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. 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.

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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)

  10. 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)

  11. 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

  12. 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...

  13. 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

  14. 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.

  15. 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

  16. 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...

  17. 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, ...

  18. 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

  19. 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.

  20. 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

  1. 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...

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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,

  9. 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.

  10. 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

  11. 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...

  12. 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

  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. 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)

  15. 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

  16. 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.

  17. 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

  18. 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)

  19. 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)

  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. 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

  2. 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)

  3. 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

  4. 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

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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...

  11. 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.

  12. 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] ...

  13. 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

  14. 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

  15. 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...

  16. 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

  17. 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...

  18. 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

  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. 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.

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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)

  6. 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

  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. 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...

  9. 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.

  10. 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)

  11. 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.

  12. 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.

  13. 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.)

  14. 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)

  15. 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

  16. 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...

  17. 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

  18. 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

  19. 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

  20. 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

  1. 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.

  2. 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

  3. 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

  4. 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)

  5. 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.

  6. 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...

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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] ...

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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

  1. 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,

  2. 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.

  3. 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

  4. 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)

  5. 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

  6. 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

  7. Environmental Monitoring Plan, Revision 5

    Energy Technology Data Exchange (ETDEWEB)

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

    2010-01-27

    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 450.1A, Environmental Protection Program. Specifically, in conformance with DOE Order 450.1A, Attachment 1, paragraph 1(b)(5), 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 also serves to demonstrate compliance with 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. (3) An integrated sampling approach to avoid duplicative data collection. Until its cancellation in January 2003, DOE Order 5400.1 required the preparation of an environmental monitoring plan. Neither DOE Order 450.1A nor the ISO 14001 standard are as prescriptive as DOE Order 5400.1, in that neither expressly requires an EMP. However, LLNL continues to prepare the EMP because it provides an organizational framework for

  8. 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

  9. 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.

  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. 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

  12. 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...

  13. 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

  14. 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)

  15. 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

  16. 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

  17. 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

  18. An automated, self-verifying system for monitoring uranium in effluent streams

    International Nuclear Information System (INIS)

    Reda, R.J.; Pickett, J.L.

    1992-01-01

    In nuclear facilities such as nuclear fuel fabrication plants, a constant vigil is required to ensure that the concentrations of uranium in process or waste streams do not exceed required specifications. The specifications may be dictated by the process owner, a regulatory agency such as the US Nuclear Regulatory Agency or Environmental Protection Agency, or by criticality safety engineering criteria. Traditionally, uranium monitoring in effluent streams has been accomplished by taking periodic samples of the liquid stream and determining the concentration by chemical analysis. Despite its accuracy, chemical sampling is not timely enough for practical use in continuously flowing systems because of the possibility that a significant quantity of uranium may be discharged between sampling intervals. To completely satisfy regulatory standards, the liquid waste stream must be monitored for uranium on a 100% basis. To this end, an automated, radioisotopic liquid-waste monitoring system was developed by GE Nuclear Energy as an integral part of the uranium conversion and waste recovery operations. The system utilizes passive gamma-ray spectroscopy and is thus a robust, on-line, and nondestructive assay for uranium. The system provides uranium concentration data for process monitoring and assures regulatory compliance for criticality safety. A summary of the principles of system operation, calibration, and verification is presented in this paper

  19. 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

  20. 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

  1. 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.

  2. 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)

  3. 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)

  4. 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...

  5. 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)

  6. 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.

  7. 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

  8. 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.)

  9. 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.

  10. 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

  11. 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

  12. 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.

  13. 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

  14. 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.

  15. 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

  16. Information system fur the management of a regulatory programme

    International Nuclear Information System (INIS)

    Ortiz, P.; Mrabit, K.; Miaw, S.

    1998-01-01

    A Regulatory Programme to monitor safety of activities involving radiation sources, implies the existence of a Regulatory Authority empowered by legislation to issue radiation protection regulations and to monitor compliance with those regulations. The core element of the programme is a system of notification and authorization (registration and licensing), inspection and enforcement. The efficiency of this system is largely dependent on the availability of reliable information on the inventory of radiation sources and installations, the administrative status of the facilities (authorization), prompt processing of inspection reports and follow up of regulatory actions, including monitoring deadlines. Essential data relevant to safety, such as personal dosimetry for occupationally exposed individuals, inspection findings and incident reports would provide, in addition, an insight on the overall safety of the country. A simple but comprehensive Regulatory Authority Information System (RAIS) linked to the authorization and inspection process will largely facilitate regulatory decisions and actions. A readily available and reliable information from the various regulatory activities will facilitate planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and follow up regulatory actions including monitoring dead lines. The implementation of the system in more than 50 countries will contribute to experience exchange and harmonization of regulatory activities. (author)

  17. 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...

  18. 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...

  19. 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.

  20. 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

  1. 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.

  2. 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

  3. 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.)

  4. 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...

  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. 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

  7. 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

  8. 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...

  9. 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)

  10. 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...

  11. 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

  12. 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

  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. 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.

  15. 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.

  16. 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)

  17. 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.

  18. 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)

  19. 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

  20. 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.

  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. Comparative Analysis of Monitoring Devices for Particulate Content in Exhaust Gases

    Directory of Open Access Journals (Sweden)

    Beatrice Castellani

    2014-07-01

    Full Text Available The installation and operation of continuous particulate emission monitors in industrial processes has become well developed and common practice in industrial stacks and ducts over the past 30 years, reflecting regulatory monitoring requirements. Continuous emissions monitoring equipment is installed not only for regulatory compliance, but also for the monitoring of plant performance, calculation of emissions inventories and compilation of environmental impact assessments. Particulate matter (PM entrained in flue gases is produced by the combustion of fuels or wastes. The size and quantity of particles released depends on the type of fuel and the design of the plant. The present work provides an overview of the main industrial emission sources, a description of the main types of monitoring systems offered by manufacturers and a comparative analysis of the currently available technologies for measuring dust releases to atmosphere.

  3. Technical specifications requirements: Automated reasoning applications

    International Nuclear Information System (INIS)

    Lidsky, L.M.; Dobrzeniecki, A.B.

    1990-03-01

    Several software systems were developed and tested to determine what advantages could be gained from explicitly translating complicated regulatory requirements into computerized relationships. The Technical Specifications for US nuclear power plants were chosen as the test-bed application domain, and two analysis systems were developed to monitor plant compliance with operational limits, and track and schedule equipment test and maintenance activities mandated by Technical Specifications. Choosing PROLOG as the computer language to represent these regulatory requirements resulted in a natural match between the semantic structure of the written specifications and the corollary coded rules. Additional research results affirmed the utility of declarative programming styles, explicit management of problem complexity, and attention to the robustness and flexibility of the overall software systems. 5 refs., 2 figs

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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

  10. 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...

  11. 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)

  12. 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

  13. 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.

  14. 2002 WIPP Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Washington TRU Solutions LLC

    2002-09-30

    DOE Order 5400.1, General Environmental Protection Program, requires each DOE | facility to prepare an environmental management plan (EMP). This document is | prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment; applicable sections of Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) Part 834, ''Radiation Protection of the Public and Environment'' (draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1, which is the driver for the annual Site Environmental Report (SER) and the guidance source for preparing many environmental program documents. The WIPP Project is operated by Westinghouse TRU Solutions (WTS) for the DOE. This plan defines the extent and scope of WIPP's effluent and environmental | monitoring programs during the facility's operational life and also discusses WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP Project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance.

  15. 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.

  16. 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

  17. 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...

  18. 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...

  19. ENVIRONMENTAL SPECIFICATION REQUIREMENTS

    International Nuclear Information System (INIS)

    TIFFT, S.R.

    2003-01-01

    Through regulations, permitting or binding negotiations, Regulators establish requirements, limits, permit conditions and Notice of Construction (NOC) conditions with which the Office of River Protection (ORP) and the Tank Farm Contractor (TFC) must comply. Operating Specifications are technical limits which are set on a process to prevent injury to personnel, or damage to the facility or environment. The main purpose of this document is to provide specification limits and recovery actions for the TFC Environmental Surveillance Program at the Hanford Site. Specification limits are given for monitoring frequencies and permissible variation of readings from an established baseline or previous reading. The requirements in this document are driven by environmental considerations and data analysis issues, rather than facility design or personnel safety issues. This document is applicable to all SST and DST waste tanks, and the associated catch tanks and receiver tanks, and transfer systems. This Tank Farm ESD implements environmental-regulatory limits on the configuration and operation of the Hanford Tank Farms facility that have been established by Regulators. This ESD contains specific field operational limits and recovery actions for compliance with airborne effluent regulations and agreements, liquid effluents regulations and agreements, and environmental tank system requirements. The scope of this ESD is limited to conditions that have direct impact on Operations/Projects or that Operations/Projects have direct impact upon. This document does not supercede or replace any DOE Orders, regulatory permits, notices of construction, or Regulatory agency agreements binding on the ORP or the TFC. Refer to the appropriate regulation, permit, or NOC for an inclusive listing of requirements

  20. 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)

  1. Data Acquisition for Low-Temperature Geothermal Well Tests and Long-Term Monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Lienau, P J

    1992-03-01

    Groundwater monitoring is an essential part of the development of a low-temperature geothermal field for production and injection wells. State water resource and environmental departments are requiring both geothermal well testing and long-term monitoring as a part of the permitting process for geothermal developments. This report covers water-level measurement methods, instruments used for well testing, geochemical sampling, examples of data acquisition and regulatory mandates on groundwater monitoring.

  2. Data acquisition for low-temperature geothermal well tests and long-term monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Lienau, P.J.

    1992-09-01

    Groundwater monitoring is an essential part of the development of a low-temperature geothermal field for production and injection wells. State water resource and environmental departments are requiring both geothermal well testing and long-term monitoring as a part of the permitting process for geothermal developments. This report covers water-level measurement methods, instruments used for well testing, geochemical sampling, examples of data acquisition and regulatory mandates on groundwater monitoring.

  3. Compliance Groundwater Monitoring of Nonpoint Sources - Emerging Approaches

    Science.gov (United States)

    Harter, T.

    2008-12-01

    and its typically large spatial extend requires extensive networks at an individual site to accurately and fairly monitor individual compliance. In contrast, regional networks seemingly fail to hold individual landowners accountable. But regional networks can effectively monitor large-scale impacts and water quality trends; and thus inform regulatory programs that enforce management practices tied to nonpoint source pollution. Regional monitoring networks for compliance purposes can face significant challenges in the implementation due to a regulatory and legal landscape that is exclusively structured to address point sources and individual liability, and due to the non-intensive nature of a regional monitoring program (lack of control of hot spots; lack of accountability of individual landowners).

  4. 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)

  5. 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

  6. 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)

  7. Risk monitor riskangel for risk-informed applications in nuclear power plants

    International Nuclear Information System (INIS)

    Wang, Fang; Wang, Jiaqun; Wang, Jin; Li, Yazhou; Hu, Liqin; Wu, Yican

    2016-01-01

    Highlights: • A general risk monitor riskangel with high-speed cutsets generator engine. • Benchmarks of actual nuclear power plant (NPP) instantaneous risk models. • Applications in daily operation, maintenance plan and component out of service. - Abstract: This paper studied the requirements of risk monitor software and its applications as a plant specific risk monitor, which supports risk-informed configuration risk management for the two CANDU 6 units at the Third Qinshan nuclear power plant (TQNPP) in China. It also describes the regulatory prospective on risk-informed Probabilistic Safety Assessment (PSA) applications and the use of risk monitor at operating nuclear power plants, high level technical and functional requirements for the development of CANDU specific risk monitor software, and future development trends.

  8. 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.

  9. Experience during the monitoring of inactive scrap for the detection of inadvertent presence of radioactivity

    International Nuclear Information System (INIS)

    Sharma, Ranjit; Anoj Kumar; Vikas; Singh, Rajvir; Patra, R.P.; Vikas Kumar; Pradeepkumar, K.S.

    2012-01-01

    The paper describes about the experience gained during the radiation monitoring of inactive scrap generated at various nuclear facilities. This type surveillance is carried out to prevent the spread of radioactivity in public domain and also as requirement by regulatory authorities. The inspection and certification of scrap material from nuclear facilities is a regulatory requirement to ensure that no radioactive material reaches public domain. This paper describes the methodology and experience in detection of radioactivity at inactive Scrap monitoring facility. Inactive scraps (metallic and non metallic) generated from various nuclear facilities of BARC, Trombay is dispatched to Trombay Village Store (TVS) for temporary storage before auction to the public. The monitoring at the facility includes visual inspection and radiation measurement before loading the scrap in the truck. An online PC based monitoring system and portable monitoring instruments in the range (nSv/h-µSv/h) are used to carry out radiation monitoring of inactive scrap loaded in a vehicle. Radioactive source of high activity with potential for serious environmental hazard has not been detected, but few cases of presence of radioactive/contaminated material (MS plate/equipments with low level of 137 Cs contamination) have been detected and identified using portable gamma spectrometer. Implementation of strict regulatory measures and radiation monitoring at nuclear facilities can minimize the probability of radioactive material reaching the public domain. The methodology followed for monitoring of inactive scrap is found to be effective even for detection of presence of radioactivity in scrap if any. (author)

  10. 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

  11. NRPA develops regulatory cooperation with Central Asian authorities for nuclear safety and radiation protection

    International Nuclear Information System (INIS)

    2009-01-01

    With the support of the Norwegian Ministry of Foreign Affairs, the NRPA has initiated a regional regulatory cooperation project with Kazakhstan, Kyrgyzstan and Tajikistan to improve regulations on nuclear safety, radiation protection and environmental issues, and assist the countries in re mediating radioactively contaminated sites. There is a critical lack in the regulatory basis for carrying out such remediation work, including a lack of relevant radiation and environmental safety norms and standards, licensing procedures and requirements for monitoring, as well as expertise to transform such a basis into practice. (Author)

  12. 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)

  13. 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

  14. 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

  15. 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.

  16. Operational readiness of filtered air discharge monitoring systems

    International Nuclear Information System (INIS)

    Lafortune, J.F.; Jamieson, T.J.

    1993-08-01

    An assessment of the operational readiness of the Filtered Air Discharge (FAD) Stack Monitoring systems, installed in Canadian CANDU nuclear power plants, was performed in this project. Relevant Canadian and foreign standards and regulatory requirements have been reviewed and documentation on FAD stack monitoring system design, operation, testing and maintenance have been assessed to identify likely causes and potential failures of FAD stack monitoring systems and their components under both standby and accident conditions. Recommendations have also been provided in this report for design and performance review guidelines for CANDU stations. A case study of the FAD stack monitoring system at Pickering NGS is also documented in this report

  17. Long-term monitoring for closed special sites

    International Nuclear Information System (INIS)

    Golchert, N.W.; Sedlet, J.

    1987-01-01

    A methodology is presented for planning and implementing a long-term environmental monitoring program for closed special radioactive waste disposal sites. The steps in the method involve collection of the available background information on the site history, site and area characteristics, waste inventory, pathway analysis, prior monitoring programs, applicable standards, and the legal/regulatory requirements. This information is coupled with factors such as experience, half-life, radionuclide migration rates, and potential hazard to develop a monitoring program. As an example, a site-specific long-term monitoring program is described for the AMAX site using the available information. Sampling techniques and practices for the monitoring program are discussed and techniques and practices expected to be available in the future are considered. 7 references, 2 tables

  18. 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.

  19. ENVIRONMENTAL SPECIFICATION REQUIREMENTS

    International Nuclear Information System (INIS)

    TIFFT, S.R.

    2003-01-01

    Through regulations, permitting or binding negotiations, Regulators establish requirements, limits, permit conditions and Notice of Construction (NOC) conditions with which the Office of River Protection (ORP) and the Tank Farm Contractor (TFC) must comply. Operating Specifications are technical limits which are set on a process to prevent injury to personnel, or damage to the facility or environment. The main purpose of this document is to provide specification limits and recovery actions for the TFC Environmental Surveillance Program at the Hanford Site. Specification limits are given for monitoring frequencies and permissible variation of readings from an established baseline or previous reading. The requirements in this document are driven by environmental considerations and data analysis issues, rather than facility design or personnel safety issues. This document is applicable to all single-shell tank (SST) and double-shell tank (DST) waste tanks, and the associated catch tanks and receiver tanks, and transfer systems. This Tank Farm Environmental Specifications Document (ESD) implements environmental-regulatory limits on the configuration and operation of the Hanford Tank Farms facility that have been established by Regulators. This ESD contains specific field operational limits and recovery actions for compliance with airborne effluent regulations and agreements, liquid effluents regulations and agreements, and environmental tank system requirements. The scope of this ESD is limited to conditions that have direct impact on Operations Projects or that Operations/Projects have direct impact upon. This document does not supercede or replace any DOE Orders, regulatory permits, notices of construction, or Regulatory agency agreements binding on the ORP or the TFC. Refer to the appropriate regulation, permit, or NOC for an inclusive listing of requirements

  20. 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.

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

    International Nuclear Information System (INIS)

    2002-01-01

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

  2. Conformity check of JMTR to new regulatory standards

    International Nuclear Information System (INIS)

    Watahiki, Shunsuke; Ide, Hiroshi; Hanakawa, Hiroki; Yamaura, Takayuki; Kaminaga, Masanori

    2015-01-01

    With the lesson learned from the accident of TEPCO Fukushima Daiichi Nuclear Power Station, also based on the international standards, the 'New regulatory standards for nuclear facilities for research! was enforced by the Nuclear Regulatory Authority in December 2013. The main requirements of the new standards are as follows: (1) measures for earthquake, tsunami, and damage from the outside, (2) severity classification, (3) fire protection, (4) flood protection, (5) communication and contacting, (6) measures for the loss of external power supply, (7) monitoring equipment, and (8) expansion prevention of accident that releases a large amounts of radioactive materials. Under the new regulatory standards, it is demanded that the constructions, systems, and equipment with safety functions of the current nuclear facilities should maintain the safety functions in accordance with their importance against the basic ground motions and possible natural phenomena. For the buildings, equipment, and machineries of JMTR nuclear facilities, the severity classification was performed on each of safety function and seismic resistance. Based on the classification results, seismic evaluation and safety analysis were carried out. (A.O.)

  3. 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

  4. 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

  5. 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

  6. 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.

  7. 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

  8. Environment, safety, and health regulatory implementation plan

    International Nuclear Information System (INIS)

    1993-01-01

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

  9. 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.

  10. 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...

  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. 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. Environmental and Source Monitoring for Purposes of Radiation Protection. Safety Guide (Spanish ed.)

