WorldWideScience

Sample records for monitoring regulatory requirements

  1. Franchise Values, Regulatory Monitoring, and Capital Requirements in Optimal Bank Regulation

    DEFF Research Database (Denmark)

    Andersen, Thomas Barnebeck; Harr, Thomas

    2008-01-01

    This paper demonstrates that financial deregulation is likely to make standard prudential regulatory instruments less effective in curbing excessive risk-taking incentives among banks. This has interesting implications for optimal bank regulation. When there is an increase in competition......, the optimal capital requirement should increase, whereas regulatory auditing should decrease. In contrast, when there is an increase in gambling yields, auditing should always increase, whereas the optimal capital requirement may increase or decrease....

  2. 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.

  3. Safeguards inventory and process monitoring regulatory comparison

    Energy Technology Data Exchange (ETDEWEB)

    Cavaluzzi, Jack M. [Texas A & M Univ., College Station, TX (United States); Gibbs, Philip W. [Brookhaven National Lab. (BNL), Upton, NY (United States)

    2013-06-27

    Detecting the theft or diversion of the relatively small amount of fissile material needed to make a nuclear weapon given the normal operating capacity of many of today’s running nuclear production facilities is a difficult task. As throughput increases, the ability of the Material Control and Accountability (MC&A) Program to detect the material loss decreases because the statistical measurement uncertainty also increases. The challenge faced is the ability of current accounting, measurement, and material control programs to detect small yet significant losses under some regulatory approaches can decrease to the point where it is extremely low if not practically non-existent at normal operating capacities. Adding concern to this topic is that there are variations among regulatory bodies as far as what is considered a Significant Quantity (SQ). Some research suggests that thresholds should be lower than those found in any current regulation which if adopted would make meeting detection goals even more difficult. This paper reviews and compares the current regulatory requirements for the MA elements related to physical inventory, uncertainty of the Inventory Difference (ID), and Process Monitoring (PM) in the United States Department of Energy (DOE) and Nuclear Regulatory Commission (NRC), Rosatom of the Russian Federation and the Chinese Atomic Energy Agency (CAEA) of China. The comparison looks at how the regulatory requirements for the implementation of various MA elements perform across a range of operating capacities in example facilities.

  4. Development of regulatory technical rationale for risk monitoring program

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Chang Hyun; Kim, Ju Youl; Kim, Yoon Ik; Yang, Hui Chang; Lee, Yong Suk; Ahn, Kwang Won; Kim, Se Hyung [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In Korea, the risk monitoring program will be developed and applied to each plants till 2003 by the severe accident management plan to enhance the safety functions of the nuclear power plants. Through this plan, the risk monitoring for the full power and low power and shutdown operation will be performed. Therefore the development of consistent risk monitoring system and overall regulatory guides for the risk monitoring program are necessary. The objective of this study is the development of regulatory technical rationales for the nuclear power plant risk monitoring program and the derivation of the requirements need for the development of risk monitoring system. Through this the improvement of regulatory effectiveness to assure the safe operation of nuclear power plant, is expected.

  5. Development of regulatory technical rationale for risk monitoring program

    Energy Technology Data Exchange (ETDEWEB)

    Chung, Chang Hyun; Kim, Ju Youl; Kim, Yoon Ik; Yang, Hui Chang; Lee, Yong Suk; Ahn, Kwang Won; Kim, Se Hyung [Seoul National Univ., Seoul (Korea, Republic of)

    2002-03-15

    In Korea, the risk monitoring program will be developed and applied to each plants till 2003 by the severe accident management plan to enhance the safety functions of the nuclear power plants. Through this plan, the risk monitoring for the full power and low power and shutdown operation will be performed. Therefore the development of consistent risk monitoring system and overall regulatory guides for the risk monitoring program are necessary. The objective of this study is the development of regulatory technical rationales for the nuclear power plant risk monitoring program and the derivation of the requirements need for the development of risk monitoring system. Through this the improvement of regulatory effectiveness to assure the safe operation of nuclear power plant, is expected.

  6. Theory of Regulatory Compliance for Requirements Engineering

    CERN Document Server

    Jureta, Ivan; Mylopoulos, John; Perini, Anna; Susi, Angelo

    2010-01-01

    Regulatory compliance is increasingly being addressed in the practice of requirements engineering as a main stream concern. This paper points out a gap in the theoretical foundations of regulatory compliance, and presents a theory that states (i) what it means for requirements to be compliant, (ii) the compliance problem, i.e., the problem that the engineer should resolve in order to verify whether requirements are compliant, and (iii) testable hypotheses (predictions) about how compliance of requirements is verified. The theory is instantiated by presenting a requirements engineering framework that implements its principles, and is exemplified on a real-world case study.

  7. EMC Part Ⅱ Regulatory Requirements

    Institute of Scientific and Technical Information of China (English)

    JohnWong

    2005-01-01

    As described in the Part I, the goal of electromagnetic compatibility, or EMC, is to design electronic systems that are electromagnetically compatible with their environment. EMC requirements exist so that electronic systems designers have a set of guidelines that explain the limits of what is considered electromagnetically compatible. There is not, however, one allencompassing set of EMC guidelines. Instead, EMC guidelines are created by individual product manufacturers,

  8. Regulatory capital requirements and bail in mechanisms

    NARCIS (Netherlands)

    Joosen, B.P.M.; Haentjens, M.; Wessels, B.

    2015-01-01

    With the introduction of the Capital Requirements Regulation (CRR) in the European Union, the qualitative requirements for bank regulatory capital have changed. These changes aim at implementing in Europe the Basel III principles for better bank capital that is able to absorb losses of banks,

  9. Regulatory capital requirements and bail in mechanisms

    NARCIS (Netherlands)

    Joosen, B.P.M.; Haentjens, M.; Wessels, B.

    2015-01-01

    With the introduction of the Capital Requirements Regulation (CRR) in the European Union, the qualitative requirements for bank regulatory capital have changed. These changes aim at implementing in Europe the Basel III principles for better bank capital that is able to absorb losses of banks, withou

  10. 17 CFR 1.52 - Self-regulatory organization adoption and surveillance of minimum financial requirements.

    Science.gov (United States)

    2010-04-01

    ... Miscellaneous § 1.52 Self-regulatory organization adoption and surveillance of minimum financial requirements... the minimum financial and related reporting requirements adopted by such self-regulatory organizations... monitoring and auditing for compliance with the minimum financial rules of the self-regulatory...

  11. Advances in ambulatory monitoring: regulatory considerations.

    Science.gov (United States)

    Buckles, David; Aguel, Felipe; Brockman, Randall; Cheng, James; Demian, Cindy; Ho, Charles; Jensen, Donald; Mallis, Elias

    2004-01-01

    Conventional ambulatory electrocardiogram (ECG) (Holter) monitoring involves 2 or 3 surface leads recorded with electrode positions and signal characteristics that are different from diagnostic quality 12-lead ECGs due to the limitations imposed by technology on the ambulatory recorders. The rapid pace of technological development for medical devices, particularly electrocardiography, has now enabled the recording of diagnostic quality 12-lead ECG waveforms for extended time periods. This capability allows Holter recording to become another source for diagnostic 12-lead ECG records on a par with other modalities such as resting ECG and exercise stress testing. Additionally, other diagnostic techniques such as S-T segment analysis and Q-T interval analysis that rely on diagnostic quality waveforms can now be applied. All of these enhancements to the traditional Holter modality have altered the regulatory perspective of these devices, since the enhancements may represent a new intended use for the device.

  12. Regulatory standards and other guidelines for goundwater monitoring programs

    Energy Technology Data Exchange (ETDEWEB)

    Keller, J.F.; Schmidt, A.J.; Selby, K.B.

    1989-07-01

    This report has been prepared to provide information on regulatory programs relevant to a groundwater monitoring program. The information provides a framework within which planners and decisions makers can systematically consider the maze of specific requirements and guidance as they develop a groundwater strategy for the Hanford Site. Although this report discusses legislation and regulations as they pertain to groundwater monitoring activities, it is not intended as a legal opinion. Rather, it is provided as a guide to the relationships among the various regulatory programs related to groundwater. Federal and state environmental pollution control statutes and regulations that have been reviewed in this document include the Resource Conservation and Recovery Act (RCRA); Washington's Hazardous Waste Management Act; Washington's Solid Waste Management Act; the Comprehensive Environmental Response, Liability, and Compensation Act (CERCLA); the Superfund Amendments and Reauthorization Act (SARA); the Safe Drinking Water Act (SDWA); and the Clean Water Act (CWA). The implications and details of these regulations as they may apply to Hanford are discussed. The information contained within this report can be used to develop the Hanford Site's groundwater quality protection programs, assess regulatory compliance, and characterize the Hanford Site for potential remediation and corrective actions. 5 refs., 14 tabs.

  13. Soil quality assessment under emerging regulatory requirements.

    Science.gov (United States)

    Bone, James; Head, Martin; Barraclough, Declan; Archer, Michael; Scheib, Catherine; Flight, Dee; Voulvoulis, Nikolaos

    2010-08-01

    New and emerging policies that aim to set standards for protection and sustainable use of soil are likely to require identification of geographical risk/priority areas. Soil degradation can be seen as the change or disturbance in soil quality and it is therefore crucial that soil and soil quality are well understood to protect soils and to meet legislative requirements. To increase this understanding a review of the soil quality definition evaluated its development, with a formal scientific approach to assessment beginning in the 1970s, followed by a period of discussion and refinement. A number of reservations about soil quality assessment expressed in the literature are summarised. Taking concerns into account, a definition of soil quality incorporating soil's ability to meet multifunctional requirements, to provide ecosystem services, and the potential for soils to affect other environmental media is described. Assessment using this definition requires a large number of soil function dependent indicators that can be expensive, laborious, prone to error, and problematic in comparison. Findings demonstrate the need for a method that is not function dependent, but uses a number of cross-functional indicators instead. This method to systematically prioritise areas where detailed investigation is required, using a ranking based against a desired level of action, could be relatively quick, easy and cost effective. As such this has potential to fill in gaps and compliment existing monitoring programs and assist in development and implementation of current and future soil protection legislation.

  14. Environmental regulatory guide for radiological effluent monitoring and environmental surveillance

    Energy Technology Data Exchange (ETDEWEB)

    1991-01-01

    Under the Atomic Energy Act of 1954, as amended, the US Department of Energy (DOE) is obligated to regulate its own activities so as to provide radiation protection for both workers and the public.'' Presidential Executive Order 12088, Federal Compliance with Pollution Control Standards,'' further requires the heads of executive agencies to ensure that all Federal facilities and activities comply with applicable pollution control standards and to take all actions necessary for the prevention, control, and abatement of environmental pollution. This regulatory guide describes the elements of an acceptable effluent monitoring and environmental surveillance program for DOE sites involving radioactive materials. These elements are applicable to all DOE and contractor activities for which the DOE exercises environmental, safety, and health responsibilities, and are intended to be applicable over the broad range of DOE facilities and sites. In situations where the high-priority elements may not provide sufficient coverage of a specific monitoring or surveillance topic, the document provides additional guidance. The high-priority elements are written as procedures and activities that should'' be performed, and the guidance is written as procedures and activities that should'' be performed. The regulatory guide both incorporates and expands on requirements embodied in DOE 5400.5 and DOE 5400.1. 221 refs., 2 figs., 6 tabs.

  15. 24 CFR 266.505 - Regulatory agreement requirements.

    Science.gov (United States)

    2010-04-01

    ... AUTHORITIES HOUSING FINANCE AGENCY RISK-SHARING PROGRAM FOR INSURED AFFORDABLE MULTIFAMILY PROJECT LOANS Project Management and Servicing § 266.505 Regulatory agreement requirements. (a) General. (1) The HFA... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Regulatory agreement requirements...

  16. 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

  17. Experience in implementing regulatory requirements to protect against industrial sabotage

    Energy Technology Data Exchange (ETDEWEB)

    Knuth, D.F.

    1978-01-01

    Some of the problems and concerns in implementing the current regulatory requirements in physical protection of nuclear power plants are discussed. Until 1973, the Nuclear Regulatory Commission (NRC) was of the opinion that a determined group of professional saboteurs was beyond the scope of protection required. Since then regulatory changes have altered that concept; each successive regulatory change envisions a higher level of threat, and, hence, requires more provisions to protect the facilities. The author contends that, in some areas, NRC's decisions were hastily conceived with unrealistic implementation schedules. These decisions and regulations, if fully implemented, could be counterproductive to maintaining good security in a nuclear power plant, and are counterproductive to safety and operability of the plants.

  18. Regulatory requirements for providing adequate veterinary care to research animals.

    Science.gov (United States)

    Pinson, David M

    2013-09-01

    Provision of adequate veterinary care is a required component of animal care and use programs in the United States. Program participants other than veterinarians, including non-medically trained research personnel and technicians, also provide veterinary care to animals, and administrators are responsible for assuring compliance with federal mandates regarding adequate veterinary care. All program participants therefore should understand the regulatory requirements for providing such care. The author provides a training primer on the US regulatory requirements for the provision of veterinary care to research animals. Understanding the legal basis and conditions of a program of veterinary care will help program participants to meet the requirements advanced in the laws and policies.

  19. Regulatory requirements for marketing fixed dose combinations

    Directory of Open Access Journals (Sweden)

    B G Jayasheel

    2010-01-01

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

  20. 10 CFR 20.1502 - Conditions requiring individual monitoring of external and internal occupational dose.

    Science.gov (United States)

    2010-01-01

    ... 10 Energy 1 2010-01-01 2010-01-01 false Conditions requiring individual monitoring of external and internal occupational dose. 20.1502 Section 20.1502 Energy NUCLEAR REGULATORY COMMISSION STANDARDS FOR PROTECTION AGAINST RADIATION Surveys and Monitoring § 20.1502 Conditions requiring individual monitoring of external and internal...

  1. A Perspective into Regulatory Requirements for Intentional Aircraft Crash

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Sang Yun; Park, Jong Seuk; Chung, Yun Suk [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of); Kim, Inn Seock [ISSA Technology, Maryland (Korea, Republic of); Choi, Eong Soo; Kim, Jong Hyun [ACT Co., Daejeon (Korea, Republic of)

    2010-10-15

    In the aftermath of the 9/11 terrorist attacks on the United States, there was heightened interest worldwide in protecting nuclear power plants against intentional aircraft attack by terrorists. This paper presents our perspective into regulatory requirements for intentional aircraft crash that were set forth in foreign countries, including the latest rulemaking by the U.S. Nuclear Regulatory Commission (NRC), i.e., 10 CFR 50.54(hh) and 10 CFR 50.150 that have been made effective in May and July of 2009, respectively. In light of these international efforts to further enhance safety of NPPs, a study is also underway at the Korea Institute of Nuclear Safety (KINS) to establish an effective and efficient regulatory approach in consideration of the state of the art in this area

  2. 40 CFR 433.12 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements. (a) In lieu of requiring monitoring for TTO, the permitting authority (or, in the case of... the permit limitation for total toxic organics (TTO), I certify that, to the best of my knowledge and... TTO standard, the industrial discharger need analyse for only those pollutants which would...

  3. Performance, requirements and testing in individual monitoring

    DEFF Research Database (Denmark)

    Julius, H.W.; Christensen, P.; Marshall, T.O.

    1990-01-01

    monitoring, and in particular of those related to the energy and angular dependences of the dosemeters. These data are important for the testing of the dosimetry systems. Finally testing programmes in individual monitoring are discussed and four categories of testing are proposed.......For implementation of the ICRP requirements in practical routine monitoring, a specification is needed with respect to specific performance criteria of the dosimetry system. This includes the dosemeters, and procedures for initial and on-going testing of the dosimetry systems to ensure...... that the specified criteria are continuously met. Methods are here specified for establishing performance criteria, and satisfying the ICRP overall accuracy requirements for individual monitoring. Furthermore, procedures are given for obtaining numerical values of the uncertainties connected with individual...

  4. Data Quality Objectives for Regulatory Requirements for Hazardous and Radioactive Air Emissions Sampling and Analysis

    Energy Technology Data Exchange (ETDEWEB)

    MULKEY, C.H.

    1999-07-06

    This document describes the results of the data quality objective (DQO) process undertaken to define data needs for state and federal requirements associated with toxic, hazardous, and/or radiological air emissions under the jurisdiction of the River Protection Project (RPP). Hereafter, this document is referred to as the Air DQO. The primary drivers for characterization under this DQO are the regulatory requirements pursuant to Washington State regulations, that may require sampling and analysis. The federal regulations concerning air emissions are incorporated into the Washington State regulations. Data needs exist for nonradioactive and radioactive waste constituents and characteristics as identified through the DQO process described in this document. The purpose is to identify current data needs for complying with regulatory drivers for the measurement of air emissions from RPP facilities in support of air permitting. These drivers include best management practices; similar analyses may have more than one regulatory driver. This document should not be used for determining overall compliance with regulations because the regulations are in constant change, and this document may not reflect the latest regulatory requirements. Regulatory requirements are also expected to change as various permits are issued. Data needs require samples for both radionuclides and nonradionuclide analytes of air emissions from tanks and stored waste containers. The collection of data is to support environmental permitting and compliance, not for health and safety issues. This document does not address health or safety regulations or requirements (those of the Occupational Safety and Health Administration or the National Institute of Occupational Safety and Health) or continuous emission monitoring systems. This DQO is applicable to all equipment, facilities, and operations under the jurisdiction of RPP that emit or have the potential to emit regulated air pollutants.

  5. 40 CFR 63.8 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... standard(s) unless the Administrator— (i) Specifies or approves the use of minor changes in methodology for the specified monitoring requirements and procedures (see § 63.90(a) for definition); or (ii) Approves... (see § 63.90(a) for definition). (iii) Owners or operators with flares subject to § 63.11(b) are...

  6. Multi-media regulatory requirements for an organic solvent wastewater

    Energy Technology Data Exchange (ETDEWEB)

    Pintenich, J.L.; Bazydola, M.T. [Eckenfelder Inc., Nashville, TN (United States)

    1997-12-31

    The increasingly complex sets of environmental statutes and regulations in the United States have and will continue to present the designers and operators of aqueous waste treatment systems with significant challenges to meet regulatory performance standards for all media receiving an emission or discharge of some type. This paper summarizes the rigorous evaluations of multi-media environmental regulatory requirements for air emissions, water discharges, and treatment sludge which established that a groundwater treatment system at a National Priorities List (NPL) Superfund site could be designed and operated in a cost-effective manner. Pilot-scale treatability studies were used to develop the process design and demonstrate the attainment of extremely stringent water-quality based effluent limitations for this organic solvent wastewater. Dispersion modeling using Industrial Source Complex Long Term (ISCLT) demonstrated that predicted ground level concentrations of vinyl chloride and other hazardous air pollutants (HAPs) would be below state air toxics values. Emission rates were demonstrated to be below the relevant National Emission Standard for Hazardous Air Pollutants (NESHAPs) as well as state emissions rate guidelines. Candidate emission control technologies were identified and evaluated on a life-cycle cost basis in accordance with the QAQPS Control Cost Manual published by USEPA to assess the feasibility of control. Adsorption with granular activated carbon, adsorption with a proprietary adsorbent, and catalytic oxidation were conceptualized for possible use at the site. The project received a discharge permit approval for the treated wastewater as well as a permit exemption for the air emission. During the first six months after startup, the treatment system was demonstrated to achieve the regulatory performance requirements.

  7. Review of FEWS NET biophysical monitoring requirements

    Energy Technology Data Exchange (ETDEWEB)

    Ross, K W; Underwood, L W [Science Systems and Applications, Incorporated, 411 West Michigan Street, Poplarville, MS 39470 (United States); Brown, M E [NASA-Goddard Space Flight Center, Code 614.4, Greenbelt, MD 20771 (United States); Verdin, J P [United States Geological Survey, National Integrated Drought Information System, NOAA/ESRL, 325 Broadway, Boulder, CO 80305 (United States)], E-mail: kenton_ross@ssaihq.com, E-mail: molly.brown@nasa.gov, E-mail: verdin@usgs.gov, E-mail: lauren_underwood@ssaihq.com

    2009-04-15

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

  8. Review of FEWS NET Biophysical Monitoring Requirements

    Science.gov (United States)

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

    2009-01-01

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

  9. Requirements of CLIC Beam Loss Monitoring System

    CERN Document Server

    Sapinski, M; Holzer, EB; Jonker, M; Mallows, S; Otto, T; Welsch, C

    2010-01-01

    The Compact Linear Collider (CLIC) [1] is a proposed multi-TeV linear electron-positron collider being designed by a world-wide collaboration. It is based on a novel twobeam acceleration scheme in which two beams (drive and main beam) are placed in parallel to each other and energy is transferred from the drive beam to the main one. Beam losses on either of them can have catastrophic consequences for the machine, because of high intensity (drive beam) or high energy and small emittance (main beam). In the framework of machine protection, a Beam Loss Monitoring (BLM) system has to be put in place. This paper discusses the requirements for the beam loss system in terms of detector sensitivity, resolution, dynamic range and ability to distinguish losses originating from various sources. The two-beam module where the protection from beam losses is particularly challenging and important, is studied.

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

    Science.gov (United States)

    2010-01-01

    ... maintenance at nuclear power plants. 50.65 Section 50.65 Energy NUCLEAR REGULATORY COMMISSION DOMESTIC... Construction Permits § 50.65 Requirements for monitoring the effectiveness of maintenance at nuclear power..., including normal shutdown operations. (a)(1) Each holder of an operating license for a nuclear power......

  11. Defining regulatory requirements for water supply systems in Vietnam

    Directory of Open Access Journals (Sweden)

    Deryushev Leonid Georgiyevich

    2014-01-01

    Full Text Available In the article the authors offer their suggestions for improving the reliability of the standardization requirements for water supply facilities in Vietnam, as an analog of building regulations of Russia 31.13330.2012. In Russia and other advanced countries the reliability of the designed water supply systems is usual to assess quantitatively. Guidelines on the reliability assessment of water supply systems and facilities have been offered by many researchers, but these proposals are not officially approved. Some methods for assessing the reliability of water supply facilities are informally used in practice when describing their quality. These evaluation methods are simple and useful. However, the given estimations defy common sense and regulatory requirements used by all the organizations, ministries and departments, for example, of Russia, in the process of allowances for restoration and repair of water supply facilities. Inadequacy of the water supply facilities assessment is shown on the example of assessing the reliability of pipeline system. If we take MTBF of specific length of the pipeline as reliability index for a pipeline system, for example, 5 km, a pipeline of the similar gauge, material and working conditions with the length of 5 m, according to the estimation on the basis of non-official approach, must have a value of MTBF 1000 times greater than with the length of 5 km. This conclusion runs counter to common sense, for the reason that all the pipes in the area of 5 km are identical, have the same load and rate of wear (corrosion, fouling, deformation, etc.. It was theoretically and practically proved that products of the same type in the same operating conditions (excluding determined impact of a person, work as an entity, which MTBF is equal to the average lifetime. It is proposed to take the average service life as a reliability indicator of a pipeline. Durability, but not failsafety of the pipe guarantees pipeline functioning

  12. 40 CFR 51.190 - Ambient air quality monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 2 2010-07-01 2010-07-01 false Ambient air quality monitoring... PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Ambient Air Quality Surveillance § 51.190 Ambient air quality monitoring requirements. The requirements for monitoring ambient...

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

    DEFF Research Database (Denmark)

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

    2002-01-01

    requirements and regulatory activity that might be required to prepare regulators for the large number of requests to terminate postclosure monitoring expected over the next 20 years. An approach in which the frequency and extent of postclosure monitoring is reduced as warranted by site-specific data......Regulations governing the disposal of solid waste in landfills specify that they must be monitored for 30 years after closure unless this period is extended by the governing regulatory authority. Given the wide range of conditions under which refuse is buried, technical criteria, rather than...... water or groundwater. The acceptability of gaseous releases should be evaluated against criteria for odors, the potential for subsurface migration, and greenhouse gas and ozone precursor emissions. The approach presented here must be tested on a site-specific basis to identify additional data...

  14. 40 CFR 413.03 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... lieu of monitoring for TTO, the control authority may allow industrial users of POTWs to make the... for total toxic organics (TTO), I certify that, to the best of my knowledge and belief, no dumping of... or leak into the wastewater. (c) If monitoring is necessary to measure compliance with the...

  15. 40 CFR 63.564 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the... when the measured values (i.e., daily calibrations, multipoint calibrations, and performance audits... pressure device once each calendar year with a reference pressure monitor (traceable to National...

  16. 40 CFR 63.364 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... obtained. For monitoring equipment purchased from a vendor, verification of the operational status of the... operated. From 15-minute or shorter period temperature values, a data acquisition system for the... year with a reference temperature monitor (traceable to National Institute of Standards and...

  17. 78 FR 57668 - U.S. Nuclear Regulatory Commission Planned for Monitoring Activities for the Saltstone Disposal...

    Science.gov (United States)

    2013-09-19

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION U.S. Nuclear Regulatory Commission Planned for Monitoring Activities for the Saltstone Disposal... availability of ``U.S. Nuclear Regulatory Commission Plan for Monitoring Disposal Actions Taken by the...

  18. 40 CFR 63.828 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... product and packaging rotogravure or wide-web flexographic presses with intermittently-controllable work... emission monitors to measure total organic volatile matter concentration and volumetric gas flow rate...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-07-01

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

  20. 40 CFR 63.1657 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... compressed air supply for pulse-jet baghouses. (iv) An appropriate methodology for monitoring cleaning cycles... document “Fabric Filter Bag Leak Detection Guidance” (EPA-454/R-98-015). Other bag leak detection systems... baghouse for air leaks, torn or broken bags or filter media, or any other condition that may cause...

  1. 40 CFR 63.605 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... rock dryer or phosphate rock calciner subject to the provisions of this subpart shall install... either the mass flow of phosphorus-bearing feed material to the dryer or calciner, or the mass flow of product from the dryer or calciner. The monitoring system shall have an accuracy of ±5 percent over...

  2. 40 CFR 52.346 - Air quality monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 3 2010-07-01 2010-07-01 false Air quality monitoring requirements. 52... (CONTINUED) APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS Colorado § 52.346 Air quality monitoring... VIII Administrator, the State submitted a revised Air Quality Monitoring State Implementation Plan....

  3. 40 CFR 146.68 - Testing and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... to provide other site specific data; (iii) Periodic monitoring of the ground water quality in the first aquifer overlying the injection zone; (iv) Periodic monitoring of the ground water quality in the... Applicable to Class I Hazardous Waste Injection Wells § 146.68 Testing and monitoring requirements....

  4. 40 CFR 146.13 - Operating, monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ...; (iii) Periodic monitoring of the ground water quality in the first aquifer overlying the injection zone; (iv) Periodic monitoring of the ground water quality in the lowermost USDW; and (v) Any additional... Applicable to Class I Wells § 146.13 Operating, monitoring and reporting requirements. (a)...

  5. 40 CFR 63.9631 - What are my monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ...) through (e) and monitor the daily average secondary voltage, daily average stack outlet temperature, and... maintain a bag leak detection system to monitor the relative change in particulate matter loadings... according to the requirements in paragraphs (a)(1) through (8) of this section. (1) Monitor the...

  6. 40 CFR 429.12 - Monitoring requirements. [Reserved

    Science.gov (United States)

    2010-07-01

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

  7. Radiation monitoring in interventional cardiology: a requirement

    Science.gov (United States)

    Rivera, T.; Uruchurtu, E. S.

    2017-01-01

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

  8. 40 CFR 410.02 - Monitoring requirements. [Reserved

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 28 2010-07-01 2010-07-01 true Monitoring requirements. 410.02 Section 410.02 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) EFFLUENT GUIDELINES AND STANDARDS TEXTILE MILLS POINT SOURCE CATEGORY General Provisions § 410.02 Monitoring requirements....

  9. Regulatory T cells (Tregs) monitoring in environmental diseases.

    Science.gov (United States)

    Mićović, Vladimir; Vojniković, Bozo; Bulog, Aleksandar; Coklo, Miran; Malatestinić, Dulija; Mrakovcić-Sutić, Ines

    2009-09-01

    The prevalence of environmental diseases is increasing worldwide and these diseases are an onerous burden both to the individual and to the public health. Urban air pollution is a grave problem in majority of metropolises, which contain high levels of traffic congestion generating great amounts of genotoxic substances. The contribution of such environmental exposure to increase prevalence of many allergic, environmental diseases and multiple chemical sensitivity or other related syndromes, as a result of an abnormal immune response based on environmental damage of lymphocyte subsets, is marked. Benzene is one of the most important air pollutants that are emitted by oil industry, since they are involved in almost every refinery process. Volatile organic compounds (VOCs) are a major group of air pollutants and play a crucial role in ecological damages, disturbing the ecosystem and human health. The variability of pollutants is an important factor in determining human exposure to these chemicals. The immune system possess a capacity to distinguish between innocuous and harmful foreign antigens and controls this action by mechanisms of central and peripheral tolerance, where crucial role play regulatory T cells (Tregs). We analyzed the characteristics of human Tregs of inhabitants living near gasoline industry which have assessed moderate spyrometric tests and compared them with those situated in rural areas. Our data demonstrate that the chronic inhalation exposure increases the percentage of Tregs cells, but contrary those of inhabitants with decreased spirometry values have shown diminished number of Tregs, which may contribute to the new therapeutic approach of environmental diseases.

  10. 40 CFR 63.751 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... design flow rate and organic concentration in the gas stream vented to the carbon adsorption system. The... requirements of part 60, appendix A, Method 21, sections 2, 3, 4.1, 4.2, and 4.4. The calibration gas shall either be representative of the compounds to be measured or shall be methane, and shall be at...

  11. 40 CFR 60.13 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... shall be subject to the provisions of this section upon promulgation of performance specifications for... Performance Specification 1, appendix B, of this part before the performance test required under § 60.8 is... under § 60.8 or within 30 days thereafter in accordance with the applicable performance specification...

  12. 78 FR 13712 - U.S. Nuclear Regulatory Commission Planned Monitoring Activities for F-Area Tank Farm at the...

    Science.gov (United States)

    2013-02-28

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION U.S. Nuclear Regulatory Commission Planned Monitoring Activities for F-Area Tank Farm at the Savannah River Site, Revision 0 AGENCY: Nuclear Regulatory Commission. ACTION: Document issuance....

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

    Science.gov (United States)

    Mao, Grace; Brody, James P

    2007-11-09

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

  14. Regulatory compliance requirements for an open source electronic image trial management system.

    Science.gov (United States)

    Rhodes, Colin; Moore, Steve; Clark, Ken; Maffitt, David; Perry, John; Handzel, Toni; Prior, Fred

    2010-01-01

    There is a global need for software to manage imaging based clinical trials to speed basic research and drug development. Such a system must comply with regulatory requirements. The U.S. Food and Drug Administration (FDA) has regulations regarding software development process controls and data provenance tracking. A key unanswered problem is the identification of which data changes are significant given a workflow model for image trial management. We report on the results of our study of provenance tracking requirements and define an architecture and software development process that meets U.S. regulatory requirements using open source software components.

  15. Requirements to a Norwegian national automatic gamma monitoring system

    DEFF Research Database (Denmark)

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

    2005-01-01

    An assessment of the overall requirements to a Norwegian gamma-monitoring network is undertaken with special emphasis on the geographical distribution of automatic gamma monitoring stations, type of detectors in such stations and the sensitivity of thesystem in terms of ambient dose equivalent rate...

  16. 50 CFR 660.312 - Vessel Monitoring System (VMS) requirements.

    Science.gov (United States)

    2010-10-01

    ... 50 Wildlife and Fisheries 9 2010-10-01 2010-10-01 false Vessel Monitoring System (VMS... West Coast Groundfish Fisheries § 660.312 Vessel Monitoring System (VMS) requirements. (a) What is a VMS? A VMS consists of a NMFS OLE type-approved mobile transceiver unit that automatically...

  17. 40 CFR 464.03 - Monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... Monitoring and reporting requirements. (a) As an alternative to monitoring for TTO (total toxic organics), an... Grease standard shall be considered equivalent to complying with the TTO standard. Alternate Oil and Grease standards are provided as substitutes for the TTO standards provided in §§ 464.15, 464.16,...

  18. 50 CFR 216.185 - Requirements for monitoring.

    Science.gov (United States)

    2010-10-01

    ... Low Frequency Active (SURTASS LFA sonar) Sonar § 216.185 Requirements for monitoring. (a) In order to... sunset); (2) Use low frequency passive SURTASS sonar to listen for vocalizing marine mammals; and (3)...

  19. 40 CFR 141.625 - Conditions requiring increased monitoring.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Conditions requiring increased monitoring. 141.625 Section 141.625 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) WATER PROGRAMS (CONTINUED) NATIONAL PRIMARY DRINKING WATER REGULATIONS Stage 2 Disinfection Byproducts Requirements § 141.625 Conditions...

  20. Required accuracy and dose thresholds in individual monitoring

    DEFF Research Database (Denmark)

    Christensen, P.; Griffith, R.V.

    1994-01-01

    to energy and angular dependencies of the dosemeter. In type testing of personal dosimetry systems, the estimated overall standard deviation of the dosimetry system is the main parameter to be tested. An important characteristic of a personal dosimetry system is its capability of measuring low doses......The paper follows the approach given in recent revisions of CEC and IAEA recommendations on requirements in individual monitoring for external radiations. The ICRP requirements on overall accuracy for individual monitoring, as given in ICRP Publication 35 (1982), form the basis...... for the specification of detailed accuracy requirements which are needed in practical routine monitoring. The ICRP overall accuracy requirement is defined as an allowable maximum uncertainty factor at the 95% confidence level for a single measurement of the relevant dose quantity, i.e. H(p)(10) and H(p)(0.07). From...

  1. 76 FR 67622 - Modification of Regulatory Provisions Requiring Credit Rating or Assessments in Accordance With...

    Science.gov (United States)

    2011-11-02

    ...- worthiness of a security or money market instrument. DOE has identified regulatory provisions that may be... credit-worthiness of a security or money market instrument; and (2) any reference to or requirements in... by the Federal Government, including influential scientific information related to agency...

  2. Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-08-01

    OAK B188 Risk-informed assessment of regulatory and design requirements for future nuclear power plants. Annual report. The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-formed approach for the design and regulation of nuclear power plants. This approach will include the development and/or confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRS) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go further by focusing on the design of new plants.

  3. Interferon regulatory factor 1 is required for mouse Gbp gene activation by gamma interferon.

    OpenAIRE

    1995-01-01

    Full-scale transcriptional activation of the mouse Gbp genes by gamma interferon (IFN-gamma) requires protein synthesis in embryonic fibroblasts. Although the Gbp-1 and Gbp-2 promoters contain binding sites for transcription factors Stat1 and IFN regulatory factor 1 (IRF-1), deletion analysis revealed that the Stat1 binding site is dispensable for IFN-gamma inducibility of Gbp promoter constructs in transfected fibroblasts. However, activation of the mouse Gbp promoter by IFN-gamma requires t...

  4. Requirements to a Norwegian National Automatic Gamma Monitoring System

    Energy Technology Data Exchange (ETDEWEB)

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

    2005-04-01

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

  5. Monitored Retrievable Storage System Requirements Document. Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    1994-03-01

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

  6. 17 CFR 249.821 - Form PILOT, information required of self-regulatory organizations operating pilot trading systems...

    Science.gov (United States)

    2010-04-01

    ... required of self-regulatory organizations operating pilot trading systems pursuant to § 240.19b-5 of this... Associations § 249.821 Form PILOT, information required of self-regulatory organizations operating pilot trading systems pursuant to § 240.19b-5 of this chapter. This form shall be used by all...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2000-05-01

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

  8. Modeling regulatory policies associated with offshore structure removal requirements in the Gulf of Mexico

    Energy Technology Data Exchange (ETDEWEB)

    Kaiser, Mark J. [Center for Energy Studies, Louisiana State University, Energy Coast and Environment Building, Baton Rouge, LA (United States)

    2008-07-15

    Federal regulations require that a lease in the Outer Continental Shelf of the Gulf of Mexico be cleared of all structures within one year after production on the lease ceases, but in recent years, the Minerals Management Service has begun to encourage operators to remove idle (non-producing) structures on producing leases that are no longer ''economically viable''. At the end of 2003, there were 2175 producing structures, 898 idle (non-producing) structures, and 440 auxiliary (never-producing) structures on 1356 active leases; and 329 idle structures and 65 auxiliary structures on 273 inactive leases. The purpose of this paper is to model the impact of alternative regulatory policies on the removal trends of structures and the inventory of idle iron, and to provide first-order estimates of the cost of each regulatory option. A description of the modeling framework and implementation results is presented. (author)

  9. Global regulatory requirements for mutagenicity assessment in the registration of industrial chemicals.

    Science.gov (United States)

    Ji, Zhiying; Ball, Nicholas S; LeBaron, Matthew J

    2017-06-01

    Mutagenicity is an important toxicological endpoint that requires thorough evaluation during the industrial chemical registration process. Regulatory requirements for mutagenicity assessment in registration of industrial chemicals vary in geographic regions (and in some cases by intended application). Here we compile the mutagenicity testing requirements for registration of industrial chemicals from representative geographic regions (in alphabetical order), that is Australia, Brazil, Canada, China, European Union (EU), India, Japan, South Korea, Taiwan, and United States (US). We further discuss the challenges that industry is facing to meet global regulations, for example, different testing requirements among geographic regions, different strategies in follow-up tests to in vitro positive findings, no-observed-adverse-effect-levels in genetic toxicity testing, and human relevance of mutagenicity. Environ. Mol. Mutagen. 58:345-353, 2017. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

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

    Energy Technology Data Exchange (ETDEWEB)

    Vajgel, Stefan

    2009-03-15

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

  11. [Regulatory requirements regarding cell-based medicinal products for human and veterinary use - a comparison].

    Science.gov (United States)

    Kuhlmann-Gottke, Johanna; Duchow, Karin

    2015-11-01

    At present, there is no separate regulatory framework for cell-based medicinal products (CBMP) for veterinary use at the European or German level. Current European and national regulations exclusively apply to the corresponding medicinal products for human use. An increasing number of requests for the regulatory classification of CBMP for veterinary use, such as allogeneic stem cell preparations and dendritic cell-based autologous tumour vaccines, and a rise in scientific advice for companies developing these products, illustrate the need for adequate legislation. Currently, advice is given and decisions are made on a case-by-case basis regarding the regulatory classification and authorisation requirements.Since some of the CBMP - in particular in the area of stem-cell products - are developed in parallel for human and veterinary use, there is an urgent need to create specific legal definitions, regulations, and guidelines for these complex innovative products in the veterinary sector as well. Otherwise, there is a risk that that the current legal grey area regarding veterinary medicinal products will impede therapeutic innovations in the long run. A harmonised EU-wide approach is desirable. Currently the European legislation on veterinary medicinal products is under revision. In this context, veterinary therapeutics based on allogeneic cells and tissues will be defined and regulated. Certainly, the legal framework does not have to be as comprehensive as for human CBMP; a leaner solution is conceivable, similar to the special provisions for advanced-therapy medicinal products laid down in the German Medicines Act.

  12. Evolution of New cis-Regulatory Motifs Required for Cell-Specific Gene Expression in Caenorhabditis.

    Directory of Open Access Journals (Sweden)

    Michalis Barkoulas

    2016-09-01

    Full Text Available Patterning of C. elegans vulval cell fates relies on inductive signaling. In this induction event, a single cell, the gonadal anchor cell, secretes LIN-3/EGF and induces three out of six competent precursor cells to acquire a vulval fate. We previously showed that this developmental system is robust to a four-fold variation in lin-3/EGF genetic dose. Here using single-molecule FISH, we find that the mean level of expression of lin-3 in the anchor cell is remarkably conserved. No change in lin-3 expression level could be detected among C. elegans wild isolates and only a low level of change-less than 30%-in the Caenorhabditis genus and in Oscheius tipulae. In C. elegans, lin-3 expression in the anchor cell is known to require three transcription factor binding sites, specifically two E-boxes and a nuclear-hormone-receptor (NHR binding site. Mutation of any of these three elements in C. elegans results in a dramatic decrease in lin-3 expression. Yet only a single E-box is found in the Drosophilae supergroup of Caenorhabditis species, including C. angaria, while the NHR-binding site likely only evolved at the base of the Elegans group. We find that a transgene from C. angaria bearing a single E-box is sufficient for normal expression in C. elegans. Even a short 58 bp cis-regulatory fragment from C. angaria with this single E-box is able to replace the three transcription factor binding sites at the endogenous C. elegans lin-3 locus, resulting in the wild-type expression level. Thus, regulatory evolution occurring in cis within a 58 bp lin-3 fragment, results in a strict requirement for the NHR binding site and a second E-box in C. elegans. This single-cell, single-molecule, quantitative and functional evo-devo study demonstrates that conserved expression levels can hide extensive change in cis-regulatory site requirements and highlights the evolution of new cis-regulatory elements required for cell-specific gene expression.

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

    DEFF Research Database (Denmark)

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

    2016-01-01

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

  14. 40 CFR 75.74 - Annual and ozone season monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... every five years and is also required if the flow monitor polynomial coefficients or K factor(s) are...-diluent monitoring system, each flow rate monitoring system, each moisture monitoring system and each... not apply, and, for flow rate monitoring systems, the required RATA load level(s) (or operating level...

