WorldWideScience

Sample records for regulatory agency mhra

  1. Finasteride and male breast cancer: Does the MHRA report show a link?

    Directory of Open Access Journals (Sweden)

    Niraj K Shenoy

    2010-01-01

    Full Text Available Finasteride is an important drug for the management of androgenetic alopecia. However, there are concerns about the possible side effects of the drug such as impotence. Recently stray reports have appeared about the occurrence of male breast carcinoma in patients who received the drug. These have been looked in to by Medicines and Health care products Regulatory Agency (MHRA. This article summarizes the MHRA report.

  2. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

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

  3. Effects of MHRA drug safety advice on time trends in prescribing volume and indices of clinical toxicity for quinine

    Science.gov (United States)

    Acheampong, Paul; Cooper, Gill; Khazaeli, Behshad; Lupton, David J; White, Sue; May, Margaret T; Thomas, Simon H L

    2013-01-01

    Aims To ascertain the effects of the Medicines and Healthcare products Regulatory Agency's (MHRA) safety update in June 2010 on the volume of prescribing of quinine and on indices of quinine toxicity. Methods We analysed quarterly primary care total and quinine prescribing data for England and quinine prescribing volume for individual Primary Care Trusts in the North East of England from 2007/8 to 2011/12 obtained from the ePACT.net database. We also analysed quinine toxicity enquiries to the National Poisons Information Service (NPIS) via Toxbase® and by telephone between 2004/5 and 2011/12. Joinpoint regression and Pearson's correlation tests were used to ascertain changes in trends in prescribing and indices of toxicity and associations between prescribing and indices of toxicity, respectively. Results Total prescribing continued to increase, but annual growth in quinine prescribing in England declined from 6.0 to −0.6% following the MHRA update [difference −0.04 (95% confidence interval −0.07 to −0.01) quinine prescriptions per 100 patients per quarter, P = 0.0111]. Much larger reductions were observed in Primary Care Trusts that introduced comprehensive prescribing reviews. The previously increasing trend in Toxbase® quinine searches was reversed [difference −19.76 (95% confidence interval −39.28 to −9.20) user sessions per quarter, P = 0.0575]. Telephone enquiries to NPIS for quinine have declined, with stabilization of the proportion of moderate to severe cases of quinine poisoning since the update. Conclusions The MHRA advice was followed by limited reductions in the growth in quinine prescribing and in indicators of quinine overdose and toxicity. Quinine prescribing, however, remains common, and further efforts are needed to reduce availability and use. PMID:23594200

  4. 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...

  5. Regulatory Powers in Public Procurement Law of Peruvian Administrative Agencies

    Directory of Open Access Journals (Sweden)

    Juan Carlos Morón Urbina

    2017-12-01

    Full Text Available Peruvian law has explicitly recognized regulatory powers to administrative agencies, which allows them to have a preponderant role in the production of rules in public procurement. Although these delegations of legislative authority are positively defined, distortions in the system of legal sources arise when agencies exceed delegated powers or when measures issued by administrative entities are mistaken for regulations. This paper aims to identify regulatory powers of Peruvian administrative agencies, as well as the regulatory measures they issue, and their relation with other sources of law.

  6. 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.

  7. Environmental Protection Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... of the economy, productivity, competition, jobs, the environment, public health or safety, or State... Steve Fruh, Environmental Protection Agency, Air and Radiation, 1200 Pennsylvania Ave, NW, Washington, DC 20460 Phone: 919 541-2837 Fax: 919 541-4991 Email: fruh.steve@epamail.epa.gov RIN: 2060-AP69...

  8. Safety Culture Implementation in Indonesian Nuclear Energy Regulatory Agency (BAPETEN)

    International Nuclear Information System (INIS)

    Nurwidi Astuti, Y.H.; Dewanto, P.

    2016-01-01

    The Indonesia Nuclear Energy Act no. 10 of 1997 clearly stated that Nuclear Energy Regulatory Agency (BAPETEN) is the Nuclear Regulatory Body. This is the legal basis of BAPETEN to perform regulatory functions on the use of nuclear energy in Indonesia, including regulation, authorisation, inspection and enforcement. The Independent regulatory functions are stipulated in Article 4 and Article 14 of the Nuclear Energy Act no. 10 (1997) which require the government to establish regulatory body that is reporting directly to the president and has responsibility to control of the use of nuclear energy. BAPETEN has been start fully its functioning on January 4, 1999. In it roles as a regulatory body, the main aspect that continues and always to be developed is the safety culture. One of the objectives of regulatory functions is “to increase legal awareness of nuclear energy of the user to develop safety culture” (Article 15, point d), while in the elucidation of article 15 it is stipulated that “safety culture is that of characteristics and attitudes in organizations and individual that emphasise the importance of safety”.

  9. Decisions by regulatory agencies: are they evidence-based?

    Directory of Open Access Journals (Sweden)

    Furberg Curt D

    2007-04-01

    Full Text Available Abstract Contradictory statements about the non-steroidal anti-inflammatory drugs from the European Medicines Agency and the United States Food and Drug Administration have raised questions about whether regulatory decisions are evidence-based. For the selective COX-2 inhibitors, there are clear contraindications and warnings in Europe, but only a vaguely worded Black Box warning in the United States. All the non-selective agents are given an almost "clean bill of health" in Europe, while all of them are judged to have a similar risk-benefit ratio as celecoxib in the United States. The regulatory agencies have failed to recognize the clinical trial evidence that the risk of cardiovascular events varies substantially among the non-selective agents, with diclofenac carrying the highest risk of harm.

  10. Bioremediation, regulatory agencies and public acceptance of this technology

    International Nuclear Information System (INIS)

    Westlake, D. W. S.

    1997-01-01

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

  11. Knowledge Management Implementation In Indonesia Nuclear Energy Regulatory Agency (BAPETEN)

    International Nuclear Information System (INIS)

    Nurwidi Astuti, Y.H.

    2016-01-01

    Full text: Indonesian Nuclear Energy Regulatory Agency (BAPETEN) acquires the task and function to control the safety, security and safeguards in the field of nuclear energy through the development of legislation, licensing services, inspection and enforcement. Which is supported by review and assessment, emergency preparedness. Knowledge Management (KM) is importance for BAPETEN to achieve the Regulatory body effectiveness and product innovation. The Chairman of BAPETEN has set policies statement for KM implementation. To implement a knowledge management program, BAPETEN creates KM guidelines that includes blueprint and roadmap KM programme based on a KM readiness survey. The KM readiness survey involves 20% of staff who represent each unit and discussions with the senior manager of BAPETEN, and the result of readiness survey produce 13 KM BAPETEN initiatives strategic. After the initiative strategic has been obtained, BAPETEN creates the Roadmap of BAPETEN Knowledge Management for 2015–2019 programme for KM People with the activity sozialization of KM Guidebook, workshop SMART knowledge worker, nurture Community of practices (COP) and develop social network analysis (SNE). KM Process with activity focus group discussion, KM Readyness survey, KM Statement, KM Bapeten Guidebook, knowledge mapping, knowledge harvesting. KM Technology with activity develop knowledge system or portal, e-learning. (author

  12. Survey of regulatory agency review of generating unit performance

    International Nuclear Information System (INIS)

    Roach, E.M. Jr.; Tarletz, D.B.

    1985-01-01

    Regulatory agencies across the country are being called upon increasingly to monitor the management of electric utilities. Such activity, which once was relatively rare, is now common. Most frequently this oversight centers around the operating performance of generating units, both nuclear and fossil. There are, perhaps, several reasons for this increased interest in the efficient operation of generating units: increased fuel costs and fuel cost differentials, increased lead times and costs for construction of new generating units, and increased dependence on existing units because of construction programs being revised to meet decreased load growth. The monitoring of generating units has taken the form of after the fact evaluation of performance on a case-by-case basis and the implementation of productivity incentive programs. Performance standards are used in these contexts both to measure the adequacy of unit performance and to implement incentives in the form of rewards or penalties. The standard used may be a subjective test of prudent performance or some numerical index of plant performance, e.g., equivalent availability, capacity factor or heat rate. Some of the activity by regulators is reviewed in applying subjective and numerical standards and the considerations involved in applying such standards are discussed

  13. 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.

  14. Regulatory experience of TOPS: an internet-based system to prevent healthy subjects from over-volunteering for UK clinical trials.

    Science.gov (United States)

    Allen, C; Francis, G; Martin, J; Boyce, M

    2017-12-01

    The aim was to review the use of The Over-volunteering Prevention System (TOPS) since the HRA began hosting it in 2013, and the Medicines and Healthcare products Regulatory Agency (MHRA) experience of monitoring its use by UK clinical research units. The HRA searched the TOPS database for the number, type and location of units and the number of entries. The MHRA inspectors reviewed their findings from routine inspections. Twenty-two additional UK units registered to use TOPS during 2013-2016, making a total of 84 units since TOPS was established in 2002. Use of TOPS is now a condition of research ethics committee approval of a phase 1 study and fulfils MHRA accreditation requirements for preventing over-volunteering. The total number of entries by all active units during 2013-2016 was 89,335, of which 84% were UK citizens and 16% non-UK citizens. The total number of entries during 2002-2016 was 249,612. Only 15 of 24,531 subjects (1/1600) and 18 of 18,745 subjects (1/1040) entered in 2015 and 2016, respectively, were deemed potential over-volunteers. The findings continue to support the concept that TOPS not only helps to prevent over-volunteering, but also deters subjects from trying to do so. Regulation of TOPS by the HRA and MHRA has enhanced its effectiveness, benefited all users and helped to improve the safety of volunteers who participate in non-therapeutic trials in the UK. The UK is still the only country with a national database to prevent over-volunteering that has published data on its widespread use and effectiveness.

  15. 75 FR 54917 - Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency...

    Science.gov (United States)

    2010-09-09

    ... NUCLEAR REGULATORY COMMISSION [NRC-2010-0294] Criteria for Nominating Materials Licensees for the U.S. Nuclear Regulatory Commission's Agency Action Review Meeting AGENCY: Nuclear Regulatory Commission. ACTION: Request for comment. SUMMARY: It is the policy of the U.S. Nuclear Regulatory Commission...

  16. Court-agency interaction in environmental policymaking: the cases of the Nuclear Regulatory Commission and the Environmental Protection Agency

    International Nuclear Information System (INIS)

    Thomas, L.W.

    1981-01-01

    This study examines the increasingly active participation of courts in the administrative process as well as agency responses to court-imposed policy shifts. More specifically, it is an investigation of the interaction between the federal courts, primarily the Supreme Court and the District of Columbia Court of Appeals, and two federal regulatory agencies, the Nuclar Regulatory Commission and the Environmental Protection Agency. There are five objectives to the study. The first is to examine the natura of court-agency interaction and to determine the extent to which patterns of judicial review of administrative actions can be discerned. The second is to examine the effect of court orders on agency programs and policies. The third is to assess the anticipatory dimension of court-agency relations. The fourth is to inquire into the recurring dimension of court-agency interaction and to determine its effect on subsequent court decisions. The last is to assess the institutional capacity of courts to deal with scientific and technological issues. This study indicates that judicial review has a substantial effect on the NRC's and the EPA's decision-making activities. Few, if any, recent major policy decisions of the two agencies have not been scrutinized closely by federal appellate courts. During the past decade, the courts have blocked policy initiative on numerous occasions and have been the primary source of change in others. In addition, the mere anticipation of judicial review was found to be a factor motivating the two agencies to make reasoned decisions

  17. 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.

  18. 77 FR 12896 - Self-Regulatory Organizations; Midwest Clearing Corporation; Order Cancelling Clearing Agency...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66458; File No. 600-9] Self-Regulatory Organizations; Midwest Clearing Corporation; Order Cancelling Clearing Agency Registration February 24, 2012. I... Act provides that in the event any self- regulatory organization is no longer in existence or has...

  19. 77 FR 12898 - Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66461; File No. 600-7] Self-Regulatory Organizations; Midwest Securities Trust Company; Order Cancelling Clearing Agency Registration February 24, 2012... the event any self-regulatory organization is no longer in existence or has ceased to do business in...

  20. 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...

  1. 76 FR 41585 - Regulation and Independent Regulatory Agencies

    Science.gov (United States)

    2011-07-14

    ... permitted by law, such decisions should be made only after consideration of their costs and benefits (both... concerning public participation, integration and innovation, flexible approaches, and science. To the extent... public a plan, consistent with law and reflecting its resources and regulatory priorities and processes...

  2. Independent regulatory agencies and rules harmonization for the electricity sector and renewables in the Mediterranean region

    International Nuclear Information System (INIS)

    Cambini, Carlo; Franzi, Donata

    2013-01-01

    The paper analyses the existing regulatory framework for the electricity and renewables sectors, and the role of regulatory agencies in Northern Africa and Middle East countries, under the promotion by the European Union. Using data collected through an original survey directed at regulators, ministry departments and energy companies of the southern Mediterranean, the study is aimed at assessing the extent of agencies' independence looking at three main dimensions of independence: regulatory instruments available to regulators and decision making autonomy; regulators' organizational autonomy; and regulators accountability. Results show that those countries having established an independent regulator have a more credible regulatory framework than those countries in which such a body does not exist. In particular, the analysis shows that Turkey, Croatia and Jordan have defined a regulatory framework that limits administrative expropriation and, consequently, creates an environment more suitable for attracting investments in the electricity and renewables sector. On the institutional ground, this is probably related with the harmonization of regulatory standards promoted by the European Union through the neighboring policy, for the Jordan case, and the membership perspective, in the Turkish and Croatian cases. - Highlights: • We analyze the existing regulatory framework in Northern Africa and Middle East countries. • We construct an original dataset through a survey directed to national regulators. • The extent of agencies' independence has been assessed in different dimensions. • These dimensions are decision making autonomy; organizational autonomy; and accountability. • Few countries have defined a regulatory framework limiting administrative expropriation

  3. Bureaucratic Minimal Squawk Behavior: Theory and Evidence from Regulatory Agencies

    OpenAIRE

    Clare Leaver

    2009-01-01

    This paper argues that bureaucrats are susceptible to `minimal squawk` behavior. I develop a simple model in which a desire to avoid criticism can prompt, otherwise public-spirited, bureaucrats to behave inefficiently. Decisions are taken to keep interest groups quiet and mistakes out of the public eye. The policy implications of this behavior are at odds with the received view that agencies should be structured to minimise the threat of `capture`. I test between theories of bureaucratic beha...

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

    Energy Technology Data Exchange (ETDEWEB)

    Stevenson, J D

    1976-04-01

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

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

    International Nuclear Information System (INIS)

    Stevenson, J.D.

    1976-01-01

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

  6. Guideline for regulatory agencies in evaluating contents of root cause analysis by operators

    International Nuclear Information System (INIS)

    Hata, Takaya; Makino, Maomi; Kosaka, Atsuhiko

    2008-01-01

    'Guideline for Regulatory Agencies in Evaluating Contents of Root cause Analysis by Operators' was enacted as the policy for new inspection system in Japan. The objective is to indicate the view point to verify the appropriateness of the corrective actions and preventive actions implemented by operators based on root cause analysis and its analysis results. This guideline is leading to take four points into special consideration for adequate application. They are encouragement of further activities of the operators, flexible interpretation of the intention, versatility of the analysis methods and concepts and consideration of no blame culture. Moreover, as view point for regulatory agencies, it indicates with special emphasis that neutrality of the analyzing party, objectivity of analysis result, and logicality of the analysis method are ensured. This guideline shall be continuously reviewed through integration of lessons learned from active use in future. (author)

  7. Driven by expertise and insulation?: the autonomy of European regulatory agencies

    OpenAIRE

    Ossege, Christoph

    2015-01-01

    Expertise and autonomy are cornerstones to the effective operation and legitimacy of European Regulatory Agencies (ERAs). Yet, we know little about ERAs' actual autonomy, nor about factors shaping it. This article studies ERAs' actual autonomy from public and private actors, emphasising two crucial explanatory factors: expertise and rulemaking competences. The lack of insights on expertise is particularly striking, as expertise -the "raison d'être" and main resource of expert bodies- provides...

  8. The Environmental Protection Agency in the Early Trump Administration: Prelude to Regulatory Capture.

    Science.gov (United States)

    Dillon, Lindsey; Sellers, Christopher; Underhill, Vivian; Shapiro, Nicholas; Ohayon, Jennifer Liss; Sullivan, Marianne; Brown, Phil; Harrison, Jill; Wylie, Sara

    2018-04-01

    We explore and contextualize changes at the Environmental Protection Agency (EPA) over the first 6 months of the Trump administration, arguing that its pro-business direction is enabling a form of regulatory capture. We draw on news articles, public documents, and a rapid response, multisited interview study of current and retired EPA employees to (1) document changes associated with the new administration, (2) contextualize and compare the current pro-business makeover with previous ones, and (3) publicly convey findings in a timely manner. The lengthy, combined experience of interviewees with previous Republican and Democratic administrations made them valuable analysts for assessing recent shifts at the Scott Pruitt-led EPA and the extent to which these shifts steer the EPA away from its stated mission to "protect human and environmental health." Considering the extent of its pro-business leanings in the absence of mitigating power from the legislative branch, we conclude that its regulatory capture has become likely-more so than at similar moments in the agency's 47-year history. The public and environmental health consequences of regulatory capture of the EPA will probably be severe and far-reaching.

  9. Organizational behavior of regulatory agencies: a case study of the Bureau of Consumer Services in the Pennsylvania Public Utility Commission

    Energy Technology Data Exchange (ETDEWEB)

    Silver, J.H.

    1981-01-01

    Regulatory agencies operate in a complex field of organizations and interest groups. The variety of behaviors that occur in the regulatory field are not satisfactorily explained by current interpretative frameworks. Regulatory agencies are at once criticized and praised. They flourish as organizational entities, yet they exhibit behavior that is often inexplicable. Notions like clientele capture, the politics of regulation, exchange theory, and institutionalized organizations do not singly explain the vagaries of regulatory behavior. A merger of these viewpoints, however, provides a foundation for a comprehensive interpretative framework. A bureau of consumer services within a state public utility commission is viewed as an institutionalized organization. From this perspective, a variety of ritual behaviors, based upon symbolic and tangible interorganizational exchanges are observed and characterized. The outcome of these exchanges is the establishment of the Bureau of Consumer Services as a legitimate regulatory agent with significant impact upon the formulation of regulatory policy in the formal proceedings of the Pennsylvania Public Utility Commission.

  10. Driven by Expertise and Insulation? The Autonomy of European Regulatory Agencies

    Directory of Open Access Journals (Sweden)

    Christoph Ossege

    2015-03-01

    Full Text Available Expertise and autonomy are cornerstones to the effective operation and legitimacy of European Regulatory Agencies (ERAs. Yet, we know little about ERAs’ actual autonomy, nor about factors shaping it. This article studies ERAs’ actual autonomy from public and private actors, emphasising two crucial explanatory factors: expertise and rulemaking competences. The lack of insights on expertise is particularly striking, as expertise—the “raison d’être” and main resource of expert bodies—provides ERAs with a potentially powerful means to increase autonomy. Relying on a rational institutionalist framework within which ERAs enjoy substantive discretion to pursue their goals, the study empirically compares three powerful ERAs—the European Medicines Agency, the European Chemicals Agency, and the European Food Safety Authority. Based on the analysis of 39 semi-structured expert interviews, findings show that expertise is a crucial explanation for ERAs’ substantive autonomy from the Commission. Towards research intensive private stakeholders, the role of expertise becomes less pronounced. Instead, ERAs are more successful in protecting their autonomy by engaging in the risk-averse interpretation of the regulatory framework and by adapting rules over time to adapt their needs: they engage in “procedural insulation”. Political salience provides a scope condition for ERAs to use expert knowledge and rulemaking competences more strategically—potentially undermining scientific quality.

  11. Hazardous waste management system--Environmental Protection Agency. Notice of regulatory reform actions; request for comments.

    Science.gov (United States)

    1982-12-13

    In response to Executive Order 12291 and the President's Task Force on Regulatory Relief, the Environmental Protection Agency is reviewing and reassessing the hazardous waste regulations developed under the Resource Conservation and Recovery Act (RCRA). A variety of activities are underway that will simplify procedures and reduce paperwork, modify existing regulations to make them more workable and cost effective, and control new wastes and new processes. The purpose of this notice is to inform the public of these activities and invite comments on the general approaches being taken.

  12. 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. PMID:28949463

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

    International Nuclear Information System (INIS)

    Lechner, L.J.; Mathieson, B.

    1998-01-01

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

  14. Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers.

    Science.gov (United States)

    Eichler, Hans-Georg; Bloechl-Daum, Brigitte; Abadie, Eric; Barnett, David; König, Franz; Pearson, Steven

    2010-04-01

    Drug regulatory agencies have traditionally assessed the quality, safety and efficacy of drugs, and the current paradigm dictates that a new drug should be licensed when the benefits outweigh the risks. By contrast, third-party payers base their reimbursement decisions predominantly on the health benefits of the drug relative to existing treatment options (termed relative efficacy; RE). Over the past decade, the role of payers has become more prominent, and time-to-market no longer means time-to-licensing but time-to-reimbursement. Companies now have to satisfy the sometimes divergent needs of both regulators and payers, and to address RE during the pre-marketing stages. This article describes the current political background to the RE debate and presents the scientific and methodological challenges as they relate to RE assessment. In addition, we explain the impact of RE on drug development, and speculate on future developments and actions that are likely to be required from key players.

  15. Toward a functional definition of a "rare disease" for regulatory authorities and funding agencies.

    Science.gov (United States)

    Clarke, Joe T R; Coyle, Doug; Evans, Gerald; Martin, Janet; Winquist, Eric

    2014-12-01

    The designation of a disease as "rare" is associated with some substantial benefits for companies involved in new drug development, including expedited review by regulatory authorities and relaxed criteria for reimbursement. How "rare disease" is defined therefore has major financial implications, both for pharmaceutical companies and for insurers or public drug reimbursement programs. All existing definitions are based, somewhat arbitrarily, on disease incidence or prevalence. What is proposed here is a functional definition of rare based on an assessment of the feasibility of measuring the efficacy of a new treatment in conventional randomized controlled trials, to inform regulatory authorities and funding agencies charged with assessing new therapies being considered for public funding. It involves a five-step process, involving significant negotiations between patient advocacy groups, pharmaceutical companies, physicians, and public drug reimbursement programs, designed to establish the feasibility of carrying out a randomized controlled trial with sufficient statistical power to show a clinically significant treatment effect. The steps are as follows: 1) identification of a specific disease, including appropriate genetic definition; 2) identification of clinically relevant outcomes to evaluate efficacy; 3) establishment of the inherent variability of measurements of clinically relevant outcomes; 4) calculation of the sample size required to assess the efficacy of a new treatment with acceptable statistical power; and 5) estimation of the difficulty of recruiting an adequate sample size given the estimated prevalence or incidence of the disorder in the population and the inclusion criteria to be used. Copyright © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  16. Governance and oversight of researcher access to electronic health data: the role of the Independent Scientific Advisory Committee for MHRA database research, 2006-2015.

    Science.gov (United States)

    Waller, P; Cassell, J A; Saunders, M H; Stevens, R

    2017-03-01

    In order to promote understanding of UK governance and assurance relating to electronic health records research, we present and discuss the role of the Independent Scientific Advisory Committee (ISAC) for MHRA database research in evaluating protocols proposing the use of the Clinical Practice Research Datalink. We describe the development of the Committee's activities between 2006 and 2015, alongside growth in data linkage and wider national electronic health records programmes, including the application and assessment processes, and our approach to undertaking this work. Our model can provide independence, challenge and support to data providers such as the Clinical Practice Research Datalink database which has been used for well over 1,000 medical research projects. ISAC's role in scientific oversight ensures feasible and scientifically acceptable plans are in place, while having both lay and professional membership addresses governance issues in order to protect the integrity of the database and ensure that public confidence is maintained.

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

    NARCIS (Netherlands)

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

    2014-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Aiwanehi Barbara Ofuani

    2015-09-01

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

  19. 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.

