WorldWideScience

Sample records for ccs regulatory development

  1. 4th IEA International CCS Regulatory Network Meeting

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    On 9 and 10 May 2012, the IEA International CCS Regulatory Network (Network), launched in Paris in May 2008 to provide a neutral forum for CCS regulators, policy makers and stakeholders to share updates and views on CCS regulatory developments, held its fourth meeting at the International Energy Agency (IEA) offices in Paris, France. The aim of the meeting was to: provide an update on government efforts to develop and implement carbon capture and storage (CCS) legal and regulatory frameworks; and consider ways in which governments are dealing with some of the more difficult or complex aspects of CCS regulation. This report summarises the proceedings of the meeting.

  2. CCS: Legal and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA has estimated that the broad deployment of low-carbon energy technologies could reduce projected 2050 emissions to half 2005 levels -- and that CCS could contribute about one-fifth of those reductions. Reaching that goal, however, would require around 100 CCS projects to be implemented by 2020 and over 3 000 by 2050.

  3. Regulatory Promotion of Emergent CCS Technology

    Energy Technology Data Exchange (ETDEWEB)

    Davies, Lincoln; Uchitel, Kirsten; Johnson, David

    2014-01-01

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

  4. Value chain assesment in a CCS business development setting

    Energy Technology Data Exchange (ETDEWEB)

    Hektor, Erik A.; Lyngroth, Steinar; Midtsund, Marte Aaberg; Bratfos, Hans A.

    2010-09-15

    Carbon Capture and Storage (CCS) is perceived by many as a necessary bridge to a sustainable future solely based on renewable energy. However, one of the barriers to the commercial implementation of CCS is cost. Today's cost estimates are high due to the large amount of uncertainty relating to this new technology and hence restrain the utility sector from investing in the development of CCS and making it a viable business. This paper presents Value Chain Assessment (VCA) as a powerful tool to help understand how such uncertainties influence the NPV for the various stakeholders in CCS development projects.

  5. CCS development for a low carbon future

    OpenAIRE

    Selosse, Sandrine; Garcia, Nicolas

    2014-01-01

    Giving the challenge of mitigating the effects of climate change and so reducing carbon emissions, this study highlights the possible technological trajectories in a future climate regime and particularly the role of carbon capture and storage. This research is developed with TIAM-FR, a bottom-up optimization model describing the world energy system expressed by regions and sectors in great detail of current and future technologies.

  6. Carbon Capture and Storage (CCS): Overview, Developments, and Challenges

    Science.gov (United States)

    Busch, Andreas; Amann, Alexandra; Kronimus, Alexander; Kühn, Michael

    2010-05-01

    largest piece of cake is referring to R&D projects on a small-scale demonstration basis. Numerous further demonstration or small-scale commercial projects have been announced for the near future. Such developments demonstrate that there are no major technological barriers to widespread geological CO2 storage. Main challenges are rather on the public acceptance, legislation and commercial site. Commercially CCS costs are mainly dominated by the high costs of CO2 capture where, depending on the capture method, CO2 needs to be separated from the emission gas stream produced during energy production. Policy, legislation and regulatory framework issues are further hurdles that need to be considered for large scale implementation of this technology. Finally public acceptance of this technology will likely affect the large-scale implementation of CO2 geological storage.

  7. Evaluation of BPA uptake in clear cell sarcoma (CCS) in vitro and development of an in vivo model of CCS for BNCT studies

    Energy Technology Data Exchange (ETDEWEB)

    Fujimoto, T., E-mail: fujitaku@hp.pref.hyogo.jp [Department of Orthopaedic Surgery, Hyogo Cancer Center, Akashi 673-0021 (Japan); Andoh, T. [Faculty of Pharmaceutical Sciences and Cooperative Research Center of Life Sciences, Kobe Gakuin University, Kobe 650-8586 (Japan); Sudo, T. [Section of Translational Research, Hyogo Cancer Center, Akashi 673-0021 (Japan); Fujita, I.; Imabori, M. [Department of Orthopaedic Surgery, Hyogo Cancer Center, Akashi 673-0021 (Japan); Moritake, H. [Division of Pediatrics, University of Miyazaki, Miyazaki 889-1692 (Japan); Sugimoto, T. [Department of Pediatrics, Saiseikai Shigaken Hospital, Ritto 520-3046 (Japan); Sakuma, Y. [Department of Pathology, Hyogo Cancer Center, Akashi 673-0021 (Japan); Takeuchi, T. [Department of Pathology, Kochi Medical School, Nangoku 783-8505 (Japan); Sonobe, H. [Department of Pathology, Chugoku Central Hospital, Fukuyama 720-0001 (Japan); Epstein, Alan L. [Department of Pathology, Keck School of Medicine,University of Southern California, Los Angeles,CA 90033 (United States); Akisue, T. [Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Kobe 650-0017 (Japan); Kirihata, M. [Graduate School of Life and Environmental Sciences, Osaka Prefecture University, Sakai 599-8531 (Japan); Kurosaka, M. [Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Kobe 650-0017 (Japan); Fukumori, Y.; Ichikawa, H. [Faculty of Pharmaceutical Sciences and Cooperative Research Center of Life Sciences, Kobe Gakuin University, Kobe 650-8586 (Japan)

    2011-12-15

    Clear cell sarcoma (CCS), a rare malignant tumor with a predilection for young adults, is of poor prognosis. Recently however, boron neutron capture therapy (BNCT) with the use of p-borono-L-phenylalanine (BPA) for malignant melanoma has provided good results. CCS also produces melanin; therefore, the uptake of BPA is the key to the application of BNCT to CCS. We describe, for the first time, the high accumulation of boron in CCS and the CCS tumor-bearing animal model generated for BNCT studies.

  8. Development of environmental impact monitoring protocol for offshore carbon capture and storage (CCS): A biological perspective

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Hyewon, E-mail: hyewon@ldeo.columbia.edu [Division of Biology and Paleo Environment, Lamont-Doherty Earth Observatory, Columbia University, Palisades, NY 10964 (United States); Kim, Yong Hoon, E-mail: Yong.Kim@rpsgroup.com [RPS ASA, 55 Village Square Drive, South Kingstown, RI 02879 (United States); Kang, Seong-Gil, E-mail: kangsg@kriso.re.kr [Offshore CCS Research Unit, Korea Research Institute of Ships and Ocean Engineering, 32 1312 Beon-gil, Yuseong-daero, Yuseong-gu, Deaejeon (Korea, Republic of); Park, Young-Gyu, E-mail: ypark@kiost.ac.kr [Ocean Circulation and Climate Change Research Center, Korea Institute of Ocean Science and Technology, 787 Haeanro, Ansan (Korea, Republic of)

    2016-02-15

    Offshore geologic storage of carbon dioxide (CO{sub 2}), known as offshore carbon capture and sequestration (CCS), has been under active investigation as a safe, effective mitigation option for reducing CO{sub 2} levels from anthropogenic fossil fuel burning and climate change. Along with increasing trends in implementation plans and related logistics on offshore CCS, thorough risk assessment (i.e. environmental impact monitoring) needs to be conducted to evaluate potential risks, such as CO{sub 2} gas leakage at injection sites. Gas leaks from offshore CCS may affect the physiology of marine organisms and disrupt certain ecosystem functions, thereby posing an environmental risk. Here, we synthesize current knowledge on environmental impact monitoring of offshore CCS with an emphasis on biological aspects and provide suggestions for better practice. Based on our critical review of preexisting literatures, this paper: 1) discusses key variables sensitive to or indicative of gas leakage by summarizing physico-chemical and ecological variables measured from previous monitoring cruises on offshore CCS; 2) lists ecosystem and organism responses to a similar environmental condition to CO{sub 2} leakage and associated impacts, such as ocean acidification and hypercapnia, to predict how they serve as responsive indicators of short- and long-term gas exposure, and 3) discusses the designs of the artificial gas release experiments in fields and the best model simulation to produce realistic leakage scenarios in marine ecosystems. Based on our analysis, we suggest that proper incorporation of biological aspects will provide successful and robust long-term monitoring strategies with earlier detection of gas leakage, thus reducing the risks associated with offshore CCS. - Highlights: • This paper synthesizes the current knowledge on environmental impact monitoring of offshore Carbon Capture and Sequestration (CCS). • Impacts of CO{sub 2} leakage (ocean acidification

  9. Development of environmental impact monitoring protocol for offshore carbon capture and storage (CCS): A biological perspective

    International Nuclear Information System (INIS)

    Kim, Hyewon; Kim, Yong Hoon; Kang, Seong-Gil; Park, Young-Gyu

    2016-01-01

    Offshore geologic storage of carbon dioxide (CO 2 ), known as offshore carbon capture and sequestration (CCS), has been under active investigation as a safe, effective mitigation option for reducing CO 2 levels from anthropogenic fossil fuel burning and climate change. Along with increasing trends in implementation plans and related logistics on offshore CCS, thorough risk assessment (i.e. environmental impact monitoring) needs to be conducted to evaluate potential risks, such as CO 2 gas leakage at injection sites. Gas leaks from offshore CCS may affect the physiology of marine organisms and disrupt certain ecosystem functions, thereby posing an environmental risk. Here, we synthesize current knowledge on environmental impact monitoring of offshore CCS with an emphasis on biological aspects and provide suggestions for better practice. Based on our critical review of preexisting literatures, this paper: 1) discusses key variables sensitive to or indicative of gas leakage by summarizing physico-chemical and ecological variables measured from previous monitoring cruises on offshore CCS; 2) lists ecosystem and organism responses to a similar environmental condition to CO 2 leakage and associated impacts, such as ocean acidification and hypercapnia, to predict how they serve as responsive indicators of short- and long-term gas exposure, and 3) discusses the designs of the artificial gas release experiments in fields and the best model simulation to produce realistic leakage scenarios in marine ecosystems. Based on our analysis, we suggest that proper incorporation of biological aspects will provide successful and robust long-term monitoring strategies with earlier detection of gas leakage, thus reducing the risks associated with offshore CCS. - Highlights: • This paper synthesizes the current knowledge on environmental impact monitoring of offshore Carbon Capture and Sequestration (CCS). • Impacts of CO 2 leakage (ocean acidification, hypercapnia) on marine

  10. How will Germany's CCS policy affect the development of a European CO2 transport infrastructure?

    OpenAIRE

    Bertram, Christine; Heitmann, Nadine; Narita, Daiju; Schwedeler, Markus

    2012-01-01

    CO2 storage opportunities and the location of coal-fired power plants are located far apart throughout Europe, suggesting the need for a region-wide CO2 pipeline network or at least a considerable number of cross-border transport pipelines. Regionally coherent policy would be needed to embed a CCS infrastructure into an evolving European electricity system. However, the current EU's CCS Directive leaves the decision to allow carbon storage on their territory to individual MSs and makes no pro...

  11. The future of Carbon Capture and Storage (CCS) in Nigeria ...

    African Journals Online (AJOL)

    Carbon Capture and Storage (CCS) is one of the techniques for greenhouse gas (GHG) emissions reduction. This article reviews the current status of CCS technology, highlights costs and discusses legal and regulatory issues of CCS. The main purpose of the article is to review CCS and CO2-EOR experience from ongoing ...

