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Sample records for regulatory guidance document

  1. 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

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

    Science.gov (United States)

    2011-01-04

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

  4. Codes and standards and other guidance cited in regulatory documents

    International Nuclear Information System (INIS)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800)

  5. Codes and standards and other guidance cited in regulatory documents

    Energy Technology Data Exchange (ETDEWEB)

    Nickolaus, J.R.; Bohlander, K.L.

    1996-08-01

    As part of the U.S. Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program (SRP-UDP), Pacific Northwest National Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. The SRP-UDP has been completed and the SRP-Maintenance Program (SRP-MP) is now maintaining this listing. Besides updating previous information, Revision 3 adds approximately 80 citations. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Enforcement Manual, Generic Letters, Inspection Manual, Policy Statements, Regulatory Guides, Standard Technical Specifications and the Standard Review Plan (NUREG-0800).

  6. Nuclear Regulatory Commission staff approaches to improving the integration of regulatory guidance documents and prelicensing reviews

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-01-01

    The Nuclear Regulatory Commission staff is conducting numerous activities to improve the integration of its regulatory guidance documents (i.e., License Application Review Plan (LARP) and open-quotes Format and Content for the License Application for the High-Level Waste repositoryclose quotes (FCRG)) and pre-license application (LA) reviews. Those activities related to the regulatory guidance documents consist of: (1) developing an hierarchy of example evaluation findings for LARP; (2) identifying LARP review plan interfaces; (3) conducting an integration review of LARP review strategies; (4) correlating LARP to the ongoing technical program; and (5) revising the FCRG. Some of the more important strategies the staff is using to improve the integration of pre-LA reviews with the LA review include: (1) use of the draft LARP to guide the staff's pre-LA reviews; (2) focus detailed pre-LA reviews on key technical uncertainties; (3) identify and track concerns with DOE's program; and (4) use results of pre-LA reviews in LA reviews. The purpose of this paper is to describe these ongoing activities and strategies and discuss some of the new work that is planned to be included in LARP Revision 1 and the final FCRG, which are scheduled to be issued in late 1994. These activities reflect both the importance the staff has placed on integration and the staff's approach to improving integration in these areas. The staff anticipates that the results of these activities, when incorporated in the FCRG, LARP, and pre-LA reviews, will improve its guidance for DOE's ongoing site characterization program and LA annotated outline development

  7. Codes and standards and other guidance cited in regulatory documents. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R. [Pacific Northwest Lab., Richland, WA (United States)

    1994-08-01

    As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC`s Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800).

  8. Codes and standards and other guidance cited in regulatory documents. Revision 1

    International Nuclear Information System (INIS)

    Ankrum, A.; Nickolaus, J.; Vinther, R.; Maguire-Moffitt, N.; Hammer, J.; Sherfey, L.; Warner, R.

    1994-08-01

    As part of the US Nuclear Regulatory Commission (NRC) Standard Review Plan Update and Development Program, Pacific Northwest Laboratory developed a listing of industry consensus codes and standards and other government and industry guidance referred to in regulatory documents. In addition to updating previous information, Revision 1 adds citations from the NRC Inspection Manual and the Improved Standard Technical Specifications. This listing identifies the version of the code or standard cited in the regulatory document, the regulatory document, and the current version of the code or standard. It also provides a summary characterization of the nature of the citation. This listing was developed from electronic searches of the Code of Federal Regulations and the NRC's Bulletins, Information Notices, Circulars, Generic Letters, Policy Statements, Regulatory Guides, and the Standard Review Plan (NUREG-0800)

  9. Environmental guidance regulatory bulletin

    International Nuclear Information System (INIS)

    1997-01-01

    This document describes the background on expanding public participation in the Resource Conservation and Recovery Act and DOE's response. The bulletin also describes the changes made by the final rule to existing regulations, guidance provided by EPA in the preamble and in the revised RCRA Public Participation Manual, the relationship between public participation and environmental justice, and DOE's recent public participation and environmental justice initiatives

  10. Regulatory guidance for license renewal

    International Nuclear Information System (INIS)

    Thoma, John A.

    1991-01-01

    The proposed 10 CFR Part 54 rule proceduralizes the process for license renewal by identifying both the administrative and technical requirements for a renewal application. To amplify and support this regulation, written guidance has been provided in the form of a draft Regulatory Guide (DG 1009) and a draft Standard Review Plan for License Renewal (NUREG 1299). This guidance is scheduled to be finalized in 1992. Similar guidance will be provided for the proposed revisions to 10 CFR Part 51 concerning the environmental aspects of license renewal. (author)

  11. 21 CFR 601.29 - Guidance documents.

    Science.gov (United States)

    2010-04-01

    ... Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, Food and Drug Administration... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Guidance documents. 601.29 Section 601.29 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS...

  12. 21 CFR 312.145 - Guidance documents.

    Science.gov (United States)

    2010-04-01

    ... of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New... Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. [65 FR... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Guidance documents. 312.145 Section 312.145 Food...

  13. USNRC regulatory guidance for engineered safety feature air cleaning systems

    International Nuclear Information System (INIS)

    Bellamy, R.R.

    1991-01-01

    The need for clear, technically appropriate, and easily implementable guidance for the design, testing, and maintenance of nuclear air cleaning systems has long been recognized. Numerous industry consensus standards have been issued and revised over the last 30 years. Guidance has also been published by the US Nuclear Regulatory Commission in the form of regulations, regulatory guides, standard review plans, NUREG documents, and information notices. This paper will summarize the latest revisions to these documents and emphasize Regulatory Guide 1.52, Design, Testing, and Maintenance Criteria for Post-Accident Engineered-Safety-Feature Atmosphere Cleanup System Air Filtration and Adsorption Units of Light-Water-Cooled Nuclear Power Plants, which was last revised in 1978. The USNRC has undertaken a project to revise this regulatory guide, and the status of that revision is highlighted

  14. Environmental restoration value engineering guidance document

    International Nuclear Information System (INIS)

    1995-07-01

    This document provides guidance on Value Engineering (VE). VE is an organized team effort led by a person trained in the methodology to analyze the functions of projects, systems, equipment, facilities, services, and processes for achieving the essential functions at the lowest life cycle cost while maintaining required performance, reliability, availability, quality, and safety. VE has proven to be a superior tool to improve up-front project planning, cut costs, and create a better value for each dollar spent. This document forms the basis for the Environmental Restoration VE Program, describes the VE process, and provides recommendations on when it can be most useful on ER projects

  15. Guidance documents relating to landfills and contaminants

    Energy Technology Data Exchange (ETDEWEB)

    Schomaker, N.B.; Zunt, D.A.

    1990-01-01

    The Environmental Protection Agency is developing and updating a series of Technical Guidance Documents to provide best engineering control technology to meet the needs of the Resource Conservation and Recovery Act (RCRA) and the Comprehensive Environmental Response Compensation and Liability Act (CERCLA), respectively. These documents are the compilation of the research efforts to date relating to containment of pollutants from waste disposal to the land as relates to residuals management. The specific areas of research being conducted under the RCRA land disposal program relates to laboratory, pilot and field validation studies in cover systems, waste leaching and solidification, liner systems and disposal facility evaluation. The specific areas of research being conducted under the CERCLA uncontrolled waste sites (Superfund) program relate to in situ treatment, solidification/stabilization for treating hazardous waste, combustion technologies, best demonstrated available technology (BDAT), on-site treatment technologies, emerging biosystems, expert systems, personnel health protection equipment, and site and situation assessment. The Guidance Documents are intended to assist both the regulated community and the permitting authorities, as well as the Program Offices, and Regions, as well as the states and other interested parties, with the latest information relevant to waste management.

  16. The development of AECB regulatory documents

    International Nuclear Information System (INIS)

    Joyce, M.

    1981-01-01

    This document describes the Atomic Energy Control Board's (AECB) approach to the development and preparation of regulatory documents. The principal factors that have shaped the AECB'a regulatory approach are identified as background to the evolution of regulatory documents as are a number of current influences that affect the present and future development of these documents. Also described are the process by which regulatory documents are prepared and published and the points of contact between this process and the Canadian Standards Association program for nuclear standards. (author)

  17. 76 FR 1173 - Draft Guidance for Industry on Electronic Source Documentation in Clinical Investigations...

    Science.gov (United States)

    2011-01-07

    ... Web page at http://www.fda.gov/RegulatoryInformation/Guidances/default.htm . FDA guidances are issued and updated regularly. We recommend you check the Web site to ensure that you have the most up-to-date... electronic diaries provided by study subjects. When paper source documents are available for review, tracing...

  18. 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

  19. 78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-07-01

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

  20. Improvements in inservice testing regulatory guidance

    Energy Technology Data Exchange (ETDEWEB)

    Campbell, P.L.

    1996-12-01

    Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees` efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST.

  1. Improvements in inservice testing regulatory guidance

    International Nuclear Information System (INIS)

    Campbell, P.L.

    1996-01-01

    Over the last few years, the NRC has issued guidance to licensees toward improving the quality of requests for relief or alternatives to the code requirements and bring some measure of consistency to the implementation of the code requirements. Based on the majority of the recent submittals, the overall quality has improved. If all of the steps in the internal process for responding to the requests are timely, the review of an updated program can be completed in six to nine months. When a single or only a few requests are submitted, the staff is generally able to complete an evaluation in less than three months. When schedules are related to outages or exigent circumstances, the NRC responds accordingly. The improvements in schedules can be attributed to publication of staff guideline documents, licensees' efforts in preparing more complete descriptions and justification and an increase in the number of NRC technical staff reviewers assigned to IST

  2. 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

  3. 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

    Improving communication of NRU's requirements is the subject of this study. This summary is organized in terms of four decisions on whether safeguards regulatory documents as communication instruments should be an explicit NRC program, what communication methods should be focused on, what actions are feasible and desirable, and how should the NRC divide its effort and resources among desirable actions

  4. Guidance and Control Software Project Data - Volume 2: Development Documents

    Science.gov (United States)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the development documents from the GCS project. Volume 2 contains three appendices: A. Guidance and Control Software Development Specification; B. Design Description for the Pluto Implementation of the Guidance and Control Software; and C. Source Code for the Pluto Implementation of the Guidance and Control Software

  5. Guidance and Control Software Project Data - Volume 1: Planning Documents

    Science.gov (United States)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the planning documents from the GCS project. Volume 1 contains five appendices: A. Plan for Software Aspects of Certification for the Guidance and Control Software Project; B. Software Development Standards for the Guidance and Control Software Project; C. Software Verification Plan for the Guidance and Control Software Project; D. Software Configuration Management Plan for the Guidance and Control Software Project; and E. Software Quality Assurance Activities.

  6. Guidance and Control Software Project Data - Volume 3: Verification Documents

    Science.gov (United States)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes the verification documents from the GCS project. Volume 3 contains four appendices: A. Software Verification Cases and Procedures for the Guidance and Control Software Project; B. Software Verification Results for the Pluto Implementation of the Guidance and Control Software; C. Review Records for the Pluto Implementation of the Guidance and Control Software; and D. Test Results Logs for the Pluto Implementation of the Guidance and Control Software.

  7. Laboratory Biosafety and Biosecurity Risk Assessment Technical Guidance Document

    Energy Technology Data Exchange (ETDEWEB)

    Astuto-Gribble, Lisa M; Caskey, Susan Adele

    2014-07-01

    The purpose of this document is threefold: 1) to describe the laboratory bio safety and biosecurity risk assessment process and its conceptual framework; 2) provide detailed guidance and suggested methodologies on how to conduct a risk assessment; and 3) present some practical risk assessment process strategies using realistic laboratory scenarios.

  8. Regulatory Guidance for Lightning Protection in Nuclear Power Plants

    International Nuclear Information System (INIS)

    Kisner, Roger A.; Wilgen, John B.; Ewing, Paul D.; Korsah, Kofi; Antonescu, Christina E.

    2006-01-01

    Oak Ridge National Laboratory (ORNL) was engaged by the U.S. Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) to develop the technical basis for regulatory guidance to address design and implementation practices for lightning protection systems in nuclear power plants (NPPs). Lightning protection is becoming increasingly important with the advent of digital and low-voltage analog systems in NPPs. These systems have the potential to be more vulnerable than older analog systems to the resulting power surges and electromagnetic interference (EMI) when lightning strikes facilities or power lines. This paper discusses the technical basis for guidance to licensees and applicants covered in Regulatory Guide (RG) 1.204, Guidelines for Lightning Protection of Nuclear Power Plants, issued August 2005. RG 1.204 describes guidance for practices that are acceptable to the NRC staff for protecting nuclear power structures and systems from direct lightning strikes and the resulting secondary effects.

  9. Probabilistic risk assessment (PRA): status report and guidance for regulatory application. Draft report for comment

    International Nuclear Information System (INIS)

    1984-02-01

    This document describes the current status of the methodologies used in probabilistic risk assessment (PRA) and provides guidance for the application of the results of PRAs to the nuclear reactor regulatory process. The PRA studies that have been completed or are underway are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed

  10. Studying Wind Energy/Bird Interactions: A Guidance Document

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, R. [California Energy Commission (US); Morrison, M. [California State Univ., Sacramento, CA (US); Sinclair, K. [Dept. of Energy/National Renewable Energy Lab. (US); Strickland, D. [WEST, Inc. (US)

    1999-12-01

    This guidance document is a product of the Avian Subcommittee of the National Wind Coordinating Committee (NWCC). The NWCC was formed to better understand and promote responsible, credible, and comparable avian/wind energy interaction studies. Bird mortality is a concern and wind power is a potential clean and green source of electricity, making study of wind energy/bird interactions essential. This document provides an overview for regulators and stakeholders concerned with wind energy/bird interactions, as well as a more technical discussion of the basic concepts and tools for studying such interactions.

  11. Draft Updates to the Planning for Natural Disaster Debris Guidance and to Related Documents

    Science.gov (United States)

    EPA is requesting comment on the draft update of the Planning for Natural Disaster Debris Guidance, along with two other documents. This Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

  12. Guidance document for preparing water sampling and analysis plans for UMTRA Project sites. Revision 1

    International Nuclear Information System (INIS)

    1995-09-01

    A water sampling and analysis plan (WSAP) is prepared for each Uranium Mill Tailings Remedial Action (UMTRA) Project site to provide the rationale for routine ground water sampling at disposal sites and former processing sites. The WSAP identifies and justifies the sampling locations, analytical parameters, detection limits, and sampling frequency for the routine ground water monitoring stations at each site. This guidance document has been prepared by the Technical Assistance Contractor (TAC) for the US Department of Energy (DOE). Its purpose is to provide a consistent technical approach for sampling and monitoring activities performed under the WSAP and to provide a consistent format for the WSAP documents. It is designed for use by the TAC in preparing WSAPs and by the DOE, US Nuclear Regulatory Commission, state and tribal agencies, other regulatory agencies, and the public in evaluating the content of WSAPS

  13. Improving nuclear regulation. Compilation of Nea regulatory guidance booklets

    International Nuclear Information System (INIS)

    2009-01-01

    A common theme throughout the series of NEA regulatory guidance reports, or 'green booklets', is the premise that the fundamental objective of all nuclear safety regulatory bodies is to ensure that nuclear facilities are operated at all times and later decommissioned in an acceptably safe manner. In meeting this objective the regulator must keep in mind that it is the operator that has responsibility for safely operating a nuclear facility; the role of the regulator is to oversee the operator's activities as related to assuming that responsibility. For the first time, the full series of these reports have been brought together in one edition. As such, it is intended to serve as a knowledge management tool both for current regulators and the younger generation of nuclear experts entering the regulatory field. While the audience for this publication is primarily nuclear regulators, the information and ideas may also be of interest to nuclear operators, other nuclear industry organisations and the general public. (author)

  14. 78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-05-09

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

  15. Energy Efficiency/Renewable Energy Programs in State Implementation Plans - Guidance Documents

    Science.gov (United States)

    final document that provides guidance to States and local areas on quantifying and including emission reductions from energy efficiency and renewable energy measures in State Implementation Plans (SIPS).

  16. 78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2013-04-26

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

  17. TECHNICAL GUIDANCE DOCUMENT: CONSTRUCTION QUALITY MANAGEMENT FOR REMEDIAL ACTION AND REMEDIAL DESIGN WASTE CONTAINMENT SYSTEMS

    Science.gov (United States)

    This Technical Guidance Document is intended to augment the numerous construction quality control and construction quality assurance (CQC and CQA) documents that are available far materials associated with waste containment systems developed for Superfund site remediation. In ge...

  18. 78 FR 48175 - Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances

    Science.gov (United States)

    2013-08-07

    ... guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. ``Qualifying for... to the pharmaceutical industry. In most cases, FDA has developed other guidances and resources to... guidances: 1. ``Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients''--issued April 1998...

  19. Preparation of safety and regulatory document for BARC Facilities

    International Nuclear Information System (INIS)

    Prasad, S.S.; Jayarajan, K.

    2017-01-01

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

  20. Comparison of ISO 9000 and recent software life cycle standards to nuclear regulatory review guidance

    International Nuclear Information System (INIS)

    Preckshot, G.G.; Scott, J.A.

    1998-01-01

    Lawrence Livermore National Laboratory is assisting the Nuclear Regulatory Commission with the assessment of certain quality and software life cycle standards to determine whether additional guidance for the U.S. nuclear regulatory context should be derived from the standards. This report describes the nature of the standards and compares the guidance of the standards to that of the recently updated Standard Review Plan

  1. Public Comment Period Open for the Draft Update to the Planning for Natural Disaster Debris Guidance and to Related Documents

    Science.gov (United States)

    EPA is requesting comment on the draft Planning for Natural Disaster Debris Guidance, and two other documents. The Guidance is an update of the Planning for Natural Disaster Debris guidance that EPA published in March 2008.

  2. Technical and Regulatory Guidance Document for Constructed Treatment Wetlands

    Science.gov (United States)

    2003-12-01

    horizon in which organic material is being added. This horizon often has the characteristics of cultivation and other disturbances. Under the A horizon is...intermediate between III and II (commonly called “green rust”) induces the reduction of Se. In the case of Se accumulation, ecotoxicological effects should be...consulted before a constructed wetland system design can be approved, specifically because many restrict the use and cultivation of plant species that

  3. 75 FR 24718 - Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability

    Science.gov (United States)

    2010-05-05

    ...] Guidance for Industry on Documenting Statistical Analysis Programs and Data Files; Availability AGENCY... documenting statistical analyses and data files submitted to the Center for Veterinary Medicine (CVM) for the... on Documenting Statistical Analysis Programs and Data Files; Availability'' giving interested persons...

  4. 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.

  5. 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

  6. Guidance Document on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

    DEFF Research Database (Denmark)

    Satya, Sneha; Wade, Mike; Hass, Ulla

    This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing and Asses......This guidance document was developed as a follow-up to the workshop on OECD countries’ activities regarding testing, assessment and management of endocrine disrupters, which was held in Copenhagen (Denmark) on 22-24 September 2010 (see document No. 118 published in the Series on Testing...... on testing and assessment of endocrine disrupters (EDTA AG). In November 2010, comments were requested from the WNT, the EDTA AG, the Task Force on Hazard Assessment and experts involved in the assessment of chemicals. The EDTA AG addressed the comments from the WNT at a meeting held in April 2011...... the conclusions and next steps recommended in the draft guidance document are sensible and helpful when assessed in light of comprehensive datasets. The draft guidance document and the three case studies were reviewed again and revised at a meeting of the EDTA AG in December 2011. The draft guidance document...

  7. Regulatory commitment management and the managing of licensing documents

    International Nuclear Information System (INIS)

    Roxey, T.E.

    1993-01-01

    The Regulatory Commitment Management (RCM) Project was designed to strengthen Baltimore Gas ampersand Electric's (BG ampersand E's) ability to identify, implement, and maintain regulatory commitments. The first part of this project involved the development of a clear commitment management process. The second part was the development of a tool that enhances the ability to retrieve information from documents, and the third part of the project dealt with the actual identification of historical commitments. This paper represents the first opportunity for BG ampersand E to discuss some of the success of the second part and the preliminary findings of the third part of the project

  8. Guidance and Control Software Project Data - Volume 4: Configuration Management and Quality Assurance Documents

    Science.gov (United States)

    Hayhurst, Kelly J. (Editor)

    2008-01-01

    The Guidance and Control Software (GCS) project was the last in a series of software reliability studies conducted at Langley Research Center between 1977 and 1994. The technical results of the GCS project were recorded after the experiment was completed. Some of the support documentation produced as part of the experiment, however, is serving an unexpected role far beyond its original project context. Some of the software used as part of the GCS project was developed to conform to the RTCA/DO-178B software standard, "Software Considerations in Airborne Systems and Equipment Certification," used in the civil aviation industry. That standard requires extensive documentation throughout the software development life cycle, including plans, software requirements, design and source code, verification cases and results, and configuration management and quality control data. The project documentation that includes this information is open for public scrutiny without the legal or safety implications associated with comparable data from an avionics manufacturer. This public availability has afforded an opportunity to use the GCS project documents for DO-178B training. This report provides a brief overview of the GCS project, describes the 4-volume set of documents and the role they are playing in training, and includes configuration management and quality assurance documents from the GCS project. Volume 4 contains six appendices: A. Software Accomplishment Summary for the Guidance and Control Software Project; B. Software Configuration Index for the Guidance and Control Software Project; C. Configuration Management Records for the Guidance and Control Software Project; D. Software Quality Assurance Records for the Guidance and Control Software Project; E. Problem Report for the Pluto Implementation of the Guidance and Control Software Project; and F. Support Documentation Change Reports for the Guidance and Control Software Project.

  9. 75 FR 9607 - National Protection and Programs Directorate; Guidance Document Request and Evaluation

    Science.gov (United States)

    2010-03-03

    ... information for continuous improvement to its documents. Guidance document request forms and evaluation forms... Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the... will be accepted until May 3, 2010. This process is conducted in accordance with 5 CFR 1320.1...

  10. Air pollution and public health: a guidance document for risk managers.

    Science.gov (United States)

    Craig, Lorraine; Brook, Jeffrey R; Chiotti, Quentin; Croes, Bart; Gower, Stephanie; Hedley, Anthony; Krewski, Daniel; Krupnick, Alan; Krzyzanowski, Michal; Moran, Michael D; Pennell, William; Samet, Jonathan M; Schneider, Jurgen; Shortreed, John; Williams, Martin

    2008-01-01

    This guidance document is a reference for air quality policymakers and managers providing state-of-the-art, evidence-based information on key determinants of air quality management decisions. The document reflects the findings of five annual meetings of the NERAM (Network for Environmental Risk Assessment and Management) International Colloquium Series on Air Quality Management (2001-2006), as well as the results of supporting international research. The topics covered in the guidance document reflect critical science and policy aspects of air quality risk management including i) health effects, ii) air quality emissions, measurement and modeling, iii) air quality management interventions, and iv) clean air policy challenges and opportunities.

  11. Guidance document for revision of DOE Order 5820.2A, Radioactive Waste Technical Support Program

    International Nuclear Information System (INIS)

    Kudera, D.E.; McMurtrey, C.D.; Meagher, B.G.

    1993-04-01

    This document provides guidance for the revision of DOE Order 5820.2A, ''Radioactive Waste Management.'' Technical Working Groups have been established and are responsible for writing the revised order. The Technical Working Groups will use this document as a reference for polices and procedures that have been established for the revision process. The overall intent of this guidance is to outline how the order will be revised and how the revision process will be managed. In addition, this document outlines technical issues considered for inclusion by a Department of Energy Steering Committee

  12. Guidance document to the BC emission offsets regulation

    International Nuclear Information System (INIS)

    2010-11-01

    British Columbia's (BC) emission offset regulations were established under the Greenhouse Gas Reduction Targets Act passed in 2007. Targets for greenhouse gas (GHG) emission reductions included a 6 percent reduction by 2012; an 18 percent reduction by 2016; a 33 percent reduction by 2020; and an 80 percent reduction by 2050. Carbon neutral agreements began in 2008, and covered emissions produced from government business travel and by provincial government ministries and agencies. This report presented a list of key recommendations developed by the Pacific Carbon Trust for use in future carbon offset projects. Recommendations included the use of correct emission factors when quantifying projected emission reductions from an offset project; the use of a robust data management system; and the use of evidence in supporting additionality arguments. The document outlined planning procedures for project baseline selection processes, protocol selections, and the identification of sources sinks and reservoirs. Issues related to quantification and measurements, emissions factors, and accuracy and uncertainty were also addressed. Validation, verification, and contracting options were also presented. 6 tabs., 3 figs.

  13. Cost consideration in the clinical guidance documents of physician specialty societies in the United States.

    Science.gov (United States)

    Schwartz, Jennifer A T; Pearson, Steven D

    2013-06-24

    Despite increasing concerns regarding the cost of health care, the consideration of costs in the development of clinical guidance documents by physician specialty societies has received little analysis. To evaluate the approach to consideration of cost in publicly available clinical guidance documents and methodological statements produced between 2008 and 2012 by the 30 largest US physician specialty societies. Qualitative document review. Whether costs are considered in clinical guidance development, mechanism of cost consideration, and the way that cost issues were used in support of specific clinical practice recommendations. Methodological statements for clinical guidance documents indicated that 17 of 30 physician societies (57%) explicitly integrated costs, 4 (13%) implicitly considered costs, 3 (10%) intentionally excluded costs, and 6 (20%) made no mention. Of the 17 societies that explicitly integrated costs, 9 (53%) consistently used a formal system in which the strength of recommendation was influenced in part by costs, whereas 8 (47%) were inconsistent in their approach or failed to mention the exact mechanism for considering costs. Among the 138 specific recommendations in these guidance documents that included cost as part of the rationale, the most common form of recommendation (50 [36%]) encouraged the use of a specific medical service because of equal effectiveness and lower cost. Slightly more than half of the largest US physician societies explicitly consider costs in developing their clinical guidance documents; among these, approximately half use an explicit mechanism for integrating costs into the strength of recommendations. Many societies remain vague in their approach. Physician specialty societies should demonstrate greater transparency and rigor in their approach to cost consideration in documents meant to influence care decisions.

  14. The bibliographical documentation in the Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Carregado, M.A.

    1998-01-01

    Full text: The presentation of the following work serves to display the recourses which the Information Center (I.C.) - Ezeiza Sector of the Nuclear Regulatory Authority of the Argentine Republic possesses. These recourses help the investigation and application of the regulatory subject as well as the scientific technical community, which uses the information about radiation protection and nuclear safety. Periodical publications, reports, books, standards, etc., are specified quantitatively in detail. Mainly, the automated means are emphasized in order to get to safe ways of information. Data bases in CD-ROM are also enumerated. These are now essential in order to track down the expert information on each theme. The most outstanding ones among these data bases are: INIS, Nuclear Science Abstracts, Nuclear Regulatory Library, Medline and Poltox. Some recourses for obtaining important documents are mentioned, e.g.: The British Library, HMSO and NTIS, as well as addresses of institutions, catalogues of publication on Internet, etc., which allow an easy access to the bibliography required. An evaluation of periodical publications by the Information Center is carried out, as well as information about users connected to the request of bibliographical searches and documents. (author) [es

  15. 76 FR 9381 - Notice of Availability of Interim Staff Guidance Documents for Spent Fuel Storage Casks

    Science.gov (United States)

    2011-02-17

    .... FOR FURTHER INFORMATION CONTACT: Matthew Gordon, Structural Mechanics and Materials Branch, Division... transportation packaging licensing actions.'' This ISG document would provide guidance to the NRC staff when... a fee. Comments and questions on ISG-23 should be directed to Matthew Gordon, Structural Mechanics...

  16. Physical protection of shipments of irradiated reactor fuel; Interim guidance. Regulatory report

    International Nuclear Information System (INIS)

    1980-06-01

    During May, 1979, the U.S. Nuclear Regulatory Commission approved for issuance in effective form new interim regulations for strengthening the protection of spent fuel shipments against sabotage and diversion. The new regulations were issued without benefit of public comment, but comments from the public were solicited after the effective date. Based upon the public comments received, the interim regulations were amended and reissued in effective form as a final interim rule in May, 1980. The present document supersedes a previously issued interim guidance document, NUREG-0561 (June, 1979) which accompanied the original rule. This report has been revised to conform to the new interim regulations on the physical protection of shipments of irradiated reactor fuel which are likely to remain in effect until the completion of an ongoing research program concerning the response of spent fuel to certain forms of sabotage, at which time the regulations may be rescinded, modified or made permanent, as appropriate. This report discusses the amended regulations and provides a basis on which licensees can develop an acceptable interim program for the protection of spent fuel shipments

  17. Equipment design guidance document for flammable gas waste storage tank new equipment

    International Nuclear Information System (INIS)

    Smet, D.B.

    1996-01-01

    This document is intended to be used as guidance for design engineers who are involved in design of new equipment slated for use in Flammable Gas Waste Storage Tanks. The purpose of this document is to provide design guidance for all new equipment intended for application into those Hanford storage tanks in which flammable gas controls are required to be addressed as part of the equipment design. These design criteria are to be used as guidance. The design of each specific piece of new equipment shall be required, as a minimum to be reviewed by qualified Unreviewed Safety Question evaluators as an integral part of the final design approval. Further Safety Assessment may be also needed. This guidance is intended to be used in conjunction with the Operating Specifications Documents (OSDs) established for defining work controls in the waste storage tanks. The criteria set forth should be reviewed for applicability if the equipment will be required to operate in locations containing unacceptable concentrations of flammable gas

  18. Development of digital library system on regulatory documents for nuclear power plants

    International Nuclear Information System (INIS)

    Lee, K. H.; Kim, K. J.; Yoon, Y. H.; Kim, M. W.; Lee, J. I.

    2001-01-01

    The main objective of this study is to establish nuclear regulatory document retrieval system based on internet. With the advancement of internet and information processing technology, information management patterns are going through a new paradigm. Getting along the current of the time, it is general tendency to transfer paper-type documents into electronic-type documents through document scanning and indexing. This system consists of nuclear regulatory documents, nuclear safety documents, digital library, and information system with index and full text

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

    International Nuclear Information System (INIS)

    2011-01-01

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

  20. Development of a treatability variance guidance document for US DOE mixed-waste streams

    International Nuclear Information System (INIS)

    Scheuer, N.; Spikula, R.; Harms, T.

    1990-03-01

    In response to the US Department of Energy's (DOE's) anticipated need for variances from the Resource Conservation and Recovery Act (RCRA) Land Disposal Restrictions (LDRs), a treatability variance guidance document was prepared. The guidance manual is for use by DOE facilities and operations offices. The manual was prepared as a part of an ongoing effort by DOE-EH to provide guidance for the operations offices and facilities to comply with the RCRA (LDRs). A treatability variance is an alternative treatment standard granted by EPA for a restricted waste. Such a variance is not an exemption from the requirements of the LDRs, but rather is an alternative treatment standard that must be met before land disposal. The manual, Guidance For Obtaining Variance From the Treatment Standards of the RCRA Land Disposal Restrictions (1), leads the reader through the process of evaluating whether a variance from the treatment standard is a viable approach and through the data-gathering and data-evaluation processes required to develop a petition requesting a variance. The DOE review and coordination process is also described and model language for use in petitions for DOE radioactive mixed waste (RMW) is provided. The guidance manual focuses on RMW streams, however the manual also is applicable to nonmixed, hazardous waste streams. 4 refs

  1. Cycle water chemistry based on film forming amines at power plants: evaluation of technical guidance documents

    Science.gov (United States)

    Dyachenko, F. V.; Petrova, T. I.

    2017-11-01

    Efficiency and reliability of the equipment in fossil power plants as well as in combined cycle power plants depend on the corrosion processes and deposit formation in steam/water circuit. In order to decrease these processes different water chemistries are used. Today the great attention is being attracted to the application of film forming amines and film forming amine products. The International Association for the Properties of Water and Steam (IAPWS) consolidated the information from all over the World, and based on the research studies and operating experience of researchers and engineers from 21 countries, developed and authorized the Technical Guidance Document: “Application of Film Forming Amines in Fossil, Combined Cycle, and Biomass Power Plants” in 2016. This article describe Russian and International technical guidance documents for the cycle water chemistries based on film forming amines at fossil and combined cycle power plants.

  2. Technical Basis for Electromagnetic Compatibility Regulatory Guidance Update

    Energy Technology Data Exchange (ETDEWEB)

    Ewing, Paul D. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Korsah, Kofi [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Harrison, Thomas J. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Wood, Richard Thomas [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States); Mays, Gary T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States)

    2016-03-01

    The objective of this report is to serve as the technical basis document for the next, planned revision of this RG that highlights and provides the rationale for the recommended changes. The structure of this document follows and summarizes the several assessment activities undertaken during the course of this project to evaluate new and updated electromagnetic compatibility (EMC) standards, testing methods and limits, and relevant technology developments being incorporated into plant activities that may have EMI/RFI implications, as well as other specific issues, including impacts of electrostatic discharge (ESD) on safety equipment and impacts on increased usage of wireless devices in nuclear power plants.

  3. Regulatory impact analysis of the proposed great lakes water quality guidance. Final report

    International Nuclear Information System (INIS)

    Raucher, R.; Dixon, A.; Trabka, E.

    1993-01-01

    The Regulatory Impact Analysis provides direction to the Great Lakes States and Tribes on minimum water quality standards and contains numerical water quality criteria for 32 pollutants as well as methodologies for the development of water quality criteria for additional pollutants discharged to these waters. It also provides guidance to the Great Lakes States and Tribes on antidegradation policies and standards and implementation procedures

  4. DEVELOPMENT OF TECHNOLOGY AND REGULATORY DOCUMENTATION ON PROCESSED BROCCOLI PRODUCT

    Directory of Open Access Journals (Sweden)

    T. I. Kryachko

    2017-01-01

    Full Text Available The aim of the present investigation was development of an efficient technology for obtaining powders from fresh broccoli; determination of the possibility of using domestic production of broccoli as an import-substituting product; development of regulatory documentation for broccoli powders for the food industry. The research was carried out jointly with the representatives of the Federal Scientific cen-ter of vegetable production on an experimental basis in 2016. The domestic Tonus variety of broccoli (Federal Scientific center of vegetable production and the Maraton F1 hybrid (France, differing in appearance, vegetative period, biochemical and physical characteristics were chosen. Technology of broccoli powder production from domestic and imported products was developed using two methods of drying convection and lyophilization. The gentle drying conditions of broccoli freeze drying compared to convective drying technology provided higher content of both vitamin C and polyphenols in the final powder. Comparative studies of organoleptic and physico-chemical properties of powders obtained from domestic and imported broccoli demonstrated close quality parameters, indicating the possibility of effective domestic broccoli utilization and import substitution. For the first time in the Russian Federation, the "Organization Standard" was developed for regulation of the quality parameters of broccoli powders intended for use in the food industry.

  5. Offshore Wind Guidance Document: Oceanography and Sediment Stability (Version 1) Development of a Conceptual Site Model.

    Energy Technology Data Exchange (ETDEWEB)

    Roberts, Jesse D.; Jason Magalen; Craig Jones

    2014-06-01

    This guidance document provide s the reader with an overview of the key environmental considerations for a typical offshore wind coastal location and the tools to help guide the reader through a thoro ugh planning process. It will enable readers to identify the key coastal processes relevant to their offshore wind site and perform pertinent analysis to guide siting and layout design, with the goal of minimizing costs associated with planning, permitting , and long - ter m maintenance. The document highlight s site characterization and assessment techniques for evaluating spatial patterns of sediment dynamics in the vicinity of a wind farm under typical, extreme, and storm conditions. Finally, the document des cribe s the assimilation of all of this information into the conceptual site model (CSM) to aid the decision - making processes.

  6. EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

    NARCIS (Netherlands)

    Arnold, G.; Boesten, J.J.T.I.; Clook, M.

    2013-01-01

    The Guidance Document is intended to provide guidance for notifiers and authorities in the context of the review of plant protection products (PPPs) and their active substances under Regulation (EC) 1107/2009. The scientific opinion on the science behind the development of a risk assessment of plant

  7. Guidance Document on Anaerobic Digester Foaming Prevention and Control Methods (WERF Report INFR1SG10a)

    Science.gov (United States)

    The development of this anaerobic digester (AD) foaming guidance document is based on the need for a specific detailed methodology that water resource recovery facilities (WRRF) personnel can follow and implement to manage or mitigate AD foam incidents. This guidance manual is th...

  8. 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)

  9. Quality Assurance Guidance for the Collection of Meteorological Data Using Passive Radiometers

    Science.gov (United States)

    This document augments the February 2000 guidance entitled Meteorological Monitoring Guidance for Regulatory Modeling Applications and the March 2008 guidance entitled Quality Assurance Handbook for Air Pollution Measurement Systems Volume IV: Meteorological Measurements Version ...

  10. 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

  11. 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)

  12. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection

    NARCIS (Netherlands)

    Debast, S.B.; Bauer, M.P.; Kuijper, E.J.; et al.,

    2014-01-01

    In 2009 the first European Society of Clinical Microbiology and Infection (ESCMID) treatment guidance document for Clostridium difficile infection (CDI) was published. The guideline has been applied widely in clinical practice. In this document an update and review on the comparative effectiveness

  13. Guidance document for revision of DOE Order 5820.2A, Radioactive Waste Technical Support Program. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    Kudera, D.E.; McMurtrey, C.D.; Meagher, B.G.

    1993-04-01

    This document provides guidance for the revision of DOE Order 5820.2A, ``Radioactive Waste Management.`` Technical Working Groups have been established and are responsible for writing the revised order. The Technical Working Groups will use this document as a reference for polices and procedures that have been established for the revision process. The overall intent of this guidance is to outline how the order will be revised and how the revision process will be managed. In addition, this document outlines technical issues considered for inclusion by a Department of Energy Steering Committee.

  14. Development of guidance and methodical documents for providing the decommissioning of radiation-hazardous objects

    International Nuclear Information System (INIS)

    Ermakov, A.

    2015-01-01

    Federal Center for Nuclear and Radiation Safety (JSC FCNRS) developed and approbated guidance and methodical documents for providing the facility to radiologically safe status in the course of Building B decommissioning activity at JSC VNIINM (A.A. Bochvar High-Technology Scientific Research Institute for Inorganic Materials). The scope of application of the documents developed is as follows: - preliminary segregation of radwaste into streams during its collection and preparation for removal from facilities/sites under decommissioning; - express assessment of specific activity (activity) of radwaste generated in the course of dismantling and decontamination activities; - radiological survey of premises and building structures following completion of dismantling and decontamination activities; - SRW processing (compaction, reduction in size), packaging, characterisation and containerisation in order to reduce risks of spread of radioactive contamination. Documents that have been developed can be used both at nuclear facilities/ sites similar to the JSC VNIINM Building B in terms of work stages and types of waste to be generated, and other facilities/ sites taking into consideration their peculiarities. (author)

  15. An electronic regulatory document management system for a clinical trial network.

    Science.gov (United States)

    Zhao, Wenle; Durkalski, Valerie; Pauls, Keith; Dillon, Catherine; Kim, Jaemyung; Kolk, Deneil; Silbergleit, Robert; Stevenson, Valerie; Palesch, Yuko

    2010-01-01

    A computerized regulatory document management system has been developed as a module in a comprehensive Clinical Trial Management System (CTMS) designed for an NIH-funded clinical trial network in order to more efficiently manage and track regulatory compliance. Within the network, several institutions and investigators are involved in multiple trials, and each trial has regulatory document requirements. Some of these documents are trial specific while others apply across multiple trials. The latter causes a possible redundancy in document collection and management. To address these and other related challenges, a central regulatory document management system was designed. This manuscript shares the design of the system as well as examples of it use in current studies. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  16. NASA-STD-7009 Guidance Document for Human Health and Performance Models and Simulations

    Science.gov (United States)

    Walton, Marlei; Mulugeta, Lealem; Nelson, Emily S.; Myers, Jerry G.

