Strategies of bringing drug product marketing applications to meet current regulatory standards.

Science.gov (United States)

Wu, Yan; Freed, Anita; Lavrich, David; Raghavachari, Ramesh; Huynh-Ba, Kim; Shah, Ketan; Alasandro, Mark

2015-08-01

In the past decade, many guidance documents have been issued through collaboration of global organizations and regulatory authorities. Most of these are applicable to new products, but there is a risk that currently marketed products will not meet the new compliance standards during audits and inspections while companies continue to make changes through the product life cycle for continuous improvement or market demands. This discussion presents different strategies to bringing drug product marketing applications to meet current and emerging standards. It also discusses stability and method designs to meet process validation and global development efforts.

Review of regulatory requirements for digital I and C systems

Energy Technology Data Exchange (ETDEWEB)

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

2001-11-01

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

Review of regulatory requirements for digital I and C systems

International Nuclear Information System (INIS)

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

2001-11-01

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

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

International Nuclear Information System (INIS)

1997-08-01

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

Regulatory issues associated with the Multi-Purpose (MPC) system

International Nuclear Information System (INIS)

Roberts, J.P.; Desell, L.J.; Birch, M.L.; Morgan, R.G.

1994-01-01

The US Department of Energy Office of Civilian Radioactive Waste Management is developing a Multi-Purpose Canister system to promote compatibility between the waste program elements of storage, transportation, and disposal. The development of a Multi-Purpose Canister system requires meeting various regulatory requirements. These regulatory requirements are set forth in environmental and Nuclear Regulatory Commission (NRC) regulations. This paper discusses the more significant regulatory issues that must be addressed in the development of a Multi-Purpose Canister system by the Department of Energy

Regulatory capital requirements and bail in mechanisms

NARCIS (Netherlands)

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

2015-01-01

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

Fuel utilization experience in Bohunice NPP and regulatory requirements for implementation of progressive fuel management strategies

Energy Technology Data Exchange (ETDEWEB)

Patenyi, V [Nuclear Regulatory Authority, Bratislava (Slovakia); Darilek, P; Majercik, J [Vyskumny Ustav Jadrovych Elektrarni, Trnava (Slovakia)

1994-12-31

The experience gained in fuel utilization and the basic requirements for fuel licensing in the Slovak NPPs is described. The original project of WWER-440 reactors supposes 3-year fuel cycle with cycle length of about 320 full power days (FPD). Since 1984 it was reduced to 290 FPD. Based on the experience of other countries, a 4-year fuel cycle utilization started in 1987. It is illustrated with data from the Bohunice NPP units. Among 504 fuel assemblies left for the fourth burnup cycle no leakage was observed. The mean burnup achieved in the different units varied from 33.1 to 38.5 Mwd/kg U. The new fuel assemblies used are different from the recent ones in construction, thermohydraulics, water-uranium ratio, enrichment and material design. To meet the safety criteria, regulatory requirements for exploitation of new fuel in WWER-440 were formulated by the Nuclear Regulatory Authority of Slovak Republic. 1 tab., 5 refs.

Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for the Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements

Data Quality Objectives for Regulatory Requirements for Dangerous Waste Sampling and Analysis; FINAL

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

This document describes sampling and analytical requirements needed to meet state and federal regulations for dangerous waste (DW). The River Protection Project (RPP) is assigned to the task of storage and interim treatment of hazardous waste. Any final treatment or disposal operations, as well as requirements under the land disposal restrictions (LDRs), fall in the jurisdiction of another Hanford organization and are not part of this scope. The requirements for this Data Quality Objective (DQO) Process were developed using the RPP Data Quality Objective Procedure (Banning 1996), which is based on the U.S. Environmental Protection Agency's (EPA) Guidance for the Data Quality Objectives Process (EPA 1994). Hereafter, this document is referred to as the DW DQO. Federal and state laws and regulations pertaining to waste contain requirements that are dependent upon the composition of the waste stream. These regulatory drivers require that pertinent information be obtained. For many requirements, documented process knowledge of a waste composition can be used instead of analytical data to characterize or designate a waste. When process knowledge alone is used to characterize a waste, it is a best management practice to validate the information with analytical measurements

Perceived success/failure and attributions associated with self-regulatory efficacy to meet physical activity recommendations for women with arthritis.

Science.gov (United States)

Spink, Kevin S; Brawley, Lawrence R; Gyurcsik, Nancy C

2016-10-01

The relationship between attributional dimensions women assign to the cause of their perceived success or failure at meeting the recommended physical activity dose and self-regulatory efficacy for future physical activity was examined among women with arthritis. Women (N = 117) aged 18-84 years, with self-reported medically-diagnosed arthritis, completed on-line questions in the fall of 2013 assessing endurance physical activity, perceived outcome for meeting the recommended levels of endurance activity, attributions for one's success or failure in meeting the recommendations, and self-regulatory efficacy to schedule/plan endurance activity over the next month. The main theoretically-driven finding revealed that the interaction of the stability dimension with perceived success/failure was significantly related to self-regulatory efficacy for scheduling and planning future physical activity (β = 0.35, p = .002). Outcomes attributed to more versus less stable factors accentuated differences in self-regulatory efficacy beliefs following perceived success and failure at being active. It appears that attributional dimensions were associated with self-regulatory efficacy in women with arthritis. This suggests that rather than objectively observed past mastery experience, women's subjective perceptions and explanations of their past experiences were related to efficacy beliefs, especially following a failure experience.

Regulatory requirements for desalination plant coupled with nuclear reactor plant

International Nuclear Information System (INIS)

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

2005-01-01

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

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

40 CFR 1603.6 - Business requiring a meeting.

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false Business requiring a meeting. 1603.6... THE GOVERNMENT IN THE SUNSHINE ACT § 1603.6 Business requiring a meeting. The Board may, by majority vote of its Members, determine that particular items or classes of Board business cannot be...

Meeting Quay 2k30's requirements

NARCIS (Netherlands)

Wijnants, G.H.; Toorn, A. van der; Schuylenburg, M.; Heijnen, H.P.J.; Gijt, J.G. de; Molenaar, W.F.; Ligteringen, H.; Krom, A.H.M.

2005-01-01

The requirements that a quay design should meet in order to yield a viable port infrastructure, vary widely from flexibility due to future customers requirements to durability due to owners requirements. In a Port of Rotterdam backed project, current and future requirements have been aggregated by

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

International Nuclear Information System (INIS)

Goicea, Lucian

2012-01-01

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

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

International Nuclear Information System (INIS)

1987-01-01

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

Development of regulatory requirements/guides for desalination unit coupled with nuclear plant

International Nuclear Information System (INIS)

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

2005-10-01

The basic design of System-integrated Modular Advanced Reactor (SMART), a small-to-medium sized integral type pressurized water reactor (PWR) with the capacity of 330MWth, has been developed in Korea. In order to demonstrate the safety and performance of the SMART design, 'Development Project of SMART-P (SMART-Pilot Plant)' has been being performed as one of the 'National Mid and Long-term Atomic Energy R and D Programs', which includes design, construction, and start-up operation of the SMART-P with the capacity of 65MWth, a 1/5 scaled-down design of the SMART. At the same time, a study on the development of regulatory requirements/guides for the desalination unit coupled with nuclear plant has been carried out by KINS in order to prepare for the forthcoming SMART-P licensing. The results of this study performed from August of 2002 to October of 2005 can be summarized as follows: (1) The general status of desalination technologies has been survey. (2) The design of the desalination plant coupled with the SMART-P has been investigated. (3) The regulatory requirements/guides relevant to a desalination unit coupled with a nuclear plant have been surveyed. (4) A direction on the development of domestic regulatory requirements/guides for a desalination unit has been established. (5) A draft of regulatory requirements/guides for a desalination unit has been developed. (6) Expert technical reviews have been performed for the draft regulatory requirements/guides for a desalination unit. The draft regulatory requirements/guides developed in this study will be finalized and can be applied directly to the licensing of the SMART-P and SMART. Furthermore, it will be also applied to the licensing of the desalination unit coupled with the nuclear plant

Meeting regulatory standards with BeO ceramic TLD

International Nuclear Information System (INIS)

Gammage, R.B.; Christian, D.J.

1978-01-01

Measurements of exposures below 1 mR are possible with BeO ceramic TLD by signal recording that discriminates against an interfering pyroelectric incandescence. Performance under environmental monitoring conditions is considered in light of current regulatory criteria. Factors such as reproducibility and batch uniformity are satisfactory. An anomalous energy dependence causes an over-response that will probably require use of an energy compensation shield

Safety and regulatory requirements of nuclear power plants

International Nuclear Information System (INIS)

Kumar, S.V.; Bhardwaj, S.A.

2000-01-01

A pre-requisite for a nuclear power program in any country is well established national safety and regulatory requirements. These have evolved for nuclear power plants in India with participation of the regulatory body, utility, research and development (R and D) organizations and educational institutions. Prevailing international practices provided a useful base to develop those applicable to specific system designs for nuclear power plants in India. Their effectiveness has been demonstrated in planned activities of building up the nuclear power program as well as with unplanned activities, like those due to safety related incidents etc. (author)

Understanding how to maintain compliance in the current regulatory climate

International Nuclear Information System (INIS)

Bignell, D.T.; Burns, R.

1995-01-01

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

Meeting the latest qualification requirements for Class 1E protection system equipment: a practical approach

International Nuclear Information System (INIS)

Daigle, R.P.; Breen, R.J.

1977-01-01

The requirements for qualifying Class 1E equipment for Nuclear Power Generating Stations were significantly revised in 1974 and 1975. These new requirements reflect the desire of the industry to provide improved methods of determining the qualification of this vital equipment. The revised standards do, in fact, meet these industry goals in a generally acceptable manner. The Nuclear Regulatory Commission is presently requiring utilities to comply with these revised standards and regulatory guides in order to obtain the necessary permits. Manufacturers are developing and implementing programs to comply with the new requirements. One of the more difficult new requirements of qualification is aging to achieve advanced life condition. The objectives and methods described for aging are difficult for much of the equipment within the Protection System. The use of thermal and vibrational techniques to simulate aging is valid for some components (i.e., capacitors, transistors, cable and/or motor insulation) but may be neither valid nor practical for many items (e.g., complete instrument systems, etc.). A seemingly obvious approach, although rarely followed, in regarding new or revised standards is to refrain from making any type of commitment until the standards are thoroughly understood. Often too hasty a decision is made by a utility (concerned about licensing) or a manufacturer (concerned about being competitive) to commit to new requirements. Consequently, the broad range of interpretations that usually develops for a given set of requirements may result in difficult relations between organizations. This paper deals with solutions for qualification in a practical sense, with emphasis on the aging issue and does not elaborate on seismic qualification

A Review on Regulatory Enforcement Policy

International Nuclear Information System (INIS)

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

2017-01-01

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

Meeting Ecologists Requirements with Adaptive Data Acquisition

DEFF Research Database (Denmark)

Chang, Marcus; Bonnet, Philippe

their potential if they meet the scientists requirements. In an ideal world, an ecologist expresses requirements in terms of a target dataset, which the sensor network then actually collects and stores. In fact, failures occur and interesting events happen making uniform, systematic ecosys- tem sampling neither...

77 FR 77073 - York Haven Power Company, LLC; Notice of Meeting

Science.gov (United States)

2012-12-31

... Company, LLC; Notice of Meeting On Wednesday, January 9, 2013, Commission staff will meet with York Haven Power Company, LLC (applicant) in Washington, DC. The purpose of the meeting is to discuss the required... begin at 10 a.m. at the Federal Energy Regulatory Commission headquarters building located at 888 First...

29 CFR 4.174 - Meeting requirements for holiday fringe benefits.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Meeting requirements for holiday fringe benefits. 4.174... Compensation Standards Compliance with Compensation Standards § 4.174 Meeting requirements for holiday fringe benefits. (a) Determining eligibility for holiday benefits—in general. (1) Most fringe benefit...

Regulatory and administrative requirements for practice of nuclear medicine in India

International Nuclear Information System (INIS)

Tandon, Pankaj

1998-01-01

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

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

International Nuclear Information System (INIS)

Williams, C.R.

1999-01-01

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

Communication and Consultation with Interested Parties by the Regulatory Body. General Safety Guide

International Nuclear Information System (INIS)

2017-01-01

This Safety Guide provides recommendations on meeting the safety requirements concerning communication and consultation with the public and other interested parties by the regulatory body about the possible radiation risks associated with facilities and activities, and about processes and decisions of the regulatory body. The Safety Guide can be used by authorized parties in circumstances where there are regulatory requirements placed on them for communication and consultation. It may also be used by other organizations or individuals considering their responsibilities for communication and consultation with interested parties.

17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Self-regulatory organization... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements. (a) Each self-regulatory organization must adopt, and submit for Commission approval, rules...

Galectin-1 is required for the regulatory function of B cells.

Science.gov (United States)

Alhabbab, R; Blair, P; Smyth, L A; Ratnasothy, K; Peng, Q; Moreau, A; Lechler, R; Elgueta, R; Lombardi, G

2018-02-09

Galectin-1 (Gal-1) is required for the development of B cells in the bone marrow (BM), however very little is known about the contribution of Gal-1 to the development of B cell regulatory function. Here, we report an important role for Gal-1 in the induction of B cells regulatory function. Mice deficient of Gal-1 (Gal-1 -/- ) showed significant loss of Transitional-2 (T2) B cells, previously reported to include IL-10 + regulatory B cells. Gal-1 -/- B cells stimulated in vitro via CD40 molecules have impaired IL-10 and Tim-1 expression, the latter reported to be required for IL-10 production in regulatory B cells, and increased TNF-α expression compared to wild type (WT) B cells. Unlike their WT counterparts, T2 and T1 Gal-1 -/- B cells did not suppress TNF-α expression by CD4 + T cells activated in vitro with allogenic DCs (allo-DCs), nor were they suppressive in vivo, being unable to delay MHC-class I mismatched skin allograft rejection following adoptive transfer. Moreover, T cells stimulated with allo-DCs show an increase in their survival when co-cultured with Gal-1 -/- T2 and MZ B cells compared to WT T2 and MZ B cells. Collectively, these data suggest that Gal-1 contributes to the induction of B cells regulatory function.

Regulation of the life cycle of nuclear installations. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

1999-06-01

This report arises from the sixth series of peer discussions on regulatory practices entitled 'Regulation of Life Cycle of Nuclear Installations'. Senior regulators from 18 Member States participated in three peer group discussions during 1997-1998. 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 nominating organizations, or the IAEA. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to the policies, principles and requirements imposed by regulatory bodies for the safe management of the life cycle of a nuclear installation. The intention of doing this is to assist Member States in the formulation and enhancement of their regulatory control over PLCM by identifying commonly accepted good practices. This report is structured to cover the subject matter under the following main headings: Policies and Principles for the Life Cycle Management of Nuclear Installations; Responsibilities of the Regulatory Body and the Operating Organization; Requirements and Criteria Imposed by the Regulatory Body; Licensing and Regulatory Assessment for Plant Life Cycle Management; and Good Practices

Analysis of regulatory requirement for beyond design basis events of SMART

International Nuclear Information System (INIS)

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

2000-01-01

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

Quality Assurance Source Requirements Traceability Database

International Nuclear Information System (INIS)

MURTHY, R.; NAYDENOVA, A.; DEKLEVER, R.; BOONE, A.

2006-01-01

At the Yucca Mountain Project the Project Requirements Processing System assists in the management of relationships between regulatory and national/industry standards source criteria, and Quality Assurance Requirements and Description document (DOE/R W-0333P) requirements to create compliance matrices representing respective relationships. The matrices are submitted to the U.S. Nuclear Regulatory Commission to assist in the commission's review, interpretation, and concurrence with the Yucca Mountain Project QA program document. The tool is highly customized to meet the needs of the Office of Civilian Radioactive Waste Management Office of Quality Assurance

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

Science.gov (United States)

2010-04-01

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

Regulatory objectives, requirements and guidelines for the disposal of radioactive wastes - long-term aspects

International Nuclear Information System (INIS)

1987-01-01

It is the purpose of this document to present the regulatory basis for judging the long-term acceptability of radioactive waste disposal options, assuming that the operational aspects of waste emplacement and facility closure satisfy the existing regulatory framework of requirements. Basic objectives of radioactive waste disposal are given, as are the regulatory requirements which must be satisfied in order to achieve these objectives. In addition, guidelines are given on the application of the radiological requirements to assist proponents in the preparation of submissions to the Atomic Energy Control Board (AECB). The primary focus of the requirements is on radiation protection, although environmental protection and institutional controls are also addressed in a more general way since these factors stem directly from the overall objectives for radioactive waste disposal

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

International Nuclear Information System (INIS)

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

1987-05-01

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

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

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

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

Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

1998-01-01

The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

Development of safety-related regulatory requirements for nuclear power in developing countries. Key issue paper no. 4

International Nuclear Information System (INIS)

Han, K.I.

2000-01-01

In implementing a national nuclear power program, balanced regulatory requirements are necessary to ensure nuclear safety and cost competitive nuclear power, and to help gain public acceptance. However, this is difficult due to the technology-intensive nature of the nuclear regulatory requirements, the need to reflect evolving technology and the need for cooperation among multidisciplinary technical groups. This paper suggests approaches to development of balanced nuclear regulatory requirements in developing countries related to nuclear power plant safety, radiation protection and radioactive waste management along with key technical regulatory issues. It does not deal with economic or market regulation of electric utilities using nuclear power. It suggests that national regulatory requirements be developed using IAEA safety recommendations as guidelines and safety requirements of the supplier country as a main reference after careful planning, manpower buildup and thorough study of international and supplier country's regulations. Regulation making is not recommended before experienced manpower has been accumulated. With an option that the supplier country's regulations may be used in the interim, the lack of complete national regulatory requirements should not deter introduction of nuclear power in developing countries. (author)

Reliability programs for nuclear power plants. Regulatory standard S-98 revision 1

International Nuclear Information System (INIS)

2005-07-01

The purpose of this regulatory standard is to help assure, in accordance with the purpose of the Nuclear Safety and Control Act (NSCA), that a licensee who constructs or operates a nuclear power plant (NPP) develops and implements a reliability program that assures that the systems important to safety at the plant can and will meet their defined design and performance specifications at acceptable levels of reliability throughout the lifetime of the facility. This regulatory standard describes the requirements of a reliability program for a nuclear power plant. The licensee shall implement the requirements described in this regulatory standard when a condition of a licence or other legally enforceable instrument so requires.(author)

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

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-09-15

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

Animal testing, 3R models and regulatory acceptance : Technology transition in a risk-averse context

NARCIS (Netherlands)

Schiffelers, M.J.W.A.

2016-01-01

Risk avoidance has resulted in a broad range of regulations to guarantee the safety of products such as pharmaceuticals and chemicals. Many of these regulations rely on animal tests. About 3 million laboratory animals are used annually in Europe to meet such regulatory requirements.Regulatory animal

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

International Nuclear Information System (INIS)

Izquierdo, J.M.

1979-01-01

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

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

International Nuclear Information System (INIS)

2015-03-01

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

Economic analysis requirements in support of orbital debris regulatory policy

Science.gov (United States)

Greenberg, Joel S.

1996-10-01

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

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

Energy Technology Data Exchange (ETDEWEB)

Stevenson, J D

1976-04-01

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

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

International Nuclear Information System (INIS)

Stevenson, J.D.

1976-01-01

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

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

International Nuclear Information System (INIS)

Erp, J.B. van

1978-01-01

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

76 FR 14896 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

Science.gov (United States)

2011-03-18

... specific regulatory guidance and information on standards concerning biosafety and biosecurity issues... assessments, biosafety requirements, and security measures. DATES: The meeting will be held on May 10, 2011... meeting to address questions and concerns. Entity registration, security risk assessments, biosafety...

Regulatory activities

International Nuclear Information System (INIS)

2001-01-01

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

Regulatory requirements for radiation protection

International Nuclear Information System (INIS)

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

1977-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

MULKEY, C.H.

1999-07-06

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

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

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

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

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

International Nuclear Information System (INIS)

Stade, R.E.

1978-01-01

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

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

International Nuclear Information System (INIS)

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

2013-11-01

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

Regulatory requirement of the Juragua nuclear Power Plant PSA

International Nuclear Information System (INIS)

Valhuerdi Debesa, C.

1996-01-01

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

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

International Nuclear Information System (INIS)

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

1990-03-01

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

Upgrading nuclear regulatory infrastructure in Armenia

International Nuclear Information System (INIS)

Martirosyan, A.; Amirjanyan, A.; Kacenelenbogen, S.

2010-01-01

Armenia is contemplating an upgrade to its national power generation capacity to meet replacement and future energy needs. Unit 2 of ANPP is scheduled for shutdown after replacement power generation capacities are in place. A recent alternative energy study indicates viability of the nuclear option to replace this capacity. Some technology-specific proposals are being considered by the Ministry of Energy of Armenia. It is likely that the reactor technology decision will be made in the not too distant future. The existing reactor continues to be operated in the regulatory framework developed in the Soviet Union and adopted in Armenia. Given the interest in the new reactor, Armenia launched a project to review the existing system of regulation and to bring it into harmony with modern practice in preparation for the new reactor project development. The new regulatory framework will be needed as a basis for any potential tendering process. The US NRC and ANRA have agreed to perform a review and update nuclear legislation and the system of regulation in this area. The first step in this process was to develop an action plan for such program. The action plan describes the overall strategy of ANRA to modify existing or develop new processes and requirements, identifies the major Laws that need to be reviewed given practical legal considerations to construct and operate the reactor and Armenia's international obligations under various conventions. This work included review of existing models of regulation in different countries with 'small' nuclear program, including IAEA recommendations as well as existing legislation in Armenia in this area and development of a strategy for the regulatory model development. In addition, the plan to develop requirements for ANRA staffing and training needs to meet its regulatory obligations under the new reactor development process was developed

49 CFR 40.213 - What training requirements must STTs and BATs meet?

Science.gov (United States)

2010-10-01

... 49 Transportation 1 2010-10-01 2010-10-01 false What training requirements must STTs and BATs meet? 40.213 Section 40.213 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Alcohol Testing Personnel § 40.213 What training requirements must STTs and BATs meet? To be...

NTL 11 spent fuel flask - meeting the challenge of regulatory and technological change

International Nuclear Information System (INIS)

Cory, A.R.

2004-01-01

By June 2005, when shipments of spent fuel for reprocessing from Germany are concluded, the NTL11 flask type will have been responsible for transporting a total of 1500 tonnes of heavy metal in the form of spent fuel. Excluding domestic transports in France and the UK, this represents 25% of the total European spent fuel transported for reprocessing since the flasks came into service in 1977. Approximately 40% of the total for the flask type will have been transported to BNFL's Sellafield facility, the remainder to Cogema at La Hague. The NTL11 flask can justifiably be described as being the workhorse of BNFL's European spent fuel transport business. The NTL11 flask started life under the ownership of Nuclear Transport Limited, an associate company of BNFL, and in recent years the original fleet of five flasks has been absorbed into the BNFL inventory. A recent build programme has seen a further four flasks added to the fleet, an expedient measure to cope with the additional transport requirements imposed by the need to meet the June 2005 deadline for the removal of contracted fuels from Germany. While there have been certain evolutionary changes affecting the package design, there have also been more significant changes in the Design Safety Case. These have sometimes been necessary to meet regulatory changes, or the challenges posed by the regulators. In other cases advantage has been taken of improvements in analytical techniques to demonstrate increased margins of operational safety. Where possible those margins have also been increased by other means, such as taking advantage of commercial trends to reduce package thermal loads. The NTL11 flask was designed around the reactor and fuel characteristics prevailing in the 1970's. Over the lifetime of the flask the responsible engineering teams have faced and met the successive challenges to develop the capability of the Package to face the changing requirements of the industry and the Transport Regulations. Both

A study on the influence of the regulatory requirements of a nuclear facility during decommissioning activities

Energy Technology Data Exchange (ETDEWEB)

Park, Hee Seong; Park, Seung Kook; Park, Kook Nam; Hong, Yun Jeong; Park, Jang Jin; Choi, Jong Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2016-10-15

The preliminary decommissioning plan should be written with various chapters such as a radiological characterization, a decommissioning strategy and methods, a design for decommissioning usability, a safety evaluation, decontamination and dismantling activities, radioactive waste management, an environmental effect evaluation, and fire protection. The process requirements of the decommissioning project and the technical requirements and technical criteria should comply with regulatory requirements when dismantling of a nuclear facility. The requirements related to safety in the dismantling of a nuclear facility refer to the IAEA safety serious. The present paper indicates that a decommissioning design and plan, dismantling activities, and a decommissioning project will be influenced by the decommissioning regulatory requirements when dismantling of a nuclear facility. We hereby paved the way to find the effect of the regulatory requirements on the decommissioning of a whole area from the decommissioning strategy to the radioactive waste treatment when dismantling a nuclear facility. The decommissioning requirements have a unique feature in terms of a horizontal relationship as well as a vertical relationship from the regulation requirements to the decommissioning technical requirements. The decommissioning requirements management will be conducted through research that can recognize a multiple relationship in the next stage.

Managing engineering to meet construction requirements

International Nuclear Information System (INIS)

Martin, D.F.; Houchen, J.D.

1976-01-01

The San Onofre Units 2 and 3 Project schedule is compared with Bechtel's Generic Nuclear Power Plant schedule. This comparison shows that the major delays experienced on the San Onofre Project have resulted from the regulatory process. To date, Engineering has met Construction's requirements and the Project has not experienced any Engineering related delays. The San Onofre Project has been faced with many uncertainties, such as limited site area, high seismic design criteria, new and changing Federal and State regulations, shifts in supplier market conditions and unpredictable supplier performance. Each of these uncertainties has impacted the Engineering effort and jeopardized project schedule goals. The SCE-Bechtel Engineering Management team has acted to mitigate the impact of these uncertainties through use of a cost trend program, simplification of SCE-Bechtel interfaces, close Engineering-Construction coordination, the use of task forces to handle critical supplier problems and the use of additional Engineering personnel, etc. so that Construction requirements have been met

Regulatory challenges associated with conducting multicountry clinical trials in resource-limited settings.

Science.gov (United States)

Ndebele, Paul; Blanchard-Horan, Christina; Shahkolahi, Akbar; Sanne, Ian

2014-01-01

International public health and infectious diseases research has expanded to become a global enterprise transcending national and continental borders in organized networks addressing high-impact diseases. In conducting multicountry clinical trials, sponsors and investigators have to ensure that they meet regulatory requirements in all countries in which the clinical trials will be conducted. Some of these requirements include review and approval by national drug regulatory authorities and recognized research ethics committees. A limiting factor to the efficient conduct of multicountry clinical trials is the regulatory environment in each collaborating country, with significant differences determined by various factors including the laws and the procedures used in each country. The long regulatory processes in resource-limited countries may hinder the efficient implementation of multisite clinical trials, delaying research important to the health of populations in these countries and costing millions of dollars a year.

Methods for ensuring compliance with regulatory requirements: regulators and operators

International Nuclear Information System (INIS)

Fleischmann, A.W.

1989-01-01

Some of the methods of ensuring compliance with regulatory requirements contained in various radiation protection documents such as Regulations, ICRP Recommendations etc. are considered. These include radiation safety officers and radiation safety committees, personnel monitoring services, dissemination of information, inspection services and legislative power of enforcement. Difficulties in ensuring compliance include outmoded legislation, financial and personnel constraints

75 FR 5355 - Sunshine Act; Meeting Notice

Science.gov (United States)

2010-02-02

...). (Contact: Dominick Orlando, 301-415-6749.) This meeting will be webcast live at the Web address, http://www... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act; Meeting Notice AGENCY HOLDING THE MEETINGS: Nuclear Regulatory Commission. DATES: Weeks of February 1, 8, 15, 22, March 1, 8, 2010. PLACE...

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

International Nuclear Information System (INIS)

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

1988-01-01

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

Regulatory requirements for designing PET-CT facility in India

International Nuclear Information System (INIS)

Tandon, Pankaj

2010-01-01

In India, cyclotron-produced radionuclides are gaining importance in molecular imaging in Nuclear Medicine (NM) departments. The importance of this modality among others is due to the fact that it provides valuable clinical information, which was lacking in other available modalities. Presently, every well-established hospital would like to procure Medical Cyclotron or positron emission tomography-computed tomography (PET-CT) facility in their NM department. Because cyclotron-produced radionuclides have higher energy than the other routinely used radionuclides for diagnosis, it becomes essential for the user to know about the regulatory requirement and radiation safety precautions that one has to take for the installation of this new modality in their premises. The various stages of approval of PET-CT facility by the Atomic Energy Regulatory Board (AERB) and important steps that one has to know/follow before planning for this new facility are summarized

Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis; FINAL

International Nuclear Information System (INIS)

MULKEY, C.H.

