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.

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

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...

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.

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

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

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

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

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.

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

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.

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.

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.

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.

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...

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...

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

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.

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.

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.

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

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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...

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...

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

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.

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

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)

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)

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

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

International Nuclear Information System (INIS)

Whitehead, W.

1986-09-01

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

Regulatory 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.

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.

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...

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

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

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

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...

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...

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...

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

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)

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

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...

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.

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

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

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...

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...

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...

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...

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...

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...

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...

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.

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.

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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)

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...

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...

76 FR 48908 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2011-08-09

...-mail addresses, school information/grades, employment information/histories, and works of writing... minimized, including the use of automated collection techniques or other forms of information technology... NUCLEAR REGULATORY COMMISSION [Docket No. NRC-2011-0160] Agency Information Collection Activities...

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

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

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.

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

78 FR 68907 - Agency Information Collection (Foot (Including Flatfeet (pes planus)) Conditions Disability...

Science.gov (United States)

2013-11-15

... planus)) Conditions Disability Benefits Questionnaire). Type of Review: New data collection. Abstract... (Including Flatfeet (pes planus)) Conditions Disability Benefits Questionnaire) Under OMB Review AGENCY...)) Conditions Disability Benefits Questionnaire)'' in any correspondence. FOR FURTHER INFORMATION CONTACT...

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

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

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...

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...

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...

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.

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...

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...

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...

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...

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.

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...

U.S. Nuclear Regulatory Commission fiscal year 1980 supplemental budget request

International Nuclear Information System (INIS)

1979-01-01

The proposed supplemental will enable the Nuclear Regulatory Commission to implement necessary additional effort arising from the agency's assessment of the accident at the Three Mile Island Unit 2 facility on March 28, 1979. The TMI accident has had a major impact on all NRC program areas, in particular on research activities and reactor operations. In addition, funds are requested to enhance the agency's Waste Management program to reflect the recommendations of the President's Interagency Review Group on Waste Management. Specific activities involved in this effort will include developing regulatory guidance, developing a licensing review capability and completing a plan for the site characterization review, all in support of the preparation of NRC guidelines necessary to conduct a construction authorization review. FY 1980 appropriations did not include funds to cover these requirements. A detailed analysis across program lines of the supplemental request is contained in this report

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...

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

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health; Minister for the Environment/Minister of Transport and Energy; Minister of Justice; Minister of Defence; National Board of Health; Emergency Management Agency); 2. Advisory bodies (The Danish Ministry of Energy, Supply and Climate and the Danish Energy Agency); 3. Public and semi-public agencies (Risoe National Laboratory)

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...

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...

78 FR 73211 - Agency Information Collection Activities: Proposed Collection; Comment Request

Science.gov (United States)

2013-12-05

... Education Grants. The survey will allow the NRC to collect information that is not otherwise available from... minimized, including the use of automated collection techniques or other forms of information technology... NUCLEAR REGULATORY COMMISSION [NRC-2013-0256] Agency Information Collection Activities: Proposed...

Development of measures to assess the safety of existing NPPs and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches). Peer discussions on regulatory practices

International Nuclear Information System (INIS)

1996-09-01

This report arises from the fourth series of peer discussions on regulatory practices entitled D evelopment of measures to assess the safety of existing nuclear power plants and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches) . Senior regulators from 23 Member States participated in four peer group discussions during 1995-1996. This report presents the outcome of these meetings and recommendations of good practices identified by these senior regulators. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to measures used for assessing the safety of existing nuclear power plants and evaluating the effectiveness of regulators and regulatory actions. The intention in doing this is to assist Member States in the enhancement of their regulatory practices by identifying commonly accepted good practices. This report is structured so that it covers the subject matter under the following main headings: 'Prescriptive and Performance Based' Approaches to Regulation; Common Features of Regulatory Approaches; Effectiveness of the Regulator and Regulatory Actions; Recommendations of Good Practice. It is important to note that recommendations of good practice are included if they have been identified by at least one of the groups. It does not follow that all of the groups or individual Member States would necessarily endorse all of the recommendations. However, it is considered that if a single group of senior regulators judge that a particular practice is worthy of recommendation then it should be included for serious consideration. In some cases the same recommendations arise from all of the Groups

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

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...

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...

A tale of three labels: translating the JUPITER trial data into regulatory claims.

Science.gov (United States)

Ridker, Paul M

2011-08-01

Whether a pivotal randomized trial will be interpreted in a similar and consistent manner by different regulatory agencies is uncertain as policy perspectives may play a role in data interpretation and the translation of trial results into clinical practice. Using a contemporary example, to compare and contrast regulatory claims in the United States, Europe, and Canada that derive from a pivotal clinical trial. The recently completed JUPITER trial of rosuvastatin as compared to placebo conducted among 17,802 men and women with LDL-C JUPITER trial provides an opportunity to compare and contrast how regulatory agencies in the United States, Canada, and Europe chose to interpret an identical database. Labeling indications based on earlier statin trials of primary and secondary prevention were also reviewed. JUPITER demonstrated a 44% reduction (p JUPITER trial population by stipulating that those eligible for treatment should be older men and women with hsCRP >2 mg/L, plus one additional risk factor for heart disease. The Canadian label is silent on age and hsCRP (the major trial inclusion criterion), stipulating instead that treatment can be considered for those with 'at least two conventional risk factors for cardiovascular disease,' a group more inclusive than that studied. In contrast, the European Medicines Agency label limits treatment only to 'high risk individuals' ignoring hsCRP and using instead a post hoc definition of 'high risk' that comprised a subgroup of less than 10% of the study population who contributed but 67 events to the study total and did not show statistical significance when compared to placebo. None of the regulatory labels included the trial primary endpoint; instead, each focused on separate and different components of the primary endpoint. Similar discrepancies were found between European and North American regulatory agencies with regard to earlier pivotal trials of statins for primary prevention, but not for secondary prevention. The

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...

76 FR 22450 - Agency Information Collection Activities; Proposed Information Collection Requirements; Comment...

Science.gov (United States)

2011-04-21

... Officer, (202) 452-3829, Division of Research and Statistics, Board of Governors of the Federal Reserve... the information collection, including the validity of the methodology and assumptions used; (c) Ways... measures (such as regulatory or accounting). The agencies' burden estimates for these information...

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)

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.

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.)

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

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...

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

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.

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

Creating a comprehensive, efficient, and sustainable nuclear regulatory structure. A Process Report from the U.S. Department of Energy's Material Protection, Control and Accounting Program

International Nuclear Information System (INIS)

Davis, Gregory E.; Brownell, Lorilee; Wright, Troy L.; Tuttle, John D.; Cunningham, Mitchel E.; O'Brien, Patricia E.

2006-01-01

This paper describes the strategies and process used by the U.S. Department of Energy's (DOE) nuclear Material Protection, Control and Accounting (MPC and A) Regulatory Development Project (RDP) to restructure its support for MPC and A regulations in the Russian Federation. The RDP adopted a project management approach to defining, implementing, and managing an effective nuclear regulatory structure. This approach included defining and developing the regulatory documents necessary to provide the Russian Federation with a comprehensive regulatory structure that supports an effective and sustainable MPC and A Program in Russia. This effort began in February 2005, included a series of three multi-agency meetings in April, June, and July, and culminated in August 2005 in a mutually agreed-upon plan to define and populate the nuclear regulatory system in the Russian Federation for non-military, weapons-usable material. This nuclear regulatory system will address all non-military Category I and II nuclear material at the Russian Federal Atomic Energy Agency (Rosatom), the Russian Agency for Industry (Rosprom), and the Federal Agency for Marine and River Transport (FAMRT) facilities; nuclear material in transport and storage; and nuclear material under the oversight of the Federal Environmental, Industrial and Nuclear Supervisory Service of Russia (Rostechnadzor). The Russian and U.S. MPC and A management teams approved the plan, and the DOE National Nuclear Security Administration's (NNSA) NA-255, Office of Infrastructure and Sustainability (ONIS), is providing funding. The Regulatory Development Project is managed by the Pacific Northwest National Laboratory (PNNL) for the U.S. Department of Energy's (DOE) NNSA

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...

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

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.

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...

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

International Nuclear Information System (INIS)

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

2002-01-01

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

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...

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

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...

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)

Knowledge sharing to facilitate regulatory decision-making in regard to alternatives to animal testing: Report of an EPAA workshop.

Science.gov (United States)

Ramirez, Tzutzuy; Beken, Sonja; Chlebus, Magda; Ellis, Graham; Griesinger, Claudius; De Jonghe, Sandra; Manou, Irene; Mehling, Annette; Reisinger, Kerstin; Rossi, Laura H; van Benthem, Jan; van der Laan, Jan Willem; Weissenhorn, Renate; Sauer, Ursula G

2015-10-01

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a workshop Knowledge sharing to facilitate regulatory decision-making. Fifty invited participants from the European Commission, national and European agencies and bodies, different industry sectors (chemicals, cosmetics, fragrances, pharmaceuticals, vaccines), and animal protection organizations attended the workshop. Four case studies exemplarily revealed which procedures are in place to obtain regulatory acceptance of new test methods in different sectors. Breakout groups discussed the status quo identifying the following facilitators for regulatory acceptance of alternatives to animal testing: Networking and communication (including cross-sector collaboration, international cooperation and harmonization); involvement of regulatory agencies from the initial stages of test method development on; certainty on prerequisites for test method acceptance including the establishment of specific criteria for regulatory acceptance. Data sharing and intellectual property issues affect many aspects of test method development, validation and regulatory acceptance. In principle, all activities should address replacement, reduction and refinement methods (albeit animal testing is generally prohibited in the cosmetics sector). Provision of financial resources and education support all activities aiming at facilitating the acceptance and use of alternatives to animal testing. Overall, workshop participants recommended building confidence in new methodologies by applying and gaining experience with them. Copyright © 2015 Elsevier Inc. All rights reserved.

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...

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...

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

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

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...

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.

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....

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...

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

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Special nuclear material; Source material; By-product material; Agreement state programmes); 4. Nuclear installations (Initial licensing; Operation and inspection, including nuclear safety; Operating licence renewal; Decommissioning; Emergency response); 5. Radiological protection (Protection of workers; Protection of the public); 6. Radioactive waste management (High-level waste; Low-level waste; Disposal at sea; Uranium mill tailings; Formerly Utilized Sites Remedial Action Program - FUSRAP); 7. Non-proliferation and exports (Exports of source material, special nuclear material, production or utilisation facilities and sensitive nuclear technology; Exports of components; Exports of by-product material; Exports and imports of radiation sources; Conduct resulting in the termination of exports or economic assistance; Subsequent arrangements; Technology exports; Information and restricted data); 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Nuclear Regulatory Commission - NRC; Department of Energy - DOE; Department of Labor - DOL; Department of Transportation - DOT; Environmental Protection Agency - EPA); 2. Public and semi-public agencies: A. Cabinet-level departments (Department of

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

International Nuclear Information System (INIS)

2017-01-01

The NEA has updated, in coordination with the Permanent Delegation of Japan to the OECD, the report on the Regulatory and Institutional Framework for Nuclear Activities in Japan. This country report provides comprehensive information on the regulatory and institutional framework governing nuclear activities in Japan. It provides a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. Content: I - General Regulatory Regime: Introduction; Mining regime; Radioactive substances and equipment; Nuclear installations (Reactor Regulation, Emergency response); Trade in nuclear materials and equipment; Radiological protection; Radioactive waste management; Nuclear safeguards and nuclear security; Transport; Nuclear third party liability. II - Institutional Framework: Regulatory and supervisory authorities (Cabinet Office, Nuclear Regulation Authority (NRA), Ministry of Economy, Trade and Industry (METI), The Agency for Natural Resources and Energy (ANRE), Ministry of Land, Infrastructure, Transport and Tourism (MLIT), Ministry of Education, Culture, Sports, Science and Technology (MEXT)); Advisory bodies (Atomic Energy Commission (AEC), Reactor Safety Examination Committee, Nuclear Fuel Safety Examination Committee, Radiation Council, Other advisory bodies); Public and semi-public agencies (Japan Atomic Energy Agency (JAEA), National Institutes for Quantum and Radiological Science and Technology (QST), Nuclear Damage Compensation and Decommissioning Facilitation Corporation (NDF), Nuclear Waste Management Organisation (NUMO))

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...

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

Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.