  20. 77 FR 12896 - Self-Regulatory Organizations; Pacific Clearing Corporation; Order Cancelling Clearing Agency...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66459; File No. 600-11] Self-Regulatory..., 2006), 72 FR 814 (Jan. 8, 2007). Section 19(a)(3) of the Act \\14\\ provides that in the event any self-regulatory organization is no longer in existence or has ceased to do business in the capacity specified in...

  1. As agências reguladoras e o modelo constitucional brasileiro / Regulatory Agencies and the Constitutional Brazilian System

    Directory of Open Access Journals (Sweden)

    Ana Carolina Borges de Oliveira

    2018-05-01

    Full Text Available Purpose – This article tackles the role of the regulatory agencies and, therefore, verifies the separation of powers model adopted by the Brazilian Constitution, focused on how the constitutional Brazilian system adopted the liberal principle of the separation of powers. Methodology/approach/design – This research analyzes Montesquieu’s theory of separation of powers and its influence on the constitutional Brazilian system. It studies the model proposed by Jürgen Habermas, who proposes a discursive theory of law. Finally, it examines the regulatory phenomenon in Brazil, as well as the structure and the roles played by regulatory agencies in acts. Findings – It is concluded that the role of regulatory agencies in the constitutional Brazilian system can be framed as the new actor in the policy formation process that culminates in decisions about laws and policies. Resumo Propósito – O presente estudo pretende investigar o papel normativo das agências reguladoras e, por conseguinte, verificar se o modelo de separação de poderes adotado pela atual Constituição Federal estaria superado, ou seja, busca-se analisar se há uma incompatibilidade entre o modelo constitucional brasileiro e a atividade normativa desenvolvida pelas agências reguladoras no Brasil. Metodologia/abordagem/design – A presente pesquisa terá como pressupostos teóricos a teoria da separação de poderes desenvolvida por Montesquieu e sua influência nas ordens política e jurídica brasileiras. Adotará, também, como base teórica, o modelo proposto por Jürgen Habermas. Por fim, analisará o fenômeno regulatório no Brasil, bem como a estrutura e os papéis desempenhados pelas agências reguladoras no atual sistema; a fim de verificar se é possível defender que a teoria da separação dos poderes proposta pela Constituição Federal de 1988 está superada Resultados – Conclui-se que o papel desempenhado pelas agências reguladoras no contexto jur

  2. 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)

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

    DEFF Research Database (Denmark)

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

    2018-01-01

    for the best interest of the people, they can have their own rational agendas; such as career advancement, self-aggrandizement and loyalty for a particular political ideology. We show that when officials are non-benevolent and agencies have unequal relative decision-making power, it is likely that a more...

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

    International Nuclear Information System (INIS)

    Frickel, Scott; Campanella, Richard; Vincent, M. Bess

    2009-01-01

    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

  5. 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.

  6. Health Physics Society Comments to U.S. Environmental Protection Agency Regulatory Reform Task Force.

    Science.gov (United States)

    Ring, Joseph; Tupin, Edward; Elder, Deirdre; Hiatt, Jerry; Sheetz, Michael; Kirner, Nancy; Little, Craig

    2018-05-01

    The Health Physics Society (HPS) provided comment to the U.S. Environmental Protection Agency (EPA) on options to consider when developing an action plan for President Trump's Executive Order to evaluate regulations for repeal, replacement, or modification. The HPS recommended that the EPA reconsider their adherence to the linear no-threshold (LNT) model for radiation risk calculations and improve several documents by better addressing uncertainties in low-dose, low dose-rate (LDDR) radiation exposure environments. The authors point out that use of the LNT model near background levels cannot provide reliable risk projections, use of the LNT model and collective-dose calculations in some EPA documents is inconsistent with the recommendations of international organizations, and some EPA documents have not been exposed to the public comment rule-making process. To assist in establishing a better scientific basis for the risks of low dose rate and low dose radiation exposure, the EPA should continue to support the "Million Worker Study," led by the National Council on Radiation Protection and Measurement.

  7. 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.

  8. Consumer agency in cannabis supply - Exploring auto-regulatory documents of the cannabis social clubs in Spain.

    Science.gov (United States)

    Belackova, Vendula; Wilkins, Chris

    2018-04-01

    There is growing experience with the not-for-profit, consumer-driven cannabis social club (CSC) model that builds on self-supply, self-organization and harm-reduction; these are principles upon which people who use drugs (PWUD) have been engaging for decades. Recent legalization of cannabis in a number of jurisdictions and the related challenges in regulating production, sale, taxation and health-related matters have raised interest in non-commercial models of cannabis supply. The "codes of conduct" (CsoC) of CSC federations in Spain might reveal whether a consumer-based model could overcome these challenges. To examine the content of the CSC auto-regulatory documents, an online search using key terms to identify the CsoC was conducted. Six documents were found; analysis of the main thematic categories and overarching themes was conducted. It was discussed how these corresponded to the areas of cannabis policy regulation and what the main limitations of the CSC model were. The CsoC detailed the rules for CSC administration, not-for-profit aims, "invitation only" and other conditions of membership, collective cultivation and security as well as for operation of the consumption venue and health-related initiatives. The themes in the CsoC overlapped with cannabis regulatory areas as outlined internationally. Concern over cannabis prices and potency was missing in the CsoC. The potential strengths of the CSC model might include safe environment for peer-delivered harm reduction practice, preventing illicit transactions, quality control, shifting economic surplus to the consumers and increased consumer responsibility. The limitations of the CSC model include high threshold, disguised motives, tax revenue and the risk of both under- and over-regulation. CSCs represent an opportunity to enhance consumer agency and responsibility. The right "to be self-supplied" with psychoactive substances can be granted to consumer associations - but authorities need to provide a

  9. 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

  10. The role of radiation regulatory agencies of the Republic of the Philippines in the education and training of workers occupationally exposed to radiation

    International Nuclear Information System (INIS)

    Perio Peralta, Agnette de

    2008-01-01

    In the Republic of the Philippines, there are two national radiation regulatory agencies. One is the Philippine Nuclear Research Institute (PNRI) which has the regulatory mandate over radioactive materials. The other one is the Bureau of Health Devices and Technology (BHDT) which has the regulatory mandate over radiation devices. Since a major requirement in regulating use of radiation sources is the appropriate qualification of the workers occupationally exposed to radiation, the paper discusses the strategies and activities of these two agencies to ensure that these workers have the necessary education and training to do their work properly. Some of these are the conduct of training courses in cooperation with the relevant professional societies, conduct of distance aided training in cooperation with the IAEA, initiation and active involvement in the establishment and continued existence of the masteral degree program in medical physics which was established with IAEA technical assistance, assistance to lawmakers in drafting pertinent legislation, and creation of joint technical working groups to ensure harmonization of standards and regulations, among others. The Philippines has adopted a national policy that users of radiation and radioactive materials have the primary responsibility for radiation safety. The PNRI and the BHDT have adopted strategies which have been very useful in the effective implementation of their regulations. (author)

  11. 2014 White Paper on recent issues in bioanalysis: a full immersion in bioanalysis (Part 2 - hybrid LBA/LCMS, ELN & regulatory agencies' input).

    Science.gov (United States)

    Dufield, Dawn; Neubert, Hendrik; Garofolo, Fabio; Kirkovsky, Leo; Stevenson, Lauren; Dumont, Isabelle; Kaur, Surinder; Xu, Keyang; Alley, Stephen C; Szapacs, Matthew; Arnold, Mark; Bansal, Surendra; Haidar, Sam; Welink, Jan; Le Blaye, Olivier; Wakelin-Smith, Jason; Whale, Emma; Ishii-Watabe, Akiko; Bustard, Mark; Katori, Noriko; Amaravadi, Lakshmi; Aubry, Anne-Françoise; Beaver, Chris; Bergeron, Annik; Cai, Xiao-Yan; Cojocaru, Laura; DeSilva, Binodh; Duggan, Jeff; Fluhler, Eric; Gorovits, Boris; Gupta, Swati; Hayes, Roger; Ho, Stacy; Ingelse, Benno; King, Lindsay; Lévesque, Ann; Lowes, Steve; Ma, Mark; Musuku, Adrien; Myler, Heather; Olah, Timothy; Patel, Shefali; Rose, Mark; Schultz, Gary; Smeraglia, John; Swanson, Steven; Torri, Albert; Vazvaei, Faye; Wilson, Amanda; Woolf, Eric; Xue, Li; Yang, Tong-Yuan

    2014-01-01

    The 2014 8th Workshop on Recent Issues in Bioanalysis (8th WRIB), a 5-day full immersion in the evolving field of bioanalysis, took place in Universal City, California, USA. Close to 500 professionals from pharmaceutical and biopharmaceutical companies, contract research organizations and regulatory agencies worldwide convened to share, review, discuss and agree on approaches to address current issues of interest in bioanalysis. The topics covered included both small and large molecules, and involved LCMS, hybrid LBA/LCMS, LBA approaches and immunogenicity. From the prolific discussions held during the workshop, specific recommendations are presented in this 2014 White Paper. As with the previous years' editions, this paper acts as a practical tool to help the bioanalytical community continue advances in scientific excellence, improved quality and better regulatory compliance. Due to its length, the 2014 edition of this comprehensive White Paper has been divided into three parts for editorial reasons. This publication (Part 2) covers the recommendations for Hybrid LBA/LCMS, Electronic Laboratory Notebook and Regulatory Agencies' Input. Part 1 (Small molecules bioanalysis using LCMS) was published in the Bioanalysis issue 6(22) and Part 3 (Large molecules bioanalysis using LBA and Immunogenicity) will be published in the Bioanalysis issue 6(24).

  12. Cross-border temporary agency work : Social sustainability of a business model (too often) based on regulatory arbitrage

    NARCIS (Netherlands)

    Houwerzijl, Mijke; Rombouts, Bas

    Presentation held at the European Regional Congress of the International Society for Labour and Social Security Law (ISLSSL) on Temporary Agency Work in the context of cross-border movement & service provision within the EU.

  13. Delegação e controle político das agências reguladoras no Brasil Delegation and political control of the regulatory agencies in Brazil

    Directory of Open Access Journals (Sweden)

    Fernanda Meirelles

    2006-08-01

    Full Text Available A partir de um esforço de sistematização dos mecanismos de controle político previstos no modelo institucional originalmente concebido para as agências reguladoras, este artigo avalia os mecanismos de controle político presentes no arcabouço institucional das agências reguladoras independentes (ARIs brasileiras e analisa as alterações relacionadas ao controle político introduzidas pelo projeto de lei encaminhado pelo governo ao Congresso em 12 de abril de 2004. Após contextualizar o debate sobre o controle político das ARIs no Brasil, o artigo discute as relações entre delegação e responsabilização. Em seguida, na busca de um parâmetro para avaliar o modelo brasileiro de agências reguladoras (ARs, identifica os instrumentos de controle político utilizados na experiência americana. Finalmente, avalia a realidade institucional atual das ARIs brasileiras e comenta as contribuições do recente projeto de lei em relação ao controle político das agências.This article systematizes the political control mechanisms provided by the institutional model originally conceived for the regulatory agencies in order to assess the political control mechanisms in the institutional framework of the Brazilian independent regulatory agencies (IRAs and analyze the political control changes introduced by the law proposed by the government to Congress in April 12, 2004. After putting into context the debate on political control over the Brazilian IRAs, the article discusses the relationship between delegation and accountability. Then, so as to find a parameter for assessing the Brazilian regulatory agency model, it identifies the political control mechanisms used by the American experience. Finally, it assesses the current institutional situation of the Brazilian IRAs and comments on the contribution of the recent law proposal in relation to agency political control.

  14. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].

    Science.gov (United States)

    Enzmann, Harald; Broich, Karl

    2013-01-01

    For innovative oncological medicines the centralised procedure at the European Medicines Agency is mandatory for a marketing authorisation application for the European Union. As with other medical drugs, the marketing authorisation decision is based on the assessment of its efficacy, safety and pharmaceutical quality but does not consider price or reimbursement. More sophisticated diagnostic methods drive an increasing stratification of cancer into a multitude of different diseases. Regardless of their different pathogenesis and therapeutic options the most relevant clinical endpoints remain cure, overall survival and progression free survival. These endpoints include both efficacy and safety, as patient survival reflects the sum of the beneficial anti-tumour effects (increasing survival) AND the adverse effects (decreasing survival). The benefit of an anticancer medicine should be evident from both overall survival and progression free survival (e.g. used as primary and secondary endpoints). Mature data on overall survival may not be needed for marketing authorisation if a clear increase in progression free survival convincingly predicts a beneficial effect on overall survival. In these exceptional cases treatment of patients with an obviously beneficial medicine must not be delayed - possibly for years - until the exact size of the benefit has been established. The continued stratification of the disease cancer results in a lower prevalence for each of the newly distinguished disease entities and an ever increasing number of orphan designations for medicines for rare diseases. Incentives for the development of orphan medicines include market exclusivity for up to ten years. In specific circumstances, however, the orphan legislation may restrict the authorisation and marketing of competing generic products even beyond these ten years. Conditional approval and approval under exceptional circumstances may accelerate patients' access to a new medicine. Both postulate

  15. 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

  16. 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

  17. Promoting Implementation of Safety Culture in Nuclear Application for Industrial Facilities; an Important Role of Nuclear Energy Regulatory Agency in Indonesia

    Energy Technology Data Exchange (ETDEWEB)

    Setianingsih, Lilis Susanti [KINS-KAIST Master Degree Program, Daejeon (Korea, Republic of)

    2012-03-15

    Implementation of nuclear energy for industrial purposes has reached its highest peak. BAPETEN, as Nuclear Energy Regulatory Agency of Indonesia has published regulations regarding nuclear energy utilization. As high risk associating such utilization requires direct and thoroughly supervision in order to assure its compliance to safety and security aspect, procedures related to operational activities must by fully applied. Radiation Protection Program as one type of procedures that must be available in nuclear energy utilization operation is intended to provide operators specifically technical guidance to avoid undesired negative effects of incidents or accidents. It is the responsibility of managerial level in a company to provide the procedures and to further supervise their application in the field. Radiation workers, those are all employees working in or within radiation area must understand how to execute the procedures properly. The radiation protection program is intended to protect workers, member of community and property as well as the environment from the negative impacts of nuclear utilization operational due to its radiation exposure. Safety culture, a compound of nature derived from behavior of organization and people within the organization to pay a full attention and give main priority in radiation safety matters, is expected to be achieved by implementing the radiation protection program as safety habits at the work place. It requires a management commitment to ensure that all aspect in safety and, whenever necessary, security are accomplished within the radiation protection program in order to build a safety culture in a radiation work place. Government Regulation No. 33 2007 about Safety for Ionizing Radiation and Security for Radioactive Source and Government Regulation No. 29 2008 regarding Licensing for Utilization of Ionizing Radiation and Nuclear Material present regulation and arrangement related to radiation protection program as a basic

  18. 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

    International Nuclear Information System (INIS)

    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

  19. Promoting Implementation of Safety Culture in Nuclear Application for Industrial Facilities; an Important Role of Nuclear Energy Regulatory Agency in Indonesia

    International Nuclear Information System (INIS)

    Setianingsih, Lilis Susanti

    2012-01-01

    Implementation of nuclear energy for industrial purposes has reached its highest peak. BAPETEN, as Nuclear Energy Regulatory Agency of Indonesia has published regulations regarding nuclear energy utilization. As high risk associating such utilization requires direct and thoroughly supervision in order to assure its compliance to safety and security aspect, procedures related to operational activities must by fully applied. Radiation Protection Program as one type of procedures that must be available in nuclear energy utilization operation is intended to provide operators specifically technical guidance to avoid undesired negative effects of incidents or accidents. It is the responsibility of managerial level in a company to provide the procedures and to further supervise their application in the field. Radiation workers, those are all employees working in or within radiation area must understand how to execute the procedures properly. The radiation protection program is intended to protect workers, member of community and property as well as the environment from the negative impacts of nuclear utilization operational due to its radiation exposure. Safety culture, a compound of nature derived from behavior of organization and people within the organization to pay a full attention and give main priority in radiation safety matters, is expected to be achieved by implementing the radiation protection program as safety habits at the work place. It requires a management commitment to ensure that all aspect in safety and, whenever necessary, security are accomplished within the radiation protection program in order to build a safety culture in a radiation work place. Government Regulation No. 33 2007 about Safety for Ionizing Radiation and Security for Radioactive Source and Government Regulation No. 29 2008 regarding Licensing for Utilization of Ionizing Radiation and Nuclear Material present regulation and arrangement related to radiation protection program as a basic

  20. Review of hazardous chemical regulation at nuclear facilities by the Nuclear Regulatory Commission and other federal agencies. Hearing before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-Ninth Congress, Second Session, March 14, 1986

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    Seven witnesses from agencies and the nuclear industry testified on the status of chemical regulation at nuclear facilities, the potential for accidents, and the quality of emergency plans in the event of a release of chemical substances. Impetus for the review came from incidents at Kerr-McGhee's Sequoyah plant in Oklahoma and the release of uranium hexafluoride, as well as a pattern of accidents which occur after the potential hazard has already been identified. The witnesses included Richard Krimm of the Federal Emergency Management Agency, James Makris of the Environmental Protection Agency, John Miles of the Occupational Safety and Health Administration, Nunxio Palladino of the Nuclear Regulatory Commission, and representatives of DOE and Kerr-McGee. Additional materials submitted for the record follows the testimony

  1. 75 FR 7526 - Withdrawal of Regulatory Guide

    Science.gov (United States)

    2010-02-19

    ...'s Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are... NUCLEAR REGULATORY COMMISSION [NRC-2010-0052] Withdrawal of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 1.56, ``Maintenance of Water Purity in Boiling...

  2. Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2010-04-26

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

  3. Communication Received from the Permanent Mission of Pakistan to the International Atomic Energy Agency Concerning the Promulgation of the Pakistan Nuclear Regulatory Authority Ordinance 2001

    International Nuclear Information System (INIS)

    2001-01-01

    The Director General has received a communication dated 30 January 2001 from the Permanent Mission of Pakistan forwarding a press release concerning the promulgation of the Pakistan Nuclear Regulatory Authority Ordinance 2001. As requested in that communication, the press release is attached hereto for the information of Member States

  4. O lugar da política na atuação das agências reguladoras independentes brasileiras: reflexões sobre a separação dos poderes no Estado moderno / The Role of Politics in the Brazilian Independent Regulatory Agencies: Reflections on the Separation of Powers in the Modern State

    Directory of Open Access Journals (Sweden)

    Milton Carvalho Gomes

    2017-04-01

    Full Text Available Purpose – The purpose of the proposed article is to investigate the practice of politics in the performance of activities of Brazilian independent regulatory agencies Methodology/approach/design – ... The approach is based on the study of theories about separation of state powers and functions, evaluating the application of these theories in the understanding of the role played by independent regulatory agencies in Brazil Findings – It was concluded that the independence granted by the National Congress to the Brazilian regulatory agencies implied in the expansion of the space of politics in its operation, placing these agencies in a unique position in the context of the separation of powers, changing the traditional institutional arrangement of submission to the executive branch. Practical implications (if applicable –The conclusions permit new reflections on the limits of the influence of the President of the Republic and of the sectoral ministries in the decisions taken by the regulatory agencies, both in the decisions of a technical nature and those of a political nature, allowing the expansion of the debate on the instruments of democratic legitimation of these decisions. Originality/value (optional – The text is original, since there are few in-depth studies in Brazil about the space for politics in the field of independent regulatory agencies, usually understood as purely technical / administrative entities.

  5. As agências reguladoras independentes e o Tribunal de Contas da União: conflito de jurisdições? The independent regulatory agencies and the Federal Court of Accounts: a jurisdictional conflict?

    Directory of Open Access Journals (Sweden)

    Eduardo Granha Magalhães Gomes

    2006-08-01

    Full Text Available Este artigo analisa a emergência, no Brasil, de agências reguladoras independentes (ARIs e suas especificidades quanto ao desenho institucional; analisa ainda a evolução recente da atuação do Tribunal de Contas da União (TCU no contexto da nova gestão pública. No desenho das ARIs têm destaque os mecanismos que lhes conferem independência política, dada a natureza de suas atribuições e competências. Por outro lado, o TCU vem ampliando seu campo de atuação, passando a avaliar não mais apenas os aspectos formais da legalidade de procedimentos, mas também o desempenho e resultados alcançados por órgãos e entidades públicas. O TCU passa a atuar no acompanhamento e avaliação do desempenho das agências. O artigo analisa a interface entre independência e controle, discutindo possíveis conflitos institucionais entre as agências reguladoras e o TCU.This article analyzes the emergence of the independent regulatory agencies (IRAs in Brazil and their specificities as to their institutional design. It also discusses the recent developments in the Federal Court of Accounts' actions within the new public management context. IRAs were designed with emphasis on the features that give them political independence, considering the nature of their attributions and capabilities. On the other hand, the Federal Court of Accounts (FCA has broadened its area of activities, assessing not only the formal aspects of the legality of procedures, but also the performance and the results of organisms and public institutions. The FCA is tracking and assessing the agencies' performance. The article analyzes the interface between independence and control, discussing possible institutional conflicts between regulatory agencies and the FCA.

  6. 75 FR 79049 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-12-17

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2008-0427] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3.12...

  7. 75 FR 45173 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-08-02

    ... ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are... NUCLEAR REGULATORY COMMISSION [NRC-2008-0638] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.151...

  8. 76 FR 18262 - Notice of issuance of Regulatory Guide

    Science.gov (United States)

    2011-04-01

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2009-0277] Notice of issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.44...

  9. 76 FR 14107 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-03-15

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2009-0276] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.43...

  10. 76 FR 14108 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-03-15

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . The regulatory... NUCLEAR REGULATORY COMMISSION [NRC-2009-0275] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.50...

  11. 77 FR 8082 - Regulatory Flexibility Agenda

    Science.gov (United States)

    2012-02-13

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

  12. 75 FR 22868 - Withdrawal of Regulatory Guide

    Science.gov (United States)

    2010-04-30

    ...'s public Web site under ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are also available for inspection at the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2010-0167] Withdrawal of Regulatory Guide AGENCY: Nuclear...

  13. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    Wieland, Patricia; Almeida, Ivan Pedro Salati de

    2011-01-01

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

  14. Federal Energy Regulatory Commission (FERC) Regions

    Data.gov (United States)

    Department of Homeland Security — Federal Energy Regulatory Commission (FERC) Regions. FERC is an independent agency that regulates the interstate transmission of electricity, natural gas, and oil....

  15. Regulatory issues for Waste Isolation Pilot Plant long-term compliance with U.S. Environmental Protection Agency 40 CFR 191B and 268

    International Nuclear Information System (INIS)

    Anderson, D.R.; Marietta, M.G.; Higgins, P.J. Jr.

    1993-10-01

    Before disposing of transuranic radioactive waste at the Waste Isolation Pilot Plant (WIPP), the United States Department of Energy (DOE) must evaluate compliance with long-term regulations of the United States Environmental Protection Agency (EPA), specifically the Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes (40 CFR 191), and the Land Disposal Restrictions (40 CFR 268) of the Hazardous and Solid Waste Amendments to the Resource Conservation and Recovery Act (RCRA). Sandia National Laboratories (SNL) is conducting iterative performance assessments (PAs) of the WIPP for the DOE to provide interim guidance while preparing for final compliance evaluations. This paper provides background information on the regulations, describes the SNL WIPP PA Departments approach to developing a defensible technical basis for consistent compliance evaluations, and summarizes the major observations and conclusions drawn from the 1991 and 1992 PAs

  16. Importance of the awareness, training exchange of information and co-operation between regulatory authorities and customs, police and other law enforcement agencies

    International Nuclear Information System (INIS)

    Shakshooki, S.K.; Al-Ahaimer, R.O.

