WorldWideScience

Sample records for monitoring regulatory requirements

  1. Regulatory requirements and quality assurance of radiation monitoring instruments

    International Nuclear Information System (INIS)

    Narasimharao, K.L.; Sharma, Ranjit

    2005-01-01

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

  2. Regulatory requirements related to maintenance and compliance monitoring

    International Nuclear Information System (INIS)

    Ling, A.K.H.

    1997-01-01

    The maintenance related regulatory requirements are identified in the regulatory documents and licence conditions. Licensee complies with these requirements by operating the nuclear power plant within the safe operating envelope as given in the operating policies and principles and do maintenance according to approved procedures and/or work plans. Safety systems are regularly tested. AECB project officers review and check to ensure that the licensee operates the nuclear power plant in accordance with the regulatory requirements and licence conditions. (author). 6 tabs

  3. 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

  4. 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.

  5. 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...

  6. 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.

  7. 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

  8. Grand Gulf-prioritization of regulatory requirements

    International Nuclear Information System (INIS)

    Meisner, M.J.

    1993-01-01

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

  9. BIOSENSORS FOR ENVIRONMENTAL MONITORING: A REGULATORY PERSPECTIVE

    Science.gov (United States)

    Biosensors show the potential to complement laboratory-based analytical methods for environmental applications. Although biosensors for potential environmental-monitoring applications have been reported for a wide range of environmental pollutants, from a regulatory perspective, ...

  10. 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

  11. 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,

  12. Radiation monitor reporting requirements

    International Nuclear Information System (INIS)

    Bates, W.F.

    1993-01-01

    Within High-Level Waste Management (HLWM), CAMs and VAMPs are currently considered Class B equipment, therefore, alarm conditions associated with the CAMs and VAMPs result in an Unusual Occurrence or Off-Normal notification and subsequent occurrence reporting. Recent equipment difficulties associated with Continuous Air Monitors (CAMs) and Victoreen Area Radiation Monitors (VAMPs) have resulted in a significant number of notification reports. These notification have the potential to decrease operator sensitivity to the significance of specific CAM and VAMP failures. Additionally, the reports are extremely costly and are not appropriate as a means for tracking and trending equipment performance. This report provides a technical basis for a change in Waste Management occurrence reporting categorization for specific CAM and VAMP failure modes

  13. 12 CFR 567.2 - Minimum regulatory capital requirement.

    Science.gov (United States)

    2010-01-01

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

  14. Use of prioritization in meeting regulatory requirements

    International Nuclear Information System (INIS)

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

    1993-01-01

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

  15. Requirements for flexible learner monitoring

    NARCIS (Netherlands)

    Glahn, Christian; Specht, Marcus; Koper, Rob

    2007-01-01

    Glahn, C., Specht, M., & Koper, R. (2007). Requirements for flexible learner monitoring. In T. Navarette, J. Blat & R. Koper (Eds.). Proceedings of the 3rd TENCompetence Open Workshop 'Current Research on IMS Learning Design and Lifelong Competence Development Infrastructures' (pp. 89-96). June,

  16. Radiological environmental monitoring program for Angra I: basis and methodology proposed for executing the requirements of the regulatory member and to assure the population safety

    International Nuclear Information System (INIS)

    Kircher, E.; Dezordi, W.L.

    1984-01-01

    It is presented, applyed to Angra-1, a methodology for implanting the monitoring program of the vicinity level radiation exposure to the installation. The method considers two kinds of radioactive effluents in the environment: gaseous (in the atmosphere) and liquid (in the marine aquatic environment). It is based on the generation and ordering of the important relation: radiation exposure pathway/radionuclide group. (M.C.K.) [pt

  17. 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

  18. 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.

  19. Groundwater monitoring of hydraulic fracturing in California: Recommendations for permit-required monitoring

    Science.gov (United States)

    Esser, B. K.; Beller, H. R.; Carroll, S.; Cherry, J. A.; Jackson, R. B.; Jordan, P. D.; Madrid, V.; Morris, J.; Parker, B. L.; Stringfellow, W. T.; Varadharajan, C.; Vengosh, A.

    2015-12-01

    California recently passed legislation mandating dedicated groundwater quality monitoring for new well stimulation operations. The authors provided the State with expert advice on the design of such monitoring networks. Factors that must be considered in designing a new and unique groundwater monitoring program include: Program design: The design of a monitoring program is contingent on its purpose, which can range from detection of individual well leakage to demonstration of regional impact. The regulatory goals for permit-required monitoring conducted by operators on a well-by-well basis will differ from the scientific goals of a regional monitoring program conducted by the State. Vulnerability assessment: Identifying factors that increase the probability of transport of fluids from the hydrocarbon target zone to a protected groundwater zone enables the intensity of permit-required monitoring to be tiered by risk and also enables prioritization of regional monitoring of groundwater basins based on vulnerability. Risk factors include well integrity; proximity to existing wellbores and geologic features; wastewater disposal; vertical separation between the hydrocarbon and groundwater zones; and site-specific hydrogeology. Analyte choice: The choice of chemical analytes in a regulatory monitoring program is guided by the goals of detecting impact, assuring public safety, preventing resource degradation, and minimizing cost. Balancing these goals may be best served by tiered approach in which targeted analysis of specific chemical additives is triggered by significant changes in relevant but more easily analyzed constituents. Such an approach requires characterization of baseline conditions, especially in areas with long histories of oil and gas development. Monitoring technology: Monitoring a deep subsurface process or a long wellbore is more challenging than monitoring a surface industrial source. The requirement for monitoring multiple groundwater aquifers across

  20. Monitoring compliance with requirements during site characterization

    International Nuclear Information System (INIS)

    Herrington, C.C.; Jennetta, A.R.; Dobson, D.C.

    1991-01-01

    The question of when a program of Regulatory Compliance should be applied and what it should be applied to, when the subject of compliance is a High Level Radioactive Waste Repository, defies resolution by merely relating to past practices of licensees of the US Nuclear Regulatory Commission (NRC). NRC regulations governing the disposal of High Level Waste include interactions with the potential applicant (US DOE) during the pre-license application phase of the program when the basis for regulatory compliance is not well defined. To offset this shortcoming, the DOE will establish an expanded basis for regulatory compliance, keeping the NRC apprised of the basis as it develops. As a result, the preapplication activities of DOE will assume the added benefit of qualification to a suitable Regulatory Compliance monitoring and maintenance plan

  1. 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

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

    International Nuclear Information System (INIS)

    Goldammer, Wolfgang; Batandjieva, Borislava; Nasvit, Oleg; German, Olga

    2009-06-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-06-15

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

  4. 24 CFR 266.505 - Regulatory agreement requirements.

    Science.gov (United States)

    2010-04-01

    ... force for the duration of the insured mortgage and note or bond. The Regulatory Agreement must include a... Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... payments due under the mortgage and note/bond. (2) Where necessary, establish a sinking fund for future...

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

    Science.gov (United States)

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

    2015-01-01

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

  6. Watershed monitoring and modelling and USA regulatory compliance.

    Science.gov (United States)

    Turner, B G; Boner, M C

    2004-01-01

    The aim of the Columbus program was to implement a comprehensive watershed monitoring-network including water chemistry, aquatic biology and alternative sensors to establish water environment health and methods for determining future restoration progress and early warning for protection of drinking water supplies. The program was implemented to comply with USA regulatory requirements including Total Maximum Daily Load (TMDL) rules of the Clean Water Act (CWA) and Source Water Assessment and Protection (SWAP) rules under the Safe Drinking Water Act (SDWA). The USEPA Office of Research and Development and the Water Environment Research Foundation provided quality assurance oversight. The results obtained demonstrated that significant wet weather data is necessary to establish relationships between land use, water chemistry, aquatic biology and sensor data. These measurements and relationships formed the basis for calibrating the US EPA BASINS Model, prioritizing watershed health and determination of compliance with water quality standards. Conclusions specify priorities of cost-effective drainage system controls that attenuate stormwater flows and capture flushed pollutants. A network of permanent long-term real-time monitoring using combination of continuous sensor measurements, water column sampling and aquatic biology surveys and a regional organization is prescribed to protect drinking water supplies and measure progress towards water quality targets.

  7. 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.

  8. 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

  9. Monitoring control program as a tool for regulatory control

    International Nuclear Information System (INIS)

    Silva Peres, Sueli da; Lauria, Dejanaira C.; Martins, Nadia S.F.; Rio, Monica A.P.

    2008-01-01

    Full text: The Institute of Radiation Protection and Dosimetry (IRD) of the Brazilian Commission of Nuclear Energy (CNEN) is responsible for developing, establishing and carrying out an independent assessment to verify the adequacy, effectiveness and accuracy of environmental radiological control carried out by licensed and controlled facilities. This independent assessment is performed by Environmental Monitoring Control Program (MCP). The MCP is a regulatory control and its main goal is to provide public and environment with an appropriate protection level against harmful effects of ionising radiation. The main purpose of the MCP is to verify whether applicable requirements prescribed by legislation are met, the environmental radiological control of the facilities are adequate and effective and the facilities are able to generate valid measuring results. The MCP is carried out in order to evaluate the quality of environmental radiation monitoring programs (EMP) and the effectiveness of their implementation, sampling conditions in the field, changes of environmental aspects in the impact area, adequacy of and adherence to procedures established and other applicable documents, technical competence of the staff and the necessary resources to ensure the required quality of the EMP. The MCP has been performed by activities should include inspecting and auditing of several types of nuclear and radioactive facilities. The inspection programme include the joint sampling program (CCP). The aim of the CCP is to check data of environmental monitoring of operator. The MCP was implemented in 1994. Ever since several problems related to the environmental control performed by operator was identified. The most important of them include problems related to the preparation and analysis of environmental samples, training of personnel, necessary resources, adherence of procedures to the purpose of the monitoring, fulfillment of procedures established, adequacy of the EMP and EMP

  10. 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

  11. Regulatory requirements for marketing fixed dose combinations

    Directory of Open Access Journals (Sweden)

    B G Jayasheel

    2010-01-01

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

  12. 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)

  13. 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

  14. 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)

  15. 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.

  16. Basic requirements for personnel monitoring. 1980 ed

    International Nuclear Information System (INIS)

    1980-01-01

    This Code of Practice sets forth the objectives of an adequate system of personnel monitoring for radiation workers. It covers individual dosimetry, including internal radiation monitoring, and area monitoring to the extent required for the assessment of individual radiation doses. The responsibilities of authorities for organizing monitoring of radiation workers are discussed, together with brief descriptions of monitoring methods and the rules governing their application. The general principles to be considered in selecting instrumentation and the appropriate monitoring techniques are described, as well as calibration techniques, methods of data handling and record keeping. Current concepts and recommendations of the International Commission on Radiological Protection, as presented in ICRP Publication No.26, have been incorporated. New developments in techniques and instruments have been reflected, and several sections such as calibration and record keeping have been elaborated. The bibliography has been updated and new annexes added.

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

    International Nuclear Information System (INIS)

    Bergren, C.L.

    1992-01-01

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

  18. 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

  19. 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.)

  20. 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)

  1. Regulation E 69-14. Monitoring requirements for medical devices

    International Nuclear Information System (INIS)

    2015-01-01

    In the 'Regulations for the State Evaluation and Registration of Medical Equipment' force (Hereinafter Rules) set forth in Chapter VII, Articles 79 and 86, the monitoring activity as one of the programs necessary for evaluating the safety and effectiveness of medical monitoring equipment. In the years 2008 and 2011 were approved and implemented by the Center for State Control of Medical Equipment (CCEEM) Regulations and -1.1 ER and ER-1 that support and regulatory requirements 'Control and monitoring of pacemakers and implantable defibrillators' and 'Assessment, recording and control after market surgical silicone implants,' which are specific to these products and have provided a useful result for the performance of the activity. Given the number and diversity of high-risk medical devices as implantable or sustain human life that are brought into our National Health System (SNS), a regulation establishing control over the behavior becomes necessary safety and effectiveness of this equipment during use, which provide inputs to risk management. The objective of this regulation is to establish the regulatory requirements for tracking medical equipment introduced in the NHS. The provisions of this Regulation is aimed at health institutions, to CECMED as manufacturers, suppliers, distributors and importers of medical equipment.

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 40 CFR 413.03 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 28 2010-07-01 2010-07-01 true Monitoring requirements. 413.03 Section 413.03 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND... for total toxic organics (TTO), I certify that, to the best of my knowledge and belief, no dumping of...

  7. 40 CFR 425.06 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Monitoring requirements. 425.06 Section 425.06 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS LEATHER TANNING AND FINISHING POINT SOURCE CATEGORY General Provisions § 425.06...

  8. 40 CFR 437.4 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... wastewater resulting from the treatment of metal-bearing waste, oily waste, or organic-bearing waste must... STANDARDS THE CENTRALIZED WASTE TREATMENT POINT SOURCE CATEGORY § 437.4 Monitoring requirements. (a) Permit... compliance for each subpart after treatment and before mixing of the waste with wastes of any other subpart...

  9. 10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

    Science.gov (United States)

    2010-01-01

    ... external and internal occupational dose. Each licensee shall monitor exposures to radiation and radioactive... 10 Energy 1 2010-01-01 2010-01-01 false Conditions requiring individual monitoring of external and internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR...

  10. Monitored Retrievable Storage System Requirements Document

    International Nuclear Information System (INIS)

    1994-03-01

    This Monitored Retrievable Storage System Requirements Document (MRS-SRD) describes the functions to be performed and technical requirements for a Monitored Retrievable Storage (MRS) facility subelement and the On-Site Transfer and Storage (OSTS) subelement. The MRS facility subelement provides for temporary storage, at a Civilian Radioactive Waste Management System (CRWMS) operated site, of spent nuclear fuel (SNF) contained in an NRC-approved Multi-Purpose Canister (MPC) storage mode, or other NRC-approved storage modes. The OSTS subelement provides for transfer and storage, at Purchaser sites, of spent nuclear fuel (SNF) contained in MPCs. Both the MRS facility subelement and the OSTS subelement are in support of the CRWMS. The purpose of the MRS-SRD is to define the top-level requirements for the development of the MRS facility and the OSTS. These requirements include design, operation, and decommissioning requirements to the extent they impact on the physical development of the MRS facility and the OSTS. The document also presents an overall description of the MRS facility and the OSTS, their functions (derived by extending the functional analysis documented by the Physical System Requirements (PSR) Store Waste Document), their segments, and the requirements allocated to the segments. In addition, the top-level interface requirements of the MRS facility and the OSTS are included. As such, the MRS-SRD provides the technical baseline for the MRS Safety Analysis Report (SAR) design and the OSTS Safety Analysis Report design

  11. Regulatory approach of the monitoring the effectiveness of maintenance at nuclear power plants program

    International Nuclear Information System (INIS)

    Vajgel, Stefan

    2009-03-01

    The electrical power generation using nuclear power plants requires this installation being safety, reliable and available for the working periods. For this purpose, an adequate, effective and well conducted maintenance program makes an essential and useful tool to the owner of the plant. However, it is necessary to follow the regulatory requirements for this program implementation which monitories this maintenance effectiveness. There are Brazilian norms requirements which must be followed. The international regulatory guides establish these requirements in good details but it is necessary to verify if this methodology for implementing can be totally applied here in Brazil. Then, the american guide NUMARC 93-01 which details how can be implemented a program for this monitoring, shows some methods for using. In this thesis, the Delphi and Probabilistic Safety Analysis were briefly included because they were preferred for implementing this monitoring.in a Brazilian plant. The results which are being obtained show that, looking the regulatory aspects, the NUMARC 93-01 follows our regulations and gives good results for the plant management. (author)

  12. Requirements for internal contamination monitoring units

    International Nuclear Information System (INIS)

    Werner, E.; Beyer, D.; Doerfel, H.; Erlenbach, H.; Fischbach, G.; Henrichs, K.; Keller, K.D.; Koenig, K.; Riedel, W.; Scheler, R.; Schieferdecker, H.

    1994-01-01

    For the evaluation of internal contamination by officially authorized monitoring units according to section 63 (6) of the German radiation protection ordinance, a directive will be prepared in order to define uniform requirements for the laboratories in charge of incorporation monitoring by appointment of the relevant authorities. These requirements refer to equipment, to performance of measurements, to interpretation of measured values, to quality control as well as to documentation and to delivery of results. The duties of such laboratories comprise measurements of radioactivity, evaluation of intakes of radionuclides and of the resulting internal radiation dose, but also transmission of results to the employer, to the central dose registry, and under certain circumstances to the authorities. Among the requirements to be met by the laboratory for incorporation control are a sufficient measuring efficiency, the implementation of in-house checks, and the participation in intercomparison programs. For the accomplishment of such duties the laboratory needs appropriate apparatus, rooms, facilities, and staffing. (orig.) [de

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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)

  18. Review of FEWS NET Biophysical Monitoring Requirements

    Science.gov (United States)

    Ross, K. W.; Brown, Molly E.; Verdin, J.; Underwood, L. W.

    2009-01-01

    The Famine Early Warning System Network (FEWS NET) provides monitoring and early warning support to decision makers responsible for responding to famine and food insecurity. FEWS NET transforms satellite remote sensing data into rainfall and vegetation information that can be used by these decision makers. The National Aeronautics and Space Administration has recently funded activities to enhance remote sensing inputs to FEWS NET. To elicit Earth observation requirements, a professional review questionnaire was disseminated to FEWS NET expert end-users: it focused upon operational requirements to determine additional useful remote sensing data and; subsequently, beneficial FEWS NET biophysical supplementary inputs. The review was completed by over 40 experts from around the world, enabling a robust set of professional perspectives to be gathered and analyzed rapidly. Reviewers were asked to evaluate the relative importance of environmental variables and spatio-temporal requirements for Earth science data products, in particular for rainfall and vegetation products. The results showed that spatio-temporal resolution requirements are complex and need to vary according to place, time, and hazard: that high resolution remote sensing products continue to be in demand, and that rainfall and vegetation products were valued as data that provide actionable food security information.

  19. 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

  20. 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

  1. Development of an air-operated actuator performance monitoring system for regulatory usage

    International Nuclear Information System (INIS)

    Sung, K. Y.; Kwon, S. J.

    2004-01-01

    The performance monitoring system of air-operated actuators for regulatory usage has been being developed. Essential elements and operating parameters affecting the actuator performance have been investigated to provide basic information for system development. The monitoring system including an air-operated actuator testing facility and analysis softwares for monitoring and evaluation are also introduced in this paper. As a result of simulated tests, it was known that the system could be a useful tool for the effective monitoring of actuator performance change and fault conditions. This system would be applied to regulatory inspection for utility's data validation and to the training of regulatory staff in future after some modification and expansion

  2. Monitoring requirements for assessment of internal dose

    International Nuclear Information System (INIS)

    Eckerman, K.F.

    1985-01-01

    Data obtained by routine personnel monitoring is usually not a sufficient basis for estimation of dose. Collected data must be interpreted carefully and supplemented with appropriate information before reasonably accurate estimates of dose (i.e., accurate enough to indicate whether or nor personnel are exposed in excess of recommended limits) can be developed. When the exposure is of sufficient magnitude that a rather precise estimate of dose is needed, the health physicist will bring to bear on the problem other, more refined, methods of dosimetry. These might include a reconstruction of the incident and, for internal emitters, an extensive series of in vivo measurements or analyses of excreta. Thus, cases of special significance must often be evaluated using techniques and resources beyond those routinely employed. This is not a criticism of most routine monitoring programs. These programs are usually carefully designed in a manner commensurate with the degree of exposure routinely encountered and the requirement of a practical program of radiation protection. 10 refs

  3. The Basic Requirements for Personnel Monitoring

    International Nuclear Information System (INIS)

    1965-01-01

    The code of practice presented here as part of the Agency's Safety Standards deals with the problem of personnel monitoring in establishments in which, or in part of which, work is primarily with radiation sources. It is a development of the fundamental requirements on the subject contained in the Agency's Basic Safety Standards. The code has been prepared by the Secretariat of the Agency on the basis of the work of a panel of experts drawn from a number of Member States. In addition, representatives of several interested international organizations participated in the work of the panel. The Board of Governors of the Agency considered this code of practice in September 1964 and authorized its application to Agency and Agency-assisted operations and recommended to Member States that it be taken into account in the formulation of national regulations or recommendations.

  4. Basic requirements to the methods of personnel monitoring

    International Nuclear Information System (INIS)

    Keirim-Markus, I.B.

    1981-01-01

    Requirements to methods of personnel monitoring (PMM) depending on irradiation conditions are given. The irradiation conditions determine subjected to monitoring types of irradiation, measurement ranges, periodicity of monitoring, operativeness of obtaining results and required accuracy. The PMM based on the photographic effect of ionizing radiation is the main method of the mass monitoring [ru

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-07-01

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

  6. 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

  7. 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)

  8. 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...

  9. 40 CFR 429.12 - Monitoring requirements. [Reserved

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Monitoring requirements. [Reserved] 429.12 Section 429.12 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT... Monitoring requirements. [Reserved] ...

  10. 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)

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-03-15

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

  12. 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

  13. Regulatory Requirements to Combat Illicit Trafficking of Hazardous Materials

    International Nuclear Information System (INIS)

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

    2011-01-01

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

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

    International Nuclear Information System (INIS)

    Servant, J.

    1977-01-01

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

  15. 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

  16. 40 CFR 63.1510 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... Analysis Division; Emission Measurement Center (MD-19), Research Triangle Park, NC 27711. This document... inspector training program; (3) An established correlation between visual inspection and physical... operating parameters to be monitored, the monitoring approach and technique, and how the limit is to be...

  17. 40 CFR 60.563 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... input design capacity of less than 150 million Btu/hr, a temperature monitoring device shall be... input design capacity of 150 million Btu/hr or greater, such records to indicate the periods of... monitoring device shall be installed at the outlet of the absorber. (5) If a condenser is the final unit in a...

  18. 40 CFR 141.132 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... must monitor for alkalinity in the source water prior to any treatment. Systems must take one paired sample and one source water alkalinity sample per month per plant at a time representative of normal... reduce monitoring for both TOC and alkalinity to one paired sample and one source water alkalinity sample...

  19. 15 CFR 971.424 - Monitoring requirements.

    Science.gov (United States)

    2010-01-01

    ... information as necessary to permit evaluation of environmental effects. The environmental monitoring plan and... ENVIRONMENTAL DATA SERVICE DEEP SEABED MINING REGULATIONS FOR COMMERCIAL RECOVERY PERMITS Issuance/Transfer... TCRs; (b) To cooperate with Federal officers and employees in the performance of monitoring functions...

  20. 40 CFR 63.1657 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... practices that minimizes emissions per § 63.6(e)(1)(i) of subpart A. (b) Venturi scrubbers. (1) The owner or operator must monitor the pressure drop across the venturi at least every 5 minutes and record the average...

  1. 40 CFR 63.751 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... challenge the monitors with compounds representative of the gaseous emission stream being controlled. (B) If... substantial heat exchange occurs. (10) Where a catalytic incinerator is used, thermocouples, each equipped...

  2. 40 CFR 63.1303 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ...) Pump revolutions; or (ii) Flow rate. (3) The device used to monitor the parameter from paragraph (b)(2... the National Institute of Standards and Technology Handbook 44 at least once per year by a registered...

  3. 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.

  4. Design basis ground motion (Ss) required on new regulatory guide

    International Nuclear Information System (INIS)

    Kamae, Katsuhiro

    2013-01-01

    New regulatory guide is enforced on July 8. Here, it is introduced how the design basis ground motion (Ss) for seismic design of nuclear power reactor facilities was revised on the new guide. Ss is formulated as two types of earthquake ground motions, earthquake ground motions with site specific earthquake source and with no such specific source locations. The latter is going to be revised based on the recent observed near source ground motions. (author)

  5. 40 CFR 141.74 - Analytical and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Analytical and monitoring requirements... Analytical and monitoring requirements. (a) Analytical requirements. Only the analytical method(s) specified... as set forth in the article “National Field Evaluation of a Defined Substrate Method for the...

  6. 40 CFR 430.02 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... monoxide (Cl2O). (g) Analyst may use NCASI Method CP-86.07, “Chlorinated Phenolics in Water by In situ Acetylation and GC/MS Determination” (January 2002) for determination of certain chlorinated phenols... chlorinated organic pollutants. The following monitoring frequencies apply to discharges subject to subpart B...

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

    International Nuclear Information System (INIS)

    Schroeder, H.C.; Kauer, R.

    2003-01-01

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

  8. 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.)

  9. 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

  10. Radiation monitoring in interventional cardiology: a requirement

    Science.gov (United States)

    Rivera, T.; Uruchurtu, E. S.

    2017-01-01

    The increasing of procedures using fluoroscopy in interventional cardiology procedures may increase medical and patients to levels of radiation that manifest in unintended outcomes. Such outcomes may include skin injury and cancer. The cardiologists and other staff members in interventional cardiology are usually working close to the area under examination and they receive the dose primarily from scattered radiation from the patient. Mexico does not have a formal policy for monitoring and recording the radiation dose delivered in hemodynamic establishments. Deterministic risk management can be improved by monitoring the radiation delivered from X-ray devices. The objective of this paper is to provide cardiologist, techniques, nurses, and all medical staff an information on DR levels, about X-ray risks and a simple a reliable method to control cumulative dose.

  11. Independent regulatory control and monitoring of the environment at the uranium legacy sites under reclamation

    International Nuclear Information System (INIS)

    Shandala, N.K.; Titov, A.V.; Kiselev, S.M.; Isaev, D.V.; Aladova, R.A.

    2012-01-01

    Full text: Radiation safety at areas affected by the natural uranium mining and milling facilities is very important for the environment protection and human health. For this purpose the close operator-regulator contact is required during remedial operations. One of the key mechanisms of the operating regulatory supervision of radiation safety at uranium legacy sites is organization of independent radiation control and monitoring in the course of reclamation and after its completion. The main stages of this strategy include: detailed radiation survey at the area and in the vicinity of the former uranium mining sites; threat assessment in order to identify the regulatory priorities; environmental radiation control and monitoring. Tailings and shallow disposal sites of the uranium mining wastes are the most critical areas in terms of potential hazard for the environment. Tailings are the source of contamination of the near-land air due to the radionuclide dust resuspension from the tailing surface; surface and ground water due to washing out from by precipitation and surface streams of toxic and radioactive elements. Frequently, contamination of surface and ground waters results in some problems, especially when using the leaching fluids for the solution mining and draining hydraulic fluids. Radiation risk for the residents of areas near not operating uranium mining and milling facilities depends on the following factors: radon exhalation from the surface of dumps and tailing; radioactive dust transfer; using radioactive material in building; contamination of surface water streams and aquifers used for drinking water supply; contamination of open ponds used for fish breeding and catching; contamination of foodstuffs grown in the nuclear legacy areas. Radiation monitoring is necessary for the up-to-date response to changing radiation situation during reclamation and arrangement of adequate countermeasures. We mean here comprehensive dynamic surveillance including long

  12. 40 CFR 410.02 - Monitoring requirements. [Reserved

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 28 2010-07-01 2010-07-01 true Monitoring requirements. [Reserved] 410.02 Section 410.02 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT... requirements. [Reserved] ...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-07-01

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

  14. Regulatory considerations for computational requirements for nuclear criticality safety

    International Nuclear Information System (INIS)

    Bidinger, G.H.

    1995-01-01

    As part of its safety mission, the U.S. Nuclear Regulatory Commission (NRC) approves the use of computational methods as part of the demonstration of nuclear criticality safety. While each NRC office has different criteria for accepting computational methods for nuclear criticality safety results, the Office of Nuclear Materials Safety and Safeguards (NMSS) approves the use of specific computational methods and methodologies for nuclear criticality safety analyses by specific companies (licensees or consultants). By contrast, the Office of Nuclear Reactor Regulation approves codes for general use. Historically, computational methods progressed from empirical methods to one-dimensional diffusion and discrete ordinates transport calculations and then to three-dimensional Monte Carlo transport calculations. With the advent of faster computational ability, three-dimensional diffusion and discrete ordinates transport calculations are gaining favor. With the proper user controls, NMSS has accepted any and all of these methods for demonstrations of nuclear criticality safety

  15. Air Quality Science and Regulatory Efforts Require Geostationary Satellite Measurements

    Science.gov (United States)

    Pickering, Kenneth E.; Allen, D. J.; Stehr, J. W.