1999-01-01

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

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

International Nuclear Information System (INIS)

2000-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-08-01

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

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.

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

International Nuclear Information System (INIS)

2010-01-01

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

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

International Nuclear Information System (INIS)

2010-01-01

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

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

International Nuclear Information System (INIS)

2010-01-01

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered

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

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-09-15

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

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

International Nuclear Information System (INIS)

Dory, A.B.

1981-10-01

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

Review of regulatory requirements relevant to calibration of monitoring instruments in research reactors

Energy Technology Data Exchange (ETDEWEB)

Gomaa, Hassan; Khedr, Ahmed; El-Din Talha, Kamal [Egyptian Nuclear and Radiological Regulatory Authority, Cairo (Egypt). Nuclear Safety Engineering Dept.

2015-05-15

The objective of this work is to demonstrate the regulatory requirements pertaining to calibration of monitoring instruments in research reactors. The regulatory statements concerning this subject in IAEA safety standards and the implementation of such regulations in twelve countries with different levels of nuclear programs are surveyed: Australia, Bulgaria, Canada, Egypt, Finland, Germany, Hungary, Slovenia, South Korea, Spain, United Kingdom of England and United States of America. In addition, the requirements of ISO/IEC17025 and NUPIC (Nuclear Utilities Procurement Issues Committee) are compared. Seven technical and administrate aspects are suggested as the comparison criteria and the explicit expression of the statements, the level of document (i.e.: act, requirement or guide) are the considered resources. The main differences and similarities between the different approaches are identified in order to provide an input for future development of the national regulations.

Romanian regulatory requirements on nuclear field specific education needs

International Nuclear Information System (INIS)

Biro, L.; Velicu, O.

2004-01-01

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

Regulatory requirements to the thermal-hydraulic and thermal-mechanical computer codes

International Nuclear Information System (INIS)

Vitkova, M.; Kalchev, B.; Stefanova, S.

2006-01-01

The paper presents an overview of the regulatory requirements to the thermal-hydraulic and thermal-mechanical computer codes, which are used for safety assessment of the fuel design and the fuel utilization. Some requirements to the model development, verification and validation of the codes and analysis of code uncertainties are also define. Questions concerning Quality Assurance during development and implementation of the codes as well as preparation of a detailed verification and validation plan are briefly discussed

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

Science.gov (United States)

Okudaira, Noriko

2017-09-01

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

Method for developing cost estimates for generic regulatory requirements

International Nuclear Information System (INIS)

1985-01-01

The NRC has established a practice of performing regulatory analyses, reflecting costs as well as benefits, of proposed new or revised generic requirements. A method had been developed to assist the NRC in preparing the types of cost estimates required for this purpose and for assigning priorities in the resolution of generic safety issues. The cost of a generic requirement is defined as the net present value of total lifetime cost incurred by the public, industry, and government in implementing the requirement for all affected plants. The method described here is for commercial light-water-reactor power plants. Estimating the cost for a generic requirement involves several steps: (1) identifying the activities that must be carried out to fully implement the requirement, (2) defining the work packages associated with the major activities, (3) identifying the individual elements of cost for each work package, (4) estimating the magnitude of each cost element, (5) aggregating individual plant costs over the plant lifetime, and (6) aggregating all plant costs and generic costs to produce a total, national, present value of lifetime cost for the requirement. The method developed addresses all six steps. In this paper, we discuss on the first three

Federal and state regulatory requirements for decontamination and decommissioning at US Department of Energy Oak Ridge Operations Facilities

International Nuclear Information System (INIS)

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

1994-06-01

The purpose of this report is to address regulatory requirements for decontamination and decommissioning (D and D) activities at the Oak Ridge Reservation and Paducah Gaseous Diffusion Plant. This report is a summary of potential federal and state regulatory requirements applicable to general D and D activities. Excerpts are presented in the text and tables from the complete set of regulatory requirements. This report should be used as a guide to the major regulatory issues related to D and D. Compliance with other federal, state, and local regulations not addressed here may be required and should be addressed carefully by project management on a site-specific basis. The report summarizes the major acts and implementing regulations (e.g., Resource and Conservation Recovery Act, Clean Air Act, and Toxic Substances Control Act) only with regard to D and D activities. Additional regulatory drivers for D and D activities may be established through negotiated agreements, such as the Federal Facility Agreement and the US Environmental Protection Agency Mixed Waste Federal Facility Compliance Agreement; these are discussed in this report. The DOE orders and Energy Systems procedures also are summarized briefly in instances where they directly apply to D and D

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

International Nuclear Information System (INIS)

2016-01-01

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

Satisfying regulatory and accreditation requirements for quality control.

Science.gov (United States)

Ehrmeyer, Sharon S

2013-03-01

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) requires all US clinical laboratories that test "materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease..." to be regulated. The CLIA mandates are site neutral; based on test complexity; and focus on the three phases of the testing process (preanalytical, analytical, and postanalytical). Many testing sites choose to meet the CLIA requirements by following the testing standards of a professional accreditation organization deemed by the Centers for Medicare and Medicaid Services. The three principal organizations are The Joint Commission, the College of American Pathologists, and COLA. Copyright © 2013 Elsevier Inc. All rights reserved.

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

International Nuclear Information System (INIS)

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

1989-06-01

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

Preparation of safety regulatory requirements for new technology like digital system

International Nuclear Information System (INIS)

2012-01-01

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

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

International Nuclear Information System (INIS)

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

2012-01-01

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

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.

77 FR 51616 - Open Meeting of the Community Development Advisory Board

Science.gov (United States)

2012-08-24

... the CDFI Fund (who has been delegated the authority to administer the CDFI Fund) on the policies... declining any particular application for monetary or non-monetary awards. The Advisory Board meets at least... and therefore regulatory impact analysis is not required. In addition, this document does not...

Regulatory activities; Actividades regulatorias

Energy Technology Data Exchange (ETDEWEB)

NONE

2001-07-01

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

The core to regulatory reform

International Nuclear Information System (INIS)

Partridge, J.W. Jr.

1993-01-01

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

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

International Nuclear Information System (INIS)

2003-06-01

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

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

International Nuclear Information System (INIS)

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

2006-01-01

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

WIPP Waste Characterization: Implementing Regulatory Requirements in the Real World

International Nuclear Information System (INIS)

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

1999-01-01

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

KWOC [Key-Word-Out-of-Context] Index of US Nuclear Regulatory Commission Regulatory Guide Series

International Nuclear Information System (INIS)

Jennings, S.D.

1990-04-01

To meet the objectives of the program funded by the Department of Energy (DOE)-Nuclear Energy (NE) Technology Support Programs, the Performance Assurance Project Office (PAPO) administers a Performance Assurance Information Program that collects, compiles, and distributes program-related information, reports, and publications for the benefit of the DOE-NE program participants. THE ''KWOC Index of US Nuclear Regulatory Commission Regulatory Guide Series'' is prepared as an aid in searching for specific topics in the US Nuclear Regulatory Commission, Regulatory Guide Series

Preparation of safety regulatory requirements for new technology like digital system

Energy Technology Data Exchange (ETDEWEB)

NONE

2013-08-15

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

40 CFR 35.4045 - What requirements must my group meet as a TAG recipient?

Science.gov (United States)

2010-07-01

... for the purpose of participating in decision making at the Superfund site for which we provide a TAG... 40 Protection of Environment 1 2010-07-01 2010-07-01 false What requirements must my group meet as... Responsibilities As A Tag Recipient § 35.4045 What requirements must my group meet as a TAG recipient? Your group...

Improved cost-benefit techniques in the US Nuclear Regulatory Commission

Energy Technology Data Exchange (ETDEWEB)

Cronin, F.J.; Nesse, R.J.; Vaeth, M.; Wusterbarth, A.R.; Currie, J.W.

1983-06-01

The major objective of this report is to help the US Nuclear Regulatory Commission (NRC) in its regulatory mission, particularly with respect to improving the use of cost-benefit analysis and the economic evaluation of resources within the NRC. The objectives of this effort are: (1) to identify current and future NRC requirements (e.g., licensing) for valuing nonmarket goods; (2) to identify, highlight, and present the relevant efforts of selected federal agencies, some with over two decades of experience in valuing nonmarket goods, in this area; and (3) to review methods for valuing nonmarket impacts and to provide estimats of their magnitudes. Recently proposed legislation may result in a requirement for not only more sophisticated valuation analyses, but more extensive applications of these techniques to issues of concern to the NRC. This paper is intended to provide the NRC with information to more efficiently meet such requirements.

A waste package strategy for regulatory compliance

International Nuclear Information System (INIS)

Stahl, D.; Cloninger, M.O.

1990-01-01

This paper summarizes the strategy given in the Site Characterization Plan for demonstrating compliance with the post closure performance objectives for the waste package and the Engineered Barrier System contained in the Code of Federal Regulations. The strategy consists of the development of a conservative waste package design that will meet the regulatory requirements with sufficient margin for uncertainty using a multi-barrier approach that takes advantage of the unsaturated nature of the Yucca Mountain site. 7 refs., 1 fig

75 FR 64306 - Sunshine Act Meeting Notice

Science.gov (United States)

2010-10-19

... Transmission System. Hydro H-1 P-12107-005 Granite County, Montana. H-2 P-2496-222 Eugene Water and Electric... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice October 14... Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b: Agency Holding Meeting: Federal Energy Regulatory Commission...

Acceptance criteria for the physical protection upgrade rule requirements for fixed sites. Information guide

International Nuclear Information System (INIS)

Dwyer, P.

1980-09-01

This document has been developed as a tool to assist in providing consistent evaluation of upgraded physical security plans submitted in response to the Physical Protection Upgrade Rule, effective March 25, 1980. It presents a means for assuring licensee compliance with every regulatory requirement of particular significance to the protection of the public health and safety. Acceptance criteria are included to determine the extent to which each licensee meets the regulatory requirements. The format parallels Regulatory Guide 5.52, Standard Format and Content of a Licensee Physical Protection Plan for Strategic Special Nuclear Material at Fixed Sites

Regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning

International Nuclear Information System (INIS)

Lipar, M.

1997-01-01

A review of regulatory requirements for demonstration of the achieved safety level at the Mochovce NPP before commissioning is given. It contains licensing steps in Slovakia during commissioning; Status and methodology of Mochovce safety analysis report; Mochovce NPP safety enhancement program; Regulatory body policy towards Mochovce NPP safety enhancement; Recent development in Mochovce pre-operational safety enhancement program review and assessment process; Licensing steps in Slovakia during commissioning

Regulatory requirements on the calibration and use of survey instruments

International Nuclear Information System (INIS)

Domondon, D.B.

1989-01-01

Regulatory requirements on the provision, calibration and occasions of use of survey instruments are enumerated for a number of licensed activities. Two methods of calibrating survey instruments are described. Factors that must be taken into consideration in conducting calibrations, contents of calibration reports and of the sticker attached to the instrument which are needed for the correct use of the instrument are discussed. The precautions to be observed in order to insure correct use of survey instruments are described. (Auth.)

1988-year of high integrity container evaluation, controversy and regulatory action

International Nuclear Information System (INIS)

Jones, D.

1989-01-01

During 1988, the Nuclear Regulatory Commission(NRC) completed review of and prepared technical evaluation reports on several topical reports describing containers designed to meet the 10CFR61 requirements for high integrity containers (HICs). An all metal Ferralium container and a stainless steel/polyethylene lined container were approved by the NRC. However, the NRC did not approve any containers designed from polyethylene material. The NRC staff concluded that polyethylene containers do not meet the structural stability requirements of Part 61, and unless they are combined with some engineered structure or overpack, they are not adequate for disposal of low-level radioactive wastes that require disposal in a structurally stable form. In conflict with these NRC findings, the State of South Carolina Department of Health and Environmental Control (SCDHEC) has given interim approval for continued use of polyethylene containers at the Barnwell disposal site with some restrictions on how the containers are buried depending on the classification of the waste. This paper reviews the applicable federal regulations, presents a chronology of events describing how the controversy over high integrity containers evolved from 1980 to 1989, summarizes the technical issues involved and suggests an approach that waste generators should follow during this situation of regulatory uncertainty

Proceedings of the meeting for coordinating precision machining of optics research and requirements

International Nuclear Information System (INIS)

Saito, T.T.

1975-12-01

The meeting for ''Coordinating Precision Machining of Optics Research and Requirements'' on September 18, 1975, was sponsored by the Air Force Weapons Laboratory at Kirtland AFB, NM. These proceedings contain an introduction to the meeting including a brief description of the participants and the objectives. The developments and capabilities of Union Carbide Y-12 plant are described in detail. A short summary of the new Moore no. 5 machine at Bendix, Kansas City, Mo. is included as well as a description of using light scattering for roughness characterization at Rockwell International, Rocky Flats, Colorado. The executive summary of the meeting mentions some of the discussions that also followed. Important conclusions of the meeting were that a 5 y lead time is required to obtain a machine and acquire the necessary skills for precision machining, and that demands for diamond turning optics will be increasing

A study for the establishment of regulatory requirement and evaluation guide for station blackout in nuclear power plants

International Nuclear Information System (INIS)

Lim, J. H.; Koo, C. S.; Joo, W. P.; Oh, S. H.; Shin, W. K.

1999-01-01

The consequence of SBO event could be a severe accident unless AC power was restored within a proper time, because many safety systems depend upon AC power. Based on the severity, the SBO has been extensively studied since it was identified as Unresolved Safety Issue at USNRC. The resolution of those studies is a rule-making such as 10 CFR 50.63 and Regulatory Guide 1.155. But there is no regulatory requirements of SBO for an operating domestic nuclear power plant up to the present time. This tudy has established SBO rule(regulatory requirements and evaluation guides) for an operating PWR type of the operating nuclear power plants in Korea

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

Directory of Open Access Journals (Sweden)

Michalis Barkoulas

2016-09-01

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

Public consultation: regulatory requirement or business principle?

International Nuclear Information System (INIS)

Seeley, R.

1999-01-01

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

Public consultation: regulatory requirement or business principle?

Energy Technology Data Exchange (ETDEWEB)

Seeley, R. [Shell Canada Oil Sands, Calgary, AB (Canada)

1999-07-01

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

NRC review of passive reactor design certification testing programs: Overview, progress, and regulatory perspective

Energy Technology Data Exchange (ETDEWEB)

Levin, A.E.

1995-09-01

New reactor designs, employing passive safety systems, are currently under development by reactor vendors for certification under the U.S. Nuclear Regulatory Commission`s (NRC`s) design certification rule. The vendors have established testing programs to support the certification of the passive designs, to meet regulatory requirements for demonstration of passive safety system performance. The NRC has, therefore, developed a process for the review of the vendors` testing programs and for incorporation of the results of those reviews into the safety evaluations for the passive plants. This paper discusses progress in the test program reviews, and also addresses unique regulatory aspects of those reviews.

75 FR 9451 - Sunshine Act Meetings

Science.gov (United States)

2010-03-02

... Tuesday, March 2, 2010 9:30 a.m. Briefing on Uranium Recovery (Public Meeting). (Contact: Dominick Orlando, 301-415-6749.) This meeting will be webcast live at the Web address-- http://www.nrc.gov , Week of... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act Meetings Agency Holding the Meetings...

Meeting challenges through good practice. Using the highlights from the third review meeting of the Convention on Nuclear Safety to improve national regulatory systems

International Nuclear Information System (INIS)

Keen, L.J.; Cameron, J.K.

2006-01-01

The third review meeting of the Convention on Nuclear Safety (CNS), held in April 2005, demonstrated collective progress on ensuring worldwide nuclear safety. The Contracting Parties highlighted areas of focus to be brought back to the fourth review meeting and also committed to a continuity process to revitalize the review processes under the CNS. Specific progress has been achieved in the first year since the conclusion of the third review meeting, but further commitment to progress is required, by the Contracting Parties and the Secretariat of the IAEA, over the next year, especially if changes to the review processes are to be achieved for the fourth review meeting in 2008. (author)

78 FR 69141 - Sunshine Act Meeting

Science.gov (United States)

2013-11-18

... POSTAL REGULATORY COMMISSION Sunshine Act Meeting TIME AND DATE: Wednesday, December 11, 2013, at.... STATUS: Part of this meeting will be open to the public. The rest of the meeting will be closed to the... December 11, 2013 meeting includes the items identified below. PORTIONS OPEN TO THE PUBLIC: 1. Report from...

Technical Meeting on Grading of the Application of Management System Requirements. Presentations

International Nuclear Information System (INIS)

2012-01-01

The objectives of this Technical Meeting are threefold: - to share international experiences and lessons learned, as well as exchange views on best practices and strategies to overcome the difficulties encountered; - to review and discuss the draft technical report on 'Grading the Application of Management System Requirements, to allow the participants to contribute to the improvement of the document and to enrich it with practical examples; and - to strengthen the international networking of specialists in the field. The topics covered during the meeting will include: - Examples and case studies presented by participants from countries with nuclear facilities (mainly focused on NPPs, and, where appropriate, from research reactors, fuel cycle and waste management facilities) on grading the application of management system requirements and lessons learned. - Reviewing and improving the final draft of a technical report on 'Grading the Application of Management System Requirements', which will supersede the previous guidance: Grading of Quality Assurance Requirement: A Manual (Technical Reports Series No. 328)

29 CFR 4.175 - Meeting requirements for health, welfare, and/or pension benefits.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Meeting requirements for health, welfare, and/or pension... health, welfare, and/or pension benefits. (a) Determining the required amount of benefits. (1) Most fringe benefit determinations containing health and welfare and/or pension requirements specify a fixed...

75 FR 4428 - Sunshine Act Meeting Notice

Science.gov (United States)

2010-01-27

....m. Briefing on Uranium Recovery (Public Meeting). (Contact: Dominick Orlando, 301-415-6749.) This... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act Meeting Notice DATES: Weeks of January... Plans (Public Meeting). (Contact: Quynh Nguyen, 301-415-5844.) This meeting will be webcast live at the...

Regulatory and extra-regulatory testing to demonstrate radioactive material packaging safety

International Nuclear Information System (INIS)

Ammerman, D.J.

1997-01-01

Packages for the transportation of radioactive material must meet performance criteria to assure safety and environmental protection. The stringency of the performance criteria is based on the degree of hazard of the material being transported. Type B packages are used for transporting large quantities of radioisotopes (in terms of A 2 quantities). These packages have the most stringent performance criteria. Material with less than an A 2 quantity are transported in Type A packages. These packages have less stringent performance criteria. Transportation of LSA and SCO materials must be in open-quotes strong-tightclose quotes packages. The performance requirements for the latter packages are even less stringent. All of these package types provide a high level of safety for the material being transported. In this paper, regulatory tests that are used to demonstrate this safety will be described. The responses of various packages to these tests will be shown. In addition, the response of packages to extra-regulatory tests will be discussed. The results of these tests will be used to demonstrate the high level of safety provided to workers, the public, and the environment by packages used for the transportation of radioactive material

75 FR 4882 - Meeting of the ACRS Subcommittee on EPR; Notice of Meeting

Science.gov (United States)

2010-01-29

... NUCLEAR REGULATORY COMMISSION Advisory Committee On Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on EPR; Notice of Meeting The ACRS U.S. Evolutionary Power Reactor (EPR) Subcommittee will hold a... with Open Items concerning the U.S. EPR Design Certification (DCD) Application and the Calvert Cliffs...

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

Use of probabilistic safety assessment in the regulatory process. Report of the technical committee meeting. Working material

International Nuclear Information System (INIS)

1994-01-01

A Technical Committee Meeting (TCM) was organized between 5-8 December 1994 to discuss and review the international situation in connection with the use made, whether formally or informally, by regulatory bodies of probabilistic safety assessment (PSA) in the course of their work, and the related question of the use and value of adopting probabilistic safety criteria (PSC) as an aid to judging the results of PSAs. The document includes the output from the four working groups, as well as 11 papers from the 12 papers presented to the TCM. A separate abstract was prepared for each paper. Refs, figs, tabs

SP-100 multimegawatt scaleup to meet electric propulsion mission requirements

International Nuclear Information System (INIS)

Newkirk, D.W.; Salamah, S.A.; Stewart, S.L.; Pluta, P.R.

1991-01-01

The SP-100 space power nuclear reactor nuclear heat source technology, utilizing uranium nitride fuel clad in PWC-11 in a fast reactor with lithium coolant circulated by an electromagnetic pump, is shown in this paper to be directly extrapolatable to thermal power levels that meet NASA nuclear electric propulsion requirements using different power conversion techniques. The SP-100 nuclear technology can be applied for missions with NEP requirements as low as 10's of kWe to 10's of MWe

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)

13 CFR 107.590 - Licensee's requirement to maintain active operations.

Science.gov (United States)

2010-01-01

..., repayments, additional capital contributions, or Leverage. (2) It is necessary for you to maintain excess... than 20 percent of your Regulatory Capital; and (ii) You cannot receive additional Leverage, solely... you meet the activity requirements in effect on January 30, 1996. (2) Rule for new Licensees. If you...

76 FR 17617 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program...

Science.gov (United States)

2011-03-30

... assessments, biosafety requirements, and security measures. DATES: The meeting will be held on May 10, 2011...) and other interested individuals to obtain specific regulatory guidance and information on standards concerning biosafety and biosecurity issues related to the Federal Select Agent Program. CDC, APHIS, and FBI...

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

International Nuclear Information System (INIS)

Husarcek, J.

2003-01-01

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

34 CFR 350.33 - What cooperation requirements must a Rehabilitation Engineering Research Center meet?

Science.gov (United States)

2010-07-01

... Rehabilitation Engineering Research Center meet? A Rehabilitation Engineering Research Center— (a) Shall... 34 Education 2 2010-07-01 2010-07-01 false What cooperation requirements must a Rehabilitation Engineering Research Center meet? 350.33 Section 350.33 Education Regulations of the Offices of the Department...

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

International Nuclear Information System (INIS)

Bobaly, P.

2001-01-01

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

Regulatory requirements for nuclear power plant site selection in Malaysia-a review.

Science.gov (United States)

Basri, N A; Hashim, S; Ramli, A T; Bradley, D A; Hamzah, K

2016-12-01

Malaysia has initiated a range of pre-project activities in preparation for its planned nuclear power programme. Clearly one of the first steps is the selection of sites that are deemed suitable for the construction and operation of a nuclear power plant. Here we outline the Malaysian regulatory requirements for nuclear power plant site selection, emphasizing details of the selection procedures and site characteristics needed, with a clear focus on radiation safety and radiation protection in respect of the site surroundings. The Malaysia Atomic Energy Licensing Board (AELB) site selection guidelines are in accord with those provided in International Atomic Energy Agency (IAEA) and United Stated Nuclear Regulatory Commission (USNRC) documents. To enhance the suitability criteria during selection, as well as to assist in the final decision making process, possible assessments using the site selection characteristics and information are proposed.

Nuclear regulatory policy concept on safety, security, safeguards and emergency preparedness (3S+EP)

International Nuclear Information System (INIS)

Ilyas, Zurias

2009-01-01

Regulatory Policy is formulated in regulations that stipulate the assurance of workers and public safety and environmental protection. Legislation and regulations on nuclear energy should consider nuclear safety, security and safeguards, as well as nuclear emergency preparedness (3S+EP) and liability for nuclear damage. Specific requirements stipulated in international conventions and agreements should also be taken into account. Regulatory Policy is formulated in regulations that stipulate the assurance of workers and public safety and environmental protection. Legislation and regulations on nuclear energy should consider nuclear safety, security and safeguards, as well as nuclear emergency preparedness (3S+EP) and liability for nuclear damage. Specific requirements stipulated in international conventions and agreements should also be taken into account. By undertaking proper regulatory oversight on Safety, Security and Emergency Preparedness (3S+EP) as an integrated and comprehensive system, safe and secure use of nuclear energy can be assured. Licence requirements and conditions should fulfil regulatory requirements pertaining to 3S+EP for nuclear installation as an integrated system. An effective emergency capacity that can be immediately mobilized is important. The capacity in protecting the personnel before, during and after the disaster should also be planned. Thus, proper emergency preparedness should be supported by adequate resources. The interface between safety, security, safeguards and emergency preparedness has to be set forth in nuclear regulations, such as regulatory requirements; 3S+EP; components, systems and structures of nuclear installations and human resources. Licensing regulations should stipulate, among others, DIQ, installations security system, safety analysis report, emergency preparedness requirements and necessary human resources that meet the 3S+EP requirements.

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

International Nuclear Information System (INIS)

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

2000-01-01

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

Nuclear safety requirements for operation licensing of Egyptian research reactors

International Nuclear Information System (INIS)

Ahmed, E.E.M.; Rahman, F.A.

2000-01-01

From the view of responsibility for health and nuclear safety, this work creates a framework for the application of nuclear regulatory rules to ensure safe operation for the sake of obtaining or maintaining operation licensing for nuclear research reactors. It has been performed according to the recommendations of the IAEA for research reactor safety regulations which clearly states that the scope of the application should include all research reactors being designed, constructed, commissioned, operated, modified or decommissioned. From that concept, the present work establishes a model structure and a computer logic program for a regulatory licensing system (RLS code). It applies both the regulatory inspection and enforcement regulatory rules on the different licensing process stages. The present established RLS code is then applied to the Egyptian Research Reactors, namely; the first ET-RR-1, which was constructed and still operating since 1961, and the second MPR research reactor (ET-RR-2) which is now in the preliminary operation stage. The results showed that for the ET-RR-1 reactor, all operational activities, including maintenance, in-service inspection, renewal, modification and experiments should meet the appropriate regulatory compliance action program. Also, the results showed that for the new MPR research reactor (ET-RR-2), all commissioning and operational stages should also meet the regulatory inspection and enforcement action program of the operational licensing safety requirements. (author)

IAEA meeting: International conference of national regulatory authorities with competence in the safety of radiation sources and the security of radioactive materials

Energy Technology Data Exchange (ETDEWEB)

Englefield, Chris [UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group, Environment Agency (United Kingdom)

2001-06-01

The meeting was the outcome of one of the actions arising from an IAEA sponsored meeting held in Dijon in 1998 on these issues. The action plan included inter alia the production of a 'Code of Conduct' (published December 2000), the production of a scheme for the 'Categorisation of Sources' (published December 2000) and a meeting to share experience and knowledge about the issues of illicit or inadvertent movements of radioactive materials across international borders. This was the major focus of the meeting held in Buenos Aires. The meeting was attended by 130 delegates representing 70 countries, the EU and the IAEA. This means that over half of the 131 IAEA Member States were present, a measure of the level of significance that is attached to the initiating issue of 'illicit trafficking'.The meeting was chaired by Dan Beninson (Argentina) and the Technical Secretariat was led by Alfonso Bilbao of IAEA. I attended as the UK delegate, in my capacity as Chairman of the UK INTERPOL Environmental Crime (Radioactive Substances) Sub-Group. The national papers were so numerous that it is not practicable to try to summarise them all here. However, a general impression will be given. The majority of papers submitted explained the regulatory structures extant in the speakers' home countries. It was useful to understand the level of development of regulatory arrangements in the Member States represented. These ranged from the highly developed such as those of EU Member States, the US and some South American states, to the very simple. In some cases, speakers frankly admitted that regulatory systems were virtually non-existent, but that as IAEA Members, their countries were ready and willing to improve their arrangements, with the assistance of IAEA . Some general conclusions may be derived: (i) A personal view is that IAEA and Member States have not clarified their risk assessment thinking: as RP practitioners we tend to concentrate on

Tuning Linux to meet real time requirements

Science.gov (United States)

Herbel, Richard S.; Le, Dang N.

2007-04-01

There is a desire to use Linux in military systems. Customers are requesting contractors to use open source to the maximal possible extent in contracts. Linux is probably the best operating system of choice to meet this need. It is widely used. It is free. It is royalty free, and, best of all, it is completely open source. However, there is a problem. Linux was not originally built to be a real time operating system. There are many places where interrupts can and will be blocked for an indeterminate amount of time. There have been several attempts to bridge this gap. One of them is from RTLinux, which attempts to build a microkernel underneath Linux. The microkernel will handle all interrupts and then pass it up to the Linux operating system. This does insure good interrupt latency; however, it is not free [1]. Another is RTAI, which provides a similar typed interface; however, the PowerPC platform, which is used widely in real time embedded community, was stated as "recovering" [2]. Thus this is not suited for military usage. This paper provides a method for tuning a standard Linux kernel so it can meet the real time requirement of an embedded system.