    1998-01-01

    Fast developments in science and technology are a great accomplishment in this century. These facilities have been utilized by criminals and deviants by identified way. Industrial developed countries have their own means to improve and to modify technology and scientific facilities to cope up with any new existing problems, such as the problem of illegal trading of nuclear materials. Facilities for exchange of information among industrial countries also play an important role to prevent any dangerous phenomena may exist. In contrast most developing countries lack the means of up-to-date follow up quick and continuous scientific and technological developments. However they have qualified personnel to follow up quickly and to prevent drug and narcotics smuggling. Recently we have heard about a dangerous phenomena, the illegal trading of nuclear materials, which derive attention internationally. The developed countries can cope easily with it. However, in developing countries, their lack of up to date facilities can cause a grate damage to their nations. Libyan Arab Jamahiriya is always willing to co-operate internationally to prevent any new dangerous phenomena. We think it is a time for conformation on international official agreement regarding this phenomena. Exchange of information between different countries through an international agency is important for prohibiting the illegal nuclear materials trading. Also to help in creation of a temporally scientific committee to provide different countries of the world the available information in this area and to co-operate specially with police, custom and law enforcement agencies of each nation providing an international legislation for dealing with such phenomena is a priority. Assistance for the arrangement of training through IAEA is of great importance. (author)

  17. 75 FR 21871 - Spring 2010 Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... Review 10/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Tad Wysor, Environmental...: wysor.tad@epamail.epa.gov Tom Eagles, Environmental Protection Agency, Air and Radiation, 6103A...

  18. H.R. 5448: a bill to amend the Atomic Energy Act of 1954, as amended, to reorganize the functions of the Nuclear Regulatory Commission by abolishing the Commission and in its place establishing the Nuclear Regulation and Safety Agency. Introduced in the House of Representatives, Ninety-Ninth Congress, Second Session, August 15, 1986

    International Nuclear Information System (INIS)

    Anon.

    1986-01-01

    The Omnibus Nuclear Safety Act of 1986 amends the Atomic Energy Act of 1954 by replacing the Nuclear Regulatory Commission with a new entity, the Nuclear Regulation and Safety Agency. The purposes are to promote an energy policy that is better coordinated and more consistent with the protection of public health and safety. The new agency would also expedite licensing for construction and operation of nuclear power plants by using pre-approved standardized designs and sites

  19. 78 FR 1634 - Regulatory Agenda

    Science.gov (United States)

    2013-01-08

    ... amendments include updates to organizational information, use of the term ``disability'' in lieu of the term.../00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W. Cosgrove, External...

  20. 78 FR 44329 - Regulatory Agenda

    Science.gov (United States)

    2013-07-23

    ... amendments include updates to organizational information, use of the term ``disability'' in lieu of the term.../00/13 Regulatory Flexibility Analysis Required: No. Agency Contact: Robert W. Cosgrove, External...

  1. 75 FR 52999 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-08-30

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition... NUCLEAR REGULATORY COMMISSION [NRC-2009-0556] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.35...

  2. 75 FR 12804 - Withdrawal of Regulatory Guide 8.6

    Science.gov (United States)

    2010-03-17

    ... ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0103] Withdrawal of Regulatory Guide 8.6 AGENCY: Nuclear Regulatory Commission. ACTION: Withdrawal of Regulatory Guide 8.6, ``Standard Test Procedure for Geiger-M...

  3. 75 FR 16202 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-03-31

    ... Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available... NUCLEAR REGULATORY COMMISSION [NRC-2008-0644] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide (RG) 1.126...

  4. 75 FR 45171 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-08-02

    ... ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ and through the NRC's Agencywide... NUCLEAR REGULATORY COMMISSION [NRC-2010-0072] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 3.13...

  5. 75 FR 20868 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-04-21

    ... available through the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc... NUCLEAR REGULATORY COMMISSION [NRC-2009-0351] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.68.2...

  6. 75 FR 42170 - Final Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-07-20

    ... NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2009-0425] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

  7. 75 FR 81675 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-12-28

    ... through the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc... NUCLEAR REGULATORY COMMISSION [NRC-2010-0031] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 4.16...

  8. 75 FR 48381 - Final Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-08-10

    ... NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0274] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Regulatory Guide...

  9. 75 FR 37842 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-06-30

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition... NUCLEAR REGULATORY COMMISSION [NRC-2009-0396] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 2.5...

  10. 75 FR 43207 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-07-23

    ... NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2009-0282] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.141...

  11. 75 FR 33361 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-06-11

    ....gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for inspection at the... NUCLEAR REGULATORY COMMISSION [NRC-2009-0308] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.28...

  12. 75 FR 20399 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-04-19

    ... the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2009-0418] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 6.9...

  13. 76 FR 31382 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-05-31

    ... the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0287] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 8.2...

  14. 76 FR 24539 - Final Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2011-05-02

    ... site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections/ . Electronic copies... NUCLEAR REGULATORY COMMISSION [NRC-2010-0181] Final Regulatory Guide: Issuance, Availability AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide...

  15. 75 FR 16525 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-04-01

    ... http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2009-0413] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of Issuance and Availability of Regulatory Guide 1.11...

  16. 75 FR 27599 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-05-17

    ...'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2009-0492] Notice of Issuance of Regulatory Guide AGENCY: Nuclear Regulatory Commission. ACTION: Notice of issuance and availability of Regulatory Guide 6.7...

  17. 78 FR 9703 - Food and Drug Administration/Xavier University PharmaLink Conference-Quality in a Global Supply...

    Science.gov (United States)

    2013-02-11

    ... Regulatory Agency (MHRA), Fimea, and Swissmedic), and many more. The experience level of our audience has... registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and... Engaging the Audience Keynote Dinner at the Cincinnati Art Museum with Chairman, CEO, and President of Eli...

  18. Hyperthyroidism (primary)

    DEFF Research Database (Denmark)

    Nygaard, Birte

    2010-01-01

    Hyperthyroidism is characterised by high levels of serum thyroxine and triiodothyronine, and low levels of thyroid-stimulating hormone. The main causes of hyperthyroidism are Graves' disease, toxic multinodular goitre, and toxic adenoma. About 20 times more women than men have hyperthyroidism. ME...... Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA)....

  19. 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...

  20. Through the regulatory hoop

    International Nuclear Information System (INIS)

    Kirner, N.P.

    1985-01-01

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

  1. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

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

  2. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

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

  3. 76 FR 59066 - Notice of Regulatory Review Plan

    Science.gov (United States)

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  4. Department of Transportation Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... result in more effective public participation. This publication in the Federal Register does not impose... contracting issues associated with subcontracting with Small Business, Small Disadvantaged Business, and Women... and Water Efficiency, Renewable Energy Technologies, Occupational Safety, and Drug-Free Workplace...

  5. Environmental Protection Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... more easily and live more healthy lives. Building on that, EPA will develop a comprehensive strategy... stakeholders working with us to identify the most practical and effective solutions to problems, and we stress...; Under the Federal Food, Drug, and Cosmetic Act: Actions regarding pesticide tolerances and food additive...

  6. 76 FR 28102 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-05-13

    ..., Probabilistic Risk Assessment Branch, Division of Risk Analysis, Office of Nuclear Regulatory Research, U.S... results of risk analyses are used to help justify regulatory action. As such, the principles, process, and... NUCLEAR REGULATORY COMMISSION [NRC-2009-0385] Notice of Issuance of Regulatory Guide AGENCY...

  7. 75 FR 2894 - Withdrawal of Regulatory Guide 1.148

    Science.gov (United States)

    2010-01-19

    ... downloading through the NRC's public Web site under ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doc-collections . Regulatory guides are also available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0013] Withdrawal of Regulatory Guide 1.148 AGENCY: Nuclear...

  8. 75 FR 70044 - Withdrawal of Regulatory Guide 1.39

    Science.gov (United States)

    2010-11-16

    ... downloading through the NRC's public Web site under ``Regulatory Guides'' in the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/doollectionsc-c . Regulatory guides are also available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0354] Withdrawal of Regulatory Guide 1.39 AGENCY: Nuclear...

  9. 76 FR 35922 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-06-20

    .... Proposed Revision 1 of Regulatory Guide (RG) 8.4, ``Personnel Monitoring Device--Direct-Reading Pocket...'' at http://www.nrc.gov/reading-rm/doc-collections/ . In addition, regulatory guides are available for... NUCLEAR REGULATORY COMMISSION [NRC-2010-0148] Notice of Issuance of Regulatory Guide AGENCY...

  10. 78 FR 44165 - Nuclear Regulatory Commission Enforcement Policy

    Science.gov (United States)

    2013-07-23

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0159] Nuclear Regulatory Commission Enforcement Policy AGENCY: Nuclear Regulatory Commission. ACTION: Enforcement policy; request for comment. SUMMARY: The U.S... Policy. In SRM-SECY-12-0047, ``Revisions to the Nuclear Regulatory Commission Enforcement Policy,'' dated...

  11. 77 FR 28467 - Identifying and Reducing Regulatory Burdens

    Science.gov (United States)

    2012-05-14

    ... online wherever practicable. Sec. 3. Setting Priorities. In implementing and improving their... regulatory priorities, to promote public participation in retrospective review, to modernize our regulatory..., agencies shall give priority, consistent with law, to those initiatives that will produce significant...

  12. 78 FR 28244 - Agency Information Collection Activities; Proposed Collection; Comment Request

    Science.gov (United States)

    2013-05-14

    ... Licensing of Production and Utilization Facilities,'' specifies technical information and data to be... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2013-0085] Agency Information Collection Activities; Proposed Collection; Comment Request AGENCY: Nuclear Regulatory Commission. ACTION: Notice of pending NRC...

  13. Nuclear regulatory decision making

    International Nuclear Information System (INIS)

    2005-01-01

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

  14. 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 rema...

  15. Advertising Agencies

    DEFF Research Database (Denmark)

    Moeran, Brian

    2015-01-01

    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...... 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....... This article is concerned with the origins, early developments, organization, compensation arrangements, and accounts of contemporary full-service advertising agencies....

  16. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

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

  17. 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...

  18. 76 FR 6587 - Pennsylvania Regulatory Program

    Science.gov (United States)

    2011-02-07

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

  19. 76 FR 64043 - Iowa Regulatory Program

    Science.gov (United States)

    2011-10-17

    ...) Requirements for permits for special categories of mining. 27--40.41(207) Permanent regulatory program--small... DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 915 [Docket No. IA-016-FOR; Docket ID: OSM-2011-0014] Iowa Regulatory Program AGENCY: Office of Surface Mining...

  20. Environmental regulatory update table, March 1989

    International Nuclear Information System (INIS)

    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

  1. Environmental Regulatory Update Table, April 1989

    International Nuclear Information System (INIS)

    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

  2. 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.

  3. Environmental Regulatory Update Table, December 1989

    International Nuclear Information System (INIS)

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

    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

  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, August 1990

    International Nuclear Information System (INIS)

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

    1990-09-01

    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 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, 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.

  7. 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.

  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, July 1991

    Energy Technology Data Exchange (ETDEWEB)

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

    1991-08-01

    This Environmental Regulatory Update Table (July 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.

  10. Assessment of regulatory effectiveness. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1999-09-01

    This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

  11. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2009-01-01

    In this last part is reviewed international regulatory activities and bilateral agreements including two parts: concerning European atomic energy community with European commission proposal for a council directive setting up a community framework for nuclear safety, update of the nuclear illustrative programme in the context of the second strategic energy review, european commission recommendation on criteria for the export of radioactive waste and spent fuel to third countries and a communication on nuclear non-proliferation and the second part in relation with international atomic energy agency with a joint convention on the safety of spent fuel management and on safety of radioactive waste management (third review meeting). (N.C.)

  12. 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......Diplomatic agency is intriguing. On the one hand, diplomats are crucial to the management of day-to-day international relations and the negotiation of war and peace. On the other hand, most diplomatic action is highly constrained or invisible. This chapter provides an overview of the ways in which...... and advocacy. It analyzes how professionalization, legalization, personalization and popularization of diplomacy have shaped diplomatic agency including how international law, bureaucracy, public diplomacy and new information technologies have impacted the scope and content of diplomatic agency. Finally...

  13. ¿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

  14. 78 FR 1624 - Fall 2012 Regulatory Agenda

    Science.gov (United States)

    2013-01-08

    ...), studies or analyses of the possible need for regulatory action, requests for public comment on the need... (NESHAP): Reinforced Plastic Composites Production To comment or learn more about these retrospective.... Agency Contact: Hans Scheifele, Environmental Protection Agency, Office of Chemical Safety and Pollution...

  15. Regulatory Support of Treatment of Savannah River Site Purex Waste

    International Nuclear Information System (INIS)

    Reid, L.T.

    2009-01-01

    This paper describes the support given by federal and state regulatory agencies to Savannah River Site (SRS) during the treatment of an organic liquid mixed waste from the Plutonium Extraction (Purex) process. The support from these agencies allowed (SRS) to overcome several technical and regulatory barriers and treat the Purex waste such that it met LDR treatment standards. (authors)

  16. 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....

  17. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...... by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh....

  18. 40 CFR 73.86 - State regulatory autonomy.

    Science.gov (United States)

    2010-07-01

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

  19. 76 FR 20052 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-04-11

    ... the NRC's public Web site under ``Regulatory Guides'' at http://www.nrc.gov/reading-rm/doc-collections... NUCLEAR REGULATORY COMMISSION [NRC-2010-0187] Notice of Issuance of Regulatory Guide AGENCY... Guide 1.149, ``Nuclear Power Plant Simulation Facilities for Use in Operator Training, License...

  20. Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron L [National Renewable Energy Laboratory (NREL), Golden, CO (United States)

    2017-12-19

    Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

  1. 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.

  2. Regulatory framework for the management of radioactive wastes in Argentina

    International Nuclear Information System (INIS)

    D'Amato, E.; Siraky, G.; Petraitis, E.; Novo, R.

    2000-01-01

    The legal and regulatory framework within which the radioactive waste management is carried out in Argentina are exposed. The activities of the Nuclear Regulatory Authority (ARN) in relation to facility inspections, safety assessments and collaboration with international agencies in the matter are also presented. Further, the regulatory criteria applied to waste management are reported. (author)

  3. Environmental Regulatory Update Table, January/February 1995

    International Nuclear Information System (INIS)

    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

  4. Canadian and international approaches to regulatory effectiveness

    International Nuclear Information System (INIS)

    Lojk, R.

    2014-01-01

    Regulatory effectiveness is an important attribute of any regulator, particularly nuclear regulators. As the nuclear industry has matured, and as the social landscape has changed, so have views on what constitutes regulatory effectiveness. Canada has evolved its regulatory structure and modernized its legislative framework and technical requirements and guidance over time. In addition, Canada continues to collaborate with international agencies, particularly the NEA and the IAEA, to ensure that there is a common understanding of the indicators and key attributes of regulatory effectiveness. This paper discusses Canadian and international views on the subject, including perspectives from other industries. (author)

  5. 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....

  6. The Agency's publications

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1961-09-15

    With regard to bulk and substance, by far the most important part of the IAEA publishing is the publication of the proceedings of the scientific conferences, symposia and seminars held by the Agency, either alone or in co-operation with the United Nations specialized agencies or scientific unions. At present, the production time between the holding of a conference and the publication of its proceedings by the Agency is between 9 and 12 months. Another important group of publications is the directories, safety manuals and monographs Of the Directory of Nuclear Reactors, three volumes have so far been issued, in which detailed information is given about the power, research, test and experimental reactors in operation or under construction in different parts of the world. International Directory of Radioisotope Teletherapy equipment lists available equipment with considerable technical data and approximate prices. In the 'Safety Series', are included manuals on the safe handling of radioisotopes, the safe transport of radioactive materials, etc., which contain the regulations applied to the Agency's own operations or to operations assisted by the Agency. The Series also includes manuals which are informative rather than regulatory, such as the Health Physics and Medical Addenda to the manual on the Safe Handling of Radioisotopes, a report on radioactive waste disposal into the sea, a guide for the safe operation of critical assemblies and research reactors, notes on the Regulations for the Safe Transport of Radioactive Materials, and a manual on the use of film-badge dosimeters. The Review Series consists of monographs on different subjects written by experts in the particular fields. They are published in their original language and in some cases a translation into one or even two other working languages is included. The 'Bibliographical Series' includes bibliographies of the world-wide literature in different branches of nuclear science and technology. One of the

  7. The Agency's publications

    International Nuclear Information System (INIS)

    1961-01-01

    With regard to bulk and substance, by far the most important part of the IAEA publishing is the publication of the proceedings of the scientific conferences, symposia and seminars held by the Agency, either alone or in co-operation with the United Nations specialized agencies or scientific unions. At present, the production time between the holding of a conference and the publication of its proceedings by the Agency is between 9 and 12 months. Another important group of publications is the directories, safety manuals and monographs Of the Directory of Nuclear Reactors, three volumes have so far been issued, in which detailed information is given about the power, research, test and experimental reactors in operation or under construction in different parts of the world. International Directory of Radioisotope Teletherapy equipment lists available equipment with considerable technical data and approximate prices. In the 'Safety Series', are included manuals on the safe handling of radioisotopes, the safe transport of radioactive materials, etc., which contain the regulations applied to the Agency's own operations or to operations assisted by the Agency. The Series also includes manuals which are informative rather than regulatory, such as the Health Physics and Medical Addenda to the manual on the Safe Handling of Radioisotopes, a report on radioactive waste disposal into the sea, a guide for the safe operation of critical assemblies and research reactors, notes on the Regulations for the Safe Transport of Radioactive Materials, and a manual on the use of film-badge dosimeters. The Review Series consists of monographs on different subjects written by experts in the particular fields. They are published in their original language and in some cases a translation into one or even two other working languages is included. The 'Bibliographical Series' includes bibliographies of the world-wide literature in different branches of nuclear science and technology. One of the

  8. The changing regulatory environment

    International Nuclear Information System (INIS)

    Caron, G.

    1999-01-01

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

  9. Strengthening Regulatory Competence in Pakistan

    International Nuclear Information System (INIS)

    Sadiq, M.

    2016-01-01

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

  10. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

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

  11. Independence and the Irish Environmental Protection Agency: A Comparative Assessment

    OpenAIRE

    Shipan, Charles

    2006-01-01

    The Environmental Protection Agency is one of the most prominent regulatory agencies in Ireland. Created in 1992, one of the hallmarks of this agency is its independence from other parts of government. Yet little is known about the actual extent of its independence. Independence and the Irish Environmental Protection Agency: A Comparative Assessment addresses several key questions about the agency's independence. Why was independence such a primary justification for the creation of this a...

  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...... ante (“hidden characteristics”) as well as ex post information asymmetry (“hidden action”), and examines conditions under which various kinds of incentive instruments and monitoring arrangements can be deployed to minimize the welfare loss. Its clear predictions and broad applicability have allowed...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

  13. 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...... ante (‘hidden characteristics’) as well as ex post information asymmetry (‘hidden action’), and examines conditions under which various kinds of incentive instruments and monitoring arrangements can be deployed to minimize the welfare loss. Its clear predictions and broad applicability have allowed...... agency theory to enjoy considerable scientific impact on social science; however, it has also attracted considerable criticism....

  14. Principles of good regulatory research

    International Nuclear Information System (INIS)

    Rogers, K.

    1991-01-01

    The Commissioner of the US Regulatory Commission addresses several important research-related subjects. The paper describes the Agency philosophy with respect to independence, openness, efficiency, clarity, and reliability; research philosophy with respect to the need for research, the need for quality, and the need for efficiency; research areas with respect to plant aging, human factors, severe accident analysis, advanced reactors, and radioactive waste management; and systems approach to reactor operations, training, licensing, and maintenance

  15. Agency doctorates

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1970-07-01

    Mr. Wen-chuan Li of China has become the first student to obtain a doctor's degree as a result of research work carried out in the Agency. Mr. Li, who is 33, graduated as a Bachelor of Agriculture at Taiwan Provincial Chung-hsing University in 1960 and in 1966 was granted a fellowship to study mutations in plant breeding at the Agency's Seibersdorf Laboratory near Vienna, under the direction of Dr. Knut Mikaelsen, a professor of the University of Bergen. The Hochschule fur Bodenkultur of Vienna accepted the research as being suitable for a thesis and have now granted the degree of Doctor of Agriculture. The subject of the thesis was modifying factors influencing the mutagenic effects of alkylating agents as compared with ionizing radiations in barley. Alkylating agents are involved in the use of chemicals as a means of changing the characteristics of seeds to bring about changes aimed at improving the quality of crops. Mr. Li's work is regarded as a significant contribution to the understanding of the mechanics by which mutations are induced, to the efficient use of chemicals and ionizing radiations in practical applications, and to the efforts of the Agency in collaboration with the Food and Agriculture Organization to benefit food supplies. Mr. Li has now completed his fellowship with the Agency and has been appointed an Assistant Professor in Plant Breeding at Taiwan Provincial Chung-hsing University. The photograph, taken in the plastic hot house at Seibersdorf, shows him studying rice plants grown from seeds subjected to irradiation. Another noteworthy achievement is that of Mr. Karl-Franz Lacina, a security guard at the Agency's headquarters. At the age of 50 he has been accorded the degree of Doctor of Philosophy at Vienna University, the result of six years' work in his leisure time. The major subject was Arabic, with French and philosophy as supporting subject. (author)

  16. Agency doctorates

    International Nuclear Information System (INIS)

    1970-01-01

    Mr. Wen-chuan Li of China has become the first student to obtain a doctor's degree as a result of research work carried out in the Agency. Mr. Li, who is 33, graduated as a Bachelor of Agriculture at Taiwan Provincial Chung-hsing University in 1960 and in 1966 was granted a fellowship to study mutations in plant breeding at the Agency's Seibersdorf Laboratory near Vienna, under the direction of Dr. Knut Mikaelsen, a professor of the University of Bergen. The Hochschule fur Bodenkultur of Vienna accepted the research as being suitable for a thesis and have now granted the degree of Doctor of Agriculture. The subject of the thesis was modifying factors influencing the mutagenic effects of alkylating agents as compared with ionizing radiations in barley. Alkylating agents are involved in the use of chemicals as a means of changing the characteristics of seeds to bring about changes aimed at improving the quality of crops. Mr. Li's work is regarded as a significant contribution to the understanding of the mechanics by which mutations are induced, to the efficient use of chemicals and ionizing radiations in practical applications, and to the efforts of the Agency in collaboration with the Food and Agriculture Organization to benefit food supplies. Mr. Li has now completed his fellowship with the Agency and has been appointed an Assistant Professor in Plant Breeding at Taiwan Provincial Chung-hsing University. The photograph, taken in the plastic hot house at Seibersdorf, shows him studying rice plants grown from seeds subjected to irradiation. Another noteworthy achievement is that of Mr. Karl-Franz Lacina, a security guard at the Agency's headquarters. At the age of 50 he has been accorded the degree of Doctor of Philosophy at Vienna University, the result of six years' work in his leisure time. The major subject was Arabic, with French and philosophy as supporting subject. (author)

  17. A global regulatory science agenda for vaccines.

    Science.gov (United States)

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

    2013-04-18

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

  18. 77 FR 8902 - Draft Regulatory Guide: Issuance, Availability Decommissioning of Nuclear Power Reactors

    Science.gov (United States)

    2012-02-15

    ... Decommissioning of Nuclear Power Reactors AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide... draft regulatory guide (DG) DG-1271 ``Decommissioning of Nuclear Power Reactors.'' This guide describes... Regulatory Guide 1.184, ``Decommissioning of Nuclear Power Reactors,'' dated July 2000. This proposed...

  19. 78 FR 70354 - Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement

    Science.gov (United States)

    2013-11-25

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0254] Conceptual Example of a Proposed Risk Management Regulatory Framework Policy Statement AGENCY: Nuclear Regulatory Commission. ACTION: Conceptual example of a... ``openness,'' a white paper on a Conceptual Example of a Proposed Risk Management Regulatory Framework (RMRF...