    International Nuclear Information System (INIS)

    2010-01-01

    The purpose of this Safety Guide is to provide international guidance, coherent with contemporary radiation protection principles and IAEA safety requirements, on the strategy of monitoring in relation to: (a) control of radionuclide discharges under practice conditions, and (b) intervention, such as in cases of nuclear or radiological emergencies or past contamination of areas with long lived radionuclides. Three categories of monitoring are discussed: monitoring at the source of the discharge (source monitoring), monitoring in the environment (environmental monitoring) and monitoring of individual exposure in emergencies (individual monitoring). The Safety Guide also provides general guidance on assessment of the doses to critical groups of the population due to the presence of radioactive materials or radiation fields in the environment both from routine operation of nuclear and other related facilities (practice) and from nuclear or radiological emergencies and past contamination of areas with long lived radionuclides (intervention). The dose assessments are based on the results of source monitoring, environmental monitoring, individual monitoring or their combinations. This Safety Guide is primarily intended for use by national regulatory bodies and other agencies involved in national systems of radiation monitoring, as well as by operators of nuclear installations and other facilities where natural or human made radionuclides are treated and monitored. Contents: 1. Introduction; 2. Meeting regulatory requirements for monitoring in practices and interventions; 3. Responsibilities for monitoring; 4. Generic aspects of monitoring programmes; 5. Programmes for monitoring in practices and interventions; 6. Technical conditions for monitoring procedures; 7. Considerations in dose assessment; 8. Interpretation of monitoring results; 9. Quality assurance; 10. Recording of results; 11. Education and training; Glossary.

  14. Monitoring and management of tritium from the nuclear power plant effluent

    Science.gov (United States)

    Zhang, Qiaoe; Liu, Ting; Yang, Lili; Meng, De; Song, Dahu

    2018-01-01

    It is important to regulate tritium nuclides from the nuclear power plant effluent, the paper briefly analyzes the main source of tritium, and the regulatory requirements associated with tritium in our country and the United States. The monitoring methods of tritium from the nuclear power plant effluent are described, and the purpose to give some advice to our national nuclear power plant about the effluent of tritium monitoring and management.

  15. 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

  16. Annual Report 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2009-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  17. Annual Report 2007. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2008-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  18. 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...

  19. 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

  20. 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)

  1. 2002 Waste Isolation Pilot Plant Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    Washington TRU Solutions LLC

    2002-01-01

    DOE Order 5400.1, General Environmental Protection Program, requires each DOE | facility to prepare an environmental management plan (EMP). This document is | prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment; applicable sections of Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) Part 834, ''Radiation Protection of the Public and Environment'' (draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1, which is the driver for the annual Site Environmental Report (SER) and the guidance source for preparing many environmental program documents. The WIPP Project is operated by Westinghouse TRU Solutions (WTS) for the DOE. This plan defines the extent and scope of WIPP's effluent and environmental | monitoring programs during the facility's operational life and also discusses WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP Project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance

  2. 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...

  3. 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)

  4. Ground-water monitoring and modeling at the Hanford Site

    International Nuclear Information System (INIS)

    Mitchell, P.J.; Freshley, M.D.

    1987-01-01

    The ground-water monitoring program at the Hanford Site in southeastern Washington State is continually evolving in response to changing operations at the site, changes in the ground-water flow system, movement of the constituents in the aquifers, and regulatory requirements. Sampling and analysis of ground water, along with ground-water flow and solute transport modeling are used to evaluate the movement and resulting distributions of radionuclides and hazardous chemical constituents in the unconfined aquifer. Evaluation of monitoring results, modeling, and information on waste management practices are being combined to continually improve the network of ground-water monitoring wells at the site

  5. Ground-water monitoring and modeling at the Hanford Site

    International Nuclear Information System (INIS)

    Mitchell, P.J.; Freshley, M.D.

    1987-01-01

    The ground-water monitoring program at the Hanford Site in southeastern Washington State is continually evolving in response to changing operations at the site, changes in the ground-water flow system, movement of the constituents in the aquifers, and regulatory requirements. Sampling and analysis of ground water, along with ground-water flow and solute transport modeling are used ito evaluate the movement and resulting distributions of radionuclides and hazardous chemical constituents in the unconfined aquifer. Evaluation of monitoring results, modeling, and information on waste management practices are being combined to continually improve the network of ground-water monitoring wells at the site

  6. Idaho National Laboratory Site Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Nordstrom, Jenifer [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2014-02-01

    This plan provides a high-level summary of environmental monitoring performed by various organizations within and around the Idaho National Laboratory (INL) Site as required by U.S. Department of Energy (DOE) Order 435.1, Radioactive Waste Management, and DOE Order 458.1, Radiation Protection of the Public and the Environment, Guide DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance, and in accordance with 40 Code of Federal Regulations (CFR) 61, National Emission Standards for Hazardous Air Pollutants. The purpose of these orders is to 1) implement sound stewardship practices that protect the air, water, land, and other natural and cultural resources that may be impacted by DOE operations, and 2) to establish standards and requirements for the operations of DOE and DOE contractors with respect to protection of the environment and members of the public against undue risk from radiation. This plan describes the organizations responsible for conducting environmental monitoring across the INL Site, the rationale for monitoring, the types of media being monitored, where the monitoring is conducted, and where monitoring results can be obtained. Detailed monitoring procedures, program plans, or other governing documents used by contractors or agencies to implement requirements are referenced in this plan. This plan covers all planned monitoring and environmental surveillance. Non-routine activities such as special research studies and characterization of individual sites for environmental restoration are outside the scope of this plan.

  7. 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.

  8. 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

  9. 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...

  10. 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...

  11. 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...

  12. Regulatory Oversight of Safety Culture in Finland: A Systemic Approach to Safety

    International Nuclear Information System (INIS)

    Oedewald, P.; Väisäsvaara, J.

    2016-01-01

    In Finland the Radiation and Nuclear Safety Authority STUK specifies detailed regulatory requirements for good safety culture. Both the requirements and the practical safety culture oversight activities reflect a systemic approach to safety: the interconnections between the technical, human and organizational factors receive special attention. The conference paper aims to show how the oversight of safety culture can be integrated into everyday oversight activities. The paper also emphasises that the scope of the safety culture oversight is not specific safety culture activities of the licencees, but rather the overall functioning of the licence holder or the new build project organization from safety point of view. The regulatory approach towards human and organizational factors and safety culture has evolved throughout the years of nuclear energy production in Finland. Especially the recent new build projects have highlighted the need to systematically pay attention to the non-technical aspects of safety as it has become obvious how the HOF issues can affect the design processes and quality of construction work. Current regulatory guides include a set of safety culture related requirements. The requirements are binding to the licence holders and they set both generic and specific demands on the licencee to understand, monitor and to develop safety culture of their own organization but also that of their supplier network. The requirements set for the licence holders has facilitated the need to develop the regulator’s safety culture oversight practices towards a proactive and systemic approach.

  13. Annual Report 2009. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  14. 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...

  15. 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...

  16. 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

  17. 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)

  18. 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

  19. TANK FARM ENVIRONMENTAL REQUIREMENTS

    International Nuclear Information System (INIS)

    TIFFT, S.R.

    2003-01-01

    Through regulations, permitting or binding negotiations, Regulators establish requirements, limits, permit conditions and Notice of Construction (NOC) conditions with which the Office of River Protection (ORP) and the Tank Farm Contractor (TFC) must comply. Operating Specifications are technical limits which are set on a process to prevent injury to personnel, or damage to the facility or environment, The main purpose of this document is to provide specification limits and recovery actions for the TFC Environmental Surveillance Program at the Hanford Site. Specification limits are given for monitoring frequencies and permissible variation of readings from an established baseline or previous reading. The requirements in this document are driven by environmental considerations and data analysis issues, rather than facility design or personnel safety issues. This document is applicable to all single-shell tank (SST) and double-shell tank (DST) waste tanks, and the associated catch tanks and receiver tanks, and transfer systems. This Tank Farm Environmental Specifications Document (ESD) implements environmental-regulatory limits on the configuration and operation of the Hanford Tank Farms facility that have been established by Regulators. This ESD contains specific field operational limits and recovery actions for compliance with airborne effluent regulations and agreements, liquid effluents regulations and agreements, and environmental tank system requirements. The scope of this ESD is limited to conditions that have direct impact on Operations/Projects or that Operations Projects have direct impact upon. This document does not supercede or replace any Department of Energy (DOE) Orders, regulatory permits, notices of construction, or Regulatory agency agreements binding on the ORP or the TFC. Refer to the appropriate regulation, permit, or Notice of Construction for an inclusive listing of requirements

  20. 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

  1. 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

  2. Regulatory framework for nuclear power plant operation

    International Nuclear Information System (INIS)

    Perez Alcaniz, T.; Esteban Barriendos, M.

    1995-01-01

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

  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. 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.

  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. 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)

  8. 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

  9. 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...

  10. 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...

  11. 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...

  12. Discussion on monitoring items of radionuclides in influents from nuclear power plants

    International Nuclear Information System (INIS)

    Zhang Yanxia; Li Jin; Liu Jiacheng; Han Shanbiao; Yu Zhengwei

    2014-01-01

    For the radionuclide monitoring items of effluents from nuclear power plant, this paper makes some comparisons and analysis from three aspects of the international atomic energy general requirements, the routine radionuclide measurement items of China's nuclear power plant and effluents low level radionuclide experimental research results. Finally, it summarizes the necessary items and recommended items of the radionuclide monitoring of effluents from nuclear power plant, which can provide references for the radioactivity monitoring activities of nuclear power plant effluent and the supervisions of regulatory departments. (authors)

  13. MCO Monitoring Plan

    International Nuclear Information System (INIS)

    SEXTON, R.A.

    2000-01-01

    The basis for development of the Multi-Canister Overpack (MCO) Monitoring Plan was established in HNF-3312, MCO Monitoring Activity Description (Sexton 1998), with the following specific objectives: The safety of Spent Nuclear Fuel (SNF) Project processes for retrieving, packaging, handling, conditioning, and storing the N Reactor spent nuclear fuel has been demonstrated by conservative analyses, as compiled in the project safety basis and licensing documentation. Appropriate quality assurance and independent checking of engineering, fabrication, and construction are being applied, and there will be in-process monitoring and verification of MCO loading and conditioning actions. Once the MCOs have been placed in storage, there is no safety requirement, regulatory requirement, or precedent to monitor them. Although not required, a monitoring program which would acquire data for use by Process Engineering is considered valuable for several reasons (Sexton 1998): Good engineering practice--Acquiring data at a reasonable cost that may be useful in developing a fuller understanding of the behavior of an engineered system is good engineering practice. Actual data on full scale MCOs is otherwise unavailable--Previous investigations have been limited to small fuel samples or simulant prototypes and have been relatively short in duration. MCO monitoring can provide data on large loads of actual fuel, in full-scale configuration, over longer time periods. Additional knowledge of the fuel type may prove valuable in future analyses or applications. On that basis, a program with two components was planned: The pressure/temperature/gas composition relationships will be observed in a limited number of MCOs during the first two years in storage. The remaining MCOs will incorporate a simple means to confirm at any time in the future, that internal pressure of the MCO is not high enough to threaten its structural integrity. The MCOs are likely to be stored for 40 years or longer

  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. Regulatory aspects of criticality control in Australia

    International Nuclear Information System (INIS)

    Zimin, Sergei

    2003-01-01

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

  16. Regulatory analysis technical evaluation handbook. Final report

    International Nuclear Information System (INIS)

    1997-01-01

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

  17. Design, placement, and sampling of groundwater monitoring wells for the management of hazardous waste disposal facilities

    International Nuclear Information System (INIS)

    Tsai, S.Y.

    1988-01-01

    Groundwater monitoring is an important technical requirement in managing hazardous waste disposal facilities. The purpose of monitoring is to assess whether and how a disposal facility is affecting the underlying groundwater system. This paper focuses on the regulatory and technical aspects of the design, placement, and sampling of groundwater monitoring wells for hazardous waste disposal facilities. Such facilities include surface impoundments, landfills, waste piles, and land treatment facilities. 8 refs., 4 figs

  18. Environmental radiation monitoring technology: Capabilities and needs

    International Nuclear Information System (INIS)

    Hofstetter, K.J.

    1994-01-01

    Radiation monitoring in the Savannah River Site (SRS) environment is conducted by a combination of automated, remote sampling and/or analysis systems, and manual sampling operations. This program provides early detection of radionuclide releases, minimizes the consequences, and assesses the impact on the public. Instrumentation installed at the release points monitor the atmospheric and aqueous releases from SRS operations. Ground water and air monitoring stations are strategically located throughout the site for radionuclide migration studies. The environmental radiological monitoring program at SRS includes: fixed monitoring stations for atmospheric radionuclide concentrations, aqueous monitors for surface water measurements, mobile laboratory operations for real-time, in-field measurements, aerial scanning for wide area contamination surveillance, and hand-held instruments for radionuclide-specific measurements. Rigorous environmentnal sampling surveillance coupled with laboratory analyses provide confirmatory results for all in-field measurements. Gaps in the technologies and development projects at SRS to fill these deficiencies are discussed in the context of customer needs and regulatory requirements

  19. 75 FR 18241 - Draft Regulatory Guide: Issuance, Availability

    Science.gov (United States)

    2010-04-09

    ... Guide, DG-8036, ``Personnel Monitoring Device--Direct-Reading Pocket Dosimeters.'' FOR FURTHER.... The draft regulatory guide (DG), entitled, ``Personnel Monitoring Device--Direct-Reading Pocket... this guide included guidance on indirect-reading pocket dosimeters, this guide excludes such dosimeters...

  20. 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.

  1. Development of quick scan whole body monitor for in-vivo monitoring of radiation workers and general public

    International Nuclear Information System (INIS)

    Sankhla, Rajesh; Singh, I.S.; Rao, D.D.; Pradeepkumar, K.S.

    2015-01-01

    Whole body monitoring of radiation workers at nuclear facilities is a regulatory requirement and is recommended for assessment of internal contamination due to gamma emitting radio nuclides. Additionally, nuclear accidents like Chernobyl, Fukushima and radiological accidents like Goiania have clearly highlighted the need for in-vivo monitoring of the members of the public during and/or after such accidents. To cater to these requirements, a high throughput, fast screening, standing linear geometry Quick Scan Whole Body Monitor (QS-WBM) is designed, fabricated and commissioned to measure internal contamination due to gamma emitting radio nuclides (E γ >200keV) incorporated in the human body. The system is designed to achieve sensitivity comparable with conventional WBM for 1 - 2 minutes counting time and to accommodate different body sizes of Indian occupational workers. It is calibrated using BARC reference Bottle Mannequin Absorption (BOMAB) type phantom and also using a family of BOMAB type phantoms representative of different age groups namely 1-, 5-, 10-, 15- and 20- years. The developed system will also be highly useful during emergency situations when large numbers of persons are to be monitored in short interval of time. (author)

  2. Waste Isolation Pilot Plant Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    2008-01-01

    U.S. Department of Energy (DOE) Order 450.1, Environmental Protection Program, requires each DOE site to conduct environmental monitoring. Environmental monitoring at the Waste Isolation Pilot Plant (WIPP) is conducted in order to: (a) Verify and support compliance with applicable federal, state, and local environmental laws, regulations, permits, and orders; (b) Establish baselines and characterize trends in the physical, chemical, and biological condition of effluent and environmental media; (c) Identify potential environmental problems and evaluate the need for remedial actions or measures to mitigate the problems; (d) Detect, characterize, and report unplanned releases; (e) Evaluate the effectiveness of effluent treatment and control, and pollution abatement programs; and (f) Determine compliance with commitments made in environmental impact statements, environmental assessments, safety analysis reports, or other official DOE documents. This Environmental Monitoring Plan (EMP) explains the rationale and design criteria for the environmental monitoring program, extent and frequency of monitoring and measurements, procedures for laboratory analyses, quality assurance (QA) requirements, program implementation procedures, and direction for the preparation and disposition of reports. Changes to the environmental monitoring program may be necessary to allow the use of advanced technology and new data collection techniques. This EMP will document changes in the environmental monitoring program. Guidance for preparation of EMPs is contained in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance.

  3. Facility Effluent Monitoring Plan for the N Reactor

    International Nuclear Information System (INIS)

    Watson, D.J.; Brendel, D.F.; Shields, K.D.

    1991-11-01

    A facility effluent monitoring plan is required by the US Department of Energy in DOE Order 5400.1 for any operations that involve hazardous materials and radioactive substances that could impact employee or public safety or the environment. This document is prepared using the specific guidelines identified in A Guide for Preparing Hanford Site Facility Effluent Monitoring Plans, WHC-EP- 0438. This facility effluent monitoring plan assesses effluent monitoring systems and evaluates whether they are adequate to ensure the public health and safety as specified in applicable federal, state, and local requirements. This facility effluent monitoring plan is the first annual report. It shall ensure long-range integrity of the effluent monitoring systems by requiring an update whenever a new process or operation introduces new hazardous materials or significant radioactive materials. This document must be reviewed annually even if there are no operational changes, and it must be updated as a minimum every three years. The primary purpose of the N Reactor Facility Effluent Monitoring Plan (FEMP), during standby, is to ensure that the radioactive effluents are properly monitored and evaluated for compliance with the applicable DOE orders and regulatory agencies at the federal, state, and local levels. A secondary purpose of the FEMP is to ensure that hazardous wastes are not released, in liquid effluents, to the environment even though the potential to do so is extremely low. The FEMP is to provide a monitoring system that collects representative samples in accordance with industry standards, performs analyses within stringent quality control (QC) requirements, and evaluates the data through the use of comparative analysis with the standards and acceptable environmental models

  4. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-06-15

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

  5. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2003-06-15

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

  6. Development of safety performance indicators of regulatory interest (SAFPER) in Pakistan

    International Nuclear Information System (INIS)

    Khatoon, Abida

    2002-01-01

    Safety performance indicators provide a very useful tool for monitoring operational safety of a nuclear power plant. Utilities in many countries have developed plant specific indicators for the assessment of their performance and safety. Regulators can make use of some of these indicators for their regulatory assessment. In addition to these regulatory bodies in some countries have also developed programs for the formulation of safety performance indicators which are used in monitoring operational safety and regulatory decision making. Realizing its usefulness Directorate of Nuclear Safety and Radiation Protection (DNSRP-the regulatory body in Pakistan) has also initiated a country specific program for the development of Safety Performance Indicators (SAFPER) based on data provided by the utility and that collected during the course of regulatory inspections. Selected areas of NPP operation to be monitored are: - Significant events; - Safety systems performance; - Barriers integrity; - Environment protection; - Workers radiation safety; and - Emergency Preparedness. One of the objectives of this program is also to monitor the effectiveness of DNSRP regulatory activities. IAEA framework is taken as one of the bases for our program. Safety performance will be assessed on the basis of Performance Indicators and inspection findings. DNSRP program as shown in Appendix includes the indicators in use and under development. It is felt that the term Safety Performance Indicators may be termed as 'SAFPER Indicators' to be used by the Regulators, as it is clear from this presentation that utility safety performance indicators together with the regulatory effectiveness indicators constitute the measure for the adequate safety to the public and the environment. Additional research is still necessary for: - indicator definition for the proposed and under developed indicators; - data collection systems; - thresholds; - trend analysis; - goal setting (benefit from the trend can be

  7. A guide for preparing Hanford Site facility effluent monitoring plans

    International Nuclear Information System (INIS)

    Nickels, J.M.