75 FR 6413 - Sunshine Act Meeting Notice

Science.gov (United States)

2010-02-09

... a.m. Briefing on Uranium Recovery (Public Meeting). (Contact: Dominick Orlando, 301-415-6749.) This... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act Meeting Notice DATES: Weeks of February.... Briefing on Regional Programs--Programs, Performance, and Future Plans (Public Meeting). (Contact: Richard...

Development of 30-pin connectors for electronic modules of C and I systems for NPP's confirming to customized MIL STD-1344 requirements

International Nuclear Information System (INIS)

Marathe, P.P.; Madala, Kalyan C.; Ramakrishna, P.

2014-01-01

The electrical connectors form an important constituent of C and I system where customized circuits and hardware is required to be configured meeting the Nuclear Power Plant regulatory requirements. C and I hardware has to handle multiple hundreds of I/O's and the system architectures are made in modular construction having C and I system hardware packaged in plug-in electronic modules in the required form factors. In addition if the system has to satisfy customized JSS 55555 requirements meeting stringent shock, vibration and environmental specifications, the connectors used for the electronic modules shall meet the customized MIL STD-1344 requirements and meet reliability target for the system. 30-pin type special connectors for electronic modules and 2x30 (60) pin field cabling connectors were developed meeting the required qualification specifications. (author)

75 FR 70955 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

Science.gov (United States)

2010-11-19

... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of meeting. SUMMARY: The U.S. Nuclear... the draft safety culture policy statement for medical licensees. A copy of the agenda for the meeting...

Regulatory requirements and quality assurance of radiation monitoring instruments

International Nuclear Information System (INIS)

Narasimharao, K.L.; Sharma, Ranjit

2005-01-01

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

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

International Nuclear Information System (INIS)

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

2004-01-01

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

Regulatory requirements for replacement of analog systems with digital upgrades

International Nuclear Information System (INIS)

Loeser, P.J.

1993-01-01

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

Regulatory requirements for the use of consumer products containing radioactive substances

International Nuclear Information System (INIS)

Mason, G.C.; Paynter, R.A.; Schmitt-Hannig, A.; Sztanyik, L.B.

1996-01-01

In almost 100 years since the discovery of radioactivity, the properties of radioactive materials have been exploited in products such as clocks and watches incorporating luminous paint which are freely available to members of the public. Over time, regulatory authorities have felt it necessary to apply some degree of control to the supply and use of such products in order to protect public health. In many areas of radiation protection, national authorities take note of international recommendations when developing national standards, but the existing detailed guidance of the International Atomic Energy Agency (IAEA) for consumer products is incomplete and out of date. Recently, a thorough revision of the International Basic Safety Standards (BSS) has occurred, which has prompted a review and revision of the related guidance published by the IAEA. A draft Guide on Regulatory Requirements for the Use of Consumer Products Containing Radioactive Substances has now been completed and is currently under review within the IAEA's system for development of documents in its Safety Series of publications. (author)

Supporting Intrinsic Motivation for Special Education Students to Meet Graduation Requirements

Science.gov (United States)

Frazier, Robert Sipplin

2015-01-01

This qualitative study examined how teachers use instructional practices and family reinforcement interventions to support intrinsic motivation for special education students as a means to meet graduation requirements. Purposeful sampling of highly qualified special education teachers certified in language arts was used in this study. The data…

Does a new steam meal catering system meet patient requirements in hospital?

Science.gov (United States)

Hickson, M; Fearnley, L; Thomas, J; Evans, S

2007-10-01

It has been consistently observed that a significant proportion of hospital inpatients are malnourished and many actually develop malnutrition in hospital. The NHS provides over 300 million meals each year at a cost of pound 500 million, yet there is relatively little research evaluating how well different catering systems provide for the needs of hospital inpatients. The aim of the study was to: (i) evaluate whether a new steam meal catering system (Steamplicity) enables patients in theory to meet their energy requirements in hospital and (ii) compare energy and protein intake using Steamplicity with a traditional bulk cook-chill system. Patients not at nutritional risk had their food intake at one lunchtime assessed. Energy intake was compared with the patients' energy requirements and energy and protein intake were compared with previous data from a bulk system. Fifty-seven patients had a median daily energy requirement of 7648 kJ (1821 kcal) [inter-quartile range (IQR): 6854-9164 kJ]. Assuming 30% [2293 kJ (546 kcal)] should be supplied by the lunch meal the average intake of 1369 kJ (326 kcal) fell short by 40%. Patients served meals from Steamplicity ate less energy [1369 kJ versus 1562 kJ (326 kcal versus 372 kcal) P = 0.04] but similar protein (18 g versus 19 g P = 0.34) to the bulk system. The largest difference was the energy provided by the dessert since the bulk system served more hot high-calorie desserts. Patient intakes did not meet their estimated requirements. The patients in this study were eating well and not at nutritional risk, thus patients with a poor appetite will be even less likely to meet their nutritional requirements. Steamplicity meals result in a lower energy intake than meals from a bulk cook-chill system, but similar protein intakes.

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

The IAEA Integrated Regulatory Review Service (IRRS) - Information Meeting Dublin

International Nuclear Information System (INIS)

Al Khatibeh, Ahmad

2014-05-01

IRRS is developed to help States evaluate the current status of compliance of their regulatory infrastructures for safety with IAEA Standards. This report discusses the function of IRRS missions as a tool for evaluating the regulatory structure for Member States. It was presented to RPII staff in a Powerpoint document in preparation for the IRRS Mission to Ireland in August 2015

Characterizing costs and benefits of uncertain future regulatory requirements on the U.S. natural gas industry

International Nuclear Information System (INIS)

Godec, M.L.; Smith, G.E.; Fitzgibbon, T.

1995-01-01

Environmental regulatory requirements at both the state and federal level are constantly changing, making it difficult for industry and R ampersand D program managers to project future compliance requirements and costs. Even if a company is trying to keep abreast of various proposed regulatory initiatives, the number of possible combinations of initiatives that could occur in the future seems virtually limitless. Uncertainty associated with potential future environmental compliance requirements makes the identification and evaluation of future investment and R ampersand D opportunities exceedingly difficult, and makes the process of systematic strategic planning increasingly complex. This paper describes a methodology for accounting for uncertain future environmental compliance costs in a systematic, comprehensive manner. Through analysis of proposed initiatives for making future environmental requirements more stringent, forecasting the likelihood of occurrence and potential timing of each initiative, and estimating potential future compliance costs associated with each initiative, a thorough process for incorporating regulatory uncertainty into strategic planning and project evaluation is described. This approach can be used for evaluating R ampersand D opportunities to determine where development of new technologies or assessment of risks posed by industry operations may have the greatest impact on future industry costs of compliance. This approach could also be used to account for the uncertainty of future environmental costs in corporate strategic planning or for factoring future compliance costs into project evaluation. This approach could also be enhanced through use in conjunction with other modeling and forecasting systems that could consider a broad range of impacts, including impacts on gas production, industry activity levels, and tax revenues

25 CFR 20.507 - What requirements must foster care providers meet?

Science.gov (United States)

2010-04-01

... ASSISTANCE AND SOCIAL SERVICES PROGRAMS Child Assistance Foster Care § 20.507 What requirements must foster care providers meet? If a child needs foster care, the social services worker must select care that... contain an approved current home study. (c) An off-reservation foster home, or residential care facility...

75 FR 8155 - Sunshine Act; Notice of Meeting

Science.gov (United States)

2010-02-23

....m. Briefing on Uranium Recovery (Public Meeting) (Contact: Dominick Orlando, 301-415-6749). This... NUCLEAR REGULATORY COMMISSION [NRC-2010-0002] Sunshine Act; Notice of Meeting DATES: Weeks of....m. Affirmation Session (Public Meeting) (Tentative). Entergy Nuclear Operations, Inc. (Indian Point...

The major cellular sterol regulatory pathway is required for Andes virus infection.

Directory of Open Access Journals (Sweden)

Josiah Petersen

2014-02-01

Full Text Available The Bunyaviridae comprise a large family of RNA viruses with worldwide distribution and includes the pathogenic New World hantavirus, Andes virus (ANDV. Host factors needed for hantavirus entry remain largely enigmatic and therapeutics are unavailable. To identify cellular requirements for ANDV infection, we performed two parallel genetic screens. Analysis of a large library of insertionally mutagenized human haploid cells and a siRNA genomic screen converged on components (SREBP-2, SCAP, S1P and S2P of the sterol regulatory pathway as critically important for infection by ANDV. The significance of this pathway was confirmed using functionally deficient cells, TALEN-mediated gene disruption, RNA interference and pharmacologic inhibition. Disruption of sterol regulatory complex function impaired ANDV internalization without affecting virus binding. Pharmacologic manipulation of cholesterol levels demonstrated that ANDV entry is sensitive to changes in cellular cholesterol and raises the possibility that clinically approved regulators of sterol synthesis may prove useful for combating ANDV infection.

The Financial Education Tool Kit: Helping Teachers Meet State- Mandated Personal Finance Requirements

Science.gov (United States)

St. Pierre, Eileen; Richert, Charlotte; Routh, Susan; Lockwood, Rachel; Simpson, Mickey

2012-01-01

States are recognizing the need for personal financial education and have begun requiring it as a condition for high school graduation. Responding to teacher requests to help them meet state-mandated financial education requirements, FCS educators in the Oklahoma Cooperative Extension Service developed a financial education tool kit. This article…

49 CFR 40.33 - What training requirements must a collector meet?

Science.gov (United States)

2010-10-01

... TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Urine Collection Personnel § 40.33 What training... 49 Transportation 1 2010-10-01 2010-10-01 false What training requirements must a collector meet...-3784, or on the ODAPC web site (http://www.dot.gov/ost/dapc). (b) Qualification training. You must...

Safety system upgrades to a research reactor: A regulatory perspective

International Nuclear Information System (INIS)

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

2003-01-01

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

Meeting licensing restrictions from a regulator's perspective

International Nuclear Information System (INIS)

Autry, V.R.; Ragan, F.A.

1990-01-01

The State of South Carolina was delegated the authority by the US Nuclear Regulatory Commission to regulate the receipt, possession, use and disposal of radioactive material as an Agreement State. Since 1970, the state has been the principal regulatory authority for the Barnwell Low-Level Waste Disposal Facility operated by Chem-Nuclear Systems, Inc. The radioactive material license issued authorizing the receipt and disposal of low level waste has experienced many changes necessitated by technical advancements which led to stricter controls and restrictions for shallow land disposal. Low level waste has evolved from simple contaminated items with minimal radioactivity, to complex waste streams requiring elaborate processing and containment of high quantities of radionuclides. Waste streams also require extensive analysis and qualification to meet many of the restrictions imposed at the burial facility and comply with national standards and regulations for classification. This paper presents a chronological history of many of these restrictions, the rationale for them, and the waste generators' abilities and inabilities to comply. In addition, case histories of some examples are discussed

CFD analyses in regulatory practice

International Nuclear Information System (INIS)

Bloemeling, F.; Pandazis, P.; Schaffrath, A.

2012-01-01

Numerical software is used in nuclear regulatory procedures for many problems in the fields of neutron physics, structural mechanics, thermal hydraulics etc. Among other things, the software is employed in dimensioning and designing systems and components and in simulating transients and accidents. In nuclear technology, analyses of this kind must meet strict requirements. Computational Fluid Dynamics (CFD) codes were developed for computing multidimensional flow processes of the type occurring in reactor cooling systems or in containments. Extensive experience has been accumulated by now in selected single-phase flow phenomena. At the present time, there is a need for development and validation with respect to the simulation of multi-phase and multi-component flows. As insufficient input by the user can lead to faulty results, the validity of the results and an assessment of uncertainties are guaranteed only through consistent application of so-called Best Practice Guidelines. The authors present the possibilities now available to CFD analyses in nuclear regulatory practice. This includes a discussion of the fundamental requirements to be met by numerical software, especially the demands upon computational analysis made by nuclear rules and regulations. In conclusion, 2 examples are presented of applications of CFD analysis to nuclear problems: Determining deboration in the condenser reflux mode of operation, and protection of the reactor pressure vessel (RPV) against brittle failure. (orig.)

A simplified ALARA approach to demonstration of compliance with surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Cook, J.C.

1998-02-01

The US Department of Transportation (DOT) and the US Nuclear Regulatory Commission (NRC) have jointly prepared a comprehensive set of draft guidance for consignors and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). The guidance is being developed to facilitate compliance with the new LSA material and SCO requirements, not to impose additional requirements. These new requirements represent, in some areas, significant departures from the manner in which packaging and transportation of these materials and objects were previously controlled. On occasion, it may be appropriate to use conservative approaches to demonstrate compliance with some of the requirements, ensuring that personnel are not exposed to radiation at unnecessary levels, so that exposures are kept as low as reasonably achievable (ALARA). In the draft guidance, one such approach would assist consignors preparing a shipment of a large number of SCOs in demonstrating compliance without unnecessarily exposing personnel. In applying this approach, users need to demonstrate that four conditions are met. These four conditions are used to categorize non-activated, contaminated objects as SCO-2. It is expected that, by applying this approach, it will be possible to categorize a large number of small contaminated objects as SCO-2 without the need for detailed, quantitative measurements of fixed, accessible contamination, or of total (fixed and non-fixed) contamination on inaccessible surfaces. The method, which is based upon reasoned argument coupled with limited measurements and the application of a sum of fractions rule, is described and examples of its use are provided

Requirements, needs, and concepts for a new broad-application test reactor

International Nuclear Information System (INIS)

Ryskamp, J.M.; Fletcher, C.D.; Denison, A.B.; Liebenthal, J.L.

1992-01-01

For a variety of reasons, including (a) the increasing demands of the 1990s regulatory environment, (b) limited existing test capactiy and capability to satisfy projected future testing missions, and (c) an expected increasing need for nuclear information to support development of advanced reactors, there is a need for requirements and preliminary concepts for a new broad-application test reactor (BATR). These requirements must include consideration not only for a broad range of projected testing missions but also for current and projected regulatory compliance and safety requirements. The requirements will form the basis for development and assessment of preconceptual reactor designs and lead to the identification of key technologies to support the government's long-term strategic and programmatic planning. This paper outlines the need for a new BATR and suggests a few preliminary reactor concepts that can meet that need

Report of the consultant meeting for review of procedure for NPP operational events reporting and investigation for the nuclear regulatory administration of Ukraine in Vienna, Austria 18-20 December 1995

International Nuclear Information System (INIS)

Lipar, M.; Koltakov, V.; Rodionov, A.; Razzell, R.; Tolstykh, V.; Kriz, Z.

1995-12-01

In response to a request from the Nuclear Regulatory Administration of Ukraine, the IAEA carried out an expert review of the Procedure for NPP Operational Events Reporting and Investigation developed by the Scientific and Technical Centre on Nuclear and Radiation Safety of the Nuclear Regulatory Administration. This report contains the recommendations and suggestions made by experts as a result of the Consultants Meeting held in Vienna between 18-20 December 1995

Radiation safety and regulatory aspects in Medical Facilities

International Nuclear Information System (INIS)

Banerjee, Sharmila

2017-01-01

Radiation safety and regulatory aspect of medical facilities are relevant in the context where radiation is used in providing healthcare to human patients. These include facilities, which carry out radiological procedures in diagnostic radiology, including dentistry, image-guided interventional procedures, nuclear medicine, and radiation therapy. The safety regulations provide recommendations and guidance on meeting the requirements for the safe use of radiation in medicine. The different safety aspects which come under its purview are the personnel involved in medical facilities where radiological procedures are performed which include the medical practitioners, radiation technologists, medical physicists, radiopharmacists, radiation protection and over and above all the patients. Regulatory aspects cover the guidelines provided by ethics committees, which regulate the administration of radioactive formulation in human patients. Nuclear medicine is a modality that utilizes radiopharmaceuticals either for diagnosis of physiological disorders related to anatomy, physiology and patho-physiology and for diagnosis and treatment of cancer

Meeting nuclear utilities manpower needs

International Nuclear Information System (INIS)

Sillin, L.F. Jr.

1982-01-01

The nuclear-power industry must attract and train 57,000 employees during the next decade, according to a survey which found a high rate of personnel turnover, 8790 unfilled positions, and 75 new plants scheduled to come on line. The Institute of Nuclear Power Operators (INPO) and the industry need to address personnel planning to find out how to meet these needs. Studies indicate a history of on-site staffing and training deficiencies. Regulatory requirements also contribute to manpower shortages. This article examines manpower problems and suggests initiatives the industry can take to support educational programs, expand training, provide employee incentives, and pool technical resources. 7 tables

Recent regulatory issues in Finland

International Nuclear Information System (INIS)

Laaksonen, J.; Tiipana, P.

2001-01-01

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

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

International Nuclear Information System (INIS)

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

2000-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2000-05-01

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

Regulatory control of nuclear power plants

International Nuclear Information System (INIS)

2002-01-01

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

Westinghouse AP1000 Electrical Generation Costs - Meeting Marketplace Requirements

International Nuclear Information System (INIS)

Paulson, C. Keith

2002-01-01

The re-emergence of nuclear power as a leading contender for new base-load electrical generation is not an occurrence of happenstance. The nuclear industry, in general, and Westinghouse, specifically, have worked diligently with the U.S. power companies and other nuclear industry participants around the world to develop future plant designs and project implementation models that address prior problem areas that led to reduced support for nuclear power. In no particular order, the issues that Westinghouse, as an engineering and equipment supply company, focused on were: safety, plant capital costs, construction schedule reductions, plant availability, and electric generation costs. An examination of the above criteria quickly led to the conclusion that as long as safety is not compromised, simplifying plant designs can lead to positive progress of the desired endpoints for the next and later generations of nuclear units. The distinction between next and later generations relates to the readiness of the plant design for construction implementation. In setting requirement priorities, one axiom is inviolate: There is no exception, nor will there be, to the Golden Rule of business. In the electric power generation industry, once safety goals are met, low generation cost is the requirement that rules, without exception. The emphasis in this paper on distinguishing between next and later generation reactors is based on the recognition that many designs have been purposed for future application, but few have been able to attain the design pedigree required to successfully meet the requirements for next generation nuclear units. One fact is evident: Another generation of noncompetitive nuclear plants will cripple the potential for nuclear to take its place as a major contributor to new electrical generation. Only two plant designs effectively meet the economic tests and demonstrate both unparalleled safety and design credibility due to extensive progress toward engineering

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.

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

Science.gov (United States)

2013-12-19

... limitations for unforeseen reasons, is the driver in violation of the Sec. 395.3 rest break provision if more... unforeseen reasons, is not in violation of the Sec. 395.3 rest-break requirements if 8 or more hours have... Regulatory Guidance on Hours of Service of Drivers Rest Break Requirement; Drivers Who Become Ineligible for...

Regulatory inspection of nuclear power plants in NEA member countries

International Nuclear Information System (INIS)

Gronow, W.S.; Ilani, O.

1977-01-01

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

78 FR 3041 - Notice of Sunshine Act Meetings

Science.gov (United States)

2013-01-15

..., 2013--Tentative Thursday, January 31, 2013 9:00 a.m. Briefing on Public Participation in NRC Regulatory Decision-Making (Public Meeting) (Contact: Lance Rakovan, 301-415-2589). This meeting will be webcast live...

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)

Waste package for Yucca Mountain repository: Strategy for regulatory compliance

International Nuclear Information System (INIS)

Cloninger, M.; Short, D.; Stahl, D.

1989-02-01

This document summarizes the strategy given in the Site Characterization Plan (1) for demonstrating compliance with the post closure performance objectives for the waste package and the Engineered Barrier System (EBS) contained in the Code of Federal Regulations. The strategy consists of the development of a conservative waste package design that will meet the regulatory requirements with sufficient margin for uncertainty using a multi-barrier approach that takes advantage of the unsaturated nature of the Yucca Mountain site. This strategy involves an iterative process designed to achieve compliance with the requirements for substantially complete containment and EBS release. The strategy will be implemented in such a manner that sufficient evidence will be provided for presentation to the Nuclear Regulatory Commission (NRC) so that it may make a finding that there is ''reasonable assurance'' that these performance requirements will indeed be met. In implementing the strategy, DOE recognizes four fundamental goals: (1) protect public health and safety; (2) minimize financial and other resource commitments; (3) comply with applicable laws and regulations; and (4) maintain an aggressive schedule. The strategy is intended to be a reasonable balance of these competing goals. 7 refs., 3 figs., 1 tab

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)

Regulatory aspects for nuclear and radiation applications

International Nuclear Information System (INIS)

Duraisamy, S.

2014-01-01

The Atomic Energy Regulatory Board (AERB) is the national authority for ensuring that the use of ionizing radiation and nuclear energy does not cause any undue risk to the health of workers, members of the public and to the environment. AERB was constituted on November 15, 1983 and derives its regulatory power from the rules and notifications promulgated under the Atomic Energy Act, 1962 and the Environment (Protection) Act, 1986. AERB is provided with the necessary powers and mandate to frame safety policies, lay down safety standards and requirements for monitoring and enforcing the safety provisions. AERB follows multi-tier system for its review and assessment, safety monitoring, surveillance and enforcement. While regulating various nuclear and radiation facilities, AERB adopts a graded approach taking into account the hazard potential associated with the facilities being regulated. The regulatory process has been continuous evolving to cater to the new developments in reactor and radiation technologies. The regulatory effectiveness and efficiency of AERB have grown over the last three decades to make it into a robust organization. The radiation protection infrastructure in the country is on a sound footing and is constantly being strengthened based on experience and continued research and development. As one of its mandates AERB prescribes radiation dose limits for the occupational workers and the public, in line with the IAEA Safety Standard and ICRP recommendations. The current dose limits and the radiation safety requirements are more stringent than past. To meet the current safety standards, it is important for the facilities to have state of art radiation monitoring system and programme in place. While recognizing the current system in place, this presentation also highlights certain key radiation protection challenges associated with the implementation of radiation protection standards in the nuclear and radiation facilities especially in the areas of

Cooperation of technical support organizations of state nuclear regulatory committee of Ukraine in sip safety regulation

International Nuclear Information System (INIS)

Bikov, V.O.; Kyilochits'ka, T.P.; Bogorins'kij, P.; Vasil'chenko, V.M.; Kondrat'jev, S.M.; Smishlyajeva, S.P.; Troter, D.

2002-01-01

The main task of the technical support in the Shelter Implementation Plan (SIP) licensing process consists in Technical Evaluation of SIP projects and documents submitted by the Licensee to State Nuclear Regulatory Committee to substantiate the safety of Shelter-related work. The goal of this task is to evaluate the submitted materials whether they meet the requirements of nuclear and radiation safety

75 FR 80083 - Advisory Committee on the Medical Uses of Isotopes: Meeting Notice

Science.gov (United States)

2010-12-21

... NUCLEAR REGULATORY COMMISSION Advisory Committee on the Medical Uses of Isotopes: Meeting Notice AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Notice of Meeting. SUMMARY: The U.S. Nuclear... the draft safety culture policy statement for medical licensees. Contingent upon the outcome of the...

77 FR 2286 - Northern Illinois Hydropower, LLC; Notice of Meeting

Science.gov (United States)

2012-01-17

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12717-002] Northern Illinois Hydropower, LLC; Notice of Meeting a. Date and Time of Meeting: Thursday, January 26, 2012 from 11... Meeting: Commission staff will meet with Northern Illinois Hydropower, LLC to discuss potentially moving...

Guide to the conduct of public meetings as part of the public information process for uranium and thorium mine-mill facilities

International Nuclear Information System (INIS)

1980-01-01

The Canadian Atomic Energy Control Board requires that an applicant for a site approval for a uranium or thorium mine-mill facility inform the public about the project and facilitate public response. For small undertakings, the information requirement may be met by a public meeting organized by the proponents of the project. This guide provides specific instructions on giving notice of the meeting, availability of documentation, choice of a chairperson, agenda, the roles of the proponents and the regulatory agencies, and means of obtaining feedback from the public. (L.L.)

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

International Nuclear Information System (INIS)

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

1994-01-01

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

Answers to questions at public meetings regarding implementation of Title 10, Code of Federal Regulations, Part 55 on operators' licenses

International Nuclear Information System (INIS)

1987-11-01

This document presents questions and answers based on the transcripts of four public meetings (and from written questions submitted after the meetings) conducted from April 9 to April 20, 1987 by the staff of the US Nuclear Regulatory Commission. The meetings discussed implementation of the Commission's final rule governing Operators' Licenses and Conforming Amendments (10 CFR Parts 55 and 50). The rule became effective May 26, 1987 and is intended to clarify the regulations for issuing licenses to operators and senior operators; revise the requirements and scope of written examinations and operating tests for operators and senior operators, require a simulation facility; clarify procedures for administering requalification examinations; and describe the form and content for operator license applications

Instruction of the CSN on the requirements of the system of management of the nuclear power plants

International Nuclear Information System (INIS)

Cid, R.; Santo, A. de; Gil Montes, B.; Toca, A.

2008-01-01

The Western European Nations Regulatory Authorities (WENRA) performed a nuclear safety requirements harmonization task, as a result of this work and its implementation, the Spanish Nuclear Safety Counsel (CSN) has the commitment to issue its own Regulation Safety Instructions) to identify the WENRA to level nuclear safety requirements, and to incorporate it in the Spanish regulatory pyramid. However, the Spain nuclear installations meet these requirements through the original criteria to fulfill the regulation of the country that supply the NSSS design, these requirements are not incorporated in our regulation. One of the issues, identified by WENRA, is the implementation of the management system requirements in accord with the IAEA GS-R-3 The Management System for Facilities and Activities. As these regards, the CSN has developed a Safety Instruction, basically endorsing the IAEA GS-R-3. The Safety Instruction is actually in a phase of external comments and should be issued by june 2008. This paper describes the bases for the Safety Instruction, summarises the requirements that would meet the management system for nuclear installations and the activities to perform for its implementations. (Author)

The Defence in Depth Concept Applied to the New Regulatory Requirements in Japan

Energy Technology Data Exchange (ETDEWEB)

Yamagata, H., E-mail: hiroshi_yamagata@nsr.go.jp [Nuclear Regulation Authority, Minato-ku, Tokyo (Japan)

2014-10-15

Full text: The new regulatory requirements based on lessons learnt from Fukushima Daiichi accident, which places emphasis on Defense-in-Depth concept, was put into effect in Japan on 8th July, 2013. It is required to prepare multi-layered protective measures. Each layer should achieve the objective only in that layer regardless of the measures in the other layers. The challenge is how to enhance independence of measures between layers. In the third layer, the current concept of design regarding safety relies on “single failure”, whose condition is elimination of common cause failure (CCF). To eliminate CCFs we introduced a more accurate approach in assessment of earthquake and tsunami, and introduction of measures against tsunami inundation. Redundancy of safety systems could not eliminate CCF by extreme natural hazards. Safety system should be designed by due consideration of diversity and independence including spatial dispersement. In the fourth layer, multi-layered protective measures are also applied for severe accidents, which consists of “prevention of core damage” under multiple failure, “prevention of containment failure”, and “prevention of large release, that is controlled release by venting”. In the fifth layer, we also require operators to prepare measures for “suppression of radioactive materials dispersion”. Of course, off-site emergency preparedness and response has been enhanced by introduction of PAZ and UPZ. Introduction of “Specialized Safety Facility” against intentional aircraft crash will contribute enhancement of some layers by providing electricity and water under extremely severe conditions. The new regulatory requirements are not our goal, just a first step. It is expected for regulator and operators to improve safety continuously by periodic comprehensive safety assessments including IPE, IPEEE, Margin test, and etc. We have to make an upward spiral of nuclear safety. (author)

In situ vitrification of mixed wastes: Progress and regulatory status

International Nuclear Information System (INIS)

Kindle, C.H.; Barich, J.J. III

1991-08-01

In situ vitrification (ISV) technology targets mixed wastes in in situ near-surface environments. Federal laws governing toxic substances (TSCA), hazardous waste (RCRA), and abandoned sites (Superfund) create the need for remediation technology and define the required performance characteristics. The need for ISV depends, in part, on the extent of regulation and how well ISV's demonstrated performance characteristics match up with regulatory criteria. The regulatory requirements are easier to identify and meet in short-duration site- and situation-specific applications of the technology than they are simpler in long-term, generalized applications. ISV's ability to treat both inorganics and organics in a single process supports applications for mixed, hazardous, and radioactive sites of moderate depth (20 ft). The durability of the ISV waste form is a major advantage of the technology when demonstrating permanence of a waste management strategy. Achieving depth and vapor containment assurance are issues being addressed as the ISV process is refined for new applications having different processing concerns. Refinements include moveable electrodes and sheet steel as the material for the containment structure. 16 refs., 4 figs., 6 tabs

Regulatory Safety Requirements for Operating Nuclear Installations

International Nuclear Information System (INIS)

Gubela, W.