Science.gov (United States)

Nasr, Moheb M; Krumme, Markus; Matsuda, Yoshihiro; Trout, Bernhardt L; Badman, Clive; Mascia, Salvatore; Cooney, Charles L; Jensen, Keith D; Florence, Alastair; Johnston, Craig; Konstantinov, Konstantin; Lee, Sau L

2017-11-01

Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this novel technology. This paper, which is based on the 2nd International Symposium on the Continuous Manufacturing of Pharmaceuticals, describes not only the advances that have taken place since the first International Symposium on Continuous Manufacturing of Pharmaceuticals in 2014, but the regulatory landscape that exists today. Key regulatory concepts including quality risk management, batch definition, control strategy, process monitoring and control, real-time release testing, data processing and management, and process validation/verification are outlined. Support from regulatory agencies, particularly in the form of the harmonization of regulatory expectations, will be crucial to the successful implementation of continuous manufacturing. Collaborative efforts, among academia, industry, and regulatory agencies, are the optimal solution for ensuring a solid future for this promising manufacturing technology. Copyright © 2017 American Pharmacists Association®. All rights reserved.

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)

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

International Nuclear Information System (INIS)

2011-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Cabinet Office; Minister of Economy, Trade and Industry - METI; Minister of Land, Infrastructure and Transport - MLIT; Minister of Education, Culture, Sports, Science and Technology - MEXT); 2. Advisory bodies (Atomic Energy Commission - AEC; Nuclear Safety Commission - NSC; Radiation Council; Special Committee on Energy Policy; Other advisory bodies); 3. Public and Semi-Public Agencies (Japan Atomic Energy Agency - JAEA)

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.

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...

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)

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.

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)

Qualifications and training of staff of the regulatory body for nuclear power plants

International Nuclear Information System (INIS)

1979-01-01

This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Agency's Safety Series No.50-C-G, entitled ''Governmental Organization for the Regulation of Nuclear Power Plants: A Code of Practice'', and is mainly concerned with the qualifications and training requirements of the staff of bodies regulating nuclear power plants. It is not concerned with staff for regulating other phases of the fuel cycle, such as fuel fabrication and management. This Guide provides recommendations and guidance for establishing the qualifications required for the staff of the regulatory body. These requirements include academic training, work experience and other abilities. It also establishes the training programmes and activities necessary for personnel within the regulatory body

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.

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

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...

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...

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)

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

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I) - General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection (Bilateral safeguards agreements; International Atomic Energy Agency Safeguards Agreement; The South Pacific Nuclear Free Zone Treaty Act; The Comprehensive Nuclear Test-Ban Treaty Act; The Nuclear Non-Proliferation (Safeguards) Act); 9. Transport; 10. Nuclear third party liability; II) - Institutional Framework: 1. Regulatory and supervisory authorities (Minister for Health and Ageing; Minister for Foreign Affairs; Minister for the Environment, Heritage and the Arts; Minister for, Resources, Energy and Tourism); 2. Advisory bodies (Radiation Health and Safety Advisory Council; Advisory Committees); 3. Public and semi-public agencies (Australian Radiation Protection and Nuclear Safety Agency (ARPANSA); Australian Safeguards and Non-Proliferation Office; Australian Nuclear Science and Technology Organisation (ANSTO); Supervising Scientist)

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...

75 FR 9443 - Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB...

Science.gov (United States)

2010-03-02

...: Recipients of Federal Financial Assistance provided by the NRC (including Educational Institutions, Other... for the Office of Management and Budget (OMB) Review; Comment Request AGENCY: U.S. Nuclear Regulatory... Programs or Activities Receiving Federal Financial Assistance''. 3. Current OMB approval number: 3150-XXXX...

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...

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

Leak-Before-Break: Further developments in regulatory policies and supporting research

International Nuclear Information System (INIS)

Wilkowski, G.M.; Chao, K.-S.

1990-02-01

The fourth in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at the National Central Library in Taipei, Taiwan on May 11 and 12, 1989. The seminar updated the international polices and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utilities, nuclear power plant fabricators, research organizations, and academic institutions. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA) Dr. B. Jarman (AECB, Canada), Dr.P. Milella (ENEA-DISP, Italy), Dr. C. Faidy (EDF/Septen, France ), and Dr. K. Takumi (NUPEC, Japan). A paper by Mr. K. Wichman and Mr. A. Lee of the US NRC Office of Nuclear Reactor Regulation is included as background material to these proceedings; it discusses the history and status of LBB applications in US nuclear power plants. In addition, several papers on the supporting research programs described regulatory policy or industry standards for flaw evaluations, e.g., the ASME Section XI code procedures. Supporting research programs were reviewed on the first and second day by several participants from Taiwan, US, Japan, Canada, Italy, and France. Each individual paper has been cataloged separately

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...

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

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...

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

International Nuclear Information System (INIS)

2010-01-01

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

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...

Regulatory aspects of teratology: role of the Food and Drug Administration

International Nuclear Information System (INIS)

Kelsey, F.O.

1982-01-01

The Food and Drug Administration is a scientific regulatory agency whose consumer protection activities cover a wide range of products including foods and additives, and pesticide residues on foods; drugs; cosmetics; medical devices; and radiation-emitting electronic products. Amongst its concerns is the possible teratogen effects of regulated products to which the pregnant woman is exposed. The policies and programs of the agency directed toward reducing such risks to the unborn are reviewed. These measures include guidelines for animal reproduction studies and for clinical trials involving women to childbearing potential; labeling of products to disclose known or possible harm to the fetus or embryo; surveillance procedures designed to detect previously unsuspected adverse effects of marketed products; research activities designed to develop better understanding of developmental toxicology and improved techniques for detecting embryocidal and embryotoxic effects; and educational efforts directed both to professionals and the public regarding hazards to the unborn of agency-regulated products

Overview of the European Medicines Agency's Development of Product-Specific Bioequivalence Guidelines.

Science.gov (United States)

Sullivan, Jane O'; Blake, Kevin; Berntgen, Michael; Salmonson, Tomas; Welink, Jan

2017-12-05

The European Medicines Agency's (EMA) product-specific bioequivalence guidelines outline harmonized regulatory requirements for studies to demonstrate bioequivalence for products that may have particular needs due to their pharmacokinetics, in addition to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision-making. Since their introduction in 2013, EMA product-specific bioequivalence guidelines continue to increase in number, and as of June 2017, encompass a number of different pharmacotherapeutic groups and pharmaceutical forms. This article further elucidates the processes involved for stakeholders and reviews the Agency's experience with the development of these guidelines, including the scientific issues witnessed with their advancement. A comparison with the United States Food and Drug Administration approach to similar guidelines is also provided. © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics.

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...

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...

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}.

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}.

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.

Analysis of regulatory structure for a potential fusion-reactor industry

International Nuclear Information System (INIS)

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

Changing innovation into a registered product: From concept to regulatory approval.

Science.gov (United States)

Rhodes, Linda

2018-05-01

Innovation in animal health pharmaceuticals is important to address unmet and underserved medical needs, and often comes from products initially developed for human medicine. The purpose of the review is to help readers understand how breakthroughs from human biotechnology may be developed for use in veterinary medicine, while understanding the key drivers to success, the difficulties of regulatory approval, and the realistic risks and rewards of developing applications for animals. The types of human drugs which may be useful for veterinary applications are reviewed, including examples. The regulatory path is discussed, with a review of the various oversight agencies, and the categories of data required to be submitted, including safety, efficacy, manufacturing, environmental impact and human food safety. In conclusion, the cost, development time, and barriers to innovation in veterinary medical pharmaceuticals are discussed. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

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

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....

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

Directory of Open Access Journals (Sweden)

Varley Dias Sousa

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

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

Science.gov (United States)

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

2016-05-01

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

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...

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...

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.

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

Ito, Juichiro; Takita, Masami

2011-01-01

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

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...

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.

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...

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...

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...

The independent inspection agency as an instrument of quality assurance

International Nuclear Information System (INIS)

Sancho, J.; Cuallado, G.

1982-01-01

The collaboration between Independent Inspection Agencies (IIA) and the regulatory body of a country in supervising the equipment and services directly related to the safety of its nuclear installations can be a valid solution, forming part of the system set up to guarantee satisfactory compliance with the safety parameters established for the purpose of avoiding damage to persons and property. In the light of the experience accumulated in recent years, the IIA in Spain is not a single body or a State body but may be chosen from among all legally established Inspection Agencies (IA). As described in detail in the paper, the IA is selected on the basis of an agreement between the owner of the facility and the supplier; it must present certain specific characteristics and is approved by the regulatory body. For a country with intermediate technological capacity and an industrial base sufficient to assimilate imported nuclear technologies, this participation of the IIA can result in significant advantages. On one side, the regulatory body exercising higher-level supervision of the work and of the units participating in the project, including of course the IIA, can reduce its allocation of personnel and of technical and material resources. On the other side, the IIA are also converted into an agency for the transfer of technology. The paper describes the principles governing their independence, structure, organization, internal control, external control, activities and scope of work. Similarly, the necessary criteria are laid down for the issue of reports and certificates, the handling of operational deviations, the system of appointing inspectors and auditors, and the method by which they should be trained, evaluated and certified. Lastly, the paper shows how the non-nuclear part of the facility is supervised in Spain and describes the role which has been played by the country's industrial and professional associations. (author)

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

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...

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...

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

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy

DEFF Research Database (Denmark)

Segec, A; Keller-Stanislawski, B; Vermeer, N S

2015-01-01

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe...... use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization....

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

Use of the Multi-Agency Radiological Laboratory Analytical Protocols Manual (MARLAP) for site cleanup activities

International Nuclear Information System (INIS)

Griggs, J.

1999-01-01

MARLAP is being developed as a multi-agency guidance manual for project managers and radioanalytical laboratories. The document uses a performance based approach and will provide guidance and a framework to assure that laboratory radioanalytical data meets the specific project or program needs and requirements. MARLAP supports a wide range of data collection activities including site characterization and compliance demonstration activities. Current participants include: US Environmental Protection Agency (EPA), US Department of Energy (DOE), US Nuclear Regulatory Commission (NRC), US Department of Defense (DoD), US National Institutes of Standards and Technology (NIST), US Geologic Survey (USGS), US Food and Drug Administration (FDA), Commonwealth of Kentucky, and the State of California. MARLAP is the radioanalytical laboratory counterpart to the Multi-Agency Radiological Survey and Site Investigation Manual (MARSSIM). MARLAP is currently in a preliminary draft stage. (author)

Techniques for analyzing the impacts of certain electric-utility ratemaking and regulatory-policy concepts. Regulatory laws and policies. [State by state

Energy Technology Data Exchange (ETDEWEB)

None

1980-08-01

This report is a legal study prepared to provide a review of the substantive and procedural laws of each regulatory jurisdiction that may affect implementation of the PURPA standards, and to summarize the current state of consideration and implementation of policies and rate designs similar or identical to the PURPA standards by state regulatory agencies and nonregulated utilities. This report is divided into three sections. The first section, the Introduction, summarizes the standards promulgated by PURPA and the results of the legal study. The second section, State Regulatory Law and Procedure, summarizes for each state or other ratemaking jurisdiction: (1) general constitutional and statutory provisions affecting utility rates and conditions of service; (2) specific laws or decisions affecting policy or rate design issues covered by PURPA standards; and (3) statutes and decisions governing administrative procedures, including judicial review. A chart showing actions taken on the policy and rate design issues addressed by PURPA is also included for each jurisdiction, and citations to relevant authorities are presented for each standard. State statutes or decisions that specifically define a state standard similar or identical to a PURPA standard, or that refer to one of the three PURPA objectives, are noted. The third section, Nonregulated Electric Utilities, summarizes information available on nonregulated utilities, i.e., publicly or cooperatively owned utilities which are specifically exempted from state regulation by state law.

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...

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...

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Science.gov (United States)

Nkeng, Lenhangmbong; Cloutier, Anne-Marie; Craig, Camille; Lelorier, Jacques; Moride, Yola

2012-07-01

Therapeutic risk management has received growing interest in recent years, particularly since the publication of regulatory guidances in 2005 and 2006, paralleled with a change in drug regulation. The characteristics of risk minimization interventions (RMIs) that have been implemented or approved remain inadequately explored. The aim of this study was to review RMIs published in the literature or posted on regulatory agency websites over the past 10 years, and to assess whether publication of regulatory guidances on risk management is associated with changes in the number and types of interventions. Sources were searched for RMIs published/posted between 1 January 2000 and 31 December 2009. For the literature search, MEDLINE and EMBASE databases were used using key words related to drug safety (i.e. 'drug toxicity') and the individual RMI names. The website review involved searches of major regulatory authority websites such as the European Medicines Agency, US FDA, Health Canada, the UK's Medicines and Healthcare products Regulatory Agency, Japan's Pharmaceutical and Medical Devices Agency and Australia's Therapeutic Goods Administration. The following eligibility criteria were applied for inclusion in the review: published/posted between the years 2000 and 2009, inclusive; involving drug products; use in humans; and involving RMIs, or tools used to increase the reporting of adverse events (AEs). Natural healthcare products, devices, diagnostic chemicals, pregnancy registries without follow-up, medication errors and products not used as therapy for illness were not retained. For each source, the following characteristics were extracted: nature of the intervention, target population, therapeutic area, AE(s) of special interest, country/regulatory agency and year of publication. A total of 119 unique interventions were identified in the literature (54 published in 2000-4 and 65 published in 2005-9). Interventions included educational material (n = 37; 31%), black

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.