  20. Regulatory Physiology

    Science.gov (United States)

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

    1999-01-01

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

  1. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of bench-marking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  2. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

    Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators. The appli......Benchmarking methods, and in particular Data Envelopment Analysis (DEA), have become well-established and informative tools for economic regulation. DEA is now routinely used by European regulators to set reasonable revenue caps for energy transmission and distribution system operators....... The application of benchmarking in regulation, however, requires specific steps in terms of data validation, model specification and outlier detection that are not systematically documented in open publications, leading to discussions about regulatory stability and economic feasibility of these techniques...

  3. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2010-01-01

    Concerning International regulatory activities, we find for the european atomic energy community an entry into force of the lisbon treaty (2009), it amends the treaty on European union and replaces the treaty establishing the European Community by the new treaty on the functioning of the European Union; more, an amendment to council regulation on the conditions governing imports of agricultural products originating in third countries following the accident at the Chernobyl nuclear power station (2009). About International atomic energy agency is reported an open-ended meeting of technical and legal experts for sharing of information on states implementation of the code of conduct on the safety and security of radioactive sources and its supplementary guidance on the import and export of radioactive sources (2010). (N.C.)

  4. 76 FR 13549 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-14

    ...'s regulatory program more effective and less burdensome in achieving its regulatory objectives by... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Chapter IX 50 CFR.... 13563 AGENCY: National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Request for...

  5. 78 FR 9991 - Agency Information Collection Activities; Information Collection Renewal; Submission for OMB Review

    Science.gov (United States)

    2013-02-12

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

  6. The Regulatory Independence of FANR

    International Nuclear Information System (INIS)

    ALNuaimi, Fatema; Choi, Kwang Shik

    2012-01-01

    Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

  7. The Regulatory Independence of FANR

    Energy Technology Data Exchange (ETDEWEB)

    ALNuaimi, Fatema; Choi, Kwang Shik [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of)

    2012-05-15

    Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

  8. How are things going. Obtaining feedback in a regulatory environment

    International Nuclear Information System (INIS)

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

    1984-08-01

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

  9. Agency doctorates

    International Nuclear Information System (INIS)

    1970-01-01

    Staff members of the Agency working at the Seibersdorf laboratory are continuing to achieve high academic distinction. Two more - both Austrian - have now been awarded the degree of Doctor of Agriculture. Joachim Kramer, who is 26, graduated from the Hochschule fur Bodenkultur in 1967 with the degree of Diplom-Ingenieur and then started work in the plant breeding and genetics section of the laboratory under the direction of Dr. Knut Mikaelsen. The results of the research work he carried out were accepted as the subject of a thesis for which he has now been granted his doctorate. The doctoral promotion took place on 30 June, at a ceremony attended by Dr. Andre Finkelstein, Deputy Director General for Research and Isotopes. The subject of Dr. Kramer's thesis was a comprehensive study of the mutagenic effects of fast neutrons and gamma rays, and the influence of various modifying factors such as water content, oxygen and metabolic state of seeds at the time of irradiation. This work has contributed significantly to the understanding of the mechanisms by which these two types of ionizing radiation produce mutations in seeds. The knowledge gained will be of great importance in the efficient use of ionizing radiation in practical plant breeding. Paul Wassermann, who is 33 years old, joined the Agency in 1965. He, too, graduated from the Hochschule fur Bodenkultur as Diplom-Ingenieur in agriculture, having graduated with honours previously from the agricultural secondary school at Raumberg, Austria, in 1958. Dr. Wassermann's own words may be used to explain how he came to gain his doctorate. 'In October, 1966, I completed my studies at the Hochschule,' he writes. 'I was employed at the Agency laboratories in Seibersdorf, working in the plant and soils group. Encouraged by the interesting research which was performed there, a thesis entitled 'the Fate of Nitrogen in Submerged Rice Soils' was started, which finally led to the doctor's degree in Agriculture in June this year

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

    International Nuclear Information System (INIS)

    2012-01-01

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

  11. 77 FR 61592 - Arkansas Electric Cooperative Corporation; Mississippi Delta Energy Agency; Clarksdale Public...

    Science.gov (United States)

    2012-10-10

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL12-110-000] Arkansas Electric Cooperative Corporation; Mississippi Delta Energy Agency; Clarksdale Public Utilities Commission.... 825(h), Arkansas Electric Cooperative Corporation, Mississippi Delta Energy Agency, and its two...

  12. The European Medicines Agency's strategies to meet the challenges of Alzheimer disease.

    Science.gov (United States)

    Haas, Manuel; Mantua, Valentina; Haberkamp, Marion; Pani, Luca; Isaac, Maria; Butlen-Ducuing, Florence; Vamvakas, Spiros; Broich, Karl

    2015-04-01

    Regulatory agencies have a key role in facilitating the development of new drugs for Alzheimer disease, particularly given the challenges associated with early intervention. Here, we highlight the strategies of the European Medicines Agency to help address such challenges.

  13. Regulatory authority infrastructure for Namibia

    International Nuclear Information System (INIS)

    Shangula, K.

    2001-01-01

    The Republic of Namibia is participating in the International Atomic Energy Agency's Model Project for the Improvement of National Regulatory Authority Infrastructures in Member States. The paper illustrates our experience in solving problems and difficulties confronted in establishing an effective regulatory authority operating within the existing national infrastructure that should be supported by the Government. An effective regulatory authority is seen as part of the wider administrative scope of our Government through ministerial mandates given by the State from time to time, guaranteeing its independence when implementing legal provisions under statutes. Sections of the report illustrate our experience in the following areas: 1. National radiation protection policy 2. Structure of our national regulatory authority 3. Laws and regulations 4. Provisions for notification, authorization and registration 5. In-depth security measures for radiation sources and radioactive material 6. Systems for the inspection of radiation sources, radioactive materials, enforcement of legal provisions 7. Extent of the applications of radiation sources and radioactive materials in the country. The paper provides information regarding existing Government policy on radiation protection; structure and legal aspects of the national regulatory, including statutes and regulations; the extent of application and uses of radiation sources and security of radioactive materials; human resources: strengths and constraints; management practices and financing of regulatory authority; and plans for emergency recovery of orphan sources. National plans for management of disused sources, recovery of orphan sources, abnormal emergencies, communication of information to affected persons on exposure effects, and the safety training of persons using these applications are discussed. the paper provides a summary and some suggestions of the way forward for Namibia. (author)

  14. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

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

    2017-01-01

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

  15. 78 FR 34386 - Agency Forms Undergoing Paperwork Act Review

    Science.gov (United States)

    2013-06-07

    ... representatives in state regulatory agencies in the 50 states and the District of Columbia primarily via telephone.... Nursing homes and skilled nursing facilities are also excluded, unless they have a unit or wing meeting...

  16. 76 FR 76413 - Agency Forms Undergoing Paperwork Reduction Act Review

    Science.gov (United States)

    2011-12-07

    ... representatives in state regulatory agencies in the 50 states and the District of Columbia primarily via telephone... exclusively are excluded. Nursing homes and skilled nursing facilities are also excluded, unless they have a...

  17. OECD Nuclear Energy Agency. 5 activity report. 1976

    International Nuclear Information System (INIS)

    1977-01-01

    The main activities of the Agency are reviewed: nuclear power trends; regulatory aspects of nuclear power; technical developments: Eurochemic, Halden, Dragon, food irradiation; gas-cooled fast reactors, isotopic batteries; nuclear data Centers

  18. OECD Nuclear Energy Agency. 3. Activity report, 1974

    International Nuclear Information System (INIS)

    1975-01-01

    The main activities of the Agency are reviewed: study of nuclear power trends; regulatory aspects of nuclear power; technical developments: Eurochemic, Halden, Dragon, food irradiation, gas-cooled fast reactors, direct conversion, isotopic batteries; nuclear energy information

  19. Regulatory perspectives of concept assessment

    International Nuclear Information System (INIS)

    Flavelle, Peter A.

    1987-09-01

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

  20. 77 FR 7968 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2012-02-13

    ... Regulation Sequence No. Title Identifier No. 392 Non-Federal Oil and Gas 1024-AD78 Rights. National Park.... Timetable: Action Date FR Cite NPRM 07/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact... anaconda, and Beni anaconda. Timetable: Action Date FR Cite ANPRM 01/31/08 73 FR 5784 ANPRM Comment Period...

  1. 78 FR 1570 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2013-01-08

    ... Deregulatory Priorities. Gregory H. Woods, General Counsel. Energy Efficiency and Renewable Energy--Proposed... Action 10/01/12 77 FR 59719 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Stephen Witkowski, Phone: 202 586-7463, Email: stephen[email protected] . RIN: 1904-AB90 [FR Doc. 2012-31497...

  2. 21 CFR 312.86 - Focused FDA regulatory research.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Focused FDA regulatory research. 312.86 Section 312.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED... Severely-debilitating Illnesses § 312.86 Focused FDA regulatory research. At the discretion of the agency...

  3. 76 FR 18457 - Regulatory Review Schedule; Tribal Consultation

    Science.gov (United States)

    2011-04-04

    ... that the NIGC provide tribal gaming commissions access to licensing information via an online database... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Tribal Consultation AGENCY: National Indian Gaming Commission. ACTION: Notice of Regulatory...

  4. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Science.gov (United States)

    2011-01-04

    ... guidance, including memoranda and letters, may no longer be relied upon to the extent they are inconsistent... Concerning Electronic Signatures and Documents AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of regulatory guidance. SUMMARY: FMCSA issues regulatory guidance concerning the...

  5. 76 FR 7762 - Drinking Water: Regulatory Determination on Perchlorate

    Science.gov (United States)

    2011-02-11

    ...-9262-8] RIN 2040-AF08 Drinking Water: Regulatory Determination on Perchlorate AGENCY: Environmental...'s) regulatory determination for perchlorate in accordance with the Safe Drinking Water Act (SDWA... substantial likelihood that perchlorate will occur in public water systems with a frequency and at levels of...

  6. 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.

  7. 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.

  8. 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.

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

    International Nuclear Information System (INIS)

    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. 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.

  11. 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.

  12. 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.

  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, 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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.

  4. Environmental regulatory update table, July/August 1994

    International Nuclear Information System (INIS)

    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

  5. 78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-07-01

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9830-1] Technical Guidance for Assessing Environmental Justice in Regulatory Analysis AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... Environmental Protection Agency (EPA) issued for public comment a document entitled, ``Technical Guidance for...

  6. Regulatory aspects of mixed waste

    International Nuclear Information System (INIS)

    Boyle, R.R.; Orlando, D.A.

    1990-01-01

    Mixed waste is waste that satisfies the definition of low-level radioactive waste in the Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) and contains hazardous waste that is either: (1) listed as a hazardous waste in 40 CFR 261, Subpart D; or (2) causes the waste to exhibit any of the characteristics identified in 40 CFR 261, Subpart C. Low-level radioactive waste is defined in the LLRWPAA as radioactive material that is not high level waste, spent nuclear fuel, or byproduct material, as defined in Section 11e(2) of the Atomic Energy Act of 1954, and is classified as low-level waste by the U.S. Nuclear Regulatory Commission (NRC). This paper discusses dual regulatory (NRC and Environmental Protection Agency) responsibility, overview of joint NRC/EPA guidance, workshops, national mixed waste survey, and principal mixed waste uncertainties

  7. As to achieve regulatory action, regulatory approaches

    International Nuclear Information System (INIS)

    Cid, R.; Encinas, D.

    2014-01-01

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

  8. 77 FR 70741 - Agency Information Collection Extension

    Science.gov (United States)

    2012-11-27

    ... Management and Budget (OMB) to revise a currently-approved data collection under the provisions of the... analysis tools for federal/state agencies, AFV suppliers, vehicle fleet managers, and other interested... sent to the: DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and...

  9. Impact assessment of the European Clinical Trials Directive: a longitudinal, prospective, observational study analyzing patterns and trends in clinical drug trial applications submitted since 2001 to regulatory agencies in six EU countries

    Directory of Open Access Journals (Sweden)

    Hartmann Markus

    2012-04-01

    Full Text Available Abstract Background Shifts in clinical trial application rates over time indicate if the attractiveness of a country or region for the conduct of clinical trials is growing or decreasing. The purpose of this observational study was to track changes in drug trial application patterns across several EU countries in order to analyze the medium-term impact of the EU Clinical Trials Directive 2001/20/EC on the conduct of drug trials. Methods Rates of Clinical Trial Applications (CTA for studies with medicinal products in those six countries in the EU, which authorize on average more than 500 trials per year, were analyzed. Publicly available figures on the number of annually submitted CTA, the distribution of trials per phase and the type of sponsorship were tracked; missing data were provided by national drug agencies. Results Since 2001, the number of CTA in Italy and Spain increased significantly (5.0 and 2.5% average annual growth. For Italy, the gain was driven by a strong increase of applications from academic trial sponsors; Spain's growth was due to a rise in trials run by commercial sponsors. The Netherlands, Germany, France and the UK saw a decline (1.9, 2.3, 3.0 and 5.3% average annual diminution; significant (P Conclusions The EU Clinical Trials Directive 2001/20/EC did not achieve the harmonization of clinical trial requirements across Europe. Rather, it resulted in the leveling of clinical trial activities caused by a continuing decrease in CTA rates in the Netherlands, Germany, France and the UK. Southern European countries, Italy and Spain, benefited to some extent from policy changes introduced by the Directive. In Italy's case, national funding measures helped to considerably promote the conduct of non-commercial trials. On the other hand, the EU Directive-driven transition from liberal policy environments, based on non-explicit trial approval through notifications, towards red-taped processes of trial authorization, contributed to

  10. 77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

    Science.gov (United States)

    2012-11-27

    ... NUCLEAR REGULATORY COMMISSION [NRC-2012-0285] Regulatory Guide 1.182, ``Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants'' AGENCY: Nuclear Regulatory Commission... withdrawing Regulatory Guide (RG)1.182, Revision (Rev.) 0, ``Assessing and Managing Risk Before Maintenance...

  11. The Independence of Vietnam Regulatory Body

    International Nuclear Information System (INIS)

    Nguyen, Hoang Anh; Choi, Kwang Sik

    2011-01-01

    In the field of peaceful purposes, the activity of nuclear agencies is often divided into 2 systems: the nuclear application system and the safety system. Depending on the magnitude of atomic energy application development, the responsibility of the safety system was assigned to a few agencies in each country. In Vietnam, the nuclear safety responsibility is assigned primarily to the radiation and nuclear safety agency. However, the provisions of the normative system of law prevailing in other sectors such as investment, construction, electricity or environmental protection, many agencies are responsible for ensuring safety in each sector, leading to a conflict of interest among those agencies. This is the weakness in the management system of Vietnam compared to other countries with nuclear power development. The purpose of this paper is to analyze the state of Vietnam's legal framework in nuclear safety regulation and its dependence of regulatory body aspects and promoting the way to overcome it

  12. 78 FR 54517 - Water Quality Standards Regulatory Clarifications

    Science.gov (United States)

    2013-09-04

    ... 131 Water Quality Standards Regulatory Clarifications; Proposed Rule #0;#0;Federal Register / Vol. 78... AGENCY 40 CFR Part 131 [EPA-HQ-OW-2010-0606; FRL-9839-7] RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

  13. 76 FR 61402 - Draft Nuclear Regulatory Commission Fiscal Year 2012-2016 Strategic Plan

    Science.gov (United States)

    2011-10-04

    ...-2016 Strategic Plan AGENCY: Nuclear Regulatory Commission. ACTION: Draft NUREG; request for comment... comment on draft NUREG-1614, Volume 5. ``U.S. Nuclear Regulatory Commission, FY 2012-2016 Strategic Plan,'' dated September 2011. The NRC's draft FY 2012-2016 strategic plan describes the agency's mission and...

  14. 77 FR 15142 - Updated Nuclear Regulatory Commission Fiscal Years 2008-2013 Strategic Plan

    Science.gov (United States)

    2012-03-14

    ... 2008-2013 Strategic Plan AGENCY: Nuclear Regulatory Commission. ACTION: Strategic plan. SUMMARY: The U...-1614, Volume 5, ``U.S. Nuclear Regulatory Commission, Fiscal Years [FY] 2008-2013 Strategic Plan,'' dated February 2012. The updated FY 2008-2013 strategic plan describes the agency's mission and...

  15. 75 FR 61485 - Regulatory Training Session With Air Carriers, EPA Regional Partners and Other Interested Parties...

    Science.gov (United States)

    2010-10-05

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9210-6] Regulatory Training Session With Air Carriers, EPA... Agency (EPA) will hold a two-day training session on the regulatory requirements of the Aircraft Drinking... session will be provided in early 2011. ADDRESSES: The training will be held at the Rosslyn Holiday Inn at...

  16. Corporate Social Responsibility and Labour Agency

    DEFF Research Database (Denmark)

    Lund-Thomsen, Peter; Coe, Neil M.

    2015-01-01

    to which the measures advocated in a new, emerging policy paradigm on CSR in GPNs enabled labour agency at Nike’s main football supplier factory in Pakistan. We argue that while such CSR policies can create enhanced space for labour agency, that potential agency is also shaped (i) by wider economic forces......This article examines the circumstances under which corporate social responsibility (CSR) initiatives facilitate and/or constrain labour agency in global production networks (GPNs). Using a case study of Nike’s CSR approach in the football manufacturing industry of Pakistan, we explore the extent...... within the global economy and (ii) relationships with local/national actors and regulatory frameworks. Understanding the intersection of these dimensions becomes vital to interpreting the potential for, and activation of, labour agency within CSR-influenced GPNs....

  17. 75 FR 9444 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Science.gov (United States)

    2010-03-02

    ... Utilization Facilities,'' specifies technical information and data to be provided to the NRC or maintained by... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2010-0063] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: U.S. Nuclear Regulatory Commission (NRC). ACTION: Notice of...

  18. 7 CFR 371.5 - Marketing and Regulatory Programs Business Services.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 5 2010-01-01 2010-01-01 false Marketing and Regulatory Programs Business Services... AUTHORITY § 371.5 Marketing and Regulatory Programs Business Services. (a) General statement. Marketing and Regulatory Programs Business Services (MRPBS) plans and provides for the agency's human, financial, and...

  19. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

    ...] Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability AGENCY: Food... announcing the availability of a guidance for industry entitled ``Regulatory Classification of Pharmaceutical... on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. This...

  20. Professional and Regulatory Search

    Science.gov (United States)

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  1. Regulatory controls for NORM contamination: Emerging issues and strategies

    International Nuclear Information System (INIS)

    Wennerberg, Linda

    1992-01-01

    Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

  2. Future nuclear regulatory challenges

    International Nuclear Information System (INIS)

    Royen, J.

    1998-01-01

    In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

  3. Wetlands: The changing regulatory landscape

    International Nuclear Information System (INIS)

    Glick, R.M.

    1993-01-01

    Protection of wetlands became a national issue in 1988 when President George Bush pledged no net loss of wetlands in the US under his open-quotes environmental presidency.close quotes As wetlands became a national issue, the job of protecting them became an obligation for many groups, including hydro-power developers. Now, when a site selected for development includes an area that may be classified as a wetland, the developer quickly discovers the importance of recognizing and protecting these natural habitats. Federal legislation severely limits development of wetland, and most states increase the restrictions with their own wetlands regulations. The difficulty of defining wetlands complicates federal and state enforcement. Land that appears to be dry may in fact be classified as a wetland. So, even if a site appears dry, potential hydro developers must confirm whether or not any jurisdictional wetlands are present. Regulated lands include much more than marshes and swamps. Further complicating the definition of wetlands, a recent court decision found that even artificially created wetlands, such as man-made ponds, may be subject to regulation. Hydro developers must be aware of current regulatory requirements before they consider development of any site that may contain wetlands. To be certain that a site is open-quotes buildableclose quotes from the standpoint of wetlands regulation, a developer must verify (with the help of state agencies) that the property does not contain any jurisdictional wetlands. If it does, the regulatory process before development becomes much more complicated. For the short term, uncertainty abounds and extreme caution is in order. Because the regulatory process has become so complex and an agreeable definition of wetlands so elusive, the trend among the Corps and collaborating agencies is to constrict nationwide permits in favor of narrowing the jurisdictional definition of wetlands

  4. Regulatory activities; Actividades regulatorias

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

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

  5. Intergovernmental organisation activities: European Atomic Energy Community, International Atomic Energy Agency, OECD Nuclear Energy Agency

    International Nuclear Information System (INIS)

    Anon.

    2012-01-01

    European Atomic Energy Community: Proposed legislative instruments, Adopted legislative instruments, Non-legislative instruments, Other activities (meetings). International Atomic Energy Agency: IAEA Action Plan on Nuclear Safety. OECD Nuclear Energy Agency: The Russian Federation to join the OECD Nuclear Energy Agency; Participation by the regulatory authorities of India and the United Arab Emirates in the Multinational Design Evaluation Programme (MDEP); NEA International Workshop on Crisis Communication, 9-10 May 2012; International School of Nuclear Law: 2013; Next NEA International Nuclear Law Essentials Course

  6. 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...

  7. The Role of Regulatory Agencies and Intellectual Property: Part II

    Science.gov (United States)

    Noonan, Kevin E.

    2015-01-01

    Patent law and antitrust law have traditionally been areas of the law involving at least some inherent tension. Champions of antitrust argue that the patent “monopoly” must be strictly limited as an exception to the general legal principle that competition should be unfettered. Patent lawyers argue that patents are the result of an exercise of congressional authority, enshrined in the Constitution, reflecting the policy decision by the Founders that granting a limited exclusionary right was justified by the public benefits derived from full disclosure of the patented invention. In the modern era these competing values have played out in the context of so-called ANDA litigation, involving disputes between branded pharmaceutical companies and generic competitors. Settlement of such litigation has been identified by the Federal Trade Commission (FTC), and private parties encouraged by the FTC’s position, as an antitrust violation, in large part because such settlements are viewed as frustrating the congressional purpose in promoting early generic competition. After almost a decade of fighting these battles in the federal courts, the Supreme Court addressed the issue directly. The result is that such settlements are not per se illegal but are also not protected by the presumption of patent validity for activities within the “scope of the patent.” Rather, the court decided that these agreements should be assessed for antitrust liability under the “rule of reason” used in other antitrust contexts. PMID:25775920

  8. 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.

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

    Science.gov (United States)

    Noonan, Kevin E

    2015-03-16

    Patent law and antitrust law have traditionally been areas of the law involving at least some inherent tension. Champions of antitrust argue that the patent "monopoly" must be strictly limited as an exception to the general legal principle that competition should be unfettered. Patent lawyers argue that patents are the result of an exercise of congressional authority, enshrined in the Constitution, reflecting the policy decision by the Founders that granting a limited exclusionary right was justified by the public benefits derived from full disclosure of the patented invention. In the modern era these competing values have played out in the context of so-called ANDA litigation, involving disputes between branded pharmaceutical companies and generic competitors. Settlement of such litigation has been identified by the Federal Trade Commission (FTC), and private parties encouraged by the FTC's position, as an antitrust violation, in large part because such settlements are viewed as frustrating the congressional purpose in promoting early generic competition. After almost a decade of fighting these battles in the federal courts, the Supreme Court addressed the issue directly. The result is that such settlements are not per se illegal but are also not protected by the presumption of patent validity for activities within the "scope of the patent." Rather, the court decided that these agreements should be assessed for antitrust liability under the "rule of reason" used in other antitrust contexts. Copyright © 2015 Cold Spring Harbor Laboratory Press; all rights reserved.

  10. 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

  11. Nuclear Regulatory Commission Information Digest 1992 edition

    International Nuclear Information System (INIS)

    Olive, K.

    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

  12. Nuclear Regulatory Commission Information Digest, 1991 edition

    International Nuclear Information System (INIS)

    Olive, K.L.

    1991-03-01

    The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, and the areas NRC licenses. This digest is a compilation of NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1990, with exceptions noted. For operating US commercial nuclear power reactors, information on generating capacity and average capacity factor is obtained from Monthly Operating Reports submitted to the NRC directly by the licensee. This information is reviewed for consistency only. No independent validation and/or verification is performed by the NRC. For detailed and complete information about tables and figures, refer to the source publications. This digest is published annually for the general use of the NRC staff and is available to the public. 30 figs., 12 tabs

  13. Transfer of Canadian nuclear regulatory technology

    International Nuclear Information System (INIS)

    Harvie, J.D.