  12. Carbon capture and storage (CCS)

    International Nuclear Information System (INIS)

    Martin-Amouroux, Jean-Marie

    2016-01-01

    The author first defines what carbon capture and storage (CCS)is, describes more precisely the various technologies, methods and processes involved in carbon capture, carbon transport, and carbon geological storage. He briefly evokes the various applications and uses of CCS. In the second part, he proposes an overview of advances and deadlocks of CCS in the world, of the status of installations and projects, of the development of capture practices in the industry, of some existing and important storage sites, of some pilot installations developed by various industrial actors in different countries (26 installations in the world). He indicates power stations equipped for CCS (in Canada, USA, United-Kingdom, Netherlands, Norway, China, South Korea and United Arab Emirates). He evokes projects which have been given up or postponed. He proposes an overview of policies implemented in different countries (USA, Canada, European Union, Australia, and others) to promote CCS

  13. The Mississippi CCS Project

    Energy Technology Data Exchange (ETDEWEB)

    Doug Cathro

    2010-09-30

    The Mississippi CCS Project is a proposed large-scale industrial carbon capture and sequestration (CCS) project which would have demonstrated advanced technologies to capture and sequester carbon dioxide (CO{sub 2}) emissions from industrial sources into underground formations. Specifically, the Mississippi CCS Project was to accelerate commercialization of large-scale CO{sub 2} storage from industrial sources by leveraging synergy between a proposed petcoke to Substitute Natural Gas (SNG) plant that is selected for a Federal Loan Guarantee and would be the largest integrated anthropogenic CO{sub 2} capture, transport, and monitored sequestration program in the U.S. Gulf Coast Region. The Mississippi CCS Project was to promote the expansion of enhanced oil recovery (EOR) in the Mississippi, Alabama and Louisiana region which would supply greater energy security through increased domestic energy production. The capture, compression, pipeline, injection, and monitoring infrastructure would have continued to sequester CO{sub 2} for many years after the completion of the term of the DOE agreement. The objectives of this project were expected to be fulfilled through two distinct phases. The overall objective of Phase 1 was to develop a fully definitive project basis for a competitive Renewal Application process to proceed into Phase 2 - Design, Construction and Operations. Phase 1 included the studies that establish the engineering design basis for the capture, compression and transportation of CO{sub 2} from the MG SNG Project, and the criteria and specifications for a monitoring, verification and accounting (MVA) plan at the Soso oil field in Mississippi. The overall objective of Phase 2, was to execute design, construction and operations of three capital projects: the CO{sub 2} capture and compression equipment, the Mississippi CO{sub 2} Pipeline to Denbury's Free State Pipeline, and an MVA system at the Soso oil field.

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

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

  15. Lake Charles CCS Project

    Energy Technology Data Exchange (ETDEWEB)

    Leib, Thomas [Leucadia Energy, LLC, Salt Lake City, UT (United States); Cole, Dan [Denbury Onshore, LLC, Plano, TX (United States)

    2015-06-30

    In late September 2014 development of the Lake Charles Clean Energy (LCCE) Plant was abandoned resulting in termination of Lake Charles Carbon Capture and Sequestration (CCS) Project which was a subset the LCCE Plant. As a result, the project was only funded through Phase 2A (Design) and did not enter Phase 2B (Construction) or Phase 2C (Operations). This report was prepared relying on information prepared and provided by engineering companies which were engaged by Leucadia Energy, LLC to prepare or review Front End Engineering and Design (FEED) for the Lake Charles Clean Energy Project, which includes the Carbon Capture and Sequestration (CCS) Project in Lake Charles, Louisiana. The Lake Charles Carbon Capture and Sequestration (CCS) Project was to be a large-scale industrial CCS project intended to demonstrate advanced technologies that capture and sequester carbon dioxide (CO2) emissions from industrial sources into underground formations. The Scope of work was divided into two discrete sections; 1) Capture and Compression prepared by the Recipient Leucadia Energy, LLC, and 2) Transport and Sequestration prepared by sub-Recipient Denbury Onshore, LLC. Capture and Compression-The Lake Charles CCS Project Final Technical Report describes the systems and equipment that would be necessary to capture CO2 generated in a large industrial gasification process and sequester the CO2 into underground formations. The purpose of each system is defined along with a description of its equipment and operation. Criteria for selection of major equipment are provided and ancillary utilities necessary for safe and reliable operation in compliance with environmental regulations are described. Construction considerations are described including a general arrangement of the CCS process units within the overall gasification project. A cost estimate is provided, delineated by system area with cost breakdown showing equipment, piping and materials

  16. Developing regulatory approaches

    International Nuclear Information System (INIS)

    Axelsson, Lars

    2012-01-01

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

  17. CCS Research Development and Deployment in a Clean Energy Future: Lessons from Australia over the Past Two Decades

    Directory of Open Access Journals (Sweden)

    Peter J. Cook

    2017-08-01

    Full Text Available There is widespread, though by no means universal, recognition of the importance of carbon capture and storage (CCS as a carbon mitigation technology. However, the rate of deployment does not match what is required for global temperatures to stay well below 2 °C. Although some consider the hurdles to achieving the widespread application of CCS to be almost insurmountable, a more optimistic view is that a great deal is now known about CCS through research, demonstration, and deployment. We know how to do it; we are confident it can be done safely and effectively; we know what it costs; and we know that costs are decreasing and will continue to do so. We also know that the world will need CCS as long as countries, companies, and communities continue to use fossil fuels for energy and industrial processes. What is lacking are the necessary policy drivers, along with a technology-neutral approach to decrease carbon emissions in a cost-effective and timely manner while retaining the undoubted benefits of ready access to reliable and secure electricity and energy-intensive industrial products. In this paper, Australia is used as an example of what has been undertaken in CCS over the past 20 years, particularly in research and demonstration, but also in international collaboration. Progress in the large-scale deployment of CCS in Australia has been too slow. However, the world’s largest storage project will soon be operational in Australia as part of the Gorgon liquefied natural gas (LNG project, and investigations are underway into several large-scale CCS Flagship program opportunities. The organization and progress of the Cooperative Research Centre for Greenhouse Gas Technologies (CO2CRC Otway Project, which is currently Australia’s only operational storage project, is discussed in some detail because of its relevance to the commercial deployment of CCS. The point is made that there is scope for building on this Otway activity to investigate

  18. Potential impacts of CCS on the CDM

    International Nuclear Information System (INIS)

    Bakker, S; Mikunda, T.; Rivera Tinoco, R.

    2011-02-01

    CO2 capture and storage can ensure that stringent climate change mitigation targets are achieved more cost-effectively. However, in order to ensure a substantial role for CCS, deployment of CCS is required on a significant global scale by 2020. Currently, the CDM is the only international instrument that could provide a financial incentive for CCS in developing countries. In December 2010 it was decided that CCS could in principle be eligible under the CDM, provided a number of issues are resolved, including non-permanence, liability, monitoring and potential perverse outcomes. The latter issue relates to the concern that that CCS projects could flood the CDM market, thereby crowding out other technologies that could be considered more sustainable. This report, therefore, aims to quantify the possible impact of CCS on the CDM market, in order to assess the relevance of the CDM market objection. However, the analysis in the report is also valid for the role of CCS in other types of international support mechanisms. The first result of this study is a marginal abatement cost curve (MAC) for CCS in developing countries for 2020. Based on existing MAC studies, the IEA CCS Roadmap and an overview of ongoing and planned CCS activities, we compiled three scenarios for CCS in the power, industry and upstream sector, as shown below. The major part of the potential below $30/tCO2eq (70 - 100 MtCO2/yr) is in the natural gas processing sector. Using the MACs for the CDM market, we estimate the economic potential for CCS projects to be 4-19% of the CDM credit supply in 2020. The potential impact inclusion of CCS in the CDM may have is assessed by using several possible CER supply and demand scenarios, as well as scenarios related to market price responsiveness and the role of CDM in the post-2012 carbon market. The impact is estimated to be between $0 and $4 per tonne of CO2-eq, with three out of four scenarios indicating the lower part of this range.

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

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

  20. CATO-2 Deliverable WP 2.3-D03 Background paper on 'Role of CCS in the international climate regime'

    International Nuclear Information System (INIS)

    Hagemann, M.; Moltmann, S.; Palenberg, A.; De Visser, E.; Hoehne, N.; Jung, M.; Bakker, S.J.A.

    2011-03-01

    In its recent roadmap the IEA argued that CCS, in order to be effective, needs to be implemented on an international level. International cooperation is necessary to reduce costs, exchange ideas with implementation issues learned from experience and increase CCS implementation in developing countries. The aim of this study is to analyse ways to increase international cooperation in order to roll out CCS globally in developed but also developing countries. In this paper, we reviewed current international support mechanisms for CCS. Under the international climate agreement, the UNFCCC and the Kyoto Protocol, CCS does not play a major role. The clean development mechanism (CDM) is an instrument that could potentially support CCS in developing countries, but currently does not allow CCS and has no approved methodology for this technology. There are some promising developments in other areas of the international negotiations under the UNFCCC, but it is open as to what role CCS will play in them. Possible instruments include nationally appropriate mitigation actions, and climate technology innovation centres under a Technology Mechanism. We conclude that it is promising to consider bilateral and multilateral country partnerships outside the UNFCCC process. A review of existing CCS-related partnerships, undertaken within this study, showed that a growing number of such partnerships exist. These processes tend to focus on a limited number of issues, namely financing and implementation of R and D projects in the power sector, general knowledge exchange and capacity building as well as broad regulatory studies, and regions such as China. They do not sufficiently cover other important issues, such as financing and the implementation of regulatory frameworks. Partnerships with countries other than China, such as South Africa and India, are only small in size to this date. Considering the background information as analysed in this paper, we suggest three possible non

  1. The Lake Charles CCS Project

    Energy Technology Data Exchange (ETDEWEB)

    Doug Cathro

    2010-06-30

    The Lake Charles CCS Project is a large-scale industrial carbon capture and sequestration (CCS) project which will demonstrate advanced technologies that capture and sequester carbon dioxide (CO{sub 2}) emissions from industrial sources into underground formations. Specifically the Lake Charles CCS Project will accelerate commercialization of large-scale CO{sub 2} storage from industrial sources by leveraging synergy between a proposed petroleum coke to chemicals plant (the LCC Gasification Project) and the largest integrated anthropogenic CO{sub 2} capture, transport, and monitored sequestration program in the U.S. Gulf Coast Region. The Lake Charles CCS Project will promote the expansion of EOR in Texas and Louisiana and supply greater energy security by expanding domestic energy supplies. The capture, compression, pipeline, injection, and monitoring infrastructure will continue to sequester CO{sub 2} for many years after the completion of the term of the DOE agreement. The objectives of this project are expected to be fulfilled by working through two distinct phases. The overall objective of Phase 1 was to develop a fully definitive project basis for a competitive Renewal Application process to proceed into Phase 2 - Design, Construction and Operations. Phase 1 includes the studies attached hereto that will establish: the engineering design basis for the capture, compression and transportation of CO{sub 2} from the LCC Gasification Project, and the criteria and specifications for a monitoring, verification and accounting (MVA) plan at the Hastings oil field in Texas. The overall objective of Phase 2, provided a successful competitive down-selection, is to execute design, construction and operations of three capital projects: (1) the CO{sub 2} capture and compression equipment, (2) a Connector Pipeline from the LLC Gasification Project to the Green Pipeline owned by Denbury and an affiliate of Denbury, and (3) a comprehensive MVA system at the Hastings oil field.

  2. Development of a technical-economic model for dynamic calculation of COE, energy demand and CO2 emissions of an integrated UCG-CCS process

    Science.gov (United States)

    Nakaten, N.; Kempka, T.; Green, M.; Preshelkova, A.; Merachev, D.; Schlüter, R.; Azzam, R.

    2012-04-01

    World-wide coal reserves can provide energy supply for several hundred years. Underground coal gasification (UCG) offers an economic and sustainable approach to convert these coal reserves into syngas. As combustion of fossil fuels releases CO2 emissions into the atmosphere, the present study considers a coupling of UCG with CO2 capture and its subsequent storage (CCS) in the previously converted seams, thereby offering a low carbon solution to coal fired power generation. The aim of the present study is to develop a technical-economic model in order to evaluate costeffectiveness, energy demand and CO2 emissions for a coupled UCG-CCS process. The model consists of five dynamic submodels which take into account the processes of air separation (ASU), UCG, syngas processing, electricity production and CCS. Capital (CAPEX) and operational expenditure (OPEX) of these process stages are combined to establish the overall levelised costs of electricity generation (COE). Therefore, the modeling approach developed within the present study allows for a comparison of the COE of the coupled processes with different technologies for electricity production. The influence of parameters relevant for COE (e.g. seam thickness and depth as well as syngas quality) and CO2 emissions (e.g. quality of coal, plant efficiency) were analysed in the context of a sensitivity analysis. Within the UCG&CO2STORAGE project, funded by the EU Research Fund for Coal and Steel (RFCS), a theoretical UCG-CCS feasibility study is being performed for the Dobrudzha coal basin, the selected study area in northeast of Bulgaria. The concealed coalfield is of carboniferous age with high rank bituminous coals. The tectonic conditions in the area are complicated and some of the faults determine coal formation distribution. Explored are four coal formations, but only three of them (Krupen, Gurkovo, Makedonka) are of interest for the project. Investigated for the Dobrudzha coal deposit were 120 geological sections

  3. Global learning on carbon capture and storage: A call for strong international cooperation on CCS demonstration

    International Nuclear Information System (INIS)

    Coninck, Heleen de; Stephens, Jennie C.; Metz, Bert

    2009-01-01

    Closing the gap between carbon dioxide capture and storage (CCS) rhetoric and technical progress is critically important to global climate mitigation efforts. Developing strong international cooperation on CCS demonstration with global coordination, transparency, cost-sharing and communication as guiding principles would facilitate efficient and cost-effective collaborative global learning on CCS, would allow for improved understanding of the global capacity and applicability of CCS, and would strengthen global trust, awareness and public confidence in the technology.