Basic policy of JMTR refurbishment and regulatory procedure

International Nuclear Information System (INIS)

Tobita, Kenji

2012-04-01

The JMTR refurbishment started from FY2007 had been completed on the end of the FY2010. The refurbishment works carried out on about 60 items nuclear reactor systems, (about 40 of facilities and about 20 constructions) with no trouble. This report review the basic policy of JMTR refurbishment, such as a selection of facilities/equipments for the refurbishment and the determination method of specifications for repairs. The deliberation and discussion by the safety review committee of Oarai Research and Development Center in the Japan Atomic Energy Agency and nuclear regulatory procedure are included in this report. (author)

PRA research and the development of risk-informed regulation at the U.S. nuclear regulatory commission

International Nuclear Information System (INIS)

Siu, Nathan; Collins, Dorothy

2008-01-01

Over the years, Probabilistic Risk Assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, Human Reliability Analysis (HRA), and Pressurized Thermal Shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities

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)

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

International Nuclear Information System (INIS)

2013-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances and Equipment; 4. Nuclear Installations (Licensing and Inspection, including Nuclear Safety; Emergency Response); 5. Trade in Nuclear Materials and Equipment; 6. Radiological Protection; 7. Radioactive Waste Management; 8. Non-proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities (Nuclear Regulatory Authority of the Slovak Republic - UJD; Ministry of Health; Ministry of the Environment; Ministry of the Interior; Ministry of Economy; Ministry of Labour and National Labour Inspectorate); 2. Public and Semi-Public Agencies

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

International Nuclear Information System (INIS)

2013-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Safeguards for nuclear material; 7. Radiation protection; 8. Radioactive waste management; 9. Nuclear security; 10. Transport; 11. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Slovenian Nuclear Safety Administration - SNSA; Slovenian Radiation Protection Administration - SRPA); 2. Advisory bodies; 3. Public and semi-public agencies; 4. Technical support organisations - approved experts

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.

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

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment (General provisions; Patents); 6. Radiation Protection (Protection of workers; Protection of the public; Protection of the environment); 7. Radioactive Waste Management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Interdepartmental Committee for Economic Planning; Nuclear Safety Agency; Prime Minister; Minister for Economic Development; Minister for Labour and Social Security; Minister for Health; Minister for the Environment; Minister for the Interior; Minister for Transport and Navigation; Minister for Foreign Trade (now incorporated in Ministry for Economic Development); Minister for Education; Treasury Minister; Minister for Universities and for Scientific and Technical Research; Minister for Foreign Affairs; State Advocate General); 2. Advisory bodies (Inter-ministerial Council for Consultation and Co-ordination; Coordinating Committee for Radiation Protection of Workers and the Public; Regional and Provincial Commissions for Public Health Protection

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

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.

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

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.

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.

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

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Directory of Open Access Journals (Sweden)

Emel Mashaki Ceyhan

2018-01-01

Full Text Available Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP in order to facilitate the TITCK progress toward agency goals.Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA, Health Canada, Singapore's Health Science Authority (HSA, and the Saudi Arabia Food and Drug Administration (SFDA.Results: The TITCK performs a full review for all new active substance (NAS applications. Submission of a Certificate of Pharmaceutical product (CPP with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized.Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP process by sharing GMP inspection outcomes and certificates issued by

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore.

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore

Science.gov (United States)

Mashaki Ceyhan, Emel; Gürsöz, Hakki; Alkan, Ali; Coşkun, Hacer; Koyuncu, Oğuzhan; Walker, Stuart

2018-01-01

Introduction: Regulatory agency comparisons can be of more value and facilitate improvements if conducted among countries with common challenges and similar health agency characteristics. A study was conducted to compare the registration review model used by the Turkish Medicines and Medical Devices Agency (Türkiye Ilaç ve Tibbi Cihaz Kurumu; TITCK) with those of four similar-sized regulatory agencies to identify areas of strength and those requiring further improvement within the TITCK in relation to the review process as well as to assess the level of adherence to good review practices (GRevP) in order to facilitate the TITCK progress toward agency goals. Methods: A questionnaire was completed and validated by the TITCK to collect data related to agency organizational structure, regulatory review process and decision-making practices. Similar questionnaires were completed and validated by Australia's Therapeutic Goods Administration (TGA), Health Canada, Singapore's Health Science Authority (HSA), and the Saudi Arabia Food and Drug Administration (SFDA). Results: The TITCK performs a full review for all new active substance (NAS) applications. Submission of a Certificate of Pharmaceutical product (CPP) with an application is not required; however, evidence of approval in another country is required for final authorization by the TITCK. Pricing data are not required by the TITCK at the time of submission; however, pricing must be completed to enable products to be commercially available. Mean approval times at the TITCK exceeded the agency's overall target time suggesting room for improved performance, consistency, and process predictability. Measures of GRevP are in place, but the implementation by the TITCK is not currently formalized. Discussion: Comparisons made through this study enabled recommendations to the TITCK that include streamlining the good manufacturing practice (GMP) process by sharing GMP inspection outcomes and certificates issued by other

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

A National Regulatory Authority set up in a developing country: case of Mali

International Nuclear Information System (INIS)

Kone, Nagantie

2008-01-01

Full text: The Republic of Mali is member of the International Atomic Energy Agency since 1961. Of since the creation of the IAEA, some African countries are members. The technical cooperation with the Agency started in the years 1975. Through that cooperation, many pacific uses of nuclear techniques have been introduced, then developed at different levels in many socio- economic domains as medicine, agriculture, research, and so on. That development of nuclear techniques use has occurred without legislation at all or in some limited cases with part of the legislation of the colonizing country), in a precise field (like radiography in medicine). Later the need of regulatory infrastructure implementation started. That implementation has followed several ways in the different African countries. Also, it started earlier in countries which had advanced activities in nuclear techniques and very later in others. Most if not all of these infrastructure (say regulatory board) were created by the greatest users of the nuclear techniques, the Ministry of Health in most cases or Energy Commission for Countries having a research reactor. After the years 90, the Agency has developed new vision in the implementation of Regulatory Authorities. The new innovation was: 1-) Development of Regulatory Authority with independent statute (decisions and finance); 2-) Assuming post graduate training in developing countries to come other the lack of human resources. That new strategy of the IAEA has facilitated the apparition and development of several new regulatory authorities. We are going to develop here the progress done by one of these new regulatory authorities, through five years being. (author)

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...

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...

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...

The Regulatory Independence of FANR

International Nuclear Information System (INIS)

ALNuaimi, Fatema; Choi, Kwang Shik

2012-01-01

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

The Regulatory Independence of FANR

Energy Technology Data Exchange (ETDEWEB)

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

2012-05-15

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

Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA.

Science.gov (United States)

Kondo, Hideyuki; Shibatsuji, Masayoshi; Yasuda, Naoyuki

2018-01-01

Micro-, small-, and medium-sized enterprises (SMEs) have been considered as key players who can bring innovative medicinal products and/or technologies into the field. However, they may need much regulatory/scientific supports to provide their products, technologies, or services to the market in a timely way. Both the Pharmaceuticals and Medical Devices Agency (PMDA) and the European Medicines Agency (EMA), regulatory authorities for medicinal products in Japan and the EU, respectively, have prepared supportive measures for SMEs from the early phase of product/technology development to the postmarketing phase. With respect to supports for SMEs, both agencies have provided similar SME-specific supportive activities, including routine administrative assistance, consultations about product development strategy from an early phase, as well as specific regulatory/scientific issues and fee incentives. In addition, there is a system to register SME status in the EU, which can be a tool for regulators to know how much potential SME-driven activities have and with whom they should communicate to provide necessary supports. Furthermore, as new technologies and novel products from SMEs are not limited to the region where they are developed, close communication about these topics between the PMDA and the EMA will contribute to advancing patients' access to necessary medicinal products.

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

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)

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

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.

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

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...

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

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

International Nuclear Information System (INIS)

2001-05-01

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

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...

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.

Strategy in Regulatory Decision-Making for Management of Progressive Multifocal Leukoencephalopathy.

Science.gov (United States)

Segec, A; Keller-Stanislawski, B; Vermeer, N S; Macchiarulo, C; Straus, S M; Hidalgo-Simon, A; De Bruin, M L

2015-11-01

Progressive multifocal leukoencephalopathy (PML) has been observed after the use of several medicines, including monoclonal antibodies. As these drugs play important roles in the therapeutic armamentarium, it is important to address the challenges that this severe adverse reaction poses to the safe use of medicines. Considering the need for consistent outcomes of regulatory decisions, the European Medicines Agency Pharmacovigilance Risk Assessment Committee (PRAC) used PML as an example to develop a systematic approach to labeling and risk minimization. © 2015 American Society for Clinical Pharmacology and Therapeutics.

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...

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.)

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...

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...

U.S. energy policy and next regulatory steps

International Nuclear Information System (INIS)

Pearce, D.

2006-01-01

This presentation examined energy policies taken in the past to develop to oil and gas activities in Alaska and examined regulatory steps that may be taken in the future. North Slope Alaska gas resources were also reviewed. The Alaska Natural Gas Transportation Act was passed in 1976, but the pipeline was not developed due to its high cost. The Alaska Natural Gas Pipeline Act was signed into law in 2004 along with a loan guarantee program and an alternate construction study. Tax bill provisions included accelerated depreciation for the pipeline as well as an enhanced oil recovery tax credit for a gas processing plant. A federal coordinator was selected to expedite reviews and actions, as well as to monitor responsibility in areas where the pipeline crosses Federal or private lands. Details of federal permitting agencies were also included. A summary of federal agency permits and approvals was provided along with details of a federal interdepartmental memorandum of understanding (MOU) and the responsibilities of the United States Department of Energy. The presentation also included outlines of technical risk management programs, support infrastructure needs, and an infrastructure upgrade study. Highway route options were discussed, as well as sites for facilities. tabs., figs

IAEA Mission Concludes Peer Review of Viet Nam's Radiation and Nuclear Regulatory Framework

International Nuclear Information System (INIS)

2014-01-01

Senior international nuclear safety and radiation protection experts today concluded a 10-day International Atomic Energy Agency (IAEA) mission to review how Viet Nam's regulatory framework for nuclear and radiation safety has incorporated recommendations and suggestions from an earlier review, conducted in 2009. The Integrated Regulatory Review Service (IRRS) follow-up mission, requested by the Viet Nam Agency for Radiation and Nuclear Safety (VARANS), also reviewed the development of the regulatory safety infrastructure to support Viet Nam's nuclear power programme. The eight-member team comprised senior regulatory experts from Canada, France, Pakistan, Slovenia, United Arab Emirates and the United States of America, as well as three IAEA staff members. The IRRS team said in its preliminary assessment that Viet Nam had made progress since 2009, but that some key recommendations still needed to be addressed. Particular strengths identified by the team included: The commitment of VARANS staff to develop legislation and regulations in the field of nuclear and radiation safety; VARANS' efforts to implement practices that are in line with IAEA Safety Standards and internationally recognized good practices; A willingness to receive feedback regarding the efforts to establish and implement a regulation programme; and Progress made in developing the regulatory framework to support the introduction of nuclear power. The team identified the following areas as high-priority steps to further strengthen radiation and nuclear safety in Viet Nam: The effective independence of the regulatory decision-making process needs to be urgently addressed; Additional resources are needed to regulate existing radiation facilities and activities, as well as the country's research reactor; Efforts to increase the capacity of VARANS to regulate the developing nuclear power programme should continue; The draft Master Plan for the Development of Nuclear Power Infrastructure should be finalized

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.

