agencies.

    Science.gov (United States)

    Hood, Katherine

    2017-08-01

    This article explores efforts to apply economic logic to human life. To do so, it looks at federal regulatory agencies, where government planners and policy makers have spent over a century trying to devise a scientifically sound way to measure the economic value of lives lost or saved by public programs. The methods they have drawn on, however, have changed drastically in the past 40 years, shifting from a 'human capital' approach based on models of economic productivity and producing relatively low dollar values to a 'willingness-to-pay' approach reflecting consumer choice and producing much higher values. Why, in an era of intense deregulatory pressures, did the valuation model that produced significantly higher estimates - making it easier to justify costly regulation - ultimately win out? This unlikely transition follows a shift in the nature of professional expertise dominating the federal bureaucracy during the 1970s and 1980s, as changing conceptions of health and safety regulation during this period gave academic economists the opportunity to make new claims about the exclusive authority of microeconomic theory for understanding the economic value of life in federal planning. Supporting this argument is a comparative case, the largely unsuccessful attempt to extend the willingness-to-pay model to the valuation of life in the courtroom. Pricing human life thus results not only from the renegotiation of moral boundaries around the economic logic of the market, but also from the reorganization of expert authority and the consolidation of scientific expertise around both the meaning and the measurement of value.

  13. The International Atomic Energy Agency's activities in radiation medicine and cancer: promoting global health through diplomacy.

    Science.gov (United States)

    Deatsch-Kratochvil, Amanda N; Pascual, Thomas Neil; Kesner, Adam; Rosenblatt, Eduardo; Chhem, Rethy K

    2013-02-01

    Global health has been an issue of seemingly low political importance in comparison with issues that have direct bearing on countries' national security. Recently, health has experienced a "political revolution" or a rise in political importance. Today, we face substantial global health challenges, from the spread of infectious disease, gaps in basic maternal and child health care, to the globalization of cancer. A recent estimate states that the "overall lifetime risk of developing cancer (both sexes) is expected to rise from more than one in three to one in two by 2015." These issues pose significant threats to international health security. To successfully combat these grave challenges, the international community must embrace and engage in global health diplomacy, defined by scholars Thomas Novotny and Vicanne Adams as a political activity aimed at improving global health, while at the same time maintaining and strengthening international relations. The IAEA (International Atomic Energy Agency) is an international organization with a unique mandate to "accelerate and enlarge the contribution of atomic energy to peace, health, and prosperity throughout the world." This article discusses global health diplomacy, reviews the IAEA's program activities in human health by focusing on radiation medicine and cancer, and the peaceful applications of atomic energy within the context of global health diplomacy.

  14. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    Science.gov (United States)

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  15. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

    Science.gov (United States)

    Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-02-07

     To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the

  16. Radiation safety during remediation of the SevRAO facilities: 10 years of regulatory experience.

    Science.gov (United States)

    Sneve, M K; Shandala, N; Kiselev, S; Simakov, A; Titov, A; Seregin, V; Kryuchkov, V; Shcheblanov, V; Bogdanova, L; Grachev, M; Smith, G M

    2015-09-01

    In compliance with the fundamentals of the government's policy in the field of nuclear and radiation safety approved by the President of the Russian Federation, Russia has developed a national program for decommissioning of its nuclear legacy. Under this program, the State Atomic Energy Corporation 'Rosatom' is carrying out remediation of a Site for Temporary Storage of spent nuclear fuel (SNF) and radioactive waste (RW) at Andreeva Bay located in Northwest Russia. The short term plan includes implementation of the most critical stage of remediation, which involves the recovery of SNF from what have historically been poorly maintained storage facilities. SNF and RW are stored in non-standard conditions in tanks designed in some cases for other purposes. It is planned to transport recovered SNF to PA 'Mayak' in the southern Urals. This article analyses the current state of the radiation safety supervision of workers and the public in terms of the regulatory preparedness to implement effective supervision of radiation safety during radiation-hazardous operations. It presents the results of long-term radiation monitoring, which serve as informative indicators of the effectiveness of the site remediation and describes the evolving radiation situation. The state of radiation protection and health care service support for emergency preparedness is characterized by the need to further study the issues of the regulator-operator interactions to prevent and mitigate consequences of a radiological accident at the facility. Having in mind the continuing intensification of practical management activities related to SNF and RW in the whole of northwest Russia, it is reasonable to coordinate the activities of the supervision bodies within a strategic master plan. Arrangements for this master plan are discussed, including a proposed programme of actions to enhance the regulatory supervision in order to support accelerated mitigation of threats related to the nuclear legacy in the

  17. The regulatory effects of radiation and histone deacetylase inhibitor on liver cancer cell cycle

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sung Ho; Choi, Hyung Seok; Jang, Dong Gun; Lee, Hong Je; Yang, Seoung Oh [Dept. Nuclear Medicine, Dongnam Institute of Radiological and Medicine Sciences Cancer Center, Busan (Korea, Republic of)

    2013-11-15

    Radiation has been an effective tool for treating cancer for a long time. Radiation therapy induces DNA damage within cancer cells and destroys their ability to reproduce. Radiation therapy is often combined with other treatments, like surgery and chemotherapy. Here, we describe the effects of radiation and histone deacetylase inhibitor, Trichostain A, on cell cycle regulation in hepatoma cells. Results demonstrate that the treatment of radiation TSA induces cell cycle arrest, thereby stimulating cell death in hepatoma cells. In addition, since different cells or tissues have different reactivity to radiation and TSA, these results might be an indicator for the combination therapy with radiation and drugs in diverse cancers.

  18. 2015 White Paper on recent issues in bioanalysis: focus on new technologies and biomarkers (Part 2 - hybrid LBA/LCMS and input from regulatory agencies).

    Science.gov (United States)

    Ackermann, Brad; Neubert, Hendrik; Hughes, Nicola; Garofolo, Fabio; Abberley, Lee; Alley, Stephen C; Brown-Augsburger, Patricia; Bustard, Mark; Chen, Lin-Zhi; Heinrich, Julia; Katori, Noriko; Kaur, Surinder; Kirkovsky, Leo; Laterza, Omar F; Le Blaye, Olivier; Lévesque, Ann; Santos, Gustavo Mendes Lima; Olah, Timothy; Savoie, Natasha; Skelly, Michael; Spitz, Susan; Szapacs, Matthew; Tampal, Nilufer; Wang, Jian; Welink, Jan; Wieling, Jaap; Haidar, Sam; Vinter, Stephen; Whale, Emma; Witte, Bärbel

    2015-12-01

    The 2015 9th Workshop on Recent Issues in Bioanalysis (9th WRIB) took place in Miami, Florida with participation of over 600 professionals from pharmaceutical and biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. It is once again a 5-day week long event - a full immersion bioanalytical week - specifically designed to facilitate sharing, reviewing, discussing and agreeing on approaches to address the most current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches including the focus on biomarkers and immunogenicity. This 2015 White Paper encompasses recommendations that emerged from the extensive discussions held during the workshop, and is aimed at providing the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to advance scientific excellence, improve quality and deliver better regulatory compliance. Due to its length, the 2015 edition of this comprehensive White Paper has been divided into three parts. Part 2 covers the recommendations for hybrid LBA/LCMS and regulatory agencies' inputs. Part 1 (small molecule bioanalysis using LCMS) and Part 3 (large molecule bioanalysis using LBA, biomarkers and immunogenicity) will be published in volume 7 of Bioanalysis, issues 22 and 24, respectively.

  19. Combination Effect of Regulatory T-Cell Depletion and Ionizing Radiation in Mouse Models of Lung and Colon Cancer

    Energy Technology Data Exchange (ETDEWEB)

    Son, Cheol-Hun [Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of); Department of Biochemistry, Pusan National University School of Medicine, Yangsan (Korea, Republic of); Bae, Jae-Ho [Department of Biochemistry, Pusan National University School of Medicine, Yangsan (Korea, Republic of); Shin, Dong-Yeok; Lee, Hong-Rae; Jo, Wol-Soon; Yang, Kwangmo [Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of); Park, You-Soo, E-mail: biotek01@hanmail.net [Dongnam Institute of Radiological and Medical Sciences, Busan (Korea, Republic of)

    2015-06-01

    Purpose: To investigate the potential of low-dose cyclophosphamide (LD-CTX) and anti-CD25 antibody to prevent activation of regulatory T cells (Tregs) during radiation therapy. Methods and Materials: We used LD-CTX and anti-CD25 monoclonal antibody as a means to inhibit Tregs and improve the therapeutic effect of radiation in a mouse model of lung and colon cancer. Mice were irradiated on the tumor mass of the right leg and treated with LD-CTX and anti-CD25 antibody once per week for 3 weeks. Results: Combined treatment of LD-CTX or anti-CD25 antibody with radiation significantly decreased Tregs in the spleen and tumor compared with control and irradiation only in both lung and colon cancer. Combinatorial treatments resulted in a significant increase in the effector T cells, longer survival rate, and suppressed irradiated and distal nonirradiated tumor growth. Specifically, the combinatorial treatment of LD-CTX with radiation resulted in outstanding regression of local and distant tumors in colon cancer, and almost all mice in this group survived until the end of the study. Conclusions: Our results suggest that Treg depletion strategies may enhance radiation-mediated antitumor immunity and further improve outcomes after radiation therapy.

  20. 75 FR 54917 - Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency...

    Science.gov (United States)

    2010-09-09

    ... annual Agency Action Review Meeting (AARM). The AARM is an integral part of the evaluative process used... investigation team (IIT) or augmented inspection team (AIT)); or (3) Performance Trend-- Licensee has...

  1. Web design and development for centralize area radiation monitoring system in Malaysian Nuclear Agency

    Science.gov (United States)

    Ibrahim, Maslina Mohd; Yussup, Nolida; Haris, Mohd Fauzi; Soh @ Shaari, Syirrazie Che; Azman, Azraf; Razalim, Faizal Azrin B. Abdul; Yapp, Raymond; Hasim, Harzawardi; Aslan, Mohd Dzul Aiman

    2017-01-01

    One of the applications for radiation detector is area monitoring which is crucial for safety especially at a place where radiation source is involved. An environmental radiation monitoring system is a professional system that combines flexibility and ease of use for data collection and monitoring. Nowadays, with the growth of technology, devices and equipment can be connected to the network and Internet to enable online data acquisition. This technology enables data from the area monitoring devices to be transmitted to any place and location directly and faster. In Nuclear Malaysia, area radiation monitor devices are located at several selective locations such as laboratories and radiation facility. This system utilizes an Ethernet as a communication media for data acquisition of the area radiation levels from radiation detectors and stores the data at a server for recording and analysis. This paper discusses on the design and development of website that enable all user in Nuclear Malaysia to access and monitor the radiation level for each radiation detectors at real time online. The web design also included a query feature for history data from various locations online. The communication between the server's software and web server is discussed in detail in this paper.

  2. Regulatory T Cells Promote β-Catenin–Mediated Epithelium-to-Mesenchyme Transition During Radiation-Induced Pulmonary Fibrosis

    Energy Technology Data Exchange (ETDEWEB)

    Xiong, Shanshan; Pan, Xiujie; Xu, Long; Yang, Zhihua [Beijing Institute of Radiation Medicine, Beijing (China); Guo, Renfeng [Department of Pathology, University of Michigan Medical School, Ann Arbor, Michigan (United States); Gu, Yongqing; Li, Ruoxi; Wang, Qianjun; Xiao, Fengjun; Du, Li; Zhou, Pingkun [Beijing Institute of Radiation Medicine, Beijing (China); Zhu, Maoxiang, E-mail: zhumx@nic.bmi.ac.cn [Beijing Institute of Radiation Medicine, Beijing (China)

    2015-10-01

    Purpose: Radiation-induced pulmonary fibrosis results from thoracic radiation therapy and severely limits radiation therapy approaches. CD4{sup +}CD25{sup +}FoxP3{sup +} regulatory T cells (Tregs) as well as epithelium-to-mesenchyme transition (EMT) cells are involved in pulmonary fibrosis induced by multiple factors. However, the mechanisms of Tregs and EMT cells in irradiation-induced pulmonary fibrosis remain unclear. In the present study, we investigated the influence of Tregs on EMT in radiation-induced pulmonary fibrosis. Methods and Materials: Mice thoraxes were irradiated (20 Gy), and Tregs were depleted by intraperitoneal injection of a monoclonal anti-CD25 antibody 2 hours after irradiation and every 7 days thereafter. Mice were treated on days 3, 7, and 14 and 1, 3, and 6 months post irradiation. The effectiveness of Treg depletion was assayed via flow cytometry. EMT and β-catenin in lung tissues were detected by immunohistochemistry. Tregs isolated from murine spleens were cultured with mouse lung epithelial (MLE) 12 cells, and short interfering RNA (siRNA) knockdown of β-catenin in MLE 12 cells was used to explore the effects of Tregs on EMT and β-catenin via flow cytometry and Western blotting. Results: Anti-CD25 antibody treatment depleted Tregs efficiently, attenuated the process of radiation-induced pulmonary fibrosis, hindered EMT, and reduced β-catenin accumulation in lung epithelial cells in vivo. The coculture of Tregs with irradiated MLE 12 cells showed that Tregs could promote EMT in MLE 12 cells and that the effect of Tregs on EMT was partially abrogated by β-catenin knockdown in vitro. Conclusions: Tregs can promote EMT in accelerating radiation-induced pulmonary fibrosis. This process is partially mediated through β-catenin. Our study suggests a new mechanism for EMT, promoted by Tregs, that accelerates radiation-induced pulmonary fibrosis.

  3. 44 CFR Appendix A to Part 353 - Memorandum of Understanding Between Federal Emergency Management Agency and Nuclear Regulatory...

    Science.gov (United States)

    2010-10-01

    ... Permit process; (3) adoption of FEMA exercise time-frames; (4) incorporation of FEMA definition of... responsibility, NRC will recognize FEMA as the interface with State and local governments for interpreting... interpretations of agreed joint guidance) prior to adoption as formal agency guidance. F. Support for...

  4. Radiation Protection

    Science.gov (United States)

    ... EPA United States Environmental Protection Agency Search Search Radiation Protection Share Facebook Twitter Google+ Pinterest Contact Us Radiation Protection Document Library View and download EPA radiation ...

  5. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)

    Science.gov (United States)

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products. PMID:28280742

  6. Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA).

    Science.gov (United States)

    do Carmo, Ana Cerúlia Moraes; Piras, Stefânia Schimaneski; Rocha, Nayrton Flávio Moura; Gratieri, Tais

    2017-01-01

    Objective. The marketing authorization of generic and similar pharmaceutical drug products involves the analysis of proposing company's administrative aspects as well as drug product technical description and scientific evaluations. This study evaluated the main reasons for registration refusal of generic and similar pharmaceutical drug products in Brazil. The aim is to help future applicants to better organize the proposal. Methods. A retrospective search of drug products registration processes was performed on the Brazilian Government Official Gazette from January 1, 2015, and December 31, 2015. Results. Drug product quality control, drug product stability study, deadline accomplishment, API quality control made by drug manufacturer, active pharmaceutical ingredient (API), and production report were the main reasons for marketing authorization application refusal of generic and similar pharmaceutical drug products in 2015. Conclusion. Disclosure of the reasons behind failed applications is a step forward on regulatory transparency. Sharing of experiences is essential to international regulatory authorities and organizations to improve legislation requirements for the marketing authorization of generic and similar pharmaceutical drug products.

  7. Public hearings as a tool to improve participation in regulatory policies: case study of the National Agency of Electric Energy

    Directory of Open Access Journals (Sweden)

    Camila Moreira de Castro

    2013-10-01

    Full Text Available The participation of citizens in public policies is an opportunity not only to educate them, but also to increase their empowerment. However, the best way for deploying participatory policies, defining their scope and approach, still remains an open and continuous debate. Using as a case study the Brazilian National Agency of Electric Energy (Aneel, with its public hearings about tariff review, this paper aims at analyzing the democratic aspects of these hearings and challenges the hypothesis of many scholars about the social participation bias in this kind of procedure. This study points out a majority participation of experts, contrasting with the political content of discussions. And, this way, it contributes to a critical analysis of the public hearings as a participatory tool, indicating their strengths and their aspects which deserve a special attention.

  8. Determining Nuclear Fingerprints: Glove Boxes, Radiation Protection, and the International Atomic Energy Agency.

    Science.gov (United States)

    Rentetzi, Maria

    2017-06-01

    In a nuclear laboratory, a glove box is a windowed, sealed container equipped with two flexible gloves that allow the user to manipulate nuclear materials from the outside in an ostensibly safe environment. As a routine laboratory device, it invites neglect from historians and storytellers of science. Yet, since especially the Gulf War, glove boxes have put the interdependence of science, diplomacy, and politics into clear relief. Standing at the intersection of history of science and international history, technological materials and devices such as the glove box can provide penetrating insight into the role of international diplomatic organizations to the global circulation and control of scientific knowledge. The focus here is on the International Atomic Energy Agency. Copyright © 2017 The Author. Published by Elsevier Ltd.. All rights reserved.

  9. Occupational Radiation Exposure at Commercial Nuclear Power Reactors and Other Facilities 2010, Prepared for the Nuclear Regulatory Commission, Office of Nuclear Regulatory Research, May 2012

    Energy Technology Data Exchange (ETDEWEB)

    D. E. Lewis D. A. Hagemeyer Y. U. McCormick

    2012-07-07

    This report summarizes the occupational exposure data that are maintained in the U.S. Nuclear Regulatory Commission’s (NRC) Radiation Exposure Information and Reporting System (REIRS). The bulk of the information contained in the report was compiled from the 2010 annual reports submitted by five of the seven categories of NRC licensees subject to the reporting requirements of 10 CFR 20.2206. Because there are no geologic repositories for high-level waste currently licensed and no NRC-licensed low-level waste disposal facilities currently in operation, only five categories will be considered in this report. The annual reports submitted by these licensees consist of radiation exposure records for each monitored individual. These records are analyzed for trends and presented in this report in terms of collective dose and the distribution of dose among the monitored individuals. Annual reports for 2010 were received from a total of 190 NRC licensees. The summation of reports submitted by the 190 licensees indicated that 192,424 individuals were monitored, 81,961 of whom received a measurable dose. When adjusted for transient workers who worked at more than one licensee during the year, there were actually 142,471 monitored individuals and 62,782 who received a measurable dose. The collective dose incurred by these individuals was 10,617 person-rem, which represents a 12% decrease from the 2009 value. This decrease was primarily due to the decrease in collective dose at commercial nuclear power reactors, as well as a decrease in the collective dose for most of the other categories of NRC licensees. The number of individuals receiving a measurable dose also decreased, resulting in an average measurable dose of 0.13 rem for 2010. The average measurable dose is defined as the total effective dose equivalent (TEDE) divided by the number of individuals receiving a measurable dose. In calendar year 2010, the average annual collective dose per reactor for light water reactor

  10. Effect of radiation on cell interactions with respect to the phenomenon of inactivation of nonsyngeneic stem cells. Quantitative parameters of the regulatory action of. beta. -lymphocytes

    Energy Technology Data Exchange (ETDEWEB)

    Dozmorov, I.M.; Petrov, R.V.; Lutsenko, G.V.; Nikolaeva, I.S.; Rudneva, T.B. (Institut Biofiziki, Moscow (USSR))

    Quantitative regularities have been revealed in the regulatory action of B-lymphocytes from mouse lymph nodes on killer activity of T-lymphocytes of low electrophoretic motility. It was shown that the radiation-inducted charges in the mode of action of B-lymphocytes may be attributed to a decrease in the number of active CPllS.

  11. Long-Term Outcomes of Fractionated Stereotactic Radiation Therapy for Pituitary Adenomas at the BC Cancer Agency

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Julian O.; Ma, Roy [Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver (Canada); Division of Radiation Oncology and Developmental Radiotherapeutics, University of British Columbia, Vancouver (Canada); Akagami, Ryojo [Division of Neurosurgery, University of British Columbia, Vancouver (Canada); McKenzie, Michael [Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver (Canada); Division of Radiation Oncology and Developmental Radiotherapeutics, University of British Columbia, Vancouver (Canada); Johnson, Michelle [Division of Endocrinology, University of British Columbia, Vancouver (Canada); Gete, Ermias [Department of Medical Physics, British Columbia Cancer Agency, Vancouver (Canada); Nichol, Alan, E-mail: anichol@bccancer.bc.ca [Department of Radiation Oncology, British Columbia Cancer Agency, Vancouver (Canada); Division of Radiation Oncology and Developmental Radiotherapeutics, University of British Columbia, Vancouver (Canada)

    2013-11-01

    Purpose: To assess the long-term disease control and toxicity outcomes of fractionated stereotactic radiation therapy (FSRT) in patients with pituitary adenomas treated at the BC Cancer Agency. Methods and Materials: To ensure a minimum of 5 years of clinical follow-up, this study identified a cohort of 76 patients treated consecutively with FSRT between 1998 and 2007 for pituitary adenomas: 71% (54/76) had nonfunctioning and 29% (22/76) had functioning adenomas (15 adrenocorticotrophic hormone-secreting, 5 growth hormone-secreting, and 2 prolactin-secreting). Surgery was used before FSRT in 96% (73/76) of patients. A median isocenter dose of 50.4 Gy was delivered in 28 fractions, with 100% of the planning target volume covered by the 90% isodose. Patients were followed up clinically by endocrinologists, ophthalmologists, and radiation oncologists. Serial magnetic resonance imaging was used to assess tumor response. Results: With a median follow-up time of 6.8 years (range, 0.6 - 13.1 years), the 7-year progression-free survival was 97.1% and disease-specific survival was 100%. Of the 2 patients with tumor progression, both had disease control after salvage surgery. Of the 22 patients with functioning adenomas, 50% (11/22) had complete and 9% (2/22) had partial responses after FSRT. Of the patients with normal pituitary function at baseline, 48% (14/29) experienced 1 or more hormone deficiencies after FSRT. Although 79% (60/76) of optic chiasms were at least partially within the planning target volumes, no patient experienced radiation-induced optic neuropathy. No patient experienced radionecrosis. No secondary malignancy occurred during follow-up. Conclusion: In this study of long-term follow-up of patients treated for pituitary adenomas, FSRT was safe and effective.

  12. Delegation, Presidential Regimes, and Latin American Regulatory Agencies Delegación, regimenes presidenciales y agencias reguladoras en América Latina

    Directory of Open Access Journals (Sweden)

    Jacint Jordana

    2010-04-01

    Full Text Available During the 1990s, a large number of regulatory agencies were created or reformed in different sectors in Latin American countries. Almost all included political delegation mechanisms, intended as formal rules to enhance credible commitments to time-consistent policies. In this paper, using an original data set of agencies’ head tenure in the telecommunications and finance regulatory agencies, we discuss if these mechanisms worked as planned, and find a divergence between actual mandates and the formally established fixed terms, effected by means of systematic early resignations. Our findings reveal, however, some consistent patterns of behavior. Stronger legislative presidential power reduced effective delegation to some extent, and agencies’ organizational strengths protected them from patron-age. We also confirmed the existence of some significant differences be-tween the two sectors examined. Having slightly weaker delegation rules, delegation practices were also less effective in telecommunications than in financial services, contrary to expectations about credible commitments. Durante los años 1990, muchas agencias reguladoras fueron creadas o reformadas en diferentes sectores en los países latinoamericanos. Casi todas incluyeron mecanismos de delegación política, entendidos como reglas formales para mejorar los compromisos creíbles sobre políticas que requieren coherencia en el tiempo. En este trabajo, utilizando un conjunto de datos originales sobre los responsables de las agencias reguladoras de las telecomunicaciones y de las finanzas, se discute si estos mecanismos funcionaron como estaba previsto, identificándose una divergencia entre los mandatos reales y los términos formalmente establecidos, debido a la existencia de numerosas renuncias anticipadas. Nuestros hallazgos revelan, sin embargo, algunos patrones consistentes de comportamiento: un mayor poder presidencial sobre el legislativo reduce la delegación efectiva

  13. Outcomes of Proton Radiation Therapy for Peripapillary Choroidal Melanoma at the BC Cancer Agency

    Energy Technology Data Exchange (ETDEWEB)

    Tran, Eric, E-mail: etran2@bccancer.bc.ca [Radiation Therapy Program, BC Cancer Agency and University of British Columbia, Vancouver, British Columbia (Canada); Ma, Roy [Radiation Therapy Program, BC Cancer Agency and University of British Columbia, Vancouver, British Columbia (Canada); Paton, Katherine [Department of Ophthalmology and Visual Sciences, Vancouver Hospital Eye Care Centre and University of British Columbia, Vancouver, British Columbia (Canada); Blackmore, Ewart [TRIUMF, Vancouver, British Columbia (Canada); Pickles, Tom [Radiation Therapy Program, BC Cancer Agency and University of British Columbia, Vancouver, British Columbia (Canada)

    2012-08-01

    Purpose: To report toxicity, local control, enucleation, and survival rates for patients with peripapillary choroidal melanoma treated with proton therapy in Canada. Methods and Materials: We performed a retrospective analysis of patients with peripapillary choroidal melanoma ({<=}2 mm from optic disc) treated between 1995 and 2007 at the only Canadian proton therapy facility. A prospective database was updated for follow-up information from a chart review. Descriptive and actuarial data are presented. Results: In total, 59 patients were treated. The median age was 59 years. According to the 2010 American Joint Committee on Cancer TNM classification, there were 20 T1 tumors (34%), 28 T2 tumors (48%), and 11 T3 tumors (19%). The median tumor diameter was 11.4 mm, and the median thickness was 3.5 mm. Median follow-up was 63 months. Nineteen patients received 54 cobalt gray equivalents (CGE) and forty patients received 60 CGE, each in 4 fractions. The 5-year actuarial local control rate was 91% (T1, 100%; T2, 93%; and T3, 59%) (p = 0.038). There was a suggestive relationship between local control and dose. The local control rate was 97% with 60 CGE and 83% with 54 CGE (p = 0.106). The metastasis-free survival rate was 82% and related to T stage (T1, 94%; T2, 84%; and T3, 47%) (p < 0.001). Twelve patients died, including eleven with metastases. The 5-year actuarial rate of neovascular glaucoma was 31% (23% for T1-T2 and 68% for T3, p < 0.001), and that of enucleation was 0% for T1, 14% for T2, and 72% for T3 (p < 0.001). Radiation retinopathy (74%) and optic neuropathy (64%) were common within-field effects. Conclusions: Proton therapy provides excellent local control with acceptable toxicity while conserving the globe in 80% of cases. These results are consistent with other single-institution series using proton radiotherapy, and toxicity rates were acceptable. T3 tumors carry a higher rate of both local recurrence and metastasis.

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

    Energy Technology Data Exchange (ETDEWEB)

    O`Donnell, E.

    1995-12-31

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

  15. THE RESPONSIBILITY FOR PREVENTING AND DETECTING ACCOUNTING FRAUDS FROM THE VIEWPOINT OF SELF-REGULATORY AGENCIES IN TURKEY: DE JURE STATUS AND DE FACTO APPLICATION

    Directory of Open Access Journals (Sweden)

    Canol KANDEMİR

    2013-07-01

    Full Text Available TÜRKİYE’DE DÜZENLEYİCİ KURULUŞLAR AÇISINDAN MUHASEBE HİLELERİNİN ÖNLENMESİ VE ORTAYA ÇIKARILMASI SORUMLULUĞU: HUKUKÎ DURUM VE FİİLÎ UYGULAMAÖzet: Düzenleyici kuruluşların yaklaşımı ve uygulamaları muhasebe hilelerinin önlenmesi ve ortaya çıkarılması sorumluluğunun kapsamının açıklığa kavuşturulmasına yardımcı olabilmektedir. Bu kuruluşların kamunun büyük bir çoğunluğunu adîl ve yansız bir şekilde temsil edeceği varsayılmaktadır. Ayrıca aldıkları kararlar ve karar alma mantıkları hem araştırmacılara, hem de finansal bilgi kullanıcılarına olası hile şüphelileri, bu kuruluşların sorumlulardan özellikle önlemesi ve ortaya çıkarmasını istedikleri hile yöntemleri, hilelerin cezaî yönleri, hilelerin önlenmesi ve ortaya çıkarılmasında temel sorumluluklar ve denetim beklenti boşluğu konularında önemli ipuçları verebilmektedir. Yine bunlar ilgili standart, yasa ve diğer düzenlemelerin oluşturulması ve uygulanmasında önemli etki sahibi olmaktadır. Bu nedenle, bağımsız denetimle ilgili faktörleri de kapsayan bir dizi değişken ile muhasebe hileleri arasında istatistiksel olarak anlamlı bir ilişki olup olmadığını sınayan bir çalışma yapılmış ve sonuç olarak Türkiye’deki düzenleyici kuruluşun muhasebe hilelerinin önlenmesi ve ortaya çıkarılması sorumluluğunu aynı tarafa, müşteri işletme ve yönetimine yüklediği bulunmuştur. Araştırmanın bulguları Türkiye’de bir denetim-beklenti boşluğu olmadığına da işaret etmektedir.THE RESPONSIBILITY FOR PREVENTING AND DETECTING ACCOUNTING FRAUDS FROM THE VIEWPOINT OF SELF-REGULATORY AGENCIES IN TURKEY: DE JURE STATUS AND DE FACTO APPLICATIONAbstract: Self-regulatory agencies’ way of understanding and practices can help clarify the scope of the responsibility for preventing and detecting frauds. They are assumed to represent a vast majority of the public in an unbiased and

  16. Viimsi water treatment plant for Ra removal: NORM residue/waste generation, radiation safety issues, and regulatory response

    Energy Technology Data Exchange (ETDEWEB)

    Kiisk, M.; Suursoo, S.; Realo, E.; Jantsikene, A.; Lumiste, L.; Vaeaer, K.; Isakar, K.; Koch, R. [University of Tartu (Estonia)

    2014-07-01

    values established for these radionuclides. The design and construction of the plant have underestimated the importance of aspects related to NORM accumulation and their management. Therefore, the level of Ra accumulation, ingrowth of daughter radionuclides (Th-228, Pb-210) and generation of Rn-220 and Rn-222 may pose great difficulties for the operation of the plant, especially in the case when/if the filter material is classified as NORM residue/waste with elevated radiation hazard for plant workers, public and the environment. As the first large-scale water treatment plant of the kind, there are no routine legal experience or administrative practice established in Estonia. This paper presents an overview of the operation of Viimsi Vesi Ltd. water treatment plant. The legal aspects and issues associated with management of NORM waste/residues, including classification (residue vs. waste), potential management options, optimisation of the management and radiation safety of the workers are discussed. Views of both the operator and the regulatory authority will be considered. Document available in abstract form only. (authors)

  17. Desenho e funcionamento dos mecanismos de controle e accountability das agências reguladoras brasileiras: semelhanças e diferenças Design and operation of the Brazilian regulatory agencies' control and accountability mechanisms: similarities and differences

    Directory of Open Access Journals (Sweden)

    Marcos Vinicius Pó

    2006-08-01

    Full Text Available Este artigo estuda o formato e o funcionamento dos mecanismos de controle e accountability das agências reguladoras, ressaltando suas similaridades e distinções. Suas observações permitem abrir novas frentes de investigação para explicar as diferenças e semelhanças encontradas, tais como a influência da burocracia no processo e os contextos histórico e político de cada setor. O artigo analisa a formatação prevista legalmente para os dispositivos que proporcionam maior accountability às agências reguladoras, como a ouvidoria, as consultas públicas e os conselhos, e verifica indicadores de seu funcionamento efetivo, de forma a avaliar se a aparente uniformidade institucional dos órgãos reflete-se em uniformidade de procedimentos e de resultados. Por fim, aponta alguns impactos que o modelo institucional das agências reguladoras provoca na accountability do Estado brasileiro.This article studies the design and operation of the regulatory agencies' control and accountability mechanisms, underlining their similarities and differences. Its observations open new investigation fronts for the explanation of the differences and similarities found, such as the influence of bureaucracy on the process and each sector's historical and political context. The article analyzes the design determined by legislation for mechanisms that provide the regulatory agencies with more accountability, such as the ombudsman department, public consultations and councils, and assesses the indicators of their effectiveness, in order to verify if the apparent institutional uniformity of the agencies corresponds to the uniformity of procedures and results. Finally, it points out some of the impacts of the regulatory agencies' institutional model on the accountability of the Brazilian state.

  18. 77 FR 10351 - Regulatory Review Plan

    Science.gov (United States)

    2012-02-22

    ... XII Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION: Notice of final regulatory review plan. SUMMARY: The Federal Housing Finance Agency (FHFA) is issuing a notice of the final FHFA regulatory review plan for review of existing regulations under Executive Order 13579, ``Regulation...

  19. 75 FR 28073 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-05-19

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-3039, ``Standard Format and Content...

  20. 75 FR 48382 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-08-10

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Draft Regulatory Guide, DG-1228, ``Standard Format and Content...