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

    NARCIS (Netherlands)

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

    2016-01-01

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

  16. A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements

    Directory of Open Access Journals (Sweden)

    Giannakou C

    2016-06-01

    Full Text Available Christina Giannakou,1,2 Margriet VDZ Park,1 Wim H de Jong,1 Henk van Loveren,1,2 Rob J Vandebriel,1 Robert E Geertsma1 1Centre for Health Protection, National Institute for Public Health and the Environment (RIVM, Bilthoven, 2Department of Toxicogenomics, Maastricht University, Maastricht, the Netherlands Abstract: Nanomaterials (NMs are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome

  17. 13 CFR 120.463 - Regulatory accounting-What are SBA's regulatory accounting requirements for SBA Supervised Lenders?

    Science.gov (United States)

    2010-01-01

    ... basis in accordance with Generally Accepted Accounting Principles (GAAP) as promulgated by the Financial... set forth in FASB Statement of Financial Accounting Standards No. 15, Accounting by Debtors and... 13 Business Credit and Assistance 1 2010-01-01 2010-01-01 false Regulatory accounting-What are SBA...

  18. Investigating electronic records management and compliance with regulatory requirements in a South African university

    Directory of Open Access Journals (Sweden)

    M.E. Kyobe

    2009-02-01

    Full Text Available This study investigated the extent to which academics and students at a leading University in South Africa managed electronic records in accordance with good practices and regulatory requirements. Literature on electronic records management (ERM and regulatory compliance was synthesised to create a framework for effective records management. A survey was then conducted to test this framework with 17 academics, 97 students and two technical staff from five faculties. The results revealed several incidents of poor records management and lack of compliance with regulations. Many academics and students were unaware of legislative requirements and penalties. They did not backup or archive records regularly and where this was done, there were no standard procedures followed, which resulted in the adoption of distinct approaches to record keeping. Furthermore, appropriate programmes for educating users on ERM did not exist and academics had not established collaborative initiatives with other nonacademics (e.g. internal auditors and legal experts to ensure effective ERM. It was also surprising to find that non-computing academics and students managed system security risks better than their computing counterparts. Useful recommendations and the way forward are provided.

  19. Engineering Runtime Requirements-Monitoring Systems Using MDA Technologies

    Science.gov (United States)

    Skene, James; Emmerich, Wolfgang

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

  20. Chemcatcher and DGT passive sampling devices for regulatory monitoring of trace metals in surface water.

    Science.gov (United States)

    Allan, Ian J; Knutsson, Jesper; Guigues, Nathalie; Mills, Graham A; Fouillac, Anne-Marie; Greenwood, Richard

    2008-07-01

    This work aimed to evaluate whether the performance of passive sampling devices in measuring time-weighted average (TWA) concentrations supports their application in regulatory monitoring of trace metals in surface waters, such as for the European Union's Water Framework Directive (WFD). The ability of the Chemcatcher and the diffusive gradient in thin film (DGT) device sampler to provide comparable TWA concentrations of Cd, Cu, Ni, Pb and Zn was tested through consecutive and overlapping deployments (7-28 days) in the River Meuse (The Netherlands). In order to evaluate the consistency of these TWA labile metal concentrations, these were assessed against total and filtered concentrations measured at relatively high frequencies by two teams using standard monitoring procedures, and metal species predicted by equilibrium speciation modeling using Visual MINTEQ. For Cd and Zn, the concentrations obtained with filtered water samples and the passive sampling devices were generally similar. The samplers consistently underestimated filtered concentrations of Cu and Ni, in agreement with their respective predicted speciation. For Pb, a small labile fraction was mainly responsible for low sampler accumulation and hence high measurement uncertainty. While only the high frequency of spot sampling procedures enabled the observation of higher Cd concentrations during the first 14 days, consecutive DGT deployments were able to detect it and provide a reasonable estimate of ambient concentrations. The range of concentrations measured by spot and passive sampling, for exposures up to 28 days, demonstrated that both modes of monitoring were equally reliable. Passive sampling provides information that cannot be obtained by a realistic spot sampling frequency and this may impact on the ability to detect trends and assess monitoring data against environmental quality standards when concentrations fluctuate.

  1. Development of regulatory T cells requires IL-7Ralpha stimulation by IL-7 or TSLP.

    Science.gov (United States)

    Mazzucchelli, Renata; Hixon, Julie A; Spolski, Rosanne; Chen, Xin; Li, Wen Qing; Hall, Veronica L; Willette-Brown, Jami; Hurwitz, Arthur A; Leonard, Warren J; Durum, Scott K

    2008-10-15

    Interleukin-7 (IL-7), a cytokine produced by stromal cells, is required for thymic development and peripheral homeostasis of most major subsets of T cells. We examined whether regulatory T (Treg) cells also required the IL-7 pathway by analyzing IL-7Ralpha(-/-) mice. We observed a striking reduction in cells with the Treg surface phenotype (CD4, CD25, GITR (glucocorticoid-induced tumor necrosis factor [TNF]-like receptor), CD45RB, CD62L, CD103) or intracellular markers (cytotoxic T-lymphocyte-associated antigen-4, CTLA-4, and forkhead box transcription factor 3, Foxp3). Foxp3 transcripts were virtually absent in IL-7Ralpha(-/-) lymphoid tissues, and no Treg cell suppressive activity could be detected. There are 2 known ligands for IL-7Ralpha: IL-7 itself and thymic stromal lymphopoietin (TSLP). Surprisingly, mice deficient in IL-7 or the other chain of the TSLP receptor (TSLPR) developed relatively normal numbers of Treg cells. Combined deletion of IL-7 and TSLP receptor greatly reduced Treg cell development in the thymus but was not required for survival of mature peripheral Treg cells. We conclude that Treg cells, like other T cells, require signals from the IL-7 receptor, but unlike other T cells, do not require IL-7 itself because of at least partially overlapping actions of IL-7 and TSLP for development of Treg cells.

  2. Evolution of metal hyperaccumulation required cis-regulatory changes and triplication of HMA4.

    Science.gov (United States)

    Hanikenne, Marc; Talke, Ina N; Haydon, Michael J; Lanz, Christa; Nolte, Andrea; Motte, Patrick; Kroymann, Juergen; Weigel, Detlef; Krämer, Ute

    2008-05-15

    Little is known about the types of mutations underlying the evolution of species-specific traits. The metal hyperaccumulator Arabidopsis halleri has the rare ability to colonize heavy-metal-polluted soils, and, as an extremophile sister species of Arabidopsis thaliana, it is a powerful model for research on adaptation. A. halleri naturally accumulates and tolerates leaf concentrations as high as 2.2% zinc and 0.28% cadmium in dry biomass. On the basis of transcriptomics studies, metal hyperaccumulation in A. halleri has been associated with more than 30 candidate genes that are expressed at higher levels in A. halleri than in A. thaliana. Some of these genes have been genetically mapped to broad chromosomal segments of between 4 and 24 cM co-segregating with Zn and Cd hypertolerance. However, the in planta loss-of-function approaches required to demonstrate the contribution of a given candidate gene to metal hyperaccumulation or hypertolerance have not been pursued to date. Using RNA interference to downregulate HMA4 (HEAVY METAL ATPASE 4) expression, we show here that Zn hyperaccumulation and full hypertolerance to Cd and Zn in A. halleri depend on the metal pump HMA4. Contrary to a postulated global trans regulatory factor governing high expression of numerous metal hyperaccumulation genes, we demonstrate that enhanced expression of HMA4 in A. halleri is attributable to a combination of modified cis-regulatory sequences and copy number expansion, in comparison to A. thaliana. Transfer of an A. halleri HMA4 gene to A. thaliana recapitulates Zn partitioning into xylem vessels and the constitutive transcriptional upregulation of Zn deficiency response genes characteristic of Zn hyperaccumulators. Our results demonstrate the importance of cis-regulatory mutations and gene copy number expansion in the evolution of a complex naturally selected extreme trait. The elucidation of a natural strategy for metal hyperaccumulation enables the rational design of technologies

  3. 40 CFR 468.03 - Monitoring and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ... monitoring procedure for TTO, indirect dischargers may monitor for oil and grease and meet the alternate... alternate monitoring oil and grease standards shall be considered to meet the TTO standard....

  4. Requirements for efficient cell-type proportioning: regulatory timescales, stochasticity and lateral inhibition

    Science.gov (United States)

    Pfeuty, B.; Kaneko, K.

    2016-04-01

    The proper functioning of multicellular organisms requires the robust establishment of precise proportions between distinct cell types. This developmental differentiation process typically involves intracellular regulatory and stochastic mechanisms to generate cell-fate diversity as well as intercellular signaling mechanisms to coordinate cell-fate decisions at tissue level. We thus surmise that key insights about the developmental regulation of cell-type proportion can be captured by the modeling study of clustering dynamics in population of inhibitory-coupled noisy bistable systems. This general class of dynamical system is shown to exhibit a very stable two-cluster state, but also metastability, collective oscillations or noise-induced state hopping, which can prevent from timely and reliably reaching a robust and well-proportioned clustered state. To circumvent these obstacles or to avoid fine-tuning, we highlight a general strategy based on dual-time positive feedback loops, such as mediated through transcriptional versus epigenetic mechanisms, which improves proportion regulation by coordinating early and flexible lineage priming with late and firm commitment. This result sheds new light on the respective and cooperative roles of multiple regulatory feedback, stochasticity and lateral inhibition in developmental dynamics.

  5. Regulatory requirements for clinical trial and marketing authorisation application for cell-based medicinal products.

    Science.gov (United States)

    Salmikangas, P; Flory, E; Reinhardt, J; Hinz, T; Maciulaitis, R

    2010-01-01

    The new era of regenerative medicine has led to rapid development of new innovative therapies especially for diseases and tissue/organ defects for which traditional therapies and medicinal products have not provided satisfactory outcome. Although the clinical use and developments of cell-based medicinal products (CBMPs) could be witnessed already for a decade, robust scientific and regulatory provisions for these products have only recently been enacted. The new Regulation for Advanced Therapies (EC) 1394/2007 together with the revised Annex I, Part IV of Directive 2001/83/EC provides the new legal framework for CBMPs. The wide variety of cell-based products and the foreseen limitations (small sample sizes, short shelf life) vs. particular risks (microbiological purity, variability, immunogenicity, tumourigenicity) associated with CBMPs have called for a flexible, case-by-case regulatory approach for these products. Consequently, a risk-based approach has been developed to allow definition of the amount of scientific data needed for a Marketing Authorisation Application (MAA) of each CBMP. The article provides further insight into the initial risk evaluation, as well as to the quality, non-clinical, and clinical requirements of CBMPs. Special somatic cell therapies designed for active immunotherapy are also addressed.

  6. Secondary use of clinical data in healthcare providers - an overview on research, regulatory and ethical requirements.

    Science.gov (United States)

    Wiesenauer, Matthias; Johner, Christian; Röhrig, Rainer

    2012-01-01

    Hospital providers, physicians and researchers are interested in a cross-institutional use of their data for clinical research. This interest has led to the question whether the scientific potential of the data stored in so many different systems can be unfolded by the establishment of a cross-institutional medical data warehouse. The aim of this paper is to describe the ethical and regulatory requirements and to develop a solution architecture considering technical and organisational aspects. The present paper uses a structured approach to collect user requirements. The requirements are discussed with legal experts. The work was complemented by extended literature research. An essential requirement is the cross-institutional merging of the data. Here, aspects of data protection as the informed consent, or transparency must be considered. In addition it is essential to protect the researchers through transparency from accusations on publication bias. Technical and organisational solutions in combination of data protection, and data security enable an operation of a central medical data warehouse in compliance with the law. The usage of this infrastructure for research can contribute to an improvement of the treatment quality, and patient safety if there is an appropriate transparency. This contributes to innovation and added value of a hospital group.

  7. Required accuracy and dose thresholds in individual monitoring

    DEFF Research Database (Denmark)

    Christensen, P.; Griffith, R.V.

    1994-01-01

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

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

    Science.gov (United States)

    Fischer, Peter; Greitemeyer, Tobias; Frey, Dieter

    2007-09-01

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

  9. 47 CFR 73.53 - Requirements for authorization of antenna monitors.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 4 2010-10-01 2010-10-01 false Requirements for authorization of antenna... antenna monitors. (a) Antenna monitors shall be verified for compliance with the technical requirements in...) An antenna monitor shall meet the following specifications: (1) The monitor shall be designed...

  10. Cutting edge: Human regulatory T cells require IL-35 to mediate suppression and infectious tolerance.

    Science.gov (United States)

    Chaturvedi, Vandana; Collison, Lauren W; Guy, Clifford S; Workman, Creg J; Vignali, Dario A A

    2011-06-15

    Human regulatory T cells (T(reg)) are essential for the maintenance of immune tolerance. However, the mechanisms they use to mediate suppression remain controversial. Although IL-35 has been shown to play an important role in T(reg)-mediated suppression in mice, recent studies have questioned its relevance in human T(reg). In this study, we show that human T(reg) express and require IL-35 for maximal suppressive capacity. Substantial upregulation of EBI3 and IL12A, but not IL10 and TGFB, was observed in activated human T(reg) compared with conventional T cells (T(conv)). Contact-independent T(reg)-mediated suppression was IL-35 dependent and did not require IL-10 or TGF-β. Lastly, human T(reg)-mediated suppression led to the conversion of the suppressed T(conv) into iTr35 cells, an IL-35-induced T(reg) population, in an IL-35-dependent manner. Thus, IL-35 contributes to human T(reg)-mediated suppression, and its conversion of suppressed target T(conv) into IL-35-induced T(reg) may contribute to infectious tolerance.

  11. 50 CFR 216.217 - Requirements for monitoring and reporting.

    Science.gov (United States)

    2010-10-01

    ..., and any other Federal, state or local agency with regulatory authority over the offshore oil-and-gas... During Offshore Structure Removal Operations on the Outer Continental Shelf in the U.S. Gulf of Mexico... aircraft. Observations are to start at the removal site and proceed leeward and outward of wind and...

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

    Science.gov (United States)

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

    2016-11-01

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

  13. Nuclear Regulatory Authority low energy germanium detection system: performance for the uranium individual monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Spinella, M.R.; Krimer, M.; Rojo, A.M.; Gregori, B.N. [Autoridad Regulatoria Nuclear, Avda. del Libertador 8250, (C1429BNP) Ciudad Autonoma de Buenos Aires (Argentina); Gomez Parada, I. [Sociedad Argentina de Radioproteccion, Avda. del Libertador 8250, (C1429BNP) Ciudad Autonoma de Buenos Aires (Argentina)

    2007-07-01

    The lung counter facility of the Nuclear Regulatory Authority (ARN) is presented. A calibration was carried out using the Lawrence Livermore National Laboratory (LLNL) phantom. This phantom is provided with a pair of lungs and lymph nodes containing uranium homogeneously distributed and a set of four overlay plates covering a chest wall thickness (CWT) ranging from 1.638 to 3.871 cm. Individual organ calibration factors were acquired for {sup 235}U photo-peaks energies and for each effective chest thickness. Using these factors, a collection of theoretical fitting curves were found. A counting efficiency formulae and a curve for simultaneously active lymph nodes and lung was obtained and checked through measures. Background measurements of the chamber with and without volunteer persons were performed in order to obtain the detection limits (DL) of the system. As this task involves the knowledge of the volunteers CWTs, these magnitudes were determined through formulae selected from the literature taking into account the detection system characteristics. The deviation in the CWT assigned to an individual, generated by applying different equations, produces variations up to 33% in the estimations of the incorporated activity and DL. An analysis of the changes in efficiencies as consequences of the detectors locations and CWT was also performed. This reveals that the DL of the camera (detectors, shield and blank phantom) is between 2.7 and 6.4 Bq of {sup 235}U, which implies 4.9 and 11.5 mg lung burden of natural uranium. An estimation of the minimum detectable intake performed with the DL considering blank persons shows that a system with the characteristics described is only adequate for non-routine individual monitoring. (authors)

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2009-04-15

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

  15. Analytical Challenges and Regulatory Requirements for Nasal Drug Products in Europe and the U.S.

    Directory of Open Access Journals (Sweden)

    Sabrina Trows

    2014-04-01

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

  16. [Requirements for drug approval and additional benefits assessment: Regulatory aspects and experiences].

    Science.gov (United States)

    Broich, K; Löbker, W; Schulte, A; Beinlich, P; Müller, T

    2016-04-01

    The early assessment of benefits of newly approved drugs with novel active substances or new applications, which came into force on 1 January 2011 still represents a challenge to all parties involved. This article highlights the definitions, regulatory requirements and interaction between drug marketing approval and early assessment of benefits in Germany. The constellation of an extensively harmonized European and even international drug authorization process with a predominantly national regulation of drug reimbursement situation inevitably causes friction, which could be markedly reduced through early joint advisory discussions during the planning phase for pivotal clinical trials. During the year 2015 the Federal Institute for Drugs and Medical Devices (BfArM) carried out 300 scientific advice procedures of which 34 were concerned with applications in the field of indications for the central nervous system (CNS). In comparison 98 advisory meetings were held by the Federal Joint Committee (G-BA) of which the BfArM provided advice in 12 instances and in 2 cases on CNS indications. Study design, endpoints and appropriate comparative therapies are the key issues in exchanges and discussions between the BfArM, the G‑BA and applicants. Under these aspects the BfArM and G‑BA promote an early and consistent involvement in early advice procedures regarding the prerequisites for drug approval and assessment of additional benefits.

  17. 40 CFR 141.87 - Monitoring requirements for water quality parameters.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Monitoring requirements for water... § 141.87 Monitoring requirements for water quality parameters. All large water systems, and all small... representative of water quality and treatment conditions throughout the system. (d) Monitoring after State...

  18. 40 CFR 141.26 - Monitoring frequency and compliance requirements for radionuclides in community water systems.

    Science.gov (United States)

    2010-07-01

    ... for radionuclides in community water systems. (a) Monitoring and compliance requirements for gross... source of water must begin to conduct initial monitoring for the new source within the first quarter... initial monitoring requirements, a community water system having only one entry point to the distribution...

  19. 50 CFR 216.155 - Requirements for monitoring and reporting.

    Science.gov (United States)

    2010-10-01

    ...) Systematic visual observations, by those individuals, described in paragraph (c) of this section, on pinniped... monitoring measures: (1) Visual Land-Based Monitoring. (i) Prior to each missile launch, an observer(s) will... subpart. (5) Both the 60-day and final reports will be subject to review and comment by the...

  20. New approaches to the electromagnetic monitoring for improving the regulatory framework “green” building

    Directory of Open Access Journals (Sweden)

    Grafkina Marina

    2016-01-01

    Full Text Available In the regulatory legal base of a “green” construction existing now in the Russian Federation for assessment of an ecological safety of rooms of residential and public buildings criteria of electromagnetic comfort aren’t used. Its completion with obligatory assessment of indicators of electromagnetic safety is reasonable. Suggestions for improvement of the existing documents regulating assessment of conformity of real estate objects to ecological requirements are given in article. For the purpose of further development of system of regulation of negative factors of the habitat and electromagnetic safety, authors offer new approach to environmental control of low-frequency electromagnetic fields – transition from measurement of amplitude characteristics to determination of energy parameters. Sanitary and hygienic assessment and regulation of low-frequency electromagnetic fields it is performed separately on intensity of electric and magnetic field that doesn’t give an idea of an overall picture of spatial distribution of energy. The energy approach offered by authors will allow to estimate total energy impact of electromagnetic fields per capita, and also to develop new system of regulation of low-frequency electromagnetic fields in energy parameters.

  1. Flow cytometry quality requirements for monitoring of minimal disease in plasma cell myeloma.

    Science.gov (United States)

    Oldaker, Teri A; Wallace, Paul K; Barnett, David

    2016-01-01

    Current therapeutic approaches for plasma cell myeloma (PCM) attain an overall survival of more than 6 years for the majority of newly diagnosed patients. However, PFS and OS are the only accepted FDA clinical endpoints for demonstrating drug efficacy before they can be become frontline therapeutic options. There is, however, recognition that the increasing gap between drug development and approval for mainstream therapeutic use needs to be shortened. As such regulatory bodies such as the FDA are now considering whether biomarker response evaluation, as in measurement of minimal residual disease (MRD) as assessed by flow cytometry (FC), can provide an early, robust prediction of survival and therefore improve the drug approval process. Recently, FC MRD using a standardized eight-color antibody methodology has been shown to have a minimum sensitivity of 0.01% and an upper sensitivity of 0.001%. To ensure that all laboratories using this approach achieve the same levels of sensitivity it is crucially important to have standardized quality management procedures in place. This manuscript accompanies those published in this special issue and describes the minimum that is required for validating and quality monitoring of this highly specific test to ensure any laboratory, irrespective of location, will achieve the expected quality standards required. © 2015 International Clinical Cytometry Society.

  2. 40 CFR 63.1452 - What are my monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ... document, “Fabric Filter Bag Leak Detection Guidance,” EPA-454/R-98-015, September 1997. You may obtain a... mechanisms. (iii) Check the compressed air supply for pulse-jet baghouses each day. (iv) Monitor...

  3. Impact of regulatory requirements on medicine registration in African countries - perceptions and experiences of pharmaceutical companies in South Africa.

    Science.gov (United States)

    Narsai, Kirti; Williams, Abeda; Mantel-Teeuwisse, Aukje Kaija

    2012-07-01

    Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource-constrained, harmonisation of

  4. Impact of regulatory requirements on medicine registration in African countries – perceptions and experiences of pharmaceutical companies in South Africa

    Science.gov (United States)

    Narsai, Kirti; Williams, Abeda; Mantel-Teeuwisse, Aukje Kaija

    2012-01-01

    Objective: Access to medicines has long been and remains a challenge in African countries. The impact of medicines registration policies in these countries poses a challenge for pharmaceutical companies wanting to register medicines in these countries. The recent AMRHI (African Medicines Registration Harmonisation Initiative) has increased the focus on the need for harmonisation. Medicines registration regulations differ across African countries. Anecdotal evidence, based on the experience of pharmaceutical companies on progress towards harmonisation is somewhat different, i.e. that country specific requirements were a barrier to the registration of medicines. The objective of this study was therefore to determine the nature and extent of regulatory hurdles experienced by pharmaceutical companies who wish to register and supply medicines to African countries. Methods: This cross-sectional descriptive pilot study was conducted across pharmaceutical companies, both local and multinational. These companies were based in South Africa and were also members of Pharmaceutical Industry Association of South Africa (PIASA). The pharmaceutical companies supply both the private and public sectors. An online survey was developed using Survey Monkey. Survey questions focused on the following strands: nature and level of current supply of medicines to African countries by companies, general regulatory requirements, region specific questions and country specific questions across four regional economic communities in Africa, namely; Southern African Development Community (SADC), East African Community (EAC), Economic Community of the West African States (ECOWAS) and Economic Community of Central African States (ECCAS). Results: A total of 33 responses were received to the questionnaire of which 26 respondents were from the PIASA Regulatory working group and 7 were from the PIASA Export working group.It was noted that since most of the regulatory authorities in Africa are resource

  5. A 3D bioprinting exemplar of the consequences of the regulatory requirements on customized processes.

    Science.gov (United States)

    Hourd, Paul; Medcalf, Nicholas; Segal, Joel; Williams, David J

    2015-01-01

    Computer-aided 3D printing approaches to the industrial production of customized 3D functional living constructs for restoration of tissue and organ function face significant regulatory challenges. Using the manufacture of a customized, 3D-bioprinted nasal implant as a well-informed but hypothetical exemplar, we examine how these products might be regulated. Existing EU and USA regulatory frameworks do not account for the differences between 3D printing and conventional manufacturing methods or the ability to create individual customized products using mechanized rather than craft approaches. Already subject to extensive regulatory control, issues related to control of the computer-aided design to manufacture process and the associated software system chain present additional scientific and regulatory challenges for manufacturers of these complex 3D-bioprinted advanced combination products.

  6. 77 FR 13977 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

    Science.gov (United States)

    2012-03-08

    ... AGENCY 40 CFR Part 60 RIN 2060-AH23 Quality Assurance Requirements for Continuous Opacity Monitoring... final rule titled, ``Quality Assurance Requirements for Continuous Opacity Monitoring Systems at... electronically in www.regulations.gov or in hard copy at the Procedure 3--Quality Assurance Requirements for...

  7. 77 FR 13997 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

    Science.gov (United States)

    2012-03-08

    ... AGENCY 40 CFR Part 60 RIN 2060-AH23 Quality Assurance Requirements for Continuous Opacity Monitoring... rule titled, ``Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary....regulations.gov or in hard copy at the Procedure 3--Quality Assurance Requirements for Continuous Opacity...

  8. 77 FR 8160 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

    Science.gov (United States)

    2012-02-14

    ... AGENCY 40 CFR Part 60 RIN 2060-AH23 Quality Assurance Requirements for Continuous Opacity Monitoring...--Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources Docket, EPA.... Rules establishing quality assurance requirements impose no costs independent from national emission...

  9. 40 CFR 141.88 - Monitoring requirements for lead and copper in source water.

    Science.gov (United States)

    2010-07-01

    ... § 141.88 Monitoring requirements for lead and copper in source water. (a) Sample location, collection... water samples in accordance with the following requirements regarding sample location, number of samples... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Monitoring requirements for lead...

  10. 40 CFR 141.86 - Monitoring requirements for lead and copper in tap water.

    Science.gov (United States)

    2010-07-01

    ... § 141.86 Monitoring requirements for lead and copper in tap water. (a) Sample site location. (1) By the... requirements of § 141.87(e)(2), that it has re-qualified for triennial monitoring. (vii) Any water system... requirements for lead (i.e., a “lead waiver”), the water system must provide certification and...

  11. Sustained activation of interferon regulatory factor 3 during infection by paramyxoviruses requires MDA5.

    Science.gov (United States)

    Grandvaux, Nathalie; Guan, Xiaochun; Yoboua, Fabrice; Zucchini, Nicolas; Fink, Karin; Doyon, Priscilla; Martin, Lydie; Servant, Marc J; Chartier, Stéfany

    2014-01-01

    Retinoic acid-inducible gene I (RIG-I) and melanoma differentiation-associated gene 5 (MDA5) are the main cytosolic sensors of single-stranded RNA viruses, including paramyxoviruses, and are required to initiate a quick and robust innate antiviral response. Despite different ligand-binding properties, the consensus view is that RIG-I and MDA5 trigger common signal(s) to activate interferon regulatory factor 3 (IRF-3) and NF-κB, and downstream antiviral and proinflammatory cytokine expression. Here, we performed a thorough analysis of the temporal involvement of RIG-I and MDA5 in the regulation of IRF-3 during respiratory syncytial virus (RSV) infection. Based on specific RNA interference-mediated knockdown of RIG-I and MDA5 in A549 cells, we confirmed that RIG-I is critical for the initiation of IRF-3 phosphorylation, dimerization and downstream gene expression. On the other hand, our experiments yielded the first evidence that knockdown of MDA5 leads to early ubiquitination and proteasomal degradation of active IRF-3. Conversely, ectopic expression of MDA5 prolonged RIG-I-induced IRF-3 activation. Altogether, we provide novel mechanistic insight into the temporal involvement of RIG-I and MDA5 in the innate antiviral response. While RIG-I is essential for initial IRF-3 activation, engagement of induced MDA5 is essential to prevent early degradation of IRF-3, thereby sustaining IRF-3-dependent antiviral gene expression. MDA5 plays a similar role during Sendai virus infection suggesting that this model is not restricted to RSV amongst paramyxoviruses.

  12. 40 CFR 63.773 - Inspection and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) National Emission Standards for Hazardous Air Pollutants From Oil and Natural Gas Production.... Owners or operators that install and operate a flare in accordance with § 63.771(d)(1)(iii) are exempt... feasible point to the catalyst bed outlet. (C) For a flare, a heat sensing monitoring device equipped...

  13. 40 CFR 141.74 - Analytical and monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... from Ozone Science & Engineering, Pergamon Press Ltd., Fairview Park, Elmsford, New York 10523. Copies... 21, 2003, available from Industrial Test Systems, Inc., 1875 Langston St., Rock Hill, SC 29730. Free... method for use with a continuous monitoring instrument provided the chemistry, accuracy, and...

  14. 40 CFR 63.1209 - What are the monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ... Administrator to use CEMS for compliance monitoring for particulate matter, mercury, semivolatile metals, low... ensure compliance with the relevant standard on a continuous basis. (B) Mercury. You may petition the... that affect adsorption and establish limits on those parameters based on the carbon used in...

  15. 40 CFR 63.11583 - What are my monitoring requirements?

    Science.gov (United States)

    2010-07-01

    ... practices at all times. (b) Operate a control device parameter (such as pressure drop or water flow, as... pressure drop. (2) Installation of the bag leak detector, parameter monitoring device, or CPMS at a... alert operators of a leak in the control device filter material. If a bag leak detection system...

  16. 40 CFR 146.23 - Operating, monitoring, and reporting requirements.

    Science.gov (United States)

    2010-07-01

    ...)); and (5) Hydrocarbon storage and enhanced recovery may be monitored on a field or project basis rather... information may be included by reference. (2) Owners or operators of hydrocarbon storage and enhanced recovery... fluid disposal operations; (ii) Monthly for enhanced recovery operations; (iii) Daily during the...

  17. 50 CFR 216.255 - Requirements for monitoring and reporting.

    Science.gov (United States)

    2010-10-01

    ... section may include retention of marine mammals without the need for a separate scientific research permit... animals sighted. (4) Conduct shipboard monitoring to reduce impacts to protected species. Trained marine..., including the time of sighting and the direction of travel, into a marine animal tracking and...

  18. 40 CFR Table 3 of Subpart Aaaa to... - Requirements for Validating Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 6 2010-07-01 2010-07-01 false Requirements for Validating Continuous Emission Monitoring Systems (CEMS) 3 Table 3 of Subpart AAAA to Part 60 Protection of Environment... Continuous Emission Monitoring Systems (CEMS) For the following continuous emission monitoring systems...

  19. Nuclear Energy Research Initiative. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants. Annual Report

    Energy Technology Data Exchange (ETDEWEB)

    Ritterbusch, S.E.

    2000-08-01

    The overall goal of this research project is to support innovation in new nuclear power plant designs. This project is examining the implications, for future reactors and future safety regulation, of utilizing a new risk-informed regulatory system as a replacement for the current system. This innovation will be made possible through development of a scientific, highly risk-informed approach for the design and regulation of nuclear power plants. This approach will include the development and.lor confirmation of corresponding regulatory requirements and industry standards. The major impediment to long term competitiveness of new nuclear plants in the U.S. is the capital cost component--which may need to be reduced on the order of 35% to 40% for Advanced Light Water Reactors (ALWRs) such as System 80+ and Advanced Boiling Water Reactor (ABWR). The required cost reduction for an ALWR such as AP600 or AP1000 would be expected to be less. Such reductions in capital cost will require a fundamental reevaluation of the industry standards and regulatory bases under which nuclear plants are designed and licensed. Fortunately, there is now an increasing awareness that many of the existing regulatory requirements and industry standards are not significantly contributing to safety and reliability and, therefore, are unnecessarily adding to nuclear plant costs. Not only does this degrade the economic competitiveness of nuclear energy, it results in unnecessary costs to the American electricity consumer. While addressing these concerns, this research project will be coordinated with current efforts of industry and NRC to develop risk-informed, performance-based regulations that affect the operation of the existing nuclear plants; however, this project will go farther by focusing on the design of new plants.

  20. Glutathione S-transferase Ya subunit gene: identification of regulatory elements required for basal level and inducible expression.

    OpenAIRE

    Telakowski-Hopkins, C A; King, R. G.; Pickett, C B

    1988-01-01

    The function of the 5'-flanking region of a rat glutathione S-transferase Ya subunit structural gene has been examined in homologous and heterologous cells. By using the 5'-flanking region of the Ya subunit gene fused to the structural gene encoding chloramphenicol acetyltransferase, we have identified two cis-acting regulatory elements in the upstream region of the Ya gene. One element is required for maximum basal level expression in homologous cells, whereas maximum basal level expression ...

  1. 47 CFR 11.52 - EAS code and Attention Signal Monitoring requirements.

    Science.gov (United States)

    2010-10-01

    ... 47 Telecommunication 1 2010-10-01 2010-10-01 false EAS code and Attention Signal Monitoring... SYSTEM (EAS) Emergency Operations § 11.52 EAS code and Attention Signal Monitoring requirements. (a) EAS Participants must be capable of receiving the Attention Signal required by § 11.32(a)(9) and emergency...

  2. 40 CFR 264.97 - General ground-water monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... FACILITIES Releases From Solid Waste Management Units § 264.97 General ground-water monitoring requirements. The owner or operator must comply with the following requirements for any ground-water monitoring... 40 Protection of Environment 25 2010-07-01 2010-07-01 false General ground-water...

  3. 40 CFR 63.2269 - What are my monitoring installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... Composite Wood Products Initial Compliance Requirements § 63.2269 What are my monitoring installation... moisture monitoring. For each furnish or veneer moisture meter, you must meet the requirements in... in the 25 to 35 percent (dry basis) moisture content range. For veneer redryers, use a...

  4. 40 CFR 63.1429 - Process vent monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... National Emission Standards for Hazardous Air Pollutant Emissions for Polyether Polyols Production § 63... required and should be equipped with a continuous recorder. If an acid or base absorbent is used, a...

  5. Comparison of bioequivalence study regulatory requirements for human and veterinary drugs.

    Science.gov (United States)

    Grabowski, Tomasz; Marczak, Monika; Jaroszewski, Jerzy Jan; Whitmire, Monica

    2012-11-01

    Guidelines published by the European Union Regulatory Authority, regarding the planning of bioequivalence studies, are the primary source of knowledge about the study design optimization. The goal of this paper is to compare the key elements (27 points) of bioequivalence study optimization based on a comparison of the two European Medicines Agency guidelines relating to medicines used for humans (HB) and to veterinary drugs (AB). In case of the latter, one can get the impression that the issues of species differences in relation to the physiology and anatomy have been completely ignored. Many details that the AB guideline omits are included in the new HB guideline and were present in many other guidelines from the last 20 years. Most have not been adopted by the AB document, even though they are the product of many years of work of many teams and specialists from various agencies in the regulatory affairs field.

  6. Requirements for US regulatory approval of the International Thermonuclear Experimental Reactor (ITER)

    Energy Technology Data Exchange (ETDEWEB)

    Petti, D.A.; Haire, J.C.

    1993-12-01

    The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project.

  7. 78 FR 16184 - Revision to Ambient Nitrogen Dioxide Monitoring Requirements

    Science.gov (United States)

    2013-03-14

    ... 98th percentile form averaged over three years and a level of 100 parts per billion (ppb), reflecting... 53 ppb. As part of the NAAQS rulemaking, the EPA promulgated revisions to requirements for minimum... groups and one citizen supporting the proposed revisions to the schedule for implementing near-road NO 2...

  8. 75 FR 81126 - Revisions to Lead Ambient Air Monitoring Requirements

    Science.gov (United States)

    2010-12-27

    ... Physicians for a Healthy Environment, Leslie and Jack Warden, WEACT for Environmental Justice and the Wasatch... requirements, the Natural Resources Defense Council (NRDC), the Missouri Coalition for the Environment... provisions of the final lead NAAQS rule. See Missouri Coalition for the Environment, et al. v. EPA, (DC...

  9. Utilization of Unmanned Aerial Vehicles for Rangeland Resources Monitoring in a Changing Regulatory Environment (Invited)

    Science.gov (United States)

    Rango, A.; Vivoni, E. R.; Browning, D. M.; Anderson, C.; Laliberte, A. S.

    2013-12-01

    It is taking longer than expected to realize the immense potential of Unmanned Aerial Vehicles (UAVs)for civil applications due to the complexity of regulations being developed by the Federal Aviation Authority (FAA) that can be applied to both manned and unmanned flight in the National Airspace System (NAS). As a result, FAA has required that for all UAV flights in the NAS, an external pilot must maintain line-of-sight contact with the UAV. Properly trained observers must also be present to assist the external pilot in collision avoidance. Additionally, in order to fly in the NAS, formal approval must be requested from FAA through application for a Certificate of Authorization (COA for government applicants or a Special Airworthiness Certificate (SAC) in the experimental category for non-government applicants. Flight crews of UAVs must pass exams also required for manned airplane pilots. Although flight crews for UAVs are not required to become manned airplane pilots, UAV flight missions are much more efficient if one or two of the UAV flight crew are also manned aircraft pilots so they can serve as the UAV mission commander. Our group has performed numerous UAV flights within the Jornada Experimental Range in southern New Mexico. Two developments with Jornada UAVs can be recommended to other UAV operators that would increase flight time experience and study areas covered by UAV images. First, do not overlook the possibility of obtaining permission to fly in Restricted Military Airspace (RMA). At the Jornada, our airspace is approximately 50% NAS and 50% RMA. With experiments ongoing in both types of airspace, we can fly in both areas and continue to increase UAV flights. Second, we have developed an air- and-ground vehicle approach for long distance, continuous pilot transport that always maintains line-of-sight requirements. This allows flying several target areas on a single mission and increasing the number of acquired UAV images - over 90,000 UAV images have

  10. [European Union regulatory and quality requirements for botanical drugs and their implications for Chinese herbal medicinal products development].

    Science.gov (United States)

    Zhu, You-Ping

    2017-06-01

    This paper introduces regulatory pathways and characteristic quality requirements for marketing authorization of herbal medicinal products in the European Union(EU), and the legal status and applications of "European Union list of herbal substances, preparations and combinations" and "European Union herbal monographs". Also introduced are Chinese herbs that have been granted the EU list entry, those with EU herbal monographs, and registered EU traditional herbal medicinal products with Chinese herbs as active ingredients. Special attention is paid to the technical details of three authorized EU herbal medicinal products (Veregen, Sativex and Episalvan) in comparison with Andrographis paniculata extract HMPL-004 that failed the phase Ⅲ clinical trial for ulcerative colitis. The paper further emphasizes the importance of enriching active fractions of herbal extracts and taking regulatory and quality considerations into account in early stage of botanical drug development. Copyright© by the Chinese Pharmaceutical Association.

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

    Directory of Open Access Journals (Sweden)

    Jonny Crocker

    2014-07-01

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

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

    Science.gov (United States)

    Crocker, Jonny; Bartram, Jamie

    2014-07-18

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

  13. The impact of implementation of the Canadian regulatory requirements on the quality of natural health products: the glucosamine case.

    Science.gov (United States)

    Aghazadeh-Habashi, Ali; Duke, John; Jamali, Fakhreddin

    2014-01-01

    We investigated whether the recent implementation of the regulatory requirements for the entry to the Canadian market of natural products has resulted in improved quality of the available glucosamine products. Eleven available products, of which 8 had been tested in 2002 (7 had contained substantially lower than the label claim of the active ingredient), and a European pharmaceutical grade tablet were assayed for their glucosamine content. The potassium and sodium contents of the products were also tested. Nine of the 11 Canadian products and the European tablet had more than 91% of the label claim of the active ingredient, hence, met the criterion. Two products contained 71 and 78% label claim. The electrolyte contents were very variable but constituted only a small fraction of the daily requirements. Most tested glucosamine products passed the Health Canada requirements. This improvement is likely due to the publicity regarding the low quality of the products in the past and also a result, at least in part, of the introduction of the new regulatory requirements. The sub-standard quality of a few tested products is still of concern.

  14. 77 FR 8209 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

    Science.gov (United States)

    2012-02-14

    ... AGENCY 40 CFR Part 60 RIN 2060-AH23 Quality Assurance Requirements for Continuous Opacity Monitoring... standards as specified in federally enforceable regulations. The quality assurance requirements will be... standards to the quality assurance requirements in Appendix F of 40 CFR Part 60 in the ``Rules and...

  15. 77 FR 18709 - Quality Assurance Requirements for Continuous Opacity Monitoring Systems at Stationary Sources

    Science.gov (United States)

    2012-03-28

    ... AGENCY 40 CFR Part 60 RIN 2060-AH23 Quality Assurance Requirements for Continuous Opacity Monitoring... final rule. SUMMARY: The EPA published a direct final rule titled ``Quality Assurance Requirements for....regulations.gov or in hard copy at the Procedure 3--Quality Assurance Requirements for Continuous Opacity...

  16. 40 CFR Appendix P to Part 51 - Minimum Emission Monitoring Requirements

    Science.gov (United States)

    2010-07-01

    ... Requirements P Appendix P to Part 51 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS REQUIREMENTS FOR PREPARATION, ADOPTION, AND SUBMITTAL OF IMPLEMENTATION PLANS Pt. 51, App. P Appendix P to Part 51—Minimum Emission Monitoring Requirements 1.0 Purpose. This appendix P sets forth...

  17. A discussion of regulatory requirements and air dispersion modeling approaches applicable to U.S. chemical demilitarization facilities.

    Science.gov (United States)

    Higgins, B W; Robbins, L B; Litynski, J

    1998-09-01

    Owners of hazardous waste treatment, storage, and disposal facilities, and certain major air pollution sources, must conduct several separate ambient air dispersion modeling analyses before beginning construction of new facilities or modifying existing facilities. These analyses are critical components of the environmental permitting and facility certification processes and must be completed to the satisfaction of federal, state, and local regulatory authorities. The U.S. Army has conducted air dispersion modeling for its proposed chemical agent disposal facilities to fulfill the following environmental regulatory and risk management requirements: (1) Resource Conservation and Recovery Act human health and ecological risk assessment analysis for the hazardous waste treatment and storage permit applications, (2) Quantitative Risk Assessment to support the site-specific risk management programs, and (3) Prevention of Significant Deterioration ambient air impact analysis for the air permit applications. The purpose of these air dispersion modeling studies is to show that the potential impacts on human health and the environment, due to operation of the chemical agent disposal facilities, are acceptable. This paper describes and compares the types of air dispersion models, modeling input data requirements, modeling algorithms, and approaches used to satisfy the three environmental regulatory and risk management requirements listed above. Although this paper discusses only one industry (i.e., chemical demilitarization), the information it contains could help those in other industries who need to communicate to the public the purpose and objectives of each modeling analysis. It may also be useful in integrating the results of each analysis into an overarching summary of compliance and potential risks.