    1992-06-01

    This document provides guidance on the format and content of effluent monitoring plans for facilities at the Hanford Site. The guidance provided in this document is designed to ensure compliance with US Department of Energy (DOE) Orders 5400.1 (DOE 1988a), 5400.3 (DOE 1989a), 5400.4 (DOE 1989b), 5400.5 (DOE 1990a), 5480.1 (DOE 1982), 5480.11 (DOE 1988b), and 5484.1 (DOE 1981). These require environmental monitoring plans for each site, facility, or process that uses, generates, releases, or manages significant pollutants of radioactive or hazardous materials. In support of DOE Orders 5400.5 (Radiation Protection of the Public and the Environment) and 5400.1 (General Environmental Protection Program), the DOE Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE 1991) should be used to establish elements of a radiological effluent monitoring program in the Facility Effluent Monitoring Plan. Evaluation of facilities for compliance with the US Environmental Protection Agency Clean Air Act of 1977 requirements also is included in the airborne emissions section of the Facility Effluent Monitoring Plans. Sampling Analysis Plans for Liquid Effluents, as required by the Hanford Federal Facility Agreement and Consent Order (Tri-Party Agreement), also are included in the Facility Effluent Monitoring Plans. The Facility Effluent Monitoring Plans shall include complete documentation of gaseous and liquid effluent sampling and monitoring systems

  8. 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...

  9. 78 FR 44275 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2013-07-23

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

  10. 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...

  11. Analysis of NRC Regulatory Guide 1.21 Revision 2

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Sung Il; Yook, Dae Sik; Lee, Byung Soo [KINS, Daejeon (Korea, Republic of)

    2015-05-15

    It is essential to have a degree of uniformity in the methods used for measuring, evaluating, recording, and reporting data on radioactive material in effluents and solid wastes. For this purpose, the U.S. Nuclear Regulatory Commission (NRC) released a revised version of the Regulatory Guide 1.21 'Measuring, evaluating, and reporting radioactive material in liquid and gaseous effluents and solid waste' (revision 2) in 2009, updating the revision 1 version released in 1974. This study compares the previous revision 1 (1974) version with the revision 2 (2009) version to elaborate on the application of the guidelines to Korea. This study consists of an analysis of the 2009 Revision 2 version of the U.S. NRC Regulatory Guidelines 1.21 and an exposition of methods for its application in the domestic environment. Major revisions were made to allow for the adoption of a risk informed approach. Radionuclides with lower than 1% contribution to emission or radiation levels can be selected as principal radionuclides. Requirements for analysis of leaks and spills have been reinforced, with additional groundwater monitoring and hydrological data analysis becoming necessary.

  12. 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

  13. Safety Committees for Argentinean Research Reactor - Regulatory Issues

    International Nuclear Information System (INIS)

    Perrin, Carlos D.

    2009-01-01

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

  14. On-line monitoring and inservice inspection in codes

    International Nuclear Information System (INIS)

    Bartonicek, J.; Zaiss, W.; Bath, H.R.

    1999-01-01

    The relevant regulatory codes determine the ISI tasks and the time intervals for recurrent components testing for evaluation of operation-induced damaging or ageing in order to ensure component integrity on the basis of the last available quality data. In-service quality monitoring is carried out through on-line monitoring and recurrent testing. The requirements defined by the engineering codes elaborated by various institutions are comparable, with the KTA nuclear engineering and safety codes being the most complete provisions for quality evaluation and assurance after different, defined service periods. German conventional codes for assuring component integrity provide exclusively for recurrent inspection regimes (mainly pressure tests and optical testing). The requirements defined in the KTA codes however always demanded more specific inspections relying on recurrent testing as well as on-line monitoring. Foreign codes for ensuring component integrity concentrate on NDE tasks at regular time intervals, with time intervals scope of testing activities being defined on the basis of the ASME code, section XI. (orig./CB) [de

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

    International Nuclear Information System (INIS)

    2015-03-01

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

  16. 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

  17. Mission Risk Reduction Regulatory Change Management

    Science.gov (United States)

    Scroggins, Sharon

    2007-01-01

    NASA Headquarters Environmental Management Division supports NASA's mission to pioneer the future in space exploration, scientific discovery, and aeronautics research by integrating environmental considerations into programs and projects early-on, thereby proactively reducing NASA's exposure to institutional, programmatic and operational risk. As part of this effort, NASA established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) as a resource for detecting, analyzing, and communicating environmental regulatory risks to the NASA stakeholder community. The RRAC PC focuses on detecting emerging environmental regulations and other operational change drivers that may pose risks to NASA programs and facilities, and effectively communicating the potential risks. For example, regulatory change may restrict how and where certain activities or operations may be conducted. Regulatory change can also directly affect the ability to use certain materials by mandating a production phase-out or restricting usage applications of certain materials. Regulatory change can result in significant adverse impacts to NASA programs and facilities due to NASA's stringent performance requirements for materials and components related to human-rated space vehicles. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented a system for proactively managing regulatory change to minimize potential adverse impacts to NASA programs and facilities. This presentation highlights the process utilized by the RRACPC to communicate regulatory change and the associated

  18. Statistical considerations in practical contamination monitoring

    International Nuclear Information System (INIS)

    Brodsky, A.; Gallaghar, R.G.

    1991-01-01

    This paper reports on an examination of smear survey practices which indicates that many radiation safety programs are lacking in important aspects of contamination monitoring. In order to satisfy regulatory and potential litigatory requirements, smear surveys should include the measurement and recording of the flowing data: area of each smear and smear procedure (by reference); total counts on smear and counting procedure; total counts on appropriate blanks and description of blank; total counts on standard and specifications of standard; and all counting times. The rationale for these smear survey requirements is obtained by examining the formulation of the minimum detectable amount (MDA) on a smear

  19. 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)

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

    International Nuclear Information System (INIS)

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

    1994-01-01

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

  1. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

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

  2. 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.

  3. Annual Report 2013. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across seven parts and eight annexes the activities developed by the organism during 2013. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.

  4. Proposed Regulatory Guideline on the PSA Quality for Risk-informed Applications

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Choi, Jong Soo

    2005-01-01

    In the policy statement on nuclear safety issued by the Korean government in 1994, the introduction of risk-informed regulations in licensing and regulation of nuclear power plants was emphasized for the first time. It also describes the implementation of comprehensive safety assessment utilizing PSA (probabilistic safety assessment). Since then, because risk-informed environment and fundamentals had not been strong, several R and D on PSA and risk-informed regulation have been done even though their application has been delayed. However, today it is not the case. Since the follow-up policy statement (called Severe Accident Policy) was issued, which prescribes strong items such as PSA implementation and its periodic reassessment, reliability database, and risk monitoring program to the utility, we have a chance to easily get all kinds of risk information for improving current regulatory framework. In addition, with the overall availability of PSA results for all operating nuclear power plants, it is expected that many risk-informed applications (RIAs) will be submitted to the regulatory authority. In general, there are a lot of regulatory concerns associated with the quality assurance of licensee's submittals for RIA. It is also noted that making general requirements and touching specific check points are essential for the regulatory decision making process. This paper summarizes the structure and contents of our regulatory guideline for assuring PSA quality

  5. 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.

  6. L-Lake zooplankton: L-Lake/Steel Creek Biological Monitoring Program, November 1985--December 1991

    Energy Technology Data Exchange (ETDEWEB)

    Bowers, J.A. [Westinghouse Savannah River Co., Aiken, SC (United States); Bowen, M. [Normandeau Associates, Inc., New Ellenton, SC (United States)

    1992-03-01

    The L- Lake Biological Monitoring Program was designed to meet environmental regulatory requirements associated with the restart of L-Reactor and address portions of Section 316(a) of the Clean Water Act, which requires an applicant for a discharge permit to provide scientific evidence that the discharge causes no significant impact on the indigenous ecosystem. The Department of Energy (DOE) must demonstrate that the discharge of L-Reactor affluent into L Lake will not inhibit the eventual establishment of a ``Balanced Biological Community`` (BBC) in at least 50% of the lake. This report details results of monitoring zooplankton populations in L-Lake.

  7. L-Lake zooplankton: L-Lake/Steel Creek Biological Monitoring Program, November 1985--December 1991

    International Nuclear Information System (INIS)

    Bowers, J.A.; Bowen, M.

    1992-03-01

    The L- Lake Biological Monitoring Program was designed to meet environmental regulatory requirements associated with the restart of L-Reactor and address portions of Section 316(a) of the Clean Water Act, which requires an applicant for a discharge permit to provide scientific evidence that the discharge causes no significant impact on the indigenous ecosystem. The Department of Energy (DOE) must demonstrate that the discharge of L-Reactor affluent into L Lake will not inhibit the eventual establishment of a ''Balanced Biological Community'' (BBC) in at least 50% of the lake. This report details results of monitoring zooplankton populations in L-Lake

  8. 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)

  9. Building the case for independent monitoring of food advertising on Australian television.

    Science.gov (United States)

    King, Lesley; Hebden, Lana; Grunseit, Anne; Kelly, Bridget; Chapman, Kathy

    2013-12-01

    To provide an independent monitoring report examining the ongoing impact of Australian self-regulatory pledges on food and drink advertising to children on commercial television. Analysis of food advertisements across comparable sample time periods in April/May 2006, 2007, 2009, 2010 and 2011. The main outcome measure comprised change in the mean rate of non-core food advertisements from 2006 to 2011. Sydney free-to-air television channels. Televised food advertisements. In 2011 the rate of non-core food advertisements was not significantly different from that in 2006 or 2010 (3·2/h v. 4·1/h and 3·1/h), although there were variations across the intervening years. The rate of fast-food advertising in 2010 was significantly higher than in 2006 (1·8/h v. 1·1/h, P advertising on Sydney television has remained essentially unchanged between 2006 and 2011, despite the implementation of two industry self-regulatory pledges. The current study illustrates the value of independent monitoring as a basic requirement of any responsive regulatory approach.

  10. Groundwater Monitoring Plan for the Solid Waste Landfill

    International Nuclear Information System (INIS)

    Lindberg, J.W.; Chou, C.J.

    2000-01-01

    The Solid Waste Landfill (SWL) is regulated by the Washington State Department of Ecology under WAC 173-304. Between 1973 and 1976, the landfill received primarily paper waste and construction debris, but it also received asbestos, sewage, and catch tank liquid waste. Groundwater monitoring results indicate the SWL has contaminated groundwater with volatile organic compounds and possibly metals at levels that exceed regulatory limits. DynCorp, Tri-Cities, Inc. operates the facility under an interim closure plan (final closure plan will be released shortly). Pacific Northwest National Laboratory (PNNL) monitors groundwater at the site. This monitoring plan includes well and constituent lists, and summarizes sampling, analytical, and quality control requirements. Changes from the previous monitoring plan include elimination of two radionuclides from the analyte list and some minor changes in the statistical analysis. Existing wells in the current monitoring network only monitor the uppermost portion of the upper-most aquifer. Therefore, two new downgradient wells and one existing upgradient well are proposed to determine whether groundwater waste constituents have reached the lower portion of the uppermost aquifer. The proposed well network includes three upgradient wells and ten downgradient wells. The wells will be sampled quarterly for 14 analytes required by WAC 173-304-490 plus volatile organic compounds and filtered arsenic as site-specific analytes

  11. Groundwater Monitoring Plan for the Solid Waste Landfill

    Energy Technology Data Exchange (ETDEWEB)

    JW Lindberg; CJ Chou

    2000-12-14

    The Solid Waste Landfill (SWL) is regulated by the Washington State Department of Ecology under WAC 173-304. Between 1973 and 1976, the landfill received primarily paper waste and construction debris, but it also received asbestos, sewage, and catch tank liquid waste. Groundwater monitoring results indicate the SWL has contaminated groundwater with volatile organic compounds and possibly metals at levels that exceed regulatory limits. DynCorp, Tri-Cities, Inc. operates the facility under an interim closure plan (final closure plan will be released shortly). Pacific Northwest National Laboratory (PNNL) monitors groundwater at the site. This monitoring plan includes well and constituent lists, and summarizes sampling, analytical, and quality control requirements. Changes from the previous monitoring plan include elimination of two radionuclides from the analyte list and some minor changes in the statistical analysis. Existing wells in the current monitoring network only monitor the uppermost portion of the upper-most aquifer. Therefore, two new downgradient wells and one existing upgradient well are proposed to determine whether groundwater waste constituents have reached the lower portion of the uppermost aquifer. The proposed well network includes three upgradient wells and ten downgradient wells. The wells will be sampled quarterly for 14 analytes required by WAC 173-304-490 plus volatile organic compounds and filtered arsenic as site-specific analytes.

  12. 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.

  13. Environmental radiation exposure: Regulation, monitoring, and assessment

    International Nuclear Information System (INIS)

    Chen, S.Y.; Yu, C.; Hong, K.J.

    1991-01-01

    Radioactive releases to the environment from nuclear facilities constitute a public health concern. Protecting the public from such releases can be achieved through the establishment and enforcement of regulatory standards. In the United States, numerous standards have been promulgated to regulate release control at nuclear facilities. Most recent standards are more restrictive than those in the past and require that radioactivity levels be as low as reasonably achievable (ALARA). Environmental monitoring programs and radiological dose assessment are means of ensuring compliance with regulations. Environmental monitoring programs provide empirical information on releases, such as the concentrations of released radioactivity in environmental media, while radiological dose assessment provides the analytical means of quantifying dose exposures for demonstrating compliance

  14. 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.)

  15. 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)

  16. 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.

  17. 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

  18. Risk-based Regulatory Evaluation Program methodology

    International Nuclear Information System (INIS)

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

    1987-01-01

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

  19. 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

  20. Global Regulatory Differences for Gene- and Cell-Based Therapies

    DEFF Research Database (Denmark)

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

    2017-01-01

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

  1. 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)

  2. Regulatory systems-based licensing guidance documentation

    International Nuclear Information System (INIS)

    Delligatti, M.S.

    1991-01-01

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

  3. 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

  4. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    1999-06-01

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

  5. Nuclear Regulatory Commission: more aggressive leadership needed

    International Nuclear Information System (INIS)

    Staats, E.B.

    1980-01-01

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

  6. 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\\%....

  7. 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)

  8. 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)

  9. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

    Science.gov (United States)

    Layton, Deborah; Shakir, Saad A W

    2015-02-01

    The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications.

  10. An application study for the class 1E digital control and monitoring system

    International Nuclear Information System (INIS)

    Hiroyuki Fukumitsu

    1998-01-01

    This paper presents an application study for the Class 1E digital control and monitoring system to the next Japanese plants, especially about MMIS. The system architecture of hardware and software is also introduced, which will explain the strategic plan for the necessary software verification and validation according to the latest requirement from Japanese regulatory guide. (author)

  11. 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.

  12. 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)

  13. 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

  14. Adequacy of individual monitoring of external exposure at the workplace

    International Nuclear Information System (INIS)

    Rannou, A.

    2006-01-01

    Individual monitoring of workers exposed to external radiations must fulfill technical, regulatory and organizational requirements. The external dosimetry should be adapted to the workplace. The relevant dosimetric techniques have to be chosen upon the workplace study that conditions both the categorization of exposed workers and classification of areas. Solutions exist which are satisfactory for the most situations. However, rational solutions still have to be found for a few specific situations. (author)

  15. 47 CFR 1.1160 - Refunds of regulatory fees.

    Science.gov (United States)

    2010-10-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-10-01

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

  17. 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...

  18. 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...

  19. Operational environmental monitoring plan for the waste isolation pilot plant

    International Nuclear Information System (INIS)

    Mercer, D.D.; Baker, P.L.; Cockman, J.S.; Fischer, N.T.; Flynn, D.T.; Harvill, J.P.; Knudtsen, K.L.; Louderbough, E.T.

    1989-01-01

    This plan defines the scope and extent of the WIPP effluent and environmental monitoring programs during the facility's operational life. It also discusses the quality assurance/quality control programs which ensure that samples collected and the resulting analytical data are representative of actual conditions at the WIPP site. This plan provides a comprehensive description of environmental activities at WIPP, including: a summary of environmental program information, including an update of the status of environmental permits and compliance activities; a description of the WIPP project and its mission; a description of the local environment, including demographics; a summary of applicable standards and regulatory requirements and brief discussions of potential exposure pathways, routine and accidental releases, and their consequences; a summary of the preoperational environmental monitoring and assessment activities and responses to the requirements (Appendix A) and guidelines presented in the ''Radiological Effluent Monitoring and Environmental Surveillance for US DOE Operations.'' 166 refs., 28 figs., 27 tabs

  20. 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

  1. 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

  2. Virginia Power's regulatory reduction program

    International Nuclear Information System (INIS)

    Miller, G.D.

    1996-01-01

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

  3. 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...

  4. Dry Cask Storage Inspection and Monitoring. Interim Report.

    Energy Technology Data Exchange (ETDEWEB)

    Bakhtiari, Susan [Argonne National Lab. (ANL), Argonne, IL (United States); Elmer, Thomas W. [Argonne National Lab. (ANL), Argonne, IL (United States); Koehl, Eugene R. [Argonne National Lab. (ANL), Argonne, IL (United States); Wang, Ke [Argonne National Lab. (ANL), Argonne, IL (United States); Raptis, Apostolos C. [Argonne National Lab. (ANL), Argonne, IL (United States); Kunerth, Dennis C. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Birk, Sandra M. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2014-03-04

    Recently, the U.S. Nuclear Regulatory Commission (NRC) issued the guidance on the aging management of dry storage facilities that indicates the necessity to monitor the conditions of dry cask storage systems (DCSSs) over extended periods of time.1 Part of the justification of the aging management plans is the requirement for inspection and monitoring to verify whether continued monitoring, inspection or mitigation are necessary. To meet this challenge Argonne National Laboratory (ANL) in collaboration with Idaho National Laboratory (INL) is conducting scoping studies on current and emerging nondestructive evaluation/examination (NDE) and online monitoring (OLM) technologies for DCSS integrity assessments. The scope of work plan includes identification and verification of technologies for long-term online monitoring of DCSSs’ crucial physical parameters such as temperature, pressure, leakage and structural integrity in general. Modifications have been made to the current technologies to accommodate field inspections and monitoring. A summary of the scoping studies and experimental efforts conducted to date as well as plans for future activities is provided below.