    2014-01-01

    Rigorous verification, validation, and credibility (VVC) processes are imperative to ensure that models and simulations (MS) are sufficiently reliable to address issues within their intended scope. The NASA standard for MS, NASA-STD-7009 (7009) [1] was a resultant outcome of the Columbia Accident Investigation Board (CAIB) to ensure MS are developed, applied, and interpreted appropriately for making decisions that may impact crew or mission safety. Because the 7009 focus is engineering systems, a NASA-STD-7009 Guidance Document is being developed to augment the 7009 and provide information, tools, and techniques applicable to the probabilistic and deterministic biological MS more prevalent in human health and performance (HHP) and space biomedical research and operations.

  17. Development of regulatory guidance for risk-informing digital system reviews

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

    In 1995, the U.S. Nuclear Regulatory Commission (NRC) issued the Probabilistic Risk Assessment (PRA) Policy Statement, which encourages the increased use of PRA and associated analyses in all regulatory matters to the extent supported by the state-of-the-art in PRA and the data. This policy applies, in part, to the review of digital systems, which offer the potential to improve plant safety and reliability through such features as increased hardware reliability and stability and improved failure detection capability. However, there are presently no universally accepted methods for modeling digital systems in current-generation PRAs. Further, there are ongoing debates among the PRA technical community regarding the level of detail that any digital system reliability model must have to adequately model the complex system interactions that can contribute to digital system failure modes. Moreover, for PRA modeling of digital reactor protection and control systems, direct interactions between system components and indirect interactions through controlled/supervised plant processes may necessitate the use of dynamic PRA methodologies. This situation has led the NRC to consider developing performance based rather than prescriptive regulatory guidance in this area. This paper will discuss the development of this guidance and some preliminary concepts. (authors)

  18. 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)

  19. Guidance Document - Full-cost Recovery for Molybdenum-99 Irradiation Services: Methodology and Implementation

    International Nuclear Information System (INIS)

    Westmacott, Chad; Cameron, Ron

    2012-02-01

    At the request of its member countries, the OECD Nuclear Energy Agency (NEA) became involved in global efforts to ensure a reliable supply of molybdenum-99 ( 99 Mo) and its decay product, technetium-99m (' 99m Tc), the most widely used medical radioisotope. The NEA established the High-level Group on the Security of Supply of Medical Radioisotopes (HLG-MR) in 2009. Under its first mandate (June 2009-2011), the HLG-MR examined the major issues that affect the short-, medium- and long-term reliability of 99 Mo/' 99m Tc supply and then developed a policy approach to move the supply chain to a sustainable basis and ensure security of supply. The objectives of the HLG-MR during its second mandate (July 2011-2013) are to work towards increasing the long-term security of supply of 99 Mo and ' 99m Tc, especially through the implementation of the HLG-MR policy approach and its associated recommendations. This will entail actions to maintain transparency on global developments, continue communication with the supply chain and end users, evaluate progress toward implementation and provide additional information and analysis where necessary. A key action under the second mandate is to provide guidance on the implementation of the HLG-MR policy approach. This document provides guidance to reactor and alternative production technology (e.g., cyclotrons, accelerators) operators on how to undertake full-cost identification and implement full-cost recovery. The document also discusses issues related to levelling the playing field between old and new reactors. In order to move toward a long-term secure supply of 99 Mo and ' 99m Tc, the HLG-MR policy approach will need to be implemented by all countries that have an impact on the global market - as producers or consumers. A key recommendation of the policy approach is the implementation of full-cost identification and recovery by operators of 99 Mo-producing research reactors or alternative technologies. This document provides the

  20. Synthesis of the IRSN report on its analysis of the safety guidance package (DOrS) of the ASTRID reactor project. Safety guidance document for the ASTRID prototype: Referral to the GPR. Opinion related to the safety guidance document of the ASTRID reactor project. ASTRID prototype: Safety guidance document for the ASTRID prototype

    International Nuclear Information System (INIS)

    Lachaume, Jean-Luc; Niel, Jean-Christophe

    2013-01-01

    A first document indicates the improvement guidelines for the ASTRID project based on the French experience in the field of sodium-cooled fast neutron reactors, addresses the safety objectives as they are presented for the ASTRID project, discusses how the project includes a regulation and design referential, and how it addresses various aspects of the design approach (ranking and analysis of operation situations, defence in depth, use of probabilistic studies, safety classification and qualification to accidental situations, taking internal and external aggressions into account and taking severe accidents into account at the design level). It comments the guidelines related to the first two barriers, to main safety functions (control of reactivity and of reactor cooling, containment of radioactive and toxic materials), to dismantling, to R and D for safety support. A second document is a letter sent by the ASN to the GPR (permanent group of experts in charge of nuclear reactors) about the safety guidance document for the ASTRID prototype. The third document is the answer and contains comments and recommendations by this group about the content of this document, and therefore addresses the same topics as the first document. The last document defines the framework of the approach to this document

  1. Guidance for a harmonized emission scenario document (ESD) on ballast water discharge

    Energy Technology Data Exchange (ETDEWEB)

    Zipperle, Andreas [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Gils, Jos van [DELTARES, Delft (Netherlands); Hattum, Bert van [Amsterdam Univ. (Netherlands). IVM - Institute for Environmental Studies; Heise, Susanne [BIS - Beratungszentrum fuer integriertes Sedimentmanagement, Hamburg (Germany); Hamburg Univ. of Applied Sciences (Germany)

    2011-05-15

    The present report provides guidance for a harmonized Emission Scenario Document (ESD) for the exposure assessment as part of the environmental risk assessment process which applicants seeking approval of a ballast water management system (BWMS) need to perform prior to notification and authorisation procedures. Despite the global variability of the marine environment, ballast water discharges and treatment methods, exposure assessments need to be comparable between different applications. In order to achieve this, this ESD points out the following aspects: - Applicants should use standardized scenarios in order to predict mean exposure. These should reflect generic situations, independent of region or port so that results are widely applicable. In addition to a harbour scenario, a standardized shipping lane scenario should be considered, - During or right after ballast water discharge, high concentrations may persist in a water body for a certain length of time until extensive mixing results in mean concentrations. Not taking exposure to peak concentrations within gradients into account could lead to an underestimation of risk, especially for rapidly degrading substances. Efforts have been made to approximate maximum exposure concentration with simple dilution factors. Their applicability was checked by near-field-evaluations. - Chemical properties determine the environmental fate of substances. If they are ambiguous, selection of a specific set of data strongly influences the result of an exposure assessment. Guidance is given on what to do about lacking data. - In order to harmonize the exposure assessments, reliable chemical model software should be used. A discussion on the requirements of suitable software and an evaluation of MAMPEC is given in this report. (orig.)

  2. Comparison of the guidance documents in support of EU risk assessments with those for the derivation of EU water quality standards

    NARCIS (Netherlands)

    Vos JH; Janssen MPM; SEC

    2005-01-01

    Risks of both new and existing substances and of biocides in Europe are being evaluated using the Technical Guidance Document (TGD). The European Water Framework Directive refers to this document for establishing Environmental Quality Standards (EQSs) for water. Another guidance document for the

  3. Review of Technical Studies in the United States in Support of Burnup Credit Regulatory Guidance

    International Nuclear Information System (INIS)

    Wagner, John C.; Parks, Cecil V.; Mueller, Don; Gauld, Ian C.

    2010-01-01

    Taking credit for the reduction in reactivity associated with fuel depletion can enable more cost-effective, higher-density storage, transport, disposal, and reprocessing of spent nuclear fuel (SNF) while maintaining sufficient subcritical margin to establish an adequate safety basis. Consequently, there continues to be considerable interest in the United States (U.S.), as well as internationally, in the increased use of burnup credit in SNF operations, particularly related to storage, transport, and disposal of commercial SNF. This interest has motivated numerous technical studies related to the application of burnup credit, both domestically and internationally, as well as the design of SNF storage, transport and disposal systems that rely on burnup credit for maintaining subcriticality. Responding to industry requests and needs, the U.S. Nuclear Regulatory Commission (NRC) initiated a burnup credit research program in 1999, with support from the Oak Ridge National Laboratory (ORNL), to develop regulatory guidance and the supporting technical bases for allowing and expanding the use of burnup credit in pressurized-water reactor SNF storage and transport applications. Although this NRC research program has not been continuous since its inception, considerable progress has been achieved in many key areas in terms of increased understanding of relevant phenomena and issues, availability of relevant information and data, and subsequently updated regulatory guidance for expanded use of burnup credit. This paper reviews technical studies performed by ORNL for the U.S. NRC burnup credit research program. Examples of topics include reactivity effects associated with reactor operating characteristics, fuel assembly characteristics, burnable absorbers, control rods, spatial burnup distributions, cooling time, and assembly misloading; methods and data for validation of isotopic composition predictions; methods and data for validation of criticality calculations; and

  4. Development of recommended practices and guidance documents for upstream oil and gas flow measurement

    Energy Technology Data Exchange (ETDEWEB)

    Dahl, Eivind; Scheers, Lex; Ting, Frank; Letton, Chip

    2005-07-01

    As first stated in the Introduction, improvements in multiphase flow meters during the last 15 years have resulted in their increased usage in upstream oil and gas applications, especially in difficult offshore locations both topside and deep subsea. To address user needs for information and standardization in the area, documentation has recently been created under the auspices of the NFOGM, API, and ISO. Our intent here was to familiarize potential users with the three new documents, which should be helpful in a number of respects, e.g., (a) distribution of best knowledge and operational practices on the subject, (b) provision of a common language for discussing multiphase flow, and (c) accounting for the requirements of governing regulatory authorities. At this stage of completion of NFOGM, API, and ISO reports, a natural question arises as to what the future holds for another round of flow measurement documentation. Candidate areas include: 1) In Situ Verification of Multiphase Flow Meters. 2) Wet Gas Flow Measurement. 3) Flare Gas Meters. 4) Virtual Metering. 5) Composition and Phase Behavior Issues In Measurement. 6) Flow Measurement Uncertainty. Addressing certain of these is already being proposed in several possible venues, among which are (1) the DeepStar Consortium, (2) a JIP for investigating total system (meter + flowline + separator) uncertainty organized by a group at Tulsa University, and (3) a program for development of drilling and production capabilities in ultradeep water to be sponsored by the US Department of Energy. The creation of the three documents discussed in this paper demonstrates the benefits that strong international cooperation can achieve in producing standardization documents, ensuring their true global input and acceptance. On the other hand, it should also be questioned why two or more documents are required, which are the result of much duplication of effort. For example, although there are differences between API RP86 and the

  5. Report 3: Guidance document on practices to model and implement Extreme Weather hazards in extended PSA

    International Nuclear Information System (INIS)

    Alzbutas, R.; Ostapchuk, S.; Borysiewicz, M.; Decker, K.; Kumar, Manorma; Haeggstroem, A.; Nitoi, M.; Groudev, P.; Parey, S.; Potempski, S.; Raimond, E.; Siklossy, T.

    2016-01-01

    The goal of this report is to provide guidance on practices to model Extreme Weather hazards and implement them in extended level 1 PSA. This report is a joint deliverable of work package 21 (WP21) and work package 22 (WP22). The general objective of WP21 is to provide guidance on all of the individual hazards selected at the End Users Workshop. This guidance is focusing on extreme weather hazards, namely: extreme wind, extreme temperature and snow pack. Other hazards, however, are considered in cases where they are correlated/ associated with the hazard under discussion. Guidance developed refers to existing guidance whenever possible. As it was recommended by end users this guidance covers questions of developing integrated and/or separated extreme weathers PSA models. (authors)

  6. Towards a standardised approach for evaluating guidelines and guidance documents on palliative sedation: study protocol.

    Science.gov (United States)

    Abarshi, Ebun; Rietjens, Judith; Caraceni, Augusto; Payne, Sheila; Deliens, Luc; Van Den Block, Lieve

    2014-01-01

    Sedation in palliative care has received growing attention in recent years; and so have guidelines, position statements, and related literature that provide recommendations for its practice. Yet little is known collectively about the content, scope and methodological quality of these materials. According to research, there are large variations in palliative sedation practice, depending on the definition and methodology used. However, a standardised approach to comparing and contrasting related documents, across countries, associations and governmental bodies is lacking. This paper reports on a protocol designed to enable thorough and systematic comparison of guidelines and guidance documents on palliative sedation. A multidisciplinary and international group of palliative care researchers, identified themes and clinical issues on palliative sedation based on expert consultations and evidence drawn from the EAPC (European Association of Palliative Care) framework for palliative sedation and AGREE II (Appraisal Guideline Research and Evaluation) instrument for guideline assessment. The most relevant themes were selected and built into a comprehensive checklist. This was tested on people working closely with practitioners and patients, for user-friendliness and comprehensibility, and modified where necessary. Next, a systematic search was conducted for guidelines in English, Dutch, Flemish, or Italian. The search was performed in multiple databases (PubMed, CancerLit, CNAHL, Cochrane Library, NHS Evidence and Google Scholar), and via other Internet resources. Hereafter, the final version of the checklist will be used to extract data from selected literature, and the same will be compiled, entered into SPSS, cleaned and analysed systematically for publication. We have together developed a comprehensive checklist in a scientifically rigorous manner to allow standardised and systematic comparison. The protocol is applicable to all guidelines on palliative sedation, and

  7. Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies' publicly available documents.

    Science.gov (United States)

    Leong Wai Yeen, James; Salek, Sam; Walker, Stuart

    2014-01-01

    The assessment report formats of four major regulatory reference agencies, US Food and Drug Administration, European Medicines Agency, Health Canada, and Australia's Therapeutic Goods Administration were compared to a benefit-risk (BR) documentation template developed by the Centre for Innovation in Regulatory Science and a four-member Consortium on Benefit-Risk Assessment. A case study was also conducted using a US FDA Medical Review, the European Public Assessment Report and Australia's Public Assessment Report for the same product. Compared with the BR Template, existing regulatory report formats are inadequate regarding the listing of benefits and risks, the assigning of relative importance and values, visualization and the utilization of a detailed, systematic, standardized structure. The BR Template is based on the principles of BR assessment common to major regulatory agencies. Given that there are minimal differences among the existing regulatory report formats, it is timely to consider the feasibility of a universal template.

  8. Framework of the NPP I and C Security for Regulatory Guidance

    International Nuclear Information System (INIS)

    Kim, Young Mi; Jeong, Choong Heui

    2013-01-01

    I and C (Instrumentation and control) systems which have computers are a critical part of the safety and security at nuclear facilities. As the use of computers in I and C continue to grow, so does the target for cyber-attack. They include desktop computers, mainframe systems, servers, network devices, embedded systems and programmable logic controllers (PLSs) and other digital computer systems. As the Stuxnet malware shows, I and C systems of the NPPs are no longer safe from the threat of cyber-attacks. These digital I and C systems must be protected from the cyber-attacks. This paper presents framework of the NPP I and C security for regulatory guidance. KINS regulatory guideline 8.22 has been applied to new and operation nuclear power plants. This guideline refers the applicable scope of the cyber security activities, cyber security policies and security plans, and assessments of cyber security and execution of the cyber security activities. Newly developed guideline will be helpful for implement security control to ensure safe operation of NPP I and C systems

  9. Framework of the NPP I and C Security for Regulatory Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Young Mi; Jeong, Choong Heui [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    I and C (Instrumentation and control) systems which have computers are a critical part of the safety and security at nuclear facilities. As the use of computers in I and C continue to grow, so does the target for cyber-attack. They include desktop computers, mainframe systems, servers, network devices, embedded systems and programmable logic controllers (PLSs) and other digital computer systems. As the Stuxnet malware shows, I and C systems of the NPPs are no longer safe from the threat of cyber-attacks. These digital I and C systems must be protected from the cyber-attacks. This paper presents framework of the NPP I and C security for regulatory guidance. KINS regulatory guideline 8.22 has been applied to new and operation nuclear power plants. This guideline refers the applicable scope of the cyber security activities, cyber security policies and security plans, and assessments of cyber security and execution of the cyber security activities. Newly developed guideline will be helpful for implement security control to ensure safe operation of NPP I and C systems.

  10. 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...

  11. 77 FR 46640 - Hours of Service of Drivers of Commercial Motor Vehicles; Regulatory Guidance for Oil Field...

    Science.gov (United States)

    2012-08-06

    ... Embassy Suites Hotel, 550 Cherrington Parkway, Coraopolis, PA 15108. The Agency will provide details on... submitted on behalf of an association, business, labor union, etc.). You may review the DOT's complete... comments online. FOR FURTHER INFORMATION CONTACT: For the regulatory guidance issued on June 5, 2012...

  12. 78 FR 41852 - Hours of Service for Commercial Motor Vehicle Drivers; Regulatory Guidance Concerning Off-Duty Time

    Science.gov (United States)

    2013-07-12

    ... provided: 1. The driver is relieved of all duty and responsibility for the care and custody of the vehicle... Service for Commercial Motor Vehicle Drivers; Regulatory Guidance Concerning Off-Duty Time AGENCY: Federal... motor vehicle (CMV) driver to record meal and other routine stops made during a work shift as off-duty...

  13. Development of joint regulatory guidance on the management of higher activity radioactive wastes on nuclear licensed sites - 16095

    International Nuclear Information System (INIS)

    Bacon, Mick; Ilett, Doug; Whittall, Andy

    2009-01-01

    In 2006 the UK Government's response (1) to recommendations by its Committee on Radioactive Waste Management (CoRWM) established, in England and Wales, that geological disposal, supported by safe and secure interim storage, is the preferred route for the long-term management of higher-activity radioactive waste (i.e. that which is not suitable for near-surface disposal). It also gave the responsibility for delivering the programme for a deep geological repository to the Nuclear Decommissioning Authority (NDA). The Scottish Government has a policy of long term, near site, near surface safe and secure interim storage. To support the open and transparent approach promised by Government, the Health and Safety Executive (HSE), the Environment Agency and the Scottish Environment Protection Agency (SEPA) are developing joint guidance on the management of higher-activity radioactive waste to explain regulatory objectives in securing safe and secure interim storage and the associated management of radioactive wastes. The guidance comes in two parts: - Guidance on the regulatory process; - Technical guidance modules. The guidance promotes a cradle to grave approach to radioactive waste management and by aligning the regulatory interests of environmental and safety regulators it delivers one of the Government's 'Better Regulation' objectives. This paper describes the process by which the joint guidance was produced with particular emphasis on stakeholder engagement. It describes the key features of the guidance, including the concept of the radioactive waste management case (RWMC). Finally the problems encountered with dissemination and implementation are discussed together with measures taken by the regulators to improve these aspects. (1) : UK Government and the devolved administrations, 'Response to the Report and Recommendations from the Committee on Radioactive Waste Management (CoRWM)', (PB 12303) October 2006. www

  14. 12 CFR 562.2 - Regulatory reports.

    Science.gov (United States)

    2010-01-01

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

  15. Guidance document on fat reduction factor, functional barrier concept, phthalates and primary aromatic amines

    DEFF Research Database (Denmark)

    Hoekstra, Eddo J.; Petersen, Jens Højslev; Bustos, Juana

    Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food contains four issues for which food inspectors and enforcement laboratories need further guidance. These issues are the concept of the fat reduction factor...

  16. Guidance Document - Provision of Outage Reserve Capacity for Molybdenum-99 Irradiation Services: Methodology and Economic Analysis

    International Nuclear Information System (INIS)

    Peykov, Pavel; Cameron, Ron; Westmacott, Chad

    2013-01-01

    radioactive waste. Since the 2009-10 supply shortage, there has been a co-ordinated effort by 99 Mo/' 99m Tc supply chain participants to improve communication and share information in a more timely and effective manner. This helps optimise operating reactor capacities and minimise the impact of potential future supply shortages. However, in addition to paying for operating capacity through a full-cost recovery methodology, the supply chain should also be responsible for maintaining adequate ORC and paying for it. All 99 Mo producers that supply the global market should maintain and pay for ORC, otherwise there will be market distortions that could jeopardise the long-term economic sustainability of the irradiation providers and thus jeopardise the long-term supply security of 99 Mo/' 99m Tc. In addition, it should be recognised by all consumers within the global market that the price increases expected by the application of full-cost recovery should flow through the supply chain and should be reflected in the costs of the final medical procedure, to be reimbursed appropriately by the health care system. This guidance document provides a methodology for determining the necessary amount of ORC to be provided, an approach to valuing and paying for ORC, and the economic effects from ORC pricing. The provision of ORC is important to achieve long-term economic sustainability of the 99 Mo/' 99m Tc supply chain and improve the global supply reliability of these key medical isotopes. To ensure that a sufficient level of ORC is maintained at all times, ORC should be appropriately priced and included in contracts between supply chain participants. This would compensate reactors for the capital and operational costs that they incur to hold it. Otherwise, reactors would have an incentive to use any reserve capacity for other missions. Paying for ORC would increase 99 Mo prices throughout the supply chain, with the largest increases occurring upstream - at the reactor and processor levels

  17. Consideration of sky-shine radiation effects for the development of Korean regulatory guidance about industrial radiography

    International Nuclear Information System (INIS)

    Yong Ki Chi; Bokyun Seo; Wantae Kim

    2015-01-01

    Although most of the sky-shine radiation levels in industrial radiography are below regulatory limits, sky-shine radiation could make a valuable contribution to the total radiation level near shielding facility with little shielding and open field without shielding. Therefore sky-shine radiation should be thoroughly predicted and supervised with the ALARA principle. In this study, we simulated sky-shine radiation for mobile irradiators using MCNP and newly suggested the equation for calculating sky-shine radiation. Also these results were applied to developing Korean regulatory guidance about industrial radiography and to recommending the requirement of the facility design, controlled or supervised area at work places. (author)

  18. Evaluation of the endocrine activity of 2,4,6-tribromophenol, benzanthrone and benzophenone-2 based on Appendix 7.8-5 of REACH guidance document

    DEFF Research Database (Denmark)

    Duis, Karen; Holbech, Henrik; Velasco-Santamaría, Yohana M.

    Within a project funded by the German Federal Environment Agency, the practicability of Appendix 7.8-5 of REACH guidance document R.7b was evaluated using three case study substances. Shortcomings in the guidance were identified. An assessment of potential endocrine activity in aquatic vertebrates...

  19. 75 FR 20606 - Guidance for Industry on Tobacco Health Document Submission; Availability

    Science.gov (United States)

    2010-04-20

    ..., adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and... documents in a digital format, which FDA strongly encourages in order to improve the management and...

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

    Science.gov (United States)

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

    2012-07-01

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

  1. Guidance for preparing user requirements documents for small and medium reactors and their application

    International Nuclear Information System (INIS)

    2000-08-01

    During the past decade, several countries with highly developed nuclear power programs established user required documents (URDs) to guide the development and implementation of advanced light water reactors. These efforts built upon the extensive experience with operating reactors and included new insights from ongoing research and development to enhance the economic performance and safety of future nuclear power plants. Subsequently, a number of developing countries with plans for introducing nuclear energy into their national programs expressed strong interest in establishing analogous requirements. The IAEA has therefore taken the initiative to assist in the elaboration of such requirements. Building upon relevant documents this report recommends a URD structure and content outline to support developing countries in preparing their URDs for various applications of small and medium reactors (e.g. electricity generation and/or desalination). This report was prepared by representatives from both developing and developed Member States

  2. In Situ Soil Venting - Full Scale Test, Hill AFB. Volume 3. Guidance Document, Literature Review

    Science.gov (United States)

    1991-08-01

    calculations of hydrocarbon removal efficiency ( Section V.J). 2. Aurea Becncath Tank Excavation The area bcncath the tank excavation was subdivided into...Capt. Michael Elliott, Mr. Doug Downey, and Capt. Edward Marchand. Section V.E. of this document consists of the text of ’Enhanced Biodegrzdation...Environics Division (The reverse of this page is blank) TABLE OF CONTENTS Section Title Page I INTRODUCTION ......................................... 1 A

  3. Guidance document for prepermit bioassay testing of low-level radioactive waste

    International Nuclear Information System (INIS)

    Anderson, S.L.; Harrison, F.L.

    1990-11-01

    In response to the mandate of Public Law 92-532, the Marine Protection, Research, and Sanctuaries Act (MPRSA) of 1972, as amended, the Environmental Protection Agency (EPA) has developed a program to promulgate regulations and criteria to control the ocean disposal of radioactive wastes. The EPA seeks to understand the mechanisms for biological response of marine organisms to the low levels of radioactivity that may arise from the release of these wastes as a result of ocean-disposal practices. Such information will play an important role in determining the adequacy of environmental assessments provided to the EPA in support of any disposal permit application. Although the EPA requires packaging of low-level radioactive waste to prevent release during radiodecay of the materials, some release of radioactive material into the deep-sea environment may occur when a package deteriorates. Therefore, methods for evaluating the impact on biota are being evaluated. Mortality and phenotypic responses are not anticipated at the expected low environmental levels that might occur if radioactive materials were released from the low-level waste packages. Therefore, traditional bioassay systems are unsuitable for assessing sublethal effects on biota in the marine environment. The EPA Office of Radiation Programs (ORP) has had an ongoing program to examine sublethal responses to radiation at the cellular level, using cytogenetic end points. This technical guidance report represents prepermit bioassay procedures that potentially may be applicable to the assessment of effects from a mixture of radionuclides that could be released from a point source at the ocean bottom. Methodologies along with rationale and a discussion of uncertainty are presented for the sediment benthic bioassay protocols identified in this report

  4. Guidance document for prepermit bioassay testing of low-level radioactive waste

    Energy Technology Data Exchange (ETDEWEB)

    Anderson, S.L.; Harrison, F.L.

    1990-11-01

    In response to the mandate of Public Law 92-532, the Marine Protection, Research, and Sanctuaries Act (MPRSA) of 1972, as amended, the Environmental Protection Agency (EPA) has developed a program to promulgate regulations and criteria to control the ocean disposal of radioactive wastes. The EPA seeks to understand the mechanisms for biological response of marine organisms to the low levels of radioactivity that may arise from the release of these wastes as a result of ocean-disposal practices. Such information will play an important role in determining the adequacy of environmental assessments provided to the EPA in support of any disposal permit application. Although the EPA requires packaging of low-level radioactive waste to prevent release during radiodecay of the materials, some release of radioactive material into the deep-sea environment may occur when a package deteriorates. Therefore, methods for evaluating the impact on biota are being evaluated. Mortality and phenotypic responses are not anticipated at the expected low environmental levels that might occur if radioactive materials were released from the low-level waste packages. Therefore, traditional bioassay systems are unsuitable for assessing sublethal effects on biota in the marine environment. The EPA Office of Radiation Programs (ORP) has had an ongoing program to examine sublethal responses to radiation at the cellular level, using cytogenetic end points. This technical guidance report represents prepermit bioassay procedures that potentially may be applicable to the assessment of effects from a mixture of radionuclides that could be released from a point source at the ocean bottom. Methodologies along with rationale and a discussion of uncertainty are presented for the sediment benthic bioassay protocols identified in this report.

  5. Best Available Technology (economically achievable) guidance document for the Hanford Site

    International Nuclear Information System (INIS)

    1988-07-01

    This document provides Westinghouse Hanford Company (Westinghouse Hanford) and the US Department of Energy (DOE) with a step-by-step procedure for the identification and documentation of the Best Available Technology (BAT) economically achievable for treating liquid effluents on the Hanford Site. The BAT determination is a key element in the DOE strategy to eliminate use of the soil column for contaminated effluents disposal. Following application of BAT, a liquid effluent is considered suitable for discharge to the environment, including the soil column. Liquid effluents on the Hanford Site are currently disposed of in accordance with DOE orders that require protection of public health and safety, and to the extent possible, minimize adverse impacts on the environment. The determination of BAT on a liquid effluent will only occur after the effluent meets all applicable release limits. As a result, the application of BAT may involve an additional level of control, as well as contribute to the overall Hanford Site as low as reasonably achievable (ALARA) program. 27 refs., 7 figs., 1 tab

  6. Data requirement comparison between the fixed site upgrade rule guidance compendium and the Structured Assessment Approach Licensee Submittal Document

    Energy Technology Data Exchange (ETDEWEB)

    Parziale, A.A.; Sacks, I.J.

    1980-12-01

    We compared the Structured Assessment Approach's (SAA) Licensee Submittal Document (LSD) with the Fixed Site Physical Protection Upgrade Rule Guidance Compendium Standard Format and Content (SFC) Guide using correlation matrices to see how well the data requirements of the SFC Guide coincided with those of a specific automated vulnerability assessment technique for fixed-site nuclear fuel cycle facilities, namely, SAA. We found that a limited SAA assessment is possible using the SFC Guide, but significant and critical safeguards vulnerabilities might be missed. Also, it was found that in some cases the organization and format of the SFC Guide input data and information made the preparation of data for the SAA somewhat awkward. 2 refs., 2 tabs.

  7. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection.

    Science.gov (United States)

    Debast, S B; Bauer, M P; Kuijper, E J

    2014-03-01

    In 2009 the first European Society of Clinical Microbiology and Infection (ESCMID) treatment guidance document for Clostridium difficile infection (CDI) was published. The guideline has been applied widely in clinical practice. In this document an update and review on the comparative effectiveness of the currently available treatment modalities of CDI is given, thereby providing evidence-based recommendations on this issue. A computerized literature search was carried out to investigate randomized and non-randomized trials investigating the effect of an intervention on the clinical outcome of CDI. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) system was used to grade the strength of our recommendations and the quality of the evidence. The ESCMID and an international team of experts from 11 European countries supported the process. To improve clinical guidance in the treatment of CDI, recommendations are specified for various patient groups, e.g. initial non-severe disease, severe CDI, first recurrence or risk for recurrent disease, multiple recurrences and treatment of CDI when oral administration is not possible. Treatment options that are reviewed include: antibiotics, toxin-binding resins and polymers, immunotherapy, probiotics, and faecal or bacterial intestinal transplantation. Except for very mild CDI that is clearly induced by antibiotic usage antibiotic treatment is advised. The main antibiotics that are recommended are metronidazole, vancomycin and fidaxomicin. Faecal transplantation is strongly recommended for multiple recurrent CDI. In case of perforation of the colon and/or systemic inflammation and deteriorating clinical condition despite antibiotic therapy, total abdominal colectomy or diverting loop ileostomy combined with colonic lavage is recommended. © 2013 The Authors Clinical Microbiology and Infection © 2013 European Society of Clinical Microbiology and Infectious Diseases.

  8. 76 FR 50433 - Regulatory Guidance: Applicability of the Federal Motor Carrier Safety Regulations to Operators...

    Science.gov (United States)

    2011-08-15

    ... operating under share-cropping agreements are common or contract carriers; and third, whether FMCSA should.... FMCSA is issuing guidance that farmers operating under share-cropping or similar arrangements are not... farmer, the Agency sought as much public involvement and comment as possible on these issues. It is worth...

  9. 76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

    Science.gov (United States)

    2011-12-02

    ... of Pharmaceutical Co-Crystals.'' This draft guidance provides applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) with the Center for Drug Evaluation and Research's (CDER's) current thinking on the appropriate classification of co-crystal solid-state forms. This draft...

  10. 75 FR 35510 - License Renewal Interim Staff Guidance Process, Revision 2 Notice of Availability

    Science.gov (United States)

    2010-06-22

    ... Related Regulatory Functions.'' An electronic copy of the revised LR-ISG process is available in the NRC's Agencywide Documents Access and Management System (ADAMS) under Accession No. ML100920158. The revised LR-ISG... interim changes to certain NRC license renewal guidance documents. These guidance documents facilitate the...

  11. Environmental guidance documents for exploration, development, Production, and transportation of crude oil and natural gas in texas: Quarterly technical report, January 1, 1997-March 31, 1997

    International Nuclear Information System (INIS)

    Savage, L.

    1997-01-01

    The following technical report provides a detailed status report of the DOE grant project entitled ''Environmental Guidance Documents for Exploration, Development, Production, and Transportation of Crude Oil and Natural Gas in Texas.'' The grant funding allocated is for the purpose of provided the Railroad Commission of Texas (Commission) with resources and capabilities to draft, publish and distribute documents that provide guidance to oil and gas operators on issues concerning oil and gas naturally occurring radioactive material (NORM) waste, oil and gas hazardous waste, remediation of crude oil spills, management of non-hazardous oil and gas wastes, and mechanical integrity testing of Class II injection and disposal wells

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

    International Nuclear Information System (INIS)

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

    2009-01-01

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

  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 (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)

  14. 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

  15. The Radioactive Waste Management Advisory Committee's. Advice on issues which need to be addressed in the Guidance to be given to the Environment Agencies on the Principles for determining Radioactive Waste Discharge Authorisations - the 'Principles Document'

    International Nuclear Information System (INIS)

    1998-07-01

    In January 1998, the Minister for the Environment, Mr Michael Meacher, informed the Radioactive Waste Management Advisory Committee (RWMAC) that, during the coming year, he would welcome the Committee's advice on proposals for guidance from the Department of the Environment, Transport and the Regions (DETR) to the Environment Agencies on assessment principles for determining radioactive waste discharge authorisations. This will hereafter be referred to as the Principles Document. The RWMAC has provided advice on the process of regulating radioactive waste discharges for many years. A summary of some of this activity is given in Annex 1. As a result, it has been pressing for this Principles Document guidance to be made available since its Twelfth Report in 1991. In response to the Minister's request, the RWMAC offered to assemble and submit early advice on what it believes the guidance needs to cover: this document fulfils that offer. The fundamental purpose of the advice is to help promote clarity of the regulatory regime for the benefit of the regulators themselves who must apply it, the industry to whom it is applied and, most importantly, the public whose safety it is designed to protect. Clarification of a number of aspects of the process is also likely to provide opportunity for efficiency gains. At a subsequent stage, the RWMAC will be happy to provide comment on any draft principles documentation prepared by the DETR. The RWMAC acknowledges that some of the issues it raises in this advice could be taken by others to be either outside the scope of the Principles Document or, by implying a need for more fundamental consideration of the discharge authorisation process, could potentially preclude its early publication. In the first instance, reference to an alternative source of relevant advice might suffice, providing this advice is itself easily accessible and understandable. In the second, the issue itself might be one to be fed into the Government's planned

  16. 78 FR 42086 - Draft Guidance for Industry on Arsenic in Apple Juice: Action Level; Supporting Document for...

    Science.gov (United States)

    2013-07-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0322... of good manufacturing practices. It also describes FDA's intended sampling and enforcement approach... the guidance, submit either electronic or written comments on the draft guidance by September 13, 2013...

  17. Guidance document on practices to model and implement Earthquake hazards in extended PSA (final version). Volume 1

    International Nuclear Information System (INIS)

    Decker, K.; Hirata, K.; Groudev, P.

    2016-01-01

    The current report provides guidance for the assessment of seismo-tectonic hazards in level 1 and 2 PSA. The objective is to review existing guidance, identify methodological challenges, and to propose novel guidance on key issues. Guidance for the assessment of vibratory ground motion and fault capability comprises the following: - listings of data required for the hazard assessment and methods to estimate data quality and completeness; - in-depth discussion of key input parameters required for hazard models; - discussions on commonly applied hazard assessment methodologies; - references to recent advances of science and technology. Guidance on the assessment of correlated or coincident hazards comprises of chapters on: - screening of correlated hazards; - assessment of correlated hazards (natural and man-made); - assessment of coincident hazards. (authors)

  18. European Society of Clinical Microbiology and Infectious Diseases: update of the diagnostic guidance document for Clostridium difficile infection.

    Science.gov (United States)

    Crobach, M J T; Planche, T; Eckert, C; Barbut, F; Terveer, E M; Dekkers, O M; Wilcox, M H; Kuijper, E J

    2016-08-01

    In 2009 the first European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guideline for diagnosing Clostridium difficile infection (CDI) was launched. Since then newer tests for diagnosing CDI have become available, especially nucleic acid amplification tests. The main objectives of this update of the guidance document are to summarize the currently available evidence concerning laboratory diagnosis of CDI and to formulate and revise recommendations to optimize CDI testing. This update is essential to improve the diagnosis of CDI and to improve uniformity in CDI diagnosis for surveillance purposes among Europe. An electronic search for literature concerning the laboratory diagnosis of CDI was performed. Studies evaluating a commercial laboratory test compared to a reference test were also included in a meta-analysis. The commercial tests that were evaluated included enzyme immunoassays (EIAs) detecting glutamate dehydrogenase, EIAs detecting toxins A and B and nucleic acid amplification tests. Recommendations were formulated by an executive committee, and the strength of recommendations and quality of evidence were graded using the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system. No single commercial test can be used as a stand-alone test for diagnosing CDI as a result of inadequate positive predictive values at low CDI prevalence. Therefore, the use of a two-step algorithm is recommended. Samples without free toxin detected by toxins A and B EIA but with positive glutamate dehydrogenase EIA, nucleic acid amplification test or toxigenic culture results need clinical evaluation to discern CDI from asymptomatic carriage. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  19. How Has CDER Prepared for the Nano Revolution? A Review of Risk Assessment, Regulatory Research, and Guidance Activities.

    Science.gov (United States)

    Tyner, Katherine M; Zheng, Nan; Choi, Stephanie; Xu, Xiaoming; Zou, Peng; Jiang, Wenlei; Guo, Changning; Cruz, Celia N

    2017-07-01

    The Nanotechnology Risk Assessment Working Group in the Center for Drug Evaluation and Research (CDER) within the United States Food and Drug Administration (FDA) was established to assess the potential impact of nanotechnology on drug products. One of the working group's major initiatives has been to conduct a comprehensive risk management exercise regarding the potential impact of nanomaterial pharmaceutical ingredients and excipients on drug product quality, safety, and efficacy. This exercise concluded that current review practices and regulatory guidance are capable of detecting and managing the potential risks to quality, safety, and efficacy when a drug product incorporates a nanomaterial. However, three risk management areas were identified for continued focus during the review of drug products containing nanomaterials: (1) the understanding of how to perform the characterization of nanomaterial properties and the analytical methods used for this characterization, (2) the adequacy of in vitro tests to evaluate drug product performance for drug products containing nanomaterials, and (3) the understanding of properties arising from nanomaterials that may result in different toxicity and biodistribution profiles for drug products containing nanomaterials. CDER continues to actively track the incorporation of nanomaterials in drug products and the methodologies used to characterize them, in order to continuously improve the readiness of our science- and risk-based review approaches. In parallel to the risk management exercise, CDER has also been supporting regulatory research in the area of nanotechnology, specifically focused on characterization, safety, and equivalence (between reference and new product) considerations. This article provides a comprehensive summary of regulatory and research efforts supported by CDER in the area of drug products containing nanomaterials and other activities supporting the development of this emerging technology.

  20. Technical and Regulatory Guidance for Surfactant/Cosolvent Flushing of DNAPL Source Zones

    Science.gov (United States)

    2003-04-01

    industry and public institutions who contributed to this document: George J . Hall – ITRC Program Advisor Doug Beal – BEM Systems Susan Gawarecki...these tests are also used during the design process to estimate hydraulic properties based on empirical correlations ( Vukovic and Soro, 1992). Samples...Journal of Environmental Engineering, 124(6): 498–503. Bear, J . 1972. Flow Through Porous Media. Elsevier, N.Y. Bedient, P.B., A.W. Holder, C.G

  1. Safety cases for radioactive waste disposal facilities: guidance on confidence building and regulatory review IAEA-ASAM co-ordinated research project

    International Nuclear Information System (INIS)

    Ben Belfadhel, M.; Bennett, D.G.; Metcalf, P.; Nys, V.; Goldammer, W.