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

    Energy Technology Data Exchange (ETDEWEB)

    Krupka, Kenneth M.; Martin, Wayne J.

    2001-07-23

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

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

    Science.gov (United States)

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

  20. 40 CFR 98.44 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... (CONTINUED) MANDATORY GREENHOUSE GAS REPORTING Electricity Generation § 98.44 Monitoring and QA/QC requirements. Follow the applicable quality assurance procedures for CO2 emissions in appendices B, D, and G to 40 CFR part 75....

  1. Do changes in regulatory requirements for energy efficiency in single-family houses result in the expected energy savings

    DEFF Research Database (Denmark)

    Kjærbye, Vibeke; Larsen, Anders; Togeby, Mikael

    2011-01-01

    This paper explores how changes in regulatory requirements for energy efficiency in buildings (in the US also known as building energy codes) affect household energy consumption. The focus in this paper is on natural gas consumption by Danish single-family owner-occupied houses. Unlike most other...... in energy used for heating. The latest revision of the Danish building regulation covered by this paper is that of 1998. This revision has resulted in a 7 pct. reduction in natural gas consumption. For comparison the ex ante expectation was 25 pct. reduction in heating demand...

  2. 75 FR 20269 - Regulatory Reporting Requirements for the Indian Community Development Block Grant Program

    Science.gov (United States)

    2010-04-19

    ... Indian Community Development Block Grants (ICDBG) program. First, the rule provides for submission of a... reporting requirements for the Indian Community Development Block Grant (ICDBG) program. The purpose of the... HUD-96010 a mandatory reporting requirement for ICDBG grant funding. As more fully described in...

  3. Monitoring regulatory T cells in clinical samples: consensus on an essential marker set and gating strategy for regulatory T cell analysis by flow cytometry.

    Science.gov (United States)

    Santegoets, Saskia J A M; Dijkgraaf, Eveline M; Battaglia, Alessandra; Beckhove, Philipp; Britten, Cedrik M; Gallimore, Awen; Godkin, Andrew; Gouttefangeas, Cecile; de Gruijl, Tanja D; Koenen, Hans J P M; Scheffold, Alexander; Shevach, Ethan M; Staats, Janet; Taskén, Kjetil; Whiteside, Theresa L; Kroep, Judith R; Welters, Marij J P; van der Burg, Sjoerd H

    2015-10-01

    Regulatory T cell (Treg)-mediated immunosuppression is considered a major obstacle for successful cancer immunotherapy. The association between clinical outcome and Tregs is being studied extensively in clinical trials, but unfortunately, no consensus has been reached about (a) the markers and (b) the gating strategy required to define human Tregs in this context, making it difficult to draw final conclusions. Therefore, we have organized an international workshop on the detection and functional testing of Tregs with leading experts in the field, and 40 participants discussing different analyses and the importance of different markers and context in which Tregs were analyzed. This resulted in a rationally composed ranking list of "Treg markers". Subsequently, the proposed Treg markers were tested to get insight into the overlap/differences between the most frequently used Treg definitions and their utility for Treg detection in various human tissues. Here, we conclude that the CD3, CD4, CD25, CD127, and FoxP3 markers are the minimally required markers to define human Treg cells. Staining for Ki67 and CD45RA showed to provide additional information on the activation status of Tregs. The use of markers was validated in a series of PBMC from healthy donors and cancer patients, as well as in tumor-draining lymph nodes and freshly isolated tumors. In conclusion, we propose an essential marker set comprising antibodies to CD3, CD4, CD25, CD127, Foxp3, Ki67, and CD45RA and a corresponding robust gating strategy for the context-dependent analysis of Tregs by flow cytometry.

  4. Cutting Edge: memory regulatory t cells require IL-7 and not IL-2 for their maintenance in peripheral tissues.

    Science.gov (United States)

    Gratz, Iris K; Truong, Hong-An; Yang, Sara Hsin-Yi; Maurano, Megan M; Lee, Karim; Abbas, Abul K; Rosenblum, Michael D

    2013-05-01

    Thymic Foxp3-expressing regulatory T cells are activated by peripheral self-antigen to increase their suppressive function, and a fraction of these cells survive as memory regulatory T cells (mTregs). mTregs persist in nonlymphoid tissue after cessation of Ag expression and have enhanced capacity to suppress tissue-specific autoimmunity. In this study, we show that murine mTregs express specific effector memory T cell markers and localize preferentially to hair follicles in skin. Memory Tregs express high levels of both IL-2Rα and IL-7Rα. Using a genetic-deletion approach, we show that IL-2 is required to generate mTregs from naive CD4(+) T cell precursors in vivo. However, IL-2 is not required to maintain these cells in the skin and skin-draining lymph nodes. Conversely, IL-7 is essential for maintaining mTregs in skin in the steady state. These results elucidate the fundamental biology of mTregs and show that IL-7 plays an important role in their survival in skin.

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

    Science.gov (United States)

    Lin, Vivian; McCabe, Pauline; Bensoussan, Alan; Myers, Stephen; Cohen, Marc; Hill, Sophie; Howse, Genevieve

    2009-01-01

    Australian health workforce regulation is premised on the need to protect public health and safety. Specific criteria are set out by governments to ascertain the degree of risk and the need for government intervention. A study was undertaken to understand the current state of usage and the practice of naturopathy and western herbal medicine, and to ascertain whether statutory regulation was warranted. We found increased use of these complementary therapies in the community, with risks arising from both the specific practices as well as consumers negotiating a parallel primary health care system. We also found highly variable standards of training, a myriad of professional associations, and a general failure of current systems of self-regulation to protect public health and safety. Statutory regulation was the preferred policy response for consumers, insurers, general practitioners, and most of the complementary therapists. While we found a case for statutory registration, we also argue that a minimalist regulatory response needs to be accompanied by other measures to educate the public, to improve the standards of practice, and to enhance our understanding of the interaction between complementary and mainstream health care. PMID:22312205

  6. Nuclear reactor effluent monitoring

    Energy Technology Data Exchange (ETDEWEB)

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

    1993-12-31

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

  7. 50 CFR 18.128 - What are the mitigation, monitoring, and reporting requirements?

    Science.gov (United States)

    2010-10-01

    ... require a monitor on the site of the activity or on board drill ships, drill rigs, aircraft, icebreakers... or require that the operator conduct activities after the female bears emerge from their dens. We... Alaska Regional Director (Attn: Marine Mammals Management Office) within 90 days after completion...

  8. 78 FR 55060 - Proposed Information Collection; Comment Request; Expanded Vessel Monitoring System Requirement...

    Science.gov (United States)

    2013-09-09

    ... commercial fishing vessels are required to install and use a vessel monitoring system (VMS) that... pilot VMS program was implemented on January 1, 2004. The pilot program required vessels registered to Pacific Coast groundfish fishery limited entry permits to carry and use VMS transceiver units...

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

    Directory of Open Access Journals (Sweden)

    Vivian Lin

    2009-02-01

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

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

    Directory of Open Access Journals (Sweden)

    McCallum Ian

    2009-08-01

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

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

    Directory of Open Access Journals (Sweden)

    Wen-Tien Tsai

    2016-09-01

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

  12. Sterol Regulatory Element Binding Protein (Srb1) Is Required for Hypoxic Adaptation and Virulence in the Dimorphic Fungus Histoplasma capsulatum

    Science.gov (United States)

    DuBois, Juwen C.; Smulian, A. George

    2016-01-01

    The Histoplasma capsulatum sterol regulatory element binding protein (SREBP), Srb1 is a member of the basic helix-loop-helix (bHLH), leucine zipper DNA binding protein family of transcription factors that possess a unique tyrosine (Y) residue instead of an arginine (R) residue in the bHLH region. We have determined that Srb1 message levels increase in a time dependent manner during growth under oxygen deprivation (hypoxia). To further understand the role of Srb1 during infection and hypoxia, we silenced the gene encoding Srb1 using RNA interference (RNAi); characterized the resulting phenotype, determined its response to hypoxia, and its ability to cause disease within an infected host. Silencing of Srb1 resulted in a strain of H. capsulatum that is incapable of surviving in vitro hypoxia. We found that without complete Srb1 expression, H. capsulatum is killed by murine macrophages and avirulent in mice given a lethal dose of yeasts. Additionally, silencing Srb1 inhibited the hypoxic upregulation of other known H. capsulatum hypoxia-responsive genes (HRG), and genes that encode ergosterol biosynthetic enzymes. Consistent with these regulatory functions, Srb1 silenced H. capsulatum cells were hypersensitive to the antifungal azole drug itraconazole. These data support the theory that the H. capsulatum SREBP is critical for hypoxic adaptation and is required for H. capsulatum virulence. PMID:27711233

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-07-01

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

  14. Dynamic regulatory interactions of Polycomb group genes: MEDEA autoregulation is required for imprinted gene expression in Arabidopsis.

    Science.gov (United States)

    Baroux, Célia; Gagliardini, Valeria; Page, Damian R; Grossniklaus, Ueli

    2006-05-01

    The imprinted Arabidopsis Polycomb group (PcG) gene MEDEA (MEA), which is homologous to Enhancer of Zeste [E(Z)], is maternally required for normal seed development. Here we show that, unlike known mammalian imprinted genes, MEA regulates its own imprinted expression: It down-regulates the maternal allele around fertilization and maintains the paternal allele silent later during seed development. Autorepression of the maternal MEA allele is direct and independent of the MEA-FIE (FERTILIZATION-INDEPENDENT ENDOSPERM) PcG complex, which is similar to the E(Z)-ESC (Extra sex combs) complex of animals, suggesting a novel mechanism. A complex network of cross-regulatory interactions among the other known members of the MEA-FIE PcG complex implies distinct functions that are dynamically regulated during reproduction.

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

    Science.gov (United States)

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

    2017-05-02

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

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

    Science.gov (United States)

    Djuris, Jelena; Djuric, Zorica

    2017-06-01

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

  17. 40 CFR Appendix A to Part 58 - Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring

    Science.gov (United States)

    2010-07-01

    ... Appendix A to Part 58—Quality Assurance Requirements for SLAMS, SPMs and PSD Air Monitoring 1. General... specifies the minimum quality system requirements applicable to SLAMS air monitoring data and PSD data for... of the air being measured. Monitoring organizations must develop quality assurance project...

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

    Directory of Open Access Journals (Sweden)

    Jason E Duncan

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

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

    Directory of Open Access Journals (Sweden)

    Pritish J Korula

    2017-01-01

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

  20. 40 CFR 63.7188 - What are my monitoring installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... Semiconductor Manufacturing Compliance Requirements § 63.7188 What are my monitoring installation, operation... emissions of your semiconductor process vent through a closed vent system to a control device, you must... evaluation procedure in § 63.7187(i) to demonstrate compliance, you must use the information from the...

  1. 40 CFR Table 6 to Subpart Jjj of... - Requirements for Validating Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 8 2010-07-01 2010-07-01 false Requirements for Validating Continuous Emission Monitoring Systems (CEMS) 6 Table 6 to Subpart JJJ of Part 62 Protection of Environment... Combustion Units Constructed on or Before August 30, 1999 Pt. 62, Subpt. JJJ, Table 6 Table 6 to Subpart JJJ...

  2. 40 CFR Table 7 to Subpart Jjj of... - Requirements for Continuous Emission Monitoring Systems (CEMS) a

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 8 2010-07-01 2010-07-01 false Requirements for Continuous Emission Monitoring Systems (CEMS) a 7 Table 7 to Subpart JJJ of Part 62 Protection of Environment ENVIRONMENTAL... Constructed on or Before August 30, 1999 Pt. 62, Subpt. JJJ, Table 7 Table 7 to Subpart JJJ of Part 62...

  3. 40 CFR 63.996 - General monitoring requirements for control and recovery devices.

    Science.gov (United States)

    2010-07-01

    ... SOURCE CATEGORIES (CONTINUED) National Emission Standards for Closed Vent Systems, Control Devices, Recovery Devices and Routing to a Fuel Gas System or a Process § 63.996 General monitoring requirements for... cycle and the temperature of the carbon bed determined within 15 minutes of the completion of...

  4. 77 FR 59053 - Fisheries of the Exclusive Economic Zone Off Alaska; Monitoring and Enforcement Requirements in...

    Science.gov (United States)

    2012-09-26

    ... the Exclusive Economic Zone Off Alaska; Monitoring and Enforcement Requirements in the Bering Sea and... sampled, or carry one observer and use a motion-compensated scale to weigh Pacific cod before it is....S. groundfish fisheries of the exclusive economic zone off Alaska under the Fishery Management...

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

    Science.gov (United States)

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

    2000-01-01

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

  6. 40 CFR 141.85 - Public education and supplemental monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 22 2010-07-01 2010-07-01 false Public education and supplemental monitoring requirements. 141.85 Section 141.85 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY... lead more than healthy adults. Lead is stored in the bones, and it can be released later in...

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

    Science.gov (United States)

    Yokotsuka, M; Aoyama, M; Kubota, K

    2000-07-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    M.A. Ebadian, Ph.D.

    1999-01-01

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

  9. Memory regulatory T cells require IL-7 and not IL-2 for their maintenance in peripheral tissues1

    Science.gov (United States)

    Gratz, Iris K.; Truong, Hong-An; Yang, Sara Hsin-Yi; Maurano, Megan M.; Lee, Karim; Abbas, Abul K.; Rosenblum, Michael D.

    2013-01-01

    Thymic Foxp3-expressing regulatory T cells are activated by peripheral self antigen to increase their suppressive function, and a fraction of these cells survive as memory Tregs (mTregs). Memory Tregs persist in non-lymphoid tissue after cessation of antigen expression and have enhanced capacity to suppress tissue-specific autoimmunity. Here, we show that murine mTregs express specific effector memory T cell markers and localize preferentially to hair follicles in skin. Memory Tregs express high levels of both IL-2Rα and IL-7Rα. Using a genetic deletion approach, we show that IL-2 is required to generate mTregs from naive CD4+ T cell precursors in vivo. However, IL-2 is not required to maintain these cells in the skin and skin-draining lymph nodes. Conversely, IL-7 is essential for maintaining mTregs in skin in the steady state. These results elucidate the fundamental biology of mTregs and show that IL-7 plays an important role in their survival in skin. PMID:23543753

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1995-04-19

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

  11. Safety system status monitoring

    Energy Technology Data Exchange (ETDEWEB)

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

    1984-03-01

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

  12. FgNoxR, a regulatory subunit of NADPH oxidases, is required for female fertility and pathogenicity in Fusarium graminearum.

    Science.gov (United States)

    Zhang, Chengkang; Lin, Yahong; Wang, Jianqiang; Wang, Yang; Chen, Miaoping; Norvienyeku, Justice; Li, Guangpu; Yu, Wenying; Wang, Zonghua

    2016-01-01

    Fusarium graminearum is a filamentous fungal pathogen that causes wheat Fusarium head blight. In this study, we identified FgNoxR, a regulatory subunit of NADPH oxidases (Nox) in F. graminearum, and found that it plays an important role in the pathogenicity of F. graminearum. FgNoxR is localized on punctate structures throughout the cytoplasm in aerial hyphae while these structures tend to accumulate at or near the plasma membrane, septa and hyphal tips in germinated conidia. Deletion of the FgNOXR gene results in reduced conidiation and germination. Importantly, sexual development is totally abolished in the FgNOXR deletion mutant. In addition, the disease lesion of FgNOXR deletion mutant is limited to the inoculated spikelets of wheat heads. Finally, FgNoxR interacts with FgRac1 and FgNoxA, and all three proteins are required for female fertility. Taken together, our data indicate that FgNoxR contributes to conidiation, sexual reproduction and pathogenesis in F. graminearum.

  13. Condition monitoring requirements for the development of a space nuclear propulsion module

    Science.gov (United States)

    Wagner, Robert C.

    1993-01-01

    To facilitate the development of a space nuclear propulsion module for manned flights to Mars, requirements must be established early in the technology cycle. The long lead times for the acquisition of the engine system and nuclear test facilities demands that the engine system, size, performance, safety goals and condition monitoring philosophy be defined at the earliest possible time. These systems are highly complex and require a large multi-disciplinary systems engineering team to develop and track the requirements and to ensure that the as-built system reflects the intent of the mission. An effective methodology has been devised coupled with sophisticated computer tools to effectivly develop and interpret the functional requirements. These requirements can then be decomposed down to the specification level for implementation. This paper discusses the application of the methodology and the analyses to develop condition monitoring requirements under a contract with the National Aeronautics and Space Administration (NASA) Lewis Research Center (LeRC) Nuclear Propulsion Office (NPO).

  14. Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard.

    Science.gov (United States)

    Ng, Kim-Gau

    2013-10-01

    Standardized protocols for validating the clinical accuracy of noninvasive blood pressure (NIBP) monitors have been available since 1987. Some of them were developed by standards bodies and others by professional organizations. They have been well-tested through use and progressively improved through multiple revisions; however, many methodological differences exist between them. In addition, for the purpose of regulatory approval or marketing clearance, some protocols are recognized in some countries but not in others; thus, manufacturers have to validate their NIBP monitors to more than one protocol in order to market them worldwide. The use of different protocols not only makes it difficult to compare one device with another but also complicates the validation, regulatory approval, marketing, and public acceptance of NIBP monitors, creating undue burden on manufacturers and unnecessary confusion among users. There is a need for protocol developers, standards bodies, and regulatory authorities to work together to develop and agree on a single unified protocol or standard, one that builds on the strengths of the various protocols that have been developed so far. It is apparent that there is already a trend toward convergence of the various protocols into two protocols, namely, the ISO 81060-2:2009 standard and the 2010 European Society of Hypertension International Protocol. With further reconciliation and consensus, it should be possible to integrate the best features of the ISO, European Society of Hypertension, and other protocols, along with further improvements, into a single unified protocol or standard.

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

    Science.gov (United States)

    Lawton, D. C.; Osadetz, K.

    2014-12-01

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

  16. Satellite data acquisition requirements for monitoring of permafrost in polar regions

    Science.gov (United States)

    Bartsch, Annett

    2015-04-01

    Requirements for space based monitoring of permafrost features had been already defined within the IGOS Cryosphere Theme Report at the start of the IPY in 2007 (IGOS, 2007). In 2012 the Polar Space Task Group (PSTG, http://www.wmo.int/pages/prog/sat/pstg_en.php) has been established as the coordinating body of space agencies, in particular the Space Task Group (STG), for space -based observations of Polar Regions after the International Polar Year (IPY) and under the auspices of the World Meteorological Organization's (WMO) Executive Council Panel of Experts on Polar Observations Research and Services (EC-PORS). The PSTG identified the need to review the requirements for permafrost monitoring and to update these requirements as necessary in 2013. Relevant surveys with focus on satellite data are already available from the ESA DUE Permafrost User requirements survey (2009), the United States National Research Council (2014) and the ESA - CliC - IPA - GTN -P workshop in February 2014. These reports have been reviewed and specific needs discussed within the community. Acquisition requirements for monitoring of especially terrain changes (incl. rock glaciers and coastal erosion) and lakes (extent, ice properties etc.) with respect to current satellite missions have been specified. Of special interest for these applications are SAR missions. Current acquisition strategies for space borne SAR data only partially cover polar permafrost regions and some of the longterm in-situ measurement sites. Many stations are located in the proximity to coastal areas and glaciers which to some extent may allow joint usage by different cryosphere applications but requirements may deviate. The results of the discussion are presented in this paper.

  17. A Next Generation Air Monitor: Combining Orion and ISS Requirements for a Common Major Constituent Analyzer

    Science.gov (United States)

    Burchfield, David E.; Tissandier, Michael; Niu, William Hsein-Chi; Lewis, John F.

    2013-01-01

    The Major Constituent Analyzer (MCA) is a mass spectrometer-based instrument designed to provide critical monitoring of six major atmospheric constituents; nitrogen, oxygen, hydrogen, carbon dioxide, methane, and water vapor on-board the International Space Station. The analyzer has been an integral part of the Environmental Control and Life Support System (ECLSS) since the station went on-line. The Orion Air Monitor (OAM) was derived from the MCA and heavily optimized for reduced mass, lower power, faster water vapor response, and maintenance-free operation. The resulting OAM is approximately the size of the analyzer portion of the MCA, orbital-replacement unit 02 (ORU 02), while incorporating the functions of three other modules: Data Processing and Communication (ORU 01), Verification Gas Assembly (ORU 08), and Low Voltage Power Supply (ORU 04). The overlap in MCA and OAM requirements makes it possible to derive a common Air Monitor design that spans both applications while minimally impacting the weight and power limits imposed by the Multipurpose Crew Vehicle (MPCV). Benefits to ISS include the retirement of ORUs 01, 04, and 08, reducing up-mass and eliminating EEE parts obsolescence issues through the extended ISS mission phases. Benefits to MPCV and future deployed habitats under the Constellation program include greater interchangeability across ECLSS subsystems. This paper discusses the results of the requirements development study, where a superset of ISS and Orion air monitoring requirements were distilled; evaluated against increases in OAM functionality, mass, and power; and traded-off where possible using simple operating mode modifications. A system architecture and preliminary design addressing the common requirements will be presented.

  18. Hydrogen Monitoring Requirements in the Global Technical Regulation on Hydrogen and Fuel Cell Vehicles: Preprint

    Energy Technology Data Exchange (ETDEWEB)

    Buttner, William; Rivkin, Carl; Burgess, Robert; Hartmann, Kevin; Bubar, Max; Post, Matthew; Boon-Brett, Lois; Weidner, Eveline; Moretto, Pietro

    2016-07-01

    The United Nations Global Technical Regulation (GTR) Number 13 (Global Technical Regulation on Hydrogen and Fuel Cell Vehicles) is the defining document regulating safety requirements in hydrogen vehicles, and in particular fuel cell electric vehicles (FCEV). GTR Number 13 has been formally implemented and will serve as the basis for the national regulatory standards for FCEV safety in North America (Canada, United States), Japan, Korea, and the European Union. The GTR defines safety requirement for these vehicles, including specifications on the allowable hydrogen levels in vehicle enclosures during in-use and post-crash conditions and on the allowable hydrogen emissions levels in vehicle exhaust during certain modes of normal operation. However, in order to be incorporated into national regulations, that is, in order to be binding, methods to verify compliance to the specific requirements must exist. In a collaborative program, the Sensor Laboratories at the National Renewable Energy Laboratory in the United States and the Joint Research Centre, Institute for Energy and Transport in the Netherlands have been evaluating and developing analytical methods that can be used to verify compliance to the hydrogen release requirement as specified in the GTR.

  19. 40 CFR Table 6 to Subpart Bbbb of... - Model Rule-Requirements for Validating Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 6 2010-07-01 2010-07-01 false Model Rule-Requirements for Validating Continuous Emission Monitoring Systems (CEMS) 6 Table 6 to Subpart BBBB of Part 60 Protection of Environment...—Requirements for Validating Continuous Emission Monitoring Systems (CEMS) For the following continuous...

  20. Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring.

    Science.gov (United States)

    Holzinger, Ulrike; Warszawska, Joanna; Kitzberger, Reinhard; Herkner, Harald; Metnitz, Philipp G H; Madl, Christian

    2009-08-01

    To evaluate the impact of circulatory shock requiring norepinephrine therapy on the accuracy and reliability of a subcutaneous continuous glucose monitoring system (CGMS) in critically ill patients. A prospective, validation study of a medical intensive care unit at a university hospital was carried out. Continuous glucose monitoring was performed subcutaneously in 50 consecutive patients on intensive insulin therapy (IIT), who were assessed according to the a priori strata of circulatory shock requiring norepinephrine therapy or not. A total of 736 pairs of sensor glucose (SG)/blood glucose (BG) values were analysed (502 without and 234 with norepinephrine therapy). For all values, repeated measures Bland-Altman analysis showed a mean difference of 0.08 mmol/l (limits of agreement: -1.26 and 1.43 mmol/l). Circulatory shock requiring norepinephrine therapy did not influence the relation of arterial BG with SG in a multivariable random effects linear regression analysis. The covariates norepinephrine dose, body mass index (BMI), glucose level and severity of illness also had no influence. Insulin titration grid analysis showed that 98.6% of the data points were in the acceptable treatment zone. No data were in the life-threatening zone. Circulatory shock requiring norepinephrine therapy, as well as other covariates, had no influence on the accuracy and reliability of the CGMS in critically ill patients.

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

    Energy Technology Data Exchange (ETDEWEB)

    Peer, Siegfried; Giacomuzzi, Salvatore M.; Peer, Regina; Gassner, Eva; Steingruber, Iris; Jaschke, Werner [Department of Radiology, University Hospital, Anichstrasse 35, 6020 Innsbruck (Austria)

    2003-02-01

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

  2. Yeast sterol regulatory element-binding protein (SREBP) cleavage requires Cdc48 and Dsc5, a ubiquitin regulatory X domain-containing subunit of the Golgi Dsc E3 ligase.

    Science.gov (United States)

    Stewart, Emerson V; Lloyd, S Julie-Ann; Burg, John S; Nwosu, Christine C; Lintner, Robert E; Daza, Riza; Russ, Carsten; Ponchner, Karen; Nusbaum, Chad; Espenshade, Peter J

    2012-01-01

    Schizosaccharomyces pombe Sre1 is a membrane-bound transcription factor that controls adaptation to hypoxia. Like its mammalian homolog, sterol regulatory element-binding protein (SREBP), Sre1 activation requires release from the membrane. However, in fission yeast, this release occurs through a strikingly different mechanism that requires the Golgi Dsc E3 ubiquitin ligase complex and the proteasome. The mechanistic details of Sre1 cleavage, including the link between the Dsc E3 ligase complex and proteasome, are not well understood. Here, we present results of a genetic selection designed to identify additional components required for Sre1 cleavage. From the selection, we identified two new components of the fission yeast SREBP pathway: Dsc5 and Cdc48. The AAA (ATPase associated with diverse cellular activities) ATPase Cdc48 and Dsc5, a ubiquitin regulatory X domain-containing protein, interact with known Dsc complex components and are required for SREBP cleavage. These findings provide a mechanistic link between the Dsc E3 ligase complex and the proteasome in SREBP cleavage and add to a growing list of similarities between the Dsc E3 ligase and membrane E3 ligases involved in endoplasmic reticulum-associated degradation.

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

    Science.gov (United States)

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

    2005-01-01

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

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

    DEFF Research Database (Denmark)

    Kubiak, Christine; de Andres-Trelles, Fernando; Kuchinke, Wolfgang

    2009-01-01

    BACKGROUND: Thorough knowledge of the regulatory requirements is a challenging prerequisite for conducting multinational clinical studies in Europe given their complexity and heterogeneity in regulation and perception across the EU member states. METHODS: In order to summarise the current situation...... with cell therapy, etc.); diagnostic studies; clinical research on nutrition; other interventional clinical research (including trials in complementary and alternative medicine, trials with collection of blood or tissue samples, physiology studies, etc.); and epidemiology studies. Our classification...

  5. 40 CFR Table 7 to Subpart Bbbb of... - Model Rule-Requirements for Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... Emission Monitoring Systems (CEMS) 7 Table 7 to Subpart BBBB of Part 60 Protection of Environment...—Requirements for Continuous Emission Monitoring Systems (CEMS) For the following pollutants Use the following span values for CEMS Use the following performance specifications in appendix B of this part for...

  6. 40 CFR Table 4 to Subpart Ffff of... - Model Rule-Requirements for Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... Emission Monitoring Systems (CEMS) 4 Table 4 to Subpart FFFF of Part 60 Protection of Environment...—Model Rule—Requirements for Continuous Emission Monitoring Systems (CEMS) As stated in § 60.3039, you... CEMS Use the following performance specifications (P.S.) in appendix B of this part for your CEMS...

  7. 40 CFR Table 6 to Subpart Ppp of... - Process Vents From Continuous Unit Operations-Monitoring, Recordkeeping, and Reporting Requirements

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 11 2010-07-01 2010-07-01 true Process Vents From Continuous Unit Operations-Monitoring, Recordkeeping, and Reporting Requirements 6 Table 6 to Subpart PPP of Part 63... Subpart PPP of Part 63—Process Vents From Continuous Unit Operations—Monitoring, Recordkeeping, and...

  8. 40 CFR Table 7 to Subpart Ggg of... - Wastewater-Inspection and Monitoring Requirements for Waste Management Units

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 11 2010-07-01 2010-07-01 true Wastewater-Inspection and Monitoring..., Subpt. GGG, Table 7 Table 7 to Subpart GGG of Part 63—Wastewater—Inspection and Monitoring Requirements...(b)(7)63.1256(b)(8) Inspect wastewater tank for control equipment failures and improper...

  9. 77 FR 39959 - Draft Guidance To Implement Requirements for the Treatment of Air Quality Monitoring Data...

    Science.gov (United States)

    2012-07-06

    ... Air Quality Monitoring Data Influenced by Exceptional Events AGENCY: Environmental Protection Agency... for the Treatment of Air Quality Monitoring Data Influenced by Exceptional Events and associated... Treatment of Air Quality Monitoring Data Influenced by Exceptional Events and associated attachments and...

  10. 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.

  11. 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.

  12. Stochastic modeling to identify requirements for centralized monitoring of distributed wastewater treatment.

    Science.gov (United States)

    Hug, T; Maurer, M

    2012-01-01

    Distributed (decentralized) wastewater treatment can, in many situations, be a valuable alternative to a centralized sewer network and wastewater treatment plant. However, it is critical for its acceptance whether the same overall treatment performance can be achieved without on-site staff, and whether its performance can be measured. In this paper we argue and illustrate that the system performance depends not only on the design performance and reliability of the individual treatment units, but also significantly on the monitoring scheme, i.e. on the reliability of the process information. For this purpose, we present a simple model of a fleet of identical treatment units. Thereby, their performance depends on four stochastic variables: the reliability of the treatment unit, the respond time for the repair of failed units, the reliability of on-line sensors, and the frequency of routine inspections. The simulated scenarios show a significant difference between the true performance and the observations by the sensors and inspections. The results also illustrate the trade-off between investing in reactor and sensor technology and in human interventions in order to achieve a certain target performance. Modeling can quantify such effects and thereby support the identification of requirements for the centralized monitoring of distributed treatment units. The model approach is generic and can be extended and applied to various distributed wastewater treatment technologies and contexts.

  13. Regulatory volume increase in astrocytes exposed to hypertonic medium requires β1 -adrenergic Na(+) /K(+) -ATPase stimulation and glycogenolysis.

    Science.gov (United States)

    Song, Dan; Xu, Junnan; Hertz, Leif; Peng, Liang

    2015-01-01

    The cotransporter of Na(+) , K(+) , 2Cl(-) , and water, NKKC1, is activated under two conditions in the brain, exposure to highly elevated extracellular K(+) concentrations, causing astrocytic swelling, and regulatory volume increase in cells shrunk in response to exposure to hypertonic medium. NKCC1-mediated transport occurs as secondary active transport driven by Na(+) /K(+) -ATPase activity, which establishes a favorable ratio for NKCC1 operation between extracellular and intracellular products of the concentrations of Na(+) , K(+) , and Cl(-) × Cl(-) . In the adult brain, astrocytes are the main target for NKCC1 stimulation, and their Na(+) /K(+) -ATPase activity is stimulated by elevated K(+) or the β-adrenergic agonist isoproterenol. Extracellular K(+) concentration is normal during regulatory volume increase, so this study investigated whether the volume increase occurred faster in the presence of isoproterenol. Measurement of cell volume via live cell microscopic imaging fluorescence to record fluorescence intensity of calcein showed that this was the case at isoproterenol concentrations of ≥1 µM in well-differentiated mouse astrocyte cultures incubated in isotonic medium with 100 mM sucrose added. This stimulation was abolished by the β1 -adrenergic antagonist betaxolol, but not by ICI118551, a β2 -adrenergic antagonist. A large part of the β1 -adrenergic signaling pathway in astrocytes is known. Inhibitors of this pathway as well as the glycogenolysis inhibitor 1,4-dideoxy-1,4-imino-D-arabinitol hydrochloride and the NKCC1 inhibitors bumetanide and furosemide abolished stimulation by isoproterenol, and it was weakened by the Na(+) /K(+) -ATPase inhibitor ouabain. These observations are of physiological relevance because extracellular hypertonicity occurs during intense neuronal activity. This might trigger a regulatory volume increase, associated with the post-excitatory undershoot.

  14. Evaluation of the applicability of existing nuclear power plant regulatory requirements in the U.S. to advanced small modular reactors.

    Energy Technology Data Exchange (ETDEWEB)

    LaChance, Jeffrey L.; Wheeler, Timothy A.; Farnum, Cathy Ottinger; Middleton, Bobby D.; Jordan, Sabina Erteza; Duran, Felicia Angelica; Baum, Gregory A.

    2013-05-01

    The current wave of small modular reactor (SMR) designs all have the goal of reducing the cost of management and operations. By optimizing the system, the goal is to make these power plants safer, cheaper to operate and maintain, and more secure. In particular, the reduction in plant staffing can result in significant cost savings. The introduction of advanced reactor designs and increased use of advanced automation technologies in existing nuclear power plants will likely change the roles, responsibilities, composition, and size of the crews required to control plant operations. Similarly, certain security staffing requirements for traditional operational nuclear power plants may not be appropriate or necessary for SMRs due to the simpler, safer and more automated design characteristics of SMRs. As a first step in a process to identify where regulatory requirements may be met with reduced staffing and therefore lower cost, this report identifies the regulatory requirements and associated guidance utilized in the licensing of existing reactors. The potential applicability of these regulations to advanced SMR designs is identified taking into account the unique features of these types of reactors.

  15. Immunological priming requires regulatory T cells and IL-10-producing macrophages to accelerate resolution from severe lung inflammation.

    Science.gov (United States)

    Aggarwal, Neil R; Tsushima, Kenji; Eto, Yoshiki; Tripathi, Ashutosh; Mandke, Pooja; Mock, Jason R; Garibaldi, Brian T; Singer, Benjamin D; Sidhaye, Venkataramana K; Horton, Maureen R; King, Landon S; D'Alessio, Franco R

    2014-05-01

    Overwhelming lung inflammation frequently occurs following exposure to both direct infectious and noninfectious agents and is a leading cause of mortality worldwide. In that context, immunomodulatory strategies may be used to limit severity of impending organ damage. We sought to determine whether priming the lung by activating the immune system, or immunological priming, could accelerate resolution of severe lung inflammation. We assessed the importance of alveolar macrophages, regulatory T cells, and their potential interaction during immunological priming. We demonstrate that oropharyngeal delivery of low-dose LPS can immunologically prime the lung to augment alveolar macrophage production of IL-10 and enhance resolution of lung inflammation induced by a lethal dose of LPS or by Pseudomonas bacterial pneumonia. IL-10-deficient mice did not achieve priming and were unable to accelerate lung injury resolution. Depletion of lung macrophages or regulatory T cells during the priming response completely abrogated the positive effect of immunological priming on resolution of lung inflammation and significantly reduced alveolar macrophage IL-10 production. Finally, we demonstrated that oropharyngeal delivery of synthetic CpG-oligonucleotides elicited minimal lung inflammation compared with low-dose LPS but nonetheless primed the lung to accelerate resolution of lung injury following subsequent lethal LPS exposure. Immunological priming is a viable immunomodulatory strategy used to enhance resolution in an experimental acute lung injury model with the potential for therapeutic benefit against a wide array of injurious exposures.

  16. A European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development.

    Science.gov (United States)

    Robinson, Sally; Delongeas, Jean-Luc; Donald, Elizabeth; Dreher, David; Festag, Matthias; Kervyn, Sophie; Lampo, Ann; Nahas, Kamil; Nogues, Vicente; Ockert, Deborah; Quinn, Kirsty; Old, Sally; Pickersgill, Nigel; Somers, Kev; Stark, Claudia; Stei, Peter; Waterson, Lynne; Chapman, Kathryn

    2008-04-01

    Regulatory guidelines indicate acute toxicity studies in animals are considered necessary for pharmaceuticals intended for human use. This is the only study type where lethality is mentioned as an endpoint. The studies are carried out, usually in rodents, to support marketing of new drugs and to identify the minimum lethal dose. A European initiative including 18 companies has undertaken an evidence-based review of acute toxicity studies and assessed the value of the data generated. Preclinical and clinical information was shared on 74 compounds. The analysis indicated acute toxicity data was not used to (i) terminate drugs from development (ii) support dose selection for repeat dose studies in animals or (iii) to set doses in the first clinical trials in humans. The conclusion of the working group is that acute toxicity studies are not needed prior to first clinical trials in humans. Instead, information can be obtained from other studies, which are performed at more relevant doses for humans and are already an integral part of drug development. The conclusions have been discussed and agreed with representatives of regulatory bodies from the US, Japan and Europe.

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

    Science.gov (United States)

    Eusebio, Lidia; Capelli, Laura; Sironi, Selena

    2016-09-21

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

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

    Directory of Open Access Journals (Sweden)

    Lidia Eusebio

    2016-09-01

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

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

    Science.gov (United States)

    Eusebio, Lidia; Capelli, Laura; Sironi, Selena

    2016-01-01

    Despite initial enthusiasm towards electronic noses and their possible application in different fields, and quite a lot of promising results, several criticalities emerge from most published research studies, and, as a matter of fact, the diffusion of electronic noses in real-life applications is still very limited. In general, a first step towards large-scale-diffusion of an analysis method, is standardization. The aim of this paper is describing the experimental procedure adopted in order to evaluate electronic nose performances, with the final purpose of establishing minimum performance requirements, which is considered to be a first crucial step towards standardization of the specific case of electronic nose application for environmental odor monitoring at receptors. Based on the experimental results of the performance testing of a commercialized electronic nose type with respect to three criteria (i.e., response invariability to variable atmospheric conditions, instrumental detection limit, and odor classification accuracy), it was possible to hypothesize a logic that could be adopted for the definition of minimum performance requirements, according to the idea that these are technologically achievable. PMID:27657086

  20. Monitoring of radiation exposure

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-02-01

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

  1. Monitoring of radiation exposure

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2000-02-01

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

  2. Environmental monitoring plan

    Energy Technology Data Exchange (ETDEWEB)

    Holland, R.C.

    1997-02-01

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

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

    LENUS (Irish Health Repository)

    Kubiak, Christine

    2009-10-16

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

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

    Directory of Open Access Journals (Sweden)

    Sanz Nuria

    2009-10-01

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

  5. Agonist-Driven Development of CD4+CD25+Foxp3+Regulatory T Cells Requires a Second Signal Mediated by Stat6

    DEFF Research Database (Denmark)

    Sanchez-Guajardo, Vanesa Maria; Tanshot, C.; O'Malley, J.T.

    2007-01-01

    The factors that induce Foxp3 expression and regulatory T (Treg) cell development remain unknown. In this study, we investigated the role of STAT4 and STAT6 in agonist-driven generation of Ag-specific Foxp3-expressing Treg cells. Our findings indicate that fully efficient induction of Foxp3...... expression and development of Ag-specific Treg cells requires the synergistic action of two signals: a TCR-mediated signal and a second signal mediated by STAT6. Indeed, by comparing the development of wild-type and STAT4- and STAT6-deficient hemagglutinin-specific T cells in the presence of hemagglutinin Ag...

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

    Energy Technology Data Exchange (ETDEWEB)

    Kent Norris

    2009-09-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Kent Norris

    2010-03-01

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

  8. The CroRS Two-Component Regulatory System Is Required for Intrinsic β-Lactam Resistance in Enterococcus faecalis

    Science.gov (United States)

    Comenge, Yannick; Quintiliani, Richard; Li, Ling; Dubost, Lionnel; Brouard, Jean-Paul; Hugonnet, Jean-Emmanuel; Arthur, Michel

    2003-01-01

    Enterococcus faecalis produces a specific penicillin-binding protein (PBP5) that mediates high-level resistance to the cephalosporin class of β-lactam antibiotics. Deletion of a locus encoding a previously uncharacterized two-component regulatory system of E. faecalis (croRS) led to a 4,000-fold reduction in the MIC of the expanded-spectrum cephalosporin ceftriaxone. The cytoplasmic domain of the sensor kinase (CroS) was purified and shown to catalyze ATP-dependent autophosphorylation followed by transfer of the phosphate to the mated response regulator (CroR). The croR and croS genes were cotranscribed from a promoter (croRp) located in the rrnC-croR intergenic region. A putative seryl-tRNA synthetase gene (serS) located immediately downstream from croS did not appear to be a target of CroRS regulation or to play a role in ceftriaxone resistance. A plasmid-borne croRp-lacZ fusion was trans-activated by the CroRS system in response to the presence of ceftriaxone in the culture medium. The fusion was also induced by representatives of other classes of β-lactam antibiotics and by inhibitors of early and late steps of peptidoglycan synthesis. The croRS null mutant produced PBP5, and expression of an additional copy of pbp5 under the control of a heterologous promoter did not restore ceftriaxone resistance. Deletion of croRS was not associated with any defect in the synthesis of the nucleotide precursor UDP-MurNAc-pentapeptide or of the d-Ala4→l-Ala-l-Ala-Lys3 peptidoglycan cross-bridge. Thus, the croRS mutant was susceptible to ceftriaxone despite the production of PBP5 and the synthesis of wild-type peptidoglycan precursors. These observations constitute the first description of regulatory genes essential for PBP5-mediated β-lactam resistance in enterococci. PMID:14645279

  9. 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)

  10. A Critical Review of Biosimilars in IBD: The Confluence of Biologic Drug Development, Regulatory Requirements, Clinical Outcomes, and Big Business.