  5. 76 FR 6587 - Pennsylvania Regulatory Program

    Science.gov (United States)

    2011-02-07

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

  6. 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

  7. Pharmacovigilance in India, Uganda and South Africa with Reference to WHO’s Minimum Requirements

    Directory of Open Access Journals (Sweden)

    Karen Maigetter

    2015-05-01

    Full Text Available Background Pharmacovigilance (PV data are crucial for ensuring safety and effectiveness of medicines after drugs have been granted marketing approval. This paper describes the PV systems of India, Uganda and South Africa based on literature and Key Informant (KI interviews and compares them with the World Health Organization’s (WHO’s minimum PV requirements for a Functional National PV System. Methods A documentary analysis of academic literature and policy reports was undertaken to assess the medicines regulatory systems and policies in the three countries. A gap analysis from the document review indicated a need for further research in PV. KI interviews covered topics on PV: structure and practices of the system; current regulatory policy; capacity limitations, staffing, funding and training; availability and reporting of data; and awareness and usage of the systems. Twenty interviews were conducted in India, 8 in Uganda and 11 in South Africa with government officials from the ministries of health, national regulatory authorities, pharmaceutical producers, Non-Governmental Organizations (NGOs, members of professional associations and academia. The findings from the literature and KI interviews were compared with WHO’s minimum requirements. Results All three countries were confronted with similar barriers: lack of sufficient funding, limited number of trained staff, inadequate training programs, unclear roles and poor coordination of activities. Although KI interviews represented viewpoints of the respondents, the findings confirmed the documentary analysis of the literature. Although South Africa has a legal requirement for PV, we found that the three countries uniformly lacked adequate capacity to monitor medicines and evaluate risks according to the minimum standards of the WHO. Conclusion A strong PV system is an important part of the overall medicine regulatory system and reflects on the stringency and competence of the regulatory

  8. ENSI’s regulatory framework strategy

    International Nuclear Information System (INIS)

    2015-03-01

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

  9. The regulatory control of radioactive sources in Argentina

    International Nuclear Information System (INIS)

    Rojkind, Roberto Hector

    1997-01-01

    Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author)

  10. Radiological monitoring plan for the Oak Ridge Y-12 Plant: Surface Water

    International Nuclear Information System (INIS)

    1997-10-01

    The Y-12 Plant conducts a surface water monitoring program in response to DOE Orders and state of Tennessee requirements under the National Pollutant Discharge Elimination System (NPDES). The anticipated codification of DOE Order 5400.5 for radiation protection of the public and the environment (10 CFR Part 834) will require an environmental radiation protection plan (ERPP). The NPDES permit issued by the state of Tennessee requires a radiological monitoring plan (RMP) for Y-12 Plant surface waters. In a May 4, 1995 memo, the state of Tennessee, Division of Water Pollution Control, stated their desired needs and goals regarding the content of RMPs, associated documentation, and data resulting from the RMPs required under the NPDES permitting system (L. Bunting, General Discussion, Radiological Monitoring Plans, Tennessee Division of Water Pollution Control, May 4,1995). Appendix A provides an overview of how the Y-12 Plant will begin to address these needs and goals. It provides a more complete, documented basis for the current Y-12 Plant surface water monitoring program and is intended to supplement documentation provided in the Annual Site Environmental Reports (ASERs), NPDES reports, Groundwater Quality Assessment Reports, and studies conducted under the Y-12 Plant Environmental Restoration (ER) Program. The purpose of this update to the Y-12 Plant RMP is to satisfy the requirements of the current NPDES permit, DOE Order 5400.5, and 10 CFR Part 834, as current proposed, by defining the radiological monitoring plan for surface water for the Y-12 Plant. This plan includes initial storm water monitoring and data analysis. Related activities such as sanitary sewer and sediment monitoring are also summarized. The plan discusses monitoring goals necessary to determine background concentrations of radionuclides, to quantify releases, determine trends, satisfy regulatory requirements, support consequence assessments, and meet requirements that releases be ''as low as

  11. Regulatory Aspects of Sabin Type 2 Withdrawal From Trivalent Oral Poliovirus Vaccine: Process and Lessons Learned.

    Science.gov (United States)

    Decina, Daniela; Fournier-Caruana, Jacqueline; Takane, Marina; Ostad Ali Dehaghi, Razieh; Sutter, Roland

    2017-07-01

    Withdrawal of type 2 oral poliovirus vaccine (OPV) in OPV-using countries required regulatory approval for use of inactivated poliovirus vaccine and bivalent OPV in routine immunization. Worldwide, a variety of mechanisms were used by member states, with some differences in approach observed between inactivated poliovirus vaccine and bivalent OPV. These included acceptance for use of World Health Organization (WHO) prequalified vaccines, registration and licensure pathways, participation in WHO-convened joint reviews of licensing dossiers, as well as pragmatic application of alternatively available mechanisms, when appropriate. Simple but effective tools were used to monitor progress and to record, authenticate, and share information. Essential to achievement of regulatory targets was ongoing communication with key stakeholders, including switch-country national regulatory authorities, vaccine manufacturers, partner organizations, and relevant units within WHO. Understanding of the regulatory environment gained through the OPV switch can be helpful in supporting further stages of the polio end game and other time-sensitive vaccine introduction programs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.

  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. 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).

  14. 14 CFR 313.4 - Major regulatory actions.

    Science.gov (United States)

    2010-01-01

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

  15. 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

  16. 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

  17. Regulatory regime and its influence in the nuclear safety

    International Nuclear Information System (INIS)

    Laaksonen, J.

    1999-01-01

    Main elements of nuclear regulatory regime in general is presented. These elements are: national rules and safety regulations, system of nuclear facility licensing, activities of regulatory body. Regulatory body is needed to specify the national safety regulations, review and assess the safety documentation presented to support license application, make inspections to verify fulfilment of safety regulations and license conditions, monitor the quality of work processes of user organization, and to assess whether these processes provide a high safety level, promote high safety culture, promote maintenance and development of national infrastructure relevant to nuclear safety, etc

  18. 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

  19. Monitoring system specifications: retrieval of surf from a salt repository

    International Nuclear Information System (INIS)

    1980-01-01

    The task of developing specifications for a reference monitoring system determined by repository environmental conditions, retrieval operations, and federal regulatory criteria is discussed. The monitoring system specified in this report is capable of measuring (1) package position and orientation, (2) vault deformation, (3) brine accumulation, (4) spent fuel dissolution, (5) temperature, (6) nuclear radiation, and (7) package condition with sufficient accuracy to provide data input to a general risk assessment model. In order to define a monitoring system which can provide probabilistic data on radiological risk to operating personnel and the general public for a salt mine repository, the following information is required: (1) a complete design of the salt SURF repository including inventory, density and waste package design details; (2) probalistic failure rate data on containment integrity of the SURF waste package; (3) probabilistic failure rate data on the monitoring system components

  20. Monitoring of MNSR operation by measuring subcritical photoneutron flux

    International Nuclear Information System (INIS)

    Haddad, Kh.; Alsomel, N.

    2011-01-01

    Passive nondestructive assay methods are used to monitor the reactor's operation. It is required for nuclear regulatory, calculation validation and safeguards purposes. So, it plays a vital role in the safety and security of the nuclear plants. The possibility of MNSR operation monitoring by measuring the subcritical state photoneutron flux were investigated in this work. The photoneutron flux is induced by the fuels hard gamma radiation in the beryllium reflector. Theoretical formulation and experimental tests were performed. The results show that within a specified cooling time range, the photoneutron flux is induced by a single dominant hard gamma emitter such as 117 Cd (activation product) and 140 Ba ( 140 La fission product). This phenomenon was utilized to monitor the cooling time and the operation neutron flux during the last campaign. Thus a passive nondestructive assay method is proposed with regard to the reactor operation's monitoring.

  1. Revamping of stack monitoring system at CORAL facility and estimation of aerosol penetration using 'DEPOSITION2001' code

    International Nuclear Information System (INIS)

    Ajoy, K.C.; Dhanasekaran, A.; Santhanam, R.; Rajagopal, V.; Jose, M.T.

    2018-01-01

    Monitoring of effluent discharge from stack forms an integral part of health physics surveillance programme and a mandatory requirement to ensure regulatory compliance. A unique challenge in stack monitoring is to obtain a representative sample from the flow stream and then transport the same to the monitoring devices with minimum losses. This paper describes the modification of the latter part of the transport line where distribution of sample begins to individual monitors. This work was initiated to address the issues of ageing, ease of use and to provide additional tapping points for future requirements. After revamping the sampling line, it was also validated using the computational code Deposition 2001a to ensure that the system meets even the ISO criteria

  2. 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.

  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. 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.

  5. 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

  6. Nuclear Regulatory Infrastructure in the Philippines

    International Nuclear Information System (INIS)

    Leonin, Teofilo V. Jr.

    2015-01-01

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

  7. Transfer of safety responsibilities to future generations: regulatory tools

    International Nuclear Information System (INIS)

    Kotra, Janet P.

    2008-01-01

    In a forward-looking local development plan, Nye County defends a series of principles like safety, equity, and societal acceptability of responsibility (safety being foremost). The Nye County community clearly advocates permanent oversight of facilities. To respond to community requirements the regulators can establish requirements and guidance to ensure that safety obligations that can reasonably be discharged are in fact carried out and that remaining obligations are transferred as responsibly as possible, so that subsequent generations have the maximum flexibility to discharge their responsibility. There are transferred burdens of cost, risk and effort and these need to be at least partially compensated for by ensuring a subsequent transfer of information, resources and continuity of education, skills and research. The US regulatory requirements for disposal in a geological repository set out obligations in terms of land-ownership and control, records maintenance, performance confirmation, post-closure monitoring, monuments and markers, archives and records preservation and post-closure oversight. For the future the Nye County is proposing that there would be a co-ordinated involvement of the county in planning, development, operation and long term monitoring of the repository. They want to encourage the development of a live-work community for the repository workers so that they will be engaged in the local community as well as working at the facility

  8. 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

  9. Advancing Sensor Technology to Monitor Wildfires

    Science.gov (United States)

    EPA and partners are looking at ways to use miniature sensors to monitor air quality near wildfires. Data from these small sensors can complement measurements obtained from more complex regulatory-grade monitors that are stationary.

  10. The regulatory control of radioactive sources in Argentina

    International Nuclear Information System (INIS)

    Rojkind, R.H.

    1998-01-01

    Argentina has been conducting nuclear activities for more than forty years, and had established a Regulatory Authority as early as in 1956. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations were in force in Argentina before the accident in Goiania. The conclusions drawn from the Goiania accident encouraged the Argentine authorities to improve some regulatory procedures and helped to enhance the quality of the regulatory process. As a result, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain have improved. Lessons learned in Argentina from the accident in Goiania are presented as well as the main characteristics of an effective enforcement programme to prevent radiological accidents when radioactive sources are used for industrial, medical, research and teaching purposes. (author)

  11. Automation of technical specification monitoring for nuclear power plants

    International Nuclear Information System (INIS)

    Lin, J.C.; Abbott, E.C.; Hubbard, F.R.

    1986-01-01

    The complexity of today's nuclear power plants combined with an equally detailed regulatory process makes it necessary for the plant staff to have access to an automated system capable of monitoring the status of limiting conditions for operation (LCO). Pickard, Lowe and Garrick, Inc. (PLG), has developed the first of such a system, called Limiting Conditions for Operation Monitor (LIMCOM). LIMCOM provides members of the operating staff with an up-to-date comparison of currently operable equipment and plant operating conditions with what is required in the technical specifications. LIMCOM also provides an effective method of screening tagout requests by evaluating their impact on the LCOs. Finally, LIMCOM provides an accurate method of tracking and scheduling routine surveillance. (author)

  12. [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.

  13. 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

  14. Radiation Exposure Monitoring and Information Transmittal (REMIT) system

    International Nuclear Information System (INIS)

    Cale, R.; Clark, T.; Dixson, R.; Hagemeyer, D.

    1993-06-01

    The Radiation Exposure Monitoring and Information Transmittal (REMIT) system is designed to assist US Nuclear Regulatory Commission (NRC)licensees in meeting the reporting requirements of the revised 10 CFR 20 and in agreement with the guidance contained in R.G. 8.7, Rev. 1, ''Instructions for Recording and Reporting Occupational Exposure Data.'' REMIT is a personal computer (PC) based menu driven system that facilitates the manipulation of data base files to record and report radiation exposure information. REMIT is designed to be user-friendly and contains the full text of R. G. 8.7, Rev. 1, on-line as well as context-sensitive help throughout the program. The user can enter data directly from NRC Forms 4 or 5, REMIT allows the user to view the individual's exposure in relation to regulatory or administrative limits and alerts the user to exposures in excess of these limits. The system also provides for the calculation and summation of dose from intakes and the determination of the dose to the maximally exposed extremity for the monitoring year. REMIT can produce NRC Forms 4 and 5 in paper and electronic format and can import/export data from ASCII and data base files

  15. 10 CFR 26.406 - Fitness monitoring.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Fitness monitoring. 26.406 Section 26.406 Energy NUCLEAR REGULATORY COMMISSION FITNESS FOR DUTY PROGRAMS FFD Program for Construction § 26.406 Fitness monitoring. (a...) Licensees and other entities shall implement a fitness monitoring program to deter substance abuse and...

  16. Understanding how to maintain compliance in the current regulatory climate

    International Nuclear Information System (INIS)

    Bignell, D.T.; Burns, R.

    1995-01-01

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

  17. 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

  18. 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

  19. 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...

  20. 77 FR 30030 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

    Science.gov (United States)

    2012-05-21

    ... Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Regulatory guide; issuance. SUMMARY... (RG) 1.160, ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide... Monitoring the Effectiveness of Maintenance at Nuclear Power Plants,'' which provides methods that are...

  1. 76 FR 64043 - Iowa Regulatory Program

    Science.gov (United States)

    2011-10-17

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

  2. Waste Isolation Pilot Plant Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    2004-01-01

    U.S. Department of Energy (DOE) Order 450.1, Environmental Protection Program, requires each DOE site to conduct environmental monitoring. Environmental monitoring at the Waste Isolation Pilot Plant (WIPP) is conducted in order to: (a) Verify and support compliance with applicable federal, state, and local environmental laws, regulations, permits, and orders; (b) Establish baselines and characterize trends in the physical, chemical, and biological condition of effluent and environmental media; (c) Identify potential environmental problems and evaluate the need for remedial actions or measures to mitigate the problem; (d) Detect, characterize, and report unplanned releases; (e) Evaluate the effectiveness of effluent treatment and control, and pollution abatement programs; and (f) Determine compliance with commitments made in environmental impact statements, environmental assessments, safety analysis reports, or other official DOE documents. This Environmental Monitoring Plan (EMP) has been written to contain the rationale and design criteria for the monitoring program, extent and frequency of monitoring and measurements, procedures for laboratory analyses, quality assurance (QA) requirements, program implementation procedures, and direction for the preparation and disposition of reports. Changes to the environmental monitoring program may be necessary to allow the use of advanced technology and new data collection techniques. This EMP will document any proposed changes in the environmental monitoring program. Guidance for preparation of Environmental Monitoring Plans is contained in DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance. The plan will be effective when it is approved by the appropriate Head of Field Organization or their designee. The plan discusses major environmental monitoring and hydrology activities at the WIPP and describes the programs established to ensure that WIPP operations do not

  3. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  4. 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...

  5. 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...

  6. Groundwater contamination from waste management sites: The interaction between risk-based engineering design and regulatory policy: 1. Methodology

    Science.gov (United States)

    Massmann, Joel; Freeze, R. Allan

    1987-02-01

    This paper puts in place a risk-cost-benefit analysis for waste management facilities that explicitly recognizes the adversarial relationship that exists in a regulated market economy between the owner/operator of a waste management facility and the government regulatory agency under whose terms the facility must be licensed. The risk-cost-benefit analysis is set up from the perspective of the owner/operator. It can be used directly by the owner/operator to assess alternative design strategies. It can also be used by the regulatory agency to assess alternative regulatory policy, but only in an indirect manner, by examining the response of an owner/operator to the stimuli of various policies. The objective function is couched in terms of a discounted stream of benefits, costs, and risks over an engineering time horizon. Benefits are in the form of revenues for services provided; costs are those of construction and operation of the facility. Risk is defined as the cost associated with the probability of failure, with failure defined as the occurrence of a groundwater contamination event that violates the licensing requirements established for the facility. Failure requires a breach of the containment structure and contaminant migration through the hydrogeological environment to a compliance surface. The probability of failure can be estimated on the basis of reliability theory for the breach of containment and with a Monte-Carlo finite-element simulation for the advective contaminant transport. In the hydrogeological environment the hydraulic conductivity values are defined stochastically. The probability of failure is reduced by the presence of a monitoring network operated by the owner/operator and located between the source and the regulatory compliance surface. The level of reduction in the probability of failure depends on the probability of detection of the monitoring network, which can be calculated from the stochastic contaminant transport simulations. While

  7. Remote real-time monitoring of subsurface landfill gas migration.

    Science.gov (United States)

    Fay, Cormac; Doherty, Aiden R; Beirne, Stephen; Collins, Fiachra; Foley, Colum; Healy, John; Kiernan, Breda M; Lee, Hyowon; Maher, Damien; Orpen, Dylan; Phelan, Thomas; Qiu, Zhengwei; Zhang, Kirk; Gurrin, Cathal; Corcoran, Brian; O'Connor, Noel E; Smeaton, Alan F; Diamond, Dermot

    2011-01-01

    The cost of monitoring greenhouse gas emissions from landfill sites is of major concern for regulatory authorities. The current monitoring procedure is recognised as labour intensive, requiring agency inspectors to physically travel to perimeter borehole wells in rough terrain and manually measure gas concentration levels with expensive hand-held instrumentation. In this article we present a cost-effective and efficient system for remotely monitoring landfill subsurface migration of methane and carbon dioxide concentration levels. Based purely on an autonomous sensing architecture, the proposed sensing platform was capable of performing complex analytical measurements in situ and successfully communicating the data remotely to a cloud database. A web tool was developed to present the sensed data to relevant stakeholders. We report our experiences in deploying such an approach in the field over a period of approximately 16 months.

  8. The regulatory control of radioactive sources in Argentina

    Energy Technology Data Exchange (ETDEWEB)

    Rojkind, Roberto Hector [Autoridade Regulatoria Nuclear, Buenos Aires (Argentina)

    1997-12-31

    Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author) 9 refs; e-mail: rrojkind at sede.arn.gov.br

  9. Regulatory issues in the maintenance of Argentine nuclear power plants

    International Nuclear Information System (INIS)

    Castro, E.; Caruso, G.

    1997-01-01

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

  10. 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.

  11. FORECAST: Regulatory effects cost analysis software annual

    International Nuclear Information System (INIS)

    Lopez, B.; Sciacca, F.W.

    1991-11-01

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

  12. 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...

  13. A Review on Regulatory Enforcement Policy

    International Nuclear Information System (INIS)

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

    2017-01-01

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

  14. Integrating environmental monitoring with cumulative effects management and decision making.

    Science.gov (United States)

    Cronmiller, Joshua G; Noble, Bram F

    2018-05-01

    Cumulative effects (CE) monitoring is foundational to emerging regional and watershed CE management frameworks, yet monitoring is often poorly integrated with CE management and decision-making processes. The challenges are largely institutional and organizational, more so than scientific or technical. Calls for improved integration of monitoring with CE management and decision making are not new, but there has been limited research on how best to integrate environmental monitoring programs to ensure credible CE science and to deliver results that respond to the more immediate questions and needs of regulatory decision makers. This paper examines options for the integration of environmental monitoring with CE frameworks. Based on semistructured interviews with practitioners, regulators, and other experts in the Lower Athabasca, Alberta, Canada, 3 approaches to monitoring system design are presented. First, a distributed monitoring system, reflecting the current approach in the Lower Athabasca, where monitoring is delegated to different external programs and organizations; second, a 1-window system in which monitoring is undertaken by a single, in-house agency for the purpose of informing management and regulatory decision making; third, an independent system driven primarily by CE science and understanding causal relationships, with knowledge adopted for decision support where relevant to specific management questions. The strengths and limitations of each approach are presented. A hybrid approach may be optimal-an independent, nongovernment, 1-window model for CE science, monitoring, and information delivery-capitalizing on the strengths of distributed, 1-window, and independent monitoring systems while mitigating their weaknesses. If governments are committed to solving CE problems, they must invest in the long-term science needed to do so; at the same time, if science-based monitoring programs are to be sustainable over the long term, they must be responsive to

  15. 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...