2017-01-01

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

Bibliography of technical guidance for the physical protection upgrade rule requirements for fixed sites

International Nuclear Information System (INIS)

Evans, L.J. Jr.; Allen, T.

1980-06-01

A bibliography of technical references covering physical security systems, components, and procedures was prepared to provide Nuclear Regulatory Commission licensees a listing of available documents that could be used by licensees to select systems, components, and procedures to meet the revised physical protection requirements of 10 CFR Part 73

The Journey to Meet Emerging Community Benefit Requirements in a Rural Hospital: A Case Study

Science.gov (United States)

Sabin, Allison V; Levin, Pamela F

2015-10-22

The Affordable Care Act requires nonprofit hospitals to collaborate with public health agencies and community stakeholders to identify and address community health needs. As a rural organization, Wabash County (Indiana) Hospital pursued new approaches to achieve these revised requirements of the community benefit mandate. Using a case study approach, the authors provide a historical review of governmental relationships with nonprofit community hospitals, offer a case study application for implementing legislative mandates and community benefit requirements, share the insights they garnered on their journey to meet the mandates, and conclude that drawing upon the existing resources in the community and using current community assets in novel ways can help conserve time, and also financial, material, and human resources in meeting legislative mandates.

29 CFR 4.172 - Meeting requirements for particular fringe benefits-in general.

Science.gov (United States)

2010-07-01

... 29 Labor 1 2010-07-01 2010-07-01 true Meeting requirements for particular fringe benefits-in... particular fringe benefits—in general. Where a fringe benefit determination specifies the amount of the..., as such costs are properly a business expense of the employer. If prevailing fringe benefits for...

Regulatory Challenges for Cartilage Repair Technologies.

Science.gov (United States)

McGowan, Kevin B; Stiegman, Glenn

2013-01-01

In the United States, few Food and Drug Administration (FDA)-approved options exist for the treatment of focal cartilage and osteochondral lesions. Developers of products for cartilage repair face many challenges to obtain marketing approval from the FDA. The objective of this review is to discuss the necessary steps for FDA application and approval for a new cartilage repair product. FDA Guidance Documents, FDA Panel Meetings, scientific organization recommendations, and clinicaltrials.gov were reviewed to demonstrate the current thinking of FDA and the scientific community on the regulatory process for cartilage repair therapies. Cartilage repair therapies can receive market approval from FDA as medical devices, drugs, or biologics, and the specific classification of product can affect the nonclinical, clinical, and regulatory strategy to bring the product to market. Recent FDA guidance gives an outline of the required elements to bring a cartilage repair product to market, although these standards are often very general. As a result, companies have to carefully craft their study patient population, comparator group, and clinical endpoint to best showcase their product's attributes. In addition, regulatory strategy and manufacturing process validation need to be considered early in the clinical study process to allow for timely product approval following the completion of clinical study. Although the path to regulatory approval for a cartilage repair therapy is challenging and time-consuming, proper clinical trial planning and attention to the details can eventually save companies time and money by bringing a product to the market in the most expeditious process possible.

Training requirements for health physicists in the decontamination/decommissioning field

International Nuclear Information System (INIS)

Copenhaver, E.D.; Parzyck, D.C.

1986-01-01

While a significant decrease in the number of new facilities requiring health physics surveillance has occurred in the past decade, there has been a tremendous increase in the need for health physicists to fill regulatory requirements at existing facilities and the Decontamination and Decommissioning requirements of older facilities nearing the end of their operational lifetime. There is a continuing long-term need to provide trained health physicists with the special skills to meet these requirements. Decontamination and decommissioning programs require both basic and specialized health physics activities to be performed (1) to evaluate the radiation environment of the facility under consideration, (2) to establish the standards to which cleanup activities must be pursued, and (3) to adequately protect the personnel involved in the cleanup. Performance-based training, based on job task analysis, is an appropriate way to define the different types of health physics expertise required for D and D programs. Materials have been developed to describe potential job requirements in the radiation protection field, and the appropriate training goals to meet these requirements. 14 refs., 3 tabs

Training requirements for health physicists in the decontamination/decommissioning field

International Nuclear Information System (INIS)

Copenhaver, E.D.; Parzyck, D.C.

1986-01-01

While a significant decrease in the number of new facilities requiring health physics surveillance has occurred in the past decade, there has been a tremendous increase in the need for health physicists to fill regulatory requirements at existing facilities and the Decontamination and Decommissioning requirements of older facilities nearing the end of their operational lifetime. There is a continuing long-term need to provide trained health physicists with the special skills to meet these requirements. Decontamination and decommissioning programs require both basic and specialized health physics activities to be performed (1) to evaluate the radiation environment of the facility under consideration, (2) to establish the standards to which cleanup activities must be pursued, and (3) to adequately protect the personnel involved in the cleanup. Performance-based training, based on job task analysis, is an appropriate way to define the different types of health physics expertise required for D and D programs. Materials have been developed to describe potential job requirements in the radiation protection field, and the appropriate training goals to meet these requirements

20 CFR 652.207 - How does a State meet the requirement for universal access to services provided under the Act?

Science.gov (United States)

2010-04-01

... 20 Employees' Benefits 3 2010-04-01 2010-04-01 false How does a State meet the requirement for universal access to services provided under the Act? 652.207 Section 652.207 Employees' Benefits EMPLOYMENT... exercising this discretion, a State must meet the Act's requirements. (b) These requirements are: (1) Labor...

Proceedings of the specialists' meeting on regulatory inspection practices in nuclear power plants

International Nuclear Information System (INIS)

1977-01-01

The sessions and contributions of this conference are dealing with: the general problems of regulatory inspection of nuclear power plants and overall national practices (in Canada, France, Germany, Italy, Spain, the United States), specific problems and practical experience of regulatory inspection during site study, evaluation, design, manufacturing and construction of nuclear plants (in Finland, Germany, Spain, Sweden, Great-Britain, United States), quality insurance issues, pressure component regulations, specific problems and practical experience of regulatory inspection during commissioning (in Spain, Sweden, Great-Britain and United States), specific problems and practical experience of regulatory inspection during operation (in Spain, Great-Britain, Unites States, Italy and Sweden), special aspects of regulatory inspection (notably public information issues in Sweden and in Great-Britain, inspection of nuclear fuel transportation in Spain, enforcement programme in the USA)

40 CFR 1045.415 - What happens if in-use engines do not meet requirements?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false What happens if in-use engines do not... VESSELS In-Use Testing § 1045.415 What happens if in-use engines do not meet requirements? (a) Determine... families showing that you designed them to exceed the minimum requirements for controlling emissions. We...

40 CFR 1048.415 - What happens if in-use engines do not meet requirements?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 32 2010-07-01 2010-07-01 false What happens if in-use engines do not... Testing In-use Engines § 1048.415 What happens if in-use engines do not meet requirements? (a) Determine... families showing that you designed them to exceed the minimum requirements for controlling emissions. We...

EPR meets the next generation PWR safety requirements

International Nuclear Information System (INIS)

Bouteille, Francois; Czech, Juergen; Sloan, Sandra

2006-01-01

At the origin was the common decision in 1989 of Framatome and Siemens to cooperate to design a Nuclear Island which meets the future needs of utilities. EDF and a group of main German Utilities joined this effort in 1991 and from that point were completely involved in the progress of the work. Compliance of the EPR with the European Utility Requirements (EUR) was verified to ensure a large acceptability of the design by other participating utilities. In addition, the entire process was backed up to the end of 1998 by the French and the German Safety Authorities which engaged into a long-lasting cooperation to define common requirements applicable to future Nuclear Power Plants. Upon signature of the Olkiluoto 3 contract, STUK, the Finnish safety and radiation authority, began reviewing the design of the EPR. Upon the favorable recommendation of STUK, the Finnish government delivered a Construction License for the Olkiluoto 3 NPP on February 17, 2005. Following the positive conclusion of the political debate in France with regard to nuclear energy, EDF will also submit a request to start the construction of an EPR on the Flamanville site. In the US, the first steps in view of a Design Certification by the NRC have been taken. These three independent decisions make the EPR the leading first generation 3+ design under construction. Important safety functions are assured by separate systems in a straightforward operating mode. Four separate, redundant trains for all safety systems are installed in four separate layout division for which a strict separation is ensured so that common mode failure, for example due to internal hazards, can be ruled out. A reduction in common mode failure potential is also obtained by design rules ensuring the systematic application of functional diversity. A four train-redundancy for the major safety systems provides flexibility in adapting the design to maintenance requirements, thus contributing to reduce the outage duration. Additional

Functions and requirements for the INEL light duty utility arm gripper end effector

International Nuclear Information System (INIS)

Pace, D.P.; Barnes, G.E.

1995-02-01

This gripper end effector system functions and requirements document defines the system functions that the end effector must perform as well as the requirements the design must meet. Safety, quality assurance, operations, environmental conditions, and regulatory requirements have been considered. The main purpose of this document is to provide a basis for the end effector engineering, design, and fabrication activities. The document shall be the living reference document to initiate the development activities and will be updated as system technologies are finalized

Functions and requirements for the INEL light duty utility arm sampler end effector

International Nuclear Information System (INIS)

Pace, D.P.; Barnes, G.E.

1995-02-01

This sampler end effector system functions and requirements document defines the system functions that the end effector must perform as well as the requirements the design must meet. Safety, quality assurance, operations, environmental conditions, and regulatory requirements have been considered. The main purpose of this document is to provide a basis for the end effector engineering, design, and fabrication activities. The document shall be the living reference document to initiate the development activities and will be updated as system technologies are finalized

Food irradiation: Some regulatory and technical aspects

International Nuclear Information System (INIS)

1985-10-01

An Advisory Group by IAEA and FAO on Regulatory and Technological Requirements for Authorization of the Food Irradiation Process was held at IAEA Headquarters in Vienna from 5 to 9 November 1984. The task of the Advisory Group was to advise on the scientific and technological considerations affecting the implementation of the food irradiation process, with particular reference to the facilitation of international trade in irradiated foods and to develop guidance on how the various provisions of the Codex General Standard on Irradiated Foods could be incorporated into national legislation in order to facilitate international trade and avoid the occurence of trade barriers. Separate abstracts were prepared for the various presentations at this meeting

Innovative nuclear reactor - Indian approach to meet user requirements for safety

International Nuclear Information System (INIS)

Saha, D.; Sinha, R.K.

2002-01-01

Full text: For sustainable development of nuclear energy, a number of key issues are to be addressed. It should be economically competitive; it must address the issues related to nuclear safety, proliferation resistance, environmental impact, waste disposal and cross cutting issues like social and infra-structural aspects. To compete successfully in the long term, in the highly competitive energy market and to overcome other challenges, it is necessary to introduce innovative reactor and fuel cycle concepts. Indian Advanced Heavy Water Reactor (AHWR) is one such innovative reactor. To guide the research and development activities related to innovative concepts, user requirements are to be formulated. User requirements covering various aspects of sustainable development are being formulated at both national and international levels. One such international project involved in the formulation of user requirements is the IAEA International Project on Innovative Nuclear Reactors and Fuel Cycles (INPRO). This paper deals with INPRO user requirements for safety and Indian approach to meet these requirements through AHWR

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

International Nuclear Information System (INIS)

Ritterbusch, S.E.

2000-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

Ritterbusch, S.E.

2000-08-01

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

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

International Nuclear Information System (INIS)

Horvath, C.L.

1991-01-01

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

Environment, safety, and health regulatory implementation plan

International Nuclear Information System (INIS)

1993-01-01

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

Regulatory status of burnup credit for storage and transport of spent fuel in Germany

International Nuclear Information System (INIS)

Neuber, J.C.; Schweer, H.H.; Johann, H.G.

2001-01-01

This paper describes the regulatory status of burnup credit applications to pond storage and dry-cask transport and storage of spent fuel in Germany. Burnup credit for wet storage of LWR fuel at nuclear power plants has to comply with the newly developed safety standard DIN 25471. This standard establishes the safety requirements for burnup credit criticality safety analysis of LWR fuel storage ponds and gives guidance on meeting these requirements. Licensing evaluations of dry transport systems are based on the application of the IAEA Safety Standards Series No.ST-1. However, because of the fact that burnup credit for dry-cask transport becomes more and more inevitable due to increasing initial enrichment of the fuel, and because of the increasing importance of dry-cask storage in Germany, the necessity of giving regulatory guidance on applying burnup credit to dry-cask transport and storage is seen. (author)

78 FR 4476 - Sunshine Act; Meeting Notice

Science.gov (United States)

2013-01-22

...: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public and Closed. Week of... live at the Web address--www.nrc.gov. 9:00 a.m. Briefing on Public Participation in NRC Regulatory Decision- Making (Public Meeting) (Contact: Lance Rakovan, 301-415-2589). This meeting will be webcast live...

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

International Nuclear Information System (INIS)

Birkholz, W.

2000-01-01

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

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

International Nuclear Information System (INIS)

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

1992-01-01

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

Proceedings of a specialist meeting on regulatory approaches for the control of environmental residues containing naturally occurring radioactive material. Working material

Energy Technology Data Exchange (ETDEWEB)

NONE

2005-07-01

Naturally occurring radionuclides are present in most material. The most common naturally occurring radionuclides in material are those of the uranium and thorium series and potassium-40. This material is commonly referred to as Naturally Occurring Radioactive Material (NORM). In some material the levels of naturally occurring radionuclides are significantly higher, to the extent that regulatory control may be required for radiation protection purposes. Regulation of NORM presents a range of new challenges for both regulators and operators. Unlike more traditional industries dealing with radionuclides, NORM industries have generally not had any radiological oversight and, for example, are not equipped for radiological monitoring. Some consumer goods containing NORM, which have not traditionally been considered as a radiological problem (such as some fertilizers), may require regulation and this may have social and economic consequences. The transport and disposal of NORM are also a concern, particularly due to the large volumes, which may need to be considered. For the majority of NORM, disposal has been by conventional means in the same way as for non-hazardous waste with no specific attention to radiological aspects. In some cases, there may be a need for intervention into existing NORM disposal sites. The International Commission on Radiological Protection (ICRP) published ICRP No. 82, Protection of the Public in Situations of Prolonged Radiation Exposure in 2000. This document provides guidance on managing residues, such as those arising from NORM industries, with potential impact on the public. However, with NORM residual waste there may be three different situations: residual waste created as the result of a past practice, residual waste created by an ongoing practice and waste which will arise from future activities. Regulation of NORM may therefore be consistent with consideration of a practice, an intervention or a combination of both. Different regulatory

Proceedings of a specialist meeting on regulatory approaches for the control of environmental residues containing naturally occurring radioactive material. Working material

International Nuclear Information System (INIS)

2005-01-01

Naturally occurring radionuclides are present in most material. The most common naturally occurring radionuclides in material are those of the uranium and thorium series and potassium-40. This material is commonly referred to as Naturally Occurring Radioactive Material (NORM). In some material the levels of naturally occurring radionuclides are significantly higher, to the extent that regulatory control may be required for radiation protection purposes. Regulation of NORM presents a range of new challenges for both regulators and operators. Unlike more traditional industries dealing with radionuclides, NORM industries have generally not had any radiological oversight and, for example, are not equipped for radiological monitoring. Some consumer goods containing NORM, which have not traditionally been considered as a radiological problem (such as some fertilizers), may require regulation and this may have social and economic consequences. The transport and disposal of NORM are also a concern, particularly due to the large volumes, which may need to be considered. For the majority of NORM, disposal has been by conventional means in the same way as for non-hazardous waste with no specific attention to radiological aspects. In some cases, there may be a need for intervention into existing NORM disposal sites. The International Commission on Radiological Protection (ICRP) published ICRP No. 82, Protection of the Public in Situations of Prolonged Radiation Exposure in 2000. This document provides guidance on managing residues, such as those arising from NORM industries, with potential impact on the public. However, with NORM residual waste there may be three different situations: residual waste created as the result of a past practice, residual waste created by an ongoing practice and waste which will arise from future activities. Regulation of NORM may therefore be consistent with consideration of a practice, an intervention or a combination of both. Different regulatory

Regulatory Oversight of Cell and Gene Therapy Products in Canada.

Science.gov (United States)

Ridgway, Anthony; Agbanyo, Francisca; Wang, Jian; Rosu-Myles, Michael

2015-01-01

Health Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTPs) presents many challenges beyond those for protein biologics. Cells cannot be subjected to pathogen removal or inactivation procedures and must frequently be administered shortly after final formulation. Viral vector design and manufacturing control are critically important to overall product quality and linked to safety and efficacy in patients through concerns such as replication competence, vector integration, and vector shedding. In addition, for many CGTPs, the value of nonclinical studies is largely limited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonisation at an international level are essential for progress in the development and commercialisation of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product approval pathway may be lacking.

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

Directory of Open Access Journals (Sweden)

Giannakou C

2016-06-01

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

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...

40 CFR 267.175 - What special requirements must I meet for incompatible wastes?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 26 2010-07-01 2010-07-01 false What special requirements must I meet for incompatible wastes? 267.175 Section 267.175 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE...

40 CFR 267.203 - What special requirements must I meet for incompatible wastes?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 26 2010-07-01 2010-07-01 false What special requirements must I meet for incompatible wastes? 267.203 Section 267.203 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE...

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

Removal of regulatory controls for materials and sites

International Nuclear Information System (INIS)

2004-01-01

Issues with the removal of regulatory controls are very important on the agenda of the regulatory authorities dealing with radioactive waste management (RWM). These issues arise prominently in decommissioning and in site remediation, and decisions can be very wide ranging having potentially important economic impacts and reaching outside the RWM area. The RWMC Regulators Forum started to address these issues by holding a topical discussion at its meeting in March 2003. Ths present document collates the national regulatory positions in the area of removal of regulatory controls. A summary of the national positions is also provided. The document is up to date to April 2004. (authors)

Using geospatial solutions to meet distribution integrity management requirements

Energy Technology Data Exchange (ETDEWEB)

McElroy, Robert A. [New Century Software, Inc., Fort Collins, CO (United States)

2010-07-01

In the United States, incidents on gas distribution pipelines kill on average 10 persons per year in addition to causing 40 serious injuries and millions of dollars of property damage. In order to remedy to this situation, the US Department of Transportation/Pipeline Hazardous Materials Safety Administration enacted new regulations requiring operators to develop distribution integrity management programs (DIMP) which must include: knowledge and identification of threats, evaluation of risk, identification and implementation of measures to address risks, performance measuring, periodic evaluation and improvement and results reporting. The aim of this paper is to show how geographic information systems (GIS) can help operators meet each requirement of the DIMP regulations. This discussion showed that GIS can help in identifying and quantifying the threats to the distribution system and in assessing the consequences of an incident. Investing in GIS will not only help operators in complying with the regulations but will also help them make economically sound, risk-based decisions.

Second review meeting of the Contracting Parties to the Convention on Nuclear Safety

International Nuclear Information System (INIS)

Rafferty, Barbara

2002-01-01

identified that require special attention, particularly, with regard to safety management, safety culture, plant ageing, upgrading and effectiveness of regulatory practices, as well as maintaining competence and knowledge in the industry, regulatory bodies and research institutions. The review process highlighted factors and circumstances, external to nuclear safety as such, which nevertheless may impact on nuclear safety. Contracting Parties were invited to provide further information in their next national reports on maintaining competence and motivation of staff needed for safe regulation and operation of nuclear installation. Since the 1999 Review Meeting, several Contracting Parties have restructured their regulatory bodies and adopted new legislation or improved existing legislation to more closely meet the requirements of the Convention. Examples of areas of new legislation are: establishing independent regulatory bodies; emergency preparedness; decommissioning; and radiation protection provisions consistent with the International Commission on Radiological Protection's 1990 Recommendations (ICRP 60) and the International Basic Safety Standards published by the IAEA (BSS). Full implementation of the ICRP 60 recommendations and BSS is not complete in some countries. Contracting Parties reported on their individual national regulatory strategies. Some Contracting Parties use probabilistic safety assessment (PSA) as an additional tool in optimizing their regulatory or inspection activities, and some use performance indicators, whether they be quantitative or qualitative, to monitor the safety of their nuclear installations. In discussions, comparison was made of the advantages and disadvantages of regulations that are detailed and prescriptive in nature as compared to less prescriptive, goal-oriented approaches and the complementary use of risk assessments. Contracting Parties agreed to review their experience and report at the next Review Meeting. All Contracting

75 FR 65485 - Sunshine Act Meeting

Science.gov (United States)

2010-10-25

... Asia-Pacific Economic Cooperation-- 33rd Transportation Working Group Meeting. 2. Commission Review of... Agreement, FMC Agreement No. 011223. 3. Staff Briefing Regarding China Maritime Regulatory Issues. Contact...

Improving nuclear regulatory effectiveness

International Nuclear Information System (INIS)

2001-01-01

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

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...

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

Science.gov (United States)

2010-09-09

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

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

Science.gov (United States)

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

2009-01-08

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

Managing Regulatory Body Competence

International Nuclear Information System (INIS)

2013-01-01

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

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...

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

Meetings and meeting modeling in smart surroundings

NARCIS (Netherlands)

op den Akker, Hendrikus J.A.; Heylen, Dirk K.J.; Nijholt, Antinus; Nishida, T.

2004-01-01

In this paper we survey our research on smart meeting rooms and its relevance for augmented reality meeting support and virtual reality generation of meetings in real-time or off-line. Intelligent real-time and off-line generation requires understanding of what is going on during a meeting. The

A regulatory adjustment process for the determination of the optimal percentage requirement in an electricity market with Tradable Green Certificates

International Nuclear Information System (INIS)

Currier, Kevin M.

2013-01-01

A system of Tradable Green Certificates (TGCs) is a market-based subsidy scheme designed to promote electricity generation from renewable energy sources such as wind power. Under a TGC system, the principal policy instrument is the “percentage requirement,” which stipulates the percentage of total electricity production (“green” plus “black”) that must be obtained from renewable sources. In this paper, we propose a regulatory adjustment process that a regulator can employ to determine the socially optimal percentage requirement, explicitly accounting for environmental damages resulting from black electricity generation. - Highlights: • A Tradable Green Certificate (TGC) system promotes energy production from renewable sources. • We consider an electricity oligopoly operated under a TGC system. • Welfare analysis must account for damages from “black” electricity production. • We characterize the welfare maximizing (optimal) “percentage requirement.” • We present a regulatory adjustment process that computes the optimal percentage requirement iteratively

Review of voluntary and regulatory carbon reporting by companies around the world

International Nuclear Information System (INIS)

Borie, Sylvain; Decq, Juliette; Wang, Xin; Alberola, Emilie; Afriat, Marion; Gourdon, Thomas

2016-01-01

What countries have instituted regulations requiring companies to measure their greenhouse gas (GHG) emissions? How could these regulations be strengthened to help meet the '2 deg. C' goal adopted by all member countries at the COP21 summit? In what ways do new French regulations on reporting of significant GHG emissions constitute a major advance in carbon reporting? To complement recent news focusing on reporting of carbon emissions in France, Carbone 4 offers its readers this review to put voluntary and regulatory carbon reporting mechanisms used by companies in a global perspective

Economics of the specification 6M safety re-evaluation and regulatory requirements

International Nuclear Information System (INIS)

Hopper, C.M.

1985-01-01

The objective of this work was to examine the potential economic impact of the DOT Specification 6M criticality safety re-evaluation and regulatory requirements. The examination was based upon comparative analyses of current authorized fissile material load limits for the 6M, current Federal regulations (and interpretations) limiting the contents of Type B fissile material packages, limiting aggregates of fissile material packages, and recent proposed fissile material mass limits derived from specialized criticality safety analyses of the 6M package. The work examines influences on cost in transportation, handling, and storage of fissile materials. Depending upon facility throughput requirements (and assumed incremental costs of fissile material packaging, storage, and transport), operating, facility storage capacity, and transportation costs can be reduced significantly. As an example of the pricing algorithm application based upon reasonable cost influences, the magnitude of the first year cost reductions could extend beyond four times the cost of the packaging nuclear criticality safety re-evaluation. 1 tab

40 CFR 63.11088 - What requirements must I meet for gasoline loading racks if my facility is a bulk gasoline...

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 14 2010-07-01 2010-07-01 false What requirements must I meet for gasoline loading racks if my facility is a bulk gasoline terminal, pipeline breakout station, or pipeline... § 63.11088 What requirements must I meet for gasoline loading racks if my facility is a bulk gasoline...

Exploring self-regulatory strategies for eating behaviour in Danish adolescents

DEFF Research Database (Denmark)

Nureeva, Liliya; Brunsø, Karen; Lähteenmäki, Liisa

2016-01-01

– Focusing on improving adolescents’ self-regulatory skills in the domain of eating behaviour is a promising approach in developing future interventions. Originality/value – The present article explores self-regulatory strategies for eating behaviour in adolescence and discusses their relevance.......Purpose – Healthy eating behaviour in adolescence may be negatively affected by lack of self-regulation. The purpose of this paper is to discuss strategies for regulating eating behaviour as formulated by adolescents themselves. Design/methodology/approach – Self-regulatory strategies were elicited...... with concept mapping, which is a group-based method. Three meetings were conducted with each of four school classes in Denmark. Participants in the 12-15-year age group were recruited for the study. At the first meeting, participants had to complete the phrase “Things I can do to ensure my healthy eating are...

Regulatory framework for nuclear power plant operation

International Nuclear Information System (INIS)

Perez Alcaniz, T.; Esteban Barriendos, M.

1995-01-01

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

Twenty-third water reactor safety information meeting. Volume 3, structural and seismic engineering, primary systems integrity, equipment operability and aging, ECCS strainer blockage research and regulatory issues

Energy Technology Data Exchange (ETDEWEB)

Monteleone, S. [comp.] [Brookhaven National Lab., Upton, NY (United States)

1996-03-01

This three-volume report contains papers presented at the Twenty- Third Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, October 23-25, 1995. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Italy, Japan, Norway, Russia, Sweden, and Switzerland. This document, Volume 3, presents topics in Structural & Seismic Engineering, Primary Systems Integrity, Equipment Operability and Aging, and ECCS Strainer Blockage Research & Regulatory Issues. Individual papers have been cataloged separately.

Twenty-third water reactor safety information meeting. Volume 3, structural and seismic engineering, primary systems integrity, equipment operability and aging, ECCS strainer blockage research and regulatory issues

International Nuclear Information System (INIS)

Monteleone, S.

1996-03-01

This three-volume report contains papers presented at the Twenty- Third Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, October 23-25, 1995. The papers are printed in the order of their presentation in each session and describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included papers presented by researchers from France, Italy, Japan, Norway, Russia, Sweden, and Switzerland. This document, Volume 3, presents topics in Structural ampersand Seismic Engineering, Primary Systems Integrity, Equipment Operability and Aging, and ECCS Strainer Blockage Research ampersand Regulatory Issues. Individual papers have been cataloged separately

Requirements for growth and IL-10 expression of highly purified human T regulatory cells

OpenAIRE

Bonacci, Benedetta; Edwards, Brandon; Jia, Shuang; Williams, Calvin; Hessner, Martin J.; Gauld, Stephen; Verbsky, James

2012-01-01

Human regulatory T cells (TR) cells have potential for the treatment of a variety of immune mediated diseases but the anergic phenotype of these cells makes them difficult to expand in vitro. We have examined the requirements for growth and cytokine expression from highly purified human TR cells, and correlated these findings with the signal transduction events of these cells. We demonstrate that these cells do not proliferate or secrete IL-10 even in the presence of high doses of IL-2. Stimu...