    Science.gov (United States)

    Ha, Christina Y; Kornbluth, Asher

    2016-10-01

    On February 9, 2016, the Food and Drug Administration Arthritis Advisory Committee recommended by a vote of 21 to 3, that the biosimilar to infliximab, CT-P13, be approved for rheumatoid arthritis and ankylosing spondylitis and, by extrapolation, for all the indications for which infliximab is currently approved, including adult and pediatric ulcerative colitis and Crohn's disease. On April 5, 2016, the Food and Drug Administration concurred with this recommendation and approved CT-P13 (Inflectra; Pfizer Inc.) for all diseases for which infliximab had previously been approved, including adult and pediatric moderate to severe ulcerative colitis and pediatric and adult moderate to severe and fistulizing Crohn's disease. This was despite the absence of any randomized controlled trials studying the infliximab biosimilar in any inflammatory bowel disease. This highly controversial approach has been criticized by various rheumatology and gastroenterology professional societies around the world. This review will cover the stepwise approach to biosimilar development, issues of extrapolation and interchangeability, and conclude with a discussion of the regulatory, intellectual property issues, and financial implications, which will all intersect in the decision and ability to prescribe a biosimilar or reference anti-tumor necrosis factor drug.

  11. Patient Reported Outcome (PRO) assessment in epilepsy: a review of epilepsy-specific PROs according to the Food and Drug Administration (FDA) regulatory requirements.

    Science.gov (United States)

    Nixon, Annabel; Kerr, Cicely; Breheny, Katie; Wild, Diane

    2013-03-11

    Despite collection of patient reported outcome (PRO) data in clinical trials of antiepileptic drugs (AEDs), PRO results are not being routinely reported on European Medicines Agency (EMA) and Food and Drug Administration (FDA) product labels. This review aimed to evaluate epilepsy-specific PRO instruments against FDA regulatory standards for supporting label claims. Structured literature searches were conducted in Embase and Medline databases to identify epilepsy-specific PRO instruments. Only instruments that could potentially be impacted by pharmacological treatment, were completed by adults and had evidence of some validation work were selected for review. A total of 26 PROs were reviewed based on criteria developed from the FDA regulatory standards. The ability to meet these criteria was classified as either full, partial or no evidence, whereby partial reflected some evidence but not enough to comprehensively address the FDA regulatory standards. Most instruments provided partial evidence of content validity. Input from clinicians and literature was common although few involved patients in both item generation and cognitive debriefing. Construct validity was predominantly compromised by no evidence of a-priori hypotheses of expected relationships. Evidence for test-retest reliability and internal consistency was available for most PROs although few included complete results regarding all subscales and some failed to reach recommended thresholds. The ability to detect change and interpretation of change were not investigated in most instruments and no PROs had published evidence of a conceptual framework. The study concludes that none of the 26 have the full evidence required by the FDA to support a label claim, and all require further research to support their use as an endpoint. The Subjective Handicap of Epilepsy (SHE) and the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E) have the fewest gaps that would need to be addressed through

  12. Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

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

    1993-07-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Jorde, K.

    1997-12-31

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

  14. Direct interaction of FliX and FlbD is required for their regulatory activity in Caulobacter crescentus

    Directory of Open Access Journals (Sweden)

    Dutton Rachel J

    2011-05-01

    Full Text Available Abstract Background The temporal and spatial expression of late flagellar genes in Caulobacter crescentus is activated by the transcription factor FlbD and its partner trans-acting factor FliX. The physical interaction of these two proteins represents an alternative mechanism for regulating the activity of σ54 transcription factors. This study is to characterize the interaction of the two proteins and the consequences of the interaction on their regulatory activity. Results FliX and FlbD form stable complexes, which can stand the interference of 2.65 M NaCl. The stability of FliX and FlbD was affected by the co-existence of each other. Five FliX mutants (R71A, L85K, Δ117-118, T130L, and L136K were created by site-directed mutagenesis in conserved regions of the protein. All mutants were successfully expressed in both wild-type and ΔfliX Caulobacter strains. All but FliXL85K could rescue the motility and cell division defects of a ΔfliX mutant strain. The ability of FliX to regulate the transcription of class II and class III/IV flagellar promoters was fully diminished due to the L85K mutation. Co-immunoprecipitation experiment revealed that FliXL85K was unable to physically interact with FlbD. Conclusions FliX interacts with FlbD and thereby directly regulates the activity of FlbD in response to flagellar assembly. Mutations in highly conserved regions of FliX could severely affect the recognition between FliX and FlbD and hence interrupt the normal progression of flagellar synthesis and other developmental events in Caulobacter.

  15. Fur is required for the activation of virulence gene expression through the induction of the sae regulatory system in Staphylococcus aureus.

    Science.gov (United States)

    Johnson, Miranda; Sengupta, Mrittika; Purves, Joanne; Tarrant, Emma; Williams, Peter H; Cockayne, Alan; Muthaiyan, Arunachalam; Stephenson, Robert; Ledala, Nagender; Wilkinson, Brian J; Jayaswal, Radheshyam K; Morrissey, Julie A

    2011-01-01

    Our previous studies showed that both Sae and Fur are required for the induction of eap and emp expression in low iron. In this study, we show that expression of sae is also iron-regulated, as sae expression is activated by Fur in low iron. We also demonstrate that both Fur and Sae are required for full induction of the oxidative stress response and expression of non-covalently bound surface proteins in low-iron growth conditions. In addition, Sae is required for the induced expression of the important virulence factors isdA and isdB in low iron. Our studies also indicate that Fur is required for the induced expression of the global regulators Agr and Rot in low iron and a number of extracellular virulence factors such as the haemolysins which are also Sae- and Agr-regulated. Hence, we show that Fur is central to a complex regulatory network that is required for the induced expression of a number of important S. aureus virulence determinants in low iron.

  16. Wireless sensor network for helicopter rotor blade vibration monitoring: Requirements definition and technological aspects

    NARCIS (Netherlands)

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

    2013-01-01

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

  17. 40 CFR 63.11527 - What are the monitoring requirements for new and existing sources?

    Science.gov (United States)

    2010-07-01

    ... paragraph (b)(1) of this section. (4) When operating a CPMS, if the 3-hour average pressure drop or scrubber.... Manufacturer's specifications for pressure drop and liquid flow rate will be used to determine normal... filters—(1) Visual monitoring. You must conduct visual monitoring of the monovent or fabric filter...

  18. 40 CFR Table 4 of Subpart Aaaa to... - Requirements for Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... Monitoring Systems (CEMS) 4 Table 4 of Subpart AAAA to Part 60 Protection of Environment ENVIRONMENTAL... Monitoring Systems (CEMS) For the following pollutants Use the following span values for your CEMS Use the following performance specifications in appendix B of this part for your CEMS If needed to meet...

  19. Regulatory requirements of radiation protection for veterinary nuclear medicine; Strahlenschutzrechtliche Voraussetzungen fuer die Nuklearmedizin in der Tierheilkunde

    Energy Technology Data Exchange (ETDEWEB)

    Ernst-Elz, Andreas [Referat Strahlenschutz, Ministerium fuer Justiz, Gleichstellung und Integration des Landes Schleswig-Holstein, Kiel (Germany)

    2010-03-15

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

  20. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2007-01-01

    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...

  1. 40 CFR 98.344 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ...) of this section, you may use total gaseous organic concentration analyzers and calculate the methane... composition monitor determines CH4 concentration on a dry basis, moisture content. (1) ASME...

  2. 50 CFR 18.118 - What are the mitigation, monitoring, and reporting requirements?

    Science.gov (United States)

    2010-10-01

    ... active seismic-source vessels and/or exploratory drilling operations. No more than four simultaneous... area. Monitors will act as an early detection system in regard to proximate bear activity to...

  3. Agonist-Driven Development of CD4+CD25+Foxp3+Regulatory T Cells Requires a Second Signal Mediated by Stat6

    DEFF Research Database (Denmark)

    Sanchez-Guajardo, Vanesa Maria; Tanshot, C.; O'Malley, J.T.;

    2007-01-01

    The factors that induce Foxp3 expression and regulatory T (Treg) cell development remain unknown. In this study, we investigated the role of STAT4 and STAT6 in agonist-driven generation of Ag-specific Foxp3-expressing Treg cells. Our findings indicate that fully efficient induction of Foxp3...... expression and development of Ag-specific Treg cells requires the synergistic action of two signals: a TCR-mediated signal and a second signal mediated by STAT6. Indeed, by comparing the development of wild-type and STAT4- and STAT6-deficient hemagglutinin-specific T cells in the presence of hemagglutinin Ag...... a role for the STAT6 pathway in Treg cell development and maintenance....

  4. A Slit/miR-218/Robo regulatory loop is required during heart tube formation in zebrafish.

    Science.gov (United States)

    Fish, Jason E; Wythe, Joshua D; Xiao, Tong; Bruneau, Benoit G; Stainier, Didier Y R; Srivastava, Deepak; Woo, Stephanie

    2011-04-01

    Members of the Slit family of secreted ligands interact with Roundabout (Robo) receptors to provide guidance cues for many cell types. For example, Slit/Robo signaling elicits repulsion of axons during neural development, whereas in endothelial cells this pathway inhibits or promotes angiogenesis depending on the cellular context. Here, we show that miR-218 is intronically encoded in slit2 and slit3 and that it suppresses Robo1 and Robo2 expression. Our data indicate that miR-218 and multiple Slit/Robo signaling components are required for heart tube formation in zebrafish and that this network modulates the previously unappreciated function of Vegf signaling in this process. These findings suggest a new paradigm for microRNA-based control of ligand-receptor interactions and provide evidence for a novel signaling pathway regulating vertebrate heart tube assembly.

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

    Science.gov (United States)

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

    2016-04-01

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

  6. Yersinia pestis requires the 2-component regulatory system OmpR-EnvZ to resist innate immunity during the early and late stages of plague.

    Science.gov (United States)

    Reboul, Angéline; Lemaître, Nadine; Titecat, Marie; Merchez, Maud; Deloison, Gaspard; Ricard, Isabelle; Pradel, Elizabeth; Marceau, Michaël; Sebbane, Florent

    2014-11-01

    Plague is transmitted by fleas or contaminated aerosols. To successfully produce disease, the causal agent (Yersinia pestis) must rapidly sense and respond to rapid variations in its environment. Here, we investigated the role of 2-component regulatory systems (2CSs) in plague because the latter are known to be key players in bacterial adaptation to environmental change. Along with the previously studied PhoP-PhoQ system, OmpR-EnvZ was the only one of Y. pestis' 23 other 2CSs required for production of bubonic, septicemic, and pneumonic plague. In vitro, OmpR-EnvZ was needed to counter serum complement and leukocytes but was not required for the secretion of antiphagocyte exotoxins. In vivo, Y. pestis lacking OmpR-EnvZ did not induce an early immune response in the skin and was fully virulent in neutropenic mice. We conclude that, throughout the course of Y. pestis infection, OmpR-EnvZ is required to counter toxic effectors secreted by polymorphonuclear leukocytes in the tissues.

  7. The origin of thymic CD4+CD25+ regulatory T cells and their co-stimulatory requirements are determined after elimination of recirculating peripheral CD4+ cells.

    Science.gov (United States)

    Zhan, Yifan; Bourges, Dorothee; Dromey, James A; Harrison, Leonard C; Lew, Andrew M

    2007-04-01

    Studies on the thymic ontogeny of naturally arising CD4(+)CD25(+) regulatory T cells (TR cells) are complicated by the contamination of recirculating cells from the periphery (both activated CD4(+) T and TR cells). We investigated TR cells in anti-CD4 antibody transgenic (Tg) (GK) mice that continuously deplete peripheral CD4 T cells but not thymocytes so that the generation of thymic TR cells and their developmental requirement can be accurately assessed. We show that in the thymuses of mice that lack peripheral CD4(+) cells, TR cells were present but were fewer in number compared with wild-type (WT) mice. Therefore, we show that peripheral TR cells do re-enter the thymus, comprising 20% of TR cells in the normal thymus. TR cells from both WT and GK mice expressed Foxp3 and GITR, and suppressed the proliferation of CD25(-)CD4(+) T cells. Furthermore, the co-stimulation requirements for TR generation were evaluated in mice with or without peripheral CD4 cells. Splenic TR cells in CD40L(-/-) mice and CTLA4Ig Tg mice were fewer compared with WT mice. Mice deficient in both co-stimulatory pathways had further reduction in splenic TR cells. Unlike the periphery, the reduction in thymic TR cells was only seen for CD40L(-/-) but not for CTLA4Ig Tg mice. Therefore, we found that the co-stimulation requirements for the thymic development of TR cells differed from those for peripheral homeostasis.

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

    Science.gov (United States)

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

    2002-05-01

    Since the introduction of digital flat panel detectors into clinical routine the discussion on monitor specifications for primary soft copy reading has gained new impetus. Major concerns exist for viewing of tiny opacities such as pulmonary nodules. In this study CDRAD phantom images were acquired on a caesium iodid/amorphous silicon detector at varying exposure levels. Images were read three times by three observers on a clinical 1K and 2K monitor workstation. All typical workstation functions such as magnification and window/level setting were applied during image reading. Correct detection ratios were calculated according to the CDRAD evaluation manual. Observer ratings were highest for high dose exposure and 2K monitor reading. No significant difference was detected in the correct detection ratio of observers. However, the difference between the two types of workstations (1K versus 2K monitors) despite less than 3% was significant at a 95% confidence level. This is in good accordance with recently published clinical studies. However, further clinical work will be needed to strengthen this laboratory based impression. Given these subtle differences in low contrast detail detection on 1K and 2K clinical PACS workstation we should probably rethink the recommendations of various national boards for the use of 2K monitors.

  9. The Proteomic Landscape of Human Ex Vivo Regulatory and Conventional T Cells Reveals Specific Metabolic Requirements

    Science.gov (United States)

    Procaccini, Claudio; Carbone, Fortunata; Di Silvestre, Dario; Brambilla, Francesca; De Rosa, Veronica; Galgani, Mario; Faicchia, Deriggio; Marone, Gianni; Tramontano, Donatella; Corona, Marco; Alviggi, Carlo; Porcellini, Antonio; La Cava, Antonio; Mauri, Pierluigi; Matarese, Giuseppe

    2016-01-01

    Summary Human CD4+CD25hiFoxp3+CD127− Treg and CD4+CD25−Foxp3− Tconv cell functions are governed by their metabolic requirements. Here we report a comprehensive comparative analysis between ex vivo human Treg and Tconv cells that comprises analyses of the proteomic networks in subcellular compartments. We identified a dominant proteomic signature at the metabolic level that primarily impacted the highly-tuned balance between glucose and fatty-acid oxidation in the two cell types. Ex vivo Treg cells were highly glycolytic while Tconv cells used predominantly fatty-acid oxidation (FAO). When cultured in vitro, Treg cells engaged both glycolysis and FAO to proliferate, while Tconv cell proliferation mainly relied on glucose metabolism. Our unbiased proteomic analysis provides a molecular picture of the impact of metabolism on ex vivo human Treg versus Tconv cell functions that might be relevant for therapeutic manipulations of these cells. PMID:26885861

  10. 77 FR 35925 - Fisheries of the Exclusive Economic Zone Off Alaska; Monitoring and Enforcement Requirements in...

    Science.gov (United States)

    2012-06-15

    ... conveyor belt in the factory before any sorting or processing was done. As described below, the operations... give an estimate of catch for unsampled sets. The current sampling methodologies produce accurate catch... current observer sampling station inspection and approval regulations or processes. Under both monitoring...

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

    NARCIS (Netherlands)

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

    2007-01-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Herold, Martin [GOFC-GOLD Land Cover Project Office, Department of Earth Observation, Friedrich-Schiller University, Jena 07743 (Germany); Johns, Tracy [Joanneum Research, Institute for Energy Research, Graz 8010 (Austria)

    2007-10-15

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

  13. 40 CFR 63.9804 - What are my monitoring system installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ..., oxidation, and galvanic corrosion. (c) For each pressure CPMS that is used to monitor the pressure drop... where it is easily recognized by plant operating personnel. (6) For positive pressure fabric filter... pressure or induced air fabric filters, the bag leak detector must be installed downstream of the...

  14. 75 FR 43487 - Proposed Information Collection; Comment Request; Vessel Monitoring System Requirements in...

    Science.gov (United States)

    2010-07-26

    ... vessel monitoring system (VMS) units on their vessels when directed to do so by NOAA enforcement personnel. VMS units automatically send periodic reports on the position of the vessel. NOAA uses the..., VMS installation and annual maintenance are considered public burden. This request combines three...

  15. 77 FR 36488 - Proposed Information Collection; Comment Request; Vessel Monitoring System Requirements Under the...

    Science.gov (United States)

    2012-06-19

    ... near real-time satellite-based position-fixing transmitters (``Vessel Monitoring System-VMS-units'') at... must transmit: (1) ``On/off reports'' to NMFS whenever the VMS unit is turned off while the vessel is in port, (2) ``activation reports'' to NMFS prior to the first use of a VMS unit, and (3)...

  16. New Approach to Purging Monitoring Wells: Lower Flow Rates Reduce Required Purging Volumes and Sample Turbidity

    Science.gov (United States)

    It is generally accepted that monitoring wells must be purged to access formation water to obtain “representative” ground water quality samples. Historically anywhere from 3 to 5 well casing volumes have been removed prior to sample collection to evacuate the standing well water...

  17. 40 CFR Table 3 to Subpart Eeee of... - Requirements for Continuous Emission Monitoring Systems (CEMS)

    Science.gov (United States)

    2010-07-01

    ... Monitoring Systems (CEMS) 3 Table 3 to Subpart EEEE of Part 60 Protection of Environment ENVIRONMENTAL... Systems (CEMS) As stated in § 60.2940, you must comply with the following: For the followingpollutants Use the following span values for your CEMS Use the following performance specifications (P.S.)...

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

    NARCIS (Netherlands)

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

    2007-01-01

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

  19. 40 CFR Table 4 to Subpart Ggg of... - Monitoring Requirements for Control Devices a

    Science.gov (United States)

    2010-07-01

    ... a diversion was detected at any time during each hour. 2. Valves sealed closed with car-seal or lock... heater fuel Temperature monitoring device... cycle(s) 1. For each regeneration cycle, record the total regeneration stream mass or volumetric...

  20. 40 CFR Table 3 to Subpart Mmm of... - Monitoring Requirements for Control Devices a

    Science.gov (United States)

    2010-07-01

    .... 2. Valves sealed closed with car-seal or lock-and-key configuration 2. Monthly inspections of sealed... the primary fuel Temperature monitoring device installed in firebox b Combustion temperature Every 15... volumetric flow during carbon bed regeneration cycle(s) 1. For each regeneration cycle, record the...

  1. Stathmin/oncoprotein 18, a microtubule regulatory protein, is required for survival of both normal and cancer cell lines lacking the tumor suppressor, p53.

    Science.gov (United States)

    Carney, Bruce K; Cassimeris, Lynne

    2010-05-01

    Stathmin, a microtubule regulatory protein, is overexpressed in many cancers and required for survival of several cancer lines. In a study of breast cancer cell lines(1) proposed that stathmin is required for survival of cells lacking p53, but this hypothesis was not tested directly. Here we tested their hypothesis by examining cell survival in cells depleted of stathmin, p53 or both proteins. Comparing HCT116 colon cancer cell lines differing in TP53 genotype, stathmin depletion resulted in significant death only in cells lacking p53. As a second experimental system, we compared the effects of stathmin depletion from HeLa cells, which normally lack detectable levels of p53 due to expression of the HPV E6 protein. Stathmin depletion caused a large percentage of HeLa cells to die. Restoring p53, by depletion of HPV E6, rescued HeLa cells from stathmin-depletion induced death. Cleaved PARP was detected in HCT116(p53-/-) cells depleted of stathmin and cell death in stathmin-depleted HeLa cells was blocked by the caspase inhibitor Z-VAD-FMK, consistent with apoptotic death. The stathmin-dependent survival of cells lacking p53 was not confined to cancerous cells because both proteins were required for survival of normal human fibroblasts. In HCT116 and HeLa cells, depletion of both stathmin and p53 leads to a cell cycle delay through G(2). Our results demonstrate that stathmin is required for cell survival in cells lacking p53, suggesting that stathmin depletion could be used therapeutically to induce apoptosis in tumors without functional p53.

  2. 40 CFR 141.563 - What follow-up action is my system required to take based on continuous turbidity monitoring?

    Science.gov (United States)

    2010-07-01

    ... combined filter effluent (CFE) for systems with 2 filters that monitor CFE in lieu of individual filters... consecutive recordings 15 minutes apart at the same filter (or CFE for systems with 2 filters that monitor CFE... as specified in paragraph (c) of this section was required. Systems with 2 filters that monitor CFE...

  3. The experience of family members of ICU patients who require extensive monitoring: a qualitative study.

    Science.gov (United States)

    Smith, Claudia DiSabatino; Custard, Kristi

    2014-09-01

    A mixed methods study using family research with a phenomenological approach (n = 5 families) was conducted to explore family members' perceptions about the extensive monitoring technology used on their critically ill family member after cardiac surgery, as experienced when family members initially visited the patient in the cardiovascular intensive care unit. Five relevant themes emerged: overwhelmed by all of the machines; feelings of uncertainty; methods of coping; meaning of the numbers on the machines; and need for education.

  4. 40 CFR 98.164 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ... requirements in § 98.3(i) of this part. (2) Determine the carbon content and the molecular weight annually of... analysis is required to determine the carbon content and molecular weight of the fuel and feedstock. (3... methods to determine the carbon content for all fuels and feedstocks, and molecular weight of...

  5. NADPH Oxidases NOX-1 and NOX-2 Require the Regulatory Subunit NOR-1 To Control Cell Differentiation and Growth in Neurospora crassa▿ †

    Science.gov (United States)

    Cano-Domínguez, Nallely; Álvarez-Delfín, Karen; Hansberg, Wilhelm; Aguirre, Jesús

    2008-01-01

    We have proposed that reactive oxygen species (ROS) play essential roles in cell differentiation. Enzymes belonging to the NADPH oxidase (NOX) family produce superoxide in a regulated manner. We have identified three distinct NOX subfamilies in the fungal kingdom and have shown that NoxA is required for sexual cell differentiation in Aspergillus nidulans. Here we show that Neurospora crassa NOX-1 elimination results in complete female sterility, decreased asexual development, and reduction of hyphal growth. The lack of NOX-2 did not affect any of these processes but led instead to the production of sexual spores that failed to germinate, even in the presence of exogenous oxidants. The elimination of NOR-1, an ortholog of the mammalian Nox2 regulatory subunit gp67phox, also caused female sterility, the production of unviable sexual spores, and a decrease in asexual development and hyphal growth. These results indicate that NOR-1 is required for NOX-1 and NOX-2 functions at different developmental stages and establish a link between NOX-generated ROS and the regulation of growth. Indeed, NOX-1 was required for the increased asexual sporulation previously observed in mutants without catalase CAT-3. We also analyzed the function of the penta-EF calcium-binding domain protein PEF-1 in N. crassa. Deletion of pef-1 resulted in increased conidiation but, in contrast to what occurs in Dictyostelium discoideum, the mutation of this peflin did not suppress the phenotypes caused by the lack of NOX-1. Our results support the role of ROS as critical cell differentiation signals and highlight a novel role for ROS in regulation of fungal growth. PMID:18567788

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

    Science.gov (United States)

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

    2002-01-01

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

  7. Sunsynchronous low Earth orbit spacecraft concepts and technology requirements for global change monitoring

    Science.gov (United States)

    Garrett, L. Bernard; Butterfield, Ansel J.; Taback, Israel; Garn, Paul A.; Burrowbridge, Donald R., Jr.

    1991-01-01

    The Global Change Technology Initiative listing of instruments for operation in low Earth, sunsynchronous orbits contain 21 entries, of which 20 are carried aboard multi-instrument spacecraft. This list identifies the temporal requirements for repetition of measurements and also includes groups of instruments that make complementing measurements. Definitions for individual spacecraft follows the temporal and grouping requirements to establish constellations which will provide the measurement data. The definitions of constellations for multi-instrument spacecraft show two alternatives: a constellation of 10 spacecraft, each compatible with launch by a Delta booster; a constellation of 4 spacecraft, each requiring a Titan booster. Operating subsystems for the individual spacecraft can use modular concepts that are adaptations based upon current plans for improving the performance of the NASA-Goddard Multimission Modular units. The descriptions of the spacecraft and constellations begins with a compilation of instrument related requirements that define the principal system performance parameters and operating capabilities.

  8. 对MRI系统噪声的法规要求及测试方法%Regulatory Requirements and Testing Methods of MRI Acoustic Noise

    Institute of Scientific and Technical Information of China (English)

    薛廷强; 裴茂增; 何超明

    2014-01-01

    MRI扫描过程中梯度线圈受变化的洛伦茨力作用会产生振动并发出噪声。过高的噪声除了会引起病人不适外,还可能影响成像效果。本文总结并分析了MRI噪声相关的法规要求及相应测试方法,旨在为相关人员客观评估MRI系统的声学噪声特性,确保系统安全,测试相应降噪措施提供参考。%Gradient coil which is subjected to a variational Lorentz force during MRI scanning can cause gradient coil vibration and then produce acoustic noise. Exorbitant acoustic noise can cause discomfort for patients, and also can affect imaging quality. This paper summarized and analyzed the regulatory requirements and corresponding testing methods of MRI acoustic noise in order to provide reference information for relevant staff to objectively evaluate acoustic noise features of MRI system to ensure system safety and test noise reduction measures.

  9. Subunit architecture of the Golgi Dsc E3 ligase required for sterol regulatory element-binding protein (SREBP) cleavage in fission yeast.

    Science.gov (United States)

    Lloyd, S Julie-Ann; Raychaudhuri, Sumana; Espenshade, Peter J

    2013-07-19

    The membrane-bound sterol regulatory element-binding protein (SREBP) transcription factors regulate lipogenesis in mammalian cells and are activated through sequential cleavage by the Golgi-localized Site-1 and Site-2 proteases. The mechanism of fission yeast SREBP cleavage is less well defined and, in contrast, requires the Golgi-localized Dsc E3 ligase complex. The Dsc E3 ligase consists of five integral membrane subunits, Dsc1 through Dsc5, and resembles membrane E3 ligases that function in endoplasmic reticulum-associated degradation. Using immunoprecipitation assays and blue native electrophoresis, we determined the subunit architecture for the complex of Dsc1 through Dsc5, showing that the Dsc proteins form subcomplexes and display defined connectivity. Dsc2 is a rhomboid pseudoprotease family member homologous to mammalian UBAC2 and a central component of the Dsc E3 ligase. We identified conservation in the architecture of the Dsc E3 ligase and the multisubunit E3 ligase gp78 in mammals. Specifically, Dsc1-Dsc2-Dsc5 forms a complex resembling gp78-UBAC2-UBXD8. Further characterization of Dsc2 revealed that its C-terminal UBA domain can bind to ubiquitin chains but that the Dsc2 UBA domain is not essential for yeast SREBP cleavage. Based on the ability of rhomboid superfamily members to bind transmembrane proteins, we speculate that Dsc2 functions in SREBP recognition and binding. Homologs of Dsc1 through Dsc4 are required for SREBP cleavage and virulence in the human opportunistic pathogen Aspergillus fumigatus. Thus, these studies advance our organizational understanding of multisubunit E3 ligases involved in endoplasmic reticulum-associated degradation and fungal pathogenesis.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1994-07-01

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

  11. 40 CFR 63.8600 - What are my monitoring installation, operation, and maintenance requirements?

    Science.gov (United States)

    2010-07-01

    ... Clay Ceramics Manufacturing Testing and Initial Compliance Requirements § 63.8600 What are my....5 inch of water or a transducer with a minimum measurement sensitivity of 1 percent of the pressure... Filter Bag Leak Detection Guidance,” (EPA-454/R-98-015, September 1997). This document is available...

  12. 40 CFR 63.7331 - What are the installation, operation, and maintenance requirements for my monitors?

    Science.gov (United States)

    2010-07-01

    ... pushing emissions, you must install, operate, and maintain CPMS to measure and record the pressure drop... the pressure drop across each multicyclone during each push according to the requirements in... a manner consistent with the guidance document, “Fabric Filter Bag Leak Detection Guidance”...

  13. 40 CFR 63.11092 - What testing and monitoring requirements must I meet?

    Science.gov (United States)

    2010-07-01

    .... Should the Administrator deem the prior test data unacceptable, the facility is still required to meet... suction line, with the measurements displayed on a gauge that can be visually observed. Each carbon bed... valve sequencing, cycle time, gasoline flow, purge air flow, and operating temperatures....

  14. 40 CFR 98.34 - Monitoring and QA/QC requirements.

    Science.gov (United States)

    2010-07-01

    ...) The carbon content and, if applicable, molecular weight of the fuels shall be determined according to... the carbon content and molecular weight of the fuel is required if the necessary equipment is in place... a particular type of fuel, sampling and analysis for carbon content and molecular weight...

  15. Monitoring and control requirement definition study for dispersed storage and generation (DSG). Volume II. Final report, Appendix A: selected DSG technologies and their general control requirements

    Energy Technology Data Exchange (ETDEWEB)

    1980-10-01

    A major aim of the US National Energy Policy, as well as that of the New York State Energy Research and Development Authority, is to conserve energy and to shift from oil to more abundant domestic fuels and renewable energy sources. Dispersed Storage and Generation (DSG) is the term that characterizes the present and future dispersed, relatively small (<30 MW) energy systems, such as solar thermal electric, photovoltaic, wind, fuel cell, storage battery, hydro, and cogeneration, which can help achieve these national energy goals and can be dispersed throughout the distribution portion of an electric utility system. The purpose of this survey and identification of DSG technologies is to present an understanding of the special characteristics of each of these technologies in sufficient detail so that the physical principles of their operation and the internal control of each technology are evident. In this way, a better appreciation can be obtained of the monitoring and control requirements for these DSGs from a remote distribution dispatch center. A consistent approach is being sought for both hardware and software which will handle the monitoring and control necessary to integrate a number of different DSG technologies into a common distribution dispatch network. From this study it appears that the control of each of the DSG technologies is compatible with a supervisory control method of operation that lends itself to remote control from a distribution dispatch center.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1996-10-01

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

  17. Assessment of Unabated Facility Emission Potentials for Evaluating Airborne Radionuclide Monitoring Requirements at Pacific Northwest National Laboratory - 2007

    Energy Technology Data Exchange (ETDEWEB)

    Ballinger, Marcel Y.; Barfuss, Brad C.; Gervais, Todd L.

    2008-01-01

    Assessments were performed to evaluate compliance with the airborne radionuclide emission monitoring requirements in the National Emission Standards for Hazardous Air Pollutants (NESHAP – U.S. Code of Federal Regulations, Title 40, Part 61, Subpart H) and Washington Administrative Code (WAC) 246-247: Radiation Protection – Air Emissions. In these NESHAP assessments, potential unabated offsite doses were evaluated for emission locations at buildings that are part of the consolidated laboratory campus of the Pacific Northwest National Laboratory. This report describes the inventory-based methods and provides the results for the NESHAP assessment performed in 2007.

  18. Assessment of Unabated Facility Emission Potentials for Evaluating Airborne Radionuclide Monitoring Requirements at Pacific Northwest National Laboratory - 2010

    Energy Technology Data Exchange (ETDEWEB)

    Ballinger, Marcel Y.; Gervais, Todd L.; Barnett, J. Matthew

    2011-05-13

    Assessments were performed to evaluate compliance with the airborne radionuclide emission monitoring requirements in the National Emission Standards for Hazardous Air Pollutants ([NESHAP]; U.S. Code of Federal Regulations, Title 40, Part 61, Subpart H) and Washington Administrative Code 246-247: Radiation Protection - Air Emissions. In these NESHAP assessments, potential unabated off-site doses were evaluated for emission locations at buildings that are part of the consolidated laboratory campus of the Pacific Northwest National Laboratory. This report describes the inventory-based methods and provides the results for the NESHAP assessment performed in 2010.

  19. Requirement for safety monitoring for approved multiple sclerosis therapies: an overview.

    Science.gov (United States)

    Rommer, P S; Zettl, U K; Kieseier, B; Hartung, H-P; Menge, T; Frohman, E; Greenberg, B M; Hemmer, B; Stüve, O

    2014-03-01

    During the last two decades, treatment options for patients with multiple sclerosis (MS) have broadened tremendously. All agents that are currently approved for clinical use have potential side effects, and a careful risk-benefit evaluation is part of a decision algorithm to identify the optimal treatment choice for an individual patient. Whereas glatiramer acetate and interferon beta preparations have been used in MS for decades and have a proven safety record, more recently approved drugs appear to be more effective, but potential risks might be more severe. The potential complications of some novel therapies might not even have been identified to their full extent. This review is aimed at the clinical neurologist in that it offers insights into potential adverse events of each of the approved MS therapeutics: interferon beta, glatiramer acetate, mitoxantrone, natalizumab, fingolimod and teriflunomide, as well as recently approved therapeutics such as dimethyl fumarate and alemtuzumab. It also provides recommendations for monitoring the different drugs during therapy in order to avoid common side effects.

  20. Regulatory guidance document

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1994-05-01

    The Office of Civilian Radioactive Waste Management (OCRWM) Program Management System Manual requires preparation of the OCRWM Regulatory Guidance Document (RGD) that addresses licensing, environmental compliance, and safety and health compliance. The document provides: regulatory compliance policy; guidance to OCRWM organizational elements to ensure a consistent approach when complying with regulatory requirements; strategies to achieve policy objectives; organizational responsibilities for regulatory compliance; guidance with regard to Program compliance oversight; and guidance on the contents of a project-level Regulatory Compliance Plan. The scope of the RGD includes site suitability evaluation, licensing, environmental compliance, and safety and health compliance, in accordance with the direction provided by Section 4.6.3 of the PMS Manual. Site suitability evaluation and regulatory compliance during site characterization are significant activities, particularly with regard to the YW MSA. OCRWM`s evaluation of whether the Yucca Mountain site is suitable for repository development must precede its submittal of a license application to the Nuclear Regulatory Commission (NRC). Accordingly, site suitability evaluation is discussed in Chapter 4, and the general statements of policy regarding site suitability evaluation are discussed in Section 2.1. Although much of the data and analyses may initially be similar, the licensing process is discussed separately in Chapter 5. Environmental compliance is discussed in Chapter 6. Safety and Health compliance is discussed in Chapter 7.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-03-15

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

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

    Science.gov (United States)

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

    2013-01-01

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

  3. 40 CFR Table A-1 to Subpart A of... - Summary of Applicable Requirements for Reference and Equivalent Methods for Air Monitoring of...

    Science.gov (United States)

    2010-07-01

    ... Reference and Equivalent Methods for Air Monitoring of Criteria Pollutants A Table A-1 to Subpart A of Part...) AMBIENT AIR MONITORING REFERENCE AND EQUIVALENT METHODS General Provisions Pt. 53, Subpt. A, Table A-1 Table A-1 to Subpart A of Part 53—Summary of Applicable Requirements for Reference and...

  4. Remote monitoring of pipeline operations

    Energy Technology Data Exchange (ETDEWEB)

    Bost, R.C. [ERM-Southwest, Inc., Houston, TX (United States); White, D. [Glenrose Systems, Austin, TX (United States)

    1995-12-31

    The demands for monitoring of pipeline operations have recently increased greatly due to new regulatory requirements. Most companies rely upon conventional System Control and Data Acquisition (SCADA) system architecture to meet their needs. Current systems are often plagued by limited data conversion and processing capacity at the workstations. A state-of-the-art Data Acquisition Node (DAN) that relieves the workstation of much of its workload is described in this paper. Use of this DAN may eliminate the need for installing completely new systems. It facilitates marrying foreign devices to existing operation monitoring systems to satisfy new regulatory requirements. The DAN allows a system to utilize commercial communications satellites or other communication networks and real-time, object oriented programming and different devices and data requirements without the necessity of custom software development.

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

    National Research Council Canada - National Science Library

    Priya Bahri; Julianna Fogd; Daniel Morales; Xavier Kurz

    2017-01-01

    .... Methods To evaluate the utility of media monitoring in real life, prospective real-time monitoring of worldwide online news was conducted from September to December 2015 with inductive content analysis, generating ‘derived questions...

  6. 21 CFR 500.88 - Regulatory method.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Regulatory method. 500.88 Section 500.88 Food and... § 500.88 Regulatory method. (a) The sponsor shall submit for evaluation and validation a regulatory method developed to monitor compliance with FDA's operational definition of no residue. (b)...

  7. Dynamics and control at feedback vertex sets. II: a faithful monitor to determine the diversity of molecular activities in regulatory networks.

    Science.gov (United States)

    Mochizuki, Atsushi; Fiedler, Bernold; Kurosawa, Gen; Saito, Daisuke

    2013-10-21

    Modern biology provides many networks describing regulations between many species of molecules. It is widely believed that the dynamics of molecular activities based on such regulatory networks are the origin of biological functions. However, we currently have a limited understanding of the relationship between the structure of a regulatory network and its dynamics. In this study we develop a new theory to provide an important aspect of dynamics from information of regulatory linkages alone. We show that the "feedback vertex set" (FVS) of a regulatory network is a set of "determining nodes" of the dynamics. The theory is powerful to study real biological systems in practice. It assures that (i) any long-term dynamical behavior of the whole system, such as steady states, periodic oscillations or quasi-periodic oscillations, can be identified by measurements of a subset of molecules in the network, and that (ii) the subset is determined from the regulatory linkage alone. For example, dynamical attractors possibly generated by a signal transduction network with 113 molecules can be identified by measurement of the activity of only 5 molecules, if the information on the network structure is correct. Our theory therefore provides a rational criterion to select key molecules to control a system. We also demonstrate that controlling the dynamics of the FVS is sufficient to switch the dynamics of the whole system from one attractor to others, distinct from the original.

  8. Continuous Glucose Monitoring Analysis as Predictor of Islet Yield and Insulin Requirements in Autologous Islet Transplantation After Complete Pancreatectomy

    Science.gov (United States)

    Georgiev, George Ivanov; Cercone, Renee; Tiwari, Mukesh; Rilo, Horacio L. R.

    2014-01-01

    We analyzed the pretransplant continuous glucose monitoring (CGM) data of 45 patients that underwent total pancreatectomy followed by autologous islet transplantation (AIT) at the University of Arizona Medical Center. Traditional and novel metrics of CGM time series were correlated to the total islet count (TIC), islet equivalents (IEQs), and weight-normalized IEQs (IEQ/kg). In a subset cohort (n = 26) we analyzed the relationship among the infused number of islets, the CGM indicators, and the first recorded insulin requirement after the procedure. We conclude that receiving a high islet yield is sufficient yet not necessary to achieve low or null insulin requirements within the first 50 days after surgery. Furthermore, CGM inertia and CGM length of curve (2 novel CGM indicators) are shown to be correlated to islet yield, and the CGMs normalized area (Ao) and time ratio above hyperglycemic level (To) are strongly correlated to insulin requirement. A screening test based on To is shown to have 100% sensitivity and 88% specificity discriminating insulin independence upon discharge. PMID:25190081

  9. NEW MATERIALS DEVELOPED TO MEET REGULATORY AND TECHNICAL REQUIREMENTS ASSOCIATED WITH IN-SITU DECOMMISSIONING OF NUCLEAR REACTORS AND ASSOCIATED FACILITIES

    Energy Technology Data Exchange (ETDEWEB)

    Blankenship, J.; Langton, C.; Musall, J.; Griffin, W.

    2012-01-18

    For the 2010 ANS Embedded Topical Meeting on Decommissioning, Decontamination and Reutilization and Technology, Savannah River National Laboratory's Mike Serrato reported initial information on the newly developed specialty grout materials necessary to satisfy all requirements associated with in-situ decommissioning of P-Reactor and R-Reactor at the U.S. Department of Energy's Savannah River Site. Since that report, both projects have been successfully completed and extensive test data on both fresh properties and cured properties has been gathered and analyzed for a total of almost 191,150 m{sup 3} (250,000 yd{sup 3}) of new materials placed. The focus of this paper is to describe the (1) special grout mix for filling the P-Reactor vessel (RV) and (2) the new flowable structural fill materials used to fill the below grade portions of the facilities. With a wealth of data now in hand, this paper also captures the test results and reports on the performance of these new materials. Both reactors were constructed and entered service in the early 1950s, producing weapons grade materials for the nation's defense nuclear program. R-Reactor was shut down in 1964 and the P-Reactor in 1991. In-situ decommissioning (ISD) was selected for both facilities and performed as Comprehensive Environmental Response, Compensations and Liability Act actions (an early action for P-Reactor and a removal action for R-Reactor), beginning in October 2009. The U.S. Department of Energy concept for ISD is to physically stabilize and isolate intact, structurally robust facilities that are no longer needed for their original purpose of producing (reactor facilities), processing (isotope separation facilities), or storing radioactive materials. Funding for accelerated decommissioning was provided under the American Recovery and Reinvestment Act. Decommissioning of both facilities was completed in September 2011. ISD objectives for these CERCLA actions included: (1) Prevent

  10. Environmental Monitoring Plan, Revision 6

    Energy Technology Data Exchange (ETDEWEB)

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

    2012-03-02

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

  11. Understanding regulatory networks requires more than computing a multitude of graph statistics. Comment on "Drivers of structural features in gene regulatory networks: From biophysical constraints to biological function" by O.C. Martin et al.

