WorldWideScience

Sample records for epa regulatory review

  1. Notification: Project Notification Memorandum for OIG Evaluation of EPA's Regulatory Flexibility Act Retrospective Reviews

    Science.gov (United States)

    Project #OPE-FY11-0024, January 6, 2012. Our overall evaluation objective remains to assess the efficiency and effectiveness of policies and procedures in place for conducting RFA Section 610 retrospective reviews and the concerns regarding past reviews.

  2. 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.

  3. 40 CFR 725.50 - EPA review.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false EPA review. 725.50 Section 725.50... REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS Administrative Procedures § 725.50 EPA review. (a) MCANs. The review period specified in section 5(a) of the Act for MCANs runs for 90 days from the date the...

  4. 3 CFR - Regulatory Review

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Regulatory Review Presidential Documents Other Presidential Documents Memorandum of January 30, 2009 Regulatory Review Memorandum for the Heads of Executive Departments and Agencies For well over two decades, the Office of Information and Regulatory Affairs (OIRA) at...

  5. 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.

  6. 40 CFR 67.41 - When EPA may review.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 15 2010-07-01 2010-07-01 false When EPA may review. 67.41 Section 67.41 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) EPA... may review. (a) The Administrator may on his own initiative or on petition review any initial, interim...

  7. Review of Policy, Regulatory, and Organizational Frameworks of ...

    African Journals Online (AJOL)

    kim

    with a focus on air pollution, occupational safety and health, and climate change. Objectives: ... climate change. Methods. First, published and unpublished national policies, regulatory and other legal documents were reviewed and important notes were taken. Then, the ..... (EPA), the Disaster Risk Management and food.

  8. Biomass Burning Emissions - The Importance of Reducing Uncertainties for Improved Regulatory Decisions; an EPA Perspective (Invited)

    Science.gov (United States)

    Szykman, J. J.; Kordzi, J.; Pouliot, G.; Pierce, T. E.; Pace, T.; Rao, T.

    2009-12-01

    Biomass burning emissions from wildland and prescribed fires can have far reaching impacts in several of EPA’s regulatory programs under the Clean Air Act, ultimately affecting decisions on actions taken under State Implementation Plans (SIPs), and programs such as Visibility and Regional Haze, Interstate Transport and Conformity. In most instances the EPA’s National Emissions Inventory (NEI), which is developed in conjunction with other federal, state, local, and tribal agencies is a cornerstone used to support air quality decision making. Over the past several years estimated wildland and prescribed fire emissions in the NEI have evolved from a crude, state-based, climatology to fire-specific, daily-resolved estimates primarily through the use of satellite measurements. In addition to research within EPA, external research partners are providing improved knowledge in areas such as chemical composition of smoke, plume rise measurements via satellites, and the development of improved emission algorithms. Accurate inputs to characterize and model the daily and hourly biomass burning emissions across the US are necessary to reduce the uncertainty in characterizing the emissions, transport, and transformation of gases and particles from their source, with the end goal of categorizing biomass burning emissions within the EPA’s regulatory structure. Reducing the uncertainty will lead to improved decision making as this information is used to support the development and implementation of EPA’s air regulatory programs. This is especially true under the National Ambient Air Quality Standards (NAAQS) where averaging times for particulate matter (PM), ozone, and the new proposed NO2 standard are at 24 hours or less, where accurate resolution of fire emissions is critical in understanding receptor impacts. This talk will highlight the impacts of wildland and prescribed fires within EPA’s regulatory program and importance of continued research to reduce the

  9. 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.

  10. 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.

  11. 40 CFR 26.1601 - EPA review of proposed human research.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false EPA review of proposed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1601 EPA review of proposed human research. (a) EPA shall review all protocols submitted under § 26.1125 in a timely manner. With...

  12. 49 CFR 355.21 - Regulatory review.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 5 2010-10-01 2010-10-01 false Regulatory review. 355.21 Section 355.21... AND REGULATIONS AFFECTING INTERSTATE MOTOR CARRIER OPERATIONS Requirements § 355.21 Regulatory review... review are provided in the appendix to this part. (b) Responsibility. The State agency designated as lead...

  13. 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

    ... AGENCY 40 CFR Part 152 Declaration of Prion as a Pest under FIFRA and Amendment of EPA's Regulatory Definition of Pests to Include Prion; Notification to the Secretaries of Agriculture and Health and Human...). The draft rule proposes to declare a prion (i.e., proteinaceous infectious particle) a ``pest'' under...

  14. 40 CFR 26.1602 - EPA review of completed human research.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false EPA review of completed human research... OF HUMAN SUBJECTS Review of Proposed and Completed Human Research § 26.1602 EPA review of completed... shall submit its review of data from human research covered by subpart Q, together with the available...

  15. Review of proposed EPA ambient lead criteria standard document. Final report. Task assignment No. 10

    Energy Technology Data Exchange (ETDEWEB)

    1984-03-04

    The proposed October 1983 EPA ambient lead criteria document, Air Quality Criteria for Lead is reviewed from the perspective of DOE's policies and programs and addresses potential impacts on energy production and energy-intensive industries. Following an introduction, the study is organized in five subsequent sections. Section 2.0 addresses environmental and health effects of exposure to lead. Section 3.0 reviews sources of lead emissions. Section 4.0 presents information on lead concentrations in ambient air. Section 5.0 examines dose-effect relationships among lead emissions, ambient air concentrations and blood lead levels. Section 6.0 presents Radian's evaluation of the regulatory implications of the criteria document and the information it provides. 10 figures, 11 tables.

  16. 78 FR 27169 - Regulatory Flexibility Act Review

    Science.gov (United States)

    2013-05-09

    ...PHMSA seeks comments on the economic impacts of its Hazardous Materials Regulations on small entities. In accordance with section 610 of the Regulatory Flexibility Act and as published in the Unified Agenda and Regulatory Plan, PHMSA is reviewing and analyzing the regulations applicable to the Hazardous Materials Program Procedures to identify requirements which may have a significant impact on a substantial number of small entities. The Unified Agenda and Regulatory plan for the Department of Transportation can be found at the following URL: http://www.gpo.gov/fdsys/pkg/FR-2013-01-15/pdf/2013-00597.pdf.

  17. EPA Proposes Rules to Improve Hazardous Waste Management and Better Protect our Waterways / New Rules Also Reduce Regulatory Burden on Businesses

    Science.gov (United States)

    WASHINGTON -- The U.S. Environmental Protection Agency (EPA) is proposing two new hazardous waste rules to strengthen environmental protection while reducing regulatory burden on businesses. One of the proposed rules will protect waterways, includin

  18. EPA Begins Reviews of 24 New England Site Cleanups during Current Fiscal Year

    Science.gov (United States)

    EPA plans to conduct comprehensive reviews of site cleanups at 24 National Priorities List Sites (Superfund Sites), including two Federal Facilities, across New England by performing required Five-Year Reviews of sites.

  19. 40 CFR 307.23 - EPA's review of preauthorization applications.

    Science.gov (United States)

    2010-07-01

    ... sufficient time to process the request for preauthorization (e.g., if a removal action is proposed); (4... correcting the deficiencies, or by proposing an alternative approach. (e) If EPA grants preauthorization, the... writing. (g) EPA will not grant preauthorization for any response actions where: (1) The proposed action...

  20. 78 FR 65980 - Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation...

    Science.gov (United States)

    2013-11-04

    ... challenges that a changing climate poses to human health and the environment. It is essential therefore, that... health and the environment. As EPA articulated in its draft Agency Climate Change Adaptation Plan, many... AGENCY Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation...

  1. EPA Response to Review of Office of Research and Development's Research Programs

    Science.gov (United States)

    EPA's response to the review report of the Office of Research and Development’s (ORD) Strategic Research Action Plans (StRAPs) and the cross-cutting program Roadmaps for Environmental Justice and Global Climate Change.

  2. 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.

  3. 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...

  4. 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...

  5. Biomass Burning Emissions – The Importance of Reducing Uncertainties for Improved Regulatory Decision; an EPA Perspective

    Science.gov (United States)

    Biomass burning emissions from wildland and prescribed fires can have far reaching impacts in several of EPA’s regulatory programs under the Clean Air Act, ultimately affecting decisions on actions taken under State Implementation Plans (SIPs), and programs such as Visibility and...

  6. 40 CFR 166.53 - EPA review of crisis exemption and revocation of authority.

    Science.gov (United States)

    2010-07-01

    ... such unreasonable health or environmental risks that the crisis authority should not be exercised or... 40 Protection of Environment 23 2010-07-01 2010-07-01 false EPA review of crisis exemption and revocation of authority. 166.53 Section 166.53 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  7. 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. ... 40 Protection of Environment 30 2010-07-01 2010-07-01 false EPA review of the TME application. 725.370 Section 725.370 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) TOXIC...

  8. 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...

  9. 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.

  10. US EPA 2014 Ozone Season Review by City

    Science.gov (United States)

    This web service contains the following layer: OzoneReview35Cities_with2000to2014data. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (available through the online link provided above) and viewing the layer description.

  11. 77 FR 10351 - Regulatory Review Plan

    Science.gov (United States)

    2012-02-22

    ... the Code of Federal Regulations and are also posted on the FHFA Internet Web site at http://www.fhfa... discernible regulatory burden or inefficiency; (3) Marketplace developments, technological evolution and...

  12. 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...

  13. 78 FR 9387 - Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation Plan

    Science.gov (United States)

    2013-02-08

    ... challenges that a changing climate poses to human health and the environment. It is essential; therefore... mission of protecting human health and the environment even as the climate changes. EPA considers public... AGENCY Notice of Availability for Public Review and Comment: Draft EPA Climate Change Adaptation Plan...

  14. Information transmission in genetic regulatory networks: a review

    CERN Document Server

    Walczak, Aleksandra M

    2011-01-01

    Genetic regulatory networks enable cells to respond to the 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 network's inputs and its 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 to understand recent work. We then discuss the functional complexity of gene regulation which arrises from the molecular nature of the regulatory interactions. We end by reviewing som...

  15. 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.

  16. 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).

  17. 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.

  18. The process of consensus on EMF: SAB review of the EPA draft document on EMF and cancer

    Science.gov (United States)

    Wilson, B. W.

    1992-06-01

    The EPA Draft Document on EMF and Cancers grew out of an earlier effort by EPA to track biological effects literature relative to radio-frequency (RF) exposure. Scope of the document was broadened to include extremely low frequency electric and magnetic fields prior to an announcement in 1986 that EPA would formally review the whole area of non-ionizing radiation. An extensive survey of the relevant bioeffects and epidemiologic literature was carried out, and writing on the document began in earnest on the document sometime in 1989. In its draft form, the document reviewed the literature on mechanisms of Interaction between electromagnetic fields and biological tissue, EMF epidemiologic studies, supporting evidence for carcinogenicity and research needs. In the early summer of 1990, a draft of the document was reviewed by some 22 individuals within the EPA and other government agencies. It was also sent out for external review to an additional 9 qualified scientists who had worked in the area and were familiar with EMF-related literature in epidemiology, biology, and physics. Many of the comments sent to EPA from this first review, prior to release of the draft for public comment, were strikingly similar to those resulting from the second (public) review process. Thus, it appears that much of the controversy that was later associated with the document could have been avoided had the authors been diligent in following the recommendations of the initial set of reviewers.

  19. 77 FR 2867 - 2010 Quadrennial Regulatory Review

    Science.gov (United States)

    2012-01-19

    ... provide data on the impact of market structure on the Commission's policy goals of competition, localism... time to review the data and analyses and now is seeking formal comment on them herein. As discussed... its rules on investigative journalism, and whether any specific aspects of the National Broadband Plan...

  20. EPA Public Notice: U.S. Environmental Protection Agency Reviews Cleanup at Niagara Mohawk Power Corp. Superfund Site

    Science.gov (United States)

    The U.S. Environmental Protection Agency (EPA) is conducting its third five-year review of the Niagara Mohawk Power Corp. Superfund Site, located in the city of Saratoga Springs, Saratoga County, New York. This review seeks to confirm that the cleanup acti

  1. 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

  2. Report: Follow-Up Review - EPA Updated Information for Indoor Mold Research Tools

    Science.gov (United States)

    Report #16-P-0308, September 8, 2016. Corrective actions taken by the EPA should help ensure that the public has correct information about EPA approved technology and tools for evaluating indoor mold.

  3. EPA Region 7 and Four States Water Quality Standards Review Process Kaizen Event Case Study

    Science.gov (United States)

    In June, 2007, participants from EPA headquarters, EPA Region 7, and the four States in EPA Region 7 (IA, KS, MO, and NE) conducted a Lean business kaizen event on the EPA–State process for developing and revising water quality standards (WQS).

  4. 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.'

  5. 76 FR 14840 - Extension of Comment Period: EPA's Plan for Retrospective Review Under Executive Order 13563

    Science.gov (United States)

    2011-03-18

    ...-2011-0165. 6. Benefits and Costs Submit a comment related to benefits and costs in ``Improving Regulations: Benefits and Costs'' at docket EPA- HQ-OA-2011- 0158. 7. Small Business Submit a comment related... docket EPA-HQ-OA-2011-0155. 11. Program Area: Pesticides Submit a comment about ``Improving Regulations...

  6. 78 FR 6094 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-01-29

    ... reducing utility-generated emissions by reducing the demand for energy. In 1991, EPA launched the Green... improving lighting quality. Since then, EPA has rolled Green Lights into ENERGY STAR and expanded ENERGY... overcome the barriers to evaluating their energy performance and investing in profitable improvements. To...

  7. 75 FR 10261 - Request for Nominations to the EPA Human Studies Review Board

    Science.gov (United States)

    2010-03-05

    ... on issues related to scientific and ethical aspects of human subjects research. The major objectives... (FACA) 5 U.S.C. App. 2 Sec. 9, providing advice and recommendations to EPA on scientific and ethical aspects of research with human subjects. DATES: Nominations (``comments'') should be submitted to EPA no...

  8. 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

    ... Monitoring AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Science Advisory... concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa.gov/sab...) for the Panel as a whole, diversity of expertise and viewpoints. The SAB Staff Office's evaluation of...

  9. 9 CFR 124.22 - Revision of regulatory review period determination.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Revision of regulatory review period determination. 124.22 Section 124.22 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE... interested person may request a revision of the regulatory review period determination within the 30 day...

  10. 76 FR 79141 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2011-12-21

    ...] List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act AGENCY: Securities and Exchange... Flexibility Act. The list is published to provide the public with notice that these rules are scheduled for...: The Regulatory Flexibility Act (``RFA''), codified at 5 U.S.C. 600-611, requires an agency to review...

  11. 78 FR 68056 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-11-13

    ... design concepts and associated wording. DfE will also sponsor two surveys to gauge public awareness and... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION... Design for the Environment (DfE) Logo Redesign Consultations AGENCY: Environmental Protection Agency (EPA...

  12. 78 FR 37806 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-06-24

    ... (6100- 17), Professional Certifying Organizations (6100-17) Consumer Awareness Survey: Survey form (6100... Quarterly Reporting Form four times each year. EPA also will conduct a Consumer Awareness Survey once over... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION...

  13. 78 FR 12054 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; EPA's...

    Science.gov (United States)

    2013-02-21

    ... & Verification Worksheet (5900-269) Multifamily High Rise Submittal Validation Form (5900-270) Multifamily High... method), by email to [email protected] , or by mail to: EPA Docket Center, Environmental Protection... energy performance in homes, and highlighting achievements utilizing the ENERGY STAR label. Verification...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1998-01-20

    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.

  15. 75 FR 77879 - Determination of Regulatory Review Period for Purposes of Patent Extension; SAMSCA

    Science.gov (United States)

    2010-12-14

    ..., animal drug product, medical device, food additive, or color additive) was subject to regulatory review...) from Otsuka Pharmaceutical Co., Ltd., and the Patent and Trademark Office requested FDA's assistance in...

  16. 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

    ... about the products. To be effective, EPA and its relevant recognized certification body must receive... will be compiled by the certification body which will then provide EPA with the appropriate data so the... accreditation bodies, laboratories and certification bodies. All of these entities seek EPA recognition by...

  17. 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

  18. Environmental Protection Agency Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... with the States and Tribes, business and industry, nonprofit organizations, environmental groups, and... Environmental Protection Agency Semiannual Regulatory Agenda ] ENVIRONMENTAL PROTECTION AGENCY (EPA) ENVIRONMENTAL PROTECTION AGENCY 40 CFR Ch. I EPA-HQ-OA-2007-1172 EPA-HQ-OW-2010-0169 EPA-HQ-OW-2010-0166 EPA-HQ...

  19. 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...

  20. 76 FR 10527 - Regulatory Flexibility Act: Section 610 Review of National Organic Program Regulations

    Science.gov (United States)

    2011-02-25

    ... comments. SUMMARY: This document announces the Agricultural Marketing Service's (AMS) plans to review the... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Part 205 Regulatory Flexibility Act: Section 610 Review of National...

  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. PMID:25954194

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

    Directory of Open Access Journals (Sweden)

    Simon eDyall

    2015-04-01

    Full Text Available 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 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, 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.

  3. 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

  4. #2) EPA Perspective - Exposure and Effects Prediction and ...

    Science.gov (United States)

    Outline •Biomarkers as a risk assessment tool–exposure assessment & risk characterization•CDC’s NHANES as a source of biomarker data–history, goals & available data•Review of NHANES publications (1999-2013)–chemicals, uses, trends & challenges•NHANES biomarker case study–recommendations for future research The National Exposure Research Laboratory (NERL) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA mission to protect human health and the environment. HEASD research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and policies for EPA.

  5. Review of U.S. EPA Office of Research and Development's Research Programs - 2017

    Science.gov (United States)

    A review report of the Office of Research and Development’s (ORD) Strategic Research Action Plans (StRAPs) and the cross-cutting program Roadmaps for Environmental Justice and Global Climate Change.

  6. Review of U.S. EPA Office of Research and Development's Research Programs

    Science.gov (United States)

    A review report of the Office of Research and Development’s (ORD) Strategic Research Action Plans (StRAPs) and the cross-cutting program Roadmaps for Environmental Justice and Global Climate Change.

  7. EPA Region 7 and Four States Water Quality Standards Review Process Kaizen Event

    Science.gov (United States)

    The submittal, review and approval process of the EPA–State process for developing and revising Water Quality Standards (WQS) was the focus of a Lean business process improvement kaizen event in June 2007.

  8. 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...

  9. 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.

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

    Science.gov (United States)

    This web service contains the following layer: PM25Review35Cities_with2000to2014data. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (available through the online link provided above) and viewing the layer description.

  11. NAFTA Revised Procedures for Joint Review of Microbials and Semiochemicals

    Science.gov (United States)

    The Canadian Pest Management Regulatory Agency and EPA have established a process for the joint review of pest control products in which the new active ingredient is a microbial or an arthropod semiochemical (including pheromones).

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

    Science.gov (United States)

    2011-07-06

    ... innovation and continuous improvement in education. V. Elements of Preliminary Plan/Compliance With E.O... Department) requests comments on its preliminary plan for the retrospective analysis of its existing... Review.'' The purpose of this preliminary plan is to make the Department's regulatory program more...

  14. 77 FR 52035 - Determination of Regulatory Review Period for Purposes of Patent Extension; TORISEL

    Science.gov (United States)

    2012-08-28

    ... approved for marketing the human drug product TORISEL (temsirolimus). TORISEL is indicated for the... marketing or use of the product. FDA has determined that the applicable regulatory review period for TORISEL... following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act...

  15. 78 FR 6826 - Determination of Regulatory Review Period for Purposes of Patent Extension; BEYAZ

    Science.gov (United States)

    2013-01-31

    ... initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward..., and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: April 4, 2007. FDA has verified...

  16. 78 FR 6826 - Determination of Regulatory Review Period for Purposes of Patent Extension; XALKORI

    Science.gov (United States)

    2013-01-31

    ... initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward.... The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act...

  17. 77 FR 66196 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Extension of Review...

    Science.gov (United States)

    2012-11-02

    ... COMMISSION Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Extension of Review... of OTC Index Options on the S&P 500 Index That Are Negotiated Bilaterally in the Over-the-Counter Market and Submitted to OCC for Clearance October 26, 2012. On August 30, 2012, the Options Clearing...

  18. 76 FR 37127 - Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL

    Science.gov (United States)

    2011-06-24

    ... indicated for the relief of symptoms associated with seasonal and perennial allergic rhinitis, and the... HUMAN SERVICES Food and Drug Administration Determination of Regulatory Review Period for Purposes of Patent Extension; XYZAL AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

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

    Science.gov (United States)

    2009-01-16

    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...