  16. Use of new scientific developments in regulatory risk assessments: challenges and opportunities.

    Science.gov (United States)

    Tarazona, Jose V

    2013-07-01

    Since the 1990s, science based ecological risk assessments constitute an essential tool for supporting decision making in the regulatory context. Using the European REACH Regulation as example, this article presents the challenges and opportunities for new scientific developments within the area of chemical control and environmental protection. These challenges can be sorted out in 3 main related topics (sets). In the short term, the challenges are directly associated with the regulatory requirements, required for facilitating a scientifically sound implementation of the different obligations for industry and authorities. It is important to mention that although the actual tools are different due to the regulatory requirements, the basic needs are still the same as those addressed in the early 1990s: understanding the ecological relevance of the predicted effects, including the uncertainty, and facilitating the link with the socio-economic assessment. The second set of challenges covers the opportunities for getting an added value from the regulatory efforts. The information compiled through REACH registration and notification processes is analyzed as source for new integrative developments for assessing the combined chemical risk at the regional level. Finally, the article discusses the challenge of inverting the process and developing risk assessment methods focusing on the receptor, the individual or ecosystem, instead of on the stressor or source. These approaches were limited in the past due to the lack of information, but the identification and dissemination of standard information, including uses, manufacturing sites, physical-chemical, environmental, ecotoxicological, and toxicological properties as well as operational conditions and risk management measures for thousands of chemicals, combined by the knowledge gathered through large scale monitoring programs and spatial information systems is generating new opportunities. The challenge is liking

  17. 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...

  18. A Review of the Environmental Impacts for Marine and Hydrokinetic Projects to Inform Regulatory Permitting: Summary Findings from the 2015 Workshop on Marine and Hydrokinetic Technologies, Washington, D.C.

    Energy Technology Data Exchange (ETDEWEB)

    Baring-Gould, E. Ian [National Renewable Energy Lab. (NREL), Golden, CO (United States); Christol, Corrie [National Renewable Energy Lab. (NREL), Golden, CO (United States); LiVecchi, Al [National Renewable Energy Lab. (NREL), Golden, CO (United States); Kramer, Sharon [H.T. Harvey and Associates, Los Gatos, CA (United States); West, Anna [Kearns & West, Inc., San Francisco, CA (United States)

    2016-07-01

    In 2014 and 2015, the U.S. Department of Energy initiated efforts to develop and implement technology- and application-focused marine and hydrokinetic (MHK) workshops to share the global experience and knowledge base on evolving MHK technologies, observed and not-observed impacts, monitoring and measurement methods, and regulatory needs. The resulting MHK Regulator Workshops engaged resource managers and other decision makers at key regulatory organizations, scientists, researchers, facilitators, and technical experts and provided an opportunity to examine the risks of single-device and small-scale deployments, explore what can be learned and observed from single devices and small-scale arrays, and consider requirements for projects at varying scales of deployment. Experts and stakeholders identified key remaining information gaps. Initial discussions focused on differentiating between monitoring required for single or small-scale deployments and MHK impact research that, although important, goes beyond what is feasible or should be needed to meet specific project regulatory requirements but is appropriate for broader research and development. Four areas of identified potential environmental impacts provided the focus for the workshop: acoustic output impacts, electromagnetic field (EMF) emissions, physical interactions, and environmental effects of MHK energy development on the physical environment. Discussions also focused on the regulatory process and experience, adaptive management, industry drivers, and lessons that can be learned from the wind energy industry. The discussion was set in the context of the types of MHK technologies that are currently proposed or planned in the United States. All presentations and the following discussions are summarized in this document.

  19. Regulatory control of fuel design and manufacturing

    International Nuclear Information System (INIS)

    1994-01-01

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

  20. 76 FR 55137 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

    Science.gov (United States)

    2011-09-06

    ... the NRC Library at http://www.nrc.gov/reading-rm/doc-collections/ . Regulatory guides are not... Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; request for... comment draft regulatory guide (DG) DG-1278, ``Monitoring the Effectiveness of Maintenance at Nuclear...

  1. Monitoring well plugging and abandonment plan, Y-12 Plant, Oak Ridge, Tennessee (revised)

    International Nuclear Information System (INIS)

    1997-05-01

    Plugging and abandonment (P ampersand A) of defunct groundwater monitoring wells is a primary element of the Oak Ridge Y-12 Plant Groundwater Protection Program (GWPP) (AJA Technical Services, Inc. 1996). This document is the revised groundwater monitoring well P ampersand A plan for the U.S. Department of Energy (DOE) Y-12 Plant located in Oak Ridge, Tennessee. This plan describes the systematic approach employed by Y-12 Plant GWPP to identify wells that require P ampersand A, the technical methods employed to perform P ampersand A activities, and administrative requirements. Original documentation for Y-12 Plant GWPP groundwater monitoring well P ampersand A was provided in HSW, Inc. (1991). The original revision of the plan specified that a comprehensive monitoring well P ampersand A was provided in HSW, Inc. (1991). The original revision of the plan specified that a comprehensive monitoring well P ampersand A schedule be maintained. Wells are added to this list by issuance of both a P ampersand A request and a P ampersand A addendum to the schedule. The current Updated Subsurface Data Base includes a single mechanism to track the status of monitoring wells. In addition, rapid growth of the groundwater monitoring network and new regulatory requirements have resulted in constant changes to the status of wells. As a result, a streamlined mechanism to identify and track monitoring wells scheduled for P ampersand A has been developed and the plan revised to formalize the new business practices

  2. Post-accident radiation monitors

    International Nuclear Information System (INIS)

    Laughlin, G.J.; Kathren, R.L.

    1982-01-01

    Under contract to the Nuclear Safety Analysis Center of the Electric Power Research Institute, technical information and specifications were obtained for commercially available radiological monitoring instrumentation designed for use as post-accident monitors. The information was collated and published in the NSAC Handbook of Postaccident Instrumentation (Kathren and Laughlin 1981), and included such data as range, accuracy, precision, sensitivity, and energy dependence of the detector, environmental and seismic limitations of the equipment, the testing program performed to evaluate the equipment, a list of references where the instrumentation is currently installed, and a list of features and accessories available with the monitoring systems. The information presented in this section reveals that, even though a number of vendors claim to be able to meet the guidance of Regulatory Guide 1.97 (USNRC 1980), few have actually conducted tests to verify that their equipment does indeed satisfy the guidance of this Regulatory Guide, and that some of the guidance may in fact be unrealistic

  3. 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.

  4. 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

  5. 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...

  6. Contemporary Approaches to Safety Culture: Lessons from Developing a Regulatory Oversight Approach

    International Nuclear Information System (INIS)

    Goebel, V.; Heppell-Masys, K.

    2016-01-01

    The Canadian Nuclear Safety Commission (CNSC) regulates the use of nuclear energy and materials to protect health, safety, security and the environment, and to implement Canada’s international commitments on the peaceful use of nuclear energy; and to disseminate objective scientific, technical and regulatory information to the public. In the late 1990s, the CNSC conducted research into an Organization and Management (O&M) assessment method. Based on this research the CNSC conducted O&M assessments at all Canadian nuclear power plants and conducted additional assessments of nuclear research and uranium mine and mill operations. The results of these assessments were presented to licencees and used to inform their ongoing actions related to safety culture. Additional safety culture outreach and oversight activities provided licencees with opportunities to develop effective safety culture assessment methods, to share best practices across industry, and to strive for continual improvement of their organizations. Recent changes to the Canadian Standards Association (CSA) management system standard have resulted in the inclusion of requirements associated to safety culture and human performance. Representatives from several sectors of Canada’s nuclear industry, as well as participation from regulators such as the CNSC took part to the development of this consensus standard. Specifically, these requirements focus on monitoring and understanding safety culture, integrating safety into all of the requirements of the management system, committing workers to adhere to the management system and supporting excellence in workers’ performance. The CNSC is currently developing a regulatory document on safety culture which includes key concepts applicable to all licencees and specific requirements related to self-assessment, and additional guidance for nuclear power plants. Developing a regulatory document on safety culture requires consultation and fact finding initiatives at

  7. European Marine Biodiversity Monitoring Networks: strengths, weaknesses, opportunities and threats

    Directory of Open Access Journals (Sweden)

    Joana Patrício

    2016-09-01

    Full Text Available By 2020, European Union Member States should achieve Good Environmental Status (GES for eleven environmental quality descriptors for their marine waters to fulfill the Marine Strategy Framework Directive (MSFD. By the end of 2015, in coordination with the Regional Seas Conventions, each EU Member States was required to develop a marine strategy for their waters, together with other countries within the same marine region or sub-region. Coherent monitoring programs, submitted in 2014, form a key component of this strategy, which then aimed to lead to a Program of Measures (submitted in 2015. The European DEVOTES FP7 project has produced and interrogated a catalogue of EU marine monitoring related to MSFD descriptors 1 (biological diversity, 2 (non-indigenous species, 4 (food webs and 6 (seafloor integrity. Here we detail the monitoring activity at the regional and sub-regional level for these descriptors, as well as for 11 biodiversity components, 22 habitats and the 37 anthropogenic pressures addressed. The metadata collated for existing European monitoring networks were subject to a SWOT (strengths, weaknesses, opportunities and threats analysis. This interrogation has indicated case studies to address the following questions: a what are the types of monitoring currently in place?; b who does what and how?; c is the monitoring fit-for-purpose for addressing the MSFD requirements?, and d what are the impediments to better monitoring (e.g. costs, shared responsibilities between countries, overlaps, co-ordination? We recommend the future means, to overcome the identified impediments and develop more robust monitoring strategies and as such the results are especially relevant to implementing coordinated monitoring networks throughout Europe, for marine policy makers, government agencies and regulatory bodies. It is emphasized that while many of the recommendations given here require better, more extensive and perhaps more costly monitoring, this is

  8. Groundwater quality monitoring well installation for waste area grouping 7 and solid waste storage area 1, Oak Ridge, Tennessee

    International Nuclear Information System (INIS)

    Mortimore, J.A.; Ebers, M.L.

    1994-09-01

    The purpose of this report is to document the drilling and installation of the groundwater quality monitoring (GQM) wells on the perimeter of Waste Area Grouping (WAG) 7 and at Solid Waste Storage Area (SWSA) 1, which is a part of WAG 1. Installation of GQM wells was required at Oak Ridge National Laboratory (ORNL) for regulatory compliance. Data obtained from these wells will be used to characterize and assess groundwater quality at the perimeter of each WAG in accordance with applicable Department of Energy, state, and Environmental Protection Agency regulatory requirements. The wells in WAG 7 and SWSA 1 were drilled and developed during the period from June 1989 to March 1990

  9. Environmental monitoring, restoration and assessment: What have we learned

    Energy Technology Data Exchange (ETDEWEB)

    Gray, R.H. (ed.)

    1990-01-01

    The Twenty-Eighth Hanford Symposium on Health and the Environment was held in Richland, Washington, October 16--19, 1989. The symposium was sponsored by the US Department of Energy and the Pacific Northwest Laboratory, operated by Battelle Memorial Institute. The symposium was organized to review and evaluate some of the monitoring and assessment programs that have been conducted or are currently in place. Potential health and environmental effects of energy-related and other industrial activities have been monitored and assessed at various government and private facilities for over three decades. Most monitoring is required under government regulations; some monitoring is implemented because facility operators consider it prudent practice. As a result of these activities, there is now a substantial radiological, physical, and chemical data base for various environmental components, both in the United States and abroad. Symposium participants, both platform and poster presenters, were asked to consider, among other topics, the following: Has the expenditure of millions of dollars for radiological monitoring and assessment activities been worth the effort How do we decide when enough monitoring is enough Can we adequately assess the impacts of nonradiological components -- both inorganic and organic -- of wastes Are current regulatory requirements too restrictive or too lenient Can monitoring and assessment be made more cost effective Papers were solicited in the areas of environmental monitoring; environmental regulations; remediation, restoration, and decommissioning; modeling and dose assessment; uncertainty, design, and data analysis; and data management and quality assurance. Individual reports are processed separately for the databases.

  10. Environmental monitoring, restoration and assessment: What have we learned?

    International Nuclear Information System (INIS)

    Gray, R.H.

    1990-01-01

    The Twenty-Eighth Hanford Symposium on Health and the Environment was held in Richland, Washington, October 16--19, 1989. The symposium was sponsored by the US Department of Energy and the Pacific Northwest Laboratory, operated by Battelle Memorial Institute. The symposium was organized to review and evaluate some of the monitoring and assessment programs that have been conducted or are currently in place. Potential health and environmental effects of energy-related and other industrial activities have been monitored and assessed at various government and private facilities for over three decades. Most monitoring is required under government regulations; some monitoring is implemented because facility operators consider it prudent practice. As a result of these activities, there is now a substantial radiological, physical, and chemical data base for various environmental components, both in the United States and abroad. Symposium participants, both platform and poster presenters, were asked to consider, among other topics, the following: Has the expenditure of millions of dollars for radiological monitoring and assessment activities been worth the effort? How do we decide when enough monitoring is enough? Can we adequately assess the impacts of nonradiological components -- both inorganic and organic -- of wastes? Are current regulatory requirements too restrictive or too lenient? Can monitoring and assessment be made more cost effective? Papers were solicited in the areas of environmental monitoring; environmental regulations; remediation, restoration, and decommissioning; modeling and dose assessment; uncertainty, design, and data analysis; and data management and quality assurance. Individual reports are processed separately for the databases

  11. Regulatory issues in accreditation of toxicology laboratories.

    Science.gov (United States)

    Bissell, Michael G

    2012-09-01

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

  12. Use of PRA in the nuclear regulatory field in South Africa

    International Nuclear Information System (INIS)

    Hill, T.F.

    1994-01-01

    The nuclear regulatory authority in South Africa (since 1988 the Council for Nuclear Safety (CNS)), established in 1973 nuclear safety criteria against which to assess the level of safety of any facility using radioactive material. It is a regulatory requirement in South Africa to develop and maintain a living PRA for each facility and thereby to provide the necessary information to demonstrate compliance against these criteria. All safety submissions to the CNS must include at least a risk statement based on an accepted PRA study. The function of the CNS is to regulate all activities in South Africa involving the use of radioactive material and posing a significant risk to the public or plant personnel. This includes most aspects of the nuclear fuel cycle and the Koeberg NPS (two 2775 MW(th) PWRs). A PRA study including source terms for the two Koeberg units was presented by the contractor in 1979. This included the risk due to power and shutdown states and non reactor related accidents involving spent fuel storage, fuel handling and waste treatment related activities. At least 20 PRA studies have been performed for other nuclear facilities in the country. The CNS maintains an in-house PRA capability to perform independent assessments of licensee submission, to participate in developments of PRA methodology in the regulatory field, to perform pro-active safety work and to assist in regulatory decision making. Present ongoing work includes the development of a risk monitor, a risk management system, improvement in PRA codes, models, data collection and analysis, off-site risk assessment methodology and associated regulatory policy. (author). 1 fig

  13. The regulatory framework in the UK

    International Nuclear Information System (INIS)

    O'Sullivan, R.

    1984-01-01

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

  14. 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

  15. 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.

  16. 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.

  17. Baseline radiological monitoring at proposed uranium prospecting site at Rohil Sikar, Rajasthan

    International Nuclear Information System (INIS)

    Kumar, Rajesh; Jha, V.N.; Sahoo, N.K.; Jha, S.K.; Tripathi, R.M.

    2018-01-01

    Once economically viable grades of uranium deposits are proposed for mining and processing by the industry radiological baseline studies are required for future comparison during operational phases. The information collected during such studies serve as connecting feature between regulatory compliance and technical information. Present paper summarizes the results of baseline monitoring of atmospheric 222 Rn and gamma level in the area at prospecting mining, milling and waste disposal sites of Rohil Rajasthan

  18. Quality Assurance Requirements and Description

    International Nuclear Information System (INIS)

    Ram Murthy

    2002-01-01

    The Quality Assurance Requirements and Description (QARD) is the principal Quality Assurance (QA) document for the Civilian Radioactive Waste Management Program (Program). It establishes the minimum requirements for the QA program [INTRODUCTION :1p2s (NOT A REQUIREMENT)]. The QARD contains regulatory requirements and program commitments necessary for the development of an effective QA program [INTRODUCTION :1p3s (NOT A REQUIREMENT)]. Implementing documents must be based on, and be consistent with the QARD. The QARD applies to the following: (1) Acceptance of spent nuclear fuel and high-level waste. (2) Transport of spent nuclear fuel and high-level waste. (3) Storage of spent nuclear fuel through receipt of storage cask certification or a facility operating license. (4) Monitored Geologic Repository, including the site characterization activities [Exploratory Studies Facility (ESF) and surface based testing], through receipt of an operating license. (5) High-level waste form development through qualification, production, and acceptance. (6) Characterization of DOE spent nuclear fuel, and conditioning through acceptance of DOE spent nuclear fuel. Section 2.0, Quality Assurance Program, defines in greater detail criteria for determining work subject to the QARD

  19. 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)

  20. Waste Management System Requirement document

    International Nuclear Information System (INIS)

    1990-04-01

    This volume defines the top level technical requirements for the Monitored Retrievable Storage (MRS) facility. It is designed to be used in conjunction with Volume 1, General System Requirements. Volume 3 provides a functional description expanding the requirements allocated to the MRS facility in Volume 1 and, when appropriate, elaborates on requirements by providing associated performance criteria. Volumes 1 and 3 together convey a minimum set of requirements that must be satisfied by the final MRS facility design without unduly constraining individual design efforts. The requirements are derived from the Nuclear Waste Policy Act of 1982 (NWPA), the Nuclear Waste Policy Amendments Act of 1987 (NWPAA), the Environmental Protection Agency's (EPA) Environmental Standards for the Management and Disposal of Spent Nuclear Fuel (40 CFR 191), NRC Licensing Requirements for the Independent Storage of Spent Nuclear and High-Level Radioactive Waste (10 CFR 72), and other federal statutory and regulatory requirements, and major program policy decisions. This document sets forth specific requirements that will be fulfilled. Each subsequent level of the technical document hierarchy will be significantly more detailed and provide further guidance and definition as to how each of these requirements will be implemented in the design. Requirements appearing in Volume 3 are traceable into the MRS Design Requirements Document. Section 2 of this volume provides a functional breakdown for the MRS facility. 1 tab

  1. Canadian and international approaches to regulatory effectiveness

    International Nuclear Information System (INIS)

    Lojk, R.

    2014-01-01

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

  2. 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.

  3. Annual Report 2007. Nuclear Regulatory Authority; Informe Anual 2007. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across tree parts and seven annexes the activities developed by the organism during 2007. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  4. Annual Report 2008. Nuclear Regulatory Authority; Informe Anual 2008. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2008. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the occupational surveillance; the environmental monitoring; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  5. Development of regulatory techniques for operational performance evaluation of nuclear power plants

    International Nuclear Information System (INIS)

    Sung, K. Y.; Lee, C. J.; Choi, J. S.; Lee, S. Y.; Kim, M. C.