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

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

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

Knowledge Management Initiatives Used to Maintain Regulatory Expertise in Transportation and Storage of Radioactive Materials - 12177

Energy Technology Data Exchange (ETDEWEB)

Lindsay, Haile; Garcia-Santos, Norma; Saverot, Pierre; Day, Neil; Gambone Rodriguez, Kimberly; Cruz, Luis; Sotomayor-Rivera, Alexis; Vechioli, Lucieann; Vera, John; Pstrak, David [United States Nuclear Regulatory Commission, Mail Stop EBB-03D-02M, 6003 Executive Boulevard, Rockville, MD 20852 (United States)

2012-07-01

The U.S. Nuclear Regulatory Commission (NRC) was established in 1974 with the mission to license and regulate the civilian use of nuclear materials for commercial, industrial, academic, and medical uses in order to protect public health and safety, and the environment, and promote the common defense and security. Currently, approximately half (∼49%) of the workforce at the NRC has been with the Agency for less than six years. As part of the Agency's mission, the NRC has partial responsibility for the oversight of the transportation and storage of radioactive materials. The NRC has experienced a significant level of expertise leaving the Agency due to staff attrition. Factors that contribute to this attrition include retirement of the experienced nuclear workforce and mobility of staff within or outside the Agency. Several knowledge management (KM) initiatives have been implemented within the Agency, with one of them including the formation of a Division of Spent Fuel Storage and Transportation (SFST) KM team. The team, which was formed in the fall of 2008, facilitates capturing, transferring, and documenting regulatory knowledge for staff to effectively perform their safety oversight of transportation and storage of radioactive materials, regulated under Title 10 of the Code of Federal Regulations (10 CFR) Part 71 and Part 72. In terms of KM, the SFST goal is to share critical information among the staff to reduce the impact from staff's mobility and attrition. KM strategies in place to achieve this goal are: (1) development of communities of practice (CoP) (SFST Qualification Journal and the Packaging and Storing Radioactive Material) in the on-line NRC Knowledge Center (NKC); (2) implementation of a SFST seminar program where the seminars are recorded and placed in the Agency's repository, Agency-wide Documents Access and Management System (ADAMS); (3) meeting of technical discipline group programs to share knowledge within specialty areas; (4

Resolution of regulatory issues facing the DOE in situ vitrification program

International Nuclear Information System (INIS)

Corathers, L.A.

1992-03-01

In situ vitrification (ISV) is being developed by researchers at the Pacific Northwest Laboratory (PNL), Idaho National Engineering Laboratory (INEL), and Oak Ridge National Laboratory (ORNL) as a technology for remediating soils, underground storage tank residuals, and buried materials that have been contaminated with hazardous, radioactive, and mixed wastes (i.e., wastes containing both radioactive and hazardous wastes) at US Department of Energy (DOE) facilities. The goal of the DOE ISV technology development program (i.e., the ISV Integrated Program) is to ensure that ISV is a workable technology for environmental restoration applications for DOE and other agencies. A DOE complex-wide plan was prepared during Fiscal Year 1991 to coordinate all levels of activities associated with the deployment of ISV. As part of this plan, a programmatic regulatory strategy was developed which focused on the federal environmental, health, safety, and nuclear regulations, including the US Environmental Protection Agency (EPA) and DOE regulations, believed to have the most significant near-term impact on the use of ISV as a remediation technology. The portion of the programmatic regulatory strategy addressing compliance with the Comprehensive Environmental Response, Compensation and Liability Act, as amended, and the Resource Conservation and Recovery Act, as amended, is presented in this paper

Crisis Communication of Nuclear Regulatory Organisations: Towards global thinking

International Nuclear Information System (INIS)

Martell, Meritxell; Menendez, Susan; Calvo, Marina

2013-01-01

The OECD Nuclear Energy Agency (NEA) Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) organised the workshop 'Crisis communication: facing the challenges' on 9-10 May 2012 in Madrid to address the international dimension of the communicative responses to crises by assessing the experience of Nuclear Regulatory Organisations of the NEA member countries and their stakeholders. The CNRA/WGPC also prepared in 2011, before the Fukushima-Daiichi nuclear accident occurred, a Road Map for Crisis Communication of Nuclear Regulatory Organisations which focused only on national aspects. This 'road map' had not considered the international dimension. CNRA mandated the WGPC to expand the Road Map so as to conclude the follow-up activity on crisis communication. The objective of the present document is to firstly, identify the key messages which can be extracted from three surveys carried out among the WGPC members after Fukushima-Daiichi's accident (Appendices II, III and IV), and incorporate them into the Road Map for Crisis Communication. Secondly, the good practices on public communication of NROs, which were presented during the OECD/NEA Workshop on Crisis Communication: Facing the Challenges, are reported. Following the structure of the road map for public communication responses during crisis included in the NEA report entitled 'Road Map for Crisis Communication of Nuclear Regulatory Organisations - National aspects', the good practices on communication before, during and after a crisis are provided. Overall, the emphasis of this report is on the international aspects of crisis communication, rather than the national dimension. (authors)

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

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)

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...

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

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive Substances and Equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities - National Radiation Laboratory - NRL; 2. Advisory bodies - Radiation Protection Advisory Council; 3. Public and semi-public agencies - Research institutes

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

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Nuclear facilities (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response; Decommissioning); 4. Trade in nuclear materials and equipment; 5. Radiological protection; 6. Radioactive waste management; 7. Non-proliferation of nuclear weapons and physical protection of nuclear material (International aspects; National control and security measures); 8. Transport; 9. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Federal Agency for Nuclear Control - FANC; Federal Public Service for Home Affairs; Federal Public Service for Economy, SME's, Self-Employed and Energy; Federal Public Service for Employment, Labour and Social Dialogue; Federal Public Service for Defence; Federal Public Service for Foreign Affairs, Foreign Trade and Development Co-operation; Federal Public Planning Service for Science Policy); 2. Advisory bodies (Scientific Council for Ionizing Radiation of the Federal Agency for Nuclear Control; Superior Health Council; Superior Council for Safety, Hygiene and Enhancement of Workplaces; Advisory Committee for the Non-Proliferation of Nuclear Weapons; Commission for Electricity and Gas Regulation - CREG)

Regulatory scientific advice in drug development: does company size make a difference?

Science.gov (United States)

Putzeist, Michelle; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G

2011-02-01

To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006-2008. Definition of company size was based on ranking by total revenues (Scrip's Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P companies (P = 0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development.

Alberta Energy and Utilities Board, regulatory highlights for 1998

International Nuclear Information System (INIS)

1999-01-01

This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta's energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB's position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board's efforts in the area of timely stakeholder consultation was highlighted. tabs., figs

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...

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.

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...

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

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.

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

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

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

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction (Licensing system; Offences, compliance and enforcement; Regulatory documents; Other relevant legislation); 2. Mining regime; 3. Nuclear substances and radiation devices; 4. Nuclear facilities; 5. Trade in nuclear materials and equipment (Exports, Other imports); 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Governor in council; Minister of natural resources; Other Ministerial authorities; Canadian Nuclear Safety Commission - CNSC); 2. Public and semi-public agencies (National Research Council - NRC; Natural Sciences and Engineering Research Council; Atomic Energy of Canada Ltd. - AECL)

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...

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...

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

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

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

Science.gov (United States)

Romero, Klaus; Clay, Robert; Hanna, Debra

2015-08-15

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

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.

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...

The International Atomic Energy Agency's program on decontamination and decommissioning

International Nuclear Information System (INIS)

Feraday, M.A.

1989-01-01

The International Atomic energy Agency (IAEA) is developing an integrated information base that will systematically cover the technical, regulatory, radiation protection, planning, and economic aspects related to the decontamination and decommissioning (D/D) of nuclear facilities. The object of this program is to assist member states in developing the required expertise, equipment, and programs so that they can decommission their nuclear facilities in a safe, timely, and cost-effective manner. In addition to providing information, the IAEA encourages research and provides technical assistance in the form of expert missions, equipment design and procurement, etc., to assist member states in implementing their D/D programs. The technology contained in some recent IAEA reports is reviewed, including the decontamination, segmentation, and demolition of concrete and steel; the recycle/reuse of components from decommissioning; and the reduction of occupational exposures in D/D and the regulatory process in decommissioning. The IAEA's future program is briefly reviewed

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.

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...

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...

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

International Nuclear Information System (INIS)

2003-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in Nuclear Materials and Equipment; 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities (Department of Trade and Industry - DTI; Secretary of State for Environment, Food and Rural Affairs and the Secretary of State for Health; Secretary of State for Transport; Secretary of State for Education); 2. Advisory Bodies (Medical Research Council - MRC; Nuclear Safety Advisory Committee; Radioactive Waste Management Advisory Committee); 3. Public and Semi-Public Agencies (United Kingdom Atomic Energy Authority - UKAEA; Health and Safety Commission and Executive - HSC/HSE; National Radiological Protection Board - NRPB; Environment Agencies; British Nuclear Fuels plc. - BNFL; Amersham International plc.; The National Nuclear Corporation Ltd. - NNC; United Kingdom Nirex Ltd.; Magnox Electric plc.; British Energy Generation Ltd.; Scottish Electricity Generator Companies; British Energy Generation Ltd.; Regional Electricity Companies in England and Wales)

Regulatory Assistance, Stakeholder Outreach, and Coastal and Marine Spatial Planning Activities in Support of Marine and Hydrokinetic Energy Deployment

Energy Technology Data Exchange (ETDEWEB)

Geerlofs, Simon H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Copping, Andrea E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Van Cleve, Frances B. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Blake, Kara M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hanna, Luke A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

2011-09-01

This fiscal year 2011 progress report summarizes activities carried out under DOE Water Power Task 2.1.7, Permitting and Planning. Activities under Task 2.1.7 address the concerns of a wide range of stakeholders with an interest in the development of the marine and hydrokinetic (MHK) energy industry, including regulatory and resource management agencies, tribes, nongovernmental organizations, and industry.

The Regulatory Cooperation Forum, an Opportunity to Strengthen International Cooperation

International Nuclear Information System (INIS)

Lachaume, J.L.; Mamoru, M.

2016-01-01

The Regulatory Cooperation Forum (RCF) is a member-driven forum of nuclear power regulators created in 2010 that promotes the sharing of regulatory knowledge and experience through international cooperation and collaboration using the IAEA Safety Standards as its basis. The RCF involves countries with advanced nuclear power programmes, countries embarking on nuclear power for the first time and countries with smaller programmes considering expansion. The primary objectives of the RCF are: • To promote collaboration and cooperation among RCF members to improve coordination of support for regulatory infrastructure development; • To contribute to achieving and sustaining a high level of nuclear safety, consistent with the IAEA Safety Standards and Guidance; • To optimize resources among RCF members and avoid unnecessary support duplication through improved coordination. Membership of the RCF is open to all Member States of the IAEA. Participants in RCF activities will normally be senior representatives from regulatory bodies in Member States and from other providers, including the IAEA, European Commission (EC) and the Nuclear Energy Agency (NEA) of the Organization for Economic Co-operation and Development (OECD). So far, more than 30 countries are members of the RCF. The RCF has developed Action Plans to support Jordan, Vietnam, Belarus and Poland. The IAEA’s Nuclear Safety Action Plan urges Member States to strengthen the effectiveness of national regulatory bodies as well as base the development of their nuclear infrastructures on IAEA Safety Standards. The RCF assists Member States in implementing both of these actions for embarking, existing and expanding nuclear programmes. (author)

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2014-05-01

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

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

Science.gov (United States)

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

2016-01-01

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

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

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...

Experts Complete IAEA Follow-up Review of Australia's Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

Full text: Nuclear and radiation safety experts today concluded an eight-day mission to review the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA), the country's nuclear regulator. At the request of the Australian Government, the International Atomic Energy Agency (IAEA) assembled a peer-review team of five regulatory experts from as many nations and three IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2007. This follow-up IRRS mission examined ARPANSA's progress in acting upon the recommendations and suggestions made during the 2007 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety regulatory aspects of all facilities and activities regulated by ARPANSA. IRRS team leader Kaare Ulbak, Chief Advisor of Denmark's National Institute of Radiation Protection, said: ''ARPANSA should be commended for the significant amount of efforts in addressing all the findings identified in the 2007 mission and for inviting this follow-up review.'' The review team found that ARPANSA has made significant progress toward improving its regulatory activities, as most of the findings identified in the 2007 report have been effectively addressed and therefore can be considered closed. Complementing the ARPANSA strengths identified during the 2007 mission, the 2011 IRRS team noted the following strengths: Response to the Tepco Fukushima Dai-ichi accident; High level of in-house technical expertise in radiation safety; Recognition of the need and willingness to re-organize ARPANSA; Timely development of the national sealed source register in good coordination with other relevant organizations; and Creation of the Australian clinical dosimetry service and the national dose reference levels database. The 2011 IRRS team also made recommendations and suggestions to further strengthen ARPANSA's regulatory system, including: Making full

Transportation of radioactive materials: the legislative and regulatory information system

International Nuclear Information System (INIS)

Fore, C.S.

1982-03-01

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

Transportation of radioactive materials: the legislative and regulatory information system

Energy Technology Data Exchange (ETDEWEB)

Fore, C.S.

1982-03-01

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

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

Croatian energy regulatory council - independent Croatian regulatory body

International Nuclear Information System (INIS)

Klepo, M.

2002-01-01

By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)

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...

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

Regulation of Federal radioactive waste activities. Summary of report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

International Nuclear Information System (INIS)

Smith, R.D.