  1. Unraveling Fungal Radiation Resistance Regulatory Networks through the Genome-Wide Transcriptome and Genetic Analyses of Cryptococcus neoformans

    Directory of Open Access Journals (Sweden)

    Kwang-Woo Jung

    2016-11-01

    Full Text Available The basidiomycetous fungus Cryptococcus neoformans has been known to be highly radiation resistant and has been found in fatal radioactive environments such as the damaged nuclear reactor at Chernobyl. To elucidate the mechanisms underlying the radiation resistance phenotype of C. neoformans, we identified genes affected by gamma radiation through genome-wide transcriptome analysis and characterized their functions. We found that genes involved in DNA damage repair systems were upregulated in response to gamma radiation. Particularly, deletion of recombinase RAD51 and two DNA-dependent ATPase genes, RAD54 and RDH54, increased cellular susceptibility to both gamma radiation and DNA-damaging agents. A variety of oxidative stress response genes were also upregulated. Among them, sulfiredoxin contributed to gamma radiation resistance in a peroxiredoxin/thioredoxin-independent manner. Furthermore, we found that genes involved in molecular chaperone expression, ubiquitination systems, and autophagy were induced, whereas genes involved in the biosynthesis of proteins and fatty acids/sterols were downregulated. Most importantly, we discovered a number of novel C. neoformans genes, the expression of which was modulated by gamma radiation exposure, and their deletion rendered cells susceptible to gamma radiation exposure, as well as DNA damage insults. Among these genes, we found that a unique transcription factor containing the basic leucine zipper domain, named Bdr1, served as a regulator of the gamma radiation resistance of C. neoformans by controlling expression of DNA repair genes, and its expression was regulated by the evolutionarily conserved DNA damage response protein kinase Rad53. Taken together, the current transcriptome and functional analyses contribute to the understanding of the unique molecular mechanism of the radiation-resistant fungus C. neoformans.

  2. 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.)

  3. 78 FR 9915 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Basel II...

    Science.gov (United States)

    2013-02-12

    ... Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory Capital Ratios... amend this collection: Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III... CORPORATION Agency Information Collection Activities: Submission for OMB Review; Comment Request; Basel...

  4. The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Peru.

    Science.gov (United States)

    Gamero, Emma Castro; Morales Pedraza, Jorge

    2009-05-01

    The tissue bank "Rosa Guerzoni Chambergo" (RGCTB) located at the Child's Health Institute was inaugurated in 1996, with the financial and technical support of the IAEA program on radiation and tissue banking. Since 1998, the biological bandage of fresh and lyophilised pigskin, amnion and bone tissue is processed routinely in this bank. In all cases, the tissue is sterilised with the use of Cobalt-60 radiation, process carried out at the Laboratories of Irradiation of the Peruvian Institute of Nuclear Energy (IPEN). The tissue bank in the Child's Health Institute helped to save lives in an accident occurred in Lima, when a New Year's fireworks celebration ran out of control in January 2002. Nearly 300 people died in the tragic blaze and hundreds more were seriously burned and injured. Eight Lima hospitals and clinics suddenly were faced with saving the lives of severely burned men, women and children. Fortunately, authorities were ready to respond to the emergency. More than 1,600 dressings were sterilised and supplied to Lima surgeons. The efforts helped save the lives of patients who otherwise might not have survived the Lima fire. Between 1998 and September 2007, 35,012 tissue grafts were produced and irradiated. Radiation sterilised tissues are used by 20 national medical institutions as well as 17 private health institutions. The tissue bank established in Peru with the support of the IAEA is now producing the following tissues: pigskin dressings, fresh and freeze-dried; bone allografts, chips, wedges and powdered, and amnion dressings air-dried. It is also now leading the elaboration of national standards, assignment being entrusted by ONDT (Organización Nacional de Donación y Transplantes; National Organisation on Donation and Transplant). This among other will permit the accreditation of the tissue bank. In this task is also participating IPEN.

  5. The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in India.

    Science.gov (United States)

    Lobo Gajiwala, Astrid; Morales Pedraza, Jorge

    2009-05-01

    The banking of tissues such bone and skin began in India in the 1980s and 1990s. Although eye banking started in 1945 there was little progress in this field for the next five decades. As part of the IAEA/RCA program to use ionising radiation for the sterilisation of biological tissues in Asia and the Pacific Region, the Tata Memorial Hospital (TMH) in 1986 decided to set up a tissue bank in Mumbai funded by the Government of India. The TMH Tissue Bank became operational in January 1988, and stands as a pioneering effort in the country to provide safe, clinically useful and cost-effective human allografts for transplantation. It uses the IAEA International Standards on Tissue Banking. All the grafts are sterilised terminally by exposure to a dose of 25 kGy of gamma radiation, which has been validated as recommended by the IAEA Code of Practice for the Radiation Sterilisation of Tissues Allografts: Requirements for Validation and Routine Control. The TMH Tissue Bank is registered with the Maharashtra State Health Authorities, and in May 2004, it became India's first Tissue Bank to receive ISO 9001:2000 certification of its Quality Management System. From 1989 to September 2007, the TMH Tissue Bank has supplied 11,369 allografts to 310 surgeons operating in 69 hospitals in Mumbai and 56 hospitals in other parts of India. These numbers have been limited by difficulties with the retrieval of tissues from deceased donors due to inadequate resources and tissue donation policies of hospitals. As the Government of India representative in the IAEA program, the TMH Tissue Bank has promoted and co-coordinated these activities in the country and the development of tissue banks using radiation sterilisation of tissue grafts. Towards this end it has been engaged in training personnel, drawing up project proposals, and supporting the establishment of a Tissue Retrieval Centre in Mumbai. Currently it networks with the Zonal Transplant Co-ordination Centre of the Government of

  6. Independent Regulatory Agencies as a Subject in Economic Law:From the Perspective of Marxist Theory of Social Agencies%论独立监管机构的经济法主体地位--以马克思主义社会权力机构学说为视角

    Institute of Scientific and Technical Information of China (English)

    倪斐

    2014-01-01

    As early as in the middle of the 19th century,Marx and Engels had already predicted the rise of social agencies. Their prediction has been confirmed by the emergence and sound development of independent regulatory agencies in the major Western countries. As an important economic manage-ment body,independent regulatory agencies,characterized by their representation of public interests and integration of legislative,judiciary and administrative powers,are totally in accordance with the basic requirements of a subject in economic law,and thus it is urgent that their legal status be defined in the theories of the subjects in economic law. Taking independent regulatory agencies into considera-tion,theory of the subjects in economic law can be improved by distinguishing their legal status from that of the state and government:explaining the differences between the government's legal statuses as subjects in economic law and administrative law respectively,and defining the legal status the social intermediate bodies have in economic law. Given the quick development of independent regulatory a-gencies,they will play a key intermediary role between the government and the market entities,and thus an interactive model of“government-independent regulatory agencies-market entity”will form be-tween the three major subjects in economic law.%早在19世纪中叶,马克思、恩格斯就已经预见到社会权力机构的兴起,这一预见已被中西方主要国家独立监管机构的产生与发展实践所证明。作为日益重要的经济管理主体,独立监管机构的公益代表性与权力合一性完全契合经济法主体特征的基本要求,亟需在经济法主体理论上对此作出回应。纳入独立监管机构考量后的经济法主体理论更加完善,可以明晰国家与政府在经济法主体类型上的差别,解释政府作为经济法主体和行政法主体在性质上的不同,并在一定程度上回答了社会中间层的

  7. The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Indonesia.

    Science.gov (United States)

    Hilmy, Nazly; Manjas, Menkher; Ferdiansyah; Abbas, Basril; Morales Pedraza, Jorge

    2009-05-01

    In 1986, the National Nuclear Energy Agency (Batan) in Jakarta started the research and development for the setting up of a tissue bank (Batan Research Tissue Bank/BRTB) by preserving fresh amnion or fetal membranes by lyophilisation and then sterilising by gamma irradiation. During the period of 1990 and 2000, three more tissue banks were set up, i.e., Biomaterial Centre in Surabaya, Jamil Tissue Bank in Padang, and Sitanala Tissue Bank in Tangerang. In 1994, BRTB produced bone allografts. The banks established under the IAEA program concentrated its work on the production of amnion, bone and soft tissues allografts, as well as bone xenografts. These tissues (allografts and xenografts) were sterilised using gamma irradiation (about 90%) and the rest were sterilized by ETO and those products have been used in the treatment of patients at more than 50 hospitals in Indonesia. In 2004, those tissue banks produced 8,500 grafts and 5,000 of them were amnion grafts for eye treatment and wound dressing. All of those grafts were used for patients as well as for research. In 2006, the production increased to 9,000 grafts. Although the capacity of those banks can produce more grafts, we are facing problems on getting raw materials from suitable donors. To fulfill the demand of bone grafts we also produced bone xenografts. The impact of the IAEA program in tissue banking activities in Indonesia can be summarised as follows: to support the national program on importing substitutes for medical devices. The price of imported tissues are between US$ 50 and US$ 6,000 per graft. Local tissue bank can produce tissues with the same quality with the price for about 10-30% of the imported tissues.

  8. The International Atomic Energy Agency (IAEA) program on radiation and tissue banking: a successful program for developing countries.

    Science.gov (United States)

    Pedraza, Jorge Morales

    2006-01-01

    Since its inception the IAEA program in radiation and tissue banking supported the establishment of twenty five tissue banks in different countries. Now more than 103 tissue banks are now operating in these countries. The production of sterilized tissues has grown in an exponential mode within the IAEA program. From 1988 until the end of 2000 the production of sterilized tissues was 224,706 grafts, with an estimated value of at least $51,768,553 million dollars at the mean current charge rate in non-commercial banks in Europe and USA. During the period 1997-2002 several countries from Asia and the Pacific region produced more than 155,000 grafts, with an estimated value of about $36.7 million dollars. Training was considered to be one of the most important tasks to be supported. A total of 192 students were registered in the training program and 146 students graduated with a University Diploma. For many developing countries an additional benefit is not having to import expensive sterilized tissues from developed countries, but the exposure of orthopedic and plastic surgeons working, to new methods of using allografts in specific surgical treatments.

  9. 77 FR 59702 - Promoting U.S. EC Regulatory Compatibility

    Science.gov (United States)

    2012-09-28

    ... Promoting U.S. EC Regulatory Compatibility AGENCY: Office of the United States Trade Representative. ACTION... greater transatlantic regulatory compatibility generally. Concrete ideas on how greater compatibility... and EC invite your views on how to promote greater transatlantic regulatory compatibility...

  10. A Regulatory Analysis and Reassessment of U.S. Environmental Protection Agency Listed Hazardous Waste Numbers for Applicability to the INTEC Liquid Waste System

    Energy Technology Data Exchange (ETDEWEB)

    Gilbert, K.L.; Venneman, T.E.

    1998-12-01

    This report concludes that there are four listed hazardous waste numbers (F001, F002, F005, and U134) applicable to the waste in the Process Equipment Waste Evaporator (PEWE) liquid waste system at the Idaho National Engineering and Environmental Laboratory. The chemical constituents associated with these listed hazardous waste numbers, including those listed only for ignitability are identified. The RCRA Part A permit application hazardous waste numbers identify chemical constituents that may be treated or stored by the PEWE liquid waste system either as a result of a particular characteristic (40 CFR, Subpart C) or as a result of a specific process (40 CFR 261, Subpart D). The RCRA Part A permit application for the PEWE liquid waste system identifies the universe of Environmental Protection Agency (EPA) hazardous waste numbers [23 characteristic (hazardous waste codes) numbers and 105 listed numbers (four F-listed hazardous waste numbers, 20 P-listed hazardous waste numbers, and 81 U-listed hazardous waste numbers)] deemed acceptable for storage and treatment. This evaluation, however, identifies only listed wastes (and their chemical constituents) that have actually entered the PEWE liquid waste system and would, therefore, be assigned to the PEWE liquids and treatment residuals.

  11. 77 FR 55473 - Agency Information Collection Activities; Renewal of a Currently Approved Collection; Comment...

    Science.gov (United States)

    2012-09-10

    ..., Implementation of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, Transition Provisions, and... collection: Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory... Request; Basel II Recordkeeping and Disclosures AGENCY: Federal Deposit Insurance Corporation...

  12. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    Energy Technology Data Exchange (ETDEWEB)

    Kroger, L. [University of California Davis (United States)

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  13. 78 FR 30384 - Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board

    Science.gov (United States)

    2013-05-22

    ... ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; Region X Regulatory Fairness Board AGENCY: U.S... Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Regional Small Business Regulatory Fairness hearing...

  14. 78 FR 36011 - Region VII Regulatory Fairness Board; Federal Regulatory Enforcement Fairness Hearing

    Science.gov (United States)

    2013-06-14

    ... ADMINISTRATION Region VII Regulatory Fairness Board; Federal Regulatory Enforcement Fairness Hearing AGENCY: U.S... Business Regulatory Fairness Board. SUMMARY: The (SBA) Office of the National Ombudsman is issuing this notice to announce the location, date and time of the Regional Small Business Regulatory Fairness hearing...

  15. Reduction of regulatory risk: a network economic approach

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    Several definitions of regulatory risk are known from the literature. From the perspective of regulatory reform it is important to differentiate between the impact of a given regulatory scheme on the firm's risk exposure and the risk arising from discretionary behavior of regulatory agencies. Whereas the conse-quences of effective regulation in principle are known and accepted, excessive regulatory discretion may cause a strong need for regulatory reform. Regulatory reform focussing on the re...

  16. Regulatory institutions in liberalised electricity markets

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    The reform of the electricity supply industry is gathering pace in many countries. Independent regulatory agencies and other regulatory bodies have been created, and regulatory responsibilities redefined. This book reviews the evolving institutional structures to regulate the electricity supply industry in IEA member countries. It is the latest in a series of IEA publications on energy market reform.

  17. MO-AB-201-00: Radiation Safety Officer Update

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  18. Environmental Protection Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... SAN No. 5367 NESHAP: Brick and Structural Clay Products and Clay Products 2060-AP69 CLEAN AIR ACT... label the models accordingly. This action does not apply to existing residential woodstoves, pellet... (EPA) Long-Term Actions Clean Air Act 448. NESHAP: BRICK AND STRUCTURAL CLAY PRODUCTS AND CLAY PRODUCTS...

  19. 76 FR 13172 - Placer County Water Agency

    Science.gov (United States)

    2011-03-10

    ... Energy Regulatory Commission Placer County Water Agency Notice of Application Tendered for Filing with... Filed: February 23, 2011 d. Applicant: Placer County Water Agency e. Name of Project: Middle Fork... Manager, Placer County Water Agency, 144 Ferguson Road, Auburn, CA 95603; Telephone: (530) 823-4490....

  20. 76 FR 59066 - Notice of Regulatory Review Plan

    Science.gov (United States)

    2011-09-23

    ...; ] FEDERAL HOUSING FINANCE AGENCY 12 CFR Chapter XII Notice of Regulatory Review Plan AGENCY: Federal Housing...) is issuing a notice of and requesting comments on the FHFA interim regulatory review plan for review.... Comments FHFA invites comments on all aspects of the interim regulatory review plan, including legal...

  1. MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223

    Energy Technology Data Exchange (ETDEWEB)

    Phillips, L. [Stanford University (United States)

    2015-06-15

    The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35

  2. Diplomatic agency

    DEFF Research Database (Denmark)

    Adler-Nissen, Rebecca

    2016-01-01

    diplomatic agency has been conceptualized in International Relations theory (English School, game theory, Foreign Policy Analysis, constructivism, practice theory, post-positivism) before presenting and exemplifying major and overlapping types of diplomatic agency, including communication, negotiation......, it discusses how diplomatic agency is linked to conceptions of diplomatic representation and legitimacy in its actual, functional and symbolic forms....

  3. THE 2015 INTER-REGIONAL SEMINARS ON RADIATION HYGIENE FOR LOCAL AGENCIES AND ORGANIZATIONS’ SPECIALISTS OF THE FEDERAL SERVICE FOR SURVEILLANCE ON CONSUMER RIGHTS PROTECTION AND HUMAN WELL-BEING

    Directory of Open Access Journals (Sweden)

    A. N. Barkovskiy

    2016-01-01

    Full Text Available The article is dedicated to the inter-regional seminars on ensuring population radiation safety held in 2015. Each one of the eight inter-regional centers of Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being conducts such seminars once in every two years in order to render organizational, methodological and practical assistance on the issues of population radiation protection ( Inter-Regional Centers on Radiation Safety – IRC RS In 2015 the inter-regional seminars were conducted by the following inter-regional centers: the Central IRC RS in Moscow on March 18–19, the Southern IRC RS in Simferopol on April 21-23, the Far Eastern IRC RS in Habarovsk on May 26-28, the Siberian IRC RS in Gorno-Altaisk on September 22-24 and the Head Scientific-Methodological Center of Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being (HSMC in St. Petersburg on October 7-8.The seminar elucidated upon current issues of ensuring population radiation protection. The presentations were made by the top-notch specialists of St. Petersburg Research Institute of Radiation Hygiene after Professor P.V. Ramzaev. They expanded upon limitation of population exposure from natural, medical and technogenic ionizing radiation sources, implementation of new regulatory-methodological documents devised by the Federal Service for Surveillance on Consumer Rights Protection and Human Well-Being. They also dwelled upon state-of the-art instruments and methods of conducting radiation monitoring. Practical matters were discussed in relation to establishment of sanitary-epidemiological supervision over population radiation protection.The article highlights the issues discussed at those seminars, major challenges underscored by the participants as the result of the discussions. It provides the general evaluation and conclusions based on the seminars’ outcomes. The smooth organization of those seminars was highly

  4. 78 FR 9991 - Agency Information Collection Activities; Information Collection Renewal; Submission for OMB Review

    Science.gov (United States)

    2013-02-12

    ..., Implementation of Basel III, Minimum Regulatory Capital Ratios, Capital Adequacy, Transition Provisions, and... a securitization. The Agencies, on August 30, 2012, proposed three rules (Basel III) that would amend this collection: Regulatory ] Capital Rules: Regulatory Capital, Implementation of Basel...

  5. Electronic Commerce Removing Regulatory Impediments

    Science.gov (United States)

    1992-05-01

    AD-A252 691 ELECTRONIC COMMERCE Removing Regulatory Impediments ~DuiG A% ELECTE I JUL1 8 1992 0 C D Daniel J. Drake John A. Ciucci ... - ""N ST AT KE...Management Institute 6400 Goldsboro Road Bethesda, Maryland 20817-5886 92 LMI Executive Summary ELECTRONIC COMMERCE : REMOVING REGULATORY IMPEDIMENTS... Electronic Commerce techniques, such as electronic mail and electronic data interchange (EDI), enable Government agencies to conduct business without the

  6. Teacher agency:

    DEFF Research Database (Denmark)

    Robinson, Sarah; Priestley, Mark; Biesta, Gert

    2015-01-01

    The concept of teacher agency has emerged in recent literature as an alternative means of understanding how teachers might enact practice and engage with policy (e.g. Lasky, 2005; Leander & Osbourne, 2008; Ketelaar et al., 2012; Priestley, Biesta & Robinson, 2013). But what is agency? Agency...... remains an inexact and poorly conceptualised construct in much of the literature, where it is often not clear whether the term refers to an individual capacity of teachers to act agentically or to an emergent ‘ecological’ phenomenon dependent upon the quality of individuals’ engagement...... with their environments (Biesta & Tedder, 2007). In this chapter, we outline the latter conception of agency, developing a conceptual model for teacher agency that emphasizes the temporal and relational dimension of the achievement of agency. Why does this matter? Recent curriculum policy in many countries heralds a [re...

  7. Human agency in social cognitive theory.

    Science.gov (United States)

    Bandura, A

    1989-09-01

    The present article examines the nature and function of human agency within the conceptual model of triadic reciprocal causation. In analyzing the operation of human agency in this interactional causal structure, social cognitive theory accords a central role to cognitive, vicarious, self-reflective, and self-regulatory processes. The issues addressed concern the psychological mechanisms through which personal agency is exercised, the hierarchical structure of self-regulatory systems, eschewal of the dichotomous construal of self as agent and self as object, and the properties of a nondualistic but nonreductional conception of human agency. The relation of agent causality to the fundamental issues of freedom and determinism is also analyzed.

  8. 33 CFR 230.16 - Lead and cooperating agencies.

    Science.gov (United States)

    2010-07-01

    ... (e) and (f). (a) Lead Agency. The Corps will normally be lead agency for Corps civil works projects..., navigation, hydropower and Corps regulatory responsibilities. See Appendix II of CEQ regulations (49 FR 49750...

  9. Regulatory framework for NORM residues in Belgium

    Energy Technology Data Exchange (ETDEWEB)

    Pepin, S.; Dehandschutter, B.; Poffijn, A.; Sonck, M. [Federal Agency for Nuclear Control (FANC), Rue Ravenstein 36, 1000 Brussels (Belgium)

    2013-07-01

    The Belgian radiation protection authority (Federal Agency for Nuclear Control - FANC) has published in March 2013 a decree regulating the acceptance of NORM residues by nonradioactive waste treatment facilities. This regulation is based on the concept of 'work activities involving natural radiation sources' in the sense of article 40 of the 96/29/EURATOM directive. The disposal or processing facilities which accept NORM residues with an activity concentration above a generic exemption level will be considered as 'work activities' and submitted to declaration according to the Belgian radiation protection regulations. On basis of this declaration, specific acceptance criteria for the different types of processing/ disposal of the residues (disposal on landfill, recycling into building materials, etc.) are imposed. FANC has drafted guidelines for these acceptance criteria. A methodological guide for the operators of the concerned facilities was also published. Moreover, sites where significant quantities of NORM residues are or have been disposed, are subjected to an environmental monitoring in the framework of the national program of radiological surveillance of FANC. FANC also introduced in its regulations the concept of anthropogenic radon-prone areas: e.g. former phosphogypsum stacks have been defined as anthropogenic radon-prone areas, which allows some form of regulatory control of these sites. (authors)

  10. Environmental Radiation Data

    Data.gov (United States)

    U.S. Environmental Protection Agency — Environmental Radiation Data (ERD) is an electronic and print journal compiled and distributed quarterly by the Office of Radiation and Indoor Air's National Air...

  11. Environmental Radiation Data

    Data.gov (United States)

    U.S. Environmental Protection Agency — Environmental Radiation Data (ERD) is an electronic and print journal compiled and distributed quarterly by the Office of Radiation and Indoor Air's National Air and...

  12. Agency Theory

    DEFF Research Database (Denmark)

    Linder, Stefan; Foss, Nicolai Juul

    Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting and informational conditions, the theory addresses problems of ex...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

  13. 77 FR 58975 - Pennsylvania Regulatory Program

    Science.gov (United States)

    2012-09-25

    ... the Pennsylvania statutory scheme via Pennsylvania's Solid Waste Management Act (``SWMA''), the Clean... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 Pennsylvania Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement (OSM), Interior. ] ACTION: Proposed rule...

  14. Mobile Source Emissions Regulatory Compliance Data Inventory

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Mobile Source Emissions Regulatory Compliance Data Inventory data asset contains measured summary compliance information on light-duty, heavy-duty, and non-road...

  15. Agency Theory

    DEFF Research Database (Denmark)

    Linder, Stefan; Foss, Nicolai Juul

    2015-01-01

    Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting, and informational conditions, the theory addresses problems of ex ...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism.......Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting, and informational conditions, the theory addresses problems of ex...

  16. Agency Theory

    DEFF Research Database (Denmark)

    Linder, Stefan; Foss, Nicolai Juul

    Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting and informational conditions, the theory addresses problems of ex a...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism.......Agency theory studies the problems and solutions linked to delegation of tasks from principals to agents in the context of conflicting interests between the parties. Beginning from clear assumptions about rationality, contracting and informational conditions, the theory addresses problems of ex...

  17. Agency employment

    OpenAIRE

    Tomčíková, Ilona

    2012-01-01

    - Agency Employment For my thesis topic, I have chosen "Agency Employment". It's a relatively young institute, which was incorporated into our legal system only on October 1st, 2004. I believe that Agency Employment topic can be always considered current and positive, because it allows us to flexibly react to the needs of the job market. Since the topic is very broad, the goal of this paper is not a detailed analysis of all aspects of this institute, but only a few of them that I consider to ...

  18. Hospice Agencies

    Data.gov (United States)

    U.S. Department of Health & Human Services — A list of all Hospice Agencies that have been certified by Medicare. The list includes addresses, phone numbers, and date of original CMS certification, as well as...

  19. Advertising Agencies

    DEFF Research Database (Denmark)

    Moeran, Brian

    2015-01-01

    for their clients, the advertisers, who are in search of customers for their goods and services. Agencies thus mediate between three different but interlocking social groups: industry, media, and consumers. The history of advertising is largely the history of the advertising agencies that have served the needs......Advertising agencies are the most significant organizations in the development of advertising and marketing worldwide. An advertising agency is an independent service company, composed of business, marketing and creative people, who develop, prepare, and place advertising in advertising media...... of these three groups. They link industry and media by creating new forms for messages about products and services; industry and consumers by developing comprehensive communications campaigns and providing information thereon; and media and consumers by conducting audience research to enable market segmentation...

  20. Transformative Agency

    DEFF Research Database (Denmark)

    Majgaard, Klaus

    The purpose of this paper is to enhance the conceptual understanding of the mediatory relationship between paradoxes on an organizational and an individual level. It presents a concept of agency that comprises and mediates between a structural and individual pole. The constitution of this agency ...... is achieved through narrative activity that oscillates between the poles and transforms paradoxes through the configuration of plots and metaphors. Empirical cases are introduced in order to illustrate the implications of this understanding....

  1. 78 FR 1646 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2013-01-08

    ...; Organizational Conflicts of Interest. 416 FAR Case 2010-013, Privacy 9000-AM02 Training. 417 Federal Acquisition...: Action Date FR Cite NPRM 12/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Edward.... L. 110-417). Timetable: Action Date FR Cite NPRM 04/00/13 Regulatory Flexibility Analysis Required...

  2. 49 CFR 355.21 - Regulatory review.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Regulatory review. 355.21 Section 355.21... AND REGULATIONS AFFECTING INTERSTATE MOTOR CARRIER OPERATIONS Requirements § 355.21 Regulatory review... review are provided in the appendix to this part. (b) Responsibility. The State agency designated as...

  3. 77 FR 47328 - Reducing Regulatory Burden

    Science.gov (United States)

    2012-08-08

    ... health and safety, and other advantages; distributive impacts; and equity). The regulatory process... businesses and the public. Agencies consider low-cost approaches that reduce burdens and maintain flexibility...-regulatory-system . The Department is committed to maintaining a consistent culture of retrospective...

  4. Environmental Regulatory Update Table, December 1991

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1992-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  5. Environmental Regulatory Update Table, December 1989

    Energy Technology Data Exchange (ETDEWEB)

    Houlbert, L.M.; Langston, M.E. (Tennessee Univ., Knoxville, TN (USA)); Nikbakht, A.; Salk, M.S. (Oak Ridge National Lab., TN (USA))

    1990-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  6. Environmental Regulatory Update Table, November 1991

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-12-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  7. Environmental Regulatory Update Table, August 1991

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M., Hawkins, G.T.; Salk, M.S.

    1991-09-01

    This Environmental Regulatory Update Table (August 1991) provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  8. Environmental Regulatory Update Table, September 1991

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-10-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  9. Environmental Regulatory Update Table, October 1991

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  10. Environmental Regulatory Update Table, April 1989

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  11. Environmental Regulatory Update Table, April 1989

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  12. Environmental regulatory update table, March 1989

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.; Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1989-04-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  13. Environmental Regulatory Update Table, November 1991

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1991-12-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  14. ¿Entes de regulación o control? Imprecisiones del "moderno" esquema de regulación: reflexiones y enseñanzas del caso argentino Regulatory or control agencies? Impreciseness of the 'modern' regulation scheme: thoughts and teachings from the Argentine case

    Directory of Open Access Journals (Sweden)

    Carolina Nahón

    2007-12-01

    Full Text Available Este artículo analiza las particularidades del "moderno" esquema de regulación de los servicios públicos de infraestructura, que se extendió a partir de los procesos de privatización del último cuarto del siglo XX. Diferenciándose de la arquitectura institucional vigente durante el período de prestación estatal (regulación "endógena", los entes reguladores emergen como el elemento neurálgico de este nuevo esquema. Sin embargo, como se desprende de la experiencia argentina, estos organismos han sido dotados de ambiguas atribuciones regulatorias e inapropiados diseños institucionales, quedando trunca su capacidad real de regulación. A raíz de la difusa delimitación de misiones y funciones e - incluso - frente a las imprecisiones teóricas en la materia, este artículo precisa el alcance de la intervención de los distintos actores del sistema de prestación y regulación: empresas prestadoras, entes reguladores, poderes del Estado (Ejecutivo y Legislativo y usuarios y consumidores. En este sentido, trabaja sobre los diseños institucionales más apropiados para que los entes desarrollen efectivas capacidades de regulación. El análisis se ejemplifica a partir de la experiencia privatizadora argentina - nacional y subnacional - en los servicios de agua potable y saneamiento y distribución de electricidad.This article analyzes the particularities of the public utilities 'modern' regulation scheme, which became predominant during the privatization processes of the last quarter of the twentieth century. In contrast with the institutional framework characteristic of the period of state provision ('endogenous' regulation, the regulatory agencies emerge as the neuralgic element of the new scheme. However, as the Argentine experience demonstrates, these organisms have been endowed with ambiguous regulatory capacities and inappropriate institutional frameworks, and therefore their actual regulatory capacity has been seriously damaged. As

  15. Ionizing radiation sources: very diversified means, multiple applications and a changing regulatory environment. Conference proceedings; Les sources de rayonnements ionisants: des moyens tres diversifies, des applications multiples et une reglementation en evolution. Recueil des presentations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-11-15

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

  16. EGFR相关的DNA修复及放射抗拒机制研究现状%Relativity of EGFR signal as a regulatory mechanism to DNA repair and radiation resistance

    Institute of Scientific and Technical Information of China (English)

    白静; 白晓平; 赵巧艳

    2012-01-01

    目的:总结国外关于表皮生长因子受体(EGFR)通过各种信号通路调节DNA修复导致辐射抗拒相关机制的研究进展.方法:应用PubMed数据库系统,以“表皮生长因子受体、信号通路、DNA损伤修复、放射抗拒”为关键词检索2005-01-2011-12的相关文献,共检索到英文文献198篇.纳入标准:1)EGFR的表达;2)辐射抗拒和DNA损伤修复机制;3)EGFR和辐射诱导的DNA损伤修复;4)EGFR信号通路调控DNA损伤修复导致放射抗拒的可能机制.根据纳入标准,纳入分析22篇文献.结果:EGFR过表达与放化疗抗拒相关.它可以通过联接DNA蛋白激酶催化亚单位(DNA-PKcs)来调节放疗诱导的DNA损伤的修复.EGFR及其对DNA修复能力之间的分子连接可能通过该受体的一个或多个下游信号通路介导.结论:EGFR作为调节DNA损伤修复机制的信号通路与放射抗拒之间存在相关性,靶向于其中激活的信号通路可以为改善放射抗拒提供新的治疗思路.%OBJECTIVE:To sum up the articles related to improvement that epidermal growth factor receptor (EGFR) modulate DNA repair after radiation-induced damage through many signal pathways. METHODS: Epidermal growth factor receptor,signal pathway ,DNA-damage repair and radiation resistance were searched as key words by Pubmed database system from 2005-01 to 2011-12, Altogether 198 English literatures were obtained. Enrolled criteria: 1, EGFR expression; 2. mechanism of DNA repair and radiation resistances 3, EGFR and radiation resistances 4, EGFR signal as a regulatory mechanism to DNA repair and radiation resistance. By extraction according to enrolled criteria, among roughing hundreds of relative articles,46 papers were selected, and 22 papers were finally analyzed. RESULTS: EGFR Overexpres-sion is associated with resistance to chemotherapy and radiotherapy. It modulates DNA repair after radiation-induced damage through association with the catalytic subunit of DNA protein

  17. Measurement and Analysis of Radio-frequency Radiation Exposure Level from Different Mobile Base Transceiver Stations in Ajaokuta and Environs, Nigeria

    CERN Document Server

    Ushie, P O; Bolaji, Ayinmode; Osahun, O D

    2013-01-01

    We present the result of a preliminary assessment of radio-frequency radiation exposure from selected mobile base stations in Ajaokuta environs. The Power density of RF radiation within a radial distance of 125m was measured. Although values fluctuated due to the influence of other factors, including wave interference from other electromagnetic sources around reference base stations, we show from analysis that radiation exposure level is below the standard limit (4.5W/sqm for 900MHz and 9W/sqm for 18000MHz) set by the International Commission on Non-ionizing Radiation Protection (ICNIRP) and other regulatory agencies.

  18. Neuro-oncology update: radiation safety and nursing care during interstitial brachytherapy

    Energy Technology Data Exchange (ETDEWEB)

    Randall, T.M.; Drake, D.K.; Sewchand, W.

