WorldWideScience

Sample records for epa regulatory review

  1. Lessons Learned from Characterization, Performance Assessment, and EPA Regulatory Review of the 1996 Actinide Source Term for the Waste Isolation Pilot Plant

    International Nuclear Information System (INIS)

    Larson, K.W.; Moore, R.C.; Nowak, E.J.; Papenguth, H.W.; Jow, H.

    1999-01-01

    The Waste Isolation Pilot Plant (WIPP) is a US Department of Energy (DOE) facility for the permanent disposal of transuranic waste from defense activities. In 1996, the DOE submitted the Title 40 CFR Part 191 Compliance Certification Application for the Waste Isolation Pilot Plant (CCA) to the US Environmental Protection Agency (EPA). The CCA included a probabilistic performance assessment (PA) conducted by Sandia National Laboratories to establish compliance with the quantitative release limits defined in 40 CFR 191.13. An experimental program to collect data relevant to the actinide source term began around 1989, which eventually supported the 1996 CCA PA actinide source term model. The actinide source term provided an estimate of mobile dissolved and colloidal Pu, Am, U, Th, and Np concentrations in their stable oxidation states, and accounted for effects of uncertainty in the chemistry of brines in waste disposal areas. The experimental program and the actinide source term included in the CCA PA underwent EPA review lasting more than 1 year. Experiments were initially conducted to develop data relevant to the wide range of potential future conditions in waste disposal areas. Interim, preliminary performance assessments and actinide source term models provided insight allowing refinement of experiments and models. Expert peer review provided additional feedback and confidence in the evolving experimental program. By 1995, the chemical database and PA predictions of WIPP performance were considered reliable enough to support the decision to add an MgO backfill to waste rooms to control chemical conditions and reduce uncertainty in actinide concentrations, especially for Pu and Am. Important lessons learned through the characterization, PA modeling, and regulatory review of the actinide source term are (1) experimental characterization and PA should evolve together, with neither activity completely dominating the other, (2) the understanding of physical processes

  2. Technical assistance for regulatory development: review and evaluation of the EPA standard 40 CFR191 for disposal of high-level waste. Vol. 1

    International Nuclear Information System (INIS)

    Ortiz, N.R.; Wahi, K.K.

    1983-04-01

    The Environmental Protection Agency (EPA) has prepared a draft Standard (40CFR191, Draft 19) which, when finalized, will provide the overall system requirements for the geologic disposal of radioactive waste. This document (Vol. 1) provides an Executive Summary of the work performed at Sandia National Laboratories, Albuquerque, NM, under contract to the US Nuclear Regulatory Commission to analyze certain aspects of the draft Standard. The issues of radionuclide release limits, interpretation, uncertainty, achievability, and assessment of compliance with respect to the requirements of the draft Standard are addressed based on the detailed analyses presented in five companion volumes to this report

  3. Regulatory decision with EPA/NRC/DOE/State Session (Panel)

    Energy Technology Data Exchange (ETDEWEB)

    O`Donnell, E.

    1995-12-31

    This panel will cover the Nuclear Regulatory Commission`s (NRC) proposed radiation limits in the Branch Technical Position on Low-Level Radioactive Waste Performance Assessment and the Environmental Protection Agency`s (EPA) draft regulation in Part 193. Representatives from NRC and EPA will discuss the inconsistencies in these two regulations. DOE and state representatives will discuss their perspective on how these regulations will affect low-level radioactive waste performance assessments.

  4. Checklist for Reviewing EPA Quality Management Plans

    Science.gov (United States)

    This checklist will be used to review the Quality Management Plans (QMPs) that are submitted to the Quality Staff of the Office of Environmental Information (OEI) for Agency review under EPA Order 5360.1 A2.

  5. Research and regulatory review

    International Nuclear Information System (INIS)

    Macleod, J.S.; Fryer, D.R.H.

    1979-01-01

    To enable the regulatory review to be effectively undertaken by the regulatory body, there is a need for it to have ready access to information generated by research activities. Certain advantages have been seen to be gained by the regulatory body itself directly allocating and controlling some portion of these activities. The princial reasons for reaching this conclusion are summarised and a brief description of the Inspectorates directly sponsored programme outlined. (author)

  6. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... as a means of promoting regulatory goals. The fundamental principles and structures governing... review. In this time of fundamental transformation, that process—and the principles governing regulation... the Office of Management and Budget (OMB) has reviewed Federal regulations. The purposes of such...

  7. 75 FR 61485 - Regulatory Training Session With Air Carriers, EPA Regional Partners and Other Interested Parties...

    Science.gov (United States)

    2010-10-05

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9210-6] Regulatory Training Session With Air Carriers, EPA... Agency (EPA) will hold a two-day training session on the regulatory requirements of the Aircraft Drinking... session will be provided in early 2011. ADDRESSES: The training will be held at the Rosslyn Holiday Inn at...

  8. EPA's LLW standards program: Below regulatory concern criteria development

    International Nuclear Information System (INIS)

    Holcomb, W.F.; Gruhlke, J.M.

    1987-01-01

    The Environmental Protection Agency (EPA) is developing generally applicable environmental standards for land disposal of low-level radioactive wastes. These standards will include criteria for determining which wastes have sufficiently low levels of radioactivity to be considered ''Below Regulatory Concern'' (BRC) in regards to their radiation hazard. Risk assessments to support the BRC criteria include an analysis of 18 surrogate radioactive waste streams, generated by nuclear power reactors and other fuel cycle facilities, industrial, medical and educational facilities, and consumers. Deregulated disposal alternatives, such as sanitary landfills, municipal dumps, incinerators and on-site landfills, situated in diverse demographic settings are used in the analysis. A number of waste streams which contributed only small doses or fractions of a health effect over 10,000 years were identified. Disposal of such wastes without consideration of their very low radioactivity could result in significant cost savings to the commercial fuel cycle and government operations as well as to medical, educational, and industrial facilities, and with minimal risk to the public. The concept of BRC wastes appears both feasible and cost effective

  9. Independent Quality Control Review of EPA OIG Operations

    Science.gov (United States)

    The review considers selected audit work performed by EPA OIG, Office of Audit, Congressional and Public Liaison, Mission Systems, and Program Evaluation, during the period for 1 October 2006 through 30 September 2007 .

  10. Regulatory Review Committee update

    Energy Technology Data Exchange (ETDEWEB)

    Steele, T. [Polishuk, Camman and Steele, London ON (Canada)

    2001-07-01

    The Committee's objectives, current membership and current issues are reviewed. Each current issue, notably the consultation process with the Ministry of Natural Resources, appeal of Ministry actions, orphan wells/security deposits, oilfield fluid disposal and labour code practices review are discussed in some detail. Dissatisfaction with the current appeals process to the Ministry is highlighted, along with a search for an all encompassing solution. The orphan well problem also received considerable attention, with similar demands for a comprehensive solution.

  11. 75 FR 38958 - Declaration of Prion as a Pest under FIFRA and Amendment of EPA's Regulatory Definition of Pests...

    Science.gov (United States)

    2010-07-07

    ... Prion as a Pest under FIFRA and Amendment of EPA's Regulatory Definition of Pests to Include Prion....e., proteinaceous infectious particle) a ``pest'' under the Federal Insecticide, Fungicide, and... is adding prion to the list of pests in EPA's regulations. This amendment, together with the formal...

  12. Geothermal industry position paper: EPA regulatory options and research and development information needs

    Energy Technology Data Exchange (ETDEWEB)

    D' Alessio, G.

    1977-08-01

    The environmental impact of geothermal energy development may be less intense or widespread than that of some other energy sources; however, it is the first example of a number of emerging energy technologies that must be dealt with by EPA. EPA may consider a spectrum of options ranging from a posutre of business as usual to one of immediate setting of standards, as favored by ERDA. The paper discusses the regulatory approaches and the potential problems that geothermal energy may present in the areas of air quality, water quality, and other impacts. It is recommended that a coordinated program of research be drawn up, comprised of specific research projects, the types of geothermal resource to which they apply, and the date by which the information is required.

  13. Geothermal Industry Position Paper: EPA Regulatory Options and Research and Development Information Needs

    Energy Technology Data Exchange (ETDEWEB)

    Swetnam, G.F.

    1976-11-01

    The environmental impact of geothermal energy development may be less intense or widespread than that of some other energy sources; however, it is the first example of a number of emerging energy technologies that must be dealt with by EPA. EPA may consider a spectrum of options ranging from a posture of business as usual to one of immediate setting of standards, as favored by ERDA. The paper discusses the regulatory approaches and the potential problems that geothermal energy may present in the areas of air quality, water quality, and other impacts. It is recommended that a coordinated program of research be drawn up, comprised of specific research projects, the types of geothermal resource to which they apply, and the date by which the information is required.

  14. 40 CFR 725.370 - EPA review of the TME application.

    Science.gov (United States)

    2010-07-01

    ... unreasonable risk of injury to health and the environment as a result of test marketing. ... Marketing § 725.370 EPA review of the TME application. General procedures for review of all submissions... with test marketing activities after receipt of EPA approval. (c) In approving a TME application, EPA...

  15. 40 CFR 70.8 - Permit review by EPA and affected States.

    Science.gov (United States)

    2010-07-01

    ... compatible with EPA's national database management system. (2) The Administrator may waive the requirements... PROGRAMS (CONTINUED) STATE OPERATING PERMIT PROGRAMS § 70.8 Permit review by EPA and affected States. (a...

  16. Averting Regulatory Enforcement: Evidence from New Source Review

    Energy Technology Data Exchange (ETDEWEB)

    Keohane, N.O.; Mansur, E.T.; Voynov, A. [Yale University, New York, NY (USA)

    2009-09-15

    This paper explores firms' response to regulatory enforcement. New Source Review (NSR), a provision of the Clean Air Act, imposes stringent emissions limitations on significantly modified older power plants. In 1999, the Environmental Protection Agency (EPA) sued owners of 46 plants for NSR violations. We study how electricity companies respond to both the perceived threat of future action, and the action itself. A discrete choice model estimates plants likelihood of being named in lawsuits increases with large historic emissions and investments. On the eve of the lawsuits, emissions at plants with a one standard deviation greater probability of being sued fell approximately 10%.

  17. Design reviews from a regulatory perspective

    International Nuclear Information System (INIS)

    Foster, B.D.

    1991-01-01

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

  18. EPA's criteria development for radioactive waste that is Below Regulatory Concern

    International Nuclear Information System (INIS)

    Holcomb, W.F.; Gruhlke, J.M.

    1987-01-01

    The EPA's program for developing environmental standards for land disposal of low-level radioactive wastes, including a criterion for determining wastes with sufficiently low levels of radioactivity to be considered Below Regulatory Concern (BRC) has completed its risk assessment and cost-effectiveness analyses. The analyses for the BRC criterion included evaluation of general population health risks, maximum annual exposures to critical population groups, and costs of risk reduction. These risk assessments include analyses of 18 surrogate radioactive waste streams, representing both fuel cycle and non-fuel cycle facilities. Less restrictive disposal alternatives typical of those used for municipal garbage disposal, such as sanitary landfills, and situated in diverse demographic settings were used in the analyses. A number of waste types which contribute only small doses or fractions of a health effect over 10,000 years from unregulated disposal were identified. Disposal of such wastes without consideration of their very low radioactivity content results in significant cost savings. 3 references, 1 figure, 4 tables

  19. 75 FR 10261 - Request for Nominations to the EPA Human Studies Review Board

    Science.gov (United States)

    2010-03-05

    ... scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide... of the following areas: Bioethics: expertise in the ethics of research with human subjects... EPA Human Studies Review Board AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY...

  20. Review of NRC Regulatory processes and functions

    International Nuclear Information System (INIS)

    1980-01-01

    The Advisory Committee on Reactor Safeguards (ACRS) has spent much time over many years observing and examining the NRC licensing process. The Committee is, consequently, in a position to comment on the situation, and it believes this review will be helpful to those examining the regulatory process by discussing how it works, where it is weak, and the opportunities for improvement. The Committee's review may also help put current proposals and discussions in perspective

  1. Use of risk information in regulatory reviews

    International Nuclear Information System (INIS)

    Sagar, B.; Benke, R.; Mohanty, S.

    2004-01-01

    The regulatory framework for licensing any high-level waste repository at Yucca Mountain in the United States, calls for appropriate use of risk information to ensure operational safety during the pre-closure period and long-term safety during the post-closure period. This paper focuses on the post-closure period. Regulations in the Code of Federal Regulations (CFR), Title 10, Part 63, apply to any repository at Yucca Mountain and envision use of probabilistic methods to develop quantitative risk information. Accumulated engineering and scientific experience at Yucca Mountain and analog sites and quantitative risk information from studies conducted by the implementer, regulator, and others are combined to formulate 'risk insights,' which are then used to plan and execute regulatory reviews. The U.S. Nuclear Regulatory Commission (NRC) and the Center for Nuclear Waste Regulatory Analyses (CNWRA) recently consolidated the knowledge gained during several g ears and developed such risk insights for the potential repository at Yucca Mountain. This paper discusses the types of risk information used to generate risk insights and how the risk insights will be used in regulatory reviews. A companion paper presents more details on sensitivity analysis methods used to generate risk information. (authors)

  2. 76 FR 59066 - Notice of Regulatory Review Plan

    Science.gov (United States)

    2011-09-23

    ... [No. 2011-N-10] Notice of Regulatory Review Plan AGENCY: Federal Housing Finance Agency. ACTION... of and requesting comments on the FHFA interim regulatory review plan for review of existing... comments on all aspects of the interim regulatory review plan, including legal and policy considerations...

  3. 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.

  4. Water Quality Indicators Data Review | ECHO | US EPA

    Science.gov (United States)

    ECHO, Enforcement and Compliance History Online, provides compliance and enforcement information for approximately 800,000 EPA-regulated facilities nationwide. ECHO includes permit, inspection, violation, enforcement action, and penalty information about facilities regulated under the Clean Air Act (CAA) Stationary Source Program, Clean Water Act (CWA) National Pollutant Elimination Discharge System (NPDES), and/or Resource Conservation and Recovery Act (RCRA). Information also is provided on surrounding demographics when available.

  5. 78 FR 58536 - Notification of a Public Meeting of the Science Advisory Board Panel for the Review of the EPA...

    Science.gov (United States)

    2013-09-24

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL--9901-26-OA] Notification of a Public Meeting of the Science Advisory Board Panel for the Review of the EPA Water Body Connectivity Report AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory Board (SAB) Staff Office announces...

  6. Regulatory review of NPP Krsko Periodic Safety Review

    International Nuclear Information System (INIS)

    Lovincic, D.; Muehleisen, A.; Persic, A.

    2004-01-01

    At the request of the Slovenian Nuclear Safety Administration (SNSA), Krsko NPP prepared a Periodic Safety Review (PSR) program in January 2001. This is the first PSR of NPP Krsko, the only nuclear power plant in Slovenia. The program was reviewed by the IAEA mission in May 2001 and approved by SNSA in July 2001. The program is made in accordance with the IAEA Safety Guide 'Periodic Safety Review of Operational Nuclear Power Plants' No. 50-SG-012 and with European practice. It contains a systematic review of operation of the NPP Krsko, including the review of the changes as a result of the modernization of the facility. The main tasks of PSR are review of plant status for each safety factor, development of aging and life cycle management program, review of seismic design and PSHA analysis and update of regulatory compliance program. The prioritization process of findings and action plan are also important tasks of PSR. The basic safety factors of the PSR review are: Operational Experience, Safety Assessment and Analyses, Equipment Qualification and Ageing Management, Safety Culture, Emergency Planing, Environmental Impact and Radioactive Waste, Compliance with license requirements and Prioritization. It had been agreed that SNSA will have reviewed all PSR reports generated during the PSR process. At the end of 2003 the PSR Summary Report with selected recommendations for action plan was completed and delivered to SNSA for review. The paper presents regulatory review of NPP Krsko PSR with emphasis on the evaluation of the PSR issues ranking process. (author)

  7. EMERGING SCIENCE: EPA'S ORD SUPPORTS REGIONAL HAZE PROGRAM; POSTERS FROM BOSC REVIEW AND SCIENCE FORUM

    Science.gov (United States)

    A series of presentations from EPA's Board of Science Councilors review in April 2005 and the Science Forum in May 2005 are being made available to the Regional Planning Organization conference on June 9-10, 2005. Attendees will be able to review the materials during the confere...

  8. 40 CFR 131.21 - EPA review and approval of water quality standards.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) WATER PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.21 EPA review and approval of water quality standards. (a) After the State submits its... analysis. (b) The Regional Administrator's approval or disapproval of a State water quality standard shall...

  9. Regulatory Review of Early Site Permit Applications

    International Nuclear Information System (INIS)

    Scott, Michael L.

    2004-01-01

    The U.S. Nuclear Regulatory Commission (NRC) has received and is reviewing three applications for early site permits (ESPs). The ESP process allows early resolution of site-related issues affecting possible construction and operation of a new nuclear power plant. The nuclear industry views a successful and predictable ESP process as an important step in assessing whether to seek authorization to construct and operate a new generation of nuclear power reactors in the United States. Because consideration of ESP applications is a first-of-a-kind activity, a number of issues have emerged prior to and during the reviews of the first three applications. Issues have included the need for design information at the ESP stage, accident analyses, quality assurance, and seismic analyses. The NRC has been working to resolve identified issues to support a Commission decision on whether to issue an ESP approximately 33-37 months after receipt of each ESP application. (authors)

  10. US EPA record of decision review for landfills: Sanitary landfill (740-G), Savannah River Site

    Energy Technology Data Exchange (ETDEWEB)

    1993-06-01

    This report presents the results of a review of the US Environmental Protection Agency (EPA) Record of Decision System (RODS) database search conducted to identify Superfund landfill sites where a Record of Decision (ROD) has been prepared by EPA, the States or the US Army Corps of Engineers describing the selected remedy at the site. ROD abstracts from the database were reviewed to identify site information including site type, contaminants of concern, components of the selected remedy, and cleanup goals. Only RODs from landfill sites were evaluated so that the results of the analysis can be used to support the remedy selection process for the Sanitary Landfill at the Savannah River Site (SRS).

  11. US EPA record of decision review for landfills: Sanitary landfill (740-G), Savannah River Site

    International Nuclear Information System (INIS)

    1993-06-01

    This report presents the results of a review of the US Environmental Protection Agency (EPA) Record of Decision System (RODS) database search conducted to identify Superfund landfill sites where a Record of Decision (ROD) has been prepared by EPA, the States or the US Army Corps of Engineers describing the selected remedy at the site. ROD abstracts from the database were reviewed to identify site information including site type, contaminants of concern, components of the selected remedy, and cleanup goals. Only RODs from landfill sites were evaluated so that the results of the analysis can be used to support the remedy selection process for the Sanitary Landfill at the Savannah River Site (SRS)

  12. 40 CFR 26.1125 - Prior submission of proposed human research for EPA review.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prior submission of proposed human research for EPA review. 26.1125 Section 26.1125 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... Pesticides Involving Intentional Exposure of Non-pregnant, Non-nursing Adults § 26.1125 Prior submission of...

  13. Radiation protection, 1975. Annual EPA review of radiation protection activities

    International Nuclear Information System (INIS)

    1976-06-01

    The EPA, under its Federal Guidance authorities, is responsible for advising the President on all matters pertaining to radiation and, through this mechanism, to provide guidance to other Federal agencies on radiation protection matters. Highlights are presented of significant radiation protection activities of all Federal agencies which were completed in 1975, or in which noteworthy progress was made during that period, and those events affecting members of the public. State or local activities are also presented where the effects of those events may be more far-reaching. At the Federal level significant strides have been made in reducing unnecessary radiation exposure through the efforts of the responsible agencies. These efforts have resulted in the promulgation of certain standards, criteria and guides. Improved control technologies in many areas make it feasible to reduce emissions at a reasonable cost to levels below current standards and guides. This report provides information on the significant activities leading to the establishment of the necessary controls for protection of public health and the environment. Radiation protection activities have been undertaken in other areas such as medical, occupational and consumer product radiation. In the context of radiation protection, ancillary activities are included in this report in order to present a comprehensive overview of the events that took place in 1975 that could have an effect on public health, either directly or indirectly. Reports of routine or continuing radiation protection operations may be found in publications of the sponsoring Federal agencies, as can more detailed information about activities reported in this document. A list of some of these reports is included

  14. US EPA 2014 Ozone Season Review by City

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web service contains the following layer: OzoneReview35Cities_with2000to2014data. Full FGDC metadata records for each layer may be found by clicking the layer...

  15. 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

  16. Drinking Water Research Division's research activities in support of EPA's regulatory agenda

    International Nuclear Information System (INIS)

    Clark, R.M.; Feige, W.A.

    1991-01-01

    The Safe Drinking Water Act and its Amendments will have a dramatic impact on the way in which one views the treatment and distribution of water in the U.S. The paper discusses the regulatory agenda, including proposed and promulgated regulations for volatile and synthetic organic contaminants, pesticides, lead, copper, inorganic contaminants, and radionuclides. In addition, the Surface Water Treatment and Coliform Rules are discussed in some detail. Tables are presented that list the Maximum Contaminant Levels (MCLs) and Maximum Contaminant Level Goals (MCLGs), as well as Best Available Technology (BAT) for reducing many of these contaminants to acceptable levels. Finally, a discussion of expected disinfection requirements and the regulation of disinfection by-products (DBP) is made. Treatment techniques for controlling DBPs are briefly described

  17. Effects of the polyunsaturated fatty acids, EPA and DHA, on hematological malignancies: a systematic review.

    Science.gov (United States)

    Moloudizargari, Milad; Mortaz, Esmaeil; Asghari, Mohammad Hossein; Adcock, Ian M; Redegeld, Frank A; Garssen, Johan

    2018-02-20

    Omega-3 polyunsaturated fatty acids (PUFAs) have well established anti-cancer properties. Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are among this biologically active family of macromolecules for which various anti-cancer effects have been explained. These PUFAs have a high safety profile and can induce apoptosis and inhibit growth of cancer cells both in vitro and in vivo , following a partially selective manner. They also increase the efficacy of chemotherapeutic agents by increasing the sensitivity of different cell lines to specific anti-neoplastic drugs. Various mechanisms have been proposed for the anti-cancer effects of these omega-3 PUFAs; however, the exact mechanisms still remain unknown. While numerous studies have investigated the effects of DHA and EPA on solid tumors and the responsible mechanisms, there is no consensus regarding the effects and mechanisms of action of these two FAs in hematological malignancies. Here, we performed a systematic review of the beneficial effects of EPA and DHA on hematological cell lines as well as the findings of related in vivo studies and clinical trials. We summarize the key underlying mechanisms and the therapeutic potential of these PUFAs in the treatment of hematological cancers. Differential expression of apoptosis-regulating genes and Glutathione peroxidase 4 (Gp-x4), varying abilities of different cancerous and healthy cells to metabolize EPA into its more active metabolites and to uptake PUFAS are among the major factors that determine the sensitivity of cells to DHA and EPA. Considering the abundance of data on the safety of these FAs and their proven anti-cancer effects in hematological cell lines and the lack of related human studies, further research is warranted to find ways of exploiting the anticancer effects of DHA and EPA in clinical settings both in isolation and in combination with other therapeutic regimens.

  18. Regulatory review - on the brink of renewal

    International Nuclear Information System (INIS)

    Braunstein, L.A.

    1993-01-01

    Under the Atomic Energy Act of 1954, US commercial nuclear energy plants are licensed to operate for 40 years each. Congress selected the 40-year term not on the basis of safety, technical, or environmental issues, but on the basis of the 40-year amortization period generally used by electric utilities for large capital investments. And nuclear power plants may apply to have their licenses renewed. Licenses for about 47 plants - totalling about 34,000 megawatts (MW) of capacity - will expire between 2000 and 2014. By 2000, 63 reactors will be more than 20 years old. Without license renewal, utilities would have to retire about 5,000 MW of capacity every year between 2010 and 2030. Moreover, the Department of Energy (DOE) estimates that renewing licenses of existing nuclear plants for 20 years would save the nation's consumers about $350 billion. The NRC has concluded that the current safety of plants, as they operate today, is adequate. Therefore, in promulgating the final rule, the commission wanted to ensure that the applicants address those technical matters that are unique to the period of plant operation beyond the initial 40 years. For this reason, the rule includes language stating that the relicensing process would examine age-related degradation unique to license renewal. Interpretation of this language is adding regulatory uncertainty to the license renewal process. NRC is reviewing its interpretation; it also has indicated that it would like to smooth out the process through the review of an actual renewal application. Utility executives, however, seem unwilling to make proposals to their boards to commit large capital investments without a clear end-point in sight. It appears that the industry is now hesitating at the renewal office door - with NRC waiting for an application, and the industry holding back

  19. EPA/NMED/LANL 1998 water quality results: Statistical analysis and comparison to regulatory standards

    International Nuclear Information System (INIS)

    Gallaher, B.; Mercier, T.; Black, P.; Mullen, K.

    2000-01-01

    Four governmental agencies conducted a round of groundwater, surface water, and spring water sampling at the Los Alamos National Laboratory during 1998. Samples were split among the four parties and sent to independent analytical laboratories. Results from three of the agencies were available for this study. Comparisons of analytical results that were paired by location and date were made between the various analytical laboratories. The results for over 50 split samples analyzed for inorganic chemicals, metals, and radionuclides were compared. Statistical analyses included non-parametric (sign test and signed-ranks test) and parametric (paired t-test and linear regression) methods. The data pairs were tested for statistically significant differences, defined by an observed significance level, or p-value, less than 0.05. The main conclusion is that the laboratories' performances are similar across most of the analytes that were measured. In some 95% of the laboratory measurements there was agreement on whether contaminant levels exceeded regulatory limits. The most significant differences in performance were noted for the radioactive suite, particularly for gross alpha particle activity and Sr-90

  20. EPA Region 1 Environmentally Sensitive Areas

    Science.gov (United States)

    This coverage represents polygon equivalents of environmentally sensitive areas (ESA) in EPA Region I. ESAs were developed as part of an EPA headquarters initiative based on reviews of various regulatory and guidance documents, as well as phone interviews with federal/state/local government agencies and private organizations. ESAs include, but are not limited to, wetlands, biological resources, habitats, national parks, archaeological/historic sites, natural heritage areas, tribal lands, drinking water intakes, marinas/boat ramps, wildlife areas, etc.

  1. A regulatory review for products containing glutathione

    Directory of Open Access Journals (Sweden)

    Nur Hidayah Abd Rahim

    2016-01-01

    Full Text Available Glutathione is a potent antioxidant as well as has important role for DNA synthesis and repair, protein synthesis, amino acid transport, and enzyme activation. Besides this, Glutathione products are now mainly selling as whitening agent which are mainly marketing through social media (Facebook and different websites. Information is not available whether glutathione product are following the regulatory guidelines of National Pharmaceutical Control Bureau of Malaysia (NPCB for selling, advertisement and promotion. This review was carried out by extracting information about glutathione from scientific database using PubMed, Cochrane Library and Embase. Analysis of the available information, case example of glutathione products showed that a brand of glutathione (Glutacaps HQ did not show the product's registration number from NPCB, and also did not show the name, address, contact number of the advertiser, and even not found the name of the manufacture. Without providing the above mentioned information, the product is selling and promoting through social media (fb which is not allowed by the NPCB guidelines part 4.14. So far, only two clinical trials were conducted on glutathione supplementation for 4 weeks duration. There was no serious or systematic adverse effects reported in clinical trials. As the two clinic trials resulted contradictory outcomes, further studies needed for conformation of the clinic benefits of glutathione. Otherwise, random use of glutathione may be risk for the health of the people. Besides, the marketer mainly promoting glutathione as the skin whitening beauty product instead of using as health supplement, it may cause additional and serious risk to the users as the manufacturer not providing sufficient information about the product, its registration number, manufacturing company, etc.

  2. Regulatory review of safety cases and safety assessments - associated challenges

    International Nuclear Information System (INIS)

    Bennett, D.G.; Ben Belfadhel, M.; Metcalf, P.E.

    2006-01-01

    Regulatory reviews of safety cases and safety assessments are essential for credible decision making on the licensing or authorization of radioactive waste disposal facilities. Regulatory review also plays an important role in developing the safety case and in establishing stakeholders' confidence in the safety of the facility. Reviews of safety cases for radioactive waste disposal facilities need to be conducted by suitably qualified and experienced staff, following systematic and well planned review processes. Regulatory reviews should be sufficiently comprehensive in their coverage of issues potentially affecting the safety of the disposal system, and should assess the safety case against clearly established criteria. The conclusions drawn from a regulatory review, and the rationale for them should be reproducible and documented in a transparent and traceable way. Many challenges are faced when conducting regulatory reviews of safety cases. Some of these relate to issues of project and programme management, and resources, while others derive from the inherent difficulties of assessing the potential long term future behaviour of engineered and environmental systems. The paper describes approaches to the conduct of regulatory reviews and discusses some of the challenges faced. (author)

  3. 76 FR 18457 - Regulatory Review Schedule; Tribal Consultation

    Science.gov (United States)

    2011-04-04

    ... that the NIGC provide tribal gaming commissions access to licensing information via an online database... DEPARTMENT OF THE INTERIOR National Indian Gaming Commission 25 CFR Chapter III Regulatory Review Schedule; Tribal Consultation AGENCY: National Indian Gaming Commission. ACTION: Notice of Regulatory...

  4. Institutional review board and regulatory solutions in the dental PBRN

    DEFF Research Database (Denmark)

    Gilbert, Gregg H; Qvist, Vibeke; Moore, Sheila D

    2010-01-01

    Effectively addressing regulatory and human participant protection issues with Institutional Review Boards (IRBs, or ethics committees) and grants administration entities is an important component of conducting research in large collaborative networks. A dental practice-based research network...

  5. EPA's Review of Concentrated Animal Feeding Operation (CAFO) Permits and Nutrient Management Plans in the Chesapeake Bay Watershed

    Science.gov (United States)

    Starting in 2013, EPA conducted reviews of Concentrated Animal Feeding Operations (CAFOs) permits and nutrient management plans (NMPs) in six of the Bay jurisdictions (Delaware, Maryland, New York, Pennsylvania, Virginia and West Virginia).

  6. Regulatory review of probabilistic safety assessment (PSA) Level 2

    International Nuclear Information System (INIS)

    2001-07-01

    Probabilistic safety assessment (PSA) is increasingly being used as part of the decision making process to assess the level of safety of nuclear power plants. The methodologies in use are maturing and the insights gained from the PSAs are being used along with those from deterministic analysis. Many regulatory authorities consider the current state of the art in PSA to be sufficiently well developed for results to be used centrally in the regulatory decision making process-referred to as risk informed regulation. For these applications to be successful, it will be necessary for the regulatory authority to have a high degree of confidence in the PSA. However, at the 1994 IAEA Technical Committee Meeting on Use of PSA in the Regulatory Process and at the OECD Nuclear Energy Agency Committee for Nuclear Regulatory Activities (CNRA) 'Special Issues' meeting in 1997 on Review Procedures and Criteria for Different Regulatory Applications of PSA, it was recognized that formal regulatory review guidance for PSA did not exist. The senior regulators noted that there was a need to produce some international guidance for reviewing PSAs to establish an agreed basis for assessing whether important technological and methodological issues in PSAs are treated adequately and to verify that conclusions reached are appropriate. In 1997, the IAEA and OECD Nuclear Energy Agency agreed to produce, in cooperation, guidance on Regulatory Review of PSA. This led to the publication of IAEA-TECDOC-1135 on the Regulatory Review of Probabilistic Safety Assessment (PSA) Level 1, which gives advice for the review of Level 1 PSA for initiating events occurring at power plants. This TECDOC extends the coverage to address the regulatory review of Level 2 PSA.These publications are intended to provide guidance to regulatory authorities on how to review the PSA for a nuclear power plant to gain confidence that it has been carried out to an acceptable level of quality so that it can be used as the

  7. A Review on Regulatory Enforcement Policy

    International Nuclear Information System (INIS)

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

    2017-01-01

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

  8. Carbon Capture and Storage Legal and Regulatory Review. Edition 2

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    The International Energy Agency (IEA) estimates that 100 carbon capture and storage (CCS) projects must be implemented by 2020 and over 3000 by 2050 if CCS is to fully contribute to the least-cost technology portfolio for CO2 mitigation. To help countries address the many legal and regulatory issues associated with such rapid deployment, the IEA launched the Carbon Capture and Storage Legal and Regulatory Review (CCS Review) in October 2010. The CCS Review gathers contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum that supports national-level CCS regulatory development. Each contribution provides a short summary of recent and anticipated developments and highlights a particular regulatory theme (such as financial contributions to long-term stewardship). To introduce each edition, the IEA provides a brief analysis of key advances and trends. Produced bi-annually, the CCS Review provides an up-to-date snapshot of global CCS regulatory developments. The theme for the second edition of the CCS Review, released in May 2011, is long-term liability for stored CO2. Other key issues addressed include: national progress towards implementation of the EU CCS Directive; developments in marine treaties relevant to CCS; international climate change negotiations; and the development process for CCS regulation.

  9. 75 FR 21871 - Spring 2010 Regulatory Agenda

    Science.gov (United States)

    2010-04-26

    ... Review 10/00/10 Regulatory Flexibility Analysis Required: No Agency Contact: Tad Wysor, Environmental...: wysor.tad@epamail.epa.gov Tom Eagles, Environmental Protection Agency, Air and Radiation, 6103A...

  10. The consideration and representation of retention processes in the WIPP performance assessment: justification of adopted approaches and interaction with the regulator. Part 2: EPA review process and approval justification

    International Nuclear Information System (INIS)

    Byrum, Ch.; Peake, T.

    2002-01-01

    The Environmental Protection Agency (EPA) was directed by Congress to review whether the Waste Isolation Pilot Plant (WIPP) would comply with EPA regulations on radioactive waste disposal. The review of the effectiveness of retardation in the Culebra Dolomite Member of the Rustler Formation was a major focus of the Agency's review since the Culebra is postulated to be the major long-term pathway for the movement of radionuclides. EPA review consisted of reviewing the Department of Energy's (DOE) data as well as conducting separate evaluations and modelling. EPA independent evaluation identified several issues of concern: First, steady-state conditions did not appear to be reached in some experiments. Second, the effect of actinide concentration did not appear to be addressed. Third, the effect of magnesium oxide backfill in the repository for creating alkaline pH conditions in the brines passing through was not considered. Fourth, the experiments for Am(III) failed for various reasons and Pu(V) was used to represent Am(III). EPA also considered other concerns voiced by different reviewers in its review. After receipt of information supplemental to DOE's Compliance Certification Application (CCA), EPA was able to determine that the experimental foundation supported the retardation conceptual model in the Culebra and the parameters used were adequate. EPA independent modelling confirmed DOE's modelling that indicated radionuclide releases through the Culebra would be greatly reduced by even low K d values. However, EPA did determine that DOE should have used a log-uniform probability distribution for the retardation distribution coefficients (K d s)instead of the uniform probability distribution used in DOE's compliance calculations. EPA required an additional Performance Assessment (PA), called the Performance Assessment Verification Test (PAVT). The change in the K d distribution from uniform to log-uniform was incorporated for the K d values used in the PAVT. The

  11. 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

  12. Carbon Capture and Storage Legal and Regulatory Review. Edition 3

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA estimates that emissions can be reduced to a level consistent with a 2°C global temperature increase through the broad deployment of low-carbon energy technologies – and that CCS would contribute about one-fifth of emission reductions in this scenario. Achieving this level of deployment will require that regulatory frameworks – or rather a lack thereof – do not unnecessarily impede environmentally safe demonstration and deployment of CCS, so in October 2010 the IEA launched the IEA Carbon Capture and Storage Legal and Regulatory Review. The CCS Review is a regular review of CCS regulatory progress worldwide. Produced annually, it collates contributions by national and regional governments, as well as leading organisations engaged in CCS regulatory activities, to provide a knowledge-sharing forum to support CCS framework development. Each two page contribution provides a short summary of recent and anticipated CCS regulatory developments and highlights a particular, pre-nominated regulatory theme. To introduce each edition, the IEA provides a brief analysis of key advances and trends, based on the contributions submitted. The theme for this third edition is stakeholder engagement in the development of CO2 storage projects. Other issues addressed include: regulating CO2-EOR, CCS and CO2-EOR for storage; CCS incentive policy; key, substantive issues being addressed by jurisdictions taking steps to finalise CCS regulatory framework development; and CCS legal and regulatory developments in the context of the Clean Energy Ministerial Carbon Capture, Use and Storage Action Group.