    2008-01-01

    The IAEA has been conducting two co-ordinated research programmes (CRPs) projects to develop and apply improved safety assessment methodologies for near-surface radioactive waste disposal facilities. The more recent of these projects, ASAM (application of safety assessment methodologies), included a Regulatory Review Working Group (RRWG) which has been working to develop guidance on how to gain confidence in safety assessments and safety cases, and on how to conduct regulatory reviews of safety assessments. This paper provides an overview of the ASAM project, focusing on the safety case and regulatory review. (authors)

  2. Report 6: Guidance document. Man-made hazards and Accidental Aircraft Crash hazards modelling and implementation in extended PSA

    International Nuclear Information System (INIS)

    Kahia, S.; Brinkman, H.; Bareith, A.; Siklossy, T.; Vinot, T.; Mateescu, T.; Espargilliere, J.; Burgazzi, L.; Ivanov, I.; Bogdanov, D.; Groudev, P.; Ostapchuk, S.; Zhabin, O.; Stojka, T.; Alzbutas, R.; Kumar, M.; Nitoi, M.; Farcasiu, M.; Borysiewicz, M.; Kowal, K.; Potempski, S.

    2016-01-01

    The goal of this report is to provide guidance on practices to model man-made hazards (mainly external fires and explosions) and accidental aircraft crash hazards and implement them in extended Level 1 PSA. This report is a joint deliverable of work package 21 (WP21) and work package 22 (WP22). The general objective of WP21 is to provide guidance on all of the individual hazards selected at the first ASAMPSA-E End Users Workshop (May 2014, Uppsala, Sweden). The objective of WP22 is to provide the solutions for purposes of different parts of man-made hazards Level 1 PSA fulfilment. This guidance is focusing on man-made hazards, namely: external fires and explosions, and accidental aircraft crash hazards. Guidance developed refers to existing guidance whenever possible. The initial part of guidance (WP21 part) reflects current practices to assess the frequencies for each type of hazards or combination of hazards (including correlated hazards) as initiating event for PSAs. The sources and quality of hazard data, the elements of hazard assessment methodologies and relevant examples are discussed. Classification and criteria to properly assess hazard combinations as well as examples and methods for assessment of these combinations are included in this guidance. In appendixes additional material is presented with the examples of practical approaches to aircraft crash and man-made hazard. The following issues are addressed: 1) Hazard assessment methodologies, including issues related to hazard combinations. 2) Modelling equipment of safety related SSC, 3) HRA, 4) Emergency response, 5) Multi-unit issues. Recommendations and also limitations, gaps identified in the existing methodologies and a list of open issues are included. At all stages of this guidance and especially from an industrial end-user perspective, one must keep in mind that the development of man-made hazards probabilistic analysis must be conditioned to the ability to ultimately obtain a representative risk

  3. Best Clinical Practice Guidance for clinicians dealing with children presenting with Molar-Incisor-Hypomineralisation (MIH): An EAPD Policy Document.

    Science.gov (United States)

    Lygidakis, N A; Wong, F; Jälevik, B; Vierrou, A-M; Alaluusua, S; Espelid, I

    2010-04-01

    The European Academy of Paediatric Dentistry (EAPD) has long recognised the necessity of promoting further research and knowledge regarding the dental defect described as molar-incisor-hypomineralisation (MIH). Following the establishment by EAPD of the defect diagnostic criteria in 2003, the publication of various papers and a whole issue assigned to the defect in the European Archives of Paediatric Dentistry (2008), an Interim Seminar and Workshop on MIH was organized in Helsinki in 2009. The outcome of this event is the present consensus paper on the prevalence, diagnosis, aetiology and treatment for children and adolescents presenting with MIH. A clear diagnostic proposal and a treatment decision-making guide are presented together with suggestions on aetiology and guidance for future research. MIH is an important clinical problem that often concerns both the general dental and specialist paediatric dentists; the present 'best clinical practice guidance' aims to further help clinicians dealing with the condition.

  4. Environmental Guidance Regulatory Bulletin

    International Nuclear Information System (INIS)

    1995-01-01

    On September 15, 1994, EPA promulgated a Final Rule revising 40 CFR Part 300: the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). NCP establishes a national response system for responding to discharges of oil and releases of hazardous substances. Figures illustrate the roles of the national response system. Response operations, planning and preparation, and designation of federal trustees are discussed, followed by definitions

  5. Environmental guidance regulatory bulletin

    International Nuclear Information System (INIS)

    1994-12-01

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

  6. EFSA Panel on Plant Protection Products and their Residues (PPR); EFSA Scientific Opinion on the science behind the revision of the guidance document on dermal absorption

    DEFF Research Database (Denmark)

    Petersen, Annette

    will be finalised and published only after adoption and publication of this opinion. This opinion has been developed after a public consultation of EFSA on the current guidance document and an outsourced project carried out by the UK Chemicals Regulation Directorate (CRD, 2010). It is not intended...... that have an impact on absorption, a description of important elements in the design of experimental studies and an analysis of available data on dermal absorption of PPPs. The PPR Panel concludes that assessment of dermal absorption in the absence of specific studies can be performed based on default...

  7. Development of regulatory guidance on safety reviews of nuclear power plants in Germany. A survey on accomplished and current PSA activities

    International Nuclear Information System (INIS)

    Berg, H.-P.; Froehmel, T.; Goertz, R.; Rehs, B.

    2005-01-01

    The paper describes the key points of the accomplished and current regulatory activities in order to revise PSA guide and the corresponding technical documents in Germany. The regulatory German PSA guide covers the fundamental requirements concerning the performance of PSAs in the frame of comprehensive safety reviews. The technical details regarding the performance of PSA are set out in two technical documents (PSA Methods and PSA Data) that have been developed by a working group of PSA experts (FAK PSA). Based on the experiences from the first series of PSRs, international experiences and the fact that PSR is mandatory since April 2002 revisions of all guides are underway. The first guide to be updated is the PSA guide together with the corresponding technical documents. The working programme and the revision process of FAK PSA was finished at the end of 2004 and the technical documents have recently been republished. (author)

  8. BENCHPAR PROJECT. How to Incorporate ThermaI-Hydro-Mechanical Coupled Processes into Performance Assessments and Design Studies for Radioactive Waste Disposal in Geological Formations. Guidance Document

    International Nuclear Information System (INIS)

    Stephansson, O.; Andersson, Johan

    2005-02-01

    The objective of this Guidance Document is to provide advice on how to incorporate thermo-hydro-mechanical (THM) coupled processes into Performance Assessments (PAS) and design studies for radioactive waste disposal in geological formations to be experienced in a European context. The document has been generated by the EU research project BENCHPAR: Benchmark Tests and Guidance on Coupled Processes for Performance Assessment of Nuclear Waste Repositories. The document starts in Section 1 with an explanation of why numerical analyses incorporating THM mechanisms are required for radioactive waste studies and provides background material on the subject. Then, the THM processes and their interactions are explained in Section 2. Three case examples of THM numerical analysis are presented in Section 3 to illustrate the type of work that can be conducted to study the near-field, upscaling, and the far-field. For the three cases, there is discussion on the main findings, the relevance to a safety case, the relative importance of the different couplings, and the uncertainties involved. The importance and priority of the THM couplings are then summarized in Section 4. It is especially important to be able to technically audit the numerical analyses in order to establish that all the relevant variables, parameters and mechanisms have been included in the modelling and hence that the numerical model adequately represents the rock and engineering reality. Accordingly, recommended soft and hard auditing procedures are presented in Section 5. In this Guidance Document, we emphasize especially that the most important step in numerical modelling is not executing the calculations per se, but the earlier conceptualization of the problem regarding the dominant processes, the material properties and parameters, the engineering perturbations, and their mathematical presentations. The associated modelling component of addressing the uncertainties and estimating their influence on the

  9. Safeguards Guidance Document for Designers of Commercial Nuclear Facilities: International Nuclear Safeguards Requirements and Practices For Uranium Enrichment Plants

    Energy Technology Data Exchange (ETDEWEB)

    Robert Bean; Casey Durst

    2009-10-01

    This report is the second in a series of guidelines on international safeguards requirements and practices, prepared expressly for the designers of nuclear facilities. The first document in this series is the description of generic international nuclear safeguards requirements pertaining to all types of facilities. These requirements should be understood and considered at the earliest stages of facility design as part of a new process called “Safeguards-by-Design.” This will help eliminate the costly retrofit of facilities that has occurred in the past to accommodate nuclear safeguards verification activities. The following summarizes the requirements for international nuclear safeguards implementation at enrichment plants, prepared under the Safeguards by Design project, and funded by the U.S. Department of Energy (DOE) National Nuclear Security Administration (NNSA), Office of NA-243. The purpose of this is to provide designers of nuclear facilities around the world with a simplified set of design requirements and the most common practices for meeting them. The foundation for these requirements is the international safeguards agreement between the country and the International Atomic Energy Agency (IAEA), pursuant to the Treaty on the Non-proliferation of Nuclear Weapons (NPT). Relevant safeguards requirements are also cited from the Safeguards Criteria for inspecting enrichment plants, found in the IAEA Safeguards Manual, Part SMC-8. IAEA definitions and terms are based on the IAEA Safeguards Glossary, published in 2002. The most current specification for safeguards measurement accuracy is found in the IAEA document STR-327, “International Target Values 2000 for Measurement Uncertainties in Safeguarding Nuclear Materials,” published in 2001. For this guide to be easier for the designer to use, the requirements have been restated in plainer language per expert interpretation using the source documents noted. The safeguards agreement is fundamentally a

  10. Interfaces between transport and geologic disposal systems for high-level radioactive wastes and spent nuclear fuel: A new international guidance document

    International Nuclear Information System (INIS)

    Pope, R.B.; Baekelandt, L.; Hoorelbeke, J.M.; Han, K.W.; Pollog, T.; Blackman, D.; Villagran, J.E.

    1994-01-01

    An International Atomic Energy Agency (IAEA) Technical Document (TECDOC) has been developed and will be published by the IAEA. The TECDOC addresses the interfaces between the transport and geologic disposal systems for, high-level waste (HLW) and spent nuclear fuel (SNF). The document is intended to define and assist in discussing, at both the domestic and the international level, regulatory, technical, administrative, and institutional interfaces associated with HLW and SNF transport and disposal systems; it identifies and discusses the interfaces and interface requirements between the HLW and SNF, the waste transport system used for carriage of the waste to the disposal facility, and the HLW/SNF disposal facility. It provides definitions and explanations of terms; discusses systems, interfaces and interface requirements; addresses alternative strategies (single-purpose packages and multipurpose packages) and how interfaces are affected by the strategies; and provides a tabular summary of the requirements

  11. HER2 testing of gastro-oesophageal adenocarcinoma: a commentary and guidance document from the Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee.

    Science.gov (United States)

    Wong, Newton A C S; Amary, Fernanda; Butler, Rachel; Byers, Richard; Gonzalez, David; Haynes, Harry R; Ilyas, Mohammad; Salto-Tellez, Manuel; Taniere, Philippe

    2018-05-01

    The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinical Pathology and the American Society of Clinical Oncology jointly published guidelines for HER2 testing and clinical decision making in gastro-oesophageal adenocarcinoma. The Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee has issued the following document as a commentary of these guidelines and, in parallel, to provide guidance on HER2 testing in National Health Service pathology departments within the UK. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such HER2 testing. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  12. Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

    Energy Technology Data Exchange (ETDEWEB)

    Garvin, L.J.

    1997-05-20

    This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements.

  13. Additional guidance for including nuclear safety equivalency in the Canister Storage Building and Cold Vacuum Drying Facility final safety analysis report

    International Nuclear Information System (INIS)

    Garvin, L.J.

    1997-01-01

    This document provides guidance for the production of safety analysis reports that must meet both DOE Order 5480.23 and STD 3009, and be in compliance with the DOE regulatory policy that imposes certain NRC requirements

  14. Requirements, guidance and logic in planning environmental investigations: Approval versus implementation

    International Nuclear Information System (INIS)

    Brice, D.A.; Meredith, D.V.; Harris, M.Q.

    1993-01-01

    In today's litigious society, it is important for both private parties and government to plan and conduct environmental investigations in a scientifically sound manner, documenting the purpose, methods, and results in a consistent fashion throughout the exercise. Planning documents are prepared during the initial phases of environmental investigations. Project objectives, including data quality requirements, specific work to be conducted to fulfill data needs, and operating procedures are specified. Regulatory agency approval of these documents is often required prior to plan implementation. These approvals are necessary and appropriate to fulfilling the agency's mandated role. Many guidance documents prepared by regulatory agencies suggest the content and format of various scoping documents. These guidances help standardize thought processes and considerations in planning, and provide a template to ensure that both the plan and the proposed work will fulfill regulatory requirements. This work describes the preparation and use of guidance documents for planning environmental studies. The goals and some of the pitfalls of such documents are discussed. Guidance should include the following elements: the purpose of the guidance and a description of where it applies; the type of items to be addressed in planning; identification of requirements are applicable to all projects for which the guidance is intended; identification of requirements only applicable in certain situations; a description of items to facilitate planning; a suggested format for fulfilling requirements; example applications of the guidance. Disagreements arise between planners and reviewers/approvers when elements of guidance are used as leverage to require work not directly related to project objectives. Guidance may be inappropriately used as a milestone by which site-specific plans are judged. Regulatory agency review and approval may be regarded as a primary objective of the plan

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

    Science.gov (United States)

    Belackova, Vendula; Wilkins, Chris

    2018-04-01

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

  16. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

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

  17. Lease Operations Environmental Guidance Document

    Energy Technology Data Exchange (ETDEWEB)

    Bureau of Land Management

    2001-02-14

    This report contains discussions in nine different areas as follows: (1) Good Lease Operating Practices; (2) Site Assessment and Sampling; (3) Spills/Accidents; (4) Containment and Disposal of Produced Waters; (5) Restoration of Hydrocarbon Impacted Soils; (6) Restoration of Salt Impacted Soils; (7) Pit Closures; (8) Identification, Removal and Disposal of Naturally Occurring Radioactive Materials (NORM); and (9) Site Closure and Construction Methods for Abandonment Wells/Locations. This report is primary directed towards the operation of oil and gas producing wells.

  18. Overseas Environmental Baseline Guidance Document

    Science.gov (United States)

    2007-05-01

    milligrams per liter (mg/L) determined before or at the first customer, and the corresponding disinfectant contact time, T , in minutes. CT values...for a CWS and NTNCWS that adds a disinfectant (oxidant, such as chlorine, chlorine dioxide, chloramines , or ozone) to any part of its treatment...drinking water. Operators may increase residual disinfectant levels of chlorine or chloramines (but not chlorine dioxide) in the distribution system to a

  19. Guidance documents: Continued support to improve operations of fish hatcheries and field sites to reduce the impact or prevent establishment of New Zealand Mudsnails and other invasive mollusks

    Science.gov (United States)

    Moffitt, Christine M.

    2017-01-01

    This project tested and revised a risk assessment/management tool authored by Moffitt and Stockton designed to provide hatchery biologists and others a structure to measure risk and provide tools to control, prevent or eliminate invasive New Zealand mudsnails (NZMS) and other invasive mollusks in fish hatcheries and hatchery operations. The document has two parts: the risk assessment tool, and an appendix that summarizes options for control or management.The framework of the guidance document for risk assessment/hatchery tool combines approaches used by the Hazard Analysis and Critical Control Points (HACCP) process with those developed by the Commission for Environmental Cooperation (CEC), of Canada, Mexico, and the United States, in the Tri-National Risk Assessment Guidelines for Aquatic Alien Invasive Species. The framework approach for this attached first document assesses risk potential with two activities: probability of infestation and consequences of infestation. Each activity is treated equally to determine the risk potential. These two activities are divided into seven basic elements that utilize scientific, technical, and other relevant information in the process of the risk assessment. To determine the probability of infestation four steps are used that have scores reported or determined and averaged. This assessment follows a familiar HACCP process to assess pathways of entry, entry potential, colonization potential, spread potential. The economic, environmental and social consequences are considered as economic impact, environmental impact, and social and cultural influences.To test this document, the Principal Investigator worked to identify interested hatchery managers through contacts at regional aquaculture meetings, fish health meetings, and through the network of invasive species managers and scientists participating in the Western Regional Panel on Aquatic Nuisance Species and the 100th Meridian Initiative's Columbia River Basin Team, and the

  20. 76 FR 74834 - Interim Staff Guidance on Aging Management Program for Steam Generators

    Science.gov (United States)

    2011-12-01

    ... for Steam Generators AGENCY: Nuclear Regulatory Commission. ACTION: Interim staff guidance; issuance... (LR-ISG), LR-ISG-2011-02, ``Aging Management Program for Steam Generators.'' This LR-ISG provides the...) document, NEI 97-06, ``Steam Generator Program Guidelines,'' (NRC's Agencywide Documents Access and...

  1. Standardization Documents

    Science.gov (United States)

    2011-08-01

    Specifications and Standards; Guide Specifications; CIDs; and NGSs . Learn. Perform. Succeed. STANDARDIZATION DOCUMENTS Federal Specifications Commercial...national or international standardization document developed by a private sector association, organization, or technical society that plans ...Maintain lessons learned • Examples: Guidance for application of a technology; Lists of options Learn. Perform. Succeed. DEFENSE HANDBOOK

  2. The LawsAndFamilies questionnaire on legal family formats for same-sex and/or different-sex couples : Text of the questions and of the accompanying guidance document.

    NARCIS (Netherlands)

    Waaldijk, C.; Lorenzo, Villaverde J.M.; Nikolina, N.; Zago, G.

    2016-01-01

    This Working Paper of the research project FamiliesAndSocieties contains the text of the LawsAndFamilies questionnaire, plus the text of the guidance document provided to legal experts answering this questionnaire. These texts are preceded by a brief introduction to the background, aims and

  3. 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.

  4. 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

  5. On the evolution of the regulatory guidance for seismic qualification of electric and active mechanical equipment for nuclear power plants

    International Nuclear Information System (INIS)

    Ng, Ching Hang; Chen, Pei-Ying

    2009-01-01

    All electric and active mechanical equipment important to safety for nuclear power plants must be seismically qualified by testing, analysis, or combined analysis and testing. The general requirements for seismic qualification of electric and active mechanical equipment in nuclear power plants are delineated in Appendix S, 'Earthquake Engineering Criteria for Nuclear Power Plants,' to Title 10, Part 50, 'Domestic Licensing of Production and Utilization Facilities,' of the Code of Federal Regulations (10 CFR Part 50), item 52.47(20) of 10 CFR 52.47, 'Contents of Applications; Technical Information,' and Appendix A, 'Seismic and Geologic Siting Criteria for Nuclear Power Plants,' to 10 CFR Part 100, 'Reactor Site Criteria.' The United States Nuclear Regulatory Commission (NRC) issued Revision 2 of Regulatory Guide (RG) 1.100, 'Seismic Qualification of Electric and Mechanical for Nuclear Power Plants' in 1988, which endorsed, with restrictions, exceptions, and clarifications, Institute of Electrical and Electronics Engineers (IEEE) Standard 344-1987 'IEEE Recommended Practice for Seismic Qualification of Class 1E Equipment for Nuclear Power Generating Stations,' for use in seismic qualification of both electric and mechanical equipment. In 2008, the staff at the NRC drafted Revision 3 of RG 1.100 to endorse, with restrictions, exceptions, and clarifications, the IEEE Std 344-2004 and the American Society of Mechanical Engineers (ASME) QME-1-2007 'Qualification of Active Mechanical Equipment Used in Nuclear Power Plants.' IEEE Std 344-2004 was an update of Std 344-1987 and ASME QME-1-2007 was an update of QME-1-2002. The major changes in IEEE Std 344-2004 and ASME QME-1-2007 include the update and expansion of criteria and procedures describing the use of experience data as a method for seismic qualification of Class 1E electric equipment (including I and C components) as well as active mechanical equipment. In this paper, the staff will compare the draft Revision 3 to

  6. FDA-EPA Public Health Guidance on Fish Consumption: A Case Study on Informal Interagency Cooperation in "Shared Regulatory Space".

    Science.gov (United States)

    Holden, Mark

    2015-01-01

    This article is a case study on how administrative agencies interact with each other in cases of shared regulatory jurisdiction. The theoretical literature on the topic of overlapping jurisdiction both (1) makes predictions about how agencies are expected to behave when they share jurisdiction, and (2) in recent iterations argues that overlapping jurisdiction can confer unique policymaking benefits. Through the lens of that theoretical literature, this article examines the relations between the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) regarding the public health risks posed by mercury in fish. It concludes that the FDA-EPA case study (1) corroborates the extant theoretical accounts of how agencies behave in cases of overlapping jurisdiction, (2) supports the conclusion of the recent scholarship that overlapping jurisdiction can confer unique policy benefits, and (3) reveals a few wrinkles not given adequate treatment in the extant literature.

  7. Safety of magnetic fusion facilities: Guidance

    International Nuclear Information System (INIS)

    1996-05-01

    This document provides guidance for the implementation of the requirements identified in DOE-STD-6002-96, Safety of Magnetic Fusion Facilities: Requirements. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While the requirements in DOE-STD-6002-96 are generally applicable to a wide range of fusion facilities, this Standard, DOE-STD-6003-96, is concerned mainly with the implementation of those requirements in large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This Standard is oriented toward regulation in the Department of Energy (DOE) environment as opposed to regulation by other regulatory agencies. As the need for guidance involving other types of fusion facilities or other regulatory environments emerges, additional guidance volumes should be prepared. The concepts, processes, and recommendations set forth here are for guidance only. They will contribute to safety at magnetic fusion facilities

  8. Significant Guidance Issued by the Federal Motor Carrier Safety Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  9. Significant Guidance Issued by the Federal Transit Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  10. Significant Guidance Issued by the Federal Aviation Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  11. Significant Guidance Issued by the Federal Highway Administration

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  12. Probabilistic risk assessment (PRA) reference document. Final report

    International Nuclear Information System (INIS)

    Murphy, J.A.

    1984-09-01

    This document describes the current status of probabilistic risk assessment (PRA) as practiced in the nuclear reactor regulatory process. The PRA studies that have been completed or are under way are reviewed. The levels of maturity of the methodologies used in a PRA are discussed. Insights derived from PRAs are listed. The potential uses of PRA results for regulatory purposes are discussed. This document was issued for comment in February 1984 entitled Probabilistic Risk Assessment (PRA): Status Report and Guidance for Regulatory Application. The comments received on the draft have been considered for this final version of the report

  13. RH Packaging Program Guidance

    International Nuclear Information System (INIS)

    Washington TRU Solutions, LLC

    2003-01-01

    The purpose of this program guidance document is to provide technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the SARP and/or C of C shall govern. The C of C states: ''...each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, ''Operating Procedures,'' of the application.'' It further states: ''...each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, ''Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M and O) contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC approved, users need to be familiar with 10 CFR (section) 71.11, ''Deliberate Misconduct.'' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the RH-TRU 72-B packaging. This Program Guidance standardizes instructions for all users. Users shall follow these instructions. Following these instructions assures that operations are safe and meet the requirements of the SARP. This document is available on the Internet at: ttp://www.ws/library/t2omi/t2omi.htm. Users are responsible for ensuring they are using the current revision and change notices. Sites may prepare their own document using the word

  14. First update to the US Nuclear Regulatory Commission's regulatory strategy for the high-level waste repository program

    International Nuclear Information System (INIS)

    Johnson, R.L.; Linehan, J.J.

    1991-01-01

    The US Nuclear Regulatory Commission (NRC) staff has updated its initial regulatory strategy for the High-Level Waste Repository Licensing Program. The update describes changes to the initial strategy and summarizes progress and future activities. This paper summarizes the first update of the regulatory strategy. In general the overall strategy of identifying and reducing uncertainties is unchanged. Identifying regulatory and institutional uncertainties is essentially complete, and therefore, the current and future emphasis is on reducing those regulatory and institutional uncertainties identified to date. The NRC staff has improved the methods of reducing regulatory uncertainties by (1) enhancing the technical basis preparation process for potential rulemakings and guidance and (2) designing a new guidance document, called a staff position, for clarifying regulatory uncertainties. For guiding the US DOE's reduction of technical uncertainties, the NRC staff will give more emphasis to prelicense application reviews and less emphasis on preparing staff technical positions

  15. Selection of the situations taken into account for the safety demonstration of a repository in deep geological formations - French regulatory guidance and IPSN modelling experience

    International Nuclear Information System (INIS)

    Escalier des Orres, P.; Greneche, D.

    1993-01-01

    A regulatory guidance has been recently set up in France for the safety assessment of radwaste deep geological disposal: the present paper deals with the methodology related to the safety demonstration of such a disposal, particularly the situations to be taken into account to address the potential evolution of the repository under natural or human induced events. This approach, based on a selection of events considered as reasonably envisageable, relies on a reference scenario characterized by a great stability of the geological formation and on hypothetical situations corresponding to the occurrence of random events of natural origin or of conventional nature. The implementation of this methodology within the framework of the IPSN (Protection and Nuclear Safety Institute, CEA) participation in the CEC EVEREST project is addressed. This programme consists in the evaluation of the sensitivity of the radiological consequences associated to deep radwaste disposal systems to the different elements of the performance assessment (scenario characteristics, phenomena, physico-chemical parameters) in three types of geological formations (granite, salt and clay).(author). 11 refs., 3 tabs

  16. RH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2006-01-01

    The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' It further states: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M and O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with 10 Code of Federal Regulations (CFR) 1.8, 'Deliberate Misconduct.' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, 'Packaging and Transportation of Radioactive Material,' certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, 'Reporting of Defects and Noncompliance,' regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these

  17. RH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2008-01-01

    The purpose of this program guidance document is to provide the technical requirements for use, operation, inspection, and maintenance of the RH-TRU 72-B Waste Shipping Package (also known as the 'RH-TRU 72-B cask') and directly related components. This document complies with the requirements as specified in the RH-TRU 72-B Safety Analysis Report for Packaging (SARP), and Nuclear Regulatory Commission (NRC) Certificate of Compliance (C of C) 9212. If there is a conflict between this document and the SARP and/or C of C, the C of C shall govern. The C of C states: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' It further states: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP tasks the Waste Isolation Pilot Plant (WIPP) Management and Operating (M and O) Contractor with assuring the packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) 71.8, 'Deliberate Misconduct.' Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the U.S. Department of Energy (DOE) Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, 'Packaging and Transportation of Radioactive Material,' certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21, 'Reporting of Defects and Noncompliance,' regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous

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

    International Nuclear Information System (INIS)

    2012-01-01

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

  19. NRC ARDC Guidance Support Status Report

    Energy Technology Data Exchange (ETDEWEB)

    Holbrook, Mark R. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2017-07-01

    This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”

  20. NRC ARDC Guidance Support Status Report

    International Nuclear Information System (INIS)

    Holbrook, Mark R.

    2017-01-01

    This report provides a summary that reflects the progress and status of proposed regulatory design criteria for advanced non-light water reactor (LWR) designs in accordance with the Level 3 milestone M3AT-17IN2001013 in work package AT-17IN200101. These criteria have been designated as advanced reactor design criteria (ARDC) and they provide guidance to future applicants for addressing the general design criteria (GDC) that are currently applied specifically to LWR designs. This report provides a summary of Phase 2 activities related to the various tasks associated with ARDC development and the subsequent development of ARDC regulatory guidance for sodium fast reactor (SFR) and modular high-temperature gas-cooled reactor (HTGR) designs. Status Report Organization: Section 2 discusses the origin of the GDC and their application to LWRs. Section 3 addresses the objective of this initiative and how it benefits the advanced non-LWR reactor vendors. Section 4 discusses the scope and structure of the initiative. Section 5 provides background on the U.S. Department of Energy (DOE) ARDC team’s original development of the proposed ARDC that were submitted to the NRC for consideration. Section 6 provides a summary of recent ARDC Phase 2 activities. Appendices A through E document the DOE ARDC team’s public comments on various sections of the NRC’s draft regulatory guide DG–1330, “Guidance for Developing Principal Design Criteria for Non-Light Water Reactors.”

  1. NPP License Renewal and Aging Management: Revised Guidance

    International Nuclear Information System (INIS)

    Hull, A.B.; Hiser, A.L.; Lindo-Talin, S.E.

    2012-01-01

    Based on the Atomic Energy Act, the NRC issues licenses for commercial power reactors to operate for up to 40 years and allows these licenses to be renewed for up to another 20 years. NRC has approved license renewal (LR) for well over 50% of U.S. located reactors originally licensed to operate for 40 years. Of these 104 reactors (69 PWRs, 35 BWRs), the NRC has issued renewed licenses for 71 units and is currently reviewing applications for another 15 units. As of May 1, 2012, ten plants at nine sites had entered their 41st year of operation and thus are in their first period of extended operation (PEO). Five more plants will enter the PEO by the end of 2012. One foundation of the license renewal process has been license renewal guidance documents (LRGDs). The U.S. Nuclear Regulatory Commission (NRC) revised key guidance documents used for nuclear power LR in 2010 and 2011. These include NUREG-1800, 'Standard Review Plan for Review of License Renewal Applications,' revision 2 (SRP-LR), and NUREG-1801, 'Generic Aging Lessons Learned (GALL) Report,' revision 2 (GALL Report). The guidance documents were updated to reflect lessons learned and operating experience gained since the guidance documents were last issued in 2005. The reactor LRGDs referenced in this poster can all be accessed at http://www.nrc.gov/reactors/operating/licensing/renewal/guidance.html (author)

  2. INTERNATIONAL REGULATORY DOCUMENTS WITH SPECIAL REGIME USED BY ROMANIAN PRINCIPALITIES IN RELATIONS WITH THE OTTOMAN AND THE RUSSIAN EMPIRE

    Directory of Open Access Journals (Sweden)

    Ion Gr. IONESCU

    2015-11-01

    Full Text Available Although the existence of some regulating documents, called capitulations, concerning the relations on various plans, between the Romanian Country, Moldavia and the Ottoman Empire was known, the first one of these diplomatic documents, that have been operational over time, was discovered only in 1974. It was an act that had been granted to Mihnea Turkished, in the year 1585. This important discovery has been completed, with others that had the same purpose. In fact, they were some diplomatic documents, with the role of Treaty, which has regulated quite explicitly, the status of the two Romanian principalities, in relations with the suzerain power. The most important fact of their contents was the recognition of the internal autonomy of principalities and a certain degree of freedom, in relations outside the borders. The price was that Romanian countries paid was ,however, to never become hostile to Ottoman interests, integrating in the Ottoman foreign policy and paying an annual tribute.

  3. Advance notification of shipments of nuclear waste and spent fuel: guidance

    International Nuclear Information System (INIS)

    1982-06-01

    U.S. Nuclear Regulatory Commission regulations in 10 CFR 70.5b and 73.37(f) require NRC licensees to notify the governor of a state prior to making a shipment of nuclear waste or spent fuel within or through the state. This guidance document was prepared to assist licensees in carrying out those requirements

  4. Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols

    International Nuclear Information System (INIS)

    2012-01-01

    This publication is aimed at enhancing States' understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in 'Safeguards Implementation Practices' (SIPs) to be published separately.

  5. Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols

    International Nuclear Information System (INIS)

    2016-01-01

    This publication is aimed at enhancing States’ understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that is supported by detailed guidance and examples in safeguards implementation practices presented in other publications in the series. (This version is the 2016 update.)

  6. Documents preparation and review

    International Nuclear Information System (INIS)

    1999-01-01

    Ignalina Safety Analysis Group takes active role in assisting regulatory body VATESI to prepare various regulatory documents and reviewing safety reports and other documentation presented by Ignalina NPP in the process of licensing of unit 1. The list of main documents prepared and reviewed is presented

  7. PSD Increment Consumption Guidance

    Science.gov (United States)

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  8. Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A. [Nuclear Regulatory Commission, Washington, DC (United States). Div. of Industrial and Medical Nuclear Safety; Tingle, W. [Dept. of Environment, Health, and Natural Resources, Raleigh, NC (United States). Div. of Radiation Protection

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ``Applications for the Use of Sealed Sources in Portable Gauging Devices,`` and in NMSs Policy and guidance Directive 2-07, ``Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.`` This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications.

  9. Consolidated guidance about materials licenses: Program-specific guidance about portable gauge licenses. Final report; Volume 1

    International Nuclear Information System (INIS)

    Vacca, P.C.; Whitten, J.E.; Pelchat, J.M.; Arredondo, S.A.; Matson, E.R.; Lewis, S.H.; Collins, D.J.; Santiago, P.A.; Tingle, W.

    1997-05-01

    As part of its redesign of the materials licensing process, NRC is consolidating and updating numerous guidance documents into a single comprehensive repository as described in NUREG-1539 and draft NUREG-1541. NUREG-1556, Vol. 1, is the first program-specific guidance developed for the new process and will serve as a template for subsequent program-specific guidance. This document is intended for use by applicants, licensees, and NRC staff and will also be available to Agreement States. This document supersedes the guidance previously found in draft Regulatory Guide DG-0008, ''Applications for the Use of Sealed Sources in Portable Gauging Devices,'' and in NMSs Policy and guidance Directive 2-07, ''Standard Review Plan for Applications for Use of Sealed Sources in Portable Gauging Devices.'' This final report takes a more risk-informed, performance-based approach to licensing portable gauges, and reduces the information(amount and level of detail) needed to support an application to use these devices. It incorporates many suggests submitted during the comment period on draft NUREG-1556, Volume 1. When published, this final report should be used in preparing portable gauge license applications. NRC staff will use this final report in reviewing these applications

  10. NPP License Renewal and Aging Management: Revised Guidance

    International Nuclear Information System (INIS)

    Hull, A.B.; Hiser, A.L.; Lindo-Talin, S.E.

    2012-01-01

    Based on the Atomic Energy Act, the NRC issues licenses for commercial power reactors to operate for up to 40 years and allows these licenses to be renewed for up to another 20 years. NRC has approved license renewal for well over 50% of U.S. located reactors originally licensed to operate for 40 years. Of these 104 reactors (69 PWRs, 35 BWRs), the NRC has issued renewed licenses for 71 units and is currently reviewing applications for another 15 units. As of May 1, 2012, ten plants at nine sites had entered their 41st year of operation and thus are in their first period of extended operation (PEO). Five more plants will enter the PEO by the end of 2012. One foundation of the license renewal process has been license renewal guidance documents (LRGDs). The U.S. Nuclear Regulatory Commission (NRC) revised key guidance documents used for nuclear power license renewal in 2010 and 2011. These include NUREG-1800, 'Standard Review Plan for Review of License Renewal Applications,' revision 2 (SRP-LR), and NUREG-1801, 'Generic Aging Lessons Learned (GALL) Report,' revision 2 (GALL Report). The guidance documents were updated to reflect lessons learned and operating experience gained since the guidance documents were last issued in 2005. (author)

  11. [International trend of guidance for nanomaterial risk assessment].

    Science.gov (United States)

    Hirose, Akihiko

    2013-01-01

    In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

  12. 77 FR 14047 - Guidance for Decommissioning Planning During Operations

    Science.gov (United States)

    2012-03-08

    ...)-4014, ``Decommissioning Planning During Operations.'' This action is necessary to correct the NRC's... NUCLEAR REGULATORY COMMISSION [NRC-2011-0286] Guidance for Decommissioning Planning During Operations AGENCY: Nuclear Regulatory Commission. ACTION: Draft regulatory guide; correction. SUMMARY: The U...

  13. Significant Guidance Issued by the Office of the Secretary of Transportation

    Data.gov (United States)

    Department of Transportation — A list of Significant Guidance documents, which include guidance document disseminated to regulated entities or the general public that may reasonably be anticipated...

  14. A Decade in the MIST: Learnings from Investigations of Drug Metabolites in Drug Development under the "Metabolites in Safety Testing" Regulatory Guidance.

    Science.gov (United States)

    Schadt, Simone; Bister, Bojan; Chowdhury, Swapan K; Funk, Christoph; Hop, Cornelis E C A; Humphreys, W Griffith; Igarashi, Fumihiko; James, Alexander D; Kagan, Mark; Khojasteh, S Cyrus; Nedderman, Angus N R; Prakash, Chandra; Runge, Frank; Scheible, Holger; Spracklin, Douglas K; Swart, Piet; Tse, Susanna; Yuan, Josh; Obach, R Scott

    2018-06-01

    Since the introduction of metabolites in safety testing (MIST) guidance by the Food and Drug Administration in 2008, major changes have occurred in the experimental methods for the identification and quantification of metabolites, ways to evaluate coverage of metabolites, and the timing of critical clinical and nonclinical studies to generate this information. In this cross-industry review, we discuss how the increased focus on human drug metabolites and their potential contribution to safety and drug-drug interactions has influenced the approaches taken by industry for the identification and quantitation of human drug metabolites. Before the MIST guidance was issued, the method of choice for generating comprehensive metabolite profile was radio chromatography. The MIST guidance increased the focus on human drug metabolites and their potential contribution to safety and drug-drug interactions and led to changes in the practices of drug metabolism scientists. In addition, the guidance suggested that human metabolism studies should also be accelerated, which has led to more frequent determination of human metabolite profiles from multiple ascending-dose clinical studies. Generating a comprehensive and quantitative profile of human metabolites has become a more urgent task. Together with technological advances, these events have led to a general shift of focus toward earlier human metabolism studies using high-resolution mass spectrometry and to a reduction in animal radiolabel absorption/distribution/metabolism/excretion studies. The changes induced by the MIST guidance are highlighted by six case studies included herein, reflecting different stages of implementation of the MIST guidance within the pharmaceutical industry. Copyright © 2018 by The American Society for Pharmacology and Experimental Therapeutics.

  15. Knowledge, workflow and electronic document management in the system of the State Nuclear Regulatory Inspectorate of Ukraine. Preparing the platform development and implementation of the Knowledge Portal

    International Nuclear Information System (INIS)

    Bozhko, S.G.; Shevchenko, Yi.A.; Pecheritsya, O.V.; Singayivs'kij, A.M.

    2016-01-01

    The previous paper considered the creation of the system for management of nuclear knowledge, workflow and electronic documents (hereinafter called the Knowledge Portal) in the field of safe nuclear energy use. It presented initial steps needed to make an informed decision on the feasibility of implementing the Knowledge Portal and proposed methodological approaches based on practical experience of the State Nuclear Regulatory Inspectorate of Ukraine and the SSTC NRS. Further pre - project activities of the state body, local authorities, enterprises, institutions and organizations irrespective of ownership (hereinafter called the Institution) involve the development and drawing attention to the package of analytical, technical and feasibility documents. In particular, it is recommended to take into account the results of analyzing world trends in the development of information technology, audit status information and telecommunication systems (hereinafter - ITS) of the Institution, detailed strategy for the development of ITS Institution (hereinafter - the Strategy), the concept of the Knowledge Portal (hereinafter - the Concept) and preliminary technical solution The results of review and approval of the Concept and architecture solution by scientific and technical council of the Institution is the basis for the preparation of Ter ms of Reference (hereinafter - TOR) on the development of the Knowledge Portal, forming schedules for the procurement of hardware and software, works on the development and implementation of portal solutions and information security systems

  16. Final guidance document for extended Level 2 PSA Volume 1. Summary report for external hazards implementation in extended L2 PSA, validation of SAMG strategy and complement of ASAMPSA2 L2PSA guidance

    International Nuclear Information System (INIS)

    Loeffler, H.; Raimond, E.