    1987-12-01

    Radiation control and safety are major considerations for nursing personnel during the care of patients receiving brachytherapy. Since the theory and practice of radiation applications are not part of the routine curriculum of nursing programs, the education of nurses and other health care professionals in radiation safety procedures is important. Regulatory agencies recommend that an annual safety course be given to all persons frequenting, using, or associated with patients containing radioactive materials. This article presents pertinent aspects of the principles and procedures of radiation safety, the role of personnel dose-monitoring devices, and the value of additional radiation control features, such as a lead cubicle, during interstitial brain implants. One institution's protocol and procedures for the care of high-intensity iridium-192 brain implants are discussed. Preoperative teaching guidelines and nursing interventions included in the protocol focus on radiation control principles.

  19. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

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

  20. 77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

    Science.gov (United States)

    2012-11-27

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Regulatory Guide 1.182, ``Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants'' AGENCY: Nuclear Regulatory Commission. ACTION: Notice of withdrawal. SUMMARY: The...

  1. 40 CFR 73.86 - State regulatory autonomy.

    Science.gov (United States)

    2010-07-01

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

  2. Environmental Regulatory Update Table, January/February 1995

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

    1995-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives impacting environmental, health, and safety management responsibilities. the table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  3. The evolution and impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Asia and the Pacific region.

    Science.gov (United States)

    Morales Pedraza, Jorge; Phillips, Glyn O

    2009-05-01

    The Asia and the Pacific region was within the IAEA program on radiation and tissue banking, the most active region. Most of the tissue banks in the Asia and the Pacific region were developed during the late 1980s and 1990s. The initial number of tissue banks established or supported by the IAEA program in the framework of the RCA Agreement for Asia and the Pacific region was 18. At the end of 2006, the number of tissue banks participating, in one way or another in the IAEA program was 59. Since the beginning of the implementation of the IAEA program in Asia and the Pacific region 63,537 amnion and 44,282 bone allografts were produced and 57,683 amnion and 36,388 bone allografts were used. The main impact of the IAEA program in the region was the following: the establishment or consolidation of at least 59 tissue banks in 15 countries in the region (the IAEA supported directly 16 of these banks); the improvement on the quality and safety of tissues procured and produced in the region reaching international standards; the implementation of eight national projects, two regional projects and two interregional projects; the elaboration of International Standards, a Code of Practice and a Public Awareness Strategies and, the application of quality control and quality assurances programs in all participating tissue banks.

  4. Credit rating agencies and moral hazard

    Directory of Open Access Journals (Sweden)

    Božović Miloš

    2011-01-01

    Full Text Available The failure of credit rating agencies to properly assess risks of complex financial securities was instrumental in setting off the global financial crisis. This paper studies the incentives of companies and rating agencies and argues that the way the current rating market is organized may provide agencies with intrinsic disincentives to accurately report credit risk of securities they rate. Informational inefficiency is only enhanced when rating agencies function as an oligopoly or when they rate structured products. We discuss possible market and regulatory solutions to these problems.

  5. 78 FR 54517 - Water Quality Standards Regulatory Clarifications

    Science.gov (United States)

    2013-09-04

    ... September 4, 2013 Part II Environmental Protection Agency 40 CFR Part 131 Water Quality Standards Regulatory... Rules#0;#0; ] ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

  6. A future vision of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking for Asia and the Pacific and Latin American regions.

    Science.gov (United States)

    Morales Pedraza, Jorge

    2009-05-01

    In order to solve some of the problems that are affecting tissue banking activities in the world, a new program/project proposal could be prepared by the IAEA and interested Member States in order to implement it in 2009. The main objective of the new program/project proposal could be the following: To consolidate tissue banks activities in a selected group of IAEA Member States by increasing the quality of the tissue processing and sterilization methods used. The specific objective to be reached by the new program/project proposal could be the following: To reach international standards in all activities carried out by a selected group of tissue banks, as well as the establishment of a limited regional tissue processing centres in specific regions. The following are the conditions to be met by the interested tissue banks, in order to participate in the new program/project proposal: To process different types of tissues for medical treatment using the ionizing radiation technique for tissue sterilization; To apply at least one of the current version of the IAEA Code of Practice, the IAEA Standards and the IAEA Public Awareness Strategies and to have the support of national health authorities for the use of the remaining IAEA documents in the near future; To have in force agreements with public and private hospitals for the use of the sterilized tissues processed by the bank for medical treatment; To have in place a donor referral system, or has the approval by the national health authorities to adopt such system in the near future; To receive the support from the national health authority to participate in the implementation of the new program/project proposal.

  7. Adjustment of the Brazilian radioprotection standards to the safety principles of the International Atomic Energy Agency; Adequacao das normas brasileiras de radioprotecao aos principios fundamentais de seguranca da International Atomic Energy Agency

    Energy Technology Data Exchange (ETDEWEB)

    Pereira, Wagner de S.; Py Junior, Delcy de A., E-mail: pereiraws@gmail.com [Industrias Nucleares do Brasil (INB), Pocos de Caldas, MG (Brazil). Unidade de Tratamento de Minerio. Grupo Multidisciplinar de Radioprotecao; Kelecom, Alphonse, E-mail: akelecom@id.uff.br [Universidade Federal Fluminense (LARARA-PLS/GETA/UFF), Niteroi, RJ (Brazil). Grupo de Estudos em Temas Ambientais. Lab. de Radiobiologia e Radiometria Pedro Lopes dos Santos; Pereira, Juliana R. de S., E-mail: pereirarsj@gmail.com [Universidade Federal de Alfenas, Pocos de Caldas, MG (Brazil)

    2013-07-01

    The International Atomic Energy Agency (IAEA) has a recommendation with 10 basic safety principles (Fundamental Safety Principles Safety Fundamentals series, number SF-1), which are: 1) Responsibility for safety; 2) Role for government; 3) Leadership and management for safety; 4) Justification of facilities and activities; 5) Optimization of protection; 6) Limitation of risk to individuals; 7) Protection of present and futures generations; 8) Prevention of accidents; 9) Emergency preparedness and response and 10) Protection actions to reduce existing or unregulated radiations risk. The aim of this study is to verify that the Brazilian standards of radiation protection meet the principles described above and how well suited to them. The analysis of the national radiation protection regulatory system, developed and deployed by the National Nuclear Energy Commission (CNEN), showed that out of the ten items, two are covered partially, the number 2 and 10. The others are fully met. The item 2 the fact that the regulatory body (CNEN) be stock controller of a large company in the sector put in check its independence as a regulatory body. In item 10 the Brazilian standard of radiation protection does not provide explicit resolution of environmental liabilities.

  8. Review of biosimilar regulatory guidelines and scientific principles:Experiences from Europe-an Medicines Agency (EMA) guidelines%生物类似物政策监管指南原则与要求研究综述--基于欧盟版生物类似物指南

    Institute of Scientific and Technical Information of China (English)

    陈名; 邵蓉

    2014-01-01

    本文通过文献综述,在明确界定生物类似物概念的基础上,阐述了生物药的特点及其研发生产过程。基于欧盟版生物类似物指南,介绍了其政策框架,并系统梳理了生物类似物政策监管指南原则与要求,包括生物相似性、安全性和免疫原性、适应症外推法、标签与命名、数据保护以及药物互换性与药物警戒等内容,旨在为促进我国生物类似物与生物制药产业的进一步发展提供政策参考与建议。%In this study, a literature review was adopted to specify terminology of biosimilars and demonstrate the basic characteristic of biologics and relevant research and development ( R&D) procedures. The regulatory frame-work of the European Medicines Agency ( EMA ) guidelines on biosimilars was introduced. Explicitly, regulatory guidelines and scientific principles, regarding biosimilarity, safety and immunogenicity, extrapolation, labels and names, data protection, were systematically introduced, as well as interchangeability and pharmacovigilance, respec-tively. The purpose of the study is to provide regulatory references for Chinese legislators and recommendations on the R&D of biosimilars in the biopharmaceutical industry.

  9. 76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

    Science.gov (United States)

    2011-10-04

    ... construct and operate new nuclear power plants including small modular reactors, while continuing to ensure... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan AGENCY:...

  10. 78 FR 60240 - Non-Application of Previously Withdrawn Regulatory Provisions Governing Targeted Dumping in...

    Science.gov (United States)

    2013-10-01

    ... Regulatory Provisions Governing Targeted Dumping in Antidumping Duty Investigations AGENCY: Import... implemented, the previously withdrawn regulatory provisions governing targeted dumping in antidumping duty... concerning the calculation of the weighted-average dumping margin and assessment rate in certain...

  11. 76 FR 72220 - Incorporation of Risk Management Concepts in Regulatory Programs

    Science.gov (United States)

    2011-11-22

    ... COMMISSION Incorporation of Risk Management Concepts in Regulatory Programs AGENCY: Nuclear Regulatory... Commission) is considering development of a strategic vision to better incorporate risk management concepts... homeland security issues, the task force ] believes that risk management concepts may represent a...

  12. Monitoring of radiation exposure

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-02-01

    The guide specifies the requirements for the monitoring of radiation exposure in instances where radiation is used. In addition to workers, the guide covers students, apprentices and visitors. The guide shall also apply to exposure from natural radiation. However, the monitoring of radiation exposure in nuclear power plants is dealt with in YVL Guide 7.10 and 7.11. The guide defines the concepts relevant to the monitoring of radiation exposure and provides guidelines for determining the necessity of monitoring and subsequently arranging such in different operations. In addition, the guide specifies the criteria for the approval and regulatory control of the dosimetric service.

  13. Monitoring of radiation exposure

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-02-01

    The guide specifies the requirements for the monitoring of radiation exposure in instances where radiation is used. In addition to workers, the guide covers students, apprentices and visitors. The guide shall also apply to exposure from natural radiation. However, the monitoring of radiation exposure in nuclear power plants is dealt with in YVL Guide 7.10 and 7.11. The guide defines the concepts relevant to the monitoring of radiation exposure and provides guidelines for determining the necessity of monitoring and subsequently arranging such in different operations. In addition, the guide specifies the criteria for the approval and regulatory control of the dosimetric service.

  14. 76 FR 4103 - Central Minnesota Municipal Power Agency, Midwest Municipal Transmission Group; Notice of Filing

    Science.gov (United States)

    2011-01-24

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Central Minnesota Municipal Power Agency, Midwest Municipal Transmission... Municipal Power Agency and Midwest Municipal Transmission Group submitted an amendment to a petition for...

  15. 78 FR 66343 - Agency Information Collection Activities; Comment Request; Special Education-Individual Reporting...

    Science.gov (United States)

    2013-11-05

    ... Agency Information Collection Activities; Comment Request; Special Education-Individual Reporting on... Performance and Results Act (GPRA) AGENCY: Office of Special Education and Rehabilitative Services (OSERS... of Collection: Special Education-Individual Reporting on Regulatory Compliance Related to the...

  16. Private investment and financing agency legal risks and regulatory path%民间投融资中介机构法律风险防范及监管路径

    Institute of Scientific and Technical Information of China (English)

    曹鹏

    2014-01-01

    Since 2013, private investment and financing intermediaries extraordinary development, as a developed from folk new format, in a short time showing explosive growth. Private investment and financing agency in rich private financial markets, expand investment and financing channels at the same time, the risk gradually increased. According to the investigation, investment and financing intermediaries exist irregularities and beyond the scope of operation, and even suspected of illegal fund-raising, legal risks appear urgent attention.%2013年以来,民间投融资中介机构超常发展,作为一种从民间发展起来的新型业态,在短时间内呈现出爆炸式增长。民间投融资中介机构在丰富民间金融市场,拓展投融资渠道的同时,风险逐步上升。据调查了解,投融资中介机构存在不规范行为和超范围经营情况,甚至涉嫌非法集资,法律风险显现亟需关注。

  17. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Science.gov (United States)

    2011-01-04

    ... govern the Agency's implementation of electronic document and signature requirements. The Government... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration Regulatory Guidance Concerning Electronic Signatures and...

  18. Regulatory aspects

    Science.gov (United States)

    Stern, Arthur M.

    1986-07-01

    At this time, there is no US legislation that is specifically aimed at regulating the environmental release of genetically engineered organisms or their modified components, either during the research and development stage or during application. There are some statutes, administered by several federal agencies, whose language is broad enough to allow the extension of intended coverage to include certain aspects of biotechnology. The one possible exception is FIFRA, which has already brought about the registration of several natural microbial pesticides but which also has provision for requiring the registration of “strain improved” microbial pesticides. Nevertheless, there may be gaps in coverage even if all pertinent statutes were to be actively applied to the control of environmental release of genetically modified substances. The decision to regulate biotechnology under TSCA was justified, in part, on the basis of its intended role as a gap-filling piece of environmental legislation. The advantage of regulating biotechnology under TSCA is that this statute, unlike others, is concerned with all media of exposure (air, water, soil, sediment, biota) that may pose health and environmental hazards. Experience may show that extending existing legislation to regulate biotechnology is a poor compromise compared to the promulgation of new legislation specifically designed for this purpose. It appears that many other countries are ultimately going to take the latter course to regulate biotechnology.

  19. 9 CFR 417.8 - Agency verification.

    Science.gov (United States)

    2010-01-01

    ... REGULATORY REQUIREMENTS UNDER THE FEDERAL MEAT INSPECTION ACT AND THE POULTRY PRODUCTS INSPECTION ACT HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS § 417.8 Agency verification. FSIS will verify the adequacy of the HACCP plan(s) by determining that each HACCP plan meets the requirements of this part...

  20. 18 CFR 270.401 - Jurisdictional agency.

    Science.gov (United States)

    2010-04-01

    ... 18 Conservation of Power and Water Resources 1 2010-04-01 2010-04-01 false Jurisdictional agency. 270.401 Section 270.401 Conservation of Power and Water Resources FEDERAL ENERGY REGULATORY COMMISSION... Boston Boulevard, Springfield, VA 22153. (24) (i) Texas, east of the 100th Meridian—Field Office Manager...

  1. 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.

  2. 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.

  3. Regulation of use of radiation for quarantine purposes; Regulamentacao do uso da radiacao para fins quarentenarios

    Energy Technology Data Exchange (ETDEWEB)

    Itepan, Natanael Marcio, E-mail: natanael.itepan@unianhanguera.edu.b [Faculdade Anhanguera, Piracicaba, SP (Brazil); Costa, Neivaldo; Furlan, Gilberto Ribeiro; Walder, Julio Marcos Melges, E-mail: neivaldo@cena.usp.b, E-mail: gilfurlan@cena.usp.b, E-mail: jmwalder@cena.usp.b [Centro de Energia Nuclear na Agricultura (CENA/USP), Piracicaba, SP (Brazil)

    2011-07-01

    The main aspects of Instruction No. 9 are: a) the nuclear plant that use ionizing radiation as a phyto sanitary treatment for quarantine purposes, must be accredited by the agency of the Agriculture, Livestock and Supply Ministry (MAPA) and the licensing by the Nuclear Energy National Commission (CNEN) and other regulatory bodies, b) control of the applied dose will follow a standard operating procedure should be performed by independent organization, authorized by the Brazilian ONPF (Phyto sanitary Protection National Organization), c) the unit of radiation treatment should ensure traceability and must maintain records of phyto sanitary treatments, d) there should be bilateral work plan between the ONPF of Brazil and other countries for the established radiation treatment protocol. The ONPF of Brazil is the Sanitary Vegetarian Department. Ionizing radiation (cold pasteurization) is shown in an alternative technology to phyto sanitary control for quarantine purposes. (author)

  4. Shaping Formal Networks throug the Regulatory Process

    NARCIS (Netherlands)

    Hall, Thad E.; O'Toole, Laurence J.

    2004-01-01

    Recent research has shown that, at the federal level, new or amended programs typically create networks consisting of multiactor structures spanning governments, sectors, and/or agencies. This study examines the implementation structures created through the regulatory process. We find that in a majo

  5. 78 FR 42893 - Statement on Regulatory Burden

    Science.gov (United States)

    2013-07-18

    ... serve the credit needs of its customers, i.e., America's farmers, ranchers, aquatic producers and... CREDIT ADMINISTRATION 12 CFR Chapter VI RIN 3052-AC88 Statement on Regulatory Burden AGENCY: Farm Credit Administration. ACTION: Notice of intent; request for comment. SUMMARY: The Farm Credit Administration (FCA,...

  6. Department of Commerce Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... Part IV Department of Commerce Semiannual Regulatory Agenda ] DEPARTMENT OF COMMERCE (DOC) DEPARTMENT OF COMMERCE Office of the Secretary 13 CFR Ch. III 15 CFR Subtitle A; Subtitle B, Chs. I, II, III..., and VI Spring 2010 Semiannual Agenda of Regulations AGENCY: Office of the Secretary, Commerce....

  7. 78 FR 10512 - Wyoming Regulatory Program

    Science.gov (United States)

    2013-02-14

    ... permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on..., among other things, ``a State law which provides for the regulation of surface coal mining and... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950 Wyoming Regulatory Program AGENCY...

  8. 77 FR 34894 - Wyoming Regulatory Program

    Science.gov (United States)

    2012-06-12

    ... for the regulation of surface coal mining and reclamation operations on non- Federal and non-Indian... law which provides for the regulation of surface coal mining and reclamation operations in accordance... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950 Wyoming Regulatory Program AGENCY...

  9. 77 FR 58053 - Kentucky Regulatory Program

    Science.gov (United States)

    2012-09-19

    ... for the regulation of surface coal mining and reclamation operations on non- Federal and non-Indian... which provides for the regulation of surface coal mining and reclamation operations in accordance with... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 917 Kentucky Regulatory Program AGENCY...

  10. 78 FR 13002 - Pennsylvania Regulatory Program

    Science.gov (United States)

    2013-02-26

    ... Section 503(a) of the SMCRA permits a State to assume primacy for the regulation of surface coal mining... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 Pennsylvania Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement (``OSM''), Interior. ACTION: Proposed rule...

  11. 78 FR 6062 - North Dakota Regulatory Program

    Science.gov (United States)

    2013-01-29

    ...) of the Act permits a State to assume primacy for the regulation of surface coal mining and... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 934 North Dakota Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public...

  12. 77 FR 18738 - Texas Regulatory Program

    Science.gov (United States)

    2012-03-28

    ... the regulation of surface coal mining and reclamation operations on non- Federal and non-Indian lands... provides for the regulation of surface coal mining and reclamation operations in accordance with the... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY...

  13. 76 FR 36040 - Wyoming Regulatory Program

    Science.gov (United States)

    2011-06-21

    ...(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950 Wyoming Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; public comment...

  14. 77 FR 73965 - Montana Regulatory Program

    Science.gov (United States)

    2012-12-12

    ... Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 926 Montana Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; withdrawal...

  15. 75 FR 21534 - Texas Regulatory Program

    Science.gov (United States)

    2010-04-26

    ... a State to assume primacy for the regulation of surface coal mining and reclamation operations on... other things, ``a State law which provides for the regulation of surface coal mining and reclamation... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY...

  16. 77 FR 46346 - Ohio Regulatory Program

    Science.gov (United States)

    2012-08-03

    ... state to assume primacy for the regulation of surface coal mining and reclamation operations on non... things, ``* * * a State law which provides for the regulation of surface coal mining and reclamation... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 935 Ohio Regulatory Program AGENCY...

  17. 75 FR 6332 - Wyoming Regulatory Program

    Science.gov (United States)

    2010-02-09

    ... for the regulation of surface coal mining and reclamation operations on non- Federal and non-Indian... law which provides for the regulation of surface coal mining and reclamation operations in accordance... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 950 Wyoming Regulatory Program AGENCY...

  18. 76 FR 36039 - Colorado Regulatory Program

    Science.gov (United States)

    2011-06-21

    ... regulation of surface coal mining and reclamation operations on non- Federal and non-Indian lands within its... for the regulation of surface coal mining and reclamation operations in accordance with the... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 906 Colorado Regulatory Program AGENCY...

  19. 77 FR 66574 - Texas Regulatory Program

    Science.gov (United States)

    2012-11-06

    ... a State to assume primacy for the regulation of surface coal mining and reclamation operations on... other things, ``a State law which provides for the regulation of surface coal mining and reclamation... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY...

  20. 75 FR 81122 - Texas Regulatory Program

    Science.gov (United States)

    2010-12-27

    ...) of the Act permits a State to assume primacy for the regulation of surface coal mining and... governments with regard to the regulation of surface coal mining and reclamation operations. One of the... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 943 Texas Regulatory Program AGENCY...

  1. 77 FR 34890 - Oklahoma Regulatory Program

    Science.gov (United States)

    2012-06-12

    ... a State to assume primacy for the regulation of surface coal mining and reclamation operations on... other things, ``* * * State law which provides for the regulation of surface coal mining and reclamation... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 936 Oklahoma Regulatory Program AGENCY...

  2. 77 FR 73966 - Utah Regulatory Program

    Science.gov (United States)

    2012-12-12

    ... regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 Utah Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; reopening and...

  3. 24 CFR 266.505 - Regulatory agreement requirements.

    Science.gov (United States)

    2010-04-01

    ... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Regulatory agreement requirements...

  4. 76 FR 76168 - Regulatory Site Visit Training Program

    Science.gov (United States)

    2011-12-06

    ... HUMAN SERVICES Food and Drug Administration Regulatory Site Visit Training Program AGENCY: Food and Drug... and quality, and the quality of its regulatory efforts and interactions, by providing CBER staff with... coordination of CBER's priorities for staff training as well as the limited available resources for this...

  5. 76 FR 4919 - Regulatory Site Visit Training Program

    Science.gov (United States)

    2011-01-27

    ... HUMAN SERVICES Food and Drug Administration Regulatory Site Visit Training Program AGENCY: Food and Drug... quality, and the quality of its regulatory efforts and interactions, by providing CBER staff with a better... priorities for staff training as well as the limited available resources for this program. In addition to...

  6. Environmental regulatory guide for radiological effluent monitoring and environmental surveillance

    Energy Technology Data Exchange (ETDEWEB)

    1991-01-01

    Under the Atomic Energy Act of 1954, as amended, the US Department of Energy (DOE) is obligated to regulate its own activities so as to provide radiation protection for both workers and the public.'' Presidential Executive Order 12088, Federal Compliance with Pollution Control Standards,'' further requires the heads of executive agencies to ensure that all Federal facilities and activities comply with applicable pollution control standards and to take all actions necessary for the prevention, control, and abatement of environmental pollution. This regulatory guide describes the elements of an acceptable effluent monitoring and environmental surveillance program for DOE sites involving radioactive materials. These elements are applicable to all DOE and contractor activities for which the DOE exercises environmental, safety, and health responsibilities, and are intended to be applicable over the broad range of DOE facilities and sites. In situations where the high-priority elements may not provide sufficient coverage of a specific monitoring or surveillance topic, the document provides additional guidance. The high-priority elements are written as procedures and activities that should'' be performed, and the guidance is written as procedures and activities that should'' be performed. The regulatory guide both incorporates and expands on requirements embodied in DOE 5400.5 and DOE 5400.1. 221 refs., 2 figs., 6 tabs.

  7. Reported radiation overexposure accidents worldwide, 1980-2013: a systematic review.

    Directory of Open Access Journals (Sweden)

    Karen Coeytaux

    Full Text Available Radiation overexposure accidents are rare but can have severe long-term health consequences. Although underreporting can be an issue, some extensive literature reviews of reported radiation overexposures have been performed and constitute a sound basis for conclusions on general trends. Building further on this work, we performed a systematic review that completes previous reviews and provides new information on characteristics and trends of reported radiation accidents.We searched publications and reports from MEDLINE, EMBASE, the International Atomic Energy Agency, the International Radiation Protection Association, the United Nations Scientific Committee on the Effects of Atomic Radiation, the United States Nuclear Regulatory Commission, and the Radiation Emergency Assistance Center/Training Site radiation accident registry over 1980-2013. We retrieved the reported overexposure cases, systematically extracted selected information, and performed a descriptive analysis.297 out of 5189 publications and reports and 194 records from the REAC/TS registry met our eligibility criteria. From these, 634 reported radiation accidents were retrieved, involving 2390 overexposed people, of whom 190 died from their overexposure. The number of reported cases has decreased for all types of radiation use, but the medical one. 64% of retrieved overexposure cases occurred with the use of radiation therapy and fluoroscopy. Additionally, the types of reported accidents differed significantly across regions.This review provides an updated and broader view of reported radiation overexposures. It suggests an overall decline in reported radiation overexposures over 1980-2013. The greatest share of reported overexposures occurred in the medical fields using radiation therapy and fluoroscopy; this larger number of reported overexposures accidents indicates the potential need for enhanced quality assurance programs. Our data also highlights variations in characteristics

  8. Environmental regulatory update table November--December 1994

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Mayer, S.J.; Salk, M.S.

    1995-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  9. Environmental Regulatory Update Table, March/April 1993. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1993-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  10. Environmental Regulatory Update Table, November--December 1993

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1994-01-01

    The Environmental Regulatory Update Table provides information on regulatory of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  11. Environmental Regulatory Update Table, May--June 1994

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

    1994-07-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  12. Environmental Regulatory Update Table, March/April 1993

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1993-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  13. Environmental Regulatory Update Table July/August 1993

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1993-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  14. Environmental Regulatory Update Table, May/June 1993

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1993-07-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bimonthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  15. Environmental Regulatory Update Table, January--February 1994

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1994-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations ad contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  16. Environmental Regulatory Update Table, September/October 1993

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1993-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operation and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  17. Environmental Regulatory Update Table, March/April 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1992-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  18. Environmental regulatory update table, March--April 1994

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E. [Oak Ridge National Lab., TN (United States). Health Sciences Research Div.; Salk, M.S. [Oak Ridge National Lab., TN (United States). Environmental Sciences Div.

    1994-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  19. Environmental Regulatory Update Table, January/February 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1992-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action. This table is for January/February 1992.

  20. Environmental Regulatory Update Table, January--February 1993

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.; Danford, G.S.; Lewis, E.B.

    1993-03-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  1. Environmental Regulatory Update Table, November--December 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1993-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  2. Environmental regulatory update table, September--October 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1992-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  3. Environmental Regulatory Update Table, November--December 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1993-01-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly wit information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  4. Environmental regulatory update table: September/October 1994

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

    1994-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  5. Environmental regulatory update table, September--October 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1992-11-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  6. Environmental Regulatory Update Table, July--August 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1992-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  7. Environmental Regulatory Update Table, March/April 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Salk, M.S.

    1992-05-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  8. Environmental regulatory update table, July/August 1994

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Bock, R.E.; Salk, M.S.

    1994-09-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated bi-monthly with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  9. Environmental sciences division: Environmental regulatory update table July 1988

    Energy Technology Data Exchange (ETDEWEB)

    Langston, M.E.; Nikbakht, A.; Salk, M.S.

    1988-08-01

    The Environmental Regulatory Update Table provides information on regulatory initiatives of interest to DOE operations and contractor staff with environmental management responsibilities. The table is updated each month with information from the Federal Register and other sources, including direct contact with regulatory agencies. Each table entry provides a chronological record of the rulemaking process for that initiative with an abstract and a projection of further action.

  10. Regulatory Streamlining and Improvement

    Energy Technology Data Exchange (ETDEWEB)

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and

  11. 75 FR 14440 - Proposed Agency Information Collection Activities; Comment Request

    Science.gov (United States)

    2010-03-25

    ... Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System. SUMMARY: Background. On June 15, 1984, the Office of Management and Budget (OMB... Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room...

  12. 75 FR 4819 - Proposed Agency Information Collection Activities; Comment Request

    Science.gov (United States)

    2010-01-29

    ... Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System. SUMMARY: Background. On June 15, 1984, the Office of Management and Budget (OMB... the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive...

  13. 78 FR 5803 - Proposed Agency Information Collection Activities; Comment Request

    Science.gov (United States)

    2013-01-28

    ... Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System. SUMMARY: Background. On June 15, 1984, the Office of Management and Budget (OMB... Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office...

  14. 75 FR 70919 - Proposed Agency Information Collection Activities; Comment Request

    Science.gov (United States)

    2010-11-19

    ... Proposed Agency Information Collection Activities; Comment Request AGENCY: Board of Governors of the Federal Reserve System. SUMMARY: Background: On June 15, 1984, the Office of Management and Budget (OMB... Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room...

  15. Regulatory control of nuclear safety in Finland. Annual report 1997

    Energy Technology Data Exchange (ETDEWEB)

    Tossavainen, K. [ed.

    1998-08-01

    The report describes regulatory control of the use of nuclear energy by the Radiation and Nuclear Safety Authority (STUK) in Finland in 1997. Nuclear regulatory control ascertained that the operation of Finnish NPPs was in compliance with the conditions set out in operating licences and current regulations. In addition to NPP normal operation, STUK oversaw projects at the plant units relating to power uprating and safety improvements. STUK prepared statements for the Ministry of Trade and Industry about the applications for renewing the operating licenses of Loviisa and Olkiluoto NPPs. The most important items of supervision in nuclear waste management were studies relating to the final disposal of spent fuel from NPPs and the review of the licence application for a repository for low- and intermediate-level reactor waste from Loviisa NPP. Preparation of general safety regulations for the final disposal of spent nuclear fuel, to be published in the form of a Council of State Decision, was started. By safeguards control, the use of nuclear materials was verified to be in compliance with current regulations and that the whereabouts of every batch of nuclear material were always known. Nuclear material safeguards were stepped up to prevent illicit trafficking of nuclear materials and other radioactive materials. In co-operation with the Ministry for Foreign Affairs and the Institute of Seismology (University of Helsinki), preparations were undertaken to implement the Comprehensive Nuclear Test Ban Treaty (CTBT). For enforcement of the Treaty and as part of the international regulatory approach, STUK is currently developing laboratory analyses relating to airborne radioactivity measurements. The focus of co-operation funded by external sources was as follows: improvement of the safety of Kola and Leningrad NPPs, improvement of nuclear waste management in North-West Russia, development of the organizations of nuclear safety authorities in Eastern Europe and development

  16. 77 FR 33253 - Regulatory Guide 8.33, Quality Management Program

    Science.gov (United States)

    2012-06-05

    ... COMMISSION Regulatory Guide 8.33, Quality Management Program AGENCY: Nuclear Regulatory Commission. ACTION... withdrawing Regulatory Guide (RG) 8.33, ``Quality Management Program.'' This guide provided guidance to ensure that the objectives of the former NRC ``Quality Management Program'' regulations were met. In...

  17. 76 FR 9630 - Federal Regulatory Enforcement Fairness Hearing; National Ombudsman and Region VI Regional Small...

    Science.gov (United States)

    2011-02-18

    ... ADMINISTRATION Federal Regulatory Enforcement Fairness Hearing; National Ombudsman and Region VI Regional Small Business Regulatory Fairness Board AGENCY: U.S. Small Business Administration (SBA). ACTION: Notice of open hearing of the Regional (Region VI) Small Business Regulatory Fairness Board. SUMMARY: The SBA, Office of...

  18. Regulatory Impact Analysis: a new tool for better regulation at ANVISA.

    Science.gov (United States)

    Alves, Flávia Neves Rocha; Peci, Alketa

    2011-08-01

    Regulatory Impact Analysis, which is recommended to regulatory departments, aims to improve regulatory quality by providing information about the costs and benefits of regulation as well as solutions to current issues to enhance the decision-making process. This article discusses the importance of Regulatory Impact Analysis in the context of the National Agency for Sanitary Surveillance performance as well as the agency's current phase of regulation improvement and strengthening. Also, the main definitions related to the regulatory field as well as some international case experiences are presented.

  19. Discretion and Public Benefit in a Regulatory Agency

    OpenAIRE

    Nagarajan, Vijaya

    2013-01-01

    This book explores the manner in which a variety of public benefits such as environmental protection and consumer safety have been accommodated through the authorisation process within competition law and policy in Australia. While the regulator’s use of its discretion can be explained as a triumph of practice over theory, this book explores the potential for competition principles to be imbued by the wider discourses of democratic participation and human rights. In doing so it makes a signif...

  20. Can regulatory agencies protect consumers. Stigler-Cohen debate revisited

    Energy Technology Data Exchange (ETDEWEB)

    Feingold, A.

    1983-01-01

    Stigler-Cohen debate, organized by the American Enterprise Institute, took place twelve years ago. Since then, the movement now known as consumerism has rapidly grown and its impact on public opinion and on political decision makers is of greatest importance to business - it cannot be simply wished away, it must be dealt with rationally and effectively. The paper recognizes the changed reality of the marketplace resulting in growing consumer impotence and a very real need for protection going beyond the general rules governing commercial transactions. At the same time, the author points out that regulation is not costless, that the cure is often worse than the disease. Public policy must be assessed in the light of its overall effects, it must not be based simply on a response to a single-minded call for redress however loudly articulated. There is a great inconsistency in piecemeal attempts at protecting the consumer from himself, while government-supplied goods and services, and government-controlled monopoly pricing afford little consumer protection. Finally, the paper reminds us that freedom itself is our most valuable possession and must not be thoughtlessly traded for perceived temporary advantages.