Lessons learned from the Fukushima Dai-ichi accident and responses in NRA regulatory requirements

International Nuclear Information System (INIS)

Fuketa, Toyoshi

2014-01-01

The author would like to present significant lessons learned from the TEPCO’s Fukushima Dai-ichi accident and responses in regulatory requirements developed by the Nuclear Regulation Authority for power-producing light water reactors. The presentation will cover prevention of structures, systems and components failures, measures to prevent common cause failures, prevention of core damage, mitigation of severe accidents, emergency preparedness, continuous improvement of safety, use of probabilistic risk assessment, and post-accident regulation on the Fukushima Dai-ichi. (author)

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

Science.gov (United States)

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

2017-10-01

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

Prediction of adaptive self-regulatory responses to arthritis pain anxiety in exercising adults: does pain acceptance matter?

Science.gov (United States)

Cary, Miranda Ashley; Gyurcsik, Nancy C; Brawley, Lawrence R

2015-01-01

Exercising for ≥ 150 min/week is a recommended strategy for self-managing arthritis. However, exercise nonadherence is a problem. Arthritis pain anxiety may interfere with regular exercise. According to the fear-avoidance model, individuals may confront their pain anxiety by using adaptive self-regulatory responses (eg, changing exercise type or duration). Furthermore, the anxiety-self-regulatory responses relationship may vary as a function of individuals' pain acceptance levels. To investigate pain acceptance as a moderator of the pain anxiety-adaptive self-regulatory responses relationship. The secondary objective was to examine whether groups of patients who differed in meeting exercise recommendations also differed in pain-related and self-regulatory responses. Adults (mean [± SD] age 49.75 ± 13.88 years) with medically diagnosed arthritis completed online measures of arthritis pain-related variables and self-regulatory responses at baseline, and exercise participation two weeks later. Individuals meeting (n=87) and not meeting (n=49) exercise recommendations were identified. Hierarchical multiple regression analysis revealed that pain acceptance moderated the anxiety-adaptive self-regulatory responses relationship. When pain anxiety was lower, greater pain acceptance was associated with less frequent use of adaptive responses. When anxiety was higher, adaptive responses were used regardless of pain acceptance level. MANOVA findings revealed that participants meeting the recommended exercise dose reported significantly lower pain and pain anxiety, and greater pain acceptance (Pself-regulatory capacity to cope with additional challenges to exercise adherence (eg, busy schedule).

[Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

Science.gov (United States)

Kuhlmann-Gottke, Johanna; Duchow, Karin

2015-11-01

At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

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)

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2013-05-01

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

Development of regulatory policy for SMART-P

Energy Technology Data Exchange (ETDEWEB)

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

2004-06-15

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

Development of regulatory policy for SMART-P

Energy Technology Data Exchange (ETDEWEB)

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

2003-06-15

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

75 FR 41858 - Notice of FERC Staff Attendance at the Southwest Power Pool ICT Stakeholder Policy Committee Meeting

Science.gov (United States)

2010-07-19

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of FERC Staff Attendance at the Southwest Power Pool ICT Stakeholder Policy Committee Meeting July 12, 2010. The Federal Energy Regulatory... is part of the Commission's ongoing outreach efforts. ICT Stakeholder Policy Committee Meeting July...

Regulatory requirements for groundwater monitoring networks at hazardous waste sites

International Nuclear Information System (INIS)

Keller, J.F.

1989-10-01

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

14 CFR 61.311 - What flight proficiency requirements must I meet to apply for a sport pilot certificate?

Science.gov (United States)

2010-01-01

... meet to apply for a sport pilot certificate? 61.311 Section 61.311 Aeronautics and Space FEDERAL... INSTRUCTORS, AND GROUND INSTRUCTORS Sport Pilots § 61.311 What flight proficiency requirements must I meet to apply for a sport pilot certificate? Except as specified in § 61.329, to apply for a sport pilot...

Multi-component nuclear energy system to meet requirement of self-consistency

International Nuclear Information System (INIS)

Saito, Masaki; Artisyuk, Vladimir; Shmelev, Anotolii; Korovin, Yorii

2000-01-01

Environmental harmonization of nuclear energy technology is considered as an absolutely necessary condition in its future successful development for peaceful use. Establishment of Self-Consistent Nuclear Energy System, that simultaneously meets four requirements - energy production, fuel production, burning of radionuclides and safety, strongly relies on the neutron excess generation. Implementation of external non-fission based neutron sources into fission energy system would open the possibility of approaching Multicomponent Self-Consistent Nuclear Energy System with unlimited fuel resources, zero radioactivity release and high protection against uncontrolled proliferation of nuclear materials. (author)

Regulatory body core competencies: when should a regulator contract a TSO?

International Nuclear Information System (INIS)

Wieland, Patricia; Salati de Almeida, Ivan P.; Almeida, Claudio U.; Costa, Eduardo M.

2008-01-01

The main nuclear regulatory functions are authorization, safety review and assessment, inspection and enforcement and development of regulations and guides. Additionally, the following supplementary functions may be executed by the regulatory body: research and development, emergency response and international cooperation. In order to function properly, the regulatory body should also have the following support functions: general management, logistics, training, communication and information, information technology support, institutional relationship, internal controls and audits, ombudsman and legal support. Technical Support Organizations (TSOs) may assist the regulatory body in meeting the challenges in a rapid growing and changing environment. Specially when there is a temporary need for a wider technical expertise diversity, short time to finish a project or when the cost of developing and maintaining infrastructure of their own laboratories for analysis and research is too high and may deviate the focus on the regulator's mission. Decision on the 'size' of the regulatory body and on what can be contracted to a Technical Support Organization (TSO) depends on the resources and capabilities needed to fulfil the regulatory functions efficiently. It is important to establish the core competencies that must be at the regulatory body, keeping the focus on the regulatory goals and define the real need to contract a TSO, weighting the benefits and disadvantages. As a contribution to the definition of the regulatory core competencies, the paper discusses what is essential to be kept at the regulatory body and what can be delegated to a TSO; how to manage and control the work of the TSO; the cost effectiveness of contracting, sharing of tacit knowledge; how to handle eventual conflicts between the parties involved in the licensing process; contract types and risk evaluation, concerning the dependence on a TSO, eventual change of partners and the intellectual capital

Proceedings of a specialist meeting on boron reactivity transients

Energy Technology Data Exchange (ETDEWEB)

NONE

1996-07-01

The CSNI Specialist Meeting on Boron Dilution Reactivity Transients was hosted by the Penn State University in collaboration with the US Nuclear Regulatory Commission and the TRAC Users Group. More than 70 experts from 12 OECD countries, as well as experts from Russia and other non-OECD countries attended the meeting. Thirty papers were presented in five technical sessions. The purpose of the meeting was to bring together experts involved in the different activities related to boron dilution transients. The experts came from all involved parties, including research organizations, regulatory authorities, vendors and utilities. Information was openly shared and discussed on the experimental results, plant and systems analysis, numerical analysis of mixing and probability and consequences of these transients. Regulatory background and licensing implications were also included to provide the proper frame work for the technical discussion. Each of these areas corresponded to a separate session. The meeting focused on the thermal-hydraulic aspects because of the current interest in that subject and the significant amount of new technical information being generated. Three papers of the same conference are already available in INIS as individual reports: Potential for boron dilution during small-break LOCAs in PWRs (Ref. number: 27029412); Analysis of boron dilution in a four-loop PWR (Ref. number: 27051651); Probability and consequences of a rapid boron dilution sequence in a PWR (Ref. number: 27029411)

78 FR 44275 - Semiannual Regulatory Agenda

Science.gov (United States)

2013-07-23

... Rights. National Park Service--Completed Actions Regulation Sequence No. Title Identifier No. 200 Winter.... Timetable: Action Date FR Cite NPRM 07/00/13 Final Action 05/00/14 Regulatory Flexibility Analysis Required...: Action Date FR Cite NPRM 10/00/14 Final Action 10/00/14 Regulatory Flexibility Analysis Required: Yes...

Meeting the regulatory challenges of mixed waste storage and monitoring: A novel approach

International Nuclear Information System (INIS)

Wilkinson, Dennis; Shaw, Mark

1992-01-01

This paper describes an original approach to providing safe storage of Remote Handled TRU Mixed Waste that is required to meet the EPA double liner and leachate collection system standards. This system, known as the 'Environmental Vault Liner', also allows a cost effective means of complying with the EPA's inspection requirements per 40 CFR 265.170, Use and Management of Containers. This approach is modular in nature, allowing additional storage capacity to be added on a demand basis, thereby eliminating significant upfront costs associated with large storage facilities built on estimated needs over many years. It reduces the financial and technical risks associated with large storage construction projects, allows modifications to new Liners put into service based on changing regulations and technologies. The Environmental Vault Liner offers additional benefits including easy waste retrieval, a 300 year design life, continuous below ground liquid detection and monitoring, replaceable instrumentation, inert (Nitrogen) atmosphere for container storage, continuous air monitoring, and remote visual container inspections. (author)

31 CFR 30.11 - Q-11: Are TARP recipients required to meet any other standards under the executive compensation...

Science.gov (United States)

2010-07-01

... meet any other standards under the executive compensation and corporate governance standards in section... TARP STANDARDS FOR COMPENSATION AND CORPORATE GOVERNANCE § 30.11 Q-11: Are TARP recipients required to meet any other standards under the executive compensation and corporate governance standards in section...

Establishment of an unrelated umbilical cord blood bank qualification program: ensuring quality while meeting Food and Drug Administration vendor qualification requirements.

Science.gov (United States)

Rabe, Fran; Kadidlo, Diane; Van Orsow, Lisa; McKenna, David

2013-10-01

Qualification of a cord blood bank (CBB) is a complex process that includes evaluation of multiple aspects of donor screening and testing, processing, accreditation and approval by professional cell therapy groups, and results of received cord blood units. The University of Minnesota Medical Center Cell Therapy Laboratory has established a CBB vendor qualification process to ensure the CBB meets established regulatory and quality requirements. The deployed qualification of CBBs is based on retrospective and prospective review of the CBB. Forty-one CBBs were evaluated retrospectively: seven CBBs were disqualified based on failed quality control (QC) results. Eight CBBs did not meet the criteria for retrospective qualification because fewer than 3 cord blood units were received and the CBB was not accredited. As of March 2012, three US and one non-US CBBs have been qualified prospectively. One CBB withdrew from the qualification process after successful completion of the comprehensive survey and subsequent failure of the provided QC unit to pass the minimum criteria. One CBB failed the prospective qualification process based on processing methods that were revealed during the paper portion of the evaluation. A CBB qualification process is necessary for a transplant center to manage the qualification of the large number of CBBs needed to support a umbilical cord blood transplantation program. A transplant center that has utilized cord blood for a number of years before implementation of a qualification process should use a retrospective qualification process along with a prospective process. © 2013 American Association of Blood Banks.

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

International Nuclear Information System (INIS)

Dory, A.B.

1981-10-01

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

Safety Committees for Argentinean Research Reactor - Regulatory Issues

International Nuclear Information System (INIS)

Perrin, Carlos D.

2009-01-01

In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)

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

78 FR 49750 - FIFRA Scientific Advisory Panel; Notice of Public Meeting

Science.gov (United States)

2013-08-15

... sequence-specific degradation of an RNA. The EPA is beginning to receive applications for regulatory... impact of regulatory actions on health and the environment. FIFRA SAP is a Federal Advisory Committee... the Agency. B. Public Meeting The use of RNA Interference (RNAi) gene silencing technology...

Design reviews from a regulatory perspective

International Nuclear Information System (INIS)

Foster, B.D.

1991-01-01

This paper presents views on the role of the licensing engineer in the design process with specific emphasis on design reviews and the automated information management tools that support design reviews. The licensing engineer is seen as an important member of a design review team. The initial focus of the licensing engineer during design reviews is shown to be on ensuring that applicable regulatory requirements are addressed by the design. The utility of an automated tool, such as a commitments management system, to support regulatory requirements identification is discussed. The next responsibility of the licensing engineer is seen as verifying that regulatory requirements are transformed into measurable performance requirements. Performance requirements are shown to provide the basis for developing detailed design review criteria. Licensing engineer input during design reviews is discussed. This input is shown to be especially critical in cases where review findings may impact application of regulatory requirements. The use of automated tools in supporting design reviews is discussed. An information structure is proposed to support design reviews in a regulated environment. This information structure is shown to be useful to activities beyond design reviews. Incorporation of the proposed information structure into the Licensing Support System is proposed

Regulatory Activities for Licensee's Safety Culture

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik

2008-01-01

Weaknesses in safety culture have contributed to a number of incidents/accidents in the nuclear and other high hazard sectors worldwide in the past. These events have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining regulatory oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. This paper presents the findings, conclusions and recommendations of international meetings and other countries' activities on safety culture and gives some suggestions for regulators to consider when planning regulatory oversight for licensee's safety culture

Regulatory requirements for fluorine 18-labelled radiotracers

International Nuclear Information System (INIS)

Prigent, A.

2005-01-01

Although European and French regulations define radiopharmaceuticals and their different conditions for use, there is no legal status of the radiotracer. Radiotracer is commonly known as a molecular entity administered in tracer doses, that means at very low masses (e.g., nano-mol amounts) and, consequently, without any pharmacological effect. A radiotracer can meet the specifications of either a radiochemical (usually restricted to research in animal models) or a radiopharmaceutical (human use for diagnostic imaging or research projects). Besides the 'proprietary medicinal product', different status have been defined to allow other uses in humans, referring to 'magistral formula' preparation, 'officinal formula' preparation, investigational medicinal product for clinical trials, or to a radiopharmaceutical with a 'patient named authorization'. However, because of the short half-life of fluorine 18 and expanding development of molecular imaging techniques using positron emission tomography (PET), the current regulation is sometimes considered as inappropriate with regard to the small-size production required for such on-site manufactured radiopharmaceuticals. It is often claimed that it could be very difficult to comply with the current Good Manufactured Practice (cGMP). As previously done for radiopharmaceuticals based on monoclonal antibodies, specific adjustments for PET radiopharmaceuticals are under discussion and the 'note for guidance on radiopharmaceuticals' will be soon revised by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA). In many cases, a status of 'magistral' product might be attributed to a PET radiopharmaceutical manufactured according with European Pharmacopoeia monographs. (author)

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

Science.gov (United States)

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

2010-01-01

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

75 FR 40816 - Northern Illinois Hydropower, LLC; Notice of Meeting

Science.gov (United States)

2010-07-14

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12626-002; Project No. 12717-002] Northern Illinois Hydropower, LLC; Notice of Meeting July 7, 2010. a. Date and Time of Meeting: Thursday, July 22, 2010 from 9 a.m. to 12 p.m. CDT. b. Place: Illinois Historic Preservation...

77 FR 27451 - Boott Hydropower, Inc.; Notice of Section 106 Consultation Meeting

Science.gov (United States)

2012-05-10

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2790-055] Boott Hydropower, Inc.; Notice of Section 106 Consultation Meeting On May 24, 2012, Federal Energy Regulatory Commission... Historic Preservation, Boott Hydropower, Inc., and any other consulting parties for the section 106 process...

40 CFR 267.174 - What special requirements must I meet for ignitable or reactive waste?

Science.gov (United States)

2010-07-01

... 40 Protection of Environment 26 2010-07-01 2010-07-01 false What special requirements must I meet for ignitable or reactive waste? 267.174 Section 267.174 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) SOLID WASTES (CONTINUED) STANDARDS FOR OWNERS AND OPERATORS OF HAZARDOUS WASTE...

Regulatory science requirements of labeling of genetically modified food.

Science.gov (United States)

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

2018-05-01

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

Regulatory compliance in the design of packages used to transport radioactive materials

International Nuclear Information System (INIS)

Raske, D.T.

1993-01-01

Shipments of radioactive materials within the regulatory jurisdiction of the US Department of Energy (DOE) must meet the package design requirements contained in Title 10 of the Code of Federal Regulations, Part 71, and DOE Order 5480.3. These regulations do not provide design criteria requirements, but only detail the approval standards, structural performance criteria, and package integrity requirements that must be met during transport. The DOE recommended design criterion for high-level Category I radioactive packagings is Section III, Division 1, of the ASME Boiler and Pressure Vessel Code. However, alternative design criteria may be used if all the design requirements are satisfied. The purpose of this paper is to review alternatives to the Code criteria and discuss their applicability to the design of containment vessels in packages for high-level radioactive materials. Issues such as design qualification by physical testing, the use of scale models, and problems encountered using a non-ASME design approach are addressed

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

75 FR 54221 - Government/Industry Aeronautical Charting Forum Meeting

Science.gov (United States)

2010-09-03

... Aeronautical Navigation Services (AeroNav Services) Group, Regulatory Support and Coordination Team, AJW-372...: The ACF is separated into two distinct groups. The Instrument Procedures Group (IPG) will meet October 26, 2010 from 8:30 a.m. to 5 p.m. The Charting Group will meet October 27 and 28, 2010 from 8:30 a.m...

76 FR 12211 - Government/Industry Aeronautical Charting Forum Meeting

Science.gov (United States)

2011-03-04

... Aeronautical Navigation Products Group (AeroNav Products), Regulatory Support and Coordination Team, AJV-3B...: The ACF is separated into two distinct groups. The Instrument Procedures Group (IPG) will meet April 26, 2011 from 8:30 a.m. to 5 p.m. The Charting Group will meet April 27 and 28, 2011 from 8:30 a.m...

Regulatory requirements on management of radioactive material safe transport in China

International Nuclear Information System (INIS)

Chu, C.

2016-01-01

Since 1980s, the IAEA Regulation for safe transport of radioactive material was introduced into China; the regulatory system of China began with international standards, and walked towards the institutionalized. In 2003 the National People’s Congress (NPC) promulgated “the Act on the Prevention of Radioactive Pollution of the People's Republic of China”. In 2009 “Regulation for the Safe Transport of Radioactive Material” (Referred to “Regulation”) was promulgated by the State Council. Subsequently, the National Nuclear Safety Administration (NNSA) began to formulate executive detailed department rules, regulations guidelines and standards. The present system of acts, regulations and standards on management of safe transport of radioactive material in China and future planning were introduced in this paper. Meanwhile, the paper described the specific administration requirements of the Regulation on classification management of radioactive materials, license management of transport packaging including design, manufacture and use, licensing management of transport activities and the provisions of illegal behaviors arising in safe transport of radioactive material. (author)

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

Risk-based Regulatory Evaluation Program methodology

International Nuclear Information System (INIS)

DuCharme, A.R.; Sanders, G.A.; Carlson, D.D.; Asselin, S.V.

1987-01-01

The objectives of this DOE-supported Regulatory Evaluation Progrwam are to analyze and evaluate the safety importance and economic significance of existing regulatory guidance in order to assist in the improvement of the regulatory process for current generation and future design reactors. A risk-based cost-benefit methodology was developed to evaluate the safety benefit and cost of specific regulations or Standard Review Plan sections. Risk-based methods can be used in lieu of or in combination with deterministic methods in developing regulatory requirements and reaching regulatory decisions

26 CFR 1.857-4 - Tax imposed by reason of the failure to meet certain source-of-income requirements.

Science.gov (United States)

2010-04-01

..., DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Real Estate Investment Trusts § 1.857-4 Tax imposed by reason of the failure to meet certain source-of-income requirements. Section 857... 26 Internal Revenue 9 2010-04-01 2010-04-01 false Tax imposed by reason of the failure to meet...

45 CFR 263.1 - How much State money must a State expend annually to meet the basic MOE requirement?

Science.gov (United States)

2010-10-01

... 45 Public Welfare 2 2010-10-01 2010-10-01 false How much State money must a State expend annually... State's Maintenance of Effort? § 263.1 How much State money must a State expend annually to meet the... historic State expenditures. (2) However, if a State meets the minimum work participation rate requirements...

Research reactor instrumentation and control technology. Report of a technical committee meeting

International Nuclear Information System (INIS)

1997-10-01

The majority of research reactors operating today were put into operation 20 years ago, and some of them underwent modifications, upgrading and refurbishing since their construction to meet the requirements for higher neutron fluxes. However, a few of these ageing research reactors are still operating with their original instrumentation and control systems (I and C) which are important for reactor safety to guard against abnormal occurrences and reactor control involving startup, shutdown and power regulation. Worn and obsolete I and C systems cause operational problems as well as difficulties in obtaining replacement parts. In addition, satisfying the stringent safety conditions laid out by the nuclear regulatory bodies requires the modernization of research reactors I and C systems and integration of additional instrumentation units to the reactor. In order to clarify these issues and to provide some guidance to reactor operators on state-of-art technology and future trends for the I and C systems for research reactors, a Technical Committee Meeting on Technology and Trends for Research Reactor Instrumentation and Controls was held in Ljubljana, Slovenia, from 4 to 8 December 1995. This publication summarizes the discussions and recommendations resulting from that meeting. This is expected to benefit the research reactor operators planning I and C improvements. Refs, figs, tabs

Global Regulatory Differences for Gene- and Cell-Based Therapies

DEFF Research Database (Denmark)

Coppens, Delphi G M; De Bruin, Marie L; Leufkens, Hubert G M

2017-01-01

Gene- and cell-based therapies (GCTs) offer potential new treatment options for unmet medical needs. However, the use of conventional regulatory requirements for medicinal products to approve GCTs may impede patient access and therapeutic innovation. Furthermore, requirements differ between...... jurisdictions, complicating the global regulatory landscape. We provide a comparative overview of regulatory requirements for GCT approval in five jurisdictions and hypothesize on the consequences of the observed global differences on patient access and therapeutic innovation....

NRC regulatory agenda

International Nuclear Information System (INIS)

1993-07-01

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

Legislative framework and regulatory requirements for the introduction of nuclear power

International Nuclear Information System (INIS)

Ha-Vinh, Phuong

1975-01-01

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

77 FR 28595 - Sunshine Act Meeting Notice

Science.gov (United States)

2012-05-15

... Power Cooperative; Great River Energy; Hoosier Energy Rural Electric Cooperative, Inc.; Indiana...-000 National Grid Transmission Services Corporation and Bangor Hydro Electric Company. Hydro H-1 P... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice The...

Approach of Czech regulatory body to LBB

Energy Technology Data Exchange (ETDEWEB)

Tendera, P.

1997-04-01

At present there are two NPPs equipped with PWR units in Czech Republic. The Dukovany, NPP is about ten years in operation (four units 440 MW - WWBFL model 213) and Tomelin NPP is under construction (two units 1000 MW - WWER model 320). Both NPPs were built to Soviet design and according to Soviet regulations and standards but most of equipment for primary circuits was supplied by home manufacturers. The objective of the Czech LBB program is to prove the LBB status of the primary piping systems of there NPPs and the LBB concept is a part of strategy to meet western style safety standards. The reason for the Czech LBB project is a lack of some standard safety Facilities too. For both Dukovany and Tomelin NPPs a full LBB analysis should be carried out. The application of LBB to the piping system should be also a cost effective means to avoid installations of pipe whip restraints and jet shields. The Czech regulatory body issued non-mandatory requirement, {open_quotes}Leak Before Break{close_quotes} which is in compliance with national legal documents and which is based on the US NRC Regulatory Procedures and US standards (ASMF CODE, ANSI). The requirement has been published in the document {open_quotes}Safety of Nuclear Facilities{close_quotes} No 1/1991 as {open_quotes}Requirements on the Content and Format of Safety Reports and their Supplements{close_quote} and consist of two parts (1) procedure for obtaining proof of evidence {open_quotes}Leak Before Break{close_quotes} (2) leak detection systems for the pressurized reactor primary circuit. At present some changes concerning both parts of the above document will be introduced. The reasons for this modifications will be presented.

Approach for Czech regulatory body to LBB

Energy Technology Data Exchange (ETDEWEB)

Tendera, P. [State Office for Nuclear Safety (SONS), Prague (Czech Republic)

1997-04-01

At present there are two NPPs equipped with PWR units in Czech Republic. The Dukovany NPP is about ten years in operation (four units 440 MW - WWER model 213) and Temelin NPP is under construction (two units 1000 MW-WWER model 320). Both NPPs were built to Soviet design and according to Soviet regulations and standards but most of equipment for primary circuits was supplied by home manufactures. The objective for the Czech LBB programme is to prove the LBB status of the primary piping systems of these NPPs and the LBB concept is a part of strategy to meet western style safety standards. The reason for the Czech LBB project is a lack of some standard safety facilities, too. For both Dukovany and Temolin NPPs a full LBB analysis should be carried out. The application of LBB to the piping system should be also a cost effective means to avoid installations of pipe whip restraints and jet shields. The Czech regulatory body issued non-mandatory requirement {open_quotes}Leak Before Break{close_quotes} which is in compliance with national legal documents and which is based on the US NRC Regulatory Procedures and US standards (ASME, CODE, ANSI). The requirement has been published in the document {open_quotes}Safety of Nuclear Facilities{close_quotes} No. 1/1991 as {open_quotes}Requirements on the Content and Format of Safety Reports and their Supplements{close_quotes} and consists of two parts (1) procedure for obtaining proof of evidence {open_quotes}Leak Before Break{close_quotes} (2) leak detection systems for the pressurized reactor primary circuit. At present some changes concerning both parts of the above document will be introduced. The reasons for this modifications will be presented.

77 FR 46528 - Sunshine Act Meeting

Science.gov (United States)

2012-08-03

...: Nuclear Regulatory Commission. DATES: Week of August 6, 2012. PLACE: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland. STATUS: Public and Closed. ADDITIONAL ITEMS TO BE CONSIDERED: Week of... Proceeding (June 18, 2012) (Tentative). This meeting will be webcast live at the Web address--www.nrc.gov...

Regulatory systems-based licensing guidance documentation

International Nuclear Information System (INIS)

Delligatti, M.S.

1991-01-01

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

40 CFR 267.202 - What special requirements must I meet for ignitable or reactive wastes?

Science.gov (United States)

2010-07-01

... material no longer meets the definition of ignitable or reactive waste under § 261.21 or § 261.23 of this... requirements for the maintenance of protective distances between the waste management area and any public ways... for ignitable or reactive wastes? 267.202 Section 267.202 Protection of Environment ENVIRONMENTAL...

Pesticide Program Dialogue Committee and Pesticide Regulatory Reform Meetings

Science.gov (United States)

EPA’s Office of Pesticide Programs will hold a public meeting of the Pesticide Program Dialogue Committee (PPDC) on Wednesday, May 3, from 9:00 a.m. to 4:45 p.m., and on Thursday, May 4, from 8:30 a.m. to noon.

The legal, regulatory and safety basis for opening WIPP

International Nuclear Information System (INIS)

Dials, G.E.

1997-01-01

Current laws in the United States of America direct the U.S. Department of Energy (DOE) to site, design, operate, and decommission a deep geological repository for safe disposal of transuranic radioactive waste (TRUW) at the Waste Isolation Pilot Plant (WIPP) site. In 1993, the DOE established the Carlsbad Area Office (CAO) to integrate the nation's management of TRUW and to open the WIPP site for safe disposal of TRUW in compliance with applicable laws and regulations. The CAO submitted the final Compliance Certification Application (CCA) in 1996, and is on schedule to open WIPP in November 1997, about three years earlier than scheduled before the establishment of the CAO. The performance assessment (PA) embodied in the CCA demonstrates that WIPP meets the EPA's regulatory requirements for radioactive releases for the 10,000 year regulatory period in both the undisturbed and disturbed (human intrusion) scenarios. Detailed planning, compliance-based research and development (R and D), teamwork among project participants and early and open iterative interactions with the regulators, oversight groups and other interested parties in the certification/permitting process are key components of the progress in the safe disposal of long-lived radioactive wastes. (author)

Quality assurance within regulatory bodies

International Nuclear Information System (INIS)

1999-06-01

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

Nuclear Regulatory Commission: more aggressive leadership needed

International Nuclear Information System (INIS)

Staats, E.B.

1980-01-01

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

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

Energy Technology Data Exchange (ETDEWEB)

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

2016-11-15

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

Evaluation of research reactor fuel reliability in support of regulatory requirements

International Nuclear Information System (INIS)

Sokolov, Eugene N.

2005-01-01

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

Evaluation of research reactor fuel reliability in support of regulatory requirements

Energy Technology Data Exchange (ETDEWEB)

Sokolov, Eugene N [Chalk River Laboratories, AECL, Chalk River, ON, K0J 1J0 (Canada)

2005-07-01

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

76 FR 45249 - Fairlawn Hydroelectric Company, LLC; Notice of Public Meeting

Science.gov (United States)

2011-07-28

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 12715-003] Fairlawn Hydroelectric Company, LLC; Notice of Public Meeting On August 5, 2011, Office of Energy Projects staff may participate in a public meeting hosted by the U.S. Army Corps of Engineers, Baltimore District (Corps) for the...