    Science.gov (United States)

    Tkačik, Gašper

    2016-07-01

    The article by O. Martin and colleagues provides a much needed systematic review of a body of work that relates the topological structure of genetic regulatory networks to evolutionary selection for function. This connection is very important. Using the current wealth of genomic data, statistical features of regulatory networks (e.g., degree distributions, motif composition, etc.) can be quantified rather easily; it is, however, often unclear how to interpret the results. On a graph theoretic level the statistical significance of the results can be evaluated by comparing observed graphs to "randomized" ones (bravely ignoring the issue of how precisely to randomize!) and comparing the frequency of appearance of a particular network structure relative to a randomized null expectation. While this is a convenient operational test for statistical significance, its biological meaning is questionable. In contrast, an in-silico genotype-to-phenotype model makes explicit the assumptions about the network function, and thus clearly defines the expected network structures that can be compared to the case of no selection for function and, ultimately, to data.

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

    NARCIS (Netherlands)

    E.N.M. Nolte-'t Hoen (Esther); E.P.J. Boot (Elmieke); J.P.A. Wagenaar-Hilbers (Josée); J.H.M. van Bilsen (Jolanda); G.J.A. Arkesteijn (Ger); G. Storm (Gert); L.A. Everse (Linda); W. van Eden (Willem); M.H.M. Wauben (Marca)

    2008-01-01

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

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

    NARCIS (Netherlands)

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

    2008-01-01

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

  14. Crop Monitoring Based on SPOT-5 Take-5 and Sentinel-1A Data for the Estimation of Crop Water Requirements

    Directory of Open Access Journals (Sweden)

    Ana Navarro

    2016-06-01

    Full Text Available Optical and microwave images have been combined for land cover monitoring in different agriculture scenarios, providing useful information on qualitative and quantitative land cover changes. This study aims to assess the complementarity and interoperability of optical (SPOT-5 Take-5 and synthetic aperture radar (SAR (Sentinel-1A data for crop parameter (basal crop coefficient (Kcb values and the length of the crop’s development stages retrieval and crop type classification, with a focus on crop water requirements, for an irrigation perimeter in Angola. SPOT-5 Take-5 images are used as a proxy of Sentinel-2 data to evaluate the potential of their enhanced temporal resolution for agricultural applications. In situ data are also used to complement the Earth O=observation (EO data. The Normalized Difference Vegetation Index (NDVI and dual (VV + VH polarization backscattering time series are used to compute the Kcb curve for four crop types (maize, soybean, bean and pasture and to estimate the length of each phenological growth stage. The Kcb values are then used to compute the crop’s evapotranspiration and to subsequently estimate the crop irrigation requirements based on a soil water balance model. A significant R2 correlation between NDVI and backscatter time series was observed for all crops, demonstrating that optical data can be replaced by microwave data in the presence of cloud cover. However, it was not possible to properly identify each stage of the crop cycle due to the lack of EO data for the complete growing season.

  15. State of work for services provided by the Waste Sampling and Characterization Facility for effluent monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Gleckler, B.P.

    1995-02-01

    This document defines the services the Waste Sampling and Characterization Facility (WSCF) shall provide Effluent Monitoring (EM) throughout the calendar year for analysis. The internal memo contained in Appendix A identifies the samples Em plans to submit for analysis in CY-1995. Analysis of effluent (liquid and air discharges) and environmental (air, liquid, animal, and vegetative) samples is required using standard laboratory procedures, in accordance with regulatory and control requirements. This report describes regulatory reporting requirements and WSCF services and data quality objectives.

  16. CCDC39 is required for assembly of inner dynein arms and the dynein regulatory complex and for normal ciliary motility in humans and dogs

    DEFF Research Database (Denmark)

    Merveille, Anne-Christine; Davis, Erica E; Becker-Heck, Anita

    2011-01-01

    cilia that are responsible for airway clearance, the flagella that propel sperm cells and the nodal monocilia that determine left-right asymmetry. Recessive mutations that cause PCD have been identified in genes encoding components of the outer dynein arms, radial spokes and cytoplasmic pre...... with axonemal disorganization and abnormal ciliary beating. Functional analyses indicated that CCDC39 localizes to ciliary axonemes and is essential for assembly of inner dynein arms and the dynein regulatory complex....

  17. Sensors for environmental monitoring and long-term environmental stewardship.

    Energy Technology Data Exchange (ETDEWEB)

    Miller, David Russell; Robinson, Alex Lockwood; Ho, Clifford Kuofei; Davis, Mary Jo (Science Applications International Corporation, Albuquerque, NM)

    2004-09-01

    This report surveys the needs associated with environmental monitoring and long-term environmental stewardship. Emerging sensor technologies are reviewed to identify compatible technologies for various environmental monitoring applications. The contaminants that are considered in this report are grouped into the following categories: (1) metals, (2) radioisotopes, (3) volatile organic compounds, and (4) biological contaminants. Regulatory drivers are evaluated for different applications (e.g., drinking water, storm water, pretreatment, and air emissions), and sensor requirements are derived from these regulatory metrics. Sensor capabilities are then summarized according to contaminant type, and the applicability of the different sensors to various environmental monitoring applications is discussed.

  18. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 1: Key ethical requirements and progress toward the definition of an international regulatory framework.

    Science.gov (United States)

    Cozzi, Emanuele; Tallacchini, Mariachiara; Flanagan, Enda B; Pierson, Richard N; Sykes, Megan; Vanderpool, Harold Y

    2009-01-01

    The outstanding results recently obtained in islet xenotransplantation suggest that porcine islet clinical trials may soon be scientifically appropriate. Before the initiation of such clinical studies, however, it is essential that a series of key ethical and regulatory conditions are satisfied. As far as ethics is concerned, the fundamental requirements have been previously reported in a position paper of the Ethics Committee of the International Xenotransplantation Association. These include aspects related to the selection of adequately informed, appropriate recipients; animal breeding and welfare; safety issues and the need for a favorable risk/benefit assessment based on strong efficacy data in relevant xenotransplantation studies in the primate. As most diabetic patients are not at risk of short-term mortality without islet transplantation, only a small subset of patients could currently be considered for any type of islet transplant. However, there are potential advantages to xenotransplantation that could result in a favorable benefit-over-harm determination for islet xenotransplantation in this subpopulation and ultimately in a broader population of diabetic patients. With regard to regulatory aspects, the key concepts underlying the development of the regulatory models in existence in the United States, Europe and New Zealand are discussed. Each of these models provides an example of a well-defined regulatory approach to ensure the initiation of well-regulated and ethically acceptable clinical islet xenotransplantation trials. At this stage, it becomes apparent that only a well-coordinated international effort such as that initiated by the World Health Organization, aimed at harmonizing xenotransplantation procedures according to the highest ethical and regulatory standards on a global scale, will enable the initiation of clinical xenotransplantation trials under the best auspices for its success and minimize any risk of failure.

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

    Directory of Open Access Journals (Sweden)

    Yuta Abe

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

  20. 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....

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

    Science.gov (United States)

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

    2009-06-01

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

  2. Routine Radiological Environmental Monitoring Plan. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Bechtel Nevada

    1999-12-31

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

  3. Current Regulations and Regulatory Actions

    Science.gov (United States)

    This site will provide basic information on clean air permitting under the title V operating permits program, provide access to state and regional permitting programs, and maintain access to proposed and final regulatory requirements.

  4. 40 CFR 63.3968 - What are the requirements for continuous parameter monitoring system installation, operation, and...

    Science.gov (United States)

    2010-07-01

    .... Monitoring failures that are caused in part by poor maintenance or careless operation are not malfunctions... install a device to monitor pressure drop across the zeolite wheel or rotary carbon bed. The pressure... signal simulations or via relative accuracy testing. (v) Conduct an accuracy audit every quarter and...

  5. 40 CFR 63.4168 - What are the requirements for continuous parameter monitoring system installation, operation, and...

    Science.gov (United States)

    2010-07-01

    ... Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) NATIONAL... monitor pressure drop across the zeolite wheel or rotary carbon bed. The pressure monitoring device must... pressure sensor(s) in or as close to a position that provides a representative measurement of the pressure...

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

    Energy Technology Data Exchange (ETDEWEB)

    Jannik, G.T.

    1994-10-01

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

  7. A founder synonymous COL7A1 mutation in three Danish families with dominant dystrophic epidermolysis bullosa pruriginosa identifies exonic regulatory sequences required for exon 87 splicing

    DEFF Research Database (Denmark)

    Covaciu, C; Grosso, F; Pisaneschi, E

    2011-01-01

    a previously unrecognized translationally silent exonic COL7A1 mutation that results in skipping of exon 87 and is associated with DDEB-Pr phenotypes in several members of three apparently unrelated Danish families. A haplotype segregation study suggested a common ancestor in these kindred. Functional splicing...... shoulders. DEB-Pr is caused by either dominant (DDEB-Pr) or recessive mutations in the COL7A1 gene encoding type VII collagen (COLVII). The full spectrum of COL7A1 mutations in DEB-Pr remains elusive and the genotype-phenotype correlation is largely incomplete. Here, we report and functionally characterize...... analysis of the mutant exon by a COL7A1 minigene construct and computational prediction for splicing regulatory cis-sequences prove that the mutation alters the activity of an exonic splicing enhancer (ESE) critical for exon inclusion. These findings substantiate for the first time the involvement...

  8. 40 CFR Table 4 to Subpart G of... - Process Vents-Monitoring, Recordkeeping, and Reporting Requirements For Maintaining a TRE Index...

    Science.gov (United States)

    2010-07-01

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

  9. 40 CFR 60.4237 - What are the monitoring requirements if I am an owner or operator of an emergency stationary SI...

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 6 2010-07-01 2010-07-01 false What are the monitoring requirements if I am an owner or operator of an emergency stationary SI internal combustion engine? 60.4237 Section 60.4237 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) STANDARDS OF PERFORMANCE FOR NEW...

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

    NARCIS (Netherlands)

    de Jong, Kim; de Goede, Marije

    2015-01-01

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

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

    NARCIS (Netherlands)

    de Jong, Kim; de Goede, Marije

    2015-01-01

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

  12. Environmental Monitoring Plan - February 2016

    Energy Technology Data Exchange (ETDEWEB)

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

    2016-02-08

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

  13. Na(+)/H(+) exchange regulatory factor 1 is required for ROMK1 K(+) channel expression in the surface membrane of cultured M-1 cortical collecting duct cells.

    Science.gov (United States)

    Suzuki, Takashi; Nakamura, Kazuyoshi; Mayanagi, Taira; Sobue, Kenji; Kubokawa, Manabu

    2017-07-22

    The ROMK1 K(+) channel, a member of the ROMK channel family, is the major candidate for the K(+) secretion pathway in the renal cortical collecting duct (CCD). ROMK1 possesses a PDZ domain-binding motif at its C-terminus that is considered a modulator of ROMK1 expression via interaction with Na(+)/H(+) exchange regulatory factor (NHERF) 1 and NHERF2 scaffold protein. Although NHERF1 is a potential binding partner of the ROMK1 K(+) channel, the interaction between NHERF1 and K(+) channel activity remains unclear. Therefore, in this study, we knocked down NHERF1 in cultured M-1 cells derived from mouse CCD and investigated the surface expression and K(+) channel current in these cells after exogenous transfection with EGFP-ROMK1. NHERF1 knockdown resulted in reduced surface expression of ROMK1 as indicated by a cell biotinylation assay. Using the patch-clamp technique, we further found that the number of active channels per patched membrane and the Ba(2+)-sensitive whole-cell K(+) current were decreased in the knockdown cells, suggesting that reduced K(+) current was accompanied by decreased surface expression of ROMK1 in the NHERF1 knockdown cells. Our results provide evidence that NHERF1 mediates K(+) current activity through acceleration of the surface expression of ROMK1 K(+) channels in M-1 cells. Copyright © 2017 Elsevier Inc. All rights reserved.

  14. CCDC39 is required for assembly of inner dynein arms and the dynein regulatory complex and for normal ciliary motility in humans and dogs

    Science.gov (United States)

    Merveille, Anne-Christine; Davis, Erica E; Becker-Heck, Anita; Legendre, Marie; Amirav, Israel; Bataille, Géraldine; Belmont, John; Beydon, Nicole; Billen, Frédéric; Clément, Annick; Clercx, Cécile; Coste, André; Crosbie, Rachelle; de Blic, Jacques; Deleuze, Stephane; Duquesnoy, Philippe; Escalier, Denise; Escudier, Estelle; Fliegauf, Manfred; Horvath, Judith; Hill, Kent; Jorissen, Mark; Just, Jocelyne; Kispert, Andreas; Lathrop, Mark; Loges, Niki Tomas; Marthin, June K; Momozawa, Yukihide; Montantin, Guy; Nielsen, Kim G; Olbrich, Heike; Papon, Jean-François; Rayet, Isabelle; Roger, Gilles; Schmidts, Miriam; Tenreiro, Henrique; Towbin, Jeffrey A; Zelenika, Diana; Zentgraf, Hanswalter; Georges, Michel; Lequarré, Anne-Sophie; Katsanis, Nicholas; Omran, Heymut; Amselem, Serge

    2012-01-01

    Primary ciliary dyskinesia (PCD) is an inherited disorder characterized by recurrent infections of the upper and lower respiratory tract, reduced fertility in males and situs inversus in about 50% of affected individuals (Kartagener syndrome). It is caused by motility defects in the respiratory cilia that are responsible for airway clearance, the flagella that propel sperm cells and the nodal monocilia that determine left-right asymmetry1. Recessive mutations that cause PCD have been identified in genes encoding components of the outer dynein arms, radial spokes and cytoplasmic pre-assembly factors of axonemal dyneins, but these mutations account for only about 50% of cases of PCD. We exploited the unique properties of dog populations to positionally clone a new PCD gene, CCDC39. We found that loss-of-function mutations in the human ortholog underlie a substantial fraction of PCD cases with axonemal disorganization and abnormal ciliary beating. Functional analyses indicated that CCDC39 localizes to ciliary axonemes and is essential for assembly of inner dynein arms and the dynein regulatory complex. PMID:21131972

  15. CCDC39 is required for assembly of inner dynein arms and the dynein regulatory complex and for normal ciliary motility in humans and dogs.

    Science.gov (United States)

    Merveille, Anne-Christine; Davis, Erica E; Becker-Heck, Anita; Legendre, Marie; Amirav, Israel; Bataille, Géraldine; Belmont, John; Beydon, Nicole; Billen, Frédéric; Clément, Annick; Clercx, Cécile; Coste, André; Crosbie, Rachelle; de Blic, Jacques; Deleuze, Stephane; Duquesnoy, Philippe; Escalier, Denise; Escudier, Estelle; Fliegauf, Manfred; Horvath, Judith; Hill, Kent; Jorissen, Mark; Just, Jocelyne; Kispert, Andreas; Lathrop, Mark; Loges, Niki Tomas; Marthin, June K; Momozawa, Yukihide; Montantin, Guy; Nielsen, Kim G; Olbrich, Heike; Papon, Jean-François; Rayet, Isabelle; Roger, Gilles; Schmidts, Miriam; Tenreiro, Henrique; Towbin, Jeffrey A; Zelenika, Diana; Zentgraf, Hanswalter; Georges, Michel; Lequarré, Anne-Sophie; Katsanis, Nicholas; Omran, Heymut; Amselem, Serge

    2011-01-01

    Primary ciliary dyskinesia (PCD) is an inherited disorder characterized by recurrent infections of the upper and lower respiratory tract, reduced fertility in males and situs inversus in about 50% of affected individuals (Kartagener syndrome). It is caused by motility defects in the respiratory cilia that are responsible for airway clearance, the flagella that propel sperm cells and the nodal monocilia that determine left-right asymmetry. Recessive mutations that cause PCD have been identified in genes encoding components of the outer dynein arms, radial spokes and cytoplasmic pre-assembly factors of axonemal dyneins, but these mutations account for only about 50% of cases of PCD. We exploited the unique properties of dog populations to positionally clone a new PCD gene, CCDC39. We found that loss-of-function mutations in the human ortholog underlie a substantial fraction of PCD cases with axonemal disorganization and abnormal ciliary beating. Functional analyses indicated that CCDC39 localizes to ciliary axonemes and is essential for assembly of inner dynein arms and the dynein regulatory complex.

  16. 椎间融合器临床试验分组及评价指标注册要求的变化%Change of Regulatory Requirement on Cohort Grouping and Endpoint Seting for Intervertebral Fusion Device Clinical Trail

    Institute of Scientific and Technical Information of China (English)

    郭晓磊

    2015-01-01

    结合国际主流监管机构技术要求与我国监管现状,目前常规的椎间融合器临床试验注册要求发生了简化,颈胸腰椎病患同组试验,并以影像学评价为主,较为合理地向减轻企业负担做出了尝试。%Combining technical requirement from main international administration and status quo of China administration, current regulatory requirement on clinical trail of conventional intervertebral fusion devices has been simplified. Cervical, thoracic and lumbar cases can be grouped into the same cohort, and primary endpoints are mainly based on imageology rather than clinical score. This is an attempt to rational y lessen industrial burdensome.

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

    Science.gov (United States)

    Nolte-'t Hoen, Esther N M; Boot, Elmieke P J; Wagenaar-Hilbers, Josée P A; van Bilsen, Jolanda H M; Arkesteijn, Ger J A; Storm, Gert; Everse, Linda A; van Eden, Willem; Wauben, Marca H M

    2008-01-01

    Major problems in the analysis of CD4+ effector cell and regulatory T cell (Treg) populations in an activated immune system are caused by the facts that both cell types can express CD25 and that the discriminatory marker forkhead box p3 can only be analyzed in nonviable (permeabilized) cells. Here, we show that CD134 (OX40) can be used as a discriminatory marker combined with CD25 to isolate and characterize viable CD4+ effector cells and Tregs. Before and during adjuvant arthritis in rats, coexpression of CD134 and CD25 identified activated Tregs consistently, as these T cells proliferated poorly to disease-associated antigens and were suppressive in vitro and in vivo. Depending on the time of isolation and location, CD4+ T cell populations expressing CD134 or CD25 contained effector/memory T cells. Analysis of the function, phenotype, and amount of the CD4+ T cell subsets in different lymph node stations revealed spatiotemporal differences in effector cell and Treg compartments during experimental arthritis.

  18. A DOE contractor`s perspective of environmental monitoring requirements at a low-level waste facility

    Energy Technology Data Exchange (ETDEWEB)

    Ferns, T.W. [Idaho National Engineering Lab., ID (United States)

    1989-11-01

    Environmental monitoring at a low-level waste disposal facility (LLWDF) should, (1) demonstrate compliance with environmental laws; (2) detect any spatial or temporal environmental changes; and (3) provide information on the potential or actual exposure of humans and/or the environment to disposed waste and/or waste by-products. Under the DOE Order system the LLWDF site manager has more freedom of implementation for a monitoring program than either the semi-prescriptive NRC, or the prescriptive EPA hazardous waste programs. This paper will attempt to compare and contrast environmental monitoring under the different systems (DOE, NRC, and EPA), and determine if the DOE might benefit from a more prescriptive system.

  19. Structural and regulatory elements of HCV NS5B polymerase--β-loop and C-terminal tail--are required for activity of allosteric thumb site II inhibitors.

    Directory of Open Access Journals (Sweden)

    Sarah E Boyce

    Full Text Available Elucidation of the mechanism of action of the HCV NS5B polymerase thumb site II inhibitors has presented a challenge. Current opinion holds that these allosteric inhibitors stabilize the closed, inactive enzyme conformation, but how this inhibition is accomplished mechanistically is not well understood. Here, using a panel of NS5B proteins with mutations in key regulatory motifs of NS5B--the C-terminal tail and β-loop--in conjunction with a diverse set of NS5B allosteric inhibitors, we show that thumb site II inhibitors possess a distinct mechanism of action. A combination of enzyme activity studies and direct binding assays reveals that these inhibitors require both regulatory elements to maintain the polymerase inhibitory activity. Removal of either element has little impact on the binding affinity of thumb site II inhibitors, but significantly reduces their potency. NS5B in complex with a thumb site II inhibitor displays a characteristic melting profile that suggests stabilization not only of the thumb domain but also the whole polymerase. Successive truncations of the C-terminal tail and/or removal of the β-loop lead to progressive destabilization of the protein. Furthermore, the thermal unfolding transitions characteristic for thumb site II inhibitor-NS5B complex are absent in the inhibitor-bound constructs in which interactions between C-terminal tail and β-loop are abolished, pointing to the pivotal role of both regulatory elements in communication between domains. Taken together, a comprehensive picture of inhibition by compounds binding to thumb site II emerges: inhibitor binding provides stabilization of the entire polymerase in an inactive, closed conformation, propagated via coupled interactions between the C-terminal tail and β-loop.

  20. Risk Informed Assessment of Regulatory and Design Requirements for Future Nuclear Power Plants (Cooperative Agreement DE-FC03-99SF21902, Am. M004) Final Technical Report

    Energy Technology Data Exchange (ETDEWEB)

    Stanley E. Ritterbusch, et. al.

    2003-01-29

    '' were evaluated. It is expected that design basis accidents would be an inherent part of the Probabilistic Safety Assessment for the plant and their evaluation would be probabilistic. Other first year accomplishments include (1) the conversion of an NRC database for cross-referencing NRC criteria and industry codes and standards to Microsoft 2000 software, (2) an assessment of the NRC's hearing process which concluded that the normal cross-examination during public hearings is not actually required by the U.S. Administrative Procedures Act, (3) the identification and listing of reliability data sources, and (4) interfacing with other industry groups (e.g., NEI and IAEA) and NRC at workshops for risk-informing regulations. The major accomplishments during the second year consisted of (1) issuance of the final report for Subtask 1.1, ''Identify Current Applicable Regulatory Requirements [and Industry Standards],'' (2) issuance of the final report for Subtask 1.2,'' Identify Structures, Systems, and Components and Their Associate d Costs for a Typical Plant,'' (3) extension of the new, highly risk-informed design and regulatory framework to non-light-water-reactor technology, (4) completion of more detailed thermal-hydraulic and probabilistic analyses of advanced conceptual reactor system/component designs, (6) initial evaluation and recommendations for improvement of the NRC design review process, and (7) initial development of the software format, procedures and statistical routines needed to store, analyze and retrieve the available reliability data. Final reports for Subtasks 1.1 (regulatory and design criteria) and 1.2 (costs for structures, systems, and components) were prepared and issued. A final report for Subtask 1.3 (Regulatory Framework) was drafted with the aim to issue it in Phase 3 (Year 3). One technical report was produced for Subtask 1.4 (methods development) and two technical reports were produced for Subtask

  1. Regulatory control of genetically modified (GM) foods: likely developments.

    Science.gov (United States)

    Schilter, Benoît; Constable, Anne

    2002-02-28

    The placing of genetically modified (GM) crops on the European market requires a regulatory approval supported by a thorough safety evaluation. This approach has been applied to all GM crops presently on the market. Despite this stringent process there has been an increasing public concern about the impact of GM foods on human health and the environment. In this context, regulatory control may develop in several directions. One response to the public concern is to strengthen the data requirements for the risk assessment process. Several avenues have been proposed. They include the application of technologies such as proteomics and metabolomics to assess unintended changes, and the development of predictive methods to evaluate allergenicity. Obligations for post-launch surveillance have appeared in regulations. Criteria are required to define when and why such approaches are necessary. Significant challenges including feasibility and validation of the methods, and safety relevance of the data generated will have to be addressed before any general application of these new approaches. Effective monitoring requires the ability to identify the presence of GM products and trace their origin. Traceability and labeling are therefore important developments in the GM food regulatory arena. Both require the development of reliable analytical detection tools.

  2. 40 CFR Table 5 to Subpart Ppp of... - Process Vents From Batch Unit Operations-Monitoring, Recordkeeping, and Reporting Requirements

    Science.gov (United States)

    2010-07-01

    ... Hazardous Air Pollutant Emissions for Polyether Polyols Production Pt. 63, Subpt. PPP, Table 5 Table 5 to... all instances when monitoring data are not collected—PR. d,e If a base absorbent is used, report all pH values that are below the minimum operating values. If an acid absorbent is used, report all...

  3. 40 CFR 63.4568 - What are the requirements for continuous parameter monitoring system installation, operation, and...

    Science.gov (United States)

    2010-07-01

    ... caused in part by poor maintenance or careless operation are not malfunctions. Any period for which the... install a device to monitor pressure drop across the zeolite wheel or rotary carbon bed. The pressure... simulations or via relative accuracy testing. (v) Conduct an accuracy audit every quarter and after every...

  4. Department of Labor Needs to Give CETA Prime Sponsors More Guidance and Assistance for Implementing Monitoring Requirements.

    Science.gov (United States)

    1981-09-03

    minimun the IMUs’ yearly monitoring plan must include 15 areas of emphasis. (See enc. I.) The letter recommended a minimum of one comprehensive...Financial management 8. Allowance payment system 9. Participant wages and benefits 10. Client tracking system 11. Complaint/grievance procedure * 12

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

    NARCIS (Netherlands)

    Proost, J. H.

    2007-01-01

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

  6. 40 CFR Table 11 to Subpart G of... - Wastewater-Inspection and Monitoring Requirements for Waste Management Units

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 9 2010-07-01 2010-07-01 false Wastewater-Inspection and Monitoring... Operations, and Wastewater Pt. 63, Subpt. G, Table 11 Table 11 to Subpart G of Part 63—Wastewater—Inspection... wastewater tank for control equipment failures and improper work practices Initially Semi-annually...

  7. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

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

    1994-02-28

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

  8. Dsc E3 ligase localization to the Golgi requires the ATPase Cdc48 and cofactor Ufd1 for activation of Sterol Regulatory Element-binding Protein in fission yeast.

    Science.gov (United States)

    Burr, Risa; Ribbens, Diedre; Raychaudhuri, Sumana; Stewart, Emerson V; Ho, Jason; Espenshade, Peter J

    2017-08-18

    Sterol regulatory element-binding proteins (SREBPs) in the fission yeast Schizosaccharomyces pombe regulate lipid homeostasis and the hypoxic response under conditions of low sterol or oxygen availability. SREBPs are cleaved in the Golgi through the combined action of the Dsc E3 ligase complex, the rhomboid protease Rbd2, and the essential ATPases Associated with diverse cellular Activities (AAA+) ATPase Cdc48. The soluble SREBP N-terminal transcription factor domain is then released in the cytosol to enter the nucleus and regulate gene expression. Previously, we reported that Cdc48 binding to Rbd2 is required for Rbd2-mediated SREBP cleavage. Here, using affinity chromatography and mass spectrometry experiments, we identified Cdc48-binding proteins in S. pombe, generating a list of many previously unknown potential Cdc48 binding partners. We show that the established Cdc48 cofactor Ufd1 is required for SREBP cleavage but does not interact with the Cdc48-Rbd2 complex. Cdc48-Ufd1 is instead required at a step prior to Rbd2 function, during Golgi localization of the Dsc E3 ligase complex. Together, these findings demonstrate that two distinct Cdc48 complexes - Cdc48-Ufd1 and Cdc48-Rbd2 - are required for SREBP activation and low-oxygen adaptation in S. pombe. Copyright © 2017, The American Society for Biochemistry and Molecular Biology.

  9. SafeLand guidelines for landslide monitoring and early warning systems in Europe - Design and required technology

    Science.gov (United States)

    Bazin, S.

    2012-04-01

    Landslide monitoring means the comparison of landslide characteristics like areal extent, speed of movement, surface topography and soil humidity from different periods in order to assess landslide activity. An ultimate "universal" methodology for this purpose does not exist; every technology has its own advantages and disadvantages. End-users should carefully consider each one to select the methodologies that represent the best compromise between pros and cons, and are best suited for their needs. Besides monitoring technology, there are many factors governing the choice of an Early Warning System (EWS). A people-centred EWS necessarily comprises five key elements: (1) knowledge of the risks; (2) identification, monitoring, analysis and forecasting of the hazards; (3) operational centre; (4) communication or dissemination of alerts and warnings; and (5) local capabilities to respond to the warnings received. The expression "end-to-end warning system" is also used to emphasize that EWSs need to span all steps from hazard detection through to community response. The aim of the present work is to provide guidelines for establishing the different components for landslide EWSs. One of the main deliverables of the EC-FP7 SafeLand project addresses the technical and practical issues related to monitoring and early warning for landslides, and identifies the best technologies available in the context of both hazard assessment and design of EWSs. This deliverable targets the end-users and aims to facilitate the decision process by providing guidelines. For the purpose of sharing the globally accumulated expertise, a screening study was done on 14 EWSs from 8 different countries. On these bases, the report presents a synoptic view of existing monitoring methodologies and early-warning strategies and their applicability for different landslide types, scales and risk management steps. Several comprehensive checklists and toolboxes are also included to support informed

  10. 78 FR 76973 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

    Science.gov (United States)

    2013-12-20

    ... #0; Federal Register #0; #0; #0;This section of the FEDERAL REGISTER contains regulatory documents #0..., and 225 Regulations H, Q, and Y RIN 7100-AD 87 Regulatory Capital Rules: Regulatory Capital... Approach for Risk-Weighted Assets, Market Discipline and Disclosure Requirements, Advanced Approaches...

  11. A review of the UK methodology used for monitoring cigarette smoke yields, aspects of analytical data variability and their impact on current and future regulatory compliance.

    Science.gov (United States)

    Purkis, Stephen W; Drake, Linda; Meger, Michael; Mariner, Derek C

    2010-04-01

    The European Union (EU) requires that tobacco products are regulated by Directive 2001/37/EC through testing and verification of results on the basis of standards developed by the International Organization for Standardization (ISO). In 2007, the European Commission provided guidance to EU Member States by issuing criteria for competent laboratories which includes accreditation to ISO 17025:2005. Another criterion requires regular laboratory participation in collaborative studies that predict the measurement tolerance that must be observed to conclude that test results on any particular product are different. However, differences will always occur when comparing overall data across products between different laboratories. A forum for technical discussion between laboratories testing products as they are manufactured and a Government appointed verification laboratory gives transparency, ensures consistency and reduces apparent compliance issues to the benefit of all parties. More than 30years ago, such a forum was set up in the UK that continued until 2007 and will be described in this document. Anticipating further testing requirements in future product regulation as proposed by the Framework Convention on Tobacco Control, cooperation between accredited laboratories, whether for testing or verification, should be established to share know-how, to ensure a standardised level of quality and to offer competent technical dialogue in the best interest of regulators and manufacturers alike.

  12. Idaho National Laboratory Site Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Jenifer Nordstrom

    2014-02-01

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

  13. 78 FR 1646 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2013-01-08

    ...; Organizational Conflicts of Interest. 416 FAR Case 2010-013, Privacy 9000-AM02 Training. 417 Federal Acquisition...: Action Date FR Cite NPRM 12/00/12 Regulatory Flexibility Analysis Required: Yes. Agency Contact: Edward.... L. 110-417). Timetable: Action Date FR Cite NPRM 04/00/13 Regulatory Flexibility Analysis Required...

  14. GROUNDWATER MONITORING REPORT GENERATION TOOLS - 12005

    Energy Technology Data Exchange (ETDEWEB)

    Lopez, N.

    2011-11-21

    Compliance with National and State environmental regulations (e.g. Resource Conservation and Recovery Act (RCRA) and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) aka SuperFund) requires Savannah River Site (SRS) to extensively collect and report groundwater monitoring data, with potential fines for missed reporting deadlines. Several utilities have been developed at SRS to facilitate production of the regulatory reports which include maps, data tables, charts and statistics. Components of each report are generated in accordance with complex sets of regulatory requirements specific to each site monitored. SRS developed a relational database to incorporate the detailed reporting rules with the groundwater data, and created a set of automation tools to interface with the information and generate the report components. These process improvements enhanced quality and consistency by centralizing the information, and have reduced manpower and production time through automated efficiencies.

  15. Environmental Monitoring Plan, Revision 5

    Energy Technology Data Exchange (ETDEWEB)

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

    2010-01-27

    The purpose of environmental monitoring is to promote the early identification of, and response to, potential adverse environmental impacts associated with Lawrence Livermore National Laboratory (LLNL) operations. Environmental monitoring supports the Integrated Safety Management System (ISMS), International Organization for Standardization (ISO) 14001 Environmental Management Systems standard, and U. S. Department of Energy (DOE) Order 450.1A, Environmental Protection Program. Specifically, in conformance with DOE Order 450.1A, Attachment 1, paragraph 1(b)(5), environmental monitoring enables LLNL to detect, characterize, and respond to releases from LLNL activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the biota in the vicinity of LLNL. Environmental monitoring also serves to demonstrate compliance with permits and other regulatory requirements. The Environmental Monitoring Plan (EMP) addresses the sample collection and analytical work supporting environmental monitoring to ensure the following: (1) A consistent system for collecting, assessing, and documenting environmental data of known and documented quality. (2) A validated and consistent approach for sampling and analysis of samples to ensure laboratory data meets program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work. (3) An integrated sampling approach to avoid duplicative data collection. Until its cancellation in January 2003, DOE Order 5400.1 required the preparation of an environmental monitoring plan. Neither DOE Order 450.1A nor the ISO 14001 standard are as prescriptive as DOE Order 5400.1, in that neither expressly requires an EMP. However, LLNL continues to prepare the EMP because it provides an organizational framework for

  16. 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).

  17. Data acquisition for low-temperature geothermal well tests and long-term monitoring. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Lienau, P.J.

    1992-09-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Lienau, P.J.

    1992-09-01

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

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

    Energy Technology Data Exchange (ETDEWEB)

    Lienau, P.J.

    1992-03-01

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

  20. ISO 13485:2016标准全面融入我国医疗器械法规解读与分析%Interpretation and Analysis on Fully Incorporating Applicable Regulatory Requirements of Medical Devices in China within ISO13485:2016

    Institute of Scientific and Technical Information of China (English)

    李欣

    2016-01-01

    本文结合我国医疗器械法规体系,解读分析了如何在标准实施过程中全面融入相关法规要求。%This paper Interpretates and analysizes on how to ful y incorporate relevant regulatory requirements within implementation process of ISO13485:2016 by Combining with the medical device regulatory system in china.

  1. 42 CFR 495.316 - State monitoring and reporting regarding activities required to receive an incentive payment.

    Science.gov (United States)

    2010-10-01

    ...) Provider adoption, implementation, or upgrade of certified EHR technology activities and payments; and (2... upgraded certified EHR technology. (ii) Aggregated data tables representing the provider adoption... STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM Requirements Specific to...

  2. The proprotein convertase encoded by amontillado (amon) is required in Drosophila corpora cardiaca endocrine cells producing the glucose regulatory hormone AKH.

    Science.gov (United States)

    Rhea, Jeanne M; Wegener, Christian; Bender, Michael

    2010-05-27

    Peptide hormones are potent signaling molecules that coordinate animal physiology, behavior, and development. A key step in activation of these peptide signals is their proteolytic processing from propeptide precursors by a family of proteases, the subtilisin-like proprotein convertases (PCs). Here, we report the functional dissection of amontillado (amon), which encodes the Drosophila homolog of the mammalian PC2 protein, using cell-type specific inactivation and rescue experiments, and we show that amon is required in the islet-like adipokinetic hormone (AKH)-producing cells that regulate sugar homeostasis. In Drosophila, AKH acts analogously to vertebrate glucagon to increase circulating sugar levels from energy stores, while insulin-like peptides (DILPs) act to decrease sugar levels. amon mutant larvae have significantly reduced hemolymph sugar levels, and thus phenocopy larvae where the AKH-producing cells in the corpora cardiaca have been ablated. Reduction of amon expression in these cells via cell-specific RNA inactivation also results in larvae with reduced sugar levels while expression of amon in AKH cells in an amon mutant background rescues hypoglycemia. Hypoglycemia in larvae resulting from amon RNA inactivation in the AKH cells can be rescued by global expression of the akh gene. Finally, mass spectrometric profiling shows that the production of mature AKH is inhibited in amon mutants. Our data indicate that amon function in the AKH cells is necessary to maintain normal sugar homeostasis, that amon functions upstream of akh, and that loss of mature AKH is correlated with loss of amon activity. These observations indicate that the AKH propeptide is a proteolytic target of the amon proprotein convertase and provide evidence for a conserved role of PC2 in processing metabolic peptide hormones.

  3. Department of Commerce Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... Shrimp Kicker to improve shrimp retention. Timetable: Action Date FR Cite NPRM 05/00/11 Regulatory... camera and other sensors to monitor fishing activity in order to maintain the integrity of the maximized... observers to monitor on board the mothership processors and thereby maintains the integrity of data...

  4. NASA's Agency-wide Strategy for Environmental Regulatory Risk Analysis and Communication

    Science.gov (United States)

    Duda, Kristen; Scroggins. Sharon

    2008-01-01

    NASA's mission is to pioneer the future in space exploration, scientific discovery, and aeronautics research. To help enable existing and future programs to pursue this mission, NASA has established the Principal Center for Regulatory Risk Analysis and Communication (RRAC PC) to proactively identify, analyze, and communicate environmental regulatory risks to the NASA community. The RRAC PC is chartered to evaluate the risks posed to NASA Programs and facilities by environmentally related drivers. The RRAC PC focuses on emerging environmental regulations, as well as risks related to operational changes that can trigger existing environmental requirements. Changing regulations have the potential to directly affect program activities. For example, regulatory changes can restrict certain activities or operations by mandating changes in how operations may be done or limiting where or how certain operations can take place. Regulatory changes also can directly affect the ability to use certain materials by mandating a production phase-out or restricting usage aPi'iications of certain materials. Such changes can result in NASA undertaking material replacement efforts. Even if a regulation does not directly affect NASA operations, U.S. and international regulations can pose program risks indirectly through requirements levied on manufacturers and vendors of components and materials. For example, manufacturers can change their formulations to comply with new regulatory requirements. Such changes can require time-consuming and costly requalification certification for use in human spaceflight programs. The RRAC PC has implemented several strategies for proactively managing regulatory change to minimize potential adverse impacts to NASA Programs and facilities. This presentation highlights the lessons learned through establishing the RRAC PC, the process by which the RRAC PC monitors and distributes information about emerging regulatory requirements, and the cross

  5. 40 CFR 60.4345 - What are the requirements for the continuous emission monitoring system equipment, if I choose to...

    Science.gov (United States)

    2010-07-01

    ... choose to use this option? If the option to use a NOX CEMS is chosen: (a) Each NOX diluent CEMS must be..., Procedure 1 in appendix F to this part is not required. Alternatively, a NOX diluent CEMS that is installed... subpart. The relative accuracy test audit (RATA) of the CEMS shall be performed on a lb/MMBtu basis....

  6. Mis17 is a regulatory module of the Mis6-Mal2-Sim4 centromere complex that is required for the recruitment of CenH3/CENP-A in fission yeast.

    Directory of Open Access Journals (Sweden)

    Yoshiharu Shiroiwa

    Full Text Available BACKGROUND: The centromere is the chromosome domain on which the mitotic kinetochore forms for proper segregation. Deposition of the centromeric histone H3 (CenH3, CENP-A is vital for the formation of centromere-specific chromatin. The Mis6-Mal2-Sim4 complex of the fission yeast S. pombe is required for the recruitment of CenH3 (Cnp1, but its function remains obscure. METHODOLOGY/PRINCIPAL FINDINGS: Mass spectrometry was performed on the proteins precipitated with Mis6- and Mis17-FLAG. The results together with the previously identified Sim4- and Mal2-TAP precipitated proteins indicated that the complex contains 12 subunits, Mis6, Sim4, Mal2, Mis15, Mis17, Cnl2, Fta1-4, Fta6-7, nine of which have human centromeric protein (CENP counterparts. Domain dissection indicated that the carboxy-half of Mis17 is functional, while its amino-half is regulatory. Overproduction of the amino-half caused strong negative dominance, which led to massive chromosome missegregation and hypersensitivity to the histone deacetylase inhibitor TSA. Mis17 was hyperphosphorylated and overproduction-induced negative dominance was abolished in six kinase-deletion mutants, ssp2 (AMPK, ppk9 (AMPK, ppk15 (Yak1, ppk30 (Ark1, wis4 (Ssk2, and lsk1 (P-TEFb. CONCLUSIONS: Mis17 may be a regulatory module of the Mis6 complex. Negative dominance of the Mis17 fragment is exerted while the complex and CenH3 remain at the centromere, a result that differs from the mislocalization seen in the mis17-362 mutant. The known functions of the kinases suggest an unexpected link between Mis17 and control of the cortex actin, nutrition, and signal/transcription. Possible interpretations are discussed.

  7. Requirements and Implementation Feasibility for a CubeSat Thermal Infrared Imaging System to Monitor the Structure of Volcanic Ash Clouds

    Science.gov (United States)

    Thorsen, D.; Carroll, R.; Webley, P.; Hawkins, J.

    2014-12-01

    The 2010 eruption of the Eyjafjallajökull volcano in Iceland caused the cancellation of approximately 108,000 flights over an 8-day period, disrupted air traffic worldwide, and cost the airline industry more than $400 million per day. The inconvenience and economic impact of this and similar events, such as Puyehue-Cordon-Caulle in 2011, have heightened the interest in developing improved satellite remote sensing techniques for monitoring volcanic plumes and drifting clouds. For aviation safety, the operational/research community has started to move towards classifying the concentrations within volcanic plumes and clouds. Additionally, volcanic ash transport and dispersion (VATD) models are often used for forecasting ash cloud locations and they require knowledge of the structure of the erupting column to improve their ash simulations and also downwind 3-D maps of the ash cloud to calibrate/validate their modeling output. Existing remote sensing satellites utilize a brightness temperature method with thermal infrared (TIR) measurements from 10 - 12 μm to determine mass loading of volcanic ash along a single line of sight, but they have infrequent revisit times and they cannot resolve the three-dimensional structure of the ash clouds. A cluster of CubeSats dedicated to the monitoring of volcanic ash and plumes could provide both more frequent updates and the multi-aspect images needed to resolve the density structure of volcanic ash clouds and plumes. In this presentation, we discuss the feasibility and requirements for a CubeSat TIR imaging system and the associated on-board image processing that would be required to monitor the structure of volcanic ash clouds from Low Earth Orbit.