  1. Is Ionizing Radiation Harmful at any Exposure? An Echo That Continues to Vibrate.

    Science.gov (United States)

    Azzam, Edouard I; Colangelo, Nicholas W; Domogauer, Jason D; Sharma, Neha; de Toledo, Sonia M

    2016-03-01

    The health risks to humans and non-human biota exposed to low dose ionizing radiation remain ambiguous and are the subject of intense debate. The need to establish risk assessment standards based on the mechanisms underlying low-level radiation exposure has been recognized by regulatory agencies as critical to adequately protect people and to make the most effective use of national resources. Here, the authors briefly review evidence showing that the molecular and biochemical changes induced by low doses of radiation differ from those induced by high doses. In particular, an array of redundant and inter-related mechanisms act in both prokaryotes and eukaryotes to restore DNA integrity following exposures to relatively low doses of sparsely ionizing radiation. Furthermore, the radiation-induced protective mechanisms often overcompensate and minimize the mutagenic potential of the byproducts of normal oxidative metabolism. In contrast to adaptive protection observed at low doses of sparsely ionizing radiation, there is evidence that even a single nuclear traversal by a densely ionizing particle track can trigger harmful effects that spread beyond the traversed cell and induce damaging effects in the nearby bystander cells. In vivo studies examining whether exposure to low dose radiation at younger age modulates the latency of expression of age-related diseases such as cancer, together with studies on the role of genetic susceptibility, will further illuminate the magnitude of risk of exposure to low dose radiation.

  2. Sacramento Regional Response Guide to Radiation Emergencies

    Science.gov (United States)

    2006-09-01

    heat, radio waves, and microwaves which are low level radiation energy which is referred to as non- ionizing radiation. High energy radiation is...Response Plan" (California Office of Emergency Services, Updated February 2001), 5. 41 • Department of Fish and Game-lead agency for petroleum spills...radiation-binding and radiation-ridding gels, foam products, films and emulsions . The goal of radiation decontamination is to be sensitive to the

  3. Belgian class II nuclear facilities such as irradiators and accelerators. Regulatory Body attention points and operating experience feedback

    Energy Technology Data Exchange (ETDEWEB)

    Minne, Etienne; Peters, Christelle; Mommaert, Chantal; Kennes, Christian; Cortenbosch, Geert; Schmitz, Frederic; Haesendonck, Michel van [Bel V, Brussels (Belgium); Carlier, Pascal; Schrayen, Virginie; Wertelaers, An [Federal Agency for Nuclear Control, Brussels (Belgium)

    2016-11-15

    The aim of this paper is to present the Regulatory Body attention points and the operating experience feedback from Belgian ''class IIA'' facilities such as industrial and research irradiators, bulk radionuclides producers and conditioners. Reinforcement of the nuclear safety and radiation protection has been promoted by the Federal Agency for Nuclear Control (FANC) since 2009. This paper is clearly a continuation of the former paper [1] presenting the evolution in the regulatory framework relative to the creation of Bel V, the subsidiary of the FANC, and to the new ''class IIA'' covering heavy installations such as those mentioned above. Some lessons learnt are extracted from the operating experience feedback based on the events declared to the authorities. Even though a real willingness to meet the new safety requirements is observed among the ''class IIA'' licensees, promoting the safety culture, the nuclear safety and radiation protection remains an endless challenge for the Regulatory Body.

  4. Summary Report Panel 2: Regulatory Issues.

    Science.gov (United States)

    Johnson, Craig; Dolman, Sarah

    2016-01-01

    The Effects of Noise on Aquatic Life 2013 Conference convened four panels to discuss specific topics related to the effects of anthropogenic noise on aquatic ecosystems. The second of these four panels, the Regulatory Issues Panel, brought together several different perspectives: representatives of agencies responsible for regulating activities that introduce anthropogenic noise into aquatic ecosystems: representatives of the regulated industries, agencies, and consultancies that advise regulators and regulated industries; and nongovernmental organizations and other stakeholders with an interest in anthropogenic noise. The goal of the panel was to help develop a more productive relationship between these groups.

  5. Radiation Resources Outside of EPA

    Science.gov (United States)

    EPA does not license nuclear power plants or regulate the non-ionizing radiation from cell phones, smart meters or power lines. This page provides links to the state and federal agencies that regulate these matters.

  6. Home Health Care Agencies

    Data.gov (United States)

    U.S. Department of Health & Human Services — A list of all Home Health Agencies that have been registered with Medicare. The list includes addresses, phone numbers, and quality measure ratings for each agency.

  7. 29 CFR 1926.53 - Ionizing radiation.

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 8 2010-07-01 2010-07-01 false Ionizing radiation. 1926.53 Section 1926.53 Labor... § 1926.53 Ionizing radiation. (a) In construction and related activities involving the use of sources of ionizing radiation, the pertinent provisions of the Nuclear Regulatory Commission's Standards for...

  8. Responding to the changing regulatory scene

    Energy Technology Data Exchange (ETDEWEB)

    Wise, P.

    1995-12-31

    The regulatory approach of the Illinois Environmental Protection Agency (EPA) is discussed in this paper. Three areas receive emphasis: (1) the changing relations between the US EPA and the states, (2) the new emphasis on pollution prevention techniques, and (3) a new environmental amnesty project. Budgetary considerations, performance partnerships, and nonregulatory compliance assistance are briefly outlined in relation to these topics. Results of the environmental amnesty program for small business, called Clean Break, are briefly reported.

  9. Technical aspects of quality assurance in radiation oncology.

    Science.gov (United States)

    Saw, Cb; Ferenci, Ms; Wanger, H

    2008-07-01

    The technical aspects of quality assurance (QA) in radiation oncology as practice in the United States will be reviewed and updated in the spirit of offering the experience to the radiation oncology communities in the Asia-Pacific region. The word "technical" is used to express the organisational components or processes and not the materials within the QA program. A comprehensive QA program in radiation oncology will have an official statement declaring the quality plan for effective patient care services it provides in a document. The QA program will include all aspects of patient care: physical, clinical, and medical aspects of the services. The document will describe the organisational structure, responsibilities, checks and procedures, and resources allocated to ensure the successful implementation of the quality of patient management. Regulatory guidelines and guidelines from accreditation agencies should be incorporated in the QA program to ensure compliance. The organisational structure will have a multidisciplinary QA committee that has the authority to evaluate continuously the effectiveness of the QA program to provide prompt corrective recommendations and to request feedback as needed to monitor the response. The continuous monitoring aspects require meetings to be held at regular intervals with the minutes of the meetings officially recorded and documented. To ensure that a QA program is effective, the program itself should be audited for quality at regular intervals at least annually. It has been recognised that the current QA program has not kept abreast with the rapid implementation of new and advanced radiation therapy technologies with the most recent in image-based radiation therapy technology. The societal bodies (ASTRO and AAPM) and federal agency (NCI) acknowledge this inadequacy and have held workshops to address this issue. The challenges for the societal bodies and federal agency are numerous that include (a) the prescriptive methodology

  10. [Advanced therapy: from European regulatory framework to national regulatory framework].

    Science.gov (United States)

    Lucas-Samuel, S

    2013-05-01

    The European regulation n(o) 1394/2007/CE published on the 13th of November 2007 defined and harmonized the European regulatory framework for advanced therapy medicinal products. It creates a specialized committee located at the European Medicine Agency, in charge of the assessment of these medicinal products. The consequences of this regulation are introduced in the French regulation by the law n(o) 2011-302 published on the 22nd of March 2011. It detailed notably the possibility for public establishments (except health establishments) and nonprofit organisms to create pharmaceutical establishments. This law defined also a specific category of advanced therapy medicinal products, which fall under the "hospital exemption" framework. The rules regarding the authorizations of the establishments able to prepare these types of medicinal products and the authorization of the products are defined by the n(o) 2012-1236 decree published on the 6th of November 2012.

  11. 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

  12. Regulatory control of nuclear safety in Finland. Annual report 1998

    Energy Technology Data Exchange (ETDEWEB)

    Tossavainen, K. [ed.

    1999-10-01

    The report describes regulatory control of the safe use of nuclear energy by the Radiation and Nuclear Safety Authority (STUK) in 1998. STUK is the Finnish nuclear safety authority. The submission of this report to the Ministry of Trade and Industry is stipulated in Section 121 of the Nuclear Energy Decree. It was verified by regulatory control that the operation of Finnish NPPs was in compliance with conditions set out in the operating licences of the plants and with regulations currently in force. In addition to supervising the normal operation of the plants, STUK oversaw projects carried out at the plant units, which related to the uprating of their power and the improvement of their safety. STUK issued to the Ministry of Trade and Industry a statement about applications for the renewal of the operating licences of Loviisa and Olkiluoto NPPs, which had been submitted by Imatran Voima Oy and Teollisuuden Voima Oy. Regulatory activities in the field of nuclear waste management were focused on the storage and final disposal of spent fuel as well as the treatment, storage and final disposal of reactor waste. STUK issued a statement to the Ministry of Trade and Industry about an environmental impact assessment programme pertaining to a spent fuel repository project, which had been submitted by Posiva Oy, as well as on Imatran Voima Oy's application concerning the operation of a repository for medium- and low-level reactor waste from Loviisa NPP. The use of nuclear materials was in compliance with the regulations currently in force and also the whereabouts of every batch of nuclear material were ensured by safeguards control. In international safeguards, important changes took place, which were reflected also in safeguards activities at national level. International co-operation continued based on financing both from STUK's budget and from additional sources. The focus of co-operation funded from outside sources was as follows: improvement of the safety of

  13. Technical Agency in Practice

    DEFF Research Database (Denmark)

    Krummheuer, Antonia Lina

    2015-01-01

    The paper combines the discussion of technical agency and hybrid networks of Actor-Network Theory (ANT) with an ethnomethodological/conversation analytical (EMCA) perspective on situated practices in which participants ascribe agency to technical artefacts. While ANT works with (ethnographic......) description of hybrid networks in which human and non-human actants are granted agency without differentiating different kinds of agency, EMCA focuses on the member's perspectives and the situated construction of technical agency that is made relevant within an ongoing interaction. Based on an EMCA analysis...... of three video recordings of situations in which technical agency is made relevant by the human participants, the paper demonstrates different ways in which agency is granted to technical artefacts. Human participants can treat a technology as communication partner, as an active part (and actant...

  14. Technical Agency in Practice

    DEFF Research Database (Denmark)

    Krummheuer, Antonia Lina

    2015-01-01

    ) description of hybrid networks in which human and non-human actants are granted agency without differentiating different kinds of agency, EMCA focuses on the member's perspectives and the situated construction of technical agency that is made relevant within an ongoing interaction. Based on an EMCA analysis......The paper combines the discussion of technical agency and hybrid networks of Actor-Network Theory (ANT) with an ethnomethodological/conversation analytical (EMCA) perspective on situated practices in which participants ascribe agency to technical artefacts. While ANT works with (ethnographic...... of three video recordings of situations in which technical agency is made relevant by the human participants, the paper demonstrates different ways in which agency is granted to technical artefacts. Human participants can treat a technology as communication partner, as an active part (and actant...

  15. 77 FR 27113 - Export and Import of Nuclear Equipment and Material; Export of International Atomic Energy Agency...

    Science.gov (United States)

    2012-05-09

    ... / Wednesday, May 9, 2012 / Rules and Regulations#0;#0; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 110 RIN 3150-AJ04 Export and Import of Nuclear Equipment and Material; Export of International Atomic Energy Agency Safeguards Samples AGENCY: Nuclear Regulatory Commission. ACTION: Final rule. SUMMARY: The U.S...

  16. Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria; Evaluacion de NORM en una instalacion de la industria petrolera venezolana para establecer los criterios reguladores

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-07-01

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

  17. Technical Agency in Practice

    DEFF Research Database (Denmark)

    Krummheuer, Antonia Lina

    2015-01-01

    ) description of hybrid networks in which human and non-human actants are granted agency without differentiating different kinds of agency, EMCA focuses on the member's perspectives and the situated construction of technical agency that is made relevant within an ongoing interaction. Based on an EMCA analysis...... of three video recordings of situations in which technical agency is made relevant by the human participants, the paper demonstrates different ways in which agency is granted to technical artefacts. Human participants can treat a technology as communication partner, as an active part (and actant...... in which the human participants orient towards the artefact in different ways; thereby, the construction of technical agency can shift from moment to moment....

  18. 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.

  19. Autonomy of State Agencies

    DEFF Research Database (Denmark)

    Hansen, Morten Balle; Niklasson, Birgitta; Roness, Paul

    NPM-doctrines states that ideal-type agencies should have a high level of managerial autonomy, while being controlled through result-based control instruments, like performance contracts. In this article, the authors present a first preliminary attempt to comparatively analyze the autonomy of state...... agencies in four Nordic countries: Denmark, Finland, Norway and Sweden. By using survey data from more than 500 state agencies in the four countries, the article analyses whether there is indeed a Scandinavian style of autonomy and result control and assesses which structural, cultural, and environmental...... variables might explain similarities and differences in the autonomy of agencies....

  20. Staff Acquisition -- Agencies

    Data.gov (United States)

    Office of Personnel Management — Job vacancy and organizational information from customer agencies sufficient to provide requested services: examining, strategic staffing, recruitment and branding,...

  1. 78 FR 13712 - U.S. Nuclear Regulatory Commission Planned Monitoring Activities for F-Area Tank Farm at the...

    Science.gov (United States)

    2013-02-28

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION U.S. Nuclear Regulatory Commission Planned Monitoring Activities for F-Area Tank Farm at the Savannah River Site, Revision 0 AGENCY: Nuclear Regulatory Commission. ACTION: Document issuance....

  2. 78 FR 31614 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

    Science.gov (United States)

    2013-05-24

    ....221 on Design-Basis Hurricane and Hurricane Missiles AGENCY: Nuclear Regulatory Commission. ACTION... guidance regarding the application of Regulatory Guide (RG) 1.221, ``Design-Basis Hurricane and Hurricane... ML13015A688 Interim Staff Guidance-024 on Implementation of Regulatory Guide 1.221 on Design-Basis...

  3. 4th IEA International CCS Regulatory Network Meeting

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

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

  4. Data Science and Political Economy: Application to Financial Regulatory Structure

    Directory of Open Access Journals (Sweden)

    Sharyn O'Halloran

    2016-11-01

    Full Text Available The development of computational data science techniques in natural language processing and machine learning algorithms to analyze large and complex textual information opens new avenues for studying the interaction between economics and politics. We apply these techniques to analyze the design of financial regulatory structure in the United States since 1950. The analysis focuses on the delegation of discretionary authority to regulatory agencies in promulgating, implementing, and enforcing financial sector laws and overseeing compliance with them. Combining traditional studies with the new machine learning approaches enables us to go beyond the limitations of both methods and offer a more precise interpretation of the determinants of financial regulatory structure.

  5. Environmental Regulatory Update Table, May/June 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1992-07-01

    This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

  6. Environmental Regulatory Update Table, May/June 1992

    Energy Technology Data Exchange (ETDEWEB)

    Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

    1992-07-01

    This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

  7. Radiation and environmental monitoring at the nuclear legacy sites in Russia

    Energy Technology Data Exchange (ETDEWEB)

    Shandala, N.; Kiselev, S.; Titov, A.; Seregin, V.; Akhromeev, S.; Aladova, R.; Isaev, D. [SRC Burnasyan Federal Medical Biophysical Center (Russian Federation); Sneve, M. [Norwegian Radiation Protection Authority - NRPA (Norway)

    2014-07-01

    In 1960's, in the Northwest and Far East regions of Russia the technical bases of the Navy Fleet were built to maintain nuclear submarines by performing reloading of nuclear fuel, receiving and storing radioactive waste (RW) and spent nuclear fuel (SNF). In 2000, SevRAO enterprise in the northwest of Russia and DalRAO enterprise in the Far East were set up for the purposes of environmental remediation of the nuclear legacy sites. Regulatory supervision for radiation protection and safety at the nuclear legacy sites in Russian Far east and Northwest regions is one of regulatory functions of the Federal medical biological agency (FMBA of Russia). Improvement of the normative and regulatory basis has significant impact on effectiveness and efficiency of industrial projects aimed at reduction of nuclear and radiation hazard risk at the sites for the SNF and RW temporary storage (STS).To get unbiased comprehensive information on the current radiation conditions at the STSs and provide the effective response to changing radiation situation, the environmental radiation monitoring of the SevRAO and DalRAO facilities has been carried out during 2005-2013. The nature and peculiarity of the STS area radioactive contamination on the Kola Peninsula and in the Far East are the following: 1) high levels of radioactive contamination on the industrial site; 2) non-uniformity of the contamination distribution; 3) spread of contamination in the area of health protection zone. The following environmental components are contaminated: soil, vegetation, bottom sediments and seaweeds at the offshore sea waters. The dominant radionuclides are cesium-137 and strontium-90. At the facilities under inspection for the purpose of the dynamic control of the radiation situation the radio-ecological monitoring system was arranged. It presupposes regular radiometry inspections in-situ, their analysis and assessment of the radiation situation forecast in the course of the STS remediation main

  8. Current european regulatory perspectives on insulin analogues

    Directory of Open Access Journals (Sweden)

    Enzmann Harald G

    2011-07-01

    Full Text Available Abstract Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.

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

    Directory of Open Access Journals (Sweden)

    Marco Antônio da Cunha

    2015-09-01

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

  10. Radiation Therapy

    Science.gov (United States)

    ... the area is stitched shut. Another treatment, called proton-beam radiation therapy , focuses the radiation on the ... after radiation treatment ends. Sore mouth and tooth decay. If you received radiation therapy to the head ...

  11. Radiation sickness

    Science.gov (United States)

    ... radiation. There are two basic types of radiation: ionizing and nonionizing. Nonionizing radiation comes in the form of light, radio waves, microwaves and radar. This kind of radiation usually ...

  12. 76 FR 48943 - Agency Information Collection Activities: Submission for OMB Review; Comment Request

    Science.gov (United States)

    2011-08-09

    .... requires that agencies: Use the best, most innovative, and least burdensome tools to achieve regulatory... servicer and any change in servicer requires 2 minutes per loan. Compliance monitoring and auditing...

  13. 75 FR 39283 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Science.gov (United States)

    2010-07-08

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB... complete the requirement or request: 365. 10. Abstract: NRC-regulated facilities and other...

  14. 78 FR 48687 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Science.gov (United States)

    2013-08-09

    ...) the use of automated collection techniques or other forms of information technology to minimize the... of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention... agency requests or requirements that members of the public submit reports, keep records, or...

  15. 76 FR 2124 - Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary...

    Science.gov (United States)

    2011-01-12

    ... an effective regulatory program for retail food establishments, establish basic quality control... illness and food defense preparedness and response, (6) compliance and enforcement, (7) industry and... HUMAN SERVICES Food and Drug Administration Agency Information Collection Activities;...

  16. 2012 Global Summit on Regulatory Science (GSRS-2012)--modernizing toxicology.

    Science.gov (United States)

    Miller, Margaret A; Tong, Weida; Fan, Xiaohui; Slikker, William

    2013-01-01

    Regulatory science encompasses the tools, models, techniques, and studies needed to assess and evaluate product safety, efficacy, quality, and performance. Several recent publications have emphasized the role of regulatory science in improving global health, supporting economic development and fostering innovation. As for other scientific disciplines, research in regulatory science is the critical element underpinning the development and advancement of regulatory science as a modern scientific discipline. As a regulatory agency in the 21st century, the Food and Drug Administration (FDA) has an international component that underpins its domestic mission; foods, drugs, and devices are developed and imported to the United States from across the world. The Global Summit on Regulatory Science, an international conference for discussing innovative technologies, approaches, and partnerships that enhance the translation of basic science into regulatory applications, is providing leadership for the advancement of regulatory sciences within the global context. Held annually, this international conference provides a platform where regulators, policy makers, and bench scientists from various countries can exchange views on how to develop, apply, and implement innovative methodologies into regulatory assessments in their respective countries, as well as developing a harmonized strategy to improve global public health through global collaboration.

  17. Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

    Energy Technology Data Exchange (ETDEWEB)

    Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

    2008-06-01

    Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

  18. Regulatory guidance document

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    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.

  19. The sense of agency

    DEFF Research Database (Denmark)

    Ritterband-Rosenbaum, Anina

    investigate the sense of agency. The central aspect of the thesis work was to understand if brain lesioned children, diagnosed with hemiplegic Cerebral Palsy (CP), have an altered sense of agency, and if this different experience has an influence on the feeling of control of their movements and their actual...

  20. Radiation dosimetry.

    OpenAIRE

    Cameron, J

    1991-01-01

    This article summarizes the basic facts about the measurement of ionizing radiation, usually referred to as radiation dosimetry. The article defines the common radiation quantities and units; gives typical levels of natural radiation and medical exposures; and describes the most important biological effects of radiation and the methods used to measure radiation. Finally, a proposal is made for a new radiation risk unit to make radiation risks more understandable to nonspecialists.

  1. On Epistemic Agency

    DEFF Research Database (Denmark)

    Ahlström, Kristoffer

    Every time we act in an effort to attain our epistemic goals, we express our epistemic agency. The present study argues that a proper understanding of the actions and goals relevant to expressions of such agency can be used to make ameliorative recommendations about how the ways in which we...... about epistemic value, the only goal relevant to inquiry is that of forming true belief; and that our dual tendency for bias and overconfidence gives us reason to implement epistemically paternalistic practices that constrain our freedom to exercise agency in substantial ways. In other words, when...... actually express our agency can be brought in line with how we should express our agency. More specifically, it is argued that the actions relevant to such expressions should be identified with the variety of actions characteristic of inquiry; that contrary to what has been maintained by recent pluralists...

  2. On Epistemic Agency

    DEFF Research Database (Denmark)

    Ahlström, Kristoffer

    Every time we act in an effort to attain our epistemic goals, we express our epistemic agency. The present study argues that a proper understanding of the actions and goals relevant to expressions of such agency can be used to make ameliorative recommendations about how the ways in which we...... actually express our agency can be brought in line with how we should express our agency. More specifically, it is argued that the actions relevant to such expressions should be identified with the variety of actions characteristic of inquiry; that contrary to what has been maintained by recent pluralists...... about epistemic value, the only goal relevant to inquiry is that of forming true belief; and that our dual tendency for bias and overconfidence gives us reason to implement epistemically paternalistic practices that constrain our freedom to exercise agency in substantial ways. In other words, when...

  3. From molecule to market access: drug regulatory science as an upcoming discipline.

    Science.gov (United States)

    Gispen-de Wied, Christine C; Leufkens, Hubertus G M

    2013-11-05

    Regulatory science as a discipline has evolved over the past years with the object to boost and promote scientific rationale behind benefit/risk and decision making by regulatory authorities. The European Medicines Agency, EMA, the Food and Drug Administration, FDA, and the Japanese Pharmaceutical and Medical Devices Agency, PMDA, highlighted in their distinct ways the importance of regulatory science as a basis of good quality assessment in their strategic plans. The Medicines Evaluation Board, MEB, states: 'regulatory science is the science of developing and validating new standards and tools to evaluate and assess the benefit/risk of medicinal products, facilitating sound and transparent regulatory decision making'. Through analysis of regulatory frameworks itself and their effectiveness, however, regulatory science can also advance knowledge of these systems in general. The comprehensive guidance that is issued to complete an application dossier for regulatory product approval has seldomly been scrutinized for its efficiency. Since it is the task of regulatory authorities to protect and promote public health, it is understood that they take a cautious approach in regulating drugs prior to market access. In general, the authorities are among the first to be blamed if dangerous or useless drugs were allowed to the market. Yet, building a regulatory framework that is not challenged continuously in terms of deliverables for public health and cost-effectiveness, might be counterproductive in the end. Regulatory science and research can help understand how and why regulatory decisions are made, and where renewed discussions may be warranted. The MEB supports regulatory science as an R&D activity to fuel primary regulatory processes on product evaluation and vigilance, but also invests in a 'looking into the mirror' approach. Along the line of the drug life-cycle, publicly available data are reviewed and their regulatory impact highlighted. If made explicit

  4. Strategy for communicating benefit-risk decisions: A comparison of regulatory agencies’ publicly available documents

    Directory of Open Access Journals (Sweden)

    James eLeong Wai Yeen

    2014-12-01

    Full Text Available The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia’s Therapeutic Goods Administration were compared to a benefit-risk (BR documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia’s Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

  5. 78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-05-09

    ..., Office of Policy, National Center for Environmental Economics, Mail code 1809T, Environmental Protection... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION AGENCY Technical Guidance for Assessing Environmental Justice in Regulatory Analysis...

  6. Regulatory Actions - Final Mercury and Air Toxics Standards (MATS) for Power Plants

    Science.gov (United States)

    The U.S. Environmental Protection Agency (EPA) has proposed Mercury and Air Toxics Standards (MATS) for power plants to limit mercury, acid gases and other toxic pollution from power plants. This page describes Federal regulatory actions.

  7. 77 FR 13617 - Agency Information Collection Activities: General Declaration

    Science.gov (United States)

    2012-03-07

    ... information (total capital/startup costs and operations and maintenance costs). The comments that are... appropriate regulatory agency staffs. CBP Form 7507 collects information about the flight routing, the numbers... about disinfecting and sanitizing treatments during the flight, and a declaration attesting to the...

  8. Credit Rating Agencies, Financial Regulations and the Capital Markets

    NARCIS (Netherlands)

    K. Shahzad (Khurram)

    2013-01-01

    textabstractThis thesis studies the role of credit rating agencies (CRAs) in capital markets, and the effects of two important regulatory decisions that are taken to improve the quality of information available to the capital markets. In particular, this thesis examines a) the importance of credit

  9. 77 FR 65908 - Agency Information Collection Activities: Comment Request

    Science.gov (United States)

    2012-10-31

    ... the agency's estimate of burden including the validity of the methodology and assumptions used; (c... other forms of information technology should be addressed to: Office of Information and Regulatory... understanding of how students effectively learn mathematics and science. The motivational force for...

  10. Credit Rating Agencies, Financial Regulations and the Capital Markets

    NARCIS (Netherlands)

    K. Shahzad (Khurram)

    2013-01-01

    textabstractThis thesis studies the role of credit rating agencies (CRAs) in capital markets, and the effects of two important regulatory decisions that are taken to improve the quality of information available to the capital markets. In particular, this thesis examines a) the importance of credit r

  11. Regulatory T cell memory

    Science.gov (United States)

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  12. NRC regulatory initiatives

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, T.C. [Nuclear Regulatory Commission (United States)

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  13. Regulatory Enforcement and Compliance

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    1999-01-01

    agencies. The latter are shown to be more important in bringing about compliance than are inspectors' enforcement styles. Municipal agencies are shown to increase compliance through the use of third parties, more frequent inspection, and setting priorities for inspection of major items. The findings about...

  14. 78 FR 50409 - Kansas Municipal Energy Agency v. Sunflower Electric Power Corporation, Mid-Kansas Electric...

    Science.gov (United States)

    2013-08-19

    ... Energy Regulatory Commission Kansas Municipal Energy Agency v. Sunflower Electric Power Corporation, Mid-Kansas Electric Company, LLC, Southwest Power Pool, Inc.; Notice of Complaint Take notice that on August... 206 of the Federal Energy Regulatory Commission's (Commission), 18 CFR 385.206 (2013), Kansas...

  15. Expert views on regulatory preparedness for managing the risks of nanotechnologies.

    Directory of Open Access Journals (Sweden)

    Christian E H Beaudrie

    Full Text Available The potential and promise of nanotechnologies depends in large part on the ability for regulatory systems to assess and manage their benefits and risks. However, considerable uncertainty persists regarding the health and environmental implications of nanomaterials, hence the capacity for existing regulations to meet this challenge has been widely questioned. Here we draw from a survey (N=254 of US-based nano-scientists and engineers, environmental health and safety scientists, and regulatory scientists and decision-makers, to ask whether nano experts regard regulatory agencies as prepared for managing nanomaterial risks. We find that all three expert groups view regulatory agencies as unprepared. The effect is strongest for regulators themselves, and less so for scientists conducting basic, applied, or health and safety work on nanomaterials. Those who see nanotechnology risks as novel, uncertain, and difficult to assess are particularly likely to see agencies as unprepared. Trust in regulatory agencies, views of stakeholder responsibility regarding the management of risks, and socio-political values were also found to be small but significant drivers of perceived agency preparedness. These results underscore the need for new tools and methods to enable the assessment of nanomaterial risks, and to renew confidence in regulatory agencies' ability to oversee their growing use and application in society.

  16. Optimization and radiation protection culture

    Energy Technology Data Exchange (ETDEWEB)

    Jeon, In Young; Shin, Hyeong Ki; Lee, Chan Mi [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-04-15

    Safety culture or radiation protection culture is based in common on the term, 'culture'. Culture is defined as the learned, shared set of symbols and patterns of basic assumptions, which is invented, discovered, or developed by a given group as it learns to cope with its problem of external adaptation and internal integration. Safety culture generally refers to the attitude and behaviors affecting safety performance. The concept of 'Safety Culture' was introduced after the Chernobyl accident in 1986. For the accident, nuclear society reached the conclusion that the cause was the wrong management attitude of the NPP, that is, deficient 'Safety Culture'. Recently, 'Radiation Protection Culture' was introduced as the core concept of nuclear safety culture. There have been many efforts to establish definition and develop assessment tool for radiation protection culture in international level such as ICRP and IRPA as well as NRC. In the same context with the safety culture, radiation protection culture is defined as 'the core values and behaviors resulting from a collective commitment by leaders and individual's to emphasize safety over competing goals to ensure protection of people and the environment.' It is worthwhile to recognize that regulatory enforcement in establishing healthy radiation protection culture of operators should be minimized because culture is not in the domain of regulatory enforcement. However, as 'ALARA', the most important concept in radiation protection, may be successfully achieved only in well established radiation protection culture, the least regulatory intervention would be needed in promoting and nurturing radiation protection culture in licensee. In addition, the concept of radiation protection culture should be addressed in plant operational policy to achieve the goals of ALARA. The pre-condition of the successful radiation protection culture is a healthy organizational

  17. new model for solar radiation estimation from measured air ...

    African Journals Online (AJOL)

    HOD

    Nigerian Meteorological Agency (NIMET) were used as inputs to the ANFIS model and monthly mean global solar radiation was ... models were used to predict solar radiation in Nigeria by. [12-15]. .... calculate them as total output [32] and [34].

  18. Regional and International Networking to Support the Energy Regulatory Commission of Thailand

    Energy Technology Data Exchange (ETDEWEB)

    Lavansiri, Direk; Bull, Trevor

    2010-09-15

    The Energy Regulatory Commission of Thailand is a new regulatory agency. The structure of the energy sector; the tradition of administration; and, the lack of access to experienced personnel in Thailand all pose particular challenges. The Commission is meeting these challenges through regional and international networking to assist in developing policies and procedures that allow it to meet international benchmarks.

  19. 78 FR 14840 - U.S.-EU High Level Regulatory Cooperation Forum-Stakeholder Session

    Science.gov (United States)

    2013-03-07

    ... BUDGET U.S.-EU High Level Regulatory Cooperation Forum--Stakeholder Session AGENCY: Office of Management...-0028-0001). The notice was part of a joint effort by the United States and the European Union (EU) to... will hold a public meeting of the U.S.-EU High Level Regulatory Cooperation Forum (the ``Forum'')...

  20. 78 FR 58500 - Water Quality Standards Regulatory Clarifications Proposed Rule; Public Meeting and Public Webinars

    Science.gov (United States)

    2013-09-24

    ... AGENCY 40 CFR Part 131 Water Quality Standards Regulatory Clarifications Proposed Rule; Public Meeting... meeting and two public webinars to be held for the proposed rule ``Water Quality Standards Regulatory... the federal water quality standards (WQS) regulation at 40 CFR Part 131 which helps implement the...

  1. 78 FR 1618 - Semiannual Agenda and Fiscal Year 2013 Regulatory Plan

    Science.gov (United States)

    2013-01-08

    ... January 8, 2013 Part XIII Department of the Treasury Semiannual Regulatory Agenda #0;#0;Federal Register / Vol. 78 , No. 5 / Tuesday, January 8, 2013 / Unified Agenda#0;#0; ] DEPARTMENT OF THE TREASURY 31 CFR Subtitles A and B Semiannual Agenda and Fiscal Year 2013 Regulatory Plan AGENCY: Department of the...

  2. Radiation protection in medicine

    Energy Technology Data Exchange (ETDEWEB)

    Vano, E.; Holmberg, O.; Perez, M. R.; Ortiz, P.

    2016-08-01

    Diagnostic, interventional and therapeutic used of ionizing radiation are beneficial for hundreds of millions of people each year by improving health care and saving lives. In March 2001, the first International Conference on the Radiological Protection of Patients was held in Malaga, Spain, which led to an international action plan for the radiation protection of patients. Ten years after establishing the international action plan, the International Conference on Radiation Protection in Medicine: Setting the Scene for the Next Decade was held in Bonn, Germany, in December 2012. the main outcome of this conference was the so called Bonn Call for Action that identifies then priority actions to enhance radiation protection in medicine for the next decade. The IAEA and WHO are currently working in close cooperation to foster and support the implementation of these ten priority actions in Member States, but their implementation requires collaboration of national governments, international agencies, researchers, educators, institutions and professional associations. (Author)

  3. Uncertainty, rationality, and agency

    CERN Document Server

    Hoek, Wiebe van der

    2006-01-01

    Goes across 'classical' borderlines of disciplinesUnifies logic, game theory, and epistemics and studies them in an agent-settingCombines classical and novel approaches to uncertainty, rationality, and agency

  4. State Agency Administrative Boundaries

    Data.gov (United States)

    Kansas Data Access and Support Center — This database comprises 28 State agency boundaries and point of contact. The Kansas Geological Survey collected legal descriptions of the boundaries for various...