    2016-01-01

    The present document is a summary of the deliverables produced within the ASAMPSA-E project for extended L2 PSA. These deliverables are: D30.7 vol. 2, 'Implementing external Events modelling in Level 2 PSA': D30.7 vol. 3: 'Verification and improvement of SAM strategy: D30.7 vol. 4: 'Consideration of shutdown states, spent fuel pools and recent R and D results'. Among many others, the following summary statements are provided: Analyses of external events: - No need for new methodology, - It is necessary to develop L1 PSA first and then clearly defined boundary conditions for the L2 PSA must be generated, - The remaining challenge is how to address adverse environmental conditions due to external hazards. Multi units: - No practical methodology exists to treat the problem, - A new methodology is necessary to be developed first for the L1 PSA. This should, from the beginning, take into account the specific needs of L2 PSA so that the boundary conditions for subsequent level 2 analysis can be generated adequately. SAM strategies verification and improvement: - L2 PSA methodology can usefully by applied and experience exists for internal initiating events L2 PSA, - How to address adverse environmental conditions due to external hazards - needs for new methodology or examples of experience, - How to model the decision process when there is a conflict of interest - needs for new methodology or examples of experience. For L2 PSA in shutdown states with open RPV, some new technical issues (fission product release, thermal load to structures above RPV) have to be addressed. Spent fuel pool issues have been developed, in particular: - Heat load from the melting spent fuel to structures above (e.g. to the containment roof) is a severe challenge for the plant and for the present-day, methodology is missing. Recent R and D achievements with relevance for L2 PSA: - Basic research has been continued in the radiochemistry (iodine and ruthenium chemistry) field, but the existing

  17. 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

  18. Model review and evaluation for application in DOE safety basis documentation of chemical accidents - modeling guidance for atmospheric dispersion and consequence assessment

    Energy Technology Data Exchange (ETDEWEB)

    Lazaro, M. A. [Argonne National Lab. (ANL), Argonne, IL (United States); Woodarad, K. [Argonne National Lab. (ANL), Argonne, IL (United States); Hanna, S. R. [Argonne National Lab. (ANL), Argonne, IL (United States); Hesse, D. J. [Argonne National Lab. (ANL), Argonne, IL (United States); Huang, J. -C. [Argonne National Lab. (ANL), Argonne, IL (United States); Lewis, J. [Argonne National Lab. (ANL), Argonne, IL (United States); Mazzola, C. A. [Argonne National Lab. (ANL), Argonne, IL (United States)

    1997-09-01

    The U.S. Department of Energy (DOE), through its Defense Programs (DP), Office of Engineering and Operations Suppon, established the Accident Phenomenology and Consequence (AP AC) Methodology Evaluation Program to identify and evaluate methodologies and computer codes to support accident phenomenological and consequence calculations for both radiological and nonradiological materials at DOE facilities and to identify development needs. The program is also intended to define and recommend "best or good engineering/safety analysis practices" to be followed in preparing ''design or beyond design basis" assessments to be included in DOE nuclear and nonnuclear facility safety documents. The AP AC effort is intended to provide scientifically sound and more consistent analytical approaches, by identifying model selection procedures and application methodologies, in order to enhance safety analysis activities throughout the DOE complex.

  19. 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

  20. Quality assurance guidance for a low-level radioactive waste disposal facility

    International Nuclear Information System (INIS)

    Pittiglio, C.L. Jr.; Hedges, D.

    1991-04-01

    This document provides guidance to an applicant on meeting the quality control (QC) requirements of 10 CFR 61.12(j) for a low-level radioactive waste (LLRW) disposal facility. The QC requirements, plus audits and managerial controls requirements, establish the need for developing a quality assurance (QA) program and the guidance provided herein. The criteria developed for this document are similar to the criteria developed for Appendix B to Title 10 of the Code of Federal Regulations (10 CFR) Part 50. Although Appendix B is not a regulatory requirement for an LLRW disposal facility, the criteria that were developed for 10 CFR Part 50 are basic to any QA program. This document establishes QA guidance for the design, construction, and operation of those structures, engineered or natural systems, and components whose function is required to meet the performance objectives of Subpart C of 10 CFR Part 61 and to limit exposure to or release of radioactivity. 7 refs

  1. Threshold guidance update

    International Nuclear Information System (INIS)

    Wickham, L.E.

    1986-01-01

    The Department of Energy (DOE) is developing the concept of threshold quantities for use in determining which waste materials must be handled as radioactive waste and which may be disposed of as nonradioactive waste at its sites. Waste above this concentration level would be managed as radioactive or mixed waste (if hazardous chemicals are present); waste below this level would be handled as sanitary waste. Last years' activities (1984) included the development of a threshold guidance dose, the development of threshold concentrations corresponding to the guidance dose, the development of supporting documentation, review by a technical peer review committee, and review by the DOE community. As a result of the comments, areas have been identified for more extensive analysis, including an alternative basis for selection of the guidance dose and the development of quality assurance guidelines. Development of quality assurance guidelines will provide a reasonable basis for determining that a given waste stream qualifies as a threshold waste stream and can then be the basis for a more extensive cost-benefit analysis. The threshold guidance and supporting documentation will be revised, based on the comments received. The revised documents will be provided to DOE by early November. DOE-HQ has indicated that the revised documents will be available for review by DOE field offices and their contractors

  2. PIV Logon Configuration Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Glen Alan [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-03-04

    This document details the configurations and enhancements implemented to support the usage of federal Personal Identity Verification (PIV) Card for logon on unclassified networks. The guidance is a reference implementation of the configurations and enhancements deployed at the Los Alamos National Laboratory (LANL) by Network and Infrastructure Engineering – Core Services (NIE-CS).

  3. Models of Co2 emission trading system for projections in MSG6. Documentation and guidance; Utviklingen i stroemforbruket, prisfoelsomheten og stroemmarkedet

    Energy Technology Data Exchange (ETDEWEB)

    Faehn, Taran; Stroem, Birger

    2012-08-15

    Present context of the EU Co2 Emission Trading System (EU ETS) from 2008, involves new measures directed towards a large portion of present emissions sources. Currently there is no basis in statistics figures to offset the consequences of these international obligations in SSB models. In the model projections is nevertheless necessary to model both the current instruments and expected future changes in the rules and forms of association. This paper documents the Ministry of Finance to establish a arrangements for implementing Norway's association with the EU ETS in the model MSG6. It also addresses the EU ETS policy instruments interacting with other objectives and instruments of climate policy, including the Kyoto commitments and various domestic Climate tax systems. The European emissions trading price affect the Norwegian economy through several channels. Firstly, allowances mean that the EU ETS will cover activities that gets an emission rate equal to the permit price, which will influence the players to reduce emissions through various adaptations. Second, the remaining emissions occur subject to quotas, and the proportion who do not receive free allowances will give the state the auction revenue / proceeds. Third, quotas purchased in international markets will affect account surplus. This paper outlines various solutions and concludes by recommending a system that easily can be adapted for studies of any interaction between the EU ETS system and other climate policy objectives. The system can also be easily updated to new data.(eb)

  4. Guidance on the application of quality assurance for characterizing a low-level radioactive waste disposal site

    International Nuclear Information System (INIS)

    Pittiglio, C.L. Jr.; Starmer, R.J.; Hedges, D.

    1990-10-01

    This document provides the Nuclear Regulatory Commission's staff guidance to an applicant on meeting the quality control (QC) requirements of Title 10 of the Code of Federal Regulations, Part 61, Section 61.12 (10 CFR 61.12), for a low-level waste disposal facility. The QC requirements combined with the requirements for managerial controls and audits are the basis for developing a quality assurance (QA) program and for the guidance provided herein. QA guidance is specified for site characterization activities necessary to meet the performance objectives of 10 CFR Part 61 and to limit exposure to or the release of radioactivity. 1 tab

  5. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions: Endorsed by the Chinese Society of Cardiology.

    Science.gov (United States)

    Räber, Lorenz; Mintz, Gary S; Koskinas, Konstantinos C; Johnson, Thomas W; Holm, Niels R; Onuma, Yoshinubo; Radu, Maria D; Joner, Michael; Yu, Bo; Jia, Haibo; Menevau, Nicolas; de la Torre Hernandez, Jose M; Escaned, Javier; Hill, Jonathan; Prati, Francesco; Colombo, Antonio; di Mario, Carlo; Regar, Evelyn; Capodanno, Davide; Wijns, William; Byrne, Robert A; Guagliumi, Giulio

    2018-05-22

    This Consensus Document is the first of two reports summarizing the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on the clinical use of intracoronary imaging including intravascular ultrasound (IVUS) and optical coherence tomography (OCT). The first document appraises the role of intracoronary imaging to guide percutaneous coronary interventions (PCIs) in clinical practice. Current evidence regarding the impact of intracoronary imaging guidance on cardiovascular outcomes is summarized, and patients or lesions most likely to derive clinical benefit from an imaging-guided intervention are identified. The relevance of the use of IVUS or OCT prior to PCI for optimizing stent sizing (stent length and diameter) and planning the procedural strategy is discussed. Regarding post-implantation imaging, the consensus group recommends key parameters that characterize an optimal PCI result and provides cut-offs to guide corrective measures and optimize the stenting result. Moreover, routine performance of intracoronary imaging in patients with stent failure (restenosis or stent thrombosis) is recommended. Finally, strengths and limitations of IVUS and OCT for guiding PCI and assessing stent failures and areas that warrant further research are critically discussed.

  6. Report on the Regulatory Experience of Risk-Informed In-service Inspection of Nuclear Power Plant Components and Common Views (consensus document)

    International Nuclear Information System (INIS)

    2004-08-01

    The present report represents the work product of the activities conducted by the Task Force. The TF performed a review and inventory of the existing approaches to risk-informed inservice inspection and testing, and completed its work in 1999 with a Current Practices Document 2, titled Report on risk-informed in-service inspection and in-service testing (EUR 19153 EN). In November 2001, the NRWG held a Special session on risk-informed applications, with emphasis on risk-informed inservice inspection, where results and experiences from pilot studies on risk-informed inservice inspection (RI-ISI), performed in several European countries, were presented and discussed. As a follow-up in May 2002, the TF was reconvened with the objectives to analyse from the regulatory point of view key aspects associated with the application of risk-informed inservice inspection, and to go beyond a state of the art report, presenting a series of recommendations of good practices or common positions reached by the regulators represented in the Task Force. (author)

  7. Regulatory viewpoint on nuclear fuel quality assurance

    International Nuclear Information System (INIS)

    Tripp, L.E.

    1976-01-01

    Considerations of the importance of fuel quality and performance to nuclear safety, ''as low reasonably achievable'' release of radioactive materials in reactor effluents, and past fuel performance problems demonstrate the need for strong regulatory input, review and inspection of nuclear fuel quality assurance programs at all levels. Such a regulatory program is being applied in the United States of America by the US Nuclear Regulatory Commission. Quality assurance requirements are contained within government regulations. Guidance on acceptable methods of implementing portions of the quality assurance program is contained within Regulatory Guides and other NRC documents. Fuel supplier quality assurance program descriptions are reviewed as a part of the reactor licensing process. Inspections of reactor licensee control of their fuel vendors as well as direct inspections of fuel vendor quality assurance programs are conducted on a regularly scheduled basis. (author)

  8. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

    Energy Technology Data Exchange (ETDEWEB)

    Hughes, P. J. [HM Nuclear Installations Inspectorate Marine Engineering Submarines Defence Nuclear Safety Regulator Serco Assurance Redgrave Court, Merton Road, Bootle L20 7HS (United Kingdom); Westwood, R.N; Mark, R. T. [FLEET HQ, Leach Building, Whale Island, Portsmouth, PO2 8BY (United Kingdom); Tapping, K. [Serco Assurance,Thomson House, Risley, Warrington, WA3 6GA (United Kingdom)

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety cases for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)

  9. Computerising documentation

    International Nuclear Information System (INIS)

    Anon.

    1992-01-01

    The nuclear power generation industry is faced with public concern and government pressures over safety, efficiency and risk. Operators throughout the industry are addressing these issues with the aid of a new technology - technical document management systems (TDMS). Used for strategic and tactical advantage, the systems enable users to scan, archive, retrieve, store, edit, distribute worldwide and manage the huge volume of documentation (paper drawings, CAD data and film-based information) generated in building, maintaining and ensuring safety in the UK's power plants. The power generation industry has recognized that the management and modification of operation critical information is vital to the safety and efficiency of its power plants. Regulatory pressure from the Nuclear Installations Inspectorate (NII) to operate within strict safety margins or lose Site Licences has prompted the need for accurate, up-to-data documentation. A document capture and management retrieval system provides a powerful cost-effective solution, giving rapid access to documentation in a tightly controlled environment. The computerisation of documents and plans is discussed in this article. (Author)

  10. Image Guidance

    Science.gov (United States)

    Guidance that explains the process for getting images approved in One EPA Web microsites and resource directories. includes an appendix that shows examples of what makes some images better than others, how some images convey meaning more than others

  11. Information architecture. Volume 3: Guidance

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-04-01

    The purpose of this document, as presented in Volume 1, The Foundations, is to assist the Department of Energy (DOE) in developing and promulgating information architecture guidance. This guidance is aimed at increasing the development of information architecture as a Departmentwide management best practice. This document describes departmental information architecture principles and minimum design characteristics for systems and infrastructures within the DOE Information Architecture Conceptual Model, and establishes a Departmentwide standards-based architecture program. The publication of this document fulfills the commitment to address guiding principles, promote standard architectural practices, and provide technical guidance. This document guides the transition from the baseline or defacto Departmental architecture through approved information management program plans and budgets to the future vision architecture. This document also represents another major step toward establishing a well-organized, logical foundation for the DOE information architecture.

  12. National ethics guidance in Sub-Saharan Africa on the collection and use of human biological specimens: a systematic review.

    Science.gov (United States)

    Barchi, Francis; Little, Madison T

    2016-10-22

    Ethical and regulatory guidance on the collection and use of human biospecimens (HBS) for research forms an essential component of national health systems in Sub-Saharan Africa (SSA), where rapid advances in genetic- and genomic-based technologies are fueling clinical trials involving HBS and the establishment of large-scale biobanks. An extensive multi-level search for publicly available ethics regulatory guidance was conducted for each SSA country. A second review documented active trials listed in the WHO International Clinical Trials Registry Platform as of January 2015 in which HBS collection was specified in the protocol. Findings were combined to determine the extent to which countries that are study sites for HBS-related research are supported by regulatory guidance language on the collection, use, ownership and storage of biospecimens. Of the 49 SSA countries, 29 had some form of national ethics guidance, yet only 17 provided language relating to HBS-related research, with specific guidance on consent (14), ownership (6), reuse (10), storage (9), and export/import/transfer (13). Ten countries accounted for 84 % of the active clinical trials involving the collection of HBS in SSA. All except one of these countries were found to have some national guidance in the form of regulations, codes of ethics, and/or standard operating procedures; however, only seven of the ten offered any language specific to HBS. Despite the fact that the bulk of registered clinical trials in SSA involving HBS, as well as existing and proposed sites for biorepositories under the H3Africa Initiative, are currently situated in countries with the most complete ethics and regulatory guidance, variability in the regulations themselves may create challenges for planned and future pan-African collaborations and may require legislative action at the national level to revise. Countries in SSA that still lack regulatory guidance on HBS will require extensive health system strengthening in

  13. 78 FR 13097 - Electric Power Research Institute; Seismic Evaluation Guidance

    Science.gov (United States)

    2013-02-26

    ... NUCLEAR REGULATORY COMMISSION [NRC-2013-0038] Electric Power Research Institute; Seismic... Electric Power Research Institute (EPRI)-1025287, ``Seismic Evaluation Guidance: Screening, Prioritization... guidance and clarification of an acceptable approach to assist nuclear power reactor licensees when...

  14. Application of international recommendations and guidance on low level radioactive waste management and remediation of contaminated land at the national level: Experience of regulatory support in Northwest Russia

    International Nuclear Information System (INIS)

    Sneve, M.; Smith, G.M.; Kerrigan, E

    2005-01-01

    This paper notes the developments in international recommendations on radioactive waste management and remediation of contaminated land and considers their implementation in the context of the Norwegian Plan of Action to improve nuclear safety in North West Russia. Summary information is provided on projects to implement waste management activities (so-called Industrial Projects) and on projects to support regulatory supervision of waste management activities (so-called Regulatory Support Projects). The links between international recommendations and national practice are discussed and it is concluded that, in practice, the details of national standards differ both among themselves and, in some respects, from the recommendations of the ICRP and IAEA. Examples of further potential collaboration projects are listed. While separate responsibilities among organisations have to clear and maintained, combined involvement of operators and regulators is recognised as a prioritised area in future cooperation between NRPA and Russia. (author)

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

    International Nuclear Information System (INIS)

    2000-02-01

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

  16. Moisture Control Guidance for Commercial and Public ...

    Science.gov (United States)

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled

  17. C-130 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) Strict Technical Order (TO) and Operating Instruction (0I) directives. The TOs and Ols govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  18. C-17 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) strict Technical Order (TO) and Operating Instruction (01) directives. The TOs and OIs govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  19. B-1 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) strict Technical Order (TO) and Operating Instruction (01) directives. The TOs and OIs govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  20. F-16 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) strict Technical Order (TO) and Operating Instruction (OI) directives. The TOs and OIs govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  1. KC-10 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) strict Technical Order (TO) and Operating Instruction (0I) directives. The TOs and Ols govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  2. C-5 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) strict Technical Order (TO) and Operating Instruction (0I) directives. The TOs and OIs govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  3. C-141 Confined Space Technical Guidance Document

    National Research Council Canada - National Science Library

    Kapranos, Sophia

    2002-01-01

    ...) strict Technical Order (TO) and Operating Instruction (0I) directives. The TOs and OIs govern procedures such as lockout/tagout and system checks prior to entering the various areas of an aircraft.

  4. Potable Water Quality Management Guidance Document

    Science.gov (United States)

    2007-09-01

    include GAC, microfiltration , ultrafiltration or nanofiltration. Because consecutive systems are buying and distributing treated water, their options for...booster chlorination and breakpoint chlorination. Booster chlorination restores chlorine residuals in the distribution system and minimizes initial...and sediments from the system; and 3) remove stagnant water. Removing stagnant water enables systems to restore disinfectant residuals to distant

  5. The Regulatory Approach for the Assessment of Safety Culture in Germany: A Tool for Practical Use for Inspections

    International Nuclear Information System (INIS)

    Fassmann, W.; Beck, J.; Kopisch, C.

    2016-01-01

    Need for methods to assess licencees’ safety culture has been recognised since the Chernobyl accident. Several conferences organized by IAEA and OECD-NEA stated the need for regulatory oversight of safety culture and for suitable methods. In 2013, IAEA published a Technical Document (TECDOC 1707) on the process of safety culture oversight by regulatory authorities which leaves much room for regulators’ ways of performing safety culture oversight. In response to these developments, the Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) as the federal regulatory body commissioned GRS in 2011 to develop a practical guidance for assessing licencees’ safety culture in the process of regulatory oversight. This research and development project was completed just recently. The publicly available documentation comprises a shorter guidance document with the indispensable information for an appropriate, practical application and a report with more detailed information about the scientific basis of this guidance. To achieve best possible adaptation to regulators’ needs, GRS asked members of the regulatory authority of Baden-Wuerttemberg (one of the federal states of Germany) for comments on a draft of the guidance which was then finalised by duly considering this highly valuable and favorable feedback. Decisions regarding future use rest with German regulatory authorities.

  6. Technical support document: Energy conservation standards for consumer products: Dishwashers, clothes washers, and clothes dryers including: Environmental impacts; regulatory impact analysis

    Energy Technology Data Exchange (ETDEWEB)

    1990-12-01

    The Energy Policy and Conservation Act as amended (P.L. 94-163), establishes energy conservation standards for 12 of the 13 types of consumer products specifically covered by the Act. The legislation requires the Department of Energy (DOE) to consider new or amended standards for these and other types of products at specified times. This Technical Support Document presents the methodology, data and results from the analysis of the energy and economic impacts of standards on dishwashers, clothes washers, and clothes dryers. The economic impact analysis is performed in five major areas: An Engineering Analysis, which establishes technical feasibility and product attributes including costs of design options to improve appliance efficiency. A Consumer Analysis at two levels: national aggregate impacts, and impacts on individuals. The national aggregate impacts include forecasts of appliance sales, efficiencies, energy use, and consumer expenditures. The individual impacts are analyzed by Life-Cycle Cost (LCC), Payback Periods, and Cost of Conserved Energy (CCE), which evaluate the savings in operating expenses relative to increases in purchase price; A Manufacturer Analysis, which provides an estimate of manufacturers' response to the proposed standards. Their response is quantified by changes in several measures of financial performance for a firm. An Industry Impact Analysis shows financial and competitive impacts on the appliance industry. A Utility Analysis that measures the impacts of the altered energy-consumption patterns on electric utilities. A Environmental Effects analysis, which estimates changes in emissions of carbon dioxide, sulfur oxides, and nitrogen oxides, due to reduced energy consumption in the home and at the power plant. A Regulatory Impact Analysis collects the results of all the analyses into the net benefits and costs from a national perspective. 47 figs., 171 tabs. (JF)

  7. Acute tier-1 and tier-2 effect assessment approaches in the EFSA Aquatic Guidance Diocument: are they sufficiently protective for insecticides?

    NARCIS (Netherlands)

    Wijngaarden, van R.P.A.; Maltby, L.; Brock, T.C.M.

    2015-01-01

    BACKGROUND The objective of this paper is to evaluate whether the acute tier-1 and tier-2 methods as proposed by the Aquatic Guidance Document recently published by the European Food Safety Authority (EFSA) are appropriate for deriving regulatory acceptable concentrations (RACs) for insecticides.

  8. Discussion of and guidance on the optimization of radiation protection in the transport of radioactive material

    International Nuclear Information System (INIS)

    1986-05-01

    The document provides guidance on one of the components of the system of dose limitation as it applies to the transport of radioactive material, namely the optimization of radiation protection. It focuses on the following parts of the transport system: design, maintenance, preparation for transport, transport, storage-in-transit and handling and it considers occupational and public exposures. The application is intended mainly for those transport situations within the regulatory requirements where potential radiation exposures could be beneficially reduced

  9. Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols (Spanish Edition)

    International Nuclear Information System (INIS)

    2015-01-01

    This publication is aimed at enhancing States’ understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in ‘Safeguards Implementation Practices’ (SIPs) to be published separately

  10. Guidance for States Implementing Comprehensive Safeguards Agreements and Additional Protocols (Arabic Edition)

    International Nuclear Information System (INIS)

    2017-01-01

    This publication is aimed at enhancing States’ understanding of the safeguards obligations of both the State and the IAEA, and at improving the cooperation between States and the IAEA in safeguards implementation. It is principally intended for State or regional safeguards regulatory authorities and facility operators, and is a reference document that will be supported by detailed guidance and examples in ‘Safeguards Implementation Practices’ (SIPs) to be published separately.

  11. 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

  12. 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...

  13. 76 FR 61098 - Guidance for 1-Hour SO2

    Science.gov (United States)

    2011-10-03

    ...Notice is hereby given that the EPA has posted its draft non- binding guidance titled, ``Guidance for 1-Hour SO2 NAAQS SIP Submissions'' on its Web site. The EPA invites public comments on this guidance document during the comment period specified below, and plans to issue an updated version of the guidance after reviewing timely submitted comments.

  14. Draft federal GHG accounting and reporting : technical support document

    Science.gov (United States)

    2010-07-01

    This is a technical support document (TSD) that accompanies the Federal Greenhouse Gas Accounting and Reporting Guidance (or Guidance). This document provides detailed information on the inventory reporting process and accepted calculation methodolog...

  15. 75 FR 69089 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0514] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance...

  16. 76 FR 29251 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance...

    Science.gov (United States)

    2011-05-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls; Guidance Document... of the guidance entitled ``Guidance for Industry and Food and Drug Administration Staff; Class II...

  17. SPAR-H Step-by-Step Guidance

    Energy Technology Data Exchange (ETDEWEB)

    April M. Whaley; Dana L. Kelly; Ronald L. Boring; William J. Galyean

    2012-06-01

    Step-by-step guidance was developed recently at Idaho National Laboratory for the US Nuclear Regulatory Commission on the use of the Standardized Plant Analysis Risk-Human Reliability Analysis (SPAR-H) method for quantifying Human Failure Events (HFEs). This work was done to address SPAR-H user needs, specifically requests for additional guidance on the proper application of various aspects of the methodology. This paper overviews the steps of the SPAR-H analysis process and highlights some of the most important insights gained during the development of the step-by-step directions. This supplemental guidance for analysts is applicable when plant-specific information is available, and goes beyond the general guidance provided in existing SPAR-H documentation. The steps highlighted in this paper are: Step-1, Categorizing the HFE as Diagnosis and/or Action; Step-2, Rate the Performance Shaping Factors; Step-3, Calculate PSF-Modified HEP; Step-4, Accounting for Dependence, and; Step-5, Minimum Value Cutoff.

  18. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  19. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment

    International Nuclear Information System (INIS)

    2001-05-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State

  20. 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)

  1. Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents.

    Science.gov (United States)

    Cornelius, Victoria R; Liu, Kun; Peacock, Janet; Sauzet, Odile

    2016-03-20

    To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. A comparison review of product information documents for antidepressants and anticonvulsants concurrently marketed by the same pharmaceutical company in the USA and Europe. For each drug, data were extracted from the US Product Inserts and the European Summary of Product Characteristics documents between 09/2013 and 01/2015. Individuals contributing ADR information to product information documents. All ADRs reported in product information sections 5 and 6 (USA), and 4·4 and 4·8 (Europe). Twelve brand drugs--24 paired documents--were included. On average, there were 77 more ADRs reported in the USA compared with in the European product information document, with a median number of 201 ADRs (range: 65-425) and 114 (range: 56-265), respectively. More product information documents in the USA reported information on the source of evidence (10 vs 5) and risk (9 vs 5) for greater than 80% of ADRs included in the document. There was negligible information included regarding duration, severity, reversibility or recurrence of ADRs. On average, only 29% of ADR terms were reported in both paired documents. Product information documents contained a large number of ADRs, but lacked contextual data and information important to patients and prescribers, such as duration, severity and reversibility. The ADR profile was found to be inconsistently reported between the USA and Europe, for the same drug. Identifying, selecting, summarising and presenting multidimensional harm data should be underpinned by practical evidence-based guidelines. In order for prescribers to provide considered risk-benefit advice across competing drug therapies to patients, they need access to comprehensible and reliable ADR information. Published by the BMJ Publishing Group Limited

  2. 78 FR 49782 - Interim Staff Guidance on Changes During Construction

    Science.gov (United States)

    2013-08-15

    ... Construction AGENCY: Nuclear Regulatory Commission. ACTION: Draft interim staff guidance; request for comment... During Construction.'' This ISG provides guidance to the NRC staff on the Preliminary Amendment Request...-ISG-025 ``Interim Staff Guidance on Changes during Construction under 10 CFR Part 52'' is available...

  3. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

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

  4. Regulatory control of nuclear power plants

    International Nuclear Information System (INIS)

    2002-01-01

    The purpose of this book is to support IAEA training courses and workshops in the field of regulatory control of nuclear power plants as well as to support the regulatory bodies of Member States in their own training activities. The target group is the professional staff members of nuclear safety regulatory bodies supervising nuclear power plants and having duties and responsibilities in the following regulatory fields: regulatory framework; regulatory organization; regulatory guidance; licensing and licensing documents; assessment of safety; and regulatory inspection and enforcement. Important topics such as regulatory competence and quality of regulatory work as well as emergency preparedness and public communication are also covered. The book also presents the key issues of nuclear safety such as 'defence-in-depth' and safety culture and explains how these should be taken into account in regulatory work, e.g. during safety assessment and regulatory inspection. The book also reflects how nuclear safety has been developed during the years on the basis of operating experience feedback and results of safety research by giving topical examples. The examples cover development of operating procedures and accident management to cope with complicated incidents and severe accidents to stress the importance of regulatory role in nuclear safety research. The main target group is new staff members of regulatory bodies, but the book also offers good examples for more experienced inspectors to be used as comparison and discussion basis in internal workshops organized by the regulatory bodies for refreshing and continuing training. The book was originally compiled on the basis of presentations provided during the two regulatory control training courses in 1997 and 1998. The textbook was reviewed at the beginning of the years 2000 and 2002 by IAEA staff members and consistency with the latest revisions of safety standards have been ensured. The textbook was completed in the

  5. 76 FR 66925 - Guidance for 1-Hour SO2

    Science.gov (United States)

    2011-10-28

    ...The EPA is announcing an extension of the public comment period for its draft non-binding guidance titled, ``Guidance for 1-Hour SO2 SIP Submissions.'' The draft of the guidance document is currently on the EPA's Web site. The EPA is extending the comment period for an additional 30-day period and invites public comments on this guidance during this period. The EPA plans to issue an updated version of the guidance after reviewing timely submitted comments.

  6. Health Service use of ionising radiations: Guidance

    International Nuclear Information System (INIS)

    1995-01-01

    This booklet gives outline guidance on the use of ionising radiations in the Health Service in the United Kingdom. Extensive reference is made to documents where more detailed information may be found. The guidance covers general advice on the medical use of ionising radiations, statutory requirements, and guidance on selected Health Service issues such as patient identification procedures, information management systems, deviations from prescribed radiation dose, imaging and radiotherapy. (57 references) (U.K.)

  7. HANDBOOK: HAZARDOUS WASTE INCINERATION MEASUREMENT GUIDANCE

    Science.gov (United States)

    This publication, Volume III of the Hazardous Waste Incineration Guidance Series, contains general guidance to permit writers in reviewing hazardous waste incineration permit applications and trial burn plans. he handbook is a how-to document dealing with how incineration measure...

  8. Guidance for implementing the long-term surveillance program for UMTRA Project Title I Disposal Sites

    International Nuclear Information System (INIS)

    1996-02-01

    This guidance document has two purposes: it provides guidance for writing site-specific long-term surveillance plans (LTSP) and it describes site surveillance, monitoring, and long-term care techniques for Title I disposal sites of the Uranium Mill Tailings Radiation Control Act (UMTRCA) (42 USC Section 7901 et seq.). Long-term care includes monitoring, maintenance, and emergency measures needed to protect public health and safety and the environment after remedial action is completed. This document applies to the UMTRCA-designated Title I disposal sites. The requirements for long-term care of the Title I sites and the contents of the LTSPs are provided in U.S. Nuclear Regulatory Commission (NRC) regulations (10 CFR Section 40.27) provided in Attachment 1

  9. RCRA Programmatic Information Policy and Guidance

    Data.gov (United States)

    U.S. Environmental Protection Agency — This asset includes program policy and guidance documents that are used by the EPA regions, states, tribes and private parties to implement the hazardous waste...

  10. 76 FR 44594 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-26

    ... Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is... Stimulation Systems.'' This guidance document describes a means by which a repetitive transcranial magnetic... guidance document is being immediately implemented as the special control for rTMS systems, but it remains...

  11. 75 FR 73107 - Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability

    Science.gov (United States)

    2010-11-29

    ...] Guidance for Industry and Food and Drug Administration Staff; Blood Lancet Labeling; Availability AGENCY... announcing the availability of the guidance entitled ``Guidance for Industry and Food and Drug Administration... single copies of the guidance document entitled ``Guidance for Industry and Food and Drug Administration...

  12. 75 FR 70254 - PSD and Title V Permitting Guidance for Greenhouse Gases

    Science.gov (United States)

    2010-11-17

    ... Guidance for Greenhouse Gases AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of availability..., ``PSD and Title V Permitting Guidance for Greenhouse Gases'' on its significant guidance Internet Web... guidance titled, ``PSD and Title V Permitting Guidance for Greenhouse Gases.'' This document has been...

  13. 78 FR 52203 - Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of...

    Science.gov (United States)

    2013-08-22

    ... guidance document consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance...] Guidance for Industry on Compliance With Regulations Restricting the Sale and Distribution of Cigarettes... Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents.'' This guidance is...

  14. Path of a patient with a rare diagnosis: regulatory documents and organization of the process of treatment and diagnosis of an orphan disease in the Russian Federation

    OpenAIRE

    S. I. Kutsev

    2017-01-01

    The main legislative document of the organization of medical care in the Russian Federation “On fundamental healthcare principles in the Russian Federation” and points related to the rare (orphan) diseases are  discussed. The organization of care, rules for managing a federal  registry of orphan diseases and routing of patients with main orphan nosological forms for which treatment is known are presented.

  15. Path of a patient with a rare diagnosis: regulatory documents and organization of the process of treatment and diagnosis of an orphan disease in the Russian Federation

    Directory of Open Access Journals (Sweden)

    S. I. Kutsev

    2017-01-01

    Full Text Available The main legislative document of the organization of medical care in the Russian Federation “On fundamental healthcare principles in the Russian Federation” and points related to the rare (orphan diseases are  discussed. The organization of care, rules for managing a federal  registry of orphan diseases and routing of patients with main orphan nosological forms for which treatment is known are presented.

  16. UV DISINFECTION GUIDANCE MANUAL FOR THE ...

    Science.gov (United States)

    Provides technical information on selection, design and operation of UV systems; provides regulatory agencies with guidance and the necessary tools to assess UV systems at the design, start-up, and routine operation phase; provides manufacturers with the testing and performance standards for UV components and systems for treating drinking water. Provide guidance to water systems, regulators and manufacturers on UV disinfection of drinking water.

  17. 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)

  18. 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)

  19. Track 2 sites: Guidance for assessing low probability hazard sites at the INEL. Revision 6

    Energy Technology Data Exchange (ETDEWEB)

    1994-01-01

    This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations.

  20. Track 2 sites: Guidance for assessing low probability hazard sites at the INEL

    International Nuclear Information System (INIS)

    1994-01-01

    This document presents guidance for assessment of Track 2 low probability hazard sites (LPHS) at the Idaho National Engineering Laboratory (INEL). The Track 2 classification was developed specifically for the INEL to streamline the implementation of Comprehensive Environmental Response, Compensation, and Liability Act. Track 2 LPHSs are described as sites where insufficient data are available to make a decision concerning the risk level or to select or design a remedy. As such, these types of sites are not described in the National Contingency Plan or existing regulatory guidance. The goal of the Track 2 process is to evaluate LPHSs using existing qualitative and quantitative data to minimize the collection of new environmental data. To this end, this document presents a structured format consisting of a series of questions and tables. A qualitative risk assessment is used. The process is iterative, and addresses an LPHS from multiple perspectives (i.e., historical, empirical, process) in an effort to generate a reproducible and defensible method. This rigorous approach follows the data quality objective process and establishes a well organized, logical approach to consolidate and assess existing data, and set decision criteria. If necessary, the process allows for the design of a sampling and analysis strategy to obtain new environmental data of appropriate quality to support decisions for each LPHS. Finally, the guidance expedites consensus between regulatory parties by emphasizing a team approach to Track 2 investigations

  1. 77 FR 34390 - Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To...

    Science.gov (United States)

    2012-06-11

    ... recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in..., submit either electronic or written comments on the draft guidance by September 10, 2012. ADDRESSES... electronic access to the draft guidance document. Submit electronic comments on the draft guidance to http...

  2. International guidance activities

    International Nuclear Information System (INIS)

    Richardson, Allan C.B.

    1989-01-01

    International principles for setting Protective Action Guides (PAGs) are contained in two key documents that contain identical statements. One is Publication Number 40 of the ICRP, which was issued in 1985. The title is 'Protection of the Public in the Event of Major Radiation Accidents, Principles for Planning'. The other is the IAEA's Safety Series Publication Number 72, also issued in 1985, written by many of the same authors and titled, 'Principles for Establishing Intervention Levels'. The principles that were set forth in these documents were identical, were incomplete, and they are, unfortunately, the only principles that are now in effect, while proposed revisions go through one draft after another. There are several such draft revisions that are of significance. The most important is that of the ICRP. The basic guidance that applies to most planned exposure to radiation is ICRP Publication 26. That document has been under revision by the Commission for a number of years, and the new version will, for the first time, include recommendations for emergency response. They are now getting close to closure, and I think it should be a very much improved and useful document. But it isn't finished yet. Such guidance doesn't get developed in a vacuum, and there have been a couple of parallel efforts which have provided significant input to the ICRP, which is essentially a behind-closed-doors effort. These other efforts are more open. One of these is being carried out within the IAEA, which has convened annual meetings of national experts for a number of years in Vienna, to generate a replacement for Safety Series No. 72, mentioned earlier. There is a meeting scheduled this December to complete this effort; and, hopefully, we will reach closure at that meeting on at least the basic principles. The Nuclear Energy Agency (NEA) has also been at work. It has convened a group of experts from member nations that have been developing recommendations. There is an overlap

  3. Technical support document: Energy efficiency standards for consumer products: Refrigerators, refrigerator-freezers, and freezers including draft environmental assessment, regulatory impact analysis

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-07-01

    The Energy Policy and Conservation Act (P.L. 94-163), as amended by the National Appliance Energy Conservation Act of 1987 (P.L. 100-12) and by the National Appliance Energy Conservation Amendments of 1988 (P.L. 100-357), and by the Energy Policy Act of 1992 (P.L. 102-486), provides energy conservation standards for 12 of the 13 types of consumer products` covered by the Act, and authorizes the Secretary of Energy to prescribe amended or new energy standards for each type (or class) of covered product. The assessment of the proposed standards for refrigerators, refrigerator-freezers, and freezers presented in this document is designed to evaluate their economic impacts according to the criteria in the Act. It includes an engineering analysis of the cost and performance of design options to improve the efficiency of the products; forecasts of the number and average efficiency of products sold, the amount of energy the products will consume, and their prices and operating expenses; a determination of change in investment, revenues, and costs to manufacturers of the products; a calculation of the costs and benefits to consumers, electric utilities, and the nation as a whole; and an assessment of the environmental impacts of the proposed standards.

  4. Individual plant examination: Submittal guidance

    International Nuclear Information System (INIS)

    1989-08-01

    Based on a Policy Statement on Severe Accidents Regarding Future Designs and Existing Plants, the performance of a plant examination is requested from the licensee of each nuclear power plant. The plant examination looks for vulnerabilities to severe accidents and cost-effective safety improvements that reduce or eliminate the important vulnerabilities. This document delineates guidance for reporting the results of that plant examination. 38 refs., 2 tabs

  5. 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.

  6. Introduction and user's information for the fixed site physical protection upgrade rule guidance compendium

    International Nuclear Information System (INIS)

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

    1980-06-01

    Licensees at fixed sites who possess, use, process, or handle strategic special nuclear material are required to design a physical security system to protect this material. This report suggests an orderly process for using guidance, with special emphasis on two regulatory guides and two NUREG series documents that comprise a compendium, to aid in the design of a physical security system that meets the requirements of the final Physical Protection Upgrade Rule. The rule was published November 28, 1979 (44 FR 68184), and became effective March 25, 1980

  7. Development of regulatory procedures for the disposal of solid radioactive waste in deep, continental formations

    International Nuclear Information System (INIS)

    1980-01-01

    For the disposal of radioactive waste, and in particular, of the high-level and alpha-bearing waste from the nuclear fuel cycle, the most favoured solution in most countries is disposal in deep, continental geological formations. Commitment to this disposal method involves a number of issues related to the various stages of the disposal programme which must be addressed through some reasoned decision-making process. Most countries are opting for regulating such a programme through licensing actions by a body whose purpose is to review, certify and ensure the safety of all the stages of the disposal programme. This regulatory body may either be one single national authority or a system of authorities designated by the government. The key to such regulation is the set of procedures, determined in advance, for the actions of the implementing organization, the review by the regulatory body and the involvement of other parties. This document concerns itself with the procedures which could logically be followed in reaching a set of rational decisions by the regulatory body. Care in the preparation and application of such procedures is an important element in the acceptability of the concept, the site and the other aspects of the disposal programme. The intention of this document is to give guidance as to what issues should be addressed in the licensing review, what decision points are important, and what guidance should be given to the applicant by the regulatory body in the course of the licensing actions. The procedures are keyed to be designed according to the logical steps involved in the development and operation of the repository. However, the document does not pretend to give guidance regarding the optimal interactions between the implementing organization and the regulatory body. This document is oriented to the disposal of solid radioactive waste in deep, continental geological formations using mining techniques

  8. Review of soil contamination guidance

    International Nuclear Information System (INIS)

    Mueller, M.A.; Kennedy, W.E. Jr.; Soldat, J.K.