  13. IAEA Mission Concludes Peer Review of Jordan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    Senior international nuclear safety and radiation protection experts today concluded an 11-day International Atomic Energy Agency (IAEA) Integrated Regulatory Review Service (IRRS) mission to review the regulatory framework for nuclear and radiation safety in Jordan. The mission team said in its preliminary findings that Jordan's nuclear regulator, the Energy and Minerals Regulatory Commission (EMRC), faces challenges because it is a relatively new body that handles a high workload while also working to recruit, train and keep competent staff. The team also noted that a recent merger provided the regulator with more of the resources it needs to perform its duty. The team made recommendations and suggestions to the regulatory body and the Government to help them strengthen the effectiveness of Jordan's regulatory framework and functions in line with IAEA Safety Standards. The main observations of the IRRS Review team comprised the following: The regulatory body, founded in 2007 and merged with other regulators in April 2014 to form EMRC, faces large challenges in terms of its regulatory workload, management system building and staff recruitment and training; The new EMRC structure and revision of the radiation and nuclear safety law represents an important opportunity to strengthen Jordan's radiation and nuclear safety infrastructure; The Government has shown commitment to radiation and nuclear safety through measures including becoming party to international conventions. It could further demonstrate its commitment by adopting a formal national policy and strategy for safety that defines the role of the Minister of Energy in relation to EMRC and protects the independence of regulatory decision-making

  14. 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

  15. Regulatory review of safety cases and safety assessments for near surface

    International Nuclear Information System (INIS)

    Nys, V.

    2003-01-01

    The activities of the ASAM Regulatory Review Working Group are presented. Regulatory review of the safety assessment is made. It includes the regulatory review of post-closure safety assessment; safety case development and confidence building. The ISAM methodology is reviewed and SA system description is presented. Recommendations on the review process management are given

  16. Information transmission in genetic regulatory networks: a review

    International Nuclear Information System (INIS)

    Tkacik, Gasper; Walczak, Aleksandra M

    2011-01-01

    Genetic regulatory networks enable cells to respond to changes in internal and external conditions by dynamically coordinating their gene expression profiles. Our ability to make quantitative measurements in these biochemical circuits has deepened our understanding of what kinds of computations genetic regulatory networks can perform, and with what reliability. These advances have motivated researchers to look for connections between the architecture and function of genetic regulatory networks. Transmitting information between a network's inputs and outputs has been proposed as one such possible measure of function, relevant in certain biological contexts. Here we summarize recent developments in the application of information theory to gene regulatory networks. We first review basic concepts in information theory necessary for understanding recent work. We then discuss the functional complexity of gene regulation, which arises from the molecular nature of the regulatory interactions. We end by reviewing some experiments that support the view that genetic networks responsible for early development of multicellular organisms might be maximizing transmitted 'positional information'. (topical review)

  17. July 2011 Memorandum: Improving EPA Review of Appalachian Surface Coal Mining Operations Under the Clean Water Act, National Environmental Policy Act, and the Environmental Justice Executive Order

    Science.gov (United States)

    Memorandum: Improving EPA Review of Appalachian Surface Coal Mining Operations Under the Clean Water Act, National Environmental Policy Act, and the Environmental Justice Executive Order, July 21, 2011

  18. Regulatory dendritic cells in autoimmunity: A comprehensive review.

    Science.gov (United States)

    Liu, Juan; Cao, Xuetao

    2015-09-01

    Dendritic cells (DCs) are professional antigen-presenting cells (APC) with significant phenotypic heterogeneity and functional plasticity. DCs play crucial roles in initiating effective adaptive immune responses for elimination of invading pathogens and also in inducing immune tolerance toward harmless components to maintain immune homeostasis. The regulatory capacity of DCs depends on their immature state and distinct subsets, yet not restricted to the immature state and one specialized subset. The tolerogenicity of DC is controlled by a complex network of environmental signals and cellular intrinsic mechanisms. Regulatory DCs play an important role in the maintenance of immunological tolerance via the induction of T cell unresponsiveness or apoptosis, and generation of regulatory T cells. DCs play essential roles in driving autoimmunity via promoting the activation of effector T cells such as T helper 1 and T helper 17 cells, and/or suppressing the generation of regulatory T cells. Besides, a breakdown of DCs-mediated tolerance due to abnormal environmental signals or breakdown of intrinsic regulatory mechanisms is closely linked with the pathogenesis of autoimmune diseases. Novel immunotherapy taking advantage of the tolerogenic potential of regulatory DCs is being developed for treatment of autoimmune diseases. In this review, we will describe the current understanding on the generation of regulatory DC and the role of regulatory DCs in promoting tolerogenic immune responses and suppressing autoimmune responses. The emerging roles of DCs dysfunction in the pathogenesis of autoimmune diseases and the potential application of regulatory DCs in the treatment of autoimmune diseases will also be discussed. Copyright © 2015 Elsevier Ltd. All rights reserved.

  19. EPA's Review of DOE's Inventory Tracking for TRU Wastes at Waste Control Specialists

    Science.gov (United States)

    On April 9, 2014, EPA's Waste Isolation Pilot Plant (WIPP) waste characterization team visited Waste Control Specialists (WCS) to determine whether DOE was meeting EPA's waste inventory tracking requirements at 40 CFR 194.24(c)(4).

  20. 78 FR 27169 - Regulatory Flexibility Act Review

    Science.gov (United States)

    2013-05-09

    ... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Chapter... parts 174, 177, 191, and 192... 2013 2014 Transportation of Natural and Other Gas by Pipeline; Annual... review of some of 49 CFR parts 106, 107, 171. The full analysis document for the hazardous materials...

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

    International Nuclear Information System (INIS)

    2014-01-01

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

  2. 76 FR 6094 - FAA Public Forum To Conduct Regulatory Review

    Science.gov (United States)

    2011-02-03

    ... DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Parts 27 and 29 FAA Public Forum To Conduct Regulatory Review AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Notice of public meeting. SUMMARY: The FAA announces an informal meeting to discuss the FAA rotorcraft rules, 14...

  3. 78 FR 23199 - NASA FAR Supplement Regulatory Review No. 1

    Science.gov (United States)

    2013-04-18

    ... 2700-AE01 NASA FAR Supplement Regulatory Review No. 1 AGENCY: National Aeronautics and Space Administration. ACTION: Proposed rule. SUMMARY: NASA is updating the NASA FAR Supplement (NFS) with the goal of... existing regulations. The revisions to this rule are part of NASA's retrospective plan under EO 13563...

  4. IAEA Mission Concludes Peer Review of Pakistan's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2014-01-01

    An international team of senior nuclear safety experts today concluded a nine-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for the safety of operating nuclear power plants in the United States of America (USA). The Integrated Regulatory Review Service (IRRS) mission was a follow-up to the IRRS mission to the US Nuclear Regulatory Commission (NRC) that was conducted in 2010, with the key additional aim of reviewing whether the response of the US regulatory regime to the implications of the accident at TEPCO's Fukushima Daiichi Plant had been timely and effective. The mission team concluded that the recommendations and suggestions made by the 2010 IRRS mission have been taken into account systematically under the NRC's subsequent action plan, with significant progress in many areas and many improvements carried out. One of two recommendations and 19 out of 20 suggestions made by the 2010 IRRS mission have been effectively addressed and can therefore be considered closed. The outstanding recommendation relates to the NRC's review of its Management System, which is in the process of being finalised. The IRRS team also found that the NRC acted promptly and effectively after the Fukushima accident in the interests of public health and safety, and that the report of its Near-Term Task Force represents a sound and ample basis for taking into account the lessons learned from the accident

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

    International Nuclear Information System (INIS)

    2002-01-01

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

  6. 40 CFR 142.310 - How can a person served by the public water system obtain EPA review of a State proposed small...

    Science.gov (United States)

    2010-07-01

    ... water system obtain EPA review of a State proposed small system variance? 142.310 Section 142.310... PRIMARY DRINKING WATER REGULATIONS IMPLEMENTATION Variances for Small System Public Participation § 142.310 How can a person served by the public water system obtain EPA review of a State proposed small...

  7. Review of regulatory requirements for digital I and C systems

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-11-01

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

  8. Review of regulatory requirements for digital I and C systems

    International Nuclear Information System (INIS)

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

    2001-11-01

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

  9. Review of SFR Design Safety using Preliminary Regulatory PSA Model

    International Nuclear Information System (INIS)

    Na, Hyun Ju; Lee, Yong Suk; Shin, Andong; Suh, Nam Duk

    2013-01-01

    The major objective of this research is to develop a risk model for regulatory verification of the SFR design, and thereby, make sure that the SFR design is adequate from a risk perspective. In this paper, the development result of preliminary regulatory PSA model of SFR is discussed. In this paper, development and quantification result of preliminary regulatory PSA model of SFR is discussed. It was confirmed that the importance PDRC and ADRC dampers is significant as stated in the result of KAERI PSA model. However, the importance can be changed significantly depending on assumption of CCCG and CCF factor of PDRC and ADRC dampers. SFR (sodium-cooled fast reactor) which is Gen-IV nuclear energy system, is designed to accord with the concept of stability, sustainability and proliferation resistance. KALIMER-600, which is under development in Korea, includes passive safety systems (e. g. passive reactor shutdown, passive residual heat removal, and etc.) as well as active safety systems. Risk analysis from a regulatory perspective is needed to support the regulatory body in its safety and licensing review for SFR (KALIMER-600). Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and delay of the SFR licensing schedule that may be caused otherwise

  10. 75 FR 71702 - Science Advisory Board Staff Office; Request for Nominations of Experts for Review of EPA's Draft...

    Science.gov (United States)

    2010-11-24

    ... men of all racial and ethnic groups. The EPA SAB Staff Office will acknowledge receipt of nominations...) absence of financial conflicts of interest; (d) absence of an appearance of a lack of impartiality; and (e... conflicts of interest will include a review of the ``Confidential Financial Disclosure Form for Special...

  11. Amoco-US Environmental Protection Agency, pollution prevention project, Yorktown, Virginia: Project peer review. Report of the Peer Review Committee of the Amoco/EPA Pollution Prevention Project at the Yorktown, Virginia refinery

    International Nuclear Information System (INIS)

    Klee, H.; Podar, M.

    1991-01-01

    The Amoco/EPA Pollution Prevention Project involved a number of representatives from federal and Virginia regulatory agencies, and Amoco's refining business. Participants believed that the Project could benefit from a broader perspective than these organizations along might provide. The Project Work Group selected an independent Peer Review Process which was conducted by Resource for the Future (RFF), a Washington DC think tank. A group of technical, policy and environmental experts from diverse backgrounds served as Peer Review members. The Peer Review Committee met on three occasions to discuss (1) the Project Work Plan (2) sampling data and interpretation and (3) project conclusions and recommendations. The focus of the meeting was on the general scope and content of the project

  12. IAEA Mission Concludes Peer Review of UK's Nuclear Regulatory Framework

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: Senior international nuclear safety and radiation protection experts today concluded a ten-day International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in the United Kingdom (UK). The Integrated Regulatory Review Service (IRRS) mission team said in its preliminary findings that the UK had made considerable progress since reviews in 2006 and 2009. It also identified good practices in the country's nuclear regulatory system. In addition to following up previous missions, a key objective was to review the effectiveness of the role of the Office of Nuclear Regulation (ONR), the UK's nuclear regulator, in ensuring the safety of radioactive waste management and decommissioning, occupational radiation protection, and public and environmental exposures, including emergency planning and response. The mission also considered the response of the UK's regulatory regime to the implications of the Fukushima Daichi accident had been timely and effective. Recommendations and suggestions were made to the ONR and the Government aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards, the control of radioactive discharges and environmental monitoring. 'The staff of ONR is clearly dedicated to their mission to secure the protection of people and society from the hazards of the nuclear industry. I am confident that ONR will use the results of this mission to further enhance their regulatory programs', said Bill Borchardt, mission leader and former Executive Director of the United States Nuclear Regulatory Commission (NRC). 'The staff were open and cooperative in their discussions; they provided the fullest practicable assistance, and accepted advice from the Team for continuous improvement in their regulatory work'. ONR's Chief Executive, John Jenkins, said that the full report of the IRRS mission will enhance regulatory effectiveness in the UK

  13. Transportation of Large Wind Components: A Permitting and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron [National Renewable Energy Lab. (NREL), Golden, CO (United States); Cook, Jeff [National Renewable Energy Lab. (NREL), Golden, CO (United States)

    2016-09-01

    This report summarizes permitting and regulatory issues associated with transporting wind turbine blades, towers, and nacelles as well as large transformers (wind components). These wind components are commonly categorized as oversized and overweight (OSOW) and require specific permit approvals from state and local jurisdictions. The report was developed based on a Quadrennial Energy Review (QER) recommendation on logistical requirements for the transportation of 'oversized or high-consequence energy materials, equipment, and components.'

  14. 78 FR 65980 - Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation...

    Science.gov (United States)

    2013-11-04

    ... Climate Change Adaptation Plan, many of the goals EPA is working to attain (e.g., clean air, safe drinking... health and the environment. It is essential therefore, that the EPA adapt to climate change in order to... of human health and the environment. Adaptation will involve anticipating and planning for changes in...

  15. 78 FR 38029 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-06-25

    ... formulators each year and to enhance program transparency. Information collection activities associated with... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPPT-2012-0675; FRL-9533-3] Information Collection Request... Environmental Protection Agency has submitted an information collection request (ICR), ``EPA's Design for the...

  16. Development of radiation protection standards at EPA

    International Nuclear Information System (INIS)

    Meyers, S.

    1987-01-01

    Development of EPA radiation protection standards combines the elements of risk assessment and risk management. The process of risk assessment consists of technical evaluation of the source term, environmental transport mechanisms, and biological effects. Engineering evaluations provide data on control options and costs. The risk management process considers the scope of legal authorities and the balancing of costs and benefits of alternatives within the framework of national priorities. The regulatory process provides for substantial public participation and is subject to legal reviews

  17. 78 FR 37806 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-06-24

    ... profanity, threats, information claimed to be Confidential Business Information (CBI) or other information... strategic planning efforts, EPA encourages programs to develop meaningful performance measures, set...), Licensed Certification Providers (6100-20), Licensed Certifying Body (6100-13) Annual Reporting Form...

  18. Notification: Audit of EPA's Data Quality Review of Self-Reported Information in XACTA System

    Science.gov (United States)

    Project #OA-FY14-0078, February 10, 2014. This memorandum is to notify you that the Office of Inspector General (OIG) for the U.S. Environmental Protection Agency (EPA) plans to begin the above subject audit.

  19. Strengthening of the nuclear safety regulatory body. Field evaluation review

    International Nuclear Information System (INIS)

    1996-10-01

    As a result of a request from the Preparation Committee of the Nuclear Regulatory Authority (NRA) in 1992, and as recommended by the CEC/RAMG (Commission of European Communities/Regulatory Assistance Management Group) and the Agency mission in July 1993 to the Slovak Republic, the project SLR/9/005 was approved in 1993 as a model project for the period 1994-1996. Current budge is $401,340 and disbursements to date amount to $312,873. The project time schedule has been extended to 1997. The major conclusions of this evaluation are as follows: The project responded to an urgent national need, as well as to a statutory mandate of the Agency, and was adequately co-ordinated with other international assistance programmes to NRA. The project was designed as a structured programme of assistance by means of expert missions, scientific visits and a limited amount of equipment, acting upon several key areas of NRA regulatory responsibilities. Agency assistance was provided in a timely manner. A high concentration of expert missions was noticed at the initial stages of the project, which posed some managements problems. This was corrected to some extent in the course of implementation. Additionally, some overlapping of expert mission recommendations suggests that improvements are needed in the design of such missions. The exposure to international regulatory practice and expertise has resulted in substantial developments of NRA, both in organizational and operational terms. The project can claim to have contributed to NRA having gained governmental and international confidence. NRA's role in the safety assessment of Bohunice V1 reconstruction, as well as in Bohunice V2 safety review, Bohunice A1 decommissioning and in informing the public, also points at the success achieved by the project. The institutional and financial support of the Government contributed decisively to the project achievements. (author). Figs, tabs

  20. 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

  1. 78 FR 6094 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-01-29

    ... encompass organization-wide energy performance improvement, such as building technology upgrades, product... help EPA promote energy-efficient technologies by evaluating the efficiency of their buildings using... Leaders--Ineligible Facilities List (5900-20) ENERGY STAR Leaders--Leaders Story (5900-20) Service and...

  2. 78 FR 12054 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-02-21

    ... not of a confidential nature. EPA has developed this ICR to obtain authorization to collect... organization interested in joining ENERGY STAR as a partner is asked to submit a partnership agreement... and the public about their partnership with ENERGY STAR, developing and implementing a plan to improve...

  3. A review of NRC regulatory processes and functions

    International Nuclear Information System (INIS)

    1981-05-01

    A reexamination by the ACRS of the Regulatory Process has been made. Objectives were to provide in a single source, ACRS' understanding of the Regulatory Process and to point out perceived weaknesses and to make appropriate recommendations for change

  4. 77 FR 26018 - Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza

    Science.gov (United States)

    2012-05-02

    ... exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval...] Determination of Regulatory Review Period for Purposes of Patent Extension; Victoza AGENCY: Food and Drug... regulatory review period for Victoza and is publishing this notice of that determination as required by law...

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

    Energy Technology Data Exchange (ETDEWEB)

    Levin, A.E.

    1995-09-01

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

  6. Survey of regulatory agency review of generating unit performance

    International Nuclear Information System (INIS)

    Roach, E.M. Jr.; Tarletz, D.B.

    1985-01-01

    Regulatory agencies across the country are being called upon increasingly to monitor the management of electric utilities. Such activity, which once was relatively rare, is now common. Most frequently this oversight centers around the operating performance of generating units, both nuclear and fossil. There are, perhaps, several reasons for this increased interest in the efficient operation of generating units: increased fuel costs and fuel cost differentials, increased lead times and costs for construction of new generating units, and increased dependence on existing units because of construction programs being revised to meet decreased load growth. The monitoring of generating units has taken the form of after the fact evaluation of performance on a case-by-case basis and the implementation of productivity incentive programs. Performance standards are used in these contexts both to measure the adequacy of unit performance and to implement incentives in the form of rewards or penalties. The standard used may be a subjective test of prudent performance or some numerical index of plant performance, e.g., equivalent availability, capacity factor or heat rate. Some of the activity by regulators is reviewed in applying subjective and numerical standards and the considerations involved in applying such standards are discussed

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

    International Nuclear Information System (INIS)

    Al Khatibeh, Ahmad

    2014-05-01

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

  8. 78 FR 9387 - Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation Plan

    Science.gov (United States)

    2013-02-08

    ... identifying and responding to the challenges that a changing climate poses to human health and the environment... fulfill its mission of protecting human health and the environment even as the climate changes. EPA...: Draft EPA Climate Change Adaptation Plan AGENCY: Environmental Protection Agency (EPA). ACTION: Notice...

  9. 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

  10. U.S. EPA. 2000. Science Policy Council Handbook: Peer Review

    Science.gov (United States)

    The goal of the Peer Review Policy and this Handbook is to enhance the quality and credibility of Agency decisions by ensuring that the scientific and technical work products underlying these decisions receive appropriate levels of peer review by independe

  11. Professional and Regulatory Search

    Science.gov (United States)

    Professional and Regulatory search are designed for people who use EPA web resources to do their job. You will be searching collections where information that is not relevant to Environmental and Regulatory professionals.

  12. 77 FR 26016 - Determination of Regulatory Review Period for Purposes of Patent Extension; Alair Bronchial...

    Science.gov (United States)

    2012-05-02

    ... approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period... asthma is not well controlled [[Page 26017

  13. 75 FR 76741 - Determination of Regulatory Review Period for Purposes of Patent Extension; SABRIL

    Science.gov (United States)

    2010-12-09

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... adults. It should be used as adjunctive therapy in patients who have responded inadequately to several...

  14. 76 FR 36927 - Determination of Regulatory Review Period for Purposes of Patent Extension; Fusilev, Levoleucovorin

    Science.gov (United States)

    2011-06-23

    ... drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA... after high-dose methotrexate therapy in osteosarcoma and is also indicated to diminish the toxicity and...

  15. 77 FR 26290 - Determination of Regulatory Review Period for Purposes of Patent Extension; KRYSTEXXA

    Science.gov (United States)

    2012-05-03

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... chronic gout in adult patients refractory to conventional therapy. Subsequent to this approval, the Patent...

  16. 75 FR 75678 - Determination of Regulatory Review Period for Purposes of Patent Extension; STELARA

    Science.gov (United States)

    2010-12-06

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review... or systemic therapy. Subsequent to this approval, the Patent and Trademark Office received a patent...

  17. 76 FR 14671 - Determination of Regulatory Review Period for Purposes of Patent Extension; ISTODAX

    Science.gov (United States)

    2011-03-17

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... in patients who have received at least one prior systemic therapy. Subsequent [[Page 14672

  18. 77 FR 59567 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2012-09-28

    ... #0;notices is to give interested persons an opportunity to participate in #0;the rule making prior to... Immigration Review 8 CFR Parts 1003, 1103, 1208, 1211, 1212, 1215, 1216, 1235 [EOIR No. 178] RIN 1125-AA71 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Executive Office for Immigration Review, Department of...

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

    International Nuclear Information System (INIS)

    2011-01-01

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

  20. The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

    Science.gov (United States)

    Keyter, Andrea; Gouws, Joey; Salek, Sam; Walker, Stuart

    2018-01-01

    The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.

  1. Long-chain omega-3 fatty acids and the brain: a review of the independent and shared effects of EPA, DPA and DHA.

    Science.gov (United States)

    Dyall, Simon C

    2015-01-01

    Omega-3 polyunsaturated fatty acids (PUFAs) exhibit neuroprotective properties and represent a potential treatment for a variety of neurodegenerative and neurological disorders. However, traditionally there has been a lack of discrimination between the different omega-3 PUFAs and effects have been broadly accredited to the series as a whole. Evidence for unique effects of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and more recently docosapentaenoic acid (DPA) is growing. For example, beneficial effects in mood disorders have more consistently been reported in clinical trials using EPA; whereas, with neurodegenerative conditions such as Alzheimer's disease, the focus has been on DHA. DHA is quantitatively the most important omega-3 PUFA in the brain, and consequently the most studied, whereas the availability of high purity DPA preparations has been extremely limited until recently, limiting research into its effects. However, there is now a growing body of evidence indicating both independent and shared effects of EPA, DPA and DHA. The purpose of this review is to highlight how a detailed understanding of these effects is essential to improving understanding of their therapeutic potential. The review begins with an overview of omega-3 PUFA biochemistry and metabolism, with particular focus on the central nervous system (CNS), where DHA has unique and indispensable roles in neuronal membranes with levels preserved by multiple mechanisms. This is followed by a review of the different enzyme-derived anti-inflammatory mediators produced from EPA, DPA and DHA. Lastly, the relative protective effects of EPA, DPA and DHA in normal brain aging and the most common neurodegenerative disorders are discussed. With a greater understanding of the individual roles of EPA, DPA and DHA in brain health and repair it is hoped that appropriate dietary recommendations can be established and therapeutic interventions can be more targeted and refined.

  2. Development of Standardized Mobile Tracer Correlation Approach for Large Area Emission Measurements (DRAFT UNDER EPA REVIEW)

    Science.gov (United States)

    Foster-wittig, T. A.; Thoma, E.; Green, R.; Hater, G.; Swan, N.; Chanton, J.

    2013-12-01

    Improved understanding of air emissions from large area sources such as landfills, waste water ponds, open-source processing, and agricultural operations is a topic of increasing environmental importance. In many cases, the size of the area source, coupled with spatial-heterogeneity, make direct (on-site) emission assessment difficult; methane emissions, from landfills for example, can be particularly complex [Thoma et al, 2009]. Recently, whole-facility (remote) measurement approaches based on tracer correlation have been utilized [Scheutz et al, 2011]. The approach uses a mobile platform to simultaneously measure a metered-release of a conservative gas (the tracer) along with the target compound (methane in the case of landfills). The known-rate tracer release provides a measure of atmospheric dispersion at the downwind observing location allowing the area source emission to be determined by a ratio calculation [Green et al, 2010]. Although powerful in concept, the approach has been somewhat limited to research applications due to the complexities and cost of the high-sensitivity measurement equipment required to quantify the part-per billion levels of tracer and target gas at kilometer-scale distances. The advent of compact, robust, and easy to use near-infrared optical measurement systems (such as cavity ring down spectroscopy) allow the tracer correlation approach to be investigated for wider use. Over the last several years, Waste Management Inc., the U.S. EPA, and collaborators have conducted method evaluation activities to determine the viability of a standardized approach through execution of a large number of field measurement trials at U.S. landfills. As opposed to previous studies [Scheutz et al, 2011] conducted at night (optimal plume transport conditions), the current work evaluated realistic use-scenarios; these scenarios include execution by non-scientist personnel, daylight operation, and full range of atmospheric condition (all plume transport

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

    International Nuclear Information System (INIS)

    1992-06-01

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

  4. 76 FR 8940 - Regulatory Review of Existing DOT Regulations

    Science.gov (United States)

    2011-02-16

    ... interested in comments about factors that the Department should consider in setting priorities and selecting... set forth in our semi-annual Regulatory Agenda published in the Federal Register (see Appendix D to... rulemaking priorities. Moreover, under 49 CFR part 5, anyone may petition the Department for rulemaking or...

  5. US EPA 2014 Fine Particulate Pollution (PM2.5) Season Review by City

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web service contains the following layer: PM25Review35Cities_with2000to2014data. Full FGDC metadata records for each layer may be found by clicking the layer...

  6. EPA's role in uranium mining and milling

    International Nuclear Information System (INIS)

    Smith, P.B.

    1980-01-01

    EPA's role and actions in regulating uranium mining and milling are reviewed and updated. Special emphasis is given to EPA's current activities under the Uranium Mill Tailings Radiation Control Act of 1978

  7. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    International Nuclear Information System (INIS)

    Wilmot, Roger D.

    2011-02-01

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  8. Treatment of differing professional opinions in the regulatory review process

    International Nuclear Information System (INIS)

    Shapar, H.K.

    1978-01-01

    The Nuclear Regulatory Commission is an independent body whose purpose is to assure that civilian nuclear activities are consistent with the public health and safety and environmental protection. To this effect, Congress has vested it with the necessary control powers. The question here is how to reconcile diverging opinions expressed within NRC by executives and technicians during the enquiry pocedure for licensing of nuclear installations. The diversity of professional viewpoints should be viewed as a positive factor strengthening the regulatory process and should therefore be maintained. However, decisions must be made; therefore some viewpoints will not prevail but that should not be construed as a signal that the internal discussion process is condemned. NRC staff are entitled to express their views and not subjected to professional and administrative sanctions for doing so. (NEA) [fr

  9. Nuclear regulatory review of licensee self-assessment (LSA)

    International Nuclear Information System (INIS)

    2003-01-01

    Licensee self-assessment (LSA) by nuclear power plant operators is described as all the activities that a licensee performs in order to identify opportunities for improvements. An LSA is part of an organisation's holistic management system, which must include other process elements. Particularly important elements are: a process for choosing which identified potential improvements should be implemented and a process of project management for implementing the improvements chosen. Nuclear regulators expect the licensee to run an effective LSA programme, which reflects the licensee's 'priority to safety'. Based on contributions from members of the NEA Committee on Nuclear Regulatory Activities (CNRA), this publication provides an overview of the current regulatory philosophy on and approaches to LSA as performed by licensees. The publication's intended audience is primarily nuclear safety regulators, but government authorities, nuclear power plant operators and the general public may also be interested. (author)

  10. 75 FR 15499 - National Primary Drinking Water Regulations; Announcement of the Results of EPA's Review of...

    Science.gov (United States)

    2010-03-29

    ...--best available technology CARC--Cancer Assessment Review Committee CBI--Confidential Business...--International Agency for Research on Cancer ICR--Information Collection Request IRED--Interim Reregistration.... Methoxychlor 48. Monochlorobenzene (Chlorobenzene) 49. Nitrate (as N) 50. Nitrite (as N) 51. Oxamyl (Vydate) 52...

  11. Completed EO 12866 Regulatory Reviews by Calendar Year

    Data.gov (United States)

    Executive Office of the President — Annual data set of draft rules reviewed by OMB under Executive Orders 12291 and 12866. The data provide information by agency, length of review in days, and economic...

  12. US EPA overview

    International Nuclear Information System (INIS)

    Rowe, W.D.

    1976-01-01

    EPA believes that effective and efficient solutions to problems in all radioactive waste disposal areas will require close coordination and cooperation among all agencies involved. In this regard, EPA already has participated in meetings with the Energy Research and Development Administration, the Nuclear Regulatory Commission, the Council on Environmental Quality, the U.S. Geological Survey, and the Office of Management and Budget to lay the groundwork for the development of a consolidated national radioactive waste disposal plan. The EPA program is directed first toward developing goals and requirements; and then, in cooperation with the public, industry, the States and Federal agencies, towards determining by what means these goals can be achieved for each waste management option. In addition, the program will develop criteria for determining when the goals of the waste management options have been achieved. In summary, EPA will provide fundamental environmental criteria and generally applicable environmental standards for permanent disposal of high level radwastes. Concurrently, ERDA will develop the necessary technology; and NRC will conduct necessary studies, develop waste-related regulations, and license specific sites and methods of control. Together, we will be able to manage the disposal of the Nation's radioactive waste in an environmentally adequate manner

  13. Nuclear Regulatory Commission's antitrust review process: an analysis of the impacts

    International Nuclear Information System (INIS)

    1981-06-01

    The Nuclear Regulatory Commission's (NRC) antitrust process is reviewed and its impacts to small systems and applicant systems are studied. This process takes the form of a description of the NRC's antitrust review process as implemented, a generic categorization of potential impacts and individual case-by-case studies of four different utilities

  14. Problems and experience of regulatory review associated with plant construction and commissioning

    International Nuclear Information System (INIS)

    Commander, W.

    1979-01-01

    The work of the Assessment Branch of NII covering the regulatory review during design safety assessment, construction, commissioning and operation is described commencing with the nuclear licensing procedure through licence variations and conditions attached to the licence, to the final stages of plant construction up to commercial operation and full power production. The importance of the application of safety assessment principles is outlined, the importance of the Safety Inspectorate Schedule described, and the need to retain organisational and regulatory flexibility emphasised. (author)

  15. Regulatory instrument review: Management of aging of LWR [light water reactor] major safety-related components

    International Nuclear Information System (INIS)

    Werry, E.V.

    1990-10-01

    This report comprises Volume 1 of a review of US nuclear plant regulatory instruments to determine the amount and kind of information they contain on managing the aging of safety-related components in US nuclear power plants. The review was conducted for the US Nuclear Regulatory Commission (NRC) by the Pacific Northwest Laboratory (PNL) under the NRC Nuclear Plant Aging Research (NPAR) Program. Eight selected regulatory instruments, e.g., NRC Regulatory Guides and the Code of Federal Regulations, were reviewed for safety-related information on five selected components: reactor pressure vessels, steam generators, primary piping, pressurizers, and emergency diesel generators. Volume 2 will be concluded in FY 1991 and will also cover selected major safety-related components, e.g., pumps, valves and cables. The focus of the review was on 26 NPAR-defined safety-related aging issues, including examination, inspection, and maintenance and repair; excessive/harsh testing; and irradiation embrittlement. The major conclusion of the review is that safety-related regulatory instruments do provide implicit guidance for aging management, but include little explicit guidance. The major recommendation is that the instruments be revised or augmented to explicitly address the management of aging

  16. 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.

  17. Overall review strategy for the Nuclear Regulatory Commission's High-Level Waste Repository Program

    International Nuclear Information System (INIS)

    Johnson, R.L.

    1994-11-01

    The Overall Review Strategy gives general guidance to the Nuclear Regulatory Commission staff for conducting it's license application and pre-license application reviews. These reviews are in support of the Commission's construction authorization decision for a geologic repository for the disposal of high-level radioactive waste. Objectives and strategies are defined that focus the staff's reviews on determining compliance with requirements of 10 CFR Part 60. These strategies define how the staff prioritizes its reviews on those key technical uncertainties considered to be most important to repository performance. Strategies also give guidance for developing, in an integrated way, the License Application Review Plan together with supporting performance assessments, analyses, and research

  18. A review and evaluation of the Draft EPA standard (40 CFR 191)

    International Nuclear Information System (INIS)

    Ortiz, N.R.; Chu, M.S.Y.; Siegel, M.D.; Wahi, K.K.

    1984-01-01

    The Environmental Protection Agency's proposed rule for the management and disposal of high-level waste (Draft Standard, 40 CFR 191), was reviewed and analyzed using the risk assessment methodology developed at Sandia National Laboratories. The methodology was exercised on hypothetical repository systems in basalt, bedded salt, and tuff. Among the issues addressed were achievability, release limits, uncertainty, and compliance. The proposed release limits were also analyzed in terms of their relationship to the health effects. The uncertainty in the input parameters of the deterministic models was taken into account in calculating releases to the accessible environment. Extentions to an existing compliance-assessment methodolog are suggested that would allow one to incorporate the uncertainty associated with the frequency of occurrence of scenarios. The results indicate that, in general, the standards are achievable and the release limits are sufficiently conservative

  19. GET SMART: EPA'S SMARTE INITIATIVE

    Science.gov (United States)

    The EPA's Office of Research and Development with the assistance of the U.S.-German Bilateral Working Group and the Interstate Technology Regulatory Council (ITRC), is developing Site-specific Management Approaches and Revitalization Tools (SMART) that will help stakeholders over...

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

    International Nuclear Information System (INIS)

    Husarcek, J.

    2003-01-01

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

  1. Reviewing the regulatory barriers for nanomedicine: global questions and challenges.

    Science.gov (United States)

    Bowman, Diana M; Gatof, Jake

    2015-01-01

    Nanomedicine will play an increasing role in prevention and treatment across the entire healthcare spectrum. However, their precise market size, economic value and areas of application remain unclear. This opacity, including the question of what constitutes nanomedicine matters, especially when considered alongside the key regulatory questions and concerns. This article begins by placing these key questions into context in relation to the current scientific state of the art, focusing particular attention on the human health and safety context. In exploring these central questions surrounding the regulation of nanomedicine, this perspective also explores existing and suggested frameworks that aim to deal with emerging technologies more generally. It then outlines priority areas for action and general conclusions specific to nanomedicine.