  4. Regulatory pathways for vaccines for developing countries.

    Science.gov (United States)

    Milstien, Julie; Belgharbi, Lahouari

    2004-01-01

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

  5. Combining Bioenergy with CCS

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2011-07-01

    Bioenergy with Carbon Capture and Storage (BECCS) is a carbon reduction technology that offers permanent net removal of carbon dioxide (CO2) from the atmosphere. This has been termed negative carbon dioxide emissions, and offers a significant advantage over other mitigation alternatives, which only decrease the amount of emissions to the atmosphere. The benefits inherent within this technology are currently receiving increased attention from policy makers. To facilitate the development of appropriate policy incentives, this paper reviews the treatment of negative carbon dioxide emissions under current and planned international carbon accounting frameworks. It finds that, while current frameworks provide limited guidance, proposed and revised guidelines could provide an environmentally sound reporting framework for BECCS. However, the paper also notes that, as they currently stand, new guidelines do not tackle a critical issue that has implications for all biomass energy systems, namely the overall carbon footprint of biomass production and use. It recommends that, to the best extent possible, all carbon impacts of BECCS are fully reflected in carbon reporting and accounting systems under the UNFCCC and Kyoto Protocol.

  6. Development of a techno-economic model for dynamic calculation of cost of electricity, energy demand and CO2 emissions of an integrated UCG–CCS process

    OpenAIRE

    Nakaten, Natalie; Schlüter, Ralph; Azzam, Rafig; Kempka, Thomas

    2014-01-01

    Underground coal gasification (UCG) allows for the utilization of coal reserves not exploitable due to unfavorable geology and economic boundary conditions. The present study examines underground coal gasification economics converting deep-situated coals into a high-calorific UCG synthesis gas. Utilizing UCG synthesis gas to fuel a combined cycle gas turbine (CCGT) considering CO2 capture and its subsequent storage (CCS) in the underground voids resulting from coal consumption, the coupled pr...

  7. V&V Plan for FPGA-based ESF-CCS Using System Engineering Approach.

    Science.gov (United States)

    Maerani, Restu; Mayaka, Joyce; El Akrat, Mohamed; Cheon, Jung Jae

    2018-02-01

    Instrumentation and Control (I&C) systems play an important role in maintaining the safety of Nuclear Power Plant (NPP) operation. However, most current I&C safety systems are based on Programmable Logic Controller (PLC) hardware, which is difficult to verify and validate, and is susceptible to software common cause failure. Therefore, a plan for the replacement of the PLC-based safety systems, such as the Engineered Safety Feature - Component Control System (ESF-CCS), with Field Programmable Gate Arrays (FPGA) is needed. By using a systems engineering approach, which ensures traceability in every phase of the life cycle, from system requirements, design implementation to verification and validation, the system development is guaranteed to be in line with the regulatory requirements. The Verification process will ensure that the customer and stakeholder’s needs are satisfied in a high quality, trustworthy, cost efficient and schedule compliant manner throughout a system’s entire life cycle. The benefit of the V&V plan is to ensure that the FPGA based ESF-CCS is correctly built, and to ensure that the measurement of performance indicators has positive feedback that “do we do the right thing” during the re-engineering process of the FPGA based ESF-CCS.

  8. Methodological developments vs. regulatory requirements.

    Science.gov (United States)

    Bauer, Peter

    2006-08-01

    This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill, 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.

  9. Carbon prices and CCS investment: A comparative study between the European Union and China

    International Nuclear Information System (INIS)

    Renner, Marie

    2014-01-01

    Carbon Capture and Storage is considered as a key option for climate change mitigation; policy makers and investors need to know when CCS becomes economically attractive. Integrating CCS in a power plant adds significant costs which can be offset by a sufficient CO 2 price. However, most markets have failed: currently, the weak carbon price threatens CCS deployment in the European Union (EU). In China, a carbon regulation is appearing and CCS encounters a rising interest. This study investigates two questions: how much is the extra-cost of a CCS plant in the EU in comparison with China? Second, what is the CO 2 price beyond which CCS plants become more profitable than reference plants in the EU and in China? To address these issues, I conducted a literature review on public studies about CCS costs. To objectively assess the profitability of CCS plants, I constructed a net present value model to calculate the Levelised Cost of Electricity and the breakeven CO 2 price. CCS plants become the most profitable plant type beyond 115 €/tCO 2 in the EU vs. 45 €/tCO 2 in China (offshore transport and storage costs). I advise on the optimal plant type choice depending on the CO 2 price in both countries. - Highlights: • I develop a method to objectively update and compare CCS costs in the EU and China. • To represent investment choices, intra and inter CO 2 switching prices are required. • EU CCS plants are profitable for a CO 2 price higher than 115 €/t (offshore storage). • Chinese CCS plants are profitable beyond 45 €/tCO 2 (35 €/tCO 2 with onshore storage). • With 2030 projections, CCS (coal) plants are profitable in China but not in the EU

  10. Investigating afforestation and bioenergy CCS as climate change mitigation strategies

    Science.gov (United States)

    Humpenöder, Florian; Popp, Alexander; Dietrich, Jan Philip; Klein, David; Lotze-Campen, Hermann; Bonsch, Markus; Bodirsky, Benjamin Leon; Weindl, Isabelle; Stevanovic, Miodrag; Müller, Christoph

    2014-05-01

    The land-use sector can contribute to climate change mitigation not only by reducing greenhouse gas (GHG) emissions, but also by increasing carbon uptake from the atmosphere and thereby creating negative CO2 emissions. In this paper, we investigate two land-based climate change mitigation strategies for carbon removal: (1) afforestation and (2) bioenergy in combination with carbon capture and storage technology (bioenergy CCS). In our approach, a global tax on GHG emissions aimed at ambitious climate change mitigation incentivizes land-based mitigation by penalizing positive and rewarding negative CO2 emissions from the land-use system. We analyze afforestation and bioenergy CCS as standalone and combined mitigation strategies. We find that afforestation is a cost-efficient strategy for carbon removal at relatively low carbon prices, while bioenergy CCS becomes competitive only at higher prices. According to our results, cumulative carbon removal due to afforestation and bioenergy CCS is similar at the end of 21st century (600-700 GtCO2), while land-demand for afforestation is much higher compared to bioenergy CCS. In the combined setting, we identify competition for land, but the impact on the mitigation potential (1000 GtCO2) is partially alleviated by productivity increases in the agricultural sector. Moreover, our results indicate that early-century afforestation presumably will not negatively impact carbon removal due to bioenergy CCS in the second half of the 21st century. A sensitivity analysis shows that land-based mitigation is very sensitive to different levels of GHG taxes. Besides that, the mitigation potential of bioenergy CCS highly depends on the development of future bioenergy yields and the availability of geological carbon storage, while for afforestation projects the length of the crediting period is crucial.

  11. Joining the CCS Club. Insights from a Northwest European CO2 Pipeline Project

    International Nuclear Information System (INIS)

    Massol, Olivier; Tchung-Ming, Stephane

    2012-01-01

    The large-scale diffusion of Carbon Capture and Storage (CCS) imposes the construction of a sizeable CO 2 pipeline infrastructure. This paper analyzes the conditions for a widespread adoption of CCS by a group of emitters that can be connected to a common pipeline system. It details a quantitative framework capable of assessing how the tariff structure and the regulatory constraints imposed on the pipeline operator impact the overall cost of CO 2 abatement via CCS. This modeling framework is applied to the case of a real European CO 2 pipeline project. We find that the obligation to use cross-subsidy-free pipeline tariffs has a minor impact on the minimum CO 2 price required to adopt the CCS. In contrast, the obligation to charge non-discriminatory prices can either impede the adoption of CCS or significantly raises that price. Besides, we compared two alternative regulatory frameworks for CCS pipelines: a common European organization as opposed to a collection of national regulations. The results indicate that the institutional scope of that regulation has a limited impact on the adoption of CCS compared to the detailed design of the tariff structure imposed to pipeline operators. (authors)

  12. A real options-based CCS investment evaluation model: Case study of China's power generation sector

    International Nuclear Information System (INIS)

    Zhu, Lei; Fan, Ying

    2011-01-01

    Highlights: → This paper establishes a carbon captures and storage (CCS) investment evaluation model. → The model is based on real options theory and solved by the Least Squares Monte Carlo (LSM) method. → China is taken as a case study to evaluate the effects of regulations on CCS investment. → The findings show that the current investment risk of CCS is high, climate policy having the greatest impact on CCS development. -- Abstract: This paper establishes a carbon capture and storage (CCS) investment evaluation model based on real options theory considering uncertainties from the existing thermal power generating cost, carbon price, thermal power with CCS generating cost, and investment in CCS technology deployment. The model aims to evaluate the value of the cost saving effect and amount of CO 2 emission reduction through investing in newly-built thermal power with CCS technology to replace existing thermal power in a given period from the perspective of power generation enterprises. The model is solved by the Least Squares Monte Carlo (LSM) method. Since the model could be used as a policy analysis tool, China is taken as a case study to evaluate the effects of regulations on CCS investment through scenario analysis. The findings show that the current investment risk of CCS is high, climate policy having the greatest impact on CCS development. Thus, there is an important trade off for policy makers between reducing greenhouse gas emissions and protecting the interests of power generation enterprises. The research presented would be useful for CCS technology evaluation and related policy-making.

  13. Collaborative Classroom Simulation (CCS): An Innovative Pedagogy Using Simulation in Nursing Education.

    Science.gov (United States)

    Berndt, Jodi; Dinndorf-Hogenson, Georgia; Herheim, Rena; Hoover, Carrie; Lanc, Nicole; Neuwirth, Janet; Tollefson, Bethany

    2015-01-01

    Collaborative Classroom Simulation (CCS) is a pedagogy designed to provide a simulation learning experience for a classroom of students simultaneously through the use of unfolding case scenarios. The purpose of this descriptive study was to explore the effectiveness of CCS based on student perceptions. Baccalaureate nursing students (n = 98) participated in the study by completing a survey after participation in the CCS experience. Opportunities for collaboration, clinical judgment, and participation as both observer and active participant were seen as strengths of the experience. Developed as a method to overcome barriers to simulation, CCS was shown to be an effective active learning technique that may prove to be sustainable.

  14. IPTV Market Development and Regulatory Aspects

    DEFF Research Database (Denmark)

    Tadayoni, Reza; Sigurdsson, Halldór Matthias

    2006-01-01

    The aim of this paper is to analyse the development of IPTV technology / market and to discuss major regulatory parameters. A general overview of architectures and the technologies deployed for establishing IPTV services is given and the main stake holder identified, along with, the current service...... architecture, the available content in IPTV platforms, and the current business models. Furthermore the regulatory framework of the TV broadcast and IPTV in Europe is analysed....

  15. Transport and Storage Economics of CCS Networks in the Netherlands

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2013-04-15

    A team from the Rotterdam Climate Initiative, CATO-2 (the Dutch national R and D programme on CCS) and the Clinton Climate Initiative, developed a financial model to assess the economics of alternative CO2 transport and storage options in the North Sea, based on common user infrastructure. The purpose of the financial model is to introduce a simple planning tool relating to the transport and storage components of an integrated CCS project using readily available, non-confidential data. A steering group of major emitters with advanced plans for CCS projects in the Netherlands and Belgium guided the project. Although the report focusses on potential projects in the Netherlands (Rotterdam and Eemshaven) and Belgium (Antwerp) in the short to medium term, the analysis and lessons could be useful to other regions considering CO2 network solutions.