  8. Remote sensing in precision farming: real-time monitoring of water and fertilizer requirements of agricultural crops

    Science.gov (United States)

    Zilberman, Arkadi; Ben Asher, Jiftah; Kopeika, Norman S.

    2016-10-01

    The advancements in remote sensing in combination with sensor technology (both passive and active) enable growers to analyze an entire crop field as well as its local features. In particular, changes of actual evapo-transpiration (ET) as a function of water availability can be measured remotely with infrared radiometers. Detection of crop water stress and ET and combining it with the soil water flow model enable rational irrigation timing and application amounts. Nutrient deficiency, and in particular nitrogen deficiency, causes substantial crop losses. This deficiency needs to be identified immediately. A faster the detection and correction, a lesser the damage to the crop yield. In the present work, to retrieve ET a novel deterministic approach was used which is based on the remote sensing data. The algorithm can automatically provide timely valuable information on plant and soil water status, which can improve the management of irrigated crops. The solution is capable of bridging between Penman-Monteith ET model and Richards soil water flow model. This bridging can serve as a preliminary tool for expert irrigation system. To support decisions regarding fertilizers the greenness of plant canopies is assessed and quantified by using the spectral reflectance sensors and digital color imaging. Fertilization management can be provided on the basis of sampling and monitoring of crop nitrogen conditions using RS technique and translating measured N concentration in crop to kg/ha N application in the field.

  9. Around-the-clock ambulatory blood pressure monitoring is required to properly diagnose resistant hypertension and assess associated vascular risk.

    Science.gov (United States)

    Hermida, Ramón C; Ayala, Diana E; Ríos, María T; Fernández, José R; Mojón, Artemio; Smolensky, Michael H

    2014-07-01

    Diagnosis of resistant hypertension (RH) is currently based upon awake-time office blood pressure (BP). An increasing number of studies have documented abnormally elevated sleep-time BP in most RH patients, indicating that diagnosis of true RH cannot be determined solely by comparison of office BP with either patient awake-time BP self-measurements or awake-BP mean from ambulatory monitoring (ABPM), as is customary in the published literature. Moreover, the ABPM-determined sleep-time BP mean is an independent and stronger predictor of cardiovascular and cerebrovascular disease (CVD) risk than either daytime office/ABPM-derived awake or 24-hour means. Results of the recently completed MAPEC (Monitorización Ambulatoria para Predicción de Eventos Cardiovasculares) prospective outcomes study, which included a large cohort of RH patients, established that time of treatment relative to circadian rhythms constituted a critically important yet often neglected variable with respect to BP control. The study found that bedtime versus morning ingestion of the full dose of ≥1 BP-lowering medications resulted in both better therapeutic normalization of sleep-time BP and reduced CVD morbidity and mortality, including in RH patients. Accordingly, ABPM is highly recommended to properly diagnose and manage true RH, with a bedtime hypertension medication regimen as the therapeutic scheme of choice.

  10. Monitoring the inputs required to extend and sustain hygiene promotion: findings from the GLAAS 2013/2014 survey.

    Science.gov (United States)

    Moreland, Leslie D; Gore, Fiona M; Andre, Nathalie; Cairncross, Sandy; Ensink, Jeroen H J

    2016-08-01

    There are significant gaps in information about the inputs required to effectively extend and sustain hygiene promotion activities to improve people's health outcomes through water, sanitation and hygiene (WASH) interventions. We sought to analyse current country and global trends in the use of key inputs required for effective and sustainable implementation of hygiene promotion to help guide hygiene promotion policy and decision-making after 2015. Data collected in response to the GLAAS 2013/2014 survey from 93 countries of 94 were included, and responses were analysed for 12 questions assessing the inputs and enabling environment for hygiene promotion under four thematic areas. Data were included and analysed from 20 External Support Agencies (ESA) of 23 collected through self-administered surveys. Firstly, the data showed a large variation in the way in which hygiene promotion is defined and what constitutes key activities in this area. Secondly, challenges to implement hygiene promotion are considerable: include poor implementation of policies and plans, weak coordination mechanisms, human resource limitations and a lack of available hygiene promotion budget data. Despite the proven benefits of hand washing with soap, a critical hygiene-related factor in minimising infection, GLAAS 2013/2014 survey data showed that hygiene promotion remains a neglected component of WASH. Additional research to identify the context-specific strategies and inputs required to enhance the effectiveness of hygiene promotion at scale are needed. Improved data collection methods are also necessary to advance the availability and reliability of hygiene-specific information. © 2016 John Wiley & Sons Ltd.

  11. FUNCTIONS AND REQUIREMENTS FOR RUSSIAN PULSATING MONITOR DEPLOYMENT IN THE GUNITE AND ASSOCIATED TANKS AT OAK RIDGE NATIONAL LABORATORY

    Energy Technology Data Exchange (ETDEWEB)

    Thomas Albert

    1999-01-01

    This document provides functions and requirements to support deployment of pulsating mixer pump technology in the Oak Ridge National Laboratory (ORNL) Gunite and Associated Tanks to mobilize and mix the settled sludge and solids in these tanks. In FY 1998 pulsating mixer pump technology, a jet mixer powered by a reciprocating air supply, was selected for FY 1999 deployment in one of the GAAT tanks to mobilize settled solids. Pulsating mixer pump technology was identified in FY 1996 during technical exchanges between the US Department of Energy (DOE) Tanks Focus Area Retrieval and Closure program, the DOE Environmental Management International Programs, and delegates from Russia as a promising technology that could be implemented in the US. The pulsating mixer pump technology, provided by the Russian Integrated Mining Chemical Company, was tested at Pacific Northwest National Laboratory (PNNL) to observe its ability to mobilize settled solids. Based on the results of this demonstration, ORNL and DOE staff determined that a modified pulsating mixer pump would meet project needs for bulk mobilization of Gunite tank sludge prior to deployment of other retrieval systems. The deployment of this device is expected to significantly reduce the costs of operation and maintenance of more expensive retrieval systems. The functions and requirements presented here were developed by evaluating the results and recommendations that resulted from the pulsating mixer pump demonstration at PNNL, and by coupling this with the remediation needs identified by staff at ORNL involved with the remediation of the Gunite and Associated Tanks.

  12. REQUIREMENTS FOR STORAGE AND TRANSPORT OF BIOTECHNOLOGICAL MEDICAL PRODUCTS IN ACCORDANCE WITH THE REGULATORY FRAMEWORK OF MINISTRY OF PUBLIC HEALTH OF UKRAINE AND DETECTION OF VIOLATIONS IN THE MEDICAL AND PHARMACEUTICAL INSTITUTIONS

    Directory of Open Access Journals (Sweden)

    Shukaeva O.

    2015-05-01

    Full Text Available Introduction. The rapid development of the pharmaceutical industry and the expansion of the range of biotech drugs require special conditions to ensure the quality, storage and transport through out the entire chain: manufacturer - distributor - pharmacy - hospital - the patient.We analyzed the current legislative frame work of Ministry of Public Health of Ukraine and conducted a study to identify and analyze of typical violations in the medical and pharmaceutical institutions. The aim of the investigation was to investigate and analyze inspection acts under storage and transport of biological medical products and identify major violations during the performance requirements for storage and transportation of drugs, level of awareness about medical products which are requiring special storage requirement. Methods: systemic, logistical, structural, marketing, regulatory. Results & discussion. According to the data presented in the report «Assessing biosimilar uptake and competition in European markets» of «IMS Health», sales of medical products with biological nature - biological medicinal products and biosymilyars is about 27% of total sales of drugs in the EU. This segment of the pharmaceutical market is characterized by faster growth compared to the pharmaceutical marketas a whole. Thus, in 2012-2013 years sales of biological medical products in the EU countries increased by 5.5% compared to 1.5% increase in total sales of drugs. It is important that in Europe, according to the 2013 preparations, the market share in value terms, with eight to prepare biological products, the term of patent protection that are either already expired or will expireby 2020, and therefore they can be competitors with biosymilars. In creasing the number of medications on the market requires a careful approach of storing and preserving the quality of distribution during throughout the life of the medical products in the chain: manufacturer - distributor

  13. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Volume 2, Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N.

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1998), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the 1978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  14. Revised analyses of decommissioning for the reference pressurized Water Reactor Power Station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure, Volume 1, Final report

    Energy Technology Data Exchange (ETDEWEB)

    Konzek, G.J.; Smith, R.I.; Bierschbach, M.C.; McDuffie, P.N. [Pacific Northwest Lab., Richland, WA (United States)

    1995-11-01

    With the issuance of the final Decommissioning Rule (July 27, 1988), owners and operators of licensed nuclear power plants are required to prepare, and submit to the US Nuclear Regulatory Commission (NRC) for review, decommissioning plans and cost estimates. The NRC staff is in need of bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to provide some of the needed bases documentation. This report contains the results of a review and reevaluation of the {prime}978 PNL decommissioning study of the Trojan nuclear power plant (NUREG/CR-0130), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the nuclear power plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5--7 year period during which time the spent fuel is stored in the spent fuel pool, prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a ``green field`` condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities.

  15. 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...

  16. 76 FR 40208 - Regulatory Flexibility Agenda

    Science.gov (United States)

    2011-07-07

    ... Comment Period End 04/04/05 Next Action Undetermined ......... Regulatory Flexibility Analysis Required... FR 10521 NPRM Comment Period End 04/04/05 Next Action Undetermined ......... Regulatory Flexibility... 70 FR 10521 NPRM Comment Period End 04/04/05 Next Action Undetermined ............

  17. 2002 WIPP Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Washington TRU Solutions LLC

    2002-09-30

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

  18. Waste Isolation Pilot Plant Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    None, None

    2008-03-12

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

  19. Establishing Bedding Requirements during Transport and Monitoring Skin Temperature during Cold and Mild Seasons after Transport for Finishing Pigs

    Directory of Open Access Journals (Sweden)

    John McGlone

    2014-05-01

    Full Text Available The broad aim of this study was to determine whether bedding level in the transport trailer influenced pig performance and welfare. Specifically, the objective was to define the bedding requirements of pigs during transportation in commercial settings during cold and mild weather. Animals (n = 112,078 pigs on 572 trailers used were raised in commercial finishing sites and transported in trailers to commercial processing plants. Dead on arrival (DOA, non-ambulatory (NA, and total dead and down (D&D data were collected and skin surface temperatures of the pigs were measured by infrared thermography. Data were collected during winter (Experiment 1 and fall/spring (Experiment 2. Total D&D percent showed no interaction between bedding level and outside air temperature in any experiments. Average skin surface temperature during unloading increased with outside air temperature linearly in both experiments (P < 0.01. In conclusion, over-use of bedding may be economically inefficient. Pig skin surface temperature could be a useful measure of pig welfare during or after transport.

  20. Regulatory aspects

    Science.gov (United States)

    Stern, Arthur M.

    1986-07-01

    At this time, there is no US legislation that is specifically aimed at regulating the environmental release of genetically engineered organisms or their modified components, either during the research and development stage or during application. There are some statutes, administered by several federal agencies, whose language is broad enough to allow the extension of intended coverage to include certain aspects of biotechnology. The one possible exception is FIFRA, which has already brought about the registration of several natural microbial pesticides but which also has provision for requiring the registration of “strain improved” microbial pesticides. Nevertheless, there may be gaps in coverage even if all pertinent statutes were to be actively applied to the control of environmental release of genetically modified substances. The decision to regulate biotechnology under TSCA was justified, in part, on the basis of its intended role as a gap-filling piece of environmental legislation. The advantage of regulating biotechnology under TSCA is that this statute, unlike others, is concerned with all media of exposure (air, water, soil, sediment, biota) that may pose health and environmental hazards. Experience may show that extending existing legislation to regulate biotechnology is a poor compromise compared to the promulgation of new legislation specifically designed for this purpose. It appears that many other countries are ultimately going to take the latter course to regulate biotechnology.

  1. Requirements for an Advanced Low Earth Orbit (LEO) Sounder (ALS) for Improved Regional Weather Prediction and Monitoring of Greenhouse Gases

    Science.gov (United States)

    Pagano, Thomas S.; Chahine, Moustafa T.; Susskind, Joel

    2008-01-01

    Hyperspectral infrared atmospheric sounders (e.g., the Atmospheric Infrared Sounder (AIRS) on Aqua and the Infrared Atmospheric Sounding Interferometer (IASI) on Met Op) provide highly accurate temperature and water vapor profiles in the lower to upper troposphere. These systems are vital operational components of our National Weather Prediction system and the AIRS has demonstrated over 6 hrs of forecast improvement on the 5 day operational forecast. Despite the success in the mid troposphere to lower stratosphere, a reduction in sensitivity and accuracy has been seen in these systems in the boundary layer over land. In this paper we demonstrate the potential improvement associated with higher spatial resolution (1 km vs currently 13.5 km) on the accuracy of boundary layer products with an added consequence of higher yield of cloud free scenes. This latter feature is related to the number of samples that can be assimilated and has also shown to have a significant impact on improving forecast accuracy. We also present a set of frequencies and resolutions that will improve vertical resolution of temperature and water vapor and trace gas species throughout the atmosphere. Development of an Advanced Low Earth Orbit (LEO) Sounder (ALS) with these improvements will improve weather forecast at the regional scale and of tropical storms and hurricanes. Improvements are also expected in the accuracy of the water vapor and cloud properties products, enhancing process studies and providing a better match to the resolution of future climate models. The improvements of technology required for the ALS are consistent with the current state of technology as demonstrated in NASA Instrument Incubator Program and NOAA's Hyperspectral Environmental Suite (HES) formulation phase development programs.

  2. Requirements for an Advanced Low Earth Orbit (LEO) Sounder (ALS) for improved regional weather prediction and monitoring of greenhouse gases

    Science.gov (United States)

    Pagano, Thomas S.; Chahine, Moustafa T.; Susskind, Joel

    2008-12-01

    Hyperspectral infrared atmospheric sounders (e.g. the Atmospheric Infrared Sounder (AIRS) on Aqua and the Infrared Atmospheric Sounding Interferometer (IASI) on MetOp) provide highly accurate temperature and water vapor profiles in the lower to upper troposphere. These systems are vital operational components of our National Weather Prediction system and the AIRS has demonstrated over 6 hrs of forecast improvement on the 5 day operational forecast1. Despite the success in the mid troposphere to lower stratosphere, a reduction in sensitivity and accuracy has been seen in these systems in the boundary layer over land. In this paper we demonstrate the potential improvement associated with higher spatial resolution (1km vs currently 13.5 km) on the accuracy of boundary layer products with an added consequence of higher yield of cloud free scenes. This latter feature is related to the number of samples that can be assimilated and has also shown to have a significant impact on improving forecast accuracy. We also present a set of frequencies and resolutions that will improve vertical resolution of temperature and water vapor and trace gas species throughout the atmosphere. Development of an Advanced Low Earth Orbit (LEO) Sounder (ALS) with these improvements will improve weather forecast at the regional scale and of tropical storms and hurricanes. Improvements are also expected in the accuracy of the water vapor and cloud properties products, enhancing process studies and providing a better match to the resolution of future climate models. The improvements of technology required for the ALS are consistent with the current state of technology as demonstrated in NASA Instrument Incubator Program and NOAA's Hyperspectral Environmental Suite (HES) formulation phase development programs.

  3. Monitoring madness

    Energy Technology Data Exchange (ETDEWEB)

    Blankinship, S.

    2006-01-15

    High quality continuous emission monitoring capability can be as essential as high quality emission control equipment. Future mercury monitoring and control requirements add to the justification for better CEMS. The article discusses two prominent mercury measurement methods - the cold vapour atomic absorptive spectrometer (CVAAs) and the atomic absorptive spectrometer (AFS). It stresses the importance of maintaining a CEMS. 1 photo.

  4. Associations between statewide prescription drug monitoring program (PDMP) requirement and physician patterns of prescribing opioid analgesics for patients with non-cancer chronic pain.

    Science.gov (United States)

    Lin, Hsien-Chang; Wang, Zhi; Boyd, Carol; Simoni-Wastila, Linda; Buu, Anne

    2018-01-01

    State-level prescription drug monitoring programs (PDMPs) have been implemented in most states. PDMPs enable registered prescribers to obtain real-time information on patients' prescription history to reduce non-medical use of controlled drugs. This study examined whether PDMP implementation and different levels of PDMP requirements were associated with physicians' patterns of prescribing opioid analgesics for patients with non-cancer chronic pain. This is a secondary analysis study using cross-sectional national data. Patients with non-cancer chronic pain from the 2012 National Ambulatory Medical Care Survey were included (weighted N=81,018,131; unweighted N=3295). Heckman two-step selection procedure employing two logistic regressions was used to explore the associations between PDMP requirements and physicians' prescribing behaviors, controlling for physician characteristics, patient characteristics, physician-healthcare system interaction, and physician-patient relationship, guided by the Eisenberg's model of physician decision making. State PDMP implementation status and requirement levels were not associated with physician opioid prescribing for non-cancer chronic pain treatment (p's ranged 0.30-0.32). Patients with Medicare coverage were more likely to be prescribed opioid analgesics than those with private health insurance (OR=1.55, prequirements and enforcement for prescribers and related stakeholders. Future studies also are needed to identify characteristics contributing to PDMP effectiveness in reducing non-medical use of prescription opioids. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. Electricity distribution networks: Changing regulatory approaches

    Science.gov (United States)

    Cambini, Carlo

    2016-09-01

    Increasing the penetration of distributed generation and smart grid technologies requires substantial investments. A study proposes an innovative approach that combines four regulatory tools to provide economic incentives for distribution system operators to facilitate these innovative practices.

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

    Directory of Open Access Journals (Sweden)

    Beatrice Castellani

    2014-07-01

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

  7. A novel sterol regulatory element-binding protein gene (sreA identified in penicillium digitatum is required for prochloraz resistance, full virulence and erg11 (cyp51 regulation.

    Directory of Open Access Journals (Sweden)

    Jing Liu

    Full Text Available Penicillium digitatum is the most destructive postharvest pathogen of citrus fruits, causing fruit decay and economic loss. Additionally, control of the disease is further complicated by the emergence of drug-resistant strains due to the extensive use of triazole antifungal drugs. In this work, an orthologus gene encoding a putative sterol regulatory element-binding protein (SREBP was identified in the genome of P. digitatum and named sreA. The putative SreA protein contains a conserved domain of unknown function (DUF2014 at its carboxyl terminus and a helix-loop-helix (HLH leucine zipper DNA binding domain at its amino terminus, domains that are functionally associated with SREBP transcription factors. The deletion of sreA (ΔsreA in a prochloraz-resistant strain (PdHS-F6 by Agrobacterium tumefaciens-mediated transformation led to increased susceptibility to prochloraz and a significantly lower EC50 value compared with the HS-F6 wild-type or complementation strain (COsreA. A virulence assay showed that the ΔsreA strain was defective in virulence towards citrus fruits, while the complementation of sreA could restore the virulence to a large extent. Further analysis by quantitative real-time PCR demonstrated that prochloraz-induced expression of cyp51A and cyp51B in PdHS-F6 was completely abolished in the ΔsreA strain. These results demonstrate that sreA is a critical transcription factor gene required for prochloraz resistance and full virulence in P. digitatum and is involved in the regulation of cyp51 expression.

  8. A novel sterol regulatory element-binding protein gene (sreA) identified in penicillium digitatum is required for prochloraz resistance, full virulence and erg11 (cyp51) regulation.

    Science.gov (United States)

    Liu, Jing; Yuan, Yongze; Wu, Zhi; Li, Na; Chen, Yuanlei; Qin, Tingting; Geng, Hui; Xiong, Li; Liu, Deli

    2015-01-01

    Penicillium digitatum is the most destructive postharvest pathogen of citrus fruits, causing fruit decay and economic loss. Additionally, control of the disease is further complicated by the emergence of drug-resistant strains due to the extensive use of triazole antifungal drugs. In this work, an orthologus gene encoding a putative sterol regulatory element-binding protein (SREBP) was identified in the genome of P. digitatum and named sreA. The putative SreA protein contains a conserved domain of unknown function (DUF2014) at its carboxyl terminus and a helix-loop-helix (HLH) leucine zipper DNA binding domain at its amino terminus, domains that are functionally associated with SREBP transcription factors. The deletion of sreA (ΔsreA) in a prochloraz-resistant strain (PdHS-F6) by Agrobacterium tumefaciens-mediated transformation led to increased susceptibility to prochloraz and a significantly lower EC50 value compared with the HS-F6 wild-type or complementation strain (COsreA). A virulence assay showed that the ΔsreA strain was defective in virulence towards citrus fruits, while the complementation of sreA could restore the virulence to a large extent. Further analysis by quantitative real-time PCR demonstrated that prochloraz-induced expression of cyp51A and cyp51B in PdHS-F6 was completely abolished in the ΔsreA strain. These results demonstrate that sreA is a critical transcription factor gene required for prochloraz resistance and full virulence in P. digitatum and is involved in the regulation of cyp51 expression.

  9. Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Althouse, P E; Biermann, A; Brigdon, S L; Brown, R A; Campbell, C G; Christofferson, E; Clark, L M; Folks, K J; Gallegos, G M; Gouveia, F J; Grayson, A; Harrach, R J; Hoppes, W G; Jones, H; Mathews, S; Merrigan, J R; Peterson, S R; Revelli, M; Rueppel, D; Sanchez, L; Tate, P J; Vellinger, R J; Ward, B; Williams, R

    2006-01-10

    Environmental monitoring personnel from Lawrence Livermore National Laboratory (LLNL) prepared this ''Environmental Monitoring Plan'' (EMP) to meet the requirements in the U.S. Department of Energy (DOE) ''Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance'' (DOE 1991) and applicable portions of DOE Orders 5400.1 and 5400.5 (see WSS B93 and B94 in Appendix B). ''Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance'' is followed as a best management practice; under Work Smart Standards, LLNL complies with portions of DOE Orders 5400.1 and 5400.5 as shown in Appendix B. This document is a revision of the May 1999 EMP (Tate et al. 1999) and is current as of March 1, 2002. LLNL is one of the nation's premier applied-science national security laboratories. Its primary mission is to ensure that the nation's nuclear weapons remain safe, secure, and reliable, and to prevent the spread and use of nuclear weapons worldwide. LLNL's programs in advanced technologies, energy, environment, biosciences, and basic science apply LLNL's unique capabilities and enhance the competencies needed for this national security mission. LLNL's mission also involves working with industrial and academic partners to increase national competitiveness and improve science education. LLNL's mission is dynamic and has changed over the years to meet new national needs. In keeping with the Laboratory's mission, the environment, safety, and health (ES&H) have top priority. LLNL's policy is to perform work in a manner that protects the health and safety of employees and the public, preserves the quality of the environment, and prevents property damage. The environment, safety, and health are to be priority considerations in the planning and execution of all work activities at the Laboratory (LLNL 2001

  10. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2004-06-15

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

  11. Development of regulatory policy for SMART-P

    Energy Technology Data Exchange (ETDEWEB)

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

    2003-06-15

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

  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. 78 FR 62417 - Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy...

    Science.gov (United States)

    2013-10-22

    ... Part 324 RIN 3064-AD95 Regulatory Capital Rules: Regulatory Capital, Implementation of Basel III, Capital Adequacy, Transition Provisions, Prompt Corrective Action, Standardized Approach for Risk-Weighted Assets, Market Discipline and Disclosure Requirements, Advanced Approaches Risk-Based Capital Rule,...

  14. Regulatory bioinformatics for food and drug safety.

    Science.gov (United States)

    Healy, Marion J; Tong, Weida; Ostroff, Stephen; Eichler, Hans-Georg; Patak, Alex; Neuspiel, Margaret; Deluyker, Hubert; Slikker, William

    2016-10-01

    "Regulatory Bioinformatics" strives to develop and implement a standardized and transparent bioinformatic framework to support the implementation of existing and emerging technologies in regulatory decision-making. It has great potential to improve public health through the development and use of clinically important medical products and tools to manage the safety of the food supply. However, the application of regulatory bioinformatics also poses new challenges and requires new knowledge and skill sets. In the latest Global Coalition on Regulatory Science Research (GCRSR) governed conference, Global Summit on Regulatory Science (GSRS2015), regulatory bioinformatics principles were presented with respect to global trends, initiatives and case studies. The discussion revealed that datasets, analytical tools, skills and expertise are rapidly developing, in many cases via large international collaborative consortia. It also revealed that significant research is still required to realize the potential applications of regulatory bioinformatics. While there is significant excitement in the possibilities offered by precision medicine to enhance treatments of serious and/or complex diseases, there is a clear need for further development of mechanisms to securely store, curate and share data, integrate databases, and standardized quality control and data analysis procedures. A greater understanding of the biological significance of the data is also required to fully exploit vast datasets that are becoming available. The application of bioinformatics in the microbiological risk analysis paradigm is delivering clear benefits both for the investigation of food borne pathogens and for decision making on clinically important treatments. It is recognized that regulatory bioinformatics will have many beneficial applications by ensuring high quality data, validated tools and standardized processes, which will help inform the regulatory science community of the requirements

  15. Data monitoring committees: Promoting best practices to address emerging challenges.

    Science.gov (United States)

    Fleming, Thomas R; DeMets, David L; Roe, Matthew T; Wittes, Janet; Calis, Karim A; Vora, Amit N; Meisel, Alan; Bain, Raymond P; Konstam, Marvin A; Pencina, Michael J; Gordon, David J; Mahaffey, Kenneth W; Hennekens, Charles H; Neaton, James D; Pearson, Gail D; Andersson, Tomas Lg; Pfeffer, Marc A; Ellenberg, Susan S

    2017-04-01

    Data monitoring committees are responsible for safeguarding the interests of study participants and assuring the integrity and credibility of clinical trials. The independence of data monitoring committees from sponsors and investigators is essential in achieving this mission. Creative approaches are needed to address ongoing and emerging challenges that potentially threaten data monitoring committees' independence and effectiveness. An expert panel of representatives from academia, industry and government sponsors, and regulatory agencies discussed these challenges and proposed best practices and operating principles for effective functioning of contemporary data monitoring committees. Prospective data monitoring committee members need better training. Options could include didactic instruction as well as apprenticeships to provide real-world experience. Data monitoring committee members should be protected against legal liability arising from their service. While avoiding breaches in confidentiality of interim data remains a high priority, data monitoring committees should have access to unblinded efficacy and safety data throughout the trial to enable informed judgments about risks and benefits. Because overly rigid procedures can compromise their independence, data monitoring committees should have the flexibility necessary to best fulfill their responsibilities. Data monitoring committee charters should articulate principles that guide the data monitoring committee process rather than list a rigid set of requirements. Data monitoring committees should develop their recommendations by consensus rather than through voting processes. The format for the meetings of the data monitoring committee should maintain the committee's independence and clearly establish the leadership of the data monitoring committee chair. The independent statistical group at the Statistical Data Analysis Center should have sufficient depth of knowledge about the study at hand and

  16. Potential effects of environmental regulatory procedures on geothermal development

    Energy Technology Data Exchange (ETDEWEB)

    Beeland, G.V.; Boies, D.B.

    1981-01-01

    The potential effects of several types of applicable environmental regulatory procedures on geothermal development were assessed, and particular problem areas were identified. The possible impact of procedures adopted pursuant to the following Federal statutes were analyzed: Clean Air Act; Clean Water Act; Safe Drinking Water Act; and Resource Conservation and Recovery Act. State regulations applicable, or potentially applicable, to geothermal facilities were also reviewed to determine: permit information requirements; pre-permit air or water quality monitoring requirements; effect of mandated time frames for permit approval; and potential for exemption of small facilities. The regulations of the following states were covered in the review: Alaska; Arizona; California; Colorado; Hawaii; Idaho; Montana; Nevada; New Mexico; Oregon; Utah; Washington; and Wyoming. (MHR)

  17. 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.

  18. LEGACY MANAGEMENT REQUIRES INFORMATION

    Energy Technology Data Exchange (ETDEWEB)

    CONNELL, C.W.; HILDEBRAND, R.D.

    2006-12-14

    ''Legacy Management Requires Information'' describes the goal(s) of the US Department of Energy's Office of Legacy Management (LM) relative to maintaining critical records and the way those goals are being addressed at Hanford. The paper discusses the current practices for document control, as well as the use of modern databases for both storing and accessing the data to support cleanup decisions. In addition to the information goals of LM, the Hanford Federal Facility Agreement and Consent Order, known as the ''Tri-Party Agreement'' (TPA) is one of the main drivers in documentation and data management. The TPA, which specifies discrete milestones for cleaning up the Hanford Site, is a legally binding agreement among the US Department of Energy (DOE), the Washington State Department of Ecology (Ecology), and the US Environmental Protection Agency (EPA). The TPA requires that DOE provide the lead regulatory agency with the results of analytical laboratory and non-laboratory tests/readings to help guide them in making decisions. The Agreement also calls for each signatory to preserve--for at least ten years after the Agreement has ended--all of the records in its or its contractors, possession related to sampling, analysis, investigations, and monitoring conducted. The tools used at Hanford to meet TPA requirements are also the tools that can satisfy the needs of LM.

  19. Waste Isolation Pilot Plant Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Washington Regulatory and Environmental Services; Washington TRU Solutions LLC

    2004-02-19

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

  20. Waste Isolation Pilot Plant Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Washington Regulatory and Environmental Services; Washington TRU Solutions LLC

    2004-02-19

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

  1. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

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

  2. 面向系统调控需求的储能系统控制策略及其经济性评估%Control Strategy for Regulatory Requirements Oriented Energy Storage System and Evaluation on Its Economy

    Institute of Scientific and Technical Information of China (English)

    严干贵; 王月; 李军徽; 冯凯翔; 葛延峰; 高凯

    2015-01-01

    提出一种面向电力系统调控需求的储能系统集中控制策略,以提高电网接纳风电规模,减少弃风电量。同时根据储能系统荷电状态(state of charge,SOC),对储能系统充放电指令进行实时修正,防止储能系统过充过放,优化其运行性能。建立了储能系统经济性评估模型,用以评估储能系统提高风电接纳的运行经济效益。以收益最大为目标,确定储能系统容量配置。基于某地区实测数据对上述控制策略和经济性评估模型进行验证,结果表明提出的面向系统调控需求的储能系统控制方法能够扩大风电入网规模,有效利用电网可接纳风电空间。%A kind of centralized control strategy for regulatory requirements oriented energy storage system for the power system was proposed to improve scale of the power grid taking in wind power and reducing curtailed wind power energy. Ac-cording to state of charge (SOC)of the energy storage system,charge and discharge instructions of the system were revised in real time for preventing over charge and over discharge and optimizing its operational performance. Evaluation model for economy of the energy storage system was established for evaluating operational economic benefits of the system improving wind power adoption. Taking maximum profit as a target,capacity configuration of the energy storage system was deter-mined. Based on measured data in some region,verification on the control strategy and evaluation model was conducted. Results indicate that the control method for energy storage system could enlarge wind power networking scale and effectively use space of the power grid taking in wind power.

  3. Genomics in the land of regulatory science.

    Science.gov (United States)

    Tong, Weida; Ostroff, Stephen; Blais, Burton; Silva, Primal; Dubuc, Martine; Healy, Marion; Slikker, William

    2015-06-01

    Genomics science has played a major role in the generation of new knowledge in the basic research arena, and currently question arises as to its potential to support regulatory processes. However, the integration of genomics in the regulatory decision-making process requires rigorous assessment and would benefit from consensus amongst international partners and research communities. To that end, the Global Coalition for Regulatory Science Research (GCRSR) hosted the fourth Global Summit on Regulatory Science (GSRS2014) to discuss the role of genomics in regulatory decision making, with a specific emphasis on applications in food safety and medical product development. Challenges and issues were discussed in the context of developing an international consensus for objective criteria in the analysis, interpretation and reporting of genomics data with an emphasis on transparency, traceability and "fitness for purpose" for the intended application. It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent, reliable, reproducible and auditable processes in the management of food and medical product safety risks. It was also recognized that training is an important mechanism in achieving internationally consistent outcomes. GSRS2014 provided an effective venue for regulators andresearchers to meet, discuss common issues, and develop collaborations to address the challenges posed by the application of genomics to regulatory science, with the ultimate goal of wisely integrating novel technical innovations into regulatory decision-making.

  4. Identification of regulatory network hubs that control lipid metabolism in Chlamydomonas reinhardtii.

    Science.gov (United States)

    Gargouri, Mahmoud; Park, Jeong-Jin; Holguin, F Omar; Kim, Min-Jeong; Wang, Hongxia; Deshpande, Rahul R; Shachar-Hill, Yair; Hicks, Leslie M; Gang, David R

    2015-08-01

    Microalgae-based biofuels are promising sources of alternative energy, but improvements throughout the production process are required to establish them as economically feasible. One of the most influential improvements would be a significant increase in lipid yields, which could be achieved by altering the regulation of lipid biosynthesis and accumulation. Chlamydomonas reinhardtii accumulates oil (triacylglycerols, TAG) in response to nitrogen (N) deprivation. Although a few important regulatory genes have been identified that are involved in controlling this process, a global understanding of the larger regulatory network has not been developed. In order to uncover this network in this species, a combined omics (transcriptomic, proteomic and metabolomic) analysis was applied to cells grown in a time course experiment after a shift from N-replete to N-depleted conditions. Changes in transcript and protein levels of 414 predicted transcription factors (TFs) and transcriptional regulators (TRs) were monitored relative to other genes. The TF and TR genes were thus classified by two separate measures: up-regulated versus down-regulated and early response versus late response relative to two phases of polar lipid synthesis (before and after TAG biosynthesis initiation). Lipidomic and primary metabolite profiling generated compound accumulation levels that were integrated with the transcript dataset and TF profiling to produce a transcriptional regulatory network. Evaluation of this proposed regulatory network led to the identification of several regulatory hubs that control many aspects of cellular metabolism, from N assimilation and metabolism, to central metabolism, photosynthesis and lipid metabolism.

  5. 78 FR 7816 - Quality Assurance Program Requirements (Operations)

    Science.gov (United States)

    2013-02-04

    ... COMMISSION Quality Assurance Program Requirements (Operations) AGENCY: Nuclear Regulatory Commission. ACTION... issuing for public comment draft regulatory guide (DG), DG-1300, ``Quality Assurance Program Requirements... analysis report. Both sections require compliance with 10 CFR Part 50, Appendix B, ``Quality Assurance...

  6. Mission Risk Reduction Regulatory Change Management

    Science.gov (United States)

    Scroggins, Sharon

    2007-01-01

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

  7. ATMPs for Cancer Immunotherapy: A Regulatory Overview.

    Science.gov (United States)

    Galli, Maria Cristina

    2016-01-01

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

  8. Regulatory issues in accreditation of toxicology laboratories.

    Science.gov (United States)

    Bissell, Michael G

    2012-09-01

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

  9. A monitor unit "odometer" for measuring linac workload.

    Science.gov (United States)

    Evans, M D; Larkin, J J; Léger, P; Podgorsak, E B

    2001-12-01

    The annual linac workload is often required by regulatory agencies to assess compliance with license conditions. Summation of the monitor units produced by the machine is generally used for this purpose. Various methods of estimating this value have inherent inaccuracies. We have built an integrating Monitor Unit "odometer" that is able to automatically accumulate all MUs delivered by the linac and segregate the total by mode (photon or electron) and energy. The device has been used to record clinical linac MU workloads for 10 months, and was installed in a new dual-energy linac during the acceptance and commissioning process.

  10. Improvement the Quality Management of Full Life-cycle of Medical Device and Incorporation Regulatory Requirements within QMS%加强全生命周期质量管理全面融入法规要求--解读新版ISO13485标准

    Institute of Scientific and Technical Information of China (English)

    陈志刚; 李欣

    2016-01-01

    The paper introduces characteristics of new ISO13485 standard, such as wide availability, wel compatibility, real-time ability, and deifnite requirements of improvement the quality management of ful life-cycle of medical device and incorporation regulatory requirements within QMS.%本文介绍了新版I S O13485的适用性广、兼容性强、动态性高三大主要特点,进一步明确了加强医疗器械全生命周期质量管理、全面融入法规的要求。

  11. Management plan for Facility Effluent Monitoring Plan activities

    Energy Technology Data Exchange (ETDEWEB)

    Nickels, J.M.; Pratt, D.R.

    1991-08-01

    The DOE/RL 89-19, United States Department of Energy-Richland Operations Office Environmental Protection Implementation Plan (1989), requires the Hanford Site to prepare an Environmental Monitoring Plan (EMP) by November 9, 1991. The DOE/EH-0173T, Environmental Regulatory Guide for Radiological Effluent Monitoring and Environmental Surveillance (1991), provides additional guidance and requires implementation of the EMP within 36 months of the effective data of the rule. DOE Order 5400.1, General Environmental Protection Program, requires each US Department of Energy (DOE) site, facility, or activity that uses, generates, releases, or manages significant quantities of hazardous materials to prepare an EMP. This EMP is to identify and discuss two major activities: (1) effluent monitoring and (2) environmental surveillance. At the Hanford Site, the site-wide EMP will consist of the following elements: (1) A conceptual plan addressing effluent monitoring and environmental surveillance; (2) Pacific Northwest Laboratory (PNL) site-wide environmental surveillance program; (3) Westinghouse Hanford Company (Westinghouse Hanford) effluent monitoring program consisting of the near-field operations environmental monitoring activities and abstracts of each Facility Effluent Monitoring Plan (FEMP). This management plan addresses the third of these three elements of the EMP, the FEMPs.

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

    Energy Technology Data Exchange (ETDEWEB)

    Gray, R.H. (ed.)

    1990-01-01

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

  13. Groundwater Monitoring Strategy for Nuclear Power Station of American Nuclear Regulatory Commission and Its Implications%美国核电厂地下水监控技术路线及借鉴

    Institute of Scientific and Technical Information of China (English)

    覃春丽; 徐月平; 陈超峰; 上官志洪

    2014-01-01

    In this paper ,NRC’ s groundwater monitoring strategy for nuclear power station is summarized . This strategy combines model development with site monitoring and has been well validated ,Meanwhile ,cur-rent situation of groundwater monitoring at nuclear power station in our country is schematically reported in or-der to provide references to establish and perfect groundwater monitoring at China ’s nuclear power stations .%介绍了美国核管理委员会对核电厂的地下水监控技术路线。该技术路线将数学模型与现场监测相结合,并得到良好的实践验证。简要分析了我国核电厂地下水监控的现状。

  14. OVERSEER: An Expert System Monitor for the Psychiatric Hospital

    Science.gov (United States)

    Bronzino, Joseph D.; Morelli, Ralph A.; Goethe, John W.

    1988-01-01

    In order to improve patient care, comply with regulatory guidelines and decrease potential liability, psychiatric hospitals and clinics have been searching for computer systems to monitor the management and treatment of patients. This paper describes OVERSEER: a knowledge based system that monitors the treatment of psychiatric patients in real time. Based on procedures and protocols developed in the psychiatric setting, OVERSEER monitors the clinical database and issues alerts when standard clinical practices are not followed or when laboratory results or other clinical indicators are abnormal. Written in PROLOG, OVERSEER is designed to interface directly with the hospital's database, and, thereby utilizes all available pharmacy and laboratory data. Moreover, unlike the interactive expert systems developed for the psychiatric clinic, OVERSEER does not require extensive data entry by the clinician. Consequently, the chief benefit of OVERSEER's monitoring approach is the unobtrusive manner in which it evaluates treatment and patient responses and provides information regarding patient management.

  15. Regulatory T cell memory

    Science.gov (United States)

    Rosenblum, Michael D.; Way, Sing Sing; Abbas, Abul K.

    2016-01-01

    Memory for antigen is a defining feature of adaptive immunity. Antigen-specific lymphocyte populations show an increase in number and function after antigen encounter and more rapidly re-expand upon subsequent antigen exposure. Studies of immune memory have primarily focused on effector B cells and T cells with microbial specificity, using prime challenge models of infection. However, recent work has also identified persistently expanded populations of antigen-specific regulatory T cells that protect against aberrant immune responses. In this Review, we consider the parallels between memory effector T cells and memory regulatory T cells, along with the functional implications of regulatory memory in autoimmunity, antimicrobial host defence and maternal fetal tolerance. In addition, we discuss emerging evidence for regulatory T cell memory in humans and key unanswered questions in this rapidly evolving field. PMID:26688349

  16. Technical support for the Ohio Clean Coal Technology Program. Volume 2, Baseline of knowledge concerning process modification opportunities, research needs, by-product market potential, and regulatory requirements: Final report

    Energy Technology Data Exchange (ETDEWEB)

    Olfenbuttel, R.; Clark, S.; Helper, E.; Hinchee, R.; Kuntz, C.; Means, J.; Oxley, J.; Paisley, M.; Rogers, C.; Sheppard, W.; Smolak, L. [Battelle, Columbus, OH (United States)

    1989-08-28

    This report was prepared for the Ohio Coal Development Office (OCDO) under Grant Agreement No. CDO/R-88-LR1 and comprises two volumes. Volume 1 presents data on the chemical, physical, and leaching characteristics of by-products from a wide variety of clean coal combustion processes. Volume 2 consists of a discussion of (a) process modification waste minimization opportunities and stabilization considerations; (b) research and development needs and issues relating to clean coal combustion technologies and by-products; (c) the market potential for reusing or recycling by-product materials; and (d) regulatory considerations relating to by-product disposal or reuse.