  2. Clean Air Act : historical information on EPA's process for reviewing California waiver requests and making waiver determinations

    Science.gov (United States)

    2009-01-01

    Emissions from mobile sources, such as automobiles and trucks, contribute to air quality degradation and can threaten public health and the environment. Under the Clean Air Act, the Environmental Protection Agency (EPA) regulates these emissions. The...

  3. Report: EPA Is Taking Steps to Improve State Drinking Water Program Reviews and Public Water Systems Compliance Data

    Science.gov (United States)

    Report #17-P-0326, July 18, 2017. The EPA is taking action to improve oversight tools used to determine whether public water systems are monitoring and reporting drinking water quality in accordance with the Safe Drinking Water Act.

  4. 78 FR 15012 - Request for Nominations of Experts for a Science Advisory Board Panel To Review EPA's Draft...

    Science.gov (United States)

    2013-03-08

    ... expertise in stream ecology or wetland ecology, particularly with respect to freshwater stream-wetland... address http://yosemite.epa.gov/sab/sabproduct.nsf/Web/ethics?OpenDocument . The approved policy under...

  5. 77 FR 15753 - Request for Nominations of Experts for a Science Advisory Board Panel To Review EPA's Web-Based...

    Science.gov (United States)

    2012-03-16

    ... indicators are intended to inform strategic planning, priority setting, and decision making across EPA and... information to inform planning and decision making. Process and Deadline for Submitting Nominations Any...

  6. Report: Follow-Up Report: EPA Proposes to Streamline the Review, Management and Disposal of Hazardous Waste Pharmaceuticals

    Science.gov (United States)

    Report #15-P-0260, August 19, 2015. EPA states that it intends to issue a proposed rule, Management Standards for Hazardous Waste, which will attempt to streamline the approach to managing and disposing of hazardous and nonhazardous pharmaceutical waste.

  7. Organization and practices on regulatory review in the licensing process of nuclear power plants in Spain

    International Nuclear Information System (INIS)

    Trueba, P.

    1979-01-01

    The actual organisation, practices and experience of the JEN Nuclear Safety Department on the regulatory review in the licensing process of nuclear power plants in Spain, are presented. Topics to be covered are: The structure, organisation, staff and principal functional areas of the NSD, the academic qualifications and work experience of the NSD personnel, recruiting and training, the conduct of the regulatory review during the licensing process and working procedures, the manpower and coverage of the different technical areas, the principal problems and conclusions. (author)

  8. Organisation and experience of the regulatory review in the United Kingdom

    International Nuclear Information System (INIS)

    Gausden, R.; Woods, P.B.

    1979-01-01

    Regulatory requirements and stages of the review in the UK are outlined. The organisation, management and working procedures of the Inspectorate are described and the effort and timescale which have been found necessary for a satisfactory safety review is discussed. A number of problem areas in the review situation have been identified from experience and these are discussed and possible solutions proposed. They include the importance of early review of generic aspects of systems which are being considered for licensing, the place of safety principles and of detailed engineering assessment in the review process, the independence of the regulatory group's activities in its study of major technical issues and the use which should be made of outside expertise. (auth.)

  9. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Yong Suk; Jung, Dae Wook [Future and Challenges Inc., Seoul (Korea, Republic of); Cho, Nam Chul [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2008-10-15

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future.

  10. The Preliminary Review for the Cross-Cutting Issues in the US Nuclear Regulatory Inspection Framework

    International Nuclear Information System (INIS)

    Lee, Yong Suk; Jung, Dae Wook; Cho, Nam Chul

    2008-01-01

    The research for the development of risk-informed and performance-based regulatory inspection is ongoing in KINS. In the USNRC, the cross-cutting issue is one of the main components the risk-informed and performance-based regulatory inspection process as shown in figure 1, which is named as ROP (Reactor Oversight Process). The following three cross-cutting areas implicitly affect all of the safety cornerstones in ROP. In this study, the preliminary review for the inspection practices of cross-cutting issues in the US and Korean safety regulatory system were performed. The elements of the cross-cutting issues were recently modified to emphasize the importance of safety culture, and the graded approach was applied for the inspection of cross-cutting issues in USNRC. The graded approach for the inspection of cross-cutting issues will be also needed to Korean safety regulatory system in the future

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

    International Nuclear Information System (INIS)

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

    2009-06-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-06-15

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

  13. Regulatory review of releases from HIFAR of radioactive airborne effluent

    International Nuclear Information System (INIS)

    Westall, D.J.; Macnab, D.I.

    1996-01-01

    Full text: The Nuclear Safety Bureau (NSB) was set up by legislation in 1992 as an independent Commonwealth corporate body reporting to the Minister for Health and Family Services. Its functions include monitoring and reviewing the safety of nuclear plant owned or operated by the Australian Nuclear Science and Technology Organisation (ANSTO). The NSB sets requirements for authorisation of the operation of the HIFAR research reactor, and may impose restrictions and conditions on its operation. The authorisation for the operation of HIFAR includes a requirement for arrangements for the treatment, safe storage and disposal of solid, liquid and gaseous radioactive wastes from the reactor. The objective is to establish conditions which would ensure that radiation exposure to plant personnel and the public from radioactive wastes are within acceptable limits and that releases are maintained as low as reasonably achievable. The NSB has developed expectations based on international best practice, against which to review HIFAR's arrangements for satisfying the requirement and achieving the objective. Arrangements for the release of airborne radioactive effluent from HIFAR were reviewed by the NSB as part of an overall review of the upgrade of safety documentation for HIFAR. The NSB's expectations for the review were drawn from the International Atomic Energy Agency (IAEA) Basic Safety Standards (Safety Series No 115-I) and the National Health and Medical Research Council (NHMRC) Recommendations for Limiting Exposure to Ionizing Radiation (1995). These expectations included a hierarchy of primary dose limits, stack discharge limits and reference levels for HIFAR aimed at ensuring that radiation doses to the public due to airborne effluent are less than the national dose limits and ANSTO's dose constraints, and are as low as reasonably achievable. An approach favoured by the operator is to work directly to a primary dose limit using an airborne dispersion computer program to

  14. International Nuclear Safety Experts Conclude IAEA Peer Review of Korea's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts concluded today a two-week mission to review the regulatory framework for nuclear safety in the Republic of Korea. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Korea, while the final report will be submitted by the end of summer 2011. At the request of the Korean Government, the IAEA assembled a team of 16 senior regulatory experts from 14 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Korean Ministry for Education, Science and Technology (MEST) and the Korean Institute for Nuclear Safety (KINS). The mission is a peer-review based on the IAEA Safety Standards. ''This was the first IRRS mission organized after Japan's Fukushima Daiichi nuclear accident and it included a review of the regulatory implications of that event,' explains Denis Flory, IAEA Deputy Director General and Head of the Department of Nuclear Safety and Security. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission and Team Leader of this mission commended the Korean authorities for their openness and commitment to sharing their experience with the world's nuclear safety community. ''IRRS missions such as the one that was just concluded here in the Republic of Korea are crucial to the enhancement of nuclear safety worldwide,'' he said. The IRRS team reviewed Korea's current regulatory framework while acknowledging the fact that the country's Government has already decided to establish, as of October 2011, a new independent regulatory body to be called Nuclear Safety Commission (NSC). As a consequence, KINS role will be as a regulatory expert organization reporting to the NSC, while MEST's role will be restricted to promoting the utilization of nuclear energy. The IRRS team identified particular strengths in the Korean regulatory system

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

    International Nuclear Information System (INIS)

    2014-01-01

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

  16. 77 FR 26768 - Determination of Regulatory Review Period for Purposes of Patent Extension; PROLIA

    Science.gov (United States)

    2012-05-07

    ... postmenopausal women with osteoporosis at high risk for fracture. Subsequent to this approval, the Patent and..., FDA-2010-E-0660, and FDA-2010-E-0659] Determination of Regulatory Review Period for Purposes of Patent... the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which...

  17. Safety research and development in relation to regulatory review in the UKAEA

    International Nuclear Information System (INIS)

    Ablitt, J.F.

    1979-01-01

    The basic functions of the regulatory review process are defined in principle, and the need for constructive interplay between regulation on the one hand and research and development on the other, in order to avoid the dangers of being over-restrictive or too permissive, is established. A number of practical examples from operating experience are quoted, which illustrate the chosen theme. (author)

  18. 76 FR 15322 - Determination of Regulatory Review Period for Purposes of Patent Extension; VPRIV

    Science.gov (United States)

    2011-03-21

    ..., medical device, food additive, or color additive) was subject to regulatory review by FDA before the item... therapy for pediatric and adult patients with type 1 Gaucher Disease. Subsequent to this approval, the...,138,262) from Shire Human Genetic Therapies, Inc., and the Patent and Trademark Office requested FDA's...

  19. 76 FR 47527 - Retrospective Regulatory Review Under E.O. 13563

    Science.gov (United States)

    2011-08-05

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Chapter VII [Docket No. 110711380-1379-01] RIN 0694-XA37 Retrospective Regulatory Review Under E.O. 13563 AGENCY: Bureau of Industry and Security, Commerce. ACTION: Notice of inquiry. SUMMARY: The Bureau of Industry and Security (BIS...

  20. A Review of International Telecommunications Industry Issues, Structure, and Regulatory Problems.

    Science.gov (United States)

    Cole, Jack E.; And Others

    Industry structure studies prior to 1968 are briefly reviewed, and an overview of industrial and technological developments up to the present is provided through synopses of more recent studies. Areas covered include overseas telephone and record carriers; the creation of the Communications Satellite Corporation; the current regulatory and…

  1. Integrated Regulatory Review Service (IRRS) Guidelines for the Preparation and Conduct of IRRS Missions

    International Nuclear Information System (INIS)

    2013-01-01

    The IAEA Integrated Regulatory Review Service (IRRS) was established to strengthen and enhance the effectiveness of national regulatory infrastructure for nuclear safety, radiation safety, radioactive waste and transport safety, and the security of radioactive sources, while recognizing the ultimate responsibility of each Member State to ensure safety in these areas. The IRRS process sets out to accomplish this expressed purpose through consideration of both technical and policy issues of a regulatory nature against IAEA safety standards and, where appropriate, good practice elsewhere. The regulatory review process directly draws upon the wide-ranging international experience and expertise of IRRS review team members. Peer exchange on technical and policy issues gives insight into the efficiency and effectiveness of the legal and governmental framework and regulatory infrastructure for safety. Through this process, opportunities for improvement are explored and potential improvement strategies identified which may be shared with other States. IRRS missions provide an opportunity for sharing regulatory experiences, harmonizing regulatory approaches among States, and creating mutual learning opportunities among regulators. IRRS discussions focus on issues arising from the State's self-assessment and the evaluation of technical areas and policy issues. The IAEA Fundamental Safety Principles (IAEA Safety Standards Series No. SF-1) provide the basis for IAEA safety standards and IAEA safety related programmes. In support of effective regulation, the IAEA has established safety standards in the area of the Governmental, Legal and Regulatory Framework for Safety (IAEA Safety Standards Series No. GSR Part 1). These safety standards form a core component of an IRRS review. Other requirements and guidance, such as The Management System for Facilities and Activities (IAEA Safety Standards Series No. GS-R-3) and Radiation Protection and Safety of Radiation Sources

  2. Workshop on Regulatory Review and Safety Assessment Issues in Repository Licensing

    Energy Technology Data Exchange (ETDEWEB)

    Wilmot, Roger D. (Galson Sciences Limited (United Kingdom))

    2011-02-15

    The workshop described here was organised to address more general issues regarding regulatory review of SKB's safety assessment and overall review strategy. The objectives of the workshop were: - to learn from other programmes' experiences on planning and review of a license application for a nuclear waste repository, - to offer newly employed SSM staff an opportunity to learn more about selected safety assessment issues, and - to identify and document recommendations and ideas for SSM's further planning of the licensing review

  3. Regulatory challenges in the review of data from global clinical trials: the PMDA perspective.

    Science.gov (United States)

    Asano, K; Tanaka, A; Sato, T; Uyama, Y

    2013-08-01

    Regulatory agencies face challenges in reviewing data from global clinical trials (GCTs) in the era of globalization of drug development. One major challenge is consideration of ethnic factors in evaluating GCT data so as to extrapolate foreign population data to one's own national population. Here, we present the Pharmaceuticals and Medical Devices Agency (PMDA) perspective in reviewing GCT data in new drug applications (NDAs) and discuss future challenges for new drug approval.

  4. Safety Experts Complete IAEA Nuclear Regulatory Review of the United States

    International Nuclear Information System (INIS)

    2010-01-01

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

  5. International nuclear safety experts complete IAEA peer review of German regulatory system

    International Nuclear Information System (INIS)

    2008-01-01

    Full text: An international expert team has today completed a two-week IAEA review of Germany's nuclear regulatory system. The team identified good practices within the system and gave advice on some areas for further improvement. The IAEA has conveyed the initial findings to German authorities but the final report will be submitted within two months. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency (IAEA) assembled a team of 14 experts to conduct an Integrated Regulatory Review Service (IRRS) mission. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. Experts from Canada, the Czech Republic, Finland, France, Japan, the Netherlands, Republic of Korea, Spain, Switzerland, the UK, the US and from the IAEA took part in the mission, which was conducted from 7 to 19 September in Bonn, Stuttgart and Berlin. The main basis for the review was a well-prepared self-assessment made by the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wuerttemberg (UM BW). 'The team members were impressed by the extensive preparation and dedication of the staff both at BMU and UM BW to excellence in nuclear safety,' said Mike Weightman, IRRS Team Leader and Chief Inspector of the UK nuclear regulatory body, the Nuclear Directorate of the Health and Safety Executive. 'We hope the IRRS mission will facilitate further improvements in the safety regulation of nuclear power in Germany and throughout the world.' 'Germany's invitation to undergo such a detailed review is a clear demonstration of its openness and commitment to continuously improve nuclear safety regulation,' said Philippe Jamet, Director of the IAEA's Nuclear Installation Safety Division. Among the particular strengths of BMU and UM BW associated with their

  6. International Expert Team Concludes IAEA Peer Review of Poland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: International safety experts last week concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Poland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that Poland's nuclear regulator, Panstwowa Agencja Atomistyki (PAA), has a clear commitment to safety, a high level of transparency, competent staff and leadership, and a good recognition of challenges ahead related to Poland's efforts to develop nuclear power. ''Poland's regulatory framework and the work of PAA give high confidence of strong radiation protection for the Polish people. Further, there has been significant progress in the development of Poland's regulatory framework in preparation for the challenge of regulating nuclear power,'' said team leader Robert Lewis, a senior executive in the US Nuclear Regulatory Commission. The mission was conducted at the request of the Government of Poland from 15-25 April. The team was made up of 11 regulatory experts from Belgium, the Czech Republic, Finland, France, the Republic of Korea, Slovakia, Slovenia, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as five IAEA staff members. The IRRS review team was very thorough in its review, and we welcome its advice on how to continue to improve our programmes to protect people and the environment , said Janusz Wlodarski, President of PAA. The team interviewed members of PAA and officials from various ministries, as well as key players in the Polish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. Among its main observations the IRRS review team identified the following good practices: Applying the considerable experience of PAA's senior management to regulatory issues; The introduction of changes to Poland's laws and regulations following broad public consultation at an early stage in

  7. 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

  8. Knowledge management for efficient quantitative analyses during regulatory reviews.

    Science.gov (United States)

    Krudys, Kevin; Li, Fang; Florian, Jeffry; Tornoe, Christoffer; Chen, Ying; Bhattaram, Atul; Jadhav, Pravin; Neal, Lauren; Wang, Yaning; Gobburu, Joga; Lee, Peter I D

    2011-11-01

    Knowledge management comprises the strategies and methods employed to generate and leverage knowledge within an organization. This report outlines the activities within the Division of Pharmacometrics at the US FDA to effectively manage knowledge with the ultimate goal of improving drug development and advancing public health. The infrastructure required for pharmacometric knowledge management includes provisions for data standards, queryable databases, libraries of modeling tools, archiving of analysis results and reporting templates for effective communication. Two examples of knowledge management systems developed within the Division of Pharmacometrics are used to illustrate these principles. The benefits of sound knowledge management include increased productivity, allowing reviewers to focus on research questions spanning new drug applications, such as improved trial design and biomarker development. The future of knowledge management depends on the collaboration between the FDA and industry to implement data and model standards to enhance sharing and dissemination of knowledge.

  9. Regulatory instrument review: Aging management of LWR cables, containment and basemat, reactor coolant pumps, and motor-operated valves

    International Nuclear Information System (INIS)

    Werry, E.V.; Somasundaram, S.

    1995-09-01

    The results of Stage 2 of the Regulatory Instrument Review are presented in this volume. Selected regulatory instruments, such as the Code of Federal Regulations (CFR), US Nuclear Regulatory Commission (NRC), Regulatory Guides, and ASME Codes, were investigated to determine the extent to which these regulations apply aging management to selected safety-related components in nuclear power plants. The Regulatory Instrument Review was funded by the NRC under the Nuclear Plant Aging Research (NPAR) program. Stage 2 of the review focused on four safety-related structures and components; namely, cables, containment and basemat, reactor coolant pumps, and motor-operated valves. The review suggests that the primary-emphasis of the regulatory instruments was on the design, construction, start-up, and operation of a nuclear power plant, and that aging issues were primarily addressed after an aging-related problem was recognized. This Stage 2 review confirms the results of the prior review; (see Regulatory Instrument Review: Management of Aging of LWR Major Safety-Related Components NUREG/CR-5490. The observations indicate that the regulations generally address management of age-related degradation indirectly. Specific age-related degradation phenomena frequently are dealt with in bulletins and notices or through generic issues, letters, etc. The major recommendation of this report, therefore, is that the regulatory instruments should more directly and explicitly address the aging phenomenon and the management of the age-related degradation process

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

    International Nuclear Information System (INIS)

    2011-01-01

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

  11. 75 FR 61481 - Agency Information Collection Activities; Submission of EPA ICR No. 2078.01 to OMB for Review and...

    Science.gov (United States)

    2010-10-05

    ... the market. Maintaining the value of this brand requires ensuring products labeled with the ENERGY... source of the data so as to protect confidentiality. Finally, Partners that wish to receive recognition... recognition of accreditation bodies, laboratories and certification bodies. All of these entities seek EPA...

  12. Nuclear Experts Complete IAEA Follow-up Review of German Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: Nuclear safety experts concluded a seven-day mission to review the German Regulatory System, conducted from 4-10 September in Bonn, Stuttgart and Berlin. At the request of the Government of the Federal Republic of Germany, the International Atomic Energy Agency assembled a peer-review team of six high-level regulatory experts from six nations (Finland, France, the Netherlands, Switzerland, the UK, the US and three IAEA senior staff members) to conduct a follow-up assessment of an Integrated Regulatory Review Service (IRRS) mission conducted in 2008. This follow-up IRRS mission examined the progress in acting upon the recommendations and suggestions made during the 2008 IRRS mission and reviewed the areas of significant regulatory changes since that review at both the Federal Ministry of Environment, Nature Conservation and Nuclear Safety (BMU) and the Ministry of Environment of the federal state of Baden-Wurttemberg (UM BW). The first mission reviewed Germany's regulatory framework against IAEA Safety Standards and fostered the exchange of information and experience on safety regulation. This is a peer review based on IAEA Standards. It is not an inspection, nor an audit. The scope of the mission was limited to the safety regulation of nuclear power plants. IRRS team leader, Mr. McCree, of the US Nuclear Safety Commission (USNRC), said, ''This was an important IRRS mission, particularly given the recent Fukushima Daiichi Nuclear Power Plant accident and the related insights which underscore the importance of having an independent, credible nuclear safety regulator.'' ''The IRRS team identified several strengths of the German nuclear safety regulators, including the prompt and coordinated incident response activities of BMU and UM BW to the Fukushima accident. Some suggestions were also made to further strengthen nuclear safety regulations concerning the future work of BMU,'' he said. The review team found that important progress has been made toward

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

    International Nuclear Information System (INIS)

    2011-01-01

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

  14. International Nuclear and Radiation Safety Experts Conclude IAEA Peer Review of Slovenia's Regulatory System

    International Nuclear Information System (INIS)

    2011-01-01

    Full text: An international team of senior nuclear safety experts today concluded a 10-day mission to review the regulatory framework for nuclear and radiation safety in Slovenia. The team identified good practices and gave advice on areas for future improvements. The IAEA has conveyed the team's main conclusions to the Government of Slovenia and a final report will be submitted by the end of 2011. At the request of the Slovenian Government, the IAEA assembled a team of 10 senior regulatory experts from nine nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Slovenian Nuclear Safety Administration (SNSA). The mission is a peer review based on the IAEA Safety Standards. Andrej Stritar, Director of Slovenian Nuclear Safety Administration, stressed ''how important it is for a small country like Slovenia to tightly follow international standards in the area of nuclear safety.'' He also expressed his gratitude to the IAEA, and the countries from which team members came, for their support and for their intensive work during the last ten days. Mission Team Leader Colin Patchett, Deputy Chief Inspector from the UK's Office for Nuclear Regulation commended ''the Slovenian authorities for their commitment to nuclear and radiation safety regulation and for sharing their experience.'' The IRRS team reviewed Slovenia's current regulatory framework and all SNSA-regulated facilities and activities, as well as the regulatory implications of the TEPCO Fukushima Daiichi accident. The IRRS team identified particular strengths in the Slovenian regulatory system, including: Through its legal framework, the Slovenian government has appointed SNSA to regulate its nuclear safety program and SNSA has in place an effective process for carrying out this responsibility; and Slovenia's response to the accident at the TEPCO Fukushima Daiichi power plant has been prompt and effective. Communications with the public, development of actions for improvement

  15. A Review on the Needs of Independent Information Channel for Regulatory Body

    International Nuclear Information System (INIS)

    Raza, Hamid Saeed; Choi, Kwang Sik

    2010-01-01

    For a regulatory body it is very important to be independent not only in its actions but also in its information gathering channels. It is thus required for an organization to get requisite information for their decision making, as well as to prevail over information asymmetries. For corporate culture, information channels sometimes prove to be extensive enough to rune valuable resources and sometime base delays. The paper will reveal nature of an independent information channel. This review will additionally confer a scenario; a regulatory body may face in case of solely depending upon licensee for its information gathering. Working in the wake of this paper comprises review of allied published materials. It might be more helpful for interested ones to persist this effort by ensuring stakeholder involvement i.e. by making this sensitive topic alive through seminars and working groups

  16. IAEA Team Concludes Peer Review of Sweden's Nuclear Regulatory Framework, 17 February 2012, Stockholm, Sweden

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Sweden. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of Sweden, noted good practices in the country's nuclear regulatory system and also made recommendations and suggestions for the Swedish Radiation Safety Authority (SSM) and the government. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''Throughout the mission, the IRRS team received full cooperation from SSM staff in its review of Sweden's regulatory, technical and policy issues,'' said Georg Schwarz, mission leader and Deputy Director General of the Swiss nuclear regulator (ENSI). 'The staff were open and candid in their discussions and provided the fullest practicable assistance', he commented. The main observations of the IRRS Review team included the following: SSM operates as an independent regulator in an open and transparent manner with well-organized regulatory processes; SSM is receptive to feedback and strives to maintain a culture of continuous learning; and Following the TEPCO Fukushima Daiichi accident, SSM responded promptly to public demand for information and communicated effectively with the national government, the public and other interested parties. Good practices identified by the IRRS team included, though they are not limited to, the following: The consolidation of the two previous national regulatory authorities into SSM was successful; Overall, SSM's management system is comprehensive and contributes to staff efficiency and effectiveness; The nuclear power plant refurbishment programme as required by SSM enhanced safety; and Sweden's regulatory framework for high-level waste disposal is comprehensive and technically sound. The IRRS Review team identified

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

    International Nuclear Information System (INIS)

    2010-01-01

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

  18. US EPA's experiences implementing environmental safety standards at the Waste Isolation Pilot Plant - 16103

    International Nuclear Information System (INIS)

    Peake, R. Thomas; Byrum, Charles; Feltcorn, Ed; Lee, Raymond; Joglekar, Rajani; Ghose, Shankar; Eagle, Mike

    2009-01-01

    The U.S. Environmental Protection Agency (EPA or the Agency) developed environmental standards for the disposal of defense-related transuranic wastes for the U.S. Department of Energy's (DOE or the Department) Waste Isolation Pilot Plant (WIPP). EPA implements these standards for WIPP, which has been in operation for over ten years. The general environmental standards are set forth in the Agency's 40 CFR Part 191 Environmental Radiation Protection Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes [1]. These standards are implemented by site-specific compliance criteria [2]. The WIPP Land Withdrawal Act requires DOE to submit a re-certification application every five years after the initial receipt of waste. DOE submitted the latest WIPP re-certification application in March 2009. For re-certification, DOE must identify changes that have occurred over the previous five years and analyze their impact on the potential long-term performance of the repository. Once EPA determines that the re-certification application is complete, the Agency has six months to review the application and make a final decision. During this review, EPA solicits and incorporates public comment where appropriate. During the first re-certification in 2004, several stakeholder groups brought up issues (e.g., karst) that were addressed in the original certification. EPA has received comments again raising some of these same issues for the 2009 re-certification. In addition, DOE must submit proposed changes to the WIPP repository to EPA for review and approval. This paper describes selected issues of concern to WIPP and highlights interactions between EPA as the regulatory authority and DOE as the implementing organization. In general EPA's experience points out the importance of communication, documentation and the regulator's responsibility in determining 'how much is enough'. (authors)

  19. International Expert Team Concludes IAEA Peer Review of Bulgaria's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2013-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded a 12-day mission to review the regulatory framework for nuclear and radiation safety in Bulgaria. The Integrated Regulatory Review Service (IRRS) mission, conducted at the request of the Government of Bulgaria, identified a series of good practices and made recommendations to help enhance the overall performance of the regulatory system. IRRS missions, which were initiated in 2006, are peer reviews based on the IAEA Safety Standards; they are not inspections or audits. ''Bulgaria has a clear national policy and strategy for safety, which are well in line with international standards and practices and contribute to a high level of nuclear safety,'' said Mission Team Leader Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of the Slovak Republic. The mission team, which conducted the review from 8 to 19 April, was made up of 16 senior regulatory experts from 16 nations, and six IAEA staff. ''The results of the IRRS mission will be valuable for the future development and reinforcement of the Bulgarian Nuclear Safety Agency (BNRA). The use of international standards and good practices helps to improve global harmonization in all areas of nuclear safety and radiation protection,'' said Sergey Tzotchev, Chairman of the BNRA. Among the main observations in its preliminary report, the IRRS mission team found that BNRA operates as an independent regulatory body and conducts its regulatory processes in an open and transparent manner. In line with the IAEA Action Plan on Nuclear Safety, the mission reviewed the regulatory implications for Bulgaria of the March 2011 accident at TEPCO's Fukushima Daiichi Nuclear Power Station in Japan. It found that the BNRA's response to the lessons learned from that accident was both prompt and effective. Strengths and good practices identified by the IRRS team include the following: A no-blame policy is enshrined in law for

  20. Safety experts complete second IAEA regulatory review of UK nuclear regulator

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: Nuclear safety experts today concluded a 10-day mission to peer-review the UK Nuclear Regulator: Health and Safety Executive (HSE), Nuclear Directorate (ND). At the request of the UK Government, the International Atomic Energy Agency assembled a team of ten high-level regulatory experts from eight nations to conduct the Integrated Regulatory Review Service (IRRS) mission. The mission was the second of three planned IRRS missions for the United Kingdom. The first was held in March 2006 to begin a process to assess the nation's readiness to regulate and license new reactor designs, considered as a result of the Energy Policy review initiated by the British Prime Minister and the Secretary of State for Trade and Industry (DTI) in 2005. The IRRS team leader Mr. William Borchardt, Executive Director of Operations from the US Nuclear Regulatory Commission, stated, ''The IAEA IRRS serves an important role in both benchmarking against its safety standards and in promoting dialogue between nuclear safety regulators from around the world.'' During the 2nd mission the IRRS the team reviewed HSE/ND progress since the first IRRS mission and recent regulatory developments, the regulation of operating power plants and fuel cycle facilities, the inspection and enforcement programme for nuclear power plants and fuel cycle facilities, and the emergency preparedness and response programme. The IAEA found that HSE/ND has made significant progress toward improving its effectiveness in regulating existing nuclear power plants and in preparing to license new nuclear reactors designs. Many of the findings identified in the 2006 report had been fully addressed and therefore could be considered closed, the others are being addressed in accordance with a comprehensive action plan. IRRS team members visited the Heysham 1 Nuclear Power Plant near Lancaster, the Sellafield site at Cumbria and the Strategic Control Centre at Hutton, and they met senior managers from HSE and a UK

  1. EPA Administrative Enforcement Dockets

    Data.gov (United States)

    U.S. Environmental Protection Agency — The EPA Administrative Enforcement Dockets database contains the electronic dockets for administrative penalty cases filed by EPA Regions and Headquarters. Visitors...

  2. EPA scientific integrity policy draft

    Science.gov (United States)

    Showstack, Randy

    2011-08-01

    The U.S. Environmental Protection Agency (EPA) issued its draft scientific integrity policy on 5 August. The draft policy addresses scientific ethical standards, communications with the public, the use of advisory committees and peer review, and professional development. The draft policy was developed by an ad hoc group of EPA senior staff and scientists in response to a December 2010 memorandum on scientific integrity from the White House Office of Science and Technology Policy. The agency is accepting public comments on the draft through 6 September; comments should be sent to osa.staff@epa.gov. For more information, see http://www.epa.gov/stpc/pdfs/draft-scientific-integrity-policy-aug2011.pdf.

  3. International Expert Team Concludes IAEA Peer Review of Slovakia's Regulatory Framework for Nuclear Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts today concluded an 11-day mission to review the regulatory framework for nuclear safety in Slovakia. At the request of the Slovak Government, the IAEA assembled a team of 12 senior regulatory experts from 12 nations to conduct the Integrated Regulatory Review Service (IRRS) mission involving the Nuclear Regulatory Authority of the Slovak Republic (UJD SR). The international experts also met officials from the Public Health Authority of the Slovak Republic (UVZ SR) regarding the regulation of occupational radiation protection in nuclear facilities. The mission is a peer review based on the IAEA Safety Standards. Marta Ziakova, Chairperson of the Nuclear Regulatory Authority of Slovak Republic, declared that ''The IRRS mission has a great value for the future development and orientation of the UJD SR.'' ''Slovakia has established a regulatory framework for nuclear safety which is in line with international standards and practice,'' said Mission Team Leader Andrej Stritar, Director of the Slovenian Nuclear Safety Administration. The main observations of the IRRS Review team included: UJD SR operates with independence and transparency; UJD SR has developed and implemented a systematic training approach to meet its competence needs; and in response to the accident at TEPCO's Fukushima Daiichi Nuclear Power Station, UJD SR has reacted and communicated to interested parties, including the public. The good practices identified by the IRRS Review Team include: UJD SR has a comprehensive and well-formalized strategic approach to informing and consulting interested parties; UJD SR has developed and implemented a structured approach to training and developing its staff; and Detailed legal requirements provide a solid basis for on-site and off-site response in nuclear emergencies coordinated with local authorities. The IRRS Review team identified areas for further improvement and believes

  4. International nuclear safety experts conclude IAEA peer review of Canada's regulatory system

    International Nuclear Information System (INIS)

    2009-01-01

    Full text: An international team of nuclear safety experts today completed a two-week IAEA review of the regulatory framework and effectiveness of the Canadian Nuclear Safety Commission (CNSC). The team identified good practices within the system and gave advice on some areas for improvement. The IAEA has conveyed initial findings to Canadian authorities; the final report will be submitted by autumn. The International Atomic Energy Agency (IAEA) assembled a team of nuclear, radiation, and waste safety experts at the request of the Government of Canada, to conduct an Integrated Regulatory Review Service (IRRS) mission. The mission from 31 May to 12 June was a peer review based on IAEA Standards, not an inspection, nor an audit. The scope of the mission included sources, facilities and activities regulated by the CNSC: the operation of nuclear power plants (NPPs), research reactors and fuel cycle facilities; the refurbishment or licensing of new NPPs; uranium mining; radiation protection and environmental protection programmes; and the implementation of IAEA Code of Conduct on Safety and Security of Radioactive Sources. The 21-member team from 13 IAEA States and from the IAEA itself reviewed CNSC's work in all relevant areas: legislative and governmental responsibilities; responsibilities and functions; organization; activities of the regulatory body, including the authorization process, review and assessment, inspection and enforcement, the development of regulations, as well as guides and its the management system of CNSC. The basis for the review was a well-prepared self-assessment by the CNSC, including an evolution of its strengths and proposed actions to improve its regulatory effectiveness. Mr. Shojiro Matsuura, IRRS Team Leader and President of the Japanese Nuclear Safety Research Association, said the team 'was impressed by the extensive preparation at all CNSC staff levels.' 'We identified a number of good practices and made recommendations and suggestions

  5. 75 FR 21299 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT-NDA 22-254

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under...). VIMPAT injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  6. 75 FR 21298 - Determination of Regulatory Review Period for Purposes of Patent Extension; VIMPAT -NDA 22-253

    Science.gov (United States)

    2010-04-23

    ... additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under... (lacosamide). VIMPAT tablets are indicated as adjunctive therapy in the treatment of partial-onset seizures in...

  7. Risk Assessment Review Group report to the U.S. Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Lewis, H.W.; Budnitz, R.J.; Kouts, H.J.C.; Loewenstein, W.B.; Rowe, W.D.; von Hippel, F.; Zachariasen, F.

    1978-09-01

    The Risk Assessment Review Group was organized by the U.S. Nuclear Regulatory Commission on July 1, 1977, with four elements to its charter: clarify the achievements and limitations of WASH-1400, the ''Rasmussen Report''; assess the peer comments thereon, and responses to those comments; study the present state of such risk assessment methodology; and recommend to the Commission how (and whether) such methodology can be used in the regulatory and licensing process. Areas of study include: risk assessment methodologies; statistical issues; completeness; the data base; and the WASH-1400 assessment of the damage to human health from radiation after a postulated accident. Specific items discussed include: Browns Ferry; common cause failure; human factors; format and scrutability; the peer review process; earthquakes; risk perception; allegations by UCS concerning WASH-1400 treatment of quality assurance and quality control; current role of probabilistic methods in the regulatory process; acts of violence; ATWS; influence of design defects in quality assurance failures; and calculation of population doses from given releases of radionuclides

  8. 75 FR 5786 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-02-04

    ... Activities; Submission to OMB for Review and Approval; Comment Request; NSPS for Steel Plants: Electric Arc... [email protected] , or by mail to: EPA Docket Center (EPA/DC), Environmental Protection Agency...., Washington, DC 20460, and (2) OMB at: Office of Information and Regulatory Affairs, Office of Management and...