  5. Supernatural agency and forgiveness

    NARCIS (Netherlands)

    Nieuwboer, W.; Schie, H.T. van; Karremans, J.C.T.M.; Wigboldus, D.H.J.

    2015-01-01

    The present research examined the hypothesis that supernatural agency attributions underlie the relation between religion and forgiveness. In two experiments a priming procedure was used to make religious concepts temporarily more salient. In Experiment 1, a religion prime marginally enhanced

  6. Regulatory Promotion of Emergent CCS Technology

    Energy Technology Data Exchange (ETDEWEB)

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

    Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensive regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.

  7. The EURATOM Supply Agency

    Energy Technology Data Exchange (ETDEWEB)

    Lightner, J.

    1989-11-01

    With the coming liberalization of trade and industry within the European Community (EC) and a more centrally-coordinated EC external trade policy, it is timely to ask if in the 1990s there will be any significant changes in the commercial relations between the EC and non-EC companies trading in nuclear fuel. The key vehicle for implementing any change of policy would probably be the European Atomic Energy Community (EURATOM) Supply Agency in Brussels, which is charged under the EURATOM Treaty with overseeing the equitable supply of nuclear fuel to and among EC companies. The EURATOM Supply Agency (the Agency) is a signatory to almost all EC-company contracts for transactions that occur on the territory of the Community, which includes Belgium, Denmark, France, the Federal Republic of Germany (FRG), Great Britain, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, and Spain. During the 1980s, the Supply Agency has rarely tried to influence the commercial decisions of EC member companies. The nuclear fuel industry has largely perceived the Agency as an administrative office that registers contracts and maintains relations with some outside governments, particularly Australia, Canada, and the USA. However, in 1988 the Agency began to have a more direct commercial impact when it reviewed the practice-previously conducted routinely by the EURATOM Safeguards Directorate in Luxembourg at the request of EC-member companies-of swapping safeguards obligations on equivalent quantities of uranium at different locations (flag swapping). The Agency`s actions inhibiting flag swaps, as well as a related de facto policy restricting material swaps of Southern African uranium, caused it to be viewed as obstructive by some EC companies. During 1989 the discussion about flag swaps and swaps involving South African and Namibian uranium has subsided, and a far-reaching discussion has arisen about EC trade policy in general.

  8. The impact of the International Atomic Energy Agency (IAEA) program on radiation and tissue banking in Uruguay: development of tissues quality control and quality management system in the National Multi-Tissue Bank of Uruguay.

    Science.gov (United States)

    Alvarez, I; Morales Pedraza, Jorge; Saldías, M C; Pérez Campos, H; Wodowóz, O; Acosta, María; Vicentino, W; Silva, W; Rodríguez, G; Machín, D; Alvarez, O

    2009-05-01

    BNOT was created and regulated in 1977 and started its operation in 1978 according to the Decree No. 86/1977. By the Decree 248/005 is transformed in the National Institute of Donation and Transplantation of Cells, Tissues and Organs (Instituto Nacional de Donación y Trasplante de Células, Tejidos y Organos--INDT). The organisation has been operating within the State University Medical School and the Public Health Secretary and it is the governmental organisation responsible for the regulation, policy and management of donation and transplantation in Uruguay. By the Decree 160/2006 is responsible for human cells and tissues regulation too. The participation of the INDT in the IAEA program facilitated the introduction of the radiation sterilisation technique for the first time in the country. The radiation sterilisation of tissues processed by INDT (ex BNOT), was initially carried out in the 60 Cobalt Industrial Plant in the National Atomic Energy Commission of Argentina and now is carried out in INDT, using a Gamma Cell 220 Excel, which was provided by the IAEA through the national project URU/7/005. The results of the implementation of tissues, quality control and quality management system, are showed.

  9. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

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

    2017-07-01

    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.

  10. 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.

  11. Australian Radiation Protection and Nuclear Safety Act 1998. Act No 133

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-11-01

    A set of legislation consisting of three Acts in the field of radiation protection and nuclear safety was passed by both Houses of Parliament on 10 December 1998 and was proclaimed on 5 February 1999. Act No. 133 - Australian Radiation Protection and Nuclear Safety Act, which is a framework Law, established the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) as the regulatory body for radiation protection and nuclear safety, in place of the Nuclear Safety Bureau. The Chief Executive Officer of ARPANSA, who is appointed by the Governor-General for a term of up to 5 years, is obliged to submit annual and quarterly reports to the Minister on the operations of the Chief Executive Officer, ARPANSA, the Council, the Radiation Health Committee and the Nuclear Safety Committee. The Council is a consultative body which examines issues relating to radiation protection and nuclear safety and advises the Chief Executive Officer on these issues as well as on the adoption of recommendations, policies and codes. The Radiation Health Committee and the Nuclear Safety Committee are to be established as advisory committees to the Chief Executive Officer or the Council. Both committees should draft national policies, codes and standards in their respective fields and review their effectiveness periodically. The second in this series of legislation, Act No. 134, Australian Radiation Protection and Nuclear Safety (License Charges) Act requires holders of both facility and source licenses to pay an annual charge, to be prescribed by the regulations. The third, Act No. 135 , Australian Radiation Protection and Nuclear Safety (Consequential Amendments) Act repeals those provisions of the 1987 Australian Nuclear Science and Technology Organisation Act which concern the Nuclear Safety Bureau, and the 1978 Environment Protection Act as a whole

  12. 76 FR 71008 - Yuba County Water Agency; Notice of Dispute Resolution Process Schedule; Panel Meeting, and...

    Science.gov (United States)

    2011-11-16

    ... Energy Regulatory Commission Yuba County Water Agency; Notice of Dispute Resolution Process Schedule... resolution process, pursuant to 18 CFR 5.14, in the relicensing proceeding for the Yuba County Water Agency's...) hydrology for anadromous fish; (3) water temperatures for anadromous fish migration, holding, spawning, and...

  13. 75 FR 6199 - Central Minnesota Municipal Power Agency and Midwest Municipal Transmission Group, Inc.; Notice...

    Science.gov (United States)

    2010-02-08

    ... Federal Energy Regulatory Commission Central Minnesota Municipal Power Agency and Midwest Municipal Transmission Group, Inc.; Notice of Filing February 1, 2010. Take notice that on January 25, 2010, Central Minnesota Municipal Power Agency and Midwest Municipal Transmission Group, Inc. (CMMPA/ MMTG) filed with...

  14. 75 FR 30013 - South Feather Water and Power Agency; Notice of Availability of Environmental Assessment

    Science.gov (United States)

    2010-05-28

    ... Energy Regulatory Commission South Feather Water and Power Agency; Notice of Availability of...), Commission staff has prepared an environmental assessment (EA) regarding South Feather Water and Power Agency... Creek development of the South Feather Power Project (FERC No. 2088). Sly Creek is located on Sly...

  15. 75 FR 7285 - Renewal of Agency Information Collection for Acquisition of Trust Land

    Science.gov (United States)

    2010-02-18

    ... Bureau of Indian Affairs Renewal of Agency Information Collection for Acquisition of Trust Land AGENCY... trust status pursuant to 25 CFR part 151, Land Acquisitions. The information collection is currently... BIA to ensure compliance with regulatory and statutory requirements for taking land into trust...

  16. Agencies and Science-Experiment Risk

    CERN Document Server

    Johnson, Eric E

    2016-01-01

    There is a curious absence of legal constraints on U.S. government agencies undertaking potentially risky scientific research. Some of these activities may present a risk of killing millions or even destroying the planet. Current law leaves it to agencies to decide for themselves whether their activities fall within the bounds of acceptable risk. This Article explores to what extent and under what circumstances the law ought to allow private actions against such non-regulatory agency endeavors. Engaging with this issue is not only interesting in its own right, it allows us to test fundamental concepts of agency competence and the role of the courts. Two case studies provide a foundation for discussion: NASA's use of plutonium power supplies on spacecraft, which critics say could cause millions of cancers in the event of atmospheric disintegration, and a Department of Energy particle-collider experiment (the RHIC, or Relativistic Heavy Ion Collider) that allegedly poses a small risk of collapsing the Earth (vi...

  17. Radiation signature on exposed cells: Relevance in dose estimation

    Institute of Scientific and Technical Information of China (English)

    Venkatachalam; Perumal; Tamizh; Selvan; Gnana; Sekaran; Venkateswarlu; Raavi; Safa; Abdul; Syed; Basheerudeen; Karthik; Kanagaraj; Amith; Roy; Chowdhury; Solomon; FD; Paul

    2015-01-01

    The radiation is considered as a double edged sword, as its beneficial and detrimental effects have been demonstrated. The potential benefits are being exploited to its maximum by adopting safe handling of radionuclide stipulated by the regulatory agencies. While the occupational workers are monitored by personnel monitoring devices, for general publics, it is not a regular practice. However, it can be achieved by using biomarkers with a potential for the radiation triage and medical management. An ideal biomarker to adopt in those situations should be rapid, specific, sensitive, reproducible, and able to categorize the nature of exposure and could provide a reliable dose estimation irrespective of the time of the exposures. Since cytogenetic markers shown to have many advantages relatively than other markers, the origins of various chromosomal abnormalities induced by ionizing radiations along with dose-response curves generated in the laboratory are presented. Current status of the gold standard dicentric chromosome assay, micronucleus assay, translocation measurement by fluorescence insitu hybridization and an emerging protein marker the g-H2 AX assay are discussed with our laboratory data. With the wide choice of methods, an appropriate assay can be employed based on the net.

  18. Radiation signature on exposed cells: Relevance in dose estimation.

    Science.gov (United States)

    Perumal, Venkatachalam; Gnana Sekaran, Tamizh Selvan; Raavi, Venkateswarlu; Basheerudeen, Safa Abdul Syed; Kanagaraj, Karthik; Chowdhury, Amith Roy; Paul, Solomon Fd

    2015-09-28

    The radiation is considered as a double edged sword, as its beneficial and detrimental effects have been demonstrated. The potential benefits are being exploited to its maximum by adopting safe handling of radionuclide stipulated by the regulatory agencies. While the occupational workers are monitored by personnel monitoring devices, for general publics, it is not a regular practice. However, it can be achieved by using biomarkers with a potential for the radiation triage and medical management. An ideal biomarker to adopt in those situations should be rapid, specific, sensitive, reproducible, and able to categorize the nature of exposure and could provide a reliable dose estimation irrespective of the time of the exposures. Since cytogenetic markers shown to have many advantages relatively than other markers, the origins of various chromosomal abnormalities induced by ionizing radiations along with dose-response curves generated in the laboratory are presented. Current status of the gold standard dicentric chromosome assay, micronucleus assay, translocation measurement by fluorescence in-situ hybridization and an emerging protein marker the γ-H2AX assay are discussed with our laboratory data. With the wide choice of methods, an appropriate assay can be employed based on the net.

  19. Image Gently: A campaign to promote radiation protection for children worldwide

    Directory of Open Access Journals (Sweden)

    Kimberly Applegate

    2015-10-01

    Full Text Available With the goal of raising awareness and developing stakeholder educational tools for the appropriate imaging of children, the Image Gently campaign was launched in 2007. This campaign is a product of a multidisciplinary alliance with international representation which now numbers nearly 100 medical and dental professional societies and organisations, and includes regulatory organisations. The alliance focuses on increasing awareness and developing education materials that support the protection of children worldwide from unnecessary radiation in medicine. The alliance members work with agencies and regulatory bodies to improve standards and measures that are specific to children. The campaign has produced open source modules for all stakeholders regarding CT, fluoroscopy, nuclear medicine, interventional radiology, digital radiography and dental imaging. The philosophy of the Image Gently steering committee is to collaborate, to share information freely, to keep messaging simple and to commit to lifelong learning. Many healthcare practitioners may not understand how to decrease children’s radiation exposure; the goal of Image Gently is to increase all stakeholders’ understanding of both the benefits and the risks and to encourage radiation reduction strategies. This article summarises the rationale and goals of the global campaign to date.

  20. 10 CFR 39.67 - Radiation surveys.

    Science.gov (United States)

    2010-01-01

    ... from the logging tool before departure from the temporary jobsite, the licensee shall confirm that the logging tool is free of contamination by energizing the logging tool detector or by using a survey meter... REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation...

  1. Vaccines in Argentina: a regulatory view.

    Science.gov (United States)

    Pérez, A C; Diez, R A

    2003-07-28

    In Argentina, vaccines for immuno-preventable diseases are regulated by the national regulatory agency, the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (the National Administration of Drugs, Food and Medical Devices, or ANMAT) created in 1992 to ensure efficacy and safety of drugs, food and medical devices available in the country, according to Law 16,463 and Decree 150/92. ANMAT has licensed 84 out of 157 vaccines registered in Argentina. Since 1994, ANMAT evaluated, approved and inspected 20 clinical trials with vaccines (1.8% of the 1062 trials approved by the agency since that time). The National System of Pharmaco-vigilance has received 318 communications of eventual adverse post-vaccination events (0.3% of the total). In addition, ANMAT provides support to the National Immunisation Programme. The current procedure is to follow international guidelines in the field, to be prepared for new, rapidly changing scenarios.

  2. Radiation Therapy

    Science.gov (United States)

    Radiation therapy is a cancer treatment. It uses high doses of radiation to kill cancer cells and stop them from ... half of all cancer patients receive it. The radiation may be external, from special machines, or internal, ...

  3. Radiation practices. Annual report 2011

    Energy Technology Data Exchange (ETDEWEB)

    Rantanen, E. (ed.)

    2012-09-15

    1791 safety licences for the use of radiation were current at the end of 2011. 1702 responsible parties were engaged in notifiable licence-exempt dental X-ray activities. Use of radiation was controlled through regular inspections performed at places of use, test packages sent by post to dental X-ray facilities and maintenance of the Dose Register. Radiation safety guides were also published and research was conducted in support of regulatory control. The Radiation and Nuclear Safety Authority (STUK) conducted 575 inspections of licensed practices in 2011. 633 repair orders and recommendations were issued in the course of inspections. A total of nearly 11 700 workers were subject to individual monitoring in 2011 and about 143 000 dose entries were made in the Dose Register maintained by STUK. Regulatory control of natural radiation focused on radon at workplaces and exposure of aircrews to cosmic radiation. 166 workplaces including a total of 288 work areas were subject to radon monitoring during 2011. Just over 3600 cockpit and cabin crew members were monitored for exposure to cosmic radiation. STUK was involved in four ionizing radiation research projects, and also took part in an international expert group evaluation of STUK research activities. New alpha and beta sources were procured for metrological activities and a Co-60 irradiation device procured in 2010 was installed and taken into use. Calibration and testing services continued as in previous years. Regulatory control of the use of non-ionizing radiation in 2011 focused particularly on mobile phones, sunbeds and lasers. Orders were issued to 5 responsible parties to discontinue the use of tattoo removal lasers. 7 sunbed facilities were inspected and 10 on-site laser display inspections were performed. Five mobile phone types were tested in market surveillance of wireless communication devices. Non-ionizing radiation research activities were also subjected to the evaluation of STUK research activities

  4. 77 FR 16990 - Notification of Submission to the Secretary of Agriculture of Two Draft Regulatory Documents...

    Science.gov (United States)

    2012-03-23

    ... of Agriculture of Two Draft Regulatory Documents Under FIFRA AGENCY: Environmental Protection Agency (EPA). ] ACTION: Notification of submission to the Secretary of Agriculture. SUMMARY: This document notifies the public as required by section 25(a) of the Federal Insecticide, Fungicide, and Rodenticide...

  5. Radiation dosimetry

    CERN Document Server

    Hine, Gerald J; Hine, Gerald J

    1956-01-01

    Radiation Dosimetry focuses on the advancements, processes, technologies, techniques, and principles involved in radiation dosimetry, including counters and calibration and standardization techniques. The selection first offers information on radiation units and the theory of ionization dosimetry and interaction of radiation with matter. Topics include quantities derivable from roentgens, determination of dose in roentgens, ionization dosimetry of high-energy photons and corpuscular radiations, and heavy charged particles. The text then examines the biological and medical effects of radiation,

  6. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  7. Some aspects of implementing Regulatory Impact Analysis in Brazil

    Directory of Open Access Journals (Sweden)

    Camila Moreira de Castro

    2014-04-01

    Full Text Available In an increasingly complex society, regulatory polices emerge as an important tool in public management. Nevertheless, regulation per se is no longer enough, and the agenda for a regulatory reform is increasing. Following this context, Brazil has implemented Regulatory Impact Analysis (RIA in its regulatory agencies. Thus, Brazilian specificities have to be considered and, in this regard, a systematic approach provides a significant contribution. This article aims to address some critical reflections about which policy-makers should ask themselves before joining the implementation of a RIA system in the Brazilian context. Through a long-term perspective, the implementation of RIA must be seen as part of a permanent change in the administrative culture, understanding that RIA should be used as a further resource in the decision-making process, rather than a final solution.

  8. The U.S.-Russian radiation health effects research program in the Southern Urals

    Energy Technology Data Exchange (ETDEWEB)

    Seligman, P.J.

    2000-07-01

    The Joint Coordinating Committee for Radiation Effects Research (JCCRER) was established through a bilateral US-Russian agreement to support research and exchange information on radiation health effects. The U.S. member agencies include the Department of Energy (DOE), Nuclear Regulatory Commission (NRC), Department of Health and Human Services (DHHS), Department of Defense (DoD), National Aeronautics and Space Administration (NASA), and Environmental Protection Agency (EPA). The Russians are represented by the Ministries of Emergencies (EMERCOM), the Atomic Energy (MINATOM) and Health (MINZDRAV), and the Russian Academy of Sciences (IBRAE). The focus of this research is on the workers from the Mayak Production Association (MAYAK) in the Southern Urals and on the neighboring populations along the Techa River exposed to contamination from the plant. The goal of the program is to better define the relationship between the health effects and the chronic low dose and dose-rate exposure, these data being essential to validate current radiation protection standards and practices. The current primary areas of JCCRER research include dose reconstruction, epidemiologic health studies, molecular epidemiology/biodosimetry, and the creation of tissue banks. The organization of the ongoing research conducted under the aegis of the JCCRER and the rationale for this work are described.

  9. 10 CFR Appendix D to Part 20 - United States Nuclear Regulatory Commission Regional Offices

    Science.gov (United States)

    2010-01-01

    ... RADIATION Pt. 20, App. D Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices..., Colorado, Hawaii, Idaho, Kansas, Louisiana, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oklahoma...

  10. Life-span effects of ionizing radiation in the beagle dog: A summary account of four decades of research funded by the US Department of Energy and its predecessor agencies

    Energy Technology Data Exchange (ETDEWEB)

    Thompson, R.C.

    1989-01-01

    Nearly 40 years ago, the US Atomic Energy Commission made a far- reaching commitment to the support of life-span radiation-effects studies in a relatively long-lived animal, the beagle dog. Something in the range of 200 million dollars has already been spent on a group of closely related experiments, many of which are only now coming to fruition. Responsible fiscal management of these studies, directed toward securing an optimum return from past investments, and toward creative planning of future directions, requires a comprehensive view of this total effort. This report is designed to provide that comprehensive view. This is primarily intended as a research management document. Evaluation and interpretation are tasks for those directly involved in conducting these experiments. The limited objective of the present document is to describe what has been done, to give some of the background for why it was done, to describe results already realized and applications that have been made of these results -- all in a manner designed to display the total effort rather than piecemeal details. While proposing no specific answers to the questions ''Where do we go from here.''it is hoped that the document will provide a basis for approaching that question in an informed manner. The maintenance of a continuity of scientific understanding and direction in these experiments, which often continue beyond the initiating investigators' working life, is no small part of the problem involved in conducting these experiments.

  11. 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...

  12. Radiation protection in medical imaging and radiation oncology

    CERN Document Server

    Stoeva, Magdalena S

    2016-01-01

    Radiation Protection in Medical Imaging and Radiation Oncology focuses on the professional, operational, and regulatory aspects of radiation protection. Advances in radiation medicine have resulted in new modalities and procedures, some of which have significant potential to cause serious harm. Examples include radiologic procedures that require very long fluoroscopy times, radiolabeled monoclonal antibodies, and intravascular brachytherapy. This book summarizes evidence supporting changes in consensus recommendations, regulations, and health physics practices associated with these recent advances in radiology, nuclear medicine, and radiation oncology. It supports intelligent and practical methods for protection of personnel, the public, and patients. The book is based on current recommendations by the International Commission on Radiological Protection and is complemented by detailed practical sections and professional discussions by the world’s leading medical and health physics professionals. It also ...

  13. Agency in Tarot

    DEFF Research Database (Denmark)

    Elias, Camelia

    2011-01-01

    This essay looks at the cross between archetypal images and symbolic language as expressed in the iconography of tarot cards ranging from the Renaissance period to the turn of the 20th century. It is also an example of how the idea of agency can be both analyzed and applied simultaneously...

  14. Sequential Common Agency

    NARCIS (Netherlands)

    Prat, A.; Rustichini, A.

    1998-01-01

    In a common agency game a set of principals promises monetary transfers to an agent which depend on the action he will take. The agent then chooses the action, and is paid the corresponding transfers. Principals announce their transfers simultaneously. This game has many equilibria; Bernheim and Whi

  15. Anselm's logic of agency

    NARCIS (Netherlands)

    S.L. Uckelman

    2009-01-01

    The origins of treating agency as a modal concept go back at least to the 11th century when Anselm, Archbishop of Canterbury, provided a modal explication of the Latin facere ‘to do’, which can be formalized within the context of modern modal logic and neighborhood semantics. The agentive logic indu

  16. Youth Media and Agency

    Science.gov (United States)

    Hauge, Chelsey

    2014-01-01

    This article addresses how capacity is conceived of and understood in youth media/civic education programming, and how beliefs about agency, development, relationality and youth manifests in the discourses, programmes, and practices of organizations operating youth media programmes. Through attention to a youth media and development programme in…

  17. The Agency of Event

    DEFF Research Database (Denmark)

    Nicholas, Paul; Tamke, Martin; Riiber, Jacob

    2014-01-01

    This paper explores the notion of agency within event-based models. We present an event-based modeling approach that links interdependent generative, analytic and decision making sub-models within a system of exchange. Two case study projects demonstrate the underlying modeling concepts...

  18. Strengthening Career Human Agency

    Science.gov (United States)

    Chen, Charles P.

    2006-01-01

    Rooted in A. Bandura's (1982, 2001b) social cognitive theory, the notion of human agency has received considerable attention in vocational and career psychology for the last 2 decades, especially with the recent emergence of social constructivist thinking in the field. This article continues in the same direction. In reviewing the notion of human…

  19. The Agency of Event

    DEFF Research Database (Denmark)

    Nicholas, Paul; Tamke, Martin; Riiber, Jacob

    2014-01-01

    This paper explores the notion of agency within event-based models. We present an event-based modeling approach that links interdependent generative, analytic and decision making sub-models within a system of exchange. Two case study projects demonstrate the underlying modeling concepts and metho...

  20. Radiation protection

    CERN Document Server

    CERN. Geneva

    2001-01-01

    This will be a simple explanation of the reasons why CERN has to be careful about radiation protections issues, a practical guide on how to recognize radiation dangers, the monitoring systems that make sure radiation levels are well tolerable norms, and a quick summary of what radiation levels mean in terms of personal risk.

  1. Data Management in a Regulatory Context

    Directory of Open Access Journals (Sweden)

    Niels Grønning

    2017-07-01

    Full Text Available With the implementation of Article 57(2 in 2012 the European Medicines Agency (EMA embarked on a digitalization journey that foreseeably would ensure greater product oversight and interoperability across the community. This initiative has subsequently led to additional focus from the agency with respect to the utilization and harmonization of data as part of the regulatory process. Driven by both internal and external factors, the EMA have through the European Union telematics strategy laid the foundation for the regulatory-driven services that may be expected from the community the coming years. Supported by standardization initiatives (e.g., ISO Identification of Medicinal Products, the EMA is gradually building an information management-driven approach to data utilization and exploitation within drug evaluation and approval. Primarily driven by the increasing demand for signal detection, the EMA is additionally hoping to leverage the establishment of defined information models and supporting controlled terms to safeguard future activities within the community. Collectively, the overall community may seek to gain from the overall digitalization roadmap proposed by the EMA and interesting opportunities may be sought as part of the transition. Already now pharmaceutical companies are gradually adapting to this new paradigm and actively seeking to explore how they may leverage the future EMA operating model to serve internal business requirements. If successful, the collective efforts from industry and regulators may lead to an unprecedented product oversight and offer regulators the opportunity to proactively drive corrective actions and, therefore, improve patient safety.

  2. 76 FR 6692 - Radiation Sources on Army Land

    Science.gov (United States)

    2011-02-08

    ... Department of the Army 32 CFR Part 655 RIN 0702-AA58 Radiation Sources on Army Land AGENCY: Department of the Army, DoD. ACTION: Final rule. SUMMARY: The Department of the Army is finalizing revisions to its regulation concerning radiation sources on Army land. The Army requires non-Army agencies (including...

  3. Using baldrige performance excellence program approaches in the pursuit of radiation oncology quality care, patient satisfaction, and workforce commitment.

    Science.gov (United States)

    Sternick, Edward S

    2011-01-01

    The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance US business competitiveness and economic growth. Administered by the National Institute of Standards and Technology, the Act created the Baldrige National Quality Program, recently renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well-suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact-based, knowledge-driven system for improving quality of care, increasing patient satisfaction, enhancing leadership effectiveness, building employee engagement, and boosting organizational innovation. This methodology also provides a valuable framework for benchmarking an individual radiation oncology practice's operations and results against guidelines defined by accreditation and professional organizations and regulatory agencies.

  4. Using Baldrige Performance Excellence Program Approaches in the Pursuit of Radiation Oncology Quality Care, Patient Satisfaction and Workforce Commitment

    Directory of Open Access Journals (Sweden)

    Edward eSternick

    2011-06-01

    Full Text Available The Malcolm Baldrige National Quality Improvement Act was signed into law in 1987 to advance U.S. business competitiveness and economic growth. Administered by the National Institute of Standards and Technology (NIST, the Act created the Baldrige National Quality Program, recently renamed the Baldrige Performance Excellence Program. The comprehensive analytical approaches referred to as the Baldrige Healthcare Criteria, are very well-suited for the evaluation and sustainable improvement of radiation oncology management and operations. A multidisciplinary self-assessment approach is used for radiotherapy program evaluation and development in order to generate a fact-based, knowledge-driven system for improving quality of care, increasing patient satisfaction, enhancing leadership effectiveness, building employee engagement and boosting organizational innovation. This methodology also provides a valuable framework for benchmarking an individual radiation oncology practice’s operations and results against guidelines defined by accreditation and professional organizations and regulatory agencies.

  5. Monitoring human factor risk characteristics at nuclear legacy sites in northwest Russia in support of radiation safety regulation.

    Science.gov (United States)

    Scheblanov, V Y; Sneve, M K; Bobrov, A F

    2012-12-01

    This paper describes research aimed at improving regulatory supervision of radiation safety during work associated with the management of spent nuclear fuel and radioactive waste at legacy sites in northwest Russia through timely identification of employees presenting unfavourable human factor risk characteristics. The legacy sites of interest include sites of temporary storage now operated by SevRAO on behalf of Rosatom. The sites were previously operational bases for servicing nuclear powered submarines and are now subject to major remediation activities. These activities include hazardous operations for recovery of spent nuclear fuel and radioactive waste from sub-optimal storage conditions. The paper describes the results of analysis of methods, procedures, techniques and informational issues leading to the development of an expert-diagnostic information system for monitoring of workers involved in carrying out the most hazardous operations. The system serves as a tool for human factor and professional reliability risk monitoring and has been tested in practical working environments and implemented as part of regulatory supervision. The work has been carried out by the Burnasyan Federal Medical Biophysical Center, within the framework of the regulatory cooperation programme between the Federal Medical-Biological Agency of Russia and the Norwegian Radiation Protection Authority.

  6. 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.

  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

    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.

  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 - 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.

  9. Education in radiation protection in the National Customs of Paraguay; Educacion en proteccion radiologica en la Direccion Nacional de Aduanas del Paraguay

    Energy Technology Data Exchange (ETDEWEB)

    Bordon, Oscar, E-mail: obordon@aduana.gov.py, E-mail: obordon@yahoo.com [Direccion Nacional de Aduanas, Departamento de Seguridad Radiologica, Administracion de Aduana de Gical, Mariano Roque Alonso (Paraguay)

    2013-07-01

    According to the IAEA-TECDOC-1312, as it is required by international agreements, the displacement of radioactive material within and among States should be subject to strict regulatory, administrative, safety and technical controls to ensure conditions of technological and physical safety. The Customs Office is one of the institutions responsible for monitoring shipments crossing international borders. Increasing illicit trafficking of radioactive materials, the use of ionizing radiation generating equipment for checking loads, and trade in radioactive substances have informed the need for education in radiation protection of customs officials. Thus, based on a course on radiation protection for Customs officials, organized by the International Atomic Energy Agency, in March 2008 was initiated a course of radiation protection, of 30 hours Carrera Tecnica del Centro de Formacion y Capacitacion Aduanera de Paraguay, which highlights the basic chapters and for transporting, nomenclature, new equipment emitting ionizing radiation and smuggling. Since then, to date, at least 10 groups have completed the training. Within the training program for customs officials, was incorporated a course for radiation protection of operators of baggage scanners with a four-hour program. Finally, since from 2011 and periodically, at various country customs, a workshop on Illicit trafficking of radioactive and nuclear materials is performed. The results of these courses have been very positive, as well as know the proper procedures for dealing with ionizing radiation has increased the safety culture within the institution.

  10. Nuclear Regulatory Commission Issuances: Opinions and decisions of the Nuclear Regulatory Commission with selected orders. Progress report, January 1, 1996--June 30, 1996. Volume 43, pages 1-358

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-05-01

    The hardbound edition of the Nuclear Regulatory Issuances is a final compilation of the monthly issuances. It includes all legal precedents for the agency within a six month period. This is the forty-third volume of issuances.

  11. Register of legislative and regulatory dispositions relative to the radiation protection of the population and workers against the dangers of ionizing radiations; Recueil des dispositions legislatives et reglementaires concernant la protection de la population et des travailleurs contre les dangers des rayonnements ionisants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2003-12-15

    This collection of legislative arrangements concerns the protection of population and workers against the risks of ionizing radiations. Each chapter is divided in two parts: a legislative part and a statutory or regulation part. We find the different chapters in relation with protection of populations, protection of workers, public health and labour laws. (N.C.)

  12. Critical evaluation of German regulatory specifications for calculating radiological exposure

    Energy Technology Data Exchange (ETDEWEB)

    Koenig, Claudia; Walther, Clemens [Hannover Univ. (Germany). Inst. of Radioecology; Smeddinck, Ulrich [Technische Univ. Braunschweig (Germany). Inst. of Law

    2015-07-01

    The assessment of radiological exposure of the public is an issue at the interface between scientific findings, juridical standard setting and political decision. The present work revisits the German regulatory specifications for calculating radiological exposure, like the already existing calculation model General Administrative Provision (AVV) for planning and monitoring nuclear facilities. We address the calculation models for the recent risk assessment regarding the final disposal of radioactive waste in Germany. To do so, a two-pronged approach is pursued. One part deals with radiological examinations of the groundwater-soil-transfer path of radionuclides into the biosphere. Processes at the so-called geosphere-biosphere-interface are examined, especially migration of I-129 in the unsaturated zone. This is necessary, since the German General Administrative Provision does not consider radionuclide transport via groundwater from an underground disposal facility yet. Especially data with regard to processes in the vadose zone are scarce. Therefore, using I-125 as a tracer, immobilization and mobilization of iodine is investigated in two reference soils from the German Federal Environment Agency. The second part of this study examines how scientific findings but also measures and activities of stakeholders and concerned parties influence juridical standard setting, which is necessary for risk management. Risk assessment, which is a scientific task, includes identification and investigation of relevant sources of radiation, possible pathways to humans, and maximum extent and duration of exposure based on dose-response functions. Risk characterization identifies probability and severity of health effects. These findings have to be communicated to authorities, who have to deal with the risk management. Risk management includes, for instance, taking into account acceptability of the risk, actions to reduce, mitigate, substitute or monitor the hazard, the setting of

  13. Occupational exposure assessment: Practices in Malaysian nuclear agency

    Science.gov (United States)

    Sarowi, S. Muhd; Ramli, S. A.; Kontol, K. Mohamad; Rahman, N. A. H. Abd.