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

International Nuclear Information System (INIS)

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

1997-01-01

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

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

International Nuclear Information System (INIS)

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

1997-01-01

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

78 FR 19332 - Sunshine Act Meeting

Science.gov (United States)

2013-03-29

...: Nuclear Regulatory Commission. DATE: Week of April 1, 2013 PLACE: Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland STATUS: Public and Closed Week of April 1, 2013--Tentative Tuesday April... the Shaw Group, Inc. (Tentative) This meeting will be webcast live at the Web address-- www.nrc.gov...

LLW Forum meeting report, May 7--9, 1997

International Nuclear Information System (INIS)

Norris, C.; Brown, H.; Lovinger, T.; Scheele, L.; Shaker, M.A.

1997-05-01

The Low-Level Radioactive Waste Forum met in Chicago, Illinois, on may 7--9, 1997. Twenty-three Forum Participants, Alternate Forum Participants, and meeting designees representing 20 compacts and states participated. A report on the meeting is given under the following subtitles: New developments in states and compacts; Upgrading an existing disposal facility; Revisions to DOE Order 5820 re DOE waste management; Conference of radiation control program directors: Recent and upcoming activities; National Conference of State Legislatures' (NCSL) low-level radioactive waste working group: Recent and upcoming activities; Executive session; LLW forum business session; Public involvement and risk communication: Success at West Valley, New York; DOE low-level waste management program; impact of the International Atomic Energy Agency's convention on waste; Panel discussion: The environmental justice concept--Past, present and future; New technologies for processing and disposal of LLRW; High-level and low-level radioactive waste: A dialogue on parallels and intersections; Draft agreement re uniform application of manifesting procedures; Regulatory issues focus; LLW forum October 1997 agenda planning; Resolutions; LLW forum regulatory issues discussion group meets; and Attendance

47 CFR 1.1160 - Refunds of regulatory fees.

Science.gov (United States)

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Refunds of regulatory fees. 1.1160 Section 1... Statutory Charges and Procedures for Payment § 1.1160 Refunds of regulatory fees. (a) Regulatory fees will be refunded, upon request, only in the following instances: (1) When no regulatory fee is required or...

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.)

On meeting capital requirements with a chance-constrained optimization model.

Science.gov (United States)

Atta Mills, Ebenezer Fiifi Emire; Yu, Bo; Gu, Lanlan

2016-01-01

This paper deals with a capital to risk asset ratio chance-constrained optimization model in the presence of loans, treasury bill, fixed assets and non-interest earning assets. To model the dynamics of loans, we introduce a modified CreditMetrics approach. This leads to development of a deterministic convex counterpart of capital to risk asset ratio chance constraint. We pursue the scope of analyzing our model under the worst-case scenario i.e. loan default. The theoretical model is analyzed by applying numerical procedures, in order to administer valuable insights from a financial outlook. Our results suggest that, our capital to risk asset ratio chance-constrained optimization model guarantees banks of meeting capital requirements of Basel III with a likelihood of 95 % irrespective of changes in future market value of assets.

13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

Science.gov (United States)

2010-01-01

... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial Accounting Standards Board (FASB), supplemented by Regulatory Accounting Principles (RAP) as identified by... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and...

U.S. petroleum refining: Meeting requirements for cleaner fuels and refineries

International Nuclear Information System (INIS)

Warden, R.B.

1993-01-01

A review is presented of a study carried out by the National Petroleum Council that assessed the ability of the U.S. oil industry to manufacture and supply the quantity and quality of products required in the 1990s and beyond. The competitiveness of domestic supply vs product imports was analyzed and the investment requirements and other costs associated with meeting new environmental legislation and regulations on petroleum products and refineries were addressed. In particular, the requirements of the 1990 Clean Air Act Amendments and other environmental, health, and safety initiatives, both current and prospective, were evaluated. Refineries and the logistics system were studied but not crude oil supply or service stations. The costs of stationary source health, safety and environmental regulations and requirements were evaluated for the years 1995, 2000 and 2010, and sources of U.S. light products and U.S. refinery utilization were modelled for these years. Three demand scenarios were considered: growth, no-growth, and decline. Annual expenditures for health, safety and environment programs inside refineries are expected to double in the 1990s. Expenditures of $106 billion are projected over the period 1990-2010 for new facilities and programs necessary for current and anticipated stationary source regulations. Refining and logistics costs will increase substantially. Other conclusions related to capital expenditures, refining capability, product compatibility, oxygenates and foreign product supply cost are drawn. 26 figs

Towards an automated TLD system that meets international requirements

International Nuclear Information System (INIS)

Boetter-Jensen, L.; Vanamo, V.

1988-01-01

The new recently introduced fully automated TLD system developed by Alnor OY on the basis of the Riso prototype, is intended to meet draft IEC/ISO proposals and ANSI requirements. Part of the system is a personal dosemeter badge and an environmental dosemeter package following ICRU recommendations. The overall system consists of a software-controlled automated reader, a programable irradiator/calibrator, a computer, and dosemeters for environmental, whole body, extremity and clinical applications. The personal TLD badge that contains four TLD pellets is designed to agree with ICRU H p (10) and H s (0.07) quantities for determining dose equivalent. The badge can accommodate a large variety of the most commonly used solid TL dosemeter products. A special effort was put into the evaluation of skin dose by considering the use of graphite-mixed hot-sintered LiF pellets. The TLD system is described and results from a performance test that comprised measurements of photon energy response, angular dependence, and reproducibility are presented

Meeting the requirements for a DOE environmental restoration project. The Fernald strategy

International Nuclear Information System (INIS)

Vanoss, R.L.; Risenhoover, G.M.

1994-01-01

Environmental Restoration (ER) of five Operable Units (OU) at Fernald Environmental Management Project (FEMP) includes compliance with the requirements of Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), Resource Conservation Recovery Act (RCRA), National Environmental Policy Act (NEPA), and DOE Orders. Each regulatory driver has differing procedural requirements for documenting calculations, decisions, and actions involved in site cleanup. Integration of documentation and avoidance of duplication can save time and money. Such savings are being achieved by OU specific application of supporting studies, revised procedures, and guidance documents. Each OU is seeking appropriate opportunities to produce single documents that simultaneously fulfill the important requirements of the other regulations and DOE orders. These opportunities are evaluated at all phases of decision making, remedial design, and remedial action. Three essential processes precede environmental restoration/remedial action at a DOE site/project: 1. Completion of decision-making documents required by governing or applicable statutes. 2. Completion of important scientific and engineering analyses of remedial alternatives, and design and implementation of the remedial solution established in the CERCLA Record of Decision (ROD). 3. Preparation of DOE-mandated documentation to record engineering evaluations and cost estimates required for budgeting, decision making, and project management. Methodology and requirements for each process have developed from long, successful practice, but independently of each other. FERMCO, as new DOE contractor at Fernald and first Environmental Restoration Management Contractor (ERMC), is committed to a process of Continuous Performance Improvement (CPI). A major reevaluation of documentation and processes for support of environmental decision-making and design of cleanup activities to remediate the five OUs at the FEMP is being undertaken

Virginia Power's regulatory reduction program

International Nuclear Information System (INIS)

Miller, G.D.

1996-01-01

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

Nutrient fertilizer requirements for sustainable biomass supply to meet U.S. bioenergy goal

Energy Technology Data Exchange (ETDEWEB)

Han, Fengxiang X.; King, Roger L.; Lindner, Jeffrey S.; Monts, David L.; Su, Yi; Luthe, John C. [Institute for Clean Energy Technology, Mississippi State University, 205 Research Blvd., Starkville, MS 39759 (United States); Yu, Tzu-Yi [Department of Information Management, National Chi-Nan University, 470 University Rd., Puli, Nantou, 54561 Taiwan (China); Durbha, Surya S.; Younan, Nicolas H. [GeoResources Institute, Mississippi State University, Starkville, MS 39759 (United States); Plodinec, M. John [Savannah River National Laboratory, Bldg 773-A, Aiken, SC 29808 (United States)

2011-01-15

The U.S. Biomass Roadmap set forth a goal that, by the year 2030, biomass will supply energy approximately equivalent to 30% of current petroleum consumption. Here we report on the amount of nutrient fertilizers required to meet the proposed 1-billion tons of sustainable bioenergy biomass production annually. To meet this goal, U.S. agriculture (assuming a scenario with high yield increase and land use change) will have net removals of 40.3, 12.7, and 36.2 Tg (million tons) of N, P{sub 2}O{sub 5}, and K{sub 2}O, respectively. The 1-billion tons of bioenergy biomass production alone will remove 16.9, 5.2, and 18.2 Tg of N, P{sub 2}O{sub 5,} and K{sub 2}O, respectively, from U.S. agricultural land. Considering the efficiencies of fertilizers in soils and the contribution of biomass residuals in fields, the overall bioenergy-focused agriculture would require 58.2, 27.3, and 31.7 Tg of N, P{sub 2}O{sub 5,} and K{sub 2}O fertilizers, respectively; this corresponds to an overall nutrient fertilizer application increase by a factor of 5.5 over the base line (1997). This study indicates an increased need for domestic and/or international production facilities for fertilizers if the goal of the Biomass Roadmap is to be attained. (author)

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...

Food irradiation: regulatory aspects in the Asia and Pacific region

International Nuclear Information System (INIS)

Luckman, G.J.

2002-01-01

Irradiation treatment of food is becoming an increasingly accepted processing option for countries in the Asia Pacific region wishing to meet growing sanitary and phytosanitary requirements in international trade. There remain however, large differences between the regulatory requirements in the countries in this region. This paper gives an outline on existing food irradiation regulations in the separate countries of the Asia Pacific region. New developments such as the recent decision by the Australia New Zealand Food Authority to start assessing applications for food irradiation treatment are discussed. Australia's intention to regulate the export of food treated by irradiation will also be outlined. Details of the decision to harmonise food irradiation regulations by 13 countries in the Asia Pacific region based on conformance with Codex requirements is outlined. The likelihood of other Asia Pacific countries enacting similar harmonisation of their regulations will be examined. Future development such as certification of irradiation as a sanitary treatment for food are discussed. The expected result of these initiatives is a likely increase in irradiated foods traded within the Asia Pacific region

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

International Nuclear Information System (INIS)

Dverstorp, B.

2010-01-01

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

ENSI’s regulatory framework strategy

International Nuclear Information System (INIS)

2015-03-01

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

National legislative and regulatory activities

International Nuclear Information System (INIS)

2015-01-01

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

75 FR 51996 - Notice of Commission Staff Attendance at Midwest ISO Meetings

Science.gov (United States)

2010-08-24

... Midwest ISO Meetings August 16, 2010. The Federal Energy Regulatory Commission hereby gives notice that members of the Commission and Commission staff may attend the following Midwest ISO-related meetings...., St. Paul, MN) [cir] September 15 [cir] October 20 [cir] November 17 [cir] December 1 Midwest ISO...

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

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

Science.gov (United States)

Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

2007-09-01

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

76 FR 71013 - Sunshine Act Meeting Notice

Science.gov (United States)

2011-11-16

.......... North American Electric Reliability Corporation. E-6 RC11-1-001........ Cedar Creek Wind Energy, LLC...-2576-151........ FirstLight Hydro Generating Company. H-3 P-2601-015........ Duke Energy Carolinas, LLC... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Sunshine Act Meeting Notice November 10...

14 CFR 313.4 - Major regulatory actions.

Science.gov (United States)

2010-01-01

...) PROCEDURAL REGULATIONS IMPLEMENTATION OF THE ENERGY POLICY AND CONSERVATION ACT § 313.4 Major regulatory... of actions shall not be deemed as major regulatory actions requiring an energy statement: (1) Tariff...

Regulatory Analysis on the Safety Assessment of NPPs against Aircraft Crash

International Nuclear Information System (INIS)

Kim, Sang Yun; Park, Jong Seuk; Chung, Yun Suk; Jung, Rae Young

2011-01-01

Following the 9/11 terror, a new regulation (10CFR 50.150) was enacted in June 2009 in the United States mandating the assessment of new nuclear power plants (NPPs) against intentional aircraft crashes, along with a regulation (10CFR 50.54 (h)(h)) in March 2009 that requires the establishment of accident mitigation measures for NPPs in operation. The UAE requested that the Korean NPP (APR 1400) design meet the U.S.'s new requirements related to the intentional aircraft crash. During the UAE NPP contract bidding process, France claimed that the Korean NPP is vulnerable to aircraft crashes comparing with the French NPP (EPR). Under these international and domestic environments, the necessity to establish a domestic regulation concerning the intentional aircraft crash was raised. This paper proposes a draft regulatory position on this issue through a comprehensive analysis of various influencing factors

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

International Nuclear Information System (INIS)

Mourlon, Sophie

2014-01-01

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

49 CFR 40.15 - May an employer use a service agent to meet DOT drug and alcohol testing requirements?

Science.gov (United States)

2010-10-01

... drug and alcohol testing requirements? 40.15 Section 40.15 Transportation Office of the Secretary of Transportation PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Employer Responsibilities § 40.15 May an employer use a service agent to meet DOT drug and alcohol testing requirements? (a...

Beyond ADA Accessibility Requirements: Meeting Seniors' Needs for Toilet Transfers.

Science.gov (United States)

Lee, Su Jin; Sanford, Jon; Calkins, Margaret; Melgen, Sarah; Endicott, Sarah; Phillips, Anjanette

2018-04-01

To identify the optimal spatial and dimensional requirements of grab bars that support independent and assisted transfers by older adults and their care providers. Although research has demonstrated that toilet grab bars based on the Americans with Disabilities Act (ADA) Accessibility Standards do not meet the needs of older adults, the specific dimensional requirements for alternative configurations are unknown. A two-phased study with older adults and care providers in residential facilities was conducted to determine the optimal requirements for grab bars. Seniors and caregivers in skilled nursing facilities performed transfers using a mock-up toilet. In Phase 1, participants evaluated three grab bar configurations to identify optimal characteristics for safety, ease of use, comfort, and helpfulness. These characteristics were then validated for using ability-matched samples in Phase 2. The optimal configuration derived in Phase 1 included fold-down grab bars on both sides of the toilet (14" from centerline [CL] of toilet, 32" above the floor, and extended a minimum of 6" in front of the toilet) with one side open and a sidewall 24" from CL of toilet on the other. Phase 2 feedback was significantly positive for independent and one-person transfers and somewhat lower, albeit still positive, for two-person transfers. The study provides substantial evidence that bilateral grab bars are significantly more effective than those that comply with current ADA Accessibility Standards. Findings provide specific spatial and dimensional attributes for grab bar configurations that would be most effective in senior facilities.

Proposed combination of training and education to meet the bachelor of science requirements

International Nuclear Information System (INIS)

Wilson, A.E.

1987-01-01

The basic similarities and differences of the education and training which, in the author's opinion, are actually needed by reactor operators are outlined and compared with the NRC requirements. Examples of engineering degree programs are presented to demonstrate that they are NOT the appropriate educational goal for a senior reactor operator. A possible program of study which could be implemented jointly by a utility and a nearby college or university is presented. The program combines both education and training to complete the requirements for a bachelors degree. Those student-operators entering the program should be able to work as auxiliary operators while pursuing the degree part time and qualify for the NRC Reactor Operator exam in five years. Then, while working as RO's, they should complete the degree requirements in another year. After an additional year of RO experience, they should meet the NRC requirements for Senior Operator. Finally, some of the possible pitfalls of such a program are discussed. These include such things as drop-outs, union agreements, inflexibility of educational institutions and, of course, cost

Instruction of the CSN on the requirements of the system of management of the nuclear power plants; Instruccion del CSN sobre los requisitos del sistema de gestion de las instalaciones nucleares

Energy Technology Data Exchange (ETDEWEB)

Cid, R.; Santo, A. de; Gil Montes, B.; Toca, A.

2008-07-01

The Western European Nations Regulatory Authorities (WENRA) performed a nuclear safety requirements harmonization task, as a result of this work and its implementation, the Spanish Nuclear Safety Counsel (CSN) has the commitment to issue its own Regulation Safety Instructions) to identify the WENRA to level nuclear safety requirements, and to incorporate it in the Spanish regulatory pyramid. However, the Spain nuclear installations meet these requirements through the original criteria to fulfill the regulation of the country that supply the NSSS design, these requirements are not incorporated in our regulation. One of the issues, identified by WENRA, is the implementation of the management system requirements in accord with the IAEA GS-R-3 The Management System for Facilities and Activities. As these regards, the CSN has developed a Safety Instruction, basically endorsing the IAEA GS-R-3. The Safety Instruction is actually in a phase of external comments and should be issued by june 2008. This paper describes the bases for the Safety Instruction, summarises the requirements that would meet the management system for nuclear installations and the activities to perform for its implementations. (Author)

Regulatory Considerations for the Long Term Cooling Safe Shutdown Requirements of the Passive Residual Heat Removal Systems in Advanced Reactors

International Nuclear Information System (INIS)

Sim, S. K.; Bae, S. H.; Kim, Y. S.; Hwang, Min Jeong; Bang, Young Seok; Hwang, Taesuk

2016-01-01

USNRC approved safe shutdown at 215.6 .deg. C for a safe and long term cooling state for the redundant passive RHRSs by SECY-94-084. USNRC issued COLA(Combined Construction and Operating License) for the Levy County NP Unit-1/2 for the AP1000 passive RHRSs in 2014. Korea Hydro and Nuclear Power(KHNP) is developing APR+ and adopted Passive Auxiliary Feedwater System(PAFS) as a new passive RHRS design. Korea Institute of Nuclear Safety(KINS) has been developing regulatory guides for the advanced safety design features of the advanced ALWRs which has plan to construct in near future in Korea[5]. Safety and regulatory issues as well as the safe shut down requirements of the passive RHRS are discussed and considerations in developing regulatory guides for the passive RHRS are presented herein. Passive RHRSs have been introduced as new safety design features for the advanced reactors under development in Korea. These passive RHRSs have potential advantages over existing active RHRS, however, their functions are limited due to inherent ability of passive heat removal processes. It is high time to evaluate the performance of the passive PRHRs and develop regulatory guides for the safety as well as the performance analyses of the passive RHRS

Base technology development enhances state-of-the-art in meeting performance requirements

International Nuclear Information System (INIS)

Freedman, J.M.; Allen, G.C. Jr.; Luna, R.E.

1987-01-01

Sandia National Laboratories (SNL) has responsibility to the United States Department of Energy (DOE) for baseline technology to support the design of radioactive material transportation packages. To fulfill this responsibility, SNL works with industry, government agencies, and national laboratories to identify and develop state-of-the-art technology required to design and test safe, cost-effective radioactive materials packages. Principal elements of the base technology program include: 1) analysis techniques, 2) testing, 3) subsystem and component development, 4) packaging systems development support, and 5) technical support for policy development. These program elements support a systems approach for meeting performance requirements and assure that there is a sound underlying technical basis for both transportation packaging design and associated policy decisions. Highlights from the base technology program included in this paper are testing, design and analysis methods, advanced materials, risk assessment and logistics models, and transportation package support

Operating the Advanced Test Reactor in today's economic and regulatory environment

International Nuclear Information System (INIS)

Furstenau, R.V.; Patrick, M.E.; Mecham, D.C.

1999-01-01

The Advanced Test Reactor (ATR), located at the Idaho National Engineering and Environmental Laboratory, is the US Department of Energy's largest and most versatile test reactor. Base programs at ATR are planned well into the 21st century. The ATR and support facilities along with an overview of current programs will be reviewed, but the main focus of the presentation will be on the impact that today's economic and regulatory concerns have had on the operation of this test reactor. Today's economic and regulatory concerns have demanded more work be completed at lower cost while increasing the margin of safety. By the beginning of the 1990 s, federal budgets for research generally and particularly for nuclear research had decreased dramatically. Many national needs continued to require testing in the ATR; but demanded lower cost, increased efficiency, improved performance, and an increased margin of safety. At the same time budgets were decreasing, there was an increase in regulatory compliance activity. The new standards imposed higher margins of safety. The new era of greater openness and higher safety standards complemented research demands to work safer, smarter and more efficiently. Several changes were made at the ATR to meet the demands of the sponsors and public. Such changes included some workforce reductions, securing additional program sponsors, upgrading some facilities, dismantling other facilities, and implementing new safety programs. (author)

Private Equity and Regulatory Capital

NARCIS (Netherlands)

Bongaerts, D.; Charlier, E.

2008-01-01

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

Nuclear Regulatory Infrastructure in the Philippines

International Nuclear Information System (INIS)

Leonin, Teofilo V. Jr.

2015-01-01

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

Meeting United States re-licensing requirements related to environmental protection using innovative technologies

International Nuclear Information System (INIS)

Taft, E.P.; Winchell, F.C.; Cook, T.C.

1998-01-01

Procedure for meeting re-licensing requirements related to environmental protection and an overview of several new and emerging technologies regarding the development of ways to prevent fish passage through hydraulic turbines at hydroelectric power dams is described. Fish mortality and injury has long been a concern in the hydroelectric industry and research and development efforts have been ongoing since the 1970s to prevent fish passage through turbines. Several new and emerging technologies are examined that have the potential for wide-spread cost-effective applications

Design requirements for new nuclear reactor facilities in Canada (focus on important improvements from RD-337 version 1 of 2008)

International Nuclear Information System (INIS)

Shim, S.; Harwood, C.; Ohn, M-Y; Liu, Y.C.; Young, T.

2014-01-01

The Canadian Nuclear Safety Commission (CNSC) has established the regulatory framework that includes the documentation of the requirements and guidance for each of CNSC's 14 Safety and Control Areas, one important area being the design of nuclear power plants (NPPs). For the design area, the CNSC published RD-337 version 1 Design of New Nuclear Power Plants in 2008. As such regulatory documents are reviewed on a regular basis, this document was recently updated as RD-337 version 2, and its guidance document GD-337, Guidance for the Design of New Nuclear Power Plants was developed to provide guidance on how to meet the requirements. REGDOC-2.5.2 Design of Reactor Facilities: Nuclear Power Plants that combines RD-337 version 2 and GD-337 version 1 was presented to the Commission on March 27, 2014 after two rounds of consultation with stakeholders, and was subsequently published in May 28, 2014. Although REGDOC-2.5.2 maintains the structure and the contents nearly the same as RD-337 version 1, it introduces several important improvements to: Include GD-337 guidance for further clarity to applicants, licensees and vendors on how to meet the requirements. This guidance provides the review criteria considered in CNSC staff's review in a transparent way; Ensure alignment with international standards including recent IAEA SSR 2/1, Safety of Nuclear Power Plants: Design; Implement CNSC Fukushima Task Force Report findings that pertain to the design of reactor facilities for severe accidents; and, Make necessary improvements such as addition of requirements for cyber security. This paper describes the overall regulatory framework related to CNSC's design requirements and guidance for NPPs, and focus on the important improvements included in REGDOC-2.5.2 and their reasoning. (author)

Design requirements for new nuclear reactor facilities in Canada (focus on important improvements from RD-337 version 1 of 2008)

Energy Technology Data Exchange (ETDEWEB)

Shim, S.; Harwood, C.; Ohn, M-Y; Liu, Y.C.; Young, T. [Canadian Nuclear Safety Commission, Ottawa, ON (Canada)

2014-07-01

The Canadian Nuclear Safety Commission (CNSC) has established the regulatory framework that includes the documentation of the requirements and guidance for each of CNSC's 14 Safety and Control Areas, one important area being the design of nuclear power plants (NPPs). For the design area, the CNSC published RD-337 version 1 Design of New Nuclear Power Plants in 2008. As such regulatory documents are reviewed on a regular basis, this document was recently updated as RD-337 version 2, and its guidance document GD-337, Guidance for the Design of New Nuclear Power Plants was developed to provide guidance on how to meet the requirements. REGDOC-2.5.2 Design of Reactor Facilities: Nuclear Power Plants that combines RD-337 version 2 and GD-337 version 1 was presented to the Commission on March 27, 2014 after two rounds of consultation with stakeholders, and was subsequently published in May 28, 2014. Although REGDOC-2.5.2 maintains the structure and the contents nearly the same as RD-337 version 1, it introduces several important improvements to: Include GD-337 guidance for further clarity to applicants, licensees and vendors on how to meet the requirements. This guidance provides the review criteria considered in CNSC staff's review in a transparent way; Ensure alignment with international standards including recent IAEA SSR 2/1, Safety of Nuclear Power Plants: Design; Implement CNSC Fukushima Task Force Report findings that pertain to the design of reactor facilities for severe accidents; and, Make necessary improvements such as addition of requirements for cyber security. This paper describes the overall regulatory framework related to CNSC's design requirements and guidance for NPPs, and focus on the important improvements included in REGDOC-2.5.2 and their reasoning. (author)

Proceedings of the tenth annual general meeting of BIOMINET

Energy Technology Data Exchange (ETDEWEB)

Gould, W D; Lortie, L; Rodrigue, D [eds.

1994-01-01

At a meeting held on the subject of applications of biotechnology in the mineral industry, papers were presented on bioleaching, metals recovery, biotechnology applications in the fossil fuel sector, biodegradation of organic compounds, bioremediation of contaminated sites, treatment of fugitive emissions by biological means, biofilters used in treating toxic substances, and the environmental and regulatory dimensions of biotechnology. Separate abstracts have been prepared for five papers from this meeting.

77 FR 68162 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Regulatory...

Science.gov (United States)

2012-11-15

... discuss Regulatory Guide 1.79, ``Preoperational Testing of Emergency Core Cooling Systems for Pressurized Water Reactors,'' Revision 2, and Regulatory Guide 1.79.1, ``Initial Test Program of Emergency Core...

76 FR 4104 - Notice of Commission Staff Attendance at Midwest ISO Meetings

Science.gov (United States)

2011-01-24

... Midwest ISO Meetings January 13, 2011. The Federal Energy Regulatory Commission hereby gives notice that members of the Commission and Commission staff may attend the following Midwest ISO-related meetings...] September 14 [cir] October 19 [cir] November 16 [cir] December 6 Midwest ISO Informational Forum (3 p.m.-5 p...

75 FR 3228 - Notice of Commission Staff Attendance at Midwest ISO Meetings

Science.gov (United States)

2010-01-20

... Midwest ISO Meetings January 12, 2010. The Federal Energy Regulatory Commission hereby gives notice that members of the Commission and Commission staff may attend the following Midwest ISO-related meetings...] November 17 [cir] December 1 Midwest ISO Informational Forum (3 p.m.-5 p.m., ET) [cir] January 19 [cir...

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

International Nuclear Information System (INIS)

Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

2016-01-01

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights: �

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls – A review

Energy Technology Data Exchange (ETDEWEB)

Lores, Marta, E-mail: marta.lores@usc.es; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J. Pablo; Garcia-Jares, Carmen

2016-04-07

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005–2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. - Highlights: �

International STakeholder NETwork (ISTNET): creating a developmental neurotoxicity (DNT) testing road map for regulatory purposes.

Science.gov (United States)

Bal-Price, Anna; Crofton, Kevin M; Leist, Marcel; Allen, Sandra; Arand, Michael; Buetler, Timo; Delrue, Nathalie; FitzGerald, Rex E; Hartung, Thomas; Heinonen, Tuula; Hogberg, Helena; Bennekou, Susanne Hougaard; Lichtensteiger, Walter; Oggier, Daniela; Paparella, Martin; Axelstad, Marta; Piersma, Aldert; Rached, Eva; Schilter, Benoît; Schmuck, Gabriele; Stoppini, Luc; Tongiorgi, Enrico; Tiramani, Manuela; Monnet-Tschudi, Florianne; Wilks, Martin F; Ylikomi, Timo; Fritsche, Ellen

2015-02-01

A major problem in developmental neurotoxicity (DNT) risk assessment is the lack of toxicological hazard information for most compounds. Therefore, new approaches are being considered to provide adequate experimental data that allow regulatory decisions. This process requires a matching of regulatory needs on the one hand and the opportunities provided by new test systems and methods on the other hand. Alignment of academically and industrially driven assay development with regulatory needs in the field of DNT is a core mission of the International STakeholder NETwork (ISTNET) in DNT testing. The first meeting of ISTNET was held in Zurich on 23-24 January 2014 in order to explore the concept of adverse outcome pathway (AOP) to practical DNT testing. AOPs were considered promising tools to promote test systems development according to regulatory needs. Moreover, the AOP concept was identified as an important guiding principle to assemble predictive integrated testing strategies (ITSs) for DNT. The recommendations on a road map towards AOP-based DNT testing is considered a stepwise approach, operating initially with incomplete AOPs for compound grouping, and focussing on key events of neurodevelopment. Next steps to be considered in follow-up activities are the use of case studies to further apply the AOP concept in regulatory DNT testing, making use of AOP intersections (common key events) for economic development of screening assays, and addressing the transition from qualitative descriptions to quantitative network modelling.