1979-09-01

The NRC Authorization Bill for FY 1979 directed NRC to conduct a study of extending the Commission's licensing or regulatory authority to include categories of existing and future Federal radioactive waste storage and disposal activities not presently subject to such authority. The report includes a complete listing and inventory of all radioactive waste storage and disposal activities now being conducted or planned by Federal agencies. The NRC study has attempted to present a general comparison of the relative hazards associated with defense-generated and commercial wastes. Options for extending Commission authority were developed and analyzed. The implications of NEPA were analyzed in the context of these options. The national security implications of extending NRC's regulatory authority over DOE programs are examined and evaluated. Costs and benefits are identified and assessed. The Commission's recommendations, based on the study, are to extend licensing authority over new DOE disposal activities involving transuranic wastes and non-defense low-level waste and to initiate a pilot program to test the feasibility of NRC playing a consultative role in the evaluation of existing DOE activities

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

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Trade and Industry - KTM; Ministry of Social Affairs and Health; Ministry of the Interior; Ministry of the Environment; Ministry of Foreign Affairs); 2. Advisory bodies (Advisory Committee on Nuclear Energy; Advisory Committee on Nuclear Safety); 3. Public and semi-public agencies (Finnish Radiation and Nuclear Safety Authority - STUK; State Nuclear Waste Management Fund)

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

International Nuclear Information System (INIS)

2011-01-01

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

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

International Nuclear Information System (INIS)

2009-01-01

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

OVERVIEW OF THE ACTIVITIES OF THE NUCLEAR ENERGY AGENCY WORKING GROUP ON EXTERNAL EVENTS

Energy Technology Data Exchange (ETDEWEB)

Nakoski, John A.; Smith, Curtis L.; Kim, Min Kyu

2016-10-01

The Orgranisation for Economic Cooperation and Development (OECD) Nuclear Energy Agency (NEA) has established a Working Group on External Events (WGEV) that provides a forum for subject matter experts from the nuclear industry and regulators to improve the understanding and treatment of external hazards that would support the continued safety performance of nuclear installations, and improve the effectiveness of regulatory practices, in NEA member countries. This report provides a description of the ongoing work of the WGEV. The work of the WGEV includes the collection of information and conducting a workshop on severe weather and storm surge that brought together a diverse group of subject matter experts to identify commendable practices related to the treatment of severe weather and storm surge consideration in regulatory and operational decision-making. Other work of the WGEV includes looking at science-based screening of external events that are factored into decisions on the safe operation of nuclear facilities; and identification of commendable practices and knowledge gaps on riverine flooding.

Alberta Energy and Utilities Board, regulatory highlights for 1998

Energy Technology Data Exchange (ETDEWEB)

NONE

1999-08-01

This new publication informs readers about what the Alberta Energy and Utilities Board (EUB) did in the past year, including important regulatory issues, trends and initiatives. The EUB is an agency of the provincial government, established to regulate Alberta`s energy resource and utility sectors. It is part of the Alberta Ministry of Energy. The four main functions of the Board are regulatory initiatives, license applications, enforcement and information. This publication summarized the EUB`s position regarding flaring (both solution gas flaring and well test flaring), and Board activities in the areas of animal health concerns, the gas over bitumen controversy, the deregulation of the electric industry and what it means to the EUB, improvements in data quality as a result of improved industry compliance in reporting, and a variety of issues related to the oil sands and the negotiated settlement process. Also, the Board has been proactive in the area of oilfield waste management guidelines, proliferation policies for gas processing facilities, sulphur recovery guidelines, and the expansion of the orphan well program to include facilities and pipelines. As a measure of the success of the EUB, a recent survey of 19 randomly selected focus groups praised EUB for its impartiality, fair and equitable enforcement and independence. It was also praised for its technically competent and experienced staff, its access to quality information and the clarity of its mandate, regulatory requirements and processes. The Board`s efforts in the area of timely stakeholder consultation was highlighted. tabs., figs.

Erosion of trust in humanitarian agencies: what strategies might help?

Science.gov (United States)

Jayasinghe, Saroj

2011-01-01

Aid agencies (AAs) provide a range of humanitarian and health related assistance globally. However, the trust placed on them is eroding. Evidence for this includes accusations of a decline in their humanitarianism, and the increasing number of conflicts with host states. An analysis of the concerns expressed yields two possible reasons: a relative lack of transparency of their work and weak accountability mechanisms. This is further supported by the existing milieu: an absence of internationally accepted instrument or mechanism to check the credentials of INGOs and an opaque system of close links between some of the INGOs and their donors. The article suggests two global strategies to tackle these issues: (a) Increase transparency by establishing a global register of aid agencies. This should have basic information: their main goals and activities, countries they are active in, number of employees, annual turnover of funds (updated regularly), principal financing sources and nature of links with donors. This could also be available as printed manual that should be freely available to client countries. (b) Ensure accountability by developing templates of fair legal instruments (to facilitate and regulate work), and a set of generic rules and procedures of engagement for the interactions between agencies and client states. These should be institutionalized within the regulatory frameworks of countries and included in the Codes of Conduct of NGOs. PMID:22110413

Erosion of trust in humanitarian agencies: what strategies might help?

Science.gov (United States)

Jayasinghe, Saroj

2011-01-01

Aid agencies (AAs) provide a range of humanitarian and health related assistance globally. However, the trust placed on them is eroding. Evidence for this includes accusations of a decline in their humanitarianism, and the increasing number of conflicts with host states. An analysis of the concerns expressed yields two possible reasons: a relative lack of transparency of their work and weak accountability mechanisms. This is further supported by the existing milieu: an absence of internationally accepted instrument or mechanism to check the credentials of INGOs and an opaque system of close links between some of the INGOs and their donors. The article suggests two global strategies to tackle these issues: (a) Increase transparency by establishing a global register of aid agencies. This should have basic information: their main goals and activities, countries they are active in, number of employees, annual turnover of funds (updated regularly), principal financing sources and nature of links with donors. This could also be available as printed manual that should be freely available to client countries. (b) Ensure accountability by developing templates of fair legal instruments (to facilitate and regulate work), and a set of generic rules and procedures of engagement for the interactions between agencies and client states. These should be institutionalized within the regulatory frameworks of countries and included in the Codes of Conduct of NGOs.

Erosion of trust in humanitarian agencies: what strategies might help?

Directory of Open Access Journals (Sweden)

Saroj Jayasinghe

2011-11-01

Full Text Available Aid agencies (AAs provide a range of humanitarian and health related assistance globally. However, the trust placed on them is eroding. Evidence for this includes accusations of a decline in their humanitarianism, and the increasing number of conflicts with host states. An analysis of the concerns expressed yields two possible reasons: a relative lack of transparency of their work and weak accountability mechanisms. This is further supported by the existing milieu: an absence of internationally accepted instrument or mechanism to check the credentials of INGOs and an opaque system of close links between some of the INGOs and their donors. The article suggests two global strategies to tackle these issues: (a Increase transparency by establishing a global register of aid agencies. This should have basic information: their main goals and activities, countries they are active in, number of employees, annual turnover of funds (updated regularly, principal financing sources and nature of links with donors. This could also be available as printed manual that should be freely available to client countries. (b Ensure accountability by developing templates of fair legal instruments (to facilitate and regulate work, and a set of generic rules and procedures of engagement for the interactions between agencies and client states. These should be institutionalized within the regulatory frameworks of countries and included in the Codes of Conduct of NGOs.

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

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...

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

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...

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

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

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

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...

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

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...

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

Directory of Open Access Journals (Sweden)

Dipak Dilip Gadade

2016-12-01

Full Text Available 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 employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

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

Science.gov (United States)

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-12-01

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 employed to improve vital physicochemical characteristics of a drug, including solubility, dissolution, bioavailability and stability of pharmaceutical compounds while maintaining its therapeutic activity. It is advantageous being a green synthesis approach for production of pharmaceutical compounds. The formation polymorphic forms, solvates, hydrates and salts of cocrystals during the synthesis reported in the literature which can be a potential issue in the development of pharmaceutical cocrystals. The approaches like hydrogen bonding rules, solubility parameters, screening through the CSD database or thermodynamic characteristics can be utilized for the rational design of cocrystals and selection of coformers for synthesis multi-component cocrystals. Considering the significance of pharmaceutical cocrystals pharmaceutical regulatory authorities in the United States and Europe issued guidance documents which may be helpful for pharmaceutical product registration in these regions. In this article, we deal with the design, synthesis, strategic aspects and characteristics of cocrystals along perspectives on its regulatory and intellectual property considerations.

Proceedings of the seminar on Leak-Before-Break: Progress in regulatory policies and supporting research

International Nuclear Information System (INIS)

Kashima, K.; Wilkowski, G.M.

1988-03-01

The third in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at TEPCO Hall in the Tokyo Electric Power Company's (TEPCO) Electric Power Museum on May 14 and 15, 1987. The seminar updated the international policies and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utility representatives, fabricators of nuclear power plants, research organizations, and university professors. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA), Dr. H. Schultz (GRS, W. Germany), Dr. P. Milella (ENEA-DISP, Italy), Dr. C. Faidy, P. Jamet, and S. Bhandari (EDF/Septen, CEA/CEN, and Framatome, France), and Mr. T. Fukuzawa (MITI, Japan). Dr. F. Nilsson presented revised nondestructive inspection requirements relative to LBB in Sweden. In addition, several papers on the supporting research programs discussed regulatory policy. Questions following the presentations of the papers focused on the impact of various LBB policies or the impact of research findings. Supporting research programs were reviewed on the first and second day by several participants from the US, Japan, Germany, Canada, Italy, Sweden, England, and France

IAEA Mission Concludes Peer Review of Slovenia's Nuclear Regulatory Framework

International Nuclear Information System (INIS)

2014-01-01

Senior international nuclear safety and radiation protection experts today concluded an eight-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety at the Slovenian Nuclear Safety Administration (SNSA). The team reviewed measures taken to address the recommendations and suggestions made during an earlier Integrated Regulatory Review Service (IRRS) mission conducted in 2011. The IRRS team said in its preliminary findings that Slovenia had made significant progress since the review in 2011. The team identified a good practice in the country's nuclear regulatory system additional to those identified in 2011 and made new recommendations and suggestions to SNSA and the Government to strengthen the effectiveness of the country's regulatory framework in line with IAEA Safety Standards. ''By hosting a follow-up mission, Slovenia demonstrated its commitment to enhance its regulatory programmes, including by implementing the recommendations of the 2011 mission,'' said Petr Krs, mission leader and Vice Chairman of the Czech Republic's State Office for Nuclear Safety. SNSA's Director, Andrej Stritar, welcomed the progress noted by the team, while also emphasizing that the mission highlighted important future nuclear safety challenges for Slovenia. The five-member review team, comprising experts from Belgium, the Czech Republic, France and Romania, as well as four IAEA staff members, conducted the mission at the request of the Slovenian Government from 9 to 16 September 2014. The main observations of the IRRS Review team included the following: SNSA has made significant progress in addressing the findings of the 2011 IRRS mission and has demonstrated commitment to effective implementation of the IRRS programme; The economic situation in Slovenia might in the short and long term affect SNSA's ability to maintain its capacity and competence; and A radioactive waste disposal project is stalled and the licensing

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

Energy Technology Data Exchange (ETDEWEB)

Ben Grunewald; Paul Jehn; Tom Gillespie; Ben Binder

2004-12-21

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

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...

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...

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

Directory of Open Access Journals (Sweden)

Bruno Fonseca-Santos

2015-03-01

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

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

Regulatory issues of natural gas distribution; Aspectos regulatorios acerca da distribuicao de gas natural

Energy Technology Data Exchange (ETDEWEB)

Leite, Fabio Augusto C.C.M.; Costa, Hirdan Katarina de M. [Universidade Federal do Rio Grande do Norte (UFRN), Natal, RN (Brazil). Faculdade de Direito

2004-07-01

In these past few years, natural gas in Brazil has arised as one of the alternatives for the energetic crisis suffered by the country. Such situation was one of the motives for its expansion, rising, after that, the importance of the regulation of its distribution. The regulation of canalized natural gas distribution can be found in the Federal Constitution, after Constitutional Amendment n. 05/95, in the article n. 25, para. 2nd, which say that belongs to the Federal States the concession or direct exercise of canalized natural gas services, now clearly classified as a public service. In order of these events, its imperative the analysis of natural gas distribution's public service, because it belongs to the Federal States. According to this situation, the study of the new regulatory function of the Administration and the tracing of action for the regulatory state agencies are the main goals of this work. As so, the present research aims to focus the reflexes from the actual dimension of natural gas distribution, specially referring to its regulatory statements, the limitations of state agencies, the National Petroleum Agency and the market where distribution belongs, and particularly the open access of new agents. (author)

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...