  20. EPAS1

    Science.gov (United States)

    vonHoldt, Bridgett; Fan, Zhenxin; Ortega-Del Vecchyo, Diego; Wayne, Robert K

    2017-01-01

    Admixture can facilitate adaptation. For example, black wolves have obtained the variant causing black coat color through past hybridization with domestic dogs and have higher fitness than gray colored wolves. Another recent example of the transfer of adaptive variation between the two species has been suggested by the similarity between high altitude Tibetan mastiffs and wolves at the EPAS1 gene, a transcription factor induced in low oxygen environments. Here, we investigate the directionality of admixture in EPAS1 between 28 reference highland gray wolves, 15 reference domestic dogs, and 21 putatively admixed highland wolves. This experimental design represents an expanded sample of Asian dogs and wolves from previous studies. Admixture was inferred using 17,709 publicly available SNP genotypes on canine chromosome 10. We additionally conducted a scan for positive selection in the highland dog genome. We find an excess of highland gray wolf ancestry at the EPAS1 locus in highland domestic dogs, suggesting adaptive introgression from wolves to dogs. The signal of admixture is limited in genomic extent to a small region on chromosome 10, indicating that it is the focus of selection in an oxygen-limited environment. Our results suggest that an adaptive variant of EPAS1 in highland wolves was transferred to highland dogs, carrying linked variants that potentially function in hypoxia response at high elevation. The intertwined history of dogs and wolves ensures a unique evolutionary dynamic where variants that have appeared in the history of either species can be tested for their effects on fitness under natural and artificial selection. Such coupled evolutionary histories may be key to the persistence of wild canines and their domesticated kin given the increasing anthropogenic modifications that characterize the future of both species.

  1. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  3. Nuclear Regulatory Commission activities to prepare for reviewing license applications and issuing licenses

    Energy Technology Data Exchange (ETDEWEB)

    Uleck, R.B.; DeFino, C.V. [Nuclear Regulatory Commission, Washington, DC (United States)

    1991-12-31

    The Low-Level Radioactive Waste Policy Amendments Act of 1985 (LLRWPAA) assigned States the responsibility to provide for disposal of commercial low-level radioactive waste (LLRW) by 1993. The LLRWPAA also required the US Nuclear Regulatory Commission (NRC) to establish procedures and develop the technical review capability to process license applications for new LLRW disposal facilities. Under the LLRWPAA, NRC is required, to the extent practicable, to complete its review of an LLRW disposal facility license application within 15 months of its submittal by a State. This provision of the LLRWPAA helps ensure that NRC, in addition to protecting public health and safety and the environment, facilitates States` achievement of LLRWPAA milestones for new facility development. A timely NRC review is needed for States to accomplish their objective of having new disposal facilities in operation on the dates prescribed in the LLRWPAA. To help assure NRC and States` compliance with the provisions of the LLRWPAA, NRC has developed a licensing review strategy that includes: (1) the further development of regulatory guidance, (2) enhancement of licensing review capability, and (3) prelicensing regulatory consultation with potential applicants.

  4. 78 FR 27235 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-05-09

    ... AGENCY Technical Guidance for Assessing Environmental Justice in Regulatory Analysis AGENCY..., ``Technical Guidance for Assessing Environmental Justice in Regulatory Analysis.'' The purpose of this... Technical Guidance for Assessing Environmental Justice in Regulatory Analysis Docket, EPA/DC, EPA West, Room...

  5. Support for 3rd regulatory review on nanomaterials – environmental legislation

    DEFF Research Database (Denmark)

    Broomfield, Mark; Hansen, Steffen Foss; Pelsy, Florent

    Ricardo Energy & Environment, in partnership with subcontractors Milieu Consulting and the Technical University of Denmark (DTU), was commissioned by the European Commission to carry out a project entitled “The preparation of the third regulatory review on nanomaterials - environmental legislation......”, specific contract number 070201/ENV/2015/SI2.716613/ENV.A3, Commission reference ENV.C.3/ETU/2015/0030. The study objective was to compile and develop information on nanomaterials and advanced materials in the environment and explore further the regulatory implementation challenges. The study had three...... main components: - A preliminary evaluation of releases of nanomaterials to different media (air, water, land, recycling and waste disposal). - A review of progress on the application of environmental and other key legislation to nanomaterials. - A prospective view on future developments in advanced...

  6. EPA Regional Boundaries (EPA.EPA_REGIONS) GIS Layer

    Data.gov (United States)

    U.S. Environmental Protection Agency — Each EPA Regional Office is responsible within its states for the execution of the Agency's programs. EPA has ten regional offices, each of which is responsible for...

  7. 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...... 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....

  8. 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

    ... the condition of whole ecosystems; (f) statisticians with expertise in analysis of environmental..., subcommittees and advisory panels; and (f) for the Panel as a whole, diversity of expertise and viewpoints. The... Environmental Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is posted on the SAB Web site...

  9. 40 CFR 142.19 - EPA review of State implementation of national primary drinking water regulations for lead and...

    Science.gov (United States)

    2010-07-01

    ... federal treatment requirements for a public water system pursuant to § 141.82 (d) and (f) and § 141.83(b... to forward to EPA the state determination and all information that was considered by the State in... the affected system(s), and explain the basis for the proposed requirements; (iv) Request public...

  10. 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...

  11. 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.

  12. A systematic literature review of the effectiveness of occupational health and safety regulatory enforcement.

    Science.gov (United States)

    Tompa, Emile; Kalcevich, Christina; Foley, Michael; McLeod, Chris; Hogg-Johnson, Sheilah; Cullen, Kim; MacEachen, Ellen; Mahood, Quenby; Irvin, Emma

    2016-11-01

    We aimed to determine the strength of evidence on the effectiveness of legislative and regulatory policy levers in creating incentives for organizations to improve occupational health and safety processes and outcomes. A systematic review was undertaken to assess the strength of evidence on the effectiveness of specific policy levers using a "best-evidence" synthesis approach. A structured literature search identified 11,947 citations from 13 peer-reviewed literature databases. Forty-three studies were retained for synthesis. Strong evidence was identified for three out of nine clusters. There is strong evidence that several OHS policy levers are effective in terms of reducing injuries and/or increasing compliance with legislation. This study adds to the evidence on OHS regulatory effectiveness from an earlier review. In addition to new evidence supporting previous study findings, it included new categories of evidence-compliance as an outcome, nature of enforcement, awareness campaigns, and smoke-free workplace legislation. Am. J. Ind. Med. 59:919-933, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  13. Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients

    OpenAIRE

    Monera-Penduka, Tsitsi G.; Maponga, Charles C.; Morse, Gene D.; Nhachi, Charles F. B.

    2017-01-01

    Background Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. Methods The national drug regulatory authority ...

  14. The Review of Regulatory Framework Applicable to the Medical Devices Sector: State of Play

    Directory of Open Access Journals (Sweden)

    Maria Judite Neves

    2016-01-01

    Full Text Available The future of the European regulatory framework for medical devices is under review. From the work initiated by the Commission, in 2008, resulted two legislative proposals (one regulation on medical devices and active implantable medical devices and another concerning in vitro diagnostic medical devices, which were submitted to the Council and to the European Parliament in September 2012. Over the past three years, these proposals have been subjected to detailed scrutiny and active discussion by the Member States and the European Parliament. Currently, negotiations in the Trialogue are developing in an atmosphere of flexibility and at a good pace, which allows foreseeing the possibility of an agreement between the three parties (Commission, Council and Parliament at a first reading, and therefore the publication of the Regulations in 2016. In this context, this article aims to inform on the negotiation process of the future European regulatory framework applicable to medical devices, providing a state of play regarding its evolution and emphasizing the participation of INFARMED, I.P. as competent authority, mainly on the technical and regulatory support to the adopted national positions.

  15. 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

  16. 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.

  17. Sucralose Non-Carcinogenicity: A Review of the Scientific and Regulatory Rationale.

    Science.gov (United States)

    Berry, Colin; Brusick, David; Cohen, Samuel M; Hardisty, Jerry F; Grotz, V Lee; Williams, Gary M

    2016-01-01

    Regulatory authorities worldwide have found the nonnutritive sweetener, sucralose, to be noncarcinogenic, based on a range of studies. A review of these and other studies found through a comprehensive search of electronic databases, using appropriate key terms, was conducted and results of that review are reported here. An overview of the types of studies relied upon by regulatory agencies to assess carcinogenicity potential is also provided as context. Physiochemical and pharmacokinetic/toxicokinetic studies confirm stability under conditions of use and reveal no metabolites of carcinogenic potential. In vitro and in vivo assays reveal no confirmed genotoxic activity. Long-term carcinogenicity studies in animal models provide no evidence of carcinogenic potential for sucralose. In studies in healthy adults, sucralose was well-tolerated and without evidence of toxicity or other changes that might suggest a potential for carcinogenic effects. In summary, sucralose does not demonstrate carcinogenic activity even when exposure levels are several orders of magnitude greater than the range of anticipated daily ingestion levels.

  18. Peripheral blood regulatory T cell counts as a predictive biomarker for the outcome of kidney transplant: A systematic review.

    Science.gov (United States)

    Herrera-Gómez, Francisco; Vásquez-Seoane, Mónica; Del Aguila, Waldo; Martín-García, Débora; Maurtua-Briseño Meiggs, Álvaro; González-López, Anunciación; Andrés-Martín, Beatriz; Nava-Rebollo, Álvaro; Casquero-Fernández, Fernando; Pascual-Núñez, Pilar; Grande-Villoria, Jesús; Bustamante-Bustamante, Jesús; Ochoa-Sangrador, Carlos; Lambert, Claude; Mendiluce-Herrero, Alicia

    2017-12-20

    Circulating regulatory T cells could become a suitable biomarker for kidney recipients. The objective of this study was to evaluate the effect of mammalian target of rapamycin (mTOR) inhibitors on regulatory T cell numbers, and the clinical interest of this effect. Systematic review of published and unpublished studies. Worldwide databases or repositories. Randomised controlled trials and cohort studies comparing regulatory T cell counts and rejection episodes between patients with and without mTOR inhibitors were searched. Correlation of regulatory T cells-glomerular filtration rate might be supplied. Co-dependency regulatory T cells-mTOR inhibitors efficacy was evaluated. Five trials and 9 studies were included. Clinical differences made it difficult to obtain quantitative estimates of the effect of immunosuppression on regulatory T cell numbers. Nevertheless, we found that there are higher regulatory T cell numbers under treatment with sirolimus or everolimus. Rejection episodes were similar under calcineurin inhibitors and mTOR inhibitors despite different regulatory T cell numbers. Pooled correlation regulatory T cells-glomerular filtration rate was, prospectively 0.114 (95% confidence interval [95% CI] 0.062-0.406), and retrospectively 0.13 (95% CI 0.0-0.361). There is direct evidence although of low level (biomarker-stratified randomisation) on the co-dependency regulatory T cells-mTOR inhibitors efficacy. Regulatory T cells counts may be associated with better outcomes under treatment with mTOR inhibitors (anti-rejection efficacy), considering that there is a relationship between these cells and kidney graft function. PROSPERO (CRD42016046285). Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  19. 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.

  20. 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.

  1. A method for independent modelling in support of regulatory review of dose assessments.

    Science.gov (United States)

    Dverstorp, Björn; Xu, Shulan

    2017-11-01

    Several countries consider geological disposal facilities as the preferred option for spent nuclear fuel due to their potential to provide isolation from the surface environment on very long timescales. In 2011 the Swedish Nuclear Fuel & Waste Management Co. (SKB) submitted a license application for construction of a spent nuclear fuel repository. The disposal method involves disposing spent fuel in copper canisters with a cast iron insert at about 500 m depth in crystalline basement rock, and each canister is surrounded by a buffer of swelling bentonite clay. SKB's license application is supported by a post-closure safety assessment, SR-Site. SR-Site has been reviewed by the Swedish Radiation Safety Authority (SSM) for five years. The main method for review of SKB's license application is document review, which is carried out by SSM's staff and supported by SSM's external experts. The review has proven a challenging task due to its broad scope, complexity and multidisciplinary nature. SSM and its predecessors have, for several decades, been developing independent models to support regulatory reviews of post-closure safety assessments for geological repositories. For the review of SR-Site, SSM has developed a modelling approach with a structured application of independent modelling activities, including replication modelling, use of alternative conceptual models and bounding calculations, to complement the traditional document review. This paper describes this scheme and its application to biosphere and dose assessment modelling. SSM's independent modelling has provided important insights regarding quality and reasonableness of SKB's rather complex biosphere modelling and has helped quantifying conservatisms and highlighting conceptual uncertainty. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    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

  3. 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.

  4. What is EPA Doing to Support Green Infrastructure?

    Science.gov (United States)

    EPA has released a series of policy memos encouraging the use of green infrastructure to meet regulatory requirements, as well as a series of Strategic Agendas describing the actions the Agency is taking to promote green infrastructure

  5. Research site monitoring for compliance with ethics regulatory standards: review of experience from Uganda.

    Science.gov (United States)

    Ochieng, Joseph; Ecuru, Julius; Nakwagala, Frederick; Kutyabami, Paul

    2013-06-05

    On site monitoring of research is one of the most effective ways to ensure compliance during research conduct. However, it is least carried out primarily for two reasons: presumed high costs both in terms of human resources and finances; and the lack of a clear framework for undertaking site monitoring. In this paper we discuss a model for research site monitoring that may be cost effective and feasible in low resource settings. This was a retrospective review of research site monitoring reports covering a period of four years. The monitoring was conducted by the Uganda National Council for Science and Technology, the National Drug Authority and the National HIV/AIDS Research and Ethics Committee over the period 2007 to 2010.The monitoring team was usually three members comprising of two experts in research ethics and an assistant. A total of 28 site monitoring visits covering 40 research projects were reviewed. 25% of the site monitoring reports revealed violation of the regulatory requirement for valid ethical approval. 36% of the site reports showed some instances of informed consent violation, 28% showed violation of the rights and welfare of research participants, 38% revealed that sites did not report SAEs to regulatory authorities and many sites lacked adequate GCP and GCLP. However, most of the sites monitored had adequate facilities to conduct the respective studies and good working practices. This model employed by the monitoring teams to evaluate research compliance is effective in auditing ethical practice. Compliance monitoring is feasible and affordable in a resource limited setting. Research protocol non compliance is still a major problem in Uganda, and there is need for a pro-active approach to this vice by all stake holders if ethical conduct of research is to be achieved.

  6. 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.

  7. EPA Regional KML Download

    Science.gov (United States)

    The EPA collects information about facilities or sites subject to environmental regulation. The EPA Geospatial Data Access Project provides downloadable files of these facilities or sites in KML format.

  8. 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)...

  9. 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...

  10. Impact of safety-related regulatory action on clinical practice: a systematic review.

    Science.gov (United States)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M; de Vries, Jonie T N; van der Elst, Menno E; de Graeff, Pieter A; Straus, Sabine M J M; Mol, Peter G M

    2012-05-01

    After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of the effects of these drug safety warnings on clinical practice to resolve the debate about their effectiveness. The aim of this systematic review is to provide an overview of studies that assessed the impact of safety warnings. A systematic search was performed for articles assessing the impact of Direct Healthcare Professional Communications or 'Dear Doctor' letters, Black Box Warnings and Public Health Advisories on clinical behaviour published between January 1996 and January 2010. The following variables were extracted: publication year, country, name of the drug, safety issue, specific safety warning (Direct Healthcare Professional Communication/Black Box Warning/Public Health Advisory), effect (intended/unintended) of the safety warning, outcome measure and study design. Papers were checked for several quality aspects. Study data were summarized using descriptive analyses. A total of 50 articles were identified. Two articles assessed two different drugs and were therefore counted twice (n = 52). Thirty-three articles described the impact of safety warnings issued for three drugs and drug groups, i.e. third-generation oral contraceptives, cisapride and selective serotonin reuptake inhibitors. The remaining 19 articles described a broad variety of 14 drugs and drug groups. Twenty-five studies applied an interrupted time series design, 23 a controlled or uncontrolled before/after design, and four articles applied both. None of the articles could rule out the influence of confounding factors. The intended effects were reported in 18 (72%) of the 25 before/after analyses, whereas only 11 (41%) of the 27 interrupted time series analyses reported an impact. Only two (8%) of the

  11. 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

    ... Research and Development (ORD) has developed a draft report reviewing and synthesizing the peer-reviewed... factors that influence them, and the mechanisms by which connected waters singly or in aggregate, affect..., individuals or groups requesting an oral presentation at a public meeting will be limited to five minutes...

  12. The Nature of Procrastination: A Meta-Analytic and Theoretical Review of Quintessential Self-Regulatory Failure

    Science.gov (United States)

    Steel, Piers

    2007-01-01

    Procrastination is a prevalent and pernicious form of self-regulatory failure that is not entirely understood. Hence, the relevant conceptual, theoretical, and empirical work is reviewed, drawing upon correlational, experimental, and qualitative findings. A meta-analysis of procrastination's possible causes and effects, based on 691 correlations,…

  13. Foundations for modeling the dynamics of gene regulatory networks: a multilevel-perspective review.

    Science.gov (United States)

    Sanchez-Osorio, Ismael; Ramos, Fernando; Mayorga, Pedro; Dantan, Edgar

    2014-02-01

    A promising alternative for unraveling the principles under which the dynamic interactions among genes lead to cellular phenotypes relies on mathematical and computational models at different levels of abstraction, from the molecular level of protein-DNA interactions to the system level of functional relationships among genes. This review article presents, under a bottom-up perspective, a hierarchy of approaches to modeling gene regulatory network dynamics, from microscopic descriptions at the single-molecule level in the spatial context of an individual cell to macroscopic models providing phenomenological descriptions at the population-average level. The reviewed modeling approaches include Molecular Dynamics, Particle-Based Brownian Dynamics, the Master Equation approach, Ordinary Differential Equations, and the Boolean logic abstraction. Each of these frameworks is motivated by a particular biological context and the nature of the insight being pursued. The setting of gene network dynamic models from such frameworks involves assumptions and mathematical artifacts often ignored by the non-specialist. This article aims at providing an entry point for biologists new to the field and computer scientists not acquainted with some recent biophysically-inspired models of gene regulation. The connections promoting intuition between different abstraction levels and the role that approximations play in the modeling process are highlighted throughout the paper.

  14. 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:

  15. 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

  16. US EPA 2014 Fine Particulate Pollution (PM2.5) Season Review by Core Based Statistical Area

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web service contains the following layer: PM25_2014_SesonReview_35CBSA. Full FGDC metadata records for each layer may be found by clicking the layer name at the...

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

    Energy Technology Data Exchange (ETDEWEB)

    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. (TEM)

  18. US EPA 2014 Fine Particulate Pollution (PM2.5) Season Review by Core Based Statistical Area

    Science.gov (United States)

    This web service contains the following layer: PM25_2014_SesonReview_35CBSA. Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (available through the online link provided above) and viewing the layer description.

  19. 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

    2018-02-09

    Per- and poly-fluoroalkyl 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 within the PFAS group, 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 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, reproductive or developmental or endocrine toxicity. This paper brings together fluoropolymer toxicity data, human clinical data, and physical-chemical-thermal-biological data for review and assessment to show that fluoropolymers satisfy widely accepted assessment criteria to be considered as "Polymers of Low Concern". This review concludes that fluoropolymers are distinctly different from other polymeric and non-polymeric per- and poly-fluoroalkyl substances 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. This article is protected by copyright. All rights

  20. "Slicer" for EPA

    CERN Document Server

    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. Impact of safety-related regulatory action on clinical practice : a systematic review

    NARCIS (Netherlands)

    Piening, S.; Haaijer-Ruskamp, F.M.; de Vries, J.T.; van der Elst, M.E.; de Graeff, P.A.; Straus, S.M.; Mol, P.G.

    2012-01-01

    Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of

  3. Impact of Safety-Related Regulatory Action on Clinical Practice A Systematic Review

    NARCIS (Netherlands)

    Piening, Sigrid; Haaijer-Ruskamp, Flora M.; de Vries, Jonie T. N.; van der Elst, Menno E.; de Graeff, Pieter A.; Straus, Sabine M. J. M.; Mol, Peter G. M.

    2012-01-01

    Background: After market approval, new serious safety issues are regularly identified for drugs that lead to regulatory action to inform healthcare professionals. However, the effectiveness of these safety-related regulatory actions is under question. We currently lack a comprehensive overview of

  4. Ozone depletion revisited: EPA regulation of chlorofluorocarbons

    Energy Technology Data Exchange (ETDEWEB)

    Rabin, R.L.

    1981-03-01

    Last October, prime news coverage focused once again on chlorofluorocarbons (CFCs). Only two years earlier, a governmental ban on using CFCs as a propellant in aerosol spray cans appeared to have met public safety concerns. But then, on October 7, 1980, the Environmental Protection Agency (EPA) indicated that the hazards associated with CFCs loomed larger than ever. EPA also announced that if additional controls are to be imposed, it leans toward a marketable permits system, an economic incentives approach that has been much discussed in the literature but is still untested. What are the hazards posed by CFCs. How does the growth in the chemical's use both here and abroad affect the regulatory problem. If further controls are needed, is the innovative marketable permits approach the best way of proceeding. As EPA considers further action, these issues deserve careful examination.

  5. EPA OIG's RSS Feed

    Science.gov (United States)

    EPA OIG's RSS Feed - The EPA OIG offers an XML news feed (RSS) covering all of our publications and news. To use our pre-made feed, click on the link below, copy the URL, then paste it into your prefferred feed reader.

  6. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

    Science.gov (United States)

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-01-01

    Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

  7. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

    Science.gov (United States)

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-10-01

    Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA's 210 day regulatory deadline. Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276-406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. © 2015 The British Pharmacological Society.