  17. 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.

  18. These Shoes Are Made for Walking: Sensitivity Performance Evaluation of Commercial Activity Monitors under the Expected Conditions and Circumstances Required to Achieve the International Daily Step Goal of 10,000 Steps.

    Directory of Open Access Journals (Sweden)

    Sandra O'Connell

    Full Text Available Physical activity is a vitally important part of a healthy lifestyle, and is of major benefit to both physical and mental health. A daily step count of 10,000 steps is recommended globally to achieve an appropriate level of physical activity. Accurate quantification of physical activity during conditions reflecting those needed to achieve the recommended daily step count of 10,000 steps is essential. As such, we aimed to assess four commercial activity monitors for their sensitivity/accuracy in a prescribed walking route that reflects a range of surfaces that would typically be used to achieve the recommended daily step count, in two types of footwear expected to be used throughout the day when aiming to achieve the recommended daily step count, and in a timeframe required to do so.Four commercial activity monitors were worn simultaneously by participants (n = 15 during a prescribed walking route reflective of surfaces typically encountered while achieving the daily recommended 10,000 steps. Activity monitors tested were the Garmin Vivofit ™, New Lifestyles' NL-2000 ™ pedometer, Withings Smart Activity Monitor Tracker (Pulse O2 ™, and Fitbit One ™.All activity monitors tested were accurate in their step detection over the variety of different surfaces tested (natural lawn grass, gravel, ceramic tile, tarmacadam/asphalt, linoleum, when wearing both running shoes and hard-soled dress shoes.All activity monitors tested were accurate in their step detection sensitivity and are valid monitors for physical activity quantification over the variety of different surfaces tested, when wearing both running shoes and hard-soled dress shoes, and over a timeframe necessary for accumulating the recommended daily step count of 10,000 steps. However, it is important to consider the accuracy of activity monitors, particularly when physical activity in the form of stepping activities is prescribed as an intervention in the treatment or prevention of a

  19. Medical research misconduct need regulatory reforms.

    Science.gov (United States)

    Bedi, Neeraj

    2014-10-01

    The medical research misconduct has become a global problem. Except from countries like the USA, China, and Germany the exact figures of misconduct are not available. The research misconduct include fabricating the data, falsifying data, and plagiarism. The irresponsible research practices are publishing research data more than once, conflicts of interest is not declared, selective reporting of data and including an author who has not contributed at all and many more. About 2% of scientists have been found to admit the fabricating the data and 33% researchers were involved in irresponsible research practices. There is no formal regulatory programs available to monitor the research projects. Few developed countries like the USA, Germany, and China tried to develop programs which can monitor the medical research misconduct. There is a need to develop a regulatory system at national and institutional level to regulate the research activity to ensure that good ethical and scientific standards are practiced by medical researchers.

  20. Medical research misconduct need regulatory reforms

    Directory of Open Access Journals (Sweden)

    Neeraj Bedi

    2014-01-01

    Full Text Available The medical research misconduct has become a global problem. Except from countries like the USA, China, and Germany the exact figures of misconduct are not available. The research misconduct include fabricating the data, falsifying data, and plagiarism. The irresponsible research practices are publishing research data more than once, conflicts of interest is not declared, selective reporting of data and including an author who has not contributed at all and many more. About 2% of scientists have been found to admit the fabricating the data and 33% researchers were involved in irresponsible research practices. There is no formal regulatory programs available to monitor the research projects. Few developed countries like the USA, Germany, and China tried to develop programs which can monitor the medical research misconduct. There is a need to develop a regulatory system at national and institutional level to regulate the research activity to ensure that good ethical and scientific standards are practiced by medical researchers.

  1. CONCEPT OF OPERATIONS PLANS for Phase I the INTERNATIONAL PILOT FOR Global Radiological source SORTING, Tracking, AND MONITORING (GradSStraM) Using eMERGING RFID AND WEB 2.0 TECHNOLOGIES TO PROVIDE TOTAL ASSET AND INFORMATION VISUALIZATIONA United states- European Union Lighthouse Priority Project for fostering trade and reducing regulatory burden

    Energy Technology Data Exchange (ETDEWEB)

    Walker, Randy M [ORNL

    2009-01-01

    Thousands of shipments of radioisotopes developed in the United States (US) are transported domestically and internationally for medical and industrial applications, including to partner laboratories in European Union (EU) countries. Over the past five years, the Environmental Protection Agency (EPA), the Department of Energy (DOE), and Oak Ridge National Laboratory (ORNL) have worked with state regulatory compliance personnel, key private sector shippers and carriers, the Department of Homeland Security (DHS), the Department of Transportation (DOT), the Department of Defense (DoD) and the Nuclear Regulatory Commission (NRC) on Radio Frequency Identification (RFID) tracking and monitoring of medical and industrial radioisotopes in commerce. The EPA Radiological Source Tracking and Monitoring (RadSTraM) project tested, evaluated, and integrated RFID technologies in laboratory settings, and at multiple private-sector shipping and distribution facilities (Perkin Elmer and DHL) using common radioisotopes used in everyday commerce. The RFID tracking was also tested in association with other deployed technologies including radiation detection, chemical/explosives detection, advanced imaging, lasers, and infrared scanning. At the 2007 EU-US Summit, the leaders of the US Department of Commerce (DOC) and EU European Commission (EC) committed to pursue jointly directed Lighthouse Priority Projects. These projects are intended to 'foster cooperation' and 'reduce regulatory burdens' with respect to transatlantic commerce. The Transatlantic Economic Council (TEC) Lighthouse Project on Radio Frequency Identification (RFID) has been directed to 'develop a joint framework for cooperation on identification and development of best practices for Radio Frequency Identification (RFID) technologies.' The RFID Lighthouse Priority Project commits both sides to endeavor to align U.S. and EU regulatory and policy approaches on RFID technologies, including pilot

  2. 78 FR 37850 - Quality Assurance Program Requirements (Operations)

    Science.gov (United States)

    2013-06-24

    ... COMMISSION Quality Assurance Program Requirements (Operations) AGENCY: Nuclear Regulatory Commission. ACTION... Regulatory Guide (RG) 1.33, ``Quality Assurance Program Requirements (Operations).'' This RG describes methods that the staff of the NRC considers acceptable for managerial and administrative Quality Assurance...

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1992-03-01

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

  4. Recommendations on legislative and regulatory framework and regulatory body of nuclear security in China

    Institute of Scientific and Technical Information of China (English)

    PU Jilong; LI Xiaoyan

    2007-01-01

    This paper describes the definition of nuclear security that has been changing from the cold war age to the post-911 period, and clarifies the close relationship and yet a clear distinction between nuclear security, nuclear safety and nuclear safeguard. Based on analyses of the current state of nuclear security activities in China as well as the requirements and the law infrastructure, a legislative and regulatory framework of nuclear security and the mandate of a regulatory body in China are recommended.

  5. Current status of developmental neurotoxicity: regulatory view

    DEFF Research Database (Denmark)

    Hass, Ulla

    2003-01-01

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

  6. The trade in human organs in Tamil Nadu: the anatomy of regulatory failure.

    Science.gov (United States)

    Muraleedharan, Vangal R; Jan, Stephen; Ram Prasad, S

    2006-01-01

    There has been much recent interest in the trade in human organs in India. This paper examines both the extent to which regulatory controls through the Transplantation of Human Organs Act (1994) are effective in curbing commercialization and the nature of the constraints on the effective implementation of this Act. The study, a politico-economic analysis of health sector regulation, is based on a stakeholder analysis drawing on the views of key decision makers, service providers, organ donors and recipients. The findings indicate widespread acknowledgement of an organs trade and highlight four major constraints on the effective implementation of the Act: the commercial interests of middlemen and service providers, the ambiguities and loopholes in the Act; the low monitoring capacity of the regulatory authorities, and the pressures and responsibilities exerted upon the Authorizing Committees. A feature of the Act is that its implementation is subject to a major incentive compatibility constraint - it is seemingly not in the interests of any of the key players, including the regulatory authorities, to restrict the organ trade. To some extent, this institutional problem is created by the specific nature of the regulatory intervention, and, as a consequence, measures involving straightforward redrafting of the regulation might go some way to addressing this incentive problem. Another solution may entail a 'harm-reduction' strategy involving a controlled trade where procurement and organ matching is carried out by a government agency (this would require, however, the prior resolution of the broader ethical question concerning the legitimacy of such trade).

  7. Cis-regulatory mutations in human disease.

    Science.gov (United States)

    Epstein, Douglas J

    2009-07-01

    Cis-acting regulatory sequences are required for the proper temporal and spatial control of gene expression. Variation in gene expression is highly heritable and a significant determinant of human disease susceptibility. The diversity of human genetic diseases attributed, in whole or in part, to mutations in non-coding regulatory sequences is on the rise. Improvements in genome-wide methods of associating genetic variation with human disease and predicting DNA with cis-regulatory potential are two of the major reasons for these recent advances. This review will highlight select examples from the literature that have successfully integrated genetic and genomic approaches to uncover the molecular basis by which cis-regulatory mutations alter gene expression and contribute to human disease. The fine mapping of disease-causing variants has led to the discovery of novel cis-acting regulatory elements that, in some instances, are located as far away as 1.5 Mb from the target gene. In other cases, the prior knowledge of the regulatory landscape surrounding the gene of interest aided in the selection of enhancers for mutation screening. The success of these studies should provide a framework for following up on the large number of genome-wide association studies that have identified common variants in non-coding regions of the genome that associate with increased risk of human diseases including, diabetes, autism, Crohn's, colorectal cancer, and asthma, to name a few.

  8. Guide relative to the regulatory requirements applicable to the radioactive materials transport in airport area; Guide relatif aux exigences reglementaires applicables au transport des matieres radioactives en zone aeroportuaire

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2006-02-15

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

  9. 40 CFR Table 3 to Subpart G of... - Process Vents-Monitoring, Recordkeeping, and Reporting Requirements for Complying With 98 Weight...

    Science.gov (United States)

    2010-07-01

    ... combustion device other than a flare) (Continued) Scrubber liquid and gas flow rates 1. Continuous records of... data are collected f—PR. Flare Presence of a flame at the pilot light 1. Hourly records of whether the... flare are absent—PR. Recapture devices The appropriate monitoring device identified in table 4 when,...

  10. Regulatory Issues Surrounding Merchant Interconnection

    Energy Technology Data Exchange (ETDEWEB)

    Kuijlaars, Kees-Jan; Zwart, Gijsbert [Office for Energy Regulation (DTe), The Hague (Netherlands)

    2003-11-01

    We discussed various issues concerning the regulatory perspective on private investment in interconnectors. One might claim that leaving investment in transmission infrastructure to competing market parties is more efficient than relying on regulated investment only (especially in the case of long (DC) lines connecting previously unconnected parts of the grids, so that externalities from e.g. loop flows do not play a significant role). We considered that some aspects of interconnection might reduce these market benefits. In particular, the large fixed costs of interconnection construction may lead to significant under investment (due to both first mover monopoly power and the fact that part of generation cost efficiencies realised by interconnection are not captured by the investor itself, and remain external to the investment decision). Second, merchant ownership restricts future opportunities for adaptation of regulation, as would be required e.g. for introduction of potentially more sophisticated methods of congestion management or market splitting. Some of the disadvantages of merchant investment may be mitigated however by a suitable regulatory framework, and we discussed some views in this direction. The issues we discussed are not intended to give a complete framework, and detailed regulation will certainly involve many more specific requirements. Areas we did not touch upon include e.g. the treatment of deep connection costs, rules for operation and maintenance of the line, and impact on availability of capacity on other interconnections.

  11. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    Science.gov (United States)

    Sabata, Roger; Verges, Josep; Zugaza, José L.; Ruiz, Adolfina; Clares, Beatriz

    2016-01-01

    Mesenchymal stem cells (MSCs) are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs). The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP). Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs. PMID:27999600

  12. Mesenchymal Stem Cells as Therapeutics Agents: Quality and Environmental Regulatory Aspects

    Directory of Open Access Journals (Sweden)

    Patricia Galvez-Martin

    2016-01-01

    Full Text Available Mesenchymal stem cells (MSCs are one of the main stem cells that have been used for advanced therapies and regenerative medicine. To carry out the translational clinical application of MSCs, their manufacturing and administration in human must be controlled; therefore they should be considered as medicine: stem cell-based medicinal products (SCMPs. The development of MSCs as SCMPs represents complicated therapeutics due to their extreme complex nature and rigorous regulatory oversights. The manufacturing process of MSCs needs to be addressed in clean environments in compliance with requirements of Good Manufacturing Practice (GMP. Facilities should maintain these GMP conditions according to international and national medicinal regulatory frameworks that introduce a number of specifications in order to produce MSCs as safe SCMPs. One of these important and complex requirements is the environmental monitoring. Although a number of environmental requirements are clearly defined, some others are provided as recommendations. In this review we aim to outline the current issues with regard to international guidelines which impact environmental monitoring in cleanrooms and clean areas for the manufacturing of MSCs.

  13. Monitoring and control requirement definition study for Dispersed Storage and Generation (DSG). Volume 3, appendix B: State of the art, trends, and potential growth of selected DSG technologies

    Science.gov (United States)

    1980-01-01

    Present and future relatively small (30 MW) energy systems, such as solar thermal electric, photovoltaic, wind, fuel cell, storage battery, hydro, and cogeneration can help achieve national energy goals and can be dispersed throughout the distribution portion of an electric utility system. Based on current projections, it appears that dispersed storage and generation (DSG) electrical energy will comprise only a small portion, from 4 to 10 percent, of the national total by the end of this century. In general, the growth potential for DSG seems favorable in the long term because of finite fossil energy resources and increasing fuel prices. Recent trends, especially in the institutional and regulatory fields, favor greater use of the DSGs for the future.

  14. 75 FR 79929 - Semiannual Regulatory Agenda

    Science.gov (United States)

    2010-12-20

    ... be a ``significant regulatory action'' under the definition in Executive Order 12866. Beginning with the fall 2007 edition, the Internet became the basic means for disseminating the Unified Agenda. The... requirements. Additional information on these entries is available in the Unified Agenda published on...

  15. 76 FR 6587 - Pennsylvania Regulatory Program

    Science.gov (United States)

    2011-02-07

    ... regulation of surface coal mining and reclamation operations on non- Federal and non-Indian lands within its... the regulation of surface coal mining and reclamation operations in accordance with the requirements... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 938 Pennsylvania Regulatory Program...

  16. 77 FR 73966 - Utah Regulatory Program

    Science.gov (United States)

    2012-12-12

    ... regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 944 Utah Regulatory Program AGENCY: Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Proposed rule; reopening and...

  17. 75 FR 81120 - North Dakota Regulatory Program

    Science.gov (United States)

    2010-12-27

    ... regulation of surface coal mining and reclamation operations in accordance with the requirements of this Act... regard to the regulation of surface coal mining and reclamation operations. One of the purposes of SMCRA... Office of Surface Mining Reclamation and Enforcement 30 CFR Part 934 North Dakota Regulatory Program...

  18. Regulatory considerations for translating gene therapy: a European Union perspective.

    Science.gov (United States)

    Galli, Maria Cristina

    2009-11-11

    A preclinical study on a gene therapy approach for treatment of the severe muscle weakness associated with a variety of neuromuscular disorders provides a forum to discuss the translational challenges of gene therapy from a regulatory point of view. In this Perspective, the findings are considered from the view of European regulatory requirements for first clinical use.

  19. Rationales for regulatory activity

    Energy Technology Data Exchange (ETDEWEB)

    Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

    1997-02-01

    The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

  20. New regulatory framework for wastewater quality control in Mexico.

    Science.gov (United States)

    Saade Hazin, L

    2000-01-01

    This paper analyses the new regulatory framework for wastewater quality control developed in Mexico. It provides a description of the Mexican government strategies for water pollution control. The discussion focuses on the policy instruments used, their evolution and the main difficulties encountered in their implementation. The new regulatory framework is discussed highlighting some of the economic implications of the reforms. The paper concludes that proper institutional development and monitoring are essential factors for the success of any policy instrument for wastewater quality control.

  1. Groundwater Monitoring of Land Application with Manure, Biosolids, and other Organic Residuals

    Science.gov (United States)

    Harter, T.; Lawrence, C.; Atwill, E. R.; Kendall, C.

    2007-12-01

    Regulatory programs frequently require monitoring of first encountered (shallow-most) groundwater for purposes of determining whether an actual or potential, permitted or incidental waste discharge has had or will have a degrading effect on groundwater quality. Traditionally, these programs have focused on monitoring of incidental discharges from industrial sites. Increasingly, sources with an implied groundwater recharge are subject to monitoring requirements. These recharging sources include, for example, land application of municipal, food processing, or animal waste to irrigated cropland. Groundwater monitoring of a recharging source requires a different approach to groundwater monitoring than traditional (incidental source) monitoring programs. Furthermore, the shallow groundwater aquifer targeted for compliance monitoring commonly consists of highly heterogeneous unconsolidated alluvial, fluvial, lacustrine, glacial, or subaeolian sediments of late tertiary or quaternary age. Particularly in arid and semi-arid climates, groundwater is also frequently subject to significant seasonal and interannual groundwater level fluctuations that may exceed ten feet seasonally and several tens of feet within a three- to five-year period. We present a hydrodynamically rigorous approach to designing groundwater monitoring wells for recharging sources under conditions of aquifer heterogeneity and water level fluctuations and present the application of this concept to monitoring confined animal farming operations (CAFOs) with irrigated crops located on alluvial fans with highly fluctuating, deep groundwater table.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2008-06-01

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

  3. Prediction of regulatory elements

    DEFF Research Database (Denmark)

    Sandelin, Albin

    2008-01-01

    Finding the regulatory mechanisms responsible for gene expression remains one of the most important challenges for biomedical research. A major focus in cellular biology is to find functional transcription factor binding sites (TFBS) responsible for the regulation of a downstream gene. As wet-lab...

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

    Energy Technology Data Exchange (ETDEWEB)

    Garcia-Talavera, M., E-mail: mgtm@csn.e [Consejo de Seguridad Nuclear (CSN), Justo Dorado, 11, E-28040 Madrid (Spain); Matarranz, J.L.M.; Salas, R.; Ramos, L. [Consejo de Seguridad Nuclear (CSN), Justo Dorado, 11, E-28040 Madrid (Spain)

    2011-01-15

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

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

    Science.gov (United States)

    Tarazona, Jose V

    2013-07-01

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

  6. VHA mental health information system: applying health information technology to monitor and facilitate implementation of VHA Uniform Mental Health Services Handbook requirements.

    Science.gov (United States)

    Trafton, Jodie A; Greenberg, Greg; Harris, Alex H S; Tavakoli, Sara; Kearney, Lisa; McCarthy, John; Blow, Fredric; Hoff, Rani; Schohn, Mary

    2013-03-01

    To describe the design and deployment of health information technology to support implementation of mental health services policy requirements in the Veterans Health Administration (VHA). Using administrative and self-report survey data, we developed and fielded metrics regarding implementation of the requirements delineated in the VHA Uniform Mental Health Services Handbook. Finalized metrics were incorporated into 2 external facilitation-based quality improvement programs led by the VHA Mental Health Operations. To support these programs, tailored site-specific reports were generated. Metric development required close collaboration between program evaluators, policy makers and clinical leadership, and consideration of policy language and intent. Electronic reports supporting different purposes required distinct formatting and presentation features, despite their having similar general goals and using the same metrics. Health information technology can facilitate mental health policy implementation but must be integrated into a process of consensus building and close collaboration with policy makers, evaluators, and practitioners.

  7. 76 FR 411 - Regulatory Guidance Concerning Electronic Signatures and Documents

    Science.gov (United States)

    2011-01-04

    ... govern the Agency's implementation of electronic document and signature requirements. The Government... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration Regulatory Guidance Concerning Electronic Signatures and...

  8. Remote Real-Time Monitoring of Subsurface Landfill Gas Migration

    Directory of Open Access Journals (Sweden)

    Alan F. Smeaton

    2011-06-01

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

  9. Groundwater Monitoring Plan for the Solid Waste Landfill

    Energy Technology Data Exchange (ETDEWEB)

    JW Lindberg; CJ Chou

    2000-12-14

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

  10. French Regulatory practice and experience feedback on steam generator tube integrity

    Energy Technology Data Exchange (ETDEWEB)

    Sandon, G.

    1997-02-01

    This paper summarizes the way the French Safety Authority applies regulatory rules and practices to the problem of steam generator tube cracking in French PWR reactors. There are 54 reactors providing 80% of French electrical consumption. The Safety Authority closely monitors the performance of tubes in steam generators, and requires application of a program which deals with problems prior to the actual development of leakage. The actual rules regarding such performance are flexible, responding to the overall performance of operating steam generators. In addition there is an inservice inspection service to examine tubes during shutdown, and to monitor steam generators for leakage during operation, with guidelines for when generators must be pulled off line.

  11. Type 2 innate lymphoid cell suppression by regulatory T cells attenuates airway hyperreactivity and requires inducible T-cell costimulator-inducible T-cell costimulator ligand interaction.

    Science.gov (United States)

    Rigas, Diamanda; Lewis, Gavin; Aron, Jennifer L; Wang, Bowen; Banie, Homayon; Sankaranarayanan, Ishwarya; Galle-Treger, Lauriane; Maazi, Hadi; Lo, Richard; Freeman, Gordon J; Sharpe, Arlene H; Soroosh, Pejman; Akbari, Omid

    2017-05-01

    Atopic diseases, including asthma, exacerbate type 2 immune responses and involve a number of immune cell types, including regulatory T (Treg) cells and the emerging type 2 innate lymphoid cells (ILC2s). Although ILC2s are potent producers of type 2 cytokines, the regulation of ILC2 activation and function is not well understood. In the present study, for the first time, we evaluate how Treg cells interact with pulmonary ILC2s and control their function. ILC2s and Treg cells were evaluated by using in vitro suppression assays, cell-contact assays, and gene expression panels. Also, human ILC2s and Treg cells were adoptively transferred into NOD SCID γC-deficient mice, which were given isotype or anti-inducible T-cell costimulator ligand (ICOSL) antibodies and then challenged with IL-33 and assessed for airway hyperreactivity. We show that induced Treg cells, but not natural Treg cells, effectively suppress the production of the ILC2-driven proinflammatory cytokines IL-5 and IL-13 both in vitro and in vivo. Mechanistically, our data reveal the necessity of inducible T-cell costimulator (ICOS)-ICOS ligand cell contact for Treg cell-mediated ILC2 suppression alongside the suppressive cytokines TGF-β and IL-10. Using a translational approach, we then demonstrate that human induced Treg cells suppress syngeneic human ILC2s through ICOSL to control airway inflammation in a humanized ILC2 mouse model. These findings suggest that peripheral expansion of induced Treg cells can serve as a promising therapeutic target against ILC2-dependent asthma. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

  12. Statutory Management Requirements on "Animal Identification and Registration" (Act A7, Act A8: monitoring methods for compliance and related costs in four Italian farms

    Directory of Open Access Journals (Sweden)

    Marisanna Speroni

    2015-11-01

    Full Text Available The European and national laws concerning the identification and registration of livestock are meant to make possible their traceability and facilitate food safety and animal health, especially in case of a disease outbreak; such rules have also become prerequisites that farmers must meet to obtain single farm payments under the common agricultural policy. Failure to comply with these obligations entails the reduction or exclusion from direct payments. Act A7, reports the obligations imposed by the EC Regulation 1760/2000 establishing a system for the identification and registration of bovine animals and regarding the labelling of beef and beef products; Act A8, report the obligations established by the EC Reg. 21/2004 establishing a system for the identification and registration of sheep and goats. The project MO.NA.CO. monitored the application of rules for identification and registration of cattle, sheep and goats and their costs. The system of identification and registration of dairy cows resulted well organized with a good level of coordination between the involved actors in both farms. The activities necessary for compliance with rules of identification and registration of cattle are distributed throughout the year, but vary from day to day. The average total cost for annual obligations amounted to € 533.34 year-1 while the average cost for individual fulfilment in the monitoring period amounted to € 4.10. Even in the case of sheep and goats, the monitoring showed a good cooperation between farms and technicians. However, some difficulties were detected, mainly due to the size of the rumen boluses and the limited effectiveness of the ear tags. The operators suggested using smaller rumen boluses and tattoo instead of ear tags; they also suggest to extend the period within which the animals have to be labelled from the current 6 months to 9 months. The cost of compliance amounted to € 5.27 head-1 for sheep and € 4.90 head-1 for

  13. Nuclear Regulatory Commission information digest

    Energy Technology Data Exchange (ETDEWEB)

    None,

    1990-03-01

    The Nuclear Regulatory Commission information digest provides summary information regarding the US Nuclear Regulatory Commission, its regulatory responsibilities, and areas licensed by the commission. This is an annual publication for the general use of the NRC Staff and is available to the public. The digest is divided into two parts: the first presents an overview of the US Nuclear Regulatory Commission and the second provides data on NRC commercial nuclear reactor licensees and commercial nuclear power reactors worldwide.

  14. Regulatory T cells as immunotherapy

    Directory of Open Access Journals (Sweden)

    Benjamin David Singer

    2014-02-01

    Full Text Available Regulatory T cells (Tregs suppress exuberant immune system activation and promote immunologic tolerance. Because Tregs modulate both innate and adaptive immunity, the biomedical community has developed intense interest in using Tregs for immunotherapy. Conditions that require clinical tolerance to improve outcomes—autoimmune disease, solid organ transplantation, and hematopoietic stem cell transplantation—may benefit from Treg immunotherapy. Investigators have designed ex vivo strategies to isolate, preserve, expand, and infuse Tregs. Protocols to manipulate Treg populations in vivo have also been considered. Barriers to clinically feasible Treg immunotherapy include Treg stability, off-cell effects, and demonstration of cell preparation purity and potency. Clinical trials involving Treg adoptive transfer to treat graft versus host disease preliminarily demonstrated the safety and efficacy of Treg immunotherapy in humans. Future work will need to confirm the safety of Treg immunotherapy and establish the efficacy of specific Treg subsets for the treatment of immune-mediated disease.

  15. Contamination monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Alamares, A.L. [Philippine Nuclear Research Inst., Diliman, Quezon City (Philippines)

    1997-06-01

    By virture of Republic Act 2067, as amended the Philippine Atomic Energy Commission (PAEC), now renamed Philippine Nuclear Research Institute (PNRI) is the government agency charged with the regulations and control of radioactive materials in the Philippines. The protection against the hazards of non-ionizing radiation is being monitored by the Radiological Health Service (RHS) of the Department of Health pursuant to the provision of Presidental Decree 480. The RHS issues licenses for possession, handling, and use of x-ray machines and equipment, both industrial and medical, and provide radiation protection training to x-ray technologists and technicians. As part of its regulatory function, the PNRI is charged with the responsibility of assuring that the radiation workers and the public are protected from the hazards associated with the possession, handling, production, manufacturing, and the use of radioactive materials and atomic energy facilities in the Philippines. The protection of radiation workers from the hazards of ionizing radiation has always been a primary concern of PNRI and by limiting the exposure of radiation workers, the risk to population is kept to within acceptable level. In this paper, the following items are described: radiation protection program, radiation protection services, radiation control, and problems encountered/recommendation. (G.K.)

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-05-01

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

  17. 77 FR 61449 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2012-10-09

    ..., regulatory and other risks of this business activity. These controls include financial risk management... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed...

  18. 77 FR 61463 - Self-Regulatory Organizations; EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

    Science.gov (United States)

    2012-10-09

    ..., regulatory and other risks of this ] business activity. These controls include financial risk management... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed...

  19. Hastening the regulatory process

    Energy Technology Data Exchange (ETDEWEB)

    Stringham, G. [Canadian Association of Petroleum Producers, Calgary, AB (Canada)

    2001-07-01

    The state of the Canadian oil industry was discussed during this power point presentation with particular emphasis on its production, exports, drilling, industry revenues and capital investment levels. The proposed projects in each of northern Alberta's oil sands deposits, the Athabasca, Peace River and Cold Lake were were announced, along with the inventory of major Alberta projects and the projection of oil sands capital investment. Since 1998, $9 billion has been invested and a further $33 billion has been announced for new or expanded oil sands projects. The year 2000 estimates for Canadian crude oil and natural gas production are 2.3 million barrels per day and 6.3 trillion cubic feet per year respectively. This represented a record year for production of both crude oil and natural gas. In 2000, more than 15,500 wells were drilled in Canada. A graph depicting Canadian crude oil supply forecasted a steady increase in supply from year 2000 to 2010. The Canadian Association of Petroleum Producers (CAPP) completed a review of the Alberta Energy and Utilities Board regulatory and enforcement processes. Both industry and government efforts are focusing on eliminating regulatory overlap and duplication. Some of the main areas of interest for exploration, drilling, production and pipeline facilities include the examination of regulatory processes for environmentally sensitive areas, rural municipalities with planning bylaws, aboriginal lands and additional fees. 8 figs.

  20. Is viscoelastic coagulation monitoring with ROTEM or TEG validated?

    Science.gov (United States)

    Solomon, Cristina; Asmis, Lars M; Spahn, Donat R

    2016-10-01

    Recent years have seen increasing worldwide interest in the use of viscoelastic coagulation monitoring tests, performed using devices such as ROTEM and TEG. The use of such tests to guide haemostatic therapy may help reduce transfusion of allogeneic blood products in bleeding patients and is supported in European guidelines for managing trauma and severe perioperative bleeding. In addition, viscoelastic tests form the basis of numerous published treatment algorithms. However, some publications have stated that viscoelastic tests are not validated. A specific definition of the term validation is lacking and regulatory requirements of the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have been fulfilled by ROTEM and TEG assays. Viscoelastic tests have been used in pivotal clinical trials, and they are approved for use in most of the world's countries. Provided that locally approved indications are adhered to, the regulatory framework for clinicians to use viscoelastic tests in routine clinical practice is in place.

  1. Water-Level Monitoring Plan for the Hanford Groundwater Monitoring Project

    Energy Technology Data Exchange (ETDEWEB)

    D.R. Newcomer; J.P. McDonald; M.A. Chamness

    1999-09-30

    This document presents the water-level monitoring plan for the Hanford Groundwater Monitoring Project, conducted by the Pacific Northwest National Laboratory (PNNL). Water-level monitoring of the groundwater system beneath the Hanford Site is performed to fulfill the requirements of various state and federal regulations, orders, and agreements. The primary objective of this monitoring is to determine groundwater flow rates and directions. To meet this and other objectives, water-levels are measured annually in monitoring wells completed within the unconfined aquifer system, the upper basalt-confined aquifer system, and in the lower basalt-confined aquifers for surveillance monitoring. At regulated waste units, water levels are taken monthly, quarterly, semi-annually, or annually, depending on the hydrogeologic conditions and regulatory status of a given site. The techniques used to collect water-level data are described in this document along with the factors that affect the quality of the data and the strategies employed by the project to minimize error in the measurement and interpretation of water levels. Well networks are presented for monitoring the unconfined aquifer system, the upper basalt-confined aquifer system, and the lower basalt-confined aquifers, all at a regional scale (surveillance monitoring), as well as the local-scale well networks for each of the regulated waste units studied by this project (regulated-unit monitoring). The criteria used to select wells for water-table monitoring are discussed. It is observed that poor well coverage for surveillance water-table monitoring exists south and west of the 200-West Area, south of the 100-F Area, and east of B Pond and the Treated Effluent Disposal Facility (TEDF). This poor coverage results from a lack of wells suitable for water-table monitoring, and causes uncertainty in representation of the regional water-table in these areas. These deficiencies are regional in scale and apply to regions outside

  2. Catering to Regulatory Requirements and Application of Fair Value Accounting:Evidence from Listed Banks in China%迎合监管与公允价值会计运用--来自中国上市银行的经验证据

    Institute of Scientific and Technical Information of China (English)

    谭洪涛; 汪洁; 黄晓芝

    2014-01-01

    By using a data set of Chinese listed commercial banks from 2007 -2012, this paper investigates the relationship between fair value accounting and adjusted behaviors of commercial banks catering to the regulatory requirements.It's found that (1 ) The preference and adoption level of fair value accounting in China's commercial banks have a significant impact on their capital adequacy ratios;(2 )When commercial banks face the regulatory pressure on the core capital adequacy ratio,bank management prefers to holding financial assets held for trading to manipulate bank capital;(3 )When the current capital adequacy ratio predicted at a low level,bank management also prefers to holding financial assets held for trading.Further study does not find significant difference between the four major state-owned commercial banks and other banks in use of fair value accounting to meet regulatory requirements.The research result provides empirical evidence on behavior adjustments of commercial banks to cater to regulatory requirements by adopting fair value accounting in capital management,and also supports the execution of Regulating the Capital Adequacy Requirement ofCommercial Banks (Trial)on January 1,2013 in China.%以我国A股上市银行2007-2012年数据为研究样本,分析公允价值会计的引入与商业银行迎合资本监管行为调整之间的关系。研究发现:(1)我国商业银行采用公允价值会计的偏好及运用程度确实对其资本充足率产生重要影响;(2)当商业银行面临核心资本充足率监管压力时,银行管理层倾向于持有交易性金融资产进行资本管理;(3)当商业银行预计当期资本充足率较低时,管理层倾向于持有交易性金融资产。进一步研究发现,四大国有银行与非四大国有商业银行在运用公允价值会计迎合监管行为方面没有显著差异。研究结论为商业银行存在迎合资本监管要求而利用公允价值会计进行

  3. 40 CFR 74.61 - Monitoring plan.

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Monitoring plan. 74.61 Section 74.61... OPT-INS Monitoring Emissions: Combustion Sources § 74.61 Monitoring plan. (a) Monitoring plan. The... monitoring plan that includes the information required in a monitoring plan under § 75.53 of this...

  4. User requirements and user acceptance of current and next-generation satellite mission and sensor complement, oriented toward the monitoring of water resources

    Science.gov (United States)

    Castruccio, P. A.; Loats, H. L., Jr.; Fowler, T. R.; Robinson, P.

    1975-01-01

    Principal water resources users were surveyed to determine the applicability of remotely sensed data to their present and future requirements. Analysis of responses was used to assess the levels of adequacy of LANDSAT 1 and 2 in fulfilling hydrological functions, and to derive systems specifications for future water resources-oriented remote sensing satellite systems. The analysis indicates that water resources applications for all but the very large users require: (1) resolutions on the order of 15 meters, (2) a number of radiometric levels of the same order as currently used in LANDSAT 1 (64), (3) a number of spectral bands not in excess of those used in LANDSAT 1, and (4) a repetition frequency on the order of 2 weeks. The users had little feel for the value of new sensors (thermal IR, passive and active microwaves). What is needed in this area is to achieve specific demonstrations of the utility of these sensors and submit the results to the users to evince their judgement.

  5. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure - appendices. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J.; McDuffie, P.N.

    1996-07-01

    The NRC staff is in need of decommissioning bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System`s Washington Nuclear Plant Two (WNP-2) located at Richland, Washington, including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not presently part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clear structures on the site and to restore the site to a {open_quotes}green field{close_quotes} condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities. Sensitivity of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances is also examined.

  6. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure - main report. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J.; McDuffie, P.N.

    1996-07-01

    The NRC staff is in need of updated bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System`s Washington Nuclear Plant Two (WNP-2), which is a boiling water reactor (BWR), located at Richland, Washington, including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives. These alternatives now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. Included for information (but not part of the license termination cost) is an estimate of the cost to demolish the decontaminated and clean structures on the site and to restore the site to a {open_quotes}green field{close_quotes} condition. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low- level waste (i.e., Greater-Than-Class C), and reflects 1993 costs for labor, materials, transport, and disposal activities. Sensitivity of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances is also examined.

  7. Occupational noise exposure and regulatory adherence in music venues in the United Kingdom.

    Science.gov (United States)

    Barlow, Christopher; Castilla-Sanchez, Francisco

    2012-01-01

    Noise in most working environments is an unwanted by-product of the process. In most countries, noise exposure for workers has been controlled by legislation for many years. In the music industry the "noise" is actually the "desired" product, and for a long time the UK entertainment industry was exempt from these regulations. From April 2008, however, it became regulated under the Noise at Work Regulations 2005, meaning that employers from orchestras to nightclubs are legally required to adhere to the same requirements (based on ISO 9612:2009) for controlling noise exposure for their staff that have been applied to other industries for many years. A key question is to what degree, 2 years after implementation, these employers are complying with their legal responsibilities to protect the staff from noise? This study assessed four public music venues where live and/or recorded music is regularly played. Thirty staff members in different roles in the venues were monitored using noise dosimetry to determine noise exposure. Questionnaires were used to determine work patterns, attitudes to noise and hearing loss, and levels of training about noise risk. Results showed that the majority of staff (70%) in all venues exceeded the daily noise exposure limit value in their working shift. Use of hearing protection was rare (noise was low, and implementation of the noise regulations was haphazard, with staff regularly exceeding regulatory limits. The implication is that the industry is failing to meet regulatory requirements.

  8. Politically Induced Regulatory Risk and Independent Regulatory Agencies

    OpenAIRE

    Strausz, Roland

    2015-01-01

    Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...

  9. Differential conformational requirements for activation of G proteins and the regulatory proteins arrestin and G protein-coupled receptor kinase in the G protein-coupled receptor for parathyroid hormone (PTH)/PTH-related protein.

    Science.gov (United States)

    Vilardaga, J P; Frank, M; Krasel, C; Dees, C; Nissenson, R A; Lohse, M J

    2001-09-07

    After stimulation with agonist, G protein-coupled receptors (GPCRs) activate G proteins and become phosphorylated by G protein-coupled receptor kinases (GRKs), and most of them translocate cytosolic arrestin proteins to the cytoplasmic membrane. Agonist-activated GPCRs are specifically phosphorylated by GRKs and are targeted for endocytosis by arrestin proteins, suggesting a connection between GPCR conformational changes and interaction with GRKs and arrestins. Previously, we showed that by substitution of histidine for residues at the cytoplasmic side of helix 3 (H3) and helix 6 (H6) of the parathyroid hormone (PTH) receptor (PTHR), a zinc metal ion-binding site is engineered that prevents PTH-stimulated G(s) activation (Sheikh, S. P., Vilardaga, J.-P., Baranski, T. J., Lichtarge, O., Iiri, T., Meng, E. C., Nissenson, R. A., and Bourne, H. R. (1999) J. Biol. Chem. 274, 17033-17041). These data suggest that relative movements between H3 and H6 are critical for G(s) activation. Does this molecular event play a similar role in activation of GRK and arrestin and in PTHR-mediated G(q) activation? To answer this question, we utilized the two previously described mutant forms of PTHR, H401 and H402, which contain a naturally present histidine residue at position 301 in H3 and a second substituted histidine residue at positions 401 and 402 in H6, respectively. Both mutant receptors showed inhibition of PTH-stimulated inositol phosphate and cAMP generation in the presence of increasing concentrations of Zn(II). However, the mutants showed no Zn(II)-dependent impairment of phosphorylation by GRK-2. Likewise, the mutants were indistinguishable from wild-type PTHR in the ability to translocate beta-arrestins/green fluorescent protein to the cell membrane and were also not affected by sensitivity to Zn(II). These results suggest that agonist-mediated phosphorylation and internalization of PTHR require conformational switches of the receptor distinct from the cAMP and inositol

  10. Clinical research: regulatory issues.

    Science.gov (United States)

    Wermeling, D P

    1999-02-01

    The regulatory issues faced by institutions performing clinical research are described. Many institutions do not have on staff an expert who understands the regulatory issues involved in managing investigational new drug research and who knows the institution's obligations under the federal rules. Because pharmacists understand the FDA regulations that apply to the management of drugs in clinical research, institutions are asking pharmacists to expand their role and manage clinical research offices. Many authorities govern various aspects of investigational drug research. FDA has published regulations for good clinical practice (GCP), and the International Conference on Harmonisation is developing an international standard for the proper management of clinical trials. The guidelines published by the Joint Commission on Accreditation of Healthcare Organizations aim to protect patients who are in the institution to receive health care and also participate in clinical trials. The Social Security Administration Acts specifically state that only items and services that are reasonable and necessary for the diagnosis and treatment of injury or disease can be billed to the government; research-related billings are excluded from coverage. Proper management of drug research is crucial to the success of a research program that is integrated with patient care.

  11. Toxicogenomics in regulatory ecotoxicology

    Science.gov (United States)

    Ankley, Gerald T.; Daston, George P.; Degitz, Sigmund J.; Denslow, Nancy D.; Hoke, Robert A.; Kennedy, Sean W.; Miracle, Ann L.; Perkins, Edward J.; Snape, Jason; Tillitt, Donald E.; Tyler, Charles R.; Versteeg, Donald

    2006-01-01

    Recently, we have witnessed an explosion of different genomic approaches that, through a combination of advanced biological, instrumental, and bioinformatic techniques, can yield a previously unparalleled amount of data concerning the molecular and biochemical status of organisms. Fueled partially by large, well-publicized efforts such as the Human Genome Project, genomic research has become a rapidly growing topical area in multiple biological disciplines. Since 1999, when the term “toxicogenomics” was coined to describe the application of genomics to toxicology (1), a rapid increase in publications on the topic has occurred (Figure 1). The potential utility of toxicogenomics in toxicological research and regulatory activities has been the subject of scientific discussions and, as with any new technology, has evoked a wide range of opinion (2–6). VIEWPOINT © 2006 american chemical Society july 1, 2006 / EnvironmEntal SciEncE & tEchnology n 4055 The purpose of this feature article is to consider the roles of toxicogenomics in the field of regulatory ecotoxicology, explore current limitations in the science and practice of genomics, and propose possible avenues to approach and resolve some of the major challenges. A significant amount of input to our analysis came from a workshop sponsored by the Society of Environmental Toxicology and Chemistry (SETAC) in Pellston, Mich., in September 2005. A complete list of names and affiliations of the experts participating in that workshop is provided online in Table 1 of the Supporting Information for this paper.