    2006-01-01

    Air quality scientists and regulatory agencies would benefit from the high spatial and temporal resolution trace gas and aerosol data that could be provided by instruments on a geostationary platform. More detailed time-resolved data from a geostationary platform could be used in tracking regional transport and in evaluating mesoscale air quality model performance in terms of photochemical evolution throughout the day. The diurnal cycle of photochemical pollutants is currently missing from the data provided by the current generation of atmospheric chemistry satellites which provide only one measurement per day. Often peak surface ozone mixing ratios are reached much earlier in the day during major regional pollution episodes than during local episodes due to downward mixing of ozone that had been transported above the boundary layer overnight. The regional air quality models often do not simulate this downward mixing well enough and underestimate surface ozone in regional episodes. Having high time-resolution geostationary data will make it possible to determine the magnitude of this lower-and mid-tropospheric transport that contributes to peak eight-hour average ozone and 24-hour average PM2.5 concentrations. We will show ozone and PM(sub 2.5) episodes from the CMAQ model and suggest ways in which geostationary satellite data would improve air quality forecasting. Current regulatory modeling is typically being performed at 12 km horizontal resolution. State and regional air quality regulators in regions with complex topography and/or land-sea breezes are anxious to move to 4-km or finer resolution simulations. Geostationary data at these or finer resolutions will be useful in evaluating such models.

  16. 40 CFR 146.13 - Operating, monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ...) Monitoring requirements. Monitoring requirements shall, at a minimum, include: (1) The analysis of the... minimum, include: (1) Quarterly reports to the Director on: (i) The physical, chemical and other relevant... in the first aquifer overlying the confining zone. When such a well is installed, the owner or...

  17. Regulatory measures for occupational health monitoring in BARC facilities

    International Nuclear Information System (INIS)

    Rajdeep; Chattopadhyay, S.

    2017-01-01

    Bhabha Atomic Research Centre (BARC) is the premier organization actively engaged in the research and developmental activities related to nuclear science and technology for the benefit of society and the nation. BARC has various facilities like nuclear fuel fabrication facilities, research reactors, spent fuel storage facilities, nuclear fuel re-cycling facilities, radioactive waste management facilities, machining workshops and various Physics, Chemistry and Biological laboratories. In BARC, aspects related to Occupational Safety and Health (OSH) are given paramount importance. The issues related OSH are subjected to multi-tier review process. BARC Safety Council (BSC) is the apex committee in the three-tier safety and security review framework of BARC. BSC functions as regulatory body for BARC facilities. BSC is responsible for occupational safety and health of employees in BARC facilities

  18. 30 CFR 938.16 - Required regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ... consistent with section 510(d) of SMCRA by requiring that the restoration of prime farmland soil productivity... of the reclamation fee, as amended in § 86.17(e), will assure that the Surface Mining Conservation... current market value. (n) By November 1, 1991, Pennsylvania shall amend § 86.158(b)(2) or otherwise amend...

  19. 24 CFR 1710.16 - Regulatory exemption-determination required.

    Science.gov (United States)

    2010-04-01

    ... sewer facilities and any existing or promised amenities; (ii) Contains a good faith estimate of the year... the purchaser signed the sales contract, a warranty deed, or its equivalent under local law, which at... the requirements of one of the exemptions available under this chapter. (2) Each contract— (i...

  20. 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.

  1. Regulatory requirements of radiation protection for veterinary nuclear medicine

    International Nuclear Information System (INIS)

    Ernst-Elz, Andreas

    2010-01-01

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

  2. Regulatory requirements for radiopharmaceutical radiochemistry and radiation dosimetry

    International Nuclear Information System (INIS)

    Bonnyman, J.

    1985-01-01

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

  3. Investigation on regulatory requirements for radiation safety management

    International Nuclear Information System (INIS)

    Han, Eun Ok; Choi, Yoon Seok; Cho, Dae Hyung

    2013-01-01

    NRC recognizes that efficient management of radiation safety plan is an important factor to achieve radiation safety service. In case of Korea, the contents to perform the actual radiation safety management are legally contained in radiation safety management reports based on the Nuclear Safety Act. It is to prioritize the importance of safety regulations in each sector in accordance with the current situation of radiation and radioactive isotopes-used industry and to provide a basis for deriving safety requirements and safety regulations system maintenance by the priority of radiation safety management regulations. It would be helpful to achieve regulations to conform to reality based on international standards if consistent safety requirements is developed for domestic users, national standards and international standards on the basis of the results of questions answered by radiation safety managers, who lead on-site radiation safety management, about the priority of important factors in radioactive sources use, sales, production, moving user companies, to check whether derived configuration requirements for radiation safety management are suitable for domestic status

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

  9. 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

  10. Dynamic SPR monitoring of yeast nuclear protein binding to a cis-regulatory element

    International Nuclear Information System (INIS)

    Mao, Grace; Brody, James P.

    2007-01-01

    Gene expression is controlled by protein complexes binding to short specific sequences of DNA, called cis-regulatory elements. Expression of most eukaryotic genes is controlled by dozens of these elements. Comprehensive identification and monitoring of these elements is a major goal of genomics. In pursuit of this goal, we are developing a surface plasmon resonance (SPR) based assay to identify and monitor cis-regulatory elements. To test whether we could reliably monitor protein binding to a regulatory element, we immobilized a 16 bp region of Saccharomyces cerevisiae chromosome 5 onto a gold surface. This 16 bp region of DNA is known to bind several proteins and thought to control expression of the gene RNR1, which varies through the cell cycle. We synchronized yeast cell cultures, and then sampled these cultures at a regular interval. These samples were processed to purify nuclear lysate, which was then exposed to the sensor. We found that nuclear protein binds this particular element of DNA at a significantly higher rate (as compared to unsynchronized cells) during G1 phase. Other time points show levels of DNA-nuclear protein binding similar to the unsynchronized control. We also measured the apparent association complex of the binding to be 0.014 s -1 . We conclude that (1) SPR-based assays can monitor DNA-nuclear protein binding and that (2) for this particular cis-regulatory element, maximum DNA-nuclear protein binding occurs during G1 phase

  11. Monitoring of the radon exposure in workplaces: Regulatory approaches

    International Nuclear Information System (INIS)

    Ettenhuber, E.

    2002-01-01

    Germany has a reference level of 2 10 6 Bqh/m 3 for radon in workplaces, corresponding to an annual dose of 6 mSv and a limit of 6 10 6 Bqh/m 3 , corresponding to 10 mSv/y. If the reference level is exceeded remedial action has to be taken and a new radon measurement should be carried out. If it is not possible to reduce the radon concentration below the reference level the competent authority has to be notified and monitoring of the radon concentrations performed. Germany has performed a study to investigate the exposure by natural radionuclides in workplaces in a large number of industrial activities, with a dose assessment of the workers under normal circumstances. They made a categorization of NORM activities in dose ranges of 20 mSv/y. Most of the NORM activities fall in the category <1 mSv/y when normal occupational hygiene measures are taken

  12. 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

  13. 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

  14. 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...

  15. 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)

  16. 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.

  17. 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)

  18. Regulatory Monitoring of Human Performance in PWR Operation in France

    International Nuclear Information System (INIS)

    LESOT, Jean Pascal; BALLOFFET, Yves

    1998-01-01

    The authors present the main components of an action initiated by the French Safety Authority to assess and possibly correct the way in which EDF takes the human factor into account in its power plants. After a description of the operation of the French Safety Authority, they recall the interest of the authority in human factors, the first steps taken on this issue in the 1990's, briefly describe the response made by EDF on three main themes: man/machine interface, training, changes in work methods and involvement and behaviour of players. They evoke the tools used by EDF to implement the third theme on site, the structures set up by EDF to develop this policy, outline the prerequisites required by the Safety Authority, and indicate the means used by ths authority. They give examples of incidents and associated reactive inspection

  19. 30 CFR 75.336 - Sampling and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... concentration of other sampling locations in the sealed area and other required information. Before miners... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Sampling and monitoring requirements. 75.336... SAFETY AND HEALTH MANDATORY SAFETY STANDARDS-UNDERGROUND COAL MINES Ventilation § 75.336 Sampling and...

  20. 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

  1. 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.

  2. 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

  3. Requirements to a Norwegian National Automatic Gamma Monitoring System

    International Nuclear Information System (INIS)

    Lauritzen, B.; Hedemann Jensen, P.; Nielsen, F.

    2005-04-01

    An assessment of the overall requirements to a Norwegian gamma-monitoring network is undertaken with special emphasis on the geographical distribution of automatic gamma monitoring stations, type of detectors in such stations and the sensitivity of the system in terms of ambient dose equivalent rate increments above the natural background levels. The study is based upon simplified deterministic calculations of the radiological consequences of generic nuclear accident scenarios. The density of gamma monitoring stations has been estimated from an analysis of the dispersion of radioactive materials over large distances using historical weather data; the minimum density is estimated from the requirement that a radioactive plume may not slip unnoticed in between stations of the monitoring network. The sensitivity of the gamma monitoring system is obtained from the condition that events that may require protective intervention measures should be detected by the system. Action levels for possible introduction of sheltering and precautionary foodstuff restrictions are derived in terms of ambient dose equivalent rate. For emergency situations where particulates contribute with only a small fraction of the total ambient dose equivalent rate from the plume, it is concluded that measurements of dose rate are sufficient to determine the need for sheltering; simple dose rate measurements however, are inadequate to determine the need for foodstuff restrictions and spectral measurements are required. (au)

  4. 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.

  5. Proposed radioactive liquid effluent monitoring requirements at the Savannah River Site

    International Nuclear Information System (INIS)

    Jannik, G.T.; Carlton, W.H.; Blunt, B.C.

    1994-01-01

    Clear regulatory guidance exists for structuring a radiological air monitoring program, however, there is no parallel guidance for radiological liquid monitoring. For Department of Energy (DOE) facilities, there are no existing applicable federal regulations, DOE orders, or DOE guidance documents that specify at what levels continuous monitoring, continuous sampling, or periodic confirmatory measurements of radioactive liquid effluents must be made. In order to bridge this gap and to technically justify and document liquid effluent monitoring decisions at DOE's Savannah River Site, Westinghouse Savannah River Company has proposed that a graded, dose-based approach be established, in conjunction with limits on facility radionuclide inventories, to determine the monitoring and sampling criteria to be applied at each potential liquid radioactive effluent point. The graded approach would be similar to--and a conservative extension of--the existing, agreed-upon SRS/EPA-IV airborne effluent monitoring approach documented in WSRC's NESHAP Quality Assurance Project Plan. The limits on facility radionuclide inventories are based on--and are a conservative extension of--the 10 CFR 834, 10 CFR 20, and SCR 61-63 annual limits on discharges to sanitary sewers. Used in conjunction with each other, the recommended source category criteria levels and facility radionuclide inventories would allow for the best utilization of resources and provide consistent, technically justifiable determinations of radioactive liquid effluent monitoring requirements

  6. 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

  7. The regulatory system of monitoring workers in Germany for intakes of radioactivity

    International Nuclear Information System (INIS)

    Dalheimer, A.; Henrichs, K.

    1996-01-01

    In Germany, the working group 'Incorporation Monitoring' of the German-Swiss Radiation Protection Association defined a new standard for the monitoring of workers occupationally exposed to radioactive material. During the last two years this draft has been accepted by the German government in the form of three guidelines. The purpose of the approach was the installation of a consistent state-of-the-art system: defining clear criteria for the necessity of routine and special monitoring programs, giving guidelines for monitoring programs ensuring that dose assessments are as reliable as necessary with the lowest possible expenses, standardizing as far as possible the procedures of dose assessments, and guaranteeing the necessary quality standards. The scientific basis of this regulatory system are the publications 30 and 54 of lCRP. (author)

  8. 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

  9. 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.

  10. 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

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

    Directory of Open Access Journals (Sweden)

    Savannah R. Hall

    2016-10-01

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

  12. Review of monitoring uncertainty requirements in the CDM

    International Nuclear Information System (INIS)

    Shishlov, Igor; Bellassen, Valentin

    2014-10-01

    In order to ensure the environmental integrity of carbon offset projects, emission reductions certified under the Clean Development Mechanism (CDM) have to be 'real, measurable and additional', which is ensured through the monitoring, reporting and verification (MRV) process. MRV, however, comes at a cost that ranges from several cents to EUR1.20 and above per ton of CO 2 e depending on the project type. This article analyzes monitoring uncertainty requirements for carbon offset projects with a particular focus on the trade-off between monitoring stringency and cost. To this end, we review existing literature, scrutinize both overarching monitoring guidelines and the 10 most-used methodologies, and finally we analyze four case studies. We find that there is indeed a natural trade-off between the stringency and the cost of monitoring, which if not addressed properly may become a major barrier for the implementation of offset projects in some sectors. We demonstrate that this trade-off has not been systematically addressed in the overarching CDM guidelines and that there are only limited incentives to reduce monitoring uncertainty. Some methodologies and calculation tools as well as some other offset standards, however, do incorporate provisions for a trade-off between monitoring costs and stringency. These provisions may take the form of discounting emissions reductions based on the level of monitoring uncertainty - or more implicitly through allowing a project developer to choose between monitoring a given parameter and using a conservative default value. Our findings support the introduction of an uncertainty standard under the CDM for more comprehensive, yet cost-efficient, accounting for monitoring uncertainty in carbon offset projects. (authors)

  13. Monitoring Requirements Coverage Using Reconstructed Views : An Industrial Case Study

    NARCIS (Netherlands)

    Lormans, M.; Gross, H.; Van Deursen, A.; Van Solingen, R.; Stehouwer, A.

    2006-01-01

    Requirements views, such as coverage and status views, are an important asset for monitoring and managing software development. We have developed a method that automates the process for reconstructing these views, and built a tool, ReqAnalyst, to support this method. In this paper, we investigate to

  14. 75 FR 81126 - Revisions to Lead Ambient Air Monitoring Requirements

    Science.gov (United States)

    2010-12-27

    ... tons per year of lead is necessary to provide sufficient information about airborne lead levels near... Revisions to Lead Ambient Air Monitoring Requirements AGENCY: Environmental Protection Agency (EPA). ACTION...) that revised the primary and secondary National Ambient Air Quality Standards (NAAQS) for lead and...

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

    International Nuclear Information System (INIS)

    Roberts, J.K.

    1976-01-01

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

  16. 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

  17. Monitored Retrievable Storage System Requirements Document. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    This Monitored Retrievable Storage System Requirements Document (MRS-SRD) describes the functions to be performed and technical requirements for a Monitored Retrievable Storage (MRS) facility subelement and the On-Site Transfer and Storage (OSTS) subelement. The MRS facility subelement provides for temporary storage, at a Civilian Radioactive Waste Management System (CRWMS) operated site, of spent nuclear fuel (SNF) contained in an NRC-approved Multi-Purpose Canister (MPC) storage mode, or other NRC-approved storage modes. The OSTS subelement provides for transfer and storage, at Purchaser sites, of spent nuclear fuel (SNF) contained in MPCs. Both the MRS facility subelement and the OSTS subelement are in support of the CRWMS. The purpose of the MRS-SRD is to define the top-level requirements for the development of the MRS facility and the OSTS. These requirements include design, operation, and decommissioning requirements to the extent they impact on the physical development of the MRS facility and the OSTS. The document also presents an overall description of the MRS facility and the OSTS, their functions (derived by extending the functional analysis documented by the Physical System Requirements (PSR) Store Waste Document), their segments, and the requirements allocated to the segments. In addition, the top-level interface requirements of the MRS facility and the OSTS are included. As such, the MRS-SRD provides the technical baseline for the MRS Safety Analysis Report (SAR) design and the OSTS Safety Analysis Report design.

  18. 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.

  19. 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

  20. 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.)

  1. Requirements to a Norwegian national automatic gamma monitoring system

    DEFF Research Database (Denmark)

    Lauritzen, B.; Jensen, Per Hedemann; Nielsen, F.

    2005-01-01

    increments above the natural background levels. The study is based upon simplified deterministic calculations of the radiological consequences of generic nuclear accident scenarios. The density of gammamonitoring stations has been estimated from an analysis of the dispersion of radioactive materials over......An assessment of the overall requirements to a Norwegian gamma-monitoring network is undertaken with special emphasis on the geographical distribution of automatic gamma monitoring stations, type of detectors in such stations and the sensitivity of thesystem in terms of ambient dose equivalent rate...

  2. 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

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  4. 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.

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

    International Nuclear Information System (INIS)

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

    1985-08-01

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

  6. 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...

  7. Baseline requirements for assessment of mining impact using biological monitoring

    International Nuclear Information System (INIS)

    Humphrey, C.L.; Dostine, P.L.

    1995-01-01

    Biological monitoring programmes for environmental protection should provide for both early detection of possible adverse effects, and assessment of the ecological significance of these effects. Monitoring techniques are required that include responses sensitive to the impact, that can be subjected to rigorous statistical analysis and for which statistical power is high. Such issues in baseline research of 'what and how to measure?' and 'for how long?' have been the focus of a programme being developed to monitor and assess effects of mining operations on the essentially pristine, freshwater ecosystems of the Alligator Rivers Region (ARR) in tropical northern Australia. Application of the BACIP (Before, After, Control, Impact, Paired differences) design, utilizing a form of temporal replication, to univariate (single species) and multivariate (community) data is described. The BACIP design incorporates data from single control and impact sites. We argue for modification of the design for particular studies conducted in streams, to incorporate additional independent control sites from adjacent catchment. Inferential power, by way of (i) more confidently attributing cause to an observed change and (ii) providing information about the ecological significance of the change, will be enhanced using a modified BACIP design. In highly valued environments such as the ARR, monitoring programmes require application of statistical tests with high power to guarantee that an impact no greater than a prescribed amount has gone undetected. A minimum number of baseline years using the BACIP approach would therefore be required in order to achieve some desired level of statistical power. This paper describes the results of power analyses conducted on 2-5 years (depending upon the technique) of baseline data from streams of the ARR and discuss the implications of these results for management. 44 refs., 1 tab., 3 figs

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-05-01

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

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

  10. 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.

  11. 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.

  12. Regulatory approach of the monitoring the effectiveness of maintenance at nuclear power plants program; Abordagem regulatoria do programa de monitoracao da eficacia da manutencao para usinas nucleoeletricas

    Energy Technology Data Exchange (ETDEWEB)

    Vajgel, Stefan

    2009-03-15

    The electrical power generation using nuclear power plants requires this installation being safety, reliable and available for the working periods. For this purpose, an adequate, effective and well conducted maintenance program makes an essential and useful tool to the owner of the plant. However, it is necessary to follow the regulatory requirements for this program implementation which monitories this maintenance effectiveness. There are Brazilian norms requirements which must be followed. The international regulatory guides establish these requirements in good details but it is necessary to verify if this methodology for implementing can be totally applied here in Brazil. Then, the american guide NUMARC 93-01 which details how can be implemented a program for this monitoring, shows some methods for using. In this thesis, the Delphi and Probabilistic Safety Analysis were briefly included because they were preferred for implementing this monitoring.in a Brazilian plant. The results which are being obtained show that, looking the regulatory aspects, the NUMARC 93-01 follows our regulations and gives good results for the plant management. (author)

  13. 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)

  14. [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.

  15. 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)

  16. 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)

  17. Engineering Runtime Requirements-Monitoring Systems Using MDA Technologies

    Science.gov (United States)

    Skene, James; Emmerich, Wolfgang

    The Model-Driven Architecture (MDA) technology toolset includes a language for describing the structure of meta-data, the MOF, and a language for describing consistency properties that data must exhibit, the OCL. Off-the-shelf tools can generate meta-data repositories and perform consistency checking over the data they contain. In this paper we describe how these tools can be used to implement runtime requirements monitoring of systems by modelling the required behaviour of the system, implementing a meta-data repository to collect system data, and consistency checking the repository to discover violations. We evaluate the approach by implementing a contract checker for the SLAng service-level agreement language, a language defined using a MOF meta-model, and integrating the checker into an Enterprise JavaBeans application. We discuss scalability issues resulting from immaturities in the applied technologies, leading to recommendations for their future development.

  18. 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)

  19. 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.

  20. 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)

  1. 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

  2. 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

  3. Requirements for internal contamination monitoring units; Anforderungen an Inkorporationsmessstellen

    Energy Technology Data Exchange (ETDEWEB)

    Werner, E. [GSF, Inst. fuer Biophysikalische Strahlenforschung, Frankfurt am Main (Germany); Beyer, D. [Forschungszentrum Juelich, Abt. ASS (Germany); Doerfel, H. [Hauptabteilung Sicherheit, Kernforschungszentrum Karlsruhe (Germany); Erlenbach, H. [Zentralstelle fuer Sicherheitstechnik NRW, Duesseldorf (Germany); Fischbach, G. [Siemens Brennelementewerk, Hanau (Germany); Henrichs, K. [Siemens AG, Muenchen (Germany); Keller, K.D. [Radiologische Universitaetsklinik, Tuebingen (Germany); Koenig, K. [Bundesamt fuer Strahlenschutz, ISH, Neuherberg (Germany); Riedel, W. [Freie Univ. Berlin, Klinikum Steglitz (Germany); Scheler, R. [Bundesamt fuer Strahlenschutz, FB Strahlenschutz, Berlin (Germany); Schieferdecker, H. [Hauptabteilung Sicherheit, Kernforschungszentrum Karlsruhe (Germany)

    1994-12-31

    For the evaluation of internal contamination by officially authorized monitoring units according to section 63 (6) of the German radiation protection ordinance, a directive will be prepared in order to define uniform requirements for the laboratories in charge of incorporation monitoring by appointment of the relevant authorities. These requirements refer to equipment, to performance of measurements, to interpretation of measured values, to quality control as well as to documentation and to delivery of results. The duties of such laboratories comprise measurements of radioactivity, evaluation of intakes of radionuclides and of the resulting internal radiation dose, but also transmission of results to the employer, to the central dose registry, and under certain circumstances to the authorities. Among the requirements to be met by the laboratory for incorporation control are a sufficient measuring efficiency, the implementation of in-house checks, and the participation in intercomparison programs. For the accomplishment of such duties the laboratory needs appropriate apparatus, rooms, facilities, and staffing. (orig.) [Deutsch] Zur Ermittlung der Koerperdosen nach Paragraph 63 StrlSchV sind fuer die gemaess Abs. 6 von der zustaendigen Behoerde zu bestimmenden Messstellen in einer Richtlinie einheitliche Anforderungen festzulegen. Diese beziehen sich auf deren Ausstattung, die Durchfuehrung der Messungen, Auswertungen und Qualitaetskontrollen sowie die Aufzeichnung und Uebermittlung der Ergebnisse. Die Aufgaben der Messstellen umfassen die Messungen der Radioaktivitaet im Koerper bzw. in Koerperausscheidungen, die Ermittlung der Zufuhr an Radionukliden sowie der daraus resultierenden Koerperdosis und die Weiterleitung der Ergebnisse an den Auftraggeber, an das zentrale Dosisregister und in bestimmten Faellen an die Behoerde. Zu den von einer Messstelle zu erfuellenden Anforderungen gehoeren eine ausreichende Messeffektivitaet, die Durchfuehrung von Eigenkontrollen

  4. Preliminary site requirements and considerations for a monitored retrievable storage facility

    International Nuclear Information System (INIS)

    1991-08-01

    This report presents preliminary requirements and considerations for siting monitored retrievable storage (MRS) facility. It purpose is to provide guidance for assessing the technical suitability of potential sites for the facility. It has been reviewed by the NRC staff, which stated that this document is suitable for ''guidance in making preliminary determinations concerning MRS site suitability.'' The MRS facility will be licensed by the US Nuclear Regulatory Commission. It will receive spent fuel from commercial nuclear power plants and provide a limited amount of storage for this spent fuel. When a geologic repository starts operations, the MRS facility will also stage spent-fuel shipments to the repository. By law, storage at the MRS facility is to be temporary, with permanent disposal provided in a geologic repository to be developed by the DOE

  5. Composition and fundamental requirements of nuclear emergency response monitoring equipment

    International Nuclear Information System (INIS)

    Lai Yongfang; Huang Weiqi; Wang Yonghong

    2009-01-01

    Nuclear emergency monitoring equipment is concrete foundation for accomplishing radiation monitoring in nuclear or radiation accidents. Based on technical report: Generic procedures for monitoring in a nuclear or radiological emergency published by IAEA in 1999, this paper presents the main task and composition of nuclear emergency monitoring briefly, and then the basic equipment and trends of nuclear emergency monitoring equipment is put forward in detail, which is useful to construction and reinforcement of our nuclear emergency monitoring. (authors)

  6. 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.

  7. 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

  8. 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...

  9. 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)

  10. 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

  11. 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

  12. Passive sampling in regulatory chemical monitoring of nonpolar organic compounds in the aquatic environment

    NARCIS (Netherlands)

    Booij, K.; Robinson, C.D.; Burgess, R.M.; Mayer, P.; Roberts, C.A.; Ahrens, L.; Allan, I.J.; Brant, J.; Jones, L.; Kraus, U.R.; Larsen, M.M.; Lepom, P.; Petersen, J.; Pröfrock, D.; Roose, P.; Schäfer, S.; Smedes, F.; Tixier, C.; Vorkamp, K.; Whitehouse, P.

    2016-01-01

    We reviewed compliance monitoring requirements in the EuropeanUnion, the United States, and the Oslo-Paris Convention for the protection of themarine environment of the North-East Atlantic, and evaluated if these are met bypassive sampling methods for nonpolar compounds. The strengths

  13. Overcoming regulatory challenges in the development of companion diagnostics for monitoring and safety.

    Science.gov (United States)

    Shimazawa, Rumiko; Ikeda, Masayuki

    2016-03-01

    Concurrent development and co-approval of a companion diagnostic (CDx) with a corresponding drug is ideal, but often unfeasible. Because of limited exposure to a drug in clinical trials, crucial information on safety is sometimes revealed only after approval. Therefore, a CDx for monitoring/safety is often developed after approval of a corresponding drug. However, regulatory guidance is insufficient if contemporaneous development is not possible, thereby leaving plenty of opportunities for improvement with respect to pharmacovigilance and retrospective validation of the CDx. Furthermore, global harmonization of guidance on how to incorporate new scientific information from retrospective analyses of biomarkers should lead to the establishment of more evidence for the development of CDx for approved drugs.

  14. 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

  15. 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)

  16. [Focus Notified Bodies. New requirements for designation and monitoring].

    Science.gov (United States)

    Poos, U; Edelhäuser, R

    2014-12-01

    For medical devices with a higher risk, Notified Bodies assess whether the manufacturers and their products fulfill the requirements laid down in the European directives on medical devices. Notified Bodies are designated through a designation procedure by the designating authority, in Germany by ZLG. The requirements for the designation arise from the respective annexes of the directives on medical devices. Since these are only minimal criteria, different documents have been compiled on a European and national level to concretize these minimal criteria regarding the organization, quality management system, resources, and certification procedure. The rules of the ZLG are thereby the essential documents for designation in Germany. Moreover, according to Implementing Regulation (EU) no. 912/2013, the European commission and the other European designating authorities also have to be involved in the designation process. The aim of continuous monitoring of the Notified Bodies with assessments on the bodies' premises as well as with observed audits is to ensure the permanent fulfillment of the requirements. If nonconformities are found in a body's quality management system or in its implementation of the conformity assessment procedures, the body is obliged to provide ZLG with a corrective actions plan. In the case that the nonconformities are not resolved in time or critical nonconformities are found, ZLG may take actions, e.g., restrict the scope of designation, suspend, or - as last resort - withdraw the designation.

  17. A review of radiology staff doses and dose monitoring requirements

    International Nuclear Information System (INIS)

    Martin, C. J.

    2009-01-01

    Studies of radiation doses received during X-ray procedures by radiology, cardiology and other clinical staff have been reviewed. Data for effective dose (E), and doses to the eyes, thyroid, hands and legs have been analysed. These data have been supplemented with local measurements to determine the most exposed part of the hand for monitoring purposes. There are ranges of 60-100 in doses to individual tissues reported in the literature for similar procedures at different centres. While ranges in the doses per unit dose-area product (DAP) are between 10 and 25, large variations in dose result from differences in the sensitivity of the X-ray equipment, the type of procedure and the operator technique, but protection factors are important in maintaining dose levels as low as possible. The influence of shielding devices is significant for determining the dose to the eyes and thyroid, and the position of the operator, which depends on the procedure, is the most significant factor determining doses to the hands. A second body dosemeter worn at the level of the collar is recommended for operators with high workloads for use in assessment of effective dose and the dose to the eye. It is proposed that the third quartile values from the distributions of dose per unit DAP identified in the review might be employed in predicting the orders of magnitude of doses to the eye, thyroid and hands, based on interventional operator workloads. Such dose estimates could be employed in risk assessments when reviewing protection and monitoring requirements. A dosemeter worn on the little finger of the hand nearest to the X-ray tube is recommended for monitoring the hand. (authors)

  18. Required accuracy and dose thresholds in individual monitoring

    DEFF Research Database (Denmark)

    Christensen, P.; Griffith, R.V.