  8. 75 FR 55295 - List of Rules To Be Reviewed Pursuant to the Regulatory Flexibility Act

    Science.gov (United States)

    2010-09-10

    ... offers, mergers, acquisitions and similar extraordinary transactions). They also permit increased... Finance Title: Regulation of Takeovers and Security Holder Communications. Citation: 17 CFR 229.1000-1016..., simplify and centralize disclosure requirements, and eliminate regulatory inconsistencies in mergers and...

  9. 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) -...

  10. 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.

  11. 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.

  12. 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.

  13. Overview of ozone human exposure and health risk analyses used in the U.S. EPA's review of the ozone air quality standard.

    Energy Technology Data Exchange (ETDEWEB)

    Whitfield, R. G.

    1999-03-04

    This paper presents an overview of the ozone human exposure and health risk analyses developed under sponsorship of the U.S. Environmental Protection Agency (EPA). These analyses are being used in the current review of the national ambient air quality standards (NAAQS) for ozone. The analyses consist of three principal steps: (1) estimating short-term ozone exposure for particular populations (exposure model); (2) estimating population response to exposures or concentrations (exposure-response or concentration-response models); and (3) integrating concentrations or exposure with concentration-response or exposure-response models to produce overall risk estimates (risk model). The exposure model, called the probabilistic NAAQS exposure model for ozone (pNEM/03), incorporates the following factors: hourly ambient ozone concentrations; spatial distribution of concentrations; ventilation state of individuals at time of exposure; and movement of people through various microenvironments (e.g., outdoors, indoors, inside a vehicle) of varying air quality. Exposure estimates are represented by probability distributions. Exposure-response relationships have been developed for several respiratory symptom and lung function health effects, based on the results of controlled human exposure studies. These relationships also are probabilistic and reflect uncertainties associated with sample size and variability of response among subjects. The analyses also provide estimates of excess hospital admissions in the New York City area based on results from an epidemiology study. Overall risk results for selected health endpoints and recently analyzed air quality scenarios associated with alternative 8-hour NAAQS and the current 1-hour standard for outdoor children are used to illustrate application of the methodology.

  14. 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)

  15. Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of 'deep' product reviews.

    Science.gov (United States)

    Mulinari, Shai; Davis, Courtney

    2017-11-09

    Relenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Administration (FDA) has approved more cautious efficacy statements in labelling than European regulators for both drugs. We conducted a qualitative analysis of United States and European Union regulatory appraisals for Relenza to investigate the reasons for divergent regulatory interpretations, pertaining to Relenza's capacity to alleviate symptoms and reduce frequency of complications of influenza. In Europe, Relenza was evaluated via the so-called national procedure with Sweden as the reference country. We show that FDA reviewers, unlike their European (i.e. Swedish) counterpart, (1) rejected the manufacturer's insistence on pooling efficacy data, (2) remained wary of subgroup analyses, and (3) insisted on stringent statistical analyses. These differences meant that the FDA was less likely to depart from prevailing regulatory and scientific standards in interpreting trial results. We argue that the differences are explained largely by divergent institutionalised review methodologies, i.e. the European regulator's reliance on manufacturer-compiled summaries compared to the FDA's examination of original data and documentation from trials. The FDA's more probing and meticulous evaluative methodology allowed its reviewers to develop 'deep' knowledge concerning the clinical and statistical facets of trials, and more informed opinions regarding suitable methods for analysing trial results. These findings challenge the current emphasis on evaluating regulatory performance mainly in terms of speed of review. We propose that persistent uncertainty and knowledge deficits regarding NIs could have been ameliorated had regulators engaged in the public debates over the drugs' efficacy and

  16. 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

  17. 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

  18. 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.

  19. EPA Geospatial Applications

    Science.gov (United States)

    EPA has developed many applications that allow users to explore and interact with geospatial data. This page highlights some of the flagship geospatial web applications but these represent only a fraction of the total.

  20. 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...

  1. EPA Collaboration with Vietnam

    Science.gov (United States)

    Vietnam, one of Asia’s emerging economies, is an important environmental partner for EPA in Asia. EPA’s current cooperation with Vietnam primarily focuses on dioxin remediation and technical assistance to reduce methane emissions.

  2. 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...

  3. 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....

  4. 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...

  5. EPA Challenges & Prizes

    Science.gov (United States)

    EPA is a government leader in tapping the power of contributions from the public to help solve difficult problems that affect the environment and public health. Prize competitions allow federal agencies to pay only for successful solutions.

  6. 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.

  7. 76 FR 38328 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-06-30

    ... Commission's regulations would amend certain fundamental definitions and recordkeeping rules; conforming... prescriptive rules, where possible. I wholeheartedly agree with the regulatory philosophy embodied in the... the existing rules will be necessary to conform with new Dodd-Frank definitions and requirements, I...

  8. Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

    Science.gov (United States)

    Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

    2017-01-01

    Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

  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. Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data.

    Science.gov (United States)

    Heneghan, Carl J; Onakpoya, Igho; Jones, Mark A; Doshi, Peter; Del Mar, Chris B; Hama, Rokuro; Thompson, Matthew J; Spencer, Elizabeth A; Mahtani, Kamal R; Nunan, David; Howick, Jeremy; Jefferson, Tom

    2016-01-01

    BACKGROUND Neuraminidase inhibitors (NIs) are stockpiled and recommended by public health agencies for treating and preventing seasonal and pandemic influenza. They are used clinically worldwide. OBJECTIVES To (1) describe the potential benefits and harms of NIs for influenza in all age groups by reviewing all clinical study reports (CSRs) of published and unpublished randomised, placebo-controlled trials and regulatory comments; and (2) determine the effect of oseltamivir (Tamiflu(®), Roche) treatment on mortality in patients with 2009A/H1N1 influenza. METHODS We searched trial registries, electronic databases and corresponded with regulators and sponsors to identify randomised trials of NIs. We requested full CSRs and accessed regulators' comments. We included only those trials for which we had CSRs. To examine the effects of oseltamivir on 2009A/H1N1 influenza mortality, we requested individual patient data (IPD) from corresponding authors of all included observational studies. RESULTS Effect of oseltamivir and zanamivir (Relenza®, GlaxoSmithKline) in the prevention and treatment of influenza: Oseltamivir reduced the time to first alleviation of symptoms in adults by 16.8 hours [95% confidence interval (CI) 8.4 to 25.1 hours]. Zanamivir reduced the time to first alleviation of symptoms in adults by 0.60 days (95% CI 0.39 to 0.81 days). Oseltamivir reduced unverified pneumonia in adult treatment [risk difference (RD) 1.00%, 95% CI 0.22% to 1.49%]; similar findings were observed with zanamivir prophylaxis in adults (RD 0.32%, 95% CI 0.09% to 0.41%). Oseltamivir treatment of adults increased the risk of nausea (RD 3.66%, 95% CI 0.90% to 7.39%) and vomiting (RD 4.56%, 95% CI 2.39% to 7.58%). In the treatment of children, oseltamivir induced vomiting (RD 5.34%, 95% CI 1.75% to 10.29%). Both oseltamivir and zanamivir prophylaxis reduced the risk of symptomatic influenza in individuals (oseltamivir RD 3.05%, 95% CI 1.83% to 3.88%; zanamivir RD 1.98%, 95% CI 0.98% to

  11. 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.

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  13. 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 ...

  14. 78 FR 39284 - Technical Guidance for Assessing Environmental Justice in Regulatory Analysis

    Science.gov (United States)

    2013-07-01

    ... entitled, ``Technical Guidance for Assessing Environmental Justice in Regulatory Analysis.'' The purpose of... Technical Guidance for Assessing Environmental Justice in Regulatory Analysis Docket, EPA/DC, EPA West, Room... Technical Guidance for Assessing Environmental Justice in Regulatory Analysis is available in the public...

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

    Energy Technology Data Exchange (ETDEWEB)

    Reer, Bernhard; Dang, V.N.; Hirschberg, Stefan [Paul Scherrer Inst. (PSI), Villigen (Switzerland); Meyer, Patrick

    2000-07-01

    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)

  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 Multimedia

    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

    2013-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 5 novembre de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel La permanence suivante aura lieu le mardi 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.

  19. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2013-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 3 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.

  20. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2013-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 7 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/ e-mail : gac-epa@gac-epa.org

  1. 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 7 avril de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 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.

  2. 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 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.

  3. 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.

  4. 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.

  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 : 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.

  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 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.

  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 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.

  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 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.

  9. 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 2 juin de 13 h 30 à 16 h 00 Salle de réunion de l’Association du personnel Les permanences suivantes auront lieu les mardis 1er septembre, 6 octobre, 3 novembre et 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.

  10. 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 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.

  11. 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 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.

  12. 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.

  13. 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.

  14. GAC-EPA

    CERN Multimedia

    GAC-EPA

    GROUPEMENT DES ANCIENS DU CERN ESO PENSIONERS’S ASSOCIATION Le GAC-EPA 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 conférence de l’Association du personnel Les permanences du GAC-EPA 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. http://www.gac-epa.org

  15. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2012-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 8 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/ e-mail : gac-epa@gac-epa.org

  16. 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).

  17. Regulatory categories of probiotics across the globe: a review representing existing and recommended categorization.

    Science.gov (United States)

    Arora, M; Baldi, A

    2015-02-01

    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.

  18. 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.

  19. 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.

  20. Commentary an urgent need for an EPA standard for disposal of coal ash

    Science.gov (United States)

    A. Dennis. Lemly

    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...

  1. 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.

  2. 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.

  3. The utility of modeling and simulation in drug development and regulatory review.

    Science.gov (United States)

    Huang, Shiew-Mei; Abernethy, Darrell R; Wang, Yaning; Zhao, Ping; Zineh, Issam

    2013-09-01

    US Food and Drug Administration (FDA) has identified innovation in clinical evaluations as a major scientific priority area. This paper provides case studies and updates to describe the efforts by the FDA's Office of Clinical Pharmacology in its development and application of regulatory science, focusing on modeling and simulation. Key issues and challenges are identified that need to be addressed to promote the uptake of modeling and simulation approaches in drug regulation. Published 2013. This article is a U.S. Government work and is in the public domain in the USA. 102:2912-2923, 2013. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

  4. 76 FR 18134 - Reducing Regulatory Burden; Review Under E.O. 13563

    Science.gov (United States)

    2011-04-01

    ... possible levels. PBGC's intent is to issue regulations that implement the law in ways that do not impede... spirit of the Executive Order, PBGC is applying the retrospective review to all of PBGC's existing...

  5. EPA Study of Hydraulic Fracturing and Drinking Water Resources

    Science.gov (United States)

    In its FY2010 Appropriations Committee Conference Report, Congress directed EPA to study the relationship between hydraulic fracturing and drinking water, using: • Best available science • Independent sources of information • Transparent, peer-reviewed process • Consultatio...

  6. Environmental, health, safety, and regulatory review of selected photovoltaic options: Copper sulfide/cadmium sulfide and polycrystalline silicon

    Science.gov (United States)

    Lawrence, K.; Morgan, S.; Schaller, D.; Wilczak, T.

    1981-06-01

    Emissions, effluents and solid wastes from the fabrication of both polycrystalline silicon and front-wall copper sulfide/cadmium sulfide photovoltaic cells are summarized. Environmental, health, and safety characteristics of cell fabrication material inputs and by products are listed. Candidate waste stream treatment methods and resultant effluents are reviewed. Environmental, health, and safety effects of photovoltaic cell/module/array installation, operation, maintenance, and decommission are summarized. Federal legislation is addressed and future regulatory trends under these laws as they may affect each cell process are discussed. Water quality, solid waste disposal, and occupational health and safety regulations will likely be those most applicable to commercial scale PV production. Currently available control technology appears sufficient to treat cell fabrication wastes.

  7. The nature of procrastination: a meta-analytic and theoretical review of quintessential self-regulatory failure.

    Science.gov (United States)

    Steel, Piers

    2007-01-01

    Procrastination is a prevalent and pernicious form of self-regulatory failure that is not entirely understood. Hence, the relevant conceptual, theoretical, and empirical work is reviewed, drawing upon correlational, experimental, and qualitative findings. A meta-analysis of procrastination's possible causes and effects, based on 691 correlations, reveals that neuroticism, rebelliousness, and sensation seeking show only a weak connection. Strong and consistent predictors of procrastination were task aversiveness, task delay, self-efficacy, and impulsiveness, as well as conscientiousness and its facets of self-control, distractibility, organization, and achievement motivation. These effects prove consistent with temporal motivation theory, an integrative hybrid of expectancy theory and hyperbolic discounting. Continued research into procrastination should not be delayed, especially because its prevalence appears to be growing. (c) 2007 APA, all rights reserved.

  8. A review of the current scientific and regulatory status of nanomedicines and the challenges ahead.

    Science.gov (United States)

    Hock, Sia Chong; Ying, Yan Mei; Wah, Chan Lai

    2011-01-01

    Nanomedicines refer to drugs, medical devices, and health products developed using nanotechnology with the aim of diagnosing, monitoring, and treating diseases at the molecular level. Due to their nano size, nanomedicines offer advantages over conventional medicines, including more effective targeting of difficult-to-reach sites, improved solubility and bioavailability, and reduced adverse effects. Hence, nanomedicines can be used to achieve the same therapeutic effect at smaller doses than their conventional counterparts. Three types of nanomedicines are described: nanocarriers used in drug delivery, nanosuspensions used in the improvement of drug solubility, and nanoparticles used in bioimaging. While nanomedicines offer promising benefits, there are concerns that the inherent properties of nanoparticles such as their size, shape, agglomeration/aggregation potential, and surface chemistry can adversely affect the safety and quality of nanomedicines. Furthermore, there are currently no regulatory guidelines developed specifically for nanomedicines due to limitations including inadequate knowledge regarding nanoparticle behavior, the absence of standardized nomenclature, test methods, and characterization of nanoparticles, as well as difficulty in determining primary jurisdiction for combination products. In addition, a shortage of trained personnel, a lack of a nanomedicine-specific safety protocol, and ineffective control of nanoparticle contamination challenge the current good manufacturing practice requirements governing the manufacture of nanomedicines. Regulatory authorities are in the midst of improving the current framework for controlling the manufacturing processes, product quality, and safety of nanomedicines. This paper proposes improvements through the adaptation of conventional regulations for nanoparticles, implementation of compulsory regulations for presently unregulated nanoparticle-containing products, and the establishment of an online database

  9. Improving food environments and tackling obesity: A realist systematic review of the policy success of regulatory interventions targeting population nutrition.

    Science.gov (United States)

    Sisnowski, Jana; Street, Jackie M; Merlin, Tracy

    2017-01-01

    This systematic review (PROSPERO: CRD42015025276) employs a realist approach to investigate the effect of "real-world" policies targeting different aspects of the food environment that shape individual and collective nutrition. We were interested in assessing intermediate outcomes along the assumed causal pathway to "policy success", in addition to the final outcome of changed consumption patterns. We performed a search of 16 databases through October 2015, with no initial restriction by language. We included all publications that reported the effect of statutory provisions aimed at reducing the consumption of energy-dense foods and beverages in the general population. We allowed all methodological approaches that contained some measure of comparison, including studies of implementation progress. We reviewed included studies using the appraisal tools for pre-post and observational studies developed by the National Heart, Lung, and Blood Institute. Given the considerable heterogeneity in interventions assessed, study designs employed, and outcome measures reported, we opted for a narrative synthesis of results. Results drawn from 36 peer-reviewed articles and grey literature reports demonstrated that isolated regulatory interventions can improve intermediate outcomes, but fail to affect consumption at clinically significant levels. The included literature covered six different types of interventions, with 19 studies reporting on calorie posting on chain restaurant menus. The large majority of the identified interventions were conducted in the US. Early results from recent taxation measures were published after the review cut-off date but these suggested more favorable effects on consumption levels. Nevertheless, the evidence assessed in this review suggests that current policies are generally falling short of anticipated health impacts.

  10. Regulatory Practices and School-based Research: Making Sense of Research Ethics/Review

    Directory of Open Access Journals (Sweden)

    Susan Ann Tilley

    2009-05-01

    Full Text Available This article focuses on the ethics/research review practices of a university Research Ethics Board (REB and a school board Research Review Committee (RRC. Applications to conduct school-based research submitted to the REB and RRC and in-depth, open-ended interviews with REB and RRC members serve as data for the study. In this paper, we highlight the institutional board decisions, especially requests for clarification documented in the applications, giving specific attention to applications proposing qualitative/teacher research. Empirical research focused on the inside workings of REBs and RRCs, which would provide particular kinds of knowledge related to research/ethics review, is recommended. URN: urn:nbn:de:0114-fqs0902326

  11. 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  

  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 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

  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. 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

  15. 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

  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 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  

  17. Maps | 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.

  18. Trends | 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.

  19. 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.

  20. 75 FR 54888 - Determination of Regulatory Review Period for Purposes of Patent Extension; IXIARO

    Science.gov (United States)

    2010-09-09

    ... phase as specified in 35 U.S.C. 156(g)(1)(B). FDA recently approved for marketing the human biologic... Reed Army Institute of Research, and the Patent and Trademark Office requested FDA's assistance in... review period and that the approval of IXIARO represented the first permitted commercial marketing or use...

  1. 75 FR 27237 - Regulatory Flexibility Act Review of the Bloodborne Pathogens Standard

    Science.gov (United States)

    2010-05-14

    ..., economic conditions, or other factors have changed in the area affected by the rule. The EO requires... protocols may also be reviewed. Since the Standard affects small businesses across a range of sectors, the... businesses by examining: the continued need for the rule; the nature of complaints or comments received...

  2. 76 FR 63276 - Reducing Regulatory Burden; Retrospective Review Under E.O. 13563

    Science.gov (United States)

    2011-10-12

    ... traditional paper format. Any person using e-filing should attach a document and otherwise comply with the... filing in the traditional paper format should send an original and 10 copies to: Surface Transportation... it was reviewing the Uniform Rail Costing System, which is the Board's general purpose costing...

  3. 77 FR 44227 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2012-07-27

    ... (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is... Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA... Policy requires new AMCC manufacturers to retain warranty and sales records. Reconditioners (sellers of...

  4. 75 FR 52003 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2010-08-24

    ... Control System Performance Warranty Regulations and Voluntary Aftermarket Part Certification Program... Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and... Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA...

  5. 76 FR 31604 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request

    Science.gov (United States)

    2011-06-01

    ... Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval: Pesticide Program Public Sector Collections (FIFRA sections 18 & 24(c)); EPA ICR No....regulations.gov (our preferred method), or by mail to: Office of Pesticide Programs (OPP) Regulatory Public...

  6. Chemicals Determined Not Likely to Present an Unreasonable Risk Following Pre-Manufacture Notification Review

    Science.gov (United States)

    This page describes the regulatory determination EPA has made following review of pre-manufacture notifications under section 5 of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century law, P.L. 114-182.

  7. Mass balance analyses of nutrients on California dairies to evaluate data quality for regulatory review.

    Science.gov (United States)

    Miller, Christine M F; Price, Patricia L; Meyer, Deanne

    2017-02-01

    Effective regulations may help reduce nitrate contamination of groundwater from agriculture. Dairy farmers in California must maintain a ratio below 1.4 of total nitrogen (N) applied to total N-removed (N-Ratio) on cropland receiving manure application. In annual reports to the regulatory agency, farmers detail nutrients applied to cropland, removed in harvests, and exported off farm. Data were extracted from all available annual reports for 62 dairies from 2011, 2012, and 2013. Excretions of N, phosphorus (P), and potassium (K) were calculated using reported herd demographics and standard excretion equations from the American Society of Agricultural and Biological Engineers. Calculated nutrient excretion values were compared to the reported values of manure nutrients applied to cropland and exported off farm. Reported N-Ratios were compared to mass balance simulations exploring variable crop yields and alfalfa management. In the nutrient excretion balance, the distribution of the percent of N and P recovered in manures applied or exported peaked at 24% (median=31%) and 26% (median=53%) of excreted, respectively. The distribution of recovered K was fairly uniform from 0% to 300% (median=146%) of excreted K. In N-ratio simulations, 62% and 66% of all reported N-ratios were lower than their respective simulated N-ratio, assuming alfalfa crops received no N fertilization and minimal fertilization (26% of N-removed in harvest) respectively. When simulated crop yields were normally (sd=0.25) or Student's t distributed (df=154) around expected crop yields, 28% and 57% of all reported ratios fell within the 95% confidence interval of the simulations, respectively. Low and erratic recovery rates of excreted P and K existed. Additionally, reported N-Ratios were generally lower and more varied than necessary for farmers to maintain crop yields while complying with regulations. Greater understanding of low recovery rates is needed before data are used to assess the impact of

  8. 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.

  9. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2012-01-01

    Le GAC-EPA organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le Mardi 5 juin 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.

  10. 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.

  11. 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...

  12. Responding to the changing regulatory scene

    Energy Technology Data Exchange (ETDEWEB)

    Wise, P.

    1995-12-31

    The regulatory approach of the Illinois Environmental Protection Agency (EPA) is discussed in this paper. Three areas receive emphasis: (1) the changing relations between the US EPA and the states, (2) the new emphasis on pollution prevention techniques, and (3) a new environmental amnesty project. Budgetary considerations, performance partnerships, and nonregulatory compliance assistance are briefly outlined in relation to these topics. Results of the environmental amnesty program for small business, called Clean Break, are briefly reported.