Meeting Vitamin D Requirements in White Caucasians at UK Latitudes: Providing a Choice

Directory of Open Access Journals (Sweden)

Ann R. Webb

2018-04-01

Full Text Available The body gains vitamin D through both oral intake (diet/supplementation and synthesis in skin upon exposure to ultraviolet radiation (UVR. Sun exposure is the major source for most people even though sun exposure is complex and limited by climate and culture. We aimed to quantify the sun exposure required to meet vitamin D targets year-round and determine whether this can be safely achieved in a simply defined manner in the UK as an alternative to increasing vitamin D oral intake. Data from observation (sun exposure, diet, and vitamin D status and UVR intervention studies performed with white Caucasian adults were combined with modeled all-weather UVR climatology. Daily vitamin D effective UVR doses (all-weather were calculated across the UK based on ten-year climatology for pre-defined lunchtime exposure regimes. Calculations then determined the time necessary to spend outdoors for the body to gain sufficient vitamin D levels for year-round needs without being sunburnt under differing exposure scenarios. Results show that, in specified conditions, white Caucasians across the UK need nine minutes of daily sunlight at lunchtime from March to September for 25(OHD levels to remain ≥25 nmol/L throughout the winter. This assumes forearms and lower legs are exposed June-August, while in the remaining, cooler months only hands and face need be exposed. Exposing only the hands and face throughout the summer does not meet requirements.

Considering public confidence in developing regulatory programs

International Nuclear Information System (INIS)

Collins, S.J.

2001-01-01

In the area of public trust and in any investment, planning and strategy are important. While it is accepted in the United States that an essential part of our mission is to leverage our resources to improving Public Confidence this performance goal must be planned for, managed and measured. Similar to our premier performance goal of Maintaining Safety, a strategy must be developed and integrated with our external stake holders but with internal regulatory staff as well. In order to do that, business is to be conducted in an open environment, the basis for regulatory decisions has to be available through public documents and public meetings, communication must be done in clear and consistent terms. (N.C.)

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

Science.gov (United States)

Zhu, You-Ping

2017-06-01

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

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

International Nuclear Information System (INIS)

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

1993-12-01

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

Regulatory requirements for the transport of radioactive materials in Canada

Energy Technology Data Exchange (ETDEWEB)

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

2004-07-01

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

Regulatory requirements for the transport of radioactive materials in Canada

International Nuclear Information System (INIS)

Garg, R.

2004-01-01

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

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

77 FR 74696 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on AP-1000...

Science.gov (United States)

2012-12-17

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on AP-1000; Notice of Meeting The ACRS Subcommittee on AP-1000 will hold a meeting on January 18, 2013, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland. The entire meeting will be open to public...

Using Risk Assessment Methodologies to Meet Management Objectives

Science.gov (United States)

DeMott, D. L.

2015-01-01

Corporate and program objectives focus on desired performance and results. ?Management decisions that affect how to meet these objectives now involve a complex mix of: technology, safety issues, operations, process considerations, employee considerations, regulatory requirements, financial concerns and legal issues. ?Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures. Using a risk assessment methodology is only a starting point. ?A risk assessment program provides management with important input in the decision making process. ?A pro-active organization looks to the future to avoid problems, a reactive organization can be blindsided by risks that could have been avoided. ?You get out what you put in, how useful your program is will be up to the individual organization.

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...

The art of leading meetings.

Science.gov (United States)

English, C B

1987-05-01

The ability to skillfully lead meetings can contribute to a manager's effectiveness. There are four types of meetings, each serving different needs and requiring different leadership. A manager must know when to hold meetings, what leadership style is appropriate, how and when to use participative management, and how to facilitate a consensus. Considerable planning must be done before a meeting is held. Various leadership and communication skills are required to effectively open, conduct, and close a meeting. Finally, the leader needs to know how to deal with participants who become problems.

75 FR 7634 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the Subcommittee on Power Uprates...

Science.gov (United States)

2010-02-22

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the Subcommittee on Power Uprates; Notice of Meeting The ACRS Subcommittee on Power Uprates will hold a meeting on... arrangements can be made. Thirty-five hard copies of each presentation or handout should be provided to the DFO...

76 FR 26775 - Advisory Committee on Reactor Safeguards Meeting of the ACRS Subcommittee on EPR; Cancellation to...

Science.gov (United States)

2011-05-09

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards Meeting of the ACRS Subcommittee on EPR; Cancellation to May 11, 2011, ACRS Meeting-- Federal Register Notice The Federal Register Notice for the ACRS Subcommittee Meeting on the design certification application review of the U.S...

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.)

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

International Nuclear Information System (INIS)

Ritterbusch, Stanley E.

2003-01-01

OAK-B135 Research under this project addresses the barriers to long term use of nuclear-generated electricity in the United States. It was agreed that a very basic and significant change to the current method of design and regulation was needed. That is, it was believed that the cost reduction goal could not be met by fixing the current system (i.e., an evolutionary approach) and a new, more advanced approach for this project would be needed. It is believed that a completely new design and regulatory process would have to be developed--a ''clean sheet of paper'' approach. This new approach would start with risk-based methods, would establish probabilistic design criteria, and would implement defense-in-depth only when necessary (1) to meet public policy issues (e.g., use of a containment building no matter how low the probability of a large release is) and (2) to address uncertainties in probabilistic methods and equipment performance. This new approach is significantly different from the Nuclear Regulatory Commission's (NRC) current risk-informed program for operating plants. For our new approach, risk-based methods are the primary means for assuring plant safety, whereas in the NRC's current approach, defense-in-depth remains the primary means of assuring safety. The primary accomplishments in the first year--Phase 1 were (1) the establishment of a new, highly risk-informed design and regulatory framework, (2) the establishment of the preliminary version of the new, highly risk-informed design process, (3) core damage frequency predictions showing that, based on new, lower pipe rupture probabilities, the design of the emergency core cooling system equipment can be simplified without reducing plant safety, and (4) the initial development of methods for including uncertainties in a new integrated structures-systems design model. Under the new regulatory framework, options for the use of ''design basis accidents'' were evaluated. It is expected that design basis

Emissions trading and compliance: Regulatory incentives and barriers

International Nuclear Information System (INIS)

South, D.W.; Bailey, K.A.; McDermott, K.A.

1992-01-01

The Title IV of the Clean Air Act Amendments of 1990 (P.L. 101-549) authorizes the use of transferable emission allowances to achieve reductions in the power generating industry's SO 2 emissions at a minimum possible cost. All electricity generators (greater than 25 MW) are required to hold emissions allowances equal to the amount (tons) of SO 2 emitted during a given year, and meet NO x reduction levels indicated by the Revised New Source Performance Standards (NSPS). This paper will examine the multifaceted goals and problems of states and utilities relative to compliance with Title IV, and in particular as they pertain to the development and functioning of the allowance market together with utility pollution control and power generation technology choice. Section 2 presents possible utility compliance strategies along with possible barriers that utilities may confront regarding the development of a SO 2 allowance market. Section 3 discusses current regulatory barriers and requirements being implemented by state public utility commissions, and Section 4 offers some policy recommendations to achieve the goals of Title IV. Finally, Section 5 presents a summary and conclusions; Appendix A provides programs/mandates developed to data by high sulfur coal states in response to Title IV compliance requirements

76 FR 14003 - International Energy Agency Meetings

Science.gov (United States)

2011-03-15

... Hub? 9. Workshop Scene Setter --Commodity Derivatives Market and Recent Regulatory Trends 10. Other... Financial Market Participants on Energy Futures Markets 1. How do the investment strategies of financial... the Oil Market (SOM) on March 22; and on March 23 and March 24 in connection with a meeting of the SEQ...

78 FR 62322 - Hydropower Regulatory Efficiency Act of 2013; Notice of Rescheduled Two-Year Licensing Process...

Science.gov (United States)

2013-10-16

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD13-9-000] Hydropower... recommendations on the feasibility of a two-year process for the issuance of a license for hydropower development... Hydropower Regulatory Efficiency Act of 2013. The workshop will be held in the Commission Meeting Room at 888...

Fronting Integrated Scientific Web Applications: Design Features and Benefits for Regulatory Environments

Science.gov (United States)

Integrated decision support systems for regulatory applications benefit from standardindustry practices such as code reuse, test-driven development, and modularization. Theseapproaches make meeting the federal government’s goals of transparency, efficiency, and quality assurance ...

Regulatory issues in the maintenance of Argentine nuclear power plants

International Nuclear Information System (INIS)

Castro, E.; Caruso, G.

1997-01-01

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

FORECAST: Regulatory effects cost analysis software annual

International Nuclear Information System (INIS)

Lopez, B.; Sciacca, F.W.

1991-11-01

Over the past several years the NRC has developed a generic cost methodology for the quantification of cost/economic impacts associated with a wide range of new or revised regulatory requirements. This methodology has been developed to aid the NRC in preparing Regulatory Impact Analyses (RIAs). These generic costing methods can be useful in quantifying impacts both to industry and to the NRC. The FORECAST program was developed to facilitate the use of the generic costing methodology. This PC program integrates the major cost considerations that may be required because of a regulatory change. FORECAST automates much of the calculations typically needed in an RIA and thus reduces the time and labor required to perform these analysis. More importantly, its integrated and consistent treatment of the different cost elements should help assure comprehensiveness, uniformity, and accuracy in the preparation of needed cost estimates

75 FR 27841 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on EPR

Science.gov (United States)

2010-05-18

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on EPR The ACRS Subcommittee on EPR will hold a meeting on May 21, 2010, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland. The entire meeting will be open to public attendance. The agenda for...

Meeting the International Health Regulations (2005) surveillance core capacity requirements at the subnational level in Europe

DEFF Research Database (Denmark)

Ziemann, Alexandra; Rosenkötter, Nicole; Riesgo, Luis Garcia-Castrillo

2015-01-01

BACKGROUND: The revised World Health Organization's International Health Regulations (2005) request a timely and all-hazard approach towards surveillance, especially at the subnational level. We discuss three questions of syndromic surveillance application in the European context for assessing...... public health emergencies of international concern: (i) can syndromic surveillance support countries, especially the subnational level, to meet the International Health Regulations (2005) core surveillance capacity requirements, (ii) are European syndromic surveillance systems comparable to enable cross...... effect of different types of public health emergencies in a timely manner as required by the International Health Regulations (2005)....

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

Science.gov (United States)

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

2013-06-01

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

Regulatory agencies and regulatory risk

OpenAIRE

Knieps, Günter; Weiß, Hans-Jörg

2008-01-01

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

Preliminary regulatory audit calculation for Shinkori Units 3 and 4 LBLOCA

Energy Technology Data Exchange (ETDEWEB)

Woo, S. W.; Kim, B. S.; Kim, J. K. (and others)

2006-12-15

The objective of this study is to perform a preliminary evaluation for Shinkori Units 3 and 4 LBLOCA by applying KINS Realistic Evaluation Methodology (REM). The following results were obtained: (1) From the evaluation for Shinkori Units 3 and 4 LBLOCA, the peak cladding temperature was evaluated to meet the regulatory requirement and the feasibility of the KINS-REM was identified. (2) The input decks that were developed in the previous studies, were reviewed and the evaluation model of the fluidic device was developed and applied for the audit calculation. (3) The treating method for the uncertainty of the gap conductance was developed and applied for the audit calculation. (4) The pre- and post-processing programs were developed for this study. (5) For the more detailed assessments, the information for the gap conductance, etc. should be improved and the effects of coolant bypass during blowdown, steam binding and so on were not sufficiently evaluated. KINS-REM should be advanced to evaluate these effects properly. The KINS methodology that was used in this study, can be further applied for independent regulatory audit calculations related to the licensing application on LOCA best estimate calculation.

US decommissioning strategy in today's regulatory, technical, political, and economic environments

International Nuclear Information System (INIS)

Colvin, J.F.

1995-01-01

The United States commercial nuclear power industry is nearly forty years old. Soon after the turn of the century, the United States expects to see a significant rise in the number of plants requiring decommissioning. This, coupled with recent economic pressures which are impacting the U.S. electrical generation industry and have resulted in the premature shutdown of some nuclear power plants, heighten the need for clear regulations and standards addressing facility closure and decommissioning. Since the issue of decommissioning involves public health and safety, technical, environmental and financial aspects, this complex regulatory environment poses a major challenge to the industry in this area. There are three fundamental issues facing utilities as they develop strategies for the eventual decommissioning of their nuclear power plants. These issues are the regulatory approach to decommissioning, the question of the availability of adequate funding, including the uncertainty resulting from the uncertainty of waste disposal options, and the need to meet environmental standards for the protection of health and safety. Futhermore, these issues, in particular the economic-related issues, are magnified in the event of prematurely shut down nuclear power plant. (Author)

76 FR 19355 - Notice of Staff Attendance at Southwest Power Pool Markets Operations Policy Committee Meeting

Science.gov (United States)

2011-04-07

...) Markets Operations Policy Committee (MOPC), as noted below. Their attendance is part of the Commission's... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Staff Attendance at Southwest Power Pool Markets Operations Policy Committee Meeting The Federal Energy Regulatory Commission hereby...

Procurement and control of spare and replacement parts - a regulatory perspective

International Nuclear Information System (INIS)

Baker, E.T.; Grimes, B.K.; Merschoff, E.W.

1987-01-01

As the nuclear industry shifts from a construction to an operations orientation, a number of fundamental changes have occurred in the type of safety-related procurements and the manner in which the utilities accomplish these procurements. Specifically, procurements have shifted from the purchase of large systems and components by architect-engineers, and nuclear steam supply system (NSSS) suppliers to the procurement by utilities of subassemblies, individual pieces of equipment (e.g., breakers, relays), and small parts for repairing individual pieces of equipment. To ensure that equipment will continue to perform its intended function and to satisfy regulatory requirements utilities must consider several things: (1) does the equipment perform a safety function; (2) does the replacement part affect the safety function; and (3) does the replacement part affect the seismic or environmental qualification. If the answer to any of these questions is yes, the purchaser has two alternatives. He may procure the item as safety-related and require the supplier or manufacturer to comply with all the applicable technical and quality requirements or he may purchase the item commercial grade and perform the necessary inspections and tests to ensure the item meets the requirements, i.e., dedicate the item

Regulatory Incentives and Disincentives for Utility Investments in Grid Modernization

Energy Technology Data Exchange (ETDEWEB)

Kihm, Steve [Seventhware, Madison, WI (United States); Beecher, Janice [Michigan State Univ., East Lansing, MI (United States). Inst. of Public Utilities; Lehr, Ronald L.

2017-05-31

changes require a better alignment of utility investment incentives with changes challenging the electricity sector, emerging grid modernization options and benefits, and public policies. For example, investor-owned utilities typically have an incentive to make capital investments, but rarely to employ expense-based solutions, since utilities do not earn profits on expenses. Further, Lehr cites a variety of factors that stand in the way of creating well targeted and well aligned utility incentives, including litigated regulatory processes. These may be a poor choice for finding the right balance among competing interests, establishing rules of prospective application, justifying demonstrations of new technologies and approaches to meeting emerging consumer demands, and keeping pace with rapid change.

26 CFR 1.856-7 - Certain corporations, etc., that are considered to meet the gross income requirements.

Science.gov (United States)

2010-04-01

... 26 Internal Revenue 9 2010-04-01 2010-04-01 false Certain corporations, etc., that are considered to meet the gross income requirements. 1.856-7 Section 1.856-7 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES Real Estate Investment...

Work-related stress risk assessment in Italy: a methodological proposal adapted to regulatory guidelines.

Science.gov (United States)

Persechino, Benedetta; Valenti, Antonio; Ronchetti, Matteo; Rondinone, Bruna Maria; Di Tecco, Cristina; Vitali, Sara; Iavicoli, Sergio

2013-06-01

Work-related stress is one of the major causes of occupational ill health. In line with the regulatory framework on occupational health and safety (OSH), adequate models for assessing and managing risk need to be identified so as to minimize the impact of this stress not only on workers' health, but also on productivity. After close analysis of the Italian and European reference regulatory framework and work-related stress assessment and management models used in some European countries, we adopted the UK Health and Safety Executive's (HSE) Management Standards (MS) approach, adapting it to the Italian context in order to provide a suitable methodological proposal for Italy. We have developed a work-related stress risk assessment strategy, meeting regulatory requirements, now available on a specific web platform that includes software, tutorials, and other tools to assist companies in their assessments. This methodological proposal is new on the Italian work-related stress risk assessment scene. Besides providing an evaluation approach using scientifically validated instruments, it ensures the active participation of occupational health professionals in each company. The assessment tools provided enable companies not only to comply with the law, but also to contribute to a database for monitoring and assessment and give access to a reserved area for data analysis and comparisons.

Regulatory control of fuel design and manufacturing

International Nuclear Information System (INIS)

1994-01-01

The regulatory control of the design and manufacturing of the nuclear fuel and of the control rods aims to ensure conformance to set requirements during normal operating conditions, anticipated operational transients and postulated accident conditions. The regulatory control of design, manufacturing, receiving inspections and the start of operation of the nuclear fuel are specified in the guide. The regulatory control procedure also applies to the control rods and the shield elements

Proceedings of the OECD/CSNI specialists meeting on boron dilution reactivity transients

International Nuclear Information System (INIS)

1997-06-01

The purpose of the meeting was to bring together experts involved in the different activities related to boron dilution transients. The experts came from all involved parties, including research organizations, regulatory authorities, vendors and utilities. Information was openly shared and discussed on the experimental results, plant and systems analysis, numerical analysis of mixing and probability and consequences of these transients. Regulatory background and licensing implications were also included to provide the proper frame work for the technical discussion. Each of these areas corresponded to a separate session. The meeting focused on the thermal-hydraulic aspects because of the current interest in that subject and the significant amount of new technical information being generated

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

Science.gov (United States)

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

2016-01-01

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

Defining regulatory requirements for water supply systems in Vietnam

Directory of Open Access Journals (Sweden)

Deryushev Leonid Georgiyevich

2014-01-01

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

Report of a consultants' meeting on a review of the methods used for leak rate measurements for WWER 440/230 confinements and WWER/440/213 containments. Extrabudgetary programme on the safety of WWER NPPS

International Nuclear Information System (INIS)

1995-01-01

During the meeting the first two days were given to the presentations of the papers, after which the meeting was divided into working groups which prepared the experts' positions on the following topics: requirements of the National Regulatory Authorities on confinement/containment leak rate testing methods; local leak rate test methods; integral leak rate test methods; structural integrity testing; methods of evaluation of leak rate test results. The reports prepared by each working group were reviewed in plenary sessions and the final conclusions were discussed and agreed upon in the plenary meeting. 16 refs, 6 tabs

Training the staff of the regulatory body for nuclear facilities: A competency framework

International Nuclear Information System (INIS)

2001-11-01

The uncertainties about the future of nuclear power in many countries, the ageing of the existing work force, and the consequential lack of interest of new professionals to engage in the nuclear field represent developments of major current international concern. The situation is compounded by the great reduction in higher education opportunities in the field of nuclear engineering and the elimination of nuclear engineering departments and research reactors in many universities and the loss of nuclear research facilities generally. Competence of regulatory staff is one of the prerequisites for the safety of nuclear facilities in the IAEA Member States. Recruitment of competent regulatory staff is difficult in many countries. Also, replacement of retiring staff members requires active efforts from the management of regulatory bodies for establishing staff qualification and training programmes. International support is needed in this domain. In 2000, the General Conference resolution GC(44)IRES/13 on education and training in radiation protection, nuclear safety and waste management urged the secretariat to 'strengthen, within available financial resources, its current efforts in this area' Several elements required for the implementation of the above resolution are already in place. A strategy paper on training in nuclear, radiation and waste safety, including specialized training courses for specific target groups, has been developed at the IAEA. The international working group on training and qualification recommended in its March meeting in 2000 that a technical document be produced on good training practices of regulatory bodies with advanced training programmes. Such a technical document would be of considerable value to many bodies. The technical document would address how training programmes for regulatory staff have been developed and implemented and include examples of training currently available. Of particular interest to regulatory agencies that have

Training the staff of the regulatory body for nuclear facilities: A competency framework

International Nuclear Information System (INIS)

2002-11-01

The uncertainties about the future of nuclear power in many countries, the ageing of the existing work force, and the consequential lack of interest of new professionals to engage in the nuclear field represent developments of major current international concern. The situation is compounded by the great reduction in higher education opportunities in the field of nuclear engineering and the elimination of nuclear engineering departments and research reactors in many universities and the loss of nuclear research facilities generally. Competence of regulatory staff is one of the prerequisites for the safety of nuclear facilities in the IAEA Member States. Recruitment of competent regulatory staff is difficult in many countries. Also, replacement of retiring staff members requires active efforts from the management of regulatory bodies for establishing staff qualification and training programmes. International support is needed in this domain. In 2000, the General Conference resolution GC(44)IRES/13 on education and training in radiation protection, nuclear safety and waste management urged the secretariat to 'strengthen, within available financial resources, its current efforts in this area' Several elements required for the implementation of the above resolution are already in place. A strategy paper on training in nuclear, radiation and waste safety, including specialized training courses for specific target groups, has been developed at the IAEA. The international working group on training and qualification recommended in its March meeting in 2000 that a technical document be produced on good training practices of regulatory bodies with advanced training programmes. Such a technical document would be of considerable value to many bodies. The technical document would address how training programmes for regulatory staff have been developed and implemented and include examples of training currently available. Of particular interest to regulatory agencies that have

Proposed standby gasoline rationing plan. Economic and regulatory analysis draft

Energy Technology Data Exchange (ETDEWEB)

1978-06-01

This economic and regulatory analysis meets the requirements of the Energy Policy and Conservation Act, which calls for an evaluation of the potential economic impacts of the gasoline rationing contingency plan. In addition, this analysis is intended to satisfy the requirements of the President's Executive Order No. 12044 of March 23, 1978, regarding government regulations, and provides an inflationary impact statement for the proposed rationing plan. To perform the analysis of rationing program impacts on the total national economy, three separate projections were required. First, a projection is made of the ''normal'' U.S. economy for a future period--the last quarter of 1980 through the third quarter of 1981 in this analysis. Second, a projection is made of the impacts which a petroleum supply interruption would have on the U.S. economy during this future period, assuming that DOE's standby allocation and price control regulations were implemented for crude oil and products. Third, and most significant, an estimate is made of the incremental impacts of the gasoline rationing program on this already-perturbed future U.S. economy.

77 FR 47628 - Eagle Mountain Pumped Storage Hydroelectric Project; Eagle Crest Energy; Notice of Meeting...

Science.gov (United States)

2012-08-09

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [P-13123-002-CA] Eagle Mountain Pumped Storage Hydroelectric Project; Eagle Crest Energy; Notice of Meeting Postponement On July 17, 2012, the...), on the Eagle Mountain Pumped Storage Hydroelectric Project. However, the meeting has been postponed...

75 FR 52046 - Development of U.S. Nuclear Regulatory Commission Safety Culture Policy Statement: Public Meeting

Science.gov (United States)

2010-08-24

... is working towards increasing the attention that is given to safety culture as part of its efforts to... NUCLEAR REGULATORY COMMISSION Development of U.S. Nuclear Regulatory Commission Safety Culture..., Nevada hearing facility to solicit comments on the revision of its draft safety culture policy statement...

76 FR 47089 - Regulatory Review Schedule; Cancellation of Consultation Meetings

Science.gov (United States)

2011-08-04

... Consultation-- Wild Horse Resort Casino, 1, 2, 3, 4, 5 Southwest. Scottsdale, AZ. September 19-20, 2011 NIGC Regional Training..... Sky Ute Casino Resort 3, 4, 5 Ignacio, CO. September 27-28, 2011 NIGC Consultation-- Turning Stone Casino, NY... 3, 5 Northeast. November 7-12, 2011 USET Annual Meeting........ Mississippi...

Regulatory issues in accreditation of toxicology laboratories.

Science.gov (United States)

Bissell, Michael G

2012-09-01

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

The regulatory framework in the UK

International Nuclear Information System (INIS)

O'Sullivan, R.

1984-01-01

The subject is covered in sections, headed: basic regulatory requirements covering the transport of radioactive material in the UK; responsibility for safety (competent authority; provision of regulations; implementation of regulations (international and national); design of transport flask; safety case; testing; assessment; approval certificate; compliance assurance; administration); advice and information on the regulatory safety standards. (U.K.)

Positive lists of cosmetic ingredients: Analytical methodology for regulatory and safety controls - A review.

Science.gov (United States)

Lores, Marta; Llompart, Maria; Alvarez-Rivera, Gerardo; Guerra, Eugenia; Vila, Marlene; Celeiro, Maria; Lamas, J Pablo; Garcia-Jares, Carmen

2016-04-07

Cosmetic products placed on the market and their ingredients, must be safe under reasonable conditions of use, in accordance to the current legislation. Therefore, regulated and allowed chemical substances must meet the regulatory criteria to be used as ingredients in cosmetics and personal care products, and adequate analytical methodology is needed to evaluate the degree of compliance. This article reviews the most recent methods (2005-2015) used for the extraction and the analytical determination of the ingredients included in the positive lists of the European Regulation of Cosmetic Products (EC 1223/2009): comprising colorants, preservatives and UV filters. It summarizes the analytical properties of the most relevant analytical methods along with the possibilities of fulfilment of the current regulatory issues. The cosmetic legislation is frequently being updated; consequently, the analytical methodology must be constantly revised and improved to meet safety requirements. The article highlights the most important advances in analytical methodology for cosmetics control, both in relation to the sample pretreatment and extraction and the different instrumental approaches developed to solve this challenge. Cosmetics are complex samples, and most of them require a sample pretreatment before analysis. In the last times, the research conducted covering this aspect, tended to the use of green extraction and microextraction techniques. Analytical methods were generally based on liquid chromatography with UV detection, and gas and liquid chromatographic techniques hyphenated with single or tandem mass spectrometry; but some interesting proposals based on electrophoresis have also been reported, together with some electroanalytical approaches. Regarding the number of ingredients considered for analytical control, single analyte methods have been proposed, although the most useful ones in the real life cosmetic analysis are the multianalyte approaches. Copyright © 2016

Improvement of the effectiveness of regulatory management

International Nuclear Information System (INIS)

2001-01-01

The project ARCAL LXVI has as its objective strengthening the national capabilities of the regulatory authorities to achieve an adequate level of radiation safety by training their staff in the implementation of the safety guidelines developed by a prior TC regional project under the framework of the ARCAL Programme and to measure its effectiveness. Detailed program of activities for the years 2001/2002 is presented at this meeting

Advanced Fuel Pellet Materials and Fuel Rod Design for Water Cooled Reactors. Proceedings of a Technical Committee Meeting

International Nuclear Information System (INIS)

2010-10-01

The economics of current nuclear power plants have improved through increased fuel burnup and longer fuel cycles, i.e. increasing the effective time that fuel remains in the reactor core and the amount of energy it generates. Efficient consumption of fissile material in the fuel element before it is discharged from the reactor means that less fuel is required over the reactor's life cycle, which results in lower amounts of fresh fuel, lower spent fuel storage costs, and less waste for ultimate disposal. Better utilization of fissile nuclear materials, as well as more flexible power manoeuvring, place challenging operational demands on materials used in reactor components, and first of all, on fuel and cladding materials. It entails increased attention to measures ensuring desired in-pile fuel performance parameters that require adequate improvements in fuel material properties and fuel rod designs. These are the main reasons that motivated the IAEA Technical Working Group on Fuel Performance and Technology (TWG-FPT) to recommend the organization of a Technical Committee Meeting on Advanced Fuel Pellet Materials and Fuel Rod Designs for Power Reactors. The proposal was supported by the IAEA TWGs on Advanced Technologies for Light and Heavy Water-Cooled Reactors (TWG-LWR and TWG-HWR), and the meeting was held at the invitation of the Government of Switzerland at the Paul Scherrer Institute in Villigen, from 23 to 26 November 2009. This was the third IAEA meeting on these subjects (the first was held in 1996 in Tokyo, Japan, and the second in 2003 in Brussels, Belgium), which reflects the continuous interest in the above issues among Member States. The purpose of the meeting was to review the current status in the development of fuel pellet materials and to explore recent improvements in fuel rod designs for light and heavy water cooled power reactors. The meeting was attended by 45 specialists representing fuel vendors, nuclear utilities, research and development

Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (French Edition); Cadre gouvernemental, legislatif et reglementaire de la surete. Prescriptions generales de surete. Partie 1

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-11-15

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1 (Spanish Edition); Marco gubernamental, juridico y regulador para la seguridad. Requisitos de Seguridad Generales. Parte 1

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-11-15

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

Strategies and policies for nuclear power plant life management. Proceedings of the IAEA specialists meeting. Working document

International Nuclear Information System (INIS)

1998-01-01

The purpose of the Specialists Meeting organized by the IAEA was to provide an international forum for discussing of recent results in national and utility experience in development of nuclear power plant life management programmes and their technical, regulatory and economic assessments. Plant life management requires detailed knowledge of ageing degradation of the components and the results of mitigation technologies. The basic conclusion includes the need of Guide on NPP Life management which should encompass: plant safety; plant availability; plant operating life extension; human resources policy; research and development needs

Towards medicines regulatory authorities' quality performance improvement: value for public health.