    1985-10-01

    This paper discusses the Canadian approach to the regulation of nuclear power reactors, and its possible application to CANDU reactors in other countries. It describes the programs which are in place to transfer information on licensing matters to egulatory agencies in other countries, and to offer training on nuclear safety regulation as it is practised in Canada. Experience to date in the transfer of regulatory technology is discussed. 5 refs

  14. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  15. 17 CFR 240.19d-2 - Applications for stays of disciplinary sanctions or summary suspensions by a self-regulatory...

    Science.gov (United States)

    2010-04-01

    ... disciplinary sanctions or summary suspensions by a self-regulatory organization. 240.19d-2 Section 240.19d-2... summary suspensions by a self-regulatory organization. If any self-regulatory organization imposes any... the appropriate regulatory agency may file with the Commission a written motion for a stay of...

  16. Regulatory Commission of Alaska

    Science.gov (United States)

    Map Help Regulatory Commission of Alaska Login Forgot Password Arrow Image Forgot password? View Cart login Procedures for Requesting Login For Consumers General Information Telephone Electric Natural Gas

  17. 76 FR 9819 - Agency Information Collection Activities: Proposed Collection; Generic Clearance for the...

    Science.gov (United States)

    2011-02-22

    ...; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery; Correction AGENCY...: Proposed Collection; Comment Request; Generic Clearance for the Collection of Qualitative Feedback on... Regulatory Commission, Office of Personnel Management, Small Business Administration, and U.S. Agency for...

  18. 78 FR 73237 - Reports, Forms and Record Keeping Requirements Agency Information Collection Activity Under OMB...

    Science.gov (United States)

    2013-12-05

    ...-0088] Reports, Forms and Record Keeping Requirements Agency Information Collection Activity Under OMB... entities over which the agency exercises regulatory authority. Recent trends lead the agency to estimate.... Requesters are not required to keep copies of any records or reports [[Page 73238

  19. Regulatory aspects of sludge management

    International Nuclear Information System (INIS)

    Sharples, F.E.

    1992-01-01

    The paper presents an overview of radioactive waste land disposal restrictions by discussing the following topics: highlights of Resource Conservation and Recovery Act history; purposes of land disposal restrictions; regulatory definition of land disposal; US Environmental Protection Agency (EPA) implementation of land disposal restrictions; schedules for implementing land disposal restrictions; solvent and dioxin wastes; classification of liquid hazardous and radioactive wastes; generator and treatment, storage, and disposal responsibilities; variances and extensions; and options for mixed waste management. Land disposal restrictions take into account the long-term uncertainties associated with land disposal, the need to manage waste right the first time they are disposed, and the persistence toxicity, mobility, propensity to bioaccumulate, and volume. In the Department of Energy system land disposal restrictions affect mixed waste management and site remedial action programs

  20. Regulatory Monitoring of Fortified Foods: Identifying Barriers and Good Practices

    Science.gov (United States)

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

    2015-01-01

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

  1. Public Perceptions of Regulatory Costs, Their Uncertainty and Interindividual Distribution.

    Science.gov (United States)

    Johnson, Branden B; Finkel, Adam M

    2016-06-01

    Public perceptions of both risks and regulatory costs shape rational regulatory choices. Despite decades of risk perception studies, this article is the first on regulatory cost perceptions. A survey of 744 U.S. residents probed: (1) How knowledgeable are laypeople about regulatory costs incurred to reduce risks? (2) Do laypeople see official estimates of cost and benefit (lives saved) as accurate? (3) (How) do preferences for hypothetical regulations change when mean-preserving spreads of uncertainty replace certain cost or benefit? and (4) (How) do preferences change when unequal interindividual distributions of hypothetical regulatory costs replace equal distributions? Respondents overestimated costs of regulatory compliance, while assuming agencies underestimate costs. Most assumed agency estimates of benefits are accurate; a third believed both cost and benefit estimates are accurate. Cost and benefit estimates presented without uncertainty were slightly preferred to those surrounded by "narrow uncertainty" (a range of costs or lives entirely within a personally-calibrated zone without clear acceptance or rejection of tradeoffs). Certain estimates were more preferred than "wide uncertainty" (a range of agency estimates extending beyond these personal bounds, thus posing a gamble between favored and unacceptable tradeoffs), particularly for costs as opposed to benefits (but even for costs a quarter of respondents preferred wide uncertainty to certainty). Agency-acknowledged uncertainty in general elicited mixed judgments of honesty and trustworthiness. People preferred egalitarian distributions of regulatory costs, despite skewed actual cost distributions, and preferred progressive cost distributions (the rich pay a greater than proportional share) to regressive ones. Efficient and socially responsive regulations require disclosure of much more information about regulatory costs and risks. © 2016 Society for Risk Analysis.

  2. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-10-01

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

  3. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-04-01

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

  4. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-01-01

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

  5. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1991-04-01

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

  6. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1991-08-01

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

  7. Trust in regulatory regimes

    NARCIS (Netherlands)

    Six, Frédérique; Verhoest, Koen

    2017-01-01

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

  8. Nuclear Regulatory legislation

    International Nuclear Information System (INIS)

    1984-06-01

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

  9. 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.

  10. Regulatory aspects of criticality control in Australia

    International Nuclear Information System (INIS)

    Zimin, Sergei

    2003-01-01

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

  11. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

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

  12. Regulatory approaches to hydrocarbon contamination from underground storage tanks

    International Nuclear Information System (INIS)

    Daugherty, S.J.

    1991-01-01

    Action or lack of action by the appropriate regulatory agency is often the most important factor in determining remedial action or closure requirements for hydrocarbon contaminated sites. This paper reports that the diversity of regulatory criteria is well known statewide and well documented nationally. In California, the diversity of approaches is due to: that very lack of a clear understanding of the true impact of hydrocarbon contamination: lack of state or federal standards for soil cleanup, and state water quality objectives that are not always achievable; vagueness in the underground storage tank law; and the number and diversity of agencies enforcing the underground storage tank regulations

  13. 75 FR 1734 - Children’s Online Privacy Protection Rule Safe Harbor Proposed Self-Regulatory Guidelines; i-SAFE...

    Science.gov (United States)

    2010-01-13

    ... Proposed Self-Regulatory Guidelines; i-SAFE, Inc. Application for Safe Harbor AGENCY: Federal Trade... for public comment concerning proposed self-regulatory guidelines submitted by i-SAFE, Inc. under the... approval self-regulatory guidelines that would implement the Rule's protections.\\3\\ \\1\\ 64 FR 59888 (1999...

  14. 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.

  15. 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}.

  16. 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}.

  17. 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.

  18. 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.

  19. Accounting for Agency

    Science.gov (United States)

    Valentine, Kylie

    2011-01-01

    Children are increasingly described as agents and agency is important to arguments for children's rights and participation. Yet agency is rarely defined or theorised in childhood studies. This article reviews common uses and meanings of agency and argues that critical, social conceptualisations have yet to be extensively taken up in childhood…

  20. Preparation of safety and regulatory document for BARC Facilities

    International Nuclear Information System (INIS)

    Prasad, S.S.; Jayarajan, K.

    2017-01-01

    In India, the necessary codes and safety guidelines for achieving the safety objectives are provided by the Atomic Energy Regulatory Board (AERB), which are in conformity with the principles of radiation protection as formulated by the International Council of Radiation Protection (ICRP) and International Atomic Energy Agency (IAEA). The same is followed by BARC Safety Council (BSC), which is the regulatory body for the BARC facilities. In addition to all types of fuel cycle facilities, BSC regulates safety of many types of conventional facilities. Many such types of facilities and projects are not under the regulatory purview of AERB. Therefore, the Council has also initiated a programme for development and publication of safety documents for installations in BARC in the fields/ topics yet not addressed by IAEA or AERB. This makes the task pioneering, as some of the areas taken up for defining the regulatory requirements are new, where standard regulatory documents are not available

  1. 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.

  2. Performance-Based (Risk-Informed) Regulation: A Regulatory Perspective

    International Nuclear Information System (INIS)

    Kadambi, N. Prasad

    2005-01-01

    Performance-based regulation (PBR) has been mandated at the national level in the United States and at the agency level, where appropriate, at the U.S. Nuclear Regulatory Commission (USNRC). Guidance has been developed that implements the USNRC's definitions of PBR and other such conceptual regulatory improvements. This paper describes why PBR is important, what constitutes PBR in the context of direction provided at the USNRC, and how PBR can be implemented using a five-step process. The process steps articulate questions to be posed by the analyst regarding various aspects of a regulatory issue so that a suitably performance-based resolution can be developed. A regulatory alternative thus developed can be included among other options to be considered as part of the regulatory decision-making process

  3. 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.

  4. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM's evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7

  5. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2015-01-01

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

  6. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

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

  7. 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.

  8. 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...

  9. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-10-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  10. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1990-04-01

    The Regulatory Agenda is a quarterly compilation of all rules on which the NRC has recently completed action or has proposed, or is considering action and of all petitions for rulemaking that the NRC has received that are pending disposition

  11. 77 FR 6517 - Economic Development Administration Regulatory Revision; Comment Period Extension

    Science.gov (United States)

    2012-02-08

    ... DEPARTMENT OF COMMERCE Economic Development Administration 13 CFR Parts 300, 301, 302, 303, 304... Development Administration Regulatory Revision; Comment Period Extension AGENCY: Economic Development.... SUMMARY: On December 7, 2011, the Department of Commerce's Economic Development Administration (EDA...

  12. 76 FR 65909 - Medicare and Medicaid Program; Regulatory Provisions To Promote Program Efficiency, Transparency...

    Science.gov (United States)

    2011-10-24

    ... Efficiency, Transparency, and Burden Reduction AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS...-regulatory changes to increase transparency and to become a better business partner. As explained in the plan...

  13. 78 FR 49530 - Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop

    Science.gov (United States)

    2013-08-14

    ...] Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop AGENCY: Food and Drug... for Drug Evaluation and Research, in cosponsorship with the American College of Gastroenterology, the... American Society for Pediatric Gastroenterology, Hepatology, and Nutrition, and the Pediatric IBD...

  14. 77 FR 7663 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2012-02-13

    ... Administration National Archives and Records Administration Office of Personnel Management Pension Benefit... National Indian Gaming Commission Nuclear Regulatory Commission AGENCY AGENDAS Cabinet Departments... has appeared in the Federal Register twice each year since 1983 and has been available online since...

  15. Characterization of the evolution of the pharmaceutical regulatory environment.

    Science.gov (United States)

    Shafiei, Nader; Ford, James L; Morecroft, Charles W; Lisboa, Paulo J; Taylor, Mark J

    2013-01-01

    This paper is part of a research study that is intended to identify pharmaceutical quality risks induced by the ongoing transformation in the industry. This study establishes the current regulatory context by characterizing the development of the pharmaceutical regulatory environment. The regulatory environment is one of the most important external factors that affects a company's organization, processes, and technological strategy. This is especially the case with the pharmaceutical industry, where its products affect the quality of life of the consumers. The quantitative analysis of regulatory events since 1813 and review of the associated literature resulted in identification of six factors influencing the regulatory environment, namely public health protection, public health promotion, crisis management, harmonization, innovation, and modernization. From 1813 to the 1970s the focus of regulators was centered on crisis management and public health protection-a basic mission that has remained consistent over the years. Since the 1980s a gradual move in the regulatory environment towards a greater focus on public health promotion, international harmonization, innovation, and agency modernization may be seen. The pharmaceutical industry is currently going through changes that affect the way it performs its research, manufacturing, and regulatory activities. The impact of these changes on the approaches to quality risk management requires more understanding. The authors are engaged in research to identify elements of the changes that influence pharmaceutical quality. As quality requirements are an integral part of the pharmaceutical regulations, a comprehensive understanding of these regulations is seen as the first step. The results of this study show that (i) public health protection, public health promotion, crisis management, harmonization, innovation, and modernization are factors that affect regulations in the pharmaceutical industry; (ii) the regulators' main

  16. How well are national guidelines relating to the general sales of aspirin and paracetamol, adhered to by retail stores: a mystery shopper study

    Science.gov (United States)

    Molloy, Phillip; Chambers, Ruth; Cork, Tania

    2016-01-01

    Objective To determine whether non-pharmaceutical retail outlets are aboding to the current Medicines and Healthcare products Regulatory Agency (MHRA) national guidelines for over-the-counter (OTC) sales of aspirin and paracetamol. Methods Stages 1 and 2 of the study deployed eight and four medical students, respectively, to undertake a mystery shopper style investigation. Stage 1: eight medical students attempted to buy ≥96 tablets/capsules aspirin or paracetamol in one transaction in 62 shops. Stage 2: four medical students attempted to purchase 32 paracetamol 500 mg along with a ‘flu remedy preparation also containing paracetamol, in 54 shops. Results Stage 1 data revealed that 58% and 57% retailers sold more than the MHRA guidelines recommended for paracetamol and aspirin, respectively. We observed that 23% and 28% retailers were willing to sell ≥96 tablets of paracetamol or aspirin with no questions asked. Stage 2 results showed that 57% retailers sold 32×500 mg paracetamol in conjunction with a paracetamol-containing ‘flu preparation; while 98% shops sold 16×paracetamol 500 mg along with a paracetamol-containing ‘flu remedy, with no questions asked of the shopper or advice given. Discussion MHRA national guidelines for OTC medicines sales appear to be poorly adhered to in non-pharmacy shops. Sales of aspirin and paracetamol OTC must be better regulated in the UK to ultimately reduce morbidity and mortality rates of deliberate and accidental overdoses. PMID:26781508

  17. Investigation of the feasibility of toll and transit agency equity sharing : white paper.

    Science.gov (United States)

    2010-04-12

    This research project frames the institutional constraints and opportunities for equity sharing that currently exist in the highway, transit and toll agency realms and identifies statutory, regulatory and/or policy changes that may be requried. It al...

  18. ADVERTISING AGENCY MARKETING MANAGEMENT

    OpenAIRE

    Denis Kislov, Yevgenia Horobei

    2015-01-01

    Goal of the paper. The goal of this article is to define the nature, specific features and factors pertaining to the advertising agency marketing management. One of the tools is the use of non-standard approaches to management of advertising agencies, which under certain conditions makes it possible to improve the situation and to bring the agency to a new higher level as well as to improve the efficiency of its functioning in the conditions of transformational economy of Ukraine. Methodol...

  19. Institutional entrepreneurship and agency

    DEFF Research Database (Denmark)

    Weik, E.

    2011-01-01

    of collective entrepreneurship and institutional work to see if they can overcome these incongruities. I conclude that although they can remedy some of the problems, these notions run the risk of describing everything until they describe nothing. In order to limit and enable the entrepreneurship literature...... to discuss agency meaningfully, I argue, it needs to develop analytical frames of agency derived either from existing sociological theories or from further developing its own brand of agency theory. © 2011 Blackwell Publishing Ltd....

  20. 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.

  1. Nuclear Regulatory Commission Information Digest: 1993 edition

    International Nuclear Information System (INIS)

    1993-03-01

    The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the U.S. Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1992, with exceptions noted. Information on generating capacity and average capacity factor for operating U.S. 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. Comments and/or suggestions on the data presented are welcomed and should be directed to Karen Olive, United States Nuclear Regulatory Commission, Office of the Controller, Division of Budget and Analysis, Washington, D.C. 20555. For detailed and complete information about tables and figures, refer to the source publications

  2. 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.

  3. 76 FR 6094 - FAA Public Forum To Conduct Regulatory Review

    Science.gov (United States)

    2011-02-03

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 27 and 29 FAA Public Forum To Conduct Regulatory Review AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of public meeting. SUMMARY: The FAA announces an informal meeting to discuss the FAA rotorcraft rules, 14...

  4. Food irradiation regulatory development in the U.S

    International Nuclear Information System (INIS)

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

    1985-01-01

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

  5. 78 FR 23199 - NASA FAR Supplement Regulatory Review No. 1

    Science.gov (United States)

    2013-04-18

    ... 2700-AE01 NASA FAR Supplement Regulatory Review No. 1 AGENCY: National Aeronautics and Space Administration. ACTION: Proposed rule. SUMMARY: NASA is updating the NASA FAR Supplement (NFS) with the goal of... existing regulations. The revisions to this rule are part of NASA's retrospective plan under EO 13563...

  6. 18 CFR 367.2540 - Account 254, Other regulatory liabilities.

    Science.gov (United States)

    2010-04-01

    ... accounts, imposed on the service company by the ratemaking actions of regulatory agencies. (See Definitions § 367.1(a)(38).) (b) The amounts included in this account are to be established by those credits which... authorized to charge for its services; or refunds to customers, not provided for in other accounts, will be...

  7. 76 FR 24836 - Regulatory Approach for Commercial Orbital Human Spaceflight

    Science.gov (United States)

    2011-05-03

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

  8. 77 FR 65840 - Chrysanthemum White Rust Regulatory Status and Restrictions

    Science.gov (United States)

    2012-10-31

    ... Regulatory Status and Restrictions AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Advance... for our advance notice of proposed rulemaking that solicits public comment on whether and how we... importation of plant material that is a host of CWR. This action will allow interested persons additional time...

  9. 7 CFR 1700.32 - Program Accounting and Regulatory Analysis.

    Science.gov (United States)

    2010-01-01

    ... Administrator with respect to management, information systems, budgets, and other such matters. (a) The... 7 Agriculture 11 2010-01-01 2010-01-01 false Program Accounting and Regulatory Analysis. 1700.32... SERVICE, DEPARTMENT OF AGRICULTURE GENERAL INFORMATION Agency Organization and Functions § 1700.32 Program...

  10. 75 FR 79811 - Department Regulatory Agenda; Semiannual Summary

    Science.gov (United States)

    2010-12-20

    ....S.C. 602), DOT's printed agenda entries include only: 1. The Agency's agenda preamble; 2. Rules that... Regulatory Flexibility Act. Printing of these entries is limited to fields that contain information required... transfer of the functions from the Office of Emergency Transportation (OET) to the Office of Intelligence...

  11. 77 FR 40817 - Low-Level Radioactive Waste Regulatory Management Issues

    Science.gov (United States)

    2012-07-11

    ...-2011-0012] RIN-3150-AI92 Low-Level Radioactive Waste Regulatory Management Issues AGENCY: Nuclear... regulatory time of compliance for a low-level radioactive waste disposal facility, allowing licensees the... system, and revising the NRC's licensing requirements for land disposal of radioactive waste. DATES: The...

  12. Role of the Nuclear Regulatory Authority in the final disposal of radioactive wastes in Argentina

    International Nuclear Information System (INIS)

    Petraitis, E.J.; Siraky, G.; Novo, R.G.

    1998-01-01

    This paper describes briefly the legislative and regulatory framework in which the final disposal of radioactive wastes is carried out in Argentina. The activities of the Nuclear Regulatory Authority (ARN) and the applied approaches in relation to inspection of facilities, safety assessments of associated systems and collaboration in the matter with international agencies are also exposed. (author) [es

  13. 78 FR 44403 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2013-07-23

    ... agenda (the Agenda) in accordance with Public Law 96-354, ``The Regulatory Flexibility Act,'' and... goals; (2) support for the Strategic Plan organizational excellence objectives; (3) a governmental... Flexibility Act Section 610 of the Regulatory Flexibility Act (RFA) requires agencies to conduct a review...

  14. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

  15. 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.

  16. 78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-05-09

    ... Justice in Regulatory Analysis.'' The purpose of this guidance is to provide EPA analysts with technical...-566-2363. Mail: Technical Guidance for Assessing Environmental Justice in Regulatory Analysis... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OA-2013-0320; FRL-9810-5] Technical Guidance for Assessing...

  17. 78 FR 55765 - Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN...

    Science.gov (United States)

    2013-09-11

    ... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Draft..., ``Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN-FIRE).'' In... caused by impaired fire protection features at nuclear power plants. The report documents the history of...

  18. 75 FR 27028 - Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues

    Science.gov (United States)

    2010-05-13

    ... regulatory issues and their potential impact on investors and the securities markets. The Committee will lend... SECURITIES AND EXCHANGE COMMISSION [Release No. 33-9123; File No. 265-26] COMMODITY FUTURES TRADING COMMISSION Joint CFTC-SEC Advisory Committee on Emerging Regulatory Issues AGENCY: Securities and...

  19. 77 FR 12897 - Self-Regulatory Organizations; Pacific Securities Depository Trust Company; Order Cancelling...

    Science.gov (United States)

    2012-03-02

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-66460; File No. 600-10] Self-Regulatory Organizations; Pacific Securities Depository Trust Company; Order Cancelling Clearing Agency Registration...(a)(3) of the Act \\14\\ provides that in the event any self-regulatory organization is no longer in...

  20. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

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

  1. Autonomy of State Agencies

    DEFF Research Database (Denmark)

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

    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......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...... variables might explain similarities and differences in the autonomy of agencies....

  2. 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,...

  3. 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.

  4. Electricity and telecommunications regulatory institutions in small and developing countries

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-09-01

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

  5. The Australian radiation protection and Nuclear Safety Agency

    International Nuclear Information System (INIS)

    Macnab, D.; Burn, P.; Rubendra, R.

    1998-01-01

    The author talks about the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the new regulatory authority which will combine the existing resources of the Australian Radiation Laboratory and the Nuclear Safety Bureau. Most uses of radiation in Australia are regulated by State or Territory authorities, but there is presently no regulatory authority for Commonwealth uses of radiation. To provide for regulation of the radiation practices of the Commonwealth, the Australian Government has decided to establish the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) and a Bill has passed through the House of Representatives and will go to the Spring sitting of the Senate. The new agency will subsume the resources and functions of the Nuclear Safety Bureau and the Australian Radiation Laboratory, with additional functions including the regulation of radiation protection and nuclear safety of Commonwealth practices. Another function of ARPANSA will be the promotion of uniform regulatory requirements for radiation protection across Australia. This will be done by developing, in consultation with the States and Territories, radiation health policies and practices for adoption by the Commonwealth, States and Territories. ARPANSA will also provide research and services for radiation health, and in support of the regulatory and uniformity functions. The establishment of ARPANSA will ensure that the proposed replacement research reactor, the future low level radioactive waste repository and other Commonwealth nuclear facilities and radiation practices are subject to a regulatory regime which reflects the accumulated experience of the States and Territories and best international practice, and meets public expectations

  6. 75 FR 79449 - Introduction to The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory...

    Science.gov (United States)

    2010-12-20

    ... Administration 79677 Office of Personnel Management 79679 Pension Benefit Guaranty Corporation 79681 Small... National Indian Gaming Commission 79706 Postal Regulatory Commission 79708 AGENCY AGENDAS Cabinet... Register twice each year since 1983 and has been available online since 1995. To further the objective of...

  7. 78 FR 11686 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

    Science.gov (United States)

    2013-02-19

    ...: Submission for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: Nuclear Regulatory... introduction of byproduct material into products or materials and transfer of the products or materials to..., Office of Information and Regulatory Affairs (3150-0001), NEOB-10202, Office of Management and Budget...

  8. 78 FR 29364 - Seminole Electric Cooperative, Inc., and Florida Municipal Power Agency v. Duke Energy Florida...

    Science.gov (United States)

    2013-05-20

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. EL13-63-000] Seminole Electric Cooperative, Inc., and Florida Municipal Power Agency v. Duke Energy Florida, Inc.; Notice of... of the Federal Energy Regulatory Commission (Commission), 18 CFR 385.206 and sections 206, 306, and...

  9. 78 FR 50409 - Kansas Municipal Energy Agency v. Sunflower Electric Power Corporation, Mid-Kansas Electric...

    Science.gov (United States)

    2013-08-19

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket Nos. EL13-84-000] Kansas Municipal Energy Agency v. Sunflower Electric Power Corporation, Mid-Kansas Electric Company, LLC, Southwest... 306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the Federal Energy Regulatory...