  16. From Explicit to Symbolic Types for Communication Protocols in CCS

    DEFF Research Database (Denmark)

    Nielson, Hanne Riis; Nielson, Flemming; Kreiker, Jörg

    2012-01-01

    We study communication protocols having several rounds and expressed in value passing CCS. We develop a type-based analysis for providing an explicit record of all communications and show the usual subject reduction result. Since the explicit records can be infinitely large, we also develop a type...

  17. Carbon dioxide capture and storage : public perception, policy and regulatory issues in the Netherlands

    Energy Technology Data Exchange (ETDEWEB)

    De Coninck, H.C. [Energy Research Centre of the Netherlands, Amsterdam (Netherlands); Huijts, N.M.A. [Energy Research Centre of the Netherlands, Amsterdam (Netherlands)]|[Eindhoven Univ. of Technology, Eindhoven (Netherlands). Dept. of Human Technology Interactions

    2005-07-01

    Carbon dioxide (CO{sub 2}) capture and storage (CCS) is emerging as a viable option to mitigate global climate change. However, uncertainty exists on the public acceptance, a legal framework, and the policy incentives for CCS. These issues must be addressed before widespread adoption of CCS technology. This paper discussed the current situation in the Netherlands. Although CCS was mentioned as a cost-effective option in the Netherlands 1998 Option Document, it was not included in the country's 1999 Climate Change Action Plan because a Dutch research team identified several threats to the implementation of geological CCS in the Netherlands. The threats included lack of public acceptance, unplanned seepage of CO{sub 2} from the reservoir, and lengthy legal and regulatory procedures. A reported public perception study highlighted the results of an inquiry on the perception of CCS with 112 people in Alkmaar and surroundings in northwest Netherlands. Alkmaar is located above a gas storage field, which in the past has caused several small earthquakes. The average attitude towards CCS was not positive but also not rejecting. The public's perception of CCS seemed to be dominated by concern. Meanwhile, the legal framework in the Netherlands is developing in great strides, allowing CCS through policy incentives that include the European Union Emissions Trading System, Joint Implementation, and an electricity subsidy. As such, CCS appears to have good chances, even of short-term commercial implementation in the Netherlands. However, it was emphasized that public opinion should continue to be taken into account when CCS is planned in populated areas. Despite public concerns, and the not in my back yard syndrome (NIMBY), CCS was rated more favourable for deep reductions in greenhouse gas emissions than nuclear, intensive energy savings, or maintaining coal. 14 refs., 2 figs.

  18. Development of multipurpose regulatory PSA model

    International Nuclear Information System (INIS)

    Lee, Chang Ju; Sung, Key Yong; Kim, Hho Jung; Yang, Joon Eon; Ha, Jae Joo

    2004-01-01

    Generally, risk information for nuclear facilities comes from the results of Probabilistic safety assessment (PSA). PSA is a systematic tool to ensure the safety of nuclear facilities, since it is based on thorough and consistent application of probability models. In particular, the PSA has been widely utilized for risk-informed regulation (RIR), including various licensee-initiated risk-informed applications (RIA). In any regulatory decision, the main goal is to make a sound safety decision based on technically defensible information. Also, due to the increased public requests for giving a safety guarantee, the regulator should provide the visible means of safety. The use of PSA by the regulator can give the answer on this problem. Therefore, in order to study the applicability of risk information for regulatory safety management, it is a demanding task to prepare a well-established regulatory PSA model and tool. In 2002, KINS and KAERI together made a research cooperation to form a working group to develop the regulatory PSA model - so-called MPAS model. The MPAS stands for multipurpose probabilistic analysis of safety. For instance, a role of the MPAS model is to give some risk insights in the preparation of various regulatory programs. Another role of this model is to provide an independent risk information to the regulator during regulatory decision-making, not depending on the licensee's information

  19. Scenario for large-scale implementation of CCS in Europe

    NARCIS (Netherlands)

    Wildenborg, T.; Coussy, P.; Doukelis, A.; Ekström, C.; Georgiou, G.; Gkountanis, S.; Kramers, L.; Kuip, M. van der; Lindeberg, E.; Nordbø, Ø.; Serbutoviez, S.; Simonsson, D.

    2009-01-01

    In the CASTOR project funded by the EU and industry the emission reduction target for CO2 Capture and Storage (CCS) was set at 30% of the CO2 emissions from power plants in Europe, which is to be achieved during the first half of this century. The developed scenario shows that this target can be

  20. Carbon capture and sequestration (CCS) technological innovation system in China: Structure, function evaluation and policy implication

    International Nuclear Information System (INIS)

    Lai Xianjin; Ye Zhonghua; Xu Zhengzhong; Husar Holmes, Maja; Henry Lambright, W.

    2012-01-01

    Carbon capture and sequestration (CCS) can be an important technology option for China in addressing global climate change and developing clean energy technologies. Promoted by international climate conventions and supported by government research and development programs, an increasing number of CCS pilot and demonstration projects have been launched in China. In this study, we analyze the structure of China’s CCS effort from a technological innovation system (TIS) perspective. Within this system, key socio-political components, including institutions, actor-networks, and technology development, are examined to evaluate the state of the innovation system. The study assessed the perceived capacity of seven functional areas of the CCS innovation system through a survey of key CCS actors and stakeholders. The findings suggest that China’s CCS innovation system has a strong functional capacity for knowledge and technology development. It is significantly weaker in the innovative functions of knowledge diffusion, market formation, facilitating entrepreneurs and new entrants into the CCS market. Based on the evaluation of China’s technological innovation system to develop CCS, the article articulates specific public policies to formulate a more robust innovation system to traverse the “valley of death” from research and development to commercial deployment and accelerate energy innovation in China. - Highlights: ► We analyze and evaluate China’s CCS innovation system from TIS perspective. ► Strong and systematic CCS innovation system structure has come into being in China. ► The system has acquired high knowledge development and accumulation. ► Weak innovation functions are identified: market creation, guidance, etc. ► Public policies are needed to improve the innovation system performance.

  1. Developing legal regulatory frameworks for modern biotechnology ...

    African Journals Online (AJOL)

    This paper looks at attempts that have been made to develop legal regulatory frameworks for modern biotechnology. The discussion is limited to the regulation of Genetically Modified Organisms (GMO) technology by the two leading producers and exporters of GMOs in Africa: South Africa and Kenya. The international and ...

  2. Technical and energy economic boundary conditions for a CCS based power generation structure in Europe; Technische und energiewirtschaftliche Rahmenbedingungen fuer eine CCS-basierte Erzeugungsstruktur in Europa

    Energy Technology Data Exchange (ETDEWEB)

    Kober, Tom; Blesl, Markus [Stuttgart Univ. (Germany). Inst. fuer Energiewirtschaft und Rationelle Energieanwendung

    2008-07-01

    The development of the power generation in Europe substantially is characterized by the process of liberalisation and the endeavours to climate protection. The ensuring of future supply security increasingly becomes more important. In order to achieve the climatic protection goal a multiplicity of technical options in the competitively organized market is available. In order to be competitive in such a market, certain requirements have to be expected to future power plants with CCS technology (CCS = carbon Capture and storage). By means of a European energy system model the question is to answered in the contribution under consideration which requirements to the CS technology have to be expected to the CCS technology.

  3. Glucocorticoids as regulatory signals during intrauterine development.

    Science.gov (United States)

    Fowden, Abigail L; Forhead, Alison J

    2015-12-01

    What is the topic of this review? This review discusses the role of the glucocorticoids as regulatory signals during intrauterine development. It examines the functional significance of these hormones as maturational, environmental and programming signals in determining offspring phenotype. What advances does it highlight? It focuses on the extensive nature of the regulatory actions of these hormones. It highlights the emerging data that these actions are mediated, in part, by the placenta, other endocrine systems and epigenetic modifications of the genome. Glucocorticoids are important regulatory signals during intrauterine development. They act as maturational, environmental and programming signals that modify the developing phenotype to optimize offspring viability and fitness. They affect development of a wide range of fetal tissues by inducing changes in cellular expression of structural, transport and signalling proteins, which have widespread functional consequences at the whole organ and systems levels. Glucocorticoids, therefore, activate many of the physiological systems that have little function in utero but are vital at birth to replace the respiratory, nutritive and excretory functions previously carried out by the placenta. However, by switching tissues from accretion to differentiation, early glucocorticoid overexposure in response to adverse conditions can programme fetal development with longer term physiological consequences for the adult offspring, which can extend to the next generation. The developmental effects of the glucocorticoids can be direct on fetal tissues with glucocorticoid receptors or mediated by changes in placental function or other endocrine systems. At the molecular level, glucocorticoids can act directly on gene transcription via their receptors or indirectly by epigenetic modifications of the genome. In this review, we examine the role and functional significance of glucocorticoids as regulatory signals during intrauterine

  4. CCS - environmental protection framework for an emerging technology. Background

    Energy Technology Data Exchange (ETDEWEB)

    Becker, Ralf; Boehringer, Alexander; Charisse, Thomas (and others)

    2009-10-15

    With this paper, the German Federal Environment Agency (Umweltbundesamt, UBA) updates1 its position paper of 20062 on the technical capture and geological storage3 of carbon dioxide (CCS: carbon capture and storage). After a brief description of the development status of the process steps of capture, transport and geological storage of carbon dioxide (CO2) in Chapter 1, we look into the possible risks for human health and the environment (Chapter 2), which up to now have been little discussed or researched. These risks will largely depend on the integrity of storage sites. On the assumption of functioning capture technology at cost-effective conditions, the capacity of available and secure storage sites will decisively determine the scale of possible greenhouse gas emission reductions through CCS (Chapter 3). In examining storage capacity, it has always to be considered that the geological storage of CO2 can compete with other uses of underground geological formations, such as geothermics or compressed-air and natural-gas storage (Chapter 4). The Federal Environment Agency takes the view that these factors determine the role that CCS can play as an additional climate protection measure (Chapter 5). In Chapter 6 we show how CCS, in its application, should be integrated into emissions trading. CO2 emission reduction should in our view only be acknowledged when it is effectively and demonstrably ensured through permanent storage. Chapter 7 deals with necessary reforms of liability law, which legislators should undertake in order to assign the dangers and risks of CCS to those responsible for them. In Chapter 8, we summarize the fundamental demands on legislators, while Chapter 9 is devoted to issues concerning the source and application of funds for research and development. (orig.)

  5. Trojan horse or horn of plenty? Reflections on allowing CCS in the CDM

    International Nuclear Information System (INIS)

    Coninck, Heleen de

    2008-01-01

    The discussion around allowing CO 2 capture and geological storage (CCS) into the Kyoto Protocol's Clean Development Mechanism (CDM) is important, as the CDM is currently the only structural incentive for reducing greenhouse gas emissions in the developing world. Without the potential incentives given by the CDM, CCS in developing countries will only take place sporadically in niche sectors. The debate around CCS in the CDM has developed into a highly polarised discussion, with a deep divide between proponents and opponents and no view on reconciliation between the various perspectives. Environmental organisations and several developing-country parties in the climate negotiations are increasingly vehemently opposed against CCS in the CDM, and industrialised countries, several large fossil-fuel-dependent developing countries and industry view CCS as a natural option under the CDM, provided some surmountable technical and procedural barriers are taken care of. This paper argues that the efforts of those trying to bring the discussion to a close by solving technical and procedural issues around CCS in the CDM will not lead to agreement because of underlying convictions of all stakeholders. Six convictions are identified and discussed. Based on the discussion of the convictions of both opponents and proponents, research needs and a potential negotiation package are suggested. The research needs are primarily in the field of the CDM market impacts of CCS, the issue of enhanced oil emission accounting, and sustainable development aspects, and particularly whether developing countries could actually benefit from technological leadership in the field of CCS, or whether they will be worse off. Devoting attention to the identified convictions could provide information for a more acceptable negotiation package on CCS in the CDM

  6. Considering public confidence in developing regulatory programs

    International Nuclear Information System (INIS)

    Collins, S.J.

    2001-01-01

    In the area of public trust and in any investment, planning and strategy are important. While it is accepted in the United States that an essential part of our mission is to leverage our resources to improving Public Confidence this performance goal must be planned for, managed and measured. Similar to our premier performance goal of Maintaining Safety, a strategy must be developed and integrated with our external stake holders but with internal regulatory staff as well. In order to do that, business is to be conducted in an open environment, the basis for regulatory decisions has to be available through public documents and public meetings, communication must be done in clear and consistent terms. (N.C.)