  13. How EPA Assesses Chemical Safety

    Science.gov (United States)

    EPA's existing chemicals programs address pollution prevention, risk assessment, hazard and exposure assessment and/or characterization, and risk management for chemicals substances in commercial use.

  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. 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

  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 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

  17. 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

  18. GAC-EPA

    CERN Multimedia

    GAC-EPA

    2012-01-01

    Le GAC organise chaque mois des permanences avec entretiens individuels. La prochaine permanence se tiendra le : Mardi 3 avril 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.     René Oberli 1930 – 2011 Nous avons le regret  de vous annoncer le décès de notre collègue et ami René Oberli survenu le 24 décembre 2011. Vous trouverez un hommage sur le site web du GAC-EPA sous http://www.gac-epa.org/History/Tributes/2011/Ren...

  19. 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.

  20. EPA Facilities and Regional Boundaries Service, US, 2012, US EPA, SEGS

    Data.gov (United States)

    U.S. Environmental Protection Agency — This SEGS web service contains EPA facilities, EPA facilities labels, small- and large-scale versions of EPA region boundaries, and EPA region boundaries extended to...

  1. Zanamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.

    Science.gov (United States)

    Heneghan, Carl J; Onakpoya, Igho; Thompson, Matthew; Spencer, Elizabeth A; Jones, Mark; Jefferson, Tom

    2014-04-09

    To describe the potential benefits and harms of zanamivir. Systematic review of clinical study reports of randomised placebo controlled trials and regulatory information Clinical study reports, trial registries, electronic databases, regulatory archives, and correspondence with manufacturers. Randomised placebo controlled trials in adults and children who had confirmed or suspected exposure to natural influenza. Time to first alleviation of symptoms, influenza outcomes and complications, admissions to hospital, and adverse events in the intention to treat (ITT) population. We included 28 trials in stage 1 (judgment of appropriate study design) and 26 in stage 2 (formal analysis). For treatment of adults, zanamivir reduced the time to first alleviation of symptoms of influenza-like illness by 0.60 days (95% confidence interval 0.39 to 0.81, Pbronchitis in adults (1.80%, 0.65% to 2.80%), but not in children. There were no data to assess effects on admissions in adults and children. Zanamivir tended to be well tolerated. In zanamivir prophylaxis studies, symptomatic influenza in individuals was significantly reduced (1.98%, (0.98% to 2.54%); reducing event rates from 3.26% to 1.27%, which means 51 people need to be treated to prevent one influenza case (95% confidence interval, 40 to 103). In contrast, the prophylaxis effect on asymptomatic influenza cases was not significant in individuals (risk difference 0.14%, -1.10% to 1.10%) or in households (1.32%, -2.20% to 3.84%). In households treated prophylactically there was an effect on symptomatic influenza (14.84%, 12.18% to 16.55%), but this was based on only two small studies including 824 participants. Prophylaxis in adults reduced unverified pneumonia (0.32%, 0.09% to 0.41%; NNTB (number needed to treat to benefit) 311, 244 to 1086) but had no effect on pneumonia in children or on bronchitis or sinusitis in adults or children (risk difference 0.32%, 0.09% to 0.41%; NNTB 311, 244 to 1086). Based on a full assessment

  2. NAFTA Minor Use Joint Reviews

    Science.gov (United States)

    EPA and Health Canada Pest Management Regulatory Agency (PMRA) worked together to develop a registration process that will permit a regulatory decision of pesticide uses for the minor use grower communities in both countries simultaneously.

  3. Overview of EPA`s environmental standards for the land disposal

    Energy Technology Data Exchange (ETDEWEB)

    Gruhlke, J.M.; Galpin, F.L.; Holcomb, W.F. [Environmental Protection Agency, Washington, DC (United States). Office of Radiation Programs

    1989-11-01

    The Environmental Protection Agency (EPA) program to develop proposed generally applicable environmental standards for land disposal of low-level radioactive waste and certain naturally occurring and accelerator-produced radioactive wastes has been completed. The elements of the proposed standards include the following: (1) exposure limits for pre-disposal management and storage operations, (2) criteria for other regulatory agencies to follow in specifying wastes that are Below Regulatory Concern (BRC), (3) post-disposal exposure limits, (4) ground water protection requirements, and (5) qualitative implementation requirements. In addition to covering those radioactive wastes subject to the Atomic Energy Act (AEA), the Agency also intends to propose a standard to require the disposal of high concentration, Naturally occurring and Accelerator-produced Radioactive Materials (NARM) wastes exceeding 2 nCi/g, excluding a few consumer items, in regulated LLW disposal facilities.

  4. Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.

    Science.gov (United States)

    Jefferson, Tom; Jones, Mark; Doshi, Peter; Spencer, Elizabeth A; Onakpoya, Igho; Heneghan, Carl J

    2014-04-09

    To describe the potential benefits and harms of oseltamivir by reviewing all clinical study reports (or similar document when no clinical study report exists) of randomised placebo controlled trials and regulatory comments ("regulatory information"). Systematic review of regulatory information. Clinical study reports, trial registries, electronic databases, regulatory archives, and correspondence with manufacturers. Randomised placebo controlled trials on adults and children who had confirmed or suspected exposure to natural influenza. Time to first alleviation of symptoms, influenza outcomes, complications, admissions to hospital, and adverse events in the intention to treat population. From the European Medicines Agency and Roche, we obtained clinical study reports for 83 trials. We included 23 trials in stage 1 (reliability and completeness screen) and 20 in stage 2 (formal analysis). In treatment trials on adults, oseltamivir reduced the time to first alleviation of symptoms by 16.8 hours (95% confidence interval 8.4 to 25.1 hours, Ptreatment trials there was no difference in admissions to hospital in adults (risk difference 0.15%, 95% confidence interval -0.91% to 0.78%, P=0.84) and sparse data in children and for prophylaxis. In adult treatment trials, oseltamivir reduced investigator mediated unverified pneumonia (risk difference 1.00%, 0.22% to 1.49%; number needed to treat to benefit (NNTB) 100, 95% confidence interval 67 to 451). The effect was not statistically significant in the five trials that used a more detailed diagnostic form for "pneumonia," and no clinical study reports reported laboratory or diagnostic confirmation of "pneumonia." The effect on unverified pneumonia in children and for prophylaxis was not significant. There was no significant reduction in risk of unverified bronchitis, otitis media, sinusitis, or any complication classified as serious or that led to study withdrawal. 14 of 20 trials prompted participants to self report all

  5. 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.

  6. 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...

  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. 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...

  9. GAC-EPA

    CERN Document Server

    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...

  10. Scientific and Regulatory Policy Committee Review: Review of the Organisation for Economic Co-operation and Development (OECD) Guidance on the GLP Requirements for Peer Review of Histopathology.

    Science.gov (United States)

    Fikes, James D; Patrick, Daniel J; Francke, Sabine; Frazier, Kendall S; Reindel, James F; Romeike, Annette; Spaet, Robert H; Tomlinson, Lindsay; Schafer, Kenneth A

    2015-10-01

    In 2014, the Organisation for Economic Co-operation and Development (OECD) issued guidance no. 16, Guidance on the GLP Requirements for Peer Review of Histopathology. The stated purpose of the guidance document is "to provide guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented, and reported in order to meet Good Laboratory Practice (GLP) expectations and requirements." On behalf of and in collaboration with the global societies of toxicologic pathology, the Society of Toxicologic Pathology initiated a review of OECD guidance no. 16. The objectives of this review are to provide a unified interpretation of the guidance, to recommend compliant processes for organizations to implement, and to avoid inconsistent process adaptations across the industry. This review of the guidance document is the product of a global collaboration with other societies of toxicologic pathology and provides a section-by-section international consensus view and interpretation of the OECD guidance on peer review. © 2015 by The Author(s).

  11. EPA LABORATORIES IMPLEMENT EMS PROGRAM

    Science.gov (United States)

    This paper highlights the breadth and magnitude of carrying out an effective Environmental Management System (EMS) program at the U.S. EPA's research and development laboratories. Federal research laboratories have unique operating challenges compared to more centralized industr...

  12. EPA Actions to Protect Pollinators

    Science.gov (United States)

    Pesticide risk management must be based on sound science, consistent with the laws under which pesticides are regulated in the United States. EPA has been working aggressively to protect bees and other pollinators from pesticide exposures.

  13. Meet EPA Scientist Diana Bless

    Science.gov (United States)

    EPA chemical engineer Diana Bless works on sustainable materials management research for rare earth elements in consumer electronics and approaches related to characterization, source control and treatment of mining-influenced waters.

  14. Radiation Resources Outside of EPA

    Science.gov (United States)

    EPA does not license nuclear power plants or regulate the non-ionizing radiation from cell phones, smart meters or power lines. This page provides links to the state and federal agencies that regulate these matters.

  15. EPA Region 1 Tribal Lands

    Data.gov (United States)

    U.S. Environmental Protection Agency — This is a dataset of Tribal/Native American lands in the New England region. EPA notes that there are some disputes over the exact boundaries of the territories of...

  16. Bridging the gap between regulatory acceptance and industry use of non-animal methods.

    Science.gov (United States)

    Clippinger, Amy J; Hill, Erin; Curren, Rodger; Bishop, Patricia

    2016-01-01

    Collaboration between industry and regulators resulted in the development of a decision tree approach using in vitro or ex vivo assays to replace animal tests when determining the eye irritation potential of antimicrobial cleaning products (AMCPs) under the United States Environmental Protection Agency (EPA) Office of Pesticide Programs' hazard classification and labeling system. A policy document issued by the EPA in 2013 and updated in 2015 describes the alternate testing framework that industry could apply to new registrations of AMCPs and, on a case-by-case basis, to conventional pesticide products. Despite the collaborative effort, the availability of relevant non-animal methods, and the EPA's change in policy, only a limited number of AMCPs have been registered using the framework. Companies continue to conduct animal tests when registering AMCPs due to various challenges surrounding adoption of the new testing framework; however, recent discussions between industry, regulators, and other interested parties have identified ways these challenges may be overcome. In this article we explore how use of the alternate framework could be expanded through efforts such as increasing international harmonization, more proactively publicizing the framework, and enhancing the training of regulatory reviewers. Not only can these strategies help to increase use of the EPA alternate eye irritation framework, they can also be applied to facilitate the uptake of other alternative approaches to animal testing in the future.

  17. 76 FR 40200 - Semiannual Regulatory Flexibility Agenda

    Science.gov (United States)

    2011-07-07

    ... Semiannual Regulatory Flexibility Agenda AGENCY: Board of Governors of the Federal Reserve System. ACTION: Semiannual regulatory agenda. SUMMARY: The Board is issuing this agenda under the Regulatory Flexibility Act... rules the Board has selected for review under section 610(c) of the Regulatory Flexibility Act, and...

  18. 75 FR 79843 - Fall 2010 Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... United States. The mobile sources addressed in that regulatory action -- light-duty vehicles and heavy...; Under the Federal Food, Drug, and Cosmetic Act: Actions regarding pesticide tolerances and food additive... are organized. Current choices include: EPA subagency; stage of rulemaking, explained below...

  19. 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.

  20. 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.

  1. 75 FR 24509 - Notice of Availability of the Regulatory Flexibility Act Review of the Methylene Chloride Standard

    Science.gov (United States)

    2010-05-05

    ... 10, 2007, on: the impacts of the rule ] on small businesses; the benefits and utility of the rule in... reduce the regulatory burden on small businesses, or whether it is no longer needed and should be... local governmental rules; and (5) The length of time since the rule has been evaluated or the degree to...

  2. 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.

  3. Canadian drug regulatory framework.

    Science.gov (United States)

    Kelly, L; Lazzaro, M; Petersen, C

    2007-03-01

    The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.

  4. EPA Facilities and Regional Boundaries Download Package, US, 2012, US EPA, SEGS

    Data.gov (United States)

    U.S. Environmental Protection Agency — This downloadable package contains the following layers: EPA facility points, EPA region boundary polygons and EPA region boundary polygons extended to the 200nm...

  5. 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

  6. 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...

  7. 75 FR 34736 - Draft FY 2011-2015 EPA Strategic Plan

    Science.gov (United States)

    2010-06-18

    ... AGENCY Draft FY 2011-2015 EPA Strategic Plan AGENCY: Environmental Protection Agency. ACTION: Notice of... announcing the availability of the Draft FY 2011-2015 EPA Strategic Plan (Strategic Plan) for public review... (GPRA). The Agency's final ] Strategic Plan will be submitted to Congress by September 30, 2010. The...

  8. 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.

  9. 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 ...

  10. 78 FR 78952 - Access by EPA Contractors to Information Claimed as Confidential Business Information (CBI...

    Science.gov (United States)

    2013-12-27

    ...) Submitted under Title II of the Clean Air Act and Related to Code of Federal Regulation Parts and Subparts... submitted to EPA under Title II of the Clean Air Act that may be claimed as, or may be determined to be... implement various Clean Air Act programs, and to permit regulated entities flexibility in meeting regulatory...

  11. EPA Facility Registry Service (FRS): Power Plants

    Science.gov (United States)

    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 Registry Service (FRS) compiled from various EPA programs.

  12. EPA's Response to NRDC's Public Statement

    Science.gov (United States)

    Natural Resource Defense Council made comments about EPA's pesticide program and protection of bees, following a FOIA request regarding clothianidin. NRDC misrepresented EPA efforts to mitigate Colony Collapse Disorder (CCD) and general pollinator decline.

  13. 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...

  14. 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...

  15. 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...

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

    Science.gov (United States)

    Lemly, A Dennis

    2014-08-01

    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. Published by Elsevier Ltd.

  17. 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

    2017-01-17

    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.

  18. Heavy metal toxicity to microbe-mediated ecologic processes: a review and potential application to regulatory policies

    Energy Technology Data Exchange (ETDEWEB)

    Babich, H.; Stotzky, G.

    1985-02-01

    Microorganisms are sensitive to heavy metal pollution as are other components of the biota. However, most studies on the interactions between microbes and heavy metals have been conducted in synthetic media or in altered (e.g., sterilized) environmental samples and usually have used only single species. Few studies have evaluated the effects of heavy metals on the activities of natural heterogeneous microbial populations, both autotrophic and heterotrophic, in terrestrial and aquatic environments. These latter studies have shown that heavy metals inhibit primary productivity, nitrogen fixation, the mineralization of carbon, nitrogen, sulfur, and phosphorus, litter decomposition, and enzyme synthesis and activity in soils, sediments, and surface waters. The potential adverse effects of heavy metals on such microbe-mediated ecologic processes need to be incorporated into the methodologies used by regulatory agencies, such as the US Environmental Protection Agency, to prepare environmental risk assessment which, in turn, are used to formulate environmental criteria. To provide appropriate data that can be assimilated into regulatory policy, it is essential that microbial ecotoxicity tests be standardized, are neither costly nor difficult to train personnel to conduct, and produce data that can be quantitated. 162 references, 1 table.

  19. Confidential Financial Disclosure Form for Environmental Protection Agency Special Government Employees (EPA Form 3110-48)

    Science.gov (United States)

    EPA uses the Confidential Financial Disclosure Form to determine whether there is a conflict of interest or the appearance of a lack of impartiality with regard to the topic under review by the FIFRA Scientific Advisory Panel.

  20. Regulatory Actions - Final Mercury and Air Toxics Standards (MATS) for Power Plants

    Science.gov (United States)

    The U.S. Environmental Protection Agency (EPA) has proposed Mercury and Air Toxics Standards (MATS) for power plants to limit mercury, acid gases and other toxic pollution from power plants. This page describes Federal regulatory actions.

  1. Regulatory elements in molecular networks.

    Science.gov (United States)

    Doane, Ashley S; Elemento, Olivier

    2017-05-01

    Regulatory elements determine the connectivity of molecular networks and mediate a variety of regulatory processes ranging from DNA looping to transcriptional, posttranscriptional, and posttranslational regulation. This review highlights our current understanding of the different types of regulatory elements found in molecular networks with a focus on DNA regulatory elements. We highlight technical advances and current challenges for the mapping of regulatory elements at the genome-wide scale, and describe new computational methods to uncover these elements via reconstructing regulatory networks from large genomic datasets. WIREs Syst Biol Med 2017, 9:e1374. doi: 10.1002/wsbm.1374 For further resources related to this article, please visit the WIREs website. © 2017 Wiley Periodicals, Inc.

  2. Air Sensor Guidebook | Science Inventory | US EPA

    Science.gov (United States)

    This Air Sensor Guidebook has been developed by the U.S. EPA to assist those interested in potentially using lower cost air quality sensor technologies for air quality measurements. Its development was in direct response to a request for such a document following a recent scientific conference (Apps and Sensors for Air Pollution-2012). Low cost air quality sensors ($100-$2500) are now commercially available in a wide variety of designs and capabilities. This is an emerging technology area and one that is quickly evolving. Even so, their availability has resulted in questions from many as to how they might be used appropriately. This document attempts to provide useful information concerning some of those questions. The National Exposure Research Laboratory’s (NERL’s) Human Exposure and Atmospheric Sciences Division (HEASD) conducts research in support of EPA’s mission to protect human health and the environment. HEASD’s research program supports Goal 1 (Clean Air) and Goal 4 (Healthy People) of EPA’s strategic plan. More specifically, our division conducts research to characterize the movement of pollutants from the source to contact with humans. Our multidisciplinary research program produces Methods, Measurements, and Models to identify relationships between and characterize processes that link source emissions, environmental concentrations, human exposures, and target-tissue dose. The impact of these tools is improved regulatory programs and pol

  3. State 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.

  4. 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.

  5. 78 FR 38314 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Science.gov (United States)

    2013-06-26

    ... before July 26, 2013. ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ- OECA-2012... from a 2011 Regulatory Impact Analysis (RIA) conducted by EPA. The previous ICR estimated 97 existing...

  6. Is EPA an obscure coercion? A critical reflection from the literature and agenda for research

    Directory of Open Access Journals (Sweden)

    Collins C Ngwakwe

    2015-12-01

    Full Text Available There is a preponderance of criticism in the literature about the EU-ACP Economic Partnership Agreement (EPA. This paper adopts a neutral stance to present some of these criticisms. The approach is a critical review that culminates in a suggested research agenda. A deduction from critical literature is critic’s censure of EU-ACP EPA apparent coercive posture, described as not meeting developmental expectations both in previous and current agreement. However, some literature avows that EU-ACP EPA has some benefits to EPA, but opines that institutional problems such as corruption in some ACP countries are a hindrance to the realisation of benefits from EPA. Accordingly, the paper suggests agenda for further research as follows: can it be conclusive that the ACP countries have not benefited from EU-ACP agreements thus far and how has corruption in the ACP countries hindered the realisation of intended benefits from EU-ACP agreements?

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

    Energy Technology Data Exchange (ETDEWEB)

    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.

  8. Caffeine (1, 3, 7-trimethylxanthine) in foods: a comprehensive review on consumption, functionality, safety, and regulatory matters.

    Science.gov (United States)

    Heckman, Melanie A; Weil, Jorge; Gonzalez de Mejia, Elvira

    2010-04-01

    Caffeine ranks as one of the top most commonly consumed dietary ingredients throughout the world. It is naturally found in coffee beans, cacao beans, kola nuts, guarana berries, and tea leaves including yerba mate. The total daily intake, as well as the major source of caffeine varies globally; however, coffee and tea are the 2 most prominent sources. Soft drinks are also a common source of caffeine as well as energy drinks, a category of functional beverages. Moderate caffeine consumption is considered safe and its use as a food ingredient has been approved, within certain limits, by numerous regulatory agencies around the world. Performance benefits attributed to caffeine include physical endurance, reduction of fatigue, and enhancing mental alertness and concentration. Caffeine has also been recently linked to weight loss and consequent reduction of the overall risks for developing the metabolic syndrome. However, the caloric contribution of caffeine-sweetened beverages needs to be considered in the overall energy balance. Despite all these benefits the potential negative effects of excessive caffeine intake should also be considered, particularly in children and pregnant women.

  9. 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.

  10. 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....

  11. A review of radiation countermeasures focusing on injury-specific medicinals and regulatory approval status: part III. Countermeasures under early stages of development along with 'standard of care' medicinal and procedures not requiring regulatory approval for use.

    Science.gov (United States)

    Singh, Vijay K; Hanlon, Briana K; Santiago, Paola T; Seed, Thomas M

    2017-09-01

    Terrorist attacks, with their intent to maximize psychological and economic damage as well as inflicting sickness and death on given targeted populations, are an ever-growing worldwide concern in government and public sectors as they become more frequent, violent, and sensational. If given the chance, it is likely that terrorists will use radiological or nuclear weapons. To thwart these sinister efforts, both physical and medical countermeasures against these weapons are currently being researched and developed so that they can be utilized by the first responders, military, and medical providers alike. This is the third article of a three-part series in which we have reviewed additional radiation countermeasures that are currently under early preclinical phases of development using largely animal models and have listed and discussed clinical support measures, including agents used for radiation-induced emesis, as well as countermeasures not requiring Food and Drug Administration approval. Despite the significant progress that has been made in this area during the last several years, additional effort is needed in order to push promising new agents, currently under development, through the regulatory pipeline. This pipeline for new promising drugs appears to be unreasonably slow and cumbersome; possible reasons for this inefficiency are briefly discussed. Significant and continued effort needs to be afforded to this research and development area, as to date, there is no approved radioprotector that can be administered prior to high dose radiation exposure. This represents a very significant, unmet medical need and a significant security issue. A large number of agents with potential to interact with different biological targets are under development. In the next few years, several additional radiation countermeasures will likely receive Food and Drug Administration approval, increasing treatment options for victims exposed to unwanted ionizing irradiation.