  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

  11. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

    This compilation of statutes and material pertaining to nuclear regulatory legislation through the 100th Congress, 2nd Session, has been prepared by the Office of the General Counsel, US Nuclear Regulatory Commission, with the assistance of staff, for use as an internal resource document. Persons using this document are placed on notice that it may not be used as an authoritative citation in lieu of the primary legislative sources. Furthermore, while every effort has been made to ensure the completeness and accuracy of this material, neither the United States Government, the Nuclear Regulatory Commission, nor any of their employees makes any expressed or implied warranty or assumes liability for the accuracy or completeness of the material presented in this compilation

  12. The Copyright Agency Limited.

    Science.gov (United States)

    Morgan, Caroline

    1993-01-01

    The evolution and functions of Australia's Copyright Agency Limited are described. The agency is a copyright collecting organization which collectively administers the rights of authors and publishers whose works are copied in education, and enters into blanket agreements with educational authorities outside the existing statutory license. Some…

  13. Nuclear Regulatory Commission: 1981 annual report

    International Nuclear Information System (INIS)

    1981-01-01

    This seventh annual report of the US Nuclear Regulatory Commission covers major actions, events and planning that occurred during fiscal year 1981, with some coverage of later events, where appropriate. Chapters of the report address the agency's various functions or areas of activity: regulating nuclear power plants; evaluating reactor operating experience; licensing nuclear materials and their transportation; safeguarding nuclear plants and materials; managing nuclear wastes; inspection and enforcement; cooperation with state governments; international activities; research and standards development; hearings; decisions and litigation; and administrative and public communications matters. Each chapter presents a detailed review of program accomplishments during the report period, fiscal year 1981

  14. 1992 Nuclear Regulatory Commission Annual Report

    International Nuclear Information System (INIS)

    1993-01-01

    This is the 18th annual report of the US Nuclear Regulatory Commission (NRC), covering events and activities occurring in fiscal year 1992 (the year ending September 30, 1992), with some treatment of events from the last quarter of calendar year 1992. The NRC was created by enactment in the Congress of the Energy Reorganization Act of 1974. It is an independent agency of the Federal Government. The five NRC Commissioners are nominated by the President and confirmed by the United States Senate. The Chairman of the Commission is appointed by the President from among the Commissioners confirmed

  15. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

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

  16. Exhibition; Image display agency

    International Nuclear Information System (INIS)

    Normazlin Ismail

    2008-01-01

    This article touches on the role of Malaysian Nuclear Agency as nuclear research institutions to promote, develop and encourage the peaceful uses of nuclear technology in its agricultural, medical, manufacturing, industrial, health and environment for the development of the country running successfully. Maturity of Malaysian Nuclear Agency in dealing with nuclear technology that are very competitive and globalization cannot be denied. On this basis Malaysian Nuclear Agency was given the responsibility to strengthen the nuclear technology in Malaysia. One way is through an exhibition featuring the research, discoveries and new technology products of the nuclear technology. Through this exhibition is to promote the nuclear technology and introduce the image of the agency in the public eye. This article also states a number of exhibits entered by the Malaysian Nuclear Agency and achievements during the last exhibition. Authors hope that the exhibition can be intensified further in the future.

  17. Prediction of regulatory elements

    DEFF Research Database (Denmark)

    Sandelin, Albin

    2008-01-01

    Finding the regulatory mechanisms responsible for gene expression remains one of the most important challenges for biomedical research. A major focus in cellular biology is to find functional transcription factor binding sites (TFBS) responsible for the regulation of a downstream gene. As wet......-lab methods are time consuming and expensive, it is not realistic to identify TFBS for all uncharacterized genes in the genome by purely experimental means. Computational methods aimed at predicting potential regulatory regions can increase the efficiency of wet-lab experiments significantly. Here, methods...

  18. 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.

  19. UK medicines regulation: responding to current challenges.

    Science.gov (United States)

    Richards, Natalie; Hudson, Ian

    2016-12-01

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

  20. Hormesis in Regulatory risk assessment - Science and Science Policy.

    Science.gov (United States)

    Gray, George

    2011-01-01

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

  1. Is the online drugs market putting patients at risk?

    Science.gov (United States)

    Wilkinson, Emma

    A leading oncologist has warned that some patients with cancer are ordering drugs on the internet because they cannot access them in the UK. Examples include bevacizumab (Avastin) for the treatment of advanced bowel cancer, and erlotinib (Tarceva) for the treatment of lung cancer. The World Health Organization and the Medicines and Healthcare products Regulatory Agency (MHRA) advise great caution about buying medicines over the internet and say it should not be done without a valid prescription. This article discusses the growth of online pharmacies, problems with regulation and the dangers of self-prescribing.

  2. 75 FR 21723 - Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2010-04-26

    ... Commission National Science Foundation Office of Government Ethics Office of Management and Budget Office of Personnel Management Peace Corps Pension Benefit Guaranty Corporation Postal Regulatory Commission Railroad... individual data fields. To see a listing of all of an agency's entries, a user can select the agency without...

  3. 78 FR 25128 - Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Amended...

    Science.gov (United States)

    2013-04-29

    ... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69362A; File No. 600-23] Self-Regulatory Organizations; Fixed Income Clearing Corporation; Notice of Filing of Amended Application for Registration as a Clearing Agency; Correction AGENCY: Securities and Exchange Commission. ACTION: Notice; correction. SUMMARY...

  4. Lessons learnt from stakeholder engagement in the UK Environment Agency

    International Nuclear Information System (INIS)

    Chandler, Steve

    2004-01-01

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

  5. Developing regulatory approaches

    International Nuclear Information System (INIS)

    Axelsson, Lars

    2012-01-01

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

  6. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1992-07-01

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

  7. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-02-01

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

  8. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1989-07-01

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

  9. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1992-11-01

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

  10. Comments on regulatory reform

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1982-01-01

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

  11. Comments on regulatory reform

    Energy Technology Data Exchange (ETDEWEB)

    Hendrie, J.M.

    1982-01-01

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

  12. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

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

  13. Nuclear energy - some regulatory aspects

    International Nuclear Information System (INIS)

    Jennekens, Jon.

    1980-03-01

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

  14. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

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

  15. Expert Views on Regulatory Preparedness for Managing the Risks of Nanotechnologies

    Science.gov (United States)

    Beaudrie, Christian E. H.; Satterfield, Terre; Kandlikar, Milind; Harthorn, Barbara H.

    2013-01-01

    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. PMID:24244662

  16. 76 FR 72497 - Agency Information Collection Activities: Proposed Collection; Comment Request

    Science.gov (United States)

    2011-11-23

    ... displays a currently valid Office of Management and Budget (OMB) control number. The Federal Financial Institutions Examination Council (FFIEC), of which the agencies are members, has approved the agencies... Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room...

  17. 77 FR 5250 - Agency Information Collection Activities: Submission for OMB Review; Joint Comment Request

    Science.gov (United States)

    2012-02-02

    ... currently valid Office of Management and Budget (OMB) control number. On November 23, 2011, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), published a notice... agencies, Shagufta Ahmed, by mail to the Office of Information and Regulatory Affairs, Office of Management...

  18. 76 FR 2747 - Reports, Forms and Recordkeeping Requirements, Agency Information Collection Activity Under OMB...

    Science.gov (United States)

    2011-01-14

    ... entities over which the agency exercises regulatory authority. Recent trends lead the agency to estimate... confidential business information provisions of 49 CFR Part 512. Requesters are not required to keep copies of any records or reports submitted to us. As a result, the cost imposed to keep records would be zero...

  19. Detecting Social Innovation agency

    DEFF Research Database (Denmark)

    Pel, Bonno; Dorland, Jens; Wittmayer, Julia

    2017-01-01

    Considering that it is important for the social innovation research field to confront its methodological challenges, this contribution addresses the challenge of choosing appropriate units of analysis. In processes of transformative social innovation, the agency is distributed and therefore...

  20. 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

  1. 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...

  2. Agency IP Data

    Data.gov (United States)

    National Aeronautics and Space Administration — Public data set for NASA Agency Intellectual Property (IP). The distribution contains both Patent information as well as General Release of Open Source Software.

  3. White House Communications Agency

    National Research Council Canada - National Science Library

    Gimble, Thomas

    1995-01-01

    ...; and the Deputy Secretary of Defense requested the audit. The Deputy Secretary of Defense emphasized that this review should be as thorough as possible of all White House Communications Agency (WHCA...

  4. Agency privileges and immunities

    International Nuclear Information System (INIS)

    1969-01-01

    Switzerland has become the thirty-fifth Member State to be a party to the Agreement on the Privileges and Immunities of the International Atomic Energy Agency. Its Resident Representative, Ambassador Alfred Eschler, deposited his Government's instrument of acceptance on 16 September. This is the fourth such instrument to be deposited with the Agency since the beginning of this year, the others being Ecuador on 16 April, Niger on 17 June and Vietnam on 31 July. (author)

  5. Standard specification for agencies performing nondestructive testing

    CERN Document Server

    American Society for Testing and Materials. Philadelphia

    2009-01-01

    1.1 This specification covers minimum requirements for agencies performing nondestructive testing (NDT). 1.2 When using this specification to assess the capability of, or to accredit NDT agencies, Guide E 1359 shall be used as a basis for the survey. It can be supplemented as necessary with more detail in order to meet the auditor's specific needs. 1.3 This specification can be used as a basis to evaluate testing or inspection agencies, or both, and is intended for use for the qualifying or accrediting, or both, of testing or inspection agencies, public or private. 1.4 The use of SI or inch-pound units, or combination thereof, will be the responsibility of the technical committee whose standards are referred to in this standard. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to...

  6. 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.

  7. Nuclear Regulatory Commission information digest

    International Nuclear Information System (INIS)

    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

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

    International Nuclear Information System (INIS)

    Whitehead, W.

    1986-09-01

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

  9. Regulatory practices and safety standards for nuclear power plants

    International Nuclear Information System (INIS)

    1989-01-01

    The International Symposium on Regulatory Practices and Safety Standards for Nuclear Power Plants was jointly organized by the International Atomic Energy Agency (IAEA), for Nuclear Energy Agency of the OECD and the Government of the Federal Republic of Germany with the objective of providing an international forum for the exchange of information on regulatory practices and safety standards for nuclear power plants. The Symposium was held in Munich, Federal Republic of Germany, from 7 to 10 November 1988. It was attended by 201 experts from some 32 Member States and 4 international organizations. Fifty-one papers from 19 Member States and 2 international organizations were presented and discussed in 5 technical sessions covering the following subjects: National Regulatory Practices and Safety Standards (14 papers); Implementation of Regulatory Practices - Technical Issues (8 papers); Implementation of Regulatory Practices - Operational Aspects (8 papers); Developments and Trends in Safety Standards and Practices (11 papers); International Aspects (10 papers). A separate abstract was prepared for each of these papers. Refs, figs and tabs

  10. Environmental guidance regulatory bulletin

    International Nuclear Information System (INIS)

    1994-12-01

    On September 22,1993, the Environmental Protection Agency (EPA) published [58 Federal Register (FR) 492001 the final OffSite Rule, which defines criteria for approving facilities for receiving waste from response actions taken under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The off-site requirements apply to the off-site management of hazardous substances, pollutants, and contaminants, as defined under CERCLA, that are generated from remedial and removal actions funded or authorized, at least in part, by CERCLA. CERCLA-authorized cleanups include those taken under lead-agency authority, Section 106 Consent Orders, Consent Agreements, Consent Degrees, and Records of Decision (RODs). EPA requires that remedial actions at Federal facilities taken under Sections 104, 106, or 120 of CERCLA comply with the Off-Site Rule for all cleanups enacted through DOE's lead-agency authority

  11. ADVERTISING AGENCY MARKETING MANAGEMENT

    Directory of Open Access Journals (Sweden)

    Denis Kislov, Yevgenia Horobei

    2015-11-01

    Full Text Available Goal of the paper. The goal of this article is to define the nature, specific features and factors pertaining to the advertising agency marketing management. One of the tools is the use of non-standard approaches to management of advertising agencies, which under certain conditions makes it possible to improve the situation and to bring the agency to a new higher level as well as to improve the efficiency of its functioning in the conditions of transformational economy of Ukraine. Methodology. Monitoring of the marketing behavior of agencies that promote advertising services. The results of monitoring and analysis demonstrated that the majority of agencies have a disorganized approach to the agency marketing, which results in sporadic activities related to the use and organization of agency marketing. Only individual agencies begin to form their own marketing strategy for the implementation of which marketing budgets are allocated. The main marketing functions of a Ukrainian advertising agency have been identified. Practical value. Rapid development of technologies, sophistication and increased variety of goods and services, reduction of their life cycle, higher customer demands, the growth of volume and speed of obtaining information, increased competition – all these changes that are taking place in the external environment make the Ukrainian companies that provide advertising services search for new approaches to ensure better adaptation to these conditions. Uncertainty, unpredictability and instability of the external environment will continue to grow. Therefore, the companies that provide advertising services need to constantly adapt not only to the existing conditions but also ensure that they are able to quickly react in the future. The basic precondition for success is stability of the quality that is achieved through strategic planning, fine-tuned search system, efficient management, which encourages creation of a position of quality

  12. Characteristics of regulatory regimes

    Directory of Open Access Journals (Sweden)

    Noralv Veggeland

    2013-03-01

    Full Text Available The overarching theme of this paper is institutional analysis of basic characteristics of regulatory regimes. The concepts of path dependence and administrative traditions are used throughout. Self-reinforcing or positive feedback processes in political systems represent a basic framework. The empirical point of departure is the EU public procurement directive linked to OECD data concerning use of outsourcing among member states. The question is asked: What has caused the Nordic countries, traditionally not belonging to the Anglo-Saxon market-centred administrative tradition, to be placed so high on the ranking as users of the Market-Type Mechanism (MTM of outsourcing in the public sector vs. in-house provision of services? A thesis is that the reason may be complex, but might be found in an innovative Scandinavian regulatory approach rooted in the Nordic model.

  13. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-07-01

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

  14. Regulatory control of radiation sources. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

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

  15. Regulatory Enforcement and Compliance

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    1999-01-01

    This study of municipal enforcement of agro-environmental regulations in Denmark provides an empirical understanding of how enforcement affects compliance. A key contribution is sorting out the relative influence of inspectors' different styles of enforcement and choices made by enforcement...... 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...

  16. A flexible regulatory framework

    International Nuclear Information System (INIS)

    Silvennoinen, T.

    2000-01-01

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

  17. Regulatory aspects of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Kristensen, K.

    1985-01-01

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

  18. 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.

  19. 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

    International Nuclear Information System (INIS)

    1997-01-01

    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

  20. Using the IRRS to Strengthen Regulatory Competence in Ireland

    International Nuclear Information System (INIS)

    Smith, K.

    2016-01-01

    In 2015, Ireland underwent an IRRS (Integrated Regulatory Review Service) review mission. The purpose of the mission was to review Ireland’s radiation and nuclear safety regulatory framework and activities against the relevant IAEA safety standards, to report on the regulatory effectiveness and to exchange information and experience in the areas covered by the IRRS. The review mission was well-timed as there had been recent changes in the regulatory infrastructure with the merger of the Radiological Protection Institute of Ireland (RPII) and the Environmental Protection Agency (EPA) in 2014, as well as the upcoming implementation of the new Euratom Basic Safety Standards (BSS) Directive. The key objectives of the mission were to enhance the national legal, governmental and regulatory framework for nuclear and radiation safety, and national arrangements for emergency preparedness and response. The agreed scope of the review covered all relevant facilities and activities regulated in Ireland and also included medical exposures and public exposure to radon. In advance of the mission, Ireland completed a process of self-assessment and review. This process identified strengths and weaknesses in the national regulatory framework compared with the international standards. In addition to the value of having Ireland’s radiation protection framework peer reviewed by senior international experts, the mission helped to further strengthen links between all the national bodies (government, licensees, regulatory) with a role in the regulation of radiation safety. The findings from the IRRS review team’s objective evaluation of Ireland’s regulatory infrastructure are being used to prioritise actions for strengthening the regulatory framework, to provide input into the transposition of the Euratom BSS, and to support the revision of the national emergency plan for nuclear accidents. It is planned to have addressed the findings of the IRRS mission in advance of a follow up

  1. US regulatory system for genetically modified [genetically modified organism (GMO), rDNA or transgenic] crop cultivars.

    Science.gov (United States)

    McHughen, Alan; Smyth, Stuart

    2008-01-01

    This paper reviews the history of the federal regulatory oversight of plant agricultural biotechnology in the USA, focusing on the scientific and political forces moulding the continually evolving regulatory structure in place today. Unlike most other jurisdictions, the USA decided to adapt pre-existing legislation to encompass products of biotechnology. In so doing, it established an overarching committee (Office of Science and Technology Policy) to study and distribute various regulatory responsibilities amongst relevant agencies: the Food and Drug Administration, Environmental Protection Agency and US Department of Agriculture. This paper reviews the history and procedures of each agency in the execution of its regulatory duties and investigates the advantages and disadvantages of the US regulatory strategy.

  2. 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.

  3. Nuclear transport - The regulatory dimension

    International Nuclear Information System (INIS)

    Green, L.

    2002-01-01

    is important that regulators and operators comprehend each others positions. There is a clear determination on industry and the key international organisations to maintain dialogue. Through the World Nuclear Transport Institute, industry has a dedicated channel through which it can develop consolidated positions on nuclear transport matters and represent industry's collective views in the key bodies where the regulatory regime is discussed. WNTI provides the nuclear transport industry, with the collective voice in the key intergovernmental agencies which are so important to it. (author)

  4. 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

  5. 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.

  6. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2013-01-01

    - International co-operation: Law ratifying the agreement between the International Atomic Energy Agency and Greece in the area of education and training; - Nuclear safety and radiological protection: Ministerial decision establishing requirements for nuclear safety and regulatory control of research reactors; Moldova - General legislation: New comprehensive law governing nuclear and radiological activities; United States - Issuance of the 'Strategy for the Management and Disposal of Used Nuclear Fuel and High-Level Radioactive Waste'; - Ongoing activities: The Blue Ribbon Commission noted the need for near-term actions that can lay the groundwork for the next generation of nuclear waste policies and programmes included in its recommendations; - Physical protection of by-product material final rulemaking: On 19 March 2013, the NRC published a final rule amending its regulations to establish security requirements for the use and transport of category 1 and category 2 quantities of radioactive material; - Update on the NRC's response to the events at the Fukushima Daiichi nuclear site regarding filtered vents and consideration of economic consequences

  7. [The regulatory regime and the health insurance industry in Brazil].

    Science.gov (United States)

    Costa, Nilson do Rosário

    2008-01-01

    This paper analyzes the regulatory regime for health insurance and prepayment schemes in Brazil. It describes the ideas that have influenced the creation of the Agência Nacional de Saúde Suplementar-ANS (National Agency of Supplementary Health) in 2000, showing that the independent agency model was a direct result of the privatization process and of the induction of new competition mechanisms in a natural state monopoly. The paper concludes that the prepayment firms in Brazil are facing a new institutional environment as refers to their market entry or exit conditions.

  8. Schedules for Regulatory Regimes

    International Nuclear Information System (INIS)

    Austvik, Ole Gunnar

    2003-01-01

    The idea of regulating transporters' terms of operations is that if the market itself does not produce optimal outcomes, then it can be mimicked to do so through regulatory and other public instruments. The first-best solution could be a subsidized (publicly owned) enterprise that sets tariffs according to marginal costs. This has been the tradition in many European countries in the aftermath of WW2. Due to lack of innovative pressure on and x-inefficiency in these companies, this solution is today viewed as inferior to the system of regulating independent (privately owned) firms. When the European gas market becomes liberalized, part of the process in many countries is to (partially) privatise the transport utilities. Privatised or not, in a liberalized market, the transport utilities should face an independent authority that overviews their operations not only in technical, but also in economic terms. Under regulation, a ''visible hand'' is introduced to correct the imperfect market's ''invisible hand''. By regulating the framework and conditions for how firms may operate, public authorities seek to achieve what is considered optimal for the society. The incentives and disincentives given for pricing and production should create mechanisms leading to an efficient allocation of resources and ''acceptable'' distribution of income. As part of intervening into firms' behavior, regulation may be introduced to direct the firm to behave in certain ways. The framework and regulatory mechanisms for the market must then be constructed in a way that companies voluntarily produce an amount at a price that gives maximal profits and simultaneously satisfies social goals. The regulations should lead to consistency between the company's desire to maximize profits and the society's desire for maximizing welfare, as in a perfectly competitive market. This is the core of regulatory economics

  9. Regulatory review of probabilistic safety assessment (PSA) level 1

    International Nuclear Information System (INIS)

    2000-02-01

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

  10. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2002-01-01

    Different international regulatory activities are presented: recommendation on the protection of the public against exposure to radon in drinking water supplies, amendment to the legislation implementing the regulation on imports of agricultural products originating in third countries following the Chernobyl accident, resolution on the commission green paper towards a European strategy for the security of energy supply, declaration of mandatory nature of the international code for the safe carriage of packaged irradiated nuclear fuel, plutonium and high level radioactive wastes on board ships, adoption of action plan against nuclear terrorism. (N.C.)

  11. The core to regulatory reform

    International Nuclear Information System (INIS)

    Partridge, J.W. Jr.

    1993-01-01

    Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

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

    OpenAIRE

    Kerber, Wolfgang; Wendel, Julia

    2016-01-01

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

  13. 77 FR 64564 - Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles

    Science.gov (United States)

    2012-10-22

    ...-Basis Hurricane and Hurricane Missiles AGENCY: Nuclear Regulatory Commission. ACTION: Proposed interim...-ISG-024, ``Implementation of Regulatory Guide 1.221 on Design-Basis Hurricane and Hurricane Missiles....221, ``Design-Basis Hurricane and Hurricane Missiles for Nuclear Power Plants.'' DATES: Submit...

  14. 77 FR 40385 - Withdrawal of Regulatory Guide 7.3; Procedures for Picking Up and Receiving Packages of...

    Science.gov (United States)

    2012-07-09

    ... Picking Up and Receiving Packages of Radioactive Material AGENCY: Nuclear Regulatory Commission. ACTION.... Nuclear Regulatory Commission (NRC or Commission) is withdrawing RG 7.3, ``Procedures for Picking Up and... Public Document Room (PDR) reference staff at 1-800-397-4209, or 301-415-4737, or by email at PDR...

  15. 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...

  16. On Epistemic Agency

    DEFF Research Database (Denmark)

    Ahlström, Kristoffer

    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...

  17. 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...

  18. The sense of agency

    DEFF Research Database (Denmark)

    Ritterband-Rosenbaum, Anina

    Imagine that you are reaching for a cup of coffee. You experience that you are moving and that you have control of the movement you are executing. This feeling of control of your own body and the movements it is performing is called the sense of agency. This thesis consists of four studies which ...

  19. Anselm's logic of agency

    NARCIS (Netherlands)

    Uckelman, S.L.

    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

  20. Data and agency

    NARCIS (Netherlands)

    Kennedy, H.; Poell, T.; van Dijck, J.

    2015-01-01

    This introduction to the special issue on data and agency argues that datafication should not only be understood as the process of collecting and analysing data about Internet users, but also as feeding such data back to users, enabling them to orient themselves in the world. It is important that

  1. Data and agency

    Directory of Open Access Journals (Sweden)

    Helen Kennedy

    2015-12-01

    Full Text Available This introduction to the special issue on data and agency argues that datafication should not only be understood as the process of collecting and analysing data about Internet users, but also as feeding such data back to users, enabling them to orient themselves in the world. It is important that debates about data power recognise that data is also generated, collected and analysed by alternative actors, enhancing rather than undermining the agency of the public. Developing this argument, we first make clear why and how the question of agency should be central to our engagement with data. Subsequently, we discuss how this question has been operationalized in the five contributions to this special issue, which empirically open up the study of alternative forms of datafication. Building on these contributions, we conclude that as data acquire new power, it is vital to explore the space for citizen agency in relation to data structures and to examine the practices of data work, as well as the people involved in these practices.