Your business in court and at Federal agencies: 2011-2012.

Science.gov (United States)

Reiss, John B; Crowder, Dawn; McCabe, Brittany; DeFeo, Marisa; Rifin, Marta; Talbot, Meghan

2013-01-01

FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.

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.

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...

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...

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

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.

Inspection and enforcement by the regulatory body for nuclear power plants

International Nuclear Information System (INIS)

1980-01-01

This Safety Guide was prepared as part of the Agency's programme, referred to as the NUSS programme, for establishing Codes of Practice and Safety Guides relating to nuclear power plants. It supplements the Code of Practice on Governmental Organization for the Regulation of Nuclear Power Plants, IAEA Safety Series No.50-C-G and should be used in conjunction with that document. The purpose of this Guide is to provide information, guidance and recommendations to assist Member States in (1) establishing and conducting a regulatory inspection programme for nuclear power plants, (2) establishing requirements for the applicant/licensee in regard to regulatory inspection, (3) establishing a system for enforcing compliance with the requirements and decisions of the regulatory body

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Republic of Korea

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection) (Protection of workers; Protection of the public); 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Education, Science and Technology, including the Nuclear Energy Bureau; Minister of Knowledge Economy); 2. Advisory bodies (Atomic Energy Commission; Atomic Energy Safety Commission); 3. Public and semi-public agencies (Korean Atomic Energy Research Institute - KAERI; Korean Institute for Nuclear Safety - KINS; Korean Electric Power Company - KEPCO; Korean Hydro and Nuclear Power - KHNP)

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)

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...

Queer in STEM Organizations: Workplace Disadvantages for LGBT Employees in STEM Related Federal Agencies

Directory of Open Access Journals (Sweden)

Erin A. Cech

2017-02-01

Full Text Available Lesbian, gay, bisexual, and transgender (LGBT individuals in U.S. workplaces often face disadvantages in pay, promotion, and inclusion and emergent research suggests that these disadvantages may be particularly pernicious within science and engineering environments. However, no research has systematically examined whether LGBT employees indeed encounter disadvantages in science, technology, engineering and math (STEM organizations. Using representative data of over 30,000 workers employed in six STEM-related federal agencies (the Department of Energy, the Environmental Protection Agency, the National Science Foundation, NASA, the Nuclear Regulatory Commission, and the Department of Transportation, over 1000 of whom identify as LGBT, we compare the workplace experiences of LGBT employees in STEM-related federal agencies with those of their non-LGBT colleagues. Across numerous measures along two separate dimensions of workplace experiences—perceived treatment as employees and work satisfaction—LGBT employees in STEM agencies report systematically more negative workplace experiences than their non-LGBT colleagues. Exploring how these disadvantages vary by agency, supervisory status, age cohort, and gender, we find that LGBT persons have more positive experiences in regulatory agencies but that supervisory status does not improve LGBT persons’ experiences, nor do the youngest LGBT employees fare better than their older LGBT colleagues. LGBT-identifying men and women report similar workplace disadvantages. We discuss the implications of these findings for STEM organizations and STEM inequality more broadly.

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...

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...

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

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

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection (Radiation protection standards; Emergency response); 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister for the Environment, Heritage and Local Government; Minister for Agriculture and Food; Minister for Communications, Marine and Natural Resources; Minister for Finance; Minister for Health and Children; Minister for Defence); 2. Public and semi-public agencies (Radiological Protection Institute of Ireland; Food Safety Authority of Ireland)

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

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Prime Minister; Ministry of Energy and Natural Resources; Ministry of Health; Ministry of the Environment and Forestry); 2. Public and semi-public agencies (Turkish Atomic Energy Authority - TAEK; General Directorate for Mineral Research and Exploration - MTA; ETI Mine Works General Management; Turkish Electric Generation and Transmission Corporation - TEAS; Turkish Electricity Distribution Corporation - TEDAS)

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)

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...

Current and future applications of PRA in regulatory activities

Energy Technology Data Exchange (ETDEWEB)

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

1995-04-01

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

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

International Nuclear Information System (INIS)

2001-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances, Nuclear Fuel and Equipment; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in Nuclear Materials and Equipment (Trade governed by nuclear energy legislation; Trade governed by radiation protection legislation; Trade governed by export/import control legislation); 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities: A. Ministerial Level (Ministry of Health and Social Affairs; Ministry of Trade and Industry; Ministry of Foreign Affairs; Other Ministries); B. Subsidiary Level: (The Norwegian Radiation Protection Authority - NRPA; The Norwegian Nuclear Emergency Organisation); 2. Public and Semi-Public Agencies - Institute for Energy Technology - IFE

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

Joint US Geological Survey, US Nuclear Regulatory Commission workshop on research related to low-level radioactive waste disposal, May 4-6, 1993, National Center, Reston, Virginia; Proceedings

Science.gov (United States)

Stevens, Peter R.; Nicholson, Thomas J.

1996-01-01

This report contains papers presented at the "Joint U.S. Geological Survey (USGS) and U.S. Nuclear Regulatory Commission (NRC) Technical Workshop on Research Related to Low-Level Radioactive Waste (LLW) Disposal" that was held at the USGS National Center Auditorium, Reston, Virginia, May 4-6, 1993. The objective of the workshop was to provide a forum for exchange of information, ideas, and technology in the geosciences dealing with LLW disposal. This workshop was the first joint activity under the Memorandum of Understanding between the USGS and NRC's Office of Nuclear Regulatory Research signed in April 1992.Participants included invited speakers from the USGS, NRC technical contractors (U.S. Department of Energy (DOE) National Laboratories and universities) and NRC staff for presentation of research study results related to LLW disposal. Also in attendance were scientists from the DOE, DOE National Laboratories, the U.S. Environmental Protection Agency, State developmental and regulatory agencies involved in LLW disposal facility siting and licensing, Atomic Energy Canada Limited (AECL), private industry, Agricultural Research Service, universities, USGS and NRC.

[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.

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...

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

OpenAIRE

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

2015-01-01

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

Assisting IAEA Member States to Strengthen Regulatory Control, Particularly in the Medical Area

International Nuclear Information System (INIS)

Johnston, P.

2016-01-01

As per its Statue and Mandate, IAEA is developing Safety Standards and is also providing assistance for their application in Member States. One target and very large audience of this programme is the community of national regulatory bodies for radiation safety, expected to be established in all 168 Member States. Ionizing radiation is being used throughout the world in medical practices and medical exposure is the most significant manmade source of exposure to the population from ionizing radiation. Radiation accidents involving medical uses have accounted for more injuries and early acute health effects than any other type of radiation accident, including accidents at nuclear facilities. With the constant emerging of new technologies using ionizing radiation for medical diagnostic and treatment, there are on-going challenges for Regulatory bodies. The presentation will highlight some figures related to the medical exposure worldwide, and then it will introduce the main safety standards and other publications developed specifically for Regulatory Bodies and focusing on medical practices. It will also highlight the most important and recent mechanisms (tools, peer reviews and advisory services, training courses, networks) that the Agency is offering to its Member States in order to cope with the main challenges worldwide, contributing thus to the efficiency and effectiveness of the regulatory oversight of medical facilities and activities. (author)

12 CFR 914.1 - Regulatory Report defined.

Science.gov (United States)

2010-01-01

... Bank. (b) Examples. Regulatory Report includes: (1) Call reports and reports of instrument-level risk... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Regulatory Report defined. 914.1 Section 914.1... DATA AVAILABILITY AND REPORTING § 914.1 Regulatory Report defined. (a) Definition. Regulatory Report...

Highlights of the EPA innovative regulatory strategies workshop: Market-based incentives and other innovations for air pollution control. Summary of workshop discussion sessions. Held in Washington, DC on January 15-17, 1992

International Nuclear Information System (INIS)

1992-06-01

The Clean Air Act Amendments of 1990 allow, and in some cases require, States to adopt market-based strategies or other innovative types of air pollution control. The U.S. Environmental Protection Agency's (EPA's) innovative regulatory strategies program seeks to encourage and facilitate, as appropriate, the development, demonstration, and implementation of a wide range of innovative regulatory air pollution programs, including market-based, informational, and pollution prevention approaches. The 3-day national workshop, attended by over two hundred people from Federal, State, and local agencies, industry, environmental and public interest groups, and the academic community highlighted issues associated with a variety of innovative, market-based strategies which are currently being developed or used by State and local authorities around the country

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.

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

Nuclear Regulatory Commission issuances. Opinions and decisions of the Nuclear Regulatory Commission with selected orders, July 1, 1994--December 31, 1994. Volume 40, Pages 1--387

International Nuclear Information System (INIS)

1994-01-01

The hardbound edition of the Nuclear Regulatory Commission Issuances is a final compilation of the monthly issuances. It includes all of the legal precedents for the agency within a six-month period. Any opinions, decisions, denials, memoranda and orders of the Commission inadvertently omitted from the monthly softbounds and any corrections submitted by the NRC legal staff to the printed softbound issuances are contained in the hardbound edition. Cross references in the text and indexes are to the NRCI page numbers which are the same as the page numbers in this publication. This book covers the following: issuances of the NRC; issuances of the Atomic Safety and Licensing Boards; and issuances of Directors' decisions

Nuclear Regulatory Commission issuances. Opinions and decisions of the Nuclear Regulatory Commission with selected orders, July 1, 1994--December 31, 1994. Volume 40, Pages 1--387

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-12-31

The hardbound edition of the Nuclear Regulatory Commission Issuances is a final compilation of the monthly issuances. It includes all of the legal precedents for the agency within a six-month period. Any opinions, decisions, denials, memoranda and orders of the Commission inadvertently omitted from the monthly softbounds and any corrections submitted by the NRC legal staff to the printed softbound issuances are contained in the hardbound edition. Cross references in the text and indexes are to the NRCI page numbers which are the same as the page numbers in this publication. This book covers the following: issuances of the NRC; issuances of the Atomic Safety and Licensing Boards; and issuances of Directors` decisions.

Does GLP enhance the quality of toxicological evidence for regulatory decisions?

Science.gov (United States)

Borgert, Christopher J.; Becker, Richard A.; Carlton, Betsy D.; Hanson, Mark; Kwiatkowski, Patricia L.; Sue Marty, Mary; McCarty, Lynn S.; Quill, Terry F.; Solomon, Keith; Van Der Kraak, Glen; Witorsch, Raphael J.; Don Yi, Kun

2016-01-01

There is debate over whether the requirements of GLP are appropriate standards for evaluating the quality of toxicological data used to formulate regulations. A group promoting the importance of non-monotonic dose responses for endocrine disruptors contend that scoring systems giving primacy to GLP are biased against non-GLP studies from the literature and are merely record-keeping exercises to prevent fraudulent reporting of data from non-published guideline toxicology studies. They argue that guideline studies often employ insensitive species and outdated methods, and ignore the perspectives of subject-matter experts in endocrine disruption, who should be the sole arbiters of data quality. We believe regulatory agencies should use both non-GLP and GLP studies, that GLP requirements assure fundamental tenets of study integrity not typically addressed by journal peer-review, and that use of standardized test guidelines and GLP promotes consistency, reliability, comparability, and harmonization of various types of studies used by regulatory agencies worldwide. This debate suffers two impediments to progress: a conflation of different phases of study interpretation and levels of data validity, and a misleading characterization of many essential components of GLP and regulatory toxicology. Herein we provide clarifications critical for removing those impediments. PMID:27208076

Overview of NRC's human factors regulatory research program

International Nuclear Information System (INIS)

Coffman, F.D. Jr.

1989-01-01

The human factors research program is divided into distinct and interrelated program activities: (1) Personnel Performance measurement, (2) Personnel Subsystem, (3) Human-System Interface, (4) Organization and Management, and (5) a group of Reliability Assessment activities. The purpose of the Personnel Performance Measurement activity is to improve the Agency's understanding of the factors influencing personnel performance and the effects on the safety of nuclear operations and maintenance by developing improvements to methods for collecting and managing personnel performance data. Personnel Subsystem research will broaden the understanding of such factors as staffing, qualifications, and training that influence human performance in the nuclear system and will develop the technical basis for regulatory guidance to reduce any adverse impact of these influences on nuclear safety. Research in the Human-System Interface activity will provide the technical basis for ensuring that the interface between the system and the human user supports safe operations and maintenance. Organization and Management research will result in the development of tools for evaluating organization and management issues within the nuclear industry. And finally, the Reliability Assessment group of activities includes multidisciplinary research that will integrate human and hardware considerations for evaluating reliability and risk in NRC licensing, inspection, and regulatory decisions

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

A strategy for regulatory action when new adverse effects of a licensed product emerge.