  7. World-wide innovations in the development of CCS-technologies and possibilities of utilization and recycling of CO{sub 2}; Weltweite Innovationen bei der Entwicklung von CCS-Technologien und Moeglichkeiten der Nutzung und des Recyclings von CO{sub 2}

    Energy Technology Data Exchange (ETDEWEB)

    Kuckshinrichs, Wilhelm; Markewitz, Peter; Linssen, Jochen; Zapp, Petra [Forschungszentrum Juelich GmbH (DE). Inst. fuer Energieforschung (IEF), Systemforschung und Technologische Entwicklung (IEF-STE); Peters, Martina; Koehler, Burkhard; Mueller, Thomas E.; Leitner, Walter [RWTH Aachen (DE). Inst. fuer Technische und Makromolekulare Chemie (ITMC und CAT Catalytic Center)

    2010-07-01

    In the context of world-wide strategies for the reduction of climatic gases the CCS technology (CCS = carbon capture and sequestration) highlights a great importance. In individual areas the capture of carbon dioxide occurs commercially. However, the losses of the efficiency in the operation of power stations must be reduced by the separation and processing of carbon dioxide. A construction of a demonstration unit is particularly important. On this basis, diaphragm-based procedures, procedures for oxygen production as well as the dry sorption of carbon dioxide are promising. The technical and chemical utilization of carbon dioxide can offer an interesting approach for the direct reduction of the global emissions of carbon dioxide.

  8. The Impact of CCS Readiness on the Evolution of China's Electric Power Sector

    Energy Technology Data Exchange (ETDEWEB)

    Dahowski, Robert T.; Davidson, Casie L.; Yu, Sha; Horing, Jill D.; Wei, Ning; Clarke, Leon E.; Bender, Sadie R.

    2017-07-01

    In this study, GCAM-China is exercised to examine the impact of CCS availability on the projected evolution of China’s electric power sector under the Paris Increased Ambition policy scenario developed by Fawcett et al. based on the Intended Nationally Determined Contributions (INDCs) submitted under the COP-21 Paris Agreement. This policy scenario provides a backdrop for understanding China’s electric generation mix over the coming century under several CCS availability scenarios: CCS is fully available for commercial-scale deployment by 2025; by 2050; by 2075; and CCS is unavailable for use in meeting the modelled mitigation targets through 2100. Without having CCS available, the Chinese electric power sector turns to significant use of nuclear, wind, and solar to meet growing demands and emissions targets, at a cost. Should large-scale CCS deployment be delayed in China by 25 years, the modeled per-ton cost of climate change mitigation is projected to be roughly $420/tC (2010 US dollars) by 2050, relative to $360/tC in the case in which CCS is available to deploy by 2025, a 16% increase. Once CCS is available for commercial use, mitigation costs for the two cases converge, equilibrating by 2085. However, should CCS be entirely unavailable to deploy in China, the mitigation cost spread, compared to the 2025 case, doubles by 2075 ($580/tC and $1130/tC respectively), and triples by 2100 ($1050/tC vs. $3200/tC). However, while delays in CCS availability may have short-term impacts on China’s overall per-ton cost of meeting the emissions reduction target evaluated here, as well as total mitigation costs, the carbon price is likely to approach the price path associated with the full CCS availability case within a decade of CCS deployment. Having CCS available before the end of the century, even under the delays examined here, could reduce the total amount of nuclear and renewable energy that must deploy, reducing the overall cost of meeting the emissions

  9. LipidCCS: Prediction of Collision Cross-Section Values for Lipids with High Precision To Support Ion Mobility-Mass Spectrometry-Based Lipidomics.

    Science.gov (United States)

    Zhou, Zhiwei; Tu, Jia; Xiong, Xin; Shen, Xiaotao; Zhu, Zheng-Jiang

    2017-09-05

    The use of collision cross-section (CCS) values derived from ion mobility-mass spectrometry (IM-MS) has been proven to facilitate lipid identifications. Its utility is restricted by the limited availability of CCS values. Recently, the machine-learning algorithm-based prediction (e.g., MetCCS) is reported to generate CCS values in a large-scale. However, the prediction precision is not sufficient to differentiate lipids due to their high structural similarities and subtle differences on CCS values. To address this challenge, we developed a new approach, namely, LipidCCS, to precisely predict lipid CCS values. In LipidCCS, a set of molecular descriptors were optimized using bioinformatic approaches to comprehensively describe the subtle structure differences for lipids. The use of optimized molecular descriptors together with a large set of standard CCS values for lipids (458 in total) to build the prediction model significantly improved the precision. The prediction precision of LipidCCS was externally validated with median relative errors (MRE) of ∼1% using independent data sets across different instruments (Agilent DTIM-MS and Waters TWIM-MS) and laboratories. We also demonstrated that the improved precision in the predicted LipidCCS database (15 646 lipids and 63 434 CCS values in total) could effectively reduce false-positive identifications of lipids. Common users can freely access our LipidCCS web server for the following: (1) the prediction of lipid CCS values directly from SMILES structure; (2) database search; and (3) lipid match and identification. We believe LipidCCS will be a valuable tool to support IM-MS-based lipidomics. The web server is freely available on the Internet ( http://www.metabolomics-shanghai.org/LipidCCS/ ).

  10. Relating R and D and investment policies to CCS market diffusion through two-factor learning

    International Nuclear Information System (INIS)

    Lohwasser, Richard; Madlener, Reinhard

    2013-01-01

    Carbon capture and storage (CCS) has the potential to play a major role in the stabilization of anthropogenic greenhouse gases. To develop the capture technology from its current demonstration phase towards commercial maturity, significant funding is directed to CCS, such as the EU’s €4.5 bn NER300 fund. However, we know little about how this funding relates to market diffusion of CCS. This paper addresses that question. We initially review past learning effects from both capacity installations and R and D efforts for a similar technology using the concept of two-factor learning. We apply the obtained learning-by-doing and learning-by-searching rates to CCS in the electricity market model HECTOR, which simulates 19 European countries hourly until 2040, to understand the impact of learning and associated policies on CCS market diffusion. We evaluate the effectiveness of policies addressing learning-by-doing and learning-by-searching by relating the policy budget to the realized CCS capacity and find that, at lower policy cost, both methods are about equally effective. At higher spending levels, policies promoting learning-by-doing are more effective. Overall, policy effectiveness increases in low CO 2 price scenarios, but the CO 2 price still remains the key prerequisite for the economic competitiveness, even with major policy support. - Highlights: ► Identified two-factor learning rates for CCS through empirical data from flue gas desulphurization. ► Evaluated effectiveness of CCS stimulation policies addressing learning-by-doing and learning-by-researching. ► Both policy types are about equally effective with small policy budgets. ► Policies addressing learning-by-doing, e.g., subsidies to CCS projects, are more effective with large policy budgets. ► Analysis deployed HECTOR power market model that simulates 19 European countries on hourly granularity until 2040.

  11. [Regulatory peptides and psychomotor development in infants].

    Science.gov (United States)

    Sokolov, O Iu; Kost, N V; Kurasova, O B; Dmitriev, A D; Gabaeva, M V; Zolotarev, Iu A; Mikheeva, I G; Zozulia, A A

    2007-01-01

    Regulatory peptides (RP) are an important homeostatic factor. The maternal organism and placenta are substantial sources of RP for fetus during the prenatal period. Not only endogenous, but also exogenous RP play an important role during early postnatal period. In this study, the concentration of exogenous RP (casomorphins-7) and the activity of peptidases (enkephalinases) in the serum of breastfed and bottle-fed infants were estimated. Possible interrelation between these two parameters and the psychomotor development (PMD) of infants were evaluated. Using specially developed RIA, the investigators estimated the presence of human and bovine casomorphins immunoreactivity (CMir) in the serum of breastfed and bottle-fed infants. A distinct correlation of CMir with PMD was demonstrated. The activity of RP-degrading serum enzymes also correlated with PMD level. The role of endo- and exogenous peptides in normal PMD process and in the pathogenesis of early child autism is discussed in the article.

  12. CCS, locations and asynchronous transition systems

    DEFF Research Database (Denmark)

    Mukund, Madhavan; Nielsen, Mogens

    1992-01-01

    We provide a simple non-interleaved operational semantics for CCS in terms of asynchronous transition systems. We identify the concurrency present in the system in a natural way, in terms of events occurring at independent locations in the system. We extend the standard interleaving transition sy....... We also introduce a notion of bisimulation on asynchronous transition systems which preserves independence. We conjecture that the induced equivalence on CCS processes coincides with the notion of location equivalence proposed by Boudol et al.......We provide a simple non-interleaved operational semantics for CCS in terms of asynchronous transition systems. We identify the concurrency present in the system in a natural way, in terms of events occurring at independent locations in the system. We extend the standard interleaving transition...... system for CCS by introducing labels on the transitions with information about the locations of events. We then show that the resulting transition system is an asynchronous transition system which has the additional property of being elementary, which means that it can also be represented by a 1-safe net...

  13. Coal + Biomass → Liquids + Electricity (with CCS)

    Science.gov (United States)

    In this presentation, Matt Aitken applies the MARKet ALlocation energy system model to evaluate the market potential for a class of technologies that convert coal and biomass to liquid fuels and electricity (CBtLE), paired with carbon capture and storage (CCS). The technology is ...

  14. Presheaf Models for CCS-like Languages

    DEFF Research Database (Denmark)

    Cattani, Gian Luca; Winskel, Glynn

    2003-01-01

    caused through traditional models not always possessing the cartesian liftings, used in the breakdown of process operations, are side stepped. The abstract results are applied to show that hereditary history-preserving bisimulation is a congruence for CCS-like languages to which is added a refinement...... operator on event structures as proposed by van Glabbeek and Goltz....

  15. Potential acidification impacts on zooplankton in CCS leakage scenarios

    International Nuclear Information System (INIS)

    Halsband, Claudia; Kurihara, Haruko

    2013-01-01

    Highlights: • Effects of CCS techniques and ocean acidification on zooplankton are under-studied. • Vulnerable zooplankton are meso-, bathypelagic and vertically migrating species. • Impacts include impaired calcification, reproduction, development and survival. • Need for modelling studies combining physico-chemical with ecological impacts. -- Abstract: Carbon capture and storage (CCS) technologies involve localized acidification of significant volumes of seawater, inhabited mainly by planktonic species. Knowledge on potential impacts of these techniques on the survival and physiology of zooplankton, and subsequent consequences for ecosystem health in targeted areas, is scarce. The recent literature has a focus on anthropogenic greenhouse gas emissions into the atmosphere, leading to enhanced absorption of CO 2 by the oceans and a lowered seawater pH, termed ocean acidification. These studies explore the effects of changes in seawater chemistry, as predicted by climate models for the end of this century, on marine biota. Early studies have used unrealistically severe CO 2 /pH values in this context, but are relevant for CCS leakage scenarios. Little studied meso- and bathypelagic species of the deep sea may be especially vulnerable, as well as vertically migrating zooplankton, which require significant residence times at great depths as part of their life cycle

  16. Carbon Capture and Sequestration: A Regulatory Gap Assessment

    Energy Technology Data Exchange (ETDEWEB)

    Lincoln Davies; Kirsten Uchitel; John Ruple; Heather Tanana

    2012-04-30

    Though a potentially significant climate change mitigation strategy, carbon capture and sequestration (CCS) remains mired in demonstration and development rather than proceeding to full-scale commercialization. Prior studies have suggested numerous reasons for this stagnation. This Report seeks to empirically assess those claims. Using an anonymous opinion survey completed by over 200 individuals involved in CCS, it concludes that there are four primary barriers to CCS commercialization: (1) cost, (2) lack of a carbon price, (3) liability risks, and (4) lack of a comprehensive regulatory regime. These results largely confirm previous work. They also, however, expose a key barrier that prior studies have overlooked: the need for comprehensive, rather than piecemeal, CCS regulation. The survey data clearly show that the CCS community sees this as one of the most needed incentives for CCS deployment. The community also has a relatively clear idea of what that regulation should entail: a cooperative federalism approach that directly addresses liability concerns and that generally does not upset traditional lines of federal-state authority.

  17. 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.

  18. 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.