  2. Federal Emergency Management Agency

    Science.gov (United States)

    ... Term(s): About the Agency Text Messages Federal Interagency Operational Plans Whole Community Technological Hazards Division - Contacts Accessible ASL ... content. Home About Us Download Plug-ins Doing Business with FEMA Privacy ... General Strategic Plan Whitehouse.gov DHS.gov Ready.gov USA.gov ...

  3. Regulatory control of the use of contractors by operating organizations. Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    2000-09-01

    This report arises from the eighth series of peer discussions on regulatory practices entitled 'Regulatory control of the use of contractors by operating organizations'. Senior regulators from 19 Member States participated in two peer group discussions in March 2000 and May 2000. This report gives an account of the outcomes of these meetings and of practical suggestions put forward by senior regulators. These suggestions do not necessarily reflect the views of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. The objective of this document is to share experience between regulatory bodies and provide practical suggestions for controlling the use of contractors and subcontractors by the operating organizations during all stages, especially operation, of a nuclear power plant, so as to ensure that the quality of work and services delivered is commensurate with the safety importance of the activities and that these are carried out in a manner that will not adversely affect the safe or reliable operation of the facility. These documented practical suggestions and experiences are the result of a series of peer discussions at the IAEA in 2000. It is considered that the manner in which control is exercised, and the various challenges connected to this control, are highly dependent upon the legislative framework, maturity of the nuclear programme, the size of the national nuclear industry and the culture in each country. The report is structured so that it covers the subject matter under the following main headings: Legal Provisions, Regulatory Strategy and Requirements; Regulatory Approaches for Controlling the Use of Contractors; Types of Contracts; Practical Suggestions

  4. Visions of regulatory renewal

    International Nuclear Information System (INIS)

    Edgeworth, A.

    1998-01-01

    The economic contribution of the CEPA (Canadian Energy Pipeline Association) member companies to Canada's trade balance was discussed. CEPA member companies transport 95 per cent of the crude oil and natural gas produced in Canada to domestic and export markets. This represents a total of 5.6 Tcf of gas annually. Half of Canada's natural gas and oil production is exported to U.S. markets. All of these exports are transported by pipeline. CEPA member companies operate 90,000 km of pipeline from British Columbia to Quebec. Expansions are needed as a result of a significant increase in demand for natural gas and crude oil since 1990. Several issues exist for regulatory renewal. They include the need to create a level playing field, the overseeing of tolls and contract renewal terms, changing risk/reward trade-offs, the right to confidentiality of information and price discovery mechanism. The drivers for regulatory reform at Westcoast Energy are the need for pricing flexibility, customers desire for toll certainty, decontracting and opposition to rolled-in expansions for gathering and processing. An overview of Westcoast Energy's negotiated toll settlement, its implications, and the components of Westcoast Energy's 'light handed regulation' (LHR) was presented

  5. The regulatory dynamic

    International Nuclear Information System (INIS)

    Dybwad, C.

    2001-01-01

    An outline of the activities and efforts expanded by the National Energy Board to adjust to the changing natural gas market was provided in this presentation. The author began by defining the role of the National Energy Board in energy markets. It must ensure the adoption of rules and procedures that result in a more competitive and efficient market. Light-handed regulatory techniques are the norm, and the National Energy Board is now committed to facilitating the availability and flow of information so that all parties know where opportunities exist, the terms offered to buy or sell goods and services, their quality and costs. It will specialize in providing new participants with information on the workings of the market, who the players are, the regulatory processes in place, and how, when and where the market can be accessed. The manner in which the Board deals with information was reviewed, providing examples along the way to clarify some points. Some of the documents produced by the National Energy Board are being reviewed with the intent of making them easier to read and understand. Audio streaming over the Internet is another avenue being pursued to ensure individuals can listen in real time to hearings without having to be present in the room. The National Energy Board is also exploring alternative dispute resolution techniques. Consultation with energy market participants represents another facet of these efforts to be more accessible and responsive

  6. 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.

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

    International Nuclear Information System (INIS)

    2014-01-01

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

  8. Innovations in the Delivery of Regulatory Services in Australia

    International Nuclear Information System (INIS)

    Dillich, J.

    2016-01-01

    The Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) is the country’s primary authority on radiation protection and nuclear safety. ARPANSA aims to promote safety, security, and emergency preparedness through efficient and effective regulation of nuclear installations, controlled facilities, and radiation sources. Recent initiatives to improve regulation by ‘cutting red tape’ and reducing regulatory burden have been introduced. ARPANSA’s Regulatory Delivery Model emphasises the key elements to good regulation and describes initiatives such as baseline inspection schedule, Performance Objectives and Criteria, and performance deficiencies. These and other initiatives have streamlined inspection efforts, increased risk-based oversight and risk-informed decision making, leading to increased efficiencies for both regulator and licence holder. In addition, ARPANSA has introduced 12 key performance indicators in its self-assessment of regulatory performance against the Australian Government’s Regulator Performance Framework. (author)

  9. Development of an international BRC [Below Regulatory Concern] limit

    International Nuclear Information System (INIS)

    Kennedy, W.E. Jr.

    1987-07-01

    The International Atomic Energy Agency (IAEA) has recently investigated the exemption from regulatory control of radiation sources containing limited quantities of radioactive materials. Early efforts were entitled de minimis and were aimed at establishing a philosophical basis and radiation dose limits. The main objectives of more recent work on exemption are to illustrate a method for developing practical radiological criteria, to establish generic criteria, and to determine the practicability of the preliminary exemption principles. The method used to develop the criteria relies on models to evaluate the potential radiation exposure pathways and scenarios for individuals and population groups potentially present following the unrestricted release of materials. This paper describes the assessment methods, presents the generic results expressed in terms of the limiting concentrations of selected radionuclides in municipal waste, and provides a comparison with recent regulatory efforts in the United States for considering selected wastes being Below Regulatory Concern (BRC). 17 refs., 4 tabs

  10. Selected legal and regulatory concerns affecting domestic energy transportation systems

    International Nuclear Information System (INIS)

    Schuller, C.R.

    1979-07-01

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

  11. Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

    OpenAIRE

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...

  12. Regulatory inspection of BARC facilities

    International Nuclear Information System (INIS)

    Rajdeep; Jayarajan, K.

    2017-01-01

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

  13. Innovative training techniques in the Canadian nuclear regulatory environment

    International Nuclear Information System (INIS)

    Martin, D.J.

    1996-01-01

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

  14. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2012-01-01

    This section gathers the following national legislative and regulatory activities sorted by country: Bulgaria: General legislation; Czech Republic: General legislation; France: General legislation, Regulatory infrastructure and activity; Germany: General legislation; India: Liability and compensation, Organisation and structure; Ireland: Radiation protection, General legislation; Korea (Republic of): Organisation and structure; Lithuania: Regulatory infrastructure and activity, Radioactive waste management, Radiation protection, international cooperation, Nuclear safety; Poland: General legislation; Romania: Environmental protection; Russian Federation: Radioactive waste management; Slovenia: Nuclear safety; Spain: Liability and compensation, Nuclear security; Sweden: Nuclear safety; Turkey: Radiation protection, Regulatory infrastructure and activity, Nuclear safety, Liability and compensation; United States: General legislation

  15. 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.

  16. Canada. Northern pipeline agency: Annual report, 1991-1992

    Energy Technology Data Exchange (ETDEWEB)

    1992-01-01

    Includes overview of the Alaska Highway Gas Pipeline Project with a review of construction activity to date, and gas markets. Discusses developments affecting operations of the pre-build, U.S. and Canadian developments for both the Eastern and Western legs, the Mackenzie Delta Gas Reserves, application of the bilateral agreement on procurement, and operations of the Canadian and US Regulatory Agencies. Also reviews finance, personnel, the Official Languages Plan and the Report of the Auditor General.

  17. 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.

  18. Research as relational agency

    DEFF Research Database (Denmark)

    Hasse, Cathrine

    2017-01-01

    the agency of iPads implemented in Danish schools challenged the implementation of a research based auxiliary artefact, the TECS-model, meant to help teachers managing teaching with iPads in Danish schools. Researchers had to develop a special sensitivity to the cultural force of all of these artefacts......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...... 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. Laboratories of Agency

    DEFF Research Database (Denmark)

    Majgaard, Klaus

    2015-01-01

    Something happens when management programmes move “into” the workplace of their participants. According to recent observations, such commissioned programmes are characterized by a more dedicated participation and transfer than open courses. This article interprets the mechanisms that can account...... for the observed pattern. One interpretation focuses on the realization of managerial regimes and forms of subjectivation. Another interpretation looks for the unleashing of new and multiple forms of agency. These two interpretations are mediated in the understanding of commissioned programmes...

  20. The Agency's budget

    International Nuclear Information System (INIS)

    1964-01-01

    A total Agency Budget of $10 406 000 for 1965 was approved by the General Conference at its session of September 1964; the Budget for the year 1964 amounted to $9 812 000. The consolidated Budget figures are shown in the table at the end of this article. The Budget falls into two parts - the Regular Budget and the Operational Budget. The Regular Budget provides for the ordinary administrative expenses of the Agency, and for expert panels, special missions, symposia and conferences, distribution of information, and scientific and technical services. In conformity with the Agency's Statute, these expenses are met by contributions made according to Voluntary contributions are paid initially into a General Fund established for this purpose, and money for operations is transferred to the respective Operating Funds as appropriate, and as approved by the Board of Governors. The scale of assessments for 1965 is based on the United Nations scale for 1964. The assessments are estimated to yield $7 713 000 - an increase of 6.8 per cent; however, more than three quarters of this increase will be offset by credits which Member States will receive as a result of a cash surplus brought forward. The Operational Budget is financed by voluntary contributions and is divided into two parts - Operating Fund I, devoted to certain laboratory and research projects, and Operating Fund II, for technical assistance, training and research contracts.

  1. Regulatory actions post - Fukushima

    International Nuclear Information System (INIS)

    Ciurea Ercau, C.

    2013-01-01

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

  2. 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.

  3. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2003-01-01

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

  4. Nuclear Regulatory Commission Issuances

    International Nuclear Information System (INIS)

    1992-01-01

    This is the thirty-sixth volume of issuances (1-396) of the Nuclear Regulatory Commission and its Atomic Safety and Licensing Boards, Administrative Law Judges, and Office Directors. It covers the period from July 1, 1992-December 31, 1992. Atomic Safety and Licensing Boards are authorized by Section 191 of the Atomic Energy Act of 1954. These Boards, comprised of three members conduct adjudicatory hearings on applications to construct and operate nuclear power plants and related facilities and issue initial decisions which, subject to internal review and appellate procedures, become the final Commission action with respect to those applications. Boards are drawn from the Atomic Safety and Licensing Board Panel, comprised of lawyers, nuclear physicists and engineers, environmentalists, chemists, and economists. The Atomic Energy Commission first established Licensing Boards in 1962 and the Panel in 1967

  5. The Texts of the Agency's Relationship Agreements with Specialized Agencies

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1962-04-10

    The text of the relationship agreement which the Agency has concluded with the Inter-Governmental Maritime Consultative Organization, together with the protocol authenticating it, is reproduced in this document for the information of all Members of the Agency.

  6. The Texts of the Agency's Relationship Agreements with Specialized Agencies

    International Nuclear Information System (INIS)

    1962-01-01

    The text of the relationship agreement which the Agency has concluded with the Inter-Governmental Maritime Consultative Organization, together with the protocol authenticating it, is reproduced in this document for the information of all Members of the Agency

  7. 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.

  8. 77 FR 72296 - Public Meeting of the U.S.-Canada Regulatory Cooperation Council (RCC) Motor Vehicles Working Group

    Science.gov (United States)

    2012-12-05

    ... the initiatives identified in the Joint Action Plan, bilateral working groups led by senior officials... Plan, bilateral working groups led by senior officials from regulatory agencies have developed work... Vehicles Working Group AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT. ACTION...

  9. 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

  10. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    Sørensen, Karsten Engsig

    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....

  11. The Texts of the Agency's Relationship Agreements with Specialized Agencies

    International Nuclear Information System (INIS)

    1960-01-01

    The texts of the relationship agreements which the Agency has concluded with the specialized agencies listed below, together with the respective protocols authenticating them, are reproduced in this document in the order which the agreements entered into force, for the information of all Members of the Agency [es

  12. The Texts of the Agency's Relationship Agreements with Specialized Agencies

    International Nuclear Information System (INIS)

    1960-01-01

    The texts of the relationship agreements which the Agency has concluded with the specialized agencies listed below, together with the respective protocols authenticating them, are reproduced in this document in the order which the agreements entered into force, for the information of all Members of the Agency [fr

  13. The Texts of the Agency's Relationship Agreements with Specialized Agencies

    International Nuclear Information System (INIS)

    1960-01-01

    The texts of the relationship agreements which the Agency has concluded with the specialized agencies listed below, together with the respective protocols authenticating them, are reproduced in this document in the order which the agreements entered into force, for the information of all Members of the Agency

  14. DOE regulatory reform initiative vitrified mixed waste

    International Nuclear Information System (INIS)

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

    1997-01-01

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

  15. 12 CFR 562.2 - Regulatory reports.

    Science.gov (United States)

    2010-01-01

    ... § 562.2 Regulatory reports. (a) Definition and scope. This section applies to all regulatory reports, as... (TFR) are examples of regulatory reports. Regulatory reports are regulatory documents, not accounting... limited to, the accounting instructions provided in the TFR, guidance contained in OTS regulations...

  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. Virginia Power's regulatory reduction program

    International Nuclear Information System (INIS)

    Miller, G.D.

    1996-01-01

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

  18. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    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......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...

  19. Competencies Setup for Nuclear Regulatory Staff in Thailand

    International Nuclear Information System (INIS)

    Pingish, Panupong; Siripirom, Lopchai; Nakkaew, Pongpan; Manuwong, Theerapatt; Wongsamarn, Vichian

    2010-01-01

    Competencies setup for regulatory bodies oversee a research reactor and nuclear power reactors in Thailand, concentrating on staff development in areas of review and assessment, inspection and enforcement, authorization, and development of regulations and guides. The regulatory body in Thailand is the Bureau of Nuclear Safety Regulation (BNSR) which belongs to the Office of Atoms for Peace (OAP). The BNSR is divided into 4 groups according to the International Atomic Energy Agency (IAEA). These groups are the nuclear safety administration group, nuclear safety technical support group, nuclear safety assessment and licensing group, and the nuclear installations inspection group. Each group is divided into senior and junior positions. The competencies model was used for implementation of staff qualification, career planning and professional progression by BNSR. Competencies are related to knowledge, skills and attitudes (KSAs) needed to perform their job. A key issue is obtaining competencies for the regulatory bodies. The systematic approach to training (SAT) has been used in several countries for improvement regulator performance. The SAT contains 5 steps, including analysis, design, development, implementation and evaluation, to achieve competencies. The SAT provides a logical progression from the identification of competencies required to perform a job to the design, development and implementation of training using the competencies model. In the first step, BNSR performs an operating analysis of training needs assessment (TNA) by using gap analysis technique, as suggested by IAEA. Individual regulatory bodies address the gap using appropriate training program, after comparing the actual and desired competency profiles to determine the gap. This paper examines competencies setup for regulatory staff of BNSR as a result of gaps analysis to establish a scheme for design characteristics of regulatory staff and training courses, thereby enhancing the regulatory

  20. The Agency's Safeguards System (1965)

    International Nuclear Information System (INIS)

    1965-01-01

    On 28 September 1965 the Board of Governors approved the Agency's revised safeguards system which is set forth in this document for the information of all Members. For ease of reference the revised system may be cited as 'The Agency's Safeguards System (1965)' to distinguish it from the original system - 'The Agency's Safeguards System (1961)'- and from the original system as extended to large reactor facilities - 'The Agency's Safeguards System (1961, as Extended in 1964)'

  1. A sense of agency

    DEFF Research Database (Denmark)

    Laerkner, Eva; Egerod, Ingrid; Olesen, Finn

    2017-01-01

    familiar in the unfamiliar situation" and "Awareness of surrounding activities". Patients had the ability to interact from the first days of critical illness and a sense of agency was expressed through initiating, directing and participating in communication and other activities. Patients appreciated...... 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...

  2. The liberal state and the rogue agency: FDA’s regulation of drugs for mood disorders, 1950s–1970s☆

    Science.gov (United States)

    Shorter, Edward

    2013-01-01

    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. PMID:18343498

  3. 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.

  4. Strengthening of the nuclear safety regulatory body. Field evaluation review

    International Nuclear Information System (INIS)

    1996-10-01

    As a result of a request from the Preparation Committee of the Nuclear Regulatory Authority (NRA) in 1992, and as recommended by the CEC/RAMG (Commission of European Communities/Regulatory Assistance Management Group) and the Agency mission in July 1993 to the Slovak Republic, the project SLR/9/005 was approved in 1993 as a model project for the period 1994-1996. Current budge is $401,340 and disbursements to date amount to $312,873. The project time schedule has been extended to 1997. The major conclusions of this evaluation are as follows: The project responded to an urgent national need, as well as to a statutory mandate of the Agency, and was adequately co-ordinated with other international assistance programmes to NRA. The project was designed as a structured programme of assistance by means of expert missions, scientific visits and a limited amount of equipment, acting upon several key areas of NRA regulatory responsibilities. Agency assistance was provided in a timely manner. A high concentration of expert missions was noticed at the initial stages of the project, which posed some managements problems. This was corrected to some extent in the course of implementation. Additionally, some overlapping of expert mission recommendations suggests that improvements are needed in the design of such missions. The exposure to international regulatory practice and expertise has resulted in substantial developments of NRA, both in organizational and operational terms. The project can claim to have contributed to NRA having gained governmental and international confidence. NRA's role in the safety assessment of Bohunice V1 reconstruction, as well as in Bohunice V2 safety review, Bohunice A1 decommissioning and in informing the public, also points at the success achieved by the project. The institutional and financial support of the Government contributed decisively to the project achievements. (author). Figs, tabs

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

    International Nuclear Information System (INIS)

    2018-01-01

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

  6. Challenges in Strengthening Regulatory Infrastructure in a Non-Nuclear Country

    International Nuclear Information System (INIS)

    Bosnjak, J.

    2016-01-01

    The State Regulatory Agency for Radiation and Nuclear Safety (SRARNS) is established as the effectively independent regulatory body for radiation and nuclear safety based on the Law on Radiation and Nuclear Safety in Bosnia and Herzegovina promulgated in November 2007. After its complete reorganization in the last few years, the regulatory system is compatible with relevant IAEA Safety Standards and Guides for safety and security of radioactive sources. The paper gives an overview of the new regulatory framework in Bosnia and Herzegovina, with special focus on challenges faced by Bosnia and Herzegovina, which are actually typical challenges for regulator in small non-nuclear country in strengthening regulatory infrastructure in regulating radiation sources and radioactive waste. (author)

  7. 75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

    Science.gov (United States)

    2010-03-10

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

  8. Ontario regulatory update

    International Nuclear Information System (INIS)

    Thompson, P.

    1998-01-01

    This paper provides a summary of recent events which when combined add up to a gradual but unmistakable movement of the energy sector in Ontario towards a fully competitive market. Some of the events precipitating this movement towards competition include the passing of the Energy Competition Act of 1998 (Bill 35), electricity deregulation, regulatory reform of the natural gas sector, and changes to the consumer protection legislation. The role of the Ontario Energy Board was also updated to bring it in line with the demands of the competitive marketplace. Among the new roles that the Board will assume are to facilitate competition, to maintain fair and reasonable rates, and to facilitate rational expansion. Another objective is to provide opportunities for including energy efficiency in government policies. Implications of the changes in the OEB's mandate for market participants were also discussed, including (1) regulated gas sales and delivery mechanisms, (2) transactional services, (3) contract restructuring, (4) consumer protection, (5) supervision of competitive market participants, and (6) market surveillance

  9. Regulatory risk coherence

    International Nuclear Information System (INIS)

    Remick, F.J.

    1992-01-01

    As one of the most progressive users of risk assessment in decision making, the US Nuclear Regulatory Commission (NRC) is in a position to play an important role in influencing the development of standard government wide policies for the application of risk assessment in decision making. The NRC, with the support of the nuclear industry, should use the opportunity provided by its experience with risk assessment to actively encourage the adoption of standard national and international health-based safety goals and at the same time accelerate its own efforts to implement the safety goals it has already developed for itself. There are signs of increased recognition of the need for consistency and coherence in the application of risk assessment in government decision making. The NRC and the nuclear industry have recently taken a great step toward establishing a consistant and coherent risk assessment-based culture in the US nuclear industry. As a result of Generic Letter 88-20, which asks each commercial nuclear power plant licensee to perform an individual plant examination by September 1992, for the first time a risk assessment characterizing initiating events in each plant will exist

  10. Southern state radiological emergency preparedness and response agencies

    International Nuclear Information System (INIS)

    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

  11. Factors Influencing Trust in Agencies That Disseminate Tobacco Prevention Information.

    Science.gov (United States)

    Ranney, Leah M; Jarman, Kristen L; Baker, Hannah M; Vu, Maihan; Noar, Seth M; Goldstein, Adam O

    2018-04-01

    Several health-related agencies administer national and targeted public education campaigns to provide health information and change health-related behaviors. The trust the public has in these agencies as the source of the message impacts the effectiveness of their communication campaigns. In this study, we explore the perceived trust of agencies that communicate health messages in the tobacco control field. As part of a larger tobacco regulatory science study, we conducted six 90-min focus groups comprising 41 participants. Five main themes emerged pertinent to the agency: (1) its integrity, (2) its competence, (3) its motives, (4) how it is portrayed in the media, and (5) skepticism and mistrust about it. Given the significant resources spent on health messaging to the public and potential benefits offered by this communication, an understanding of public trust in the agencies as the source of health messages is important. Findings suggest health information may be ignored or discounted when there is mistrust in the agency sending those messages.

  12. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

    Science.gov (United States)

    Asano, K; Tanaka, A; Sato, T; Uyama, Y

    2013-08-01

    Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

  13. 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...

  14. Argentina's regulatory body: its communication activities

    International Nuclear Information System (INIS)

    Cesario, Pablo A.; Terigi, Gabriel E.

    2008-01-01

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

  15. Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

    International Nuclear Information System (INIS)

    Illizastigui, P.F.

    2016-01-01

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

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

    Directory of Open Access Journals (Sweden)

    Varley Dias Sousa

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

  17. 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.

  18. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2004-01-01

    The 48. session of the IAEA general conference was held in Vienna from 20 to 24 september 2004 with the participation of delegates from 125 members states and representatives of various international organisations. A number of resolutions were adopted by the conference in the following fields: nuclear safety, radiation, transport and waste safety. The general conference also adopted a resolution on measures to protect against nuclear terrorism. The Director General decided in 2003 to appoint a group of experts to explore and advise on issues related to nuclear liability. This group called the International Expert Group on Nuclear Liability (I.N.L.E.X.) consists of 20 experts members from nuclear power and non nuclear power countries and from shipping and non shipping states. It serves three major functions: to create a forum of expertise to explore and advise on issues related to nuclear liability; to enhance global adherence by nuclear and non nuclear states to an effective nuclear liability regime, inter alia, on the basis of the convention on supplementary compensation for nuclear damage and the annex thereto, the Vienna convention on civil liability for nuclear damage, the Paris convention on third party liability in the field of nuclear energy, the joint protocol relating to the application of the vienna convention and the paris convention and the amendments thereto; and to assist in the development and strengthening of the national nuclear liability legal frameworks in IAEA members states to protect the public and the environment and to enhance nuclear safety. The second part of international regulatory concerns a directive on public access to environmental information made by the European Parliament. (N.C.)

  19. Neuromodulation, agency and autonomy.

    Science.gov (United States)

    Glannon, Walter

    2014-01-01

    Neuromodulation consists in altering brain activity to restore mental and physical functions in individuals with neuropsychiatric disorders and brain and spinal cord injuries. This can be achieved by delivering electrical stimulation that excites or inhibits neural tissue, by using electrical signals in the brain to move computer cursors or robotic arms, or by displaying brain activity to subjects who regulate that activity by their own responses to it. As enabling prostheses, deep-brain stimulation and brain-computer interfaces (BCIs) are forms of extended embodiment that become integrated into the individual's conception of himself as an autonomous agent. In BCIs and neurofeedback, the success or failure of the techniques depends on the interaction between the learner and the trainer. The restoration of agency and autonomy through neuromodulation thus involves neurophysiological, psychological and social factors.