  12. “AQMEII Status Update” | Science Inventory | US EPA

    Science.gov (United States)

    “AQMEII Status Update”This presentation provided an overview and status update of the Air Quality Model Evaluation International Initative (AQMEII) to participants of a workshop of the Task Force on Hemispheric Transport of Air Pollution (TF-HTAP) . In addition, the presentation also outlines the objectives and potential timeline for a possible next phase of AQMEII that would involve a collaboration with the current modeling activities of TF-HTAP. The purpose of the presentation was to provide participants at the HTAP meeting with an overview of current AQMEII activities and timelines and to obtain feedback from HTAP workshop participants regarding HTAP timelines. The National Exposure Research Laboratory (NERL) Atmospheric Modeling and Analysis Division (AMAD) conducts research in support of EPA mission to protect human health and the environment. AMAD research program is engaged in developing and evaluating predictive atmospheric models on all spatial and temporal scales for forecasting the air quality and for assessing changes in air quality and air pollutant exposures, as affected by changes in ecosystem management and regulatory decisions. AMAD is responsible for providing a sound scientific and technical basis for regulatory policies based on air quality models to improve ambient air quality. The models developed by AMAD are being used by EPA, NOAA, and the air pollution community in understanding and forecasting not only the magnitude of the air po

  13. Assessment of learning, memory, and attention in developmental neurotoxicity regulatory studies: synthesis, commentary, and recommendations.

    Science.gov (United States)

    Vorhees, Charles V; Makris, Susan L

    2015-01-01

    Cognitive tests of learning and memory (L&M) have been required by U.S. Environmental Protection Agency (EPA) developmental neurotoxicity test (DNT) guidelines for more than two decades. To evaluate the utility of these guidelines, the EPA reviewed 69 pesticide DNT studies. This review found that the DNT provided or could provide the point-of-departure for risk assessment by showing the Lowest Observable Adverse Effect Level (LOAEL) in 28 of these studies in relation to other reported end points. Among the behavioral tests, locomotor activity and auditory/acoustic startle provided the most LOAELs, and tests of cognitive function and the Functional Observational Battery (FOB) the fewest. Two issues arose from the review: (1) what is the relative utility of cognitive tests versus tests of unconditioned behavior, and (2) how might cognitive tests be improved? The EPA sponsored a symposium to address this. Bushnell reviewed studies in which both screening (locomotor activity, FOB, reflex ontogeny, etc.) and complex tests (those requiring training) were used within the same study; he found relatively little evidence that complex tests provided a LOAEL lower than screening tests (with exceptions). Levin reviewed reasons for including cognitive tests in regulatory studies and methods and evidence for the radial arm maze and its place in developmental neurotoxicity assessments. Driscoll and Strupp reviewed the value of serial reaction time operant methods for assessing executive function in developmental neurotoxicity studies. Vorhees and Williams reviewed the value of allocentric (spatial) and egocentric cognitive tests and presented methods for using the Morris water maze for spatial and the Cincinnati water maze for egocentric cognitive assessment. They also reviewed the possible use of water radial mazes. The relatively lower impact of cognitive tests in previous DNT studies in the face of the frequency of human complaints of chemical-induced cognitive dysfunction

  14. 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.

  15. Regulatory functions of microtubules.

    Science.gov (United States)

    Vasiliev, J M; Samoylov, V I

    2013-01-01

    This mini-review summarizes literature and original data about the role of microtubules in interphase animal cells. Recent data have shown that functioning of microtubules is essential for such diverse phenomena as directional cell movements, distribution of organelles in the cytoplasm, and neuronal memory in the central nervous system. It is suggested that microtubules can act as an important regulatory system in eukaryotic cells. Possible mechanisms of these functions are discussed.

  16. Field Collection Methods for an EPA Pilot Study Evaluating ...

    Science.gov (United States)

    This compilation of field collection standard operating procedures (SOPs) was assembled for the U.S. Environmental Protection Agency’s (EPA) Pilot Study add-on to the Green Housing Study (GHS). A detailed description of this add-on study can be found in the peer reviewed research protocol entitled “An EPA Pilot Study Evaluating Personal, Housing, and Community Factors Influencing Children’s Potential Exposures to Indoor Contaminants at Various Lifestages –Research Protocol” 1. Briefly, the Centers for Disease Control and Prevention’s (CDC) Green Housing Study (GHS) follows changes in environmental measurements [pesticides, volatile organic compounds (VOCs), particulate matter (i.e., PM2.5 and 1.0), indoor allergens, and fungi] in both U.S. Department of Housing and Urban Development (HUD) green-renovated and comparison (no renovation) homes and relates these changes to asthma morbidity in children ages 7-12 years. Green-renovations include (but are not limited to) use of low VOC materials, use of energy efficient appliances, and integrated pest management. The EPA has leveraged this opportunity to collect additional multimedia measurements and questionnaire data from the index children actively participating in the GHS and a sibling in order to characterize personal, housing, and community factors. The purpose of this document is to publish the methodology EPA used for a specific study for reference and use by other scientists both within the Agency

  17. 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

  18. 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...

  19. 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.

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

    OpenAIRE

    Koletzko, B.; Uauy, R; Palou, A.; Kok, F.; Hornstra, G.; Eilander, A; Moretti, D.; Osendarp, S; Zock, P.; 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 aged 2-12 years, and of research priorities. The authors concluded that EPA and DHA intakes per kg body weight may often be low in 2- to 12-year-old children, relative to intakes per kg body weigh...

  1. EPA Facilities and Regional Boundaries Service, US, 2012, US EPA, SEGS

    Science.gov (United States)

    This SEGS web service contains EPA facilities, EPA facilities labels, small- and large-scale versions of EPA region boundaries, and EPA region boundaries extended to the 200nm Exclusive Economic Zone (EEZ). Small scale EPA boundaries and boundaries extended to the EEZ render at scales of less than 5 million, large scale EPA boundaries draw at scales greater than or equal to 5 million. EPA facilities labels draw at scales greater than 2 million. Data used to create this web service are available as a separate download at the Secondary Linkage listed above. Full FGDC metadata records for each layer may be found by clicking the layer name in the web service table of contents (available through the online link provided above) and viewing the layer description. This SEGS dataset was produced by EPA through the Office of Environmental Information.

  2. A review of the regulatory energy performance gap and its underlying causes in non-domestic buildings

    Directory of Open Access Journals (Sweden)

    Chris van Dronkelaar

    2016-01-01

    Full Text Available This paper reviews the discrepancy between predicted and measured energy use in non-domestic buildings in a UK context with outlook to global studies. It explains differences between energy performance quantification and classifies this energy performance gap as a difference between compliance or performance modelling with measured energy use. Literary sources are reviewed in order to signify the magnitude between predicted and measured energy use, which is found to deviate by +34% with a standard deviation of 55% based on 62 buildings. It proceeds in describing the underlying causes for the performance gap, existent in all stages of the building life cycle, and identifies the dominant factors to be related to specification uncertainty in modelling, occupant behaviour and poor operational practices having an estimated effect of 20-60%, 10-80% and 15-80% on energy use respectively. Other factors that have a high impact are related to establishing the energy performance target, impact of early design decisions, heuristic uncertainty in modelling and occupant behaviour. Finally action measures and feedback processes in order to reduce the performance gap are discussed, indicating the need for energy in-use legislation, insight into design stage models, accessible energy data and expansion of research efforts towards building performance in-use in relation to predicted performance

  3. Healthcare regulatory concepts in Brazil.

    Science.gov (United States)

    Oliveira, Robson Rocha de; Elias, Paulo Eduardo Mangeon

    2012-06-01

    The healthcare regulatory concepts used in Brazilian scientific publications on healthcare management were reviewed. A typo-logical classification for regulatory concepts was developed from the most current ideas in five disciplines: life sciences, law, economics, sociology and political science. Four ideas stood out: control, balance, adaptation and direction, with greatest emphasis on the technical nature of regulation. The political nature of regulation was secondary. It was considered that dis-cussion of healthcare regulatory concepts was connected with comprehension of the role that the state plays in this sector. De-finition of the forms of state intervention is the key convergence point between the different ways of conceptualizing healthcare regulation.

  4. Rhadinoviral interferon regulatory factor homologues.

    Science.gov (United States)

    Koch, Sandra; Schulz, Thomas F

    2017-07-26

    Kaposi's sarcoma-associated herpesvirus (KSHV), or human herpesvirus 8 (HHV8) is a gammaherpesvirus and the etiological agent of Kaposi's sarcoma, primary effusion lymphoma and multicentric Castleman disease. The KSHV genome contains genes for a unique group of proteins with homology to cellular interferon regulatory factors, termed viral interferon regulatory factors (vIRFs). This review will give an overview over the oncogenic, antiapoptotic and immunomodulatory characteristics of KSHV and related vIRFs.

  5. Will CARICOM countries be vulnerable to financial crises as a result of the Economic Partnership Agreement (EPA): the Cotonou Agreement?

    OpenAIRE

    Reis, NCM

    2014-01-01

    Whether the EPA contains the seeds of potential financial crises in relation to the CARICOM countries, using the concepts of globalisation, volatility risk and hubris (of leadership, economic thought and a weak regulatory environment). \\ud \\ud This study seeks to establish whether financial crises may occur when the variables of globalisation, volatility risk and hubris within a weak regulatory environment coincide within the framework of the Economic Partnership Agreement between the ACP cou...

  6. 78 FR 54517 - Water Quality Standards Regulatory Clarifications

    Science.gov (United States)

    2013-09-04

    ... September 4, 2013 Part II Environmental Protection Agency 40 CFR Part 131 Water Quality Standards Regulatory... Rules#0;#0; ] ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 131 RIN 2040-AF 16 Water Quality Standards... Environmental Protection Agency (EPA) is proposing changes to the federal water quality standards (WQS...

  7. Hydraulic Fracturing Fluid Analysis for Regulatory Parameters - A Progress Report

    Science.gov (United States)

    This presentation is a progress report on the analysis of Hydraulic Fracturing Fluids for regulatory compounds outlined in the various US EPA methodologies. Fracturing fluids vary significantly in consistency and viscosity prior to fracturing. Due to the nature of the fluids the analytical challenges will have to be addressed. This presentation also outlines the sampling issues associated with the collection of dissolved gas samples.

  8. 77 FR 16990 - Notification of Submission to the Secretary of Agriculture of Two Draft Regulatory Documents...

    Science.gov (United States)

    2012-03-23

    ... of Agriculture of Two Draft Regulatory Documents Under FIFRA AGENCY: Environmental Protection Agency (EPA). ] ACTION: Notification of submission to the Secretary of Agriculture. SUMMARY: This document... Certificate Final Rule''. The draft regulatory documents are not available to the public until after they have...

  9. 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.

  10. 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.

  11. 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.

  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. 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.

  14. 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.

  15. 40 CFR 59.630 - EPA testing.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 5 2010-07-01 2010-07-01 false EPA testing. 59.630 Section 59.630... Emissions From New and In-Use Portable Fuel Containers Certifying Emission Families § 59.630 EPA testing. We... production sample testing. Upon our request, a manufacturer must supply a prototype container or a reasonable...

  16. EPA Air Pollution Control Cost Manual

    Science.gov (United States)

    EPA's Air Pollution Control Cost Manual provides guidance for the development of accurate and consistent costs for air pollution control devices. A long-standing document prepared by EPA, the Control Cost Manual focuses on point source and stationary area source air pollution con...

  17. Hispanos en la EPA: Tony Robledo

    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.

  18. Hispanos en la EPA: Enrique Manzanilla

    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.

  19. Hispanos en la EPA: Reiniero Rivera

    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.

  20. Hispanos en la EPA: Karen Milians

    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.

  1. Hispanos en la EPA: Cindy Santiago

    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.

  2. Hispanos en la EPA: Rafael Casanova

    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.

  3. Hispanos en la EPA: Jacqueline Moya

    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.

  4. Hispanos en la EPA: Andrew Almodovar

    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.

  5. Hispanos en la EPA: Lisa Almodovar

    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.

  6. Hispanos en la EPA: Jack Arias

    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.

  7. Hispanos en la EPA: Ana Rivera Lupianiez

    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: Heriberto Cabezas

    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. Hispanos en la EPA: Luis Troche

    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.

  10. 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 ...

  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. 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.

  13. Inside story on the legal challenge to EPA`s municipal waste combustor rule: The mouse that roared, Round 1

    Energy Technology Data Exchange (ETDEWEB)

    Jenkins, L.S. [Wood Quinn & Crapo, L.C., Salt Lake City, UT (United States)

    1997-12-01

    An article in the Deseret News, one of two general circulation newspapers in Salt Lake City, Utah, dated December 13, 1996, reported that {open_quotes}David{close_quotes} took on {open_quotes}Goliath{close_quotes} and won. The article referred to the Davis County Solid Waste Management and Energy Recovery Special Service District`s (the {open_quotes}District{close_quotes}) victory on its challenge to the EPA`s municipal waste combustor rules. On December 6, 1996, the United States Court of Appeals for the District of Columbia Circuit ruled that the EPA violated the plain language of Section 129 of the Clean Air Act, when it wrote size categories for municipal waste combustors ({open_quotes}MWCs{close_quotes}) based on aggregate plant capacity, rather than unit capacity. The District argued that Congress divided the universe of MWC units into two categories: those with unit capacities above 250 tons per day, and those with unit capacities equal to or less than 250 tons per day. The EPA, however, had set the dividing line at 248 tons per day aggregate plant capacity in its municipal waste combustor rule. The Court said this was wrong. The Deseret News report certainly echoed the feelings of the District. Those of you familiar with the EPA, the process of judicial review of administrative rule making, and the Biblical story of David and Goliath, however, will quickly see that this is not the best metaphor to describe what happened. When David slew Goliath, that was the end of Goliath. He didn`t get back up. Of course, that will not happen to the EPA in the Davis County case. Like an 800-pound gorilla, it will always get back up after being challenged by a mouse. This paper tells the story of the challenge to the MWC rule from the District`s perspective. The District has not been popular with either the EPA or many industry players. But, the District was faced with a real problem that, given the District`s location and the local economy, forced its hand in this case.

  14. 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.

  15. Biologic plausibility, cellular effects, and molecular mechanisms of eicosapentaenoic acid (EPA) in atherosclerosis.

    Science.gov (United States)

    Borow, Kenneth M; Nelson, John R; Mason, R Preston

    2015-09-01

    Residual cardiovascular (CV) risk remains in dyslipidemic patients despite intensive statin therapy, underscoring the need for additional intervention. Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid, is incorporated into membrane phospholipids and atherosclerotic plaques and exerts beneficial effects on the pathophysiologic cascade from onset of plaque formation through rupture. Specific salutary actions have been reported relating to endothelial function, oxidative stress, foam cell formation, inflammation, plaque formation/progression, platelet aggregation, thrombus formation, and plaque rupture. EPA also improves atherogenic dyslipidemia characterized by reduction of triglycerides without raising low-density lipoprotein cholesterol. Other beneficial effects of EPA include vasodilation, resulting in blood pressure reductions, as well as improved membrane fluidity. EPA's effects are at least additive to those of statins when given as adjunctive therapy. In this review, we present data supporting the biologic plausibility of EPA as an anti-atherosclerotic agent with potential clinical benefit for prevention of CV events, as well as its cellular effects and molecular mechanisms of action. REDUCE-IT is an ongoing, randomized, controlled study evaluating whether the high-purity ethyl ester of EPA (icosapent ethyl) at 4 g/day combined with statin therapy is superior to statin therapy alone for reducing CV events in high-risk patients with mixed dyslipidemia. The results from this study are expected to clarify the role of EPA as adjunctive therapy to a statin for reduction of residual CV risk. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

  16. 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.

  17. 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.

  18. Regulatory Physiology

    Science.gov (United States)

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

    1999-01-01

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

  19. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  20. Regulatory Benchmarking

    DEFF Research Database (Denmark)

    Agrell, Per J.; Bogetoft, Peter

    2017-01-01

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

  1. 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.

  2. The cost of developing site-specific environmental regulations: evidence from EPA's project XL.

    Science.gov (United States)

    Blackman, A; Mazurek, J

    2001-01-01

    The flagship of the Environmental Protection Agency's regulatory reinvention initiative, Project XL has been touted as a regulatory blueprint for a site-specific, performance-based pollution-control system, but widespread complaints about the costs of the program beg the question of whether the costs of tailoring regulations to individual facilities are manageable. To address this question, this paper presents original survey data on a sample of 11 XL projects. We find that the fixed costs of putting in place XL agreements are substantial, averaging over $450,000 per firm. While stakeholder negotiations are widely cited as the principal source for these costs, we find that they actually arise mainly from interaction between participating facilities and the EPA. Moreover, EPA management problems are perceived by our survey respondents as having inflated project development costs. Finally, we find that the key factors that explains differences in costs across XL projects are the scope and complexity of the project proposal. These findings suggest that Project XL favors large firms that can afford to pay significant project development costs, that EPA management problems must be resolved to reduce costs, and that there may be a significant economic bias against complex and innovative proposals--precisely the type of proposals that Project XL was designed to foster in order to improve the efficiency of the regulatory system.

  3. Anti-regulatory T cells

    DEFF Research Database (Denmark)

    Andersen, Mads Hald

    2017-01-01

    Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host...... responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells—termed anti-regulatory T cells (anti-Tregs)—that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune......-reactive T cells that recognize such targets may be activated due to the strong activation signal given by their cognate targets. The current review describes the existing knowledge regarding these self-reactive anti-Tregs, providing examples of antigen-specific anti-Tregs and discussing their possible roles...

  4. EPA Region 6 Sole Source Aquifers in Louisiana, Geographic NAD83, EPA (1996) [sole_source_aquifers_LA_EPA_1996

    Data.gov (United States)

    Louisiana Geographic Information Center — Polygon layer of EPA Region 6 sole source aquifers in Louisiana. The sole source aquifers represented are Chicot and Southern Hills in Louisiana/Mississippi.

  5. Regulatory aspects on nanomedicines.

    Science.gov (United States)

    Sainz, Vanessa; Conniot, João; Matos, Ana I; Peres, Carina; Zupancic, Eva; Moura, Liane; Silva, Liana C; Florindo, Helena F; Gaspar, Rogério S

    2015-12-18

    Nanomedicines have been in the forefront of pharmaceutical research in the last decades, creating new challenges for research community, industry, and regulators. There is a strong demand for the fast development of scientific and technological tools to address unmet medical needs, thus improving human health care and life quality. Tremendous advances in the biomaterials and nanotechnology fields have prompted their use as promising tools to overcome important drawbacks, mostly associated to the non-specific effects of conventional therapeutic approaches. However, the wide range of application of nanomedicines demands a profound knowledge and characterization of these complex products. Their properties need to be extensively understood to avoid unpredicted effects on patients, such as potential immune reactivity. Research policy and alliances have been bringing together scientists, regulators, industry, and, more frequently in recent years, patient representatives and patient advocacy institutions. In order to successfully enhance the development of new technologies, improved strategies for research-based corporate organizations, more integrated research tools dealing with appropriate translational requirements aiming at clinical development, and proactive regulatory policies are essential in the near future. This review focuses on the most important aspects currently recognized as key factors for the regulation of nanomedicines, discussing the efforts under development by industry and regulatory agencies to promote their translation into the market. Regulatory Science aspects driving a faster and safer development of nanomedicines will be a central issue for the next years. Copyright © 2015 Elsevier Inc. All rights reserved.

  6. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

    Science.gov (United States)

    van der Gronde, Toon; Uyl-de Groot, Carin A.

    2017-01-01

    Context Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. Method A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Findings Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. Conclusion A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines. PMID:28813502

  7. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks.

    Science.gov (United States)

    Gronde, Toon van der; Uyl-de Groot, Carin A; Pieters, Toine

    2017-01-01

    Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines. A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines. Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered. A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

  8. CCS: Legal and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    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 has estimated that the broad deployment of low-carbon energy technologies could reduce projected 2050 emissions to half 2005 levels -- and that CCS could contribute about one-fifth of those reductions. Reaching that goal, however, would require around 100 CCS projects to be implemented by 2020 and over 3 000 by 2050.

  9. (n-3) fatty acids and cardiovascular health: are effects of EPA and DHA shared or complementary?