Science.gov (United States)

Aronson, Jeffrey K; Price, Deirdre; Ferner, Robin E

2009-01-01

Regulatory agencies grant product licences (marketing authorizations) for medicinal products in the light of evidence that the balance between benefit and harm in the population is favourable. Here we consider a framework for allowing regulatory agencies to make rational decisions when reviewing product licences in the light of new information about harms that change that balance. The regulator can revoke the product licence, restrict the product's availability or change the 'label' in different ways. We examine the features of the adverse effect that may be relevant in making the decision: namely, individual differences in susceptibility; the possibility of monitoring; and the availability of protective strategies. The balance of benefit and harm, and the time-course and dose relation of the adverse effect play important roles in the decision-making process. We set out how these factors can help determine the logical response to new information on the balance between benefit and harm, and provide a series of relevant examples. We believe that when regulatory agencies have to decide how to amend the product licence of a drug when new serious adverse effects cause concern, they would find it useful to adopt a framework of this kind, using different strategies for different cases. Our proposed framework could also be useful in risk management planning during drug development.

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...

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.

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

Science.gov (United States)

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

2014-05-01

regulatory analysis of management options. For assessments of the current radiological situation, the types of data needed include information about the distribution of radionuclides in environmental media. For prognostic assessments, additional data are needed about the landscape features, on-shore and off-shore hydrology, geochemical properties of soils and sediments, and possible continuing source terms from continuing operations and on-site disposal. It is anticipated that shared international experience in legacy site characterization can be useful in the next steps. Although the output has been designed to support regulatory evaluation of these particular sites in northwest Russia, the methods and techniques are considered useful examples for application elsewhere, as well as providing relevant input to the International Atomic Energy Agency's international Working Forum for the Regulatory Supervision of Legacy Sites. Copyright © 2013 Elsevier Ltd. All rights reserved.

Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

Directory of Open Access Journals (Sweden)

Janis eAncans

2012-08-01

Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

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

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear items and spent fuel (Ionising radiation sources; Nuclear items; Spent fuel); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response; Decommissioning); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (State Office for Nuclear Safety - SUJB; Ministry of Industry and Trade; Ministry of the Interior; Ministry of the Environment); 2. Public and semi-public agencies (CEZ, a.s.; National Radiation Protection Institute - NRPI; Radioactive Waste Repository Authority - RAWRA; Diamo; Nuclear Physics Institute - NPI; National Institute for Nuclear, Chemical and Biological Protection; Nuclear Research Institute Rez, a.s. - NRI)

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.

Review of decision methodologies for evaluating regulatory actions affecting public health and safety. [Nuclear industry site selection

Energy Technology Data Exchange (ETDEWEB)

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.

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...

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

International Atomic Energy Agency publications. Publications catalogue 2001-2002, including IAEA technical documents

International Nuclear Information System (INIS)

2002-09-01

This catalogue lists all sales publications of the IAEA issued and forthcoming between January 2001 and September 2002. Most Agency publications are issued in English, though some are also available in Arabic, Chinese, French, Russian or Spanish. The lists all publications by subject category, in alphabetical order within each category

Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives.

Science.gov (United States)

Leong, James; McAuslane, Neil; Walker, Stuart; Salek, Sam

2013-09-01

To explore the current status and need for a universal benefit-risk framework for medicines in regulatory agencies and pharmaceutical companies. A questionnaire was developed and sent to 14 mature regulatory agencies and 24 major companies. The data were analysed using descriptive statistics, for a minority of questions preceded by manual grouping of the responses. Overall response rate was 82%, and study participants included key decision makers from agencies and companies. None used a fully quantitative system, most companies preferring a qualitative method. The major reasons for this group not using semi-quantitative or quantitative systems were lack of a universal and scientifically validated framework. The main advantages of a benefit-risk framework were that it provided a systematic standardised approach to decision-making and that it acted as a tool to enhance quality of communication. It was also reported that a framework should be of value to both agencies and companies throughout the life cycle of a product. They believed that it is possible to develop an overarching benefit-risk framework that should involve relevant stakeholders in the development, validation and application of a universal framework. The entire cohort indicated common barriers to implementing a framework were resource limitations, a lack of knowledge and a scientifically validated and acceptable framework. Stakeholders prefer a semi-quantitative, overarching framework that incorporates a toolbox of different methodologies. A coordinating committee of relevant stakeholders should be formed to guide its development and implementation. Through engaging the stakeholders, these outcomes confirm sentiments and need for developing a universal benefit-risk assessment framework. Copyright © 2013 John Wiley & Sons, Ltd.

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)

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.)

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

International Nuclear Information System (INIS)

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

2009-01-01

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

Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

International Nuclear Information System (INIS)

2010-01-01

Full text: An international team of senior nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the governmental and regulatory framework for nuclear safety in the United States. The team identified good practices within the U.S. system and offered suggestions for ways the U.S. Nuclear Regulatory Commission (NRC) could improve. The IAEA has conveyed the team's main conclusions to the NRC, and a final report will be submitted to the NRC in about two months. At the request of the United States, the IAEA assembled a team of 19 international experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This mission was a peer review based on the IAEA Safety Standards. It was not an inspection, nor an audit. The experts came from 14 different countries: Canada, China, the Czech Republic, Finland, France, Italy, Japan, Mexico, the Republic of Korea, Slovenia, Spain, Sweden, Switzerland, and the United Kingdom. Team leader Jukka Laaksonen of Finland said: ''We found a comprehensive, consistent, and mature regulatory system run by the NRC, which has a strong drive for continuous improvement.' The scope of the mission included the U.S. regulatory framework and the regulation of the nuclear plant operation. The mission was conducted from 18 to 29 October, mainly at NRC headquarters outside of Washington, D.C. To study U.S. regulatory activities, the mission conducted a series of interviews and discussions with NRC staff and other organizations to help assess the effectiveness of the regulatory system. In addition, the team observed regulatory activities at two operating nuclear power reactors and an emergency preparedness exercise. The IAEA's IRRS coordinator Gustavo Caruso said, ''This mission represents a milestone for the IRRS program because the U.S. regulatory system is the largest in the world and many nations look to it. The IRRS is a useful tool that allows host nations to gain guidance from experienced

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

International Nuclear Information System (INIS)

1997-12-01

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

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

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-12-01

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

Nuclear Regulatory Commission issuances: Opinions and decisions of the Nuclear Regulatory Commission with selected orders, July 1 - December 31, 1996. Volume 44, Pages 1 - 432

International Nuclear Information System (INIS)

1997-01-01

The hardbound edition of the Nuclear Regulatory Commission Issuances is a final compilation of the monthly issuances. It includes all of the legal precedents for the agency within a six-month period. Any opinions, decisions, denials, memoranda and orders of the Commission inadvertently omitted from the monthly softbounds and any corrections submitted by the NRC legal staff to the printed softbound issuances are contained in the hardbound edition. Cross references in the text and indexes are to the NRCI page numbers which are the same as the page numbers in this publication. Issuances are referred to as follows: Commission--CLI, Atomic Safety and Licensing Boards--LBP, Administrative Law Judges--ALJ, Directors' Decisions--DD, and Decisions on Petitions for Rulemaking--DPRM

Nuclear Regulatory Commission issuances: Opinions and decisions of the Nuclear Regulatory Commission with selected orders, July 1--December 31, 1996. Volume 44, Pages 1--432

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-10-01

The hardbound edition of the Nuclear Regulatory Commission Issuances is a final compilation of the monthly issuances. It includes all of the legal precedents for the agency within a six-month period. Any opinions, decisions, denials, memoranda and orders of the Commission inadvertently omitted from the monthly softbounds and any corrections submitted by the NRC legal staff to the printed softbound issuances are contained in the hardbound edition. Cross references in the text and indexes are to the NRCI page numbers which are the same as the page numbers in this publication. Issuances are referred to as follows: Commission--CLI, Atomic Safety and Licensing Boards--LBP, Administrative Law Judges--ALJ, Directors` Decisions--DD, and Decisions on Petitions for Rulemaking--DPRM.

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

Science.gov (United States)

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

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...

United States Nuclear Regulatory Commission information digest: 1997 edition. Volume 9

International Nuclear Information System (INIS)

1997-05-01

The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, NRC licensed activities, and general information on domestic and world-wide 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 1996, 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

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.

The waste isolation pilot plant: A new regulatory environment

International Nuclear Information System (INIS)

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

1993-01-01

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

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

International Nuclear Information System (INIS)

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

2014-01-01

regulatory analysis of management options. For assessments of the current radiological situation, the types of data needed include information about the distribution of radionuclides in environmental media. For prognostic assessments, additional data are needed about the landscape features, on-shore and off-shore hydrology, geochemical properties of soils and sediments, and possible continuing source terms from continuing operations and on-site disposal. It is anticipated that shared international experience in legacy site characterization can be useful in the next steps. Although the output has been designed to support regulatory evaluation of these particular sites in northwest Russia, the methods and techniques are considered useful examples for application elsewhere, as well as providing relevant input to the International Atomic Energy Agency's international Working Forum for the Regulatory Supervision of Legacy Sites. - Highlights: • Characterization of sites for storage of spent fuel and radioactive waste in northwest Russia. • Development of radio-ecological visualization and prognostic radiological assessment tools. • Control of radiation exposure during hazardous operations. • Application of these developments to support regulatory supervision of legacy sites

Proposal for the International Atomic Energy Agency Training Course

International Nuclear Information System (INIS)

McCarthy, T.L.

1994-06-01

The Hanford Site has hosted similar activities, including both Hanford Summits I and II. The Hanford Summits were two-day televised events to discuss the commitment of the current Presidential administration to the environmental restoration of the Hanford Site. Public involvement and strategic issues established from Hanford Summit I include: Regulatory issues, training and education, economic development and partnership, and technology transfer. Hanford Summit II provided a summary of how Secretary of Energy O'Leary is proceeding on the above strategic issues. The DOE and Westinghouse School for Environmental Excellence frequently offers a six-week course for environmental professionals and workers. Approximately thirty to forty individuals attend the training course, which provides training in environmental regulation compliance. The Hanford Site has hosted two previous International Atomic Energy Agency training courses. The courses lasted two weeks and had approximately eight to ten participants. Nuclear Material Management and Neutron Monitoring were the courses hosted by the Hanford Site

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

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Licensing; Registration and monitoring of nuclear materials and radioactive sources; High activity sources); 4. Nuclear facilities (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiological protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (The President of the National Atomic Energy Agency - Prezes Panstwowej Agencji Atomistyki (President of the PAA); Minister of Health; Minister of the Environment); 2. Advisory bodies (Council for Nuclear Safety and Radiological Protection); 3. Public and semi-public bodies (Radioactive Waste Management Plant); 4. Research institutes (Central Laboratory for Radiological Protection; National Centre for Nuclear Research; Institute of Nuclear Physics; Institute of Nuclear Chemistry and Technology; Institute of Plasma Physics and Laser Microfusion)

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

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Fissionable materials, ores, radioactive materials and equipment (Fissionable materials and ores; Radioactive materials and equipment); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection (Protection of workers; Protection of the public; Protection of individuals undergoing medical exposure); 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister for Housing, Spatial Planning and the Environment; Minister for Economic Affairs; Minister for Social Affairs and Employment; Minister for Health, Welfare and Sports; Minister for Finance; Minister for Foreign Affairs); 2. Advisory body - Health Council of the Netherlands; 3. Public and semi-public agencies (Nuclear Research and Consultancy Group - NRG; Central Organisation for Radioactive Waste - COVRA)

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

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trading in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection (Safeguards and non-proliferation; Physical protection); 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Industry, Tourism and Trade - MITYC; Ministry of the Interior - MIR; Ministry of Economy and the Exchequer - MEH; Ministry of the Environment and Rural and Marine Affairs - MARM); 2. Public and semi-public agencies (Nuclear Safety Council - CSN; Centre for Energy-related, Environmental and Technological Research - CIEMAT; National Energy Commission - CNE; 3. Public capital companies (Enusa Industrias Avanzadas, s.a. - ENUSA; Empresa Nacional de Residuos Radiactivos, s.a. - ENRESA)

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

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...

Regulatory analysis technical evaluation handbook. Final report

International Nuclear Information System (INIS)

1997-01-01

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

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

Science.gov (United States)

2013-11-20

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

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

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...

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.

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...

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...

77 FR 52791 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Minimum Regulatory...

Science.gov (United States)

2012-08-30

... the Basel Committee on Banking Supervision (BCBS) in ``Basel III: A Global Regulatory Framework for... seeking comment on the two related NPRs published elsewhere in today's Federal Register. The two related... them on Regulations.gov without change, including any business or personal information that you provide...

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.

¿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

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...

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...

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...