    1994-01-01

    this uncertainty factor, a value of 21% can be evaluated for the allowable maximum overall standard deviation for dose measurements at dose levels near the annual dose limits increasing to 45% for dose levels at the lower end of the dose range required to be monitored. A method is described for evaluating...... the overall standard deviation of the dosimetry system by combining random and systematic uncertainties in quadrature, and procedures are also given for determining each individual uncertainty connected to the dose measurement. In particular, attention is paid to the evaluation of the combined uncertainty due...... to energy and angular dependencies of the dosemeter. In type testing of personal dosimetry systems, the estimated overall standard deviation of the dosimetry system is the main parameter to be tested. An important characteristic of a personal dosimetry system is its capability of measuring low doses...

  19. Individual air pollution monitors. 2. Examination of some nonoccupational research and regulatory uses and needs

    Energy Technology Data Exchange (ETDEWEB)

    Morgan, M.G.; Morris, S.C.

    1977-01-01

    Knowledge of the relationship between ambient air pollution levels measured at fixed monitoring stations and the actual exposure of the population is very limited. Indeed, there is rapidly growing evidence that fixed-station monitors do not provide adequate data for population exposure. This report examines available data for carbon monoxide (CO) and sulfur dioxide (SO/sub 2/) and presents a new analysis. Actual population exposure to CO appears to be consistently higher than expected from fixed-station data, while limited evidence suggests that exposures to SO/sub 2/ are lower. A reported general relationship between indoor and outdoor levels of SO/sub 2/ is not supported by the data. If air pollution represents a threat to public health, then more attention must be given to total population exposure to pollutants. A selective use of individual air pollution monitors that can be worn or carried appears to be required at some stage by any experimental design seeking to uncover the relation between air pollution exposure and health effects. Additionally, potential uses of individual monitoring in air pollution regulation are explored. Current status and research needs for individual air pollution monitors are examined and a first-order evaluation is given of the promise held by the candidate instrumentation technologies. A national program of support for the development of individual air pollution monitors is recommended.

  20. 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.

  1. 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)

  2. 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

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

    International Nuclear Information System (INIS)

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

    2000-01-01

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

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

    International Nuclear Information System (INIS)

    LeClair, J.; Ashley, F.

    2006-01-01

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

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

    Science.gov (United States)

    Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

    2007-09-01

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

  6. 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)

  7. 40 CFR 60.256 - Continuous monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... facilities that use wet scrubber emission control equipment: (A) A monitoring device for the continuous measurement of the pressure loss through the venturi constriction of the control equipment. The monitoring... paragraph (c) of this section. (2) For mechanical vents with wet scrubbers, monitoring devices according to...

  8. 77 FR 64244 - Revision to Ambient Nitrogen Dioxide Monitoring Requirements

    Science.gov (United States)

    2012-10-19

    ... characterization of NO 2 exposure for susceptible and vulnerable populations.\\3\\ The EPA Regional Administrators... demands of funding other new and expanded monitoring networks, including the source and population lead... NO 2 monitors which are the second near-road NO 2 monitor in any CBSA with a population of 2,500,000...

  9. 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...

  10. 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)

  11. 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.

  12. 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

  13. 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

  14. 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)

  15. Passive Sampling in Regulatory Chemical Monitoring of Nonpolar Organic Compounds in the Aquatic Environment

    DEFF Research Database (Denmark)

    Booij, Kees; Robinson, Craig D; Burgess, Robert M

    2016-01-01

    We reviewed compliance monitoring requirements in the European Union, the United States, and the Oslo-Paris Convention for the protection of the marine environment of the North-East Atlantic, and evaluated if these are met by passive sampling methods for nonpolar compounds. The strengths...... is the best available technology for chemical monitoring of nonpolar organic compounds. Key issues to be addressed by scientists and environmental managers are outlined....... and shortcomings of passive sampling are assessed for water, sediments, and biota. Passive water sampling is a suitable technique for measuring concentrations of freely dissolved compounds. This method yields results that are incompatible with the EU's quality standard definition in terms of total concentrations...

  16. On the move to business alignment of service monitoring requirements

    NARCIS (Netherlands)

    de Alencar Silva, P.; Weigand, H.; van Sinderen, M.; Johnson, P.S.; de Alencar Silva, P.

    2011-01-01

    Current service monitoring capabilities have been not designed in alignment with business needs. We argue that service monitoring should be primarily thought of as an economic concern, with proper needs being elicited on the business strategy level and further drilled down to process and IT services

  17. 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

  18. Critical evaluation of factors required to terminate the postclosure monitoring period at solid waste landfills

    DEFF Research Database (Denmark)

    Barlaz, M.A.; Rooker, A.P.; Kjeldsen, Peter

    2002-01-01

    Regulations governing the disposal of solid waste in landfills specify that they must be monitored for 30 years after closure unless this period is extended by the governing regulatory authority. Given the wide range of conditions under which refuse is buried, technical criteria, rather than...

  19. 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

  20. 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

  1. [Incorporation monitoring of employees of a radioiodine therapy ward. Is incorporation monitoring required for routine?].

    Science.gov (United States)

    Happel, C; Kratzel, U; Selkinski, I; Bockisch, B; Etzel, M; Korkusuz, H; Sauter, B; Staudt, J; von Müller, F; Grünwald, F; Kranert, W T

    2013-01-01

    Aim of the study was to determine the annual incorporation of staff on a radioiodine therapy ward and the resulting annual effective dose (aed). Following the German incorporation guideline (gig), incorporation monitoring is not necessary for potential aed below 0.5 mSv/a. For aed > 0.5 mSv/a adherence to the 1 mSv dose limit must be verified. For doses > 1 mSv/a incorporation has to be monitored by the authority. Furthermore, the (131)I incorporation factor from the gig should be verified. To determine the actual work related incorporation, the (131)I activity concentration in urine samples (collection over 24 h) of 14 employees of different professions were examined over a period of 27 months. Measured activity concentrations were related to the individual time of exposure. A constant activity supply for at least three days was assumed. The mean annual effective doses were 2.4 · 10⁻¹ mSv/a (nursing staff; n = 3), 5.6 · 10⁻² mSv/a (cleaning staff; n = 2), 2.8 · 10⁻³ mSv/a (technical staff; n = 2) and 5.2 · 10⁻³ mSv/a (physicians; n = 7). All aed were below the dose limits of the gig. The calculated mean incorporation factors ranged from 3.0 · 10⁻⁸ for the nursing staff to 3.6 · 10⁻¹⁰ for the technical staff (cleaning staff: 7 · 10⁻⁹; physicians: 6.5 · 10⁻¹⁰) and were therefore well below the (131)I incorporation factor defined by the gig. To estimate the aed caused by incorporation of (131)I it has to be subdivided for the different requirements in the diverse fields of activity of the employees. Regarding those who spend most of their time nearby the patient an incorporation monitoring by the authority might be required. The (131)I incorporation factor from the guideline (10⁻⁶) can be reduced by a factor of 10. For (99m)Tc and (18)F an incorporation factor of 10⁻⁷ is accepted.

  2. 5 CFR 575.212 - Internal monitoring requirements and revocation or suspension of authority.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Internal monitoring requirements and... MANAGEMENT CIVIL SERVICE REGULATIONS RECRUITMENT, RELOCATION, AND RETENTION INCENTIVES; SUPERVISORY DIFFERENTIALS; AND EXTENDED ASSIGNMENT INCENTIVES Relocation Incentives § 575.212 Internal monitoring...

  3. 5 CFR 575.312 - Internal monitoring requirements and revocation or suspension of authority.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Internal monitoring requirements and... MANAGEMENT CIVIL SERVICE REGULATIONS RECRUITMENT, RELOCATION, AND RETENTION INCENTIVES; SUPERVISORY DIFFERENTIALS; AND EXTENDED ASSIGNMENT INCENTIVES Retention Incentives § 575.312 Internal monitoring...

  4. Evaluation of spot and passive sampling for monitoring, flux estimation and risk assessment of pesticides within the constraints of a typical regulatory monitoring scheme.

    Science.gov (United States)

    Zhang, Zulin; Troldborg, Mads; Yates, Kyari; Osprey, Mark; Kerr, Christine; Hallett, Paul D; Baggaley, Nikki; Rhind, Stewart M; Dawson, Julian J C; Hough, Rupert L

    2016-11-01

    In many agricultural catchments of Europe and North America, pesticides occur at generally low concentrations with significant temporal variation. This poses several challenges for both monitoring and understanding ecological risks/impacts of these chemicals. This study aimed to compare the performance of passive and spot sampling strategies given the constraints of typical regulatory monitoring. Nine pesticides were investigated in a river currently undergoing regulatory monitoring (River Ugie, Scotland). Within this regulatory framework, spot and passive sampling were undertaken to understand spatiotemporal occurrence, mass loads and ecological risks. All the target pesticides were detected in water by both sampling strategies. Chlorotoluron was observed to be the dominant pesticide by both spot (maximum: 111.8ng/l, mean: 9.35ng/l) and passive sampling (maximum: 39.24ng/l, mean: 4.76ng/l). The annual pesticide loads were estimated to be 2735g and 1837g based on the spot and passive sampling data, respectively. The spatiotemporal trend suggested that agricultural activities were the primary source of the compounds with variability in loads explained in large by timing of pesticide applications and rainfall. The risk assessment showed chlorotoluron and chlorpyrifos posed the highest ecological risks with 23% of the chlorotoluron spot samples and 36% of the chlorpyrifos passive samples resulting in a Risk Quotient greater than 0.1. This suggests that mitigation measures might need to be taken to reduce the input of pesticides into the river. The overall comparison of the two sampling strategies supported the hypothesis that passive sampling tends to integrate the contaminants over a period of exposure and allows quantification of contamination at low concentration. The results suggested that within a regulatory monitoring context passive sampling was more suitable for flux estimation and risk assessment of trace contaminants which cannot be diagnosed by spot

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-04-15

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

  6. 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)

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

    Science.gov (United States)

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

    2013-01-01

    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. Stimulation with a superagonistic anti-CD28 antibody (clone 9D4) and IL-2 partially reversed the proliferative defect, and this correlated with reversal of the defective calcium mobilization in these cells. Dendritic cells were effective at promoting TR cell proliferation, and under these conditions the proliferative capacity of TR cells was comparable to conventional CD4 lymphocytes. Blocking TGF-β activity abrogated IL-10 expression from these cells, while addition of TGF-β resulted in IL-10 production. These data demonstrate that highly purified populations of TR cells are anergic even in the presence of high doses of IL-2. Furthermore, antigen presenting cells provide proper co-stimulation to overcome the anergic phenotype of TR cells, and under these conditions they are highly sensitive to IL-2. In addition, these data demonstrate for the first time that TGF-β is critical to enable human TR cells to express IL-10. PMID:22562448

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

    International Nuclear Information System (INIS)

    Jobert, Laure; Argentini, Manuela; Tora, Laszlo

    2009-01-01

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

  9. Analytical challenges and regulatory requirements for nasal drug products in europe and the u.s.

    Science.gov (United States)

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

    2014-04-11

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

  10. 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

  11. Basic requirements of dosemeter systems for individual monitoring of external radiation

    International Nuclear Information System (INIS)

    Boehm, J.; Ambrosi, P.

    1985-01-01

    A plea is made for detailed detector independent requirements for dosemeter systems for individual monitoring of external radiation. These requirements should have their origin in the fundamental aspects and concepts of radiation protection for workers, and should be something like a translation of the general principles of individual monitoring into a language easily understandable by producers and users. This work comprises a summary of the general objectives of individual monitoring and discussion of some relevant requirements for dosemeter systems. (orig.) [de

  12. 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

  13. 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.

  14. 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

  15. 50 CFR 216.255 - Requirements for monitoring and reporting.

    Science.gov (United States)

    2010-10-01

    ... animals sighted. (4) Conduct shipboard monitoring to reduce impacts to protected species. Trained marine..., including the time of sighting and the direction of travel, into a marine animal tracking and sighting... will report all marine animals spotted and their directions of travel to the lead scientist onboard the...

  16. 50 CFR 218.5 - Requirements for monitoring and reporting.

    Science.gov (United States)

    2010-10-01

    ... array shall be deployed during daylight hours for each of the days the ship is at sea. (ii) The towed... method for standardizing data collection for VACAPES Range Complex and across range complexes. (e... Monitoring Plan. Data collection methods shall be standardized across range complexes to allow for comparison...

  17. 40 CFR 63.695 - Inspection and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... have detached from the roof rim; holes, tears, or other openings are visible in the seal fabric; the... in the rim seal or seal fabric of the floating roof; a rim seal detached from the floating roof; all... monitoring of a piece of air pollution control equipment in accordance with the applicable provisions of this...

  18. 40 CFR 63.773 - Inspection and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... the condenser design analysis and may be supplemented by the control device manufacturer's... continuous monitoring system shall be designed and operated so that a determination can be made on whether... or process heater with a design heat input capacity equal to or greater than 44 megawatts. (3) The...

  19. 40 CFR 141.40 - Monitoring requirements for unregulated contaminants.

    Science.gov (United States)

    2010-07-01

    ... reporting level b 5—Sampling location c 6—Period during which monitoring to be completed Acetanilide... μg/L EPTDS 1/1/2008-12/31/2010 Acetanilide Pesticide Parent Compounds Acetochlor 34256-82-1 EPA 525.2... preserve each sample separately. Samples collected for the analysis of Acetanilide “parent” pesticides and...

  20. Data management for urban tree monitoring -- software requirements

    Science.gov (United States)

    Deborah J. ​Boyer; Lara A. Roman; Jason G. Henning; Matthew McFarland; Dana Dentice; Sarah C. Low; Casey Thomas; Glen. Abrams

    2016-01-01

    The creation of this report was organized by the Pennsylvania Horticultural Society (PHS) and the USDA Forest Service Philadelphia Field Station to explore how technology could be used to support the longterm systematic monitoring of urban trees by trained professionals, student interns and volunteers; assist with tree planting and maintenance data processes; and...

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

    International Nuclear Information System (INIS)

    Mykolaychuk, O.; Mayboroda, O.; Krytskyy, V.; Karnaukhov, O.

    2001-01-01

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

  2. 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

  3. 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)

  4. Evolution of ITER tritium confinement strategy and adaptation to Cadrache site conditions and French regulatory requirements

    International Nuclear Information System (INIS)

    Murdoch, D.

    2007-01-01

    The ITER Nuclear Buildings include the Tokamak, Tritium and Diagnostic Buildings (Tokamak Complex) and the Hot Cell and Low Level Radioactive Waste Buildings. The Tritium Confinement Strategy of the Nuclear Buildings comprises key features of the Atmosphere and Vent Detritiation Systems (ADS/VDS) and the Heating, Ventilation and Air Conditioning (HVAC) Systems. The designs developed during the ITER EDA (Engineering Design Activities) for these systems need to be adapted to the specific conditions of the Cadarache site and modified to conform with the regulatory requirements applicable to Installations Nucleaires de Base (INB) - Basic Nuclear Installations - in France. The highest priority for such adaptation has been identified as the Tritium Confinement of the Tokamak Complex and the progress in development of a robust, coherent design concept compliant with French practice is described in the paper. The Tokamak Complex HVAC concept for generic conditions was developed for operational cost minimisation under more extreme climatic conditions (primarily temperature) than those valid for Cadarache, and incorporated recirculation of a large fraction of the air flow through the HVAC systems to achieve this objective. Due to the impracticality of precluding the spread of contamination from areas of higher activity to less contaminated areas, this concept has been abandoned in favour of a once-through configuration, which requires a complete redesign, with revised air change rates, module sizes, layout, redundancy provisions and other features. The ADS/VDS concept developed for the generic design of the ITER Tokamak Complex is undergoing a radical revision in which the system architecture, module sizing and basic process are being optimised for the Cadarache conditions. Investigation is being launched into the implementation of a wet stripper concept to replace the molecular sieve (MS) beds incorporated in the generic design, where concerns have been raised over low

  5. 40 CFR 465.03 - Monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... less than 30 days in advance of the scheduled production and shall provide the chemical analysis of the... this regulation. (a) Periodic analyses for cyanide are not required when both of the following... method required for determination of petroleum hydrocarbons (non-polar material) is given under the...

  6. 40 CFR 63.6125 - What are my monitor installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 12 2010-07-01 2010-07-01 true What are my monitor installation... Combustion Turbines Testing and Initial Compliance Requirements § 63.6125 What are my monitor installation... limitation and you are not using an oxidation catalyst, you must continuously monitor any parameters...

  7. The tritium monitoring requirements of fusion and the status of research

    International Nuclear Information System (INIS)

    Nickerson, S.B.; Gerdingh, R.F.; Penfold, K.

    1982-10-01

    This report is a summary of an investigation into the tritium monitoring requirements of tritium laboratories, D-T burning ignition experiments, and fusion reactors. There is also a summary of the status of research into tritium monitoring and a survey of commercially available tritium monitors

  8. Pre-criticality testing of radiation monitors associated with protective and regulatory channels of PHWRs and related work

    International Nuclear Information System (INIS)

    Tripathi, S.M.; Rao, Suresh; Mahant, A.K.; Sathian, V.; Ghodke, Shobha; Satam, R.A.; Singh, Yashoda; Phadnis, U.V.; Shaha, V.V.

    2006-01-01

    The paper describes the various experiments that are regularly carried out for each PHWR since RAPS-2. The work involves performance evaluation of start-up counters and ion chambers used in Protective and Regulatory channels and start-up counters used both in-core and out of core. In addition, Radiation Safety Systems Division (RSSD) also carries out calibration of Delayed Neutron Monitors (DNM) and Self Powered Neutron Detectors (SPND). Except SPND, all other detectors are tested not only at BARC but also at reactor sites prior to initial flushing of heavy water, using the actual circuitry and control instruments at site. The performance evaluation of SPNDs is carried out at A-1 location of APSARA reactor core. Apart from these, RSSD also carries out calibration of zonal classification monitors and health physics related radiation monitors at BARC. (author)

  9. 40 CFR 146.68 - Testing and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... the methodology used to make that determination. Compatibility for purposes of this requirement is... the long string casing of the well may be adversely affected by naturally-occurring or man-made events...

  10. 40 CFR 63.7330 - What are my monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ..., vibration detectors, or equivalent means. (b) For each venturi scrubber applied to pushing emissions, you... requirements in § 63.7331(e). (c) For each hot water scrubber applied to pushing emissions, you must at all...

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

    International Nuclear Information System (INIS)

    Sokolov, Eugene N.

    2005-01-01

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

  12. 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)

  13. 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

  14. Inspection frequency required to monitor measurement, recording, or surveillance devices

    International Nuclear Information System (INIS)

    Jaech, J.L.

    1980-01-01

    A problem encountered recently is identical from a mathematical viewpoint to certain types of problems encountered in nuclear materials safeguards. The general form of the solution to the problem in question is therefore of interest in safeguards applications. The specific problem which prompted the investigation is stated as follows. An automatic recording instrument is used in atmospheric monitoring. It is subject to randomly occurring breakdown. The question is, what should be the time interval between the routine checks to provide a specified probability that the recording instrument is functioning properly for at least a given percentage of the time over a specified interval of time. The stated problem is solved in general terms. An application is then made to the specific problem that prompted the study. Applications to specific safeguards problems are left to the reader. 4 refs

  15. The role of national regulatory authority in monitoring of radioactivity and in case of seizure of radioactive or nuclear material

    International Nuclear Information System (INIS)

    Morkunas, G.

    2002-01-01

    Full text: The Radiation Protection Centre is a regulatory authority in radiation protection in Lithuania. Its main tasks are licensing of practices, supervision, control and enforcement of radiation protection requirements, dosimetric, radiometric and spectrometric measurements, evaluation of exposure and its sources, expertise and advice on optimization of radiation protection. Its activities may be divided into two main parts -- regulatory and analytical ones. Food, drinking water, environmental, wipe and other samples are monitored, the appropriate evaluation of doses is done. The data on concentrations of artificial radionuclides in different bodies are available. The laboratory is to be accredited according to the ISO 17025 standard in the framework of Phare Twinning Project. In case of seized radioactive or nuclear material the Radiation Protection Centre has to identify the necessary radiation protection means for members of public and emergency workers, perform measurements of dose rate and radioactive contamination, and, if necessary, evaluate doses received due to the seized radioactive or nuclear material. Since the Radiation Protection Centre has its departments in the largest cities of Lithuania the above mentioned measures can be taken very urgently, especially the ones connected with primary evaluation of situation and identification of optimized radiation protection measures. The Radiation Protection Centre has its own possibilities of identification of radionuclides in the seized material. Such installations as HpGe spectrometers (Oxford and Canberra), equipment for radiochemical separation of U, Pu and actinides, alpha spectrometer, liquid scintillation spectrometer and neutron rem counter are available. There were a few cases when seized material had to be analyzed also. Different sources were found in different places of Lithuania, and it was necessary to define the activity and isotopic content of these sources. The following scheme is used in

  16. 78 FR 66940 - Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Draft...

    Science.gov (United States)

    2013-11-07

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

  17. 40 CFR 63.11517 - What are my monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ...) of this section. (1) Daily Method 9 testing for welding, Tier 2 or 3. Perform visual determination of... to the requirements of paragraph (d)(1) of this section. (3) Monthly Method 9 testing for welding... Method 22 testing for welding, Tier 2 or 3. If, after two consecutive months of testing, the average of...

  18. 40 CFR 63.11563 - What are my monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ... device; or (iv) By comparing the sensor output to the output from a temperature simulator. (5) Conduct... and the following requirements: (1) Locate the temperature sensor in a position that provides a representative temperature. (2) For a noncryogenic temperature range, use a temperature sensor with a minimum...

  19. 50 CFR 660.14 - Vessel Monitoring System (VMS) requirements.

    Science.gov (United States)

    2010-10-01

    ... communications service provider receives the transmission and relays it to NMFS OLE. (b) Who is Required to Have... unit and to arrange for a NMFS OLE type-approved communications service provider to receive and relay... exemption reports must be submitted by fax or by emailing an electronic copy of the actual report. In the...

  20. 78 FR 16184 - Revision to Ambient Nitrogen Dioxide Monitoring Requirements

    Science.gov (United States)

    2013-03-14

    ... requirements is for the characterization of NO 2 exposure for susceptible and vulnerable populations.\\3\\ The... intended to characterize NO 2 exposures of susceptible and vulnerable populations. Specifically, the... vulnerable populations. 1. Proposed Changes In consideration of the limited availability of state and federal...

  1. 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

  2. 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.

  3. 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

  4. Risk-Based Radioactive Liquid Effluent Monitoring Requirements at the U. S. Department of Energy's Savannah River Site

    International Nuclear Information System (INIS)

    Jannik, G.T.

    2001-01-01

    For Department of Energy (DOE) facilities, clear regulatory guidance exists for structuring radiological air emissions monitoring programs. However, there are no parallel regulations for radiological liquid effluent monitoring programs. In order to bridge this gap and to technically justify liquid effluent monitoring decisions at DOE's Savannah River Site, a graded, risk-basked approach has been established to determine the monitoring and sampling criteria to be applied at each liquid discharge point

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

    Science.gov (United States)

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

    2017-01-01

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

  6. 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

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

    Science.gov (United States)

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

    2016-11-01

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

  8. Enhanced self-monitoring blood glucose in non-insulin requiring Type 2 diabetes: A qualitative study in primary care.

    Science.gov (United States)

    Brackney, Dana Elisabeth

    2018-03-31

    To contribute to both theoretical and practical understanding of the role of self-monitoring blood glucose for self-management by describing the experience of people with non-insulin requiring Type 2 diabetes in an enhanced structured self-monitoring blood glucose intervention. The complex context of self-monitoring blood glucose in Type 2 diabetes requires a deeper understanding of the clients' illness experience with structured self-monitoring of blood glucose. Clients' numeracy skills contribute to their response to blood glucose readings. Nurses' use of motivational interviewing to increase clients' regulatory self-efficacy is important to the theoretical perspective of the study. A qualitative descriptive study. A purposive sample of eleven adults recently (diabetes who had experienced a structured self-monitoring blood glucose intervention participated in this study. Audio recordings of semi-structured interviews and photos of logbooks were analyzed for themes using constant comparison and member checking. The illness experience states of Type 2 diabetes include 'Diagnosis', 'Behavior change', and 'Routine checking'. People check blood glucose to confirm their Type 2 diabetes diagnosis, to console their diabetes related fears, to create personal explanations of health behavior's impact on blood glucose, to activate behavior change and to congratulate their diabetes self-management efforts. These findings support the Transtheoretical model's stages of change and change processes. Blood glucose checking strengthens the relationships between theoretical concepts found in Diabetes Self-management Education-Support including: engagement, information sharing, and behavioral support. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  9. Comparison and Cost Analysis of Drinking Water Quality Monitoring Requirements versus Practice in Seven Developing Countries

    Directory of Open Access Journals (Sweden)

    Jonny Crocker

    2014-07-01

    Full Text Available Drinking water quality monitoring programs aim to support provision of safe drinking water by informing water quality management. Little evidence or guidance exists on best monitoring practices for low resource settings. Lack of financial, human, and technological resources reduce a country’s ability to monitor water supply. Monitoring activities were characterized in Cambodia, Colombia, India (three states, Jordan, Peru, South Africa, and Uganda according to water sector responsibilities, monitoring approaches, and marginal cost. The seven study countries were selected to represent a range of low resource settings. The focus was on monitoring of microbiological parameters, such as E. coli, coliforms, and H2S-producing microorganisms. Data collection involved qualitative and quantitative methods. Across seven study countries, few distinct approaches to monitoring were observed, and in all but one country all monitoring relied on fixed laboratories for sample analysis. Compliance with monitoring requirements was highest for operational monitoring of large water supplies in urban areas. Sample transport and labor for sample collection and analysis together constitute approximately 75% of marginal costs, which exclude capital costs. There is potential for substantive optimization of monitoring programs by considering field-based testing and by fundamentally reconsidering monitoring approaches for non-piped supplies. This is the first study to look quantitatively at water quality monitoring practices in multiple developing countries.

  10. Comparison and cost analysis of drinking water quality monitoring requirements versus practice in seven developing countries.

    Science.gov (United States)

    Crocker, Jonny; Bartram, Jamie

    2014-07-18

    Drinking water quality monitoring programs aim to support provision of safe drinking water by informing water quality management. Little evidence or guidance exists on best monitoring practices for low resource settings. Lack of financial, human, and technological resources reduce a country's ability to monitor water supply. Monitoring activities were characterized in Cambodia, Colombia, India (three states), Jordan, Peru, South Africa, and Uganda according to water sector responsibilities, monitoring approaches, and marginal cost. The seven study countries were selected to represent a range of low resource settings. The focus was on monitoring of microbiological parameters, such as E. coli, coliforms, and H2S-producing microorganisms. Data collection involved qualitative and quantitative methods. Across seven study countries, few distinct approaches to monitoring were observed, and in all but one country all monitoring relied on fixed laboratories for sample analysis. Compliance with monitoring requirements was highest for operational monitoring of large water supplies in urban areas. Sample transport and labor for sample collection and analysis together constitute approximately 75% of marginal costs, which exclude capital costs. There is potential for substantive optimization of monitoring programs by considering field-based testing and by fundamentally reconsidering monitoring approaches for non-piped supplies. This is the first study to look quantitatively at water quality monitoring practices in multiple developing countries.

  11. [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.

  12. NRC TLD [Nuclear Regulatory Commission thermoluminescent dosimeter] direct radiation monitoring network

    International Nuclear Information System (INIS)

    Struckmeyer, R.; McNamara, N.

    1990-03-01

    This report presents the results of the NRC Direct Radiation Monitoring Network for the fourth quarter of 1989. It provides the ambient radiation levels measured in the vicinity of 75 sites throughout the United States. In addition, it describes the equipment used, monitoring station selection criteria, characterization of the dosimeter response, calibration procedures, statistical methods, intercomparison, and quality assurance program

  13. 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

  14. 30 CFR 250.457 - What equipment is required to monitor drilling fluids?

    Science.gov (United States)

    2010-07-01

    ... monitor the drilling fluid returns. The indicator may be located in the drilling fluid-logging compartment... 30 Mineral Resources 2 2010-07-01 2010-07-01 false What equipment is required to monitor drilling... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Drilling Operations...

  15. 40 CFR 141.87 - Monitoring requirements for water quality parameters.

    Science.gov (United States)

    2010-07-01

    ... § 141.87 Monitoring requirements for water quality parameters. All large water systems, and all small- and medium-size systems that exceed the lead or copper action level shall monitor water quality... methods. (i) Tap samples shall be representative of water quality throughout the distribution system...

  16. 40 CFR 98.414 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Monitoring and QA/QC requirements. 98.414 Section 98.414 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Suppliers of Industrial Greenhouse Gases § 98.414 Monitoring...