  9. International Expert Team Concludes IAEA Peer Review of Finland's Regulatory Framework for Nuclear and Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: International safety experts today concluded a two-week International Atomic Energy Agency (IAEA) mission to review the regulatory framework for nuclear and radiation safety in Finland. In its preliminary report, the Integrated Regulatory Review Service (IRRS) mission team found that the Radiation and Nuclear Safety Authority of Finland (STUK) is a competent and highly credible regulator that is open and transparent and derives great strength from the technical competence of its staff. ''Finland's comprehensive regulatory framework allows STUK to operate in practice as an independent regulatory body,'' said team leader Philippe Jamet, a commissioner of the French regulatory body ASN. The mission was conducted at the request of the Government of Finland from 15-26 October. The team interviewed members of STUK and officials from various ministries, as well as key players in the Finnish safety framework. Such IRRS missions are peer reviews based on IAEA Safety Standards, not inspections or audits. The team was made up of 18 members from Bulgaria, Canada, the Czech Republic, France, Germany, Iceland, Ireland, Romania, the Russian Federation, South Africa, Slovakia, Slovenia, Spain, Sweden, the United Arab Emirates, the United Kingdom and the United States, as well as six IAEA staff members. 'The IRRS mission and preparation for it was a unique occasion that involved the whole organization, provided motivation for improvement of the safety framework in Finland and assists STUK review its mission', said Tero Varjoranta, Director General of STUK. The IRRS team identified a number of good practices and achievements, including: - STUK's excellence in its safety assessment of nuclear power plants and waste repositories, in particular its demonstration that long-term political commitment is a necessity to sustain the creation of a waste repository as well as its regulatory oversight of medical applications of radiation sources; and - STUK's excellent record in

  10. Regulatory review and barriers for the electricity supply system for distributed generation in EU-15

    DEFF Research Database (Denmark)

    Ropenus, Stephanie; Skytte, Klaus

    2005-01-01

    When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from di...... distributed generation. This paper reviews the current regulation of the grids with respect to distributed generation in EU-15 Member States and compares the different systems. Several barriers are identified.......When distributed electricity supply surpasses a particular level, it can no longer be ignored in planning and operation of the electricity networks. Therefore, improvements of the regulatory framework of the electricity networks are required along with the growth of the electricity supply from...

  11. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2012-01-01

    It saddens us deeply to learn of the passing away of Jean-Paul Diss who died suddenly on 7 June 2012 at his home.  A tribute can be read on the GAC-EPA site. * * * * * Information: http://gac-epa.org/ e-mail: gac-epa@gac-epa.org

  12. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation.

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Most countries have applied multiple strategies to mitigate health care worker absenteeism. The success of these

  13. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Science.gov (United States)

    Kisakye, Angela N; Tweheyo, Raymond; Ssengooba, Freddie; Pariyo, George W; Rutebemberwa, Elizeus; Kiwanuka, Suzanne N

    2016-01-01

    Background A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1) organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs); 2) prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3) contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4) multifaceted work interventions being implemented in most settings; 5) the possibility of using financial and incentive regulatory mechanisms in LMICs; 6) health intervention mechanisms reducing absenteeism when integrated with exercise programs; and 7) attendance by legislation during emergencies being criticized for violating human rights in the United States and not being effective in curbing absenteeism. Conclusion Most countries have applied multiple strategies to mitigate health care

  14. Regulatory mechanisms for absenteeism in the health sector: a systematic review of strategies and their implementation

    Directory of Open Access Journals (Sweden)

    Kisakye AN

    2016-11-01

    Full Text Available Angela N Kisakye,1 Raymond Tweheyo,1 Freddie Ssengooba,1 George W Pariyo,2 Elizeus Rutebemberwa,1 Suzanne N Kiwanuka1 1Department of Health Policy Planning and Management, Makerere University School of Public Health, Kampala, Uganda; 2Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA Background: A systematic review was undertaken to identify regulatory mechanisms aimed at mitigating health care worker absenteeism, to describe where and how they have been implemented as well as their possible effects. The goal was to propose potential policy options for managing the problem of absenteeism among human resources for health in low- and middle-income countries. Mechanisms described in this review are at the local workplace and broader national policy level. Methods: A comprehensive online search was conducted on EMBASE, CINAHL, PubMed, Google Scholar, Google, and Social Science Citation Index using MEDLINE search terms. Retrieved studies were uploaded onto reference manager and screened by two independent reviewers. Only publications in English were included. Data were extracted and synthesized according to the objectives of the review. Results: Twenty six of the 4,975 published articles retrieved were included. All were from high-income countries and covered all cadres of health workers. The regulatory mechanisms and possible effects include 1 organizational-level mechanisms being reported as effective in curbing absenteeism in low- and middle-income countries (LMICs; 2 prohibition of private sector activities in LMICs offering benefits but presenting a challenge for the government to monitor the health workforce; 3 contractual changes from temporary to fixed posts having been associated with no reduction in absenteeism and not being appropriate for LMICs; 4 multifaceted work interventions being implemented in most settings; 5 the possibility of using financial and incentive regulatory mechanisms

  15. The Effect of Omega-3 Fatty Acids, EPA, and/or DHA on Male Infertility: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Hosseini, Banafshe; Nourmohamadi, Mahdieh; Hajipour, Shima; Taghizadeh, Mohsen; Asemi, Zatollah; Keshavarz, Seyed Ali; Jafarnejad, Sadegh

    2018-02-16

    The objective was to evaluate the effect of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) on sperm parameters including total sperm concentration, sperm motility, sperm DHA, and seminal plasma DHA concentration in infertile men. The literature search was conducted in PubMed, Google Scholar, and Scopus from January 1, 1990 to December 20, 2017. The systematic review and meta-analysis were based on randomized controlled trials in infertile men with DHA or EPA treatments, either alone or in combination with other micronutrients. Three studies met the inclusion criteria: 147 patients in the intervention group and 143 patients in the control group. The analysis showed that omega-3 treatments significantly increased the sperm motility (RR 5.82, 95% CI [2.91, 8.72], p DHA concentration (RR 1.61, 95% CI [0.15, 3.07], p =. 03, I 2 = 98%). Compared with the controls, the interventions did not affect the sperm concentration (RR 0.31, 95% CI [-8.13, 8.76], p =. 94, I 2 = 95%) or sperm DHA (RR 0.50, 95% CI [-4.17, 5.16], p =. 83, I 2 = 99%). The observed heterogeneity may be due to administration period and dosage of omega-3 fatty acids across the studies. Funnel plot shows no evidence of publication bias. This meta-analysis indicates that supplementing infertile men with omega-3 fatty acids resulted in a significant improvement in sperm motility and concentration of DHA in seminal plasma.

  16. Special committee review of the Nuclear Regulatory Commission's severe accident risks report (NUREG--1150)

    International Nuclear Information System (INIS)

    Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.

    1990-08-01

    In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review

  17. Statistical challenges in a regulatory review of cardiovascular and CNS clinical trials.

    Science.gov (United States)

    Hung, H M James; Wang, Sue-Jane; Yang, Peiling; Jin, Kun; Lawrence, John; Kordzakhia, George; Massie, Tristan

    2016-01-01

    There are several challenging statistical problems identified in the regulatory review of large cardiovascular (CV) clinical outcome trials and central nervous system (CNS) trials. The problems can be common or distinct due to disease characteristics and the differences in trial design elements such as endpoints, trial duration, and trial size. In schizophrenia trials, heavy missing data is a big problem. In Alzheimer trials, the endpoints for assessing symptoms and the endpoints for assessing disease progression are essentially the same; it is difficult to construct a good trial design to evaluate a test drug for its ability to slow the disease progression. In CV trials, reliance on a composite endpoint with low event rate makes the trial size so large that it is infeasible to study multiple doses necessary to find the right dose for study patients. These are just a few typical problems. In the past decade, adaptive designs were increasingly used in these disease areas and some challenges occur with respect to that use. Based on our review experiences, group sequential designs (GSDs) have borne many successful stories in CV trials and are also increasingly used for developing treatments targeting CNS diseases. There is also a growing trend of using more advanced unblinded adaptive designs for producing efficacy evidence. Many statistical challenges with these kinds of adaptive designs have been identified through our experiences with the review of regulatory applications and are shared in this article.

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

  19. IAEA Team Concludes Peer Review of Greece's Regulatory Framework for Radiation Safety

    International Nuclear Information System (INIS)

    2012-01-01

    Full text: An international team of senior nuclear safety and radiation protection experts yesterday concluded an 11-day mission to review the regulatory framework for nuclear and radiation safety in Greece. The Integrated Regulatory Review Service (IRRS) mission, which was conducted at the request of the Government of the Hellenic Republic, noted good practices in the country's nuclear regulatory system and also identified issues for improvement for the Greek Atomic Energy Commission (GAEC) and the Greek competent authorities. These are aimed at strengthening the effectiveness of the country's regulatory framework and functions in line with IAEA Safety Standards. ''The IRRS team enjoyed excellent cooperation from the GAEC throughout its mission,'' said Tom Ryan, mission leader and Director of Regulations and Information Management at the Radiological Protection Institute of Ireland. ''The GAEC staff were very open and candid in their discussions and provided the fullest practicable assistance.'' The main observations of the IRRS Review team included: While the Greek Government's commitment to safety is being demonstrated through its actions, the development of a comprehensive national policy and strategy expressed in a consolidated statement would provide a valuable framework and guidance for future actions in terms of safety; and GAEC has effective independence. The Greek government has ensured that GAEC is effectively independent in its safety-related decision-making and that it has functional separation from entities having responsibility or interests that could unduly influence its decision making. Strengths and good practices identified by the IRRS team included: Greece actively participates in the global safety regime including all relevant safety conventions; The nation's radiation monitoring system for the detection of illicit trafficking contributes significantly to identifying potential radiation emergencies due to events within or outside the country

  20. 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)

  1. EPA Regulation of Bed Bug Pesticides

    Science.gov (United States)

    All pesticides must be registered by EPA before being sold and used in the U.S., other than those that rely on a limited set of active ingredients (so-called minimum risk pesticides). EPA reviews for safety and effectiveness.

  2. Differential Ratios of Omega Fatty Acids (AA/EPA+DHA Modulate Growth, Lipid Peroxidation and Expression of Tumor Regulatory MARBPs in Breast Cancer Cell Lines MCF7 and MDA-MB-231.

    Directory of Open Access Journals (Sweden)

    Prakash P Mansara

    Full Text Available Omega 3 (n3 and Omega 6 (n6 polyunsaturated fatty acids (PUFAs have been reported to exhibit opposing roles in cancer progression. Our objective was to determine whether different ratios of n6/n3 (AA/EPA+DHA FAs could modulate the cell viability, lipid peroxidation, total cellular fatty acid composition and expression of tumor regulatory Matrix Attachment Region binding proteins (MARBPs in breast cancer cell lines and in non-cancerous, MCF10A cells. Low ratios of n6/n3 (1:2.5, 1:4, 1:5, 1:10 FA decreased the viability and growth of MDA-MB-231 and MCF7 significantly compared to the non-cancerous cells (MCF10A. Contrarily, higher n6/n3 FA (2.5:1, 4:1, 5:1, 10:1 decreased the survival of both the cancerous and non-cancerous cell types. Lower ratios of n6/n3 selectively induced LPO in the breast cancer cells whereas the higher ratios induced in both cancerous and non-cancerous cell types. Interestingly, compared to higher n6/n3 FA ratios, lower ratios increased the expression of tumor suppressor MARBP, SMAR1 and decreased the expression of tumor activator Cux/CDP in both breast cancer and non-cancerous, MCF10A cells. Low n6/n3 FAs significantly increased SMAR1 expression which resulted into activation of p21WAF1/CIP1 in MDA-MB-231 and MCF7, the increase being ratio dependent in MDA-MB-231. These results suggest that increased intake of n3 fatty acids in our diet could help both in the prevention as well as management of breast cancer.

  3. The IAEA Integrated Regulatory Review Service Mission to Sweden in February 2012

    International Nuclear Information System (INIS)

    2012-01-01

    The Swedish Government decided on January 22, 2009 to mandate the Swedish Radiation Safety Authority, SSM, to apply for an international review of the Authority and its areas of supervision, an 'IRRS' (Integrated Regulatory Review Service) carried out by the International Atomic Energy Agency (IAEA). On February 25, 2009, SSM made a formal request to the IAEA for an IRRS in Sweden. The time period for the IRRS mission was later agreed to be 6-17 February, 2012. This report summarises the project's progress immediately prior to the IRRS mission in February 2012. The report contains the findings from the self assessment performed by SSM staff. It also contains a plan to implement measures to remedy deficiencies that have been identified and to improve the radiation safety work of the Authority

  4. Conduct of regulatory review and assessment during the licensing process 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 is concerned with the review and assessment by the regulatory body of all information submitted in support of licence applications, in the various phases of the licensing process. The purpose of the Guide is to provide information, recommendations and guidance for the conduct of these activities. The scope of the review and assessment will encompass the safety aspects of siting, construction, commissioning, operation and decommissioning of each nuclear power plant

  5. Applications of pharmacogenomics in regulatory science: a product life cycle review.

    Science.gov (United States)

    Tan-Koi, W C; Leow, P C; Teo, Y Y

    2018-05-22

    With rapid developments of pharmacogenomics (PGx) and regulatory science, it is important to understand the current PGx integration in product life cycle, impact on clinical practice thus far and opportunities ahead. We conducted a cross-sectional review on PGx-related regulatory documents and implementation guidelines in the United States and Europe. Our review found that although PGx-related guidance in both markets span across the entire product life cycle, the scope of implementation guidelines varies across two continents. Approximately one-third of Food and Drug Administration (FDA)-approved drugs with PGx information in drug labels and half of the European labels posted on PharmGKB website contain recommendations on genetic testing. The drugs affected 19 and 15 World Health Organization Anatomical Therapeutic Chemical drug classes (fourth level) in the United States and Europe, respectively, with protein kinase inhibitors (13 drugs in the United States and 16 drugs in Europe) being most prevalent. Topics of emerging interest were novel technologies, adaptive design in clinical trial and sample collection.

  6. Evolution in performance assessment modeling as a result of regulatory review

    Energy Technology Data Exchange (ETDEWEB)

    Rowat, J.H.; Dolinar, G.M.; Stephens, M.E. [AECL Chalk River Labs., Ontario (Canada)] [and others

    1995-12-31

    AECL is planning to build the IRUS (Intrusion Resistant Underground Structure) facility for near-surface disposal of LLRW. The PSAR (preliminary safety assessment report) was subject to an initial regulatory review during mid-1992. The regulatory authority provided comments on many aspects of the safety assessment documentation including a number of questions on specific PA (Performance Assessment) modelling assumptions. As a result of these comments as well as a separate detailed review of the IRUS disposal concept, changes were made to the conceptual and mathematical models. The original disposal concept included a non-sorbing vault backfill, with a strong reliance on the wasteform as a barrier. This concept was altered to decrease reliance on the wasteform by replacing the original backfill with a sand/clinoptilolite mix, which is a better sorber of metal cations. This change lead to changes in the PA models which in turn altered the safety case for the facility. This, and other changes that impacted performance assessment modelling are the subject of this paper.

  7. Regulatory Aspect of Periodic Safety Review Performed in Nuclear Power Plants in the Slovak Republic

    International Nuclear Information System (INIS)

    Baszo, Z.

    2010-01-01

    The paper deals with the regulatory aspect of Nuclear Power Plant (NPP) Periodic Safety Review (PSR) as a part of license renewal process in the Slovak Republic. It summarizes the history of activities similar to PSR performed in the past for NPPs operated in the Slovak Republic. Furthermore, it describes both the requirements involved in the current Slovak legislation to be met by licensee in the Slovak Republic in this field and the procedures concerning the PSR as well. The objective and rules of PSR to be performed for NPPs in the Slovak Republic were derived from the internationally accepted International Atomic Energy Agency (IAEA) document and have been implemented into national legislation. PSR of two twin units located in Bohunice NPP and Mochovce NPP, respectively, has been initiated in the Slovak Republic based on evaluation of each area to be reviewed (safety factors) using recent methodology and practice. Other significant factors, such as ageing, modifications of NPP and the safe operation for a specified future period, have to be assessed in the frame of PSR. Report on performed PSR outlines the results of review for each area, the corrective plan, which considering mutual relations between assessed areas specifies the issues to be solved with the aim to eliminate shortcomings identified in the frame of PSR and to adopt safety improvements. The findings from PSR in the evaluated areas also serve as a source of information for updating of all documents to be attached to the written application of licensee for renewal of a nuclear power plant operating license. The presented procedure describes how the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) has reviewed the documents submitted during PSR. Based on results of submitted documents evaluation and licensee application for license renewal the license for next 10 years operation has been issued for Bohunice NPP. At present, similar procedure for Mochovce NPP unit 1 and 2 is underway.(author).

  8. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2004-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of 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. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  9. Review and assessment of nuclear facilities by the regulatory body. Safety guide

    International Nuclear Information System (INIS)

    2005-01-01

    The purpose of this Safety Guide is to provide recommendations for regulatory bodies on reviewing and assessing the various safety related submissions made by the operator of a nuclear facility at different stages (siting, design, construction, commissioning, operation and decommissioning or closure) in the facility's lifetime to determine whether the facility complies with the applicable safety objectives and requirements. This Safety Guide covers the review and assessment of submissions in relation to the safety of 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. Objectives, management, planning and organizational matters relating to the review and assessment process are presented in Section 2. Section 3 deals with the bases for decision making and conduct of the review and assessment process. Section 4 covers aspects relating to the assessment of this process. The Appendix provides a generic list of topics to be covered in the review and assessment process

  10. Recent Findings on Tax-Related Regulatory Burden on SMMEs in South Africa. Literature Review and Policy Options

    OpenAIRE

    Doubell Chamberlain; Anja Smith

    2006-01-01

    Regulatory compliance costs impose a deadweight burden on firms and therefore should be minimised. In achieving this goal, it is necessary to embrace a process of smart regulation, rather than focus on deregulation. Tax compliance cost is one type of regulatory costs that is often viewed to have a large negative impact on SMMEs. To gauge the impact of this cost on small business in South Africa, this document reviews three available studies on the impact of tax compliance costs on South Afric...

  11. EPA eXcats

    Data.gov (United States)

    U.S. Environmental Protection Agency — The EPA eXcats is an enterprise-level data tracking application that provides management complaint tracking information for the EPA's Office of Civil Rights (OCR)...

  12. EPA Web Taxonomy

    Data.gov (United States)

    U.S. Environmental Protection Agency — EPA's Web Taxonomy is a faceted hierarchical vocabulary used to tag web pages with terms from a controlled vocabulary. Tagging enables search and discovery of EPA's...

  13. The regulatory review: general comments, current status of review, identification of critical issues

    International Nuclear Information System (INIS)

    Vigfusson, J.; Franck, E.

    2004-01-01

    Typically, a lot of interesting and important details add up to give a coherent and convincing picture of a safe repository. A good portion of these details must be studied and the scientific basis of the system must be clearly understood by the reviewing authority in order to be able to pass a judgement on the safety case. HSK has already received a large part of the documentation relating to the project, including the three high level documents that summarize the synthesis of the geological information, the demonstration of repository design and construction feasibility and the safety case. After a first look at the contents of the documentation we would like to complement Nagra on the maturity and clarity of the presentation in these reports. At this early stage, we shall not present any review judgements. The reviewer usually is dependent upon having not only the high level documents but also all the detailed reference reports in front of him in order to do his job, and HSK is still receiving very relevant documents. Thus we are still at the very beginning of our review. Here, we offer some comments of general nature about the review process and mention a few points that seem to be uppermost in our mind at this stage. (author)

  14. Systematic review regulatory principles of non-coding RNAs in cardiovascular diseases.

    Science.gov (United States)

    Li, Yongsheng; Huo, Caiqin; Pan, Tao; Li, Lili; Jin, Xiyun; Lin, Xiaoyu; Chen, Juan; Zhang, Jinwen; Guo, Zheng; Xu, Juan; Li, Xia

    2017-08-16

    Cardiovascular diseases (CVDs) continue to be a major cause of morbidity and mortality, and non-coding RNAs (ncRNAs) play critical roles in CVDs. With the recent emergence of high-throughput technologies, including small RNA sequencing, investigations of CVDs have been transformed from candidate-based studies into genome-wide undertakings, and a number of ncRNAs in CVDs were discovered in various studies. A comprehensive review of these ncRNAs would be highly valuable for researchers to get a complete picture of the ncRNAs in CVD. To address these knowledge gaps and clinical needs, in this review, we first discussed dysregulated ncRNAs and their critical roles in cardiovascular development and related diseases. Moreover, we reviewed >28 561 published papers and documented the ncRNA-CVD association benchmarking data sets to summarize the principles of ncRNA regulation in CVDs. This data set included 13 249 curated relationships between 9503 ncRNAs and 139 CVDs in 12 species. Based on this comprehensive resource, we summarized the regulatory principles of dysregulated ncRNAs in CVDs, including the complex associations between ncRNA and CVDs, tissue specificity and ncRNA synergistic regulation. The highlighted principles are that CVD microRNAs (miRNAs) are highly expressed in heart tissue and that they play central roles in miRNA-miRNA functional synergistic network. In addition, CVD-related miRNAs are close to one another in the functional network, indicating the modular characteristic features of CVD miRNAs. We believe that the regulatory principles summarized here will further contribute to our understanding of ncRNA function and dysregulation mechanisms in CVDs. © The Author 2017. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  15. Review of NRC Commission Papers on Regulatory Basis for Licensing and Regulating Reprocessing Facilities

    Energy Technology Data Exchange (ETDEWEB)

    Park, Jae Yeong; Shin, Hyeong Ki [KINS, Daejeon (Korea, Republic of)

    2016-05-15

    Spent nuclear fuel (SNF) accumulated in nuclear power plant has been a serious issue in most countries with operating nuclear power plants. Direct disposal of SNF could be a solution of the problem but many countries including the Republic of Korea have had a hard time selecting a site for high level waste repository because of low public acceptance. SNF recycling technologies consisting of reprocessing and transmutation have been developed so as to reduce the final volume of the disposed radioactive waste and to diminish the radiotoxicity of the waste. The Republic of Korea is now developing pyroprocessing and sodium-cooled fast reactor (SFR) technology to be used for the recycling of the wastes. KAERI has a plan to construct a pyroprocessing facility with a capacity of 30 tHM/y and a facility manufacturing TRU fuel for SFR by 2025. However, to license these facility and secure the safety, the current regulatory system related to SNF treatment needs to be improved and amended since the system has been developed focusing on facilities to examine irradiated nuclear materials. Status of reprocessing facility regulations developed by U.S.NRC was reviewed based on SECY papers. U.S.NRC has approved the development of a new rule referred to nationally as '10CFR Part 7x'. Existing 10CFR 50 and 70 has been evolved mainly for nuclear power plants and fuel cycle facilities whose radiological hazard is much lower than reprocessing plants respectively. U.S.NRC also derived many regulatory gaps including safety assessment methods, technical specification, general design criteria and waste classification and continue to develop the regulatory framework limited in scope to the resolution of Gap 5.

  16. 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

  17. Peer Review Report for the Draft EPA Handbook on the Benefits, Costs and Impacts of Land Cleanup and Reuse (2011)

    Science.gov (United States)

    This external review has several objectives including to assess whether the literature summarized is comprehensive and accurate as of 2010, and whether the Handbook’s original portions are sound and useful.

  18. Institutional barriers to DSM (demand side management): Reviewing the regulatory bargain

    Energy Technology Data Exchange (ETDEWEB)

    Warwick, W.M.

    1990-09-01

    The paper discusses traditional arguments for utility regulation in the context of the current utility environment. It reviews several DSM delivery options using a matrix of key financial considerations for utilities and consumers. The strengths and weaknesses of each option are discussed and an assessment of current prospects for DSM implementation is provided. The premise of the paper is that adoption of DSM by utilities and consumers has lagged because of technical and behavioral uncertainties. In addition, regulatory practices and DSM delivery mechanisms have not provided adequate means to extract the benefits of DSM and allocate the risks in a way that offers clear advantages over generating options. The paper concludes with a brief discussion of the potential for value of service approaches to resolve these problems.

  19. Safety and regulatory review of dyes commonly used as excipients in pharmaceutical and nutraceutical applications.

    Science.gov (United States)

    Pérez-Ibarbia, Leire; Majdanski, Tobias; Schubert, Stephanie; Windhab, Norbert; Schubert, Ulrich S

    2016-10-10

    Color selection is one of the key elements of building a strong brand development and product identity in the pharmaceutical industry, besides to prevent counterfeiting. Moreover, colored pharmaceutical dosage forms may increase patient compliance and therapy enhancement. Although most synthetic dyes are classified as safe, their regulations are stricter than other classes of excipients. Safety concerns have increased during the last years but the efforts to change to natural dyes seem to be not promising. Their instability problems and the development of "non-toxic" dyes is still a challenge. This review focuses specifically on the issues related to dye selection and summarizes the current regulatory status. A deep awareness of toxicological data based on the public domain, making sure the compliance of standards for regulation and safety for successful product development is provided. In addition, synthetic strategies are provided to covalently bind dyes on polymers to possibly overcome toxicity issues. Copyright © 2016 Elsevier B.V. All rights reserved.

  20. Yellin's review of the Nuclear Regulatory Commission's Reactor Safety Study: comment

    International Nuclear Information System (INIS)

    Wilson, R.

    1976-01-01

    Joel Yellin (Bell J. Economics, Vol. 7, No. 1 (Spr. 1976)) reviewed the Reactor Safety Study (WASH-1400, or Rasmussen Report) published by the Nuclear Regulatory Commission and makes several criticisms. Wilson finds that some of these criticisms are much overstated, while others, although valid, are mainly criticisms of presentation. To be useful for public policy, reactor risks--and indeed all nuclear risks--must be compared with other risks society faces. Wilson feels that the Rasmussen Report is weak in these comparisons, primarily because there exist few estimates of risk in other places, but that the comparisons he does make indeed confirm that the risk is smaller than Yellin suggests. 20 references

  1. Regulatory role of prolactin in paternal behavior in male parents: A narrative review

    Directory of Open Access Journals (Sweden)

    F Hashemian

    2016-01-01

    Full Text Available In all mammalian species, a combination of neuroendocrine and experiential factors contributes to the emergence of remarkable behavioral changes observed in parental behavior. Yet, our understanding of neuroendocrine bases of paternal behavior in humans is still preliminary and more research is needed in this area. In the present review, the authors summarized hormonal bases of paternal behavior in both human and nonhuman mammalian species and focused on studies on the regulatory role of prolactin in occurrence of paternal behavior. All peer-reviewed journal articles published before 2015 for each area discussed (parental brain, hormonal bases of maternal behavior, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in nonhuman mammalian species, hormonal bases of paternal behavior and the role of prolactin in regulation of paternal behavior in humans were searched by PubMed, Medline, and Scopus for original research and review articles. Publications between 1973 and 2015 were included. Similar to female parents, elevated prolactin levels in new fathers most probably contribute to child-caring behavior and facilitate behavioral and emotional states attributed to child care. Moreover, elevated parental prolactin levels after childbirth decrease the parents′ libidos so that they invest more in parental care than in fertility behavior. According to the available clinical studies, elevation in the amounts of prolactin levels after childbirth in male parents are probably associated with paternal behavior observed in humans.

  2. NRC review of passive reactor design certification testing programs: Overview and regulatory perspective

    International Nuclear Information System (INIS)

    Levin, A.E.

    1993-01-01

    Reactor vendors are developing new designs for future deployment, including open-quotes passiveclose quotes light water reactors (LWRs), such as General Electric's (G.E.'s) simplified boiling water reactor (SBWR) and Westinghouse's AP600, which depend primarily on inherent processes, such as national convection and gravity feed, for safety injection and emergency core cooling. The U.S. Nuclear Regulatory Commission (NRC) has implemented a new process, certification of standardized reactor designs, for licensing these Plants. Part 52 of Title 10 of the Code of Federal Regulations (10CFR52) contains the requirements that vendors must meet for design certification. One important section, 10CFR52.47, reads open-quotes Certification of a standard design which . . . utilizes simplified, inherent, passive, or other innovative means to accomplish its safety functions will be granted only if: (1) The performance of each safety feature of the design has been demonstrated through either analysis, appropriate test programs, experience, or a combination thereof; (2) Interdependent effects among the safety features have been found acceptable by analysis, appropriate test programs, experience, or a combination thereof; and (3) Sufficient data exist on the safety features of the design to assess the analytical tools used for safety analyses. . . . The vendors have initiated programs to test innovative features of their designs and to develop data bases needed to validate their analytical codes, as required by the design certification rule. Accordingly, the NRC is reviewing and evaluating the vendors programs to ensure that they address adequately key issues concerning safety system performance. This paper provides an overview of the NRC's review process and regulatory perspective

  3. 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

  4. 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

  5. Pollution prevention initiatives at US EPA: 'Green Lights'

    International Nuclear Information System (INIS)

    Lawson, J.; Kwartin, R.

    1991-01-01

    US EPA is initiating a pollution prevention approach to supplement its historic command-control, regulatory approach to environmental protection. EPA believes polllution prevention, where applicable and possible, represents a quicker, less expensive and even profitable strategy for environmental protection. Most clearly, energy-efficiency provides an opportunity to prevent significant amounts of pollution related to the inefficeint generation and use of electricity. EPA's first energy productivity and pollution prevention program is Green Lights. Beyond its own merits, Green Lights will also provide important experience to EPA as it develops its Green Machines program to accelerate the market for efficient appliances and equipment

  6. 76 FR 13549 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-14

    ...'s regulatory program more effective and less burdensome in achieving its regulatory objectives by... DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 15 CFR Chapter IX 50 CFR.... 13563 AGENCY: National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Request for...

  7. 40 CFR 725.17 - Consultation with EPA.

    Science.gov (United States)

    2010-07-01

    ... ACT REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS General Provisions and..., ATTN: Biotechnology Notice Consultation. Persons wishing to consult with EPA by telephone should call...

  8. Nuclear Regulatory Commission staff development of the license application review plan for a high-level radioactive waste repository

    International Nuclear Information System (INIS)

    Johnson, R.L.; Holonich, J.J.; Lee, M.P.; Delligatti, M.S.

    1993-01-01

    The Nuclear Regulatory Commission staff has recently started a new initiative to develop the License Application Review Plan (LARP) which the staff will use in its reviews of the U.S. Department of Energy's (DOE's) license application (LA) for a geologic repository for the disposal of high-level radioactive waste (HLW). This paper describes the staff's approach for developing the LARP, the development schedule and current status, the organization and content of the LARP, and the staff's LA review strategy. Therefore, it gives a preview of the draft LARP which will be made available in late 1993. It also describes how the LARP will be used as guidance to the staff in conducting reviews of regulatory and technical issues important to the licensing of a geologic repository. Finally, the benefits to the NRC staff, DOE, and other parties are discussed

  9. Review and evaluation of the Nuclear Regulatory Commission safety research program for Fiscal Year 1983. Report to the Congress

    International Nuclear Information System (INIS)

    1982-02-01

    Public Law 95-209 includes a requirement that the Advisory Committee on Reactor Safeguards submit an annual report to Congress on the safety research program of the Nuclear Regulatory Commission. This report presents the results of the ACRS review and evaluation of the NRC safety research program for Fiscal Year 1983. The report contains a number of comments and recommendations

  10. 75 FR 34749 - Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent...

    Science.gov (United States)

    2010-06-18

    ... and FDA-2008-E-0267] Determination of Regulatory Review Period for Purposes of Patent Extension; BYSTOLIC; U.S. Patent Nos. 5,759,580 and 6,545,040 AGENCY: Food and Drug Administration, HHS. ACTION... determination because of the submission of applications to the Director of Patents and Trademarks, Department of...

  11. Standard Review Plan for a petition for rulemaking on radioactive waste streams below regulatory concern: Expedited review in accordance with Appendix B to 10 CFR, Part 2

    International Nuclear Information System (INIS)

    Larkins, P.M.

    1989-10-01

    The Standard Review Plan (SRP) provides guidance to staff reviewers acting on rulemaking petitions in an expeditious manner to exempt from regulation radioactive waste determined to be Below Regulatory Concern (BRC), as called for in the Low-Level Radioactive Waste Policy Amendments Act of 1985. The review plan is designed to ensure the quality and uniformity of staff reviews and to present a well-defined basis for the staff's evaluation of BRC petitions. The plan serves to improve the understanding of the staff's review by interested members of the public and the industry. It also provides information about the BRC rulemaking process to a wider audience. 6 refs., 7 figs

  12. Scientific and regulatory challenges in evaluating clinical trial protocols for HIV-1/AIDS vaccines - A review from a regulatory perspective.

    Science.gov (United States)

    Sheets, Rebecca L; Zhou, TieQun; Knezevic, Ivana

    2016-03-01

    Clinical development of prophylactic HIV/AIDS vaccines presents many scientific challenges that result in challenges for regulators reviewing clinical trial applications (CTAs). The World Health Organization (WHO) has the responsibility to provide technical support to these regulators. The search for an HIV/AIDS vaccine will only succeed through well-designed, -conducted and -controlled human efficacy studies reviewed and approved by regulators in countries worldwide, particularly in countries where the epidemic has hit hardest, such as in sub-Saharan Africa and Asia. This review summarizes the current candidates in development and focuses on challenges regulators face when reviewing CTAs, such as the evolving landscape of "standard of prevention," trials in adolescents, adaptive trial designs, correlates of protection and their analysis, and access to successful vaccines. There are many unknowns in the field of HIV/AIDS vaccine development and often, there is not a clear right or wrong approach because of the scientific challenges described in this review. Consequently, regulators should not feel that decisions need be made in isolation, when there are many available international collaborative efforts and opportunities to seek expert advice. The WHO provides many such opportunities and support to regulators across the globe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

  13. Proceedings of the tenth annual DOE low-level waste management conference: Session 1: Institutional and regulatory issues

    International Nuclear Information System (INIS)

    1988-12-01

    This document contains eleven papers on various aspects of low-level radioactive waste regulation. Topics include: EPA environmental standards; international exemption principles; the concept of below regulatory concern; envirocare activities in Utah; mixed waste; FUSRAP and the Superfund; and a review of various incentive programs. Individual papers are processed separately for the data base

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

    International Nuclear Information System (INIS)

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

    2016-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-04-07

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

  16. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine. PMID:29629018

  17. The legislative and regulatory framework governing herbal medicine use and practice in Kenya: a review.

    Science.gov (United States)

    Okumu, Mitchel Otieno; Ochola, Francis Okumu; Onyango, Allan Odhiambo; Mbaria, James Mucunu; Gakuya, Daniel Waweru; Kanja, Laetitia Wakonyu; Kiama, Stephen Gitahi; Onyango, Mary Atieno

    2017-01-01

    Complementary and alternative medicine is an integral component of primary healthcare in Kenya. This is because the infrastructural health setup in the country is inadequate in catering for all the medical needs of the population. This particularly holds true in the rural areas where many rural folk rely on products of herbal origin to offset their healthcare needs. More often than not these products are an elaborate cacophony of several different substances of biological origin and thus need personnel adept in their preparation. Sadly, due to loopholes in legislation and regulation, quacks have a field day in the practice. Moreover, the process of planting, harvesting, preparation and storage of herbs and related products dictates that a significant number of people will ultimately be involved in the whole process. This is likely to set the stage for manipulation and compromise of the safety, quality and efficacy of these products. This state of affairs appears unabated especially in the context of the current legal and regulatory framework governing herbal medicine use and practice in Kenya. Not only are these laws inadequate, they are shrouded in ambiguity, open to interpretation and the authorities mandated to implement them often end up performing duplicate roles. The aim of this review is to critique the legal and regulatory provisions governing herbal medicine use and practice in Kenya. In conclusion, laws and regulations meant to control herbal medicine use and practice in Kenya are wanting. Clear and definitive legislation on herbal medicine use and practice coupled with effective implementation by mandated institutions will go a long way in inspiring confidence to all stakeholders of herbal medicine.

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

    Science.gov (United States)

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

    2016-04-07

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

  19. Using the IRRS to Strengthen Regulatory Competence in Ireland

    International Nuclear Information System (INIS)

    Smith, K.