  20. 78 FR 44279 - Regulatory Agenda

    Science.gov (United States)

    2013-07-23

    ... Vol. 78 Tuesday, No. 141 July 23, 2013 Part XI Department of Justice Semiannual Regulatory Agenda #0;#0;Federal Register / Vol. 78 , No. 141 / Tuesday, July 23, 2013 / Unified Agenda#0;#0; [[Page 44280

  1. Recent regulatory issues in Finland

    International Nuclear Information System (INIS)

    Laaksonen, J.; Tiipana, P.

    2001-01-01

    This paper presents general regulatory issues from Finland since the last WWER Regulators Forum meeting in Odessa 11-13 October 2000. More specific issues concerning Loviisa NPP are described in the Annex of this paper. (author)

  2. National legislative and regulatory activities

    International Nuclear Information System (INIS)

    2016-01-01

    This section treats of the following National legislative and regulatory activities: 1 - France: General legislation, regulations and instruments; Nuclear trade (including non-proliferation); International co-operation; 2 - India: Licensing and regulatory infrastructure; Liability and compensation; 3 - Ireland: Nuclear safety and radiological protection (including nuclear emergency planning); Transport of radioactive material; Nuclear trade (including non-proliferation); 4 - Lithuania: Licensing and regulatory infrastructure; Nuclear safety and radiological protection (including nuclear emergency planning); Radioactive waste management; 5 - Luxembourg: Nuclear safety and radiological protection (including nuclear emergency planning); 6 - Slovak Republic: International co-operation; General legislation, regulations and instruments; 7 - Spain: Radioactive materials (including physical protection); Radioactive waste management; 8 - United States: Licensing and regulatory infrastructure

  3. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    1999-06-01

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

  4. State/Federal Regulatory Considerations

    Science.gov (United States)

    This page contains presentations from the Brown to Green: Make the Connection to Renewable Energy workshop held in Santa Fe, New Mexico, during December 10-11, 2008, regarding State/Federal Regulatory Considerations.

  5. Report of the International Atomic Energy Agency to the General Assembly of the United Nations

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1959-10-15

    The report is submitted in accordance with Article III.B.4 of the Statute and Article III of the Relationship Agreement between the two organizations and describes the important developments in the work of the Agency from 1 July 1950 to 30 June 1959. It is thus the first to cover a full year of the activities of the Agency. The important developments in the Agency's work since the report was prepared are covered briefly in this preface. The period covered is characterized by the fact that Member States began to make substantial requests to the Agency for assistance, which the Agency was able to meet. Furthermore, the Agency began to carry out its regulatory tasks, organized its first meeting, conferences and symposia, started its own research and greatly expanded the collection and publication of technical information.

  6. 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. Copyright © Taylor & Francis Group, LLC

  7. Report of the International Atomic Energy Agency to the General Assembly of the United Nations

    International Nuclear Information System (INIS)

    1959-10-01

    The report is submitted in accordance with Article III.B.4 of the Statute and Article III of the Relationship Agreement between the two organizations and describes the important developments in the work of the Agency from 1 July 1950 to 30 June 1959. It is thus the first to cover a full year of the activities of the Agency. The important developments in the Agency's work since the report was prepared are covered briefly in this preface. The period covered is characterized by the fact that Member States began to make substantial requests to the Agency for assistance, which the Agency was able to meet. Furthermore, the Agency began to carry out its regulatory tasks, organized its first meeting, conferences and symposia, started its own research and greatly expanded the collection and publication of technical information

  8. 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.

  9. Status report on NRC's current below regulatory concern activities

    International Nuclear Information System (INIS)

    Dragonette, K.S.

    1988-01-01

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

  10. Challenges in Establishing New Regulatory Body in Sri Lanka

    International Nuclear Information System (INIS)

    Hikkaduwa Liyanage, A.R.

    2016-01-01

    Sri Lanka's involvement with Nuclear Science and Technology began in 1957 when it became a member of the International Atomic Energy Agency. This was followed by the establishment of the Radioisotope Centre of the University of Colombo in 1962 and the establishment of the Atomic Energy Authority (AEA) in 1969 by the Atomic Energy Authority Act no. 19 of 1969. The Atomic Energy Authority Act delegated two main responsibilities to the AEA, namely, promotion of the utilization of nuclear technology for the benefit of the people of Sri Lanka, and protection of workers engaged in using radiation and radioisotopes and the public from harmful effects of ionizing radiation. Until 2014, the Atomic Energy Authority functioned as the national regulatory authority on use of radiation and radioisotopes, the national organization responsible for facilitating the use of nuclear technology in medical, industrial and agricultural sectors and as the focal point of the International Atomic Energy Agency in Sri Lanka. With the expansion of uses of radiation in Sri Lanka and commencement of use of high activity sources by the AEA for development and business activities, the need for an independent regulatory authority was realized. The importance of establishment of independent regulatory body for Sri Lanka was also emphasized by the IAEA in several advisory missions conducted in Sri Lanka and as results; a new Act on Atomic Energy was promulgated.

  11. Regulatory Framework for Controlling the Research Reactor Decommissioning Project

    International Nuclear Information System (INIS)

    Melani, Ai; Chang, Soon Heung

    2009-01-01

    Decommissioning is one of important stages in construction and operation of research reactors. Currently, there are three research reactors operating in Indonesia. These reactors are operated by the National Nuclear Energy Agency (BATAN). The age of the three research reactors varies from 22 to 45 years since the reactors reached their first criticality. Regulatory control of the three reactors is conducted by the Nuclear Energy Regulatory Agency (BAPETEN). Controlling the reactors is carried out based on the Act No. 10/1997 on Nuclear Energy, Government Regulations and BAPETEN Chairman Decrees concerning the nuclear safety, security and safeguards. Nevertheless, BAPETEN still lack of the regulation, especially for controlling the decommissioning project. Therefore, in the near future BAPETEN has to prepare the regulations for decommissioning, particularly to anticipate the decommissioning of the oldest research reactors, which probably will be done in the next ten years. In this papers author give a list of regulations should be prepared by BAPETEN for the decommissioning stage of research reactor in Indonesia based on the international regulatory practice

  12. Regulatory competition in partnership law.

    OpenAIRE

    Siems, Mathias

    2009-01-01

    Regulatory competition in company law has been extensively debated in the last few decades, but it has rarely been discussed whether there could also be regulatory competition in partnership law. This article fills this gap. It addresses the partnership law of the US, the UK, Germany, and France, and presents empirical data on the different types of partnerships and companies established in these jurisdictions. The main focus is on the use of a limited liability partnership (LLP) outside its ...

  13. Nuclear regulatory developments in Canada

    International Nuclear Information System (INIS)

    Binder, M.

    2012-01-01

    This paper from CNSC discusses nuclear regulatory developments in Canada. It starts with the Fukushima accident and the effect on the nuclear sector. It summarises what CNSC has done, what it has learned and their plans going forward. It has made recommendations to IAEA for international enhancements to regulatory procedures. It outline the activities of Canada's nuclear power plants, Canada's uranium projects, deep geological repository and waste management as well as nuclear research in Canada.

  14. 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.

  15. How Does Temporary Agency Work Impact German Agency Workers?

    OpenAIRE

    Spermann, Alexander

    2013-01-01

    The enormous speed of change in the working world is associated with greater job insecurity. As a dynamic external flexibilization instrument, temporary agency work is characterized by high labor turnover rates. As a result, agency workers might perceive more job insecurity than permanent staff. This paper surveys German empirical studies on outcome variables such as job satisfaction, commitment, health, employability, social participation and effects on personal life for agency workers. It i...

  16. Agency costs and income taxation

    Directory of Open Access Journals (Sweden)

    Ulrich Schmidt

    2012-03-01

    Full Text Available This paper analyzes agency costs and the moral hazard problem in the presence of income taxation. As basic framework, income taxes are integrated in the hidden action model of agency theory. In the case of symmetric information no agency costs occur, i.e. optimal risk-sharing can be achieved, if and only if the tax is proportional. It is well-known that asymmetric information causes a welfare loss, termed agency costs, even if no taxes are imposed. Introducing a proportional income tax now increases (decreases these agency costs if the agent exhibits decreasing (increasing absolute risk aversion. Additionally, we show that non-proportional taxes cause higher (lower agency costs than a proportional tax if the agent’s marginal tax rate exceeds (is smaller than the marginal tax rate of the principal.

  17. 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.

  18. The Members of the Agency

    International Nuclear Information System (INIS)

    1995-01-01

    The new member since the last list of Member States of the Agency was issued (INFCIRC/2/Rev.44) is Yemen. The Attachment hereto shows the dates on which the 122 States became members of the Agency, as well as the State whose application for membership of the Agency was approved by the General Conference, but which has not yet deposited an instrument of acceptance of the Statute

  19. The members of the Agency

    International Nuclear Information System (INIS)

    1994-01-01

    The new members since the last list of Member States of the Agency was issued (INFCIRC/2/Rev.42) are: Armenia, Coratia, the Czech Republic, Lithuania, the Marshall Islands, the Slovak Republic and Uzbekistan. The Attachment to the circular shows the dates on which the 120 States became members of the Agency, as well as those States whose application for membership of the Agency was approved by the General Conference, but who have not yet deposited an instrument of acceptance of the Statute

  20. The Members of the Agency

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-02-13

    The new member since the last list of Member States of the Agency was issued (INFCIRC/2/Rev.44) is Yemen. The Attachment hereto shows the dates on which the 122 States became members of the Agency, as well as the State whose application for membership of the Agency was approved by the General Conference, but which has not yet deposited an instrument of acceptance of the Statute.

  1. 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.

  2. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

  3. The Members of the Agency

    International Nuclear Information System (INIS)

    1994-01-01

    The new members since the last list of Member States of the Agency was issued (INFCIRC/2/Rev.43) are: Kazakhstan and the former Yugoslav Republic of Macedonia. The Democratic People's Republic of Korea withdrew from membership of the Agency as of 13 June 1994. The Attachment hereto shows the dates on which the 121 States became members of the Agency, as well as those States whose application for membership of the Agency was approved by the General Conference, but who have not yet deposited an instrument of acceptance of the Statute

  4. Southern states' routing agency report

    International Nuclear Information System (INIS)

    1989-02-01

    The Southern states' routing agency report is a compendium of 16-southern states' routing programs relative to the transportation of high-level radioactive materials. The report identifies the state-designated routing agencies as defined under 49 Code of Federal Regulations (CFR) Part 171 and provides a reference to the source ad scope of the agencies' rulemaking authority. Additionally, the state agency and contact designated by the state's governor to receive advance notification and shipment routing information under 10 CFR Parts 71 and 73 are also listed

  5. Southern States' Routing Agency Report

    International Nuclear Information System (INIS)

    1990-03-01

    The Southern States' Routing Agency Report is a compendium of 16-southern states' routing program for the transportation of high-level radioactive materials. The report identifies the state-designated routing agencies as defined under 49 Code of Federal Regulations (CFR) Part 171 and provides a reference to the source and scope of the agencies' rulemaking authority. Additionally, the state agency and contact designated by the state's governor to receive advance notification and shipment routing information under 10 CFR Parts 71 and 73 are also listed

  6. 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…

  7. 77 FR 7960 - Unified Agenda of Federal Regulatory and Deregulatory Actions

    Science.gov (United States)

    2012-02-13

    ... Sequence No. Title Identifier No. 377 Claims Procedures Under 1625-AA03 the Oil Pollution Act of 1990 (USCG... Regulatory Flexibility Analysis Required: Yes. Agency Contact: Jeremy F. Olson, Senior Procurement Analyst... Procedures Under the Oil Pollution Act of 1990 (USCG-2004- 17697) Legal Authority: 33 U.S.C. 2713 and 2714...

  8. 77 FR 29001 - Medicare and Medicaid Program; Regulatory Provisions to Promote Program Efficiency, Transparency...

    Science.gov (United States)

    2012-05-16

    ... Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Final Rule #0;#0;Federal..., Transparency, and Burden Reduction AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final... on providers of care. CMS has also identified non-regulatory changes to increase transparency and to...

  9. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Science.gov (United States)

    2013-11-07

    ... for such products. These inconsistent interpretations of the definitions may inadvertently result in... amplification products (PSAPs), as well as the regulatory controls that apply to each. This draft guidance is... of clarity regarding how the Agency defines a hearing aid versus a personal sound amplification...

  10. Low doses of ionizing radiation: Biological effects and regulatory control. Contributed papers

    International Nuclear Information System (INIS)

    1997-11-01

    The International Atomic Energy Agency and the World Health Organization, in cooperation with the United Nations Scientific Committee on the Effects of Atomic Radiation, organized an international conference on Low Doses of Ionizing Radiation: Biological Effects and Regulatory Control, held in seville, Spain, from 17 to 21 November 1997. This technical document contains concise papers submitted to the conference

  11. Low doses of ionizing radiation: Biological effects and regulatory control. Contributed papers

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-11-01

    The International Atomic Energy Agency and the World Health Organization, in cooperation with the United Nations Scientific Committee on the Effects of Atomic Radiation, organized an international conference on Low Doses of Ionizing Radiation: Biological Effects and Regulatory Control, held in seville, Spain, from 17 to 21 November 1997. This technical document contains concise papers submitted to the conference. Refs, figs, tabs.

  12. 78 FR 18947 - Fisheries of the Northeastern United States; Tilefish Fishery Management Plan; Regulatory...

    Science.gov (United States)

    2013-03-28

    ... during the current fishing year for failure to pay the cost recovery fee, rather than not renewing the... an IFQ cost recovery fee as described in paragraph (h)(4) of this section; or any other failure to... Plan; Regulatory Amendment, Corrections, and Clarifications AGENCY: National Marine Fisheries Service...

  13. 76 FR 9028 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2011-02-16

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire... to provide the following: (1) Firsthand exposure to industry's drug development processes and (2) a...

  14. 75 FR 10806 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2010-03-09

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration... to provide the following: (1) First hand exposure to industry's drug development processes and (2) a...

  15. 77 FR 10538 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2012-02-22

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave...) Firsthand exposure to industry's drug development processes and (2) a venue for sharing information about...

  16. 78 FR 8544 - Training Program for Regulatory Project Managers; Information Available to Industry

    Science.gov (United States)

    2013-02-06

    ...] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug... Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave... to industry's drug development processes and (2) a venue for sharing information about project...

  17. 78 FR 42572 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-07-16

    ... securities and funds which are in the custody or control of the clearing agency and, in general, help to...-based swap clearing operations of CME or any related rights or obligations of CME security-based swap... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-69956; File No. SR-CME-2013-09] Self-Regulatory...

  18. 78 FR 53490 - Self-Regulatory Organizations; Chicago Mercantile Exchange Inc.; Notice of Filing and Immediate...

    Science.gov (United States)

    2013-08-29

    ... safeguarding of securities and funds which are in the custody or control of the clearing agency or for which it... operations of CME or any rights or obligations of CME with respect to securities clearing or persons using... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-70247; File No. SR-CME-2013-16] Self-Regulatory...

  19. 78 FR 45573 - Compensatory and Alternative Regulatory Measures for Nuclear Power Plant Fire Protection (CARMEN...

    Science.gov (United States)

    2013-07-29

    ... Nuclear Power Plant Fire Protection (CARMEN-FIRE) AGENCY: Nuclear Regulatory Commission. ACTION: Notice of... Nuclear Power Plant Fire Protection (CARMEN-FIRE), Draft Report for Comment.'' DATES: Comments on this... caused by impaired fire protection features at nuclear power plants. The report documents the history of...

  20. 77 FR 17569 - United States-Canada Regulatory Cooperation Council (RCC)-Transportation-Dangerous Goods Working...

    Science.gov (United States)

    2012-03-26

    ... identified in the Joint Action Plan, the Transportation--Dangerous Goods Working Group led by senior...)-- Transportation--Dangerous Goods Working Group AGENCY: Pipeline and Hazardous Materials Safety Administration...--Dangerous Goods Working Group, of the United States-Canada Regulatory Cooperation Council (RCC). Comments...

  1. 77 FR 65815 - Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary Name...

    Science.gov (United States)

    2012-10-31

    .... 070726412-1300-02] RIN 0648-BA24 Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary Name Change; Notice of Effective Date AGENCY: Office of National Marine Sanctuaries... geographical areas to the sanctuary and change the name of the Fagatele Bay National Marine Sanctuary (FBNMS or...

  2. 77 FR 3646 - Proposed Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary...

    Science.gov (United States)

    2012-01-25

    .... 100908440-1615-01] RIN 0648-BA24 Proposed Expansion of Fagatele Bay National Marine Sanctuary, Regulatory Changes, and Sanctuary Name Change AGENCY: Office of National Marine Sanctuaries (ONMS), National Ocean... in the Federal Register to revise the regulations for the Fagatele Bay National Marine Sanctuary (76...

  3. 77 FR 59567 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2012-09-28

    ... #0;notices is to give interested persons an opportunity to participate in #0;the rule making prior to... Immigration Review 8 CFR Parts 1003, 1103, 1208, 1211, 1212, 1215, 1216, 1235 [EOIR No. 178] RIN 1125-AA71 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Executive Office for Immigration Review, Department of...

  4. 76 FR 47527 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2011-08-05

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Chapter VII [Docket No. 110711380-1379-01] RIN 0694-XA37 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Bureau of Industry and Security, Commerce. ACTION: Notice of inquiry. SUMMARY: The Bureau of Industry and Security (BIS...

  5. Agency, Context and Meaning

    DEFF Research Database (Denmark)

    Folkmann, Mads Nygaard

    2014-01-01

    The paper is a meta-discursive contribution to the discussion of how design can be understood as a medium of meaning formation and questioning of meaning. Further, the paper builds on plea for the role of humanities in relation to formulate relevant questions in design through conceptualizing the...... 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.......The paper is a meta-discursive contribution to the discussion of how design can be understood as a medium of meaning formation and questioning of meaning. Further, the paper builds on plea for the role of humanities in relation to formulate relevant questions in design through conceptualizing...... 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...

  6. 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. 

  7. The Texts of the Agency's Relationship Agreements with Specialized Agencies

    International Nuclear Information System (INIS)

    1988-03-01

    The text of the relationship agreement with the Agency has concluded with the United Nations Industrial Development Organization, together with the protocol regarding its entry into force, is reproduced in this document for the information of all Members of the Agency. The agreement entered into force on 9 October 1987 pursuant to Article 10

  8. 41 CFR 105-74.645 - Federal agency or agency.

    Science.gov (United States)

    2010-07-01

    ... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Federal agency or agency. 105-74.645 Section 105-74.645 Public Contracts and Property Management Federal Property Management... Administration 74-GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) Definitions § 105-74...

  9. 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.

  10. IRT‑Sofia, HEU to LEU conversion: regulatory approval tasks solution overview

    International Nuclear Information System (INIS)

    Mitev, Mladen; Belousov, Sergey; Dimitrov, Dobromir

    2014-01-01

    The HEU to LEU conversion of the IRT–Sofia research reactor of the Institute for Nuclear Research and Nuclear Energy of the Bulgarian Academy of Sciences was jointly studied with the Argonne National Laboratory as a part of the RERTR Programme. The main purpose of the collaboration consisted in accomplishment of safety analyses and preparation of documents used for regulatory approval tasks solution. The main steps and results which are fundamental for the preparation of IRT–Sofia Safety Analyses Report including Operating Limits and Conditions are presented in this paper. The documents prepared by INRNE in accordance with the European nuclear safety requirements and IAEA recommendations were submitted for approval to the Bulgarian Nuclear Regulatory Agency at the end of 2010. Key words: research reactor, safety analyses report, Nuclear Regulatory Agency

  11. Regulatory perspective on remaining challenges for utilization of pharmacogenomics-guided drug developments.

    Science.gov (United States)

    Otsubo, Yasuto; Ishiguro, Akihiro; Uyama, Yoshiaki

    2013-01-01

    Pharmacogenomics-guided drug development has been implemented in practice in the last decade, resulting in increased labeling of drugs with pharmacogenomic information. However, there are still many challenges remaining in utilizing this process. Here, we describe such remaining challenges from the regulatory perspective, specifically focusing on sample collection, biomarker qualification, ethnic factors, codevelopment of companion diagnostics and means to provide drugs for off-target patients. To improve the situation, it is important to strengthen international harmonization and collaboration among academia, industries and regulatory agencies, followed by the establishment of an international guideline on this topic. Communication with a regulatory agency from an early stage of drug development is also a key to success.

  12. Development of the Regulatory Framework in Mexico

    International Nuclear Information System (INIS)

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

    2015-01-01

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

  13. U.S. Nuclear Regulatory Commission Process for Risk-Informing the Nuclear Waste Arena

    International Nuclear Information System (INIS)

    Leslie, B. W.

    2003-01-01

    The U.S. Nuclear Regulatory Commission (NRC) is increasing the use of risk insights and information in its regulation of nuclear materials and waste. The objective of this risk-informed regulatory effort is to improve the effectiveness and efficiency of the agency, while maintaining or increasing its focus on safety. The agency's Office of Nuclear Material Safety and Safeguards (NMSS) proposed a five-step process to carry out a framework for increasing the use of risk information and insights in its regulation of nuclear materials and waste. The office is carrying out the five-step process to risk-inform the nuclear materials and waste arenas. NMSS's actions included forming a Risk Task Group and the use of case studies to test and complete screening criteria for identifying candidate regulatory applications amenable for risk-informing. Other actions included involving stakeholders through enhanced public participation, developing safety goals for materials and waste regulatory applications, and establishing a risk training program for staff. Through the case studies, NRC staff found the draft screening criteria to be effective in deciding regulatory areas that may be amenable to an increased use of risk insights. NRC staff also found that risk information may have the potential to reduce regulatory burden and improve staff's efficiency in making decisions, while maintaining safety. Finally, staff found that it would be possible to develop safety goals for the nuclear materials and waste arenas

  14. Review of decision methodologies for evaluating regulatory actions affecting public health and safety

    International Nuclear Information System (INIS)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

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

    International Nuclear Information System (INIS)

    2018-01-01

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

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

    International Nuclear Information System (INIS)

    Bergren, C.L.

    1992-01-01

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

  17. 76 FR 66312 - Agency Information Collection Activities: Submission for Review; Information Collection Request...

    Science.gov (United States)

    2011-10-26

    ... information collection (2) Title of the Form/Collection: Science and Technology, Biodefense Knowledge Center... (DHS), Science and Technology, Biodefense Knowledge Center (BKC) AGENCY: Science and Technology... to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should...

  18. 77 FR 47058 - Middle Fork American River Hydroelectric Project Placer County Water Agency; Notice of Draft...

    Science.gov (United States)

    2012-08-07

    ... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [P-2079-069--CA] Middle Fork American River Hydroelectric Project Placer County Water Agency; Notice of Draft Environmental Impact Statement; Public Meetings a. Date and Time of Meetings: Tuesday, August 28, 2012, from 9:00 a.m. to 11:00 a.m. and...

  19. 78 FR 69100 - Agency Information Collection Activities: Proposed Collection; Comment Request; Request for...

    Science.gov (United States)

    2013-11-18

    ... during disaster situations through the use of other Federal agency resources. DATES: Comments must be... written comments to Regulatory Affairs Division, Office of Chief Counsel, DHS/FEMA, 500 C Street SW., Room... the capacity for the State to respond to the situation on its own and what type of assistance is...

  20. 78 FR 69934 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB...

    Science.gov (United States)

    2013-11-21

    ... Comptroller of the Currency (OCC), Treasury. ACTION: Notice and request for comment. SUMMARY: The OCC, as part... DEPARTMENT OF THE TREASURY Office of the Comptroller of the Currency Agency Information Collection...: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557...