    Science.gov (United States)

    Mozaffarian, Dariush; Wu, Jason H Y

    2012-03-01

    Considerable research supports cardiovascular benefits of consuming omega-3 PUFA, also known as (n-3) PUFA, from fish or fish oil. Whether individual long-chain (n-3) PUFA have shared or complementary effects is not well established. We reviewed evidence for dietary and endogenous sources and cardiovascular effects on biologic pathways, physiologic risk factors, and clinical endpoints of EPA [20:5(n-3)], docosapentaenoic acid [DPA, 22:5(n-3)], and DHA [22:6(n-3)]. DHA requires direct dietary consumption, with little synthesis from or retroconversion to DPA or EPA. Whereas EPA is also largely derived from direct consumption, EPA can also be synthesized in small amounts from plant (n-3) precursors, especially stearidonic acid. In contrast, DPA appears principally derived from endogenous elongation from EPA, and DPA can also undergo retroconversion back to EPA. In experimental and animal models, both EPA and DHA modulate several relevant biologic pathways, with evidence for some differential benefits. In humans, both fatty acids lower TG levels and, based on more limited studies, favorably affect cardiac diastolic filling, arterial compliance, and some metrics of inflammation and oxidative stress. All three (n-3) PUFA reduce ex vivo platelet aggregation and DHA also modestly increases LDL and HDL particle size; the clinical relevance of such findings is uncertain. Combined EPA+DHA or DPA+DHA levels are associated with lower risk of fatal cardiac events and DHA with lower risk of atrial fibrillation, suggesting direct or indirect benefits of DHA for cardiac arrhythmias (although not excluding similar benefits of EPA or DPA). Conversely, EPA and DPA, but not DHA, are associated with lower risk of nonfatal cardiovascular endpoints in some studies, and purified EPA reduced risk of nonfatal coronary syndromes in one large clinical trial. Overall, for many cardiovascular pathways and outcomes, identified studies of individual (n-3) PUFA were relatively limited, especially

  10. EPA Linked Open Data: Chemical Data Reporting

    Data.gov (United States)

    U.S. Environmental Protection Agency — This resource consists of the Chemical Data Reporting database that supports the Toxic Substances Control Act (TSCA) of 1976, which provides EPA with authority to...

  11. 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...

  12. 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...

  13. 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...

  14. 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...

  15. 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.

  16. EPA RE-Powering Mapper Utility 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...

  17. 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...

  18. 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...

  19. EPA Facility Registry Service (FRS): RCRA

    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 hazardous waste...

  20. 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...

  1. EPA Facility Registry Service (FRS): RMP

    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...

  2. 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...

  3. EPA Facility Registry Service (FRS): SDWIS

    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...

  4. 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...

  5. 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...

  6. 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...

  7. 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...

  8. 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,...

  9. Environmental change: Federal courts and the EPA

    Energy Technology Data Exchange (ETDEWEB)

    O' Leary, R.

    1993-01-01

    This book presents the findings of a four-year study of the impact of federal court decisions on the policies and administration of the US Environmental Protection Agency (EPA) in all seven of its major statutory areas: clean air, clean water, hazardous waste cleanup, controlled pesticide use, resource conservation and recovery, safe drinking water, and control of toxic substances. The author use the Lexis and Westlaw legal data bases to generate a list of all cases in which the EPA was either a plaintiff or a defendant in each of the agency's seven major statutory areas. The author verified these data and at times supplemented them with EPA records and with environmental reporters published by the Bureau of National Affairs and the Environmental Law Institute. She derived settlement agreements from the EPA, the Department of Justice, and the courts.

  10. 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...

  11. 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...

  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 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,...

  14. 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...

  15. 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.

  16. Registry of EPA Applications, Models, and Databases

    Data.gov (United States)

    U.S. Environmental Protection Agency — READ is EPA's authoritative source for information about Agency information resources, including applications/systems, datasets and models. READ is one component of...

  17. "EPA'S NATIONAL BEACHES STUDY: HUNTINGTON BEACH, 2003"

    Science.gov (United States)

    The original U. S. Environmental Protection Agency (EPA) recreational water health studies, initiated in 1972 and completed in 1982, were designed to determine the relationship between swimming-associated gastroenteritis and the quality of the bathing water. However, these healt...

  18. 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,...

  19. EPA Region 1 - Valley Depth in Meters

    Data.gov (United States)

    U.S. Environmental Protection Agency — Raster of the Depth in meters of EPA-delimited Valleys in Region 1. Valleys (areas that are lower than their neighbors) were extracted from a Digital Elevation Model...

  20. 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...

  1. 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,...

  2. 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...

  3. 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,...

  4. 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,...

  5. 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...

  6. 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,...

  7. 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...

  8. 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...

  9. 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...

  10. 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...

  11. 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...

  12. 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...

  13. 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...

  14. Wellheads, 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...

  15. NODA for EPA's Updated Ozone Transport Modeling

    Science.gov (United States)

    Find EPA's NODA for the Updated Ozone Transport Modeling Data for the 2008 Ozone National Ambient Air Quality Standard (NAAQS) along with the ExitExtension of Public Comment Period on CSAPR for the 2008 NAAQS.

  16. 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...

  17. 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...

  18. 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...

  19. EPA USDA Agricultural Equipment Statement of Principles

    Science.gov (United States)

    The Agricultural Equipment Statement of Principles was developed jointly between EPA and USDA at the request of agriculture industry stakeholders seeking support for programs to assist farmers looking to invest in cleaner agricultural equipment

  20. 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,...

  1. 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,...

  2. 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,...

  3. 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...

  4. 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...

  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. 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...

  7. 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,...

  8. Level III 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,...

  9. 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,...

  10. 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.

  11. EPA Approves Okla. Drinking Water Rule

    Science.gov (United States)

    DALLAS - (Dec. 22, 2015) The U.S. Environmental Protection Agency (EPA) has approved the state of Oklahoma's revised rule for regulating total coliform in drinking water. With this approval, the Oklahoma Department of Environmental Quality (ODEQ) ha

  12. 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...

  13. 76 FR 9988 - Improving EPA Regulations

    Science.gov (United States)

    2011-02-23

    ..., which means EPA will not know your identity or contact information unless you provide it in the body of..., expand or transform a market? Which regulations could be modified so as to invite public/private...

  14. 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,...

  15. 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...

  16. 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...

  17. 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...

  18. EPA RE-Powering Mapper Region 2

    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 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...

  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...

  1. 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...

  2. 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...

  3. EPA RE-Powering Mapper Region 1

    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...

  4. Assessment of learning, memory and attention in developmental neurotoxicity regulatory studies: Introduction.

    Science.gov (United States)

    Makris, Susan L; Vorhees, Charles V

    2015-01-01

    There are a variety of chemicals, including pharmaceuticals, that alter neurobehavior following developmental exposure and guidelines for the conduct of studies to detect such effects by statute in the United States and Europe. Guidelines for Developmental Neurotoxicity Testing (DNT) studies issued by the U.S. Environmental Protection Agency (EPA) under prevailing law and European Organization for Economic Cooperation and Development (OECD) recommendations to member countries provide that such studies include a series of neurobehavioral and neuropathological assessments. Among these are assessment of cognitive function, specifically learning and memory. After reviewing 69 DNT studies submitted to the EPA, tests of learning and memory were noted to have detected the lowest observed adverse effect level (LOAELs) less frequently than behavioral tests of locomotor activity and acoustic/auditory startle, but slightly more than for the developmental Functional Observational Battery (devFOB; which is less extensive than the full FOB), but the reasons for the lower LOAEL detection rate for learning and memory assessment could not be determined. A major concern identified in the review, however, was the adequacy of the methods employed in these studies rather than on the importance of learning and memory to the proper assessment of brain function. Accordingly, a symposium was conducted to consider how the guidelines for tests of learning and memory might be improved. Four laboratories with established histories investigating the effects of chemical exposures during development on learning, memory, and attention, were invited to review the topic and offer recommendations, both theoretical and practical, on approaches to improve the assessment of these vital CNS functions. Reviewers were asked to recommend methods that are grounded in functional importance to CNS integrity, well-validated, reliable, and amenable to the context of regulatory studies as well as to basic

  5. Registration Review Process

    Science.gov (United States)

    EPA will review each registered pesticide at least every 15 years to determine whether it continues to meet the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) standard for registration. There are currently 745 registration review cases.

  6. Registration Review Schedules

    Science.gov (United States)

    This schedule indicates plans for completion of risk assessments, proposed interim decisions and interim decisions for pesticides in the Registration Review program, EPA reviews all registered pesticides at least every 15 years as required by FIFRA.

  7. EPA Facility Registry Service (FRS): CAMDBS

    Science.gov (United States)

    This web feature service contains location and facility identification information from EPA's Facility Registry Service (FRS) for the subset of facilities that link to the Clean Air Markets Division Business System (CAMDBS). Administered by the EPA Clean Air Markets Division, within the Office of Air and Radiation, CAMDBS supports the implementation of market-based air pollution control programs, including the Acid Rain Program and regional programs designed to reduce the transport of ozone. FRS identifies and geospatially locates facilities, sites or places subject to environmental regulations or of environmental interest. Using vigorous verification and data management procedures, FRS integrates facility data from EPA's national program systems, other federal agencies, and State and tribal master facility records and provides EPA with a centrally managed, single source of comprehensive and authoritative information on facilities. This data set contains the subset of FRS integrated facilities that link to CAMDBS facilities once the CAMDBS data has been integrated into the FRS database. Additional information on FRS is available at the EPA website https://www.epa.gov/enviro/facility-registry-service-frs.

  8. Meditation and its regulatory role on sleep

    Directory of Open Access Journals (Sweden)

    Ravindra P. Nagendra

    2012-04-01

    Full Text Available Intense meditation practices help to achieve a harmony between body and mind. Meditation practices influence brain functions, induce various intrinsic neural plasticity events, modulate autonomic, metabolic, endocrine and immune functions and thus mediate global regulatory changes in various behavioural states including sleep. This brief review focuses on the effect of meditation as a self regulatory phenomenon on sleep.

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

    Science.gov (United States)

    Koletzko, Berthold; Uauy, Ricardo; Palou, Andreu; Kok, Frans; Hornstra, Gerard; Eilander, Ans; Moretti, Diego; Osendarp, Saskia; Zock, Peter; Innis, Sheila

    2010-03-01

    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 aged 2-12 years, and of research priorities. The authors concluded that EPA and DHA intakes per kg body weight may often be low in 2- to 12-year-old children, relative to intakes per kg body weight of breast-fed infants and adult intakes, but reliable data are scarce. Little information is available that increasing dietary intakes of EPA or DHA in children has benefits to physical or mental function or other health endpoints. Studies addressing EPA and DHA intakes and tissue status among groups of children with different dietary habits, and measures of relevant development and health endpoints, are needed for developing potential advice on desirable intakes of EPA and/or DHA in children. At this time it appears prudent to advise that dietary intakes in childhood are consistent with future eating patterns supporting adult health, such as prevention of metabolic disorders and CVD, supporting immune function, and reproductive health. In conclusion, the available information relating dietary EPA and DHA intakes in children aged 2-12 years to growth, development and health is insufficient to derive dietary intake recommendations for EPA and DHA. Adequately designed studies addressing dietary intakes, measures of status and relevant functional or health effects across this age group are needed.

  10. 76 FR 40144 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2011-07-07

    ... Certifications Application (ORCA) now collects this data centrally from interested A&E vendors at the time they... learning (i.e., HBCUs/MIs). This is a significant regulatory action and, therefore, was subject to review...

  11. Open Letter from the GAC-EPA to the Chairman of the PFGB EPA

    CERN Multimedia

    GAC-EPA

    2012-01-01

    Following the publication by the Chairman of the Pension Fund Governing Board of  the Spring report of the Pension Fund in the CERN Bulletin issue dated 25 July 2012 (Nos 30 & 31), the GAC-EPA has reacted through an open letter. See www.gac-epa.org under Announcement.

  12. Evaluation of the WIPP Project`s compliance with the EPA radiation protection standards for disposal of transuranic waste

    Energy Technology Data Exchange (ETDEWEB)

    Neill, R.H.; Chaturvedi, L.; Rucker, D.F.; Silva, M.K.; Walker, B.A.; Channell, J.K.; Clemo, T.M. [Environmental Evaluation Group, Albuquerque, NM (United States)]|[Environmental Evaluation Group, Carlsbad, NM (United States)

    1998-03-01

    The US Environmental Protection Agency`s (EPA) proposed rule to certify that the Waste Isolation Pilot Plant (WIPP) meets compliance with the long-term radiation protection standards for geologic repositories (40CFR191 Subparts B and C), is one of the most significant milestones to date for the WIPP project in particular, and for the nuclear waste issue in general. The Environmental Evaluation Group (EEG) has provided an independent technical oversight for the WIPP project since 1978, and is responsible for many improvements in the location, design, and testing of various aspects of the project, including participation in the development of the EPA standards since the early 1980s. The EEG reviewed the development of documentation for assessing the WIPP`s compliance by the Sandia National Laboratories following the 1985 promulgation by EPA, and provided many written and verbal comments on various aspects of this effort, culminating in the overall review of the 1992 performance assessment. For the US Department of Energy`s (DOE) compliance certification application (CCA), the EEG provided detailed comments on the draft CCA in March, 1996, and additional comments through unpublished letters in 1997 (included as Appendices 8.1 and 8.2 in this report). Since the October 30, 1997, publication of the EPA`s proposed rule to certify WIPP, the EEG gave presentations on important issues to the EPA on December 10, 1997, and sent a December 31, 1997 letter with attachments to clarify those issues (Appendix 8.3). The EEG has raised a number of questions that may have an impact on compliance. In spite of the best efforts by the EEG, the EPA reaction to reviews and suggestions has been slow and apparently driven by legal considerations. This report discusses in detail the questions that have been raised about containment requirements. Also discussed are assurance requirements, groundwater protection, individual protection, and an evaluation of EPA`s responses to EEG`s comments.

  13. Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit

    Energy Technology Data Exchange (ETDEWEB)

    Levine, Aaron L [National Renewable Energy Laboratory (NREL), Golden, CO (United States)

    2017-12-19

    Hydropower Regulatory and Permitting Information Desktop (RAPID) Toolkit presentation from the WPTO FY14-FY16 Peer Review. The toolkit is aimed at regulatory agencies, consultants, project developers, the public, and any other party interested in learning more about the hydropower regulatory process.

  14. Meeting Regulatory Needs.

    Science.gov (United States)

    Weber, Michael Fred

    2017-02-01

    The world is experiencing change at an unprecedented pace, as reflected in social, cultural, economic, political, and technological advances around the globe. Regulatory agencies, like the U.S. Nuclear Regulatory Commission (NRC), must also transform in response to and in preparation for these changes. In 2014, the NRC staff commenced Project Aim 2020 to transform the agency by enhancing efficiency, agility, and responsiveness, while accomplishing NRC's safety and security mission. Following Commission review and approval in 2015, the NRC began implementing the approved strategies, including strategic workforce planning to provide confidence that NRC will have employees with the right skills and talents at the right time to accomplish the agency's mission. Based on the work conducted so far, ensuring an adequate pipeline of radiation protection professionals is a significant need that NRC shares with states and other government agencies, private industry, academia, as well as international counterparts. NRC is working to ensure that sufficient radiation protection professionals will be available to fulfill its safety and security mission and leverage the work of the National Council on Radiation Protection and Measurements, the Conference of Radiation Control Program Directors, the Health Physics Society, the Organization of Agreement States, the International Atomic Energy Agency, the Nuclear Energy Agency, and others.

  15. Report: EPA Needs to Improve Internal Controls to Increase Cost Recovery

    Science.gov (United States)

    Report #09-P-0144, April 27, 2009. Within a sample of removal actions we reviewed, EPA collected from responsible parties approximately 11 percent ($31.4 of $294.5 million) of the Federal Government’s costs for conducting the removal actions.

  16. Elevation Request Letter from RA to EPA HQ - signed September 30, 1998

    Science.gov (United States)

    A letter to request a review of the permit for a proposed industrial site in Orange County, California and pursuant to the Clean Water Act Section 404(q) Memorandum of Agreement (MOA) between the EPA and the Department of the Army.

  17. Regulatory physiology discipline science plan

    Science.gov (United States)

    1991-01-01

    The focus of the Regulatory Physiology discipline of the Space Physiology and Countermeasures Program is twofold. First, to determine and study how microgravity and associated factors of space flight affect the regulatory mechanisms by which humans adapt and achieve homeostasis and thereby regulate their ability to respond to internal and external signals; and, second, to study selected physiological systems that have been demonstrated to be influenced by gravity. The Regulatory Physiology discipline, as defined here, is composed of seven subdisciplines: (1) Circadian Rhythms, (2) Endocrinology, (3) Fluid and Electrolyte Regulation, (4) Hematology, (5) Immunology, (6) Metabolism and Nutrition, and (7) Temperature Regulation. The purpose of this Discipline Science Plan is to provide a conceptual strategy for NASA's Life Sciences Division research and development activities in the area of regulatory physiology. It covers the research areas critical to NASA's programmatic requirements for the Extended-Duration Orbiter, Space Station Freedom, and exploration mission science activities. These science activities include ground-based and flight; basic, applied, and operational; and animal and human research and development. This document summarizes the current status of the program, outlines available knowledge, establishes goals and objectives, identifies science priorities, and defines critical questions in regulatory physiology. It contains a general plan that will be used by both NASA Headquarters Program Offices and the field centers to review and plan basic, applied, and operational intramural and extramural research and development activities in this area.

  18. Anti-regulatory T cells.

    Science.gov (United States)

    Andersen, Mads Hald

    2017-04-01

    Our initial understanding of immune-regulatory cells was based on the discovery of suppressor cells that assure peripheral T-cell tolerance and promote immune homeostasis. Research has particularly focused on the importance of regulatory T cells (Tregs) for immune modulation, e.g. directing host responses to tumours or inhibiting autoimmunity development. However, recent studies report the discovery of self-reactive pro-inflammatory T cells-termed anti-regulatory T cells (anti-Tregs)-that target immune-suppressive cells. Thus, regulatory cells can now be defined as both cells that suppress immune reactions as well as effector cells that counteract the effects of suppressor cells and support immune reactions. Self-reactive anti-Tregs have been described that specifically recognize human leukocyte antigen-restricted epitopes derived from proteins that are normally expressed by regulatory immune cells, including indoleamine 2,3-dioxygenase (IDO), tryptophan 2,6-dioxygenase (TDO), programmed death-ligand 1 (PD-L1), and forkhead box P3 (Foxp3). These proteins are highly expressed in professional antigen-presenting cells under various physiological conditions, such as inflammation and stress. Therefore, self-reactive T cells that recognize such targets may be activated due to the strong activation signal given by their cognate targets. The current review describes the existing knowledge regarding these self-reactive anti-Tregs, providing examples of antigen-specific anti-Tregs and discussing their possible roles in immune homeostasis and their potential future clinical applications.

  19. Setting and Reviewing Standards to Control SO2 Pollution

    Science.gov (United States)

    EPA sets National Ambient Air Quality Standards (NAAQS) for SO2 to protect public health (primary standard) and to protect public welfare (secondary standard). The Clean Air Act also requires EPA to periodically review and revise them if appropriate.

  20. Setting and Reviewing Standards to Control NO2 Pollution

    Science.gov (United States)

    EPA sets National Ambient Air Quality Standards (NAAQS) for NO2 to protect public health (primary standard) and to protect public welfare (secondary standard). The Clean Air Act also requires EPA to periodically review and revise them if appropriate.

  1. EPA Definition of Pollution Prevention

    Science.gov (United States)

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

  2. Regulatory Information By Topic

    Science.gov (United States)

    EPA develops and enforces regulations that span many environmental topics, from acid rain reduction to wetlands restoration. Each topic listed below may include related laws and regulations, compliance enforcement information, policies guidance

  3. Cheminformatics Analysis of EPA ToxCast Chemical Libraries ...

    Science.gov (United States)

    An important goal of toxicology research is the development of robust methods that use in vitro and chemical structure information to predict in vivo toxicity endpoints. The US EPA ToxCast program is addressing this goal using ~600 in vitro assays to create bioactivity profiles on a set of 320 compounds, mostly pesticide actives, that have well characterized in vivo toxicity. These 320 compounds (EPA-320 set evaluated in Phase I of ToxCast) are a subset of a much larger set of ~10,000 candidates that are of interest to the EPA (called here EPA-10K). Predictive models of in vivo toxicity are being constructed from the in vitro assay data on the EPA-320 chemical set. These models require validation on additional chemicals prior to wide acceptance, and this will be carried out by evaluating compounds from EPA-10K in Phase II of ToxCast. We have used cheminformatics approaches including clustering, data visualization, and QSAR to develop models for EPA-320 that could help prioritizing EPA-10K validation chemicals. Both chemical descriptors, as well as calculated physicochemical properties have been used. Compounds from EPA-10K are prioritized based on their similarity to EPA-320 using different similarity metrics, with similarity thresholds defining the domain of applicability for the predictive models built for EPA-320 set. In addition, prioritized lists of compounds of increasing dissimilarity from the EPA-320 have been produced, to test the ability of the EPA-320

  4. Regulatory Promotion of Emergent CCS Technology

    Energy Technology Data Exchange (ETDEWEB)

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

    Despite the growing inevitability of climate change and the attendant need for mitigation strategies, carbon capture and sequestration (CCS) has yet to gain much traction in the United States. Recent regulatory proposals by the U.S. Environmental Protection Agency (EPA), limited in scope to new-build power plants, represent the only significant policy initiative intended to mandate diffusion of CCS technology. Phase I of this Project assessed barriers to CCS deployment as prioritized by the CCS community. That research concluded that there were four primary barriers: (1) cost, (2) lack of a carbon price, (3) liability, and (4) lack of a comprehensive regulatory regime. Phase II of this Project, as presented in this Report, assesses potential regulatory models for CCS and examines where those models address the hurdles to diffusing CCS technology identified in Phase I. It concludes (1) that a CCS-specific but flexible standard, such as a technology performance standard or a very particular type of market-based regulation, likely will promote CCS diffusion, and (2) that these policies cannot work alone, but rather, should be combined with other measures, such as liability limits and a comprehensive CCS regulatory regime.