Experts Complete IAEA Follow-up Review of Spanish Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

Full text: Nuclear safety experts today concluded an eight-day mission to review Spain's nuclear regulator, the Nuclear Safety Council (CSN). At the request of the Spanish Government, the International Atomic Energy Agency assembled a peer-review team of five high-level regulatory experts from four nations and two IAEA staff members to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined CSN's progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review. Both reviews covered safety and security regulatory aspects of all facilities and activities in Spain. The first mission reviewed Spain's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. The mission also included a peer review of the security activities within the regulatory framework. IRRS team leader Luis Reyes, Senior Executive of the US Nuclear Regulatory Commission, said today, 'In 2008, the mission found particular strengths in CSN's policy, its regulatory framework and its regulatory activities. We made a number of suggestions and recommendations for further improvement of the regulatory framework. CSN should be commended for the significant amount of efforts in addressing all the findings identified in 2008 mission.' The review team found that CSN has made significant progress toward improving its regulatory activities. Most of the findings identified in the 2008 report have been effectively addressed and therefore can be considered closed. Additional findings are being addressed in accordance with a comprehensive and systematic action plan, in particular efforts to revise the CSN Statute. Complementing the CSN strengths identified during the 2008 mission, the 2011 IRRS team noted the following strengths: Improvements in regulatory

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...

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...

Regulatory challenges related to the licensing of a new nuclear power plant

International Nuclear Information System (INIS)

Maris, M.

2010-01-01

Assuring the safety and security of nuclear power plants is recognized world-wide as a challenge for all stakeholders. Particular attention goes to plants planned to be built in countries with not sufficiently developed industrial and regulatory infrastructure and experience. A construction and commissioning project, which is usually an international undertaking, gives opportunities to all national stakeholders to develop further their organisations and competences. In the present paper the duties of a regulatory body are recalled as well as the human resources and competences needed for the licensing of a new nuclear power plant. The regulatory body and its technical safety organization(s) should be strengthened and the international cooperation should contribute to this in a systematic and coordinated way. In particular, the donor country should support the necessary development of the regulatory competences and of an effective safety assessment process supporting the national licensing process. Appropriate support can be provided by the International Atomic Energy Agency (IAEA) and through other bi-lateral or multi-lateral programmes

Regulatory approaches for addressing dissolved oxygen concerns at hydropower facilities

Energy Technology Data Exchange (ETDEWEB)

Peterson, Mark J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Cada, Glenn F. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Sale, Michael J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Eddlemon, Gerald K. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

2003-03-01

Low dissolved oxygen (DO) concentrations are a common water quality problem downstream of hydropower facilities. At some facilities, structural improvements (e.g. installation of weir dams or aerating turbines) or operational changes (e.g., spilling water over the dam) can be made to improve DO levels. In other cases, structural and operational approaches are too costly for the project to implement or are likely to be of limited effectiveness. Despite improvements in overall water quality below dams in recent years, many hydropower projects are unable to meet state water quality standards for DO. Regulatory agencies in the U.S. are considering or implementing dramatic changes in their approach to protecting the quality of the Nation’s waters. New policies and initiatives have emphasized flexibility, increased collaboration and shared responsibility among all parties, and market-based, economic incentives. The use of new regulatory approaches may now be a viable option for addressing the DO problem at some hydropower facilities. This report summarizes some of the regulatory-related options available to hydropower projects, including negotiation of site-specific water quality criteria, use of biological monitoring, watershed-based strategies for the management of water quality, and watershed-based trading. Key decision points center on the health of the local biological communities and whether there are contributing impacts (i.e., other sources of low DO effluents) in the watershed. If the biological communities downstream of the hydropower project are healthy, negotiation for site-specific water quality standards or biocriteria (discharge performance criteria based on characteristics of the aquatic biota) might be pursued. If there are other effluent dischargers in the watershed that contribute to low DO problems, watershed-scale strategies and effluent trading may be effective. This report examines the value of regulatory approaches by reviewing their use in

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...

77 FR 30323 - Agency Information Collection Activities; Extension of a Currently Approved Collection; Comments...

Science.gov (United States)

2012-05-22

... DEPARTMENT OF JUSTICE [OMB Number 1122-0008] Agency Information Collection Activities; Extension... Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503... complete a semi- annual progress report. The semi-annual progress report is divided into sections that...

77 FR 1508 - Agency Information Collection Activities: Extension of a Currently Approved Collection; Comments...

Science.gov (United States)

2012-01-10

... DEPARTMENT OF JUSTICE [OMB Number 1122-0006] Agency Information Collection Activities: Extension... Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer... hour to complete a semi-annual progress report. The semi-annual progress report is divided into...

78 FR 63493 - Agency Information Collection Activities; Extension of a Currently Approved Collection: Semi...

Science.gov (United States)

2013-10-24

... Assistance Program is divided into sections that pertain to the different types of activities in which... DEPARTMENT OF JUSTICE [OMB Number 1122-0017] Agency Information Collection Activities; Extension..., Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington...

Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

Science.gov (United States)

Ancans, Janis

2012-01-01

Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

Final environmental and regulatory assessment of using asphalt as a sealant in mine shafts

International Nuclear Information System (INIS)

1987-01-01

This report discusses the properties of asphalt, the current regulatory status governing asphalt and future regulatory implications which may be pertinent in using asphalt as a waterproof shaft sealant. An understanding of the inherent organic composition of asphalt, an increase in the number of health and environmental research publications conducted on asphalt and an examination of the apparent trend of regulatory agencies toward more stringent environmental regulation governing the use of organic materials suggests asphalt could become regulated at a future time. This would only occur, however, if asphalt was found to conform to the present regulatory definitions of pollutants, contaminants or hazardous substances or if asphalt was included on a regulated substance list. In this regard, the study points out that asphalt contains very low levels of hazardous poly-nuclear aromatics (PNA's). These levels are significantly lower than the levels present in coal tars, a substance known to contain high levels of hazardous PNA's. Asphalt, however, has the inherent potential of producing higher concentrations of PNA's if the adverse condition of cracking should occur during the refinery production stage or on-site preparation of the asphalt. Also, unless existing control technology is applied, emission levels of sulfur dioxide, carbon monoxide, particulates and volatile organic carbons from the on-site preparation facilities could approach the permissible health standard levels of EPA. The study indicates, however, that available literature is limited on these issues

Law as an organizational variable: an examination of the impact of law on the performance of the US Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Montgomery, J.M.

1984-01-01

The role of law in a federal regulatory agency is examined from an organizational perspective. While law is usually viewed in terms of its legal, political, and social value consequences, it is postulated that it also has significant organizational consequences. The impact of those consequences is examined in the case of a single agency, the US Nuclear Regulatory Commission. The legal process is shown to be a powerful organizational characteristic of the government administrative agency, beginning with statuatory definition of organization goals, structure, and procedures and ending with judicial review of actions. Agency lawyers are shown to represent a distinct professional subculture within this agency. Their values and orientations toward business, the role of regulation, and the role of nuclear utilities are different from the 95% of agency employees subculture based on a physical science/engineering background. It is concluded that agency effectiveness suffers from the cultural polarization resulting from the disparities in belief systems of the two major identifiable professional groups, lawyers and scientist/engineers. It is also concluded that the impact of law on organizational performance and effectiveness attributes is largely dysfunctional. Such dysfunctionalism could be lessened with modified legal interpretation or statutory change, improved science/law relationship, and better understanding of the legal process by nonlawyer policymakers

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

Science.gov (United States)

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

2017-06-01

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

[Regulatory supervision and radiation survey in the area of location of former military technical bases].

Science.gov (United States)

Shandala, N K; Kiselev, S M; Titov, A V; Seregin, V A; Isaev, D V; Akhromeev, S V; Filonova, A A; Semenova, M P; Gimadova, T I; Aladova, R A; Kosnikov, A S; Shchelkanova, E S; Luk'ianets, A I

2013-01-01

Activities related to the rehabilitation of areas and facilities of the temporary storage of spent nuclear fuel and radioactive waste (SNF and RW) at Andreeva Bay and Gremikha on the Kola Peninsula and in the Primorsky Krai in the Russian Far East is an important component of the regulatory functions of the Federal Medical biological Agency (FMBA of Russia). Technical support to the FMBA of Russia in this activity is provided by A.L Burnazyan Federal Medical Biophysical Center Main research interests include evaluation of radiological threats to determine the priority directions of regulation, a detailed analysis of the radiation situation at areas, territories and in vicinity of temporary waste storage facilities, radiation control and environmental monitoring, the development of digital maps and geoinformation systems, project expertise in the field of rehabilitation of PVC including the management of SNF and RW Implementation of these natural, practical and theoretical works is completed by development a set of regulatory documents ensuring adherence to radiation safety for the stuff population and the environment, and the also documents governing the management of SNF and RW waste in the territories of PVC.

Recent Status of Indonesian Nuclear Regulatory System Development in Responding the Results of IRRS Mission

International Nuclear Information System (INIS)

Pramono, Y.

2016-01-01

BAPETEN as Nuclear Energy Regulatory Agency of Indonesia faces challenges in performing its tasks for assuring the safety, security, and safeguards in nuclear energy utilization through the regulatory system. Based on the recent IRRS mission to Indonesia, hosted by BAPETEN, several recommendations and suggestions shall require special attention to provide strategic action plans in following them up. Some of the recommendations include the necessity of the Government to develop and document a national policy and strategy for safety, to provide BAPETEN with human and financial resources to ensure adequate discharge of its statutory regulatory obligations, to ensure that prime responsibility of safety is assigned to the person or organization responsible for a facility or an activity through the legal framework, to ensure appropriate coordination and liaison between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. The suggestions cover, among others, the need of having a graded approach policy in implementing all regulatory functions, clarifying the responsibility of the individual reporting on the performance of the management system to senior management, establishing procedures for assessing the safety and appropriateness of the working environment and enhancing the implementation of self-assessments by including safety culture aspects. As part of the action plans, BAPETEN is currently drafting the national policy and strategy on nuclear and radiation safety. Furthermore, BAPETEN is revising the existing act on nuclear energy in order to assign the prime responsibility of safety to be borne by the licensees, to ensure the adequacy of its human and financial resources, and to provide clearer distinction of responsibilities between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. To counter the issue on

Regulatory analysis on the medical use of ephedrine-related products in Taiwan

Directory of Open Access Journals (Sweden)

Wan-Nan Yu

2018-04-01

Full Text Available To prevent ephedrine-related products from being misused to produce amphetamine and/or its analogs, there's a need for more effective and achievable regulatory mechanisms for the health, police, investigational, prosecution and judiciary authorities in Taiwan. This review was conducted to evaluate the international and Taiwan's regulatory policies and management of medical ephedrine-related products through the corresponding information collected from international and Taiwan government agency authorities. The combat of illegal drugs should involve both supply and demand sides to be successful. Health authorities in Taiwan do not have the investigational power to manage the forbidden transformation, abusing and manufacture of the illegal drugs from ephedrine-related products. Take the judicial interventions in the United States and in Japan as the examples, the organizational cooperation in Taiwan can be one of the main key strategies to combat against illegal drugs from ephedrine-related products. It is necessary to integrate the judicial, police and health agencies to prevent the production of illegal drugs from the ephedrine-related products in Taiwan. The efforts and regulatory control measures should be integrated to speed up the collaboration between different government authorities. It might be achieved through reorganization involving Taiwan Food and Drug Administration. Keywords: Ephedrine-related products, Taiwan Food and Drug Administration (TFDA, Controlled Drugs Act, Pharmaceutical Affairs Act, Pharmacists Act

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

77 FR 63337 - Agency Information Collection Activities: Extension of a Currently Approved Collection; Comments...

Science.gov (United States)

2012-10-16

... DEPARTMENT OF JUSTICE [OMB Number 1122-0021] Agency Information Collection Activities: Extension... Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of... complete a semi-annual progress report. The semi-annual progress report is divided into sections that...

78 FR 58557 - Agency Information Collection Activities; Extension of a Currently Approved Collection; Comments...

Science.gov (United States)

2013-09-24

... DEPARTMENT OF JUSTICE [OMB Number 1122-0024] Agency Information Collection Activities; Extension... Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of...) approximately one hour to complete a semi-annual progress report. The semi-annual progress report is divided...

76 FR 76760 - Agency Information Collection Activities: Extension of a Currently Approved Collection; Comments...

Science.gov (United States)

2011-12-08

... DEPARTMENT OF JUSTICE [OMB Number 1122-0013] Agency Information Collection Activities: Extension... Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk [[Page 76761... semi-annual progress report. The semi-annual progress report is divided into sections that pertain to...

78 FR 6345 - Agency Information Collection Activities: Extension of a Currently Approved Collection; Comments...

Science.gov (United States)

2013-01-30

...-annual progress report is divided into sections that pertain to the different types of activities in... DEPARTMENT OF JUSTICE [OMB Number 1122-0023] Agency Information Collection Activities: Extension... Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of...

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.

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