    2016-01-01

    In 2015, Ireland underwent an IRRS (Integrated Regulatory Review Service) review mission. The purpose of the mission was to review Ireland’s radiation and nuclear safety regulatory framework and activities against the relevant IAEA safety standards, to report on the regulatory effectiveness and to exchange information and experience in the areas covered by the IRRS. The review mission was well-timed as there had been recent changes in the regulatory infrastructure with the merger of the Radiological Protection Institute of Ireland (RPII) and the Environmental Protection Agency (EPA) in 2014, as well as the upcoming implementation of the new Euratom Basic Safety Standards (BSS) Directive. The key objectives of the mission were to enhance the national legal, governmental and regulatory framework for nuclear and radiation safety, and national arrangements for emergency preparedness and response. The agreed scope of the review covered all relevant facilities and activities regulated in Ireland and also included medical exposures and public exposure to radon. In advance of the mission, Ireland completed a process of self-assessment and review. This process identified strengths and weaknesses in the national regulatory framework compared with the international standards. In addition to the value of having Ireland’s radiation protection framework peer reviewed by senior international experts, the mission helped to further strengthen links between all the national bodies (government, licensees, regulatory) with a role in the regulation of radiation safety. The findings from the IRRS review team’s objective evaluation of Ireland’s regulatory infrastructure are being used to prioritise actions for strengthening the regulatory framework, to provide input into the transposition of the Euratom BSS, and to support the revision of the national emergency plan for nuclear accidents. It is planned to have addressed the findings of the IRRS mission in advance of a follow up

  20. "Slicer" for EPA

    CERN Multimedia

    CERN PhotoLab

    1983-01-01

    During the design of the Electron-Positron-Accumulator (EPA), there was an apprehension about the stability-limit of positron bunch-intensity in the SPS. In case that EPA would be able to produce bunches with intensities exceeding what the SPS could digest, an electrostatic septum was to slice up the EPA beam over 2 or 4 turns, thus lowering the bunch intensity while maintaining fast filling of LEP. The "slicer" septum was built and installed, but thanks to the good appetite of the SPS its use never became necessary. The slicer was removed from EPA to lower the machine impedance.

  1. EPA Envirofacts API

    Data.gov (United States)

    U.S. Environmental Protection Agency — Envirofacts integrates information from a variety of EPA's environmental databases. Each of these databases contains information about facilities that are required...

  2. A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers.

    Science.gov (United States)

    Henry, Barbara J; Carlin, Joseph P; Hammerschmidt, Jon A; Buck, Robert C; Buxton, L William; Fiedler, Heidelore; Seed, Jennifer; Hernandez, Oscar

    2018-05-01

    Per- and polyfluoroalkyl substances (PFAS) are a group of fluorinated substances that are in the focus of researchers and regulators due to widespread presence in the environment and biota, including humans, of perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA). Fluoropolymers, high molecular weight polymers, have unique properties that constitute a distinct class within the PFAS group. Fluoropolymers have thermal, chemical, photochemical, hydrolytic, oxidative, and biological stability. They have negligible residual monomer and oligomer content and low to no leachables. Fluoropolymers are practically insoluble in water and not subject to long-range transport. With a molecular weight well over 100 000 Da, fluoropolymers cannot cross the cell membrane. Fluoropolymers are not bioavailable or bioaccumulative, as evidenced by toxicology studies on polytetrafluoroethylene (PTFE): acute and subchronic systemic toxicity, irritation, sensitization, local toxicity on implantation, cytotoxicity, in vitro and in vivo genotoxicity, hemolysis, complement activation, and thrombogenicity. Clinical studies of patients receiving permanently implanted PTFE cardiovascular medical devices demonstrate no chronic toxicity or carcinogenicity and no reproductive, developmental, or endocrine toxicity. This paper brings together fluoropolymer toxicity data, human clinical data, and physical, chemical, thermal, and biological data for review and assessment to show that fluoropolymers satisfy widely accepted assessment criteria to be considered as "polymers of low concern" (PLC). This review concludes that fluoropolymers are distinctly different from other polymeric and nonpolymeric PFAS and should be separated from them for hazard assessment or regulatory purposes. Grouping fluoropolymers with all classes of PFAS for "read across" or structure-activity relationship assessment is not scientifically appropriate. Integr Environ Assess Manag 2018;14:316-334. © 2018 The Authors

  3. EPA requirements for the uranium fuel cycle

    International Nuclear Information System (INIS)

    Dunster, H.J.

    1975-01-01

    The draft Environmental Statement issued by the Environmental Protection Agency (EPA) in the United States in preparation for Proposed Rulemaking Action concerning 'Environmental radiation protection requirements for normal operations of activities in the uranium fuel cycle' is summarized and discussed. The standards proposed by the EPA limit the annual dose equivalents to any member of the public, and also the releases of radionuclides to the 'general environment' for each gigawatt year of electrical energy produced. These standards were based on cost effectiveness arguements and levels and correspond to the ICRP recommendation to keep all exposures as low as reasonably achievable, economic and social factors being taken into account. They should be clearly distinguished from dose limits, although the EPA does not make this at all clear. The EPA seems to have shown an unexpected lack of understanding of the recommendations of ICRP Publication 9 (1965) and an apparent unawareness of ICRP Publication 22 (1973), and has therefore wrongly presented the new standards as a significant change in policy. The EPA has reviewed the information on the likely level of dose equivalents to members of the public and the likely cost reductions, thereby quantifying existing principles as applied to the fuel cycle as a whole. The EPA has stated that its proposals could be achieved as a cost in the region of Pound100,000 per death (or major genetic defect). It is pointed out that the EPA's use of the term 'waste' to exclude liquid and gaseous effluents may cause confusion. (U.K.)

  4. EPA Linked Open Data (Collection)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is a collection item referencing the following EPA Linked Data resources: - EPA Facility Registry Service (FRS) - EPA Substance Registry Service (SRS) -...

  5. EPA Library Network Communication Strategies

    Science.gov (United States)

    To establish Agency-wide procedures for the EPA National Library Network libraries to communicate, using a range of established mechanisms, with other EPA libraries, EPA staff, organizations and the public.

  6. Work-In-Progress Peer Consult on EPA's Multimedia ...

    Science.gov (United States)

    This document is a compilation of responses from four external peer reviewers on EPA's "Multimedia Exposure Analysis to Inform a Public Health-Based Value for Lead in Drinking Water." It was delivered by Versar, Inc. under contract number EP-C-12-045 Task Order 91. Peer review report compiled, written and delivered by Versar, Inc to EPA.

  7. 76 FR 9988 - Improving EPA Regulations

    Science.gov (United States)

    2011-02-23

    ... suggestions do you have for how the Agency could change the regulations to be more flexible? 6. Benefits and... public input on the design of a plan to use for periodic retrospective review of its regulations. DATES... At this time, EPA seeks help in designing the plan it will use for periodic review of regulations...

  8. EPA perspective on radionuclide aerosol sampling

    Energy Technology Data Exchange (ETDEWEB)

    Karhnak, J.M. [Environmental Protection Agency, Washington, DC (United States)

    1995-02-01

    The Environmental Protection Agency (EPA) is concerned with radionuclide aerosol sampling primarily at Department of Energy (DOE) facilities in order to insure compliance with national air emission standards, known as NESHAPs. Sampling procedures are specified in {open_quotes}National Emission Standards for Emissions of Radionuclides other than Radon from Department of Energy Sites{close_quotes} (Subpart H). Subpart H also allows alternate procedures to be used if they meet certain requirements. This paper discusses some of the mission differences between EPA and Doe and how these differences are reflected in decisions that are made. It then describes how the EPA develops standards, considers alternate sampling procedures, and lists suggestions to speed up the review and acceptance process for alternate procedures. The paper concludes with a discussion of the process for delegation of Radionuclide NESHAPs responsibilities to the States, and responsibilities that could be retained by EPA.

  9. A review of regulatory risk assessment with formaldehyde as an example.

    Science.gov (United States)

    Imbus, H R

    1988-09-01

    Quantitative risk assessment may vary by over a millionfold depending upon the model used. The EPA currently uses models which project the highest potential risk. Furthermore, there is no consideration of the probability that a chemical is a human carcinogen. Such an approach may result in unrealistically high risk at exposures far below current ambient levels. In the case of formaldehyde, three alternative approaches to risk assessment are examined. One uses the maximum likelihood estimate of the multistage model, another uses the no observable adverse effect level divided by a safety factor of 100, and the third uses a probability estimate that the substance is carcinogenic at typical ambient exposures multiplied by EPA's upper bound estimate. The probability estimate is made from considerations of metabolism and pharmacokinetics, toxicology, short-term tests, animal tests, and epidemiology.

  10. Review on the seismic safety of JRR-3 according to the revised regulatory code on seismic design for nuclear reactors

    Energy Technology Data Exchange (ETDEWEB)

    Kobayashi, Tetsuya; Araki, Masaaki; Ohba, Toshinobu; Torii, Yoshiya [Japan Atomic Energy Agency, Tokai, Ibaraki (Japan); Takeuchi, Masaki [Nuclear Safety Commission (Japan)

    2012-03-15

    JRR-3(Japan Research Reactor No.3) with the thermal power of 20MW is a light water moderated and cooled, swimming pool type research reactor. JRR-3 has been operated without major troubles. This paper presents about review on the seismic safety of JRR-3 according to the revised regulatory code on seismic design for nuclear reactors. In addition, some topics concerning damages in JRR-3 due to the Great East Japan Earthquake are presented. (author)

  11. 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)

  12. Regulatory analysis for amendments to regulations for the environmental review for renewal of nuclear power plant operating licenses. Final report

    International Nuclear Information System (INIS)

    1996-05-01

    This regulatory analysis provides the supporting information for a proposed rule that will amend the Nuclear Regulatory Commission's environmental review requirements for applications for renewal of nuclear power plant operating licenses. The objective of the proposed rulemaking is to improve regulatory efficiency by providing for the generic evaluation of certain environmental impacts associated with nuclear plant license renewal. After considering various options, the staff identified and analyzed two major alternatives. With Alternative A, the existing regulations would not be amended. This option requires that environmental reviews be performed under the existing regulations. Alternative B is to assess, on a generic basis, the environmental impacts of renewing the operating license of individual nuclear power plants, and define the issues that will need to be further analyzed on a case-by-case basis. In addition, Alternative B removes from NRC's review certain economics-related issues. The findings of this assessment are to be codified in 10 CFR 51. The staff has selected Alternative B as the preferred alternative

  13. US EPA CARE Grants

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is a provisional dataset that contains point locations for the subset of Community Action for a Renewed Environment (CARE) grants given out by the US EPA. CARE...

  14. EPA User Personas

    Science.gov (United States)

    Learn how EPA's three web user personas (Information Consumer, Information Intermediary, and Information Interpreter) can help you identify appropriate top audiences and top tasks for a topic or web area.

  15. EPA's Efforts in Eurasia

    Science.gov (United States)

    EPA has been collaborating with Russia, Central Asia, the Caucasus and Ukraine for over 20 years and continues to work with their governments and non-governmental organizations on environment, science and technology issues.

  16. US EPA EJ Grants

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is a provisional dataset that contains point locations for all Environmental Justice (EJ) grants given out by the US EPA. There are many limitations to the data...

  17. EPA Nanorelease Dataset

    Data.gov (United States)

    U.S. Environmental Protection Agency — EPA Nanorelease Dataset. This dataset is associated with the following publication: Wohlleben, W., C. Kingston, J. Carter, E. Sahle-Demessie, S. Vazquez-Campos, B....

  18. Science Inventory | US EPA

    Science.gov (United States)

    The Science Inventory is a searchable database of research products primarily from EPA's Office of Research and Development. Science Inventory records provide descriptions of the product, contact information, and links to available printed material or websites.

  19. EPA Recovery Mapper

    Data.gov (United States)

    U.S. Environmental Protection Agency — The EPA Recovery Mapper is an Internet interactive mapping application that allows users to discover information about every American Recovery and Reinvestment Act...

  20. Selected review of regulatory standards and licensing issues for nuclear power plants

    International Nuclear Information System (INIS)

    Stevenson, J.D.; Thomas, F.A.

    1982-11-01

    This report presents a compilation and description of current foreign regulatory standards and licensing issues in the areas of interest associated with Siting, Structural Engineering, Metallurgy and Materials, and Mechanical Engineering. In addition, summary comparisons of the requirements of both the US and foreign nuclear power plant regulatory standards are provided. The selected foreign countries surveyed include Canada, France, Japan, Sweden, United Kingdom of Great Britain and Northern Ireland, and the Federal Republic of Germany

  1. 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

  2. The regulatory review of construction license application and the supporting safety case

    International Nuclear Information System (INIS)

    Heinonen, Jussi

    2014-01-01

    Finland is one of the foremost countries in the world in developing the disposal of spent fuel. The construction license application for the Olkiluoto spent fuel disposal facility was submitted to the authorities at the end of 2012 and the facility is expected to start operation around 2020. This has been a long-term project with over 30 years of parallel development of the repository project and the regulatory approach to spent fuel management. In 1983 the government made a strategic decision on the objectives and target time schedule for the research, development and technical planning of nuclear waste management. While an export and international disposal solution was still the preferred option, this decision required the licensees without this possibility to prepare for disposal in Finland and it also gave the time line for the milestones on the way to an operating disposal facility by 2020. The licensing procedure for a disposal facility has several steps that are similar to all nuclear facilities in Finland and are defined in Nuclear Energy Act and Decree (1987, 1988). These licensing steps are: - Decision-in-principle is required for a nuclear facility having considerable general significance. This is essentially a political decision: the government decides if the construction project is in line with the overall good of society. The decision can be applied for one or more sites, the host municipality has a veto right and the parliament has the choice of ratifying or not ratifying the decision. - Construction license is granted by the government and authorises the construction of the disposal facility. The actual construction is regulated by STUK and includes several review and approval steps, hold points and viewpoints. - Operational license is granted by the government and authorises the operation of the facility for a certain period. The operational license is needed before nuclear waste can be disposed. The first step in the licensing process was reached

  3. EPA Environmental Chemistry Laboratory

    Science.gov (United States)

    1993-01-01

    The Environmental Protection Agency's (EPA) Chemistry Laboratory (ECL) is a national program laboratory specializing in residue chemistry analysis under the jurisdiction of the EPA's Office of Pesticide Programs in Washington, D.C. At Stennis Space Center, the laboratory's work supports many federal anti-pollution laws. The laboratory analyzes environmental and human samples to determine the presence and amount of agricultural chemicals and related substances. Pictured, ECL chemists analyze environmental and human samples for the presence of pesticides and other pollutants.

  4. Review of decision methodologies for evaluating regulatory actions affecting public health and safety

    International Nuclear Information System (INIS)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels

  5. Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.

    Science.gov (United States)

    Ibarra-Cabrera, Ricardo; Mena-Pérez, Sandra Carolina; Bondani-Guasti, Augusto; García-Arrazola, Roeb

    2013-12-01

    The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries. Copyright © 2013 Elsevier Inc. All rights reserved.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-02-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1999-02-01

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

  8. Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature.

    Science.gov (United States)

    Bujar, Magdalena; McAuslane, Neil; Walker, Stuart R; Salek, Sam

    2017-01-01

    Introduction: Although pharmaceutical companies, regulatory authorities, and health technology assessment (HTA) agencies have been increasingly using decision-making frameworks, it is not certain whether these enable better quality decision making. This could be addressed by formally evaluating the quality of decision-making process within those organizations. The aim of this literature review was to identify current techniques (tools, questionnaires, surveys, and studies) for measuring the quality of the decision-making process across the three stakeholders. Methods: Using MEDLINE, Web of Knowledge, and other Internet-based search engines, a literature review was performed to systematically identify techniques for assessing quality of decision making in medicines development, regulatory review, and HTA. A structured search was applied using key words and a secondary review was carried out. In addition, the measurement properties of each technique were assessed and compared. Ten Quality Decision-Making Practices (QDMPs) developed previously were then used as a framework for the evaluation of techniques identified in the review. Due to the variation in studies identified, meta-analysis was inappropriate. Results: This review identified 13 techniques, where 7 were developed specifically to assess decision making in medicines' development, regulatory review, or HTA; 2 examined corporate decision making, and 4 general decision making. Regarding how closely each technique conformed to the 10 QDMPs, the 13 techniques assessed a median of 6 QDMPs, with a mode of 3 QDMPs. Only 2 techniques evaluated all 10 QDMPs, namely the Organizational IQ and the Quality of Decision Making Orientation Scheme (QoDoS), of which only one technique, QoDoS could be applied to assess decision making of both individuals and organizations, and it possessed generalizability to capture issues relevant to companies as well as regulatory authorities. Conclusion: This review confirmed a general

  9. Comments on EPA's LLW preproposal

    International Nuclear Information System (INIS)

    Littleton, B.K.; Weinstock, L.

    1995-01-01

    The Environmental Protection Agency (EPA) is currently developing standards for the management, storage, and disposal of Low-Level Radioactive Waste (LLW). The Atomic Energy Act delegated EPA, among other provisions, the authority to establish generally applicable standards for the disposal of radioactive waste to ensure that the public and the environment are adequately protected from potential radiation impacts. As an initial effort to open communications on a standard for LLW, the Agency developed a preproposal draft (Preproposal Draft of 40 CFR Part 193 - 30 Nov 94) and circulated it to interested parties for review and comment. The extended comment period ended April 12, 1995. A summary of the comments received and analyzed to date follows. After all comments have been analyzed, the rule will undergo an Agency clearance process and be sent to the Office of Management and Budget for review. After that review, the formal process of publication of the proposed rule in the Federal Register and the formal public comment period will begin

  10. Joint IAEA/NEA workshop proceedings on regulatory review of plant safety analysis - Abstracts, Summary and Conclusions

    International Nuclear Information System (INIS)

    Lacey, Derek; Drozd, Andrzej; Husarcek, Jan; Modro, Mike

    1999-01-01

    Based on the final discussion, the seminar was a valuable exchange of information and helpful in understanding the safety analysis and regulatory review issues. It gave a chance for some countries to see 'where they are' regulatory-wise with respect to other countries. There was a strong support for a follow-up workshop within the next two years. A general opinion expressed by most of the participants was that the suggested next seminar should be based more on an 'overall safety analysis' review rather than on very detailed presentations on specific issues. Also, there should be more discussions on Emergency Operating Procedures (EOPs) and emergency planning. In addition, to establish a 'common language', the development of a glossary of terms would be most helpful. In general, all of the participating countries are adapting regulatory and licensing practices previously developed by other countries. Such an approach allows to utilise and rely on a broad experience of countries with a well established nuclear power industry, strong regulatory organisation and licensing practices. Since there are obvious differences in engineering traditions and in countries' legal/regulatory frameworks, questions arise about how to reconcile these differences in adapting and developing practices suitable for a given country. It was advised as a good practice to identify from the very beginning what needs to be done and the goals to be accomplished not only in the perspective of safety and technical requirements but also in the context of the economical, political, legal and regulatory situation in a given country. There has to be a consistency in any approach, but one can never follow 'blindly' the others. It became quite obvious that the needs of countries with a big nuclear program are very different from those of 'small' countries. Adaptation of other countries' rules is a big effort in itself (e.g., Romania applying Canadian regulations). In addition, the French-German co

  11. The integration of the quality assurance approach into the regulatory review stages in Italy

    International Nuclear Information System (INIS)

    Maniori, D.

    1979-01-01

    The control activities of CNEN, the Italian Regulatory Body on Nuclear Power Plant Installations, are carried out on the basis of two main lines of action. These are a thorough and detailed examination of the project at different stages of its development, and a careful assessment of the reliability of the organizations involved in respect of their capability to perform their duties correctly. The paper illustrates in some detail the different stages in which the project examinations are carried out, the documents pertinent to each stage, and the way in which the organizational requirements match the different steps. The regulatory guides and documents prepared on this subject are also briefly presented. (author)

  12. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2014-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 4 février de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org. * * * * * Carte de membre de l'Association du personnel du CERN Les membres GAC-EPA qui souhaitent recevoir une carte de membre AP en 2014 doivent  en faire la demande par email à secretariat@gac-epa.org, ou par lettre au secrétaire ...

  13. Modernizing the Regulatory System for Biotechnology Products

    Science.gov (United States)

    This Web page describes the continuing effort to modernize the federal regulatory system for biotechnology products as well as clarify various roles of EPA, FDA and USDA in evaluating new biotechnology products.

  14. 76 FR 9780 - Notification of Deletion of System of Records; EPA Parking Control Office File (EPA-10) and EPA...

    Science.gov (United States)

    2011-02-22

    ... System of Records; EPA Parking Control Office File (EPA-10) and EPA Transit and Guaranteed Ride Home... Environmental Protection Agency (EPA) is deleting the systems of records for EPA Parking Control Office File... through the EPA Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/ . Dated...

  15. 76 FR 63276 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-10-12

    ... submitted either via the Board's e-filing process or in the traditional paper format. Any person using e... objectives. The order also called for public participation in this regulatory process. Although Executive... Uniform Rail Costing System, which is the Board's general purpose costing methodology for the nation's...

  16. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2015-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 3 mars de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 7 avril, 5 mai, 2 juin, 1er septembre, 6 octobre, 3 novembre et 1er décembre 2013. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  17. GAC-EPA

    CERN Document Server

    GAC-EPA

    2013-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 1er octobre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 5 novembre et 3 décembre 2013. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  18. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 5 avril de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 3 mai, 7 juin, 6 septembre, 4 octobre, 1er et 29 novembre décembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  19. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : le mardi 29 novembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  20. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : le mardi 1er novembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel. La permanence suivante aura lieu le mardi 29 novembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  1. GAC-EPA

    CERN Document Server

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 3 mai de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 7 juin, 6 septembre, 4 octobre, 1er et 29 novembre décembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  2. GAC-EPA

    CERN Document Server

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 5 avril de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 3 mai, 7 juin, 6 septembre, 4 octobre, 1er et 29 novembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  3. GAC-EPA

    CERN Document Server

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 4 octobre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 1er et 29 novembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  4. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2015-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 1er décembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  5. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 2 février de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 1er mars, 5 avril, 3 mai, 7 juin, 6 septembre, 4 octobre, 1er et 29 novembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  6. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 1er mars de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 5 avril, 3 mai, 7 juin, 6 septembre, 4 octobre, 1er et 29 novembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  7. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2015-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 3 novembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel La permanence suivante aura lieu le mardi 1er décembre 2015. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  8. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2013-01-01

    Carte de membre de l'Association du personnel du CERN Comme cela a été précisé dans le bulletin d'automne n° 43, les membres GAC-EPA qui souhaitent recevoir une carte de membre AP en 2013 devront en faire la demande, avant le 31 janvier, par email à secretariat@gac-epa.org, ou par lettre au secrétaire du GAC-EPA, p/a Association du personnel CERN, CH-1211 GENEVE 23. Il n'y a pas de tacite reconduction de ces cartes et par conséquent une demande doit être faite chaque année par l'intéressé(e).

  9. Systematic review of qualitative literature on occupational health and safety legislation and regulatory enforcement planning and implementation.

    Science.gov (United States)

    MacEachen, Ellen; Kosny, Agnieszka; Ståhl, Christian; O'Hagan, Fergal; Redgrift, Lisa; Sanford, Sarah; Carrasco, Christine; Tompa, Emile; Mahood, Quenby

    2016-01-01

    The ability of occupational health and safety (OHS) legislation and regulatory enforcement to prevent workplace injuries and illnesses is contingent on political, economic, and organizational conditions. This systematic review of qualitative research articles considers how OHS legislation and regulatory enforcement are planned and implemented. A comprehensive search of peer-reviewed, English-language articles published between 1990 and 2013 yielded 11 947 articles. We identified 34 qualitative articles as relevant, 18 of which passed our quality assessment and proceeded to meta-ethnographic synthesis. The synthesis yielded four main themes: OHS regulation formation, regulation challenges, inspector organization, and worker representation in OHS. It illuminates how OHS legislation can be based on normative suppositions about worker and employer behavior and shaped by economic and political resources of parties. It also shows how implementation of OHS legislation is affected by "general duty" law, agency coordination, resourcing of inspectorates, and ability of workers to participate in the system. The review identifies methodological gaps and identifies promising areas for further research in "grey" zones of legislation implementation.

  10. 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.

  11. Applying a Developmental Framework to the Self-Regulatory Difficulties of Young Children with Prenatal Alcohol Exposure: A Review.

    Science.gov (United States)

    Reid, Natasha; Petrenko, Christie L M

    2018-06-01

    Prenatal alcohol exposure (PAE) can be associated with significant difficulties in self-regulatory abilities. As such, interventions have been developed that focus on improving varying aspects of self-regulation for this population. The application of a multilevel theoretical framework that describes the development of self-regulation during early childhood could further advance the field. First, this framework could assist in elucidating mechanisms in the trajectories of early adjustment problems in this population and, second, informing the development of more precise assessment and interventions for those affected by PAE. The aims of the current review were to provide an overview of the self-regulatory framework proposed by Calkins and colleagues (e.g., Calkins, 2007; Calkins and Fox, 2002); examine the self-regulatory difficulties that are commonly experienced during infancy (i.e., 0 to 2 years) and early childhood (i.e., 3 to 8 years) in children with PAE in the context of the developmental framework; and describe how the framework can inform the development of future assessment and intervention provision for young children with PAE. The application of a developmental framework, such as proposed by Calkins and colleagues, allows for a systematic and theoretically driven approach to assessment and intervention programs for young children with PAE. Copyright © 2018 by the Research Society on Alcoholism.

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

    Science.gov (United States)

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

    2016-12-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2015-05-15

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

  14. EPA Web Training Classes

    Science.gov (United States)

    Scheduled webinars can help you better manage EPA web content. Class topics include Drupal basics, creating different types of pages in the WebCMS such as document pages and forms, using Google Analytics, and best practices for metadata and accessibility.

  15. EPA's Green Roof Research

    Science.gov (United States)

    This is a presentation on the basics of green roof technology. The presentation highlights some of the recent ORD research projects on green roofs and provices insight for the end user as to the benefits for green roof technology. It provides links to currently available EPA re...

  16. Integrated resource planning for local gas distribution companies: A critical review of regulatory policy issues

    International Nuclear Information System (INIS)

    Harunuzzaman, M.; Islam, M.

    1994-08-01

    According to the report, public utility commissions (PUCs) are increasingly adopting, or considering the adoption of integrated resource planning (IRP) for local gas distribution companies (LDCs). The Energy Policy Act of 1992 (EPAct) requires PUCs to consider IRP for gas LDCs. This study has two major objectives: (1) to help PUCs develop appropriate regulatory approaches with regard to IRP for gas LDCs; and (2) to help PUCs respond to the EPAct directive. The study finds that it is appropriate for PUCs to pursue energy efficiency within the traditional regulatory framework of minimizing private costs of energy production and delivery; and PUCs should play a limited role in addressing environmental externalities. The study also finds that in promoting energy efficiency, PUCs should pursue policies that are incentive-based, procompetitive, and sensitive to rate impacts. The study evaluates a number of traditional and nontraditional ratemaking mechanisms on the basis of cost minimization, energy efficiency, competitiveness, and other criteria. The mechanisms evaluated include direct recovery of DSM expenses, lost revenue adjustments for DSM options, revenue decoupling mechanisms, sharing of DSM cost savings, performance-based rate of return for DSM, provision of DSM as a separate service, deregulation of DSM service, price caps, and deregulation of the noncore gas market. The study concludes with general recommendations for regulatory approaches and ratemaking mechanisms that PUCs may wish to consider in advancing IRP objectives

  17. Guidelines for the regulatory review of the human reliability analysis in PSAs

    International Nuclear Information System (INIS)

    Reer, Bernhard; Dang, V.N.; Hirschberg, Stefan; Meyer, Patrick

    2000-01-01

    In the review guidelines recently developed for the Swiss Federal Nuclear Inspectorate, the Human Reliability Analysis (HRA) is reviewed in two stages. The preliminary review is aimed at identifying major shortcomings and potential issues to be examined in the detailed review. The detailed review comprehensively addresses the overall adequacy and transparency of the HRA. For the two review stages, 97 indicators are defined in terms of questions focusing on verifiable features of the methodology, implementation and results. The guidelines provide steps for information gathering and present examples of acceptable practices as well as of potential deficiencies. Both review stages may result in requests for clarification, additional documentation or analyses. The first applications of the guidelines consist of the preliminary reviews of two HRAs. (author)

  18. EPA Communications Stylebook: Writing Guide

    Science.gov (United States)

    For the most part, EPA follows the Associated Press (AP) Stylebook. Other requirements of basic punctuation and grammar and usage in EPA writing modify, supplement, or in some cases reiterate AP style.

  19. EPA Alternative Dispute Resolution Contacts

    Science.gov (United States)

    The success of EPA's ADR efforts depends on a network of talented and experienced professionals in Headquarters offices and EPA Regions. For Agency-wide ADR information, please contact the Conflict Prevention and Resolution Center.

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

    Energy Technology Data Exchange (ETDEWEB)

    1985-04-01

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

  1. Regulatory categories of probiotics across the globe: A review representing existing and recommended categorization

    Directory of Open Access Journals (Sweden)

    M Arora

    2015-01-01

    Full Text Available Probiotics are friendly live microorganisms (in most cases, bacteria that are similar to beneficial micro-organisms found in the human gut, whenever consumed, have potential to confer benefit to the health of consumers by maintaining, or improving their intestinal microbial flora and are available to consumers mainly in the form of dietary supplements and foods. All-time high interest in the field of probiotics is due to emerging probiotic industry. Probiotics are available in foods and dietary supplements, even as pharmaceutical formulations (capsules, tablets and powders and in some other forms as well, but their claims of health benefits may challenge the traditional border between food and medicine. A number of probiotic products have been already introduced into the international market as food supplements, dietary supplements, natural health products, functional foods and many more other categories; as a result, the position of regulatory system for probiotics within existing categories become vague and quite unclear. Common terminology for probiotic products has become a necessity to achieve adequate regulatory control for discussion of probiotic-related issues among government, producers and consumers. The lack of a consistent terminology across the globe leads to legal uncertainty and confusion instead of being a direct obstacle for development of a mature market. This article will explain differences in regulatory categorizations across the globe; discuss the terms like food and drugs with a close relationship to probiotics, the problems associated with unsatisfactorily approached categorization as well as suggestive consolidations for the new categorization which will demarcate probiotics into categories explaining their nutritive claims, health claims or both.

  2. Proposed Changes to EPA's Transuranic Waste Characterization Approval Process

    International Nuclear Information System (INIS)

    Joglekar, R.D.; Feltcorn, E.M.; Ortiz, A.M.

    2003-01-01

    This paper describes the changes to the waste characterization (WC) approval process proposed in August 2002 by the U.S. Environmental Protection Agency (EPA or the Agency or we). EPA regulates the disposal of transuranic (TRU) waste at the Waste Isolation Pilot Plant (WIPP) repository in Carlsbad, New Mexico. EPA regulations require that waste generator/storage sites seek EPA approval of WC processes used to characterize TRU waste destined for disposal at WIPP. The regulations also require that EPA verify, through site inspections, characterization of each waste stream or group of waste streams proposed for disposal at the WIPP. As part of verification, the Agency inspects equipment, procedures, and interviews personnel to determine if the processes used by a site can adequately characterize the waste in order to meet the waste acceptance criteria for WIPP. The paper discusses EPA's mandate, current regulations, inspection experience, and proposed changes. We expect that th e proposed changes will provide equivalent or improved oversight. Also, they would give EPA greater flexibility in scheduling and conducting inspections, and should clarify the regulatory process of inspections for both Department of Energy (DOE) and the public

  3. Technical bases for regulatory review; comparison of practices, standards and guides

    International Nuclear Information System (INIS)

    Vinck, W.; Naurer, H.; Van Reijen, G.

    1979-01-01

    In first place, national licensing and regulatory scenes are presentd, as well as correlations between: a) Correlations and industrial standards; b) national and international developments. The purpose of harmonisation efforts and ongoing activities, especially within the EC, are highlighted. For the purpose of being sufficiently specific, three specific areas are dealt with as examples, explaining how actual application of practices and criteria in EC Member States correlate (or not) to one another including the points of convergence and divergences: protection against aircraft crash, seismic effects, protection against fuel handling accidents. Conclusive remarks deal with the origin in and relative importance of discrepancies in safety practices and criteria. (author)

  4. Special Report on China and Chinese Provinces. Policy and Regulatory Review

    International Nuclear Information System (INIS)

    Song, A.; Hinostroza Parades, J.A.; O'Leary, M.; Owen, G.

    2010-06-01

    This review outlines the legislation and policies and roles of institutions involved in sustainable energy (renewable energy and energy efficiency) in China at Central and Provincial Government level.

  5. A review of human biomonitoring data used in regulatory risk assessment under Canada's Chemicals Management Program.

    Science.gov (United States)

    Zidek, Angelika; Macey, Kristin; MacKinnon, Leona; Patel, Mikin; Poddalgoda, Devika; Zhang, Yi

    2017-03-01

    As a part of the Chemicals Management Plan launched in 2006, the Government of Canada is assessing and managing, where appropriate, the potential health and ecological risks associated with approximately 4300 substances under the Canadian Environmental Protection Act (1999). Since that time, nearly 3000 substances have been assessed, with human biomonitoring (HBM) data playing an increasingly important role for some substances. Case studies are presented, including both inorganic and organic substances (i.e., selenium, triclosan, phthalates), which highlight the impact and overall role HBM has had in regulatory decision making in Canada for these three substances as well as criteria used in the application of HBM data in human health risk assessment. An overview of its limitations in terms of how and when HBM data can be applied, when assessing human health in a regulatory setting, is discussed as well as the role HBM data can play in priority setting. Crown Copyright © 2016. Published by Elsevier GmbH. All rights reserved.

  6. Forum of Nuclear Regulatory Bodies in Africa: A Peer Review Mechanism

    International Nuclear Information System (INIS)

    Elegba, S.B.

    2010-01-01

    Uses of Radiation Sources in Africa has Safety and Security Implications that include exposure of workers in all and exposure of Patients in Medical Application. The Safety Principle is primarily: the prevention of harm and protection of health, safety and the environment. The Security Principle recognizes the importance of preventing diversion or malicious acts. Security of Radioactive Sources during use, storage, transportation and Disposal of radioactive waste is of great concern. IAEA Model Project on the “Establishment of Radiation Protection Infrastructure” in Member Sates started in 1995. During the 49. General Conference Statements made by several African Member States revealed the desire of the various Member States to embark on nuclear power for electricity generation. This development thus expanded the original scope of the discussion from radiation protection to now include nuclear safety and nuclear security. During the 50. General Conference of September 2006 Special Event entitled “New Framework for the Utilization of Nuclear Energy in the 21. Century: Assurances of Nuclear Supply and Non-Proliferation was established. Basic Safety Fundamentals SF-1, 2006 shows those basic safety principles for nuclear safety, radiation protection; Waste management and transport safety are similar. Regional Cooperation formed an organization to be known as the Forum of Nuclear Regulatory Bodies in Africa (FNRBA) to provide for the enhancement, strengthening and harmonization of the radiation protection, nuclear safety and security regulatory infrastructure and framework among the members of FNRBA

  7. Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations.

    Science.gov (United States)

    Lysaght, Tamra; Kerridge, Ian H; Sipp, Douglas; Porter, Gerard; Capps, Benjamin J

    2017-06-01

    Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies.