  17. Ground Water Monitoring Requirements for Hazardous Waste Treatment, Storage and Disposal Facilities

    Science.gov (United States)

    The groundwater monitoring requirements for hazardous waste treatment, storage and disposal facilities (TSDFs) are just one aspect of the Resource Conservation and Recovery Act (RCRA) hazardous waste management strategy for protecting human health and the

  18. Implementation of the waste management transfer act. Requirements from a regulatory point of view

    International Nuclear Information System (INIS)

    Mueller-Dehn, Christian

    2017-01-01

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

  19. Mound Plant Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    Bauer, L.R.; Tullis, M.S.; Paulick, R.P.; Roush, L.L.

    1994-07-01

    The purpose of this Environmental Monitoring Plan (EMP) is to describe the environmental monitoring and surveillance programs in place at Mound. The Plan is required by DOE Order 5400.1 (DOE, 1990). The programs described in the EMP are required by the DOE 5400 Order series and by the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environment Surveillance (DOE 1991a), referred to as the Regulatory Guide throughout this Plan

  20. NRC [Nuclear Regulatory Commission] TLD [thermoluminescent dosimeter] direct radiation monitoring network

    International Nuclear Information System (INIS)

    Struckmeyer, R.; McNamara, N.

    1989-09-01

    This report provides the status and results of the NRC Thermoluminescent Dosimeter (TLD) Direct Radiation Monitoring Network. It presents the radiation levels measured in the vicinity of NRC licensed facility sites throughout the country for the second quarter of 1989

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

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1990-01-01

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

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

    International Nuclear Information System (INIS)

    Yanke, R.

    2002-01-01

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

  3. 75 FR 20269 - Regulatory Reporting Requirements for the Indian Community Development Block Grant Program

    Science.gov (United States)

    2010-04-19

    .... Second, this rule requires ICDBG grantees to use the Logic Model form developed as part of HUD's Notice of Funding Availability (NOFA) process. The required use of the Logic Model will conform the ICDBG reporting requirements to those of other HUD competitive funding programs, and enhance the evaluation of...

  4. An assessment of seismic monitoring in the United States; requirement for an Advanced National Seismic System

    Science.gov (United States)

    ,

    1999-01-01

    This report assesses the status, needs, and associated costs of seismic monitoring in the United States. It sets down the requirement for an effective, national seismic monitoring strategy and an advanced system linking national, regional, and urban monitoring networks. Modernized seismic monitoring can provide alerts of imminent strong earthquake shaking; rapid assessment of distribution and severity of earthquake shaking (for use in emergency response); warnings of a possible tsunami from an offshore earthquake; warnings of volcanic eruptions; information for correctly characterizing earthquake hazards and for improving building codes; and data on response of buildings and structures during earthquakes, for safe, cost-effective design, engineering, and construction practices in earthquake-prone regions.

  5. Information processing requirements for on-board monitoring of automatic landing

    Science.gov (United States)

    Sorensen, J. A.; Karmarkar, J. S.

    1977-01-01

    A systematic procedure is presented for determining the information processing requirements for on-board monitoring of automatic landing systems. The monitoring system detects landing anomalies through use of appropriate statistical tests. The time-to-correct aircraft perturbations is determined from covariance analyses using a sequence of suitable aircraft/autoland/pilot models. The covariance results are used to establish landing safety and a fault recovery operating envelope via an event outcome tree. This procedure is demonstrated with examples using the NASA Terminal Configured Vehicle (B-737 aircraft). The procedure can also be used to define decision height, assess monitoring implementation requirements, and evaluate alternate autoland configurations.

  6. Radiometric monitoring of contaminated scrap metals imported in Italy. Technical and regulatory features

    International Nuclear Information System (INIS)

    Dobici, F.; Piermattei, S.; Susanna, A.

    1996-01-01

    During these last ten years there have been occasional reports of mishaps from trafficking of contaminated scraps or containing radioactive sources. Recently an increase of events indicated that the problem becomes more important as to generate possible consequences, from a radiation protection standpoint, for workers and general public. Following the detection of contaminated metal scraps in some recycling industries and in some consignments entering the Italian borders, the competent Authorities laid down rules to put the matter under control. In this paper technical and regulatory features are discussed. (author)

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

    International Nuclear Information System (INIS)

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

    2001-01-01

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

  8. Guide relative to the regulatory requirements applicable to the radioactive materials transport in airport area

    International Nuclear Information System (INIS)

    2006-02-01

    This guide makes an inventory of all the points necessary for the correct functioning of the transport of radioactive materials in airport zone. Stowage of the parcels, program of radiological protection (P.R.P.), operation of transport, quality assurance, radiation dose evaluation, radiation monitoring, dose optimization, storage management, are the principal points of this guide. (N.C.)

  9. Operational intervention levels and related requirements on radiation monitoring during pre-release / release phase of an accident

    International Nuclear Information System (INIS)

    Carny, P.; Cabanekova, H

    2003-01-01

    In this paper authors discusses required outputs of emergency radiological monitoring in various phases of an accident and rationale of these requirements. In various phases of an accident various intervention levels are important and consequently various radiological quantities should be preferably measured. Distinguished tasks or aims of monitoring in different phases of accident have strong influence on methods of monitoring, instrumentation and capabilities of monitoring groups. Required tasks and outputs of monitoring are discussed

  10. Subsurface Contaminant Focus Area: Monitored Natural Attenuation (MNA)--Programmatic, Technical, and Regulatory Issues

    Energy Technology Data Exchange (ETDEWEB)

    Krupka, Kenneth M.; Martin, Wayne J.

    2001-07-23

    Natural attenuation processes are commonly used for remediation of contaminated sites. A variety of natural processes occur without human intervention at all sites to varying rates and degrees of effectiveness to attenuate (decrease) the mass, toxicity, mobility, volume, or concentration of organic and inorganic contaminants in soil, groundwater, and surface water systems. The objective of this review is to identify potential technical investments to be incorporated in the Subsurface Contaminant Focus Area Strategic Plan for monitored natural attenuation. When implemented, the technical investments will help evaluate and implement monitored natural attenuation as a remediation option at DOE sites. The outcome of this review is a set of conclusions and general recommendations regarding research needs, programmatic guidance, and stakeholder issues pertaining to monitored natural attenuation for the DOE complex.

  11. 24 CFR 1710.15 - Regulatory exemption-multiple site subdivision-determination required.

    Science.gov (United States)

    2010-04-01

    ... non-waivable provision in bold face type (which must be distinguished from the type used for the rest... contract or other document by requiring a specific type of notice or by requiring that notice be given at a... font. A copy of the acknowledgement will be maintained by the developer for three years and will be...

  12. 40 CFR 141.86 - Monitoring requirements for lead and copper in tap water.

    Science.gov (United States)

    2010-07-01

    ... copper in tap water. 141.86 Section 141.86 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... § 141.86 Monitoring requirements for lead and copper in tap water. (a) Sample site location. (1) By the... the water system can collect the number of lead and copper tap samples required in paragraph (c) of...

  13. 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

  14. An assessment of monitoring requirements and costs of 'Reduced Emissions from Deforestation and Degradation'

    Directory of Open Access Journals (Sweden)

    McCallum Ian

    2009-08-01

    Full Text Available Abstract Background Negotiations on a future climate policy framework addressing Reduced Emissions from Deforestation and Degradation (REDD are ongoing. Regardless of how such a framework will be designed, many technical solutions of estimating forest cover and forest carbon stock change exist to support policy in monitoring and accounting. These technologies typically combine remotely sensed data with ground-based inventories. In this article we assess the costs of monitoring REDD based on available technologies and requirements associated with key elements of REDD policy. Results We find that the design of a REDD policy framework (and specifically its rules can have a significant impact on monitoring costs. Costs may vary from 0.5 to 550 US$ per square kilometre depending on the required precision of carbon stock and area change detection. Moreover, they follow economies of scale, i.e. single country or project solutions will face relatively higher monitoring costs. Conclusion Although monitoring costs are relatively small compared to other cost items within a REDD system, they should be shared not only among countries but also among sectors, because an integrated monitoring system would have multiple benefits for non-REDD management. Overcoming initialization costs and unequal access to monitoring technologies is crucial for implementation of an integrated monitoring system, and demands for international cooperation.

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

    International Nuclear Information System (INIS)

    1997-01-01

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

  16. Nuclear reactor effluent monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Minns, J.L.; Essig, T.H. [Nuclear Regulatory Commission, Washington, DC (United States)

    1993-12-31

    Radiological environmental monitoring and effluent monitoring at nuclear power plants is important both for normal operations, as well as in the event of an accident. During normal operations, environmental monitoring verifies the effectiveness of in-plant measures for controlling the release of radioactive materials in the plant. Following an accident, it would be an additional mechanism for estimating doses to members of the general public. This paper identifies the U.S. Nuclear Regulatory Commission (NRC) regulatory basis for requiring radiological environmental and effluent monitoring, licensee conditions for effluent and environmental monitoring, NRC independent oversight activities, and NRC`s program results.

  17. Nuclear reactor effluent monitoring

    International Nuclear Information System (INIS)

    Minns, J.L.; Essig, T.H.

    1993-01-01

    Radiological environmental monitoring and effluent monitoring at nuclear power plants is important both for normal operations, as well as in the event of an accident. During normal operations, environmental monitoring verifies the effectiveness of in-plant measures for controlling the release of radioactive materials in the plant. Following an accident, it would be an additional mechanism for estimating doses to members of the general public. This paper identifies the U.S. Nuclear Regulatory Commission (NRC) regulatory basis for requiring radiological environmental and effluent monitoring, licensee conditions for effluent and environmental monitoring, NRC independent oversight activities, and NRC's program results

  18. 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)

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

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1991-01-01

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

  20. Alignment of process compliance and monitoring requirements in dynamic business collaborations

    Science.gov (United States)

    Comuzzi, Marco

    2017-07-01

    Dynamic business collaborations are intrinsically characterised by change because processes can be distributed or outsourced and partners may be substituted by new ones with enhanced or different capabilities. In this context, compliance requirements management becomes particularly challenging. Partners in a collaboration may join and leave dynamically and tasks over which compliance requirements are specified may be consequently distributed or delegated to new partners. This article considers the issue of aligning compliance requirements in a dynamic business collaboration with the monitoring requirements induced on the collaborating partners when change occurs. We first provide a conceptual model of business collaborations and their compliance requirements, introducing the concept of monitoring capabilities induced by compliance requirements. Then, we present a set of mechanisms to ensure consistency between monitoring and compliance requirements in the presence of change, e.g. when tasks are delegated or backsourced in-house. We also discuss a set of metrics to evaluate the status of a collaboration in respect of compliance monitorability. Finally, we discuss a prototype implementation of our framework.

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

    Directory of Open Access Journals (Sweden)

    Vivian Lin

    2009-02-01

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

  2. Requirements to micro-unmanned aircraft systems in civil protection and environmental monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Fischer-Stabel, Peter; Hardt, Christopher [Univ. of Applied Sciences Trier, Birkenfeld (Germany). Dept. of Environmental Planning

    2013-07-01

    Especially in application fields such as environmental monitoring or in the field of information and operations management with technical or natural disasters, increased demands on communication and sensor technology to micro unmanned aircraft systems (UAS) are given. These are currently covered by the system manufacturers, however inadequately. The use case of wildlife monitoring with micro UAS comes with some special requirements and problems, addressed in this paper. (orig.)

  3. Environmental radiation monitoring during visits of nuclear powered warships to Australian ports: requirements, arrangements and procedures

    International Nuclear Information System (INIS)

    1988-05-01

    The Commonwealth Government has determined conditions to be met when nuclear powered warships visit Australian ports. These conditions include a requirement that appropriate State/Territory and Commonwealth authorities provide a radiation monitoring program to determine whether any radioactivity has been discharged or accidently released from a nuclear powered warship in port; to determine actual or potential levels of any consequent exposure to radiation of members of the public; and to provide this information within a timescale that allows remedial action to be taken. Part 1 of this document sets out the requirements of a radiation monitoring program capable of meeting these objectives. The fundamental arrangements and procedures for implementing the requirements are presented at Part 2 and provide a basis for the development of fully detailed, port specific, radiation monitoring programs

  4. 76 FR 67622 - Modification of Regulatory Provisions Requiring Credit Rating or Assessments in Accordance With...

    Science.gov (United States)

    2011-11-02

    ... requirements to provide a credit rating or other credit assessment as part of an application for financial... that may affect family well-being. This rule would not have any impact on the autonomy or integrity of... rating or other credit assessment as part of an application for financial assistance or an application to...

  5. Toxic Volatile Organic Compounds (VOCs in the Atmospheric Environment: Regulatory Aspects and Monitoring in Japan and Korea

    Directory of Open Access Journals (Sweden)

    Wen-Tien Tsai

    2016-09-01

    Full Text Available In the past decades, hazardous air pollutants (HAPs, so-called air toxics or toxic air pollutants, have been detected in the atmospheric air at low concentration levels, causing public concern about the adverse effect of long-term exposure to HAPs on human health. Most HAPs belong to volatile organic compounds (VOCs. More seriously, most of them are known carcinogens or probably carcinogenic to humans. The objectives of this paper were to report the regulatory aspects and environmental monitoring management of toxic VOCs designated by Japan and Korea under the Air Pollution Control Act, and the Clean Air Conservation Act, respectively. It can be found that the environmental quality standards and environmental monitoring of priority VOCs (i.e., benzene, trichloroethylene, tetrachloroethylene, and dichloromethane have been set and taken by the state and local governments of Japan since the early 2000, but not completely established in Korea. On the other hand, the significant progress in reducing the emissions of some toxic VOCs, including acrylonitrile, benzene, 1,3-butadiene, 1,2-dichloroethane, dichloromethane, chloroform, tetrachloroethylene, and trichloroethylene in Japan was also described as a case study in the brief report paper.

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

    International Nuclear Information System (INIS)

    Kwon, Hyuk Il; Lim, Nam Jin

    2005-01-01

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

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

    International Nuclear Information System (INIS)

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

    2015-01-01

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

  8. The effect of regulatory requirements on the control and instrumentation system designer

    International Nuclear Information System (INIS)

    Golder, J.A.

    1978-01-01

    The difficulties encountered by the designer of control and protection systems for nuclear plant in attempting to satisfy the large number of imprecise regulations and recommendations which exist are described. The absence of fundamental quantitative safety requirements of international acceptability is deplored and the adoption of a major incident criteria expressed in quantitative terms as the basis for the derivation of target design criteria for protection systems and plant components is suggested. (author)

  9. The impact of regulatory control on monitoring of pregnant hospital staff in diagnostic radiology

    International Nuclear Information System (INIS)

    Faulkner, K.; Rawlings, D.J.; Marshall, N.W.

    1997-01-01

    In 1990, the International Commission on Radiological Protection recommended the introduction of a supplementary dose limit for pregnant staff so that the foetus was adequately protected. This dose limit was framed in terms of an abdomen surface dose of 2 mSv for the duration of the pregnancy, once it had been declared. The philosophical basis underlying this supplementary dose limit was the desire to treat the foetus as a member of the public in respect of the occupational exposure of the mother. In the Basic Safety Standards, the International Atomic Energy Agency endorsed the need to limit the foetal dose, but in this document the dose limit refers to the foetus. The introduction of dose limits for foetal exposure to radiation has significant implications for hospitals as many workers are women of child bearing age. The practical implications of this dose limit will be discussed as well as suggested monitoring arrangements. (author)

  10. 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.

  11. 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.

  12. Classical dendritic cells are required for dietary antigen-mediated peripheral regulatory T cell and tolerance induction

    Science.gov (United States)

    Esterházy, Daria; Loschko, Jakob; London, Mariya; Jove, Veronica; Oliveira, Thiago Y.; Mucida, Daniel

    2016-01-01

    Oral tolerance prevents pathological inflammatory responses towards innocuous foreign antigens via peripheral regulatory T cells (pTreg cells). However, whether a particular subset of antigen-presenting cells (APCs) is required during dietary antigen exposure to instruct naïve CD4+ T cells to differentiate into pTreg cells has not been defined. Using myeloid lineage-specific APC depletion in mice, we found that monocyte-derived APCs are dispensable, while classical dendritic cells (cDCs) are critical for pTreg cell induction and oral tolerance. CD11b− cDCs from the gut-draining lymph nodes efficiently induced pTreg cells, and conversely, loss of IRF8-dependent CD11b− cDCs impaired their polarization, although oral tolerance remained intact. These data reveal the hierarchy of cDC subsets in pTreg cell induction and their redundancy during oral tolerance development. PMID:27019226

  13. Regulatory control of natural ionizing sources in Lithuania: Experience based on indoor radon monitoring

    International Nuclear Information System (INIS)

    Mastauskas, A.; Morkunas, G.

    1997-01-01

    The situation in legislation of protection against risks from natural sources of ionizing radiation in Lithuania is described. The requirements of new standards came into conflict with the real situation which has not been evaluated before implementation of these standards. On the basis of recommendations of ICRP Publication 60 and results of indoor radon survey new action levels are being established. (author)

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  15. 40 CFR Table 11 to Subpart G of... - Wastewater-Inspection and Monitoring Requirements for Waste Management Units

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Wastewater-Inspection and Monitoring Requirements for Waste Management Units 11 Table 11 to Subpart G of Part 63 Protection of Environment... and Monitoring Requirements for Waste Management Units To comply with Inspection or monitoring...

  16. Input data requirements for performance modelling and monitoring of photovoltaic plants

    DEFF Research Database (Denmark)

    Gavriluta, Anamaria Florina; Spataru, Sergiu; Sera, Dezso

    2018-01-01

    This work investigates the input data requirements in the context of performance modeling of thin-film photovoltaic (PV) systems. The analysis focuses on the PVWatts performance model, well suited for on-line performance monitoring of PV strings, due to its low number of parameters and high......, modelling the performance of the PV modules at high irradiances requires a dataset of only a few hundred samples in order to obtain a power estimation accuracy of ~1-2\\%....

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

    International Nuclear Information System (INIS)

    Baron, Jorge

    2006-01-01

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

  18. Awareness during anaesthesia for surgery requiring evoked potential monitoring: A pilot study

    Directory of Open Access Journals (Sweden)

    Pritish J Korula

    2017-01-01

    Full Text Available Background: Evoked potential monitoring such as somatosensory-evoked potential (SSEP or motor-evoked potential (MEP monitoring during surgical procedures in proximity to the spinal cord requires minimising the minimum alveolar concentrations (MACs below the anaesthetic concentrations normally required (1 MAC to prevent interference in amplitude and latency of evoked potentials. This could result in awareness. Our primary objective was to determine the incidence of awareness while administering low MAC inhalational anaesthetics for these unique procedures. The secondary objective was to assess the adequacy of our anaesthetic technique from neurophysiologist′s perspective. Methods: In this prospective observational pilot study, 61 American Society of Anesthesiologists 1 and 2 patients undergoing spinal surgery for whom intraoperative evoked potential monitoring was performed were included; during the maintenance phase, 0.7-0.8 MAC of isoflurane was targeted. We evaluated the intraoperative depth of anaesthesia using a bispectral (BIS index monitor as well as the patients response to surgical stimulus (PRST scoring system. Post-operatively, a modified Bruce questionnaire was used to verify awareness. The adequacy of evoked potential readings was also assessed. Results: Of the 61 patients, no patient had explicit awareness. Intraoperatively, 19 of 61 patients had a BIS value of above sixty at least once, during surgery. There was no correlation with PRST scoring and BIS during surgery. Fifty-four out of 61 patient′s evoked potential readings were deemed ′good′ or ′fair′ for the conduct of electrophysiological monitoring. Conclusions: This pilot study demonstrates that administering low MAC inhalational anaesthetics to facilitate evoked potential monitoring does not result in explicit awareness. However, larger studies are needed to verify this. The conduct of SSEP electrophysiological monitoring was satisfactory with the use of this

  19. 40 CFR 141.26 - Monitoring frequency and compliance requirements for radionuclides in community water systems.

    Science.gov (United States)

    2010-07-01

    ... identified in the finished water. (iii) Annual monitoring for strontium-90 and tritium shall be conducted by... requirements for radionuclides in community water systems. 141.26 Section 141.26 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER...

  20. 40 CFR 98.214 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Monitoring and QA/QC requirements. 98.214 Section 98.214 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS... standard method or other enhanced industry consensus standard method published by an industry consensus...

  1. 40 CFR 98.394 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Monitoring and QA/QC requirements. 98... by a consensus-based standards organization exists, such a method shall be used. Consensus-based... (NAESB). (ii) Where no appropriate standard method developed by a consensus-based standards organization...

  2. 40 CFR 98.424 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Monitoring and QA/QC requirements. 98... published by a consensus-based standards organization if such a method exists. Consensus-based standards...). (ii) Where no appropriate standard method developed by a consensus-based standards organization exists...

  3. 40 CFR 98.144 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Monitoring and QA/QC requirements. 98... fraction for each carbonate consumed based on sampling and chemical analysis using an industry consensus... testing method published by an industry consensus standards organization (e.g., ASTM, ASME, API, etc.). ...

  4. 40 CFR 98.404 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 20 2010-07-01 2010-07-01 false Monitoring and QA/QC requirements. 98... published by a consensus-based standards organization exists, such a method shall be used. Consensus-based... (NAESB). (ii) Where no appropriate standard method developed by a consensus-based standards organization...

  5. 40 CFR 98.164 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... Methods for Instrumental Determination of Carbon, Hydrogen, and Nitrogen in Petroleum Products and... Determination of Carbon, Hydrogen, and Nitrogen in Laboratory Samples of Coal (incorporated by reference, see... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Hydrogen Production § 98.164 Monitoring and QA/QC requirements...

  6. 40 CFR 63.7331 - What are the installation, operation, and maintenance requirements for my monitors?

    Science.gov (United States)

    2010-07-01

    ... continuous operation according to the site-specific monitoring plan. (e) For each venturi scrubber applied to... across the scrubber and scrubber water flow rate during each push according to the requirements in... all recorded readings. (f) For each hot water scrubber applied to pushing emissions, you must install...

  7. Microbiological Monitoring for the Constellation Program: Current Requirements and Future Considerations

    Science.gov (United States)

    Ott, C. Mark

    2007-01-01

    Microbiological requirements for spaceflight are based on assessments of infectious disease risk which could impact crew health or mission success. The determination of risk from infectious disease is composed of several factors including (1) crew susceptibility, (2) crew exposure to the infectious disease agent, (3) the concentration of the infectious agent, and (4) the characteristics of the infectious agent. As a result of the Health Stabilization Program, stringent monitoring, and cleaning protocols, in-flight environmental microbial monitoring is not necessary for short-duration spaceflights. However, risk factors change for long-duration missions, as exemplified by the presence of medically significant organisms in the environments of both the Mir and International Space Station (ISS). Based upon this historical evidence, requirements for short duration usage aboard the Orion Crew Exploration Vehicle and Lunar Lander Vehicle will not require in-flight monitoring; however, as mission duration increases with a Lunar Outpost, an ability to detect microbial hazard will be necessary. The nature of the detection requirements will depend on the maturity of technology in a rapidly evolving marketplace. Regardless, the hardware will still need to maximize information to discipline experts and the crew, while minimizing the size, mass, power consumption, and crew time usage. The refinement of these monitors will be a major goal in our efforts to travel successfully to Mars.

  8. Required sample size for monitoring stand dynamics in strict forest reserves: a case study

    Science.gov (United States)

    Diego Van Den Meersschaut; Bart De Cuyper; Kris Vandekerkhove; Noel Lust

    2000-01-01

    Stand dynamics in European strict forest reserves are commonly monitored using inventory densities of 5 to 15 percent of the total surface. The assumption that these densities guarantee a representative image of certain parameters is critically analyzed in a case study for the parameters basal area and stem number. The required sample sizes for different accuracy and...

  9. Application of real-time global media monitoring and 'derived questions' for enhancing communication by regulatory bodies: the case of human papillomavirus vaccines.

    Science.gov (United States)

    Bahri, Priya; Fogd, Julianna; Morales, Daniel; Kurz, Xavier

    2017-05-02

    The benefit-risk balance of vaccines is regularly debated by the public, but the utility of media monitoring for regulatory bodies is unclear. A media monitoring study was conducted at the European Medicines Agency (EMA) concerning human papillomavirus (HPV) vaccines during a European Union (EU) referral procedure assessing the potential causality of complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) reported to the authorities as suspected adverse reactions. To evaluate the utility of media monitoring in real life, prospective real-time monitoring of worldwide online news was conducted from September to December 2015 with inductive content analysis, generating 'derived questions'. The evaluation was performed through the validation of the predictive capacity of these questions against journalists' queries, review of the EMA's public statement and feedback from EU regulators. A total of 4230 news items were identified, containing personal stories, scientific and policy/process-related topics. Explicit and implicit concerns were identified, including those raised due to lack of knowledge or anticipated once more information would be published. Fifty derived questions were generated and categorised into 12 themes. The evaluation demonstrated that providing the media monitoring findings to assessors and communicators resulted in (1) confirming that public concerns regarding CRPS and POTS would be covered by the assessment; (2) meeting specific information needs proactively in the public statement; (3) predicting all queries from journalists; and (4) altering the tone of the public statement with respectful acknowledgement of the health status of patients with CRSP or POTS. The study demonstrated the potential utility of media monitoring for regulatory bodies to support communication proactivity and preparedness, intended to support trusted safe and effective vaccine use. Derived questions seem to be a familiar and effective

  10. IDENTIFICATION OF DOE'S POST-CLOSURE MONITORING NEEDS AND REQUIREMENTS

    Energy Technology Data Exchange (ETDEWEB)

    M.A. Ebadian, Ph.D.

    1999-01-01

    The 2006 plan sets an ambitious agenda for the U.S. Department of Energy (DOE), Office of Environmental Management (EM) and the remediation of sites contaminated by decades of nuclear weapons production activities. The plan's primary objective is to reduce overall clean up costs by first eliminating the environmental problems that are most expensive to control and safely maintain. In the context of the 2006 Plan, closure refers to the completion of area or facility specific cleanup projects. The cleanup levels are determined by the planned future use of the site or facility. Use restrictions are still undecided for most sites but are highly probable to exclude residential or agricultural activities. Most of the land will be remediated to ''industrial use'' levels with access restrictions and some areas will be closed-off through containment. Portions of the site will be reserved for waste disposal, either as a waste repository or the in-situ immobilization of contaminated soil and groundwater, and land use will be restricted to waste disposal only. The land used for waste disposal will require monitoring and maintenance activities after closure. Most of the land used for industrial use may also require such postclosure activities. The required postclosure monitoring and maintenance activities will be imposed by regulators and stakeholders. Regulators will not approve closure plans without clearly defined monitoring methods using approved technologies. Therefore, among all other more costly and labor-intensive closure-related activities, inadequate planning for monitoring and lack of appropriate monitoring technologies can prevent closure. The purpose of this project is to determine, document, and track the current and evolving postclosure monitoring requirements at DOE-EM sites. This information will aid CMST-CP in guiding its postclosure technology development and deployment efforts.

  11. Influence of regulatory requirements for nuclear power plants on the backfitting of Austrian research reactors

    International Nuclear Information System (INIS)

    Boeck, H.; Hammer, J.

    1985-01-01

    In general the licensing and backfitting activities have once more demonstrated the fact that safety assessment of a research reactor is by no means just a scaled-down version of a nuclear power plant licensing procedure. Naturally the risk potential is much lower, however, the very nature of research calls for much more flexibility in operation, for temporary installations and for experimental methods which cannot be covered by detailed regulations in advance. Therefore the application of nuclear power reactor criteria to such facilities has to be considered with extreme caution. If NPP standards are applicable at all, they have to be carefully interpreted in each individual case. It is interesting to compare the original reactor safety reports with their modern versions: emphasis has shifted from reactivity accident calculations to thermal-hydraulic considerations, to better instrumentation (both in quality and quantity) and to more effort in reducing, measuring and documenting all radioactive effluents. This tendency is also reflected in most of the backfitting requirements. In summary, the result of the lengthy licensing and backfitting process is certainly a considerable improvement in performance and safety of the Austrian research reactors

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

    Science.gov (United States)

    Djuris, Jelena; Djuric, Zorica

    2017-11-30

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

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

    Science.gov (United States)

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

    2013-01-01

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

  14. The Endocytic Recycling Regulatory Protein EHD1 Is Required for Ocular Lens Development

    Science.gov (United States)

    Arya, Priyanka; Rainey, Mark A.; Bhattacharyya, Sohinee; Mohapatra, Bhopal; George, Manju; Kuracha, Murali R; Storck, Matthew D.; Band, Vimla; Govindarajan, Venkatesh; Band, Hamid

    2015-01-01

    The C-terminal Eps15 homology domain-containing (EHD) proteins play a key role in endocytic recycling, a fundamental cellular process that ensures the return of endocytosed membrane components and receptors back to the cell surface. To define the in vivo biological functions of EHD1, we have generated Ehd1 knockout mice and previously reported a requirement of EHD1 for spermatogenesis. Here, we show that approximately 56% of the Ehd1-null mice displayed gross ocular abnormalities, including anophthalmia, aphakia, microphthalmia and congenital cataracts. Histological characterization of ocular abnormalities showed pleiotropic defects that include a smaller or absent lens, persistence of lens stalk and hyaloid vasculature, and deformed optic cups. To test whether these profound ocular defects resulted from the loss of EHD1 in the lens or in non-lenticular tissues, we deleted the Ehd1 gene selectively in the presumptive lens ectoderm using Le-Cre. Conditional Ehd1 deletion in the lens resulted in developmental defects that included thin epithelial layers, small lenses and absence of corneal endothelium. Ehd1 deletion in the lens also resulted in reduced lens epithelial proliferation, survival and expression of junctional proteins E-cadherin and ZO-1. Finally, Le-Cre-mediated deletion of Ehd1 in the lens led to defects in corneal endothelial differentiation. Taken together, these data reveal a unique role for EHD1 in early lens development and suggest a previously unknown link between the endocytic recycling pathway and regulation of key developmental processes including proliferation, differentiation and morphogenesis. PMID:26455409

  15. Identification of a cis-regulatory region of a gene in Arabidopsis thaliana whose induction by dehydration is mediated by abscisic acid and requires protein synthesis.