  19. International Earth Science Constellation Mission Operations Working Group: Constellation Coordination System (CCS) Status. [Constellation Coordination System (CCS) Status

    Science.gov (United States)

    Skeberdis, Daniel

    2016-01-01

    This is a presentation at the MOWG fall meeting that will discuss CCS purpose, future status, security enhancements, arbitrary ephemeris mission features, overview of CCS 7.3, approach for the use of NORAD TLEs, account and data security, CCS System virtualization, control box visualization modification and other enhancements.

  20. Transfer of regulatory toxicology from developed to developing countries.

    Science.gov (United States)

    Salinas, J A

    1988-12-01

    Over the past two decades, industrialized nations have addressed and attempted to solve the problems of chemical risk through the development of laws, government and private organizations, and specialized manpower. Developing nations are now recognizing that the presence of toxicants in the environment, foods, consumer products, and the workplace can seriously affect human health, the ecology, international relations, and economic activities such as trade and tourism. The design and implementation of regulatory programs in developing countries is hampered by lack of government and public concern, pressure of more urgent needs, vested interests of industry, and lack of adequately trained professionals. These factors have allowed developed nations to sell abroad drugs, pesticides, and other chemicals considered too hazardous for use in their own countries. Conversely, products from developing nations must comply with rigorous standards for acceptance by developed nations. Some of these problems would be lessened by agreement on international chemical control guidelines. Multilateral availability of complete information about chemicals is essential. The coordination of this effort should be in the hands of international organizations and reinforced by bilateral agreements between countries. Appropriate public education and economic incentives at the national level would help in enforcing regulatory toxicology.

  1. Technology of CCS coal utilization (outline of large-size demonstration test for CCS); CCS tan riyo gijutsu

    Energy Technology Data Exchange (ETDEWEB)

    Konno, K. [Center for Coal Utilization, Japan, Tokyo (Japan); Hironaka, H. [Idemitsu Kosan Co. Ltd., Tokyo (Japan)

    1996-09-01

    The coal cartridge system (CCS) is a series of the total system, in which coal is processed centrally at a supply base for each unit of consumer areas, supplied as pulverized coal in bulk units, and coal ash after combustion is recovered and treated. The system is expected of advantages resulted from the centralized production, elimination of handling troubles, and cleanliness. Following a small scale demonstration test, a large demonstration test for practically usable scale has begun in 1990, and completed in fiscal 1995. This paper introduces the CCS and reports the result of the test. In the large demonstration test, a supply station (with manufacturing capability of 200,000 tons a year) was installed in the Aichi refinery of Idemitsu Kosan Co., Ltd., and systematization on quality design and system technologies has been carried out. Long-term continuous operation for five years was achieved (operation time of the supply facilities was about 19,000 hours) without a failure and accident, to which every elemental technology was evaluated highly, and convenience and reliability of the system was verified. 13 figs., 3 tabs.

  2. The Value of CCS under Current Policy Scenarios: NDCs and Beyond

    Energy Technology Data Exchange (ETDEWEB)

    Davidson, Casie L.; Dahowski, Robert T.; McJeon, Haewon C.; Clarke, Leon E.; Iyer, Gokul C.; Muratori, Matteo

    2017-07-01

    This paper describes preliminary results of analysis using the Global Change Assessment Model (GCAM) to evaluate the potential role of CCS in addressing emissions reduction targets. Scenarios are modelled using the Paris-Increased Ambition (PIA) case developed by Fawcett et al. (2015), and a more aggressive Paris Two-Degree Ambition (P2A) case. Both cases are based upon nationally determined contributions (NDCs) agreed to at the UNFCCC Conference of Parties (COP-21) in December 2015, coupled with additional mitigation effort beyond the 2030 Paris timeframe, through the end of the century. Analysis of CCS deployment and abatement costs under both policy scenarios suggests that, as modelled, having CCS in the technological portfolio could reduce the global cost of addressing emissions reduction targets specified under the policy scenario by trillions of dollars, primarily by enabling a smoother and lower-cost transition to next-generation technologies. Through the end of the century, total global abatement costs associated with the PIA case – with five percent annual reduction in emission intensity and reaching 2.2 degrees by 2100 – are reduced by $15 trillion USD in the scenario where CCS is available to deploy by 2025 and remains available through 2100, reflecting a 47 percent savings in the cost of climate change abatement. Under the more ambitious P2A case, with 8 percent annual reduction in emission intensity and reaching 1.9 degrees by 2100, the availability of CCS reduces global abatement costs by $22 trillion USD through the end of the century, again nearly halving the costs of addressing the policy, relative to achieving the same target using an energy portfolio that does not include CCS. PIA and P2A scenarios with CCS result in 1,250 and 1,580 GtCO2 of global geologic storage by the end of the century, respectively.

  3. Development of independent generalized probabilistic models for regulatory activities

    International Nuclear Information System (INIS)

    Gashev, M.Kh.; Zinchenko, Yu.A.; Stefanishin, N.A.

    2012-01-01

    The paper discusses the development of probabilistic models to be used in regulatory activities. Results from the development of independent generalized PSA-1 models for purposes of SNRIU risk-informed regulation are presented

  4. Public engagement with CCS: barriers, key issues and ways forward

    Science.gov (United States)

    Xenias, Dimitrios

    2017-04-01

    Although Carbon Capture and Storage (CCS) is recognised as a crucial transition technology to a low-carbon world, it has not been popular with the public or some governments (e.g. the UK). Also, despite its use in industrial processes for decades, CCS remains and unfamiliar technology for most publics. It is therefore important to foster top-down and bottom-up acceptance of large scale CCS. In an exploratory round of interviews we canvassed the views of British, Dutch, German and Norwegian experts (N=13) with previous experience in public engagement with CCS. They identified barriers and drivers for CCS deployment and public engagement with CCS. Thematic analysis revealed a small number of recurrent issues, including: (a) lack of political leadership on CCS; (b) lack of public knowledge on relevant technologies and (c) difficulty communicating why CCS is necessary. Emphasis on these barriers varied with the level of experts' engagement with the public. More interestingly, although most experts agreed on the importance of public engagement, their views divided between 'why' engage and 'how' best to do this. In a subsequent expert survey (N=99) interview findings were reinforced: public support was seen as important for CCS roll-out (72%), though lower than political support and funding. The survey also showed that local public was expected to experience most risks, while global public will experience most benefits; whereas local business is seen to benefit more than global. Experts were overwhelmingly positive about CCS - risks outweigh benefits, and are confident that CCS will play a major role in climate change mitigation (along with reduced energy demand and renewables). These findings will be expanded on and triangulated in a follow-up public survey which will benefit those involved with public engagement with CCS.

  5. CCS TECHNOLOGY: OVERVIEW OF PROJECTS, TECHNOLOGY AND MONITORING

    Directory of Open Access Journals (Sweden)

    Nediljka Gaurina-Međimurec

    2018-01-01

    Full Text Available Carbon capture and storage (CCS in terms of geological sequestration presents the process of capturing CO2 from large point sources, transporting it to a storage site, and depositing it into an underground geological formation. In addition to ecological benefits, underground injection of CO2 shows certain potential risks associated with unwanted migration of CO2 to groundwater and surface, so the possibility of carrying out such projects depends on the possibility of reducing mentioned risks to an acceptable level. For this purpose, a detailed risk assessment and analysis must be carried out, serving as the basis for a monitoring plan. Well designed and implemented monitoring plan and program provide important data on site integrity, well injectivity, and entire storage complex performance. This paper gives the overview of large scale and pilot projects of CO2 capture and geological storage in operation, under construction and in the phase of development all over the world, technology basics and available monitoring techniques. An example of CCS project monitoring is given through the monitoring program of the Lacq pilot project in France

  6. Establishment of regulatory framework for the development reactor licensing

    International Nuclear Information System (INIS)

    Jo, Jong C.; Yune, Young G.; Kim, Woong S.; Ahn, Sang K.; Kim, In G.; Kim, Hho J.

    2003-01-01

    With a trend that various types of advanced reactor designs are currently under development worldwide, the Korea Atomic Energy Research Institute has been developing an advanced reactor called ' System-integrated Modular Advanced Reactor (SMART)', which is a small sized integral type pressurized water reactor with a rated thermal power of 330 MW. To demonstrate the safety and the performance of the SMART reactor design, the SMART Research and Development Center has embarked to build a scaled-down pilot plant of SMART, called 'SMART-P' with a rated thermal power of 65 MW. In preparation for the forthcoming applications for both construction permit and operating license of SMART-P in the near future, the Korea Institute of Nuclear Safety is developing a new regulatory framework for licensing review of such a development reactor, which covers establishment of licensing process, identification and resolution of technical and safety issues, development of regulatory evaluation or verification-purpose computer codes and analytical methods, and establishment of design-specific, general design and operating criteria, regulations, and associated regulatory guides. This paper presents the current activities for establishing a regulatory framework for the licensing of a research and development reactor. Discussions are made on the SMART-P development program, the current Korean regulatory framework for reactor licensing, the SMART-P licensing-related issues, and the approach and strategy for developing an effective regulatory framework for the SMART-P licensing

  7. Study on Economic Aspects and the Introduction of Clean Coal Technologies with CCS

    Science.gov (United States)

    Yoshizaki, Haruki; Nakata, Toshihiko

    The advantages of coal are the largest reserves among any other fossil fuels, and can be found in many places including some developed countries. Due to the weak energy security of Japan, it is necessary to use coal as an energy source. We have designed the detailed energy model of electricity sector in which we take both energy conversion efficiency and economic aspects into consideration. The Japan model means an energy-economic model focusing on the structure of the energy supply and demand in Japan. Furthermore, the most suitable carbon capture and storage (CCS) system consisting of CO2 collection, transportation, storages are assumed. This paper examines the introduction of clean coal technologies (CCT's) with CCS into the electricity market in Japan, and explores policy options for the promotion of CCT's combined with CCS. We have analyzed the impacts of carbon tax where each fossil technology, combined with CCS, becomes competitive in possible market. CO2 mitigation costs for all plants with CCS are detailed and compared.

  8. Drafting a monitoring plan for the ROAD project under the EU CCS directive

    NARCIS (Netherlands)

    Steegs, T.P.H.; Neelse, F.P.; Gittins, C.; Ros, M.

    2014-01-01

    The Rotterdam Capture and Storage Demonstration Project (ROAD) is an integrated CCS project in the Netherlands that has recently completed the storage permitting process. Development of the monitoring and contingency plans is a key component of this process. Our paper discusses the development of

  9. Joint IEA-OPEC workshop on CO2-enhanced oil recovery with CCS

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-07-01

    The IEA and OPEC jointly organised a workshop to discuss CO2-EOR and its role in supporting the early demonstration of CCS. The workshop was hosted by Kuwait Petroleum Corporation, and held in Kuwait City on 7-8 February 2012. It brought together OPEC Member country experts and international CO2-EOR experts to discuss commercial, economic, technical, regulatory and policy aspects associated with the technology. Issues discussed include factors that can promote CO2-EOR ahead of ''pure'' CCS, barriers preventing uptake of the technology,and the range of policy interventions that could be employed to promote its use in OPEC Member countriesand other parts of the world. This report presents a synthesis of the discussions that took place, and lays the foundation for future analysis.