    2016-01-01

    Malaysian Nuclear Agency (Nuclear Malaysia) is the leading agency in introducing and promoting the application of nuclear science technology in Malaysia. The agency provides major nuclear facilities purposely for research and commercialisation such as reactor, irradiation plants and radioisotope production laboratory. When dealing with ionizing radiation, there is an obligatory requirement to monitor and assess the radiation exposure to the workers. The personal dose of radiation workers were monitored monthly by assessing their Thermoluminescence Dosimeter (TLD) dose reading. This paper will discuss the current practice in managing, assessing, record keeping and reporting of the occupational exposure in Nuclear Malaysia including the Health Physic Group roles and challenges. The statistics on occupational radiation exposure of monitored workers working in different fields in Nuclear Malaysia from 2011 - 2013 will also be presented. The results show that the null hypothesis (H₀) was accepted which the means of every populations are all equal or not differ significantly. This hypothesis states that the dose exposure received by the radiation workers in Nuclear Malaysia is similar and there were no significant changes from 2011 to 2013. The radiation monitoring programme correlate with the requirement of our national law, the Atomic Energy Licensing Act 1984 (Act 304).

  14. Occupational exposure assessment: Practices in Malaysian nuclear agency

    Energy Technology Data Exchange (ETDEWEB)

    Sarowi, S. Muhd, E-mail: suzie@nuclearmalaysia.gov.my; Ramli, S. A.; Kontol, K. Mohamad [Radiation Safety & Health Division, Malaysian Nuclear Agency, 43000 Kajang, Selangor (Malaysia); Rahman, N. A. H. Abd. [Faculty of Science & Mathematics, Sultan Idris of Education Universit, 35900, Tanjong Malim, Perak Darul Ridzuan (Malaysia)

    2016-01-22

    Malaysian Nuclear Agency (Nuclear Malaysia) is the leading agency in introducing and promoting the application of nuclear science technology in Malaysia. The agency provides major nuclear facilities purposely for research and commercialisation such as reactor, irradiation plants and radioisotope production laboratory. When dealing with ionizing radiation, there is an obligatory requirement to monitor and assess the radiation exposure to the workers. The personal dose of radiation workers were monitored monthly by assessing their Thermoluminescence Dosimeter (TLD) dose reading. This paper will discuss the current practice in managing, assessing, record keeping and reporting of the occupational exposure in Nuclear Malaysia including the Health Physic Group roles and challenges. The statistics on occupational radiation exposure of monitored workers working in different fields in Nuclear Malaysia from 2011 - 2013 will also be presented. The results show that the null hypothesis (H{sub 0}) was accepted which the means of every populations are all equal or not differ significantly. This hypothesis states that the dose exposure received by the radiation workers in Nuclear Malaysia is similar and there were no significant changes from 2011 to 2013. The radiation monitoring programme correlate with the requirement of our national law, the Atomic Energy Licensing Act 1984 (Act 304)

  15. Hastening the regulatory process

    Energy Technology Data Exchange (ETDEWEB)

    Stringham, G. [Canadian Association of Petroleum Producers, Calgary, AB (Canada)

    2001-07-01

    The state of the Canadian oil industry was discussed during this power point presentation with particular emphasis on its production, exports, drilling, industry revenues and capital investment levels. The proposed projects in each of northern Alberta's oil sands deposits, the Athabasca, Peace River and Cold Lake were were announced, along with the inventory of major Alberta projects and the projection of oil sands capital investment. Since 1998, $9 billion has been invested and a further $33 billion has been announced for new or expanded oil sands projects. The year 2000 estimates for Canadian crude oil and natural gas production are 2.3 million barrels per day and 6.3 trillion cubic feet per year respectively. This represented a record year for production of both crude oil and natural gas. In 2000, more than 15,500 wells were drilled in Canada. A graph depicting Canadian crude oil supply forecasted a steady increase in supply from year 2000 to 2010. The Canadian Association of Petroleum Producers (CAPP) completed a review of the Alberta Energy and Utilities Board regulatory and enforcement processes. Both industry and government efforts are focusing on eliminating regulatory overlap and duplication. Some of the main areas of interest for exploration, drilling, production and pipeline facilities include the examination of regulatory processes for environmentally sensitive areas, rural municipalities with planning bylaws, aboriginal lands and additional fees. 8 figs.

  16. Final Regulatory Determination for Special Wastes From Mineral Processing (Mining Waste Exclusion) - Federal Register Notice, June 13, 1991

    Science.gov (United States)

    This action presents the Agency's final regulatory determination required by section 3001(b)(3)(C) of the Resource Conservation and Recovery Act (RCRA) for 20 special wastes from the processing of ores and minerals.

  17. Agency, time, and causality.

    Science.gov (United States)

    Widlok, Thomas

    2014-01-01

    Cognitive Scientists interested in causal cognition increasingly search for evidence from non-Western Educational Industrial Rich Democratic people but find only very few cross-cultural studies that specifically target causal cognition. This article suggests how information about causality can be retrieved from ethnographic monographs, specifically from ethnographies that discuss agency and concepts of time. Many apparent cultural differences with regard to causal cognition dissolve when cultural extensions of agency and personhood to non-humans are taken into account. At the same time considerable variability remains when we include notions of time, linearity and sequence. The article focuses on ethnographic case studies from Africa but provides a more general perspective on the role of ethnography in research on the diversity and universality of causal cognition.

  18. Research as relational agency

    DEFF Research Database (Denmark)

    Hasse, Cathrine

    2017-01-01

    Studying the impact of educational technologies ‘in the wild’ put new demands on researchers than when researchers are conducting experiments in a laboratory. When researchers work within institutional boundaries they cannot take for granted that all members engaged in institutional work share...... technologies like iPads are not just educational tools helping teachers teach as books, blackboards and chalk. They are forceful agents with an agency tied to the fact that they are also persuasive signs of innovation and thus preferred by managers over more traditional means. The article discuss how...... the same conception of material artefacts, which are non-human in the sense that they are not just material but agentic and persuasive like humans. Local conceptualisations of artefacts must be explored as the researchers develop relational agency with the different local people involved. New educational...

  19. Agency, time and causality

    Directory of Open Access Journals (Sweden)

    Thomas eWidlok

    2014-11-01

    Full Text Available Cognitive Scientists interested in causal cognition increasingly search for evidence from non-WEIRD people but find only very few cross-cultural studies that specifically target causal cognition. This article suggests how information about causality can be retrieved from ethnographic monographs, specifically from ethnographies that discuss agency and concepts of time. Many apparent cultural differences with regard to causal cognition dissolve when cultural extensions of agency and personhood to non-humans are taken into account. At the same time considerable variability remains when we include notions of time, linearity and sequence. The article focuses on ethnographic case studies from Africa but provides a more general perspective on the role of ethnography in research on the diversity and universality of causal cognition.

  20. Consequences of the new radiation protection law on the radiation protection register and the occupational radiation protection; Auswirkungen des neuen Strahlenschutzgesetzes auf das Strahlenschutzregister und die berufliche Strahlenueberwachung

    Energy Technology Data Exchange (ETDEWEB)

    Frasch, Gerhard

    2017-08-01

    The implementation of the guideline 2013/59/EURATOM has been performed in the new radiation protection law. The most important consequences of the new radiation protection law for the occupational radiation protection are the following: the introduction of an explicit personal indicator and the actualization of occupational categories for employees. These facts require technical and administrative reorganization in data transmission of the licensee to the regulatory monitoring executive and the radiation protection register.

  1. Radiation Therapy: Professions in Radiation Therapy

    Science.gov (United States)

    ... Resources Professions Site Index A-Z Professions in Radiation Therapy Radiation Oncologist Therapeutic Medical Physicist Radiation Therapist Dosimetrist Radiation Oncology Nurse Social Worker Dietitian Radiation Oncologist Radiation oncologists are physicians who oversee the ...

  2. Data Integrity-A Study of Current Regulatory Thinking and Action.

    Science.gov (United States)

    Shafiei, Nader; De Montardy, Regis; Rivera-Martinez, Edwin

    2015-01-01

    In reaction to breaches of data integrity in the pharmaceutical industry, regulatory authorities have introduced inspection approaches or initiatives with the aim of reducing occurrences of data integrity problems. This review article-based on study of 65 cases of regulatory action from 2002 to 2014-provides an overview of current regulatory thinking and action on breaches of data integrity affecting GxP (health-related regulations) processes supporting non-clinical studies, clinical studies, laboratory controls, and production controls. These case studies largely represent position of the U.S. Food and Drug Administration and the regulatory agencies affiliated with the European Medicines Agency. Also discussed is the role of human factors as a potential source of data integrity problems. The article concludes by recommending some remedial controls that could be established to avoid or reduce occurrences of data integrity problems.Lay Abstract: In fulfilling their mission to protect public health, regulatory agencies (e.g., U.S. Food and Drug Administration, European Medicines Agency) must establish confidence that medical products they approve are fit for their intended use. In so doing they rely on scientific and operational data generated during research, development, manufacturing, sales, marketing, distribution, and post-marketing surveillance activities. The level of confidence they build is directly proportional to the scientific validity and integrity of data presented to them by the sponsors of medical products. In this article we present analysis of 65 case studies that document regulatory action taken by various regulatory agencies on breach of data integrity between 2002 and 2014. The ensuing discussion on current trends largely represents position of the U.S. Food and Drug Administration and European Medicines Agency. The article concludes by proposing some remedial controls that could be established by pharmaceutical companies to avoid or reduce

  3. Are we failing to communicate? Internet-based patient education materials and radiation safety

    Energy Technology Data Exchange (ETDEWEB)

    Hansberry, David R., E-mail: hansbedr@njms.rutgers.edu; Ramchand, Tekchand, E-mail: ramchate@njms.rutgers.edu; Patel, Shyam, E-mail: patel288@njms.rutgers.edu; Kraus, Carl, E-mail: krauscf@njms.rutgers.edu; Jung, Jin, E-mail: jungjk@njms.rutgers.edu; Agarwal, Nitin, E-mail: nitin.agarwal@rutgers.edu; Gonzales, Sharon F., E-mail: gonzalsh@njms.rutgers.edu; Baker, Stephen R., E-mail: bakersr@njms.rutgers.edu

    2014-09-15

    Introduction: Patients frequently turn to the Internet when seeking answers to healthcare related inquiries including questions about the effects of radiation when undergoing radiologic studies. We investigate the readability of online patient education materials concerning radiation safety from multiple Internet resources. Methods: Patient education material regarding radiation safety was downloaded from 8 different websites encompassing: (1) the Centers for Disease Control and Prevention, (2) the Environmental Protection Agency, (3) the European Society of Radiology, (4) the Food and Drug Administration, (5) the Mayo Clinic, (6) MedlinePlus, (7) the Nuclear Regulatory Commission, and (8) the Society of Pediatric Radiology. From these 8 resources, a total of 45 articles were analyzed for their level of readability using 10 different readability scales. Results: The 45 articles had a level of readability ranging from 9.4 to the 17.2 grade level. Only 3/45 (6.7%) were written below the 10th grade level. No statistical difference was seen between the readability level of the 8 different websites. Conclusions: All 45 articles from all 8 websites failed to meet the recommendations set forth by the National Institutes of Health and American Medical Association that patient education resources be written between the 3rd and 7th grade level. Rewriting the patient education resources on radiation safety from each of these 8 websites would help many consumers of healthcare information adequately comprehend such material.

  4. Nuclear Safety and Radiation Protection in France in 2005; La surete nucleaire et la radioprotection en France en 2005. Dossier de presse

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-04-15

    In 2005, the Asn pursued its significant investment in radiation protection and reaffirms its ambition to become as efficient in radiation protection as it is in nuclear safety as of 2009. 2005 was a year of great progress for the Asn as it consolidated its organisation and working methods, in accordance with the 2005-2007 strategic plan it set for itself. The Asn continued progress in the field of radiation protection has given rise to various new regulations to improve the legislative and regulatory framework in this area. The Asn plans to step up its efforts to ensure better monitoring of patient exposure to ionizing radiation and to provide better management of radon-related risks, particularly in housing. Fully aware that its newfound power in this area requires outside evaluation, the Asn has asked the International Atomic Energy Agency (IAEA) to organize an I.R.R.S. (Integrated Regulatory Review Service) assignment consisting of a peer-conducted audit. The IAEA has confirmed that this audit will take place in November 2006. (N.C.)

  5. Radiation dose assessment methodology and preliminary dose estimates to support US Department of Energy radiation control criteria for regulated treatment and disposal of hazardous wastes and materials

    Energy Technology Data Exchange (ETDEWEB)

    Aaberg, R.L.; Baker, D.A.; Rhoads, K.; Jarvis, M.F.; Kennedy, W.E. Jr.

    1995-07-01

    This report provides unit dose to concentration levels that may be used to develop control criteria for radionuclide activity in hazardous waste; if implemented, these criteria would be developed to provide an adequate level of public and worker health protection, for wastes regulated under U.S, Environmental Protection Agency (EPA) requirements (as derived from the Resource Conservation and Recovery Act [RCRA] and/or the Toxic Substances Control Act [TSCA]). Thus, DOE and the US Nuclear Regulatory Commission can fulfill their obligation to protect the public from radiation by ensuring that such wastes are appropriately managed, while simultaneously reducing the current level of dual regulation. In terms of health protection, dual regulation of very small quantities of radionuclides provides no benefit.

  6. Protecting sensitive systems and data in an open agency

    Science.gov (United States)

    Hunt, Douglas B.; Tompkins, Frederick G.

    1987-01-01

    This paper focuses on the policy and definitional issues associated with providing adequate and reasonable levels of protection for sensitive systems and data in an agency whose basic charter mandates the open sharing of information and transfer of technology into the market economy. An information model based on current Federal regulatory issuances is presented. A scheme for determining sensitivity levels, based on a categorization taxonomy,is provided.

  7. Legal nature of the agency in legal system of the Republic of Serbia

    Directory of Open Access Journals (Sweden)

    Martinović Aleksandar

    2012-01-01

    Full Text Available The roots of the agency as a public law, go back to the nineteenth century, when the first independent regulatory agency - Interstate Trade Commission was formed by the United States. In the legal system of the Republic of Serbia, agencies have the right to acquire citizenship since 2001. In the past ten years, a very large number of agencies were formed in different areas of social life, with their different legal nature. Disparity in legal character agency in the Republic of Serbia in general raises no small problems. The economic and financial characteristics of agencies are expressed especially in situations when a same social area 'covered' simultaneously by the relevant ministry and its counterpart - the agency.

  8. Carbon Capture and Storage Legal and Regulatory Review. Edition 2

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The International Energy Agency (IEA) estimates that 100 carbon capture and storage (CCS) projects must be implemented by 2020 and over 3000 by 2050 if CCS is to fully contribute to the least-cost technology portfolio for CO2 mitigation. To help countries address the many legal and regulatory issues associated with such rapid deployment, the IEA launched the Carbon Capture and Storage Legal and Regulatory Review (CCS Review) in October 2010. The CCS Review gathers contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum that supports national-level CCS regulatory development. Each contribution provides a short summary of recent and anticipated developments and highlights a particular regulatory theme (such as financial contributions to long-term stewardship). To introduce each edition, the IEA provides a brief analysis of key advances and trends. Produced bi-annually, the CCS Review provides an up-to-date snapshot of global CCS regulatory developments. The theme for the second edition of the CCS Review, released in May 2011, is long-term liability for stored CO2. Other key issues addressed include: national progress towards implementation of the EU CCS Directive; developments in marine treaties relevant to CCS; international climate change negotiations; and the development process for CCS regulation.

  9. Meeting the Needs for Radiation Protection: Diagnostic Imaging.

    Science.gov (United States)

    Frush, Donald P

    2017-02-01

    Radiation and potential risk during medical imaging is one of the foremost issues for the imaging community. Because of this, there are growing demands for accountability, including appropriate use of ionizing radiation in diagnostic and image-guided procedures. Factors contributing to this include increasing use of medical imaging; increased scrutiny (from awareness to alarm) by patients/caregivers and the public over radiation risk; and mounting calls for accountability from regulatory, accrediting, healthcare coverage (e.g., Centers for Medicare and Medicaid Services), and advisory agencies and organizations as well as industry (e.g., NEMA XR-29, Standard Attributes on CT Equipment Related to Dose Optimization and Management). Current challenges include debates over uncertainty with risks with low-level radiation; lack of fully developed and targeted products for diagnostic imaging and radiation dose monitoring; lack of resources for and clarity surrounding dose monitoring programs; inconsistencies across and between practices for design, implementation and audit of dose monitoring programs; lack of interdisciplinary programs for radiation protection of patients; potential shortages in personnel for these and other consensus efforts; and training concerns as well as inconsistencies for competencies throughout medical providers' careers for radiation protection of patients. Medical care providers are currently in a purgatory between quality- and value-based imaging paradigms, a state that has yet to mature to reward this move to quality-based performance. There are also deficits in radiation expertise personnel in medicine. For example, health physics academic programs and graduates have recently declined, and medical physics residency openings are currently at a third of the number of graduates. However, leveraging solutions to the medical needs will require money and resources, beyond personnel alone. Energy and capital will need to be directed to

  10. 77 FR 64564 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

    Science.gov (United States)

    2012-10-22

    ... COMMISSION Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles AGENCY....221 on Design-Basis Hurricane and Hurricane Missiles.'' The purpose of this ISG is to supplement the guidance regarding the application of Regulatory Guide 1.221, ``Design-Basis Hurricane and...

  11. 76 FR 23513 - Public and Closed Meeting To Discuss Comments on Draft Regulatory Basis for Rulemaking Revising...

    Science.gov (United States)

    2011-04-27

    ... Regulatory Basis for Rulemaking Revising Security Requirements for Facilities Storing Spent Nuclear Fuel and High-Level Radioactive Waste AGENCY: Nuclear Regulatory Commission. ACTION: Public meeting. SUMMARY... nuclear fuel (SNF) and high-level radioactive waste (HLW). This meeting is a follow-up to the NRC's notice...

  12. Development of Questionnaire for Self-Assessment of Regulatory Capture

    Energy Technology Data Exchange (ETDEWEB)

    Muhmood, Ul Hassan; Lee, Young Eal [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    Nuclear industry with its evolution in 60s came with a number of pros and cons. In order to avoid any accident or incident, highest safety standards and quality control mechanism were established. The relation of regulator with its licensee is critical in the sense of public safety and welfare. The situation when the regulator starts to work for the interests of the industry instead of the public interest and fails to cling with his mission is known as 'regulatory capture' which may cause a number of serious negative effects like radiological or radiation risk. According to George Stigler, as a rule regulation is acquired by the industry and is designed and operated primarily for its benefit. The phenomenon of regulatory capture may hamper the safety culture and can also be considered as regulatory failure. It is therefore necessary to clearly understand this type of government failure to avoid the happening of serious accidents like TMI and Fukushima in the future. This paper aims to explore whether the regulatory body works independently and effectively to achieve its assigned tasks and objectives. Hence we proposed a questionnaire for the self-assessment of regulatory capture within the regulatory body. It also includes the results of an experimental assessment which was carried out to check the relevance and reliability of the questions to this subject. This assessment survey was conducted with the officers and staff members of Pakistan Nuclear Regulatory Authority (PNRA). We checked the significance of the proposed questionnaire and found some of the questions like Q. 27, 30 and 33 (written in italic) are not directly related to the phenomenon of regulatory capture. However, the existence of the situation which has been asked in these questions may lead towards the hampering of regulatory culture.

  13. Biological effects of low level exposures to chemicals and radiation

    Energy Technology Data Exchange (ETDEWEB)

    Calabrese, E.J. (ed.)

    1992-01-01

    In May 1990 a group of scientists representing several federal agencies, the International Society of Regulatory Toxicology and Pharmacology, the private sector, and academia met to develop a strategy to encourage the study of the biological effects of low level exposures (BELLE) to chemical agents and radioactivity. A workshop was held in 1991 with seven invited speakers focusing on the toxicological implications of biological adaptations. The selection of topics and speakers was designed to consider critically the concept of hormesis, not only in a broad, conceptual manner, but also at the molecular and biochemical levels. These presentations offered a complementary perspective on the diverse range of molecular mechanisms that can become activated at low levels of toxicant exposure. In addition to chemical toxicology research, an overview of current research on Effects of low-dose radiation on the immune response' was presented as well as Cellular adaptation as an important response during chemical carcinogenesis'. The final presentation was devoted to biostatistical considerations when designing studies that address issues associated with the biological responses to low doses of chemicals and radiation, as well as issues in interpretation of the findings from such studies.

  14. Agency, Context and Meaning

    DEFF Research Database (Denmark)

    Folkmann, Mads Nygaard

    2014-01-01

    history, 2) the question of context in and of design, i.e. which contexts give meaning to design; this question calls for interpretive models of cultural analysis of the circuit of design in acknowledging phases and aspects of production, mediation and consumption, and 3) the question of the meaning...... of meaning formulation and cultural contexts and, by this, contest design. In reflecting the foundational ground of design in terms of its agency, contexts and meaning constituents, design and its questioning of meaning can be critically reframed....

  15. Quality Indicators in Radiation Oncology

    Energy Technology Data Exchange (ETDEWEB)

    Albert, Jeffrey M. [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States); Das, Prajnan, E-mail: prajdas@mdanderson.org [Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas (United States)

    2013-03-15

    Oncologic specialty societies and multidisciplinary collaborative groups have dedicated considerable effort to developing evidence-based quality indicators (QIs) to facilitate quality improvement, accreditation, benchmarking, reimbursement, maintenance of certification, and regulatory reporting. In particular, the field of radiation oncology has a long history of organized quality assessment efforts and continues to work toward developing consensus quality standards in the face of continually evolving technologies and standards of care. This report provides a comprehensive review of the current state of quality assessment in radiation oncology. Specifically, this report highlights implications of the healthcare quality movement for radiation oncology and reviews existing efforts to define and measure quality in the field, with focus on dimensions of quality specific to radiation oncology within the “big picture” of oncologic quality assessment efforts.

  16. Nuclear Regulatory Commission issuances, September 1995. Volume 42, Number 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-09-01

    This book contains an issuance of the Atomic Safety and Licensing Board and a Director`s Decision, both of the US Nuclear Regulatory Commission. The issuance concerns the dismissal of a case by adopting a settlement reached by the Staff of the Nuclear Regulatory Commission and a Radiation Safety Officer of a hospital in which the safety officer pled guilty to deliberate misconduct. The Director`s Decision was to deny a petition to impose a fine on Tennessee Valley Authority concerning alleged harassment of the petitioner and to appoint an independent arbitration board to review all past complaints filed against TVA concerning the Watts Bar Nuclear Plant.

  17. Nuclear Regulatory Commission Information Digest 1992 edition. Volume 4

    Energy Technology Data Exchange (ETDEWEB)

    Olive, K [ed.

    1992-03-01

    The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. This digest is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and industry it regulates. In general, the data cover 1975 through 1991, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed.

  18. Clinical research: regulatory issues.

    Science.gov (United States)

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  19. Toxicogenomics in regulatory ecotoxicology

    Science.gov (United States)

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6). VIEWPOINT © 2006 american chemical Society july 1, 2006 / EnvironmEntal SciEncE & tEchnology n 4055 The purpose of this feature article is to consider the roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry (SETAC) in Pellston, Mich., in September 2005. A complete list of names and affiliations of the experts participating in that workshop is provided online in Table 1 of the Supporting Information for this paper.

  20. Regulatory supervision of sites for spent fuel and radioactive waste storage in the Russian northwest.

    Science.gov (United States)

    Shandala, N K; Sneve, M K; Smith, G M; Kiselev, M F; Kochetkov, O A; Savkin, M N; Simakov, A V; Novikova, N Ya; Titov, A V; Romanov, V V; Seregin, V A; Filonova, A V; Semenova, M P

    2008-12-01

    In the 1960s two technical bases for the Northern Fleet were created in the Russian northwest at Andreeva Bay in the Kola Peninsula and Gremikha village on the coast of the Barents Sea. They maintained nuclear submarines, receiving and storing radioactive waste and spent nuclear fuel. No further waste was received after 1985, and the technical bases have since been re-categorised as temporary storage sites. The handling of these materials to put them into a safe condition is especially hazardous because of their degraded state. This paper describes regulatory activities which have been carried out to support the supervision of radiological protection during recovery of waste and spent fuel, and to support regulatory decisions on overall site remediation. The work described includes: an assessment of the radiation situation on-site; the development of necessary additional regulatory rules and standards for radiation protection assurance for workers and the public during remediation; and the completion of an initial threat assessment to identify regulatory priorities. Detailed consideration of measures for the control of radiation exposure of workers and radiation exposure of the public during and after operations and emergency preparedness and response are complete and provided in sister papers. The continuing requirements for regulatory activities relevant to the development and implementation of on-going and future remediation activities are also outlined. The Norwegian Radiation Protection Authority supports the work, as part of the Norwegian Government's plan of action to promote improvements in radiation protection and nuclear safety in northwest Russia.

  1. Pelvic radiation - discharge

    Science.gov (United States)

    Radiation of the pelvis - discharge; Cancer treatment - pelvic radiation; Prostate cancer - pelvic radiation; Ovarian cancer - pelvic radiation; Cervical cancer - pelvic radiation; Uterine cancer - pelvic radiation; Rectal cancer - pelvic radiation

  2. Carbon Capture and Storage Legal and Regulatory Review. Edition 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

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

  3. 36 CFR 1236.10 - What records management controls must agencies establish for records in electronic information...

    Science.gov (United States)

    2010-07-01

    ..., legal, and regulatory requirements of the business activity; and (g) Structure: controls to ensure the... controls must agencies establish for records in electronic information systems? 1236.10 Section 1236.10... Implementing Electronic Information Systems § 1236.10 What records management controls must agencies establish...

  4. 77 FR 66607 - Placer County Water Agency; Notice of Application for Approval of Contract for the Sale of Power...

    Science.gov (United States)

    2012-11-06

    ... Energy Regulatory Commission Placer County Water Agency; Notice of Application for Approval of Contract for the Sale of Power for a Period Extending Beyond the Term of the License Take notice that on July 17, 2012, Placer County Water Agency filed with the Commission an application for approval of:...

  5. Environmental radiation monitoring of low-level wastes by the State of Washington

    Energy Technology Data Exchange (ETDEWEB)

    Conklin, A.W.; Mooney, R.R.; Erickson, J.L. [Dept. of Health, Olympia, WA (United States). Div. of Radiation Protection

    1989-11-01

    The Washington State Department of Health, as the state`s regulatory agency for radiation, monitors several forms of low-level radioactive wastes. The monitoring is done to assess the potential impact on the environment and on public health. The emphasis of the monitoring program is placed on the solid and liquid wastes from defense activities on the Hanford Reservation, commercial wastes at the site located on leased land at Hanford and uranium mill tailings in Northeastern Washington. Although not classified as low-level waste, monitoring is also periodically conducted at selected landfills and sewage treatment facilities and other licensees, where radioactive wastes are known or suspected to be present. Environmental pathways associated with waste disposal are monitored independently, and/or in conjunction with the waste site operators to verify their results and evaluate their programs. The Department also participates in many site investigations conducted by site operators and other agencies, and conducts it`s own special investigations when deemed necessary. Past investigations and special projects have included allegations of adverse environmental impact of I-129, uranium in ground water, impacts of wastes on the agricultural industry, radioactivity in seeps into the Columbia River from waste sites, identifying lost waste sites at Hanford, differentiating groundwater contamination from defense versus commercial sources, and radioactivity in municipal landfills and sewers. The state`s environmental radiation monitoring program has identified and verified a number of environmental problems associated with radioactive waste disposal, but has, to date, identified no adverse offsite impacts to public health.

  6. Atoms, Radiation, and Radiation Protection

    CERN Document Server

    Turner, James E

    2007-01-01

    Atoms, Radiation, and Radiation Protection offers professionals and advanced students a comprehensive coverage of the major concepts that underlie the origins and transport of ionizing radiation in matter. Understanding atomic structure and the physical mechanisms of radiation interactions is the foundation on which much of the current practice of radiological health protection is based. The work covers the detection and measurement of radiation and the statistical interpretation of the data. The procedures that are used to protect man and the environment from the potential harmful effects of

  7. Recent regulatory experience of low-Btu coal gasification. Volume III. Supporting case studies

    Energy Technology Data Exchange (ETDEWEB)

    Ackerman, E.; Hart, D.; Lethi, M.; Park, W.; Rifkin, S.

    1980-02-01

    The MITRE Corporation conducted a five-month study for the Office of Resource Applications in the Department of Energy on the regulatory requirements of low-Btu coal gasification. During this study, MITRE interviewed representatives of five current low-Btu coal gasification projects and regulatory agencies in five states. From these interviews, MITRE has sought the experience of current low-Btu coal gasification users in order to recommend actions to improve the regulatory process. This report is the third of three volumes. It contains the results of interviews conducted for each of the case studies. Volume 1 of the report contains the analysis of the case studies and recommendations to potential industrial users of low-Btu coal gasification. Volume 2 contains recommendations to regulatory agencies.

  8. Southern state radiological emergency preparedness and response agencies

    Energy Technology Data Exchange (ETDEWEB)

    1988-11-01

    This Report provides information on the state agencies assigned to radioactive materials transportation incidents in 16 Southern States Energy Board member states. For each, the report lists the agencies with primary authority for preparedness and response, their responsibilities and personnel within the agencies who can offer additional information on their radioactive materials transportation programs. The report also lists each state's emergency team members and its laboratory and analytical capabilities. Finally, the governor's designee for receiving advance notification of high-level radioactive materials and spent fuel shipments under 10 CFR Parts 71 and 73 of the US Nuclear Regulatory Commission's regulations is listed for each state. Part 71 requires prenotification for large quantity radioactive waste shipments. Part 73 addresses prenotification for spent nuclear reactor fuel shipments.

  9. Southern state radiological emergency preparedness and response agencies

    Energy Technology Data Exchange (ETDEWEB)

    1988-11-01

    This Report provides information on the state agencies assigned to radioactive materials transportation incidents in 16 Southern States Energy Board member states. For each, the report lists the agencies with primary authority for preparedness and response, their responsibilities and personnel within the agencies who can offer additional information on their radioactive materials transportation programs. The report also lists each state`s emergency team members and its laboratory and analytical capabilities. Finally, the governor`s designee for receiving advance notification of high-level radioactive materials and spent fuel shipments under 10 CFR Parts 71 and 73 of the US Nuclear Regulatory Commission`s regulations is listed for each state. Part 71 requires prenotification for large quantity radioactive waste shipments. Part 73 addresses prenotification for spent nuclear reactor fuel shipments.

  10. Regulatory aspects of specific immunotherapy in Europe.

    Science.gov (United States)

    Kaul, Susanne; Englert, Lisa; May, Sibylle; Vieths, Stefan

    2010-12-01

    The recent developments in the regulation of allergen products and their impact on specific immunotherapy (SIT) in Europe are summarized, and unmet needs are discussed. New guidance on the quality, the clinical development, and marketing authorization status of allergen products for SIT has been released. The most important documents are Guidelines from the European Medicines Agency, a revision of the European Pharmacopoeia Monograph on Allergens, regulations, and position papers of scientific societies. The increased demands on quality, safety, and efficacy will lead to allergen products being better characterized and with enhanced proof of efficacy and safety. In addition, national activities to regulate the existing broad spectrum of named patient allergen products have been started. At the same time these developments represent a challenge to manufacturers to meet all new requirements. Some problems, for example regarding patient-tailored products containing recombinant allergens remain and may require novel regulatory approaches.

  11. Radiation Chemistry

    Science.gov (United States)

    Wojnárovits, L.

    Ionizing radiation causes chemical changes in the molecules of the interacting medium. The initial molecules change to new molecules, resulting in changes of the physical, chemical, and eventually biological properties of the material. For instance, water decomposes to its elements H2 and O2. In polymers, degradation and crosslinking take place. In biopolymers, e.g., DNS strand breaks and other alterations occur. Such changes are to be avoided in some cases (radiation protection), however, in other cases they are used for technological purposes (radiation processing). This chapter introduces radiation chemistry by discussing the sources of ionizing radiation (radionuclide sources, machine sources), absorption of radiation energy, techniques used in radiation chemistry research, and methods of absorbed energy (absorbed dose) measurements. Radiation chemistry of different classes of inorganic (water and aqueous solutions, inorganic solids, ionic liquids (ILs)) and organic substances (hydrocarbons, halogenated compounds, polymers, and biomolecules) is discussed in concise form together with theoretical and experimental backgrounds. An essential part of the chapter is the introduction of radiation processing technologies in the fields of polymer chemistry, food processing, and sterilization. The application of radiation chemistry to nuclear technology and to protection of environment (flue gas treatment, wastewater treatment) is also discussed.

  12. 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, draft report for comment. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J. [Pacific Northwest Lab., Richland, WA (United States)] [and others

    1994-09-01

    On June 27, 1988, the U.S. Nuclear Regulatory Commission (NRC) published in the Federal Register (53 FR 24018) the final rule for the General Requirements for Decommissioning Nuclear Facilities. With the issuance of the final rule, owners and operators of licensed nuclear power plants are required to prepare, and submit to the NRC for review, decommissioning plans and cost estimates. 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), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB alternatives, which 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. 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. Costs for labor, transport, and disposal activities are given in 1993 dollars. Sensitivities 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 are also examined.