    1981-08-01

    A review of existing and proposed radioactive soil contamination standards and guidance was conducted for United Nuclear Corporation (UNC), Office of Surplus Facilities Management. Information was obtained from both government agencies and other sources during a literature survey. The more applicable standards were reviewed, evaluated, and summarized. Information pertaining to soil contamination for both facility operation and facility decommissioning was obtained from a variety of sources. These sources included: the Code of Federal Regulations, regulatory guides, the Federal Register, topical reports written by various government agencies, topical reports written by national laboratories, and publications from the American National Standards Institute (ANSI). It was difficult to directly compare the standards and guidance obtained from these sources since each was intended for a specific situation and different units or bases were used. However, most of the information reviewed was consistent with the philosophy of maintaining exposures at levels as low as reasonably achievable

  9. Rating of transport and radiation source events. Draft additional guidance for the INES national officers for pilot use and feedback; Echelle de classement des incidents de radioprotection: document d'application du systeme international propose par l'AIEA pour les sources radioactives et les transports

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2004-09-15

    The International Nuclear Event Scale (INES) is a means for promptly communicating to the public in consistent terms the safety significance of any reported event associated with radioactive material and/or radiation and to any event occurring during the transport of radioactive material. As described in the 2001 Edition of the INES User.s Manual, events are classified on the scale at seven levels: the upper levels (4-7) are termed accidents. and the lower levels (1-3) incidents. Events which have no safety significance are classified below scale at Level 0 and termed deviations. An overview of the principles for the rating under INES together with flow charts summarizing the rating process is provided in Appendix I. The 2001 Edition of the INES User.s Manual provides some guidance for the rating of transport and radiation source events. At the technical meeting held in 2002 the INES National Officers requested the IAEA/NEA Secretariat to prepare additional guidance. Progress was reported at the Technical Meeting of the INES National Officers in March 2004 where preparation of this draft additional guidance was requested for pilot use. This note provides additional guidance on the rating of transport and radiation source events. It is for pilot use and feedback and is broadly consistent with the INES User.s Manual. It provides more detailed information and an expanded approach for the rating based on actual exposure of workers and members of the public. It is designed to be used as a self-standing document with limited need for reference to the INES User Manual. (author)

  10. Streamlining of the Decontamination and Demolition Document Preparation Process

    International Nuclear Information System (INIS)

    Durand, Nick; Meincke, Carol; Peek, Georgianne

    1999-01-01

    During the past five years, the Sandia National Labo- ratories Decontamination, Decommissioning, Demolition, and Reuse (D3R) Program has evolved and become more focused and efficient. Historical approaches to project documentation, requirements, and drivers are discussed detailing key assumptions, oversight authority, and proj- ect approvals. Discussion of efforts to streamline the D3R project planning and preparation process include the in- corporation of the principles of graded approach, Total Quality Management, and the Observational Method (CH2MHILL April 1989).1 Process improvements were realized by clearly defining regulatory requirements for each phase of a project, establishing general guidance for the program and combining project-specific documents to eliminate redundant and unneeded information. Proc- ess improvements to cost, schedule, and quality are dis- cussed in detail for several projects

  11. Staff technical position on regulatory considerations in the design and construction of the exploratory shaft facility

    International Nuclear Information System (INIS)

    Gupta, D.; Peshel, J.; Bunting, J.

    1991-07-01

    The staff of the US Nuclear Regulatory Commission has prepared this staff technical position for the purpose of compiling and further clarifying previous staff positions on regulatory considerations in the design and construction of the exploratory shaft facility (ESF). (The US Department of Energy (DOE) now refers to the ESF as the ''exploratory studies facility.'' DOE's change in terminology does not affect the positions taken in this guidance.) This document lists the key regulations in 10 CFR Part 60 that should be considered in the design and construction of the ESF and presents the staff position statements and corresponding discussions. 13 refs., 1 fig

  12. 76 FR 75771 - Emergency Planning Guidance for Nuclear Power Plants

    Science.gov (United States)

    2011-12-05

    ... Guidance for Nuclear Power Plants AGENCY: Nuclear Regulatory Commission. ACTION: Issuance of NUREG... Support of Nuclear Power Plants;'' NSIR/DPR-ISG-01, ``Interim Staff Guidance Emergency Planning for Nuclear Power Plants;'' and NUREG/CR-7002, ``Criteria for Development of Evacuation Time Estimate Studies...

  13. Regulatory guidelines for biosimilars in Malaysia.

    Science.gov (United States)

    Abas, Arpah

    2011-09-01

    The biosimilars sector continues to attract huge interest and controversy. Biosimilars are new biopharmaceuticals that are "similar" but not identical to the innovator product. Characteristics of biopharmaceuticals are closely related to the manufacturing process, which implies that the products cannot be exactly duplicated. Minuscule differences in the product's structure and manufacturing process can result in different clinical outcome. This raises concerns over the safety, efficacy and even pharmacovigilance of biosimilars. Thus, biosimilars are unique - they are not a true chemical generic and are regulated via a distinct regulatory framework. This report discusses the features of Malaysian regulatory oversight of biosimilars and experience acquired in the evaluation of some products from various countries. Ensuring regulatory position adequately reflects scientific advancement, expertise/resources is key. The regulatory situation is an evolving process. Various guidance documents are being prepared with the aim of developing a uniform global framework towards assuring the dual goal of lower costs and patient safety while expediting the availability of important biosimilar products. Copyright © 2011. Published by Elsevier Ltd.

  14. Assessment by peer review of the effectiveness of a regulatory programme for radiation safety. Interim report for comment; Evaluacion mediante examen por pares de la efectividad de un programa regulador para la seguridad radiologica. Informe provisional para formular comentarios

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-06-01

    This document covers assessment of those aspects of a radiation protection and safety infrastructure that are implemented by the Regulatory Authority for radiation sources and practices using such sources and necessarily includes those ancillary technical services, such as dosimetry services, which directly affect the ability of the Regulatory Authority to discharge its responsibilities. The focus of the guidance in this TECDOC is on assessment of a regulatory programme intended to implement the BSS. The BSS address transportation and waste safety mainly by reference to other IAEA documents. When conducting an assessment, the Review Team members should be aware of the latest IAEA documents (or similar national documents) concerning transportation and waste safety and, if appropriate, nuclear safety, and take them into account to the extent applicable when assessing the effectiveness of the regulatory programme governing radiation protection and safety of radiation source practices in a particular State.

  15. Nuclear Regulatory legislation

    International Nuclear Information System (INIS)

    1984-06-01

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

  16. 77 FR 16123 - Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls...

    Science.gov (United States)

    2012-03-19

    ... Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document... Drug Administration 21 CFR Part 866 Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the...

  17. 77 FR 20826 - Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and...

    Science.gov (United States)

    2012-04-06

    ...] Guidance for Industry and Food and Drug Administration Staff; Food and Drug Administration and Industry... Administration (FDA) is announcing the availability of the guidance entitled ``Guidance for Industry and Food and... written requests for single copies of the guidance document entitled ``Guidance for Industry and Food and...

  18. Graphic Turbulence Guidance

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  19. Graphical Turbulence Guidance - Composite

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Forecast turbulence hazards identified by the Graphical Turbulence Guidance algorithm. The Graphical Turbulence Guidance product depicts mid-level and upper-level...

  20. Career guidance in communities

    DEFF Research Database (Denmark)

    Thomsen, Rie

    for the development of a critically reflexive career guidance practice. The considerations are organised around seven elements. 1. Creating opportunity, structure and access 2. Entering a community and increasing visibility 3. Providing guidance in communities 4. Exploring potentials in guidance situations 5...... in career guidance practices as well as in the lives of the people in the communities. This paper falls into two parts: The first part considers the collective as the starting point for the development of meaningful career guidance activities. Based on previous research on career guidance in communities......The aim of this paper is to inspire practitioners and professionals to leave their offices to bring career guidance into communities that might not identify with career guidance in the first instance. By making the effort to engage with communities, practitioners may bring about a critical change...

  1. 78 FR 13069 - Draft Guidance for Industry: Recommendations for Screening, Testing, and, Management of Blood...

    Science.gov (United States)

    2013-02-26

    ... components, including Source Plasma. The guidance announced in this notice replaces the draft guidance... before it begins work on the final version of the guidance, submit either electronic or written comments... the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. Submit...

  2. 76 FR 9583 - Draft Guidance for Industry on Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase...

    Science.gov (United States)

    2011-02-18

    ... final version of the guidance, submit either electronic or written comments on the draft guidance by... electronic access to the guidance document. Submit electronic comments on the draft guidance to http://www... body tissue or fluid (e.g., blood, plasma, cerebrospinal fluid). Drug response results from the...

  3. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    Washington TRU Solutions LLC

    2003-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: ''each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.'' They further state: ''each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP charges the WIPP management and operating (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with 10 CFR 71.11. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document provides the instructions to be followed to operate, maintain, and test the TRUPACT-II and HalfPACT packaging. The intent of these instructions is to standardize operations. All users will follow these instructions or equivalent instructions that assure operations are safe and meet the requirements of the SARPs

  4. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    Washington TRU Solutions LLC

    2002-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT Shipping Package, and directly related components. This document complies with the minimum requirements as specified in TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event there is a conflict between this document and the SARP or C of C, the SARP and/or C of C shall govern. C of Cs state: ''each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.'' They further state: ''each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SAR P charges the WIPP Management and Operation (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with 10 CFR 71.11. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. CBFO will evaluate the issue and notify the NRC if required. This document details the instructions to be followed to operate, maintain, and test the TRUPACT-II and HalfPACT packaging. The intent of these instructions is to standardize these operations. All users will follow these instructions or equivalent instructions that assure operations are safe and meet the requirements of the SARPs

  5. Guidance for performing preliminary assessments under CERCLA

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1991-09-01

    EPA headquarters and a national site assessment workgroup produced this guidance for Regional, State, and contractor staff who manage or perform preliminary assessments (PAs). EPA has focused this guidance on the types of sites and site conditions most commonly encountered. The PA approach described in this guidance is generally applicable to a wide variety of sites. However, because of the variability among sites, the amount of information available, and the level of investigative effort required, it is not possible to provide guidance that is equally applicable to all sites. PA investigators should recognize this and be aware that variation from this guidance may be necessary for some sites, particularly for PAs performed at Federal facilities, PAs conducted under EPA`s Environmental Priorities Initiative (EPI), and PAs at sites that have previously been extensively investigated by EPA or others. The purpose of this guidance is to provide instructions for conducting a PA and reporting results. This guidance discusses the information required to evaluate a site and how to obtain it, how to score a site, and reporting requirements. This document also provides guidelines and instruction on PA evaluation, scoring, and the use of standard PA scoresheets. The overall goal of this guidance is to assist PA investigators in conducting high-quality assessments that result in correct site screening or further action recommendations on a nationally consistent basis.

  6. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

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

  7. 75 FR 22813 - Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of...

    Science.gov (United States)

    2010-04-30

    ...] Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test... availability of a document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors... document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred...

  8. Regulatory inspection of the implementation of quality assurance programmes

    International Nuclear Information System (INIS)

    1989-01-01

    This Manual provides guidance to Member States in the organization and performance of their regulatory inspection functions regarding the implementation of nuclear power plant quality assurance programmes. It addresses the interface between, and is consistent with, the IAEA Nuclear Safety Standards (NUSS programme) documents on quality assurance and governmental organization. The Manual offers a practical model and examples for performing regulatory inspections to ensure that the quality assurance programme is operating satisfactorily in the siting, design, manufacturing, construction, commissioning, operation and decommissioning of nuclear power plants. The primary objective is to confirm that the licensee has the capability to manage and control the effective performance of all quality assurance responsibilities during all phases of a nuclear power project. The guidance provided through this Manual for proper establishment and execution of the regulatory inspections helps to enforce the effective implementation of the quality assurance programme as a management control system that the nuclear industry should establish and use in attaining the safety and reliability objectives for nuclear installations. This enforcement action by national regulatory bodies and the emphasis on the purposes and advantages of quality assurance as an important management tool integrated within the total project task have been recommended by the IAEA International Nuclear Safety Advisory Group (INSAG). The primary intended users of this Manual are the management personnel and high level staff from regulatory bodies but it will also be helpful to management personnel from nuclear utilities and vendors. They all are inevitable partners in a nuclear power project and this document offers all of them valuable information on the better accomplishment of quality assurance activities to ensure the common objective of safe and reliable nuclear power production

  9. Radionuclide Data Quality Evaluation Guidance

    International Nuclear Information System (INIS)

    Tucker, B.J.; Winters, M.S.; Evans, D.

    2009-01-01

    A considerable amount of radioanalytical data is generated during various phases of the characterization and remediation of radiologically-contaminated sites and properties. It is critical that data generated from the analysis of collected samples be to a level of quality usable by the project and acceptable to stakeholders. In July 2004, the final version of a multi-agency guidance manual entitled Multi-Agency Radiological Analytical Protocols Manual (MARLAP) was issued by the Environmental Protection Agency, Department of Energy, Department of Homeland Security, Nuclear Regulatory Commission, Department of Defense, National Institute of Standards and Technology, U. S. Geological Survey, Food and Drug Administration, and the States of Kentucky and California. The authors' purpose is to introduce readers to some key elements of MARLAP as it relates to radioanalytical lab quality control, and to demonstrate how these guidance elements can be effectively incorporated into mature radioanalytical lab operations and data validation regimes. Based upon the logic and statistical methodologies presented in MARLAP, the authors have revised existing project-specific Radioanalytical Data Evaluation Guidance (RadDEG) used at the FUSRAP Maywood Site in Maywood, NJ. The RadDEG allows users to qualify data in a meaningful way by tying the usability of the data to its activity and uncertainty relative to project action levels and QC results. This exercise may be useful to other projects looking to implement a MARLAP-based approach into their project/site-specific data evaluation methodologies. (authors)

  10. Variable & Recode Definitions - SEER Documentation

    Science.gov (United States)

    Resources that define variables and provide documentation for reporting using SEER and related datasets. Choose from SEER coding and staging manuals plus instructions for recoding behavior, site, stage, cause of death, insurance, and several additional topics. Also guidance on months survived, calculating Hispanic mortality, and site-specific surgery.

  11. 78 FR 11654 - Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About...

    Science.gov (United States)

    2013-02-19

    ...] Draft Guidance for Industry and Food and Drug Administration Staff; Providing Information About... Guidance for Industry and Food and Drug Administration Staff: Providing Information About Pediatric Uses of...ComplianceRegulatoryInformation/default.htm . To receive ``Draft Guidance for Industry and Food and Drug...

  12. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: ''each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.'' They further state: ''each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.'' Chapter 9.0 of the SARP charges the Waste Isolation Pilot Plant (WIPP) management and operating (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) 71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.

  13. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2008-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the pplication.' They further state: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) 71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations

  14. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2009-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' They further state: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) 71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required. In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations

  15. CNEA's quality system documentation

    International Nuclear Information System (INIS)

    Mazzini, M.M.; Garonis, O.H.

    1998-01-01

    Full text: To obtain an effective and coherent documentation system suitable for CNEA's Quality Management Program, we decided to organize the CNEA's quality documentation with : a- Level 1. Quality manual. b- Level 2. Procedures. c-Level 3. Qualities plans. d- Level 4: Instructions. e- Level 5. Records and other documents. The objective of this work is to present a standardization of the documentation of the CNEA's quality system of facilities, laboratories, services, and R and D activities. Considering the diversity of criteria and formats for elaboration the documentation by different departments, and since ultimately each of them generally includes the same quality management policy, we proposed the elaboration of a system in order to improve the documentation, avoiding unnecessary time wasting and costs. This will aloud each sector to focus on their specific documentation. The quality manuals of the atomic centers fulfill the rule 3.6.1 of the Nuclear Regulatory Authority, and the Safety Series 50-C/SG-Q of the International Atomic Energy Agency. They are designed by groups of competent and highly trained people of different departments. The normative procedures are elaborated with the same methodology as the quality manuals. The quality plans which describe the organizational structure of working group and the appropriate documentation, will asses the quality manuals of facilities, laboratories, services, and research and development activities of atomic centers. The responsibilities for approval of the normative documentation are assigned to the management in charge of the administration of economic and human resources in order to fulfill the institutional objectives. Another improvement aimed to eliminate unnecessary invaluable processes is the inclusion of all quality system's normative documentation in the CNEA intranet. (author) [es

  16. Spent Nuclear Fuel Project document control and Records Management Program Description

    International Nuclear Information System (INIS)

    MARTIN, B.M.

    2000-01-01

    The Spent Nuclear Fuel (SNF) Project document control and records management program, as defined within this document, is based on a broad spectrum of regulatory requirements, Department of Energy (DOE) and Project Hanford and SNF Project-specific direction and guidance. The SNF Project Execution Plan, HNF-3552, requires the control of documents and management of records under the auspices of configuration control, conduct of operations, training, quality assurance, work control, records management, data management, engineering and design control, operational readiness review, and project management and turnover. Implementation of the controls, systems, and processes necessary to ensure compliance with applicable requirements is facilitated through plans, directives, and procedures within the Project Hanford Management System (PHMS) and the SNF Project internal technical and administrative procedures systems. The documents cited within this document are those which directly establish or define the SNF Project document control and records management program. There are many peripheral documents that establish requirements and provide direction pertinent to managing specific types of documents that, for the sake of brevity and clarity, are not cited within this document

  17. Maury Documentation

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Supporting documentation for the Maury Collection of marine observations. Includes explanations from Maury himself, as well as guides and descriptions by the U.S....

  18. Documentation Service

    International Nuclear Information System (INIS)

    Charnay, J.; Chosson, L.; Croize, M.; Ducloux, A.; Flores, S.; Jarroux, D.; Melka, J.; Morgue, D.; Mottin, C.

    1998-01-01

    This service assures the treatment and diffusion of the scientific information and the management of the scientific production of the institute as well as the secretariat operation for the groups and services of the institute. The report on documentation-library section mentions: the management of the documentation funds, search in international databases (INIS, Current Contents, Inspects), Pret-Inter service which allows accessing documents through DEMOCRITE network of IN2P3. As realizations also mentioned are: the setup of a video, photo database, the Web home page of the institute's library, follow-up of digitizing the document funds by integrating the CD-ROMs and diskettes, electronic archiving of the scientific production, etc

  19. Security of radioactive sources. Interim guidance for comment

    International Nuclear Information System (INIS)

    2003-06-01

    In previous IAEA publications, there have been only rather general security requirements for non-nuclear radioactive material. These requirements were primarily directed to such issues as unintentional exposure to radiation, negligence and inadvertent loss. However, it is clear that more guidance is needed to not only try and prevent further events involving orphan sources, but also to prevent the deliberate attempt to acquire radioactive sources for malevolent purposes. Member States have requested guidance on the type and nature of security measures that might be put in place and on the methodology to be used in choosing such measures. These requests were also endorsed in the findings of the international conference on 'Security of Radioactive Sources' held in March 2003. Practical advice on assessing and implementing security measures complements the general commitments in the proposed Revised Code of Conduct on Safety and Security of radioactive Sources. A Safety Guide entitled 'Safety and Security of Radiation Sources' that, amongst other things, discusses these issues is being drafted. However, it is recognized that guidance material is required before this document will be finalized in order to allow Member States opportunity to put in place appropriate actions and planning to address current issues. Hence the purpose of the current document is to provide advice on security approaches and to allow comment on detailed recommendations for levels of security on radioactive sources that may be incorporated within the Safety Guide. This report is primarily addressed to Regulatory Authorities but it is also intended to provide guidance to manufacturers, suppliers and users of sources. Its objective is to assist Member States in deciding which security measures are needed to ensure consistency with the International Basic Safety Standards and the Revised Code of Conduct for the Safety and Security of Radioactive Sources. It is recognized that there must be a

  20. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2006-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' They further state: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant| (WIPP) management and operating (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations(CFR) 71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations

  1. CH Packaging Program Guidance

    International Nuclear Information System (INIS)

    2007-01-01

    The purpose of this document is to provide the technical requirements for preparation for use, operation, inspection, and maintenance of a Transuranic Package Transporter Model II (TRUPACT-II), a HalfPACT shipping package, and directly related components. This document complies with the minimum requirements as specified in the TRUPACT-II Safety Analysis Report for Packaging (SARP), HalfPACT SARP, and U.S. Nuclear Regulatory Commission (NRC) Certificates of Compliance (C of C) 9218 and 9279, respectively. In the event of a conflict between this document and the SARP or C of C, the C of C shall govern. The C of Cs state: 'each package must be prepared for shipment and operated in accordance with the procedures described in Chapter 7.0, Operating Procedures, of the application.' They further state: 'each package must be tested and maintained in accordance with the procedures described in Chapter 8.0, Acceptance Tests and Maintenance Program of the Application.' Chapter 9.0 of the SARP charges the U.S. Department of Energy (DOE) or the Waste Isolation Pilot Plant (WIPP) management and operating (M and O) contractor with assuring packaging is used in accordance with the requirements of the C of C. Because the packaging is NRC-approved, users need to be familiar with Title 10 Code of Federal Regulations (CFR) 71.8. Any time a user suspects or has indications that the conditions of approval in the C of C were not met, the Carlsbad Field Office (CBFO) shall be notified immediately. The CBFO will evaluate the issue and notify the NRC if required.In accordance with 10 CFR Part 71, certificate holders, packaging users, and contractors or subcontractors who use, design, fabricate, test, maintain, or modify the packaging shall post copies of (1) 10 CFR Part 21 regulations, (2) Section 206 of the Energy Reorganization Act of 1974, and (3) NRC Form 3, Notice to Employees. These documents must be posted in a conspicuous location where the activities subject to these regulations

  2. Technical approach document

    International Nuclear Information System (INIS)

    1988-04-01

    This document describes the general technical approaches and design criteria adopted by the US Department of Energy (DOE) in order to implement Remedial Action Plans (RAPs) and final designs that comply with EPS standards. This document is a revision to the original document. Major revisions were made to the sections in riprap selection and sizing, and ground-water; only minor revisions were made to the remainder of the document. The US Nuclear Regulatory Commission (NRC) has prepared a Standard Review Plan (NRC-SRP) which describes factors to be considered by the NRC in approving the RAP. Sections 3.0, 4.0, 5.0, and 7.0 of this document are arranged under the same headings as those used in the NRC-SRP. This approach is adopted in order to facilitate joint use of the documents. Section 2.0 (not included in the NRC-SRP) discusses design considerations; Section 3.0 describes surface-water hydrology and erosion control; Section 4.0 describes geotechnical aspects of pile design; Section 5.0 discusses the Alternate Site Selection Process; Section 6.0 deals with radiological issues (in particular, the design of the radon barrier); Section 7.0 discusses protection of groundwater resources; and Section 8.0 discusses site design criteria for the RAC

  3. Key Regulatory Issues for Digital Instrumentation and Control Systems at Nuclear Power Plants

    International Nuclear Information System (INIS)

    Korsah, Kofi; Wood, Richard Thomas

    2008-01-01

    To help reduce the uncertainty associated with application of digital instrumentation and controls (I and C) technology in nuclear power plants, the Nuclear Regulatory Commission (NRC) has issued six Interim Staff Guidance (ISG) documents that address the current regulatory positions on what are considered the significant digital I and C issues. These six documents address the following topics: Cyber Security, Diversity and Defense-in-Depth, Risk Informed Digital I and C Regulation, Communication issues, Human Factors and the Digital I and C Licensing Process (currently issued as Draft). After allowing for further refinement based on additional technical insight gathered by NRC staff through near-term research and detailed review of relevant experience, it is expected that updated positions ultimately will be incorporated into regulatory guides and staff review procedures. This paper presents an overview of the guidance provided by the NRC-issued ISGs on key technology considerations (i.e., the first five documents above) for safety-related digital I and C systems.

  4. 78 FR 18353 - Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility...

    Science.gov (United States)

    2013-03-26

    ... SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on... document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's... document to http://www.regulations.gov or written comments to the Division of Dockets Management (see...

  5. HUMAN FACTORS GUIDANCE FOR CONTROL ROOM EVALUATION

    International Nuclear Information System (INIS)

    OHARA, J.; BROWN, W.; STUBLER, W.; HIGGINS, J.; WACHTEL, J.; PERSENSKY, J.J.

    2000-01-01

    The Human-System Interface Design Review Guideline (NUREG-0700, Revision 1) was developed by the US Nuclear Regulatory Commission (NRC) to provide human factors guidance as a basis for the review of advanced human-system interface technologies. The guidance consists of three components: design review procedures, human factors engineering guidelines, and a software application to provide design review support called the ''Design Review Guideline.'' Since it was published in June 1996, Rev. 1 to NUREG-0700 has been used successfully by NRC staff, contractors and nuclear industry organizations, as well as by interested organizations outside the nuclear industry. The NRC has committed to the periodic update and improvement of the guidance to ensure that it remains a state-of-the-art design evaluation tool in the face of emerging and rapidly changing technology. This paper addresses the current research to update of NUREG-0700 based on the substantial work that has taken place since the publication of Revision 1

  6. Environmental Guidance Program Reference Book: American Indian Religious Freedom Act

    Energy Technology Data Exchange (ETDEWEB)

    1987-11-01

    This Reference Book contains a copy of the American Indian Religious Freedom Act and guidance for DOE compliance with the statute. The document is provided to DOE and contractor staff for informational purposes only and should not be interpreted as legal guidance. Updates that include important new requirements will be provided periodically.

  7. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  8. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  9. Vocational guidance in social volunteering

    Directory of Open Access Journals (Sweden)

    Nikolay S. Pryazhnikov

    2017-03-01

    Full Text Available The paper discusses the possibilities and limitations of vocational guidance in the social volunteering system. The essence of volunteer work is closely related with assistance to desperate people in searching for the meaning of living, often coinciding with labour activity that are deemed in terms of “the main matter of life” and “the leading activity”. For adolescents, it is the choice of career, and for adults, it is the work proper (i.e. an essential condition for personal self-realization. The problem of “forced volunteering” for experts in vocational guidance also means that they often have to work voluntarily and unselfishly outside the official guidelines. To clarify the terms «volunteer» and «a person in desperate need of help» the study used the method of analyzing the documents, e.g. the Regulations on Social Volunteering, the generalization of psychological sources, the initial survey of university students as active supporters of the volunteer movement, On the essence of volunteering and the place of career guidance in selfless social work. Vocational guidance is not excluded from the general system of volunteerism, but has an insufficiently defined status and low popularity among participants in social volunteering. Also, the problem of «forced volunteering» of experts in career counseling, which often requires voluntary and unselfish performance of quality work outside the framework of official instructions, is also indicated. Simultaneously, positive aspects of such disinterested career initiatives are noted, in particular, less control by the official inspectors (or customers and, accordingly, greater freedom of creativity than when someone else does the work.

  10. 76 FR 66311 - Draft Documents To Support Submission of an Electronic Common Technical Document; Availability

    Science.gov (United States)

    2011-10-26

    ...] Draft Documents To Support Submission of an Electronic Common Technical Document; Availability AGENCY... making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD....S. regional document type definition, version 3.0) and ``Comprehensive Table of Contents Headings...

  11. Severe accident management guidance for third Qinshan Nuclear Power Plant

    International Nuclear Information System (INIS)

    Su Changsong

    2010-01-01

    The paper describes the background, document structure and the summaries of Severe Accident Management Guidance (SAMG) for Third Qinshan Nuclear Power Plant (TQNPP), and also introduces briefly some design features and their impacts on SAMG. (authors)

  12. Data Management-Supplement to Section 106 Tribal Guidance

    Science.gov (United States)

    The document supplements the Tribal 106 Guidance by providing useful suggestions and tips to tribes about how to establish a data management system that reflects tribal water quality goals and objectives.

  13. 76 FR 20992 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0189] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS...

  14. 75 FR 70271 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0515] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is...

  15. 75 FR 68364 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2010-11-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0275] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full-Field Digital Mammography System; Availability AGENCY: Food and Drug Administration, HHS. [[Page...

  16. 76 FR 16425 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-03-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0028] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System; Availability AGENCY: Food and Drug Administration, HHS...

  17. 76 FR 6622 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-02-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0645] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  18. 76 FR 22906 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-04-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2006-D-0094] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  19. 76 FR 43332 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0500] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use; Availability AGENCY: Food and Drug Administration...

  20. 76 FR 43690 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-07-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2007-D-0149] (Formerly 2007D-0309) Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Electrocardiograph Electrodes; Availability AGENCY: Food and Drug...

  1. 77 FR 14403 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2012-03-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-0167] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Norovirus Serological Reagents; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice...

  2. 76 FR 48870 - Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance...

    Science.gov (United States)

    2011-08-09

    ... selection inclusion and exclusion criteria section. The revisions define and differentiate the required... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-D-0428] Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document...

  3. Sandia Software Guidelines, Volume 2. Documentation

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-09-01

    This volume is one in a series of Sandia Software Guidelines intended for use in producing quality software within Sandia National Laboratories. In consonance with the IEEE Standards for software documentation, this volume provides guidance in the selection of an adequate document set for a software project and example formats for many types of software documentation. A tutorial on life cycle documentation is also provided. Extended document thematic outlines and working examples of software documents are available on electronic media as an extension of this volume.

  4. Early Site Permit Demonstration Program: Regulatory criteria evaluation report

    International Nuclear Information System (INIS)

    1993-03-01

    The primary objective of the Early Site Plan Demonstration Program (ESPDP) is to demonstrate successfully the use of 10CFR52 to obtain ESPs for one or more US sites for one (or more) ALWR nuclear power plants. It is anticipated that preparation of the ESP application and interaction with NRC during the application review process will result not only in an ESP for the applicant(s) but also in the development of criteria and definition of processes, setting the precedent that facilitates ESPs for subsequent ESP applications. Because siting regulatory processes and acceptance criteria are contained in over 100 separate documents, comprehensive licensing and technical reviews were performed to establish whether the requirements and documentation are self-consistent, whether the acceptance criteria are sufficiently well-defined and clear, and whether the licensing process leading to the issuance of an ESP is unambiguously specified. This document provides appendices A and B of this report. Appendix A contains a list of regulations, regulatory guidance, and acceptance criteria; Appendix B contains a cross-reference index of siting-related documentation

  5. Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

    International Nuclear Information System (INIS)

    Baeckstroem, Ola; Haeggstroem, Anna; Maennistoe, Ilkka

    2010-04-01

    document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174

  6. Guidance to risk-informed evaluation of technical specifications using PSA

    International Nuclear Information System (INIS)

    Baeckstroem, O.; Haeggstroem, A.; Maennistoe, I.

    2010-10-01

    document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174. (Author)

  7. Guidance to risk-informed evaluation of technical specifications using PSA

    Energy Technology Data Exchange (ETDEWEB)

    Baeckstroem, O.; Haeggstroem, A. (Scandpower AB, Stockholm (Sweden)); Maennistoe, I. (VTT, Helsingfors (Finland))

    2010-04-15

    document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174. (Author)

  8. Guidance to Risk-Informed Evaluation of Technical Specifications using PSA

    Energy Technology Data Exchange (ETDEWEB)

    Baeckstroem, Ola; Haeggstroem, Anna (Scandpower AB, Stockholm (Sweden)); Maennistoe, Ilkka (VTT, Helsingfors (Finland))

    2010-04-15

    document is to a large content influenced by the structure and guidance given in the NRC Regulatory Guide 1.174

  9. 10 CFR 21.31 - Procurement documents.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Procurement documents. 21.31 Section 21.31 Energy NUCLEAR REGULATORY COMMISSION REPORTING OF DEFECTS AND NONCOMPLIANCE Procurement Documents § 21.31 Procurement documents. Each individual, corporation, partnership, dedicating entity, or other entity subject to the...

  10. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

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

  11. Configuration management: Phase II implementation guidance

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

    Configuration management (CM) is essential to maintaining an acceptable level of risk to the public, workers, environment, or mission success. It is a set of activities and techniques used to maintain consistency among physical and functional configuration, applicable requirements, and key documents. This document provides guidance for continuing the implementation of CM in a phased and graded manner. It describes a cost-effective approach to documented consistency with requirements, with early emphasis on items most important to safety and environmental protection. It is intended to help responsible line managers and configuration management staff personnel in meeting the Energy Systems configuration management policy standard.

  12. Inspection and enforcement by the regulatory body for nuclear power plants

    International Nuclear Information System (INIS)

    1980-01-01

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

  13. NRC regulatory uses of PSA

    International Nuclear Information System (INIS)

    Murley, T.E.

    1991-01-01

    The publication in 1975 of WASH-1400, with its new probabilistic safety assessment (PSA) methodology, had the effect of presenting a pair of eyeglasses to a man with poor eyesight. Suddenly, it gave us a view of nuclear safety with a new clarity, and it allowed us to sort out the important safety issues from the unimportant. In the intervening years, PSA insights have permeated the fabric of nearly all our safety judgments. This acceptance can be seen from the following list of broad areas where the Nuclear Regulatory Commission (NRC) staff uses PSA insights and methodology: evaluating the safety significance of operating events and recommending safety improvements where warranted; requesting licensees to systematically look for design vulnerabilities in each operating reactor; evaluating the safety significance of design weaknesses or non-compliances when judging the time frame for necessary improvements; conducting sensitivity analyses to judge where safety improvements are most effective; assessing the relative safety benefits of design features for future reactors. In judging where PSA methodology can be improved to give better safety insights, it is believed that the following areas need more attention: better modeling of cognitive errors; more comprehensive modeling of accident sequences initiated from conditions other than full power; more comprehensive modeling of inter-system loss of coolant accident (ISLOCA) sequences. Although PSA is widely used in the staff's regulatory activities, the NRC deliberately chooses not to include probabilistic prescriptions in regulations or guidance documents. The staff finds the bottom line risk estimates to be one of the least reliable products of a PSA. The reason for this view is that PSA cannot adequately address cognitive errors nor assess the effects of a pervasive poor safety attitude

  14. ANS severe accident program overview & planning document

    Energy Technology Data Exchange (ETDEWEB)

    Taleyarkhan, R.P.

    1995-09-01

    The Advanced Neutron Source (ANS) severe accident document was developed to provide a concise and coherent mechanism for presenting the ANS SAP goals, a strategy satisfying these goals, a succinct summary of the work done to date, and what needs to be done in the future to ensure timely licensability. Guidance was received from various bodies [viz., panel members of the ANS severe accident workshop and safety review committee, Department of Energy (DOE) orders, Nuclear Regulatory Commission (NRC) requirements for ALWRs and advanced reactors, ACRS comments, world-wide trends] were utilized to set up the ANS-relevant SAS goals and strategy. An in-containment worker protection goal was also set up to account for the routine experimenters and other workers within containment. The strategy for achieving the goals is centered upon closing the severe accident issues that have the potential for becoming certification issues when assessed against realistic bounding events. Realistic bounding events are defined as events with an occurrency frequency greater than 10{sup {minus}6}/y. Currently, based upon the level-1 probabilistic risk assessment studies, the realistic bounding events for application for issue closure are flow blockage of fuel element coolant channels, and rapid depressurization-related accidents.

  15. Implementation of NUREG-1318 guidance within the Yucca Mountain Project

    International Nuclear Information System (INIS)

    La Monica, L.B.; Waddell, J.D.; Hardin, E.L.

    1990-01-01

    The US Department of Energy's Yucca Mountain Project is implementing a quality assurance program that fulfills the requirements of the US Nuclear Regulatory Commission (NRC). Additional guidance for this program was provided in NUREG 1318, ''Technical Position on Items and Activities in the High-Level Waste Geologic Repository Program Subject to Quality Assurance Requirements'' for identification of items and activities important to public radiological safety and waste isolation. The process and organization for implementing this guidance is discussed. 3 refs., 2 figs

  16. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the iCMS Web site. The following items can be found on: http://cms.cern.ch/iCMS/ General - CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. LHC Symposiums Management - CB - MB - FB - FMC Agendas and minutes are accessible to CMS members through their AFS account (ZH). However some linked documents are restricted to the Board Members. FB documents are only accessible to FB members. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2006 Annual reviews are posted.   CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral students upon completion of their theses. Therefore it is requested that Ph.D students inform the CMS Secretariat a...

  17. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the iCMS Web site. The following items can be found on: http://cms.cern.ch/iCMS/ General - CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. LHC Symposiums Management - CB - MB - FB - FMC Agendas and minutes are accessible to CMS members through their AFS account (ZH). However some linked documents are restricted to the Board Members. FB documents are only accessible to FB members. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2006 Annual reviews are posted. CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral students upon completion of their theses. Therefore it is requested that Ph.D students inform the CMS Secretariat about the natu...

  18. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the iCMS Web site. The following items can be found on: http://cms.cern.ch/iCMS/ General - CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. LHC Symposiums Management - CB - MB - FB - FMC Agendas and minutes are accessible to CMS members through their AFS account (ZH). However some linked documents are restricted to the Board Members. FB documents are only accessible to FB members. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2006 Annual reviews are posted. CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral students upon completion of their theses. Therefore it is requested that Ph.D students inform the CMS Secretariat about the natur...

  19. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the iCMS Web site. The following items can be found on: http://cms.cern.ch/iCMS/ Management- CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. Management - CB - MB - FB Agendas and minutes are accessible to CMS members through their AFS account (ZH). However some linked documents are restricted to the Board Members. FB documents are only accessible to FB members. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2007 Annual reviews are posted. CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral students upon completion of their theses. Therefore it is requested that Ph.D students inform the CMS Secretariat about the nature of employment and ...

  20. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the iCMS Web site. The following items can be found on: http://cms.cern.ch/iCMS/ Management- CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. Management - CB - MB - FB Agendas and minutes are accessible to CMS members through their AFS account (ZH). However some linked documents are restricted to the Board Members. FB documents are only accessible to FB members. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2007 Annual reviews are posted. CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral students upon completion of their theses. Therefore it is requested that Ph.D students inform the CMS Secretariat about the nature of em¬pl...

  1. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the iCMS Web site. The following items can be found on: http://cms.cern.ch/iCMS/ General - CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. LHC Symposiums Management - CB - MB - FB - FMC Agendas and minutes are accessible to CMS members through their AFS account (ZH). However some linked documents are restricted to the Board Members. FB documents are only accessible to FB members. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2006 Annual reviews are posted. CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral students upon completion of their theses. Therefore it is requested that Ph.D students inform the CMS Secretariat about the na...

  2. Technical approach document

    International Nuclear Information System (INIS)

    1989-12-01

    The Uranium Mill Tailings Radiation Control Act (UMTRCA) of 1978, Public Law 95-604 (PL95-604), grants the Secretary of Energy the authority and responsibility to perform such actions as are necessary to minimize radiation health hazards and other environmental hazards caused by inactive uranium mill sites. This Technical Approach Document (TAD) describes the general technical approaches and design criteria adopted by the US Department of Energy (DOE) in order to implement remedial action plans (RAPS) and final designs that comply with EPA standards. It does not address the technical approaches necessary for aquifer restoration at processing sites; a guidance document, currently in preparation, will describe aquifer restoration concerns and technical protocols. This document is a second revision to the original document issued in May 1986; the revision has been made in response to changes to the groundwater standards of 40 CFR 192, Subparts A--C, proposed by EPA as draft standards. New sections were added to define the design approaches and designs necessary to comply with the groundwater standards. These new sections are in addition to changes made throughout the document to reflect current procedures, especially in cover design, water resources protection, and alternate site selection; only minor revisions were made to some of the sections. Sections 3.0 is a new section defining the approach taken in the design of disposal cells; Section 4.0 has been revised to include design of vegetated covers; Section 8.0 discusses design approaches necessary for compliance with the groundwater standards; and Section 9.0 is a new section dealing with nonradiological hazardous constituents. 203 refs., 18 figs., 26 tabs

  3. Optimal Aerocapture Guidance

    Data.gov (United States)

    National Aeronautics and Space Administration — The main goal of my research is to develop, implement, verify, and validate an optimal numerical predictor-corrector aerocapture guidance algorithm that is...