  10. Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

    International Nuclear Information System (INIS)

    Moe, Wayne Leland

    2015-01-01

    This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a ''critical path'' for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain ''minimum'' levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial ''first step'' in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by

  11. Advanced Reactor Technologies - Regulatory Technology Development Plan (RTDP)

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne L. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2017-08-23

    This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory

  12. Advanced Reactor Technology -- Regulatory Technology Development Plan (RTDP)

    Energy Technology Data Exchange (ETDEWEB)

    Moe, Wayne Leland [Idaho National Lab. (INL), Idaho Falls, ID (United States)

    2015-05-01

    This DOE-NE Advanced Small Modular Reactor (AdvSMR) regulatory technology development plan (RTDP) will link critical DOE nuclear reactor technology development programs to important regulatory and policy-related issues likely to impact a “critical path” for establishing a viable commercial AdvSMR presence in the domestic energy market. Accordingly, the regulatory considerations that are set forth in the AdvSMR RTDP will not be limited to any one particular type or subset of advanced reactor technology(s) but rather broadly consider potential regulatory approaches and the licensing implications that accompany all DOE-sponsored research and technology development activity that deal with commercial non-light water reactors. However, it is also important to remember that certain “minimum” levels of design and safety approach knowledge concerning these technology(s) must be defined and available to an extent that supports appropriate pre-licensing regulatory analysis within the RTDP. Final resolution to advanced reactor licensing issues is most often predicated on the detailed design information and specific safety approach as documented in a facility license application and submitted for licensing review. Because the AdvSMR RTDP is focused on identifying and assessing the potential regulatory implications of DOE-sponsored reactor technology research very early in the pre-license application development phase, the information necessary to support a comprehensive regulatory analysis of a new reactor technology, and the resolution of resulting issues, will generally not be available. As such, the regulatory considerations documented in the RTDP should be considered an initial “first step” in the licensing process which will continue until a license is issued to build and operate the said nuclear facility. Because a facility license application relies heavily on the data and information generated by technology development studies, the anticipated regulatory

  13. Electricity and telecommunications regulatory institutions in small and developing countries

    Energy Technology Data Exchange (ETDEWEB)

    Stern, J. [London Business School, London (United Kingdom)

    2000-09-01

    The spread of utility liberalisation and privatisation to middle and low income developing countries raises the problem of whether and how they can establish an effective regulatory capability of whether the supply of regulatory services is likely to be insufficient. The paper presents evidence on the size of electricity regulatory agencies in 24 mainly middle and lower income countries as well as the number of high-level, specialist regulatory staff and the potential resource pool from post-school education. The paper also discusses how far the problem can be alleviated and/or avoided by the use of regulation by contract, regulation by multi-national regulatory agency or contracting-out. The paper concludes that such solutions are unlikely to be generally effective but that informal exchanges of information and pooling of resources between national regulators on a market-driven basis, as seen in Southern Africa and the EU, is a promising option. The paper concludes by pointing to the need to ascertain the minimum required regulatory capability in developing countries as perceived by Governments and potential investors. (author)

  14. 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.

  15. Challenges in orphan drug development and regulatory policy in China.

    Science.gov (United States)

    Cheng, Alice; Xie, Zhi

    2017-01-18

    While regulatory policy is well defined for orphan drug development in the United States and Europe, rare disease policy in China is still evolving. Many Chinese patients currently pay out of pocket for international treatments that are not yet approved in China. The lack of a clear definition and therefore regulatory approval process for rare diseases has, until now, de-incentivized pharmaceutical companies to pursue rare disease drug development in China. In turn, many grassroots movements have begun to support rare disease patients and facilitate drug discovery through research. Recently, the Chinese FDA set new regulatory guidelines for drugs being developed in China, including an expedited review process for life-saving treatments. In this review, we discuss the effects of these new policy changes on and suggest potential solutions to innovate orphan drug development in China.

  16. Multiscale modeling of integrated CCS systems

    Science.gov (United States)

    Alhajaj, Ahmed; Shah, Nilay

    2015-01-01

    The world will continue consuming fossil fuel within the coming decades to meet its growing energy demand; however, this source must be cleaner through implementation of carbon capture, transport and storage (CCTS). This process is complex and involves multiple phases, owned by different operational companies and stakeholders with different business models and regulatory framework. The objective of this work is to develop a multiscale modeling approach to link process models, post-combustion capture plant model and network design models under an optimization framework in order to design and analyse the cost optimal CO2 infrastructure that match CO2 sources and sinks in capacity and time. The network comprises a number of CO2 sources at fixed locations and a number of potential CO2 storage sites. The decisions to be determined include from which sources it is appropriate to capture CO2 and the cost-optimal degree-of-capture (DOC) for a given source and the infrastructural layout of the CO2 transmission network.

  17. Development of an international BRC [Below Regulatory Concern] limit

    International Nuclear Information System (INIS)

    Kennedy, W.E. Jr.

    1987-07-01

    The International Atomic Energy Agency (IAEA) has recently investigated the exemption from regulatory control of radiation sources containing limited quantities of radioactive materials. Early efforts were entitled de minimis and were aimed at establishing a philosophical basis and radiation dose limits. The main objectives of more recent work on exemption are to illustrate a method for developing practical radiological criteria, to establish generic criteria, and to determine the practicability of the preliminary exemption principles. The method used to develop the criteria relies on models to evaluate the potential radiation exposure pathways and scenarios for individuals and population groups potentially present following the unrestricted release of materials. This paper describes the assessment methods, presents the generic results expressed in terms of the limiting concentrations of selected radionuclides in municipal waste, and provides a comparison with recent regulatory efforts in the United States for considering selected wastes being Below Regulatory Concern (BRC). 17 refs., 4 tabs

  18. PROSPECTS OF CCS PROJECTS IMPLEMENTATION IN RUSSIA: ENVIRONMENTAL PROTECTION AND ECONOMIC OPPORTUNITIES

    Directory of Open Access Journals (Sweden)

    Pavel Tcvetkov

    2016-04-01

    Full Text Available The urgency of environmental protection is determined by its intensive change because of human impact, which, among other things, accompanied by an increasing of carbon dioxide (CO2 emissions. One of the ways to reduce the emission is Carbon Capture and Storage (CCS technologies. To date, developed countries have successfully implemented a number of CCS demonstration projects. Their main purpose is to study the effectiveness of CO2 storage. Russia is one of the world’s largest producers of CO2 emissions. However, CO2 capture and storage issues are not studied by Russian enterprises due to the absence of environmental taxes. The experience of developed countries shows that CO2 storage projects, in addition to the reduction of anthropogenic impact, can be commercially effective not only by reducing the tax burden. This review presents the analysis of international experience in the field of CO2 capture and storage. Given the immaturity of technology and lack of the necessary volume of statistical data, it was an attempt to determine the minimum conditions, which permit the implementation of CCS projects in Russian oil fields. On the basis of the Russian development forecast and the fuel balance structure the volumes of CO2 emissions in the 2016–2030 years were calculated. According to significant difference in opinions about the feasibility of CCS implementation in Russia, this review presents the main arguments for and against such projects. Evaluation of the potential effectiveness of CCS projects to enhance oil recovery factor showed that in spite of the absence of CO2 emissions taxes, such projects could be commercially effective in Russia due to the increase in oil recovery.

  19. Influence of methane in CO2 transport and storage for CCS technology.

    Science.gov (United States)

    Blanco, Sofía T; Rivas, Clara; Fernández, Javier; Artal, Manuela; Velasco, Inmaculada

    2012-12-04

    CO(2) Capture and Storage (CCS) is a good strategy to mitigate levels of atmospheric greenhouse gases. The type and quantity of impurities influence the properties and behavior of the anthropogenic CO(2), and so must be considered in the design and operation of CCS technology facilities. Their study is necessary for CO(2) transport and storage, and to develop theoretical models for specific engineering applications to CCS technology. In this work we determined the influence of CH(4), an important impurity of anthropogenic CO(2), within different steps of CCS technology: transport, injection, and geological storage. For this, we obtained new pressure-density-temperature (PρT) and vapor-liquid equilibrium (VLE) experimental data for six CO(2) + CH(4) mixtures at compositions which represent emissions from the main sources in the European Union and United States. The P and T ranges studied are within those estimated for CO(2) pipelines and geological storage sites. From these data we evaluated the minimal pressures for transport, regarding the density and pipeline's capacity requirements, and values for the solubility parameter of the mixtures, a factor which governs the solubility of substances present in the reservoir before injection. We concluded that the presence of CH(4) reduces the storage capacity and increases the buoyancy of the CO(2) plume, which diminishes the efficiency of solubility and residual trapping of CO(2), and reduces the injectivity into geological formations.

  20. Barriers and incentives of CCS deployment in China. Results from semi-structured interviews

    International Nuclear Information System (INIS)

    Dapeng, Liang; Weiwei, Wu

    2009-01-01

    From March to July of 2008, we conducted semi-structured interviews with 31 experts from the Chinese government, scientific institutes and industrial sectors. This paper summarizes the experts' opinions and draws conclusions about four crucial aspects that influence CO 2 capture and storage (CCS) deployment in China: technology research and experience accumulation, finance support, market development and policy and system. According to interviews result, technological improvement is necessary to cut down on CO 2 capture cost and decrease technological uncertainty. Then, to make some rational policies and systems, with elements such as a carbon tax and clean electricity pricing, to drive power plants to adopt CO 2 capture technology. Furthermore, financial incentive in both the long term and the short term, such as subsidies and CDM, will be important for CCS incentives, encouraging enterprises' enthusiasm for CCS and their capacity to enact it. Lastly, CCS deployment should be conducted under a market-oriented framework in the long term, so a business model and niche market deployment should be considered in advance. Among these aspects, policy and system is more complex than other three aspects, to resolve this obstacle, the innovation on electricity market and government decision model for climate change is crucial. (author)

  1. Informed public preferences for electricity portfolios with CCS and other low-carbon technologies.

    Science.gov (United States)

    Fleishman, Lauren A; De Bruin, Wändi Bruine; Morgan, M Granger

    2010-09-01

    Public perceptions of carbon capture and sequestration (CCS) and other low-carbon electricity-generating technologies may affect the feasibility of their widespread deployment. We asked a diverse sample of 60 participants recruited from community groups in Pittsburgh, Pennsylvania to rank 10 technologies (e.g., coal with CCS, natural gas, nuclear, various renewables, and energy efficiency), and seven realistic low-carbon portfolios composed of these technologies, after receiving comprehensive and carefully balanced materials that explained the costs and benefits of each technology. Rankings were obtained in small group settings as well as individually before and after the group discussions. The ranking exercise asked participants to assume that the U.S. Congress had mandated a reduction in carbon dioxide emissions from power plants to be built in the future. Overall, rankings suggest that participants favored energy efficiency, followed by nuclear power, integrated gasification combined-cycle coal with CCS and wind. The most preferred portfolio also included these technologies. We find that these informed members of the general public preferred diverse portfolios that contained CCS and nuclear over alternatives once they fully understood the benefits, cost, and limitations of each. The materials and approach developed for this study may also have value in educating members of the general public about the challenges of achieving a low-carbon energy future. © 2010 Society for Risk Analysis.

  2. A study on macroeconomic cost of CCS in Korea

    Science.gov (United States)

    Kim, Ji-Whan; Kim, Yoon Kyung

    2015-04-01

    CCS is an important measure for mitigating the problem of World Climate Change and already several projects are entered the step of commercialization. The benefits of CCS implementation ultimately depends on the alleviation level of CO2 on earth because it is caused by the mitigation of the World Climate Change problem. Thus it is possible not to coincide at same time between starting the CCS and getting the benefits. Considering the high costs of CCS, the time mismatch between imposing the costs and getting the benefits is apt to impose some heavy burden on the individual national economy. For this reason, at the political decision-making, the policy makers should consider the macroeconomic effects. Meanwhile, Korean electricity market's supply side is comprised of competitive production and a sole distributor(public enterprise) and then electricity is supplied by a single price structure(administered pricing). Under this condition, if CCS is introduced to power setor, electric charges must be increased and production costs will go high. High production costs will have unfavourable effects on disposable income, price level, purchasing power and so on. In order to minimize these effects, policy makers have to consider the economic effects of introducing CCS. This study estimates the microscopic cost of CCS using ICCSEM 2.0 methodology made by CO2CRC and after that, the macroeconomic effects of introducing CCS is estimated on the basis of microscopic cost estimating results. The macroeconomic effects of CCS applied to Power Generation sector are estimated using macroeconometrics model and Input-Output analysis. A macroeconometrics model is an analytical tool designed to describe the operation of the national economy. This model is usually applied to examine the dynamics of aggregate quantities such as the total amount of goods and services produced, total income earned, the level of employment of productive resources, the level of prices and so forth. Introducing

  3. Development of the Level 1 PSA Model for PGSFR Regulatory

    International Nuclear Information System (INIS)

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

    2014-01-01

    SFR (sodium-cooled fast reactor) is Gen-IV nuclear energy system, which is designed for stability, sustainability and proliferation resistance. KALIMER-600 and PGSFR (Prototype Gen-IV SFR) are under development in Korea with enhanced passive safety concepts, e.g. passive reactor shutdown, passive residual heat removal, and etc. Risk analysis from a regulatory perspective is necessary for regulatory body to support the safety and licensing review of SFR. Safety issues should be identified in the early design phase in order to prevent the unexpected cost increase and the delay of PGSFR licensing schedule. In this respect, the preliminary PSA Model of KALIMER-600 had been developed for regulatory. In this study, the development of PSA Level 1 Model is presented. The important impact factors in the risk analysis for the PGSFR, such as Core Damage Frequency (CDF), have been identified and the related safety insights have been derived. The PSA level 1 model for PGSFR regulatory is developed and the risk analysis is conducted. Regarding CDF, LOISF frequency, uncertainty parameter for passive system CCF, loss of 125V DC control center bus and damper CCF are identified as the important factors. Sensitivity analyses show that the CDF would be differentiated (lowered) according to their values

  4. Food irradiation regulatory development in the U.S

    International Nuclear Information System (INIS)

    Miller, S.A.; Coleman, E.C.