  13. 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, draft report for comment. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J. [Pacific Northwest Lab., Richland, WA (United States)] [and others

    1994-09-01

    On June 27, 1988, the U.S. Nuclear Regulatory Commission (NRC) published in the Federal Register (53 FR 24018) the final rule for the General Requirements for Decommissioning Nuclear Facilities. With the issuance of the final rule, owners and operators of licensed nuclear power plants are required to prepare, and submit to the NRC for review, decommissioning plans and cost estimates. 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 WNP-2, 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, which 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. 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. Costs for labor, materials, transport, and disposal activities are given in 1993 dollars. Sensitivities 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 are also examined.

  14. A sense of agency

    DEFF Research Database (Denmark)

    Laerkner, Eva; Egerod, Ingrid; Olesen, Finn

    2017-01-01

    at the interface between agency and powerlessness as they were able to interact, yet were bound by contextual factors such as bodily weakness, technology, spatial position and relational aspects. This knowledge is important to develop patient-centered nursing practice in the context of lighter sedation....... competent and compassionate nurses who were attentive and involved them as individual persons. Initiatives to enhance familiar aspects such as relatives, personal items and care, continuity and closeness of nurses contributed to the patients' experience of feeling safe and secure in the unfamiliar setting....... Patients were aware of the surrounding activities and felt powerless when ignored by the staff and were affected when witnessing fellow patients' suffering. CONCLUSION: Being awake during mechanical ventilation entailed new opportunities and challenges for critically ill patients. Patients found themselves...

  15. The sense of agency

    DEFF Research Database (Denmark)

    Ritterband-Rosenbaum, Anina

    to their sensorimotor and perceptual problems. The result showed that children with CP have a different perception of control, and that they attribute to a larger extend movements to themselves even though they were not responsible for them. Study IV looked at how an intensive motor, perceptual and cognitive training...... program can change the sense of agency in children with CP. At the same time the study explored if this alteration of feeling in control of the movements has an impact on the children’s motor abilities. The results showed that the CP children, who completed the training, displayed an improved performance...... in identifying their own movements and an optimized motor behavior. In conclusion, the thesis has revealed a neural network between sensorimotor region which is important for understanding and experiencing own movements. Furthermore, brain lesioned children were found to display an altered perception...

  16. Regulatory mark; Marco regulatorio

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-10-15

    This chapter is based on a work performed in distinct phases. The first phase consisted in of the analysis regulatory legislation existent in Brazil for the sugar-alcohol sector since the beginning of the X X century. This analysis allowed the identification of non existent points and legal devices related to the studied aspects, and that were considered as problematic for the sector expansion. In the second phase, related treaties and international agreements was studied and possible obstacles for the brazilian bio ethanol exportation for the international market. Initiatives were examined at European Union, United States of America, Caribbean and countries of the sub-Saharan Africa. In this phase, policies were identified related to the incentives and adoption of use of bio fuels added to the gasoline in countries or group of countries considered as key for the consolidation of bio ethanol as a world commodity.

  17. Environmental Protection Agency, Office of Air and Radiation

    Science.gov (United States)

    ... Location: Research Triangle Park, North Carolina OAQPS Organization Steve Page, Director Phone: 919-541-5616 Bill Harnett, ... Organization Chart Staff Directory Planning, Budget and Results Jobs and Internships Headquarters Offices Regional Offices Labs and ...

  18. 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.

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

    Science.gov (United States)

    Phartiyal, P.

    2015-12-01

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

  20. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  1. The liberal state and the rogue agency: FDA's regulation of drugs for mood disorders, 1950s-1970s.

    Science.gov (United States)

    Shorter, Edward

    2008-01-01

    The theory of the liberal state does not generally contemplate the possibility that regulatory agencies will turn into "rogues," regulating against the interests of their clients and, indeed, the public interest. In the years between circa 1955 and 1975 this seems to have happened to one of the prime regulatory agencies of the US federal government: the Food and Drug Administration (FDA). Intent upon transforming itself from a traditional "cop" agency to a regulatory giant, the FDA campaigned systematically to bring down some safe and effective drugs. This article concentrates on hearings in the area of psychopharmacology regarding several antianxiety drugs, namely meprobamate (Miltown), chlordiazepoxide (Librium) and diazepam (Valium). In addition, from 1967 to 1973 this regulatory vengefulness occurred on a broad scale in the Drug Efficacy Study Implementation (DESI), an administrative exercise that removed from the market almost half of the psychopharmacopoeia. The article explores possible bureaucratic motives for these actions.

  2. Radiation-induced gene expression in the nematode caenorhabditis elegans

    Energy Technology Data Exchange (ETDEWEB)

    Nelson, G.A.; Jones, T.A.; Chesnut, A.; Smith, A.L. [Loma Linda Univ., CA (United States)

    2002-12-01

    We used the nematode C. elegans to characterize the genotoxic and cytotoxic effects of ionizing radiation in a simple animal model emphasizing the unique effects of charged particle radiation. Here we demonstrate by reverse transcription polymerase chain reaction (RT-PCR) differential display and whole genome microarray hybridization experiments that gamma rays, accelerated protons and iron ions at the same physical dose lead to unique transcription profiles. 599 of 17871 genes analyzed (3.4%) showed differential expression 3 hrs after exposure to 3 Gy of radiation. 193 were up-regulated, 406 were down-regulated and 90% were affected only by a single species of radiation. A novel statistical clustering technique identified the regulatory relationships between the radiation-modulated genes and showed that genes affected by each radiation species were associated with unique regulatory clusters. This suggests that independent homeostatic mechanisms are activated in response to radiation exposure as a function of track structure or ionization density. (author)

  3. Radiation-induced gene expression in the nematode Caenorhabditis elegans

    Science.gov (United States)

    Nelson, Gregory A.; Jones, Tamako A.; Chesnut, Aaron; Smith, Anna L.

    2002-01-01

    We used the nematode C. elegans to characterize the genotoxic and cytotoxic effects of ionizing radiation in a simple animal model emphasizing the unique effects of charged particle radiation. Here we demonstrate by RT-PCR differential display and whole genome microarray hybridization experiments that gamma rays, accelerated protons and iron ions at the same physical dose lead to unique transcription profiles. 599 of 17871 genes analyzed (3.4%) showed differential expression 3 hrs after exposure to 3 Gy of radiation. 193 were up-regulated, 406 were down-regulated and 90% were affected only by a single species of radiation. A novel statistical clustering technique identified the regulatory relationships between the radiation-modulated genes and showed that genes affected by each radiation species were associated with unique regulatory clusters. This suggests that independent homeostatic mechanisms are activated in response to radiation exposure as a function of track structure or ionization density.

  4. Radiation carcinogenesis

    Energy Technology Data Exchange (ETDEWEB)

    Fry, R.J.M.

    1976-01-01

    The risk of iatrogenic tumors with radiation therapy is so outweighed by the benefit of cure that estimates of risk have not been considered necessary. However, with the introduction of chemotherapy, combined therapy, and particle radiation therapy, the comparative risks should be examined. In the case of radiation, total dose, fractionation, dose rate, dose distribution, and radiation quality should be considered in the estimation of risk. The biological factors that must be considered include incidence of tumors, latent period, degree of malignancy, and multiplicity of tumors. The risk of radiation induction of tumors is influenced by the genotype, sex, and age of the patient, the tissues that will be exposed, and previous therapy. With chemotherapy the number of cells at risk is usually markedly higher than with radiation therapy. Clearly the problem of the estimation of comparative risks is complex. This paper presents the current views on the comparative risks and the importance of the various factors that influence the estimation of risk.

  5. Radiation acoustics

    CERN Document Server

    Lyamshev, Leonid M

    2004-01-01

    Radiation acoustics is a developing field lying at the intersection of acoustics, high-energy physics, nuclear physics, and condensed matter physics. Radiation Acoustics is among the first books to address this promising field of study, and the first to collect all of the most significant results achieved since research in this area began in earnest in the 1970s.The book begins by reviewing the data on elementary particles, absorption of penetrating radiation in a substance, and the mechanisms of acoustic radiation excitation. The next seven chapters present a theoretical treatment of thermoradiation sound generation in condensed media under the action of modulated penetrating radiation and radiation pulses. The author explores particular features of the acoustic fields of moving thermoradiation sound sources, sound excitation by single high-energy particles, and the efficiency and optimal conditions of thermoradiation sound generation. Experimental results follow the theoretical discussions, and these clearl...

  6. Use of benefit-cost analysis in establishing Federal radiation protection standards: a review

    Energy Technology Data Exchange (ETDEWEB)

    Erickson, L.E.

    1979-10-01

    This paper complements other work which has evaluated the cost impacts of radiation standards on the nuclear industry. It focuses on the approaches to valuation of the health and safety benefits of radiation standards and the actual and appropriate processes of benefit-cost comparison. A brief historical review of the rationale(s) for the levels of radiation standards prior to 1970 is given. The Nuclear Regulatory Commission (NRC) established numerical design objectives for light water reactors (LWRs). The process of establishing these numerical design criteria below the radiation protection standards set in 10 CFR 20 is reviewed. EPA's 40 CFR 190 environmental standards for the uranium fuel cycle have lower values than NRC's radiation protection standards in 10 CFR 20. The task of allocating EPA's 40 CFR 190 standards to the various portions of the fuel cycle was left to the implementing agency, NRC. So whether or not EPA's standards for the uranium fuel cycle are more stringent for LWRs than NRC's numerical design objectives depends on how EPA's standards are implemented by NRC. In setting the numerical levels in Appendix I to 10 CFR 50 and 40 CFR 190 NRC and EPA, respectively, focused on the costs of compliance with various levels of radiation control. A major portion of the paper is devoted to a review and critique of the available methods for valuing health and safety benefits. All current approaches try to estimate a constant value of life and use this to vaue the expected number of lives saved. This paper argues that it is more appropriate to seek a value of a reduction in risks to health and life that varies with the extent of these risks. Additional research to do this is recommended. (DC)

  7. Hawking radiation

    Science.gov (United States)

    Parentani, Renaud; Spindel, Philippe

    2011-12-01

    Hawking radiation is the thermal radiation predicted to be spontaneously emitted by black holes. It arises from the steady conversion of quantum vacuum fluctuations into pairs of particles, one of which escaping at infinity while the other is trapped inside the black hole horizon. It is named after the physicist Stephen Hawking who derived its existence in 1974. This radiation reduces the mass of black holes and is therefore also known as black hole evaporation.

  8. Powerplant productivity improvements and regulatory incentives

    Energy Technology Data Exchange (ETDEWEB)

    Hardy, D; Brown, D

    1980-10-27

    The purpose of this study was to examine the benefits to be gained from increased powerplant productivity and to validate and demonstrate the use of incentives within the regulatory process to promote the improvement of powerplant productivity. The system-wide costs savings to be gained from given productivity improvement scenarios are estimated in both the short and long term. Numerous reports and studies exist which indicate that productivity improvements at the powerplant level are feasible and cost effective. The efforts of this study widen this focus and relate system-wide productivity improvements with system-wide cost savings. The initial thrust of the regulatory section of this study is to validate the existence of reasonable incentive procedures which would enable regulatory agencies to better motivate electric utilities to improve productivity on both the powerplant and system levels. The voluntary incentive format developed in this study was designed to facilitate the link between profit and efficiency which is typically not clear in most regulated market environments. It is concluded that at the present time, many electric utilities in this country could significantly increase the productivity of their base load units, and the adoption of an incentive program of the general type recommended in this study would add to rate of return regulation the needed financial incentives to enable utilities to make such improvements without losing long-run profit. In light of the upcoming oil import target levels and mandatory cutbacks of oil and gas as boiler fuels for electric utilities, the use of incentive programs to encourage more efficient utilization of coal and nuclear base load capacity will become far more inviting over the next two decades.

  9. Regulatory practices for nuclear power plants in India

    Indian Academy of Sciences (India)

    S S Bajaj

    2013-10-01

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

  10. Regulatory focus in groupt contexts

    NARCIS (Netherlands)

    Faddegon, Krispijn Johannes

    2009-01-01

    The thesis examines the influence of group processes on the regulatory focus of individual group members. It is demonstrated that the group situation can affect group members' regulatory focus both in a top-down fashion (via the identitiy of the group) and in a bottom-up fashion (emerging from the g

  11. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    2000-01-01

    This study addresses enforcement styles of regulatory inspectors, based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about i...

  12. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    J. May, Peter; Winter, Søren

    2007-01-01

    This study addresses enforcement styles of regulatory inspectors based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about in...

  13. Regulatory Foci and Organizational Commitment

    Science.gov (United States)

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  14. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    2006-01-01

    The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law.......The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law....

  15. Quality management as knowledge sharing: experiences of the Napa County Health and Human Services Agency.

    Science.gov (United States)

    Harrison, Lindsay

    2012-01-01

    Lacking a coordinated effort in utilizing data and tracking program outcomes, one agency developed a Quality Management (QM) division to facilitate and manage more effective data use. To support this process, the agency sought to develop a collective, agency-wide understanding and investment in improving and measuring client outcomes. Similarly, the agency also focused efforts on creating a culture of transparency and accountability, with goals of improving service, increasing agency integrity, meeting regulatory compliance, and engaging in effective risk management. Operationalizing the QM initiative involved developing procedures, systems, and guidelines that would facilitate the generation of reliable and accurate data that could be used to inform program change and decision-making. This case study describes this agency's experience in successfully creating and implementing a QM initiative aimed at engaging in greater knowledge sharing.

  16. Regulatory cross-cutting topics for fuel cycle facilities.

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-10-01

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

  17. 76 FR 72952 - Guidance for Industry on Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic...

    Science.gov (United States)

    2011-11-28

    ... a guidance for industry entitled ``Nonclinical Evaluation of Late Radiation Toxicity of Therapeutic... guidance represents the Agency's current thinking on nonclinical evaluation of late radiation toxicity of... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Nonclinical Evaluation of...

  18. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host...... responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells—termed anti-regulatory T cells (anti-Tregs)—that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune...... reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells...

  19. Japan Sports Arbitration Agency (JSAA

    Directory of Open Access Journals (Sweden)

    Ekaterina P. Rusakova

    2015-12-01

    Full Text Available In this article author analyzes the activities of Japan Sports Arbitration Agency. Author considers the goals, objectives and procedure for dealing with disputes relating to the use of performance-enhancing drugs by athletes. Author study the regulation of Japan Sports Arbitration Agency, to resolve disputes relating to the use of doping, as well as the procedure for application and acceptance of its agency, the choice of arbitrators, counterclaim, protection of evidence.

  20. Copyright agencies in Beijing, China

    Institute of Scientific and Technical Information of China (English)

    PEI; Yonggang; WANG; Jingui

    2009-01-01

    Based on a study of copyright agencies in Beijing area,this paper reviews the historical development of the work of copyright agencies and their agents.It analyzes their business related problems that these copyright agencies and agents are facing today.This paper also proposes a few remedial measures that may usher this copyright industry into a more sustainable development and also with a more promising outlook.

  1. [Overview of regulatory aspects guiding tablet scoring].

    Science.gov (United States)

    Teixeira, Maíra Teles; Sá-Barreto, Lívia Cristina Lira; Silva, Dayde Lane Mendonça; Cunha-Filho, Marcílio Sergio Soares

    2016-06-01

    Tablet scoring is a controversial but common practice used to adjust doses, facilitate drug intake, or lower the cost of drug treatment, especially in children and the elderly. The risks of tablet scoring are mainly related to inaccuracies in the resulting dose and stability problems. The aim of this article is to provide an overview of worldwide guidelines regarding tablet scoring. We found that regulatory health agencies in Mercosur countries as well as other South American countries do not have published standards addressing tablet splitting. Among the surveyed health agencies, the Food and Drug Administration (FDA) in the United States is the only one to present standards, ranging from splitting instructions to regulation of the manufacturing process. The concept of functional scoring implemented by the FDA has introduced some level of guarantee as to the ability of tablets to be split. In conclusion, technical and scientific bases are still insufficient to guide health rules on this subject, making the decision on scoring, in certain situations, random and highly risky to public health. The need for more detailed regulation is vital to ensure the safety of tablet medications.

  2. Agency and Algorithms

    Directory of Open Access Journals (Sweden)

    Hanns Holger Rutz

    2016-11-01

    Full Text Available Although the concept of algorithms has been established a long time ago, their current topicality indicates a shift in the discourse. Classical definitions based on logic seem to be inadequate to describe their aesthetic capabilities. New approaches stress their involvement in material practices as well as their incompleteness. Algorithmic aesthetics can no longer be tied to the static analysis of programs, but must take into account the dynamic and experimental nature of coding practices. It is suggested that the aesthetic objects thus produced articulate something that could be called algorithmicity or the space of algorithmic agency. This is the space or the medium – following Luhmann’s form/medium distinction – where human and machine undergo mutual incursions. In the resulting coupled “extimate” writing process, human initiative and algorithmic speculation cannot be clearly divided out any longer. An observation is attempted of defining aspects of such a medium by drawing a trajectory across a number of sound pieces. The operation of exchange between form and medium I call reconfiguration and it is indicated by this trajectory. 

  3. Implementation of Information Management System for Radiation Safety of Personnel at the Russian Northwest Center for Radioactive Waste Management 'SevRAO' - 13131

    Energy Technology Data Exchange (ETDEWEB)

    Chizhov, K.; Simakov, A.; Seregin, V.; Kudrin, I.; Shandala, N.; Tsovyanov, A.; Kryuchkov, V. [Burnasyan Federal Medical Biophysical Center of Federal Medical Biological Agency, RF Ministry of Health and Social Development. 46, Zhivopisnaya St., Moscow, 123182 (Russian Federation); Krasnoschekov, A.; Kosnikov, A. [Northwest Center for Radioactive Waste Management ' SevRAO' - a branch of the Federal State Unitary Enterprise ' Enterprise for Radioactive Waste Management' ' RosRAO' 183017, Murmansk, Lobova st., 100 (Russian Federation); Kemsky, I. [Regional management - 120 of the Federal Medical-Biological Agency, 184682, Snezhnogorsk, Valentina Biryukova St., 5/1 (Russian Federation); Sneve, M. [Norwegian Radiation Protection Authority, Postboks 55, 1332 Oesteraas (Norway)

    2013-07-01

    The report is an overview of the information-analytical system designed to assure radiation safety of workers. The system was implemented in the Northwest Radioactive Waste Management Center 'SevRAO' (which is a branch of the Federal State Unitary Enterprise 'Radioactive Waste Management Enterprise RosRAO'). The center is located in the Northwest Russia. In respect to 'SevRAO', the Federal Medical-Biological Agency is the regulatory body, which deals with issues of radiation control. The main document to regulate radiation control is 'Reference levels of radiation factors in radioactive wastes management center'. This document contains about 250 parameters. We have developed a software tool to simplify control of these parameters. The software includes: input interface, the database, dose calculating module and analytical block. Input interface is used to enter radiation environment data. Dose calculating module calculates the dose on the route. Analytical block optimizes and analyzes radiation situation maps. Much attention is paid to the GUI and graphical representation of results. The operator can enter the route at the industrial site or watch the fluctuations of the dose rate field on the map. Most of the results are presented in a visual form. Here we present some analytical tasks, such as comparison of the dose rate in some point with control levels at this point, to be solved for the purpose of radiation safety control. The program helps to identify points making the largest contribution to the collective dose of the personnel. The tool can automatically calculate the route with the lowest dose, compare and choose the best route. The program uses several options to visualize the radiation environment at the industrial site. This system will be useful for radiation monitoring services during the operation, planning of works and development of scenarios. The paper presents some applications of this system on real data

  4. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  5. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

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

    OpenAIRE

    Bruno Fonseca-Santos; Marcos Antonio Corrêa; Marlus Chorilli

    2015-01-01

    The interest in sustainable products has increased along the years, since the choice of products, packaging and production processes have a great impact on the environment. These products are classified by regulatory agencies in different categories, aggregating advantages to the product and increasing the demand by consumers. However, there is no harmonization in guidelines of these certifying agencies and each cosmetic industry formulates their product and packaging in a more rational way, ...

  7. Politics versus Science in the Making of a New Regulatory Regime for Food in Europe

    OpenAIRE

    Richard Keefer

    2001-01-01

    The European Union's new food regulatory regime can be understood as a political, rather than science-based solution to the problem of recurrent food crises that have threatened the foundations of the single market. The failure of first, mutual trust and subsequently, its remedy, comitology, led to calls for an agency solution. The question of whether to invest an agency with the three powers of risk assessment, communication, and management can be understood as a struggle to define the role ...

  8. Regulating regulatory T cells.

    Science.gov (United States)

    Le, N T; Chao, N

    2007-01-01

    Regulatory T cells (Tregs) are a specialized subpopulation of T cells that act to suppress activation of other immune cells and thereby maintain immune system homeostasis, self-tolerance as well as control excessive response to foreign antigens. The mere concept of Tregs was the subject of significant controversy among immunologists for many years owing to the paucity of reliable markers for defining these cells and the ambiguity of the nature and molecular basis of suppressive phenomena. However, recent advances in the molecular characterization of this cell population have firmly established their existence and their vital role in the vertebrate immune system. Of interest, accumulating evidence from both humans and experimental animal models has implicated the involvement of Tregs in the development of graft-versus-host disease (GVHD). The demonstration that Tregs could separate GVHD from graft-versus-tumor (GVT) activity suggests that their immunosuppressive potential could be manipulated to reduce GVHD without detrimental consequence on GVT effect. Although a variety of T lymphocytes with suppressive capabilities have been reported, the two best-characterized subsets are the naturally arising, intrathymic-generated Tregs (natural Tregs) and the peripherally generated, inducible Tregs (inducible Tregs). This review summarizes our current knowledge of the generation, function and regulation of these two populations of Tregs during an immune response. Their role in the development of GVHD and their therapeutic potential for the prevention and treatment of GVHD will also be described.

  9. 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.

  10. Radiation measurements in Egyptian pyramids and tombs -- occupational exposure of workers and the public

    Energy Technology Data Exchange (ETDEWEB)

    Bigu, J.; Hussein, Mohamed I.; Hussein, A.Z

    2000-02-01

    A radiation survey of seven archaeological sites within Egyptian pyramids and tombs has been conducted in the Saggara area. Measurements were made of radon ({sup 222}Rn) and its short-lived decay products (progeny), as well as thoron ({sup 220}Rn) progeny and {gamma}-radiation. The results of these measurements have been used to calculate the maximum annual effective dose (MAD) and other important occupational radiation exposure variables. It was found that for the limited time to which occupational workers and visitors were exposed, their respective MAD values were lower than that recommended by the regulatory agency (i.e., 20 mSv per year for occupational workers and 1 mSv in a year for the public). However, it is shown that if the exposure times for occupational workers were to increase to 'normal' working schedules their MAD would be exceeded at three archaeological sites. Implementation of improved ventilation practices is recommended in those sites to reduce the exposure to occupational workers were their working schedules to be significantly increased. It is also recommended that further monitoring be conducted in the future to verify these results.

  11. Student Agency for Powerful Learning

    Science.gov (United States)

    Wiliams, Philip

    2017-01-01

    School libraries play a powerful role in enabling, informing, and sustaining student agency, and nothing engages and motivates students more deeply than enabling them to become the active agents in the process of learning. Students with agency are powerful learners who are prepared to engage with the world with sustained, courageous curiosity.…

  12. A Guidebook for Chartering Agencies.

    Science.gov (United States)

    Millot, Marc Dean

    As of November 1996, at least 25 states had passed charter-school legislation empowering agencies of state government to enter into agreements with private individuals and groups to operate public schools. This is a guidebook for government agencies given the power to permit individuals and groups to operate autonomous public schools under state…

  13. Healthcare regulatory concepts in Brazil.

    Science.gov (United States)

    Oliveira, Robson Rocha de; Elias, Paulo Eduardo Mangeon

    2012-06-01

    The healthcare regulatory concepts used in Brazilian scientific publications on healthcare management were reviewed. A typo-logical classification for regulatory concepts was developed from the most current ideas in five disciplines: life sciences, law, economics, sociology and political science. Four ideas stood out: control, balance, adaptation and direction, with greatest emphasis on the technical nature of regulation. The political nature of regulation was secondary. It was considered that dis-cussion of healthcare regulatory concepts was connected with comprehension of the role that the state plays in this sector. De-finition of the forms of state intervention is the key convergence point between the different ways of conceptualizing healthcare regulation.

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

    Science.gov (United States)

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

    2016-05-01

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

  15. The Danish Regulatory Reform of Telecommunications

    DEFF Research Database (Denmark)

    Skouby, Knud Erik

    1998-01-01

    An overview of the liberalisation process and regulatory reform of telecommunications in Denmark......An overview of the liberalisation process and regulatory reform of telecommunications in Denmark...

  16. Thermal Radiation Source Test Facility,

    Science.gov (United States)

    1984-01-01

    KEY WORDS (Continu on revers side I eesr and identify by block nuMb.,) Thermal Radiation Source Thermal Test Facility 20 ABSTRACT (Continue on reverse...SECTION 1 INTRODUCTION 1-1 GENERAL Defense Nuclear Agency’s Field Command, located at Kirtland AFB in New Mexico, has recently upgraded its thermal test facility...is used to evaluate damage and survivability in a nuclear environment. The thermal test facility was first established in 1979 and used O large

  17. Pesticide regulations for agriculture: Chemically flawed regulatory practice.

    Science.gov (United States)

    Gamble, Donald S; Bruccoleri, Aldo G

    2016-08-02

    Two categories of pesticide soil models now exist. Government regulatory agencies use pesticide fate and transport hydrology models, including versions of PRZM.gw. They have good descriptions of pesticide transport by water flow. Their descriptions of chemical mechanisms are unrealistic, having been postulated using the universally accepted but incorrect pesticide soil science. The objective of this work is to report experimental tests of a pesticide soil model in use by regulatory agencies and to suggest possible improvements. Tests with experimentally based data explain why PRZM.gw predictions can be wrong by orders of magnitude. Predictive spreadsheet models are the other category. They are experimentally based, with chemical stoichiometry applied to integral kinetic rate laws for sorption, desorption, intra-particle diffusion, and chemical reactions. They do not account for pesticide transport through soils. Each category of models therefore lacks what the other could provide. They need to be either harmonized or replaced. Some preliminary tests indicate that an experimental mismatch between the categories of models will have to be resolved. Reports of pesticides in the environment and the medical problems that overlap geographically indicate that government regulatory practice needs to account for chemical kinetics and mechanisms. Questions about possible cause and effect links could then be investigated.

  18. Drug-device combination products: regulatory landscape and market growth.

    Science.gov (United States)

    Bayarri, L

    2015-08-01

    Combination products are therapeutic and diagnostic products that combine drugs, devices and/or biological products, leading to safer and more effective treatments thanks to careful and precise drug targeting, local administration and individualized therapy. These technologies can especially benefit patients suffering from serious diseases and conditions such as cancer, heart disease, multiple sclerosis and diabetes, among others. On the other hand, drug-device combination products have also introduced a new dynamic in medical product development, regulatory approval and corporate interaction. Due to the increasing integration of drugs and devices observed in the latest generation of combination products, regulatory agencies have developed specific competences and regulations over the last decade. Manufacturers are required to fully understand the specific requirements in each country in order to ensure timely and accurate market access of new combination products, and the development of combination products involves a very specific pattern of interactions between manufacturers and regulatory agencies. The increased sophistication of the products brought to market over the last couple of decades has accentuated the need to develop drugs and devices collaboratively using resources from both industries, fostering the need of business partnering and technology licensing. This review will provide a global overview of the market trends, as well as (in the last section) an analysis of the drug-device combination products approved by the FDA during the latest 5 years. Copyright 2015 Prous Science, S.A.U. or its licensors. All rights reserved.

  19. Radiation Hydrodynamics

    Energy Technology Data Exchange (ETDEWEB)

    Castor, J I

    2003-10-16

    The discipline of radiation hydrodynamics is the branch of hydrodynamics in which the moving fluid absorbs and emits electromagnetic radiation, and in so doing modifies its dynamical behavior. That is, the net gain or loss of energy by parcels of the fluid material through absorption or emission of radiation are sufficient to change the pressure of the material, and therefore change its motion; alternatively, the net momentum exchange between radiation and matter may alter the motion of the matter directly. Ignoring the radiation contributions to energy and momentum will give a wrong prediction of the hydrodynamic motion when the correct description is radiation hydrodynamics. Of course, there are circumstances when a large quantity of radiation is present, yet can be ignored without causing the model to be in error. This happens when radiation from an exterior source streams through the problem, but the latter is so transparent that the energy and momentum coupling is negligible. Everything we say about radiation hydrodynamics applies equally well to neutrinos and photons (apart from the Einstein relations, specific to bosons), but in almost every area of astrophysics neutrino hydrodynamics is ignored, simply because the systems are exceedingly transparent to neutrinos, even though the energy flux in neutrinos may be substantial. Another place where we can do ''radiation hydrodynamics'' without using any sophisticated theory is deep within stars or other bodies, where the material is so opaque to the radiation that the mean free path of photons is entirely negligible compared with the size of the system, the distance over which any fluid quantity varies, and so on. In this case we can suppose that the radiation is in equilibrium with the matter locally, and its energy, pressure and momentum can be lumped in with those of the rest of the fluid. That is, it is no more necessary to distinguish photons from atoms, nuclei and electrons, than it is

  20. Collection of regulatory texts relative to radiation protection. Part 2: orders and decisions taken in application of the Public Health Code and Labour Code concerning the protection of populations, patients and workers against the risks of ionizing radiations; Recueil de textes reglementaires relatifs a la radioprotection. Partie 2: arretes et decisions pris en application du Code de Sante Publique et du Code du Travail concernant la protection de la population, des patients et des travailleurs contre les dangers des rayonnements ionisants

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-05-15

    This collection of texts includes the general measures of population protection, exposure to natural radiations, general system of authorizations and statements, protection of persons exposed to ionizing radiations for medical purpose, situations of radiological emergency and long exposure to ionizing radiations, penal dispositions, application of the Public Health code and application of the Labour code. Chronological contents by date of publication is given. (N.C.)

  1. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    Directory of Open Access Journals (Sweden)

    Joana P Gonçalves

    Full Text Available Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1 apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2 ignore local patterns, abundant in most interesting cases of transcriptional activity; (3 neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4 limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots. Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in

  2. Taking Stock of Regulatory Variation.

    Science.gov (United States)

    Maurano, Matthew T; Stamatoyannopoulos, John A

    2015-07-29

    Three recent studies measure individual variation in regulatory DNA accessibility. What do they tell us about the prospects of assessing variation in single cells and across populations? Copyright © 2015 Elsevier Inc. All rights reserved.

  3. Current Regulations and Regulatory Actions

    Science.gov (United States)

    This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

  4. RadNet (Environmental Radiation Ambient Monitoring System)

    Data.gov (United States)

    U.S. Environmental Protection Agency — RadNet, formerly Environmental Radiation Ambient Monitoring System (ERAMS), is a national network of monitoring stations that regularly collect air, precipitation,...

  5. Radiations from GSM Base Stations and its Biological Effects on ...

    African Journals Online (AJOL)

    Michael Horsfall

    The levels of radiofrequency (RF) radiations around the base stations were found .... of Turk's solution (Glacial Acetic Acid tinted with ... dissolved in distilled, 40% formaldehyde) is balanced .... agencies in different countries have come up with.

  6. 77 FR 74880 - Agency Information Collection Activities; Submission for OMB Review; Comment Request...

    Science.gov (United States)

    2012-12-18

    ... submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR... Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th...., permitting electronic submission of responses. Agency: DOL-ETA. Title of Collection:...

  7. 77 FR 36577 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Tax...

    Science.gov (United States)

    2012-06-19

    ... Employment and Training Administration (ETA) sponsored information collection request (ICR) titled, ``Tax... this request to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA..., e.g., permitting electronic submission of responses. Agency: DOL-ETA. Title of Collection:...

  8. 78 FR 45565 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; National...

    Science.gov (United States)

    2013-07-29

    ... 31, 2013, the Department of Labor (DOL) will submit the Employment and Training Administration (ETA... Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th... submission of responses. Agency: DOL-ETA. Title of Collection: National Emergency Grant...

  9. 77 FR 71449 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Benefit...

    Science.gov (United States)

    2012-11-30

    ... Labor (DOL) will submit the Employment and Training Administration (ETA) sponsored information... Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th..., e.g., permitting electronic submission of responses. Agency: DOL-ETA. Title of Collection:...

  10. 76 FR 13255 - Office of Directives Management (A/GIS/DIR); Agency Information Collection Activities: Proposed...

    Science.gov (United States)

    2011-03-10

    ... of Directives Management (A/GIS/DIR); Agency Information Collection Activities: Proposed Collection... the Office of Management and Budget and request for comments. SUMMARY: As part of a Federal Government... of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of...

  11. 78 FR 55300 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Science.gov (United States)

    2013-09-10

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB... needed annually to complete the requirement or request: 365. 10. Abstract: NRC-regulated facilities...

  12. 10 CFR 9.17 - Agency records exempt from public disclosure.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Agency records exempt from public disclosure. 9.17 Section 9.17 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Freedom of Information Act Regulations § 9... investigations or prosecutions, if the disclosure could reasonably be expected to risk circumvention of the law...