  4. Coral Reef Guidance

    Science.gov (United States)

    Guidance prepared by EPA and Army Corps of Engineers concerning coral reef protection under the Clean Water Act, Marine Protection, Research, and Sanctuaries Act, Rivers and Harbors Act, and Federal Project Authorities.

  5. Laser Guidance Analysis Facility

    Data.gov (United States)

    Federal Laboratory Consortium — This facility, which provides for real time, closed loop evaluation of semi-active laser guidance hardware, has and continues to be instrumental in the development...

  6. Guidelines for Teaching Undergraduate Sport Sociology. Guidance Document

    Science.gov (United States)

    Coakley, Jay; Riemer, Brenda; Sailes, Gary; Harrison, Louis; Pittman, Beverly

    2009-01-01

    Sport sociology is a subdiscipline of sociology that, since the late 1960s, has produced knowledge about sports as social phenomena in a wide range of societies. It may be included as a major specialization area in graduate programs in kinesiology, sports studies and physical education departments, and is widely offered as a single undergraduate…

  7. Geo-location Requirements for UXO Discrimination (Guidance Document)

    Science.gov (United States)

    2008-05-01

    Signatures Measured by MTADS," Proceedings of the UXO Forum, Anaheim, pp. 282-291, May 1998. [5] Billings, S., L. Pasion and D. Oldenburg, "UXO...February 2002. [6] Billings, S., L. Pasion and D. Oldenburg, "Inversion of Magnetics for UXO Discrimination and Identification," UXO/Countermine Forum...1286-1293, June 2001. [10] Pasion , L. and D. Oldenburg, "A Discrimination Algorithm for UXO Using Time Domain Electromagnetics," J. Environmental

  8. Institutional capacities for NDC implementation: a guidance document

    DEFF Research Database (Denmark)

    Bakhtiari, Fatemeh; Hinostroza, Miriam L.; Puig, Daniel

    , the time horizon for implementing NDC goals is 2030. By ratifying the 2015 Paris Agreement of the UNFCCC, parties commit to submitting revised NDCs every five years. The revised NDCs must have an implementation period of five years, and must be submitted five years in advance of the start date...... for implementation. The Paris Agreement further calls on parties to increase progressively the level of ambition of their NDCs. Implementation of the first NDCs is to start in 2021. Delivering on this requirement and within this time horizon requires increased institutional capacities on the part of national...

  9. MMRP Guidance Document for Soil Sampling of Energetics and Metals

    Science.gov (United States)

    2011-10-01

    studies have measured the persistence of HE in the field. Radtke et al. (2002) sampled surface soils at an explosives testing area that had not been...Munitions Residues. CRREL Report CR-92-5. Radtke C. W., D. Gianotto, and F. F. Roberto. 2002. Effects of particulate explosives on estimating

  10. Minimum Competencies in Undergraduate Motor Development. Guidance Document

    Science.gov (United States)

    National Association for Sport and Physical Education, 2004

    2004-01-01

    The minimum competency guidelines in Motor Development described herein at the undergraduate level may be gained in one or more motor development course(s) or through other courses provided in an undergraduate curriculum. The minimum guidelines include: (1) Formulation of a developmental perspective; (2) Knowledge of changes in motor behavior…

  11. 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

  12. Document Models

    Directory of Open Access Journals (Sweden)

    A.A. Malykh

    2017-08-01

    Full Text Available In this paper, the concept of locally simple models is considered. Locally simple models are arbitrarily complex models built from relatively simple components. A lot of practically important domains of discourse can be described as locally simple models, for example, business models of enterprises and companies. Up to now, research in human reasoning automation has been mainly concentrated around the most intellectually intensive activities, such as automated theorem proving. On the other hand, the retailer business model is formed from ”jobs”, and each ”job” can be modelled and automated more or less easily. At the same time, the whole retailer model as an integrated system is extremely complex. In this paper, we offer a variant of the mathematical definition of a locally simple model. This definition is intended for modelling a wide range of domains. Therefore, we also must take into account the perceptual and psychological issues. Logic is elitist, and if we want to attract to our models as many people as possible, we need to hide this elitism behind some metaphor, to which ’ordinary’ people are accustomed. As such a metaphor, we use the concept of a document, so our locally simple models are called document models. Document models are built in the paradigm of semantic programming. This allows us to achieve another important goal - to make the documentary models executable. Executable models are models that can act as practical information systems in the described domain of discourse. Thus, if our model is executable, then programming becomes redundant. The direct use of a model, instead of its programming coding, brings important advantages, for example, a drastic cost reduction for development and maintenance. Moreover, since the model is well and sound, and not dissolved within programming modules, we can directly apply AI tools, in particular, machine learning. This significantly expands the possibilities for automation and

  13. 78 FR 32668 - Draft Guidance for Industry: Changes to an Approved Application: Biological Products: Human Blood...

    Science.gov (United States)

    2013-05-31

    ..., including Source Plasma, with recommendations intended to assist with determining which reporting mechanism... final version of the guidance, submit either electronic or written comments on the draft guidance by... INFORMATION section for electronic access to the draft guidance document. Submit electronic comments on the...

  14. 77 FR 6625 - Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and Health Care...

    Science.gov (United States)

    2012-02-08

    ... DEPARTMENT OF VETERANS AFFAIRS Meeting the Challenge of Pandemic Influenza: Ethical Guidance for... guidance document entitled ``Meeting the Challenge of Pandemic Influenza: Ethical Guidance for Leaders and... should indicate that they are submitted in response to ``Meeting the Challenge of Pandemic Influenza...

  15. 76 FR 9028 - Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability

    Science.gov (United States)

    2011-02-16

    ...] Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products; Availability AGENCY: Food and... Therapy Products'' dated January 2011. The guidance document provides manufacturers of cellular and gene... for Industry: Potency Tests for Cellular and Gene Therapy Products'' dated January 2011. The guidance...

  16. Guidance for closure of existing DOE LLW disposal sites

    International Nuclear Information System (INIS)

    Blanchfield, L.

    1987-01-01

    During FY 1986, a closure guidance document was developed. The purpose of this document is to provide guidance in support of DOE Order 5820.2 to site operating contractors for the stabilization and closure of existing low-level waste (LLW) shallow land disposal sites at US Department of Energy (DOE) facilities. Guidance is provided to aid operators in placing existing LLW sites in a closed conditions, i.e., a condition in which a nonoperational site meets postclosure performance requirements and can be shown, within a high degree of confidence, to perform as anticipated in the future, under the most cost-effective maintenance approach. Guidance is based on the philosophy that closure should be planned and performed using a systems approach. Plans for FY 1987 call for revision of the document to incorporate more information on closure of LLW sites also containing radioactive mixed waste and/or transuranic waste. 4 references, 3 figures, 2 tables

  17. Regulatory Framework and Radiation Protection as Basis for Evaluation

    International Nuclear Information System (INIS)

    Elegba, S.B.

    2010-01-01

    Regulatory Framework for Nuclear Safety and Radiation Protection International Instruments: Conventions; Safety Fundamentals; Codes of Conduct; Safety Requirements and Guide, and National Instruments:-Legislation; Regulations; Guidance Documents. The Sustainable Development Principle recognizes a duty to prevent undue burden and degradation of the environment for future generations. The prime responsibility for safety must rest with the person or organization responsible for facilities…that give rise to radiation risks” (IAEA Safety Fundamentals – SF-1). Compliance with regulations and requirements imposed by the Regulatory Body shall not relieve the organization of its prime responsibility for safety. The regulatory body shall establish and implement appropriate arrangements for a systematic approach to quality management which extend throughout the range of responsibilities and functions undertaken.”. The IAEA self-assessment model for a Regulatory Body is based on a three tier approach. This model is modular and can be used and adopted for implementation by any regulator at any stage of maturity “Start up”, “On the way”, “Mature” Small, medium size, big. The IAEA is required by its Statute to promote international cooperation while regulating safety is a national responsibility. However, radiation risks may transcend national borders and international cooperation that serves to promote and enhance safety globally by exchanging experience and by improving capabilities to control hazards, to prevent accidents, to respond to emergencies and to mitigate any harmful consequences

  18. Moisture Control Guidance for Commercial and Public Buildings (EPA 402-F-13053)

    Science.gov (United States)

    This document provides guidance to designers, construction mangers, and building operation/maintenance managers to improve IEQ and reduce risks of encountering IEQ problems due to insufficient moisture control. EPA will be producing a document entitled "Moisture Control Guida...

  19. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1992-07-01

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

  20. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1993-02-01

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

  1. NRC Regulatory Agenda

    International Nuclear Information System (INIS)

    1989-07-01

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

  2. NRC regulatory agenda

    International Nuclear Information System (INIS)

    1992-11-01

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

  3. Nuclear Regulatory Legislation

    International Nuclear Information System (INIS)

    1989-08-01

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

  4. Orbitmpi Documentation

    International Nuclear Information System (INIS)

    Lowe, Lisa L.

    2000-01-01

    Orbitmpi is a parallelized version of Roscoe White's Orbit code. The code has been parallelized using MPI, which makes it portable to many types of machines. The guidelines used for the parallelization were to increase code performance with minimal changes to the code's original structure. This document gives a general description of how the parallel sections of the code run. It discusses the changes made to the original code and comments on the general procedure for future additions to Orbitmpi, as well as describing the effects of a parallelized random number generator on the code's output. Finally, the scaling results from Hecate and from Puffin are presented. Hecate is a 64-processor Origin 2000 machine, with MIPS R12000 processors and 16GB of memory, and Puffin is a PC cluster with 9 dual-processor 450 MHz Pentium III (18 processors max.), with 100Mbits ethernet communication

  5. Title list of documents made publicly available

    International Nuclear Information System (INIS)

    1990-04-01

    This document is a monthly publication containing descriptions of information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials, and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. The following indexes are included: Personal Author, Corporate Source, Report Number, and Cross Reference to Principal Documents

  6. Draft Guidance for Protective Action Strategies Development

    Energy Technology Data Exchange (ETDEWEB)

    Park, Sang Hyun; Jeong, Seung Young; Kim, Wanjoo [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2016-10-15

    National nuclear emergency preparedness and response (EPR) framework has been improved since the Fukushima accident in 2011. There are still many needs to be amended and improved in regulatory requirements and technical criteria to warrant efficacy of the EPR framework. As an important part of the framework, protective actions have to be implemented with optimized and justified manner during whole emergency phases. In this study, to enhance protective action strategies in response to severe accident or general emergency, existing procedures were reviewed. And generic guidance to develop protective action recommendations (PARs) was proposed considering revised EPZ and recent technical information on protective action strategies. The generic guidance for PARs based on facility status was introduced. Revision of EPZ and some recent information on protective action strategies, such as staged evacuation, specific approach for rapidly progressing accident were considered. It would be employed as a basis to develop site-specific strategies of PARs and regulatory guidance for emergency plan by nuclear licensee. It was focused on an early phase of nuclear emergency. Further efforts to develop site specific strategies of PARs and strategies which cover full range of nuclear emergency would be followed by several stake holders.

  7. A guide to approaching regulatory considerations for lentiviral-mediated gene therapies.

    Science.gov (United States)

    White, Michael; Whittaker, Roger; Stoll, Elizabeth Ann

    2017-06-12

    Lentiviral vectors are increasingly the gene transfer tool of choice for gene or cell therapies, with multiple clinical investigations showing promise for this viral vector in terms of both safety and efficacy. The third-generation vector system is well-characterized, effectively delivers genetic material and maintains long-term stable expression in target cells, delivers larger amounts of genetic material than other methods, is non-pathogenic and does not cause an inflammatory response in the recipient. This report aims to help academic scientists and regulatory managers negotiate the governance framework to achieve successful translation of a lentiviral vector-based gene therapy. The focus is on European regulations, and how they are administered in the United Kingdom, although many of the principles will be similar for other regions including the United States. The report justifies the rationale for using third-generation lentiviral vectors to achieve gene delivery for in vivo and ex vivo applications; briefly summarises the extant regulatory guidance for gene therapies, categorised as advanced therapeutic medicinal products (ATMPs); provides guidance on specific regulatory issues regarding gene therapies; presents an overview of the key stakeholders to be approached when pursuing clinical trials authorization for an ATMP; and includes a brief catalogue of the documentation required to submit an application for regulatory approval of a new gene therapy.

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

    Science.gov (United States)

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

    2015-08-01

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

  9. Guidance levels, achievable doses and expectation levels

    International Nuclear Information System (INIS)

    Li, Lianbo; Meng, Bing

    2002-01-01

    The National Radiological Protection Board (NRPB), the International Atomic Energy Agency (IAEA) and the Commission of the European Communities (CEC) published their guidance levels and reference doses for typical X-ray examination and nuclear medicine in their documents in 1993, 1994 and 1996 respectively. From then on, the concept of guidance levels or reference doses have been applied to different examinations in the field of radiology and proved to be effective for reduction of patient doses. But the guidance levels or reference doses are likely to have some shortcomings and can do little to make further reduction of patient dose in the radiology departments where patient dose are already below them. For this reason, the National Radiological Protection Board (NRPB) proposed a concept named achievable doses which are based on the mean dose observed for a selected sample of radiology departments. This paper will review and discuss the concept of guidance levels and achievable doses, and propose a new concept referred to as Expectation Levels that will encourage the radiology departments where patient dose are already below the guidance levels to keep patient dose as low as reasonably achievable. Some examples of the expectation levels based on the data published by a few countries are also illustrated in this paper

  10. Asset Management Plans, Appraisal Guidance for 2003-04.

    Science.gov (United States)

    Department for Education and Skills, London (England).

    This document is one in a series which aims to assist Local Authorities in Britain with asset management planning (AMPs) for schools. AMPs set out the information needed, and the criteria used, to make decisions about spending on school premises. The document provides guidance on the appraisal of school AMPs in 2002 to inform 3-year formulaic…

  11. Generic Overview of the Status of Characterization Surveys and Guidance for Decommissioning

    International Nuclear Information System (INIS)

    Abu Eid, Rateb Boby

    2012-01-01

    This paper presents an overview of several topical areas pertaining to characterization and survey for decommissioning, including: U.S. NRC regulatory requirements for decommissioning and survey; a description of the decommissioning processes particularly role of characterization and survey; characterization survey types and NRC categorization of decommissioning groups; status of U.S. characterization survey guidance; and overview of key characterization and survey Issues. The specific topical areas are briefly discussed below: - The paper addresses the U.S. NRC requirements under 10 CFR Part 20, Subpart E - 'Radiological Criteria for License Termination', and final status surveys requirements under 10 CFR 20.1501(a). Other requirements under 10CFR Parts 50.75, 50.82, 51.53, and 51.95) as well as, reporting and record keeping for decommissioning planning will be outlined. The paper also discusses NRC general decommissioning process for materials and fuel cycle facilities, as well as, for power reactor facilities. - Strategy and planning for decommissioning using the data quality objectives (DQO) approach and its seven step process will be presented in some detail. - The US NRC 'Surveys and Site Investigation Process' as described in NUREG 1757 and categorization of 'Decommissioning Groups' in the context of characterization and survey needs will be addressed. - The paper briefly outlines methodologies, approaches, and status of U.S. multi-agency key guidance documents such as MARSSIM (NUREG-1575), MARSAME (NUREG- 1575, Supp.1), and more recently, the NRC Subsurface Guidance NUREG/CR 7021. - Dose modeling and software development/update in support of radiological survey and characterization for derivation of derived concentration guideline levels. - Lessons Learned from Regulatory 'Reviews of Survey Plans' particularly attributes of survey plans, common survey issues, and key aspects for decommissioning success are discussed in the paper. (author)

  12. CMS DOCUMENTATION

    CERN Multimedia

    CMS TALKS AT MAJOR MEETINGS The agenda and talks from major CMS meetings can now be electronically accessed from the ICMS Web site. The following items can be found on: http://cms.cern.ch/iCMS Management – CMS Weeks (Collaboration Meetings), CMS Weeks Agendas The talks presented at the Plenary Sessions. Management – CB – MB – FB Agendas and minutes are accessible to CMS members through Indico. LHCC The talks presented at the ‘CMS Meetings with LHCC Referees’ are available on request from the PM or MB Country Representative. Annual Reviews The talks presented at the 2008 Annual Reviews are posted in Indico. CMS DOCUMENTS It is considered useful to establish information on the first employment of CMS doctoral student upon completion of their theses.  Therefore it is requested that Ph.D students inform the CMS Secretariat about the nature of employment and name of their first employer. The Notes, Conference Reports and Theses published si...

  13. Guidance on enforcement of the requirements of the surface water treatment rule

    International Nuclear Information System (INIS)

    1992-06-01

    The document provides guidance on several specific issues relating to the enforcement of the Surface Water Treatment Rule. The guidance deals with the provisions of the Rule relating to unfiltered systems. Enforcements of the requirements relating to the filtered systems will be dealt with in a later document

  14. 77 FR 24722 - Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes...

    Science.gov (United States)

    2012-04-25

    ...] Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes... Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food... determining whether changes in manufacturing process, including the intentional reduction in particle size to...

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

    International Nuclear Information System (INIS)

    1999-09-01

    regulatory approaches of the regulatory body and its organization are important factors. Whilst regulatory effectiveness cannot easily be measured directly, there are various characteristics which can be attributed to an effective regulatory body. These characteristics can be used as indicators. They can also provide guidance on the assessment of regulatory effectiveness. They may also indicate possible fields of enhancement of the effectiveness of a regulatory body. In order to assist Member States in achieving and maintaining a high level of regulatory effectiveness, the IAEA convened the seventh series of peer discussions on 'Assessment of Regulatory Effectiveness'. The results and findings of these discussions are summarized in this report which concentrates on common findings and good practices identified during the discussions. Its intention is primarily to disseminate information on existing experience and to identify beneficial aspects of practices in order to provide guidance to Member States. This report is structured so that it covers the subject matter under the following main headings: Elements of an Effective Regulatory Body; Possible Indicators of Regulatory Effectiveness; Assessment and Suggestions for Good Practices to Enhance Effectiveness. It is important to note that recommendations of good practice are included if they have been identified by at least one of the groups. It does not follow that all of the groups or individual Member States would necessarily endorse all of the recommendations. However, it is considered that if a single group of senior regulators judge that a particular practice is worthy of recommendation, it needs to receive serious consideration. In some cases the same recommendations arise from all of the groups. These are considered to be particularly meritorious

  16. 78 FR 52776 - Documents to Support Submission of an Electronic Common Technical Document; Availability

    Science.gov (United States)

    2013-08-26

    ... Contents Headings and Hierarchy,'' version 2.2; ``Specifications for eCTD Validation Criteria,'' version 3... characterization of promotional marketing and advertising material, and facilitate automated processing of...ComplianceRegulatoryInformation/Guidances/UCM072349.pdf )). ``The Comprehensive Table of Contents Headings...

  17. Omega documentation

    Energy Technology Data Exchange (ETDEWEB)

    Howerton, R.J.; Dye, R.E.; Giles, P.C.; Kimlinger, J.R.; Perkins, S.T.; Plechaty, E.F.

    1983-08-01

    OMEGA is a CRAY I computer program that controls nine codes used by LLNL Physical Data Group for: 1) updating the libraries of evaluated data maintained by the group (UPDATE); 2) calculating average values of energy deposited in secondary particles and residual nuclei (ENDEP); 3) checking the libraries for internal consistency, especially for energy conservation (GAMCHK); 4) producing listings, indexes and plots of the library data (UTILITY); 5) producing calculational constants such as group averaged cross sections and transfer matrices for diffusion and Sn transport codes (CLYDE); 6) producing and updating standard files of the calculational constants used by LLNL Sn and diffusion transport codes (NDFL); 7) producing calculational constants for Monte Carlo transport codes that use group-averaged cross sections and continuous energy for particles (CTART); 8) producing and updating standard files used by the LLNL Monte Carlo transport codes (TRTL); and 9) producing standard files used by the LANL pointwise Monte Carlo transport code MCNP (MCPOINT). The first four of these functions and codes deal with the libraries of evaluated data and the last five with various aspects of producing calculational constants for use by transport codes. In 1970 a series, called PD memos, of internal and informal memoranda was begun. These were intended to be circulated among the group for comment and then to provide documentation for later reference whenever questions arose about the subject matter of the memos. They have served this purpose and now will be drawn upon as source material for this more comprehensive report that deals with most of the matters covered in those memos.

  18. Omega documentation

    International Nuclear Information System (INIS)

    Howerton, R.J.; Dye, R.E.; Giles, P.C.; Kimlinger, J.R.; Perkins, S.T.; Plechaty, E.F.

    1983-08-01

    OMEGA is a CRAY I computer program that controls nine codes used by LLNL Physical Data Group for: 1) updating the libraries of evaluated data maintained by the group (UPDATE); 2) calculating average values of energy deposited in secondary particles and residual nuclei (ENDEP); 3) checking the libraries for internal consistency, especially for energy conservation (GAMCHK); 4) producing listings, indexes and plots of the library data (UTILITY); 5) producing calculational constants such as group averaged cross sections and transfer matrices for diffusion and Sn transport codes (CLYDE); 6) producing and updating standard files of the calculational constants used by LLNL Sn and diffusion transport codes (NDFL); 7) producing calculational constants for Monte Carlo transport codes that use group-averaged cross sections and continuous energy for particles (CTART); 8) producing and updating standard files used by the LLNL Monte Carlo transport codes (TRTL); and 9) producing standard files used by the LANL pointwise Monte Carlo transport code MCNP (MCPOINT). The first four of these functions and codes deal with the libraries of evaluated data and the last five with various aspects of producing calculational constants for use by transport codes. In 1970 a series, called PD memos, of internal and informal memoranda was begun. These were intended to be circulated among the group for comment and then to provide documentation for later reference whenever questions arose about the subject matter of the memos. They have served this purpose and now will be drawn upon as source material for this more comprehensive report that deals with most of the matters covered in those memos

  19. Title list of documents made publicly available

    International Nuclear Information System (INIS)

    1994-06-01

    The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to Court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index

  20. Title list of documents made publicly available

    International Nuclear Information System (INIS)

    1982-03-01

    The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to Court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index

  1. South African HIV self-testing policy and guidance considerations

    Directory of Open Access Journals (Sweden)

    Francois Venter

    2017-10-01

    Full Text Available The gap in HIV testing remains significant and new modalities such as HIV self-testing (HIVST have been recommended to reach key and under-tested populations. In December 2016, the World Health Organization (WHO released the Guidelines on HIV Self-Testing and Partner Notification: A Supplement to the Consolidated Guidelines on HIV Testing Services (HTS and urged member countries to develop HIVST policy and regulatory frameworks. In South Africa, HIVST was included as a supplementary strategy in the National HIV Testing Services Policy in 2016, and recently, guidelines for HIVST were included in the South African National Strategic Plan for HIV, sexually transmitted infections and tuberculosis 2017–2022. This document serves as an additional guidance for the National HIV Testing Services Policy 2016, with specific focus on HIVST. It is intended for policy advocates, clinical and non-clinical HTS providers, health facility managers and healthcare providers in private and public health facilities, non-governmental, community-based and faith-based organisations involved in HTS and outreach, device manufacturers, workplace programmes and institutes of higher education.

  2. Addressing the regulatory and scientific challenges in multiple sclerosis--a statement from the EU regulators.

    Science.gov (United States)

    Balabanov, Pavel; Haas, Manuel; Elferink, Andre; Bakchine, Serge; Broich, Karl

    2014-09-01

    Improving and facilitating the process of making new drugs available to patients with multiple sclerosis (MS) requires cooperation among the regulators and other stakeholders. This cooperation will also positively contribute towards developing guidelines of the highest quality in medical, regulatory and scientific aspects. This would be beneficial both in areas that require further guideline development, but also in fields where existing guidance should be adapted to take into account evolution in science. Considering the input from all stakeholders, the European Medicines Agency confirmed its intention to update the relevant guideline and apply a flexible approach towards new drug development strategies in MS. This article is the first official position from the EU regulators, presenting the main changes to be expected in the guidance document. © The Author(s) 2014.

  3. 78 FR 59038 - Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff...

    Science.gov (United States)

    2013-09-25

    ... FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and...] Mobile Medical Applications; Guidance for Industry and Food and Drug Administration Staff; Availability...) is announcing the availability of the guidance entitled ``Mobile Medical Applications.'' The FDA is...

  4. Developing regulatory approaches

    International Nuclear Information System (INIS)

    Axelsson, Lars

    2012-01-01

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

  5. Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome

    DEFF Research Database (Denmark)

    Bueno, Héctor; de Graeff, Pieter; Richard-Lordereau, Isabelle

    2016-01-01

    syndrome (ACS) to achieve consistency with current knowledge in the field. This manuscript summarizes the key output from a collaborative workshop, organized by the Cardiovascular Round Table and the European Affairs Committee of the European Society of Cardiology, involving clinicians, academic...... researchers, trialists, European and US regulators, and pharmaceutical industry researchers. Specific questions in four key areas were selected as priorities for changes in regulatory guidance: patient selection, endpoints, methodologic issues and issues related to the research for novel agents. Patients......Regulatory authorities interpret the results of randomized controlled trials according to published principles. The European Medicines Agency (EMA) is planning a revision of the 2000 and 2003 guidance documents on clinical investigation of new medicinal products for the treatment of acute coronary...

  6. 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)

  7. Patterns for Effectively Documenting Frameworks

    Science.gov (United States)

    Aguiar, Ademar; David, Gabriel

    Good design and implementation are necessary but not sufficient pre-requisites for successfully reusing object-oriented frameworks. Although not always recognized, good documentation is crucial for effective framework reuse, and often hard, costly, and tiresome, coming with many issues, especially when we are not aware of the key problems and respective ways of addressing them. Based on existing literature, case studies and lessons learned, the authors have been mining proven solutions to recurrent problems of documenting object-oriented frameworks, and writing them in pattern form, as patterns are a very effective way of communicating expertise and best practices. This paper presents a small set of patterns addressing problems related to the framework documentation itself, here seen as an autonomous and tangible product independent of the process used to create it. The patterns aim at helping non-experts on cost-effectively documenting object-oriented frameworks. In concrete, these patterns provide guidance on choosing the kinds of documents to produce, how to relate them, and which contents to include. Although the focus is more on the documents themselves, rather than on the process and tools to produce them, some guidelines are also presented in the paper to help on applying the patterns to a specific framework.

  8. Regulatory oversight of safety culture in nuclear installations - New IAEA developments

    International Nuclear Information System (INIS)

    Kerhoas, Anne; )

    2012-01-01

    Ms. Anne Kerhoas described the IAEA work on guidance for regulatory oversight of safety culture. She summarised the various IAEA, OECD/NEA and ANS meetings that have been held on the topic between 1995 and 2011. The IAEA has carried out two recent projects with the Bulgarian and Romanian regulatory bodies to develop a safety culture oversight program. The work was funded by the Norwegian government and has involved 30 experts from 17 different countries. Draft guidance for regulators on how to monitor licensee safety culture has also been produced (IAEA-TECDOC-DD1070). The document is intended to provide practical guidance on oversight strategies and is applicable to a wide range of nuclear installations, including nuclear power plants, fuel cycle facilities, research reactors and waste management facilities. A number of principles for regulatory oversight of safety culture were summarised. For example, the primary responsibility for safety remains with the licensee, safety culture oversight should be performed at all stages of the life cycle of the nuclear installation, and multiple data collection methods should be used. The overall approach to safety culture described in the draft IAEA Tech doc includes a range of approaches to build up a meaningful picture of the licensee's safety culture. These include interviews, observations, review of documents, review of events, discussions and surveys. The importance of ongoing discussion with the licensee throughout the process to develop a deeper shared understanding of issues was emphasised. The results of the Chester 2 workshop will be used as an input to finalization of the draft Tech Doc

  9. General Merchandise 50% Energy Savings Technical Support Document

    Energy Technology Data Exchange (ETDEWEB)

    Hale, E.; Leach, M.; Hirsch, A.; Torcellini, P.

    2009-09-01

    This report documents technical analysis for medium-box general merchandise stores aimed at providing design guidance that achieves whole-building energy savings of at least 50% over ASHRAE Standard 90.1-2004.

  10. Request for Guidance on PSD Applicability Determinations for Boiler Emissions

    Science.gov (United States)

    This document may be of assistance in applying the New Source Review (NSR) air permitting regulations including the Prevention of Significant Deterioration (PSD) requirements. This document is part of the NSR Policy and Guidance Database. Some documents in the database are a scanned or retyped version of a paper photocopy of the original. Although we have taken considerable effort to quality assure the documents, some may contain typographical errors. Contact the office that issued the document if you need a copy of the original.

  11. Guidance for implementing the UMTRA Project long-term surveillance program

    International Nuclear Information System (INIS)

    1992-09-01

    The US Nuclear Regulatory Commission (NRC) has issued a general license for the custody and long-term care of US Department of Energy (DOE) Uranium Mill Tailings Remedial Action (UMTRA) Project permanent disposal sites. The purpose of this general license is to ensure that the UMTRA disposal sites will be cared for in such a manner as to protect the public health and safety and the environment upon completion of remedial actions. The general license will be in effect for a disposal site when NRC accepts the disposal site long-term surveillance plan (LTSP) that meets the requirements of 10 CFR 40.27. The site LTSP describes in detail the long-term surveillance program, including any monitoring, maintenance, and emergency measures necessary to fulfill the conditions of the general license. This guidance document provides (1) instructions for preparing the disposal site LTSPs and (2) instructions for carrying out the UMTRA Project long-term surveillance program, including any monitoring that may be required. The information provided in this document also is in accordance with the regulatory requirements set forth in 40 CFR 192. On January 5, 1985, the US Tenth Circuit Court of Appeals remanded the groundwater standards, 40 CFR 192.02. Proposed groundwater standards were issued for comment on September 24, 1987 (52 FR 3600). When the groundwater standards become final, this document will be revised, as appropriate. This document also will be updated in response to any changes to 10 CFR 40, or in response to changes in the manner in which the long-term care of the licensed disposal sites is carried out

  12. Builders Challenge Quality Criteria Support Document

    Energy Technology Data Exchange (ETDEWEB)

    None

    2009-06-01

    This document provides guidance to U.S. home builders participating in Builders Challenge. To qualify for the Builders Challenge, a home must score 70 or less on the EnergySmart Home Scale (E-Scale). Homes also must meet the Builders Challenge Quality Cri

  13. Information Quality in Regulatory Decision Making: Peer Review versus Good Laboratory Practice.

    Science.gov (United States)

    McCarty, Lynn S; Borgert, Christopher J; Mihaich, Ellen M

    2012-07-01

    There is an ongoing discussion on the provenance of toxicity testing data regarding how best to ensure its validity and credibility. A central argument is whether journal peer-review procedures are superior to Good Laboratory Practice (GLP) standards employed for compliance with regulatory mandates. We sought to evaluate the rationale for regulatory decision making based on peer-review procedures versus GLP standards. We examined pertinent published literature regarding how scientific data quality and validity are evaluated for peer review, GLP compliance, and development of regulations. Some contend that peer review is a coherent, consistent evaluative procedure providing quality control for experimental data generation, analysis, and reporting sufficient to reliably establish relative merit, whereas GLP is seen as merely a tracking process designed to thwart investigator corruption. This view is not supported by published analyses pointing to subjectivity and variability in peer-review processes. Although GLP is not designed to establish relative merit, it is an internationally accepted quality assurance, quality control method for documenting experimental conduct and data. Neither process is completely sufficient for establishing relative scientific soundness. However, changes occurring both in peer-review processes and in regulatory guidance resulting in clearer, more transparent communication of scientific information point to an emerging convergence in ensuring information quality. The solution to determining relative merit lies in developing a well-documented, generally accepted weight-of-evidence scheme to evaluate both peer-reviewed and GLP information used in regulatory decision making where both merit and specific relevance inform the process.

  14. National Environmental Policy Act guidance: A model process

    International Nuclear Information System (INIS)

    Angle, B.M.; Lockhart, V.A.T.; Sema, B.; Tuott, L.C.; Irving, J.S.

    1995-04-01

    The ''Model National Environmental Policy Act (NEPA) Process'' includes: References to regulations, guidance documents, and plans; training programs; procedures; and computer databases. Legislative Acts and reference documents from Congress, US Department of Energy, and Lockheed Idaho Technologies Company provide the bases for conducting NEPA at the Idaho National Engineering Laboratory (INEL). Lockheed Idaho Technologies Company (LITCO) NEPA / Permitting Department, the Contractor Environmental Organization (CEO) is responsible for developing and maintaining LITCO NEPA and permitting policies, guidance, and procedures. The CEO develops procedures to conduct environmental evaluations based on NEPA, Council on Environmental Quality (CEQ) regulations, and DOE guidance. This procedure includes preparation or support of environmental checklists, categorical exclusion determinations, environmental assessment determinations, environmental assessments, and environmental impact statements. In addition, the CEO uses this information to train personnel conducting environmental evaluations at the INEL. Streamlining these procedures fosters efficient use of resources, quality documents, and better decisions on proposed actions

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

    Directory of Open Access Journals (Sweden)

    Dipak Dilip Gadade

    2016-12-01

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

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

    Science.gov (United States)

    Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

    2016-12-01

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

  17. Guidance For The Proper Characterization And Classification Of Low Specific Activity Materials And Surface Contaminated Objects For Disposal

    International Nuclear Information System (INIS)

    Portsmouth, J.H.; Blackford, L.T.

    2012-01-01

    Regulatory concerns over the proper characterization of certain waste streams led CH2M HILL Plateau Remediation Company (CHPRC) to develop written guidance for personnel involved in Decontamination and Decommissioning (D and D) activities, facility management and Waste Management Representatives (WMRs) involved in the designation of wastes for disposal on and off the Hanford Site. It is essential that these waste streams regularly encountered in D and D operations are properly designated, characterized and classified prior to shipment to a Treatment, Storage or Disposal Facility (TSDF). Shipments of waste determined by the classification process as Low Specific Activity (LSA) or Surface Contaminated Objects (SCO) must also be compliant with all applicable U.S. Department of Transportation (DOE) regulations as well as Department of Energy (DOE) orders. The compliant shipment of these waste commodities is critical to the Hanford Central Plateau cleanup mission. Due to previous problems and concerns from DOE assessments, CHPRC internal critiques as well as DOT, a management decision was made to develop written guidance and procedures to assist CHPRC shippers and facility personnel in the proper classification of D and D waste materials as either LSA or SCO. The guidance provides a uniform methodology for the collection and documentation required to effectively characterize, classify and identify candidate materials for shipping operations. A primary focus is to ensure that waste materials generated from D and D and facility operations are compliant with the DOT regulations when packaged for shipment. At times this can be difficult as the current DOT regulations relative to the shipment of LSA and SCO materials are often not clear to waste generators. Guidance is often sought from NUREG 1608/RAMREG-003 (3): a guidance document that was jointly developed by the DOT and the Nuclear Regulatory Commission (NRC) and published in 1998. However, NUREG 1608 (3) is now thirteen

  18. Documentation Experiences for Jamaican SLOWPOKE-2 Conversion from HEU to LEU

    International Nuclear Information System (INIS)

    Warner, T.-A.; Dennis, H.; Antoine, J.

    2015-01-01

    The Jamaican SLOWPOKE–2 (JM–1) is a 20 kW research reactor manufactured by Atomic Energy of Canada Limited and has been operating since March 1984, in the department of the International Centre for Environmental and Nuclear Sciences (ICENS), at the University of the West Indies, Mona Campus in Kingston, Jamaica. The pool type reactor has been primarily used for Neutron Activation Analysis in environmental, agricultural, geochemical, health-related studies and mineral exploration. The University, assisted by the IAEA under the GTRI/RERTR program, is currently in the process of converting from HEU to LEU. Extensive documentation on policies, general requirements, elements of the conversion quality assurance (QA) system and conversion QA administrative procedures is required for the conversion. The core conversion activities are being carried out in accordance with current international standards and regulatory guidelines of the newly established Jamaican Radiation Safety Authority (RSA) with agreement between the RSA and IAEA or DOE related to Nuclear Safety and Control. The documentation structure has taken into consideration nuclear safety and licensing, LEU fuel design and conversion analysis, LEU fuel procurement and fabrication, removal of HEU fuel and reactor maintenance and conversion and commissioning, with the conversion QA manual at the apex of the structure. To a large extent, the documentation format will adhere to that of the IAEA applicable regulatory standards and guidance documents. The major challenge of the conversion activities, it is envisioned, will come from the absence of any previous regulatory framework in Jamaica; however, a timeline for the process, which includes training and equipping of regulators, will guide operation. (author)

  19. 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

  20. Evaluating physical protection systems of licensed nuclear facilities using systems engineered inspection guidance

    International Nuclear Information System (INIS)

    Bradley, R.T.; Olson, A.W.; Rogue, F.; Scala, S.; Richard, E.W.

    1980-01-01

    The Lawrence Livermore National Laboratory (LLNL) and the US Nuclear Regulatory Commission (NRC) Office of Nuclear Regulatory Research (RES) have applied a systems engineering approach to provide the NRC Office of Inspection and Enforcement (IE) with improved methods and guidance for evaluating the physical protection systems of licensed nuclear facilities

  1. 75 FR 53316 - Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money...

    Science.gov (United States)

    2010-08-31

    ...] Draft Guidance for Food and Drug Administration Staff and Tobacco Retailers on Civil Money Penalties and... guidance entitled ``Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers.'' This guidance document is intended to describe FDA's current policies with respect to civil money penalties and no...

  2. International guidance, evolution and trends

    International Nuclear Information System (INIS)

    Ruiz Lopez, C.

    2010-01-01

    Carmen Ruiz Lopez, (CSN) addressed the evolution of some of the fundamental concepts related to the objective of protecting future generations, with the intention of encouraging the discussion, and to determine whether the recent international guidance implied any change in philosophy and approach regarding the practical interpretation and implementation of such fundamental concepts. C. Ruiz presented a general overview of the ICRP and IAEA guidance developments as well as the major changes or reorientations introduced by the latest ICRP Recommendations and IAEA Safety Standards that are relevant to long-term issues of geological disposal, namely, ICRP 103 (2009), ICRP 101 (2006), IAEA Safety Fundamentals SF-1(2006) and WS-R-4. As for the ICRP developments, ICRP 103 confirms the validity of ICRP 81(1998) as the main ICRP reference for long-lived waste disposal. C. Ruiz then noted the extension of the scope of ICPR 81 mentioning some of the principles and recommendations related to the objective of protecting future generations and the view of the Commission for demonstrating compliance. ICRP 103 and ICRP 101 reinforce the importance of transparency in the decision-making process and in the demonstration of confidence in situations of increasing uncertainties about time, giving more weight to the process itself and strengthening the need for an open dialogue between regulator and implementer. In both recommendations the Commission recognises the influence of societal values in the final decision on the level of radiological protection, as well as the influence of social concerns and political aspects in the decision-making process. The evolution of internationally agreed safety fundamental objectives and principles can be observed in the changes from the IAEA's Waste Safety Fundamentals of 1995 to the new Safety Fundamentals of 2006. C Ruiz presented a comparison of both documents focussing on the differences in dealing with fundamental concepts related to the

  3. Old TNX Seepage Basin: Environmental information document

    International Nuclear Information System (INIS)

    Dunaway, J.K.; Johnson, W.F.; Kingley, L.E.; Simmons, R.V.; Bledsoe, H.W.; Smith, J.A.