  8. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2016-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 1er novembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel La permanence suivante aura lieu le mardi 29 novembre 2016. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/ Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php  

  9. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 31 octobre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel La permanence suivante aura lieu le mardi 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/ Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  10. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 29 août de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/ Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php  

  11. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 28 novembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/ Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  12. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 30 mai de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/ Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  13. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 26 septembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 31 octobre et 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/ Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  14. EPA's Radioactive Source Program

    International Nuclear Information System (INIS)

    Kopsick, D.

    2004-01-01

    The US EPA is the lead Federal agency for emergency responses to unknown radiological materials, not licensed, owned or operated by a Federal agency or an Agreement state (Federal Radiological Emergency Response Plan, 1996). The purpose of EPA's clean materials programme is to keep unwanted and unregulated radioactive material out of the public domain. This is achieved by finding and securing lost sources, maintaining control of existing sources and preventing future losses. The focus is on both, domestic and international fronts. The domestic program concentrates on securing lost sources, preventing future losses, alternative technologies like tagging of radioactive sources in commerce, pilot radioactive source roundup, training programs, scrap metal and metal processing facilities, the demolition industry, product stewardship and alternatives to radioactive devices (fewer radioactive source devices means fewer orphan sources). The international program consists of securing lost sources, preventing future losses, radiation monitoring of scrap metal at ports and the international scrap metal monitoring protocol

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

    International Nuclear Information System (INIS)

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

    2015-01-01

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

  16. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 31 janvier de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 28 février, 28 mars, 25 avril, 30 mai, 29 août, 26 septembre, 31 octobre et 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. e-mail : gac-epa@gac-epa.org.

  17. A comprehensive review of regulatory test methods for endocrine adverse health effects.

    Science.gov (United States)

    Manibusan, M K; Touart, L W

    2017-07-01

    Development of new endocrine disruption-relevant test methods has been the subject of intensive research efforts for the past several decades, prompted in part by mandates in the 1996 Food Quality Protection Act (FQPA). While scientific understanding and test methods have advanced, questions remain on whether current scientific methods are capable of adequately addressing the complexities of the endocrine system for regulatory health and ecological risk assessments. The specific objective of this article is to perform a comprehensive, detailed evaluation of the adequacy of current test methods to inform regulatory risk assessments of whether a substance has the potential to perturb endocrine-related pathways resulting in human adverse effects. To that end,  approximately 42 existing test guidelines (TGs) were considered in the evaluation of coverage for endocrine-related adverse effects. In addition to evaluations of whether test methods are adequate to capture endocrine-related effects, considerations of further enhancements to current test methods, along with the need to develop novel test methods to address existing test method gaps are described. From this specific evaluation, up to 35 test methods are capable of informing whether a chemical substance perturbs known endocrine related biological pathways. Based on these findings, it can be concluded that current validated test methods are adequate to discern substances that may perturb the endocrine system, resulting in an adverse health effect. Together, these test methods predominantly form the core data requirements of a typical food-use pesticide registration submission. It is recognized, however, that the current state of science is rapidly advancing and there is a need to update current test methods to include added enhancements to ensure continued coverage and public health and environmental protection.

  18. 76 FR 38328 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-06-30

    ... process? 2. What criteria should the Commission use to prioritize the review of existing regulations? 3... the spirit of the Executive Orders. The Commission states that ``Phase One'' of a retrospective...

  19. Development of Risk Insights for Regulatory Review of a Near-Surface Disposal Facility for Radioactive Waste

    International Nuclear Information System (INIS)

    Esh, D.W.; Ridge, A.C.; Thaggard, M.

    2006-01-01

    Section 3116 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA) requires the Department of Energy (DOE) to consult with the Nuclear Regulatory Commission (NRC) about non-High Level Waste (HLW) determinations. In its consultative role, NRC performs technical reviews of DOE's waste determinations but does not have regulatory authority over DOE's waste disposal activities. The safety of disposal is evaluated by comparing predicted disposal facility performance to the performance objectives specified in NRC regulations for the disposal of low-level waste (10 CFR Part 61 Subpart C). The performance objectives contain criteria for protection of the public, protection of inadvertent intruders, protection of workers, and stability of the disposal site after closure. The potential radiological dose to receptors typically is evaluated with a performance assessment (PA) model that simulates the release of radionuclides from the disposal site, transport of radionuclides through the environment, and exposure of potential receptors to residual contamination for thousands of years. This paper describes NRC's development and use of independent performance assessment modeling to facilitate review of DOE's non-HLW determination for the Saltstone Disposal Facility (SDF) at the Savannah River Site. NRC's review of the safety of near-surface disposal of radioactive waste at the SDF was facilitated and focused by risk insights developed with an independent PA model. The main components of NRC's performance assessment model are presented. The development of risk insights that allow the staff to focus review efforts on those areas that are most important to satisfying the performance objectives is discussed. Uncertainty analysis was performed of the full stochastic model using genetic variable selection algorithms. The results of the uncertainty analysis were then used to guide the development of simulations of other scenarios to understand the key risk

  20. Strengthening Transparency in Regulatory Science

    Science.gov (United States)

    Where available and appropriate, EPA will use peer-reviewed information, standardized test methods, consistent data evaluation procedures, and good laboratory practices to ensure transparent, understandable, and reproducible scientific assessments.

  1. 76 FR 44583 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2011-07-26

    ... designated method are manufactured in an ISO 9001-registered facility. Also, an applicant must submit a minor... of Management and Budget (OMB) for review and approval. This is a request to renew an existing... and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725...

  2. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 5. Summary - Piping Review Committee conclusions and recommendations

    International Nuclear Information System (INIS)

    1985-04-01

    This document summarizes a comprehensive review of NRC requirements for Nuclear Piping by the US NRC Piping Review Committee. Four topical areas, addressed in greater detail in Volumes 1 through 4 of this report, are included: (1) Stress Corrosion Cracking in Piping of Boiling Water Reactor Plants; (2) Evaluation of Seismic Design; (3) Evaluation of Potential for Pipe Breaks; and (4) Evaluation of Other Dynamic Loads and Load Combinations. This volume summarizes the major issues, reviews the interfaces, and presents the Committee's conclusions and recommendations for updating NRC requirements on these issues. This report also suggests research or other work that may be required to respond to issues not amenable to resolution at this time

  3. Fifty Years of Safeguards under the EURATOM Treaty. A Regulatory Review

    International Nuclear Information System (INIS)

    Patel, B.; Chare, P.

    2007-01-01

    March 2007 marked the 50th anniversary of the signing of one of the founding treaties of the European Community. The EURATOM Treaty has its origins at a time when the stability of energy supplies in Europe was a major concern. Recently, much debate has centred on the possible reform or repeal of some parts of the treaty, given that its original aim was to promote and oversee the development of nuclear energy in Europe. This debate has focused attention on the future contribution of nuclear power to increasing energy demands in an enlarged Europe. However, despite these issues there is near universal agreement that the EURATOM Treaty has played a vital role in the protection of European citizens through the controls required for nuclear materials. Chapter 7 of the treaty (Safeguards) confers wide regulatory powers to the European Commission to ensure that civil nuclear materials are not diverted from their intended use as declared by the operators. This paper describes the early period of operation of the safeguards inspectorate, and gives statistics on the numbers and types of inspections carried out by the EURATOM inspectors, and discusses from an operational point of view the value of inspection activities. Further, a critical appraisal of Articles 77-85 within Chapter 7 is made. The paper also considers those safeguards requirements that are important to strengthen, in order to maintain a strong regulatory system to oversee future challenges, particularly in the context of increasing decommissioning activities within Europe. It is noteworthy that fifty-years after the founding of the treaty, many of the concerns about security of energy supply have re-emerged. It is a measure of the vision and forward thinking of its founders that the treaty has successfully overseen the safe and secure development of nuclear power in Europe (which currently provides a third of its electricity needs) and despite the many changes and developments that have occurred, that the

  4. 76 FR 39343 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-07-06

    ... proposes to use to set priorities for the retrospective review of its regulations; (2) identifies an... agency use in setting priorities? The factors ED will use in setting priorities for the retrospective... existing regulations), and priorities, requirements, definitions, and selection criteria governing...

  5. 76 FR 79141 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2011-12-21

    ... initial notice within a reasonable time after establishing a customer relationship in two additional..., requires an agency to review its rules that have a significant economic impact upon a substantial number of... be amended or rescinded * * * to minimize any significant economic impact of the rules upon a...

  6. 76 FR 13532 - Reducing Regulatory Burden; Retrospective Review Under Executive Order 13563

    Science.gov (United States)

    2011-03-14

    ... maintain and strengthen the Nation's economy by enabling the establishment and viability of small... review existing rules to remove outdated regulations that stifle job creation and make the U.S. economy... needs fixing and why. Comments do not necessarily have to address how to fix the perceived problem...

  7. 77 FR 71743 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2012-12-04

    ... complexity of the rule; The extent to which the rule overlaps, duplicates or conflicts with other federal... 19251 (Mar. 30, 1981). List of Rules To Be Reviewed Title: Role of Independent Directors of Investment... solely of independent directors that oversees the fund's accounting and auditing processes; (ii) adopts...

  8. 76 FR 18134 - Reducing Regulatory Burden; Review Under E.O. 13563

    Science.gov (United States)

    2011-04-01

    ... regulations for review, alternative approaches, etc.--to help prepare the preliminary plan. There will be... private defined benefit plans. PBGC receives no funds from general tax revenues. Operations are financed... participants, improve transparency, simplify filing, provide relief for small businesses, and assist plans to...

  9. 76 FR 17572 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-03-30

    ... businesses and the public. Agencies must consider approaches that maintain freedom of choice and flexibility... regulations, invites interested members of the public to submit comments on its preliminary plan to review....regulations.gov . Additional Instructions. In general, comments received, including attachments and other...

  10. US EPA Region 4 Brownfields

    Science.gov (United States)

    To improve public health and the environment, the United States Environmental Protection Agency (USEPA) collects information about facilities, sites, or places subject to environmental regulation or of environmental interest. Through the Geospatial Data Download Service, the public is now able to download the EPA Geodata shapefile containing facility and site information from EPA's national program systems. The file is Internet accessible from the Envirofacts Web site (https://www3.epa.gov/enviro/). The data may be used with geospatial mapping applications. (Note: The shapefile omits facilities without latitude/longitude coordinates.) The EPA Geospatial Data contains the name, location (latitude/longitude), and EPA program information about specific facilities and sites. In addition, the file contains a Uniform Resource Locator (URL), which allows mapping applications to present an option to users to access additional EPA data resources on a specific facility or site. This dataset shows Brownfields listed in the 2012 Facility Registry System.

  11. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 25 avril de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 30 mai, 29 août, 26 septembre, 31 octobre et 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  12. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 28 février de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 28 mars, 25 avril, 30 mai, 29 août, 26 septembre, 31 octobre et 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  13. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 28 mars de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 25 avril, 30 mai, 29 août, 26 septembre, 31 octobre et 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  14. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2017-01-01

    Le GAC organise des permanences avec entretiens individuels qui se tiennent le dernier mardi de chaque mois, sauf en juin, juillet et décembre. La prochaine permanence se tiendra le : Mardi 30 mai de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 29 août, 26 septembre, 31 octobre et 28 novembre 2017. Les permanences du Groupement des Anciens sont ouvertes aux bénéficiaires de la Caisse de pensions (y compris les conjoints survivants) et à tous ceux qui approchent de la retraite. Nous invitons vivement ces derniers à s’associer à notre groupement en se procurant, auprès de l’Association du personnel, les documents nécessaires. Informations : http://gac-epa.org/. Formulaire de contact : http://gac-epa.org/Organization/ContactForm/ContactForm-fr.php

  15. Electrostatic Plasma Accelerator (EPA)

    Science.gov (United States)

    Brophy, John R.; Aston, Graeme

    1995-01-01

    The application of electric propulsion to communications satellites, however, has been limited to the use of hydrazine thrusters with electric heaters for thrust and specific impulse augmentation. These electrothermal thrusters operate at specific impulse levels of approximately 300 s with heater powers of about 500 W. Low power arcjets (1-3 kW) are currently being investigated as a way to increase specific impulse levels to approximately 500 s. Ion propulsion systems can easily produce specific impulses of 3000 s or greater, but have yet to be applied to communications satellites. The reasons most often given for not using ion propulsion systems are their high level of overall complexity, low thrust with long burn times, and the difficulty of integrating the propulsion system into existing commercial spacecraft busses. The Electrostatic Plasma Accelerator (EPA) is a thruster concept which promises specific impulse levels between low power arcjets and those of the ion engine while retaining the relative simplicity of the arcjet. The EPA thruster produces thrust through the electrostatic acceleration of a moderately dense plasma. No accelerating electrodes are used and the specific impulse is a direct function of the applied discharge voltage and the propellant atomic mass.

  16. The U.S. Nuclear Regulatory Commission's antitrust review of nuclear power plants: the conditioning of licenses

    International Nuclear Information System (INIS)

    Penn, D.W.; Delaney, J.B.; Honeycutt, T.C.

    1976-04-01

    The 1970 amendments to Section 105 of the Atomic Energy Act require the Nuclear Regulatory Commission to conduct a prelicensing antitrust review of applications for licenses to construct and operate nuclear power plants. The Commission must make a finding as to whether the granting of a license 'would create or maintain a situation inconsistent with the antitrust laws,' and it has the authority to issue or continue a license, to refuse to issue a license, to rescind or amend a license, and to issue a license with conditions that it deems appropriate. This report provides information about the antitrust license conditions that have resulted from the NRC's antitrust review process. The process itself is described and a catalog of the applications requiring antitrust license conditions is presented. For each application, the license conditions are put into the general categories of unit access, transmission services, coordination, and contractual provisions. For completeness, the report also catalogs applications requiring no antitrust license conditions, and lists applications that were exempted from the 1970 amendments, are the subject of litigation, or have been withdrawn

  17. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 3. Evaluation of potential for pipe breaks

    Energy Technology Data Exchange (ETDEWEB)

    1984-11-01

    The Executive Director for Operations (EDO) in establishing the Piping Review Committee concurred in its overall scope that included an evaluation of the potential for pipe breaks. The Pipe Break Task Group has responded to this directive. This report summarizes a review of regulatory documents and contains the Task Group's recommendations for application of the leak-before-break (LBB) approach to the NRC licensing process. The LBB approach means the application of fracture mechanics technology to demonstrate that high energy fluid piping is very unlikely to experience double-ended ruptures or their equivalent as longitudinal or diagonal splits. The Task Group's reommendations and discussion are founded on current and ongoing NRC staff actions as presented in Section 3.0 of this report. Additional more detailed comments and discussion are presented in Section 5.0 and in Appendices A and B. The obvious issues are the reexamination of the large pipe break criteria and the implications of any changes in the criteria as they influence items such as jet loads and pipe whip. The issues have been considered and the Task Group makes the following recommendations.

  18. Insight from a Critical Review on the Safety Analysis of Nuclear Fuel Cycle Facility for Domestic Regulatory System

    International Nuclear Information System (INIS)

    Hong, Soon Joon; Chung, Young Wook; Jeong, Seung Young

    2010-01-01

    Korea has 20 nuclear power plants in operation, and 10,761 ton of spent fuel deposited in plant sites. The capacity of reservoir for spent fuel in plant sites is to begin to be full in 2016. The light water reactors of 16 units generate around 320 ton/year and the heavy water reactors of 4 units around 380 ton/year in Korea. And the electricity generated by nuclear power plants is planned to increase up to 59% share by 2030. Spent fuel classified as high level radioactive waste in law is characterized by high level radiation, high heat generation, and high radiological toxicity. In the contrary, it is also a very useful domestic energy source. Thus, the safe management of spent fuel is very important confronting job in nuclear industry. Advanced fuel cycle (AFC) using pyro-process is an innovative technology, by which environmental load is drastically relieved because the extracted long-lived fission products are burn in fast breeder reactors. Domestic nuclear industry also has a perspective road map for the construction of AFC facilities. However, there is not a sufficiently detailed licensing regulatory system yet. Moreover, there is no systematic frame for the safety evaluation. This paper reviews the safety analysis system of foreign fuel cycle facilities. Critical review leads to the insight for setting-up safety analysis system of domestic AFC facilities

  19. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 3. Evaluation of potential for pipe breaks

    International Nuclear Information System (INIS)

    1984-11-01

    The Executive Director for Operations (EDO) in establishing the Piping Review Committee concurred in its overall scope that included an evaluation of the potential for pipe breaks. The Pipe Break Task Group has responded to this directive. This report summarizes a review of regulatory documents and contains the Task Group's recommendations for application of the leak-before-break (LBB) approach to the NRC licensing process. The LBB approach means the application of fracture mechanics technology to demonstrate that high energy fluid piping is very unlikely to experience double-ended ruptures or their equivalent as longitudinal or diagonal splits. The Task Group's reommendations and discussion are founded on current and ongoing NRC staff actions as presented in Section 3.0 of this report. Additional more detailed comments and discussion are presented in Section 5.0 and in Appendices A and B. The obvious issues are the reexamination of the large pipe break criteria and the implications of any changes in the criteria as they influence items such as jet loads and pipe whip. The issues have been considered and the Task Group makes the following recommendations

  20. Weight of evidence approaches for the identification of endocrine disrupting properties of chemicals: Review and recommendations for EU regulatory application.

    Science.gov (United States)

    Gross, Melanie; Green, Richard M; Weltje, Lennart; Wheeler, James R

    2017-12-01

    A Weight-of-evidence (WoE) evaluation should be applied in assessing all the available data for the identification of endocrine disrupting (ED) properties of chemicals. The European Commission draft acts specifying criteria under the biocidal products and plant protection products regulations require that WoE is implemented for the assessment of such products. However, only some general considerations and principles of how a WoE should be conducted are provided. This paper reviews WoE approaches to distil key recommendations specifically for the evaluation of potential ED properties of chemicals. In a manner, which is consistent with existing, published WoE frameworks, the WoE evaluation of ED properties can be divided into four phases: 1) Definition of causal questions and data gathering and selection, 2) Review of individual studies, 3) Data integration and evaluation, and 4) Drawing conclusions based on inferences. Recommendations are made on how to conduct each phase robustly and transparently to help guide the WoE evaluation of potential endocrine disrupting properties of chemicals within a European regulatory context. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

  1. The NEA International FEP Database and its use in support of regulatory review

    International Nuclear Information System (INIS)

    Sumerling, T.

    1999-01-01

    A working group of the Nuclear Energy Agency has developed a database of features, events and processes (FEPs) relevant to the assessment of the long-term safety of radioactive waste disposal facilities. The Environment Agency participated in this work as described in a previous report, R and D Technical Report P97. This report describes work done in order to (i) provide an electronic version of the NEA International FEP Database in a convenient form suited to the Agency's needs; (ii) determine procedures for use of the Database in support of the Agency's review of an applicant's safety case for solid radioactive disposal, and in other appropriate Agency activities. Section 1 of the report outlines the objectives and work done. Section 2 gives an overview of the current status, development and international use of the NEA FEP Database. Alternative uses of the Database by the Agency, and procedures for use, are discussed in Section 3. Two alternative procedures for use of the Database in scientific and technical review of an applicant's safety case are outlined and compared; these provide a framework for orderly identification and discussion of technical issues within the review. It is concluded that the way in which the Database is used will depend on the circumstances and also the aims and preferences of the Agency. Detailed procedures for the use of the Database are best defined for the specific circumstances, taking account of the level of information available from the applicant, and the time and resources which the Agency may wish to devote to a given phase of review. The NEA FEP Database has been developed as a tool to assist in performing or reviewing safety assessments of radioactive waste disposal facilities. The principle of the Database, and also the software framework, may be equally applicable to other technical or scientific assessments, e.g. of landfill facilities or river catchment pollution studies. Since the Database is now available to the Agency

  2. Modifying EPA radiation risk models based on BEIR VII

    International Nuclear Information System (INIS)

    Pawel, D.; Puskin, J.

    2007-01-01

    This paper summarizes a 'draft White Paper' that provides details on proposed changes in EPA's methodology for estimating radiogenic cancer risks. Many of the changes are based on the contents of a recent National Academy of Sciences (NAS) report (BEIR VII), that addresses cancer and genetic risks from low doses of low-LET radiation. The draft White Paper was prepared for a meeting with the EPA's Science Advisory Board's Radiation Advisory Committee (RAC) in September for seeking advice on the application of BEIR VII and on issues relating to these modifications and expansions. After receiving the Advisory review, we plan to implement the changes by publishing the new methodology in an EPA report, which we expect to submit to the RAC for final review. The revised methodology could then be applied to update the cancer risk coefficients for over 800 radionuclides that are published in EPA's Federal Guidance Report 13. (author)

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

    International Nuclear Information System (INIS)

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

    1987-05-01

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

  4. EPA'S ENVIRONMENTAL TECHNOLOGIES

    Science.gov (United States)

    The use of innovative technology is impeded by the lack of independent, credible information as to how the technology performs. Such data is needed by technology buyers and regulatory decision makers to make informed decisions on technologies that represent good financial invest...

  5. The role of efficiency estimates in regulatory price reviews: Ofgem's approach to benchmarking electricity networks

    International Nuclear Information System (INIS)

    Pollitt, Michael

    2005-01-01

    Electricity regulators around the world make use of efficiency analysis (or benchmarking) to produce estimates of the likely amount of cost reduction which regulated electric utilities can achieve. This short paper examines the use of such efficiency estimates by the UK electricity regulator (Ofgem) within electricity distribution and transmission price reviews. It highlights the place of efficiency analysis within the calculation of X factors. We suggest a number of problems with the current approach and make suggestions for the future development of X factor setting. (author)

  6. 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...

  7. EPA's radon study results

    International Nuclear Information System (INIS)

    Dowd, R.M.

    1988-01-01

    Last winter, in cooperation with agencies in 10 states and two metropolitan area counties, EPA measured the indoor air radon concentrations of 14,000 houses, some chosen statistically at random and some by request of the homeowner. Passive measurement methodologies were used, such as exposing a charcoal canister to the air for a few days and allowing the air to migrate in to the charcoal naturally. To reduce dilution of radon by the outside air, the protocol required that the house be shut up; therefore, the study was conducted during winter. The measuring device was placed in the lowest livable area (usually the basement) of each house to maximize potential concentration. It should be noted that these procedures are generally considered to be screening tests because they result in a worst-case measurement rather than a best value. The results of these findings are presented

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

    International Nuclear Information System (INIS)

    Kwon, Hyuk Il; Lim, Nam Jin

    2005-01-01

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

  9. Development of regulatory guide for review of aging management of the operating NPP

    Energy Technology Data Exchange (ETDEWEB)

    Shin, Tae Myung; Lee, Jae Kyung [Cheongju Univ., Cheongju (Korea, Republic of); Kim, Young Ryul [Korea Advanced Institute of Science and Technology, Taejon (Korea, Republic of)

    2001-03-15

    This is the final report of the second year study. Based on the first year study, proposal of revised guidelines, analysis of revised or newly issued IAEA safety guides and reference guidelines of developed countries, and proposal of detailed guidelines of aging management in PSR have been performed in the second year study. The summary of results in the study so far can be summarized as below, overall view on PSR and idea of effective domestic application were leaded through additional investigation and comparison of legal basis, experiences and current status of PSR implementation among the countries having operating NPPs including Korea. Strategies of adequate application of PSR are roughly reevaluated and totally reestablished in summary from the analysis in factor by factor basis of PSR implementation experience in foreign countries and background of IAEA guidelines. Models and draft framework of PSR report in the first year study were summarized and reevaluated, and structure and outline options of PSR guidelines for judging the PSR report are newly proposed with comparison of their strengths and weaknesses based on the first year study. Among the opt ions, guidelines framework equivalent to the PSR report was picked up as the best. For the judgement of aging management, the most appropriate one was chosen for the detailed judgement of aging management review in our PSR being based on the Standard Review Plan for License Renewal (SRP-LR) in United States considering potential future usage in the judgement for continued operation of old NPP at the time of expiration of its design life. A draft PSR guidelines is prepared and attached by revision of basic guidelines issued in 2000, considering the issues discussed for the draft revision of IAEA PSR guide, the draft IAEA document about 'experience of PSR implementation of member states', and the characteristics of Hungarian PSR Guidelines.

  10. Special regulatory T-cell review: T-cell dependent suppression revisited.

    Science.gov (United States)

    Basten, Antony; Fazekas de St Groth, Barbara

    2008-01-01

    The concept of T-cell dependent regulation of immune responses has been a central tenet of immunological thinking since the delineation of the two cell system in the 1960s. Indeed T-cell dependent suppression was discovered before MHC restriction. When reviewing the data from the original wave of suppression, it is intriguing to reflect not just on the decline and fall of suppressor T cells in the 1980s, but on their equally dramatic return to respectability over the past decade. Hopefully their resurgence will be supported by solid mechanistic data that will underpin their central place in our current and future understanding of the immune system. Cannon to right of them, Cannon to left of them, Cannon in front of them Volley'd and thunder'd Storm'd at with shot and shell, Boldly they rode and well, Into the jaws of Death, Into the mouth of Hell, Rode the six hundred (suppressionists). (Adapted from The Charge of the Light Brigade, Alfred, Lord Tennyson)

  11. EPA's Information Architecture and Web Taxonomy

    Science.gov (United States)

    EPA's Information Architecture creates a topical organization of our website, instead of an ownership-based organization. The EPA Web Taxonomy allows audiences easy access to relevant information from EPA programs, by using a common vocabulary.

  12. A review of diazinon use, contamination in surface waters, and regulatory actions in California across water years 1992-2014.

    Science.gov (United States)

    Wang, Dan; Singhasemanon, Nan; Goh, Kean S

    2017-07-01

    Diazinon is an organophosphorus insecticide that has been widely used in the USA and in California resulting in contamination of surface waters. Several federal and state regulations have been implemented with the aim of reducing its impact to human health and the environment, e.g., the cancellation of residential use products by the USEPA and dormant spray regulations by the California Department of Pesticide Regulation. This study reviewed the change in diazinon use and surface water contamination in accordance with the regulatory actions implemented in California over water years 1992-2014. We observed that use amounts began declining when agencies announced the intention to regulate certain use patterns and continued to decline after the implementation of those programs and regulations. The reduction in use amounts led to a downward trend in concentration data and exceedance frequencies in surface waters. Moreover, we concluded that diazinon concentrations in California's surface waters in recent years (i.e., water years 2012-2014) posed a de minimis risk to aquatic organisms.

  13. BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

    Directory of Open Access Journals (Sweden)

    Maya Lyapina

    2015-02-01

    Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

  14. 78 FR 54517 - Water Quality Standards Regulatory Clarifications

    Science.gov (United States)

    2013-09-04

    ... 131 Water Quality Standards Regulatory Clarifications; Proposed Rule #0;#0;Federal Register / Vol. 78... AGENCY 40 CFR Part 131 [EPA-HQ-OW-2010-0606; FRL-9839-7] RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

  15. 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...

  16. A Review on the VHTR PIRT Development Status of Both Regulatory Authority and Licensee

    International Nuclear Information System (INIS)

    Hwang, Su Hyun; Jeon, Seong Su; Hong, Soon Joon; Lee, Byung Chul; Huh, Chang Wook; Jin, Chang Yong; Kim, Kyun Tae

    2011-01-01

    characteristics among NRC, KAERI and ANL will be reviewed here. The typical shape for each PIRT is shown in Figure 1

  17. 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...

  18. EPA Metadata Style Guide Keywords and EPA Organization Names

    Science.gov (United States)

    The following keywords and EPA organization names listed below, along with EPA’s Metadata Style Guide, are intended to provide suggestions and guidance to assist with the standardization of metadata records.

  19. EPA Office Points, Tutuila AS, 2009, US EPA Region 9

    Data.gov (United States)

    U.S. Environmental Protection Agency — The EPA office location in Tutila Island in American Samoa. American Samoa is an unincorporated and unorganized territory of the United States, and administered by...

  20. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2013-01-01

    Dear GAC-EPA members, This year, owing to works in the main Auditorium, we have to hold our General assembly in the auditorium of the Globe on 27 March 2013 and we really hope that you can be present. We wish to give you some preliminary practical recommendations: Do not forget your CERN access card, the guards may carry out checks. As far as possible, use public transport because there is very limited parking. If you come by car, park your vehicle on the car parks inside CERN because the outside car park cannot be used by visitors. Refreshments cannot be organized in the Globe; they will be held in cafeteria n°1, which will force us to move by using CERN entrances A or B or via building 33 (access cards required here too). We thank you for your attention and hope to see you soon. Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 2 avril de 13 h 30 à 16 h 00 Salle de réunion de l&rsquo...

  1. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2013-01-01

    En tant que Président du GAC-EPA, je porte à votre connaissance ce communiqué émanant de la Direction du CERN. Le 2 juin 2013, le CERN inaugure le projet Passeport Big Bang, un parcours touristique et scientifique formé de dix plates-formes d'exposition devant dix sites du CERN dans le Pays de Gex et le Canton de Genève. Les plateformes sont reliées par des itinéraires balisés et par un jeu de piste. C'est un projet est mené en collaboration avec les communes du Pays de Gex, Meyrin et Genève Tourisme dans un souci de renforcer notre dialogue avec nos voisins : http://passeport-big-bang.web.cern.ch/fr. A l’occasion de cette inauguration, nous organisons un événement populaire et festif : le matin, les familles pourront participer à des randonnées à vélo tandis que les sportifs pourront tester les 5...

  2. EPA Collaboration with South Korea

    Science.gov (United States)

    EPA, the Ministry of Environment of Korea, and partner agencies in both countries cooperate to strengthen environmental governance, improve air and water quality, and reduce exposure to toxic chemicals.

  3. EPA Nonregulatory Nonroad Duty Cycles

    Science.gov (United States)

    EPA nonregulatory, nonroad duty cycles for equipment such as agricultural tractors, backhoe loaders,crawlers tractors, excavators, arc welding skid steer loaders, and wheel loaders. Also,test procedures, laboratory methods, and emissions for this equipmen

  4. Regulatory review and confidence building in post-closure safety assessments and safety cases for near surface disposal facilities-IAEA ASAM coordinated research programme

    International Nuclear Information System (INIS)

    Gonzales, A.; Simeonov, G.; Bennett, D.G.; Nys, V.; Ben Belfadhel, M.

    2005-01-01

    Some years ago, the IAEA successfully concluded a Coordinated Research Program (CRP) called Islam, which focussed on the development of an Improved Safety Assessment Methodology for near-surface radioactive waste disposal facilities. In November 2002, and as an extension of ISAM, the IAEA launched a new CRP called ASAM, designed to test the Application of the Safety Assessment Methodology by considering a range of near-surface disposal facilities. The ASAM work programme is being implemented by three application working groups and two cross-cutting working groups. The application working groups are testing the applicability of the ISAM methodology by assessing an existing disposal facility in Hungary, a copper mine in South Africa, and a hypothetical facility containing heterogenous wastes, such as disused sealed sources. The first cross-cutting working group is addressing a number of technical issues that are common to all near-surface disposal facilities, while the second group, the Regulatory Review Working Group (RRWG) is developing 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 a brief overview of the work being conducted by the Regulatory Review Working Group. (author)

  5. EPA for Businesses and Non-Profits

    Science.gov (United States)

    Information and links to EPA web pages that are meant to help businesses and non-profits adhere to EPA regulations and otherwise protect the environment, take advantage of opportunities to collaborate with the EPA, and find training EPA training programs.

  6. A review of the methods used by the US Environmental Protection Agency to assess the financial impacts of the repository regulations

    International Nuclear Information System (INIS)

    Pflum, C.G.; Mattson, S.R.; Matthusen, A.C.

    1994-01-01

    All Federal agencies must consider the financial impacts of their regulations. When costs significantly outweigh benefits, the Office of Management and Budget can recommend that Congress not provide the funds needed to implement the regulation. Without funds, the agency is forced to either revise or retract the regulation. This has happened previously with a regulation on uranium mill tailings proposed by the US Nuclear Regulatory Commission (NRC) and it could happen again with the US Environmental Protection Agency (EPA) regulations that govern the disposal of high-level radioactive waste (HLW). The EPA (1985, 1992) claims that its regulation: ''Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Waste'' (40 CFR Part 191 or standards) does not increase costs above what the US Department of Energy (DOE) would spend anyway or, at most, what the DOE would spend to comply with 10 CFR Part 60: a regulation promulgated by the NRC. This report reviews and disputes the EPA claim. In Chapter 2 a summary of the basis for the EPA claim is presented and in Chapter 3 a critique of the basis of the claim is presented. This critique finds the EPA basis unrealistic, incomplete, and misleading. According to the EPA, a repository at Yucca Mountain would easily meet 40 CFR Part 191 even without the use of special engineered barriers. Because the NRC regulation (10 CFR Part 60) requires engineered barriers, the EPA places the onus for regulatory costs on the NRC. We disagree; the EPA standards drive regulatory costs as much as NRC regulations. The EPA has the higher responsibility for setting the overall standard for safety while the NRC can only implement this standard

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

    Energy Technology Data Exchange (ETDEWEB)

    Hendrickson, P.L.; McDonald, C.L.; Schilling, A.H.

    1976-12-01

    This report examines several aspects of the problems and choices facing the governmental decision maker who must take regulatory actions with multiple decision objectives and attributes. Particular attention is given to the problems facing the U.S. Nuclear Regulatory Commission (NRC) and to the decision attribute of chief concern to NRC, the protection of human health and safety, with emphasis on nuclear power plants. The study was undertaken to provide background information for NRC to use in refining its process of value/impact assessment of proposed regulatory actions. The principal conclusion is that approaches to rationally consider the value and impact of proposed regulatory actions are available. These approaches can potentially improve the decision-making process and enable the agency to better explain and defend its decisions. They also permit consistent examination of the impacts, effects of uncertainty and sensitivity to various assumptions of the alternatives being considered. Finally, these approaches can help to assure that affected parties are heard and that technical information is used appropriately and to the extent possible. The principal aspects of the regulatory decision problem covered in the report are: the legal setting for regulatory decisions which affect human health and safety, elements of the decision-making process, conceptual approaches to decision making, current approaches to decision making in several Federal agencies, and the determination of acceptable risk levels.