    2003-04-01

    In order to provide the technical rationale for future risk-informed regulatory applications, four essential regulatory areas, i.e., PSA regulatory audit model, quality certification procedure on PSA, risk-informed performance indicator, and risk monitoring were surveyed, and the corresponding state-of- technology for each area was summarized. Actually, this study was performed by way of the analysis and in-depth survey on the previous experience done by any individual organizations like USNRC or US NEI, as well as the international organizations like IAEA or OECD/NEA. Through the survey results, we might look for the regulatory positions on national development

  6. A regulatory perspective on the radiological impact of NORM industries: the case of the Spanish phosphate industry

    International Nuclear Information System (INIS)

    Garcia-Talavera, M.; Matarranz, J.L.M.; Salas, R.; Ramos, L.

    2011-01-01

    Radioactive and chemical risks coexist in NORM industries although they are usually addressed separately by regulations. The European Union (EU) has developed extensive legislation concerning both matters, which has been diversely reflected in national policies. We consider the case of the Spanish phosphate industry and analyse to which extent regulatory mandates have reduced the historical and ongoing radiological impact on the environment of phosphate facilities. Although no specific radiological constraints on effluent monitoring and release or on waste disposal have yet been imposed on NORM industries in Spain, other environmental regulations have achieved a substantial reduction on the phosphate industry impact. Nevertheless, a more efficient control could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks in NORM industries. We highlight research needs to accomplish so and propose shorter-term measures that require active cooperation among the regulatory bodies involved. - Research highlights: → The radiological impact of the Spanish phosphate industry has substantially decreased as a side result of environmental regulations on chemical pollution.→ A more efficient control of NORM industries could be established by eliminating the current conceptual and practical separation of chemical and radioactive risks.→ Further research is needed on how interactions between radiation and chemicals might affect regulatory limits and on a systematic way to input stakeholder preferences in MCDA.→ On shorter-term, administrative measures that require active cooperation among the regulatory bodies involved can be taken.

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

    International Nuclear Information System (INIS)

    Whitehead, W.

    1986-09-01

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

  8. Implementation of a laboratory information management system for environmental regulatory analyses

    Energy Technology Data Exchange (ETDEWEB)

    Spencer, W.A.; Aiken, H.B.; Spatz, T.L.; Miles, W.F.; Griffin, J.C.

    1993-09-07

    The Savannah River Technology Center created a second instance of its ORACLE based PEN LIMS to support site Environmental Restoration projects. The first instance of the database had been optimized for R&D support and did not implement rigorous sample tracking, verification, and holding times needed to support regulatory commitments. Much of the R&D instance was transferable such as the work control functions for backlog reports, work assignment sheets, and hazard communication support. A major enhancement of the regulatory LIMS was the addition of features to support a {open_quotes}standardized{close_quotes} electronic data format for environmental data reporting. The electronic format, called {open_quotes}AN92{close_quotes}, was developed by the site environmental monitoring organization and applies to both onsite and offsite environmental analytical contracts. This format incorporates EPA CLP data validation codes as well as details holding time and analytical result reporting requirements. The authors support this format by using special SQL queries to the database. The data is then automatically transferred to the environmental databases for trending and geological mapping.

  9. Development of web based system for internal monitoring programme

    Energy Technology Data Exchange (ETDEWEB)

    Lima, Vanessa R. de; Rodrigues Junior, Orlando; Todo, Alberto S. [Instituto de Pesquisas Energeticas e Nucleares (IPEN/CNEN-SP), Sao Paulo, SP (Brazil)]. E-mail: vrlima@ipen.br; rodrijr@ipen.br; astodo@ipen.br

    2007-07-01

    The purposes of monitoring in general are to verify and to document that each worker is protected adequately against risks from radionuclide intakes and the protection complies with legal requirements. Therefore, it forms part of the overall radiation protection programme, which starts with an assessment to identify work situations in which there is a risk of internal contamination of workers and to quantify the likely intake of radioactive material and the resulting committed effective dose. As a part of a continuous improvement of the monitoring programme for occupationally exposed workers at IPEN, it is being developed a Web based system to access the internal dosimetry database. The system was implemented using Hypertext Preprocessor, PHP, and a PostgreSQL database. This system will introduce a new paradigm in the routine of the internal dosimetry service, providing a fast access to the information among the measurement laboratories staff, dose evaluation group and the radiation protection supervisor. The database maintains information about worker identification, physical and chemical characteristics of the radionuclide, type of monitoring, measurement data and the dose. Moreover, this information will be readily available to provide support for regulatory compliance and quality control requirements. (author)

  10. Safety system upgrades to a research reactor: A regulatory perspective

    International Nuclear Information System (INIS)

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

    2003-01-01

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

  11. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

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

  12. RESEARCH OF PROCESS OF FINANCIAL MONITORING ORGANIZING IN BANKS

    Directory of Open Access Journals (Sweden)

    Viktoriia Kovalenko

    2017-03-01

    Full Text Available The article aims to study methods and tools for financial monitoring by banks. It is proved that one of the main global financial problems in recent years is increasing number of cases of banks participating in the money laundering. It causes banks huge losses, undermines the credibility of honest depositors, in addition, circulation of funds like these hurts the national economy. The article is to develop recommendations to improve the effectiveness of financial monitoring in banks. It is proved that the current model of the national financial monitoring system includes the following elements: the purpose of macroeconomic and microeconomic levels; principles; function; facilities; subjects; types of financial monitoring; methods of implementation and regulatory prevue regulation. It is proved that the major problems related to the financial monitoring of banks are the following: lack of legislatively established quality requirements of customer information; persons engaged in legalization of illegal incomes are highly qualified, which greatly facilitates them through the bank of suspicious transactions; the process of settlement bank failure in the conduct of questionable transactions. Keywords: financial monitoring, suspicious transactions, bank, money laundering, financing of terrorism.

  13. Evaluation of NORM in facility Venezuelan oil industry to establish regulatory criteria

    International Nuclear Information System (INIS)

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

    2013-01-01

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

  14. International Nuclear Safety Experts Conclude IAEA Peer Review of Swiss Regulatory Framework

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: A team of international nuclear safety experts today completed a two-week International Atomic Energy Agency (IAEA) review of the regulatory framework for nuclear safety in Switzerland. The Integrated Regulatory Review Service (IRRS) mission noted good practices in the Swiss system and also made recommendations for the nation's nuclear regulatory authority, the Swiss Federal Nuclear Safety Inspectorate (ENSI). ''Our team developed a good impression of the independent Swiss regulator - ENSI - and the team considered that ENSI deserves particular credit for its actions to improve Swiss safety capability following this year's nuclear accident in Japan,'' said IRRS Team Leader Jean-Christophe Niel of France. The mission's scope covered the Swiss nuclear regulatory framework for all types of nuclear-related activities regulated by ENSI. The mission was conducted from 20 November to 2 December, mainly at ENSI headquarters in Brugg. The team held extensive discussions with ENSI staff and visited many Swiss nuclear facilities. IRRS missions are peer reviews, not inspections or audits, and are conducted at the request of host nations. For the Swiss review, the IAEA assembled a team of 19 international experts from 14 countries. The experts came from Belgium, Brazil, the Czech Republic, Finland, France, Germany, Italy, the Republic of Korea, Norway, Russia, Slovakia, Sweden, the United Kingdom, and the United States. ''The findings of the IRRS mission will help us to further improve our work. That is part of our safety culture,'' said ENSI Director General Hans Wanner. ''As Switzerland argued at international nuclear safety meetings this year for a strengthening of the international monitoring of nuclear power, we will take action to fulfil the recommendations.'' The IRRS team highlighted several good practices of the Swiss regulatory system, including the following: ENSI requires Swiss nuclear operators to back-fit their facilities by continuously upgrading

  15. L-Lake fish: L-Lake/Steel Creek Biological Monitoring Program, January 1986--December 1991

    International Nuclear Information System (INIS)

    Sayers, R.E. Jr.; Mealing, H.G. III

    1992-04-01

    The L Lake Biological Monitoring Program was designed to meet environmental regulatory requirements associated with the re-start of L-Reactor and address portions of Section 316(a) of the Clean Water Act, which requires an applicant for a discharge permit to provide scientific evidence that the discharge causes no significant impact on the indigenous ecosystem. The Department of Energy (DOE) must demonstrate that the discharge of L-Reactor effluent into L Lake will not inhibit the eventual establishment of a ''Balanced Biological Community'' (BBC) in at least 50% of the lake

  16. L-Lake fish: L-Lake/Steel Creek Biological Monitoring Program, January 1986--December 1991

    Energy Technology Data Exchange (ETDEWEB)

    Sayers, R.E. Jr.; Mealing, H.G. III [Normandeau Associates, Inc., New Ellenton, SC (United States)

    1992-04-01

    The L Lake Biological Monitoring Program was designed to meet environmental regulatory requirements associated with the re-start of L-Reactor and address portions of Section 316(a) of the Clean Water Act, which requires an applicant for a discharge permit to provide scientific evidence that the discharge causes no significant impact on the indigenous ecosystem. The Department of Energy (DOE) must demonstrate that the discharge of L-Reactor effluent into L Lake will not inhibit the eventual establishment of a ``Balanced Biological Community`` (BBC) in at least 50% of the lake.

  17. [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.

  18. Monitoring well installation plan for the Department of Energy Y-12 Plant, Oak Ridge, Tennessee

    International Nuclear Information System (INIS)

    1997-09-01

    The installation and development of groundwater monitoring wells is a primary element of the Y-12 Plant Groundwater Protection Program (GWPP), which monitors groundwater quality and hydrologic conditions at the Oak Ridge Y-12 Plant. This document is a groundwater monitoring well installation and development plan for the US Department of Energy (DOE) Y-12 Plant located in Oak Ridge, Tennessee. This plan formalizes well installation and construction methods, well development methods, and core drilling methods that are currently implemented at the Y-12 Plant under the auspices of the GWPP. Every three years, this plan will undergo a review, during which revisions necessitated by changes in regulatory requirements or GWPP objectives may be made

  19. Revised ground-water monitoring compliance plan for the 300 area process trenches

    Energy Technology Data Exchange (ETDEWEB)

    Schalla, R.; Aaberg, R.L.; Bates, D.J.; Carlile, J.V.M.; Freshley, M.D.; Liikala, T.L.; Mitchell, P.J.; Olsen, K.B.; Rieger, J.T.

    1988-09-01

    This document contains ground-water monitoring plans for process-water disposal trenches located on the Hanford Site. These trenches, designated the 300 Area Process Trenches, have been used since 1973 for disposal of water that contains small quantities of both chemicals and radionuclides. The ground-water monitoring plans contained herein represent revision and expansion of an effort initiated in June 1985. At that time, a facility-specific monitoring program was implemented at the 300 Area Process Trenches as part of a regulatory compliance effort for hazardous chemicals being conducted on the Hanford Site. This monitoring program was based on the ground-water monitoring requirements for interim-status facilities, which are those facilities that do not yet have final permits, but are authorized to continue interim operations while engaged in the permitting process. The applicable monitoring requirements are described in the Resource Conservation and Recovery Act (RCRA), 40 CFR 265.90 of the federal regulations, and in WAC 173-303-400 of Washington State's regulations (Washington State Department of Ecology 1986). The program implemented for the process trenches was designed to be an alternate program, which is required instead of the standard detection program when a facility is known or suspected to have contaminated the ground water in the uppermost aquifer. The plans for the program, contained in a document prepared by the US Department of Energy (USDOE) in 1985, called for monthly sampling of 14 of the 37 existing monitoring wells at the 300 Area plus the installation and sampling of 2 new wells. 27 refs., 25 figs., 15 tabs.

  20. 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.)

  1. Structure and drafting of safeguards regulatory documents

    International Nuclear Information System (INIS)

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

    1977-09-01

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

  2. 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)

  3. Regulatory difficulties in a developing country

    International Nuclear Information System (INIS)

    Jacobs, W.R. Jr.

    1978-01-01

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

  4. 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

  5. 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...

  6. 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...

  7. Cost-benefit and regulatory decision making

    International Nuclear Information System (INIS)

    Harvie, J.

    1996-01-01

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

  8. 1982 environmental-monitoring program report for the West Valley Demonstration Project site

    International Nuclear Information System (INIS)

    1983-05-01

    This report is prepared and submitted in accordance with the requirements of DOE Order 5484.1 and presents environmental monitoring program data collected at the West Valley Demonstration Project (WVDP) site from February 26, 1982, through December 31, 1982. The WVDP objective is to solidify approximately 600,000 gallons of high-level liquid radioactive waste stored at the former Nuclear Fuel Services reprocessing facility at West Valley, New York. Nuclear Fuel Services conducted an environmental monitoring program in accordance with Nuclear Regulatory Commission requirements which were appropriate for shutdown maintenance operations conducted at the site. That program was embraced by West Valley Nuclear Services Company (WVNS) at the time of transition (February 26, 1982) and will be modified to provide a comprehensive monitoring program in preparation for waste solidification operations scheduled for startup in June 1988. As such, the data presented in this report is considered preoperational in nature in accordance with DOE Order 5484.1, Chapter III, Paragraph 1. The environmental monitoring program planned for the operating phase of the project will be fully implemented by fiscal year 1985 and will provide at least two years of preoperational data prior to startup

  9. Waste Isolation Pilot Plant Environmental Monitoring Plan

    International Nuclear Information System (INIS)

    Westinghouse Electric Company Waste Isolation Division

    1999-01-01

    DOE Order 5400.1, General Environmental Protection Program Requirements (DOE, 1990a), requires each DOE facility to prepare an EMP. This document is prepared for WIPP in accordance with the guidance contained in DOE Order 5400.1; DOE Order 5400.5, Radiation Protection of the Public and Environment (DOE, 1990b); Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE/EH-0173T; DOE, 1991); and the Title 10 Code of Federal Regulations (CFR) 834, Radiation Protection of the Public and Environment (Draft). Many sections of DOE Order 5400.1 have been replaced by DOE Order 231.1 (DOE, 1995), which is the driver for the Annual Site Environmental Report (ASER) and the guidance source for preparing many environmental program documents. The WIPP project is operated by Westinghouse Electric Company, Waste Isolation Division (WID), for the DOE. This plan defines the extent and scope of the WIPP's effluent and environmental monitoring programs during the facility's operational life and also discusses the WIPP's quality assurance/quality control (QA/QC) program as it relates to environmental monitoring. In addition, this plan provides a comprehensive description of environmental activities at WIPP including: A summary of environmental programs, including the status of environmental monitoring activities A description of the WIPP project and its mission A description of the local environment, including demographics An overview of the methodology used to assess radiological consequences to the public, including brief discussions of potential exposure pathways, routine and accidental releases, and their consequences Responses to the requirements described in the Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (DOE, 1991). This document references DOE orders and other federal and state regulations affecting environmental monitoring programs at the site. WIPP procedures, which implement

  10. 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)

  11. Annual Report 2009. Nuclear Regulatory Authority; Informe Anual 2009. Autoridad Regulatoria Nuclear

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across four parts and seven annexes the activities developed by the organism during 2009. The main topic are: the organization and the activity of the ARN; the regulatory standards; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the environmental monitoring; the occupational surveillance; the training and the public information; improved organizational and budgetary developments. Also, this publication have annexes with the following content: regulatory documents; inspections to medical, industrial and training installations; regulatory guides; measurement and evaluation of the drinking water of Ezeiza.

  12. 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

  13. SI:FatiguePro 4 Advanced Approach for Fatigue Monitoring

    International Nuclear Information System (INIS)

    Evon, Keith; Gilman, Tim; Carney, Curt

    2012-01-01

    Many nuclear plants are making commitments to implement fatigue monitoring systems in support of license renewal. Current fatigue monitoring systems use the methodology of ASME Code Subarticle NB-3200, which is a design code intended to compute a bounding cumulative usage factor (CUF). The first generation of fatigue monitoring software utilized a simplified, single stress term assumption and classical stress cycle-counting methods that take order into account such as Rainflow or Ordered Overall Range counting. Recently, the NRC has indicated in Regulatory Issue Summary 2008-30 that any fatigue analyses in support of License Renewal should use ASME Code Section III methodologies considering all six stress components. In addition, fatigue calculations for the license renewal term are required to consider the effects of environment. The implementation of a six stress term NB-3200 fatigue calculation to a Boiling Water Reactor (BWR) feedwater nozzle, including environmental effects, is the topic of this paper. Differences in results between the advanced methodology and the simplified methodology are discussed. (author)

  14. Continuous improvement of the regulatory framework for the control of medical exposure

    International Nuclear Information System (INIS)

    Larcher, Ana M.; Ortiz Lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2008-01-01

    One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for more specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need for regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual user of radiation, to enable them compliance with safety standards. Purpose: Within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self-assessment tool for the regulatory control of medical exposure has been designed. Method: National experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are analyzed and a self-assessment approach and possible regulatory solutions a are presented. Results and discussion: In this study the following documents are being produced: 1) transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self-assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (author)

  15. 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...

  16. 7 CFR 1710.105 - State regulatory approvals.

    Science.gov (United States)

    2010-01-01

    ... and Basic Policies § 1710.105 State regulatory approvals. (a) In States where a borrower is required... loans are approved by RUS: (1) Loans requiring an Environmental Impact Statement; (2) Loans to finance...

  17. Hydrogen mitigation systems - a Canadian regulatory perspective

    International Nuclear Information System (INIS)

    Khosla, J.K.; Rizk, M.

    1997-01-01

    This is a discussion paper to examine the regulatory requirements that may be necessary for the design, operation and maintenance of the hydrogen mitigation systems. These systems (if deemed necessary to maintain the containment function), may be considered to be a part of the containment systems. Therefore, these requirements are derived mostly from the AECB Regulatory Document R-7, which specifies the requirements for containment systems for CANDU nuclear power plants. Some additional requirements, which are specific to these systems have also been included. These requirements relate to a systematic examination of the hazards of hydrogen, the design basis for the mitigation systems, their functional and design requirements, analytical support to justify their selection, and operating and testing requirements. The requirements for severe accident have not yet been developed. It is, however, anticipated that the design of the hydrogen mitigation system would be such that future requirement can be accommodated. These requirements are intended for application to the new reactors in Canada. For the existing reactors, their application will be subjected to practicability. (author)

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-06-01

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

  19. Enhancing Self-Regulatory Skills through an Intervention Embedded in a Middle School Mathematics Curriculum

    Science.gov (United States)

    Digiacomo, Gregory; Chen, Peggy P.

    2016-01-01

    We investigated the effects of a self-regulatory intervention strategy designed to improve middle-school students' calibration accuracy, self-regulatory skills, and math achievement. Focusing on self-monitoring and self-reflection as the two key processes of this intervention in relation to improving students' math achievement and overall…

  20. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, S.S.; Bock, R.E.; Francis, M.W.; Gove, R.M.; Johnson, P.E.; Kovac, F.M.; Mynatt, J.O. [Oak Ridge National Lab., TN (United States); Rymer, A.C. [Transportation Consulting Services, Knoxville, TN (United States)

    1994-02-28

    The Regulatory Facility Guide (RFG) has been developed for the DOE and contractor facilities located in the state of Ohio. It provides detailed compilations of international, federal, and state transportation-related regulations applicable to shipments originating at destined to Ohio facilities. This RFG was developed as an additional resource tool for use both by traffic managers who must ensure that transportation operations are in full compliance with all applicable regulatory requirements and by oversight personnel who must verify compliance activities.