    Science.gov (United States)

    Iwasaki, T; Yamaguchi-Shinozaki, K; Shinozaki, K

    1995-05-20

    In Arabidopsis thaliana, the induction of a dehydration-responsive gene, rd22, is mediated by abscisic acid (ABA) but the gene does not include any sequence corresponding to the consensus ABA-responsive element (ABRE), RYACGTGGYR, in its promoter region. The cis-regulatory region of the rd22 promoter was identified by monitoring the expression of beta-glucuronidase (GUS) activity in leaves of transgenic tobacco plants transformed with chimeric gene fusions constructed between 5'-deleted promoters of rd22 and the coding region of the GUS reporter gene. A 67-bp nucleotide fragment corresponding to positions -207 to -141 of the rd22 promoter conferred responsiveness to dehydration and ABA on a non-responsive promoter. The 67-bp fragment contains the sequences of the recognition sites for some transcription factors, such as MYC, MYB, and GT-1. The fact that accumulation of rd22 mRNA requires protein synthesis raises the possibility that the expression of rd22 might be regulated by one of these trans-acting protein factors whose de novo synthesis is induced by dehydration or ABA. Although the structure of the RD22 protein is very similar to that of a non-storage seed protein, USP, of Vicia faba, the expression of the GUS gene driven by the rd22 promoter in non-stressed transgenic Arabidopsis plants was found mainly in flowers and bolted stems rather than in seeds.

  16. Regulatory requirements for radiation safety in the design of a new Finish NPP

    Energy Technology Data Exchange (ETDEWEB)

    Alm-Lytz, Kirsi; Vilkamo, Olli [Radiation and Nuclear Safety Authority, STUK, PO Box 14, Laippatie 4, 00881 Helsinki (Finland)

    2004-07-01

    There are two operating nuclear power plants in Finland, two BWR units at Olkiluoto site and two PWR units at Loviisa site. These reactors were commissioned between 1977 and 1981. The total electricity capacity in Finland is about 15 GW. In 2003, nuclear power plants generated one fourth of Finland's electricity. Despite of the diversity of the electricity generation methods, Finland is highly dependent on imported energy. Electricity consumption is estimated to increase and the demand for extra capacity has been estimated at about 2500-3000 MW by 2010. It should also be taken into account that a considerable proportion of the production capacity constructed in the 1970's must be replaced with production capacity of new power plants in the near future. In practice, the climate politics commitments made by Finland exclude coal power. Therefore, the capacity can be increased significantly only by natural gas, nuclear power and biofuels. The paper presents the following issues: Licensing a new nuclear power plant in Finland; FIN5 Project at STUK; Work planning and a tool for requirement management; Radiation safety related YVL guides; Collective dose target; On-site habitability during accident situation. Habitability was evaluated on the basis of the calculated dose rate levels, the occupancy times and the dose limits. Radiation hazard was classified into three parts, i.e., possible direct radiation from the containment, air contamination and systems carrying radioactive air or water. The results showed that direct radiation from the containment is generally adequately shielded but penetrations and hatches have to be separately analysed and the radiation dose levels near them are usually rather high. Skyshine radiation from the reactor containment is a special feature at the Loviisa NPP and the nearby area outside the buildings might have very limited access for the first hours after the accident. The skyshine effect is not usually relevant hazard in

  17. Functions and requirements for Hanford single-shell tank leakage detection and monitoring

    International Nuclear Information System (INIS)

    Cruse, J.M.; Ohl, P.C.

    1995-01-01

    This document provides the initial functions and requirements for leakage detection and monitoring applicable to past and potential future leakage from the Hanford Site's 149 single-shell high-level waste tanks. This mission is a part of the overall mission of the Westinghouse Hanford Company Tank Waste Remediation System division to remediate the tank waste in a safe and acceptable manner. Systems engineering principles are being applied to this effort. This document reflects the an initial step in the systems engineering approach to decompose the mission into primary functions and requirements. The document is considered approximately 30% complete relative to the effort required to produce a final version that can be used to support demonstration and/or procurement of technologies. The functions and requirements in this document apply to detection and monitoring of below ground leaks from SST containment boundaries and the resulting soil contamination. Leakage detection and monitoring is invoked in the TWRS Program in three fourth level functions: (1) Store Waste, (2) Retrieve Waste, and (3) Disposition Excess Facilities (as identified in DOE/RL-92-60 Rev. 1, Tank Waste Remediation System Functions and Requirements)

  18. General technical requirements (GTR) for inventory monitoring systems (IMS) for the trilateral initiative

    International Nuclear Information System (INIS)

    Pshakin, Gennady M.; Kuleshov, I.; Shea, T.; Puckett, J.M.; Zhukov, I.; Mangan, Dennis L.; Matter, John C.; Waddoups, I.; Smathers, D.; Abhold, M.E.; Hsue, S.-T.; Chiaro, P.

    2002-01-01

    Pursuant to the Trilateral Initiative, the three parties (The Russian Federation, the United States, and the International Atomic Energy Agency) have been engaged in discussions concerning the structure of reliable monitoring systems for storage facilities having large inventories. The intent of these monitoring systems is to provide the capability for the IAEA to maintain continuity of knowledge in a sufficiently reliable manner that should there be equipment failure, loss of continuity of knowledge would be restricted to a small population of the inventory, and thus reinventory of the stored items would be minimized These facility-specific monitoring systems, referred to as Inventory Monitoring Systems (IMS) are to provide the principal means for the M A to assure that the containers of fissile material remain accounted under the Verification Agreements which are to be concluded between the IAEA and the Russian Federation and the lAEA and the United States for the verification of weapon-origin and other fissile material specified by each State as released from its defense programs. A technical experts working group for inventory monitoring systems has been meeting since Feb- of 2000 to formulate General Technical Requirements (GTR) for Inventory Monitoring Systems for the Trilateral Initiative. Although provisional agreement has been reached by the three parties concerning the GTR, it is considered a living document that can be updated as warranted by the three parties. This paper provides a summary of the GTR as it currently exists.

  19. Regulatory requirements on the design and construction of nuclear power plant control and instrumentation systems in Finland

    International Nuclear Information System (INIS)

    Heikkila, M.A.

    1978-01-01

    The Department of Reactor Safety of the Institute of Radiation Protection, being the nuclear regulatory authority in Finland, has set up regulations which govern the design and construction of NPP systems and components. The regulations are partly compiled from existing codes and standards, published primarily in the United States and Federal Republic of Germany, and partly worked out at the Institute. The regulations are collected to a special set of YVL guides (guides for nuclear power plants), and one of these gives requirements on the design and construction of NPPCI systems and components. The scope of the requirements is based on the safety classification of the CI systems and components. Three safety classes have been singled out: the first for CI systems which take part in reactor protection, the second for other directly safety related, and the third for remaining CI systems important enough to deserve supervision. The safety class for CI components is inherited from the system they belong to. The safety classification of IC systems has direct bearing on the initial assumptions of plant accident analysis. The design principles of IC systems are inspected as part of the preliminary and final safety reports. Focus is directed on the principles of redundancy, separation, diversity, testability, etc. The requirements on IC components are directed to different stages of manufacture, installation and operation. The type tests shall be adequate and acceptably documented. The manufacture of components is followed, the test reports reviewed and the efficiency of manufacturers quality assurance program evaluated. Further requirements concern the installation phase and tests at the end of it, and finally guides include directions for maintenance and testing during the operations phase. (author)

  20. The use of a medical dictionary for regulatory activities terminology (MedDRA) in prescription-event monitoring in Japan (J-PEM).

    Science.gov (United States)

    Yokotsuka, M; Aoyama, M; Kubota, K

    2000-07-01

    The Medical Dictionary for Regulatory Activities Terminology (MedDRA) version 2.1 (V2.1) was released in March 1999 accompanied by the MedDRA/J V2.1J specifically for Japanese users. In prescription-event monitoring in Japan (J-PEM), we have employed the MedDRA/J for data entry, signal generation and event listing. In J-PEM, the lowest level terms (LLTs) in the MedDRA/J are used in data entry because the richness of LLTs is judged to be advantageous. A signal is generated normally at the preferred term (PT) level, but it has been found that various reporters describe the same event using descriptions that are potentially encoded by LLTs under different PTs. In addition, some PTs are considered too specific to generate the proper signal. In the system used in J-PEM, when an LLT is selected as a candidate to encode an event, another LLT under a different PT, if any, is displayed on the computer screen so that it may be coded instead of, or in addition to, the candidate LLT. The five-level structure of the MedDRA is used when listing events but some modification is required to generate a functional event list.

  1. Monitoring groundwater: optimising networks to take account of cost effectiveness, legal requirements and enforcement realities

    Science.gov (United States)

    Allan, A.; Spray, C.

    2013-12-01

    The quality of monitoring networks and modeling in environmental regulation is increasingly important. This is particularly true with respect to groundwater management, where data may be limited, physical processes poorly understood and timescales very long. The powers of regulators may be fatally undermined by poor or non-existent networks, primarily through mismatches between the legal standards that networks must meet, actual capacity and the evidentiary standards of courts. For example, in the second and third implementation reports on the Water Framework Directive, the European Commission drew attention to gaps in the standards of mandatory monitoring networks, where the standard did not meet the reality. In that context, groundwater monitoring networks should provide a reliable picture of groundwater levels and a ';coherent and comprehensive' overview of chemical status so that anthropogenically influenced long-term upward trends in pollutant levels can be tracked. Confidence in this overview should be such that 'the uncertainty from the monitoring process should not add significantly to the uncertainty of controlling the risk', with densities being sufficient to allow assessment of the impact of abstractions and discharges on levels in groundwater bodies at risk. The fact that the legal requirements for the quality of monitoring networks are set out in very vague terms highlights the many variables that can influence the design of monitoring networks. However, the quality of a monitoring network as part of the armory of environmental regulators is potentially of crucial importance. If, as part of enforcement proceedings, a regulator takes an offender to court and relies on conclusions derived from monitoring networks, a defendant may be entitled to question those conclusions. If the credibility, reliability or relevance of a monitoring network can be undermined, because it is too sparse, for example, this could have dramatic consequences on the ability of a

  2. Geotechnical instrumentation requirements for atdepth testing and repository monitoring in tuff

    International Nuclear Information System (INIS)

    Zimmerman, R.M.

    1983-01-01

    This paper outlines geotechnical instrumentation requirements for the possible establishment of a nuclear waste repository in tuff on the Nevada Test Site (NTS). The Nuclear Regulatory Commission (NRC) has specified a continuing program to confirm performance during the operational period of the repository, which could last 50 years. Minimum required geotechnical measurements for confirmation of performance include thermal and thermomechanical responses; changes in stress, strain, and displacements; and pore pressure and groundwater flow characteristics. Conditions expected in tuff are: maximum rock temperatures of less than 250 0 C, stresses less than 100 MPa, strains between + or -0.01 mm/mm, and pore pressures less than 35 KPa in the unsaturated zone where hydraulic head is not the primary contributor. The paper describes instrumentation needed to make the desired measurements. In general, the instrumentation and data system are required to be stable and reliable for tens of years. Designs must consider requirements for temperature stability, temperature expansion compensation, moisture resistance, and long-term durability in mining-type environments. Severe requirements such as these suggest consideration of techniques for in-situ replacement of instrumentation. State-of-the-art instrumentation is briefly described along with a discussion of needs for refinement, replacement/recalibration and instrumentation development

  3. Safety system status monitoring

    International Nuclear Information System (INIS)

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide

  4. Safety system status monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, J.R.; Morgenstern, M.H.; Rideout, T.H.; Cowley, P.J.

    1984-03-01

    The Pacific Northwest Laboratory has studied the safety aspects of monitoring the preoperational status of safety systems in nuclear power plants. The goals of the study were to assess for the NRC the effectiveness of current monitoring systems and procedures, to develop near-term guidelines for reducing human errors associated with monitoring safety system status, and to recommend a regulatory position on this issue. A review of safety system status monitoring practices indicated that current systems and procedures do not adequately aid control room operators in monitoring safety system status. This is true even of some systems and procedures installed to meet existing regulatory guidelines (Regulatory Guide 1.47). In consequence, this report suggests acceptance criteria for meeting the functional requirements of an adequate system for monitoring safety system status. Also suggested are near-term guidelines that could reduce the likelihood of human errors in specific, high-priority status monitoring tasks. It is recommended that (1) Regulatory Guide 1.47 be revised to address these acceptance criteria, and (2) the revised Regulatory Guide 1.47 be applied to all plants, including those built since the issuance of the original Regulatory Guide.

  5. Ongoing regulatory compliance required.

    Science.gov (United States)

    Harris, Peter

    2005-06-01

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

  6. Monitoring Conformance and Containment for Geological Carbon Storage: Can Technology Meet Policy and Public Requirements?

    Science.gov (United States)

    Lawton, D. C.; Osadetz, K.

    2014-12-01

    The Province of Alberta, Canada identified carbon capture and storage (CCS) as a key element of its 2008 Climate Change strategy. The target is a reduction in CO2 emissions of 139 Mt/year by 2050. To encourage uptake of CCS by industry, the province has provided partial funding to two demonstration scale projects, namely the Quest Project by Shell and partners (CCS), and the Alberta Carbon Trunk Line Project (pipeline and CO2-EOR). Important to commercial scale implementation of CCS will be the requirement to prove conformance and containment of the CO2 plume injected during the lifetime of the CCS project. This will be a challenge for monitoring programs. The Containment and Monitoring Institute (CaMI) is developing a Field Research Station (FRS) to calibrate various monitoring technologies for CO2 detection thresholds at relatively shallow depths. The objective being assessed with the FRS is sensitivity for early detection of loss of containment from a deeper CO2 storage project. In this project, two injection wells will be drilled to sandstone reservoir targets at depths of 300 m and 700 m. Up to four observation wells will be drilled with monitoring instruments installed. Time-lapse surface and borehole monitoring surveys will be undertaken to evaluate the movement and fate of the CO2 plume. These will include seismic, microseismic, cross well, electrical resistivity, electromagnetic, gravity, geodetic and geomechanical surveys. Initial baseline seismic data from the FRS will presented.

  7. 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

  8. Management and technical requirements for laboratories in charge of water monitoring

    International Nuclear Information System (INIS)

    Ottaviani, M.; Bonadonna, L.; Lucentini, L.; Pettine, P.

    2008-01-01

    This report completes the series of volumes focused on microbiological (Rapporti ISTISAN 07/5) and chemical methods (Rapporti ISTISAN 07/31) for the monitoring of water intended for human consumption according to the Italian Legislative Decree 31/2001 (transposition of European Directive 98/83/EC) and its integrations. The guidelines here presented concern management and technical requirements for laboratories in charge of testing parameters required by the Decree also taking into account the criteria stated by the standard UNI CEI EN ISO/IEC 17025 [it

  9. FOXP3: required but not sufficient. the role of GARP (LRRC32) as a safeguard of the regulatory phenotype.

    Science.gov (United States)

    Probst-Kepper, M; Balling, R; Buer, J

    2010-08-01

    FOXP3 is essential for the development and function of regulatory CD4(+)CD25(hi) T (T(reg)) cells. However, recent evidence suggests that FOXP3 alone is not sufficient to completely explain the regulatory phenotype of these key players in autoimmunity and inflammation: after being activated, conventional human CD4(+) T cells transiently up-regulate FOXP3 without acquiring a regulatory function. Researchers have recently found that glycoprotein A repetitions predominant (GARP, or LRRC32) is a T(reg)-specific receptor that binds latent TGF-beta and dominantly controls FOXP3 and the regulatory phenotype via a positive feedback loop. This finding provides a missing link in our molecular understanding of FOXP3 in T(reg) cells. This viewpoint focuses on GARP as safeguard of FOXP3 and the regulatory phenotype.

  10. Regulatory good practices relating to monitoring and assessment of ageing nuclear power plants. A compilation of the 1991/92 Peer Group discussion considerations as they relate to operational plants. Working material

    International Nuclear Information System (INIS)

    1993-01-01

    In 1974 the IAEA established a Nuclear Safety Standards (NUSS) programme within which 5 Codes and 55 Safety Guides have been produced in the areas of Governmental Organization, Siting, Design, Operation and Quality Assurance. The NUSS Codes and Guides are a collection of basic and derived requirements for the safety of nuclear power plants with thermal neutron reactors. They have been developed in such a manner as to ensure the broadest international consensus. This broad consensus is one of the reasons for the relatively general wording of the main principles and sometimes causes problems when these principles are applied in the design of nuclear power plants. The requirements, particularly those of the Codes, often need interpretation in specific cases. In many areas national regulations and technical standards are available, but often these leave some questions unanswered and their practical application on a case-by-case basis is necessary. To assist in the application and interpretation of the NUSS Safety Standards and Safety Guides, the preparation of a number of Safety Practices publications has been commenced. Ibis publication is intended to assist regulators and also operating organizations. It is a compilation of the reports of the 1991/92 Peer Group discussions which considered regulatory good practices relating to monitoring and assessment of the ageing of nuclear power plants. Therefore names of participated countries in this documents are those at time of 1991/92 Peer Group discussions. It identifies those common regulatory features which require continuous reinforcement and examples of good regulatory practices that were recommended by senior regulators in the Peer Group discussions. The purpose of this publication is to provide a compilation of the 1991/92 Peer Group discussions relating to operational plant. This document the covers practices in the 20 countries participating in this round of Peer Group discussions. The document is a synopsis of

  11. Regulatory good practices relating to monitoring and assessment of ageing nuclear power plants. A compilation of the 1991/92 Peer Group discussion considerations as they relate to operational plants. Working material

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1993-07-01

    In 1974 the IAEA established a Nuclear Safety Standards (NUSS) programme within which 5 Codes and 55 Safety Guides have been produced in the areas of Governmental Organization, Siting, Design, Operation and Quality Assurance. The NUSS Codes and Guides are a collection of basic and derived requirements for the safety of nuclear power plants with thermal neutron reactors. They have been developed in such a manner as to ensure the broadest international consensus. This broad consensus is one of the reasons for the relatively general wording of the main principles and sometimes causes problems when these principles are applied in the design of nuclear power plants. The requirements, particularly those of the Codes, often need interpretation in specific cases. In many areas national regulations and technical standards are available, but often these leave some questions unanswered and their practical application on a case-by-case basis is necessary. To assist in the application and interpretation of the NUSS Safety Standards and Safety Guides, the preparation of a number of Safety Practices publications has been commenced. Ibis publication is intended to assist regulators and also operating organizations. It is a compilation of the reports of the 1991/92 Peer Group discussions which considered regulatory good practices relating to monitoring and assessment of the ageing of nuclear power plants. Therefore names of participated countries in this documents are those at time of 1991/92 Peer Group discussions. It identifies those common regulatory features which require continuous reinforcement and examples of good regulatory practices that were recommended by senior regulators in the Peer Group discussions. The purpose of this publication is to provide a compilation of the 1991/92 Peer Group discussions relating to operational plant. This document the covers practices in the 20 countries participating in this round of Peer Group discussions. The document is a synopsis of

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

    Directory of Open Access Journals (Sweden)

    Sarvari Velaga

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

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

    Science.gov (United States)

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

    2014-01-01

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

  14. Software requirements elicitation to support internal monitoring of quality assurance system for higher education in Indonesia

    Science.gov (United States)

    Amalia, A.; Gunawan, D.; Hardi, S. M.; Rachmawati, D.

    2018-02-01

    The Internal Quality Assurance System (in Indonesian: SPMI (Sistem Penjaminan Mutu Internal) is a systemic activity of quality assurance of higher education in Indonesia. SPMI should be done by all higher education or universities in Indonesia based on the Regulation of the Minister of Research, Technology and Higher Education of the Republic of Indonesia Number 62 of 2016. Implementation of SPMI must refer to the principle of SPMI that is independent, standardize, accurate, well planned and sustainable, documented and systematic. To assist the SPMI cycle properly, universities need a supporting software to monitor all the activities of SPMI. But in reality, many universities are not optimal in building this SPMI monitoring system. One of the obstacles is the determination of system requirements in support of SPMI principles is difficult to achieve. In this paper, we observe the initial phase of the engineering requirements elicitation. Unlike other methods that collect system requirements from users and stakeholders, we find the system requirements of the SPMI principles from SPMI guideline book. The result of this paper can be used as a choice in determining SPMI software requirements. This paper can also be used by developers and users to understand the scenario of SPMI so that could overcome the problems of understanding between this two parties.

  15. 40 CFR Table 7 to Subpart Ggg of... - Wastewater-Inspection and Monitoring Requirements for Waste Management Units

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 11 2010-07-01 2010-07-01 true Wastewater-Inspection and Monitoring Requirements for Waste Management Units 7 Table 7 to Subpart GGG of Part 63 Protection of Environment... for Waste Management Units To comply with Inspection or monitoring requirement Frequency of inspection...

  16. Resolution requirements for monitor viewing of digital flat-panel detector radiographs: a contrast detail analysis

    International Nuclear Information System (INIS)

    Peer, Siegfried; Giacomuzzi, Salvatore M.; Peer, Regina; Gassner, Eva; Steingruber, Iris; Jaschke, Werner

    2003-01-01

    With the introduction of digital flat-panel detector systems into clinical practice, the still unresolved question of resolution requirements for picture archiving communication system (PACS) workstation monitors has gained new momentum. This contrast detail analysis was thus performed to define the differences in observer performance in the detection of small low-contrast objects on clinical 1K and 2K monitor workstations. Images of the CDRAD 2.0 phantom were acquired at varying exposures on an indirect-type digital flat-panel detector. Three observers evaluated a total of 15 images each with respect to the threshold contrast for each detail size. The numbers of correctly identified objects were determined for all image subsets. No significant difference in the correct detection ratio was detected among the observers; however, the difference between the two types of workstations (1K vs 2K monitors) despite less than 3% was significant at a 95% confidence level. Slight but statistically significant differences exist in the detection of low-contrast nodular details visualized on 1K- and 2K-monitor workstations. Further work is needed to see if this result holds true also for comparison of clinical flat-panel detector images and may, for example, exert an influence on the diagnostic accuracy of chest X-ray readings. (orig.)

  17. A STUDY ASSESSING THE IMPACTS OF NEW REGULATORY PROPOSALS ON CYCLICALITY OF CAPITAL REQUIREMENTS: THE CASE OF THE CZECH REPUBLIC

    OpenAIRE

    Bartůsek, Michal

    2011-01-01

    This work focuses on new regulatory proposals, primarily Basel III accords and analyzes its ability to create a buffer for recurrent credit bubbles. This paper follows a research made by Lis, Pagés and Saurina [2000]. Their paper has illustrated the cyclicality of loan growth and GDP growth for Spain. This cyclicality is supported by cyclical Basel II regulation. In this paper is examined the ability of new regulatory proposals such as Basel III, statistical provisions and change in the appro...

  18. A case study on determining air monitoring requirements in a radioactive materials handling area

    International Nuclear Information System (INIS)

    Newton, G.J.; Bechtold, W.E.; Hoover, M.D.; Ghanbari, F.; Herring, P.S.; Jow, Hong-Nian

    1993-01-01

    A technical, defensible basis for the number and placement of air sampling instruments in a radioactive materials handling facility was developed. Historical air sampling data, process and physicochemical knowledge, qualitative smoke dispersion studies with video documentation, and quantitative trace gas dispersion studies were used to develop a strategy for number and placement of air samplers. These approaches can be used in other facilities to provide a basis for operational decisions. The requirements for retrospective sampling, personal sampling, and real-time monitoring are included. Other relevant operational decisions include selecting the numbers, placement, and appropriate sampling rates for instruments, identifying areas of stagnation or recirculation, and determining the adequacy and efficiency of any sampling transport lines. Justification is presented for using a graded approach to characterizing the workplace and determining air sampling and monitoring needs

  19. 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)

  20. 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

  1. 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

  2. Monitoring requirements for detecting tidal barrage induced changes to estuary bird populations

    International Nuclear Information System (INIS)

    Davenport, T.; Jeffers, J.N.R.; North, P.M.; Clark, N.A.; Langston, R.H.W.; Prys-Jones, R.P.

    1990-01-01

    This study was performed to examine the monitoring requirements for detecting tidal barrage induced changes to estuary bird populations, focussing mainly on the Mersey estuary. The degree of variability in populations between years for a number of species within the Mersey, Dee, Alt and Ribble were ascertained. The number of counts needed each winter, before and after barrage construction, were assessed. The percentage charge detectable for species was predicted. One east coast estuary (the Wash) was investigated for comparison of the effects of influences of severe weather. (UK)

  3. Requirements for the authorization of operation os a calibration laboratory of gamma-ray monitors

    International Nuclear Information System (INIS)

    Silva, Raimundo Dias da; Kibrit, Eduardo

    2011-01-01

    This paper describes the process for obtaining the authorization of operation of a laboratory designed to calibrate area and personal monitors with gamma radiation, by using a sealed Cs-137 source. The regulations of Comissao Nacional de Energia Nuclear (CNEN) are deeply analysed and discussed. The authorization for construction, the authorization for modification of items important to safety, the authorization for the acquisition and handling of radiation sources, the authorization for operating, and the authorization for withdrawal of operation of the laboratory are also discussed. The paper also describes the technical and managerial requirements necessary to operate a gamma radiation calibration laboratory in Brazil. . (author)

  4. Monitoring of performance management using Quality Assurance Indicators and ISO requirement

    Directory of Open Access Journals (Sweden)

    Dargahi H

    2007-06-01

    Full Text Available Background: Quality assurance is a prevention-oriented system that can be used to improve the quality of care, increase productivity and monitor the performance management in clinical laboratories. ISO 9001: 2000 requirements are a collection of management and technical systems designed to implement quality assurance and monitor performance management in organizations. Methods: A checklist was prepared to monitor the preanalytical, analytical and postanalytical stages of laboratory performance management in 16 areas and all laboratory activities in 14 of the clinical laboratories of the Tehran University of Medical Sciences (TUMS hospitals. Collected data were stored and statistically analyzed using SPSS software. Results: The best performance, in which 77.73% of quality assurance indicators were observed, was found in Sina Hospital. However, only 57.56% of these indicators were fulfilled at Farabi Hospital, with the lowest-level performance among the clinical laboratories of TUMS hospitals. The highest level of compliance with quality assurance indicators was in the hematology departments and for facility demands in management areas. Overall, quality assurance indicators were appropriately followed in only 7% of the clinical laboratories. Conclusion: The average quality assurance observation rate in the clinical laboratories studied was 67.22%, which is insufficient and must be remedied with stricter enforcement of the ISO 9001: 2000 regulations.

  5. Low Cost Environmental Sensors for Spaceflight: NMP Space Environmental Monitor (SEM) Requirements

    Science.gov (United States)

    Garrett, Henry B.; Buehler, Martin G.; Brinza, D.; Patel, J. U.

    2005-01-01

    An outstanding problem in spaceflight is the lack of adequate sensors for monitoring the space environment and its effects on engineering systems. By adequate, we mean low cost in terms of mission impact (e.g., low price, low mass/size, low power, low data rate, and low design impact). The New Millennium Program (NMP) is investigating the development of such a low-cost Space Environmental Monitor (SEM) package for inclusion on its technology validation flights. This effort follows from the need by NMP to characterize the space environment during testing so that potential users can extrapolate the test results to end-use conditions. The immediate objective of this effort is to develop a small diagnostic sensor package that could be obtained from commercial sources. Environments being considered are: contamination, atomic oxygen, ionizing radiation, cosmic radiation, EMI, and temperature. This talk describes the requirements and rational for selecting these environments and reviews a preliminary design that includes a micro-controller data logger with data storage and interfaces to the sensors and spacecraft. If successful, such a sensor package could be the basis of a unique, long term program for monitoring the effects of the space environment on spacecraft systems.