    1986-12-01

    This document provides environmental information on postulated closure options for the Old TNX Seepage Basin at the Savannah River Plant and was developed as background technical documentation for the Department of Energy's proposed Environmental Impact Statement (EIS) on waste management activities for groundwater protection at the plant. The results of groundwater and atmospheric pathway analyses, accident analysis, and other environmental assessments discussed in this document are based upon a conservative analysis of all foreseeable scenarios as defined by the National Environmental Policy Act (40 CFR 1500-1508). The scenarios do not necessarily represent actual environmental conditions. This document is not meant to be used as a regulatory closure plan or other regulatory document to comply with required federal or state environmental regulations

  4. ADM guidance-Ceramics: guidance to the use of fractography in failure analysis of brittle materials.

    Science.gov (United States)

    Scherrer, Susanne S; Lohbauer, Ulrich; Della Bona, Alvaro; Vichi, Alessandro; Tholey, Michael J; Kelly, J Robert; van Noort, Richard; Cesar, Paulo Francisco

    2017-06-01

    To provide background information and guidance as to how to use fractography accurately, a powerful tool for failure analysis of dental ceramic structures. An extended palette of qualitative and quantitative fractography is provided, both for in vivo and in vitro fracture surface analyses. As visual support, this guidance document will provide micrographs of typical critical ceramic processing flaws, differentiating between pre- versus post sintering cracks, grinding damage related failures and occlusal contact wear origins and of failures due to surface degradation. The documentation emphasizes good labeling of crack features, precise indication of the direction of crack propagation (dcp), identification of the fracture origin, the use of fractographic photomontage of critical flaws or flaw labeling on strength data graphics. A compilation of recommendations for specific applications of fractography in Dentistry is also provided. This guidance document will contribute to a more accurate use of fractography and help researchers to better identify, describe and understand the causes of failure, for both clinical and laboratory-scale situations. If adequately performed at a large scale, fractography will assist in optimizing the methods of processing and designing of restorative materials and components. Clinical failures may be better understood and consequently reduced by sending out the correct message regarding the fracture origin in clinical trials. Copyright © 2017 The Academy of Dental Materials. All rights reserved.

  5. Dissecting Attending Surgeons' Operating Room Guidance: Factors That Affect Guidance Decision Making.

    Science.gov (United States)

    Chen, Xiaodong Phoenix; Williams, Reed G; Smink, Douglas S

    2015-01-01

    The amount of guidance provided by the attending surgeon in the operating room (OR) is a key element in developing residents' autonomy. The purpose of this study is to explore factors that affect attending surgeons' decision making regarding OR guidance provided to the resident. We used video-stimulated recall interviews (VSRI) throughout this 2-phase study. In Phase 1, 3 attending surgeons were invited to review separately 30 to 45 minute video segments of their prerecorded surgical operations to explore factors that influenced their OR guidance decision making. In Phase 2, 3 attending surgeons were observed and documented in the OR (4 operations, 341min). Each operating surgeon reviewed their videotaped surgical performance within 5 days of the operation to reflect on factors that affected their decision making during the targeted guidance events. All VSRI were recorded. Thematic analysis and manual coding were used to synthesize and analyze data from VSRI transcripts, OR observation documents, and field notes. A total of 255 minutes of VSRI involving 6 surgeons and 7 surgical operations from 5 different procedures were conducted. A total of 13 guidance decision-making influence factors from 4 categories were identified (Cohen's κ = 0.674): Setting (case schedule and patient morbidity), content (procedure attributes and case progress), resident (current competency level, trustworthiness, self-confidence, and personal traits), and attending surgeon (level of experience, level of comfort, preferred surgical technique, OR training philosophy, and responsibility as surgeon). A total of 5 factors (case schedule, patient morbidity, procedure attributes, resident current competency level, and trustworthiness) influenced attending surgeons' pre-OR guidance plans. "OR training philosophy" and "responsibility as surgeon" were anchor factors that affected attending surgeons' OR guidance decision-making patterns. Surgeons' OR guidance decision making is a dynamic process

  6. Implementation of NUREG 1318 guidance within the Yucca Mountain Project

    International Nuclear Information System (INIS)

    La Monica, L.B.; Waddell, J.D.; Hardin, E.L.

    1990-01-01

    This paper discusses the implementation of a quality assurance program that fulfills the requirements of the U.S. Nuclear Regulatory Commission (NRC). Additional guidance for this program was provided in NUREG 1318, Technical Position on Items and Activities in the High-Level Waste Geologic Repository Program Subject to Quality Assurance Requirements for the identification of items and activities important to public radiological safety and waste isolation for placement on a Q-List and Quality Activities List and also for graded application of QA measures. The process and organization for implementing this guidance is discussed

  7. Environmental Guidance Regulatory Bulletin - revised rule issued, October 17, 1994

    International Nuclear Information System (INIS)

    1995-01-01

    On September 15, 1994, at 59 FR 47384-47495, the Environmental Protection Agency promulgated a Final Rule revising 40 CFR Part 300; the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). One of the primary purposes of the revised NCP is to provide for efficient, coordinated, and effective action to minimize adverse impact from oil discharges and hazardous substance releases. The NCP is required by Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act and Section 311 (c) (2) of the Clean Water Act. The NCP establishes an organizational structure and procedures for preparing for and responding to discharges of oil and releases of hazardous substances, pollutants, and contaminants under these two Acts. The Oil Pollution Act of 1990 (OPA) amends the existing provisions of the Clean Water Act (CWA) and creates major new authorities addressing oil, and to a lesser extent, hazardous substance spill response. These amendments to the CWA, in turn, require revision of the NCP. The OPA specifies a number of revisions to the NCP that enhance and expand upon the current framework, standards, and procedures for response. A Notice of Proposed Rulemaking on changes to the NCP was issued on October 22, 1993 (58 FR 54702). DOE solicited comments on the proposed rule from DOE program and field offices, and submitted those comments to EPA on December 20, 1993

  8. Phytotechnology Technical and Regulatory Guidance and Decision Trees, Revised

    Science.gov (United States)

    2009-02-01

    Anderson, Guthrie, and Walton 1993 Demeton-8- methyl Duckweed ( Lemna minor ) PE, PD Approximately 10% total transformation (PE and PD) measured in 48...Duckweed ( Lemna minor ) PE, PD Approximately 25% total transformation (PE and PD) measured in 24 hours Gao et al. 1998 Malathion Parrot feather...in 14 days Anderson, Kruger, and Coats 1994 Metolachor Duckweed ( Lemna minor ) PE 25% remaining in the water after 16 days Rice, Anderson, and

  9. A CASE STUDY DEMONSTRATING U.S. EPA GUIDANCE FOR EVALUATING LANDFILL GAS EMISSIONS FROM CLOSED OR ABANDONED FACILITIES--BUSH VALLEY LANDFILL, HARFORD COUNTY, MARYLAND

    Science.gov (United States)

    The purpose of the activities described in this document is to provide a demonstration of the procedures and methodologies described within the "Guidance for Evaluating Landfill Gas Emissions from Closed or Abandoned Facilities" (Guidance). This demonstration provides an example ...

  10. Non-cable vehicle guidance

    Energy Technology Data Exchange (ETDEWEB)

    Daugela, G.C.; Willott, A.M.; Chopiuk, R.G.; Thornton, S.E.

    1988-06-01

    The purpose is to determine the most promising driverless mine vehicle guidance systems that are not dependent on buried cables, and to plan their development. The project is presented in two phases: a preliminary study and literature review to determine whether suitable technologies exist to justify further work; and an in-depth assessment and selection of technologies for vehicle guidance. A large number of guidance elements are involved in a completely automated vehicle. The technologies that hold the best potential for development of guidance systems for mine vehicles are ultrasonics, radar, lasers, dead reckoning, and guidance algorithms. The best approach to adaptation of these technologies is on a step by step basis. Guidance modules that are complete in themselves and are designed to be integrated with other modules can provide short term benefits. Two modules are selected for development: the dragline operations monitor and automated machine control for optimized mining (AMCOM). 99 refs., 20 figs., 40 tabs.

  11. Equal employment opportunity plan development guidance

    Energy Technology Data Exchange (ETDEWEB)

    None

    1978-09-01

    The purpose of this publication is to provide instructions for the development of EEO Plans for Fiscal Year 1979. It supplements the National EEO Plan for the Department of Energy issued in August 1978 (DOE/S-0002). The material included should be used immediately as guidance to develop, document, and implement subordinate echelon commitments to EEO. A schedule for the development and submission of EEO Plans is included. Most of the continuing requirements will be published at a later date as part of the directives system. Any comments or helpful suggestions concerned with the program outlined would be appreciated by the Office of Equal Opportunity.

  12. Title list of documents made publicly available

    International Nuclear Information System (INIS)

    1991-01-01

    The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes docketed material associated with civilian nuclear power plants and other uses of radioactive materials and nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index. The docketed information contained in the Title List includes the information formerly issued though the Department of Energy publication Power Reactor Docket Information, last published in January 1979

  13. Title List of documents made publicly available

    International Nuclear Information System (INIS)

    1982-05-01

    This document contains descriptions of the information received and generated by the US NRC. This information includes: (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index

  14. Safeguards-by-Design: Guidance for High Temperature Gas Reactors (HTGRs) With Pebble Fuel

    Energy Technology Data Exchange (ETDEWEB)

    Philip Casey Durst; Mark Schanfein

    2012-08-01

    The following is a guidance document from a series prepared for the U.S. Department of Energy (DOE) National Nuclear Security Administration (NNSA), under the Next Generation Safeguards Initiative (NGSI), to assist facility designers and operators in implementing international Safeguards-by-Design (SBD). SBD has two main objectives: (1) to avoid costly and time consuming redesign work or retrofits of new nuclear fuel cycle facilities and (2) to make the implementation of international safeguards more effective and efficient at such facilities. In the long term, the attainment of these goals would save industry and the International Atomic Energy Agency (IAEA) time, money, and resources and be mutually beneficial. This particular safeguards guidance document focuses on pebble fuel high temperature gas reactors (HTGR). The purpose of the IAEA safeguards system is to provide credible assurance to the international community that nuclear material and other specified items are not diverted from peaceful nuclear uses. The safeguards system consists of the IAEA’s statutory authority to establish safeguards; safeguards rights and obligations in safeguards agreements and additional protocols; and technical measures implemented pursuant to those agreements. Of foremost importance is the international safeguards agreement between the country and the IAEA, concluded pursuant to the Treaty on the Non-Proliferation of Nuclear Weapons (NPT). According to a 1992 IAEA Board of Governors decision, countries must: notify the IAEA of a decision to construct a new nuclear facility as soon as such decision is taken; provide design information on such facilities as the designs develop; and provide detailed design information based on construction plans at least 180 days prior to the start of construction, and on "as-built" designs at least 180 days before the first receipt of nuclear material. Ultimately, the design information will be captured in an IAEA Design Information

  15. Environmental guidance for public participation in environmental restoration activities

    Energy Technology Data Exchange (ETDEWEB)

    1991-11-01

    The US Department of Energy (DOE) is issuing this document, entitled Guidance on Public Participation for US Department of Energy Environmental Restoration Activities, to summarize policy and provide guidance for public participation in environmental restoration activities at DOE Headquarters, Field Offices, facilities, and laboratories. While the Office of Environmental Restoration and Waste Management (EM) has environmental restoration responsibility for the majority of DOE sites and facilities, other DOE Project Offices have similar responsibilities at their sites and facilities. This guidance is applicable to all environment restoration activities conducted by or for DOE under the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA) as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA); the Resource Conservation and Recovery Act of 1976 (RCRA) as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA) (corrective actions only); and the National Environmental Policy Act of 1969 (NEPA). This guidance also is applicable to CERCLA remedial action programs under the Uranium Mill Tailings Radiation Control Act of 1978 and the Formerly Utilized Sites Remedial Action Program, where DOE is the designated lead. The primary objectives of this guidance document are as follows: acclimate DOE staff to a changing culture that emphasizes the importance of public participation activities; provide direction on implementing these public participation activities; and, provide consistent guidance for all DOE Field Offices and facilities. The purpose of this document is to provide guidance on conducting effective public participation activities for environmental restoration activities under CERCLA; RCRA corrective actions under sections 3004(u), 3004(v), and 3008(h); and NEPA public participation activities.

  16. 76 FR 6143 - Draft Guidance for Industry on “Target Animal Safety and Effectiveness Protocol Development and...

    Science.gov (United States)

    2011-02-03

    ... this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine (CVM), Office of New Animal Drug Evaluation (ONADE), to reduce the time to... Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of...

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

    Science.gov (United States)

    Romero, Klaus; Clay, Robert; Hanna, Debra

    2015-08-15

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

  18. Documents and legal texts

    International Nuclear Information System (INIS)

    2015-01-01

    This section treats of the following Documents and legal texts: 1 - Canada: Nuclear Liability and Compensation Act (An Act respecting civil liability and compensation for damage in case of a nuclear incident, repealing the Nuclear Liability Act and making consequential amendments to other acts); 2 - Japan: Act on Compensation for Nuclear Damage (The purpose of this act is to protect persons suffering from nuclear damage and to contribute to the sound development of the nuclear industry by establishing a basic system regarding compensation in case of nuclear damage caused by reactor operation etc.); Act on Indemnity Agreements for Compensation of Nuclear Damage; 3 - Slovak Republic: Act on Civil Liability for Nuclear Damage and on its Financial Coverage and on Changes and Amendments to Certain Laws (This Act regulates: a) The civil liability for nuclear damage incurred in the causation of a nuclear incident, b) The scope of powers of the Nuclear Regulatory Authority (hereinafter only as the 'Authority') in relation to the application of this Act, c) The competence of the National Bank of Slovakia in relation to the supervised financial market entities in the financial coverage of liability for nuclear damage; and d) The penalties for violation of this Act)

  19. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2010-01-01

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

  20. Waste management system requirements document

    International Nuclear Information System (INIS)

    1991-02-01

    This volume defines the top level requirements for the Mined Geologic Disposal System (MGDS). It is designed to be used in conjunction with Volume 1 of the WMSR, General System Requirements. It provides a functional description expanding the requirements allocated to the MGDS in Volume 1 and elaborates on each requirement by providing associated performance criteria as appropriate. Volumes 1 and 4 of the WMSR provide a minimum set of requirements that must be satisfied by the final MGDS design. This document sets forth specific requirements that must be fulfilled. It is not the intent or purpose of this top level document to describe how each requirement is to be satisfied in the final MGDS design. Each subsequent level of the technical document hierarchy must provide further guidance and definition as to how each of these requirements is to be implemented in the design. It is expected that each subsequent level of requirements will be significantly more detailed. Section 2 of this volume provides a functional description of the MGDS. Each function is addressed in terms of requirements, and performance criteria. Section 3 provides a list of controlling documents. Each document cited in a requirement of Chapter 2 is included in this list and is incorporated into this document as a requirement on the final system. The WMSR addresses only federal requirements (i.e., laws, regulations and DOE orders). State and local requirements are not addressed. However, it will be specifically noted at the potentially affected WMSR requirements that there could be additional or more stringent regulations imposed by a state or local requirements or administering agency over the cited federal requirements

  1. CANDU severe accident management guidance update

    International Nuclear Information System (INIS)

    Jones, L.; Popov, N.; Gilbert, L.; Weed, J.

    2014-01-01

    The CANDU Owners Group (COG) developed a set of generic and initial station-specific Severe Accident Management Guidance (SAMG) documents to mitigate the consequences to the public in the event of a severe accident. The generic portion of the COG SAMG was completed in 2006; the overall project including the station-specific phase was completed in April 2007. Over the years, the CANDU industry and utilities have continuously increased the knowledge base for SAMG and have incorporated various engineered features based on the knowledge obtained. As a result of the event that occurred at the Fukushima Daiiachi nuclear power plant (NPP) in Japan, the Canadian Nuclear Safety Commission (CNSC) established the CNSC Fukushima Task Force. The results of the task force were documented in INFO-0828, CNSC Staff Action Plan on the CNSC Fukushima Task Force Recommendations. Among the recommendation documented in INFO-828 were Fukushima Action Items (FAIs) directed towards the CANDU utilities in Canada; a portion of which are related to SAMG documentation updates and directed at enhancing SAM response. A COG joint project was established to support the closure of the CNSC FAIs and to revise the current CANDU documentation accordingly. This paper provides a high level summary of the COG project scope and results. It also demonstrates that the CANDU SAMG programs in Canada provide robust protection and mitigation of severe accidents. (author)

  2. CANDU severe accident management guidance update

    Energy Technology Data Exchange (ETDEWEB)

    Jones, L., E-mail: lisa.m.jones@opg.com [Ontario Power Generation, Pickering, ON (Canada); Popov, N., E-mail: nik.popov@rogers.com [Candu Owners Group, Toronto, ON (Canada); Gilbert, L., E-mail: lovell.gilbert@brucepower.com [Bruce Power, Tiverton, ON (Canada); Weed, J., E-mail: jeff.weed@candu.gov [Candu Owners Group, Toronto, ON (Canada)

    2014-07-01

    The CANDU Owners Group (COG) developed a set of generic and initial station-specific Severe Accident Management Guidance (SAMG) documents to mitigate the consequences to the public in the event of a severe accident. The generic portion of the COG SAMG was completed in 2006; the overall project including the station-specific phase was completed in April 2007. Over the years, the CANDU industry and utilities have continuously increased the knowledge base for SAMG and have incorporated various engineered features based on the knowledge obtained. As a result of the event that occurred at the Fukushima Daiiachi nuclear power plant (NPP) in Japan, the Canadian Nuclear Safety Commission (CNSC) established the CNSC Fukushima Task Force. The results of the task force were documented in INFO-0828, CNSC Staff Action Plan on the CNSC Fukushima Task Force Recommendations. Among the recommendation documented in INFO-828 were Fukushima Action Items (FAIs) directed towards the CANDU utilities in Canada; a portion of which are related to SAMG documentation updates and directed at enhancing SAM response. A COG joint project was established to support the closure of the CNSC FAIs and to revise the current CANDU documentation accordingly. This paper provides a high level summary of the COG project scope and results. It also demonstrates that the CANDU SAMG programs in Canada provide robust protection and mitigation of severe accidents. (author)

  3. 21 CFR 10.115 - Good guidance practices.

    Science.gov (United States)

    2010-04-01

    ... understanding, or other communications directed to individual persons or firms. (c) What other terms have a... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... communication that are excluded from the definition of guidance document to informally communicate new or...

  4. Buried Waste Integrated Demonstration Technology Preparedness and Status Report Guidance

    International Nuclear Information System (INIS)

    Blacker, P.B.; Bonnenberg, R.W.; Cannon, P.G.; Hyde, R.A.; Watson, L.R.

    1994-04-01

    A Technology Preparedness and Status Report is required for each Technical Task Plan funded by the Buried Waste Integrated Demonstration. This document provides guidance for the preparation of that report. Major sections of the report will include a subset of the need for the technology, objectives of the demonstration, technology description and readiness evaluation, demonstration requirements, and preparedness checklist and action plan

  5. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

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

  6. 75 FR 17143 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Documents; Availability AGENCY: Food and Drug Administration, HHS. ACTION...

  7. 75 FR 44267 - Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological...

    Science.gov (United States)

    2010-07-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0495] Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices; Neurological and Physical Medicine Device Guidance Document; Reopening of Comment Period AGENCY: Food and Drug...

  8. 76 FR 23824 - Guidance for Industry: “Computer Crossmatch” (Computerized Analysis of the Compatibility Between...

    Science.gov (United States)

    2011-04-28

    ... Plasma Type)'' dated June 2007. DATES: Submit either electronic or written comments on Agency guidances... the Compatibility Between the Donor's Cell Type and the Recipient's Serum or Plasma Type... Serum or Plasma Type)'' dated April 2011. The guidance document provides blood establishments that...

  9. 76 FR 570 - Draft Guidance for Industry and Food and Drug Administration Staff; Establishing the Performance...

    Science.gov (United States)

    2011-01-05

    ... electronic or written comments on the draft guidance by April 5, 2011. ADDRESSES: Submit written requests for... INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the..., plasma, and blood. These devices are used to aid in the diagnosis of Lyme disease. This document does not...

  10. 78 FR 34392 - Guidance for Industry and Food and Drug Administration Staff: Technical Considerations for Pen...

    Science.gov (United States)

    2013-06-07

    ... adhesive label to assist the office in processing your requests. The guidance may also be obtained by mail... and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION... June 2013. FDA is providing this final guidance document to assist industry in developing technical and...

  11. 78 FR 78974 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

    Science.gov (United States)

    2013-12-27

    ... chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco... related to substantial equivalence. In a Level 1 guidance document issued under the Good Guidances Practices regulation (21 CFR 10.115), FDA provides recommendations intended to assist persons submitting...

  12. 75 FR 62820 - Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA

    Science.gov (United States)

    2010-10-13

    ... Providers of Synthetic Double- Stranded DNA AGENCY: Department of Health and Human Services, Office of the.... Government has developed Guidance that provides a framework for screening synthetic double-stranded DNA (dsDNA). This document, the Screening Framework Guidance for Providers of Synthetic Double-Stranded DNA...

  13. 78 FR 70307 - Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy...

    Science.gov (United States)

    2013-11-25

    ...] Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products... Assessment of Investigational Cellular and Gene Therapy Products'' dated November 2013. The guidance document... products reviewed by the Office of Cellular, Tissue and Gene Therapies (OCTGT). The product areas covered...

  14. 76 FR 60503 - Guidance for Industry on Target Animal Safety and Effectiveness Protocol Development and...

    Science.gov (United States)

    2011-09-29

    ... Safety and Effectiveness Protocol Development and Submission.'' The purpose of this document is to provide sponsors guidance in preparation of study protocols for review by the Center for Veterinary Medicine, Office of New Animal Drug Evaluation. The recommendations included in this guidance are intended...

  15. 76 FR 59142 - Guidance for Industry on Reproductive and Developmental Toxicities-Integrating Study Results To...

    Science.gov (United States)

    2011-09-23

    ... of study results to assess concerns about human reproductive and developmental toxicities. It does... assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to http://www.regulations.gov...

  16. WHO Regional Office for Europe guidance for influenza surveillance in humans.

    NARCIS (Netherlands)

    Brown, C.S.; Andraghetti, R.; Paget, J.

    2009-01-01

    Recent international mandates, and the emergent circulation of pandemic (H1N1) 2009 virus in human populations, call for strengthening influenza surveillance to better target seasonal influenza control programmes and support pandemic preparedness. This document provides technical guidance to

  17. USDOT guidance for connected vehicle deployments : institutional and business models and financial sustainability.

    Science.gov (United States)

    2016-07-01

    This document provides guidance material in regards to Institutional and Business issues as well as Financial Sustainability for the CV Pilots Deployment Concept Development Phase. This material also provides part of the foundation for the Performanc...

  18. Sampling quality assurance guidance in support of EM environmental sampling and analysis activities

    International Nuclear Information System (INIS)

    1994-05-01

    This document introduces quality assurance guidance pertaining to the design and implementation of sampling procedures and processes for collecting environmental data for DOE's Office of EM (Environmental Restoration and Waste Management)

  19. ANS severe accident program overview ampersand planning document

    International Nuclear Information System (INIS)

    Taleyarkhan, R.P.

    1995-09-01

    The Advanced Neutron Source (ANS) severe accident document was developed to provide a concise and coherent mechanism for presenting the ANS SAP goals, a strategy satisfying these goals, a succinct summary of the work done to date, and what needs to be done in the future to ensure timely licensability. Guidance was received from various bodies [viz., panel members of the ANS severe accident workshop and safety review committee, Department of Energy (DOE) orders, Nuclear Regulatory Commission (NRC) requirements for ALWRs and advanced reactors, ACRS comments, world-wide trends] were utilized to set up the ANS-relevant SAS goals and strategy. An in-containment worker protection goal was also set up to account for the routine experimenters and other workers within containment. The strategy for achieving the goals is centered upon closing the severe accident issues that have the potential for becoming certification issues when assessed against realistic bounding events. Realistic bounding events are defined as events with an occurrency frequency greater than 10 -6 /y. Currently, based upon the level-1 probabilistic risk assessment studies, the realistic bounding events for application for issue closure are flow blockage of fuel element coolant channels, and rapid depressurization-related accidents

  20. Safety culture as a matter of regulatory control and regulatory effectiveness

    International Nuclear Information System (INIS)

    Camargo, C.T.M.; Furieri, E.B.; Arrieta, L.A.I.; Almeida, C.U.C.

    2002-01-01

    More than 15 years have passed since the term 'safety culture' was introduced by the International Nuclear Safety Advisory Group (INSAG), and although the concept now is widely accepted, practical applications and characteristics have been disseminated mainly for nuclear power plant operating organizations. There is still a lack of international guidance on the use of safety culture as a regulatory matter and on the application of the concept within regulatory organizations. This work explores the meaning of safety culture in two different fields: as an element of safety management systems it shall be a matter of regulatory control; as a complementary tool for quality management it should be used to enhance regulatory effectiveness. Brazilian recent experience on regulating nuclear power reactors provide some examples on how the concept of safety culture may influence regulatory strategies and regulatory management. (author)

  1. Generic safety documentation model

    International Nuclear Information System (INIS)

    Mahn, J.A.

    1994-04-01

    This document is intended to be a resource for preparers of safety documentation for Sandia National Laboratories, New Mexico facilities. It provides standardized discussions of some topics that are generic to most, if not all, Sandia/NM facilities safety documents. The material provides a ''core'' upon which to develop facility-specific safety documentation. The use of the information in this document will reduce the cost of safety document preparation and improve consistency of information

  2. Plowshare radiation protection guidance

    International Nuclear Information System (INIS)

    Parker, H.M.

    1969-01-01

    The recommendations of the ICRP and the NCRP were developed primarily for occupational radiation exposures. They were later modified and applied to non-occupational exposures of populations. These, with appropriate interpretations, can be used to provide Plowshare radiation protection guidance. Exposures from Plowshare operations will tend to be acute, arising from radionuclides of relatively short half-life, but will have some chronic aspects due to small amounts of long-lived radionuclides generated. In addition, the neutron activation process of Plowshare technology will produce radionuclides not commonly encountered in routine nuclear energy programs. How these radionuclides contribute to personnel exposure is known for only a few situations that may not be representative of Plowshare exposure. Further complications arise from differences in radionuclide deposition and physiological sensitivity among individuals of different ages and states of health in the exposed population. All parameters necessary to evaluate such exposures are not available, even for good quantitative approximations, resulting in the need for interpretive experience. (author)

  3. Plowshare radiation protection guidance

    Energy Technology Data Exchange (ETDEWEB)

    Parker, H M [Environmental and Life Sciences Division, Battelle Memorial Institute, Pacific Northwest Laboratory, Richland, WA (United States)

    1969-07-01

    The recommendations of the ICRP and the NCRP were developed primarily for occupational radiation exposures. They were later modified and applied to non-occupational exposures of populations. These, with appropriate interpretations, can be used to provide Plowshare radiation protection guidance. Exposures from Plowshare operations will tend to be acute, arising from radionuclides of relatively short half-life, but will have some chronic aspects due to small amounts of long-lived radionuclides generated. In addition, the neutron activation process of Plowshare technology will produce radionuclides not commonly encountered in routine nuclear energy programs. How these radionuclides contribute to personnel exposure is known for only a few situations that may not be representative of Plowshare exposure. Further complications arise from differences in radionuclide deposition and physiological sensitivity among individuals of different ages and states of health in the exposed population. All parameters necessary to evaluate such exposures are not available, even for good quantitative approximations, resulting in the need for interpretive experience. (author)

  4. NGST fine guidance sensor

    Science.gov (United States)

    Rowlands, Neil; Hutchings, John; Murowinski, Richard G.; Alexander, Russ

    2003-03-01

    Instrumentation for the Next Generation Space Telescope (NGST) is currently in the Phase A definition stage. We have developed a concept for the NGST Fine Guidance Sensor or FGS. The FGS is a detector array based imager which resides in the NGST focal plane. We report here on tradeoff studies aimed at defining an overall configuration of the FGS which will meet the performance and interface requirements. A key performance requirement is a noise equivalent angle of 3 milli-arcseconds to be achieved with 95% probability for any pointing of the observatory in the celestial sphere. A key interface requirement is compatibility with the architecture of the Integrated Science Instrument Module (ISIM). The concept developed consists of two independent and redundant FGS modules, each with a 4' x 2' field of view covered by two 2048 x 2048 infrared detector arrays, providing 60 milli-arcsecond sampling. Performance modeling supporting the choice of this architecture and the trade space considered is presented. Each module has a set of readout electronics which perform star detection, pixel-by-pixel correction, and in fine guiding mode, centroid calculation. These readout electronics communicate with the ISIM Command &Data Handling Units where the FGS control software is based. Rationale for this choice of architecture is also presented.

  5. Guidance Manual for Conducting Screening Level Ecological Risk Assessments at the INEL

    Energy Technology Data Exchange (ETDEWEB)

    R. L. VanHorn; N. L. Hampton; R. C. Morris

    1995-06-01

    This document presents reference material for conducting screening level ecological risk assessments (SLERAs)for the waste area groups (WAGs) at the Idaho National Engineering Laboratory. Included in this document are discussions of the objectives of and processes for conducting SLERAs. The Environmental Protection Agency ecological risk assessment framework is closely followed. Guidance for site characterization, stressor characterization, ecological effects, pathways of contaminant migration, the conceptual site model, assessment endpoints, measurement endpoints, analysis guidance, and risk characterization are included.

  6. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

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

  7. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

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

  8. 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

  9. Risk-informed design guidance for future reactor systems

    International Nuclear Information System (INIS)

    Delaney, Michael J.; Apostolakis, George E.; Driscoll, Michael J.

    2005-01-01

    Future reactor designs face an uncertain regulatory environment. It is anticipated that there will be some level of probabilistic insights in the regulations and supporting regulatory documents for Generation-IV nuclear reactors. Central to current regulations are design basis accidents (DBAs) and the general design criteria (GDC), which were established before probabilistic risk assessments (PRAs) were developed. These regulations implement a structuralist approach to safety through traditional defense in depth and large safety margins. In a rationalist approach to safety, accident frequencies are quantified and protective measures are introduced to make these frequencies acceptably low. Both approaches have advantages and disadvantages and future reactor design and licensing processes will have to implement a hybrid approach. This paper presents an iterative four-step risk-informed methodology to guide the design of future-reactor systems using a gas-cooled fast reactor emergency core cooling system as an example. This methodology helps designers to analyze alternative designs under potential risk-informed regulations and to anticipate design justifications the regulator may require during the licensing process. The analysis demonstrated the importance of common-cause failures and the need for guidance on how to change the quantitative impact of these potential failures on the frequency of accident sequences as the design changes. Deliberation is an important part of the four-step methodology because it supplements the quantitative results by allowing the inclusion in the design choice of elements such as best design practices and ease of online maintenance, which usually cannot be quantified. The case study showed that, in some instances, the structuralist and the rationalist approaches were inconsistent. In particular, GDC 35 treats the double-ended break of the largest pipe in the reactor coolant system with concurrent loss of offsite power and a single

  10. Title List of documents made publicly available

    International Nuclear Information System (INIS)

    1982-07-01

    The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes: (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to Court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index. The docketed information contained in the Title List includes the information formerly issued through the Department of Energy publication Power Reactor Docket Information, last published in January 1979. Microfiche of the docketed information listed in the Title List is available for sale on a subscription basis from the National Technical Information Service (NTIS)

  11. Title List of documents made publicly available

    International Nuclear Information System (INIS)

    1982-06-01

    The Title List of Documents Made Publicly Available is a monthly publication. It contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes: (1) docketed material associated with civilian nuclear power plants and other uses of radioactive materials and (2) nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. As used here, docketed does not refer to Court dockets; it refers to the system by which NRC maintains its regulatory records. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index. The docketed information contained in the Title List includes the information formerly issued throught the Department of Energy publication Power Reactor Docket Information, last published in January 1979. Microfiche of the docketed information listed in the Title List is available for sale on a subscription basis from the National Technical Information Service (NTIS)

  12. 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

  13. WCATS: Waste Documentation, Course No. 8504

    Energy Technology Data Exchange (ETDEWEB)

    Simpson, Sandy [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-04-14

    This course was developed for individuals at Los Alamos National Laboratory (LANL) who characterize and document waste streams in the Waste Compliance and Tracking System (WCATS) according to Environmental Protection Agency (EPA) Department of Transportation (DOT) regulations, Department of Energy Orders, and other applicable criteria. When you have completed this course, you will be able to recognize how waste documentation enables LANL to characterize and classify hazardous waste for compliant treatment, storage, and disposal, identify the purpose of the waste stream profile (WSP), identify the agencies that provide guidance for waste management, and more.

  14. Supplemental design requirements document, Project W026

    International Nuclear Information System (INIS)

    Weidert, J.R.

    1993-01-01

    This document supplements and extends the Functional Design Criteria, SP-W026-FDC-001, for the Waste Receiving and Processing Facility (WRAP), Module 1. It provides additional detailed requirements, summarizes key Westinghouse Hanford Company design guidance, and establishes baseline technical agreements to be used in definitive design of the WRAP-1 facility. Revision 3 of the Supplemental Design Requirements Document has been assigned an Impact Level of 3ESQ based on the content of the entire revision. The actual changes made from Revision 2 have an Impact Level of 3S and the basis for these changes was previously reviewed and approved per WHC correspondence No. 9355770

  15. General RMP Guidance - Appendix D: OSHA Guidance on PSM

    Science.gov (United States)

    OSHA's Process Safety Management (PSM) Guidance on providing complete and accurate written information concerning process chemicals, process technology, and process equipment; including process hazard analysis and material safety data sheets.

  16. CAREER GUIDANCE EXPERIENCE ABROAD

    Directory of Open Access Journals (Sweden)

    Sergey N. Tolstoguzov

    2015-01-01

    Full Text Available The aim of this paper is to describe the experience of careeroriented activities carried out with students of schools in developed and developing countries. Career Guidance in Russia, despite the vast experience of its implementation, is experiencing serious difficulties. In this regard, it is important to take into account the international experience career-oriented activities, such as in the developed countries of North America and the European Union as well as in several Asian countries with rapidly growing economies and a large demographic potential, taking into account the best variants for the Russian education system. Methods. The experience of career-oriented work undertaken with pupils of the USA, Canada, Israel, France, UK, Germany, Denmark, Sweden, Japan, Singapore, China and India is shown on the basis of the comparative analysis of different publications and information sources. The author has made an attempt to generalize the principles of psycho-pedagogical and administrative assistance in professional self-determination of senior pupils abroad. Scientific novelty. The approaches to career-oriented activities in countries with different levels of economic development are compared for the first time. Some principles are revealed. Firstly, the higher the income level per capita in the country, the greater attention is given to vocational guidance. The politics in the developed countries is based on interests of the individual: children’s acquaintance with the world of professions begins already at younger school and the moment of definitive selfdetermination is postponed till the end of their senior stage of education; the possibility of direction change of professional preparation in case of detection of discrepancy of qualities of the pupil to originally selected profile is provided. Career-oriented activity in developing countries, on the contrary, is rigidly coordinated to requirements of economy and a labour market

  17. Water chemistry guidance in nuclear power plants in Japan

    International Nuclear Information System (INIS)

    Uchida, Shunsuke; Okada, Hidetoshi; Suzuki, Hiroaki; Naitoh, Masanori

    2012-01-01

    Water chemistry plays important roles in safe and reliable plant operation which are very critical for future power rate increases as well as aging plant management. Water chemistry control is required to satisfy the need for improved integrity of target materials, and at the same time it must be optimal for all materials and systems in a plant. Optimal water chemistry can be maintained by expert engineers who are knowledgeable about plant water chemistry, who have sufficient experience with plant operation, and whose knowledge is based on fundamental technologies. One of the latest subjects in the field of water chemistry is achieving suitable technical transfers, in which the achievements and experience with plant water chemistry accumulated by experts are successfully transferred to the next generation of engineers. For this purpose, documents on experience with water chemistry are being compiled as the guidance for water chemistry control and water chemistry standards, e.g., standards for chemical analysis procedures and guidance for water chemistry control procedures. This paper introduces the latest activities in Japan in establishing water chemistry guidance involving water chemistry standards, guidance documents and their supporting documents. (orig.)

  18. Consideration of health inequalities in systematic reviews: a mapping review of guidance.

    Science.gov (United States)

    Maden, Michelle

    2016-11-28

    Given that we know that interventions shown to be effective in improving the health of a population may actually widen the health inequalities gap while others reduce it, it is imperative that all systematic reviewers consider how the findings of their reviews may impact (reduce or increase) on the health inequality gap. This study reviewed existing guidance on incorporating considerations of health inequalities in systematic reviews in order to examine the extent to which they can help reviewers to incorporate such issues. A mapping review was undertaken to identify guidance documents that purported to inform reviewers on whether and how to incorporate considerations of health inequalities. Searches were undertaken in Medline, CINAHL and The Cochrane Library Methodology Register. Review guidance manuals prepared by international organisations engaged in undertaking systematic reviews, and their associated websites were scanned. Studies were included if they provided an overview or discussed the development and testing of guidance for dealing with the incorporation of considerations of health inequalities in evidence synthesis. Results are summarised in narrative and tabular forms. Twenty guidance documents published between 2009 and 2016 were included. Guidance has been produced to inform considerations of health inequalities at different stages of the systematic review process. The Campbell and Cochrane Equity Group have been instrumental in developing and promoting such guidance. Definitions of health inequalities and guidance differed across the included studies. All but one guidance document were transparent in their method of production. Formal methods of evaluation were reported for six guidance documents. Most of the guidance was operationalised in the form of examples taken from published systematic reviews. The number of guidance items to operationalise ranges from 3 up to 26 with a considerable overlap noted. Adhering to the guidance will require more

  19. Safeguarding critical e-documents implementing a program for securing confidential information assets

    CERN Document Server

    Smallwood, Robert F

    2012-01-01

    Practical, step-by-step guidance for corporations, universities and government agencies to protect and secure confidential documents and business records Managers and public officials are looking for technology and information governance solutions to "information leakage" in an understandable, concise format. Safeguarding Critical E-Documents provides a road map for corporations, governments, financial services firms, hospitals, law firms, universities and other organizations to safeguard their internal electronic documents and private communications.Provides practical, step-by-step guidance o

  20. The continuum of behavior guidance.

    Science.gov (United States)

    Nelson, Travis

    2013-01-01

    Behavior guidance is a continuum of techniques, basic and advanced, fundamental to the provision of quality dental care for pediatric patients. This practice must be individualized, pairing the correct method of behavior guidance with each child. To select the appropriate technique, the clinician must have a thorough understanding of each aspect of the continuum and anticipate parental expectations, child temperament, and the technical procedures necessary to complete care. By effectively using techniques within the continuum of behavior guidance, a healing relationship with the family is maintained while addressing dental disease and empowering the child to receive dental treatment throughout their lifetime. Copyright © 2013 Elsevier Inc. All rights reserved.

  1. Development of a stable uranium recovery regulatory framework for uranium recovery activities in the United States

    International Nuclear Information System (INIS)

    Layton, M.C.; Abrams, C.E.