  12. Regulatory Challenges for Cartilage Repair Technologies.

    Science.gov (United States)

    McGowan, Kevin B; Stiegman, Glenn

    2013-01-01

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

  13. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

    Bommarito, Michael J., II; Katz, Daniel Martin

    2017-07-01

    Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

  14. Measuring and Modeling the U.S. Regulatory Ecosystem

    Science.gov (United States)

    Bommarito, Michael J., II; Katz, Daniel Martin

    2017-09-01

    Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

  15. The role of veterinary medicine regulatory agencies.

    Science.gov (United States)

    Smith, M V

    2013-08-01

    An effective animal medicine regulatory programme includes a systematic, evidence-based means of documenting the safety and effectiveness of products before they are produced, marketed or used in a particular country or region. The programme must also include adequate monitoring and controls over the use of these substances. It is clearthat such programmes provide veterinarians, farmers and other animal medicine users with greater assurance that veterinary drugs and biologicals will be safe and effective in preventing and mitigating disease. It is important that these regulatory controls include programmes to ensure that human food obtained from treated animals is safe and that all potential toxicological and microbiological hazards that may be associated with the use of veterinary medicines have been adequately evaluated. There is a great need worldwide for veterinary medicines that provide needed therapies for vast numbers of animals and animal species and, in the case of food-producing animals, for medicinal products that enhance the productivity and efficiency of food production and ensure food safety when they are used in accordance with their approval specifications. The public health mission of regulatory agencies succeeds when they are able to put into the hands of the user an approved, safe and effective, well-manufactured and appropriately labelled medicine, and when there are adequate controls in place to assure proper compliance.

  16. Impact of regulatory science on global public health.

    Science.gov (United States)

    Patel, Meghal; Miller, Margaret Ann

    2012-07-01

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

  17. Robust, low-cost data loggers for stream temperature, flow intermittency, and relative conductivity monitoring

    Science.gov (United States)

    Chapin, Thomas; Todd, Andrew S.; Zeigler, Matthew P.

    2014-01-01

    Water temperature and streamflow intermittency are critical parameters influencing aquatic ecosystem health. Low-cost temperature loggers have made continuous water temperature monitoring relatively simple but determining streamflow timing and intermittency using temperature data alone requires significant and subjective data interpretation. Electrical resistance (ER) sensors have recently been developed to overcome the major limitations of temperature-based methods for the assessment of streamflow intermittency. This technical note introduces the STIC (Stream Temperature, Intermittency, and Conductivity logger); a robust, low-cost, simple to build instrument that provides long-duration, high-resolution monitoring of both relative conductivity (RC) and temperature. Simultaneously collected temperature and RC data provide unambiguous water temperature and streamflow intermittency information that is crucial for monitoring aquatic ecosystem health and assessing regulatory compliance. With proper calibration, the STIC relative conductivity data can be used to monitor specific conductivity.

  18. NGNP Project Regulatory Gap Analysis for Modular HTGRs

    Energy Technology Data Exchange (ETDEWEB)

    Wayne Moe

    2011-09-01

    The Next Generation Nuclear Plant (NGNP) Project Regulatory Gap Analysis (RGA) for High Temperature Gas-Cooled Reactors (HTGR) was conducted to evaluate existing regulatory requirements and guidance against the design characteristics specific to a generic modular HTGR. This final report presents results and identifies regulatory gaps concerning current Nuclear Regulatory Commission (NRC) licensing requirements that apply to the modular HTGR design concept. This report contains appendices that highlight important HTGR licensing issues that were found during the RGA study. The information contained in this report will be used to further efforts in reconciling HTGR-related gaps in the NRC licensing structure, which has to date largely focused on light water reactor technology.

  19. Global nuclear material monitoring

    Energy Technology Data Exchange (ETDEWEB)

    Howell, J.A.; Monlove, H.O.; Goulding, C.A.; Martinez, B.J.; Coulter, C.A.

    1997-08-01

    This is the final report of a one-year Laboratory-Directed Research and Development (LDRD) project at the Los Alamos National Laboratory (LANL). This project provided a detailed systems design for advanced integrated facility monitoring and identified the components and enabling technologies required to facilitate the development of the monitoring system of the future.

  20. Lunar Health Monitor Project

    Data.gov (United States)

    National Aeronautics and Space Administration — Orbital Research has successfully demonstrated a dry electrode (no electrolyte or gel required) for heart rate and ECG monitoring. Preliminary data has indicated...

  1. Regulatory mark; Marco regulatorio

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2009-10-15

    This chapter is based on a work performed in distinct phases. The first phase consisted in of the analysis regulatory legislation existent in Brazil for the sugar-alcohol sector since the beginning of the X X century. This analysis allowed the identification of non existent points and legal devices related to the studied aspects, and that were considered as problematic for the sector expansion. In the second phase, related treaties and international agreements was studied and possible obstacles for the brazilian bio ethanol exportation for the international market. Initiatives were examined at European Union, United States of America, Caribbean and countries of the sub-Saharan Africa. In this phase, policies were identified related to the incentives and adoption of use of bio fuels added to the gasoline in countries or group of countries considered as key for the consolidation of bio ethanol as a world commodity.

  2. Adaptation by Plasticity of Genetic Regulatory Networks

    Science.gov (United States)

    Brenner, Naama

    2007-03-01

    Genetic regulatory networks have an essential role in adaptation and evolution of cell populations. This role is strongly related to their dynamic properties over intermediate-to-long time scales. We have used the budding yeast as a model Eukaryote to study the long-term dynamics of the genetic regulatory system and its significance in evolution. A continuous cell growth technique (chemostat) allows us to monitor these systems over long times under controlled condition, enabling a quantitative characterization of dynamics: steady states and their stability, transients and relaxation. First, we have demonstrated adaptive dynamics in the GAL system, a classic model for a Eukaryotic genetic switch, induced and repressed by different carbon sources in the environment. We found that both induction and repression are only transient responses; over several generations, the system converges to a single robust steady state, independent of external conditions. Second, we explored the functional significance of such plasticity of the genetic regulatory network in evolution. We used genetic engineering to mimic the natural process of gene recruitment, placing the gene HIS3 under the regulation of the GAL system. Such genetic rewiring events are important in the evolution of gene regulation, but little is known about the physiological processes supporting them and the dynamics of their assimilation in a cell population. We have shown that cells carrying the rewired genome adapted to a demanding change of environment and stabilized a population, maintaining the adaptive state for hundreds of generations. Using genome-wide expression arrays we showed that underlying the observed adaptation is a global transcriptional programming that allowed tuning expression of the recruited gene to demands. Our results suggest that non-specific properties reflecting the natural plasticity of the regulatory network support adaptation of cells to novel challenges and enhance their evolvability.

  3. Integrated monitoring plan for the Hanford groundwater monitoring project

    Energy Technology Data Exchange (ETDEWEB)

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

    1998-09-01

    Groundwater is monitored in hundreds of wells at the Hanford Site to fulfill a variety of requirements. Separate monitoring plans are prepared for various requirements, but sampling is coordinated and data are shared among users to avoid duplication of effort. The US Department of Energy (DOE) manages these activities through the Hanford Groundwater Monitoring Project (groundwater project), which is the responsibility of Pacific Northwest National Laboratory. The groundwater project does not include all of the monitoring to assess performance of groundwater remediation or all monitoring associated with active facilities. This document is the first integrated monitoring plan for the groundwater project and contains: well and constituent lists for monitoring required by the Atomic Energy Act of 1954 and its implementing orders; other, established monitoring plans by reference; and a master well/constituent/frequency matrix for the entire Hanford Site.

  4. 75 FR 54210 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

    Science.gov (United States)

    2010-09-03

    ...-2010-032] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of... Transactions August 30, 2010. On June 17, 2010, the Financial Industry Regulatory Authority, Inc....

  5. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Main report, draft report for comment. Volume 1

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J. [Pacific Northwest Lab., Richland, WA (United States)] [and others

    1994-09-01

    On June 27, 1988, the U.S. Nuclear Regulatory Commission (NRC) published in the Federal Register (53 FR 24018) the final rule for the General Requirements for Decommissioning Nuclear Facilities. With the issuance of the final rule, owners and operators of licensed nuclear power plants are required to prepare, and submit to the NRC for review, decommissioning plans and cost estimates. The NRC staff is in need of updated bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System`s Washington Nuclear Plant Two (WNP-2), including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB alternatives, which now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste. Costs for labor, transport, and disposal activities are given in 1993 dollars. Sensitivities of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances are also examined.

  6. Revised analyses of decommissioning for the reference boiling water reactor power station. Effects of current regulatory and other considerations on the financial assurance requirements of the decommissioning rule and on estimates of occupational radiation exposure: Appendices, draft report for comment. Volume 2

    Energy Technology Data Exchange (ETDEWEB)

    Smith, R.I.; Bierschbach, M.C.; Konzek, G.J. [Pacific Northwest Lab., Richland, WA (United States)] [and others

    1994-09-01

    On June 27, 1988, the U.S. Nuclear Regulatory Commission (NRC) published in the Federal Register (53 FR 24018) the final rule for the General Requirements for Decommissioning Nuclear Facilities. With the issuance of the final rule, owners and operators of licensed nuclear power plants are required to prepare, and submit to the NRC for review, decommissioning plans and cost estimates. The NRC staff is in need of updated bases documentation that will assist them in assessing the adequacy of the licensee submittals, from the viewpoint of both the planned actions, including occupational radiation exposure, and the probable costs. The purpose of this reevaluation study is to update the needed bases documentation. This report presents the results of a review and reevaluation of the PNL 1980 decommissioning study of the Washington Public Power Supply System`s WNP-2, including all identifiable factors and cost assumptions which contribute significantly to the total cost of decommissioning the plant for the DECON, SAFSTOR, and ENTOMB decommissioning alternatives, which now include an initial 5-7 year period during which time the spent fuel is stored in the spent fuel pool prior to beginning major disassembly or extended safe storage of the plant. This report also includes consideration of the NRC requirement that decontamination and decommissioning activities leading to termination of the nuclear license be completed within 60 years of final reactor shutdown, consideration of packaging and disposal requirements for materials whose radionuclide concentrations exceed the limits for Class C low-level waste. Costs for labor, materials, transport, and disposal activities are given in 1993 dollars. Sensitivities of the total license termination cost to the disposal costs at different low-level radioactive waste disposal sites, to different depths of contaminated concrete surface removal within the facilities, and to different transport distances are also examined.

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

    Energy Technology Data Exchange (ETDEWEB)

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

    1992-04-01

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

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

    Science.gov (United States)

    Massmann, Joel; Freeze, R. Allan

    1987-02-01

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

  9. 76 FR 16627 - Statutory Provisions Affecting State Appraiser Regulatory Programs

    Science.gov (United States)

    2011-03-24

    ... the authority of the Appraisal Subcommittee (ASC) and requirements for States' appraiser regulatory... Programs, on March 18, 2011. The Appraisal Subcommittee (ASC) is issuing this Bulletin to State Appraiser... requirements for State licensing in a State with criteria for the licensing of a real estate...

  10. Regulatory focus in groupt contexts

    NARCIS (Netherlands)

    Faddegon, Krispijn Johannes

    2009-01-01

    The thesis examines the influence of group processes on the regulatory focus of individual group members. It is demonstrated that the group situation can affect group members' regulatory focus both in a top-down fashion (via the identitiy of the group) and in a bottom-up fashion (emerging from the g

  11. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    May, Peter J.; Winter, Søren

    2000-01-01

    This study addresses enforcement styles of regulatory inspectors, based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about i...

  12. Reconsidering Styles of Regulatory Enforcement

    DEFF Research Database (Denmark)

    J. May, Peter; Winter, Søren

    2007-01-01

    This study addresses enforcement styles of regulatory inspectors based on an examination of the municipal enforcement of agro-environmental policies in Denmark. Our findings make three contributions to the regulatory literature. One contribution is to add empirical support for theorizing about in...

  13. Regulatory Foci and Organizational Commitment

    Science.gov (United States)

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  14. Disclosure as a regulatory tool

    DEFF Research Database (Denmark)

    2006-01-01

    The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law.......The chapter analyses how disclure can be used as a regulatory tool and analyses how it has been applied so far in the area of financial market law and consumer law....

  15. Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 2: Appendices

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-12-31

    On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 2 contains copies of the documents which established the relationship between NRC, DOE, USEC, and DOL (Dept of Labor) required to facilitate regulatory oversight transition.

  16. Regulatory overview of digital I and C system in Taiwan Lungmen Project

    Energy Technology Data Exchange (ETDEWEB)

    Chuang, C.F. [Department of Engineering and System Science, National Tsing Hua University, Taipei, Taiwan (China); Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: chuang@aec.gov.tw; Chou, H.P. [Department of Engineering and System Science, National Tsing Hua University, Taipei, Taiwan (China)], E-mail: hpc@mx.nthu.edu.tw; Chen, Y.B. [Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: ybchen@aec.gov.tw; Shiao, H. [Nuclear Regulatory Division, Atomic Energy Council, Taiwan (China)], E-mail: shiao@aec.gov.tw

    2008-05-15

    The Lungmen Nuclear Power Plant (LMNPP) is currently under construction in Taiwan, which consists of two Advanced Boiling Water Reactor (ABWR) units. The instrumentation and control (I and C) systems of the Lungmen NPS are based on the state-of-the-art modernized fully integrated digital design. The design and architecture of digital systems are inherently different from those of analog systems. We face challenges in areas where there is limited technical guidance and regulatory precedent. This paper presents regulatory overviews, regulatory requirements, current major regulatory issues, as well as the areas of regulatory concerns and the lessons learned on the digital I and C systems in the Lungmen Project.

  17. 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...... 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...

  18. Regulatory Science in Professional Education.

    Science.gov (United States)

    Akiyama, Hiroshi

    2017-01-01

     In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

  19. Environmental management and monitoring of coal bed methane development and production, northern San Juan Basin, Colorado, USA

    Energy Technology Data Exchange (ETDEWEB)

    Witherbee, K.G.; Salwerowicz, F.A.; Hoffmann, K.L.; Swanson, D.M.; Lovato, J.A. [Colorado State Office, Lakewood, CO (United States). Bureau of Land Management

    1994-12-31

    Potential contamination of groundwater supplies from methane produced from coal has become a critical environmental concern in the northern San Juan basin, Colorado. BLM`s San Juan Resources Area (SJRA) office was instrumental and proactive in building citizens` confidence in our regulatory responsibilities, establishing an environmental baseline, identifying potential sources of contamination, and instituting annual monitoring (Bradenhead testing) of all jurisdictional wells. Outreach programs by the SJRA have continued to maintain lines of communication among the various regulatory agencies, special interest groups, and concerned citizens. These programs emphasized the regulatory requirements necessary to protect valid existing rights to develop the gas resources, as well as protecting the resource values of the surface. Future activity includes continued coordination with other governmental agencies, state and local governments, and citizens groups and remains among our highest priority in managing resource development. This coordination is necessary to maintain the starting of information, identificating and mitigating of problems, and for developing reasonable alternatives. 4 refs.

  20. Regulatory Streamlining and Improvement

    Energy Technology Data Exchange (ETDEWEB)

    Mark A. Carl

    2006-07-11

    The Interstate Oil and Gas Compact Commission (IOGCC) engaged in numerous projects outlined under the scope of work discussed in the United States Department of Energy (DOE) grant number DE-FC26-04NT15456 awarded to the IOGCC. Numerous projects were completed that were extremely valuable to state oil and gas agencies as a result of work performed utilizing resources provided by the grant. There are numerous areas in which state agencies still need assistance. This additional assistance will need to be addressed under future scopes of work submitted annually to DOE's Project Officer for this grant. This report discusses the progress of the projects outlined under the grant scope of work for the 2005-2006 areas of interest, which are as follows: Area of Interest No. 1--Regulatory Streamlining and Improvement: This area of interest continues to support IOGCC's regulatory streamlining efforts that include the identification and elimination of unnecessary duplications of efforts between and among state and federal programs dealing with exploration and production on public lands. Area of Interest No. 2--Technology: This area of interest seeks to improve efficiency in states through the identification of technologies that can reduce costs. Area of Interest No. 3--Training and Education: This area of interest is vital to upgrading the skills of regulators and industry alike. Within the National Energy Policy, there are many appropriate training and education opportunities. Education was strongly endorsed by the President's National Energy Policy Development group. Acting through the governors offices, states are very effective conduits for the dissemination of energy education information. While the IOGCC favors the development of a comprehensive, long-term energy education plan, states are also supportive of immediate action on important concerns, such as energy prices, availability and conservation. Area of Interest No. 4--Resource Assessment and

  1. 75 FR 30453 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-06-01

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving..., Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of Securities Dealers... National Association of Securities Dealers, Inc., the Financial Industry Regulatory Authority, Inc., or...

  2. 75 FR 40000 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

    Science.gov (United States)

    2010-07-13

    ... COMMISSION Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change Relating to the Restated Certificate of Incorporation of Financial Industry Regulatory Authority, Inc. July 2, 2010. On May 21, 2010, Financial Industry Regulatory Authority, Inc....

  3. Methodology of assessment of the impact on the risk of changes of monitoring requirements of safety equipment integrating treatment and analysis of uncertainty of model and parameter; Metodologia de evaluacion del impacto en el riego de cambios de requisitos de vigilancia de equipos de seguridad integrando tratamiento y analisis de incertidumbres de modelo y parametros

    Energy Technology Data Exchange (ETDEWEB)

    Martorell, S.; Villamizar, M.; Marton, I.; Villanueva, J. f.; Carlos, S.; Sanchez, A. I.

    2013-07-01

    The feasibility of the proposed methodology has been demonstrated with the results obtained in a case of application for the analysis of changes in the requirements of maximum time of unavailability of system batteries using an APS level 1. The proposed methodology is consistent with the proposal by the American regulatory guide RG 1,174, applicable to LWR designs in Spanish, although large plants their level of technical development.

  4. Environmental Monitoring Plan

    Energy Technology Data Exchange (ETDEWEB)

    Althouse, P E; Bertoldo, N A; Bowen, B M; Brown, R A; Campbell, C G; Christofferson, E; Gallegos, G M; Grayson, A R; Jones, H E; Larson, J M; Laycak, D; Mathews, S; Peterson, S R; Revelli, M J; Rueppel, D; Williams, R A; Wilson, K; Woods, N

    2005-11-23

    The purpose of the environmental monitoring plan (EMP) is to promote the early identification of, and response to, potential adverse environmental impacts associated with DOE operations. Environmental monitoring supports the Integrated Safety Management System (ISMS) to detect, characterize, and respond to releases from DOE activities; assess impacts; estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the biota in the vicinity of the DOE activity. In addition, the EMP addresses the analytical work supporting environmental monitoring to ensure the following: (1) A consistent system for collecting, assessing, and documenting environmental data of known and documented quality; (2) A validated and consistent approach for sampling and analysis of radionuclide samples to ensure laboratory data meets program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work; and (3) An integrated sampling approach to avoid duplicative data collection. Until recently, environmental monitoring at Lawrence Livermore National Laboratory (LLNL) was required by DOE Order 5400.1, which was canceled in January 2003. LLNL is in the process of adopting the ISO 14001 Environmental Management Systems standard, which contains requirements to perform and document environmental monitoring. The ISO 14001 standard is not as prescriptive as DOE Order 5400.1, which expressly required an EMP. LLNL will continue to prepare the EMP because it provides an organizational framework for ensuring that the work is conducted appropriately. The environmental monitoring addressed by the plan includes preoperational characterization and assessment, and effluent and surveillance monitoring. Additional environmental monitoring is conducted at LLNL as part of the compliance with the

  5. Dismantlement of nuclear facilities decommissioned from the Russian navy: Enhancing regulatory supervision of nuclear and radiation safety

    Energy Technology Data Exchange (ETDEWEB)

    Sneve, M.K.

    2013-03-01

    The availability of up to date regulatory norms and standards for nuclear and radiation safety, relevant to the management of nuclear legacy situations, combined with effective and efficient regulatory procedures for licensing and monitoring compliance, are considered to be extremely important. Accordingly the NRPA has set up regulatory cooperation programs with corresponding authorities in the Russian Federation. Cooperation began with the civilian regulatory authorities and was more recently extended to include the military authority and this joint cooperation supposed to develop the regulatory documents to improve supervision over nuclear and radiation safety while managing the nuclear military legacy facilities in Northwest Russia and other regions of the country. (Author)

  6. Regulating regulatory T cells.

    Science.gov (United States)

    Le, N T; Chao, N

    2007-01-01

    Regulatory T cells (Tregs) are a specialized subpopulation of T cells that act to suppress activation of other immune cells and thereby maintain immune system homeostasis, self-tolerance as well as control excessive response to foreign antigens. The mere concept of Tregs was the subject of significant controversy among immunologists for many years owing to the paucity of reliable markers for defining these cells and the ambiguity of the nature and molecular basis of suppressive phenomena. However, recent advances in the molecular characterization of this cell population have firmly established their existence and their vital role in the vertebrate immune system. Of interest, accumulating evidence from both humans and experimental animal models has implicated the involvement of Tregs in the development of graft-versus-host disease (GVHD). The demonstration that Tregs could separate GVHD from graft-versus-tumor (GVT) activity suggests that their immunosuppressive potential could be manipulated to reduce GVHD without detrimental consequence on GVT effect. Although a variety of T lymphocytes with suppressive capabilities have been reported, the two best-characterized subsets are the naturally arising, intrathymic-generated Tregs (natural Tregs) and the peripherally generated, inducible Tregs (inducible Tregs). This review summarizes our current knowledge of the generation, function and regulation of these two populations of Tregs during an immune response. Their role in the development of GVHD and their therapeutic potential for the prevention and treatment of GVHD will also be described.

  7. 30 CFR 938.16 - Required regulatory program amendments.

    Science.gov (United States)

    2010-07-01

    ... located where failure could cause loss of life or serious property damage. (jjj) By October 5, 1993... officer signatures for each corporate indemnitor, an affidavit from the corporation(s) certifying that...

  8. 7 CFR 1951.872 - Other regulatory requirements.

    Science.gov (United States)

    2010-01-01

    ... successor agency under Public Law 103-354 in making its decision on the request. (c) Equal opportunity and....872 Agriculture Regulations of the Department of Agriculture (Continued) RURAL HOUSING SERVICE, RURAL BUSINESS-COOPERATIVE SERVICE, RURAL UTILITIES SERVICE, AND FARM SERVICE AGENCY, DEPARTMENT OF...

  9. Regulatory and Skills Requirements for Higher Education in the Philippines

    Science.gov (United States)

    Adeyemo, Kolawole Samuel

    2015-01-01

    The provision of public resources to manage the expansion of the higher education system in the Philippines has been inadequate, and this has given rise to many private providers entering the HE domain. The proper regulation of higher education in the country is important if the Philippines is to respond to the challenge of producing the skills it…

  10. 40 CFR 63.1350 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... carbon injection. The accuracy of the rate measurement device must be ±1 percent of the rate being... filter), detectors may share the system instrumentation and alarm. (6) All BLDS must be installed... leak detection system include concepts from EPA's “Fabric Filter Bag Leak Detection Guidance”...

  11. 40 CFR 63.1258 - Monitoring Requirements.

    Science.gov (United States)

    2010-07-01

    ... gas other than methane in air may be used if the instrument does not respond to methane or if the... each condenser, the owner or operator shall establish the maximum condenser outlet gas temperature or... shall establish the minimum temperature of the gases exiting the combustion chamber as the...

  12. 40 CFR 63.1547 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... removal mechanisms. (3) Daily check of compressed air supply for pulse-jet baghouses. (4) An appropriate... Agency guidance document “Fabric Filter Bag Leak Detection Guidance” (EPA-454/R-98-015). Other bag leak..., torn or broken bags or filter media, or any other condition that may cause an increase in emissions....

  13. 40 CFR 63.1510 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ...) For positive pressure fabric filter systems, a bag leak detection system must be installed in each baghouse compartment or cell. For negative pressure or induced air fabric filters, the bag leak detector... maintaining a load cell, carrier gas/lime flow indicator, carrier gas pressure drop measurement system...

  14. 40 CFR 63.548 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... or filter media. (iii) Replacing defective bags or filter media, or otherwise repairing the control... broken filters. (2) Replacing defective filter media, or otherwise repairing the control device. (3... the total hydrocarbon compliance test and determine an arithmetic average for the recorded temperature...

  15. 40 CFR 63.453 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    .... (b) A CMS shall be operated to measure the temperature in the firebox or in the ductwork immediately... times as requested by the Administrator. The visual inspection shall include inspection of ductwork...) through (k)(5) of this section identifies visible defects in ductwork, piping, enclosures or...

  16. 40 CFR 63.526 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... expected to yield the highest flow rate and concentration. Engineering assessment includes, but is not... purpose of determining de minimis status for emission points, engineering assessment may be used to.... (D) Design analysis based on accepted chemical engineering principles, measurable process...

  17. 40 CFR 444.12 - Monitoring Requirements

    Science.gov (United States)

    2010-07-01

    ... I,” EPA-600/R-94-111, May 1994. 8 American National Standard on Photographic Processing Effluents.... . American Society for Testing and Materials, 1916 Race Street, Philadelphia, PA 19103. (4) “Methods for the...., Dept. 0742, McLean, VA 22109-0742. (8) “American National Standard on Photographic Processing...

  18. 40 CFR 430.02 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... AND STANDARDS THE PULP, PAPER, AND PAPERBOARD POINT SOURCE CATEGORY General Provisions § 430.02...-TCF: Pertains to any fiber line that does not use exclusively TCF bleaching processes. b TCF: Pertains to any fiber line that uses exclusively TCF bleaching processes, as disclosed by the discharger...

  19. 40 CFR 141.132 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ... water from a single aquifer as one treatment plant for determining the minimum number of TTHM and HAA5... One sample per year per treatment plant during month of warmest water temperature. Locations... water sample per quarter per treatment plant 2 Locations representing maximum residence time. 1...

  20. 40 CFR 63.625 - Monitoring requirements.

    Science.gov (United States)

    2010-07-01

    ...) National Emission Standards for Hazardous Air Pollutants From Phosphate Fertilizers Production Plants § 63... continuously measures and permanently records the flow rate of the scrubbing liquid to each scrubber in the... liquid to each scrubber in the process scrubbing system is ±20 percent of the baseline average...

  1. Technical requirements for implementation of an individual monitoring service for evaluation of operational quantity HP(10) using thermoluminescent dosimetry; Requisitos tecnicos para a implantacao de um servico de monitoracao individual externa de corpo inteiro para fotons utilizando dosimetria termoluminescente

    Energy Technology Data Exchange (ETDEWEB)

    Francisco, Adelaide Benedita Armando

    2016-11-01

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

  2. Monitoring well inspection and maintenance plan Y-12 Plant, Oak Ridge, Tennessee (revised)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-09-01

    Inspection and maintenance of groundwater monitoring wells is a primary element of the Oak Ridge Y-12 Plant Groundwater Protection Program (GWPP). This document is the revised groundwater monitoring well inspection and maintenance plan for the U.S. Department of Energy (DOE) Y-12 Plant in Oak Ridge, Tennessee. The plan provides a systematic program for: (1) inspecting the physical condition of monitoring wells at the Y-12 Plant and (2) identifying maintenance needs that will extend the life of each well and ensure that representative groundwater quality samples and hydrologic data are collected from the wells. Original documentation for the Y-12 Plant GWPP monitoring well inspection and maintenance program was provided in HSW, Inc. 1991a. The original revision of the plan specified that only a Monitoring Well Inspection/Maintenance Summary need be updated and reissued each year. Rapid growth of the monitoring well network and changing regulatory requirements have resulted in constant changes to the status of wells (active or inactive) listed on the Monitoring Well Inspection/Maintenance Summary. As a result, a new mechanism to track the status of monitoring wells has been developed and the plan revised to formalize the new business practices. These changes are detailed in Sections 2.4 and 2.5.

  3. Policy and Regulatory Issues for Underground Coal Gasification in India

    Science.gov (United States)

    Singh, Sunil K.

    2017-07-01

    Underground coal gasification (UCG) is in its nascent stage of development. Most of the projects are in the nature of pilot projects. UCG technology requires acceptance in general commercial framework as it matures with the progress of time. Policy and regulatory framework, therefore, is considered here only in the expectation that UCG technology may finally be rolled out sooner than later. India is actively pursuing consultations with major countries which have recorded successes in implementing UCG technology in varying measures. In this background, the discussion on policy and regulatory framework is essentially an effort to capture the broad outline of the understanding of the UCG process in a regulatory construct as compared with other regulatory regimes of similar nature.

  4. 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.

  5. Automatic chemical monitoring in the composition of functions performed by the unit level control system in the new projects of nuclear power plant units

    Science.gov (United States)

    Denisova, L. G.; Khrennikov, N. N.

    2014-08-01

    The article presents information on the state of regulatory framework and development of a subsystem for automated chemical monitoring of water chemistries in the primary and secondary coolant circuits used as part of the automatic process control system in new projects of VVER reactor-based nuclear power plant units. For the strategy of developing and putting in use the water chemistry-related part of the automated process control system within the standard AES-2006 nuclear power plant project to be implemented, it is necessary to develop regulatory documents dealing with certain requirements imposed on automatic water chemistry monitoring systems in accordance with the requirements of federal codes and regulations in the field of using atomic energy.

  6. Monitoring the effectiveness evaluation of investment projects

    Directory of Open Access Journals (Sweden)

    Skopin Alex O.

    2012-02-01

    Full Text Available The article raised the question of monitoring regulatory evaluation of the effectiveness of regional investment projects. This is justified by the fact that the current regulatory framework defined indicators for measuring the effectiveness of regional investment projects, but these figures are usually used only at the design stage of the project, an interim assessment of the effectiveness of a sufficiently simplified and based on the level of exploration investment.

  7. Evolution of cichlid vision via trans-regulatory divergence

    Directory of Open Access Journals (Sweden)

    O’Quin Kelly E

    2012-12-01

    Full Text Available Abstract Background Phenotypic evolution may occur through mutations that affect either the structure or expression of protein-coding genes. Although the evolution of color vision has historically been attributed to structural mutations within the opsin genes, recent research has shown that opsin regulatory mutations can also tune photoreceptor sensitivity and color vision. Visual sensitivity in African cichlid fishes varies as a result of the differential expression of seven opsin genes. We crossed cichlid species that express different opsin gene sets and scanned their genome for expression Quantitative Trait Loci (eQTL responsible for these differences. Our results shed light on the role that different structural, cis-, and trans-regulatory mutations play in the evolution of color vision. Results We identified 11 eQTL that contribute to the divergent expression of five opsin genes. On three linkage groups, several eQTL formed regulatory “hotspots” associated with the expression of multiple opsins. Importantly, however, the majority of the eQTL we identified (8/11 or 73% occur on linkage groups located trans to the opsin genes, suggesting that cichlid color vision has evolved primarily via trans-regulatory divergence. By modeling the impact of just two of these trans-regulatory eQTL, we show that opsin regulatory mutations can alter cichlid photoreceptor sensitivity and color vision at least as much as opsin structural mutations can. Conclusions Combined with previous work, we demonstrate that the evolution of cichlid color vision results from the interplay of structural, cis-, and especially trans-regulatory loci. Although there are numerous examples of structural and cis-regulatory mutations that contribute to phenotypic evolution, our results suggest that trans-regulatory mutations could contribute to phenotypic divergence more commonly than previously expected, especially in systems like color vision, where compensatory changes in the

  8. The Danish Regulatory Reform of Telecommunications

    DEFF Research Database (Denmark)

    Skouby, Knud Erik

    1998-01-01

    An overview of the liberalisation process and regulatory reform of telecommunications in Denmark......An overview of the liberalisation process and regulatory reform of telecommunications in Denmark...

  9. Future water quality monitoring - Adapting tools to deal with mixtures of pollutants in water resource management

    NARCIS (Netherlands)

    Altenburger, R.; Ait-Aissa, S.; Antczak, P.; Backhaus, T.; Barcelo, D.; Seiler, T.; Brion, F.; Focks, A.

    2015-01-01

    Environmental quality monitoring of water resources is challenged with providing the basis for safeguarding the environment against adverse biological effects of anthropogenic chemical contamination from diffuse and point sources. While current regulatory efforts focus on monitoring and assessing a

  10. 76 FR 55137 - Monitoring the Effectiveness of Maintenance at Nuclear Power Plants

    Science.gov (United States)

    2011-09-06

    ... COMMISSION Monitoring the Effectiveness of Maintenance at Nuclear Power Plants AGENCY: Nuclear Regulatory..., ``Monitoring the Effectiveness of Maintenance at Nuclear Power Plants.'' This guide endorses Revision 4A to... Effectiveness of Maintenance at Nuclear Power Plants,'' which provides methods that......

  11. Regulatory Snapshots: integrative mining of regulatory modules from expression time series and regulatory networks.

    Directory of Open Access Journals (Sweden)

    Joana P Gonçalves

    Full Text Available Explaining regulatory mechanisms is crucial to understand complex cellular responses leading to system perturbations. Some strategies reverse engineer regulatory interactions from experimental data, while others identify functional regulatory units (modules under the assumption that biological systems yield a modular organization. Most modular studies focus on network structure and static properties, ignoring that gene regulation is largely driven by stimulus-response behavior. Expression time series are key to gain insight into dynamics, but have been insufficiently explored by current methods, which often (1 apply generic algorithms unsuited for expression analysis over time, due to inability to maintain the chronology of events or incorporate time dependency; (2 ignore local patterns, abundant in most interesting cases of transcriptional activity; (3 neglect physical binding or lack automatic association of regulators, focusing mainly on expression patterns; or (4 limit the discovery to a predefined number of modules. We propose Regulatory Snapshots, an integrative mining approach to identify regulatory modules over time by combining transcriptional control with response, while overcoming the above challenges. Temporal biclustering is first used to reveal transcriptional modules composed of genes showing coherent expression profiles over time. Personalized ranking is then applied to prioritize prominent regulators targeting the modules at each time point using a network of documented regulatory associations and the expression data. Custom graphics are finally depicted to expose the regulatory activity in a module at consecutive time points (snapshots. Regulatory Snapshots successfully unraveled modules underlying yeast response to heat shock and human epithelial-to-mesenchymal transition, based on regulations documented in the YEASTRACT and JASPAR databases, respectively, and available expression data. Regulatory players involved in

  12. Population Dynamics of Genetic Regulatory Networks

    Science.gov (United States)

    Braun, Erez

    2005-03-01

    Unlike common objects in physics, a biological cell processes information. The cell interprets its genome and transforms the genomic information content, through the action of genetic regulatory networks, into proteins which in turn dictate its metabolism, functionality and morphology. Understanding the dynamics of a population of biological cells presents a unique challenge. It requires to link the intracellular dynamics of gene regulation, through the mechanism of cell division, to the level of the population. We present experiments studying adaptive dynamics of populations of genetically homogeneous microorganisms (yeast), grown for long durations under steady conditions. We focus on population dynamics that do not involve random genetic mutations. Our experiments follow the long-term dynamics of the population distributions and allow to quantify the correlations among generations. We focus on three interconnected issues: adaptation of genetically homogeneous populations following environmental changes, selection processes on the population and population variability and expression distributions. We show that while the population exhibits specific short-term responses to environmental inputs, it eventually adapts to a robust steady-state, largely independent of external conditions. Cycles of medium-switch show that the adapted state is imprinted in the population and that this memory is maintained for many generations. To further study population adaptation, we utilize the process of gene recruitment whereby a gene naturally regulated by a specific promoter is placed under a different regulatory system. This naturally occurring process has been recognized as a major driving force in evolution. We have recruited an essential gene to a foreign regulatory network and followed the population long-term dynamics. Rewiring of the regulatory network allows us to expose their complex dynamics and phase space structure.

  13. Evolution of evolvability in gene regulatory networks.

    Directory of Open Access Journals (Sweden)

    Anton Crombach

    Full Text Available Gene regulatory networks are perhaps the most important organizational level in the cell where signals from the cell state and the outside environment are integrated in terms of activation and inhibition of genes. For the last decade, the study of such networks has been fueled by large-scale experiments and renewed attention from the theoretical field. Different models have been proposed to, for instance, investigate expression dynamics, explain the network topology we observe in bacteria and yeast, and for the analysis of evolvability and robustness of such networks. Yet how these gene regulatory networks evolve and become evolvable remains an open question. An individual-oriented evolutionary model is used to shed light on this matter. Each individual has a genome from which its gene regulatory network is derived. Mutations, such as gene duplications and deletions, alter the genome, while the resulting network determines the gene expression pattern and hence fitness. With this protocol we let a population of individuals evolve under Darwinian selection in an environment that changes through time. Our work demonstrates that long-term evolution of complex gene regulatory networks in a changing environment can lead to a striking increase in the efficiency of generating beneficial mutations. We show that the population evolves towards genotype-phenotype mappings that allow for an orchestrated network-wide change in the gene expression pattern, requiring only a few specific gene indels. The genes involved are hubs of the networks, or directly influencing the hubs. Moreover, throughout the evolutionary trajectory the networks maintain their mutational robustness. In other words, evolution in an alternating environment leads to a network that is sensitive to a small class of beneficial mutations, while the majority of mutations remain neutral: an example of evolution of evolvability.

  14. Taking Stock of Regulatory Variation.

    Science.gov (United States)

    Maurano, Matthew T; Stamatoyannopoulos, John A

    2015-07-29

    Three recent studies measure individual variation in regulatory DNA accessibility. What do they tell us about the prospects of assessing variation in single cells and across populations? Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Electronic Commerce Removing Regulatory Impediments

    Science.gov (United States)

    1992-05-01

    AD-A252 691 ELECTRONIC COMMERCE Removing Regulatory Impediments ~DuiG A% ELECTE I JUL1 8 1992 0 C D Daniel J. Drake John A. Ciucci ... - ""N ST AT KE...Management Institute 6400 Goldsboro Road Bethesda, Maryland 20817-5886 92 LMI Executive Summary ELECTRONIC COMMERCE : REMOVING REGULATORY IMPEDIMENTS... Electronic Commerce techniques, such as electronic mail and electronic data interchange (EDI), enable Government agencies to conduct business without the

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2013-10-01

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

  17. An analysis of Technical Security Control Requirements For Digital I and C Systems in Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Song, Jaegu; Lee, Jungwoon; Park, Geeyong; Kwon, Keechoon; Lee, Dongyoung; Lee, Cheolkwon [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2013-10-15

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

  18. Marine monitoring surveys for desalination plants-A critical review

    KAUST Repository

    Lattemann, Sabine

    2013-01-01

    Environmental impact assessment (EIA) studies are standard practice and a regulatory requirement for most new desalination projects today. However, most of the EIA studies are limited to predictive information; that is, they gather information on the project and the project\\'s environment before project implementation to make predictions about likely impacts. The EIAs may involve comprehensive studies, such as field monitoring, laboratory toxicity testing, and modeling studies. Consequently, the"surprising paucity of useful experimental data, either from laboratory tests or from field monitoring studies", which was observed by the US National Research Council in 2008, has been gradually decreasing. However, there is still a long-term research need on the site-specific effects of desalination plants after project commissioning has taken place. A main challenge of field research is the adequate design of the monitoring studies, which have to adequately distinguish the effects of the desalination project from natural processes over long periods of time. The existing monitoring studies have so far used a wide range of approaches and methods to investigate the environmental impacts of desalination plant discharges. Shortfalls are often that they are limited in scope, short-term, or localized. In essence, many studies fall short of recognizing the potentially synergetic effects of the single waste components of the discharges on marine organisms and the complexity of the potential responses by the ecosystem. While the possible risk of damage arising from the concentrate discharge to the marine environment in close proximity to the outfall is at hand, no conclusive evidence can yet be provided concerning the long-term impacts of desalination plant discharges, let alone the cumulative impacts on certain sea areas. This paper conducts a critical review of existing monitoring programs for desalination plants. Shortcomings of current practices are identified and relevant

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-09-01

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

  20. Data Quality Objectives Summary Report Supporting Radiological Air Surveillance Monitoring for the INL Site

    Energy Technology Data Exchange (ETDEWEB)

    Haney, Thomas Jay [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-05-01

    This report documents the Data Quality Objectives (DQOs) developed for the Idaho National Laboratory (INL) Site ambient air surveillance program. The development of the DQOs was based on the seven-step process recommended “for systematic planning to generate performance and acceptance criteria for collecting environmental data” (EPA 2006). The process helped to determine the type, quantity, and quality of data needed to meet current regulatory requirements and to follow U.S. Department of Energy guidance for environmental surveillance air monitoring design. It also considered the current air monitoring program that has existed at INL Site since the 1950s. The development of the DQOs involved the application of the atmospheric dispersion model CALPUFF to identify likely contamination dispersion patterns at and around the INL Site using site-specific meteorological data. Model simulations were used to quantitatively assess the probable frequency of detection of airborne radionuclides released by INL Site facilities using existing and proposed air monitors.