  8. Regulatory impact analysis of national emissions standards for hazardous air pollutants for by-product coke oven charging, door leaks, and topside leaks. Draft report

    International Nuclear Information System (INIS)

    1992-11-01

    Under the authority of the 1990 Clean Air Act Amendments, a Natioal Emissions Standard for Hazardous Air Pollutants is proposed to control emissions from By-product Coke Oven Charging, door leaks, and topside leaks. Because the EPA considers the regulation for By-product Coke Oven batteries to be a major rule, the attached Regulatory Impact Analysis was prepared to fulfill the requirements of E012291. The document reviews the need for regulation, control techniques, regulatory options, costs of control, economic impacts, benefits of the regulation, and compares benefits and costs associated with the regulation

  9. Memorandum of Understanding Between U.S. EPA Superfund and U.S. NRC

    International Nuclear Information System (INIS)

    Walker, Stuart

    2008-01-01

    The Environmental Protection Agency (EPA) Office of Superfund Remediation and Technology Innovation (OSRTI) and the Nuclear Regulatory Commission (NRC) are responsible for implementing the 'Memorandum of Understanding Between the Environmental Protection Agency and the Nuclear Regulatory Commission: Consultation and Finality on Decommissioning and Decontamination of Contaminated Sites'. This paper provides a brief overview of the origin of the Memorandum of Understanding (MOU), the major features of the MOU, and how the MOU has been implemented site specifically. EPA and NRC developed the MOU in response to direction from the House Committee on Appropriations to EPA and NRC to work together to address the potential for dual regulation. The MOU was signed by EPA on September 30, 2002 and NRC on October 9, 2002. The two agencies had worked on the MOU since March 2000. While both EPA and NRC have statutory authority to clean up these sites, the MOU provides consultation procedures between EPA and NRC to eliminate dual regulation. Under the MOU, EPA and NRC identified the interactions of the two agencies for the decommissioning and decontamination of NRC-licensed sites and the ways in which those responsibilities will be exercised. Except for Section VI, which addresses corrective action under the Resource Conservation and Recovery Act (RCRA), this MOU is limited to the coordination between EPA, when acting under its CERCLA authority, and NRC, when a facility licensed by the NRC is undergoing decommissioning, or when a facility has completed decommissioning, and the NRC has terminated its license. EPA believes that implementation of the MOU between the two agencies will ensure that future confusion about dual regulation does not occur regarding the cleanup and reuse of NRC-licensed sites. NRC and EPA have so far exchanged MOU consultation letters on eight NRC-licensed sites. EPA has responded to each consultation request with a letter expressing its views on actions

  10. EPA's Response to the February 2014 Release of Radioactive Material from the Waste Isolation Pilot Plant (WIPP): EPA's WIPP Air Sampling Data from April 2014

    Science.gov (United States)

    In April 2014, U.S. Environmental Protection Agency (EPA) environmental monitoring and assessment team members reviewed DOE's air sampling plan, visited DOE's air samplers and placed air samplers onsite near existing DOE samplers to corroborate results.

  11. Improving nuclear regulatory effectiveness

    International Nuclear Information System (INIS)

    2001-01-01

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

  12. 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)

  13. 75 FR 14593 - Environmental Impact Statements and Regulations; Availability of EPA Comments

    Science.gov (United States)

    2010-03-26

    ... Management Plan for Reef Fish Resources, Addresses Bycatch of Sea Turtles in the Bottom Longline Component of... ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-8989-4] Environmental Impact Statements and Regulations; Availability of EPA Comments Availability of EPA comments prepared pursuant to the Environmental Review Process...

  14. 40 CFR 131.22 - EPA promulgation of water quality standards.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 21 2010-07-01 2010-07-01 false EPA promulgation of water quality... PROGRAMS WATER QUALITY STANDARDS Procedures for Review and Revision of Water Quality Standards § 131.22 EPA promulgation of water quality standards. (a) If the State does not adopt the changes specified by the Regional...

  15. Dietary intake of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in children - a workshop report

    NARCIS (Netherlands)

    Koletzko, B.; Uauy, R.; Palou, A.; Kok, F.J.; Hornstra, G.; Eilander, A.; Moretti, D.; Osendarp, S.J.M.; Zock, P.L.; Innis, S.

    2010-01-01

    There is controversy whether children should have a dietary supply of preformed long-chain polyunsaturated n-3 fatty acids EPA and DHA. The aims of the workshop were to review evidence for a possible benefit of a preformed EPA and/or DHA supply, of data required to set desirable intakes for children

  16. 75 FR 62738 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides...

    Science.gov (United States)

    2010-10-13

    ... addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides; Notification to... protection of human subjects of research that apply to third parties who conduct or support research for...

  17. 76 FR 5735 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

    Science.gov (United States)

    2011-02-02

    ... addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn..., which suggest ethical considerations relevant to evaluation of human studies. Third, Petitioners argued... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides AGENCY...

  18. The relationship between time perspective and self-regulatory processes, abilities and outcomes: a protocol for a meta-analytical review.

    Science.gov (United States)

    Baird, Harriet M; Webb, Thomas L; Martin, Jilly; Sirois, Fuschia M

    2017-07-05

    Both theoretical and empirical evidence suggests that time perspective is likely to influence self-regulatory processes and outcomes. Despite the theoretical and practical significance of such relations, the relationship between time perspective and self-regulatory processes and outcomes across different measures, samples and life domains, including health, has yet to be explored. The proposed review will develop a taxonomy for classifying measures according to the self-regulatory process, ability or outcome that they are likely to reflect. Electronic scientific databases will be searched, along with relevant conference abstract booklets and citation lists. Additionally, a call for unpublished data will be submitted to relevant bodies. To be eligible for inclusion, studies must include a measure of time perspective and a measure of at least one self-regulatory process, ability and/ or outcome. Eligibility will not be restricted by publication date, language, type of sample or setting. The bivariate correlations will be extracted (or calculated) and submitted to a random-effects meta-analysis. The sample-weighted average effect size, heterogeneity, risk of bias and publication bias will be calculated, and the effects of categorical and continuous moderator variables on the effect sizes will be determined. The proposed meta-analysis will synthesise previously conducted research; thus, ethical approval is not required. The findings will be submitted for publication in an international peer-reviewed journal and reported as part of the first author’s PhD thesis. The findings will also be disseminated to the research community and, where appropriate, to other interested parties through presentations at relevant academic and non-academic conferences. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Electron-Positron Accumulator (EPA)

    CERN Multimedia

    Photographic Service

    1986-01-01

    After acceleration in the low-current linac LIL-W, the electrons and positrons are accumulated in EPA to obtain a sufficient intensity and a suitable time-structure, before being passed on to the PS for further acceleration to 3.5 GeV. Electrons circulate from right to left, positrons in the other direction. Dipole bending magnets are red, focusing quadrupoles blue, sextupoles for chromaticity-control orange. The vertical tube at the left of the picture belongs to an optical transport system carrying the synchrotron radiation to detectors for beam size measurement. Construction of EPA was completed in spring 1986. LIL-W and EPA were conceived for an energy of 600 MeV, but operation was limited to 500 MeV.

  20. 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

  1. Regulatory Forum Review*: Utility of in Vitro Secondary Pharmacology Data to Assess Risk of Drug-induced Valvular Heart Disease in Humans: Regulatory Considerations.

    Science.gov (United States)

    Papoian, Thomas; Jagadeesh, Gowraganahalli; Saulnier, Muriel; Simpson, Natalie; Ravindran, Arippa; Yang, Baichun; Laniyonu, Adebayo A; Khan, Imran; Szarfman, Ana

    2017-04-01

    Drug-induced valvular heart disease (VHD) is a serious side effect linked to long-term treatment with 5-hydroxytryptamine (serotonin) receptor 2B (5-HT 2B ) agonists. Safety assessment for off-target pharmacodynamic activity is a common approach used to screen drugs for this undesired property. Such studies include in vitro assays to determine whether the drug is a 5-HT 2B agonist, a necessary pharmacological property for development of VHD. Measures of in vitro binding affinity (IC 50 , K i ) or cellular functional activity (EC 50 ) are often compared to maximum therapeutic free plasma drug levels ( fC max ) from which safety margins (SMs) can be derived. However, there is no clear consensus on what constitutes an appropriate SM under various therapeutic conditions of use. The strengths and limitations of SM determinations and current risk assessment methodology are reviewed and evaluated. It is concluded that the use of SMs based on K i values, or those relative to serotonin (5-HT), appears to be a better predictor than the use of EC 50 or EC 50 /human fC max values for determining whether known 5-HT 2B agonists have resulted in VHD. It is hoped that such a discussion will improve efforts to reduce this preventable serious drug-induced toxicity from occurring and lead to more informed risk assessment strategies.

  2. Applicability of federal and state hazardous waste regulatory programs to waste chemical weapons and chemical warfare agents.; TOPICAL

    International Nuclear Information System (INIS)

    Haffenden, R.; Kimmell, T.

    2002-01-01

    This report reviews federal and state hazardous waste regulatory programs that govern the management of chemical weapons or chemical warfare agents. It addresses state programs in the eight states with chemical weapon storage facilities managed by the U.S. Army: Alabama, Arkansas, Colorado, Indiana, Kentucky, Maryland, Oregon, and Utah. It also includes discussions on 32 additional states or jurisdictions with known or suspected chemical weapons or chemical warfare agent presence (e.g., disposal sites containing chemical agent identification sets): Alaska, Arizona, California, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Louisiana, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, the U.S. Virgin Islands, Virginia, Washington, Washington, D.C., and Wyoming. Resource Conservation and Recovery Act (RCRA) hazardous waste programs are reviewed to determine whether chemical weapons or chemical warfare agents are listed hazardous wastes or otherwise defined or identified as hazardous wastes. Because the U.S. Environmental Protection Agency (EPA) military munitions rule specifically addresses the management of chemical munitions, this report also indicates whether a state has adopted the rule and whether the resulting state regulations have been authorized by EPA. Many states have adopted parts or all of the EPA munitions rule but have not yet received authorization from EPA to implement the rule. In these cases, the states may enforce the adopted munitions rule provisions under state law, but these provisions are not federally enforceable

  3. Learning from nuclear regulatory self-assessment. International peer review of the CSN report on lessons learnt from the essential service water system degradation event at the Vandellos nuclear power plant

    International Nuclear Information System (INIS)

    2006-01-01

    Nuclear regulatory self-assessment together with the benchmarking of regulatory practices against those of other countries operating nuclear power plants are key elements in maintaining a high level of nuclear safety. In that light, the Spanish Consejo de Seguridad Nuclear (CSN) formally asked the OECD Nuclear Energy Agency (NEA) to establish an international peer review team to assess the CSN report on the lessons learnt as a result of the 2004 Vandellos II event involving essential service water system degradation. The International Review Team considers the CSN report prepared in follow-up to the Vandellos event to be a commendable effort in regulatory self-assessment. The report, complemented by this international peer review, should enable the CSN to take appropriate action to ensure that its regulatory supervision is in line with best international practice. (authors)

  4. Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel

    Science.gov (United States)

    Fregni, F; Nitsche, MA; Loo, C.K.; Brunoni, AR; Marangolo, P; Leite, J; Carvalho, S; Bolognini, N; Caumo, W; Paik, NJ; Simis, M; Ueda, K; Ekhitari, H; Luu, P; Tucker, DM; Tyler, WJ; Brunelin, J; Datta, A; Juan, CH; Venkatasubramanian, G; Boggio, PS; Bikson, M

    2014-01-01

    The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. PMID:25983531

  5. A review from the regulatory position of the control of occupational exposure associated with the first 20 years of the United Kingdom commercial nuclear power programme

    International Nuclear Information System (INIS)

    Emmerson, B.W.

    1980-01-01

    The control of occupational exposure received at commercial nuclear generating plants in the United Kingdom has been subject to regulatory requirements embodied in site licence conditions since 1959, and at commercial fuel production and reprocessing plants since 1971. The paper indicates the main radiological control objectives which have applied, reviews the statutory measures introduced for their achievement and indicates some of the administrative arrangements made by site operators in order to comply. The principal sources of occupational exposure associated with each stage of the fuel cycle are identified and exposure data since licensed operations commenced are reviewed. The effectiveness of the United Kingdom site licensing procedure in ensuring adequate radiological control procedures, including the minimisation of occupational exposure, is examined in relation to the relevant ICRP recommendations and against the background of the first 20 years of commercial nuclear power production. The impact on these procedures of more recently introduced legislation relating to health and safety at all places of employment in the United Kingdom is discussed. The paper considers the changes in current regulatory procedures that may result from the introduction of ICRP-26 and the recommendations of ICRP Committee 2, and concludes with a review of the more important problems facing the licensee and the Nuclear Inspectorate with regard to the implementation of future radiological control procedures. (H.K.)

  6. Considerations in the development of EPA's proposed BRC criteria

    International Nuclear Information System (INIS)

    Holcomb, W.F.; Gruhlke, J.M.; Galpin, F.L.

    1988-01-01

    To support the concept of criteria for potential below-regulatory-concern (BRC) wastes the US Environmental Protection Agency (EPA) has developed technical information, cost data, a methodology for analyzing promising candidate waste streams, and a rationale for proposing the criteria. Risk assessments to support the BRC criteria include an analysis of surrogate radioactive waste streams, disposal alternatives, and diverse demographic settings. In arriving at a proposed BRC level, EPA carefully weighed and considered many factors. Foremost was protection of the public and the development of an exposure level with assurance of no undue risk. Also considered were other daily risks encountered, ability to demonstrate compliance, guidance for similar exemptions by other groups, consistency with other regulated risk levels, general population health risks, maximum annual exposures to critical population groups, and the costs presently associated with the regulation of these wastes

  7. EPA Principles for Greener Cleanups

    Science.gov (United States)

    A goal of the U.S. Environmental Protection Agency (EPA) Office and Land and Emergency Management (OLEM) and its many partners is to preserve and restore land by promoting and using protective waste management practices and by assessing and cleaning..

  8. EPA's Benchmark Dose Modeling Software

    Science.gov (United States)

    The EPA developed the Benchmark Dose Software (BMDS) as a tool to help Agency risk assessors facilitate applying benchmark dose (BMD) method’s to EPA’s human health risk assessment (HHRA) documents. The application of BMD methods overcomes many well know limitations ...

  9. EPA Region 1 Environmentally Sensitive Areas

    Data.gov (United States)

    U.S. Environmental Protection Agency — This coverage represents polygon equivalents of environmentally sensitive areas (ESA) in EPA Region I. ESAs were developed as part of an EPA headquarters initiative...

  10. U.S. EPA Metadata Editor (EME)

    Data.gov (United States)

    U.S. Environmental Protection Agency — The EPA Metadata Editor (EME) allows users to create geospatial metadata that meets EPA's requirements. The tool has been developed as a desktop application that...

  11. EPA Linked Open Data: Substance Registry Service

    Data.gov (United States)

    U.S. Environmental Protection Agency — Substance Registry Services (SRS) is the Environmental Protection Agency's (EPA) central system for information about substances that are tracked or regulated by EPA...

  12. 2011 EPA Pesticide General Permit (PGP)

    Data.gov (United States)

    U.S. Environmental Protection Agency — The 2011 EPA Pesticide General Permit (PGP) covers discharges of biological pesticides, and chemical pesticides that leave a residue, in areas where EPA is the NPDES...

  13. EPA-Registered Repellents for Mosquitoes Transmitting Emerging Viral Disease.

    Science.gov (United States)

    Patel, Radha V; Shaeer, Kristy M; Patel, Pooja; Garmaza, Aleksey; Wiangkham, Kornwalee; Franks, Rachel B; Pane, Olivia; Carris, Nicholas W

    2016-12-01

    In many parts of the United States, mosquitoes were previously nuisance pests. However, they now represent a potential threat in the spread of viral diseases. The Aedes aegypti, Aedes albopictus, and Culex species mosquitoes are endemic to the United States and together may transmit a variety of viral diseases of growing concern, including West Nile virus, chikungunya, dengue fever, and Zika virus. The Centers for Disease Control and Prevention and the Environmental Protection Agency (EPA) recommend N,N-diethyl-meta-toluamide (DEET) as a first-line mosquito repellent, but for patients refusing to use DEET or other conventional repellents, guidance is limited to any EPA-registered product. Therefore, we conducted a systematic review of the literature to identify which EPA-registered personal mosquito repellent provides the best protection from A. aegypti, A. albopictus, and Culex spp. mosquitoes. We abstracted data from 62 published reports of EPA-registered mosquito repellents. The conventional repellent picaridin has the strongest data to support its use as a second-line agent, while IR3535 and oil of lemon eucalyptus are reasonably effective natural products. Citronella, catnip, and 2-undecanone offer limited protection or have limited data. These results can be used by pharmacists and other health care professionals to advise patients on the selection of an EPA-registered mosquito repellent. Regardless of the repellent chosen, it is vital for patients to follow all instructions/precautions in the product labeling to ensure safe and effective use. © 2016 Pharmacotherapy Publications, Inc.

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

    International Nuclear Information System (INIS)

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

    1995-12-01

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

  15. Custom Search | ECHO | US EPA

    Science.gov (United States)

    ECHO, Enforcement and Compliance History Online, provides compliance and enforcement information for approximately 800,000 EPA-regulated facilities nationwide. ECHO includes permit, inspection, violation, enforcement action, and penalty information about facilities regulated under the Clean Air Act (CAA) Stationary Source Program, Clean Water Act (CWA) National Pollutant Elimination Discharge System (NPDES), and/or Resource Conservation and Recovery Act (RCRA). Information also is provided on surrounding demographics when available.

  16. Watershed Statistics | ECHO | US EPA

    Science.gov (United States)

    ECHO, Enforcement and Compliance History Online, provides compliance and enforcement information for approximately 800,000 EPA-regulated facilities nationwide. ECHO includes permit, inspection, violation, enforcement action, and penalty information about facilities regulated under the Clean Air Act (CAA) Stationary Source Program, Clean Water Act (CWA) National Pollutant Elimination Discharge System (NPDES), and/or Resource Conservation and Recovery Act (RCRA). Information also is provided on surrounding demographics when available.

  17. Review of nuclear regulatory activities associated with safety culture and the management of safety in the United Kingdom

    International Nuclear Information System (INIS)

    Woodhouse, P.A.

    1995-01-01

    This paper describes some of the key regulatory activities which have taken place in the United Kingdom in recent years in the areas of safety culture and management of safety. It explains how the UK's nuclear licensing regime, regulated and enforced by the Nuclear Installations Inspectorate, (NII), provides the framework for a viable safety management system and identifies a management of safety model which a NII Task Force has developed. It finally identifies further work which is being undertaken by the NII. (author). 4 refs, 2 figs

  18. Review of Regulatory Emphasis on Transportation Safety in the United States, 2002-2009: Public versus Private Modes.

    Science.gov (United States)

    Waycaster, Garrett C; Matsumura, Taiki; Bilotkach, Volodymyr; Haftka, Raphael T; Kim, Nam H

    2018-05-01

    The U.S. Department of Transportation is responsible for implementing new safety improvements and regulations with the goal of ensuring limited funds are distributed to where they can have the greatest impact on safety. In this work, we conduct a study of new regulations and other reactions (such as recalls) to fatal accidents in several different modes of transportation implemented from 2002 to 2009. We find that in the safest modes of commercial aviation and bus transport, the amount of spending on new regulations is high in relation to the number of fatalities compared to the regulatory attention received by less safe modes of general aviation and private automobiles. Additionally, we study two major fatal accident investigations from commercial aviation and two major automotive recalls associated with fatal accidents. We find differences in the cost per expected fatality prevented for these reactions, with the airline accident investigations being more cost effective. Overall, we observe trends in both the automotive and aviation sectors that suggest that public transportation receives more regulatory attention than private transport. We also observe that the types of safety remedies utilized, regulation versus investigation, have varying levels of effectiveness in different transport modes. We suggest that these differences are indicative of increased public demand for safety in modes where a third party may be held responsible, even for those not participating in the transportation. These findings have important implications for the transportation industry, policymakers, and for estimating the public demand for safety in new transport modes. © 2017 Society for Risk Analysis.

  19. EPA proposes options for control of industrial radioactivity

    International Nuclear Information System (INIS)

    Anon.

    1989-01-01

    The US Environmental Protection Agency on February 28 proposed four alternative approaches for controlling radionuclides from a dozen industrial sources. The proposal outlines four alternatives for regulating toxic air pollutant. The proposal is designed to elicit comment on such regulatory issues as: What are acceptable health risks? What are appropriate criteria for establishing a margin of safety? What are the technological feasibility and the costs of regulatory controls? How should uncertainty by considered? EPA intends to use the approach finally selected as the framework for future hazardous-air pollutant-control decisions. Industry uses hundreds of distinct radionuclides in solid, liquid and gaseous forms. Industrial radionuclide emissions occur either as a result of an inability to contain the radioactive materials or as an unintended consequence of other activity, such as radionuclide emissions from mining or milling

  20. EPA`s program for risk assessment guidelines: Quantification issues

    Energy Technology Data Exchange (ETDEWEB)

    Dourson, M.L. [Environmental Protection Agency, Washington, DC (United States)

    1990-12-31

    The quantitative procedures associated with noncancer risk assessment include reference dose (RfD), benchmark dose, and severity modeling. The RfD, which is part of the EPA risk assessment guidelines, is an estimation of a level that is likely to be without any health risk to sensitive individuals. The RfD requires two major judgments: the first is choice of a critical effect(s) and its No Observed Adverse Effect Level (NOAEL); the second judgment is choice of an uncertainty factor. This paper discusses major assumptions and limitations of the RfD model.

  1. US EPA - A*Star Partnership - Accelerating the Acceptance of ...

    Science.gov (United States)

    The path for incorporating new alternative methods and technologies into quantitative chemical risk assessment poses a diverse set of scientific challenges. Some of these challenges include development of relevant and predictive test systems and computational models to integrate and extrapolate experimental data, and rapid characterization and acceptance of these systems and models. The series of presentations will highlight a collaborative effort between the U.S. Environmental Protection Agency (EPA) and the Agency for Science, Technology and Research (A*STAR) that is focused on developing and applying experimental and computational models for predicting chemical-induced liver and kidney toxicity, brain angiogenesis, and blood-brain-barrier formation. In addressing some of these challenges, the U.S. EPA and A*STAR collaboration will provide a glimpse of what chemical risk assessments could look like in the 21st century. Presentation on US EPA – A*STAR Partnership at international symposium on Accelerating the acceptance of next-generation sciences and their application to regulatory risk assessment in Singapore.

  2. Review of a site developer's geo-scientific data and site-characterisation information to support repository certification

    International Nuclear Information System (INIS)

    Peake, R.T.; Byrum, C.; Ghose, S.

    2007-01-01

    The Waste Isolation Pilot Plant (WIPP) in New Mexico is a first-of-a-kind deep geologic facility for the disposal of transuranic (TRU) radioactive waste from weapons production in the United States. In 1993, Congress authorised the Environmental Protection Agency (EPA) to develop and implement WIPP-site-specific compliance criteria based on the general safety and environmental standards in EPA's high-level and transuranic radioactive waste regulations [1]. EPA published its site-specific regulations [2] in 1996 and certified WIPP to open in 1998. This regulatory framework set the stage for balancing diverse input data, provided a structure for document development, provided a mechanism for interaction between EPA and the Department of Energy (DOE), and provided a guide to support our review of WIPP's safety assessment. EPA's involvement continues during WIPP's operational phase. Confidence in repository site geo-scientific data enhances the regulator's ability to make a credible and defensible certification (licensing) decision and to communicate the basis for the decision to the public. Lack of confidence in the data can lead to lack of credibility about site suitability. Clear regulations and specific quality standards can enhance the quality of site-characterisation documentation and assist the regulator in its approval process of the site. In EPA's regulations, documentation is required on numerous issues, and EPA supplemented this with guidance. High-quality documentation is essential, especially for EPA. In the certification process for WIPP, the documentation in the record and our written interpretation of the record was what was used in legal proceedings that followed EPA's certification of WIPP. EPA and DOE had frequent and generally open communication. During formal regulatory proceedings, all communication had to be documented. Some decisions were made at the staff level, but major decisions were typically addressed and resolved through correspondence

  3. Review and evaluation of the Nuclear Regulatory Commission Safety Research Program for Fiscal Years 1984 and 1985

    International Nuclear Information System (INIS)

    1983-02-01

    This is the sixth report by the Advisory Committee on Reactor Safeguards (ACRS) that has been prepared in response to the Congressional requirement for an annual report on the Nuclear Regulatory Commission (NRC) Reactor Safety Research Program. Part I is a compilation of our general comments and recommendations regarding the NRC Safety Research Program, and includes budget recommendations and an identification of matters of special importance that deserve increased emphasis. It is intended to serve as an Executive Summary. Part II is divided into ten chapters, each of which represents a Decision Unit of the NRC research program. In each chapter, specific comments are included on the research involved in the Decision Unit, an assessment of priorities, and recommendations regarding new directions and levels of funding

  4. Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

    Science.gov (United States)

    Dearfield, Kerry L; Hoelzer, Karin; Kause, Janell R

    2014-08-01

    Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

  5. Regulatory Review: Delay of Effective Dates of Final Rules Subject to the Administration's January 20, 2001, Memorandum

    National Research Council Canada - National Science Library

    Rezendes, Victor

    2002-01-01

    ... taken effect.Citing the desire to ensure that the President s appointees have the opportunity to review any new or pending regulations, on January 20,,2001,Assistant to the President and Chief of Staff...

  6. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature

    Directory of Open Access Journals (Sweden)

    Wafula Francis N

    2012-07-01

    Full Text Available Abstract Background Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. Methods We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. Results We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory

  7. Examining characteristics, knowledge and regulatory practices of specialized drug shops in Sub-Saharan Africa: a systematic review of the literature.

    Science.gov (United States)

    Wafula, Francis N; Miriti, Eric M; Goodman, Catherine A

    2012-07-27

    Specialized drug shops such as pharmacies and drug shops are increasingly becoming important sources of treatment. However, knowledge on their regulatory performance is scarce. We set out to systematically review literature on the characteristics, knowledge and practices of specialized drug shops in Sub-Saharan Africa. We searched PubMed, EMBASE, WEB of Science, CAB Abstracts, PsycINFO and websites for organizations that support medicine policies and usage. We also conducted open searches using Google Scholar, and searched manually through references of retrieved articles. Our search included studies of all designs that described characteristics, knowledge and practices of specialized drug shops. Information was abstracted on authors, publication year, country and location, study design, sample size, outcomes investigated, and primary findings using a uniform checklist. Finally, we conducted a structured narrative synthesis of the main findings. We obtained 61 studies, mostly from Eastern Africa, majority of which were conducted between 2006 and 2011. Outcome measures were heterogeneous and included knowledge, characteristics, and dispensing and regulatory practices. Shop location and client demand were found to strongly influence dispensing practices. Whereas shops located in urban and affluent areas were more likely to provide correct treatments, those in rural areas provided credit facilities more readily. However, the latter also charged higher prices for medicines. A vast majority of shops simply sold whatever medicines clients requested, with little history taking and counseling. Most shops also stocked popular medicines at the expense of policy recommended treatments. Treatment policies were poorly communicated overall, which partly explained why staff had poor knowledge on key aspects of treatment such as medicine dosage and side effects. Overall, very little is known on the link between regulatory enforcement and practices of specialized drug shops

  8. 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.

  9. US EPA Region 4 RMP Facilities

    Science.gov (United States)

    To improve public health and the environment, the United States Environmental Protection Agency (USEPA) collects information about facilities, sites, or places subject to environmental regulation or of environmental interest. Through the Geospatial Data Download Service, the public is now able to download the EPA Geodata shapefile containing facility and site information from EPA's national program systems. The file is Internet accessible from the Envirofacts Web site (http://www.epa.gov/enviro). The data may be used with geospatial mapping applications. (Note: The shapefile omits facilities without latitude/longitude coordinates.) The EPA Geospatial Data contains the name, location (latitude/longitude), and EPA program information about specific facilities and sites. In addition, the file contains a Uniform Resource Locator (URL), which allows mapping applications to present an option to users to access additional EPA data resources on a specific facility or site.

  10. Session II-H. Regulatory implementation

    International Nuclear Information System (INIS)

    Farzin, M.H.

    1981-01-01

    During FY 1981, the program concepts for implementing the NRC and EPA regulations were formed. These concepts consist of: review and critique of proposed rules; interpretation of rules into practical performance objectives; and planning to achieve compliance of total system performance with the rules. Although still flexible because of the lack of final rules, notable advances in implementation of these concepts were achieved in FY 1981. Technically, proposed and draft rules were evaluated and resulting radionuclide release limits were compared for consistency. For issue identification and resolution activity, six LTR's were initiated, and other topics were identified. In activities leading to total system compliance with regulations, planning and implementation efforts were more clearly defined and integrated. Papers reported in this session are: (1) regulatory implementation concepts and program overview; (2) licensing issue resolution; (3) status of NEPA activities in the NNWSI Program; (4) status of NEPA activities in the ONWI Program; (5) NWTS approach to site characterization reporting; and (6) quality assurance perspectives relative to licensing needs

  11. 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

  12. Agriculture: About EPA's National Agriculture Center

    Science.gov (United States)

    EPA's National Agriculture Center (Ag Center), with the support of the United States Department of Agriculture, serves growers, livestock producers, other agribusinesses, and agricultural information/education providers.

  13. EPA Region 1 Environmentally Sensitive Areas (Points)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This coverage represents point equivalents of environmentally sensitive areas in EPA New England. This coverage represents polygon equivalents of environmentally...

  14. Report of the US Nuclear Regulatory Commission Piping Review Committee. Volume 4. Evaluation of other loads and load combinations

    International Nuclear Information System (INIS)

    1984-12-01

    Six topical areas were covered by the Task Group on Other Dynamic Loads and Load Combinations as described below: Event Combinations - dealing with the potential simultaneous occurrence of earthquakes, pipe ruptures, and water hammer events in the piping design basis; Response Combinations - dealing with multiply supported piping with independent inputs, the sequence of combinations between spacial and modal components of response, and the treatment of high frequency modes in combination with low frequency modal responses; Stress Limits/Dynamic Allowables - dealing with inelastic allowables for piping and strain rate effects; Water Hammer Loadings - dealing with code and design specifications for these loadings and procedures for identifying potential water hammer that could affect safety; Relief Valve Opening and Closing Loads - dealing with the adequacy of analytical tools for predicting the effects of these events and, in addition, with estimating effective cycles for fatigue evaluations; and Piping Vibration Loads - dealing with evaluation procedures for estimating other than seismic vibratory loads, the need to consider reciprocating and rotary equipment vibratory loads, and high frequency vibratory loads. NRC staff recommendations or regulatory changes and additional study appear in this report

  15. Technical and regulatory review of the Rover nuclear fuel process for use on Fort St. Vrain fuel

    International Nuclear Information System (INIS)

    Hertzler, T.

    1993-02-01

    This report describes the results of an analysis for processing and final disposal of Fort St. Vrain (FSV) irradiated fuel in Rover-type equipment or technologies. This analysis includes an evaluation of the current Rover equipment status and the applicability of this technology in processing FSV fuel. The analyses are based on the physical characteristics of the FSV fuel and processing capabilities of the Rover equipment. Alternate FSV fuel disposal options are also considered including fuel-rod removal from the block, disposal of the empty block, or disposal of the entire fuel-containing block. The results of these analyses document that the current Rover hardware is not operable for any purpose, and any effort to restart this hardware will require extensive modifications and re-evaluation. However, various aspects of the Rover technology, such as the successful fluid-bed burner design, can be applied with modification to FSV fuel processing. The current regulatory climate and technical knowledge are not adequately defined to allow a complete analysis and conclusion with respect to the disposal of intact fuel blocks with or without the fuel rods removed. The primary unknowns include the various aspects of fuel-rod removal from the block, concentration of radionuclides remaining in the graphite block after rod removal, and acceptability of carbon in the form of graphite in a high level waste repository

  16. 75 FR 28517 - 2004 and 2006 Biennial Regulatory Reviews-Streamlining and Other Revisions of the Commission's...

    Science.gov (United States)

    2010-05-21

    ... Commission for the transmission of radio energy, the owner of the tower shall maintain the prescribed.... FOR FURTHER INFORMATION CONTACT: John Borkowski, Wireless Telecommunications Bureau, (202) 418-0626, e... its 2004 Biennial Review Comments, PCIA--the Wireless Infrastructure Association (PCIA) states that...

  17. 75 FR 20843 - Notice of Workshop To Discuss Policy-Relevant Science to Inform EPA's Integrated Plan for the...

    Science.gov (United States)

    2010-04-21

    ... Policy-Relevant Science to Inform EPA's Integrated Plan for the Review of the Lead National Ambient Air.... Environmental Protection Agency (EPA) is announcing that a workshop entitled, ``Workshop to Discuss Policy... workshop will be open to attendance by interested public observers on a first-come, first-served basis up...

  18. International regulatory activities

    International Nuclear Information System (INIS)

    Anon.

    2009-01-01

    In this last part is reviewed international regulatory activities and bilateral agreements including two parts: concerning European atomic energy community with European commission proposal for a council directive setting up a community framework for nuclear safety, update of the nuclear illustrative programme in the context of the second strategic energy review, european commission recommendation on criteria for the export of radioactive waste and spent fuel to third countries and a communication on nuclear non-proliferation and the second part in relation with international atomic energy agency with a joint convention on the safety of spent fuel management and on safety of radioactive waste management (third review meeting). (N.C.)

  19. Review: Regulatory mechanisms of gonadotropin-inhibitory hormone (GnIH synthesis and release in photoperiodic animals

    Directory of Open Access Journals (Sweden)

    Kazuyoshi eTsutsui

    2013-04-01

    Full Text Available Gonadotropin-inhibitory hormone (GnIH is a novel hypothalamic neuropeptide that was discovered in quail as an inhibitory factor for gonadotropin release. GnIH inhibits gonadotropin synthesis and release in birds through actions on gonadotropin-releasing hormone (GnRH neurons and gonadotropes, mediated via the GnIH receptor (GnIH-R, GPR147. Subsequently, GnIH was identified in mammals and other vertebrates. As in birds, mammalian GnIH inhibits gonadotropin secretion, indicating a conserved role for this neuropeptide in the control of the hypothalamic-pituitary-gonadal (HPG axis across species. Identification of the regulatory mechanisms governing GnIH expression and release is important in understanding the physiological role of the GnIH system. A nocturnal hormone, melatonin, appears to act directly on GnIH neurons through its receptor to induce expression and release of GnIH in quail, a photoperiodic bird. Recently, a similar, but opposite, action of melatonin on the inhibition of expression of mammalian GnIH was shown in hamsters and sheep, photoperiodic mammals. These results in photoperiodic animals demonstrate that GnIH expression is photoperiodically modulated via a melatonin-dependent process. Recent findings indicate that GnIH may be a mediator of stress-induced reproductive disruption in birds and mammals, pointing to a broad role for this neuropeptide in assessing physiological state and modifying reproductive effort accordingly. This paper summarizes the advances made in our knowledge regarding the regulation of GnIH synthesis and release in photoperiodic birds and mammals. This paper also discusses the neuroendocrine integration of environmental signals, such as photoperiods and stress, and internal signals, such as GnIH, melatonin and glucocorticoids, to control avian and mammalian reproduction.

  20. State regulatory issues in acid rain compliance

    International Nuclear Information System (INIS)

    Solomon, B.D.; Brick, S.

    1992-01-01

    This article discusses the results of a US EPA workshop for state regulators and commission staff on acid rain compliance concerns. The topics of the article include the results of market-based emissions control, how emissions trading is expected to reduce emissions, public utility commissions approval of compliance plans, the purposes of the workshop, market information, accounting issues, regulatory process and utility planning, multi-state compliance planning, and relationship to other compliance issues

  1. Olive oil authentication: A comparative analysis of regulatory frameworks with especial emphasis on quality and authenticity indices, and recent analytical techniques developed for their assessment. A review.

    Science.gov (United States)

    Bajoub, Aadil; Bendini, Alessandra; Fernández-Gutiérrez, Alberto; Carrasco-Pancorbo, Alegría

    2018-03-24

    Over the last decades, olive oil quality and authenticity control has become an issue of great importance to consumers, suppliers, retailers, and regulators in both traditional and emerging olive oil producing countries, mainly due to the increasing worldwide popularity and the trade globalization of this product. Thus, in order to ensure olive oil authentication, various national and international laws and regulations have been adopted, although some of them are actually causing an enormous debate about the risk that they can represent for the harmonization of international olive oil trade standards. Within this context, this review was designed to provide a critical overview and comparative analysis of selected regulatory frameworks for olive oil authentication, with special emphasis on the quality and purity criteria considered by these regulation systems, their thresholds and the analytical methods employed for monitoring them. To complete the general overview, recent analytical advances to overcome drawbacks and limitations of the official methods to evaluate olive oil quality and to determine possible adulterations were reviewed. Furthermore, the latest trends on analytical approaches to assess the olive oil geographical and varietal origin traceability were also examined.