    2000-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has historically regulated operations at all uranium and thorium recovery facilities under the authority of the Atomic Energy Act of 1954, as amended. Uranium recovery facilities are those plants, or portions of facilities that process uranium- or thorium-bearing material primarily for its source material content. The uranium recovery industry expressed some concerns over several aspects of the NRC's practices, as described in the NRC's guidance documents. In April 1998, the National Mining Association submitted a report to the Commission, that identified specific concerns with NRC's current position and guidance regarding concurrent jurisdiction at uranium mills; dual regulatory authority at in situ leach facilities; the use of mill tailings impoundments for disposal of radioactive material other than 11e.(2) byproduct material; and the ability to process alternate feed material at uranium mills. The NRC staff addressed most of these concerns in two SECY (staff recommendations) papers that were concurrently provided to the Commission, along with a SECY paper on a draft rulemaking plan relating to these and other issues. The issues addressed in these papers included a new rulemaking, disposal of materials other than 11 e.(2) byproduct material, processing of materials other than natural ores, and improved efficiency for regulating in situ leach uranium facilities. The Commission issued final policy decisions on these issues and directions for NRC staff to implement those decisions in July 2000. (author)

  2. 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)

  3. A Nordic perspective on career competences and guidance

    DEFF Research Database (Denmark)

    Thomsen, Rie

    This concept note reflects an initiative within the Nordic ELPGN group, in partnership with the Nordic network for adult learning (NVL), to investigate the possibilities for collaboration between the Nordic countries in developing a number of joint documents on career competences and....../or a competence framework for career learning in the Nordic countries. The objective for this concept note is to contribute to a shared Nordic frame of understanding for career competences which can be used in the ongoing development of guidance in the Nordic countries. The intended audience is guidance...... professionals, teachers, researchers, managers, policy makers and clients....

  4. Revised guidance on reporting of offshore hydrocarbon releases

    International Nuclear Information System (INIS)

    1996-11-01

    The application offshore of the Reporting of Injuries, Disease and Dangerous Occurrences Regulations 1995 (RIDDOR 1995) has resulted in a new statutory reporting form. The definitions in RIDDOR 95 covering offshore hydrocarbon releases have been slightly revised, making it necessary to revise the guidance on reporting of offshore hydrocarbon releases. RIDDOR 1995 does not affect the existing voluntary arrangements for completion of forms. The receipt of correctly completed forms is important to ensure good output data from the database, and the guidance contained in this document is therefore aimed at assisting completion of the voluntary form. (UK)

  5. Safety of magnetic fusion facilities: Volume 2, Guidance

    International Nuclear Information System (INIS)

    1995-01-01

    This document provides guidance for the implementation of the requirements identified in Vol. 1 of this Standard. This guidance is intended for the managers, designers, operators, and other personnel with safety responsibilities for facilities designated as magnetic fusion facilities. While Vol. 1 is generally applicable in that requirements there apply to a wide range of fusion facilities, this volume is concerned mainly with large facilities such as the International Thermonuclear Experimental Reactor (ITER). Using a risk-based prioritization, the concepts presented here may also be applied to other magnetic fusion facilities. This volume is oriented toward regulation in the Department of Energy (DOE) environment

  6. Guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health

    DEFF Research Database (Denmark)

    Tetens, Inge

    2011-01-01

    The Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked by the European Food Safety Authority (EFSA) t to draft guidance on scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health. This guidance has been drawn from scientific...... opinions of the NDA Panel on such health claims. Thus, this guidance document represents the views of the NDA Panel based on the experience gained to date with the evaluation of health claims in these areas. It is not intended that the document should include an exhaustive list of beneficial effects...

  7. Quality assurance guidance for low-level radioactive waste disposal facility: Final report

    International Nuclear Information System (INIS)

    Pittiglio, C.L. Jr.

    1989-01-01

    This document provides guidance to an applicant on meeting the quality control (QC) requirements for a low-level waste (LLW) disposal facility. The QC requirements are the basis for developing of a quality assurance (QA) program and for the guidance provided herein. The criteria are basic to any QA program. The document specifically establishes QA guidance for the design, construction, and operation of those structures, systems, components, as well as, for site characterization activities necessary to meet the performance objectives and to limit exposure to our release of radioactivity. 7 refs

  8. Analytical laboratory quality assurance guidance in support of EM environmental sampling and analysis activities

    International Nuclear Information System (INIS)

    1994-05-01

    This document introduces QA guidance pertaining to design and implementation of laboratory procedures and processes for collecting DOE Environmental Restoration and Waste Management (EM) ESAA (environmental sampling and analysis activities) data. It addresses several goals: identifying key laboratory issues and program elements to EM HQ and field office managers; providing non-prescriptive guidance; and introducing environmental data collection program elements for EM-263 assessment documents and programs. The guidance describes the implementation of laboratory QA elements within a functional QA program (development of the QA program and data quality objectives are not covered here)

  9. Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines.

    Science.gov (United States)

    Hess, Ralf D; Weber, Friedemann; Watson, Keith; Schmitt, Siegfried

    2012-04-05

    In the development of novel substrates used for production of human vaccines there has been significant progress made in recent years. Emerging and re-emerging infectious diseases like the recent porcine Influenza A virus (H1N1) pandemic necessitated the availability of unprecedented amounts of vaccines. In addition, the high demand for vaccines in the industrialised countries has also been paralleled by a steep increase in demand in developing countries. The manufacturing capability for viral vaccines produced in embryonated hen eggs and conventional/classical cell substrates, such as chicken embryo fibroblasts, has now reached its capacity limit. This constraint may be overcome by utilising other recognised cell substrates such as Madin Darby Canine Kidney (MDCK) (dog origin), Chinese Hamster Ovary (CHO) (hamster cells) or Vero cells (monkey origin) or as an alternative, introduce new cell substrates of human or avian origin. Using new cell substrates may prove to be a highly replication-proficient way of producing live viral vaccines such as Influenza A viruses. Despite some advantages, cell substrates may pose a small residual risk to humans since some of them are known to be tumourigenic in immunosuppressed animals. However, this residual risk should be considered acceptable by regulators. Safety testing requirements for cell substrates used in the manufacture of vaccines is mandated by published guidance from organisations such as World Health Organization (WHO), United States Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conferences on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH) as well as requirements laid down in compendial monographs (Ph. Eur. and USP). This paper considers the guidance contained in these regulatory documents. In addition, the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human

  10. Civilian Radioactive Waste Management System Requirements Document

    International Nuclear Information System (INIS)

    1992-12-01

    This document specifies the top-level requirements for the Civilian Radioactive Waste Management System (CRWMS). The document is referred to herein as the CRD, for CRWMS Requirements document. The OCRWM System Engineering Management Plan (SEMP) establishes the technical document hierarchy (hierarchy of technical requirements and configuration baseline documents) for the CRWMS program. The CRD is the top-level document in this hierarchy. The immediate subordinate documents are the System Requirements Documents (SRDS) for the four elements of the CRWMS and the Interface Specification (IFS). The four elements of the CRWMS are the Waste Acceptance System, the Transportation System, the Monitored Retrievable Storage (MRS) System and the Mined Geologic Disposal System (MGDS). The Interface Specification describes the six inter-element interfaces between the four elements. This hierarchy establishes the requirements to be addressed by the design of the system elements. Many of the technical requirements for the CRWMS are documented in a variety of Federal regulations, DOE directives and other Government documentation. It is the purpose of the CRD to establish the technical requirements for the entire program. In doing so, the CRD summarizes source documentation for requirements that must be addressed by the program, specifies particular requirements, and documents derived requirements that are not covered in regulatory and other Government documentation, but are necessary to accomplish the mission of the CRWMS. The CRD defines the CRWMS by identifying the top-level functions the elements must perform (These top-level functions were derived using functional analysis initially documented in the Physical System Requirements (PSR) documents). The CRD also defines the top-level physical architecture of the system and allocates the functions and requirements to the architectural elements of the system

  11. Guidance manual for conducting technology demonstration activities

    Energy Technology Data Exchange (ETDEWEB)

    Jolley, Robert L.; Morris, Michael I.; Singh, Suman P.N.

    1991-12-01

    This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety.

  12. Guidance manual for conducting technology demonstration activities

    International Nuclear Information System (INIS)

    Jolley, R.L.; Morris, M.I.; Singh, S.P.N.

    1991-12-01

    This demonstration guidance manual has been prepared to assist Martin Marietta Energy Systems, Inc. (Energy Systems), staff in conducting demonstrations. It is prepared in checklist style to facilitate its use and assumes that Energy Systems personnel have project management responsibility. In addition to a detailed step-by-step listing of procedural considerations, a general checklist, logic flow diagram, and several examples of necessary plans are included to assist the user in developing an understanding of the many complex activities required to manage technology demonstrations. Demonstrations are pilot-scale applications of often innovative technologies to determine the commercial viability of the technologies to perform their designed function. Demonstrations are generally conducted on well-defined problems for which existing technologies or processes are less than satisfactory in terms of effectiveness, cost, and/or regulatory compliance. Critically important issues in demonstration management include, but are not limited to, such factors as communications with line and matrix management and with the US Department of Energy (DOE) and Energy Systems staff responsible for management oversight, budgetary and schedule requirements, regulatory compliance, and safety

  13. SPLC Sustainable Purchasing Guidance Profile

    Science.gov (United States)

    To help you find the resource that is right for your organization, EPA conducted a scan of the landscape and developed summary profiles of some of the leading sources of sustainable purchasing guidance around the globe.

  14. CDM Convective Forecast Planning guidance

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The CDM Convective Forecast Planning (CCFP) guidance product provides a foreast of en-route aviation convective hazards. The forecasts are updated every 2 hours and...

  15. Guidance at the educational marketplace

    DEFF Research Database (Denmark)

    Lystbæk, Christian Tang

    in educational policies and institutions. As educational systems have expanded and, further, have been restructured with the expansion of choice opportunities since the 1980s, guidance has become prioritized as a form of counseling or coaching, which can support students. Thus, guidance has become an important...... `agent´ on the educational "market´, assisting (potential) students into and around the `marketplace´. Consequently, guidance is also an important `agent´ for educational institutions that increasingly use marketing strategies to promote themselves on the market to attract and hold on to their “customers......” in order for the institutions to increase their ´market value´, `sales” and “turnover”. Thus, the expansion of guidance is nurtured by the expansion of the logic of marketization and consumerism. Drawing on Foucauldian perspectives in educational research, which highlight the expansion of powerful...

  16. Establishing exemption and clearance criteria by the regulatory authority

    International Nuclear Information System (INIS)

    Salih, A.E.A.

    2012-04-01

    This Project work discusses the relationship between the concepts of exemption and clearance, and their practical use in the overall scheme of regulatory control of practices. It also discusses how exemptions and clearance is established and the scope of its applications for regulatory control. The concept of general clearance levels for any type of material and any possible pathway of disposal is also introduced in this work. Guidance of the Group of Experts establishing scenarios for general clearance, parameter values, and a nuclide-specific list of calculated clearance levels is also presented. Regulatory authorities are required to develop guidance on exemption and clearance levels to assist licensees and registrants to know which practices and sources within practices are exempted from regulatory control and those to be cleared from further controls. Exemption and clearance levels are tools for assisting the Regulatory Authority to optimize the use of resources. (author)

  17. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    Energy Technology Data Exchange (ETDEWEB)

    Kroger, L. [University of California Davis (United States)

    2015-06-15

    requirements as they relate to the everyday practice of Nuclear Medicine and Radiation Oncology. Understand the nature of available guidance documents (e.g., NUREG 1556). Examine the commonalities between TJC and CMS preparedness.

  18. MO-AB-201-03: The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections

    International Nuclear Information System (INIS)

    Kroger, L.

    2015-01-01

    requirements as they relate to the everyday practice of Nuclear Medicine and Radiation Oncology. Understand the nature of available guidance documents (e.g., NUREG 1556). Examine the commonalities between TJC and CMS preparedness

  19. [Anterior guidance in complete dentures].

    Science.gov (United States)

    Dubreuil, J; Trevelo, A

    1990-01-01

    Although the anterior guidance in complete dentures is not really a guide, the arrangement of the anterior maxillary and mandibular prosthetic teeth, defines a propulsive line called the virtual anterior guidance, a part from the cinematic criterias. The influence of this guide on cuspal movement is superior, in all mandibular points, to the influence of the condylar pathway. If this line is not respected, the practitioner may have to do excessive grindings during occlusal adjustments.

  20. Regulatory aspects of mixed waste

    International Nuclear Information System (INIS)

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

    1990-01-01

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

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

    International Nuclear Information System (INIS)

    2001-11-01

    only a small staff are examples of training programmes, and their development, for individual staff members. Maintaining the qualification and competence of regulatory staff would also be addressed.To respond to the above requests and recommendations, the purpose of this technical document is to provide guidance on training and qualification based on the competency framework required for the regulatory body to perform its functions. The main aim is to support the Regulatory Bodies supervising nuclear facilities such as nuclear power plants and research reactors. To support regulatory training activities in nuclear installation safety, the IAEA has also developed two standardized training courses to provide basic knowledge needed for work in nuclear safety. A basic professional training course on nuclear safety was organized for the first time in 1999 in Saclay, France, in English. In 2000, the course was provided in Romania, in English, and in Brazil, in Spanish. In 2001, the course was organized as a six-week course in Saclay, France for the European countries and in Argonne, USA, for the Asian countries. For the course, a textbook was developed and used that included test questions to support and control learning. At the next level of specialized knowledge, a training course on regulatory control of nuclear power plants, aimed at new staff members in regulatory organizations with varying experience levels, has been organized in Europe on an annual basis from 1995 to 2001 in the framework of the Department of Technical Co-operation. A textbook has also been developed and used for this training course

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

    International Nuclear Information System (INIS)

    2002-11-01

    only a small staff are examples of training programmes, and their development, for individual staff members. Maintaining the qualification and competence of regulatory staff would also be addressed.To respond to the above requests and recommendations, the purpose of this technical document is to provide guidance on training and qualification based on the competency framework required for the regulatory body to perform its functions. The main aim is to support the Regulatory Bodies supervising nuclear facilities such as nuclear power plants and research reactors. To support regulatory training activities in nuclear installation safety, the IAEA has also developed two standardized training courses to provide basic knowledge needed for work in nuclear safety. A basic professional training course on nuclear safety was organized for the first time in 1999 in Saclay, France, in English. In 2000, the course was provided in Romania, in English, and in Brazil, in Spanish. In 2001, the course was organized as a six-week course in Saclay, France for the European countries and in Argonne, USA, for the Asian countries. For the course, a textbook was developed and used that included test questions to support and control learning. At the next level of specialized knowledge, a training course on regulatory control of nuclear power plants, aimed at new staff members in regulatory organizations with varying experience levels, has been organized in Europe on an annual basis from 1995 to 2001 in the framework of the Department of Technical Co-operation. A textbook has also been developed and used for this training course

  3. A Review on the Regulatory Strategy of Human Factors Engineering Consideration in Pakistan Nuclear Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Sohail, Sabir [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of); Choi, Seong Nam [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2013-10-15

    In this paper, the legal and regulatory infrastructure available in Pakistan for HFE requirements is assessed, and the methodology for strengthening of legal infrastructure is presented. The regulatory strategy on evaluation of HFE consideration should provide reviewers with guidance on review process. Therefore, the suggested methodology is based on preparation of guidance documents such as checklist, working procedures, S and Gs etc.; incorporation of PRM elements in regulatory system; and finally the development of PRM implementation criteria. Altogether, the scheme provide the enhancement in regulatory infrastructure and also the effective and efficient review process. The Three Mile Island (TMI) accident brought the general consensus among the nuclear community on the integration of human factors engineering (HFE) principles in all phases of nuclear power. This notion has further strengthened after the recent Fukushima nuclear accident. Much effort has been put over to incorporate the lesson learned and continuous technical evolution on HFE to device different standards. The total of 174 ergonomics standards are alone identified by Dul et al. (2004) published by International Organization for Standardization (ISO) and the European Committee for Standardization (CEN) and number of standards and HFE guidelines (S and Gs) are also published by organizations like Institute for Electrical and Electronics Engineering (IEEE), International Electrotechnical Commission (IEC), International Atomic Energy Agency (IAEA), United States Nuclear Regulatory Commission (USNRC), etc. The ambition of effective review on HFE integration in nuclear facility might be accomplished through the development of methodology for systematic implementation of S and Gs. Such kind of methodology would also be beneficial for strengthening the regulatory framework and practices for countries new in the nuclear arena and with small scale nuclear program. The objective of paper is to review the

  4. High-level waste storage tank farms/242-A evaporator standards/requirements identification document (S/RID), Vol. 2

    Energy Technology Data Exchange (ETDEWEB)

    1994-04-01

    The Quality Assurance Functional Area Requirements Identification Document (RID), addresses the programmatic requirements that ensure risks and environmental impacts are minimized, ensure safety, reliability, and performance are maximized through the application of effective management systems commensurate with the risks posed by the Tank Farm Facility and its operation. This RID incorporates guidance intended to provide Tank Farms management with the necessary requirements information to develop, upgrade, or assess the effectiveness of a Quality Assurance Program in the performance of organizational and functional activities. Quality Assurance is defined as all those planned and systematic actions necessary to provide adequate confidence that a facility, structure, system, or component will perform satisfactorily and safely in service. This document will provide the specific requirements to meet DNFSB recommendations and the guidance provided in DOE Order 5700.6C, utilizing industry codes, standards, regulatory guidelines, and industry good practices that have proven to be essential elements for an effective and efficient Quality Assurance Program as the nuclear industry has matured over the last thirty years.

  5. High-level waste storage tank farms/242-A evaporator standards/requirements identification document (S/RID), Vol. 2

    International Nuclear Information System (INIS)

    1994-04-01

    The Quality Assurance Functional Area Requirements Identification Document (RID), addresses the programmatic requirements that ensure risks and environmental impacts are minimized, ensure safety, reliability, and performance are maximized through the application of effective management systems commensurate with the risks posed by the Tank Farm Facility and its operation. This RID incorporates guidance intended to provide Tank Farms management with the necessary requirements information to develop, upgrade, or assess the effectiveness of a Quality Assurance Program in the performance of organizational and functional activities. Quality Assurance is defined as all those planned and systematic actions necessary to provide adequate confidence that a facility, structure, system, or component will perform satisfactorily and safely in service. This document will provide the specific requirements to meet DNFSB recommendations and the guidance provided in DOE Order 5700.6C, utilizing industry codes, standards, regulatory guidelines, and industry good practices that have proven to be essential elements for an effective and efficient Quality Assurance Program as the nuclear industry has matured over the last thirty years

  6. Registration document 2005; Document de reference 2005

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2005-07-01

    This reference document of Gaz de France provides information and data on the Group activities in 2005: financial informations, business, activities, equipments factories and real estate, trade, capital, organization charts, employment, contracts and research programs. (A.L.B.)

  7. Vocational Guidance and Counselling for Young People and Adults in the European Community. Findings of a Conference (Berlin, West Germany, December 7-8, 1989).

    Science.gov (United States)

    de Vries, Heinz J., Ed.

    1990-01-01

    This document reports on a conference centered around three topics: vocational guidance in the Member States of the European Community (EC), the "Europeanization" of vocational guidance, and approaches to cross-frontier vocational guidance. Among the recommendations of the conference participants are the following: the tasks of…

  8. Advanced alarm system design and human performance: Guidance development and current research

    Energy Technology Data Exchange (ETDEWEB)

    O` Hara, J M [Brookhaven National Lab., Upton, NY (United States)

    1997-09-01

    This paper describes a research program sponsored by the U.S. Nuclear Regulatory Commission to address the human factors engineering (HFE) aspects of nuclear power plant alarm systems. The overall objective of the program is to develop HFE review guidance for advanced alarm systems. Guidance has been developed based on a broad base of technical and research literature. As part of the development effort, aspects of alarm system design for which the technical basis was insufficient to support guidance development were identified and prioritized. Research is currently underway to address the highest priority topics: alarm processing and display characteristics. (author). 29 refs, 2 figs.

  9. Advanced alarm system design and human performance: Guidance development and current research

    International Nuclear Information System (INIS)

    O'Hara, J.M.

    1997-01-01

    This paper describes a research program sponsored by the U.S. Nuclear Regulatory Commission to address the human factors engineering (HFE) aspects of nuclear power plant alarm systems. The overall objective of the program is to develop HFE review guidance for advanced alarm systems. Guidance has been developed based on a broad base of technical and research literature. As part of the development effort, aspects of alarm system design for which the technical basis was insufficient to support guidance development were identified and prioritized. Research is currently underway to address the highest priority topics: alarm processing and display characteristics. (author). 29 refs, 2 figs

  10. 2002 reference document; Document de reference 2002

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2002-07-01

    This 2002 reference document of the group Areva, provides information on the society. Organized in seven chapters, it presents the persons responsible for the reference document and for auditing the financial statements, information pertaining to the transaction, general information on the company and share capital, information on company operation, changes and future prospects, assets, financial position, financial performance, information on company management and executive board and supervisory board, recent developments and future prospects. (A.L.B.)

  11. 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.

  12. 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.

  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. Guidelines for IAEA International Regulatory Review Teams (IRRTs)

    International Nuclear Information System (INIS)

    1993-04-01

    This document is intended to be used by International regulatory review teams in reviewing the activities of a regulatory body as applicable to the regulation of nuclear power plants. The mission will, however, take note of any other activities of the regulatory body when drawing up the review report. The document does not specifically deal with the functions of a regulatory body responsible for other types of nuclear facilities or related nuclear activities, but it is intended that the concepts presented in the document could be applied where appropriate. Refs

  15. Challenges and regulatory considerations in the acoustic measurement of high-frequency (>20 MHz) ultrasound.

    Science.gov (United States)

    Nagle, Samuel M; Sundar, Guru; Schafer, Mark E; Harris, Gerald R; Vaezy, Shahram; Gessert, James M; Howard, Samuel M; Moore, Mary K; Eaton, Richard M

    2013-11-01

    This article examines the challenges associated with making acoustic output measurements at high ultrasound frequencies (>20 MHz) in the context of regulatory considerations contained in the US Food and Drug Administration industry guidance document for diagnostic ultrasound devices. Error sources in the acoustic measurement, including hydrophone calibration and spatial averaging, nonlinear distortion, and mechanical alignment, are evaluated, and the limitations of currently available acoustic measurement instruments are discussed. An uncertainty analysis of acoustic intensity and power measurements is presented, and an example uncertainty calculation is done on a hypothetical 30-MHz high-frequency ultrasound system. This analysis concludes that the estimated measurement uncertainty of the acoustic intensity is +73%/-86%, and the uncertainty in the mechanical index is +37%/-43%. These values exceed the respective levels in the Food and Drug Administration guidance document of 30% and 15%, respectively, which are more representative of the measurement uncertainty associated with characterizing lower-frequency ultrasound systems. Recommendations made for minimizing the measurement uncertainty include implementing a mechanical positioning system that has sufficient repeatability and precision, reconstructing the time-pressure waveform via deconvolution using the hydrophone frequency response, and correcting for hydrophone spatial averaging.

  16. Hanford Site guide for preparing and maintaining generator group pollution prevention program documentation

    International Nuclear Information System (INIS)

    Place, B.G.

    1998-01-01

    This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 1998a) and Prime contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and 3005(h) (RCRA and EPA, 1994). Documentation guidance for the following five P2/WMin elements are discussed: Fiscal Year (FY) Goals; Budget and Staffing; Waste Minimization (WMin) Assessments (WMAs); Quarterly Pollution Prevention (P2) Reporting WMin Certification

  17. Hanford Site Guide for Preparing and Maintaining Fenerator Group Pollution Prevention Program Documentation

    International Nuclear Information System (INIS)

    PLACE, B.G.

    1999-01-01

    This document provides guidance to generator groups for preparing and maintaining documentation of Pollution Prevention/Waste Minimization (P2/WMin) Program activities. The guidance is one of a hierarchical series that includes the Hanford Site Waste Minimization and Pollution Prevention Awareness Program Plan (DOE-RL, 1998a) and Prime Contractor implementation plans describing programs required by Resource Conservation and Recovery Act of 1976 (RCRA) 3002(b) and (300501) (RCRA and EPA, 1994). Documentation guidance for the following five P2/WMin elements are discussed: Fiscal Year (FY) Goals; Budget and Staffing; Waste Minimization (WMinn ) Assessments (WMAs); Pollution Prevention (P2) Reporting; WMin Certification

  18. National Emission Standards for Hazardous Air Pollutants (NESHAP) for Major Sources: Industrial, Commercial, and Institutional Boilers - Guidance for Calculating Emission Credits Resulting from Implementation of Energy Conservation Measures

    Science.gov (United States)

    The purpose of this July 2012 document is to provide guidance for developing a consistent approach to documenting efficiency credits generated from energy conservation measures in the Implementation Plan for boilers covered by the Boiler MACT rule.

  19. Web document engineering

    International Nuclear Information System (INIS)

    White, B.

    1996-05-01

    This tutorial provides an overview of several document engineering techniques which are applicable to the authoring of World Wide Web documents. It illustrates how pre-WWW hypertext research is applicable to the development of WWW information resources

  20. Enterprise Document Management

    Data.gov (United States)

    US Agency for International Development — The function of the operation is to provide e-Signature and document management support for Acquisition and Assisitance (A&A) documents including vouchers in...

  1. Quality in career guidance: The Danish case

    DEFF Research Database (Denmark)

    Plant, Peter

    2011-01-01

    Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach......Quality assurance systems are introduced in career guidance to monitor, control and develop guidance interventions. The Danish case represents at centrally driven, top-down approach...

  2. Review of probabilistic safety assessments by regulatory bodies

    International Nuclear Information System (INIS)

    2002-01-01

    This report provides guidance to assist regulatory bodies in carrying out reviews of the PSAs produced by utilities. In following this guidance, it is important that the regulatory body is able to satisfy itself that the PSA has been carried out to an acceptable standard and that it can be used for its intended applications. The review process becomes an important phase in determining the acceptability of the PSA since this provides a degree of assurance of the PSA scope, validity and limitations, as well as a better understanding of plants themselves. This report is also intended to assist technical experts managing or performing PSA reviews. A particular aim is to promote a standardized framework, terminology and form of documentation for the results of PSA reviews. The information presented in this report supports IAEA Safety Guide No. GS-G-1.2. Recommendations on the scope and methods to be used by the utility in the preparation of a PSA study is provided in IAEA Safety Guide No. NSG- 1.2. Information on these Safety Guides and other IAEA safety standards for nuclear power plants can be found on the following Internet site: http://www.iaea.org/ns/coordinet. The scope of this report covers the review of Level 1, 2 and 3 PSAs for event sequences occurring in all modes of plant operation (including full power, low power and shutdown). Where the scope of the analysis is narrower than this, a subset of the guidance can be identified and used. Information is provided on carrying out the review of a PSA throughout the PSA production process, i.e. from the initial decision to carry out the PSA through to the completion of the study and the production of the final PSA report. However, the same procedure can be applied to a completed PSA or to one already in progress. As a result of the performance of a PSA, changes to the design or operation of the plant are often identified that would increase the level of safety. This might include the addition of further safety

  3. Title list of documents made publicly available

    International Nuclear Information System (INIS)

    1979-12-01

    This monthly publication contains descriptions of the information received and generated by the US Nuclear Regulatory Commission (NRC). This information includes docketed material associated with civilian nuclear power plants and other uses of radioactive materials, and nondocketed material received and generated by NRC pertinent to its role as a regulatory agency. This series of documents is indexed by a Personal Author Index, a Corporate Source Index, and a Report Number Index. The docketed information includes the inforation formerly issued through the Department of Energy's Technical Information Center under the title Power Reactor Docket Information (PRDI) and, in addition, information received or generated on other uses of radioactive materials

  4. WIPP documentation plan

    International Nuclear Information System (INIS)

    Plung, D.L.; Montgomery, T.T.; Glasstetter, S.R.

    1986-01-01

    In support of the programs at the Waste Isolation Pilot Plant (WIPP), the Publications and Procedures Section developed a documentation plan that provides an integrated document hierarchy; further, this plan affords several unique features: 1) the format for procedures minimizes the writing responsibilities of the technical staff and maximizes use of the writing and editing staff; 2) review cycles have been structured to expedite the processing of documents; and 3) the numbers of documents needed to support the program have been appreciably reduced

  5. Commercial radioactive waste minimization program development guidance

    International Nuclear Information System (INIS)

    Fischer, D.K.

    1991-01-01

    This document is one of two prepared by the EG ampersand G Idaho, Inc., Waste Management Technical Support Program Group, National Low-Level Waste Management Program Unit. One of several Department of Energy responsibilities stated in the Amendments Act of 1985 is to provide technical assistance to compact regions Host States, and nonmember States (to the extent provided in appropriations acts) in establishing waste minimization program plans. Technical assistance includes, among other things, the development of technical guidelines for volume reduction options. Pursuant to this defined responsibility, the Department of Energy (through EG ampersand G Idaho, Inc.) has prepared this report, which includes guidance on defining a program, State/compact commission participation, and waste minimization program plans

  6. GUIDANCE ON SELECTING AGE GROUPS FOR ...

    Science.gov (United States)

    This guidance document provides a set of early-lifestage age groups for Environmental Protection Agency scientists to consider when assessing children’s exposure to environmental contaminants and the resultant potential dose. These recommended age groups are based on current understanding of differences in behavior and physiology which may impact exposures in children. A consistent set of early-life age groups, supported by an underlying scientific rationale, is expected to improve Agency exposure and risk assessments for children by increasing the consistency and comparability of risk assessments across the Agency; by improving accuracy and transparency in assessments for those cases where current practice might too broadly combine behaviorally and physiologically disparate age groups; and by fostering a consistent approach to future exposure surveys and monitoring efforts to generate improved exposure factors for children. see description

  7. Documenting Employee Conduct

    Science.gov (United States)

    Dalton, Jason

    2009-01-01

    One of the best ways for a child care program to lose an employment-related lawsuit is failure to document the performance of its employees. Documentation of an employee's performance can provide evidence of an employment-related decision such as discipline, promotion, or discharge. When properly implemented, documentation of employee performance…

  8. EPRI Guidance for Transition from Operations to Decommissioning

    International Nuclear Information System (INIS)

    McGrath, Richard; Reid, Richard; Snyder, Michael

    2016-01-01

    A wide range of key activities are necessary after permanent shutdown of a nuclear power plant before active dismantlement of the plant can begin. This period is typically referred to as the transition period. In some cases these activities are prescribed by regulation and in others they may be more practically driven or even optional. In either case, planning for transition activities should optimally take place prior to final shutdown. Additionally, execution of some transition period activities, such as filing required regulatory submittals, may be performed prior to plant shut down. In addition to general transition period activities such as defueling, management of operational wastes, fulfilling regulatory requirements and changes to plant technical specifications, there are a number of optional activities that may have a long-range impact on future decommissioning activities. This includes activities such as the timing of staff reductions and performance of chemical decontamination. EPRI is nearing completion of a project to develop guidance for transitioning a nuclear power plant to decommissioning. This project includes the following elements: - A review of required and recommended transition period activities. For countries where a clear regulatory framework exists, this includes country-specific requirements; - A review of pending regulatory activities in the US and other countries where there is currently no clear regulatory framework for transitioning to decommissioning; - A summary of activities that have been performed during the transition period for past and current decommissioning sites, as well as current sites that are actively planning decommissioning activities; and - Guidance for development of a transition plan for changing from an operational to decommissioning status. Informed planning of the transition period activities will provide immediate benefits in reducing costs and minimizing the duration of the transition period, as well as longer

  9. 76 FR 18467 - Pennsylvania Regulatory Program

    Science.gov (United States)

    2011-04-04

    ... initiated. Pennsylvania has relied on the investigative expertise of the OSM Applicant/Violator System (AVS... reference purposes only: Guidance Documents 562-3000-802 Coal Mining Applicant Violator System (AVS... Construction Contracts, and 562-3000-110 Applicant Violator System (AVS) Inspections; 5600-PM-MR0025...

  10. Technical Basis Document (TBD) and user guides

    International Nuclear Information System (INIS)

    Chiaro, P.J. Jr.

    1998-09-01

    A Technical Basis Document (TBD) should provide the background information for establishment of an instrument's operational requirements. Due to the amount and location of DOE facilities, no one set of requirements is possible. Operational requirements will vary based on the local environments and missions at each facility. Environmental conditions that can affect an instrument's operations are ambient temperature, humidity, and radio frequency, and to a lesser extent, magnetic fields, and interfering ionizing radiations. Consideration should also be made regarding how an instrument is to be used. If an instrument will be transported around the facility, vibration and shock can cause problems if they are not addressed in the TBD. This document provides guidance for the development of a TBD. This document applies to radiation instruments used for personnel and equipment contamination monitoring, dose rate monitoring, and air monitoring

  11. Waste treatability guidance program. User's guide. Revision 0

    International Nuclear Information System (INIS)

    Toth, C.

    1995-01-01

    DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatability groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User's Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan

  12. Waste treatability guidance program. User`s guide. Revision 0

    Energy Technology Data Exchange (ETDEWEB)

    Toth, C.

    1995-12-21

    DOE sites across the country generate and manage radioactive, hazardous, mixed, and sanitary wastes. It is necessary for each site to find the technologies and associated capacities required to manage its waste. One role of DOE HQ Office of Environmental Restoration and Waste Management is to facilitate the integration of the site- specific plans into coherent national plans. DOE has developed a standard methodology for defining and categorizing waste streams into treatability groups based on characteristic parameters that influence waste management technology needs. This Waste Treatability Guidance Program automates the Guidance Document for the categorization of waste information into treatability groups; this application provides a consistent implementation of the methodology across the National TRU Program. This User`s Guide provides instructions on how to use the program, including installations instructions and program operation. This document satisfies the requirements of the Software Quality Assurance Plan.

  13. Guidance on the environmental risk assessment of genetically modified plants

    DEFF Research Database (Denmark)

    Bartsch, Detlef; Chueca, Cristina; De-Schrijver, Adinda

    risk evaluation. The scientific Panel on Genetically Modified Organisms (of the European Food Safety Authority (EFSA GMO Panel) considers seven specific areas of concern to be addressed by applicants and risk assessors during the ERA (1) persistence and invasiveness of the GM plant , or its compatible......This document provides guidance for the environmental risk assessment (ERA) of genetically modified (GM) plants submitted within the framework of Regulation (EC) No. 1829/2003 on GM food and feed or under Directive 2001/18/EC on the deliberate release into the environment of genetically modified...... organisms (GMOs). This document provides guidance for assessing potential effects of GM plants on the environment and the rationales for the data requirements for a comprehensive ERA of GM plants. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach...

  14. 78 FR 79328 - Amendments to Material Control and Accounting Regulations and Proposed Guidance for Fuel Cycle...

    Science.gov (United States)

    2013-12-30

    ..., 72, 74, and 150 [NRC-2009-0096 and NRC-2013-0195] RIN 3150-AI61 Amendments to Material Control and Accounting Regulations and Proposed Guidance for Fuel Cycle Facility Material Control and Accounting Plans... of this document. NRC's Agencywide Documents Access and Management System (ADAMS): You may access...

  15. Starlink Document Styles

    Science.gov (United States)

    Lawden, M. D.

    This document describes the various styles which are recommended for Starlink documents. It also explains how to use the templates which are provided by Starlink to help authors create documents in a standard style. This paper is concerned mainly with conveying the ``look and feel" of the various styles of Starlink document rather than describing the technical details of how to produce them. Other Starlink papers give recommendations for the detailed aspects of document production, design, layout, and typography. The only style that is likely to be used by most Starlink authors is the Standard style.

  16. Subject (of documents)

    DEFF Research Database (Denmark)

    Hjørland, Birger

    2017-01-01

    This article presents and discuss the concept “subject” or subject matter (of documents) as it has been examined in library and information science (LIS) for more than 100 years. Different theoretical positions are outlined and it is found that the most important distinction is between document......-oriented views versus request-oriented views. The document-oriented view conceive subject as something inherent in documents, whereas the request-oriented view (or the policy based view) understand subject as an attribution made to documents in order to facilitate certain uses of them. Related concepts...

  17. Petitions to delist hazardous wastes: A guidance manual. Second edition

    International Nuclear Information System (INIS)

    1993-03-01

    EPA developed the guidance document to assist facilities in preparing delisting petitions for the exclusion of listed hazardous wastes. The manual provides general information on hazardous waste delisting, discusses sampling strategies and testing protocols in detail, and presents a step-by-step approach to compiling a complete delisting petition. This updated edition incorporates recent changes in RCRA regulations, agency policies, and delisting criteria. It also reflects the current emphasis on ground-water monitoring data and new concepts such as upfront delistings

  18. Planning guidance for the Chemical Stockpile Emergency Preparedness Program

    Energy Technology Data Exchange (ETDEWEB)

    Shumpert, B.L.; Watson, A.P.; Sorensen, J.H. [and others

    1995-02-01

    This planning guide was developed under the direction of the U.S. Army and the Federal Emergency Management Agency (FEMA) which jointly coordinate and direct the development of the Chemical Stockpile Emergency Preparedness Program (CSEPP). It was produced to assist state, local, and Army installation planners in formulating and coordinating plans for chemical events that may occur at the chemical agent stockpile storage locations in the continental United States. This document provides broad planning guidance for use by both on-post and off-post agencies and organizations in the development of a coordinated plan for responding to chemical events. It contains checklists to assist in assuring that all important aspects are included in the plans and procedures developed at each Chemical Stockpile Disposal Program (CSDP) location. The checklists are supplemented by planning guidelines in the appendices which provide more detailed guidance regarding some issues. The planning guidance contained in this document will help ensure that adequate coordination between on-post and off-post planners occurs during the planning process. This planning guide broadly describes an adequate emergency planning base that assures that critical planning decisions will be made consistently at every chemical agent stockpile location. This planning guide includes material drawn from other documents developed by the FEMA, the Army, and other federal agencies with emergency preparedness program responsibilities. Some of this material has been developed specifically to meet the unique requirements of the CSEPP. In addition to this guidance, other location-specific documents, technical studies, and support studies should be used as needed to assist in the planning at each of the chemical agent stockpile locations to address the specific hazards and conditions at each location.

  19. Long-Term Stewardship Baseline Report and Transition Guidance

    Energy Technology Data Exchange (ETDEWEB)

    Kristofferson, Keith

    2001-11-01

    Long-term stewardship consists of those actions necessary to maintain and demonstrate continued protection of human health and the environment after facility cleanup is complete. As the Department of Energy’s (DOE) lead laboratory for environmental management programs, the Idaho National Engineering and Environmental Laboratory (INEEL) administers DOE’s long-term stewardship science and technology efforts. The INEEL provides DOE with technical, and scientific expertise needed to oversee its long-term environmental management obligations complexwide. Long-term stewardship is administered and overseen by the Environmental Management Office of Science and Technology. The INEEL Long-Term Stewardship Program is currently developing the management structures and plans to complete INEEL-specific, long-term stewardship obligations. This guidance document (1) assists in ensuring that the program leads transition planning for the INEEL with respect to facility and site areas and (2) describes the classes and types of criteria and data required to initiate transition for areas and sites where the facility mission has ended and cleanup is complete. Additionally, this document summarizes current information on INEEL facilities, structures, and release sites likely to enter long-term stewardship at the completion of DOE’s cleanup mission. This document is not intended to function as a discrete checklist or local procedure to determine readiness to transition. It is an overarching document meant as guidance in implementing specific transition procedures. Several documents formed the foundation upon which this guidance was developed. Principal among these documents was the Long-Term Stewardship Draft Technical Baseline; A Report to Congress on Long-Term Stewardship, Volumes I and II; Infrastructure Long-Range Plan; Comprehensive Facility Land Use Plan; INEEL End-State Plan; and INEEL Institutional Plan.

  20. Management of Documents and Information in BSC Secretariat

    International Nuclear Information System (INIS)

    Sumathi, E.; Jayarajan, K.

    2017-01-01

    The regulatory and safety function of BARC facilities is being carried out by BARC Safety Framework with BARC Safety Council as an apex body. Presently, about one hundred safety committees and task forces are functional in the framework. BSC Secretariat (BSCS) provides technical and administrative support to the BARC Safety Framework for the regulatory activities in BARC. Important documents/records related to committee decisions and facilities are maintained in BSCS, through an established documentation and record keeping system. The compliance of regulatory recommendations is verified during regulatory inspections and subsequent submissions made by the facility authority. This supports the effective regulatory decision making of various committees. This article elaborates the maintenance of records and information at BSC