  1. Development of Web based system for individual internal monitoring programme

    International Nuclear Information System (INIS)

    Lima, Vanessa Rogeria de

    2007-01-01

    The purposes of the internal monitoring, in general, are to verify and document that each worker is protected adequately against risks from radionuclide intakes and the protection complies with legal requirements. Therefore, an overall radiation protection programme, starts with an assessment to identify work situations in which there is a risk of internal contamination of workers and to quantify the likely intake of radioactive material and the resulting committed effective dose. As a part of a continuous improvement of the monitoring programme for occupationally exposed workers at IPEN, it is being developed a Web based system to access the internal dosimetry database. The system was implemented using Hypertext Preprocessor, PHP, and a PostgreSQL database. This system will introduce a new paradigm in the routine of the internal dosimetry service, providing a fast access to the information among the measurement laboratories staff, dose evaluation group and the radiation protection supervisor. The database maintains information about worker identification, physical and chemical characteristics of the radionuclide, type of monitoring, measurement data and the dose. Moreover, this information will be readily available to provide support for regulatory compliance and quality control requirements. (author)

  2. 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.

  3. 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.)

  4. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

    in the testing strategy for new and existing substances, and biocides. Hopefully, this will lead to an improved database for risk assessment of potential developmental neurotoxicants. However, the regulatory authorities and toxicologists will also be faced with the challenge that decisions have to be made......The need for developmental neurotoxicity testing has been recognized for decades and guidelines are available, as the USEPA guideline and the OECD draft TG 426. Regulatory testing of industrial chemicals for developmental neurotoxicity is required to some extent, especially for pesticides in the US....... Until recently, however, developmental neurotoxicity testing of industrial chemicals has not been a clear regulatory requirement in EU, probably due to the lack of an accepted OECD TG. The revised EU Technical Guidance Document for Risk Assessment (EU-TGD) has now included the OECD draft TG 426...

  5. 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.

  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. 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

  8. Development of the Guardian environmental monitoring system

    International Nuclear Information System (INIS)

    Gould, J.L.; Thompson, I.M.G.

    1982-01-01

    The report describes the Guardian Environmental Monitoring System, developed jointly by the CEGB's Berkeley Nuclear Laboratories (BNL) and GEC Energy Systems Limited (ESL). The basic battery operated instrument was developed by BNL for the measurement of any nuclear facility contribution to the overall environmental dose. It uses an energy compensated Geiger counter to provide a continuous record for over a month of dose rates from 1 μR h -1 (10nGy h -1 ). Results are presented of initial development trials and of an intercomparison with the USA Environmental Measurement Laboratory. The Guardian system, however, was developed, not only to meet the CEGB requirements for a recording monitor, but also to meet the requirements of US Regulatory Commission Guide RG 1.97, introduced as a result of the accident at Three Mile Island. This system, by using two energy compensated Geiger counters has a range from 1μRh -1 up to 10Rh -1 (approximately equal to 100mGyh -1 ), and the associated electronics provides automatic range changing, including fast response to ramp exposure rate changes, alarm and test facilities and telemetry by line or radio to a central station. (author)

  9. Experience of TLD personnel monitoring laboratory

    International Nuclear Information System (INIS)

    Jakhete, Prashant

    2002-01-01

    Full text: Renentech Laboratories is the first Private Enterprise in India to have been chosen to provide Personnel radiation monitoring services to radiation workers at different parts of the country. Since 1992 the Company has been manufacturing TLD phosphor powder of requisite quality and from 1995 commenced the production of TLD cards for radiation monitoring. After getting the necessary approval from the competent authorities in the country, the company undertook a rigorous quality assurance programme and received the accreditation in 1999 to carry out the personnel monitoring of radiation. Since then the trained staff of the Company is covering 1200 institutions in 16 states where radiation is being used. This translates to processing of 60,000 Till cards annually, the maximum limit permitted by BARC. Processing of exposure data is done strictly according well-laid guidelines. Any cases of overexposure are immediately referred to Calibration and Dose Record Section of BARC to meet the regulatory requirements. Necessary procedural guidelines are followed to handle such cases. In this lecture, learning, operation and implementation experience of a typical Private Company in a task, which, hitherto had been regarded as exclusive responsibility of state owned institution, is enumerated

  10. 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)

  11. REMIT, Radiation Exposure Monitoring and Information Transmittal System

    International Nuclear Information System (INIS)

    Cale, R.; Clark, T.; Dixson, P.; Hagemeyer, D.; Hardwick, C.; Pippen, H.

    1997-01-01

    1 - Description of program or function: The Radiation Exposure Monitoring and Information Transmittal (REMIT) system is designed to assist U.S. Nuclear Regulatory Commission (NRC) licensees in meeting the reporting requirements of the Revised 10 CFR Part 20 and in agreement with the guidance contained in Regulatory Guide 8.7, Rev.1, Instructions for Recording and Reporting Occupational Exposure Data. REMIT is a personal computer (PC) -based menu driven system that facilitates the manipulation of data base files to record and report radiation exposure information. REMIT is designed to be user-friendly and contains the full text of Regulatory Guide 8.7, Rev.1, on-line as well as context-sensitive help throughout the program. The user can enter data directly from NRC Form 5s or Form 4s. REMIT allows the user to view the individual's exposure in relation to regulatory or administrative limits and will alert the user to exposures in excess of these limits. The system also provides for the calculation and summation of dose from intakes and the determination of the dose to the maximally exposed extremity for the monitoring year. REMIT can produce NRC Form 5s and 4s in paper and electronic format and can import/export data from ASCII and data base files. 2 - Method of solution: REMIT makes use of the dose conversion factors from EPA Report 11 Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submission, and Ingestion, to calculate the Committed Dose Equivalent to the maximally exposed organ and the committed Effective Dose Equivalent from intakes measured in micro-curies. REMIT also estimates the amount (in micrograms) of uranium intake from the activity entered in micro-curies. This calculation is based on the specific activities of the uranium isotopes. 3 - Restrictions on the complexity of the problem: REMIT is a single- user system that only runs on IBM compatible PC systems under DOS and supports only Hewlett

  12. 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

  13. On-line monitoring for calibration reduction

    International Nuclear Information System (INIS)

    Hoffmann, Mario; Gran, Frauke Schmitt; Thunem, Harald P-J.

    2004-04-01

    On-Line Monitoring (OLM) of a channel's calibration state evaluates instrument channel performance by assessing its consistency with other plant indications. Industry and experience at several plants has shown this overall approach to be very effective in identifying instrument channels that are exhibiting degrading or inconsistent performance characteristics. The Halden Reactor Project has developed the signal validation system PEANO, which can be used to assist with the tasks of OLM. To further enhance the PEANO System for use as a calibration reduction tool, the following two additional modules have been developed; HRP Prox, which performs pre-processing and statistical analysis of signal data, Batch Monitoring Module (BMM), which is an off-line batch monitoring and reporting suite. The purpose and functionality of the HRP Prox and BMM modules are discussed in this report, as well as the improvements made to the PEANO Server to support these new modules. The Halden Reactor Project has established a Halden On-Line Monitoring User Group (HOLMUG), devoted to the discussion and implementation of on-line monitoring techniques in power plants. It is formed by utilities, vendors, regulatory bodies and research institutes that meet regularly to discuss implementation aspects of on-line monitoring, technical specification changes, cost-benefit analysis and regulatory issues. (Author)

  14. Compliance. Regulatory policy P-211

    International Nuclear Information System (INIS)

    2001-05-01

    This regulatory policy describes the basic principles and directives for establishing and conducting the Canadian Nuclear Safety Commission (CNSC) Compliance Program. The program is aimed at securing compliance by regulated persons with regulatory requirements made under the Nuclear Safety and Control Act ('the Act'). The policy applies to persons who are regulated by the CNSC through the Act, regulations and licences, as well as by decisions and orders made under the Act. The policy applies to officers and employees of the CNSC, and its authorized representatives or agents, who are involved in developing and carrying out compliance activities. Compliance, in the context of this policy, means conformity by regulated persons with the legally binding requirements of the Act, and the CNSC regulations, licences, decisions, and orders made under the Act. Compliance activities are CNSC measures of promotion, verification and enforcement aimed at securing compliance by regulated person with the applicable legally binding requirements. (author)

  15. [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.

  16. 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)

  17. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    2002-01-01

    The IAEA International Regulatory Review Team (IRRT) programme provides advice and assistance to Member States to strengthen and enhance the effectiveness of the nuclear regulatory body whilst recognizing the ultimate responsibility of each Member State for nuclear safety. The IRRT programme, initiated in 1989, is not restricted to any particular group of Member States, whether developing or industrialized, but is available to all countries with nuclear installations in operation or approaching operation. The basic concepts, purposes and functions of a national regulatory body are well recognized in all Member States having a nuclear power programme. The IAEA Safety Standards Series publication entitled 'Legal and Governmental Infrastructure for Nuclear, Radiation, Radioactive Waste and Transport Safety, Safety: Requirements', No. GS-R-1 (2000), provides a general consensus reference for the practices necessary for a national organization to fulfil the regulatory purposes and discharge the regulatory functions. The Requirements also defines the terms used in these guidelines. The guidance given in the Requirements recognizes that the organizational structure and regulatory processes will vary from country to country depending on their existing constitutional, legal and administrative systems; the size and structure of their nuclear programme; the technical skills and professional and financial resources available to their regulatory body, and social customs and cultural traditions. The objective of this report is to provide guidance on the basic structure of an IRRT mission and provide a common reference both across the various areas covered by an IRRT mission and across all the missions in the programme. As such, it is addressed, principally, to the team members of IRRT missions but it also provides guidance to a host regulatory body receiving a mission. This report identifies the objectives of the IRRT mission and sets out the scope of the topic areas that are

  18. 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.

  19. Continuous Improvement of the Regulatory Framework for the Control of Medical Exposure

    International Nuclear Information System (INIS)

    Larcher, A.M.; Ortiz lopez, Pedro; Arias, Cesar; Marechal, Maria H.; Hernandez Alvarez, Ramon; Ferrer Garcia, Natividad; Castaneda Mucino, Antonia; Faller, Blanca

    2011-01-01

    Background: One of the key elements to guide the improvement of the regulatory control is the availability of a self-assessment tool for regulatory performance. Although there is general guidance on self-assessment for regulators and users (IAEA), there is a need for specific advice on how to address challenges and difficulties faced by regulatory bodies, when regulating radiation protection of patients. Examples of these challenges are the need of regulatory initiatives, in cooperation with health and education authorities, professional bodies and equipment suppliers, and to put in place necessary elements that are beyond responsibility of individual users of radiation, to enable them compliance with safety standards. Purpose: within the programme of the Ibero American Forum of Nuclear and Radiation Safety Regulatory Organizations, a project to develop such a self assessment tool for the regulatory control of medical exposure has been designed. Method: national experiences in transposing and enforcing the international radiation safety standards, as to how the requirements are included in national regulations are reviewed. Further, difficulties to the implementation of safety requirements are included in national regulations are analyzed and a self assessment approach and possible regulatory solutions are presented. Results and discussion: in tis study the following documents are being produced: 1) Transposition of international requirements into national regulations in the six countries of the Forum, 2) difficulties to implement and enforce the requirements, 3) guidance on self assessment of regulatory framework for medical exposure, 4) suggested contribution to the revision of international radiation safety standards. (authors)

  20. A complex process - transforming scientific research into regulatory rules for environmental protection

    International Nuclear Information System (INIS)

    Yan, J.J.; Goss, D.; Huffman, A.

    2002-01-01

    The protection of isolated wetlands from consumptive use withdrawals has been a policy in the South Florida Water Management District (SFWMD) for over 15 years. A guideline for protecting isolated wetlands was established in the mid-1980's for the consumptive water use permitting program administered by the SFWMD. The guideline specifies groundwater drawdown criteria associated with well field pumpage. In 1994, the SFWMD convened a panel of wetland scientists to review the existing groundwater drawdown criteria. The panel concluded there was insufficient information to determine if the criteria were either too restrictive or insufficient in protecting wetlands. The panel recommended that the SFWMD conduct research to answer related questions. Since that time, staff at the SFWMD have developed a research plan, selected 38 isolated wetland monitoring sites in seven study areas, collected over four years of data, and developed an integrated surface water and groundwater simulation model. However, the staff at the SFWMD has had difficulties in transforming the research results into regulatory rules. The nature of an isolated wetland is quite complicated. Its setting changes significantly from time to time depending on the variation of rainfall, hydro-geological conditions, and human activities. A regulatory rule requires simple and more easily measurable criteria. The regulatory staff need simple tools to evaluate many permit applications within a limited time frame. The tools used in the research process are often complicated and time consuming. This paper describes the wetland research, and the difficulties of transforming research results into regulatory rules. (author)

  1. 78 FR 73577 - Self-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2013-12-06

    ...-Regulatory Organizations; BATS Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify the Risk Monitoring Functionality Offered by the Exchange December 2, 2013....19b-4(f)(6)(iii). I. Self-Regulatory Organization's Statement of the Terms of Substance of the...

  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. 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

  4. 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.

  5. Current status of herbal product: Regulatory overview

    Science.gov (United States)

    Sharma, Sanjay

    2015-01-01

    A review of the regulatory status of herbal drugs/products was done for few countries forming part of Asia, Africa, America, Europe, and Australia, to understand various categories under which the trade of herbal products is permitted and their premarketing requirements. A critical assessment was done, to know the hindrances in the process of harmonization of herbal products. It has been found that there is a lack of harmonization in the regulatory requirements of herbal products internationally, besides the issues of availability of herbs and their conservation. These are hindering the international trade and growth of the herbal products segment. PMID:26681886

  6. 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)

  7. 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

  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. REMIT5.1, Radiation exposure monitoring and information transmittal system

    International Nuclear Information System (INIS)

    2007-01-01

    1 - Description of program or function - The Radiation Exposure Monitoring and Information Transmittal (REMIT) is a PC-based menu driven system that facilitates the manipulation of data base files to record and report radiation exposure information. REMIT is designed to be user-friendly and contains the full text of Regulatory Guide 8.7, Rev.1, on-line as well as context-sensitive help throughout the program. The user can enter data directly from NRC Forms 4 or 5. REMIT allows the user to view the individual's exposure in relation to regulatory or administrative limits and will alert the user to exposures in excess of these limits. The system also provides for the calculation and summation of dose from intakes and the determination of the dose to the maximally exposed extremity for the monitoring year. REMIT can produce NRC Forms 4 and 5 in paper and electronic format and can import/export data from ASCII and data base files. Additional information is available from the web page www.reirs.com. REMIT system is designed to assist U.S. Nuclear Regulatory Commission (NRC) licensees in meeting the reporting requirements of the Revised 10 CFR Parts 20.1001 through 20.2401 as outlined in Regulatory Guide 8.7, Rev.1, Instructions for Recording and Reporting Occupational Exposure Data. 2 - Methods - REMIT makes use of the dose conversion factors from EPA Report 11 Limiting Values of Radionuclide Intake and Air Concentration and Dose Conversion Factors for Inhalation, Submission, and Ingestion, to calculate the Committed Dose Equivalent to the maximally exposed organ and the Committed Effective Dose Equivalent from intakes measured in microcuries. REMIT also estimates the amount (in micrograms) of uranium intake from the activity entered in microcuries. This calculation is based on the specific activities of the uranium isotopes. 3 - Restrictions on the complexity of the problem - None noted

  10. 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.

  11. 17 CFR 201.420 - Appeal of determinations by self-regulatory organizations.

    Science.gov (United States)

    2010-04-01

    ... self-regulatory organizations. 201.420 Section 201.420 Commodity and Securities Exchanges SECURITIES... Review § 201.420 Appeal of determinations by self-regulatory organizations. (a) Application for review... by a self-regulatory organization determination as to which a notice is required to be filed with the...

  12. Regulatory Oversight of Safety Culture in Nuclear Installations

    International Nuclear Information System (INIS)

    2013-03-01

    Experience across the international nuclear industry and in other technical fields over the past few decades has demonstrated the importance of a healthy safety culture in maintaining the safety of workers, the public and the environment. Both regulators and the nuclear industry recognize the need for licensees to develop a strong safety culture in order to support successful and sustainable nuclear safety performance. Progress over recent years can be observed in the rapid development of approaches to overseeing licensees' safety culture. This publication follows on and complements earlier publications on safety culture, from the publication Safety Culture (Safety Series No. 75-INSAG-4 (1991)), published after the Chernobyl accident, to the more recently published Safety Requirements on The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3 (2006)), which states that the management system is to be used to promote and support a strong safety culture. A number of attempts have been made at both the international and national levels to establish practical approaches to regulatory oversight of safety culture. During 2010 and 2011, two projects were conducted by the IAEA under the scope of the Safe Nuclear Energy - Regional Excellence Programme within the Norwegian Cooperation Programme with Bulgaria and Romania. These projects were implemented at the Bulgarian and Romanian regulatory bodies. They encompassed the development of a specific process to oversee licensees' safety culture, and involved 30 experts from 17 countries and 22 organizations. The IAEA continues to support Member States in the area of safety culture through its projects on safety management and capacity building. This publication addresses the basics of regulatory oversight of safety culture, describes the approaches currently implemented at several regulatory bodies around the world and, based on these examples, proposes a path to developing such a process

  13. 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.

  14. Analytical Chemistry in the Regulatory Science of Medical Devices.

    Science.gov (United States)

    Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

    2018-06-12

    In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections.

  15. Monitoring and operation system for severe accidents

    International Nuclear Information System (INIS)

    Fukui, Toshiki; Niida, Shinji; Kato, Yumeto

    2017-01-01

    Monitoring and operation system for Severe Accidents (SA-MOS) is a compact Instrumentation and Control (I and C) system developed by Mitsubishi Heavy Industries (MHI) and certificated by the Japanese Nuclear Regulatory Agency (NRA) as a design application for Japanese existing PWR nuclear power plants. The system is tailored to provide monitoring and operation for Severe Accident (SA) conditions, and consists of digitalized I and C System, Human Systems Interface (HSI) system and Power Supply (PS) system as further improvement of reliability and safety. This design plans to be applied to the next Japanese PWR plants. In accordance with the new regulatory standards that NRA has established corresponding to the Fukushima accident, a long-term Station Black Out (SBO) scenario and 24-hours power supply by the storage battery in case of SA has been required. In order to address 24-hours power supply requirement in SA condition, the storage battery volume shall be increased. However, it may be difficult to introduce additional batteries to the existing plant site because of room space constraints, etc. Therefore, power distributions for the facilities which are only used for Design Basis Accident (DBA), are shut down in order to secure 24-hours operations of facilities for SA conditions including SA-MOS. That enables efficient battery resource operations as well as optimizes room space factors shared by battery cabinets. Another benefit is to introduce dedicate HSI system for SA condition and operators shift their operations using that dedicated HSI system to cope with SA events. That can reduce operator workload which forces operators to verify or choose which controllers and indicators are available in SA conditions. Furthermore, application of SA-MOS, secures the independence of the layers (DBA⇔SA) as well as secures the plant data transfer for SA conditions outside of plant. Those plant data assets can be shared by plant operation supporting personnel and

  16. Monitoring the performance of off-site processors

    International Nuclear Information System (INIS)

    Miller, C.C.