  6. Fatigue crack growth monitoring: fracture mechanics and non-destructive testing requirements

    International Nuclear Information System (INIS)

    Williams, S.; Mudge, P.J.

    1982-01-01

    If a fatigue crack is found in a component in service, two options exist if plant integrity is to be maintained: first, the plant can be removed from service and repairs effected or replacements fitted; second, the growth of the crack can be monitored non-destructively until it is either considered to be too large to tolerate, in which case it must be repaired, or until a convenient down time when repair can be effected. The second option has obvious benefits for plant operators, but in such a situation it is essential that errors of the non-destructive estimate of defect size, which will undoubtedly exist, and uncertainties in the fatigue crack growth laws in operation must both be allowed for if a safe extension of service life is to be obtained; i.e. without failure by leakage or fast fracture arising from the fatigue crack. This paper analyses the accuracy required of non-destructive crack measurement techniques to permit the safe monitoring of crack growth by periodic inspection. It then demonstrates that it is possible to achieve adequate crack monitoring using conventional ultrasonic techniques. (author)

  7. 45 CFR 310.40 - What requirements apply for accessing systems and records for monitoring Computerized Tribal IV-D...

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 2 2010-10-01 2010-10-01 false What requirements apply for accessing systems and records for monitoring Computerized Tribal IV-D Systems and Office Automation? 310.40 Section 310.40... COMPUTERIZED TRIBAL IV-D SYSTEMS AND OFFICE AUTOMATION Accountability and Monitoring Procedures for...

  8. Monitoring of regulatory T cell frequencies and expression of CTLA-4 on T cells, before and after DC vaccination, can predict survival in GBM patients.

    Directory of Open Access Journals (Sweden)

    Brendan Fong

    Full Text Available PURPOSE: Dendritic cell (DC vaccines have recently emerged as an innovative therapeutic option for glioblastoma patients. To identify novel surrogates of anti-tumor immune responsiveness, we studied the dynamic expression of activation and inhibitory markers on peripheral blood lymphocyte (PBL subsets in glioblastoma patients treated with DC vaccination at UCLA. EXPERIMENTAL DESIGN: Pre-treatment and post-treatment PBL from 24 patients enrolled in two Phase I clinical trials of dendritic cell immunotherapy were stained and analyzed using flow cytometry. A univariate Cox proportional hazards model was utilized to investigate the association between continuous immune monitoring variables and survival. Finally, the immune monitoring variables were dichotomized and a recursive partitioning survival tree was built to obtain cut-off values predictive of survival. RESULTS: The change in regulatory T cell (CD3(+CD4(+CD25(+CD127(low frequency in PBL was significantly associated with survival (p = 0.0228; hazard ratio = 3.623 after DC vaccination. Furthermore, the dynamic expression of the negative co-stimulatory molecule, CTLA-4, was also significantly associated with survival on CD3(+CD4(+ T cells (p = 0.0191; hazard ratio = 2.840 and CD3(+CD8(+ T cells (p = 0.0273; hazard ratio = 2.690, while that of activation markers (CD25, CD69 was not. Finally, a recursive partitioning tree algorithm was utilized to dichotomize the post/pre fold change immune monitoring variables. The resultant cut-off values from these immune monitoring variables could effectively segregate these patients into groups with significantly different overall survival curves. CONCLUSIONS: Our results suggest that monitoring the change in regulatory T cell frequencies and dynamic expression of the negative co-stimulatory molecules on peripheral blood T cells, before and after DC vaccination, may predict survival. The cut-off point generated from these data can be utilized in future

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

    Energy Technology Data Exchange (ETDEWEB)

    1985-04-01

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

  10. 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

  11. 10 CFR 39.65 - Personnel monitoring.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...

  12. 10 CFR 34.47 - Personnel monitoring.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...

  13. Regulation for continuous improvements - the new regulatory strategy of SKI

    International Nuclear Information System (INIS)

    Hoegberg, L.; Svensson, G.; Viktorsson, C.

    1998-01-01

    This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)

  14. 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.

  15. Electronic Nose Testing Procedure for the Definition of Minimum Performance Requirements for Environmental Odor Monitoring

    Directory of Open Access Journals (Sweden)

    Lidia Eusebio

    2016-09-01

    Full Text Available Despite initial enthusiasm towards electronic noses and their possible application in different fields, and quite a lot of promising results, several criticalities emerge from most published research studies, and, as a matter of fact, the diffusion of electronic noses in real-life applications is still very limited. In general, a first step towards large-scale-diffusion of an analysis method, is standardization. The aim of this paper is describing the experimental procedure adopted in order to evaluate electronic nose performances, with the final purpose of establishing minimum performance requirements, which is considered to be a first crucial step towards standardization of the specific case of electronic nose application for environmental odor monitoring at receptors. Based on the experimental results of the performance testing of a commercialized electronic nose type with respect to three criteria (i.e., response invariability to variable atmospheric conditions, instrumental detection limit, and odor classification accuracy, it was possible to hypothesize a logic that could be adopted for the definition of minimum performance requirements, according to the idea that these are technologically achievable.

  16. Fabrication of sterile experimental radiopharmaceuticals: technical and regulatory requirements; Fabrication des medicaments experimentaux radiopharmaceutiques steriles: exigences reglementaires et techniques

    Energy Technology Data Exchange (ETDEWEB)

    Briand, S

    2008-03-15

    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.)

  17. 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.

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

    International Nuclear Information System (INIS)

    Couasnon, Olivier

    2014-01-01

    Workers of the concerned company and other persons and teams called 'intervention personnel' (specialized firemen, first aider, etc.) are to be involved in radiological emergency situations. Radiation protection provisions for workers and for intervention personnel complement one another because they cover persons with different statutes (workers under the responsibility of an employer and persons acting within the framework of agreements with the public authorities or within the framework of the requisitions). Work or operations exposing workers to ionizing radiation in radiological emergency situations can be assigned only to workers satisfying all of the following conditions: classification in category A worker; free of any medical unfitness; on a list drawn up in advance for this purpose; having received appropriate information on the risks and the precautions to take during the work or the operation; not having received, during the preceding twelve months, a dose greater than one of the annual limit values for exposures subject to special authorization. In addition, the worker must be a volunteer to carry out the work or the operations concerned in radiological emergency situations and have individual dosimetry means appropriate for the situation. Intervention personnel are possibly composed of personnel from responding organizations, such as police officers, fire-fighters, medical personnel, drivers and crews of evacuation vehicles, or of workers employed by the head of the damaged plant. In order to determine their selection, training and medical and radiological monitoring conditions, intervention personnel are classified into two groups: personnel forming the special technical, medical and health intervention teams readied in advance to deal with radiological emergency situations and persons not belonging to special teams but intervening as part of the tasks within the scope of their competence. In case of an existing exposure situation (post

  19. Comparison and Cost Analysis of Drinking Water Quality Monitoring Requirements versus Practice in Seven Developing Countries

    OpenAIRE

    Crocker, Jonny; Bartram, Jamie

    2014-01-01

    Drinking water quality monitoring programs aim to support provision of safe drinking water by informing water quality management. Little evidence or guidance exists on best monitoring practices for low resource settings. Lack of financial, human, and technological resources reduce a country’s ability to monitor water supply. Monitoring activities were characterized in Cambodia, Colombia, India (three states), Jordan, Peru, South Africa, and Uganda according to water sector responsibilities, ...

  20. On the Move to Business-Driven Alignment of Service Monitoring Requirements

    OpenAIRE

    Alencar Silva , Patrício ,; Weigand , Hans

    2011-01-01

    Part 2: Full Papers; International audience; Current service monitoring capabilities have been not designed in alignment with business needs. We argue that service monitoring should be primarily thought of as an economic concern, with proper needs being elicited on the business strategy level and further drilled down to process and IT services management layers. Monitoring needs and capabilities should be designed independently from each other and exposed as abstract monitoring interfaces for...

  1. Diversity of gut microflora is required for the generation of B cell with regulatory properties in a skin graft model.

    Science.gov (United States)

    Alhabbab, R; Blair, P; Elgueta, R; Stolarczyk, E; Marks, E; Becker, P D; Ratnasothy, K; Smyth, L; Safinia, N; Sharif-Paghaleh, E; O'Connell, S; Noelle, R J; Lord, G M; Howard, J K; Spencer, J; Lechler, R I; Lombardi, G

    2015-06-25

    B cells have been reported to promote graft rejection through alloantibody production. However, there is growing evidence that B cells can contribute to the maintenance of tolerance. Here, we used a mouse model of MHC-class I mismatched skin transplantation to investigate the contribution of B cells to graft survival. We demonstrate that adoptive transfer of B cells prolongs skin graft survival but only when the B cells were isolated from mice housed in low sterility "conventional" (CV) facilities and not from mice housed in pathogen free facilities (SPF). However, prolongation of skin graft survival was lost when B cells were isolated from IL-10 deficient mice housed in CV facilities. The suppressive function of B cells isolated from mice housed in CV facilities correlated with an anti-inflammatory environment and with the presence of a different gut microflora compared to mice maintained in SPF facilities. Treatment of mice in the CV facility with antibiotics abrogated the regulatory capacity of B cells. Finally, we identified transitional B cells isolated from CV facilities as possessing the regulatory function. These findings demonstrate that B cells, and in particular transitional B cells, can promote prolongation of graft survival, a function dependent on licensing by gut microflora.

  2. Diversity of gut microflora is required for the generation of B cell with regulatory properties in a skin graft model

    Science.gov (United States)

    Alhabbab, R.; Blair, P.; Elgueta, R.; Stolarczyk, E.; Marks, E.; Becker, P. D.; Ratnasothy, K.; Smyth, L.; Safinia, N.; Sharif-Paghaleh, E.; O’Connell, S.; Noelle, R. J.; Lord, G. M.; Howard, J. K.; Spencer, J.; Lechler, R. I.; Lombardi, G.

    2015-01-01

    B cells have been reported to promote graft rejection through alloantibody production. However, there is growing evidence that B cells can contribute to the maintenance of tolerance. Here, we used a mouse model of MHC-class I mismatched skin transplantation to investigate the contribution of B cells to graft survival. We demonstrate that adoptive transfer of B cells prolongs skin graft survival but only when the B cells were isolated from mice housed in low sterility “conventional” (CV) facilities and not from mice housed in pathogen free facilities (SPF). However, prolongation of skin graft survival was lost when B cells were isolated from IL-10 deficient mice housed in CV facilities. The suppressive function of B cells isolated from mice housed in CV facilities correlated with an anti-inflammatory environment and with the presence of a different gut microflora compared to mice maintained in SPF facilities. Treatment of mice in the CV facility with antibiotics abrogated the regulatory capacity of B cells. Finally, we identified transitional B cells isolated from CV facilities as possessing the regulatory function. These findings demonstrate that B cells, and in particular transitional B cells, can promote prolongation of graft survival, a function dependent on licensing by gut microflora. PMID:26109230

  3. Cutting Edge: c-Maf Is Required for Regulatory T Cells To Adopt RORγt+ and Follicular Phenotypes.

    Science.gov (United States)

    Wheaton, Joshua D; Yeh, Chen-Hao; Ciofani, Maria

    2017-12-15

    Regulatory T cells (Tregs) adopt specialized phenotypes defined by coexpression of lineage-defining transcription factors, such as RORγt, Bcl-6, or PPARγ, alongside Foxp3. These Treg subsets have unique tissue distributions and diverse roles in maintaining organismal homeostasis. However, despite extensive functional characterization, the factors driving Treg specialization are largely unknown. In this article, we show that c-Maf is a critical transcription factor regulating this process in mice, essential for generation of both RORγt + Tregs and T follicular regulatory cells, but not for adipose-resident Tregs. c-Maf appears to function primarily in Treg specialization, because IL-10 production, expression of other effector molecules, and general immune homeostasis are not c-Maf dependent. As in other T cells, c-Maf is induced in Tregs by IL-6 and TGF-β, suggesting that a combination of inflammatory and tolerogenic signals promote c-Maf expression. Therefore, c-Maf is a novel regulator of Treg specialization, which may integrate disparate signals to facilitate environmental adaptation. Copyright © 2017 by The American Association of Immunologists, Inc.

  4. The new German regulatory system of monitoring workers for intakes of radioactivity with special reference to thorium

    International Nuclear Information System (INIS)

    Henrichs, K.

    1995-01-01

    In Germany, the Association for Radiation Protection (member of IRPA) defined a new standard for the monitoring of workers occupationally exposed to radioactive material. During the last two years this draft has been accepted by the German government in the form of three directives. The purpose of our approach was the installation of a system defining clear criteria for the necessity of regular and special monitoring programs, giving directives for monitoring programs ensuring that dose assessments are as reliable as necessary with the lowest possible expenses, standardizing as far as possible the procedures of dose assessments, and guaranteeing the necessary quality standards. The most important features of these regulations will be discussed in this contribution and their application will be exemplified for the specially difficult monitoring of thorium intakes. (author). 2 figs., 2 tabs

  5. Monitoring of radiation exposure

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-02-01

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

  6. Monitoring of radiation exposure

    International Nuclear Information System (INIS)

    2000-02-01

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

  7. Environmental monitoring plan

    International Nuclear Information System (INIS)

    Holland, R.C.

    1997-02-01

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 52 refs., 10 figs., 12 tabs

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

    Directory of Open Access Journals (Sweden)

    Sanz Nuria

    2009-10-01

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

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

    LENUS (Irish Health Repository)

    Kubiak, Christine

    2009-10-16

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

  10. Regulatory quality control in the metal and semi metal environmental monitoring program at IPEN/CNEN-SP

    International Nuclear Information System (INIS)

    Faustino, Mainara G.; Silva, Doulgas Batista; Monteiro, Lucilena R.; Dantas, Elizabeth S.K.; Pires, Maria Aparecida F.; Cotrim, Marycel E.B.

    2013-01-01

    The CONAMA's Resolution 430 recently published in May 13 th of 2011, that completes and modifies the Resolution 357/2005, defined new quality standards to perform liquid effluent monitoring essays in order to allow the release in the public sewer system. This Resolution has established that the essay laboratories must be certified by Brazilian National Metrology, Normalization and Industrial Quality Institute - INMETRO and also count with an implemented quality control system. Thereby this publication affected directly IPEN's Environmental Monitoring Program of Stables Chemical Compound (PMA-Q), performed since 2007. In this program, 20 parameters related to the metallic and non-metallic chemical elements content are monitored by using sensitive analytical techniques such as graphite furnace atomic absorption spectrometry - GF-AAS or inductively coupled plasma spectrometry - ICP-OES. Therefore this paper presents improvements to determine the laboratory individual performance performed by GF-AAS and ICP-OES. To achieve the legislation compliance for these parameters, the following actions were implemented: the construction of control charts (internal quality control) and the participation of the laboratory in interlaboratory proficiency tests (external quality control). These actions are presented and discussed with the results of elements such as Arsenic and Lead that are analyzed through GF-AAS as well as Chromium, Cooper, Zinc, Iron and Nickel, that are analyzed through ICP-OES. These actions of quality control allowed the continuous monitoring of laboratory performance, the identification and resolution of analytic problems and interlaboratory differences, provide additional confidence to monitoring program. (author)

  11. 10 CFR 50.65 - Requirements for monitoring the effectiveness of maintenance at nuclear power plants.

    Science.gov (United States)

    2010-01-01

    ... maintenance at nuclear power plants. 50.65 Section 50.65 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC..., including normal shutdown operations. (a)(1) Each holder of an operating license for a nuclear power plant... corrective action shall be taken. For a nuclear power plant for which the licensee has submitted the...

  12. Monitoring of radioactive ferrous scarp and products, current practices and regulatory problems in North-Eastern Italy

    International Nuclear Information System (INIS)

    Barbina, V.; Bianco, L.

    1997-01-01

    Radioactive scrap metal is a major source of concern among the steel industries of northeastern Italy, since most of the scrap supply comes from east-European countries and may originate from dismantled nuclear installations or dismissed radioactive devices. In this respect reliable monitoring procedures and consistent regulations are essential to face the many economic, legal and safety problems involved in the control and management of radioactive scrap and products. The authors describe the monitoring methods developed in more than two years practice at the steel works Ferriere Nord, Osoppo UD, Italy, as a realistic compromise between reliability, radiation protection and cost. They also discuss the drawbacks sometimes due to the lack of coherent monitoring protocols and exemption levels in Italian regulations, which leave some ways out for the uncontrolled recycling of radioactive metal scrap. (author)

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

    Energy Technology Data Exchange (ETDEWEB)

    Kent Norris

    2009-09-01

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

  14. State Child Care Regulatory, Monitoring and Evaluation Systems as a Means for Ensuring Quality Child Development Programs.

    Science.gov (United States)

    Fiene, Richard

    The development of a checklist for use in monitoring and evaluating the quality of child care services, and the implications of use of the checklist by day care providers, are discussed. Several research studies that used the indicator checklist model have attempted to determine whether compliance with state child care regulations has a positive…

  15. 40 CFR 141.563 - What follow-up action is my system required to take based on continuous turbidity monitoring?

    Science.gov (United States)

    2010-07-01

    ... required to take based on continuous turbidity monitoring? 141.563 Section 141.563 Protection of... Individual Filter Turbidity Requirements § 141.563 What follow-up action is my system required to take based on continuous turbidity monitoring? Follow-up action is required according to the following tables...

  16. Wireless Sensor Network for Helicopter Rotor Blade Vibration Monitoring: Requirements Definition and Technological Aspects

    NARCIS (Netherlands)

    Sanchez Ramirez, Andrea; Das, Kallol; Loendersloot, Richard; Tinga, Tiedo; Havinga, Paul J.M.; Basu, Biswajit

    The main rotor accounts for the largest vibration source for a helicopter fuselage and its components. However, accurate blade monitoring has been limited due to the practical restrictions on instrumenting rotating blades. The use of Wireless Sensor Networks (WSNs) for real time vibration monitoring

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

    International Nuclear Information System (INIS)

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

    2015-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-02-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-02-01

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

  20. 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...

  1. Environmental Monitoring Plan, Sandia National Laboratories, Livermore

    International Nuclear Information System (INIS)

    Holland, R.C.

    1992-06-01

    This Environmental Monitoring Plan was written to fulfill the requirements of DOE Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories, Livermore. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. 61 refs

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

    International Nuclear Information System (INIS)

    Morrison, A.R.

    1985-01-01

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

  3. Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Holland, R.C. [Science Applications International Corp., San Diego, CA (United States)

    1993-07-01

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. This revision to the Environmental Monitoring Plan was written to document the changes made to the Monitoring Program during 1992. Some of the data (most notably the statistical analyses of past monitoring data) has not been changed.

  4. Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    Holland, R.C.

    1993-07-01

    This Environmental Monitoring Plan was written to fulfill the requirements of Department of Energy (DOE) Order 5400.1 and DOE Environmental Regulatory Guide DOE/EH 0173T. This Plan documents the background, organizational structure, and methods used for effluent monitoring and environmental surveillance at Sandia National Laboratories/California. The design, rationale, and historical results of the environmental monitoring system are discussed in detail. Throughout the Plan, recommendations for improvements to the monitoring system are made. This revision to the Environmental Monitoring Plan was written to document the changes made to the Monitoring Program during 1992. Some of the data (most notably the statistical analyses of past monitoring data) has not been changed

  5. Telemetry system for monitoring the ECG for patients with high cardiovascular risk. Main design requirements and technical solutions

    International Nuclear Information System (INIS)

    Rodriguez, J; Meissimilly, G; Berovides, JD

    2005-01-01

    In this paper the main design requirements concerning the setting up of a telemetry ECG monitoring system are presented. The design's most important technical solutions as well as some details are also discussed. This system is intended to provide skilled medical assistance during the cardiac rehabilitation of both asymptomatic and high risk coronary patients

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

    Energy Technology Data Exchange (ETDEWEB)

    Jorde, K.

    1997-12-31

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Jorde, K

    1998-12-31

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

  8. 40 CFR Table 13 to Subpart G of... - Wastewater-Monitoring Requirements for Control Devices

    Science.gov (United States)

    2010-07-01

    ... recorder b Combustion temperature Continuous. Condenser Temperature monitoring device installed at condenser exit and equipped with continuous recorder b Condenser exit (product side) temperature Continuous... intervals no greater than 20 percent of the design carbon replacement interval, whichever is greater...

  9. FEMO, A FLOW AND ENRICHMENT MONITOR FOR VERIFYING COMPLIANCE WITH INTERNATIONAL SAFEGUARDS REQUIREMENTS AT A GAS CENTRIFUGE ENRICHMENT FACILITY

    International Nuclear Information System (INIS)

    Gunning, John E.; Laughter, Mark D.; March-Leuba, Jose A.

    2008-01-01

    A number of countries have received construction licenses or are contemplating the construction of large-capacity gas centrifuge enrichment plants (GCEPs). The capability to independently verify nuclear material flows is a key component of international safeguards approaches, and the IAEA does not currently have an approved method to continuously monitor the mass flow of 235U in uranium hexafluoride (UF6) gas streams. Oak Ridge National Laboratory is investigating the development of a flow and enrichment monitor, or FEMO, based on an existing blend-down monitoring system (BDMS). The BDMS was designed to continuously monitor both 235U mass flow and enrichment of UF6 streams at the low pressures similar to those which exists at GCEPs. BDMSs have been installed at three sites-the first unit has operated successfully in an unattended environment for approximately 10 years. To be acceptable to GCEP operators, it is essential that the instrument be installed and maintained without interrupting operations. A means to continuously verify flow as is proposed by FEMO will likely be needed to monitor safeguards at large-capacity plants. This will enable the safeguards effectiveness that currently exists at smaller plants to be maintained at the larger facilities and also has the potential to reduce labor costs associated with inspections at current and future plants. This paper describes the FEMO design requirements, operating capabilities, and development work required before field demonstration.

  10. 10 CFR 36.55 - Personnel monitoring.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 36.55 Section 36.55 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR IRRADIATORS Operation of Irradiators § 36.55 Personnel monitoring. (a) Irradiator operators shall wear a personnel dosimeter that is...

  11. CEMs turn monitoring giant

    International Nuclear Information System (INIS)

    White, J.R.

    1993-01-01

    Crucial to complying with environmental regulations is selecting appropriate pollution control equipment to capture or destroy regulated pollutants. But just as important is selecting a continuous emissions monitoring system (CEM). CEMs play a dual role in an overall compliance strategy. On one hand, they identify the type and quantity of emissions at a source as a first step for determining which regulatory requirements and control technologies are applicable. They also provide ongoing emissions data to demonstrate compliance with air and other environmental regulations. Facilities are required to monitor their processes with CEMs, or a comparable technology, under several titles of the Clean Air Act Amendments of 1990. CEMs meet regulatory requirements if they include a SO 2 concentration monitor, nitrogen oxides (NO x ) concentration monitor, volumetric flow monitor, opacity monitor, diluent gas monitor and data acquisition and handling system. The entire system and each subsystem has to be installed and certified before it can be used for compliance. A written quality assurance/quality control (QA/QC) plan for the CEMs must accompany the permit application. The acid rain rules also impose performance standards and frequent calibration checks to ensure the integrity of CEMs data

  12. Environmental challenges and opportunities of the evolving North American electricity market : European electricity generating facilities: an overview of European regulatory requirements and standardization efforts

    International Nuclear Information System (INIS)

    Nichols, L.

    2002-06-01

    Several factors are affecting power generating facilities, such as the opening of both electricity and gas markets, and the pressure applied on generators and governments to ensure a steady energy supply for consumers. An additional factor is the pressure for the closing of nuclear power facilities. European siting and emissions requirements for coal-fired and natural gas generating facilities were presented in this background paper. In addition, the author provided an overview of the standardization process in place in Europe. The European Union and its functioning were briefly described, as well as a listing of relevant organizations. The current trends were examined. The document first introduced the European Union, and the next section dealt with Regulatory regime: the internal energy market. The third section examined the issue of Regulatory regime: generation and environmental regulations. Section four presented environmental management systems, followed by a section on standardization. Section six discussed European organizations involved in electricity issues, while the following section dealt with European commission programs. The last section briefly looked at the trends in the electricity sector, broaching topics such as compliance, electricity generation, and emissions trading. 52 refs., 2 tabs

  13. Existing nuclear power plants and new safety requirements - an international survey. A description of the legal situation and of the regulatory practice in eight countries and in Germany

    International Nuclear Information System (INIS)

    Raetzke, C.; Micklinghoff, M.

    2006-01-01

    In our days, the question of whether existing nuclear power plants can be expected to comply with new standards is relevant for many reasons. The idea of writing this report was sparked by the fact that the German Federal Ministry of the Environment is planning a thorough revision of the regulations concerning nuclear safety. Since in Germany, according to the latest amendment to the Nuclear Act, a licence for a new plant cannot be granted, this project inevitably raises the basic question of whether the existing plants can be forced to comply with new safety regulation, if necessary by performing substantial backfitting. Aim of the enquiry is to find out how the question outlined above - new requirements for existing nuclear power plants - is dealt with in nine countries, namely Germany, Switzerland, France, Sweden, Finland, the United Kingdom, the USA, Spain and Belgium. In order to give a legible and qualified account, the authors have also investigated and depicted the general legislative and regulatory framework for nuclear of each country. Therefore, the book can also be read as a general introduction into the legal system and regulatory practice of these countries. (orig.)

  14. 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.

  15. CsrB, a noncoding regulatory RNA, is required for BarA-dependent expression of biocontrol traits in Rahnella aquatilis HX2.

    Science.gov (United States)

    Mei, Li; Xu, Sanger; Lu, Peng; Lin, Haiping; Guo, Yanbin; Wang, Yongjun

    2017-01-01

    Rahnella aquatilis is ubiquitous and its certain strains have the applicative potent as a plant growth-promoting rhizobacteria. R. aquatilis HX2 is a biocontrol agent to produce antibacterial substance (ABS) and showed efficient biocontrol against crown gall caused by Agrobacterium vitis on sunflower and grapevine plants. The regulatory network of the ABS production and biocontrol activity is still limited known. In this study, a transposon-mediated mutagenesis strategy was used to investigate the regulators that involved in the biocontrol activity of R. aquatilis HX2. A 366-nt noncoding RNA CsrB was identified in vitro and in vivo, which regulated ABS production and biocontrol activity against crown gall on sunflower plants, respectively. The predicted product of noncoding RNA CsrB contains 14 stem-loop structures and an additional ρ-independent terminator harpin, with 23 characteristic GGA motifs in the loops and other unpaired regions. CsrB is required for ABS production and biocontrol activity in the biocontrol regulation by a two-component regulatory system BarA/UvrY in R. aquatilis HX2. The noncoding RNA CsrB regulates BarA-dependent ABS production and biocontrol activity in R. aquatilis HX2. To the best of our knowledge, this is the first report of noncoding RNA as a regulator for biocontrol function in R. aquatilis.

  16. Integrated environmental monitoring -- prototype demonstration

    International Nuclear Information System (INIS)

    Bryce, R.W.; Vail, L.W.; Hostetler, D.D.; Meyer, P.D.; Carlson, T.J.; Miller, P.L.

    1994-01-01

    Groundwater monitoring is an important activity at US Department of Energy (DOE) sites. Monitoring programs at DOE facilities have evolved in response to operational needs at the facilities, public outcries for information, regulatory requirements, DOE orders, and improvements in monitoring technology. Decisions regarding sampling location, sampling frequency, analyses performed, and other aspects of monitoring network design can have major implications for detecting releases and for making subsequent higher level decisions about facility operation and remediation. The Integrated Environmental Monitoring (IEM) concept is a set of analytical procedures and software tools that can be used to improve monitoring network design decisions. Such decisions include the choice of monitoring locations, sampling frequencies, sensor technologies, and monitored constituents. IEM provides a set of monitoring alternatives that balance the tradeoffs between competing monitoring objectives such as the minimization of cost and the minimization of uncertainty. The alternatives provided are the best available with respect to the monitoring objectives, consistent with the physical and chemical characteristics of the site, and consist with applicable regulatory requirements. The selection of the best monitoring alternative to implement is made by the stakeholders after reviewing the alternatives and tradeoffs produced by the IEM process

  17. [Optimal intravascular brachytherapy: safety and radiation protection, reliability and precision guaranteed by guidelines, recommendations and regulatory requirements].