Science.gov (United States)

Pejović, Gordana; Filipović, Jovan; Tasić, Ljiljana; Marinković, Valentina

2016-01-01

The purpose of this article is to explore the possibility of implementing total quality management (TQM) principles in national medicines regulatory authorities in Europe to achieve all public health objectives. Bearing in mind that medicines regulation is a governmental function that serves societal objectives to protect and promote public health, measuring the effective achievement of quality objectives related to public health is of utmost importance. A generic TQM model for meeting public health objectives was developed and was tested on 10 European national medicines regulatory authorities with different regulatory performances. Participating national medicines regulatory authorities recognised all TQM factors of the proposed model in implemented systems with different degrees of understanding. An analysis of responses was performed within the framework of two established criteria-the regulatory authority's category and size. The value of the paper is twofold. First, the new generic TQM model proposes to integrate four public health objectives with six TQM factors. Second, national medicines regulatory authorities were analysed as public organisations and health authorities to develop a proper tool for assessing their regulatory performance. The paper emphasises the importance of designing an adequate approach to performance measurement of quality management systems in medicines regulatory authorities that will support their public service missions. Copyright © 2014 John Wiley & Sons, Ltd.

76 FR 76712 - Notice of Staff Attendance at Southwest Power Pool Markets and Operations Policy Committee Meeting

Science.gov (United States)

2011-12-08

.... Markets and Operations Policy Committee. Their attendance is part of the Commission's ongoing outreach... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Staff Attendance at Southwest Power Pool Markets and Operations Policy Committee Meeting The Federal Energy Regulatory Commission...

76 FR 28023 - Duke Energy Carolinas, LLC, South Carolina Electric & Gas Company; Notice of Meetings

Science.gov (United States)

2011-05-13

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2232-522; Project No. 516-459] Duke Energy Carolinas, LLC, South Carolina Electric & Gas Company; Notice of Meetings On March 18, 2011, the National Marine Fisheries Service (NMFS) requested a meeting with Duke Energy Carolinas, LLC...

78 FR 8202 - Meeting of the Joint ACRS Subcommittees on Thermal Hydraulic Phenomena and Materials, Metallurgy...

Science.gov (United States)

2013-02-05

... NUCLEAR REGULATORY COMMISSION Advisory Committee on Reactor Safeguards (ACRS) Meeting of the Joint ACRS Subcommittees on Thermal Hydraulic Phenomena and Materials, Metallurgy and Reactor Fuels; Notice of Meeting The Joint ACRS Subcommittees on Thermal Hydraulic Phenomena and Materials, Metallurgy and...

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

International Nuclear Information System (INIS)

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

2000-01-01

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

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)

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

Science.gov (United States)

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

2015-01-01

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

Regulatory Physiology

Science.gov (United States)

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

1999-01-01

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

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

Topics raised by the summary report of the first review meeting

International Nuclear Information System (INIS)

2001-01-01

This document presents the fulfilling of the Brazilian obligations under the Convention on Nuclear Safety. The Chapter 7 of the document contains topics raised by the summary report of the first review meeting. The chapter covers status and position of the regulatory body, collective doses, effluents release trends, adoption of the ICRP 60 and basic safety standards, regulatory strategy, quality assurance, monitoring safety management, international cooperation, probabilistic safety assessment and safety improvement programmes

Programmatic and technical requirements for the FMDP fresh MOX fuel transport package

International Nuclear Information System (INIS)

Ludwig, S.B.; Michelhaugh, R.D.; Pope, R.B.

1997-12-01

This document is intended to guide the designers of the package to all pertinent regulatory and other design requirements to help ensure the safe and efficient transport of the weapons-grade (WG) fresh MOX fuel under the Fissile Materials Disposition Program. To accomplish the disposition mission using MOX fuel, the unirradiated MOX fuel must be transported from the MOX fabrication facility to one or more commercial reactors. Because the unirradiated fuel contains large quantities of plutonium and is not sufficient radioactive to create a self-protecting barrier to deter the material from theft, DOE intends to use its fleet of safe secure trailers (SSTs) to provide the necessary safeguards and security for the material in transit. In addition to these requirements, transport of radioactive materials must comply with regulations of the Department of Transportation and the Nuclear Regulatory Commission (NRC). In particular, NRC requires that the packages must meet strict performance requirements. The requirements for shipment of MOX fuel (i.e., radioactive fissile materials) specify that the package design is certified by NRC to ensure the materials contained in the packages are not released and remain subcritical after undergoing a series of hypothetical accident condition tests. Packages that pass these tests are certified by NRC as a Type B fissile (BF) package. This document specifies the programmatic and technical design requirements a package must satisfy to transport the fresh MOX fuel assemblies

Regulatory practices for nuclear power plants in India

International Nuclear Information System (INIS)

Bajaj, S.S.

2013-01-01

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

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

DEFF Research Database (Denmark)

Andersen, Thomas Barnebeck; Harr, Thomas

2008-01-01

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

76 FR 37805 - Progress Energy Carolinas; Notice of Meeting

Science.gov (United States)

2011-06-28

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2206-030] Progress Energy Carolinas; Notice of Meeting On May 31, 2011, Progress Energy Carolinas (Progress Energy), licensee for the... National Marine Fisheries Service (NMFS) and staff to discuss what is needed to complete formal...

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.

Interactions of severe accident research and regulatory positions (ISARRP)

International Nuclear Information System (INIS)

Sehgal, B.R.

2001-12-01

The work Programme of the ISARRP Project was divided into several work packages. The work was conducted in the form of presentations and discussions, held during several meetings whose character was that of workshops. Short reports were prepared by the partners assigned to each task. Work Package 1: Critical review of the SA phenomenological research. The objective of this work package was to consider the progress made world-wide in research on the resolution of the outstanding phenomenological issues posed by severe accidents. Work Package 2: Relevance of severe accident research to SAMG requirements and implementation. The objective of this work package was to relate the progress made in the resolution of the SA issues to the practical matter of what results are required or have been used for the management of severe accidents. Clearly, the SAMG is the most important avenue employed by the regulatory organizations to assure themselves of the safe (from public perspective) performance of a nuclear plant in a postulated severe accident event. Work Package 3: Relevance of severe accident research to PSA and the risk informed regulatory approach. The objectives of this work package is to relate the results obtained by the severe accident research to the requirements of a PSA and of the new trend of employing the risk informed approach in promulgating regulations. Clearly a PSA identifies vulnerabilities in the knowledge base, however, their importance is decidedly plant specific. Nevertheless the uncertainties in the phenomenology or in resolution of issues lead to uncertainties in the PSA conclusions and in the adoption of the risk informed approach. Work Package 4: Questionnaire and the evaluation of responses to the questions. The purpose of this work package is to solicit the views of the regulatory organizations towards the results of the SA research and the benefits they have derived from it in terms of regulatory actions, or in the confidence they have gained

Interactions of severe accident research and regulatory positions (ISARRP)

Energy Technology Data Exchange (ETDEWEB)

Sehgal, B.R. (comp.) [Royal Inst. of Tech., Stockholm (Sweden). Nuclear Power Safety

2001-12-01

The work Programme of the ISARRP Project was divided into several work packages. The work was conducted in the form of presentations and discussions, held during several meetings whose character was that of workshops. Short reports were prepared by the partners assigned to each task. Work Package 1: Critical review of the SA phenomenological research. The objective of this work package was to consider the progress made world-wide in research on the resolution of the outstanding phenomenological issues posed by severe accidents. Work Package 2: Relevance of severe accident research to SAMG requirements and implementation. The objective of this work package was to relate the progress made in the resolution of the SA issues to the practical matter of what results are required or have been used for the management of severe accidents. Clearly, the SAMG is the most important avenue employed by the regulatory organizations to assure themselves of the safe (from public perspective) performance of a nuclear plant in a postulated severe accident event. Work Package 3: Relevance of severe accident research to PSA and the risk informed regulatory approach. The objectives of this work package is to relate the results obtained by the severe accident research to the requirements of a PSA and of the new trend of employing the risk informed approach in promulgating regulations. Clearly a PSA identifies vulnerabilities in the knowledge base, however, their importance is decidedly plant specific. Nevertheless the uncertainties in the phenomenology or in resolution of issues lead to uncertainties in the PSA conclusions and in the adoption of the risk informed approach. Work Package 4: Questionnaire and the evaluation of responses to the questions. The purpose of this work package is to solicit the views of the regulatory organizations towards the results of the SA research and the benefits they have derived from it in terms of regulatory actions, or in the confidence they have gained

Third International E. coli genome meeting

Energy Technology Data Exchange (ETDEWEB)

NONE

1994-12-31

Proceedings of the Third E. Coli Genome Meeting are provided. Presentations were divided into sessions entitled (1) Large Scale Sequencing, Sequence Analysis; (2) Databases; (3) Sequence Analysis; (4) Sequence Divergence in E. coli Strains; (5) Repeated Sequences and Regulatory Motifs; (6) Mutations, Rearrangements and Stress Responses; and (7) Origins of New Genes. The document provides a collection of abstracts of oral and poster presentations.

76 FR 15307 - Notice of Staff Attendance at Southwest Power Pool Strategic Planning Committee Meeting

Science.gov (United States)

2011-03-21

... Power Pool Strategic Planning Committee Meeting The Federal Energy Regulatory Commission hereby gives notice that members of its staff may attend the meeting of the Southwest Power Pool, Inc. (SPP) Strategic Planning Committee (SPC), as noted below. Their attendance is part of the Commission's ongoing outreach...

Summary report of consultants' meeting to review the requirements to improve and extend the IRDF library (International Reactor Dosimetry File (IRDF-2002))

International Nuclear Information System (INIS)

Greenwood, L.R.; Nichols, A.L.

2007-01-01

Presentations, recommendations and conclusions of a Consultants' Meeting to 'Review the Requirements to Improve and Extend the IRDF library (International Reactor Dosimetry File (IRDF-2002))' are summarized is this report. The main aims of this meeting were to discuss scientific and technical matters related to reactor dosimetry and to consider the needs for improvements to the existing data in IRDF-2002 and possible extensions to other higher neutron energy applications. Specific tasks were assigned and deadlines agreed. The requirements for fusion studies are particularly challenging (up to 60 MeV) and should include adequate covariance data - the provision of these neutron cross sections will require additional effort and assessment prior to initiating any work programme, and specific participants agreed to undertake preliminary exercises. (author)

Technical Memory 2010. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2010-01-01

The technical memory 2010 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety presented in journals, technical reports, congress or meetings of these subjects by the ARN personnel during 2010. In this edition the documents are presented on: environmental protection; safety transport of radioactive materials; regulations; licensing of medical installations; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; radioactive waste management [es

Technical Memory 2011. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

The technical memory 2011 of the Nuclear Regulatory Authority of Argentine Republic, compile the papers published in the subject on radiation protection and nuclear safety presented in journals, technical reports, congress or meetings of these subjects by the ARN personnel during 2011. In this edition the documents are presented on: environmental protection; safety transport of radioactive materials; regulations; licensing of medical installations; biological radiation effects; therapeutic uses of ionizing radiation and radioprotection of patients; internal dosimetry; radioactive waste management [es

OECD/CSNI specialist meeting on fuel coolant interactions: summary and conclusions

International Nuclear Information System (INIS)

1997-01-01

Research activities and interest on fuel-coolant interaction (FCI) have been increased and broadened since the last CSNI Specialist Meeting held in January 1993. Significant experimental and analytical research has been performed in many OECD countries and others. The growing international interest is, in large part, due to the emphasis on broader aspects of FCI ranging from melt quenching and coolability to energetic explosions (both in- and ex-vessel), and their relevance and applications to next-generation reactor design as well as accident management strategies. The objectives of the meeting are to review the knowledge and to obtain consensus on the phenomenology of FCI and in predicting FCI behavior in LWRs severe accidents; to identify those areas of FCI phenomena and prediction which are important for reactor safety but still poorly understood and require further study with clear methodologies; to inform the community and the regulatory agencies of the status of FCI issues, especially in the application to accident management and future reactor designs. The various sessions are: reactor applications, pre-mixing, propagation / trigger, experiments

Proceedings of the seventh annual participants' information meeting. DOE Low-Level Waste Management Program

International Nuclear Information System (INIS)

1986-02-01

The Seventh Annual Department of Energy (DOE) Low-Level Waste Management Program (LLWMP) Participants' Information Meeting was held September 10-13, 1985 in Las Vegas, Nevada. The purpose of the meeting was to provide a forum for exchange of information on low-level radioactive waste management activities, requirements, and plans. Attendees included representatives from the DOE Nuclear Energy and Defense Low-Level Waste Management Programs, interim operations offices and their contractor operators; representatives from the US Nuclear Regulatory Commission, US Environmental Protection Agency, US Geological Survey, and their contractors; representatives of states and regions responsible for development of new commercial low-level waste disposal facilities; representatives of Great Britain, France, and Canada; representatives of utilities, private contractors, and parties concerned with low-level waste management issues. The meeting was organized by topical areas to allow for the exchange of information and the promotion of discussion on specific aspects of low-level waste management. Plenary sessions were held at the start and conclusion of the meeting while seven concurrent topical sessions were held during the intervening day and a half. Session chairmen from each of these concurrent sessions presented a summary of the discussion and conclusions resulting from their respective sessions at the final plenary session

Improving nuclear regulation. NEA regulatory guidance booklets volumes 1-14

International Nuclear Information System (INIS)

2011-01-01

A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are continuously maintained and operated in an acceptably safe manner. In meeting this objective the regulator must bear in mind that it is the operator that has responsibility for safely operating the nuclear facility; the role of the regulator is to assess and to provide assurance regarding the operator's activities in terms of assuming that responsibility. The full series of these reports was brought together in one edition for the first time in 2009 and was widely found to be a useful resource. This second edition comprises 14 volumes, including the latest on The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services. The reports address various challenges that could apply throughout the lifetime of a nuclear facility, including design, siting, manufacturing, construction, commissioning, operation, maintenance and decommissioning. The compilation is intended to serve as a knowledge management tool both for current regulators and the new nuclear professionals and organisations entering the regulatory field. Contents: Executive Summary; Regulatory Challenges: 1. The Role of the Nuclear Regulator in Promoting and Evaluating Safety Culture; 2. Regulatory Response Strategies for Safety Culture Problems; 3. Nuclear Regulatory Challenges Related to Human Performance; 4. Regulatory Challenges in Using Nuclear Operating Experience; 5. Nuclear Regulatory Review of Licensee Self-assessment (LSA); 6. Nuclear Regulatory Challenges Arising from Competition in Electricity Markets; 7. The Nuclear Regulatory Challenge of Judging Safety Back-fits; 8. The Regulatory Challenges of Decommissioning Nuclear Reactors; 9. The Nuclear Regulator's Role in Assessing Licensee Oversight of Vendor and Other Contracted Services

RNAi technologies in agricultural biotechnology: The Toxicology Forum 40th Annual Summer Meeting.

Science.gov (United States)

Sherman, James H; Munyikwa, Tichafa; Chan, Stephen Y; Petrick, Jay S; Witwer, Kenneth W; Choudhuri, Supratim

2015-11-01

During the 40th Annual Meeting of The Toxicology Forum, the current and potential future science, regulations, and politics of agricultural biotechnology were presented and discussed. The meeting session described herein focused on the technology of RNA interference (RNAi) in agriculture. The general process by which RNAi works, currently registered RNAi-based plant traits, example RNAi-based traits in development, potential use of double stranded RNA (dsRNA) as topically applied pesticide active ingredients, research related to the safety of RNAi, biological barriers to ingested dsRNA, recent regulatory RNAi science reviews, and regulatory considerations related to the use of RNAi in agriculture were discussed. Participants generally agreed that the current regulatory framework is robust and appropriate for evaluating the safety of RNAi employed in agricultural biotechnology and were also supportive of the use of RNAi to develop improved crop traits. However, as with any emerging technology, the potential range of future products, potential future regulatory frameworks, and public acceptance of the technology will continue to evolve. As such, continuing dialogue was encouraged to promote education of consumers and science-based regulations. Copyright © 2015 Elsevier Inc. All rights reserved.

Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements

International Nuclear Information System (INIS)

Briand, S.

2008-03-01

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

Safety requirements, facility user needs, and reactor concepts for a new Broad Application Test Reactor

International Nuclear Information System (INIS)

Ryskamp, J.M.; Liebenthal, J.L.; Denison, A.B.; Fletcher, C.D.

1992-07-01

This report describes the EG ampersand G Laboratory Directed Research and Development Program (LDRD) Broad Application Test Reactor (BATR) Project that was conducted in fiscal year 1991. The scope of this project was divided into three phases: a project process definition phase, a requirements development phase, and a preconceptual reactor design and evaluation phase. Multidisciplinary teams of experts conducted each phase. This report presents the need for a new test reactor, the project process definition, a set of current and projected regulatory compliance and safety requirements, a set of facility user needs for a broad range of projected testing missions, and descriptions of reactor concepts capable of meeting these requirements. This information can be applied to strategic planning to provide the Department of Energy with management options

Structure and drafting of safeguards regulatory documents

International Nuclear Information System (INIS)

Cole, R.J.; Bennett, C.A.; Edelhertz, H.; Wood, M.T.; Brown, R.J.; Roberts, F.P.

1977-09-01

This study develops hypothesis about the relation between the structure and drafting of safeguards regulatory documents and the ability of document users to understand and implement them in a way that reflects the intent and requirements of the NRC. Four decisions are needed to improve communication: (1) Should improvement of safeguards regulatory documents as communication instruments be an explicit NRC program. (2) What specific methods of communication should be the focus of improvement efforts. (3) What actions to improve communications are feasible and desirable. (4) How should the NRC divide its available effort and resources among desirable actions in order to provide the most effective communication through regulatory documents. This volume contains: introduction, conceptual bases, legal requirements, targets, choice of documents, preparation of documents, readability, and further study of recommended changes in structure and drafting

Challenges for the registration of vaccines in emerging countries: Differences in dossier requirements, application and evaluation processes.

Science.gov (United States)

Dellepiane, Nora; Pagliusi, Sonia

2018-06-07

The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines' registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2-5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures. Copyright © 2018.

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

75 FR 71122 - Erie Boulevard Hydropower L.P.; Notice of Scoping Meetings and Environmental Site Review

Science.gov (United States)

2010-11-22

... DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 7518-012--New York] Erie Boulevard Hydropower L.P.; Notice of Scoping Meetings and Environmental Site Review November 15, 2010. Commission staff will be conducting two public scoping meetings and an environmental site review in support...

A regulatory perspective on design and performance requirements for engineered systems in high-level waste

International Nuclear Information System (INIS)

Bernero, R.M.

1992-01-01

For engineered systems, this paper gives an overview of some of the current activities at the U.S. Nuclear Regulatory Commission (NRC), with the intent of elucidating how the regulatory process works in the management of high-level waste (HLW). Throughout the waste management cycle, starting with packaging and transportation, and continuing to final closure of a repository, these activities are directed at taking advantage of the prelicensing consultation period, a period in which the NRC, DOE and others can interact in ways that will reduce regulatory, technical and institutional uncertainties, and open the path to development and construction of a deep geologic repository for permanent disposal of HLW. Needed interactions in the HLW program are highlighted. Examples of HLW regulatory activities are given in discussions of a multipurpose-cask concept and of current NRC work on the meaning of the term substantially complete containment

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...

Cost-benefit and regulatory decision making

International Nuclear Information System (INIS)

Harvie, J.

1996-01-01

The Atomic Energy Control Board is investigating the feasibility of developing methods for factoring cost-benefit considerations into its regulatory decision-making. This initiative results, in part, from the federal government policy requiring cost-benefit considerations to be taken into account in regulatory processes, and from the recommendations of an Advisory Panel on Regulatory Review in 1993, submitted to the Minister of Natural Resources Canada. One of these recommendations stated: 'that mechanisms be developed to examine cost benefit issues and work towards some consensus of opinion among stake holders: a task force on the subject could be an appropriate starting point'. (author)

Proceedings of the US Nuclear Regulatory Commission twentieth water reactor safety information meeting

International Nuclear Information System (INIS)

Weiss, A.J.

1993-03-01

This three-volume report contains papers presented at the Twentieth Water Reactor Safety Information Meeting held at the Bethesda Marriott Hotel, Bethesda, Maryland, during the week of October 21--23, 1992. The papers describe progress and results of programs in nuclear safety research conducted in this country and abroad. Foreign participation in the meeting included 10 different papers presented by researchersfrom CEC, China, Finland, France, Germany, Japan, Spain and Taiwan

Occupational noise exposure and regulatory adherence in music venues in the United Kingdom

Directory of Open Access Journals (Sweden)

Christopher Barlow

2012-01-01

Full Text Available Noise in most working environments is an unwanted by-product of the process. In most countries, noise exposure for workers has been controlled by legislation for many years. In the music industry the "noise" is actually the "desired" product, and for a long time the UK entertainment industry was exempt from these regulations. From April 2008, however, it became regulated under the Noise at Work Regulations 2005, meaning that employers from orchestras to nightclubs are legally required to adhere to the same requirements (based on ISO 9612:2009 for controlling noise exposure for their staff that have been applied to other industries for many years. A key question is to what degree, 2 years after implementation, these employers are complying with their legal responsibilities to protect the staff from noise? This study assessed four public music venues where live and/or recorded music is regularly played. Thirty staff members in different roles in the venues were monitored using noise dosimetry to determine noise exposure. Questionnaires were used to determine work patterns, attitudes to noise and hearing loss, and levels of training about noise risk. Results showed that the majority of staff (70% in all venues exceeded the daily noise exposure limit value in their working shift. Use of hearing protection was rare (<30% and not enforced by most venues. The understanding of the hazard posed by noise was low, and implementation of the noise regulations was haphazard, with staff regularly exceeding regulatory limits. The implication is that the industry is failing to meet regulatory requirements.

TRUPACT-II, a regulatory perspective

International Nuclear Information System (INIS)

Gregory, P.C.; Spooner, O.R.

1995-01-01

The Transuranic Package Transporter II (TRUPACT-II) is a US Nuclear Regulatory Commission (NRC) certified Type B packaging for the shipment of contact-handled transuranic (CH-TRU) material by the US Department of Energy (DOE). The NRC approved the TRUPACT-II design as meeting the requirements of Title 10, Code of Federal Regulations, Part 71 (10 CFR 71) and issued Certificate of Compliance (CofC) Number 9218 to the DOE. There are currently 15 certified TRUPACT-IIs. Additional TRUPACT-IIs will be required to make more than 15,000 shipments of CH-TRU waste to the Waste Isolation Pilot Plant (WIPP) site near Carlsbad, New Mexico. The TRUPACT-II may also be used for the DOE inter-site and intra-site shipments of CH-TRU waste. The Land Withdrawal Act (Public Law 102-579), enacted by the US Congress, October 30, 1992, and an agreement between the DOE and the State of New Mexico, signed August 4, 1987, both stipulate that only NRC approved packaging may be used for shipments of TRU waste to the WIPP. Early in the TRUPACT-II development phase it was decided that the transportation system (tractor, trailer, and TRUPACT-II) should be highway legal on all routes without the need for oversize and/or overweight permits. In large measure, public acceptance of the DOE's efforts to safely transport CH-TRU waste depends on the public's perception that the TRUPACT-II is in compliance with all applicable regulations, standards, and quality assurance requirements. This paper addresses some of the numerous regulations applicable to Type B packaging, and it describes how the TRUPACT-II complies with these regulations

Report of the consultants meeting on good manufacturing practices and clean room requirements for radiopharmaceuticals

International Nuclear Information System (INIS)

2000-07-01

be carried out in special facilities often with shielding and remote handling to protect the operators from radiation exposure. There are international norms for radiation exposure allowed for radiation workers and strong national organizations for monitoring and implementing radiation protection measures. Being part of the national nuclear programmes, radiopharmaceutical production has been from the very beginning subjected to regulations of radioactive material handling, transportation and use. However, the systems of surveillance and control for pharmaceutical products have not been implemented in many places to the same extent as for radiation protection. There are also technical difficulties in harmonizing the requirements of radiation safety and pharmaceutical safety. Simultaneously, there have been several technical developments in the field of Quality Assurance of pharmaceuticals. The concepts of Good Manufacturing Practices (GMP) and the requirements for clean rooms define quality of air for pharmaceutical production areas. Efforts have been made in recent years to apply these concepts also to radiopharmaceutical production. Significant progress appears to have been made in the developed countries and in the technology needed to fulfil these standards. The technical problems in upgrading the facilities of radioisotope laboratories to conform with the clean air requirements and the cost involved are still to be clearly understood in many developing countries. In many countries the regulatory authorities apply the same set of regulations for radiopharmaceuticals as for other pharmaceuticals. Some guidelines for radiopharmaceuticals have been published, e.g. Scandinavian, US FDA, Australian, Canadian and EU guidelines. No such guidelines are yet available from international agencies such as the International Atomic Energy Agency (IAEA) or World Health Organization (WHO). A guideline from an international body of this nature would be very useful for institutions

Extra-regulatory impact tests and analyses of the structural evaluation test unit

International Nuclear Information System (INIS)

Ludwigsen, J.S.; Ammerman, D.J.

1995-01-01

The structural evaluation test unit is roughly equivalent to a 1/3 scale model of a high level waste rail cask. The test unit was designed to just meet the requirements of NRC Regulatory Guide 7.6 when subjected to a 9 m (30 ft) free drop resulting in an impact velocity of 13.4 m/s (30 mph) onto an unyielding target in the end-on orientation. The test unit was then subjected to impacts with higher velocities to determine the amount of built-in conservatism in this design approach. Test impacts of 13.4, 20.1 and 26.8 m/s (30, 45, and 60 mph) were performed. This paper will describe the design, testing, and comparison of measured strains and deformations to the equivalent analytical predictions

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

International Nuclear Information System (INIS)

Staudinger, Deborah K.

2004-01-01

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

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

Regulatory acceptance and use of 3R models for pharmaceuticals and chemicals: expert opinions on the state of affairs and the way forward.

Science.gov (United States)

Schiffelers, Marie-Jeanne W A; Blaauboer, Bas J; Bakker, Wieger E; Beken, Sonja; Hendriksen, Coenraad F M; Koëter, Herman B W M; Krul, Cyrille

2014-06-01

Pharmaceuticals and chemicals are subjected to regulatory safety testing accounting for approximately 25% of laboratory animal use in Europe. This testing meets various objections and has led to the development of a range of 3R models to Replace, Reduce or Refine the animal models. However, these models must overcome many barriers before being accepted for regulatory risk management purposes. This paper describes the barriers and drivers and options to optimize this acceptance process as identified by two expert panels, one on pharmaceuticals and one on chemicals. To untangle the complex acceptance process, the multilevel perspective on technology transitions is applied. This perspective defines influences at the micro-, meso- and macro level which need alignment to induce regulatory acceptance of a 3R model. This paper displays that there are many similar mechanisms within both sectors that prevent 3R models from becoming accepted for regulatory risk assessment and management. Shared barriers include the uncertainty about the value of the new 3R models (micro level), the lack of harmonization of regulatory requirements and acceptance criteria (meso level) and the high levels of risk aversion (macro level). In optimizing the process commitment, communication, cooperation and coordination are identified as critical drivers. Copyright © 2014 Elsevier Inc. All rights reserved.