    1995-01-01

    Commercial nuclear power plants have been able to utilize the latest technologies and achieve large volume reduction by obtaining off-site waste processor services. Although the use of such services reduce the burden of waste processing it also reduces the utility's control over the process. Monitoring the performance of off-site processors is important so that the utility is cognizant of the waste disposition for required regulatory reporting. In addition to obtaining data for Reg Guide 1.21 reporting, Performance monitoring is important to determine which vendor and which services to utilize. Off-site processor services were initially offered for the decontamination of metallic waste. Since that time the list of services has expanded to include supercompaction, survey for release, incineration and metal melting. The number of vendors offering off-site services has increased and the services they offer vary. processing rates vary between vendors and have different charge bases. Determining which vendor to use for what service can be complicated and confusing

  17. 1985 environmental monitoring report

    Energy Technology Data Exchange (ETDEWEB)

    Day, L.E.; Miltenberger, R.P.; Naidu, J.R. (eds.)

    1986-04-01

    The environmental monitoring program is designed to determine that BNL facilities operate such that the applicable environmental standards and effluent control requirements have been met. The data were evaluated using the appropriate environmental regulatory criteria. The environmental levels of radioactivity and other pollutants found in the vicinity of BNL during 1985 are summarized in this report. Detailed data are not included in the main body of the report, but are tabulated and presented in Appendix D. The environmental data include external radiation levels; radioactive air particulates; tritium concentrations; the amounts and concentrations of radioactivity in and the water quality of the stream into which liquid effluents are released; the water quality of the potable supply wells; the concentrations of radioactivity in biota from the stream; the concentrations of radioactivity in and the water quality of ground waters underlying the Laboratoy; concentrations of radioactivity in milk samples obtained in the vicinity of the Laboratory; and the 1984 strontium-90 data which was not available for inclusion in the 1984 Environmental Monitoring Report. In 1985, the results of the surveillance program demonstraed that the Laboratory has operated within the applicable environmental standards.

  18. 47 CFR 1.1159 - Filing locations and receipts for regulatory fees.

    Science.gov (United States)

    2010-10-01

    ... fees. 1.1159 Section 1.1159 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL PRACTICE AND... for regulatory fees. (a) Regulatory fee payments must be directed to the location and address set forth in §§ 1.1152 through 1.1156 for the specific category of fee involved. Any regulatory fee required...

  19. Development of Checklist for Self-Assessment of Regulatory Capture in Nuclear Safety Regulation

    International Nuclear Information System (INIS)

    Choi, K. S.; Lee, Y. E.; Chang, H. S.; Jung, S. J.

    2011-01-01

    Regulatory body performs its mission on behalf of the general public. As for nuclear industries, the public delegates the authority to the regulatory body for monitoring the safety in nuclear facilities and for ensuring that it is maintained in the socially and globally acceptable level. However, when the situation that a regulatory body behaves in the interests of industries happens, not working primarily for protecting public health and safety on behalf of the public, it is charged that regulatory body acts as an encouragement for industries which produce negative externalities such as radiation risk or radiation hazards. In this case, the regulatory body is called as 'Captured' or it is called that 'Regulatory Capture' happened. Regulatory capture is important as it may cause regulatory failure, one form of government failure, which is very serious phenomenon: severe nuclear accident at Fukushima nuclear power plants recently occurred in March, 2011. This paper aims to introduce the concept of regulatory capture into nuclear industry field through the literature survey, and suggest the sample checklist developed for self-assessment on the degree of regulatory capture within regulatory body

  20. Regulatory Risk Management of Advanced Nuclear Power Plants

    International Nuclear Information System (INIS)

    George, Glenn R.

    2002-01-01

    Regulatory risk reflects both the likelihood of adverse outcomes during regulatory interactions and the severity of those outcomes. In the arena of advanced nuclear power plant licensing and construction, such adverse outcomes may include, for example, required design changes and construction delays. These, in turn, could significantly affect the economics of the plant and the generation portfolio in which it will operate. In this paper, the author addresses these issues through the lens of risk management. The paper considers various tools and techniques of regulatory risk management, including design diversity and hedging strategies. The effectiveness of alternate approaches is weighed and recommendations are made in several regulatory contexts. (author)

  1. Radiation monitoring systems: current status and future prospects

    International Nuclear Information System (INIS)

    McArthur, W.C.; Kniazewycz, B.G.

    1978-01-01

    The Radiation Monitoring System (RMS) in a nuclear power plant is used for assessing radiological impact of plant operation. A classical RMS consists of several types of radiation detectors strategically placed about a nuclear plant to ensure the safety of operating personnel and the surrounding environment. It serves in conjunction with, and as a backup to, a comprehensive sampling program to quantitatively evaluate process systems and effluent activity levels. The development of the computerized and digitalized RMS is reviewed with emphasis upon its added capability and flexibility. The potential future requirements for the RMS, as a result of regulatory criteria development, is briefly discussed

  2. 1988 Monitoring Activities Review (MAR) of the environmental monitoring program

    International Nuclear Information System (INIS)

    1989-03-01

    The EGandG Idaho Environmental Monitoring (EM) Unit is responsible for coordinating and conducting environmental measurements of radioactive and hazardous contaminants around facilities operated by EGandG Idaho. The EM Unit has several broad program objectives, which include complying with regulatory standards and developing a basis for estimating future impacts of operations at EGandG Idaho facilities. To improve program planning and to provide bases for technical improvement of the monitoring program, the EGandG Environmental Monitoring organization has regularly used the Monitoring Activities Review (MAR) process since 1982. Each MAR is conducted by a committee of individuals selected for their experience in the various types of monitoring performed by the EM organization. Previous MAR studies have focused on procedures for all currently monitored media except biota. Biotic monitoring was initiated following the last MAR. This report focuses on all currently monitored media, and includes the first review of biotic monitoring. The review of biotic monitoring has been conducted at a level of detail consistent with initial MAR reports for other parts of the Waste Management Program Facilities Environmental Monitoring Program. The review of the biotic monitoring activities is presented in Section 5.5 of this report. 21 refs., 7 figs., 4 tabs

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

    Science.gov (United States)

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

    2013-06-01

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

  4. Revised ground-water monitoring compliance plan for the 183-H Solar Evaporation Basins

    International Nuclear Information System (INIS)

    1986-09-01

    This document contains ground-water monitoring plans for a mixed waste storage facility located on the Hanford Site in southeastern Washington State. This facility has been used since 1973 for storage of mixed wastes, which contain both chemicals and radionuclides. The ground-water monitoring plans presented here represent revision and expansion of an effort in June 1985. At that time, a facility-specific monitoring program was implemented at the 183-H Basins as part of the regulatory compliance effort being conducted on the Hanford Site. This monitoring program was based on the ground-water monitoring requirements for interimstatus facilities, which are those facilities that do not yet have final permits, but are authorized to continue interim operations while engaged in the permitting process. The program initially implemented for the 183-H Basins was designed to be an alternate program, which is required instead of the standard detection program when a facility is known or suspected to have contaminated the ground water in the uppermost aquifer. This effort, named the RCRA Compliance Ground-Water Monitoring Project for the 183-H Basins, was implemented. A supporting project involving ground-water flow modeling for the area surrounding the 183-H Basins was also initiated during 1985. Those efforts and the results obtained are described in subsequent chapters of this document. 26 refs., 55 figs., 14 tabs

  5. Cost-benefit considerations in regulatory decision-making

    International Nuclear Information System (INIS)

    Harvie, J.D.

    1996-01-01

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

  6. Impact of regulatory science on global public health

    Directory of Open Access Journals (Sweden)

    Meghal Patel

    2012-07-01

    Full Text Available Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

  7. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

    Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies. Copyright © 2012. Published by Elsevier B.V.

  8. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    Science.gov (United States)

    Galli, Maria Cristina

    2016-01-01

    This chapter discusses European regulatory requirements for development of advanced therapy medicinal products (ATMP) for cancer immunotherapy approaches, describing the framework for clinical trials and for marketing authorization.Regulatory critical issues and challenges for developing ATMP are also discussed, with focus on potency determination, long-term follow-up, comparability, and insertional mutagenesis issues. Some of the most critical features of GMP application to ATMP are also described.

  9. AN ANALYSIS OF TECHNICAL SECURITY CONTROL REQUIREMENTS FOR DIGITAL I&C SYSTEMS IN NUCLEAR POWER PLANTS

    Directory of Open Access Journals (Sweden)

    JAE-GU SONG

    2013-10-01

    Full Text Available Instrumentation and control systems in nuclear power plants have been digitalized for the purpose of maintenance and precise operation. This digitalization, however, brings out issues related to cyber security. In the most recent past, international standard organizations, regulatory institutes, and research institutes have performed a number of studies addressing these systems cyber security. In order to provide information helpful to the system designers in their application of cyber security for the systems, this paper presents methods and considerations to define attack vectors in a target system, to review and select the requirements in the Regulatory Guide 5.71, and to integrate the results to identify applicable technical security control requirements. In this study, attack vectors are analyzed through the vulnerability analyses and penetration tests with a simplified safety system, and the elements of critical digital assets acting as attack vectors are identified. Among the security control requirements listed in Appendices B and C to Regulatory Guide 5.71, those that should be implemented into the systems are selected and classified in groups of technical security control requirements using the results of the attack vector analysis. For the attack vector elements of critical digital assets, all the technical security control requirements are evaluated to determine whether they are applicable and effective, and considerations in this evaluation are also discussed. The technical security control requirements in three important categories of access control, monitoring and logging, and encryption are derived and grouped according to the elements of attack vectors as results for the sample safety system.

  10. Regulatory aspects of NPP safety

    International Nuclear Information System (INIS)

    Kastchiev, G.

    1999-01-01

    Extensive review of the NPP Safety is presented including tasks of Ministry of Health, Ministry of Internal Affairs, Ministry of Environment and Waters, Ministry of Defense in the field of national system for monitoring the nuclear power. In the frame of national nuclear safety legislation Bulgaria is in the process of approximation of the national legislation to that of EC. Detailed analysis of the status of regulatory body, its functions, organisation structure, responsibilities and future tasks is included. Basis for establishing the system of regulatory inspections and safety enforcement as well as intensification of inspections is described. Assessment of safety modifications is concerned with complex program for reconstruction of Units 1-4 of Kozloduy NPP, as well as for modernisation of Units 5 and 6. Qualification and licensing of the NPP personnel, Year 2000 problem, priorities and the need of international assistance are mentioned

  11. 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...

  12. Comparison of remote sensing and fixed-site monitoring approaches for examining air pollution and health in a national study population

    Science.gov (United States)

    Prud'homme, Genevieve; Dobbin, Nina A.; Sun, Liu; Burnett, Richard T.; Martin, Randall V.; Davidson, Andrew; Cakmak, Sabit; Villeneuve, Paul J.; Lamsal, Lok N.; van Donkelaar, Aaron; Peters, Paul A.; Johnson, Markey

    2013-12-01

    Satellite remote sensing (RS) has emerged as a cutting edge approach for estimating ground level ambient air pollution. Previous studies have reported a high correlation between ground level PM2.5 and NO2 estimated by RS and measurements collected at regulatory monitoring sites. The current study examined associations between air pollution and adverse respiratory and allergic health outcomes using multi-year averages of NO2 and PM2.5 from RS and from regulatory monitoring. RS estimates were derived using satellite measurements from OMI, MODIS, and MISR instruments. Regulatory monitoring data were obtained from Canada's National Air Pollution Surveillance Network. Self-reported prevalence of doctor-diagnosed asthma, current asthma, allergies, and chronic bronchitis were obtained from the Canadian Community Health Survey (a national sample of individuals 12 years of age and older). Multi-year ambient pollutant averages were assigned to each study participant based on their six digit postal code at the time of health survey, and were used as a marker for long-term exposure to air pollution. RS derived estimates of NO2 and PM2.5 were associated with 6-10% increases in respiratory and allergic health outcomes per interquartile range (3.97 μg m-3 for PM2.5 and 1.03 ppb for NO2) among adults (aged 20-64) in the national study population. Risk estimates for air pollution and respiratory/allergic health outcomes based on RS were similar to risk estimates based on regulatory monitoring for areas where regulatory monitoring data were available (within 40 km of a regulatory monitoring station). RS derived estimates of air pollution were also associated with adverse health outcomes among participants residing outside the catchment area of the regulatory monitoring network (p health among participants living outside the catchment area for regulatory monitoring suggest that RS can provide useful estimates of long-term ambient air pollution in epidemiologic studies. This is

  13. Ground-water monitoring under RCRA

    International Nuclear Information System (INIS)

    Coalgate, J.

    1993-11-01

    In developing a regulatory strategy for the disposal of hazardous waste under the Resource Conservation and Recovery Act (RCRA), protection of ground-water resources was the primary goal of the Environmental Protection Agency (EPA). EPA's ground-water protection strategy seeks to minimize the potential for hazardous wastes and hazardous constituents in waste placed in land disposel units to migrate into the environment. This is achieved through liquids management (limiting the placement of liquid wastes in or on the land, requiring the use of liners beneath waste, installing leachate collection systems and run-on and run-off controls, and covering wastes at closure). Ground-water monitoring serves to detect any failure in EPA's liquids management strategy so that ground-water contamination can be detected and addressed as soon as possible

  14. 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.

  15. Optimizing liquid effluent monitoring at a large nuclear complex.

    Science.gov (United States)

    Chou, Charissa J; Barnett, D Brent; Johnson, Vernon G; Olson, Phil M

    2003-12-01

    Effluent monitoring typically requires a large number of analytes and samples during the initial or startup phase of a facility. Once a baseline is established, the analyte list and sampling frequency may be reduced. Although there is a large body of literature relevant to the initial design, few, if any, published papers exist on updating established effluent monitoring programs. This paper statistically evaluates four years of baseline data to optimize the liquid effluent monitoring efficiency of a centralized waste treatment and disposal facility at a large defense nuclear complex. Specific objectives were to: (1) assess temporal variability in analyte concentrations, (2) determine operational factors contributing to waste stream variability, (3) assess the probability of exceeding permit limits, and (4) streamline the sampling and analysis regime. Results indicated that the probability of exceeding permit limits was one in a million under normal facility operating conditions, sampling frequency could be reduced, and several analytes could be eliminated. Furthermore, indicators such as gross alpha and gross beta measurements could be used in lieu of more expensive specific isotopic analyses (radium, cesium-137, and strontium-90) for routine monitoring. Study results were used by the state regulatory agency to modify monitoring requirements for a new discharge permit, resulting in an annual cost savings of US dollars 223,000. This case study demonstrates that statistical evaluation of effluent contaminant variability coupled with process knowledge can help plant managers and regulators streamline analyte lists and sampling frequencies based on detection history and environmental risk.

  16. Regulatory control and challenges in Medical facilities using ionising radiation sources

    International Nuclear Information System (INIS)

    Agarwal, S.P.

    2008-01-01

    Medical facilities utilising ionising radiation sources for diagnostic and treatment of cancer are regulated under the provisions of Atomic Energy (Radiation Protection) Rules, 2004 promulgated under the Atomic Energy Act 1962. The Competent Authority for the enforcement of the rules is Chairman, Atomic Energy Regulatory Board (AERB). Practice specific codes are issued by AERB for medical facilities such as Radiotherapy, Nuclear Medicine and Radiology. Regulatory process for control of medical facilities covers the entire life cycle of the radiation sources in three stages viz pre-Iicensing, during useful life and decommissioning and disposal. Pre-Iicensing requirements include use of type approved sources and equipment, approval of design layout of the facility and installation, exclusive (safe and secure) source storage facility when the equipment is not in use, radiation (area/individual) monitoring devices, qualified, trained and certified manpower, emergency response plans and commitment from the licensee for the safe disposal of disused/decayed sources. Compliance to these requirements makes the applicant eligible to obtain license from AERB for the operation of the medical facility. During the use of radiation sources, specific prior approval of the Competent Authority is required in respect of every source replacement, sale, transfer, transport, import and export. Further, all licensees are required to send the periodic safety Status reports to AERB as well as reporting of any off normal events. AERB conducts inspection of the facilities to ensure compliance with the safety requirements during operation of the facility. Violation of safety norms by licensee attracts enforcement action which includes suspension, modification or withdrawal of licensee for operation of the facility. Upon completion of the useful life of the source, the licensee decommissions the facility and returns the source to the original supplier. For returning the source, prior

  17. Licensing and regulatory control of nuclear power plants in Canada

    International Nuclear Information System (INIS)

    Atchison, R.J.

    1975-01-01

    The paper discusses the safety philosophy adopted in Canada, the safety criteria and regulatory requirements necessary for the application of this philosophy to reactor design and operation, and finally the means by which compliance with Board requirements is effected. It is emphasized that the effectiveness of regulatory control depends not only on the underlying philosophy but also on the detailed way in which it is applied. (orig./HP) [de

  18. Regulatory issues of digital instrumentation and control system in Lungmen project

    International Nuclear Information System (INIS)

    Chuang, C.F.; Chou, H.P.

    2004-01-01

    The Lungmen Nuclear Power Station (LNPS) is currently under construction in Taiwan, which consists of 2 advanced boiling water reactor (ABWR) units. The instrumentation and control (IC) systems of the LNPS are based on the state-of-the-art modernized fully integrated digital design. These IC systems possess many advantages and distinguished features comparing to traditional analog IC systems, they enjoy set-point stability, self-diagnostic and automatic testing ability, fault tolerance and avoidance, low power requirements, data handling and storage capability, as well as enhanced human-machine interfaces. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital IC systems in the Lungmen Project

  19. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

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

  20. Regulatory issues for nuclear power plant life management

    International Nuclear Information System (INIS)

    Roe, J.

    2000-01-01

    The workshop of 26-27 june 2000, on nuclear power Plant LIfe Management (PLIM), also included working groups in which major issues facing PLIM activities for nuclear power plants were identified and discussed. The second group was on Regulation. The Regulatory Working Group will attempt to identify some of the more pertinent issues affecting nuclear plant regulation in a changing PLIM environment, to identify some possible actions to be taken to address these issues, and to identify some of the parties responsible for taking these actions. Some preliminary regulatory issues are noted below. This is not intended to be a comprehensive list of such issues but rather is intended to stimulate discussion among the experts attending this Workshop. One of the concerns in the regulatory arena is how the structural integrity of the plants can be assured for an extended lifetime. Technological advances directed toward the following are likely to be important factors in the regulatory process of life extension. - Preventive and corrective maintenance (e.g., water chemistry control, pressure vessel annealing, and replacement of core internals). - Ageing and degradation mechanisms and evaluation (e.g., embrittlement, wear, corrosion/erosion, fatigue, and stress corrosion). - Monitoring, surveillance, and inspection (e.g., fatigue monitoring and non-destructive testing). - Optimisation of maintenance (e.g., using risk-based analysis). On the business side, there is concern about technical support by manufacturers, fuel companies, and construction companies. Maintaining a strong technical base and skilled workers in a potentially declining environment is another concern in the regulatory community. Waste management and decommissioning remain significant issue regarding PLIM. These issues affect all three areas of concern - technology, business, and regulation. It is against this background, that the issues put forth in this paper are presented. The objective of presenting these