    Science.gov (United States)

    Quast, Ulrich; Kaulich, Theodor W; Lorenz, Joachim

    2002-02-01

    The success of intravascular brachytherapy relies entirely on the interdisciplinary approach. Interventional cardiologists, radiation oncologists and medical physicists must form a team from day 1. All members of the team need special knowledge and regular training in the field of vascular radiation therapy. Optimization of intravascular brachytherapy requires the use of standardized methods of dose specification, recording and reporting. This also implies using standardized methods of source calibration in terms of absorbed dose to water and having methods for simple internal control of the dosimetric quantities of new or replaced sources. Guidance is offered by international recommendations (AAPM TG 60, DGMP Report 16, NCS and EVA GEC-ESTRO). LEGAL REQUIREMENTS FOR RADIATION PROTECTION--WHAT'S NEW?: In Europe, new legal requirements on radiation protection issues have to be fulfilled. For Germany, the revised "Strahlenschutzverordnung" has been released recently. Nearly all organizational and medical processes are affected. For intravascular brachytherapy, several changes of requirements have to be considered. However, to follow these requirements does not cause serious problems. DGMP REPORT 16: GUIDELINES FOR MEDICAL PHYSICAL ASPECTS OF INTRAVASCULAR BRACHYTHERAPY: Evaluation of clinical results by comparison of intravascular brachytherapy treatment parameters is possible only if the prescribed dose and the applied dose distribution are reported clearly, completely and uniformly. The DGMP guidelines thus recommend to prescribe the dose to water at the system related reference point PRef at 2 mm radial distance for intracoronary application (and at 5 mm for peripheral vessels). The mean dose at 1 mm tissue depth (respectively at 2 mm) should be reported in addition. To safely define the planning target volume from the injured length, safety margins of at least 5 mm (10 mm) have to be taken into account on both ends. Safety margins have also to be considered for

  18. 40 CFR 63.5725 - What are the requirements for monitoring and demonstrating continuous compliance?

    Science.gov (United States)

    2010-07-01

    ... sensitivity of 0.0004 millimeters mercury (mmHg) to check gauge calibration quarterly and transducer... volumetric flow rate or duct static pressure, as specified in paragraphs (f)(5)(i) and (ii) of this section....5716 and described in § 63.5719, you must monitor and record either the gas volumetric flow rate or the...

  19. 40 CFR 60.584 - Monitoring of operations and recordkeeping requirements.

    Science.gov (United States)

    2010-07-01

    ... Performance for Flexible Vinyl and Urethane Coating and Printing § 60.584 Monitoring of operations and... continuously measures and records the VOC concentration of the exhaust vent stream from the control device and... other processes. (2) During the performance test, the owner or operator shall determine and record the...

  20. 40 CFR 63.114 - Process vent provisions-monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... for any bypass line between the origin of the gas stream (i.e., at an air oxidation reactor... continuous recorder shall be installed to monitor the pH of the scrubber effluent. (ii) A flow meter equipped with a continuous recorder shall be located at the scrubber influent for liquid flow. Gas flow rate...

  1. 50 CFR 216.108 - Requirements for monitoring and reporting under incidental harassment authorizations for Arctic...

    Science.gov (United States)

    2010-10-01

    ... location, and the time. (d) Where the proposed activity may affect the availability of a species or stock of marine mammal for taking for subsistence purposes, proposed monitoring plans or other research... an incidental harassment authorization for Arctic waters must submit reports to the Assistant...

  2. Bronchial thermoplasty: a novel treatment for severe asthma requiring monitored anesthesia care.

    Science.gov (United States)

    Lee, Jamille A; Rowen, David W; Rose, David D

    2011-12-01

    Dexmedetomidine used in monitored anesthesia care produces a safe and effective technique well documented in research. We report the successful use of dexmedetomidine for sedation during bronchial thermoplasty, a new treatment for patients with severe persistent asthma refractory to inhaled corticosteroids and long-term beta-2 agonists.

  3. 77 FR 35925 - Fisheries of the Exclusive Economic Zone Off Alaska; Monitoring and Enforcement Requirements in...

    Science.gov (United States)

    2012-06-15

    ... these processing vessels could be made to pass through a single point on a conveyor belt in the factory... share programs, NMFS developed a suite of monitoring and enforcement measures designed to ensure... they are not designed to give a precise estimate of the catch for each set of hook-and-line gear. In...

  4. 77 FR 8160 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

    Science.gov (United States)

    2012-02-14

    ... with the opacity measurement/reference beam(s), spectrally selective optical filters, beam splitters... Monitor Manufacturers to Certify Conformance with Design and Performance Specifications, whereas the 2003... my COMS? Necessary components of the routine system checks will depend on the design details of your...

  5. 40 CFR 98.364 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... by Gas Chromatography (incorporated by reference see § 98.7). All gas composition monitors shall be calibrated prior to the first reporting year for biogas methane and carbon dioxide content using ASTM D1946... composition, temperature, and pressure measurements. These procedures include, but are not limited to...

  6. Use of models to support the monitoring requirements in the water framework directive

    NARCIS (Netherlands)

    Højberg, A.L.; Refsgaard, J.C.; Geer, F. van; Jørgensen, L.F.; Zsuffa, I.

    2007-01-01

    Implementation of the EU Water Framework Directive (WFD) poses many new challenges to European water managers. Monitoring programmes play a key role to assess the status and identify possible trends in the environmental conditions of river basins; to gain new knowledge on water processes and to

  7. 40 CFR 264.97 - General ground-water monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... has not been affected by leakage from a regulated unit; (i) A determination of background ground-water...) Represent the quality of ground water passing the point of compliance. (3) Allow for the detection of... elevation each time ground water is sampled. (g) In detection monitoring or where appropriate in compliance...

  8. Linking requirements with capabilities for deforestation monitoring in the context of the UNFCCC-REDD process

    International Nuclear Information System (INIS)

    Herold, Martin; Johns, Tracy

    2007-01-01

    As the United Nations Framework Convention on Climate Change nears the end of a two-year period of evaluation of the issue of reducing emissions from deforestation in developing countries, participating countries have agreed on the need to address this globally important source of greenhouse gas emissions. Negotiations on policy frameworks to monitor and reduce deforestation rely on an understanding of the scientific and technical capacity to support these efforts. Current UNFCCC programs to improve observation of land and forest cover change can provide valuable input to a future policy mechanism focusing on deforestation emissions from developing countries. Countries participating in the current debate have officially referenced the value of remote sensing tools and methods for deforestation monitoring, and have identified specific needs and goals related to their implementation. Based on these identified needs, this paper outlines recommendations for a monitoring framework that can be globally applied with sufficient levels of accuracy and certainty. This framework can serve as a starting point for monitoring programs, and can be modified in response to expected progress in establishing an international policy framework for reducing emissions from deforestation

  9. 40 CFR 98.174 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Iron and Steel Production § 98.174 Monitoring and QA/QC... moisture content of the stack gas. (5) Determine the mass rate of process feed or process production (as... Fusion Techniques (incorporated by reference, see § 98.7) for iron and ferrous scrap. (v) ASM CS-104 UNS...

  10. 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...

  11. Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction.

    Science.gov (United States)

    Sheth-Shah, Radhika; Vernon, Amanda J; Seetharaman, Shankar; Neale, Michael H; Daniels, Julie T

    2016-04-01

    In the past decade, stem cell therapy has been increasingly employed for the treatment of various diseases. Subsequently, there has been a great interest in the manufacture of stem cells under good manufacturing practice, which is required by law for their use in humans. The cells for sight Stem Cell Therapy Research Unit, based at UCL Institute of Ophthalmology, delivers somatic cell-based and tissue-engineered therapies to patients suffering from blinding eye diseases at Moorfields Eye Hospital (London, UK). The following article is based on our experience in the conception, design, construction, validation and manufacturing within a good manufacturing practice manufacturing facility based in the UK. As such the regulations can be extrapolated to the 28 members stated within the EU. However, the principles may have a broad relevance outside the EU.

  12. Energy Monitoring and Control Systems Operator Training - Recommended Qualifications, Staffing, Job Description, and Training Requirements for EMCS Operators.

    Science.gov (United States)

    1982-06-01

    start/stop chiller optimization , and demand limiting were added. The system monitors a 7,000 ton chiller plant and controls 74 air handlers. The EMCS does...Modify analog limits. g. Adjust setpoints of selected controllers. h. Select manual or automatic control modes. i. Enable and disable individual points...or event schedules and controller setpoints ; make nonscheduled starts and stops of equipment or disable field panels when required for routine

  13. Real Time Physiological Status Monitoring (RT-PSM): Accomplishments, Requirements, and Research Roadmap

    Science.gov (United States)

    2016-03-01

    actionable information. With many lessons learned , the first implementation of real time physiological monitoring (RT-PSM) uses thermal-work strain... Bidirectional Inductive On-Body Network (BIONET) for WPSM Develop sensor links and processing nodes on-Soldier and non-RF links off-Soldier Elintrix...recent sleep watches (e.g., BASIS Peak, Intel Corp.) are attempting to parse sleep quality beyond duration and interruptions into deep and REM sleep

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

    International Nuclear Information System (INIS)

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

    2006-01-01

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

  15. 40 CFR 98.54 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... accounting purposes. (d) You must conduct all required performance tests according to the methods in § 98.54... requirements. (a) You must conduct a new performance test and calculate a new facility-specific emissions...) Conduct the performance test annually. (2) Conduct the performance test when your adipic acid production...

  16. 40 CFR 98.34 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ...-derived gaseous fuels, and for biogas; sampling and analysis is required at least once per calendar.... (iv) For solid fuels other than coal and MSW, weekly sampling is required to obtain composite samples... obtained at less than the minimum frequency specifed in paragraph (a)(2) of this section, appropriate...

  17. Link Performance Analysis and monitoring - A unified approach to divergent requirements

    Science.gov (United States)

    Thom, G. A.

    Link Performance Analysis and real-time monitoring are generally covered by a wide range of equipment. Bit Error Rate testers provide digital link performance measurements but are not useful during real-time data flows. Real-time performance monitors utilize the fixed overhead content but vary widely from format to format. Link quality information is also present from signal reconstruction equipment in the form of receiver AGC, bit synchronizer AGC, and bit synchronizer soft decision level outputs, but no general approach to utilizing this information exists. This paper presents an approach to link tests, real-time data quality monitoring, and results presentation that utilizes a set of general purpose modules in a flexible architectural environment. The system operates over a wide range of bit rates (up to 150 Mbs) and employs several measurement techniques, including P/N code errors or fixed PCM format errors, derived real-time BER from frame sync errors, and Data Quality Analysis derived by counting significant sync status changes. The architecture performs with a minimum of elements in place to permit a phased update of the user's unit in accordance with his needs.

  18. Army requirements for micro and nanotechnology-based sensors in weapons health and battlefield environmental monitoring applications

    Science.gov (United States)

    Ruffin, Paul; Brantley, Christina; Edwards, Eugene; Hutcheson, Guilford

    2006-03-01

    The Army Aviation and Missile Research, Development, and Engineering Center (AMRDEC) and the Army Research Laboratory (ARL) have initiated a joint advanced technology demonstration program entitled "Prognostics/Diagnostics for the Future Force (PDFF)" with a key objective of developing low or no power embedded sensor suites for harsh environmental monitoring. The most critical challenge of the program is to specify requirements for the embedded sensor suites which will perform on-board diagnostics, maintain a history of sensor data, and forecast weapon health. The authors are currently collaborating with the PDFF program managers and potential customers to quantify the requirements for remotely operated, micro/nano-technology-based sensors for a host of candidate weapon systems. After requirements are finalized, current micro/nanotechnology-based temperature, humidity, g-shock, vibration and chemical sensors for monitoring the out-gassing of weapons propellant, as well as hazardous gaseous species on the battlefield and in urban environments will be improved to meet the full requirements of the PDFF program. In this paper, performance requirements such as power consumption, reliability, maintainability, survivability, size, and cost, along with the associated technical challenges for micro/nanotechnology-based sensor systems operating in military environments, are discussed. In addition, laboratory results from the design and testing of a wireless sensor array, which was developed using a thin film of functionalized carbon nanotube materials, are presented. Conclusions from the research indicate that the detection of bio-hazardous materials is possible using passive and active wireless sensors based on monitoring the reflected phase from the sensor.

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

    International Nuclear Information System (INIS)

    Ritterbusch, Stanley E.

    2000-01-01

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

  20. Power Control and Monitoring Requirements for Thermal Vacuum/Thermal Balance Testing of the MAP Observatory

    Science.gov (United States)

    Johnson, Chris; Hinkle, R. Kenneth (Technical Monitor)

    2002-01-01

    The specific heater control requirements for the thermal vacuum and thermal balance testing of the Microwave Anisotropy Probe (MAP) Observatory at the Goddard Space Flight Center (GSFC) in Greenbelt, Maryland are described. The testing was conducted in the 10m wide x 18.3m high Space Environment Simulator (SES) Thermal Vacuum Facility. The MAP thermal testing required accurate quantification of spacecraft and fixture power levels while minimizing heater electrical emissions. The special requirements of the MAP test necessitated construction of five (5) new heater racks.

  1. Regulatory oversight of maintenance activities at nuclear power plants

    International Nuclear Information System (INIS)

    Pape, M.

    1997-01-01

    Regulation of nuclear safety in the UK is based on monitoring of compliance with licence conditions. This paper discusses legislation aspects, license conditions, license requirements for maintenance and maintenance activities in the UK. It also addresses the regulator utility interaction, the regulatory inspection of maintenance and the trends in maintenance. (author)

  2. Review of the knowledge available to date on the effects of tritium exposure on health and the environment in Canada - a tool to guide regulatory compliance monitoring

    International Nuclear Information System (INIS)

    Thompson, P.A.; Hamlat, M.S.; Lane, R.; Mihok, S.; Reinhardt, P.; Bundy, K.

    2011-01-01

    The use of tritium in CANDU (Canadian Deuterium-Uranium) reactors, in industry to produce self-luminescent lights and paints, in oil and gas exploration, in hospitals for diagnostic tests and radio-therapeutics, and in research makes the control of tritium releases generated by these activities particularly important in Canada. Releases are regulated and carefully monitored by the Canadian Nuclear Safety Commission (CNSC). Some special interest and citizen groups, however, claim that the scientific uncertainty regarding the effects of tritium on health and on the environment is such that regulation of the facilities releasing or using tritium may be inadequate. In response to these concerns, the CNSC asked its staff to initiate the 'Tritium Studies' project. As part of the project, the environmental fate of tritium and its health effects were studied through direct field measurements and the review of the latest scientific literature on the subject. The project made it possible to conclude that the tritium radiation protection measures and regulatory mechanisms are adequate in protecting the health and safety of Canadians. (authors)

  3. 40 CFR 63.7525 - What are my monitoring, installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... Industrial, Commercial, and Institutional Boilers and Process Heaters Testing, Fuel Analyses, and Initial... (e.g., weigh belt, weigh hopper, or hopper flow measurement device), you must meet the requirements...

  4. Geotechnical instrumentation requirements for at-depth testing and repository monitoring in tuff

    International Nuclear Information System (INIS)

    Zimmerman, R.M.

    1982-01-01

    Minimum required geotechnical measurements for confirmation of repository performance include thermal and thermomechanical responses; changes in stress, strain, and displacements; and pore pressure and groundwater flow characteristics. Conditions expected in tuff are: maximum rock temperatures of less than 250 0 C, stresses less than 100 MPa, strains between +-0.01 mm/mm, and pore pressures less than 35 KPa in the unsaturated zone where hydraulic head is not the primary contributor. The paper describes instrumentation needed to make the desired measurements. In general, the instrumentation and data system are required to be stable and reliable for tens of years. Designs must consider requirements for temperature stability, temperature expansion compensation, moisture resistance, and long-term durability in mining-type environments. Severe requirements such as these suggest consideration of techniques for in-situ replacement of instrumentation. State-of-the-art instrumentation is briefly described along with a discussion of needs for refinement, replacement/recalibration and instrumentation development

  5. Requirements for drug monitoring of verapamil: experience from an unselected group of patients with cardiovascular disease

    DEFF Research Database (Denmark)

    Husum, D; Johnsen, A; Jensen, Gorm Boje

    1990-01-01

    variation (variation coefficient 35.8, 1.9, and 7.4, at the dosage levels 120, 240 and 340 mg per day). No significant correlation was found between serum verapamil levels age, sex, or weight. No significant effect of digoxin on the concentration of serum verapamil was found. No relation was observed...... 620 and D 617 indicated saturation of the first-pass metabolism. In conclusion, therapeutic drug monitoring is not indicated during routine verapamil treatment, whereas single measurements of verapamil may be warranted in patients not responding to treatment in order to identify fast metabolizers...

  6. Monitoring and dose recording for the individual

    International Nuclear Information System (INIS)

    1988-01-01

    This document specifies the conditions under which monitoring of individuals is required. For workers identified as Atomic Radiation Workers, determination of dose or exposure must be made. In circumstances where personal monitoring techniques are impractical, doses and exposures may be estimated by non-personal monitoring techniques. For workers not identified as Atomic Radiation Workers, licensees must be able to demonstrate that there is no reasonable potential for accumulating radiation doses or exposures in excess of regulatory limits. (L.L.)

  7. SNM gamma-ray fingerprint monitor functional requirements and design specifications

    International Nuclear Information System (INIS)

    Bieber, A.M. Jr.; Kane, W.R.

    1994-07-01

    A number of DOE facilities need to perform confirmatory inventory measurements on items of special nuclear material (SNM). The DOE Office of Safeguards and Security (OSS) has tasked the Safeguards, Safety and Nonproliferation Division (SSN) of the Department of Advanced Technology at Brookhaven National Laboratory (BNL) to develop a high-resolution gamma-ray-spectroscopy-based instrument for performing confirmatory inventory measurements on such materials, a ''gamma-ray fingerprint monitor'' (GRFM). This document is a conceptual design for the SSN GRFM system. This conceptual design is based on previous experience with measurements of plutonium-bearing materials and comparison of gamma-ray spectrum features, not on actual tests of the procedures or hardware described. As a result, modifications may be necessary when actual prototype hardware and software are tested in realistic circumstances on actual materials of interest

  8. 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)

  9. 40 CFR 63.7741 - What are the installation, operation, and maintenance requirements for my monitors?

    Science.gov (United States)

    2010-07-01

    ... paragraphs (a)(1)(i) through (iv) of this section. (i) Locate the flow sensor and other necessary equipment... the requirements in paragraph (e)(2)(i) through (iv) of this section. (i) Locate the pH sensor in a... sensor with a minimum measurement sensitivity of 2 percent of the flow rate. (iii) Conduct a flow sensor...

  10. 40 CFR 75.74 - Annual and ozone season monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... operator shall, at a minimum, perform the following diagnostic testing and quality assurance assessments... adjustments, data validation, and quality assurance of data with respect to daily assessments, shall also... defined in the quality assurance/quality control program for the unit required by section 1 in appendix B...

  11. 40 CFR 98.314 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements. (a) You must measure your consumption of calcined petroleum coke using plant instruments used for.... Alternatively, facilities can measure monthly carbon contents of the petroleum coke using ASTM D3176-89... Nitrogen in Laboratory Samples of Coal (incorporated by reference, see § 98.7). (d) For quality assurance...

  12. 40 CFR 98.284 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements. (a) You must measure your consumption of petroleum coke using plant instruments used for... supplier. Alternatively, facilities can measure monthly carbon contents of the petroleum coke using ASTM... quality assurance and quality control of the supplier data, you must conduct an annual measurement of the...

  13. 40 CFR 98.344 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... Other Technical Requirements For Weighing and Measuring Devices” NIST Handbook 44 (2009)(incorporated by... Natural Gas by Gas Chromatography (incorporated by reference, see § 98.7). (3) ASTM D1946-90 (Reapproved 2006), Standard Practice for Analysis of Reformed Gas by Gas Chromatography (incorporated by reference...

  14. 50 CFR 18.118 - What are the mitigation, monitoring, and reporting requirements?

    Science.gov (United States)

    2010-10-01

    ... reporting requirements? 18.118 Section 18.118 Wildlife and Fisheries UNITED STATES FISH AND WILDLIFE SERVICE... avoid significant additive and synergistic effects from multiple oil and gas exploration activities on... conducted i.e., a plan of operation; (B) A food and waste management plan; (C) Personnel training materials...

  15. 40 CFR 63.7917 - What are my inspection and monitoring requirements for transfer systems?

    Science.gov (United States)

    2010-07-01

    ... annually inspect the unburied portion of pipeline and all joints for leaks and other defects. In the event that a defect is detected, you must repair the leak or defect according to the requirements of... days after detection and repair shall be completed as soon as possible but no later than 45 calendar...

  16. 40 CFR 63.8450 - What are my monitoring installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... measurement sensitivity of 0.5 inch of water or a transducer with a minimum measurement sensitivity of 1... electrical connections for continuity, and all mechanical connections for leakage. (d) For each pH... bag leak detection system, you must meet the requirements in paragraphs (e)(1) through (11) of this...

  17. 40 CFR 63.7113 - What are my monitoring installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... continuity, and all mechanical connections for leakage. (d) For each bag leak detection system (BLDS), you... mechanical connections for leakage. (c) For each pressure measurement device, you must meet the requirements...) Use a gauge with a minimum tolerance of 0.5 inch of water or a transducer with a minimum tolerance of...

  18. Monitoring and evaluation of Blyth Offshore Wind Farm. NAVAID (Navigational Aid) requirements for UK offshore wind farms

    Energy Technology Data Exchange (ETDEWEB)

    Pepper, L.

    2001-07-01

    The principle aim of this report is to review and evaluate the Navigational Aid (NAVAID) requirements for the Blyth Offshore Wind Farms as specified by Trinity House. The effectiveness of the NAVAIDs was monitored and reviewed by the project team with the assistance of the harbour master and the local vessel operators regularly using Blyth Harbour. This report particularly looks at the reasons for the NAVAID specification and the practicalities of using a similar system on larger offshore wind farms. The document not only describes the specification, but also reviews its effectiveness including any difficulties that were encountered during the installation. (author)

  19. Monitored retrievable storage program. Status and plans for meeting NWPA requirements

    International Nuclear Information System (INIS)

    Hall, R.J.; Fletcher, J.F.

    1983-12-01

    Accomplishments of the Monitored Retrieval Storage (MRS) Program since passage of the Nuclear Waste Policy Act of 1982 (NWPA) are as follows: (1) R and D needs report was submitted; (2) conceptual design analysis of 8 MRS concepts was performed; (3) selection of two MRS concepts (primary, alternative) are underway; (4) Parson/Westinghouse/Golder were selected as architect-engineer; (5) functional design criteria were established; (6) reports to accompany proposal were defined; and (7) evaluations of mission, cost-effectiveness, deployment time were performed. Future work, plans and schedule include completion of facility advanced conceptual design and accompanying design reports in early 1985, for submittal with proposal in June. Designs are being prepared for the primary concept, and in less detail, for the alternate. Three separate site locations will be assumed for each concept. A siting plan, to accompany the proposal, will also be completed in early 1985, as will an environmental assessment now under preparation. It is planned that the proposal be accompanied by several reports augmenting the planning base for post-proposal actions, to be activated at the time MRS deployment is authorized by Congress. 9 figures

  20. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  1. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  2. Several requirements made on the quality of nuclide-specific gamma radiation measuring rigs with germanium detectors for nuclear power plant monitoring

    International Nuclear Information System (INIS)

    Wuensch, K.D.

    1986-01-01

    The measuring set-ups are used for nuclide-specific analysis of all samples from nuclear power plants, i.e. solid, liquid, or gaseous. Depending on the nature of the sample, various requirements made by ordinances and guidelines discussed in detail must be met, relating to emission monitoring, environmental monitoring, system monitoring, room air monitoring, and contamination monitoring. The state-of-the-art is shown emphasizing the resolution and the evaluation scheme. Experience gained in the control of such systems is reported on in brief. The quality of in-service inspections is discussed. (orig./PW) [de

  3. Brookhaven National Laboratory environmental monitoring plan for Calendar Year 1996

    Energy Technology Data Exchange (ETDEWEB)

    Naidu, J.R.; Paquette, D.; Lee, R. [and others

    1996-10-01

    As required by DOE Order 5400.1, each U.S. Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials shall provide a written Environmental Monitoring Plan (EMP) covering effluent monitoring and environmental surveillance. DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, provides specific guidance regarding environmental monitoring activities.

  4. Brookhaven National Laboratory environmental monitoring plan for Calendar Year 1996

    International Nuclear Information System (INIS)

    Naidu, J.R.; Paquette, D.; Lee, R.

    1996-01-01

    As required by DOE Order 5400.1, each U.S. Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials shall provide a written Environmental Monitoring Plan (EMP) covering effluent monitoring and environmental surveillance. DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, provides specific guidance regarding environmental monitoring activities

  5. Routine Radiological Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    Bechtel Nevada

    1998-01-01

    The U.S. Department of Energy manages the Nevada Test Site in a manner that meets evolving DOE Missions and responds to the concerns of affected and interested individuals and agencies. This Routine Radiological Monitoring Plan addressess complicance with DOE Orders 5400.1 and 5400.5 and other drivers requiring routine effluent monitoring and environmental surveillance on the Nevada Test Site. This monitoring plan, prepared in 1998, addresses the activities conducted onsite NTS under the Final Environmental Impact Statement and Record of Decision. This radiological monitoring plan, prepared on behalf of the Nevada Test Site Landlord, brings together sitewide environmental surveillance; site-specific effluent monitoring; and operational monitoring conducted by various missions, programs, and projects on the NTS. The plan provides an approach to identifying and conducting routine radiological monitoring at the NTS, based on integrated technical, scientific, and regulatory complicance data needs

  6. 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

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

    Energy Technology Data Exchange (ETDEWEB)

    Oh, Se Ki; Shin, Y. K.; Kim, J. S.; Yu, Y. J.; Lee, Y. J. [Ajou Univ., Suwon (Korea, Republic of)

    2001-03-15

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

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

    Directory of Open Access Journals (Sweden)

    Karen Artiles

    2009-11-01

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

  9. Satellite Sensor Requirements for Monitoring Essential Biodiversity Variables of Coastal Ecosystems

    Science.gov (United States)

    Muller-Karger, Frank E.; Hestir, Erin; Ade, Christiana; Turpie, Kevin; Roberts, Dar A.; Siegel, David; Miller, Robert J.; Humm, David; Izenberg, Noam; Keller, Mary; hide

    2018-01-01

    The biodiversity and high productivity of coastal terrestrial and aquatic habitats are the foundation for important benefits to human societies around the world. These globally distributed habitats need frequent and broad systematic assessments, but field surveys only cover a small fraction of these areas. Satellite-based sensors can repeatedly record the visible and near-infrared reflectance spectra that contain the absorption, scattering, and fluorescence signatures of functional phytoplankton groups, colored dissolved matter, and particulate matter near the surface ocean, and of biologically structured habitats (floating and emergent vegetation, benthic habitats like coral, seagrass, and algae). These measures can be incorporated into Essential Biodiversity Variables (EBVs), including the distribution, abundance, and traits of groups of species populations, and used to evaluate habitat fragmentation. However, current and planned satellites are not designed to observe the EBVs that change rapidly with extreme tides, salinity, temperatures, storms, pollution, or physical habitat destruction over scales relevant to human activity. Making these observations requires a new generation of satellite sensors able to sample with these combined characteristics: (1) spatial resolution on the order of 30 to 100-m pixels or smaller; (2) spectral resolution on the order of 5 nm in the visible and 10 nm in the short-wave infrared spectrum (or at least two or more bands at 1,030, 1,240, 1,630, 2,125, and/or 2,260 nm) for atmospheric correction and aquatic and vegetation assessments; (3) radiometric quality with signal to noise ratios (SNR) above 800 (relative to signal levels typical of the open ocean), 14-bit digitization, absolute radiometric calibration less than 2%, relative calibration of 0.2%, polarization sensitivity less than 1%, high radiometric stability and linearity, and operations designed to minimize sunglint; and (4) temporal resolution of hours to days. We refer

  10. 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

  11. Experience with neutron flux monitoring systems qualified for post-accident monitoring

    International Nuclear Information System (INIS)

    Shugars, H.G.; Miller, J.F.

    1995-01-01

    In this paper we discuss the environmental requirements for excore neutron flux monitors that are qualified for use during and after postulated accidents in Pressurized Water Reactors (PWRs). We emphasize PWRs designed in the United States, which are similar to those used also in parts of Western Europe and Eastern Asia. We then discuss design features of the flux monitoring systems necessary to address the environmental, functional, and regulatory requirements, and the experience with these systems. (author). 9 refs, 2 figs

  12. Improving regulatory oversight of maintenance programs

    International Nuclear Information System (INIS)

    Cook, S.

    2008-01-01

    Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

  13. Regulatory point of view of SAT application

    International Nuclear Information System (INIS)

    Juhasz, L.

    2002-01-01

    I present the regulatory system for monitoring operator training and check competency of operator personnel in Hungary and the effects of SAT to the regulatory framework/practice related to recruitment, training and authorisation of operating personnel. Also I introduce an application to manage the initial and refreshing training to regulatory bodies. (author)

  14. Drosophila-Cdh1 (Rap/Fzr) a regulatory subunit of APC/C is required for synaptic morphology, synaptic transmission and locomotion.