  5. EPA Scientific Knowledge Management Assessment and ...

    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 is linked to the increased complexity of environmental assessments in the 21st century. This complexity is manifest in the form of problems that require integrated multi-disciplinary solutions. To enable the means to develop these solutions (i.e., science software systems) it is necessary to integrate software developed by disparate groups representing a variety of science domains. Thus, reuse and interoperability becomes imperative. This report briefly describes the chronology of activities conducted by the group of scientists to provide context for the primary purpose of this report, that is, to describe the proceedings and outcomes of the latest activity, a workshop entitled “Workshop on Advancing US EPA integration of environmental and information sciences”. The EPA has been lagging in digital maturity relative to the private sector and even other government agencies. This report helps begin the process of improving the agency’s use of digital technologies, especially in the areas of efficiency and transparency. This report contributes to SHC 1.61.2.

  6. EPA H2O Software Tool

    Science.gov (United States)

    EPA H2O allows user to: Understand the significance of EGS in Tampa Bay watershed; visually analyze spatial distribution of the EGS in Tampa Bay watershed; obtain map and summary statistics of EGS values in Tampa Bay watershed; analyze and compare potential impacts of development...

  7. Manufacturer Tier 3 Questions and EPA Answers

    Science.gov (United States)

    This document contains a record of EPA responses to manufacturer questions received prior to October 16, 2015 with respect to implementation of the Tier 3 final rule intended to aid regulated parties in achieving compliance with regulations for light-duty

  8. Controlling Methane Emissions in the Natural Gas Sector. A Review of Federal and State Regulatory Frameworks Governing Production, Gathering, Processing, Transmission, and Distribution

    Energy Technology Data Exchange (ETDEWEB)

    Paranhos, Elizabeth [Energy Innovation Partners, Seoul (South Korea); Kozak, Tracy G. [Energy Innovation Partners, Seoul (South Korea); Boyd, William [Univ. of Colorado, Boulder, CO (United States); Bradbury, James [U.S. Department of Energy, Washington, DC (United States); Steinberg, D. C. [National Renewable Energy Laboratory (NREL), Golden, CO (United States); Arent, D. J. [Joint Inst. for Strategic Energy Alaysis, Washington, DC (United States)

    2015-04-23

    This report provides an overview of the regulatory frameworks governing natural gas supply chain infrastructure siting, construction, operation, and maintenance. Information was drawn from a number of sources, including published analyses, government reports, in addition to relevant statutes, court decisions and regulatory language, as needed. The scope includes all onshore facilities that contribute to methane emissions from the natural gas sector, focusing on three areas of state and federal regulations: (1) natural gas pipeline infrastructure siting and transportation service (including gathering, transmission, and distribution pipelines), (2) natural gas pipeline safety, and (3) air emissions associated with the natural gas supply chain. In addition, the report identifies the incentives under current regulatory frameworks to invest in measures to reduce leakage, as well as the barriers facing investment in infrastructure improvement to reduce leakage. Policy recommendations regarding how federal or state authorities could regulate methane emissions are not provided; rather, existing frameworks are identified and some of the options for modifying existing regulations or adopting new regulations to reduce methane leakage are discussed.

  9. National Air Toxics Assessment - 1999, EPA Region 2 (EPA.AIR.NATA99_R2)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This data layer is based on the model results of the 1999 National-Scale Assessment (N-SA), a part of the National Air Toxics Assessment (NATA), conducted by EPA's...

  10. National Air Toxics Assessment - 2005, EPA Region 2 (EPA.AIR.NATA99_R2)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This data layer is based on the model results of the 1999 National-Scale Assessment (N-SA), a part of the National Air Toxics Assessment (NATA), conducted by EPA's...

  11. Nonattainment Areas in Louisiana, Geographic NAD83, EPA (2006) [Nonattainment_LA_EPA_2006

    Data.gov (United States)

    Louisiana Geographic Information Center — EPA Region 6 NonAttainment Areas in Louisiana, current as of May 2006. This shapefile contains parish boundaries and attributes that determine whether the parishes...

  12. Privacy Act System of Records: EPA Personnel Emergency Contact Files, EPA-44

    Science.gov (United States)

    Learn about the EPA Personnel Emergency Contact Files System, including including who is covered in the system, the purpose of data collection, routine uses for the system's records, and other security procedure.

  13. Privacy Act System of Records: Invention Reports Submitted to the EPA, EPA-38

    Science.gov (United States)

    Learn about the Invention Reports Submitted to the EPA System, including who is covered in the system, the purpose of data collection, routine uses for the system's records, and other security procedures.

  14. Privacy Act System of Records: EPA Telecommunications Detail Records, EPA-32

    Science.gov (United States)

    Learn more about the EPA Telecommunications Detail Records System, including who is covered in the system, the purpose of data collection, routine uses for the system's records, and other security procedures.

  15. EPA Pacific Southwest Enforcement Division Inspected Tax Map Key Polygons, Hawaii, 2017, US EPA Region 9

    Data.gov (United States)

    U.S. Environmental Protection Agency — This feature class contains the 64 tax map key polygons across the state of Hawaii that have been inspected by US EPA Pacific Southwest Enforcement Division as of...

  16. National Air Toxics Assessment - 2002, EPA Region 2 (EPA.AIR.NATA99_R2)

    Data.gov (United States)

    U.S. Environmental Protection Agency — This data layer is based on the model results of the 1999 National-Scale Assessment (N-SA), a part of the National Air Toxics Assessment (NATA), conducted by EPA's...

  17. US EPA Regional Masks Web Service, US, 2015, US EPA, SEGS

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web service contains the following map layers: masks and labels for EPA regions 1 through 10. Mask layers are drawn at all scales. Label layers draw at scales...

  18. Use of benefit-cost analysis in establishing Federal radiation protection standards: a review

    Energy Technology Data Exchange (ETDEWEB)

    Erickson, L.E.

    1979-10-01

    This paper complements other work which has evaluated the cost impacts of radiation standards on the nuclear industry. It focuses on the approaches to valuation of the health and safety benefits of radiation standards and the actual and appropriate processes of benefit-cost comparison. A brief historical review of the rationale(s) for the levels of radiation standards prior to 1970 is given. The Nuclear Regulatory Commission (NRC) established numerical design objectives for light water reactors (LWRs). The process of establishing these numerical design criteria below the radiation protection standards set in 10 CFR 20 is reviewed. EPA's 40 CFR 190 environmental standards for the uranium fuel cycle have lower values than NRC's radiation protection standards in 10 CFR 20. The task of allocating EPA's 40 CFR 190 standards to the various portions of the fuel cycle was left to the implementing agency, NRC. So whether or not EPA's standards for the uranium fuel cycle are more stringent for LWRs than NRC's numerical design objectives depends on how EPA's standards are implemented by NRC. In setting the numerical levels in Appendix I to 10 CFR 50 and 40 CFR 190 NRC and EPA, respectively, focused on the costs of compliance with various levels of radiation control. A major portion of the paper is devoted to a review and critique of the available methods for valuing health and safety benefits. All current approaches try to estimate a constant value of life and use this to vaue the expected number of lives saved. This paper argues that it is more appropriate to seek a value of a reduction in risks to health and life that varies with the extent of these risks. Additional research to do this is recommended. (DC)

  19. EPA Facility Registry Service (FRS): Wastewater Treatment Plants

    Data.gov (United States)

    U.S. Environmental Protection Agency — This GIS dataset contains data on wastewater treatment plants, based on EPA's Facility Registry Service (FRS), EPA's Integrated Compliance Information System (ICIS)...

  20. EPA Region 1 Coast Guard Jurisdictional Boundary - Polygons

    Data.gov (United States)

    U.S. Environmental Protection Agency — Jurisdictional boundary between EPA and Coast Guard for EPA Region I. Created from 1:100000 USGS DLGs with greater detail drawn from 1:24000 commercial street data...

  1. Meet EPA Ecologist Paul Mayer, Ph.D.

    Science.gov (United States)

    EPA ecologist Paul Mayer, Ph.D. works in EPA's Groundwater and Ecosystem Restoration division where he studies riparian zones (the area along rivers and streams where the habitats are influenced by both the land and water) and stream restoration

  2. Meet EPA Engineer Shawn Ryan, Ph.D.

    Science.gov (United States)

    Shawn Ryan, Ph.D. is a chemical engineer at EPA's National Homeland Security Research Center. He has worked at EPA for 12 years, nine of which have been devoted to leading research to support decontamination and consequence management.

  3. Meet EPA Scientist Ana Rappold, Ph.D.

    Science.gov (United States)

    EPA Scientist Ana Rappold is a statistician in EPA's Environmental Public Health Division of the National Health and Environmental Effects Research Lab. Her research is focused on the health effects of air pollution.

  4. U.S. EPAs Public Geospatial Metadata Service

    Data.gov (United States)

    U.S. Environmental Protection Agency — EPAs public geospatial metadata service provides external parties (Data.gov, GeoPlatform.gov, and the general public) with access to EPA's geospatial metadata...

  5. EPA Region 1 Coast Guard Jurisdictional Boundary - Arcs

    Data.gov (United States)

    U.S. Environmental Protection Agency — Jurisdictional boundary between EPA and Coast Guard for EPA Region I. Created from 1:100000 USGS DLGs with greater detail drawn from 1:24000 commercial street data...

  6. Consecutive Connections, US EPA Region 9, 2013, SDWIS

    Data.gov (United States)

    U.S. Environmental Protection Agency — EPA's Safe Drinking Water Information System (SDWIS) databases store information about drinking water. The federal version (SDWIS/FED) stores the information EPA...

  7. 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.

    Science.gov (United States)

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

    2015-06-01

    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. 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, advertising literacy programmes and parental communication styles. Relevant media included TV, internet, radio, magazines and newspaper advertising. No studies were excluded based on language or publication date. Forty-seven publications were included: 19 provided evidence for the results of statutory regulation, 25 for self-regulation, and six for educational approaches. Outcome measures varied in approach, quality and results. Findings suggested statutory regulation could reduce the volume of and children's exposure to advertising for foods HFSS, and had potential to impact more widely. Self-regulatory approaches showed varied results in reducing children's exposure. There was some limited support for educational measures. Consistency in measures from evaluations over time would assist the development and interpretation of the evidence base on successful actions and measures to reduce the volume, exposure and impact of advertising for foods HFSS to children. Copyright © 2015 Elsevier Inc. All rights reserved.

  8. A comparison of actual versus stated label amounts of EPA and DHA in commercial omega-3 dietary supplements in the United States.

    Science.gov (United States)

    Kleiner, Alison C; Cladis, Dennis P; Santerre, Charles R

    2015-04-01

    Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are associated with health benefits throughout life and are obtained primarily through fish and fish oil supplements. Due to the growing popularity of dietary supplements, 47 commercial fish, krill, and algal oil supplements were analyzed for EPA, DHA, and other fatty acids. For fish- and krill-based supplements, the range of EPA was 81.8 to 454.6 mg g(-1) oil and DHA was 51.6 to 220.4 mg g(-1) oil. For algal oil supplements, EPA ranged from 7.7 to 151.1 mg g(-1) oil and DHA ranged from 237.8 to 423.5 mg g(-1) oil. The percentage of the stated label amount for EPA and DHA ranged from 66 to 184% and 62 to 184%, respectively. Only 10 supplements (21% of those tested) had at least 100% of the stated label amount of EPA, while 12 supplements (25% of those tested) had at least 100% of the stated amount of DHA. Over 70% of the supplements tested did not contain the stated label amount of EPA or DHA. These results indicate that the quality of fish oil supplements is not being adequately monitored by manufacturers or government agencies and increased testing is needed to ensure regulatory compliance. © 2014 Society of Chemical Industry.

  9. Careers Other Than Academia EPA/AAAS Graduate Fellowship Expo

    Science.gov (United States)

    NCER invited Emilie to speak to the EPA STAR graduate fellows about her transition from graduate school into a postdoctoral position with the EPA. Discussion of what led Emilie to seek a position with the EPA, how she conducted her job search, and what qualities she thinks gradu...

  10. 40 CFR 40.120 - Publication of EPA research objectives.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Publication of EPA research objectives... FEDERAL ASSISTANCE RESEARCH AND DEMONSTRATION GRANTS § 40.120 Publication of EPA research objectives. The Office of Research and Development of EPA publishes a statement of research objectives and priorities...

  11. 40 CFR 147.901 - EPA-administered program.

    Science.gov (United States)

    2010-07-01

    ... lands, is administered by EPA. This program consists of the UIC program requirements of 40 CFR parts 124, 144, 146, 148, and any additional requirements set forth in the remainder of this subpart. Injection... (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS Kentucky § 147.901 EPA...

  12. 40 CFR 147.601 - EPA-administered program.

    Science.gov (United States)

    2010-07-01

    ... administered by EPA. This program consists of the UIC program requirements of 40 CFR parts 124, 144, 146, 148, and any additional requirements set forth in the remainder of this subpart. Injection well owners and... (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS Hawaii § 147.601 EPA...

  13. 40 CFR 147.801 - EPA-administered program.

    Science.gov (United States)

    2010-07-01

    ... administered by EPA. This program consists of the UIC program requirements of 40 CFR parts 124, 144, 146, 148, and any additional requirements set forth in the remainder of this subpart. Injection well owners and... (CONTINUED) STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION CONTROL PROGRAMS Iowa § 147.801 EPA...

  14. Notification: EPA's Preparedness and Response Efforts to the 2017 Hurricanes in EPA Regions 2, 4 and 6

    Science.gov (United States)

    Project #OPE-FY18-0005, December 13, 2017. The EPA OIG plans to begin preliminary research on the EPA’s preparedness and response efforts to the 2017 hurricanes that impacted EPA Regions 2, 4 and 6.

  15. Regulatory considerations for biosimilars

    Directory of Open Access Journals (Sweden)

    Ranjani Nellore

    2010-01-01

    Full Text Available Currently there is considerable interest in the legislative debate around generic biological drugs or "biosimilars" in the EU and US due to the large, lucrative market that it offers to the industry. While some countries have issued a few regulatory guidelines as well as product specific requirements, there is no general consensus as to a single, simple mechanism similar to the bioequivalence determination that leads to approval of generic small molecules all over the world. The inherent complex nature of the molecules, along with complicated manufacturing and analytical techniques to characterize them make it difficult to rely on a single human pharmacokinetic study for assurance of safety and efficacy. In general, the concept of comparability has been used for evaluation of the currently approved "similar" biological where a step by step assessment on the quality, preclinical and clinical aspects is made. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have an efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products.

  16. Why We Review Pesticides

    Science.gov (United States)

    As required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA periodically reviews existing registered pesticides to ensure they can be used safely, without unreasonable risks to human health and the environment.

  17. EPA recognizes industry leaders for beneficial use

    Energy Technology Data Exchange (ETDEWEB)

    Goss, D. [American Coal Ash Association (United States)

    2007-07-01

    The EPA's Coal Combustion Products Partnership C{sup 2}P{sup 2})recognized industry leaders in beneficial use during the second annual C{sup 2}P{sup 2} awards ceremony held 23 October 2006 in Atlanta, Georgia. The C{sup 2}P{sup 2} program is led by the EPA with the ACAA, DOE, FHWA, USDA - Agricultural Research Services (ARS), and Utilities Solid Waste Activities Group (USWAG). The award for overall achievement went to Great River Energy of Underwood, ND who partnered with more than 10 public and private organizations to develop an extensive market for fly ash from Coal Creek Station, the world's largest lignite-fired plant. Other awards were given for environmental achievement, innovation, partnership, research and communications and outreach. 9 photos.

  18. Search Results Help - Air | 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.

  19. Water Pollution 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.

  20. Detailed Facility Report | 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.

  1. Water Pollution Search (beta) | 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.

  2. Watershed Statistics Help | 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.

  3. Drinking Water Dashboard Help | 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.

  4. Mobile Bay.pdf | 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. Search Results Help - Biosolids | 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.

  6. Technical Users Background Document | 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.

  7. US EPA Digital Science: An Evolution

    Science.gov (United States)

    Ziegler, C. R.; Burch, K.; Laniak, G.; Vega, A.; Harten, P.; Kremer, J.; Brookes, A.; Yuen, A.; Subramanian, B.

    2015-12-01

    The United States Environmental Protection Agency's (US EPA) digital science "enterprise" plays a critical role in US EPA's efforts to achieve its mission to protect human health and the environment. This enterprise is an evolving cross-disciplinary research and development construct, with social and institutional dimensions. It has an active development community and produces a portfolio of digital science products including decision support tools, data repositories, Web interfaces, and more. Earth sciences and sustainable development organizations from around the world - including US government agencies - have achieved various levels of success in taking advantage of the rapidly-evolving digital age. Efficiency, transparency and ability to innovate are tied to an organization's digital maturity and related social characteristics. Concepts like participatory web, data and software interoperability, global technology transfer, ontological harmonization, big data, scaling, re-use and open science are no longer "new and emerging." They have emerged and - in some cases - are tied to US government directives. We assess maturity, describe future scenarios, discuss new initiatives and outline steps for better leveraging the information age to more effectively and efficiently achieve US EPA's mission. The views expressed herein are those of the authors and do not necessarily reflect the views or policies of the organizations for which they work and/or represent.

  8. US EPA Nonattainment Areas and Designations

    Science.gov (United States)

    This web service contains the following state level layers:Ozone 8-hr (1997 standard), Ozone 8-hr (2008 standard), Lead (2008 standard), SO2 1-hr (2010 standard), PM2.5 24hr (2006 standard), PM2.5 Annual (1997 standard), PM2.5 Annual (2012 standard), and PM10 (1987 standard). Full FGDC metadata records for each layer may be found by clicking the layer name at the web service endpoint (https://gispub.epa.gov/arcgis/rest/services/OAR_OAQPS/NonattainmentAreas/MapServer) and viewing the layer description. These layers identify areas in the U.S. where air pollution levels have not met the National Ambient Air Quality Standards (NAAQS) for criteria air pollutants and have been designated nonattainment?? areas (NAA). The data are updated weekly from an OAQPS internal database. However, that does not necessarily mean the data have changed. The EPA Office of Air Quality Planning and Standards (OAQPS) has set National Ambient Air Quality Standards for six principal pollutants, which are called criteria pollutants. Under provisions of the Clean Air Act, which is intended to improve the quality of the air we breathe, EPA is required to set National Ambient Air Quality Standards for six common air pollutants. These commonly found air pollutants (also known as criteria pollutants) are found all over the United States. They are particle pollution (often referred to as particulate matter), ground-level ozone, carbon monoxide, sulfur oxides, nitrogen oxides, and lead. For each

  9. Evaluation of organ weights for rodent and non-rodent toxicity studies: a review of regulatory guidelines and a survey of current practices.

    Science.gov (United States)

    Michael, Bindhu; Yano, Barry; Sellers, Rani S; Perry, Rick; Morton, Daniel; Roome, Nigel; Johnson, Julie K; Schafer, Ken; Pitsch, Sue

    2007-08-01

    The Society of Toxicologic Pathology convened a working group to evaluate current practices regarding organ weights in toxicology studies. A survey was distributed to pharmaceutical, veterinary, chemical, food/nutritional and consumer product companies in Europe, North America, and Japan. Responses were compiled to identify organs routinely weighed for various study types in rodent and non-rodent species, compare methods of organ weighing, provide perspectives on the value of organ weights and identify the scientist(s) responsible for organ weight data interpretation. Data were evaluated as a whole as well as by industry type and geographic location. Regulatory guidance documents describing organ weighing practices are generally available, however, they differ somewhat dependent on industry type and regulatory agency. While questionnaire respondents unanimously stated that organ weights were a good screening tool to identify treatment-related effects, opinions varied as to which organ weights are most valuable. The liver, kidneys, and testes were commonly weighed and most often considered useful by most respondents. Other organs that break were commonly weighed included brain, adrenal glands, ovaries, thyroid glands, uterus, heart, and spleen. Lungs, lymph nodes, and other sex organs were weighed infrequently in routine studies, but were often weighed in specialized studies such as inhalation, immunotoxicity, and reproduction studies. Organ-to-body weight ratios were commonly calculated and were considered more useful when body weights were affected. Organ to brain weight ratios were calculated by most North American companies, but rarely according to respondents representing veterinary product or European companies. Statistical analyses were generally performed by most respondents. Pathologists performed interpretation of organ weight data for the majority of the industries.