  2. Reducing the volume, exposure and negative impacts of advertising for foods high in fat, sugar and salt to children: a systematic review of the evidence from statutory and self-regulatory actions and educational measures

    OpenAIRE

    Chambers, Stephanie; Freeman, Ruth; Anderson, Annie S.; MacGillivray, Steve

    2015-01-01

    Purpose:\\ud To identify and review evidence on 1) the effectiveness of statutory and self-regulatory actions to reduce the volume, exposure or wider impact of advertising for foods high in fat, sugar and salt (HFSS) to children, and 2) the role of educational measures.\\ud Design/methodology/approach:\\ud A systematic review of three databases (Medline, CINAHL and PsycINFO) and grey literature was carried out. Relevant evidence included studies evaluating advertising bans and restrictions, adve...

  3. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission`s dispositions

    Energy Technology Data Exchange (ETDEWEB)

    Watanabe, Norio; Suzudo, Tomoaki [Japan Atomic Energy Research Inst., Tokai, Ibaraki (Japan). Tokai Research Establishment

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission`s (USNRC`s) responses to the recommendations made by the NRC`s study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC`s dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  4. Review report: safety and reliability issues on digital instrumentation and control systems in nuclear power plants and United States Nuclear Regulatory Commission's dispositions

    International Nuclear Information System (INIS)

    Watanabe, Norio; Suzudo, Tomoaki

    1998-09-01

    Recently, digital instrumentation and control (I and C) systems have been applied to nuclear power plants (NPPs) in various countries. Introduction of digital I and C systems, however, raises special issues on design, implementation, safety and licensing. Since FY 1997, the Japan Atomic Energy Research Institute (JAERI) has been carrying out a project, Study on Reliability of Digital I and C Systems, which includes extensive reviews of design approaches, technical standards, regulatory processes, especially, in the United States. This report summarizes the results from the study of National Research Council (NRC) and the U.S. Nuclear Regulatory Commission's (USNRC's) responses to the recommendations made by the NRC's study. That study identified six technical key issues (system aspects of digital I and C technology, software quality assurance, common-mode software failure potential, safety and reliability assessment methods, human factors and man-machine interface, dedication of commercial off-the-shelf hardware and software) and two strategic key issues (case-by-case licensing process, adequacy of technical infrastructure) that arise from the introduction of digital I and C technology and then, made recommendations to the USNRC for coping with digital I and C applications. The USNRC responded to each recommendation and showed their own dispositions in which the USNRC agreed with most of the recommendations. In Japan, it is expected that introduction of digital I and C technology is inevitable in NPPs because the vendors are gradually discontinuing support and stocking of analog components. To cope with such situations, there is a need to develop and update the standards and guidelines applicable to digital I and C technology. The key issues and the USNRC's dispositions provided in this report is believed to be useful for developing and updating them. (J.P.N.)

  5. SSI's independent consequence calculations in support of the regulatory review of the SR-Can safety assessment

    International Nuclear Information System (INIS)

    Shulan Xu; Dverstorp, Bjoern; Woerman, Anders; Marklund, Lars; Klos, Richard; Shaw, George

    2008-03-01

    With the publication of the SR-Can report at the end of 2006, Swedish Nuclear Fuel and Waste Management Co (SKB) have presented a complete assessment of long-term safety for a KBS-3 repository. The SR-Can project demonstrates progress in SKB's capabilities in respect of the methodology for assessment of long-term safety in support of a licence application for a final repository. According to SKB's plans, applications to construct a geological repository will be submitted in 2009, supported by post-closure safety assessments. Project CLIMB (Catchment LInked Models of radiological effects in the Biosphere) was instituted in 2004 to provide SSI with an independent modelling capability when reviewing SKB's assessments. Modelling in CLIMB covers all aspects of performance assessment (PA) from nearfield releases to radiological consequences in the surface environment. This review of SR-Can provides the first opportunity to apply the models and to compare the CLIMB approach with developments at SKB. The aim of the independent calculations is to investigate key aspects of the PA models and so to better understand the assessment methodology used by SKB. Independent modelling allows critical review issues to be addressed by the application of alternative models and assumptions. Three reviews are undertaken here: - Reproduction of selected cases from SR-Can in order to demonstrate an adequate understanding of the PA model from details given in the SR-Can documentation. - Alternative conceptualisation of radionuclide transport and accumulation in the surface system. Two modelling approaches have been used: GEMA (the Generic Ecosystem Modelling Approach) is a traditional compartmental model similar to that used by SKB in SR-Can but with additional functionality and flexibility. The second approach takes continuous transport models to investigate contaminant migration through the Quaternary deposits into the surface drainage system. - The final strand of the CLIMB investigation

  6. SSI's independent consequence calculations in support of the regulatory review of the SR-Can safety assessment

    Energy Technology Data Exchange (ETDEWEB)

    Shulan Xu; Dverstorp, Bjoern (Swedish Radiation Protection Authority, Stockholm (Sweden)); Woerman, Anders; Marklund, Lars (Royal Institute of Technology (KTH), Stockholm (SE)); Klos, Richard (Aleksandria Sciences, Sheffield (GB)); Shaw, George (Univ. of Nottingham (GB))

    2008-03-15

    With the publication of the SR-Can report at the end of 2006, Swedish Nuclear Fuel and Waste Management Co (SKB) have presented a complete assessment of long-term safety for a KBS-3 repository. The SR-Can project demonstrates progress in SKB's capabilities in respect of the methodology for assessment of long-term safety in support of a licence application for a final repository. According to SKB's plans, applications to construct a geological repository will be submitted in 2009, supported by post-closure safety assessments. Project CLIMB (Catchment LInked Models of radiological effects in the Biosphere) was instituted in 2004 to provide SSI with an independent modelling capability when reviewing SKB's assessments. Modelling in CLIMB covers all aspects of performance assessment (PA) from nearfield releases to radiological consequences in the surface environment. This review of SR-Can provides the first opportunity to apply the models and to compare the CLIMB approach with developments at SKB. The aim of the independent calculations is to investigate key aspects of the PA models and so to better understand the assessment methodology used by SKB. Independent modelling allows critical review issues to be addressed by the application of alternative models and assumptions. Three reviews are undertaken here: - Reproduction of selected cases from SR-Can in order to demonstrate an adequate understanding of the PA model from details given in the SR-Can documentation. - Alternative conceptualisation of radionuclide transport and accumulation in the surface system. Two modelling approaches have been used: GEMA (the Generic Ecosystem Modelling Approach) is a traditional compartmental model similar to that used by SKB in SR-Can but with additional functionality and flexibility. The second approach takes continuous transport models to investigate contaminant migration through the Quaternary deposits into the surface drainage system. - The final strand of the CLIMB

  7. Hispanos en la EPA: Grace Robiou

    Science.gov (United States)

    La diversidad de la fuerza laboral es importante para la Agencia de Protección Ambiental de EE.UU. (EPA, por sus siglas en inglés). Los empleados hispanos de la EPA contribuyen diariamente hacia la protección de la salud y el medio ambiente.

  8. Hispanos en la EPA: Fabiola Estrada

    Science.gov (United States)

    La diversidad de la fuerza laboral es importante para la Agencia de Protección Ambiental de EE.UU. (EPA, por sus siglas en inglés). Los empleados hispanos de la EPA contribuyen diariamente hacia la protección de la salud y el medio ambiente.

  9. Perfiles de hispanos en la EPA

    Science.gov (United States)

    La diversidad de la fuerza laboral es importante para la Agencia de Protección Ambiental de EE.UU. (EPA, por sus siglas en inglés). Los empleados hispanos de la EPA contribuyen diariamente hacia la protección de la salud y el medio ambiente de todos.

  10. Hispanos en la EPA: Nadtya Y. Hong

    Science.gov (United States)

    La diversidad de la fuerza laboral es importante para la Agencia de Protección Ambiental de EE.UU. (EPA, por sus siglas en inglés). Los empleados hispanos de la EPA contribuyen diariamente hacia la protección de la salud y el medio ambiente.

  11. Hispanos en la EPA: Matthew Tejada

    Science.gov (United States)

    La diversidad de la fuerza laboral es importante para la Agencia de Protección Ambiental de EE.UU. (EPA, por sus siglas en inglés). Los empleados hispanos de la EPA contribuyen diariamente hacia la protección de la salud y el medio ambiente.

  12. Hispanos en la EPA: Joel Corona

    Science.gov (United States)

    La diversidad de la fuerza laboral es importante para la Agencia de Protección Ambiental de EE.UU. (EPA, por sus siglas en inglés). Los empleados hispanos de la EPA contribuyen diariamente hacia la protección de la salud y el medio ambiente.

  13. EPA Scientific Knowledge Management Assessment and Needs

    Science.gov (United States)

    A series of activities have been conducted by a core group of EPA scientists from across the Agency. The activities were initiated in 2012 and the focus was to increase the reuse and interoperability of science software at EPA. The need for increased reuse and interoperability ...

  14. 40 CFR 73.52 - EPA recordation.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false EPA recordation. 73.52 Section 73.52... ALLOWANCE SYSTEM Allowance Transfers § 73.52 EPA recordation. (a) General recordation. Except as provided in...) following receipt of an allowance transfer request pursuant to § 73.50, by moving each allowance from the...

  15. EPA perspective on federal facility agreements

    International Nuclear Information System (INIS)

    Grundler, C.

    1988-01-01

    Although DOE's image with Congress and the media concerning environmental compliance may be poor, EPA sees the Department's recent attitude toward the environment as good. DOE and EPA must continue to move forward. In particular, EPA would like to emphasize less study of a problem and more clean-up. Strong, enforceable agreements will allow this goal to be met by letting EPA take more risks in its decision making. Currently EPA is developing an enforcement strategy for Federal facilities. This strategy will address identifying Federal facilities of concern, increasing enforcement and compliance monitoring activities at those facilities, implementing the model agreements, resource planning, and the establishment of an Agency Management System for Federal facilities. There are over 1000 Federal facilities which are listed on the EPA compliance docket. Over 200 Federal facilities are expected to be included on the NPL. Increased EPA attention may increase the ability of the various Federal agencies to obtain the necessary funding. Another subject being addressed by EPA is the liability of government contractors under the environmental statutes. The Agency is developing a GoCo enforcement strategy. In the hazardous waste enforcement program, three criteria are being considered for determining when to proceed against a contractor: Degree of contractor control over the hazardous waste management activity. Who is actually performing the work, and Degree of Departmental cooperation

  16. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

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

  17. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

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

  18. Review of European regulatory and tariff experience with the sale of heat and electricity from combined heat and power plants

    International Nuclear Information System (INIS)

    Dyrelund, A.

    1991-12-01

    The Prince Edward Island Energy Corporation, Edmonton Power, Energy, Mines and Resources Canada and the Canadian Electrical Association commissioned a study to understand how electrical power and district heat from combined heat and power (CHP) plants is priced in Europe. Four northern European countries were investigated, Denmark, Germany, Sweden and Finland. These countries produce 45.8 TWh of power from combined heat and power plants, 7.1% of their annual consumption. In the case of Denmark, CHP accounts for 37.5% of its total power production. The energy situation in each country is reviewed using published statistics, and in particular the rapidly changing situation with regard to environmental and fuel taxes is examined. In order to obtain practical insights with regard to tariffs used by the various utilities, a series of generic examples were examined, supported by specific case studies. Technologies reviewed included: CHP from coal-fuelled extraction plant, CHP from coal-fuelled back pressure plant, waste heat from a municipal waste plant, and gas turbine with waste heat recovery. The benefits and risks associated with different tariff designs are discussed in detail including tariff formulae. This should enable interested parties to develop appropriate tariffs for combined heat and power plants in the context of current electrical utility policies. As a complement to the tariffs for combined heat and power plants, the design of district heating tariffs is also addressed. The typical concepts used in different countries are presented and discussed. 23 tabs

  19. Application of Adverse Outcome Pathways to U.S. EPA's Endocrine Disruptor Screening Program.

    Science.gov (United States)

    Browne, Patience; Noyes, Pamela D; Casey, Warren M; Dix, David J

    2017-09-01

    The U.S. EPA's Endocrine Disruptor Screening Program (EDSP) screens and tests environmental chemicals for potential effects in estrogen, androgen, and thyroid hormone pathways, and it is one of the only regulatory programs designed around chemical mode of action. This review describes the EDSP's use of adverse outcome pathway (AOP) and toxicity pathway frameworks to organize and integrate diverse biological data for evaluating the endocrine activity of chemicals. Using these frameworks helps to establish biologically plausible links between endocrine mechanisms and apical responses when those end points are not measured in the same assay. Pathway frameworks can facilitate a weight of evidence determination of a chemical's potential endocrine activity, identify data gaps, aid study design, direct assay development, and guide testing strategies. Pathway frameworks also can be used to evaluate the performance of computational approaches as alternatives for low-throughput and animal-based assays and predict downstream key events. In cases where computational methods can be validated based on performance, they may be considered as alternatives to specific assays or end points. A variety of biological systems affect apical end points used in regulatory risk assessments, and without mechanistic data, an endocrine mode of action cannot be determined. Because the EDSP was designed to consider mode of action, toxicity pathway and AOP concepts are a natural fit. Pathway frameworks have diverse applications to endocrine screening and testing. An estrogen pathway example is presented, and similar approaches are being used to evaluate alternative methods and develop predictive models for androgen and thyroid pathways. https://doi.org/10.1289/EHP1304.

  20. Purchasing Supplies, Equipment and Services Under EPA Grants

    Science.gov (United States)

    EPA developed this guidance to help ensure you meet EPA requirements when making such necessary purchases. With very few exceptions, you must follow a competitive process when you use EPA grant funds to acquire equipment and professional services.

  1. 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

  2. An urgent need for an EPA standard for disposal of coal ash

    International Nuclear Information System (INIS)

    Lemly, A. Dennis

    2014-01-01

    EPA, the White House, and electric utilities are stalled in a struggle over a proposed new rule on coal ash disposal. Although this rule is long overdue, EPA now stands on the cusp of bringing forward a landmark decision that could benefit aquatic resources in the USA for decades to come and also set an important regulatory leadership example for the international community to follow. However, multi-million dollar wildlife losses are continuing to pile up as things stall in Washington. In this commentary I use a newly reported example, Wildlife Damage Case 23, to further illustrate serious flaws in the National Pollutant Discharge Elimination System that EPA's new rule can address. Case 23 provides additional impetus for EPA and the White House to move swiftly and decisively to end surface impoundment disposal of coal ash and the associated toxic impacts to wildlife. - Wildlife poisoning from coal combustion waste shows how regulatory policy is influenced by politics and industry rather than prudent decisions based on credible scientific investigation

  3. The role of the EPA radiation quality assurance program in the measurement quality assurance accreditation program for radioassay laboratories

    Energy Technology Data Exchange (ETDEWEB)

    Grady, T.M. [Environmental Monitoring Systems Laboratory, Las Vegas, NV (United States)

    1993-12-31

    As the nature and extent of radiological contamination becomes better documented and more public, radioanalytical laboratories are faced with a constantly expanding variety of new and difficult analytical requirements. Concurrent with those requirements is the responsibility to provide customers, regulatory officials, or the public with defensible data produced in an environment of verifiable, controlled quality. To meet that need, a quality assurance accreditation program for radioassay laboratories has been proposed by the American National Standards Institute (ANSI). The standard will provide the organizational framework and functional requirements needed to assure the quality of laboratory outputs. Under the proposed program, the U.S. Environmental Protection Agency`s (EPA`s) Laboratory Intercomparison Program plays a key role as a reference laboratory. The current and proposed roles of the EPA Intercomparison Program are discussed, as are the functional relationships between EPA, the accreditating organization, and the service and monitoring laboratories.

  4. Characterization of cotton gin PM10 emissions based on EPA stack sampling methodologies and particle size distributions

    Science.gov (United States)

    A project to characterize cotton gin emissions in terms of stack sampling was conducted during the 2008 through 2011 ginning seasons. The impetus behind the project was the urgent need to collect additional cotton gin emissions data to address current regulatory issues. EPA AP-42 emission factors ar...

  5. Notification: EPA Region 10 Management Controls Over Allowing Substantial Public Funds to Construct the Spokane County Wastewater Treatment Facility

    Science.gov (United States)

    January 20, 2012. This EPA's OIG is initiating a review from an OIG hotline complaint regarding whether federal funds were properly used to construct the new Spokane County wastewater treatment facility in accordance with 40 CFR 35, Subpart K.

  6. EPA's approach to regulation of mixed waste and status of future activities

    International Nuclear Information System (INIS)

    Shackleford, B.

    1988-01-01

    Regulation of radioactive mixed waste is a topic that has received much attention in the past several years. Much of the discussion and confusion stemmed from uncertainty about applicable regulatory authorities. On July 3, 1986, EPA clarified its position that the Resource Conservation and Recovery Act (RCRA) applied to the hazardous component of radioactive mixed waste. The Agency announced this clarification in the Federal Register and informed States that they must seek authority to regulate mixed waste in order to obtain or maintain RCRA authorization to administer and enforce a hazardous waste program in lieu of EPA. Since that time, five States have received authorization to regulate mixed waste: Colorado, South Carolina, Tennessee, Washington, and Georgia. Authorized States issue RCRA permits in lieu of EPA. Currently, 44 States have been authorized for the base RCRA program, Conversely, 12 States and Trust Territories have no RCRA authorization. In these States and territories, EPA administers that RCRA hazardous waste program. A more stringent State requirement occurs when a State allows less time for compliance than would be provided under Federal law, for example. There is a third authorization category with respect to mixed waste that I have yet to address. This category is made up of States which have EPA authorization to regulate hazardous waste but have yet to obtain mixed waste authorization. Most States fall into this category. In these States, of which there are 39, mixed wastes are not hazardous wastes and subject to Subtitle C regulations

  7. Acceptability of CO2 capture and storage. A review of legal, regulatory, economic and social aspects of CO2 capture and storage

    International Nuclear Information System (INIS)

    De Coninck, H.C.; Groenenberg, H.; Anderson, J.; Curnow, P.; Flach, T.; Flagstad, O.A.; Norton, C.; Reiner, D.; Shackley, S.

    2006-05-01

    Capture and storage of CO2 (CCS) has been studied as an option in the portfolio of climate change mitigation strategies for about 20 years. Although the technical maturity of CCS is generally less than other mitigation options, such as renewable energy or energy efficiency, many of the CCS components are generally regarded as mature enough for deployment. CCS, however, has a number of other aspects that may inhibit its deployment. The aim of the ACCSEPT project is to identify the main gaps in knowledge in the non-technical aspects of CCS, to research them, and to propose recommendations to address them. Although in the recent past several large and influential reports have been published in the field of CCS, many of them have focussed on the technical aspects of CCS. The IPCC Special Report on CCS did not have the mandate to address policy aspects and could only touch upon public perception issues. An IEA report focussed on the costs and economic aspects of CCS and touched upon regulatory and risk issues, but was at the time of publication unable to dive deep into it. This report provides a critical literature review for the non-technical aspects of CCS in the following categories: (a) Legal issues: National and international legislation relevant to CCS. Examples include national drinking water and mining laws, and the London Convention (Chapter 2). (b) Regulatory issues: National and international policies in the field of energy or climate change that can act as support mechanisms for CCS (Chapter 3). (c) Costs and economics: Addresses the question whether the current costs assumed for CCS are interpreted correctly, and reviews the assumptions made in economic models informing the policymaking process (Chapter 4). (d) Social and acceptability issues: A review of all studies currently done that focus on public perception of CCS. Methods used are questionnaires with lay public, focal group discussions, and expert polls (Chapter 5). (e) Crosscutting issues: CCS as a

  8. A review of the current situation of aflatoxin M1 in cow's milk in Serbia: risk assessment and regulatory aspects.

    Science.gov (United States)

    Milićević, Dragan R; Spirić, Danka; Radičević, Tatjana; Velebit, Branko; Stefanović, Srdjan; Milojević, Lazar; Janković, Saša

    2017-09-01

    The aim of this systematic review is to provide information regarding the incidence and levels of aflatoxin M 1 (AFM 1 ) in raw and heat processed cow's milk in Serbia during 2015-16 and to compare these with collected data on the occurrence of AFM 1 in raw milk and dairy products during the last decade in our region. Estimation of dietary exposure (EDI) and hazard index (HI) calculations for different age groups of the population were also carried out, based on the AFM 1 content of milk samples and on available food consumption data in Serbia. AFM 1 was detected in 69.9% (984/1408) of raw milk samples in 2015 versus 84.9% (3094/3646) in 2016, while in heat-processed milk, AFM 1 was detected in 77.8% (364/468) in 2015 versus 98.5% (753/765) in 2016. On the basis of the obtained results, 450 (9%) of raw and 14 (1.1%) of heat-processed milk samples were contaminated with AFM 1 levels above the maximum permitted level in Serbia (0.25 μg kg -1 ). However, a large percentage of raw and heat processed milk in Serbia (30.1% and 17.3%, respectively) was contaminated with AFM 1 levels above the maximum permitted level regulated in the European Union (0.05 μg kg -1 ). Therefore, in order to protect consumer health, it is extremely important to further control the level of aflatoxins in milk, and this should be considered as a high priority for risk management actions.

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

    International Nuclear Information System (INIS)

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

    2011-01-01

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

  10. Changes of regulatory T cells, transforming growth factor-beta and interleukin-10 in patients with type 1 diabetes mellitus: A systematic review and meta-analysis.

    Science.gov (United States)

    Qiao, Yong-Chao; Shen, Jian; Hong, Xue-Zhi; Liang, Ling; Bo, Chao-Sheng; Sui, Yi; Zhao, Hai-Lu

    2016-09-01

    Regulatory T lymphocyte cells (Treg) associated with interleukin-10 (IL-10) and transforming growth factor-β (TGF-β) have implicated in the development of type 1 diabetes mellitus (T1DM), yet the existing evidence remains unclear. Hereby we performed a systematic review and meta-analysis to characterize the changes in T1DM patients. A total of 1407 T1DM patients and 1373 healthy controls from 40 case-control studies were eventually included in the pooling analysis. Compared with the controls, T1DM patients had decreased frequency of CD4(+)CD25(+)Treg (p=0.0003), CD4(+)CD25(+)Foxp3(+)Treg (p=0.020), and the level of TGF-β (p=0.030). Decrease in IL-10 (p=0.14) was not significant. All the changes remained significant when the studies with low NOS scores and publication bias were excluded. In conclusion, peripheral Treg and serum TGF-β are reduced in type 1 diabetes mellitus whereas changes in serum IL-10 are not significant. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. A systematic review of the effectiveness of smartphone applications that encourage dietary self-regulatory strategies for weight loss in overweight and obese adults.

    Science.gov (United States)

    Semper, H M; Povey, R; Clark-Carter, D

    2016-09-01

    The aim of this paper is to systematically review the evidence to explore whether smartphone applications that use self-regulatory strategies are beneficial for weight loss in overweight and obese adults over the age of 18 years. Sixteen electronic databases were searched for articles published up to April 2015 including MEDLINE, OVID, Ingenta, PSYCARTICLES and PSYCINFO, CINAHL, Sportdiscus, Science Direct, Web of Knowledge, Cochrane Library, JSTOR, EBSCO, Proquest, Wiley and Google Scholar. Twenty nine eligible studies were retrieved of which six studies met the inclusion criteria. Studies that recruited participants under the age of 18 years, adults with a chronic condition or did not report weight loss outcomes were excluded. Study findings were combined using a narrative synthesis. Overall, evidence suggests that smartphone applications may be a useful tool for self-regulating diet for weight loss as participants in the smartphone application group in all studies lost at least some bodyweight. However, when compared to other self-monitoring methods, there was no significant difference in the amount of weight lost. Findings should be interpreted with caution based on the design of the studies and the comparator groups used. Future research needs to be more methodologically rigorous and incorporate measures of whether eating habits become healthier in addition to measuring weight and BMI. © 2016 World Obesity.

  12. Parabens can enable hallmarks and characteristics of cancer in human breast epithelial cells: a review of the literature with reference to new exposure data and regulatory status.

    Science.gov (United States)

    Darbre, Philippa D; Harvey, Philip W

    2014-09-01

    A framework for understanding the complexity of cancer development was established by Hanahan and Weinberg in their definition of the hallmarks of cancer. In this review, we consider the evidence that parabens can enable development in human breast epithelial cells of four of six of the basic hallmarks, one of two of the emerging hallmarks and one of two of the enabling characteristics. In Hallmark 1, parabens have been measured as present in 99% of human breast tissue samples, possess oestrogenic activity and can stimulate sustained proliferation of human breast cancer cells at concentrations measurable in the breast. In Hallmark 2, parabens can inhibit the suppression of breast cancer cell growth by hydroxytamoxifen, and through binding to the oestrogen-related receptor gamma may prevent its deactivation by growth inhibitors. In Hallmark 3, in the 10 nm-1 μm range, parabens give a dose-dependent evasion of apoptosis in high-risk donor breast epithelial cells. In Hallmark 4, long-term exposure (>20 weeks) to parabens leads to increased migratory and invasive activity in human breast cancer cells, properties that are linked to the metastatic process. As an emerging hallmark methylparaben has been shown in human breast epithelial cells to increase mTOR, a key regulator of energy metabolism. As an enabling characteristic parabens can cause DNA damage at high concentrations in the short term but more work is needed to investigate long-term, low-dose mixtures. The ability of parabens to enable multiple cancer hallmarks in human breast epithelial cells provides grounds for regulatory review of the implications of the presence of parabens in human breast tissue. Copyright © 2014 John Wiley & Sons, Ltd.

  13. Plan for implementing EPA standards for UMTRA sites

    International Nuclear Information System (INIS)

    1984-01-01

    The Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA), authorizes the Department of Energy (DOE) to undertake remedial actions at 24 DOE designated processing sites. The term ''processing site,'' by statutory definition, means the inactive uranium mill or processing site and any other real property or improvement which is in the vicinity of the mill or processing site and is determined to be contaminated with residual radioactive materials derived from the mill or processing site. For purposes of this document, the inactive mill or processing site is referred to as the ''processing site'' and the other real property or improvement in the vicinity of such site is referred to as a 'vicinity property.'' The purpose of the remedial actions is to stabilize and control the uranium mill tailings and other residual radioactive materials in a safe and environmentally sound manner. Remedial actions undertaken by DOE are to be accomplished: With the full participation of the affected states and Indian tribes, in accordance with standards issued by the Environmental Protection Agency (EPA), and with the concurrence of the Nuclear Regulatory Commission (NRC). This plan is designed to be a generic presentation on methodology that will be followed in implementing the EPA standards. 5 refs., 1 tab

  14. 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

  15. Environmental Protection Agency - EPA Pub Central

    Data.gov (United States)

    U.S. Environmental Protection Agency — PubMed Central (PMC) is a full-text, online archive of journal literature operated by the National Library of Medicine. The EPA is using PMC to permanently preserve...

  16. EPA Facility Registry Service (FRS): RADINFO

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  17. EPA CIO Governance Board Membership List

    Science.gov (United States)

    In keeping with OMB guidance on implementing the Federal Information Technology Reform Act (FITARA), EPA is publishing its list of officials who perform the duties or responsibilities of a Bureau CIO.

  18. Level IV Ecoregions of EPA Region 1

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  19. Level III Ecoregions of EPA Region 1

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  20. EPA Linked Open Data: Toxics Release Inventory

    Data.gov (United States)

    U.S. Environmental Protection Agency — TRI is a publicly available EPA database reported annually by certain covered industry groups, as well as federal facilities. It contains information about more than...

  1. Concerns raised over new EPA members

    Science.gov (United States)

    Gwynne, Peter

    2017-12-01

    The Trump administration has nominated three new members of the Environmental Protection Agency (EPA) who critics say are undermining laws and “pampering” the industries they are supposed to regulate.

  2. Meet EPA Researcher Endalkachew Sahle-Demessie

    Science.gov (United States)

    Meet EPA Researcher Endalkachew Sahle-Demessie. Chemical and Environmental Engineer Endalkachew Sahle-Demessie, Ph.D., works on various projects, including nanomaterials and water resources, in EPA’s National Risk Management Research Laboratory.

  3. EPA Administrative Law Judge Legal Documents

    Data.gov (United States)

    U.S. Environmental Protection Agency — This dataset contains Decisions and Orders originating from EPAs Office of Administrative Law Judges (OALJ), which is an independent office in the Office of the...

  4. EPA Facility Registry Service (FRS): NEI

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  5. EPA RE-Powering Mapper Feasibility Studies

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  6. EPA Facility Registry Service (FRS): BIA

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  7. EPA RE-Powering Mapper Region 7

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  8. EPA RE-Powering Mapper Large Scale

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  9. EPA RE-Powering Mapper Region 6

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  10. EPA RE-Powering Mapper Region 8

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  11. EPA RE-Powering Mapper Region 5

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  12. EPA RE-Powering Mapper Region 3

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  13. EPA Facility Registry Service (FRS): BRAC

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  14. EPA Region 6 REAP Composite Geodatabse

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Regional Ecological Assessment Protocol (REAP) is a screening level tool created as a way to identify priority ecological resources within the five EPA Region 6...

  15. EPA Facility Registry Service (FRS): NCDB

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  16. EPA Center for Corporate Climate Leadership

    Science.gov (United States)

    EPA's Center for Corporate Climate Leadership is a comprehensive resource to help organizations measure & manage GHG emissions. The Center provides technical tools, educational resources, opportunities for information sharing & highlights best practices.

  17. Level IV Ecoregions of EPA Region 5

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  18. Level IV Ecoregions of EPA Region 10

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  19. Level IV Ecoregions of EPA Region 2

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  20. Level IV Ecoregions of EPA Region 3

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  1. Level III Ecoregions of EPA Region 2

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  2. Level III Ecoregions of EPA Region 4

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  3. Level III Ecoregions of EPA Region 8

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions for EPA Administrative Regions were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the...

  4. Level IV Ecoregions of EPA Region 7

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  5. Level IV Ecoregions of EPA Region 6

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  6. Substance Identification Information from EPA's Substance Registry

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Substance Registry Services (SRS) is the authoritative resource for basic information about substances of interest to the U.S. EPA and its state and tribal...

  7. Springs, US EPA Region 9, 2013, SDWIS

    Data.gov (United States)

    U.S. Environmental Protection Agency — EPAâ??s Safe Drinking Water Information System (SDWIS) databases store information about drinking water. The federal version (SDWIS/FED) stores the information EPA...

  8. Reservoirs, US EPA Region 9, 2013, SDWIS

    Data.gov (United States)

    U.S. Environmental Protection Agency — EPAâ??s Safe Drinking Water Information System (SDWIS) databases store information about drinking water. The federal version (SDWIS/FED) stores the information EPA...

  9. EPA Monthly Key Performance Indicator Dashboards 2018

    Science.gov (United States)

    2018 reports are added each month, which measure how well EPA web content is meeting three performance goals: increases in how much users consume content, are able to find or discover what they need, and their level of engagement.

  10. EPA RE-Powering Screening Shapefile

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Center for Program Analysis (CPA) initiated the RE-Powering America’s...

  11. EPA Region 1 Sole Source Aquifers

    Data.gov (United States)

    U.S. Environmental Protection Agency — This coverage contains boundaries of EPA-approved sole source aquifers. Sole source aquifers are defined as an aquifer designated as the sole or principal source of...

  12. Quality Management Plan for EPA Region 1

    Science.gov (United States)

    The QMP describes policies, procedures & management systems within EPA NE that govern quality assurance & quality control activities supporting the transparency & scientific defensibility of environmental data collected, used & disseminated by the Region.

  13. EPA Facility Registry Service (FRS): Power Plants

    Data.gov (United States)

    U.S. Environmental Protection Agency — This GIS dataset contains data on power plants, based on the Energy Information Administration's EIA-860 dataset and supplemented with data from EPA's Facility...

  14. EPA Communications Stylebook: Training and Education

    Science.gov (United States)

    It is the policy of EPA that our staff should have and develop good communications skills. Besides writing, style, and design skills, we seek to develop audience analysis and targeting, marketing and media selection, and computer skills.

  15. EPA Linked Open Data: Facility Registry Service

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Facility Registry Service (FRS) identifies facilities, sites, or places subject to environmental regulation or of environmental interest to EPA programs or...

  16. Level IV Ecoregions of EPA Region 8

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions for EPA Administrative Regions were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the...

  17. Level III Ecoregions of EPA Region 10

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  18. Level IV Ecoregions of EPA Region 4

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  19. Level IV Ecoregions of EPA Region 9

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions for EPA Administrative Regions were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the...

  20. Level III Ecoregions of EPA Region 3

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  1. Level III Ecoregions of EPA Region 9

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions for EPA Administrative Regions were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the...

  2. 2013 EPA Vessels General Permit (VGP)

    Data.gov (United States)

    U.S. Environmental Protection Agency — Information for any vessel that submitted a Notice of Intent (NOI), Notice of Termination (NOT), or annual report under EPA's 2013 Vessel General Permit (VGP)....

  3. EPA Region 6 REAP Diversity Geodatabase

    Data.gov (United States)

    U.S. Environmental Protection Agency — The Regional Ecological Assessment Protocol (REAP) is a screening level tool created as a way to identify priority ecological resources within the five EPA Region 6...

  4. EPA Facility Registry Service (FRS): TRI

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  5. EPA Facility Registry Service (FRS): ICIS

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  6. EPA Facility Registry Service (FRS): OIL

    Data.gov (United States)

    U.S. Environmental Protection Agency — This dataset contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link to the Oil...

  7. EPA Facility Registry Service (FRS): RBLC

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  8. EPA Facility Registry Service (FRS): ACRES

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service consists of location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of sites that link to...

  9. EPA Facility Registry System (FRS): NCES

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry System (FRS) for the subset of facilities that link...

  10. EPA Facility Registry Service (FRS): LANDFILL

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of non-hazardous waste...

  11. EPA Facility Registry Service (FRS): CAMDBS

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link...

  12. Level III Ecoregions of EPA Region 7

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  13. Level III Ecoregions of EPA Region 5

    Data.gov (United States)

    U.S. Environmental Protection Agency — Ecoregions by EPA region were extracted from the seamless national shapefile. Ecoregions denote areas of general similarity in ecosystems and in the type, quality,...

  14. VT US EPA Regulated Facilities Point Locations

    Data.gov (United States)

    Vermont Center for Geographic Information — (Link to Metadata) The EnvironPollution_ENVPTS2001 data layer is based on the U.S. EPA's Envirofacts point shapefile. The data was provided to VCGI by the Vermont...

  15. EPA RE-Powering Mapper Completed Installations

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  16. Methane Tracking and Mitigation Options - EPA CMOP

    Data.gov (United States)

    U.S. Environmental Protection Agency — This dataset contains the sub-model for EPA's MARKAL model, which tracks methane emissions from the energy system, and limited other sources (landfills and manure...

  17. EPA RE-Powering Mapper Region 9

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  18. EPA RE-Powering Mapper Region 10

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...

  19. EPA Facility Registry System (FRS): NEPT

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web feature service contains location and facility identification information from EPA's Facility Registry System (FRS) for the subset of facilities that link...

  20. EPA RE-Powering Mapper Region 4

    Data.gov (United States)

    U.S. Environmental Protection Agency — The U.S. Environmental Protection Agency (EPA) Office of Land and Emergency Management (OLEM) Office of Communications, Partnerships and Analysis (OCPA) initiated...