    Science.gov (United States)

    Wise, Alexandria; Schatoff, Emma; Flores, Julian; Hua, Shao-Ying; Ueda, Atsushi; Wu, Chun-Fang; Venkatesh, Tadmiri

    2013-11-01

    The assembly of functional synapses requires the orchestration of the synthesis and degradation of a multitude of proteins. Protein degradation and modification by the conserved ubiquitination pathway has emerged as a key cellular regulatory mechanism during nervous system development and function (Kwabe and Brose, 2011). The anaphase promoting complex/cyclosome (APC/C) is a multi-subunit ubiquitin ligase complex primarily characterized for its role in the regulation of mitosis (Peters, 2002). In recent years, a role for APC/C in nervous system development and function has been rapidly emerging (Stegmuller and Bonni, 2005; Li et al., 2008). In the mammalian central nervous system the activator subunit, APC/C-Cdh1, has been shown to be a regulator of axon growth and dendrite morphogenesis (Konishi et al., 2004). In the Drosophila peripheral nervous system (PNS), APC2, a ligase subunit of the APC/C complex has been shown to regulate synaptic bouton size and activity (van Roessel et al., 2004). To investigate the role of APC/C-Cdh1 at the synapse we examined loss-of-function mutants of Rap/Fzr (Retina aberrant in pattern/Fizzy related), a Drosophila homolog of the mammalian Cdh1 during the development of the larval neuromuscular junction in Drosophila. Our cell biological, ultrastructural, electrophysiological, and behavioral data showed that rap/fzr loss-of-function mutations lead to changes in synaptic structure and function as well as locomotion defects. Data presented here show changes in size and morphology of synaptic boutons, and, muscle tissue organization. Electrophysiological experiments show that loss-of-function mutants exhibit increased frequency of spontaneous miniature synaptic potentials, indicating a higher rate of spontaneous synaptic vesicle fusion events. In addition, larval locomotion and peristaltic movement were also impaired. These findings suggest a role for Drosophila APC/C-Cdh1 mediated ubiquitination in regulating synaptic morphology

  15. 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

  16. Technical requirements for implementation of an individual monitoring service for evaluation of operational quantity HP(10) using thermoluminescent dosimetry

    International Nuclear Information System (INIS)

    Francisco, Adelaide Benedita Armando

    2016-01-01

    This work aims to establish technical requirements for the development of a TLDs system for the assessment of operational quantity H P (10), in order to implement an external individual monitoring service in countries who do not have. This allows a better understanding of the technic and the thermoluminescent dosimetry system, thus contributing to identify the technical criteria to be followed by a dosimetry laboratory and evaluation of the dosimetric system performance. For this, the review of the specific literature of the dosimetry field was conducted and later the type and performance tests that must be followed by a dosimetric system were reproduced in practice. In additional was made a analysis of internationals standards norms and the technical regulation used in Brazil, to define the essentials type testes to a dosimetric system. To check the performance of a dosimetry system, a performance analysis of the Brazilian TLDs system was carried out over the past 6 years using the trumpet curve, where it was observed that most of TLDs system, in this review period, were approved and have excellent performance. The technical requirements for the development of a thermoluminescent dosimetry system ensure that the system provides technically reliable results and allow demonstration of compliance with the standard criteria established by national and international standards, and the implementation of the dosimetry system, is verified the compliance of the annual doses limits set for occupationally exposed. (author)

  17. Environmental Monitoring Plan, Revision 6

    Energy Technology Data Exchange (ETDEWEB)

    Gallegos, G M; Bertoldo, N A; Blake, R G; Campbell, C G; Grayson, A R; Nelson, J C; Revelli, M A; Rosene, C A; Wegrecki, T; Williams, R A; Wilson, K R; Jones, H E

    2012-03-02

    The purpose of environmental monitoring is to promote the early identification of, and response to, potential adverse environmental impacts associated with Lawrence Livermore National Laboratory (LLNL) operations. Environmental monitoring supports the Integrated Safety Management System (ISMS), International Organization for Standardization (ISO) 14001 Environmental Management Systems standard, and U. S. Department of Energy (DOE) Order 458.1, Radiation Protection of the Public and the Environment. Specifically, environmental monitoring enables LLNL to detect, characterize, and respond to releases from LLNL activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the biota in the vicinity of LLNL. Environmental monitoring is also a major component of compliance demonstration for permits and other regulatory requirements. The Environmental Monitoring Plan (EMP) addresses the sample collection and analytical work supporting environmental monitoring to ensure the following: (1) A consistent system for collecting, assessing, and documenting environmental data of known and documented quality; (2) A validated and consistent approach for sampling and analysis of samples to ensure laboratory data meets program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work; and (3) An integrated sampling approach to avoid duplicative data collection. LLNL prepares the EMP because it provides an organizational framework for ensuring that environmental monitoring work, which is integral to the implementation of LLNL's Environmental Management System, is conducted appropriately. Furthermore, the Environmental Monitoring Plan helps LLNL ensure compliance with DOE Order 231.1 Change 2, Environment, Safety and Health Reporting

  18. 40 CFR Table 5 to Subpart Ppp of... - Process Vents From Batch Unit Operations-Monitoring, Recordkeeping, and Reporting Requirements

    Science.gov (United States)

    2010-07-01

    ... all instances when monitoring data are not collected—PR. d,e If a base absorbent is used, report all p... all instances when monitoring data are not collected—PR. d,e Catalytic Incinerator Temperature... instances when monitoring data are not collected. e Boiler or Process Heater with a design heat input...

  19. Identification and monitoring of effector and regulatory T cells during experimental arthritis based on differential expression of CD25 and CD134

    NARCIS (Netherlands)

    Nolte-'t Hoen, E.N.M.; Boot, E.P.J.; Wagenaar-Hilbers, J.P.A.; Bilsen, J.H.M. van; Arkesteijn, G.J.A.; Storm, G.; Everse, L.A.; Eden, W. van; Wauben, M.H.M.

    2008-01-01

    Major problems in the analysis of CD4+ effector cell and regulatory T cell (Treg) populations in an activated immune system are caused by the facts that both cell types can express CD25 and that the discriminatory marker forkhead box p3 can only be analyzed in nonviable (permeabilized) cells. Here,

  20. Continuous remote monitoring of COPD patients-justification and explanation of the requirements and a survey of the available technologies.

    Science.gov (United States)

    Tomasic, Ivan; Tomasic, Nikica; Trobec, Roman; Krpan, Miroslav; Kelava, Tomislav

    2018-04-01

    Remote patient monitoring should reduce mortality rates, improve care, and reduce costs. We present an overview of the available technologies for the remote monitoring of chronic obstructive pulmonary disease (COPD) patients, together with the most important medical information regarding COPD in a language that is adapted for engineers. Our aim is to bridge the gap between the technical and medical worlds and to facilitate and motivate future research in the field. We also present a justification, motivation, and explanation of how to monitor the most important parameters for COPD patients, together with pointers for the challenges that remain. Additionally, we propose and justify the importance of electrocardiograms (ECGs) and the arterial carbon dioxide partial pressure (PaCO 2 ) as two crucial physiological parameters that have not been used so far to any great extent in the monitoring of COPD patients. We cover four possibilities for the remote monitoring of COPD patients: continuous monitoring during normal daily activities for the prediction and early detection of exacerbations and life-threatening events, monitoring during the home treatment of mild exacerbations, monitoring oxygen therapy applications, and monitoring exercise. We also present and discuss the current approaches to decision support at remote locations and list the normal and pathological values/ranges for all the relevant physiological parameters. The paper concludes with our insights into the future developments and remaining challenges for improvements to continuous remote monitoring systems. Graphical abstract ᅟ.

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

    Directory of Open Access Journals (Sweden)

    Yuta Abe

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

  2. 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

  3. Monitoring and control requirement definition study for Dispersed Storage and Generation (DSG). Volume 2, appendix A: Selected DSG technologies and their general control requirements

    Science.gov (United States)

    1980-01-01

    A consistent approach was sought for both hardware and software which will handle the monitoring and control necessary to integrate a number of different DSG technologies into a common distribution dispatch network. It appears that the control of each of the DSG technologies is compatible with a supervisory control method of operation that lends itself to remote control from a distribution dispatch center.

  4. 76 FR 35922 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2011-06-20

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

  5. Comments on regulatory reform

    International Nuclear Information System (INIS)

    Hendrie, J.M.

    1982-01-01

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

  6. Comments on regulatory reform

    Energy Technology Data Exchange (ETDEWEB)

    Hendrie, J.M.

    1982-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2017-11-15

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

  8. Ig synthesis and class switching do not require the presence of the hs4 enhancer in the 3' IgH regulatory region.

    Science.gov (United States)

    Vincent-Fabert, Christelle; Truffinet, Véronique; Fiancette, Remi; Cogné, Nadine; Cogné, Michel; Denizot, Yves

    2009-06-01

    Several studies have reported that regulatory elements located 3' of the IgH locus (namely hs3a, hs1,2, hs3b, and hs4) might play a role during class switch recombination (CSR) and Ig synthesis. While individual deletion of hs3a or hs1,2 had no effect, pairwise deletion of hs3b (an inverted copy of hs3a) and hs4 markedly affected CSR and Ig expression. Among these two elements, hs4 was tentatively presented with the master role due to its unique status within the 3' regulatory region: distal position outside repeated regions, early activation in pre-B cells, strong activity throughout B cell ontogeny. To clarify its role, we generated mice with a clean deletion of the hs4 after replacement with a floxed neo(R) cassette. Surprisingly, and as for previous deletion of hs3a or hs1,2, deletion of hs4 did not affect either in vivo CSR or the secretion level of any Ig isotype. In vitro CSR and Ig secretion in response to LPS and cytokines was not affected either. The only noticeable effects of the hs4 deletion were a decrease in the number of B splenocytes and a decreased membrane IgM expression. In conclusion, while dispensable for CSR and Ig transcription in plasma cells, hs4 mostly appears to contribute to Ig transcription in resting B lymphocytes.

  9. Routine Radiological Environmental Monitoring Plan. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Bechtel Nevada

    1999-12-31

    The U.S. Department of Energy manages the Nevada Test Site in a manner that meets evolving DOE Missions and responds to the concerns of affected and interested individuals and agencies. This Routine Radiological Monitoring Plan addressess complicance with DOE Orders 5400.1 and 5400.5 and other drivers requiring routine effluent monitoring and environmental surveillance on the Nevada Test Site. This monitoring plan, prepared in 1998, addresses the activities conducted onsite NTS under the Final Environmental Impact Statement and Record of Decision. This radiological monitoring plan, prepared on behalf of the Nevada Test Site Landlord, brings together sitewide environmental surveillance; site-specific effluent monitoring; and operational monitoring conducted by various missions, programs, and projects on the NTS. The plan provides an approach to identifying and conducting routine radiological monitoring at the NTS, based on integrated technical, scientific, and regulatory complicance data needs.

  10. 40 CFR Table 4 to Subpart G of... - Process Vents-Monitoring, Recordkeeping, and Reporting Requirements For Maintaining a TRE Index...

    Science.gov (United States)

    2010-07-01

    ..., and Reporting Requirements For Maintaining a TRE Index Value >1.0 and. â¤4.0 4 Table 4 to Subpart G of... TRE Index Value >1.0 and. ≤4.0 Final recovery device Parameters to be monitored a Recordkeeping and... for Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry for...

  11. 40 CFR Table 4 to Subpart F of... - Organic Hazardous Air Pollutants Subject to Cooling Tower Monitoring Requirements in § 63.104

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Organic Hazardous Air Pollutants Subject to Cooling Tower Monitoring Requirements in § 63.104 4 Table 4 to Subpart F of Part 63 Protection... 4 Table 4 to Subpart F of Part 63—Organic Hazardous Air Pollutants Subject to Cooling Tower...

  12. 100-N pilot project: Proposed consolidated groundwater monitoring program

    International Nuclear Information System (INIS)

    Borghese, J.V.; Hartman, M.J.; Lutrell, S.P.; Perkins, C.J.; Zoric, J.P.; Tindall, S.C.

    1996-11-01

    This report presents a proposed consolidated groundwater monitoring program for the 100-N Pilot Project. This program is the result of a cooperative effort between the Hanford Site contractors who monitor the groundwater beneath the 100-N Area. The consolidation of the groundwater monitoring programs is being proposed to minimize the cost, time, and effort necessary for groundwater monitoring in the 100-N Area, and to coordinate regulatory compliance activities. The integrity of the subprograms requirements remained intact during the consolidation effort. The purpose of this report is to present the proposed consolidated groundwater monitoring program and to summarize the process by which it was determined

  13. A memorandum of understanding between Alberta Environmental Protection and the Alberta Energy and Utilities Board regarding coordination of release notification requirements and subsequent regulatory response : informational letter IL 98-1

    International Nuclear Information System (INIS)

    1998-01-01

    Text outlining the process to be used by the upstream oil and gas industry to notify either Alberta Environmental Protection or the Alberta Energy and Utilities Board (EUB) whenever a spill or other form of release has occurred, is provided. This MOU further clarifies the release notification requirements for any release that is capable of causing damage to the environment, human health or safety. Industry operators are required to orally notify the appropriate regulatory authority as soon as they become aware of a reportable release of unrefined products such as conventional crude oil, LPG, diluent, condensate, synthetic crude, sour gas, produced water, and other produced fluids resulting from pipeline fractures or from incidents involving oilfield wastes. For releases of refined products such as diesel, gasoline, sulphur and solvents, industry operators are required to orally notify the Pollution Control Division as soon as they become aware of the problem. 3 tabs., 2 figs

  14. 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

  15. Management of waste from nuclear facilities as a regulatory problem. Requirements to be met by legislation under conditions of uncertainty. Die Entsorgung der Kernenergie als Regelungsproblem. Zu den Anforderungen an Gesetzgebung unter Ungewissheitsbedingungen

    Energy Technology Data Exchange (ETDEWEB)

    Ladeur, K.H.

    1989-07-01

    The author presents a brief review of the development of the nuclear waste management regime in the Atomic Energy Act, referring also to court decissions and the literature. The article analyses the constitutionality of the waste management regulations of section 9a and following sections, and of the provisions on reprocessing (section 7, sub-sec. (1)), primarily under the aspect of the principle of proviso of legality in general, reformulated by the theory of materiality, and in particular with regard to the requirement of 'backfitting' in order to improve the regulatory system for complex and especially technological matters. (orig./RST).

  16. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

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

  17. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

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

  18. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

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

  19. Savannah River Site Environmental Monitoring Plan. Volume 1, Section 1000 Addendum: Revision 3

    International Nuclear Information System (INIS)

    Jannik, G.T.

    1994-01-01

    This document -- the Savannah River Site Environmental Monitoring Plan (SRS EM Plan) -- has been prepared according to guidance contained in the DOE 5400 Series orders, in 10 CFR 834, and in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and environmental Surveillance [DOE, 1991]. The SRS EM Plan's purpose is to define the criteria, regulations, and guideline requirements with which SRS will comply. These criteria and requirements are applicable to environmental monitoring activities performed in support of the SRS Environmental Monitoring Program (SRS EM Program), WSRC-3Q1-2, Volume 1, Section 1100. They are not applicable to monitoring activities utilized exclusively for process monitoring/control. The environmental monitoring program requirements documented in the SRS EM Plan incorporate all applicable should requirements of DOE/EH-0173T and expand upon them to include nonradiological environmental monitoring program requirements

  20. 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...

  1. 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...

  2. Environmental monitoring programme

    International Nuclear Information System (INIS)

    1991-08-01

    During 1989 there were about 1000 premises in England and Wales authorised to discharge radioactive wastes. The majority of these premises consisted of hospitals, universities and industrial, research or manufacturing centres. Discharges from these premises when made in accordance with the strict conditions specified in their authorisations will have been of little radiological significance. In the case of nuclear sites authorisations or approvals are issued jointly by the DoE and the Ministry of Agriculture, Fisheries and Food (MAFF) known collectively as the Authorising Departments. In Wales these functions are undertaken by the Welsh Office with the support of HMIP and MAFF. The Authorising Departments specify numerical limits on the amounts of radioactivity which operators may discharge to the environment. In addition operators are required to demonstrate that the best practicable means (BPM) to minimise discharges is undertaken. Operators are also required to carry out appropriate environmental monitoring to demonstrate the effectiveness of BPM. As part of their regulatory functions the Authorising Departments undertake their own environmental monitoring programmes to act as both a check on site operator's returns and to provide independent data on the exposure of the public. HM Inspectorate of Pollution has monitored levels of radioactivity in drinking water sources for many years and published results annually. MAFF undertakes two programmes to monitor radioactivity in the aquatic environment and in terrestrial foodstuffs and publishes annual reports. Environmental monitoring programmes undertaken by both nuclear site operators and government departments are summarised. (author)

  3. EXPERIENCE OF APPLICATION OF A PORTABLE OPTICO – EMISSION SPECTROMETER FOR MONITORING OF CHEMICAL COMPOSITION OF HOT-ROLLED PRODUCTS TO IMPLEMENT THE CUSTOMER’S REQUIREMENTS

    Directory of Open Access Journals (Sweden)

    E. A. Kazakova

    2017-01-01

    Full Text Available One of requirements of customers in the automotive industry is the guarantee of lack of intermix of various brands of steel in a mill process of manufacture. For ensuring implementation of this requirement, it is necessary to carry out monitoring of chemical composition of each bar just before shipment, after its packing and application of the required marking. An optimal solution of this problem is application of the portable optico-emission spectrometer allowing to carry out tests of samples directly in place of location.

  4. Why do some therapists not deal with outcome monitoring feedback? A feasibility study on the effect of regulatory focus and person–organization fit on attitude and outcome

    NARCIS (Netherlands)

    de Jong, Kim; de Goede, Marije

    2015-01-01

    Objective: Despite research on its effectiveness, many therapists still have negative attitudes toward using outcome monitoring feedback. The current study aims to investigate how the perceived match between values of an individual and those of the organization (Person–Organization fit; PO fit), and

  5. Integrated Monitoring Plan for the Hanford Groundwater Monitoring Project

    International Nuclear Information System (INIS)

    Hartman, Mary J.; Dresel, P. Evan; Lindberg, Jon W.; Newcomer, Darrell R.; Thornton, Edward C.

    2000-01-01

    Groundwater is monitored at the Hanford Site to fulfill a variety of state and federal regulations, including the Atomic Energy Act of 1954; the Resource Conservation and Recovery Act of 1976; the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; and Washington Administrative Code. Separate monitoring plans are prepared for various requirements, but sampling is coordinated and data are shared among users to avoid duplication of effort. The U.S. Department of Energy manages these activities through the Hanford Groundwater Monitoring Project. This document is an integrated monitoring plan for the groundwater project. It documents well and constituent lists for monitoring required by the Atomic Energy Act of 1954 and its implementing orders; includes other, established monitoring plans by reference; and appends a master well/constituent/ frequency matrix for the entire site. The objectives of monitoring fall into three general categories: plume and trend tracking, treatment/ storage/disposal unit monitoring, and remediation performance monitoring. Criteria for selecting Atomic Energy Act of 1954 monitoring networks include locations of wells in relation to known plumes or contaminant sources, well depth and construction, historical data, proximity to the Columbia River, water supplies, or other areas of special interest, and well use for other programs. Constituent lists were chosen based on known plumes and waste histories, historical groundwater data, and, in some cases, statistical modeling. Sampling frequencies were based on regulatory requirements, variability of historical data, and proximity to key areas. For sitewide plumes, most wells are sampled every 3 years. Wells monitoring specific waste sites or in areas of high variability will be sampled more frequently

  6. Integrated Monitoring Plan for the Hanford Groundwater Monitoring Project

    International Nuclear Information System (INIS)

    Newcomer, D.R.; Thornton, E.C.; Hartman, M.J.; Dresel, P.E.

    1999-01-01

    Groundwater is monitored at the Hanford Site to fulfill a variety of state and federal regulations, including the Atomic Energy Act of 1954 the Resource Conservation and Recovery Act of 1976 the Comprehensive Environmental Response, Compensation, and Liability Act of 1980; and Washington Administrative Code. Separate monitoring plans are prepared for various requirements, but sampling is coordinated and data are shared among users to avoid duplication of effort. The US Department of Energy manages these activities through the Hanford Groundwater Monitoring Project. This document is an integrated monitoring plan for the groundwater project. It documents well and constituent lists for monitoring required by the Atomic Energy Act of 1954 and its implementing orders; includes other, established monitoring plans by reference; and appends a master well/constituent/frequency matrix for the entire site. The objectives of monitoring fall into three general categories plume and trend tracking, treatment/storage/disposal unit monitoring, and remediation performance monitoring. Criteria for selecting Atomic Energy Act of 1954 monitoring networks include locations of wells in relation to known plumes or contaminant sources, well depth and construction, historical data, proximity to the Columbia River, water supplies, or other areas of special interest, and well use for other programs. Constituent lists were chosen based on known plumes and waste histories, historical groundwater data, and, in some cases, statistical modeling. Sampling frequencies were based on regulatory requirements, variability of historical data, and proximity to key areas. For sitewide plumes, most wells are sampled every 3 years. Wells monitoring specific waste sites or in areas of high variability will be sampled more frequently

  7. Meeting Earth Observation Requirements for Global Agricultural Monitoring: An Evaluation of the Revisit Capabilities of Current and Planned Moderate Resolution Optical Earth Observing Missions

    Directory of Open Access Journals (Sweden)

    Alyssa K. Whitcraft

    2015-01-01

    Full Text Available Agriculture is a highly dynamic process in space and time, with many applications requiring data with both a relatively high temporal resolution (at least every 8 days and fine-to-moderate (FTM < 100 m spatial resolution. The relatively infrequent revisit of FTM optical satellite observatories coupled with the impacts of cloud occultation have translated into a barrier for the derivation of agricultural information at the regional-to-global scale. Drawing upon the Group on Earth Observations Global Agricultural Monitoring (GEOGLAM Initiative’s general satellite Earth observation (EO requirements for monitoring of major production areas, Whitcraft et al. (this issue have described where, when, and how frequently satellite data acquisitions are required throughout the agricultural growing season at 0.05°, globally. The majority of areas and times of year require multiple revisits to probabilistically yield a view at least 70%, 80%, 90%, or 95% clear within eight days, something that no present single FTM optical observatory is capable of delivering. As such, there is a great potential to meet these moderate spatial resolution optical data requirements through a multi-space agency/multi-mission constellation approach. This research models the combined revisit capabilities of seven hypothetical constellations made from five satellite sensors—Landsat 7 Enhanced Thematic Mapper (Landsat 7 ETM+, Landsat 8 Operational Land Imager and Thermal Infrared Sensor (Landsat 8 OLI/TIRS, Resourcesat-2 Advanced Wide Field Sensor (Resourcesat-2 AWiFS, Sentinel-2A Multi-Spectral Instrument (MSI, and Sentinel-2B MSI—and compares these capabilities with the revisit frequency requirements for a reasonably cloud-free clear view within eight days throughout the agricultural growing season. Supplementing Landsat 7 and 8 with missions from different space agencies leads to an improved capacity to meet requirements, with Resourcesat-2 providing the largest

  8. Environmental Monitoring Plan - February 2016

    Energy Technology Data Exchange (ETDEWEB)

    Gallegos, G. M. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Bertoldo, N. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Blake, R. G. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Fish, C. B. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Grayson, A. R. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Griffin, D. M. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Jones, H. E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Patterson, L. E. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Revelli, M. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Rosene, C. A. [Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States); Wegrecki, T M; Williams, R A; Wilson, K R

    2016-02-08

    The purpose of environmental monitoring is to promote the early identification of, and response to, potential adverse environmental impacts associated with Lawrence Livermore National Laboratory (LLNL) operations. Environmental monitoring supports the Integrated Safety Management System (ISMS), International Organization for Standardization (ISO) 14001 Environmental Management Systems standard, and U. S. Department of Energy (DOE) Order 458.1, Radiation Protection oft/ic Pubile and the Environment. Specifically, environmental monitoring enables LLNL to detect, characterize, and respond to releases from LLNL activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the hiota in the vicinity of LLNL. Environmental monitoring is also a major component of compliance demonstration for permits and other regulatory requirements.

  9. 40 CFR 63.4967 - What are the requirements for continuous parameter monitoring system installation, operation, and...

    Science.gov (United States)

    2010-07-01

    ... according to the manufacturer's requirements. (iv) Before using the sensor for the first time or upon... sensor calibration in accordance with the manufacturer's requirements. (iv) Perform a validation check... calibration of the sensor according to the manufacturer's requirements. (iv) Conduct a validation check before...

  10. Identification of technical guidance related to ground water monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

    1987-05-01

    Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act.

  11. Identification of technical guidance related to ground water monitoring

    International Nuclear Information System (INIS)

    Vogelsberger, R.R.; Smith, E.D.; Broz, M.; Wright, J.C. Jr.

    1987-05-01

    Monitoring of ground water quality is a key element of ground water protection and is mandated by several federal and state laws concerned with water quality or waste management. Numerous regulatory guidance documents and technical reports discuss various aspects of ground water monitoring, but at present there is no single source of guidance on procedures and practices for ground water monitoring. This report is intended to assist US Department of Energy (DOE) officials and facility operating personnel in identifying sources of guidance for developing and implementing ground water monitoring programs that are technically sound and that comply with applicable regulations. Federal statutes and associated regulations were reviewed to identify requirements related to ground water monitoring, and over 160 documents on topics related to ground water monitoring were evaluated for their technical merit, their utility as guidance for regulatory compliance, and their relevance to DOE's needs. For each of 15 technical topics involved in ground water monitoring, the report presents (1) a review of federal regulatory requirements and representative state requirements, (2) brief descriptions of the contents and merits of available guidance documents and technical references, and (3) recommendations of the guidance documents or other technical resources that appear to be most appropriate for use in DOE's monitoring activities. The contents of the report are applicable to monitoring activities involving both radioactive and nonradioactive substances. The main sources of regulatory requirements considered in the report are the Atomic Energy Act (including the Uranium Mill Tailings Radiation Control Act), Resource Conservation and Recovery Act, Comprehensive Environmental Response, Compensation and Liability Act, Safe Drinking Water Act, Toxic Substances Control Act, and Federal Water Pollution Control Act

  12. 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

  13. 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...

  14. Minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge - Towards a water reuse regulatory instrument at EU level Réédition

    OpenAIRE

    ALCALDE SANZ LAURA; GAWLIK BERND

    2017-01-01

    As an input to the design of a Legal Instrument on Water Reuse in Europe, this report recommends minimum quality requirements for water reuse in agricultural irrigation and aquifer recharge based on a risk management approach.

  15. 40 CFR 63.4168 - What are the requirements for continuous parameter monitoring system installation, operation, and...

    Science.gov (United States)

    2010-07-01

    ... divert the emissions away from the add-on control device to the atmosphere. (ii) Car-seal or lock-and-key valve closures. Secure any bypass line valve in the closed position with a car-seal or a lock-and-key... the monitor will indicate valve position. (iv) Automatic shutdown system. Use an automatic shutdown...

  16. 40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

    Science.gov (United States)

    2010-07-01

    ... Administrator, or his or her representative. The quality system will be reviewed during the systems audits.... Environmental Protection Agency in Research Triangle Park, North Carolina. 2.5Technical Systems Audit Program. Technical systems audits of each ambient air monitoring organization shall be conducted at least every 3...

  17. 40 CFR Table 6 to Subpart Ppp of... - Process Vents From Continuous Unit Operations-Monitoring, Recordkeeping, and Reporting Requirements

    Science.gov (United States)

    2010-07-01

    ... when insufficient monitoring data are collected. e Boiler or Process Heater with a design heat input... operating value established in the NCS or operating—PR. d,e Condenser f Exit (product side) temperature 1... operating permit—PR. d,e Absorber, Condenser, and Carbon Adsorber (as an alternative to the above...

  18. Validation of limited sampling models (LSM) for estimating AUC in therapeutic drug monitoring - is a separate validation group required?

    NARCIS (Netherlands)

    Proost, J. H.

    Objective: Limited sampling models (LSM) for estimating AUC in therapeutic drug monitoring are usually validated in a separate group of patients, according to published guidelines. The aim of this study is to evaluate the validation of LSM by comparing independent validation with cross-validation

  19. 40 CFR 63.7927 - What are my inspection and monitoring requirements for closed vent systems and control devices?

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 13 2010-07-01 2010-07-01 false What are my inspection and monitoring... Pollutants: Site Remediation Closed Vent Systems and Control Devices § 63.7927 What are my inspection and... temperature at the inlet of the catalyst bed, the hourly average temperature at the outlet of the catalyst bed...

  20. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

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