  10. Regulatory Information By Sector

    Science.gov (United States)

    Find environmental regulatory, compliance, & enforcement information for various business, industry and government sectors, listed by NAICS code. Sectors include agriculture, automotive, petroleum manufacturing, oil & gas extraction & other manufacturing

  11. Internationalization of regulatory requirements.

    Science.gov (United States)

    Juillet, Y

    2003-02-01

    The aim of harmonisation of medicines regulatory requirements is to allow the patient quicker access to new drugs and to avoid animal and human duplications. Harmonisation in the European Union (EU) is now completed, and has led to the submission of one dossier in one language study leading to European marketing authorizations, thanks in particular to efficacy guidelines published at the European level. With the benefit of the European experience since 1989, more than 40 guidelines have been harmonised amongst the EU, Japan and the USA through the International Conference on Harmonisation (ICH). ICH is a unique process gathering regulators and industry experts from the three regions. Its activity is built on expertise and trust. The Common Technical Document (CTD), an agreed common format for application in the three regions, is a logical follow-up to the ICH first phase harmonising the content of the dossier. The CTD final implementation in July 2003 will have considerable influence on the review process and on the exchange of information in the three regions.

  12. Regulatory analysis technical evaluation handbook. Final report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-01-01

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

  13. Effects of different dietary DHA:EPA ratios on gonadal steroidogenesis in the marine teleost, tongue sole (Cynoglossus semilaevis).

    Science.gov (United States)

    Xu, Houguo; Cao, Lin; Wei, Yuliang; Zhang, Yuanqin; Liang, Mengqing

    2017-08-01

    The present study was conducted to investigate the effects of dietary DHA and EPA on gonadal steroidogenesis in mature females and males, with a feeding trial on tongue sole, a typical marine teleost with sexual dimorphism. Three experimental diets differing basically in DHA:EPA ratio, that is, 0·68 (diet D:E-0·68), 1·09 (D:E-1·09) and 2·05 (D:E-2·05), were randomly assigned to nine tanks of 3-year-old tongue sole (ten females and fifteen males in each tank). The feeding trail lasted for 90 d before and during the spawning season. Fish were reared in a flowing seawater system and fed to apparent satiation twice daily. Compared with diet D:E-0·68, diet D:E-1·09 significantly enhanced the oestradiol production in females, whereas diet D:E-2·05 significantly enhanced the testosterone production in males. In ovaries, diet D:E-1·09 induced highest mRNA expression of follicle-stimulating hormone receptor (FSHR), steroidogenic acute regulatory protein, 17α-hydroxylase (P450c17) and 3β-hydroxysteroid dehydrogenase (3β-HSD). In testes, diet 2·05 resulted in highest mRNA expression of FSHR, cholesterol side-chain cleavage enzyme, P450c17 and 3β-HSD. Fatty acid profiles in fish tissues reflected closely those of diets. Female fish had more gonadal EPA content but less DHA content than male fish, whereas there was a reverse observation in liver. In conclusion, the dietary DHA:EPA ratio, possibly combined with the dietary EPA:arachidonic acid ratio, differentially regulated sex steroid hormone synthesis in mature female and male tongue soles. Females seemed to require more EPA but less DHA for the gonadal steroidogenesis than males. The results are beneficial to sex-specific nutritive strategies in domestic teleost.

  14. RESRAD for Radiological Risk Assessment. Comparison with EPA CERCLA Tools - PRG and DCC Calculators

    Energy Technology Data Exchange (ETDEWEB)

    Yu, C. [Argonne National Lab. (ANL), Argonne, IL (United States); Cheng, J. -J. [Argonne National Lab. (ANL), Argonne, IL (United States); Kamboj, S. [Argonne National Lab. (ANL), Argonne, IL (United States)

    2015-07-01

    The purpose of this report is two-fold. First, the risk assessment methodology for both RESRAD and the EPA’s tools is reviewed. This includes a review of the EPA’s justification for 2 using a dose-to-risk conversion factor to reduce the dose-based protective ARAR from 15 to 12 mrem/yr. Second, the models and parameters used in RESRAD and the EPA PRG and DCC Calculators are compared in detail, and the results are summarized and discussed. Although there are suites of software tools in the RESRAD family of codes and the EPA Calculators, the scope of this report is limited to the RESRAD (onsite) code for soil contamination and the EPA’s PRG and DCC Calculators also for soil contamination.

  15. Search Results Help - Water | 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. Search Results Help explains how to navigate the search results page and describes the data presented.

  16. Economic, Labor, and Regulatory Moderators of the Effect of Individual Placement and Support Among People With Severe Mental Illness: A Systematic Review and Meta-analysis.

    Science.gov (United States)

    Metcalfe, Justin D; Drake, Robert E; Bond, Gary R

    2018-01-13

    As Individual Placement and Support (IPS) has become the international standard for vocational rehabilitation of adults with serious mental illness, researchers must consider the relationship between IPS and local environments. This meta-analysis used mixed-effects meta-regressions to assess the impact of site-level moderators on the likelihood that IPS recipients, compared with recipients of alternative vocational services, achieved competitive employment. Potential moderators included change in gross domestic product (GDP), local unemployment and unionization rates, and indices describing employment protection regulations, level of disability benefits compensation, and efforts to integrate people with disabilities into the workforce. Regulatory moderators represent facilitators and barriers to employment that may reinforce or detract from the effectiveness of IPS. Across 30 sites drawn from 21 randomized controlled trials in 12 countries (33% in the United States), IPS recipients were 2.31 (95% CI 1.99-2.69) times more likely to find competitive employment than recipients of alternative vocational rehabilitation services. The significant competitive-employment rate advantage of IPS over control services increased in the presence of weaker employment protection legislation and integration efforts, and less generous disability benefits. Policy makers should recognize and account for the fact that labor and disability regulations can create an arrangement of incentives that reduces the relative efficacy of supported employment. © The Author(s) 2017. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  17. 78 FR 13872 - Proposed Information Collection Request; Comment Request; EPA's WaterSense Program (Renewal); EPA...

    Science.gov (United States)

    2013-03-01

    ... Professional Certifying Organizations 6100-17 Consumer Awareness Survey Survey form 6100-X2 Respondents.... EPA also will conduct a Consumer Awareness Survey once over the three-year period of the ICR. Total... From the Federal Register Online via the Government Publishing Office ENVIRONMENTAL PROTECTION...

  18. EPA`s decision-making by internal and external signals

    Energy Technology Data Exchange (ETDEWEB)

    Cho, S.K. [Hansei University, Anyang (Korea, Republic of)

    1998-03-01

    In 1989, Environmental Protection Agency (EPA) of USA banned the manufacture, import, processing and sales of some products including asbestos dividing in three (3) stages under the provision of Toxic Substances Control Act (TSCA). This thesis divides asbestos regulation into decision of ban and decision on ban priority, and reasons the primary decision-making factors of EPA inherent in each decision. This thesis esp., applies internal signals (estimates of expenses and benefits) and external signals (participation of external organizations) that Magat et al. (1986), Asch and Seneca (1989) and Cropper et al. (1992) presented as the primary decision-making factors of EPA to asbestos regulation and contemplates the roles of these. On the one hand, this thesis assumes that written comments presented by the special interest group that are influenced by regulation during the comment period of EPA represents the external signals. In the decision of ban contemplated with Probit model, EPA balanced the expenses and benefits observing the regulation of TSCA, and the participation of enterprises and environmental protection organizations too influenced the decision-making of EPA. That is, if the expense required to ban certain product is big, the odd of banning the product is small. If there are many written comments from enterprises that object to the ban, the odd of banning the product is also small. But, there appears the problem that statistical significance of internal signals decreases in the model including external signals. On the other hand, the inference result shows that the implicit estimation of EPA on one case of decreased cancer due to the ban goes over USD 50 million. In decision on ban priority inferred by Ordered Probit model, the less the unit cost of benefits is, and the more the written comments from environmental protection organizations that object to the ban are, the earlier stages the products were banned. In this case, the statistical significance

  19. Regulatory Myeloid Cells in Transplantation

    Science.gov (United States)

    Rosborough, Brian R.; Raïch-Regué, Dàlia; Turnquist, Heth R.; Thomson, Angus W.

    2013-01-01

    Regulatory myeloid cells (RMC) are emerging as novel targets for immunosuppressive (IS) agents and hold considerable promise as cellular therapeutic agents. Herein, we discuss the ability of regulatory macrophages (Mreg), regulatory dendritic cells (DCreg) and myeloid-derived suppressor cells (MDSC) to regulate alloimmunity, their potential as cellular therapeutic agents and the IS agents that target their function. We consider protocols for the generation of RMC and the selection of donor- or recipient-derived cells for adoptive cell therapy. Additionally, the issues of cell trafficking and antigen (Ag) specificity following RMC transfer are discussed. Improved understanding of the immunobiology of these cells has increased the possibility of moving RMC into the clinic to reduce the burden of current IS agents and promote Ag-specific tolerance. In the second half of this review, we discuss the influence of established and experimental IS agents on myeloid cell populations. IS agents believed historically to act primarily on T cell activation and proliferation are emerging as important regulators of RMC function. Better insights into the influence of IS agents on RMC will enhance our ability to develop cell therapy protocols to promote the function of these cells. Moreover, novel IS agents may be designed to target RMC in situ to promote Ag-specific immune regulation in transplantation and usher in a new era of immune modulation exploiting cells of myeloid origin. PMID:24092382

  20. Updated Regulatory Considerations for Nanomedicines.

    Science.gov (United States)

    Subin, Sankarankutty; Vijayan, Venugopal; Kumar, Jaya Raja

    2017-06-14

    Nanomedicine is a branch which deals with medicinal products, devices, non-biological complex drugs and antibody-nanoparticle conjugates and general health products that are manufactured using nanotechnology. Nanomedicine provide the same efficacies as traditional medicines owing to their improved solubility and bioavailability with reduced dosages. However, there are currently safety concerns due to the difficulties related to nanomaterial characterization; this might be the reason for unawareness of such medicines among the patients. The absence of clear regulatory guidelines further complicates matters, as it makes the path to registering them with regulatory bodies difficult. However, some products have overcome these obstacles and have been registered. While there are many international initiatives to harmonize the regulatory requirements and helps the industry to determining the most important characteristics that influence in vivo product performance. This review focuses on the various types of nanopharmaceuticals, and developments process with strategies tailored to upcoming regulations may satisfy the patients' needs. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  1. Scientific Analysis and Documentation Provided by EPA Regional Labs

    Science.gov (United States)

    The 10 EPA Regional laboratories provide maximum flexibility to support Agency response to natural disasters and emergencies by developing effective approaches for a wide range of analytical challenges.

  2. Meet EPA Scientist Richard Zepp, Ph.D.

    Science.gov (United States)

    EPA Senior Research Scientist Dr. Richard Zepp's research interests include nanomaterials transformation in the environment, keeping recreational waters safe, and how climate change might affect ecosystems.

  3. Potential environmental benefits from regulatory consideration of synthetic drilling muds

    Energy Technology Data Exchange (ETDEWEB)

    Burke, C.J.; Veil, J.A. [Argonne National Lab., IL (United States). Environmental Assessment Div.

    1995-02-01

    When drilling exploration and production wells for oil and gas, drillers use specialized drilling fluids, referred to as muds, to help maintain well control and to remove drill cuttings from the hole. Historically, either water-based muds (WBMs) or oil-based muds (OBMs) have been used for offshore wells. Recently, in response to US Environmental Protection Agency (EPA) regulations and drilling-waste discharge requirements imposed by North Sea nations, the drilling industry has developed several types of synthetic-based muds (SBMs) that combine the desirable operating qualities of OBMs with the lower toxicity and environmental impact qualities of WBMs. This report describes the operational, environmental, and economic features of all three types of muds and discusses potential EPA regulatory barriers to wider use of SBMs.

  4. Changes of Regulatory T Cells and of Proinflammatory and Immunosuppressive Cytokines in Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis

    Directory of Open Access Journals (Sweden)

    Yong-chao Qiao

    2016-01-01

    Full Text Available Objective. The aim of this study was to investigate the changes of regulatory T cells (Treg, interleukin-6 (IL-6, IL-10, transforming growth factor-β (TGF-β, and tumor necrosis factor-alpha (TNF-α in patients with type 2 diabetes mellitus (T2DM. Methods. We performed a comprehensive search up to July 2016 for all clinical studies about the changes of Treg, IL-6, IL-10, IL-17, TGF-β, and TNF-α in T2DM patients versus healthy controls. Results. A total of 91 articles (5642 cases and 7378 controls were included for this meta-analysis. Compared with the controls (all p<0.001, the patients had increased serum levels of IL-6, TGF-β, and TNF-α but decreased the percentage of peripheral CD4+CD25+Foxp3+Treg and serum IL-10 level. Furthermore, the percentage of peripheral CD4+CD25+Foxp3+Treg (p<0.001 and serum IL-10 level (p=0.033 were significantly lower in the patients with complication and in the patients without complication, respectively. No significant changes about the percentage of CD4+CD25+Treg (p=0.360 and serum IL-17 level (p=0.459 were found in T2DM patients. Conclusions. T2DM patients have decreased the percentage of peripheral CD4+CD25+Foxp3+Treg and levels of serum IL-10 but elevated serum levels of IL-6, TGF-β, and TNF-α. Presence of diabetic complications further lowers the peripheral CD4+CD25+Foxp3+Treg number.

  5. EPA's Response to Health Risks from Dioxin and Related Compounds Evaluation of the EPA Reassessment Published by the National Research Council of the National Academies (Interagency Science Consultation Draft)

    Science.gov (United States)

    On May 21, 2010, the updated EPA's Reanalysis of Key Issues Related to Dioxin Toxicity and Response to NAS Comments report was released for external peer review and public comment. This report was renamed after interagency comments from the original report title of E...

  6. Field Collection Methods for an EPA Pilot Study Evaluating Personal, Housing, and Community Factors Influencing Children’s Potential Exposures to Indoor Contaminants at Various Lifestages (EPA Pilot Study Add-On to the GreenHousing Study)

    Science.gov (United States)

    This compilation of field collection standard operating procedures (SOPs) was assembled for the U.S. Environmental Protection Agency’s (EPA) Pilot Study add-on to the Green Housing Study (GHS). A detailed description of this add-on study can be found in the peer reviewed research...

  7. Study on the establishment of efficient plan for regulatory activities at NPPs

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Sang Hun; Son, Mun Gyu [Korea Association for Nuclear Technology, Taejon (Korea, Republic of); Kang, Chang Sun; Yun, Jeong Ik; Ko, Hyun Seok; Lee, Young Wook [Seoul National Univ., Seoul (Korea, Republic of)

    2001-03-15

    In-operation regulatory activities at sites are very important and it should be improved to cope with accidents efficiently and quickly. In case of site survey and safety regulatory inspection regulatory system based on not regulatory headquarter but site regional office should be constructed. In other words, safety assurance and pending problem management considering site situation are needed. In this study, regulatory system at Nuclear Power Plant sites all over the world were reviewed and effective regulatory system of Korea are suggested to maximize the efficiency of license and regulatory manpower and consider the interest of local government and residents.

  8. 40 CFR 26.109 - IRB review of research.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false IRB review of research. 26.109 Section... Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA § 26.109 IRB review of research. (a) An IRB shall review and have authority to approve, require modifications in (to...

  9. 75 FR 22868 - Withdrawal of Regulatory Guide

    Science.gov (United States)

    2010-04-30

    ... site response; and new methods for defining a site-specific, performance-based ground motion response... Regulatory Guide (RG) 1.165, ``Identification and Characterization of Seismic Sources and Determination of..., Geosciences & Geotechnical Engineering Branch 1, Division of Site & Environmental Reviews, Office of New...

  10. 77 FR 47328 - Reducing Regulatory Burden

    Science.gov (United States)

    2012-08-08

    ... into account, among other things, and to the extent practicable, the costs of cumulative regulations...-regulatory-system . The Department is committed to maintaining a consistent culture of retrospective review... overtaken by technological developments? Can new technologies be leveraged to modify, streamline, or do away...

  11. APHIS Phytophthora ramorum regulatory strategy for nurseries

    Science.gov (United States)

    Jonathan M. Jones

    2006-01-01

    A review of the U. S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) regulatory response to Phytophthora ramorum is presented as it impacts nurseries and the nursery industry. The Agency responded in 2004 with three Federal Orders, each more restrictive than the previous one because the appropriate response called...

  12. 75 FR 16525 - Notice of Issuance of Regulatory Guide

    Science.gov (United States)

    2010-04-01

    ... Branch, Division of Engineering, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory... problems or postulated accidents, and data that the staff needs in its review of applications for permits... defines a basis that the staff of the NRC considers acceptable to implement the intent of General Design...

  13. [Regulatory genes of garden pea (Pisum sativum L.) controlling the development of nitrogen-fixing nodules and arbuscular mycorrhiza: a review of basic and applied aspects].

    Science.gov (United States)

    Borisov, A Iu; Vasil'chikov, A G; Voroshilova, V A; Danilova, T N; Zhernakov, A I; Zhukov, V A; Koroleva, T A; Kuznetsova, E V; Madsen, L; Mofett, M; Naumkina, T S; Nemankin, T A; Ovchinnikova, E S; Pavlova, Z B; Petrova, N E; Pinaev, A G; Radutoiu, S; Rozov, S M; Rychagova, T S; Solovov, I I; Stougaard, J; Topunov, A F; Weeden, N F; Tsyganov, V E; Shtark, O Iu; Tikhonovich, I A

    2007-01-01

    The review sums up the long experience of the authors and other researchers in studying the genetic system of garden pea (Pisum sativum L.), which controls sthe development of nitrogen-fixing symbiosis and arbuscular mycorrhiza. A justified phenotypic classification of pea mutants is presented. Progress in identifying and cloning symbiotic genes is adequately reflected. The feasibility of using double inoculation as a means of increasing the plant productivity is demonstrated, in which the potential of a tripartite symbiotic system (pea plants-root nodule bacteria-arbuscular mycorrhiza) is mobilized.

  14. IRIS Toxicological Review of Naphthalene (1998 Final)

    Science.gov (United States)

    EPA announced the release of the final report, Toxicological Review of Naphthalene: in support of the Integrated Risk Information System (IRIS). The updated Summary for Naphthalene and accompanying toxicological review have been added to the IRIS Database.

  15. Comparison of EPA's QMS to SEI's CMMI.

    Science.gov (United States)

    Mills, P; Braun, L; Marohl, D

    2001-01-01

    EPA and other government organizations make decisions based on environmental measurements. How good are the data? How well are the data generators performing? What measurements apply to them? How can the data life cycle processes be improved so data generators can continually provide the best data? EPA's Quality Management System requirements go beyond evaluation of environmental data quality itself to examine systems associated with production, collection, processing (validation/verification), transfer, reduction, storage, and retrieval of data throughout a life cycle. This QMS specifies minimum quality requirements for particular environmental programs. But how can you measure and compare programs that go well beyond the minimum, towards optimal quality? This paper compares EPA's requirements for Quality Management Systems (R2) and Project Plans (R5) to the Software Engineering Institute Capability Maturity Model (CMMISM). The CMMISM model provides for growth (staged or continuous) and a comprehensive assessment that is not yet provided in EPA's R2 or R5. Properly implemented, the CMMISM model serves as a quality framework for integrating and aligning organizational processes and implementing a program of continual process improvements. It identifies process areas ("things to do"), and provides measures of performance ("how well things are done") against specific goals and practices. CMMISM uses a Systems Engineering Management approach, built on process models, that helps identify "how good" the system is. Goodness is defined as stages in a complete model for optimal operation. CMMISM provides two methods for evaluating the goodness of the project. The Staged model in CMMISM provides a Maturity Level that is a well-defined evolutionary plateau describing the manner in which a specified set of processes are performed. As the organization advances in maturity, these levels become more defined and processes are tailored for specific project needs. The other method

  16. NRC regulatory initiatives

    Energy Technology Data Exchange (ETDEWEB)

    Johnson, T.C. [Nuclear Regulatory Commission (United States)

    1989-11-01

    The US Nuclear Regulatory Commission (NRC) is addressing several low-level waste disposal issues that will be important to waste generators and to States and Compacts developing new disposal capacity. These issues include Greater-Than-Class C (GTCC) waste, mixed waste, below regulatory concern (BRC) waste, and the low-level waste data base. This paper discusses these issues and their current status.

  17. Regulatory unbundling in telecommunications

    OpenAIRE

    Knieps, Günter

    2011-01-01

    Due to its dynamic nature, and the increasing importance of competitive sub-parts, the telecommunications sector provides particularly interesting insights for studying regulatory unbundling. Based on the theory of monopolistic bottle-necks the fallacies of overregulation by undue unbundling obligations are indicated. Neither the promotion of infrastructure competition by mandatory un-bundling of competitive subparts of telecommunications infrastructure, nor regulatory induced network fragmen...

  18. Hispanos en la EPA: Evelyn Rivera-Ocasio

    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.

  19. Hispanos en la EPA: Elias Rodríguez

    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.

  20. Hispanos en la EPA: Rafael DeLeón

    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.