  13. 76 FR 29248 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Science.gov (United States)

    2011-05-20

    ... Federal Information Security Management Act (FISMA) of 2002 to properly protect all PII data maintained by..., oversight agencies or DUAs for disproportionate share hospital (DSH) data requests as well as updates to...: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations...

  14. 75 FR 19453 - Reports, Forms and Record Keeping Requirements; Agency Information Collection Activity Under OMB...

    Science.gov (United States)

    2010-04-14

    ... National Highway Traffic Safety Administration Reports, Forms and Record Keeping Requirements; Agency... Officer, Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: by fax... automated collection techniques or other forms of information technology. A Comment to OMB is most...

  15. 78 FR 16361 - Agency Information Collection Activities: Information Collection Renewal; Comment Request...

    Science.gov (United States)

    2013-03-14

    ... Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0219, 400 7th... 1320.3(c) to include agency requests or requirements that members of the public submit reports, keep... on respondents, including through the use of automated collection techniques or other forms...

  16. 78 FR 64494 - FFP Qualified Hydro 14, LLC, Western Minnesota Municipal Power Agency; Notice Announcing Filing...

    Science.gov (United States)

    2013-10-29

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission FFP Qualified Hydro 14, LLC, Western Minnesota Municipal Power Agency... drawing, the order of priority is as follows: 1. FFP Qualified Hydro 14, LLC--Project No. 13579-002...

  17. 10 CFR 9.37 - Fees for search and review of agency records by NRC personnel.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Fees for search and review of agency records by NRC personnel. 9.37 Section 9.37 Energy NUCLEAR REGULATORY COMMISSION PUBLIC RECORDS Freedom of Information Act... review at a salary rate that is equivalent to a GG-7/step 7, plus 16 percent fringe benefits;...

  18. 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.

  19. Radiation Exposure

    Science.gov (United States)

    ... on to any children you have after the exposure. A lot of radiation over a short period, ... skin burns and reduced organ function. If the exposure is large enough, it can cause premature aging ...

  20. Radiation damage

    CERN Document Server

    Heijne, Erik H M; CERN. Geneva

    1998-01-01

    a) Radiation damage in organic materials. This series of lectures will give an overview of radiation effects on materials and components frequently used in accelerator engineering and experiments. Basic degradation phenomena will be presented for organic materials with comprehensive damage threshold doses for commonly used rubbers, thermoplastics, thermosets and composite materials. Some indications will be given for glass, scintillators and optical fibres. b) Radiation effects in semiconductor materials and devices. The major part of the time will be devoted to treat radiation effects in semiconductor sensors and the associated electronics, in particular displacement damage, interface and single event phenomena. Evaluation methods and practical aspects will be shown. Strategies will be developed for the survival of the materials under the expected environmental conditions of the LHC machine and detectors. I will describe profound revolution in our understanding of black holes and their relation to quantum me...

  1. Radiation Transport

    Energy Technology Data Exchange (ETDEWEB)

    Urbatsch, Todd James [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2015-06-15

    We present an overview of radiation transport, covering terminology, blackbody raditation, opacities, Boltzmann transport theory, approximations to the transport equation. Next we introduce several transport methods. We present a section on Caseology, observing transport boundary layers. We briefly broach topics of software development, including verification and validation, and we close with a section on high energy-density experiments that highlight and support radiation transport.

  2. Radiation Protection

    Energy Technology Data Exchange (ETDEWEB)

    Loos, M

    2001-04-01

    Major achievements of SCK-CEN's Radiation Protection Department in 2000 are described. The main areas for R and D of the department remain neutron dosimetry and neutron activation analysis, safeguards information handling and non-destructive assay techniques. Further activities include low-level radioactivity measurements in environmental and biological samples and radiation protection research. Finally, achievements in decision strategy research and social sciences in nuclear research are reported.

  3. Food irradiation--US regulatory considerations

    Energy Technology Data Exchange (ETDEWEB)

    Morehouse, Kim M. E-mail: kim.morehouse@cfsan.fda.gov

    2002-03-01

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

  4. Credibility Discourse of PR Agencies

    DEFF Research Database (Denmark)

    Isaksson, Maria; Jørgensen, Poul Erik Flyvholm

    2008-01-01

    This research examines the credibility discourse posted on the corporate websites of 60 British, Danish and Norwegian public relations agencies. The purpose was to determine the nature and patterns of the statements of credibility that PR agencies from different cultures have considered...... instrumental in establishing dependable and likeable images of their ethos. More specifically, the study seeks to establish whether there are distinct cross-cultural preferences in PR credibility discourse. Our assumption was that British and Scandinavian PR agencies assign similar relative importance...

  5. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... nonionic interactions. Thus, pharmaceutical co-crystals offer the advantage of generating a diverse array... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... entitled ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This draft guidance...

  6. 77 FR 26556 - Determination of Regulatory Review Period for Purposes of Patent Extension; EQUIDONE GEL

    Science.gov (United States)

    2012-05-04

    ... Patent Extension; EQUIDONE GEL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for EQUIDONE GEL and is....S.C. 156(g)(4)(B). FDA approved for marketing the animal drug product EQUIDONE GEL...

  7. 76 FR 67622 - Modification of Regulatory Provisions Requiring Credit Rating or Assessments in Accordance With...

    Science.gov (United States)

    2011-11-02

    ...- worthiness of a security or money market instrument. DOE has identified regulatory provisions that may be... credit-worthiness of a security or money market instrument; and (2) any reference to or requirements in... by the Federal Government, including influential scientific information related to agency...

  8. 78 FR 60695 - Regulatory Reorganization; Administrative Changes to Regulations Due to the Consolidation of the...

    Science.gov (United States)

    2013-10-02

    ... Fiscal Service Bureau of the Fiscal Service 31 CFR Chapter II, Parts 202-391 RIN 1510-AB31 Regulatory Reorganization; Administrative Changes to Regulations Due to the Consolidation of the Financial Management Service and the Bureau of the Public Debt Into the Bureau of the Fiscal Service AGENCY: Bureau of...

  9. 76 FR 8674 - Notice of a Public Meeting: Environmental Justice Considerations for Drinking Water Regulatory...

    Science.gov (United States)

    2011-02-15

    ... AGENCY 40 CFR Part 1 Notice of a Public Meeting: Environmental Justice Considerations for Drinking Water... the drinking water Contaminant Candidate List 3. EPA recently announced its intentions to develop drinking water regulatory actions for perchlorate and carcinogenic volatile organic compounds (VOCs)....

  10. Teaching Negotiation in the Context of Environmental Regulatory Enforcement: An Experiential Learning Approach

    Science.gov (United States)

    Choy, Marisa S.; Johnson, Stephen A.; Ortolano, Leonard

    2011-01-01

    This article describes a simulation-based teaching approach that helps university students learn about negotiation in the context of environmental regulatory enforcement. The approach centers on negotiation of a penalty between government agencies and a fictitious corporation that has violated provisions of the U.S. Clean Water Act. The exercise…

  11. 76 FR 10527 - Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations

    Science.gov (United States)

    2011-02-25

    ... Agricultural Marketing Service 7 CFR Part 205 Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations AGENCY: Agricultural Marketing Service, USDA. ACTION: Review and request for... regulations implementing the National Organic Program (NOP) were published December 21, 2000 (65 FR...

  12. 40 CFR 761.257 - Determining the regulatory status of sampled pipe.

    Science.gov (United States)

    2010-07-01

    ... sampled pipe. 761.257 Section 761.257 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED... Samples § 761.257 Determining the regulatory status of sampled pipe. (a) For purposes of removal for disposal of a pipe segment that has been sampled, the sample results for that segment determines its PCB...

  13. 76 FR 79738 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of...

    Science.gov (United States)

    2011-12-22

    ... examined less frequently, every two to four years, depending on the risk ranking and size of their... regulatory agency (``bank regulators'') in the case of dealers that are not members of a registered... securities dealers and examined primarily by the various Federal bank regulators. \\9\\ 15 U.S.C. 78o(c)(7...

  14. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

    ... Pharmaceutical Co-Crystals; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Regulatory Classification of Pharmaceutical Co-Crystals.'' This guidance provides applicants of new drug...-crystal solid-state forms. This guidance also provides information about the data the applicant...

  15. Initial Human Response to Nuclear Radiation

    Science.gov (United States)

    1982-04-01

    symptoms and course of the illness. Herbert Fanger and Clarence C. Lushbaugh, "Radiation Death from Cardiovascular Shock Following a Criticality...irradiated victim died on day 32. The least-irradiated victim recovered more slowly than the others. Herbert Fanger and Clarence C. Lushbaugh, "Radiation...Sources Accident (A) Fanger and Lushbaugh, 1967 Hubner and Fry (eds.), 1980 Karas and Stanbury, 1965 International Atomic Energy Agency and World Health

  16. 78 FR 19148 - Shielding and Radiation Protection Review Effort and Licensing Conditions for Dry Storage...

    Science.gov (United States)

    2013-03-29

    ...; ] NUCLEAR REGULATORY COMMISSION 10 CFR Part 72 Shielding and Radiation Protection Review Effort and...-ISG-26A), Revision 0, ``Shielding and Radiation Protection Review Effort and Licensing Conditions for... to NRC staff when reviewing the shielding and radiation protection portions of applications...

  17. 44 CFR 208.9 - Agreements between Sponsoring Agencies and Participating Agencies.

    Science.gov (United States)

    2010-10-01

    .... Every agreement between a Sponsoring Agency and a Participating Agency regarding the System must include... EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY DISASTER ASSISTANCE NATIONAL URBAN SEARCH AND...

  18. Regulatory T cells in radiotherapeutic responses

    Directory of Open Access Journals (Sweden)

    Dörthe eSchaue

    2012-08-01

    Full Text Available Radiation therapy (RT can extend its influence in cancer therapy beyond what can be attributed to in-field cytotoxicity by modulating the immune system. While complex, these systemic effects can help tip the therapeutic balance in favor of treatment success or failure. Engagement of the immune system is generally through recognition of damage-associated molecules expressed or released as a result of tumor and normal tissue radiation damage. This system has evolved to discriminate pathological from physiological forms of cell death by signaling danger. The multiple mechanisms that can be evoked include a shift towards a pro-inflammatory, pro-oxidant microenvironment that can promote maturation of dendritic cells and, in cancer treatment, the development of effector T cell responses to tumor-associated antigens. Control over these processes is exerted by regulatory T cells (Tregs, suppressor macrophages and immunosuppressive cytokines that act in consort to maintain tolerance to self, limit tissue damage, and re-establish tissue homeostasis. Unfortunately, by the time RT for cancer is initiated the tumor-host relationship has already been sculpted in favor of tumor growth and against immune-mediated mechanisms for tumor regression. Reversing this situation is a major challenge. However, recent data show that removal of Tregs can tip the balance in favor of the generation of radiation-induced anti-tumor immunity. The clinical challenge is to do so without excessive depletion that might precipitate serious autoimmune reactions and increase the likelihood of normal tissue complications. The selective modulation of Treg biology to maintain immune tolerance and control of normal tissue damage, while releasing the brakes on anti-tumor immune responses, is a worthy aim with promise for enhancing the therapeutic benefit of RT for cancer.

  19. Regulatory Compliance in Multi-Tier Supplier Networks

    Science.gov (United States)

    Goossen, Emray R.; Buster, Duke A.

    2014-01-01

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

  20. Synchrotron radiation with radiation reaction

    Science.gov (United States)

    Nelson, Robert W.; Wasserman, Ira

    1991-04-01

    A rigorous discussion is presented of the classical motion of a relativistic electron in a magnetic field and the resulting electromagnetic radiation when radiation reaction is important. In particular, for an electron injected with initial energy gamma(0), a systematic perturbative solution to the Lorentz-Dirac equation of motion is developed for field strengths satisfying gamma(0) B much less than 6 x 10 to the 15th G. A particularly accurate solution to the electron orbital motion in this regime is found and it is demonstrated how lowest-order corrections can be calculated. It is shown that the total energy-loss rate corresponds to what would be found using the exact Larmor power formula without including radiation reaction. Provided that the particle energy and field strength satisfy the same contraint, it is explicitly demonstrated that the intuitive prescription for calculating the time-integrated radiation spectrum described above is correct.

  1. European Space Agency Sentinel-2

    Data.gov (United States)

    U.S. Geological Survey, Department of the Interior — The Sentinel-2A satellite is operated by the European Space Agency (ESA). The Sentinel Multispectral Instrument (MSI) acquires 13 spectral bands ranging from Visible...

  2. European Space Agency Sentinel-2

    Data.gov (United States)

    U.S. Geological Survey, Department of the Interior — The Sentinel-2A satellite is operated by the European Space Agency (ESA). The Sentinel Multispectral Instrument (MSI) acquires 13 spectral bands ranging from Visible...

  3. HUD Approved Housing Counseling Agencies

    Data.gov (United States)

    Department of Housing and Urban Development — HUD sponsors housing counseling agencies throughout the country that can provide advice on buying a home, renting, defaults, foreclosures, and credit issues. This...

  4. Markets: The Credit Rating Agencies

    National Research Council Canada - National Science Library

    White, Lawrence J

    2010-01-01

    ...—to the center of the U.S. bond markets—and thereby virtually guaranteed that when these rating agencies did make mistakes, these mistakes would have serious consequences for the financial sector...

  5. Abdominal radiation - discharge

    Science.gov (United States)

    Radiation - abdomen - discharge; Cancer - abdominal radiation; Lymphoma - abdominal radiation ... When you have radiation treatment for cancer, your body goes through changes. About 2 weeks after radiation treatment starts, you might notice changes ...

  6. Brain radiation - discharge

    Science.gov (United States)

    Radiation - brain - discharge; Cancer-brain radiation; Lymphoma - brain radiation; Leukemia - brain radiation ... Decadron) while you are getting radiation to the brain. It may make you hungrier, cause leg swelling ...

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

    Energy Technology Data Exchange (ETDEWEB)

    1981-03-01

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

  8. Legal and regulatory concerns about transgenic plants in Brazil.

    Science.gov (United States)

    Fontes, Eliana M G

    2003-06-01

    Brazil has a biosafety law that was approved in 1995. This law provides for a horizontal type of regulation that coordinates other existing regulatory frameworks in the areas of agriculture, health and environment. Various federal government departments are responsible for implementing the law. The National Technical Biosafety Commission is the national competent authority on biosafety with overall responsibility. In the case of Bt plants or any insecticidal organism, the Agrochemical Law also applies and authorization for laboratory, greenhouse and field studies must be obtained from the Plant Protection Secretariat, the Brazilian Institute of Environment and the National Agency of Health. Furthermore, the National Environmental Council must issue a license for commercialization of any GMO. There is pressure needed for capacity building and to harmonize the regulatory and administrative frameworks among the different federal departments involved. Some perspectives and challenges for the commercial registration of transgenic crops are discussed.

  9. Regulatory Expectations for Safety Culture

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-05-15

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety.

  10. 49 CFR Attachment 3 - Offices Within Federal Agencies and Federal-State Agencies for Information Regarding the Agencies...

    Science.gov (United States)

    2010-10-01

    ... Attachment 3 Transportation Other Regulations Relating to Transportation (Continued) NATIONAL HIGHWAY TRAFFIC.... Attachment 3—Offices Within Federal Agencies and Federal-State Agencies for Information Regarding...

  11. General trends in the evolution of prokaryotic transcriptional regulatory networks.

    Science.gov (United States)

    Madan Babu, M; Balaji, S; Aravind, L

    2007-01-01

    Gene expression in organisms is controlled by regulatory proteins termed transcription factors, which recognize and bind to specific nucleotide sequences. Over the years, considerable information has accumulated on the regulatory interactions between transcription factors and their target genes in various model prokaryotes, such as Escherichia coli and Bacillus subtilis. This has allowed the representation of this information in the form of a directed graph, which is commonly referred to as the transcriptional regulatory network. The network representation provides us with an excellent conceptual framework to understand the structure of the transcriptional regulation, both at local and global levels of organization. Several studies suggest that the transcriptional network inferred from model organisms may be approximated by a scale-free topology, which in turn implies the presence of a relatively small group of highly connected regulators (hubs or global regulators). While the graph theoretical principles have been applied to infer various properties of such networks, there have been few studies that have actually investigated the evolution of the transcriptional regulatory networks across diverse organisms. Using recently developed computational methods that exploit various evolutionary principles, we have attempted to reconstruct and compare these networks across a wide-range of prokaryotes. This has provided several insights on the modification and diversification of network structures of various organisms in course of evolution. Firstly, we observed that target genes show a much higher level of conservation than their transcriptional regulators. This in turn suggested that the same set of functions could be differently controlled across diverse organisms, contributing significantly to their adaptive radiations. In particular, at the local level of network structure, organism-specific optimization of the transcription network has evolved primarily via tinkering

  12. Regulatory Consequences of "Brexit" for the Development of Medicinal Products.

    Science.gov (United States)

    Jackson, E L; Feldschreiber, P; Breckenridge, A

    2017-08-01

    The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework. The European Medicines Agency (EMA), which is currently located in London, will move elsewhere in Europe. The pharmaceutical industry will reassess its commitment to the UK health scene. © 2017, ASCPT.

  13. Averting Regulatory Enforcement: Evidence from New Source Review

    Energy Technology Data Exchange (ETDEWEB)

    Keohane, N.O.; Mansur, E.T.; Voynov, A. [Yale University, New York, NY (USA)

    2009-09-15

    This paper explores firms' response to regulatory enforcement. New Source Review (NSR), a provision of the Clean Air Act, imposes stringent emissions limitations on significantly modified older power plants. In 1999, the Environmental Protection Agency (EPA) sued owners of 46 plants for NSR violations. We study how electricity companies respond to both the perceived threat of future action, and the action itself. A discrete choice model estimates plants likelihood of being named in lawsuits increases with large historic emissions and investments. On the eve of the lawsuits, emissions at plants with a one standard deviation greater probability of being sued fell approximately 10%.

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

    Energy Technology Data Exchange (ETDEWEB)

    Schuller, C.R.

    1979-07-01

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

  15. Regulatory and safety aspects of ageing in nuclear power plants

    Energy Technology Data Exchange (ETDEWEB)

    Kaufer, B. [OECD/Nuclear Energy Agency, Issy-les-Moulineaux (France). Nuclear Safety Div.

    2002-08-01

    The OECD Nuclear Energy Agency (NEA) is a semi-autonomous body within the OECD established in 1958 with the mandate to promote co-operation among the governments of its participating countries in furthering the development of nuclear power as a safe, environmentally acceptable and economicy energy source. While all of groups have detailed programmes involving important aspects, this paper will focus specifically on the work of Committee on Nuclear Regulatory Activities (CNRA) and the Committee on the Safety of Nuclear Installations (CSNI). (orig.)

  16. 41 CFR 102-2.125 - What source of information can my agency use to identify materials that describe how to do...

    Science.gov (United States)

    2010-07-01

    ... Non-Regulatory Material § 102-2.125 What source of information can my agency use to identify materials... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false What source of information can my agency use to identify materials that describe how to do business with GSA? 102-2.125...

  17. 41 CFR 102-117.330 - When, or under what circumstances, would GSA delegate authority to an agency to appear on its own...

    Science.gov (United States)

    2010-07-01

    ... circumstances, would GSA delegate authority to an agency to appear on its own behalf before a transportation... circumstances, would GSA delegate authority to an agency to appear on its own behalf before a transportation regulatory body proceeding? GSA will delegate authority when it does not have the expertise, or when it is...

  18. Applying radiation health effects data to radiation protection policies

    Energy Technology Data Exchange (ETDEWEB)

    Muckerheide, James [Center for Nuclear Technology and Society at WPI, Worcester Polytechnic Institute, Worcester, MA (United States)

    2000-05-01

    Data from the peer-reviewed scientific literature establish a sound basis to define a low-dose, low-dose-rate, dose-response. These data include human health dose-response studies; immunologically 'whole' animal studies; and cellular and molecular biological studies of complete biological systems for the relevant immunological and physiological responses. Initiatives are required to constructively apply these data to both radiation research and radiation protection policies. First, current low level radiation health effects research must apply existing data to define research projects to integrate and confirm existing dose-response data, with specific emphasis on the biological bases that exist in definitive and reproducible cellular and biological dose-response. Second, dose-response assessment must identify and incorporate all existing substantial and confirmed data, including natural radiation sources, to establish the bases for radiation protection policy for interventions to protect public health and safety. A preliminary assessment of these data is applied to: 1) Specify research that can be constructively applied to describe radiation health effects dose-response. 2) Apply health effects dose-response to radiation and radioactivity applications policies to maximize radiation health effects interventions for occupational applications, medical applications, and other radiation and radioactive materials applications controls to cost-effectively assure public health and safety. An assessment of the proposed revisions to ICRP radiation protection policies is provided that associates the basis for administrative limits with the previous proposal of the US NRC for a 'Below Regulatory Concern' (BRC) policy. This proposal ignores the context of the fact that very low levels of radiation exposure are far within the variations of natural radiation exposures, and therefore can have no gross net consequences. The equivalent failure of the BRC proposal

  19. Developments of radiation safety requirements for the management of radiation devices

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Hee Seock [Pohang Accelerator Lab, Pohang (Korea, Republic of); Choi, Jin Ho [Gachun University of Medicine and science, Incheon (Korea, Republic of); Cheong, Yuon Young [Asan Medical Center, Seoul (Korea, Republic of)] (and others)

    2002-03-15

    The approach of the risk-informed regulatory options was studied to develop the radiation safety requirements for the managements for radiation devices. The task analysis, exposure, accident scenario development, risk analysis, and systematic approach for regulatory options was considered in full, based on the NRC report, 'NUREG/CR-6642', and the translation of its core part was conducted for ongoing research. In this methodology, the diamond tree that includes human factors, etc, additionally with normal event tree, was used. According to the analysis results of this approach, the risk analysis and the development of regulatory options were applied for the electron linear accelerators and the qualitative results were obtained. Because the field user groups were participated in this study could contribute to the basis establishment of the risk-informed regulation policy through securing consensus and inducing particle interests. It will make an important role of establishing the detail plan of ongoing research.

  20. Directional radiation detectors

    Energy Technology Data Exchange (ETDEWEB)

    Dowell, Jonathan L.

    2017-09-12

    Directional radiation detectors and systems, methods, and computer-readable media for using directional radiation detectors to locate a radiation source are provided herein. A directional radiation detector includes a radiation sensor. A radiation attenuator partially surrounds the radiation sensor and defines an aperture through which incident radiation is received by the radiation sensor. The aperture is positioned such that when incident radiation is received directly through the aperture and by the radiation sensor, a source of the incident radiation is located within a solid angle defined by the aperture. The radiation sensor senses at least one of alpha particles, beta particles, gamma particles, or neutrons.

  1. Enhancement of Regulatory Supervision of the nuclear legacy in northwest Russia: involving the military authorities

    Energy Technology Data Exchange (ETDEWEB)

    Roudak, S.F.; Sneve, M.K.; Bulatov, O.R.; Vasiliev, A.P.; Malinkin, V.M.

    2011-10-15

    This report describes work carried out within the cooperation programme between the Norwegian Radiation Protection Authority and the Directorate of State Supervision for Nuclear and Radiation Safety of the Ministry of Defense of the Russian Federation performed in 2008-2009. It focuses on development of improved regulatory documents and supervision procedures for handling spent nuclear fuel and radioactive waste at facilities that are no longer used by the Russian Federation Navy but that are still under military supervision and control. (Author)

  2. Regulatory processes in Aspergillus niger

    DEFF Research Database (Denmark)

    Poulsen, Lars

    some disadvantages as well, those are byproduct formation, secretion of proteolytic enzymes and formation of mycotoxins. The aim of this project was to reduce these disadvantages, though investigating the regulatory processes. The first objective was to study the regulatory events leading to A. niger......T. The physiological batch characterization showed that the ΔprtT strain had the lowest protease activity (fivefold reduced), but also featured excessive CO2 yield, reduced growth rate and lower biomass yields. The ΔprtB strain had a close to twofold reduced levels of secreted proteases but with additional beneficial...

  3. Maintenance of radiation safety information system

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-12-15

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

  4. 75 FR 19302 - Radiation Sources on Army Land

    Science.gov (United States)

    2010-04-14

    ... Department of the Army 32 CFR Part 655 RIN 0702-AA58 Radiation Sources on Army Land AGENCY: Department of the Army, DoD. ACTION: Proposed rule; request for comments. SUMMARY: The Department of the Army proposes to revise its regulations concerning radiation sources on Army land. The Army requires Non-Army...

  5. CARCINOGENIC EFFECTS OF LOW DOSES OF IONIZING RADIATION

    Science.gov (United States)

    Carcinogenic Effects of Low Doses of Ionizing RadiationR Julian Preston, Environmental Carcinogenesis Division, NHEERL, U.S. Environmental Protection Agency, Research Triangle Park, NC 27711The form of the dose-response curve for radiation-induced cancers, particu...

  6. 77 FR 55199 - Radiation Detection Technologies, Inc.

    Science.gov (United States)

    2012-09-07

    ... Technology Transfer and Intellectual Property, U.S. Department of Energy, Forrestal Building, Room 6F- ] 067..., the Assistant General Counsel for Technology Transfer and Intellectual Property, Department of Energy... Radiation Detection Technologies, Inc. AGENCY: Office of the General Counsel, Department of Energy....

  7. Loss of agency in apraxia

    Directory of Open Access Journals (Sweden)

    Mariella ePazzaglia

    2014-09-01

    Full Text Available The feeling of acting voluntarily is a fundamental component of human behavior and social life and is usually accompanied by a sense of agency. However, this ability can be impaired in a number of diseases and disorders. An important example is apraxia, a disturbance traditionally defined as a disorder of voluntary skillful movements that often results from frontal-parietal brain damage. The first part of this article focuses on direct evidence of some core symptoms of apraxia, emphasizing those with connections to agency and free will. The loss of agency in apraxia is reflected in the monitoring of internally driven action, in the perception of specifically self-intended movements and in the neural intention to act. The second part presents an outline of the evidences supporting the functional and anatomical link between apraxia and agency. The available structural and functional results converge to reveal that the frontal–parietal network contributes to the sense of agency and its impairment in disorders such as apraxia. The current knowledge on the generation of motor intentions and action monitoring could potentially be applied to develop therapeutic strategies for the clinical rehabilitation of voluntary action.

  8. Queer in STEM Organizations: Workplace Disadvantages for LGBT Employees in STEM Related Federal Agencies

    Directory of Open Access Journals (Sweden)

    Erin A. Cech

    2017-02-01

    Full Text Available Lesbian, gay, bisexual, and transgender (LGBT individuals in U.S. workplaces often face disadvantages in pay, promotion, and inclusion and emergent research suggests that these disadvantages may be particularly pernicious within science and engineering environments. However, no research has systematically examined whether LGBT employees indeed encounter disadvantages in science, technology, engineering and math (STEM organizations. Using representative data of over 30,000 workers employed in six STEM-related federal agencies (the Department of Energy, the Environmental Protection Agency, the National Science Foundation, NASA, the Nuclear Regulatory Commission, and the Department of Transportation, over 1000 of whom identify as LGBT, we compare the workplace experiences of LGBT employees in STEM-related federal agencies with those of their non-LGBT colleagues. Across numerous measures along two separate dimensions of workplace experiences—perceived treatment as employees and work satisfaction—LGBT employees in STEM agencies report systematically more negative workplace experiences than their non-LGBT colleagues. Exploring how these disadvantages vary by agency, supervisory status, age cohort, and gender, we find that LGBT persons have more positive experiences in regulatory agencies but that supervisory status does not improve LGBT persons’ experiences, nor do the youngest LGBT employees fare better than their older LGBT colleagues. LGBT-identifying men and women report similar workplace disadvantages. We discuss the implications of these findings for STEM organizations and STEM inequality more broadly.

  9. Cherenkov radiation; La radiation Cerenkov

    Energy Technology Data Exchange (ETDEWEB)

    Hubert, P. [Commissariat a l' Energie Atomique, Saclay (France). Centre d' Etudes Nucleaires

    1955-07-01

    When the radioactivity has been discovered, it was observed by researchers that different materials as mineral salts or solutions were emitting a weak light when submitted to radioactivity beams. At the beginning it has been thought that it was fluorescent light. In 1934, Cherenkov, a russian physicist, worked on the luminescence of uranyl salts solutions caused by gamma radiation and observed a very weak light was emitted by pure liquid. After further studies, he concluded that this phenomena was different from fluorescence. Since then, it has been called Cherenkov effect. This blue light emission is produced when charged particles are going through a transparent medium with an upper velocity than light velocity. This can happen only in medium with large refractive index as water or glass. It also presents its different properties discovered afterwards. The different applications of the Cherenkov radiation are discussed as counting techniques for radiation detectors or comic ray detectors. (M.P.)

  10. Radiation Technology Against Bioterrorism

    Science.gov (United States)

    2004-10-25

    application of radiation processing: radiation crosslinking of polymers and radiation sterilization of health care products have developed into substantial...municipal waste water, • radiation inactivation of bioterrorism agents, • electron beam processing of flue gases, • radiation crosslinking , • radiation...Electron beam processing of flue gases 6. Radiation crosslinking 7. Radiation curing 3 Radiation Technology Against Bioterrorism L.G. Gazsó and G

  11. 75 FR 70757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-11-18

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a... 12, 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc... Kimmel, Executive Director, Financial Information Forum, to Elizabeth M. Murphy, Secretary,...

  12. 77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2012-08-08

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal... FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority,...

  13. 77 FR 55517 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2012-09-10

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a.... Introduction On May 24, 2012, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the... General Counsel, Securities Industry and Financial Markets Association, dated June 26, 2012...

  14. 75 FR 62439 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving a...

    Science.gov (United States)

    2010-10-08

    ...-2010-043] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., 2010. I. Introduction On August 6, 2010, the Financial Industry Regulatory Authority, Inc. (``FINRA..., 2010 (``Wiesenberg Letter''); Letter from Manisha Kimmel, Executive Director, Financial...

  15. 77 FR 12340 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2012-02-29

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... Accounting Support Fee February 23, 2012. I. Introduction On December 20, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

  16. 76 FR 20757 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

    Science.gov (United States)

    2011-04-13

    ... From the Federal Register Online via the Government Publishing Office SECURITIES AND EXCHANGE COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting... February 4, 2011, the Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the...

  17. 75 FR 61793 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-10-06

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving... Encrypted September 29, 2010. I. Introduction On June 2, 2010, the Financial Industry Regulatory Authority... Taunt, Chief Executive Officer, Regal Financial Group, to Elizabeth M. Murphy, Secretary,...

  18. Subordinate regulatory mode and leader power: Interpersonal regulatory complementarity predicts task performance

    NARCIS (Netherlands)

    Hamstra, M.R.W.; Orehek, E.; Holleman, M.

    2014-01-01

    This research examines the implications of locomotion regulatory mode (orientation toward making progress on goals) and assessment regulatory mode (orientation toward critically evaluating alternatives) for employees' performance. Regulatory mode theory suggests that, although these are both integra

  19. A study on room design and radiation safety around room for Co-60 after loading HDR brachytherapy unit converted from room for Ir-192 after loading HDR brachytherapy unit

    Directory of Open Access Journals (Sweden)

    Om Prakash Gurjar

    2015-01-01

    Full Text Available Context: Use of Co-60 source in place of Ir-192 in high dose rate brachytherapy unit (HDR unit has come for discussion in recent publications. Co-60 based system has been advocated for centers which have fewer brachytherapy procedures as it has comparative economically and administrative advantage. This study has direct practical application for such institutions, which are at the cusp of moving from Ir-192 to Co-60 based brachytherapy. Aims: Conversion of Ir-192 HDR room to Co-60 HDR room and to analyze radiation safety around the room. Materials and Methods: Uniform thickness of 15 cm concrete was added to all walls (except one wall adjoining to linear accelerator bunker to convert existing room forIr-192 HDR unit to suitable room for Co-60 HDR unit. Radiation survey around room was done. Actual and calculated wall thicknesses were compared. Results: Radiation survey data indicates that modified room is suitable for Co-60 HDR unit and all values are in full conformity to annual dose limits mentioned in Safety Code for Radiation Therapy Sources (SCRTS, Atomic Energy Regulatory Body (AERB; the regulatory body in India. Also, modified wall thicknesses are appropriate for annual design dose limits mentioned in Safety Report Series No. 47 of International Atomic Energy Agency (IAEA. However, console wall thickness (0.45 m is less than the calculated thickness (0.53 m for instantaneous dose rate (IDR design dose limit (7.5 ΅Sv/h as perabove safety report of IAEA. Conclusions: The modified wall thicknesses are appropriate for annual design dose limits. However, console wall thickness is less than the required thickness for IDR design dose limit. It has been suggested to add 2.64 cm steel on console wall. It has been found that design dose limits should be considered while making room layout plan and regulatory body should add these constraints inSCRTS.

  20. Strengthening the Canadian alcohol advertising regulatory system.

    Science.gov (United States)

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

    2012-05-24

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