    1985-01-01

    The Food and Drug Administration's involvement in food irradiation dates back more than thirty years. The agency has been involved with the wholesomeness testing of the irradiated foods from both nutritional and toxicological standpoints. Knowledge about the nutritional and toxicological aspects of irradiated foods is fundamental in the development of a regulatory strategy for assuring the safe use of such foods. (author)

  5. ACM CCS 2013-2015 Student Travel Support

    Science.gov (United States)

    2016-10-29

    Student Metrics This section only applies to graduating undergraduates supported by this agreement in this reporting period The number of undergraduates...ACM CCS 2013-2015 Student Travel Support Under the ARO funded effort titled “ACM CCS 2013-2015 Student Travel Support,” from 2013 to 2015, George...Mason University awarded 10 students travel awards every year. These grants enabled the students to offset the cost to attend the ACM Conference on

  6. Social Science Insights for the BioCCS Industry

    Directory of Open Access Journals (Sweden)

    Anne-Maree Dowd

    2015-05-01

    Full Text Available BioCCS is a technology gaining support as a possible emissions reduction policy option to address climate change. The process entails the capture, transport and storage of carbon dioxide produced during energy production from biomass. Globally, the most optimistic energy efficiency scenarios cannot avoid an average temperature increase of +2 °C without bioCCS. Although very much at the commencement stage, bioCCS demonstration projects can provide opportunity to garner knowledge, achieve consensus and build support around the technology’s properties. Yet many challenges face the bioCCS industry, including no guarantee biomass will always be from sustainable sources or potentially result in carbon stock losses. The operating environment also has no or limited policies, regulations and legal frameworks, and risk and safety concerns abound. Some state the key problem for bioCCS is cultural, lacking in a ‘community of support’, awareness and credibility amongst its own key stakeholders and the wider public. Therefore, the industry can benefit from the growing social science literature, drawing upon other energy and resource based industries with regard to social choice for future energy options. To this end, the following scoping review was conducted in order to ascertain gaps in existing public perception and acceptance research focusing on bioCCS.

  7. Scientific, statistical, practical, and regulatory considerations in design space development.

    Science.gov (United States)

    Debevec, Veronika; Srčič, Stanko; Horvat, Matej

    2018-03-01

    The quality by design (QbD) paradigm guides the pharmaceutical industry towards improved understanding of products and processes, and at the same time facilitates a high degree of manufacturing and regulatory flexibility throughout the establishment of the design space. This review article presents scientific, statistical and regulatory considerations in design space development. All key development milestones, starting with planning, selection of factors, experimental execution, data analysis, model development and assessment, verification, and validation, and ending with design space submission, are presented and discussed. The focus is especially on frequently ignored topics, like management of factors and CQAs that will not be included in experimental design, evaluation of risk of failure on design space edges, or modeling scale-up strategy. Moreover, development of a design space that is independent of manufacturing scale is proposed as the preferred approach.

  8. Development of Regulatory Thermal-Hydraulic Analysis System (RETAS)

    Energy Technology Data Exchange (ETDEWEB)

    Ahn, Seung-Hoon; Kim, In-Goo; Kim, Hho-Jung; Cho, Yong Jin [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2007-10-15

    A review is provided of the reasons why the Korea Institute of Nuclear Safety needs improvement of the existing codes employed for a regulatory audit. The proposed new organization of the codes, developed or to be developed, is presented together with illustrative applications. Inspection of the quality assurance activities is planned to ensure the robustness of MARS (Multi-dimensional Analysis for Reactor Safety) code, served as a pivot of the organization.

  9. Recent Advances in Drug Development and Regulatory Science in China.

    Science.gov (United States)

    Chen, Jie; Zhao, Naiqing

    2018-01-01

    As the second largest pharmaceutical market with a great potential for future growth, China has drawn much attention from the global pharmaceutical community. With an increasing government investment in biomedical research, the domestic biopharmaceutical (biotechnological) companies in China are turning their attention to the development of innovative medicines and targeting the global market. To introduce innovative products to Chinese patients sooner, to improve the efficiency of its review and approval processes, and to harmonize its regulatory science with international standards, the China Food and Drug Administration (CFDA) has initiated a series of major changes to its policies and regulations. This paper presents a snapshot of China's pharmaceutical market, and research and development status, and introduces technical guidelines pertaining to clinical trials and new drug applications. The recent wave of ground-breaking reforms in CFDA's regulatory science is discussed. Examples of clinical trials and new drug applications are provided throughout the discussion.

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

    OpenAIRE

    Dipak Dilip Gadade; Sanjay Sudhakar Pekamwar

    2016-01-01

    Cocrystal is a concept of the supramolecular chemistry which is gaining the extensive interest of researchers from pharmaceutical and chemical sciences and of drug regulatory agencies. The prominent reason of which is its ability to modify physicochemical properties of active pharmaceutical ingredients. During the development of the pharmaceutical product, formulators have to optimize the physicochemical properties of active pharmaceutical ingredients. Pharmaceutical cocrystals can be employe...

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

    International Nuclear Information System (INIS)

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

    2006-05-01

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

  12. The regulatory challenges for utility reform in developing countries

    Energy Technology Data Exchange (ETDEWEB)

    Spiller, P.T. [California Univ., Berkeley, CA (United States). Haas School of Business]|[Law and Economics Consulting Group, Inc. (United States)

    1997-02-01

    Throughout the developing world, private sector participation in utilities is being favoured as a policy option. Private sector investors are currently undertaking projects in sectors ranging from the by now familiar electricity and telecommunication, to gas distribution, water and sanitation, and transport including roads, ports and airports. The purpose of this article is to provide an analysis of the regulatory challenges and opportunities that developing countries may face in the next decade. In particular, I will discuss those challenges and opportunities arising from the use of franchise licensing procedures for the privatization of utilities. (Author)

  13. How may CCS technology affect the electricity market in North-Western Europe?

    International Nuclear Information System (INIS)

    Seebregts, A.J.; Groenenberg, H.

    2008-11-01

    The EU electricity market is changing. Electricity demand in Europe is on the rise, the power plant fleet is aging, and a large share of the capacity will need to be replaced in the coming decades. An ambitious target has been formulated for the share of renewable energy, and CO2 prices are anticipated to increase. On top of this, CO2 Capture and Storage (CCS) has appeared as an important technology in the transition to a long term sustainable energy supply. This paper discusses the implications of all the fore-mentioned developments for the EU electricity market, with an emphasis on the Northwest European market. On the whole, electricity prices in the Northwestern part of Europe are anticipated to increase until 2020, but this may only partly be ascribed to the pending introduction of CCS

  14. Overcoming regulatory barriers: DOE environmental technology development program

    International Nuclear Information System (INIS)

    Kurtyka, B.M.; Clodfelter-Schumack, K.; Evans, T.T.

    1995-01-01

    The potential to improve environmental conditions via compliance or restoration is directly related to the ability to produce and apply innovative technological solutions. However, numerous organizations, including the US General Accounting Office (GAO), the EPA National Advisory Council for Environmental Policy and Technology (NACEPT), the DOE Environmental Management Advisory Board (EMAB), and the National Science and Technology Council (NSTC) have determined that significant regulatory barriers exist that inhibit the development and application of these technologies. They have noted the need for improved efforts in identifying and rectifying these barriers for the purpose of improving the technology development process, providing innovative alternatives, and enhancing the likelihood of technology acceptance by all. These barriers include, among others, regulator and user bias against ''unknown/unproven'' technologies; multi-level/multi-media permit disincentives; potential liability of developers and users for failed implementation; wrongly defined or inadequate data quality objectives: and lack of customer understanding and input. The ultimate goal of technology development is the utilization of technologies. This paper will present information on a number of regulatory barriers hindering DOE's environmental technology development program and describe DOE efforts to address these barriers

  15. Switzerland; Financial Sector Assessment Program: Factual Update: Insurance Sector Market and Regulatory Developments

    OpenAIRE

    International Monetary Fund

    2007-01-01

    This paper presents a factual update of the Insurance Core Principles including insurance sector market and regulatory developments for Switzerland. Regulatory reforms since 2003 have updated Switzerland’s regulatory and supervisory regime for the insurance industry to bring it in line with international best practices. The Insurance Supervision Law (ISL) has reoriented the regulatory focus and expanded the regulatory scope to include group/conglomerate supervision, corporate governance, risk...

  16. Development Approach of General Regulatory Requirements for SFR in Korea

    International Nuclear Information System (INIS)

    Yune, Young Gill; Song, Jae Ho; Huh, Chang Wook; Jin, Chang Yong; Bae, Moo Hoon; Kim, Kyun Tae

    2011-01-01

    The Atomic Energy Commission of Korea established a long-term R and D plan for future reactor systems including sodium-cooled fast reactor (SFR) in Dec. 2008. According to the plan, an application for the design approval of an SFR demonstration reactor is scheduled in 2017. A project to develop the SFR was launched in 2010 to implement the long-term R and D plan. Korea Institute of Nuclear Safety (KINS) also started to develop general regulatory requirements (GRRs) for SFR for the preparation of the licensing application of the SFR. In this paper, the development approach of KINS was introduced. The GRRs for SFR are developed based on the current GRRs for LWR, 'Regulations on Technical Standards for Nuclear Reactor Facilities, Etc.'. And design characteristics of SFRs are reflected in the current GRRs. Also, the following items are considered: strengthening of safety by the IAEA, foreign regulatory requirements for SFR, risk-informed regulations, and the lessons learned from Hukushima accident

  17. Legal, regulatory & institutional issues facing distributed resources development

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-10-01

    This report describes legal, regulatory, and institutional considerations likely to shape the development and deployment of distributed resources. It is based on research co-sponsored by the National Renewable Energy Laboratory (NREL) and four investor-owned utilities (Central & South West Services, Cinergy Corp., Florida Power Corporation, and San Diego Gas & Electric Company). The research was performed between August 1995 and March 1996 by a team of four consulting firms experienced in energy and utility law, regulation, and economics. It is the survey phase of a project known as the Distributed Resources Institutional Analysis Project.

  18. Carbon capture and storage (CCS) in Nigeria: fundamental science ...

    African Journals Online (AJOL)

    ... consequences of its application are not well understood in many African countries like Nigeria that are majorly dependent on oil and gas economy and contributing emitters of greenhouse gases. This paper described the fundamental science of CCS and addressed the potential risks of its future implementation in Nigeria.

  19. Why are small scale demonstration projects important for the future of CCS?

    Science.gov (United States)

    Leetaru, H. E.; Bauer, R. A.; McBride, J. H.; Freiburg, J. T.; Greenberg, S. E.

    2017-12-01

    Carbon Capture and Storage (CCS) is moving toward large-scale commercial projects and the U.S. Department of Energy is supporting a new CarbonSAFE initiative to assist in the development of a 50 million tonnes geologic storage project. This type of large commercial CCS project will rely on lessons learned from smaller DOE CCS projects such as the Illinois Basin-Decatur Project (IBDP) and the Illinois Industrial Carbon Capture and Storage (IL-ICCS) Project located one mile north of IBDP. Over a three year period ending 2014 IBDP injected almost one million tonnes of CO2 into the Mt. Simon Sandstone, and the IL-ICCS project which commenced injection in 2017 will inject another four million tonnes over a four year period. The IBDP has recorded microseismic events within the study area through continuous downhole seismic monitoring before, during, and after injection. Monitoring shows that microseismicity increased during injection and originate not only in the Cambrian Mt. Simon Sandstone (the target reservoir), but also in the underlying Argenta clastics and deeper Precambrian igneous rocks as SW-NE elongate clusters aligned in strike to the maximum in situ stress direction. An interpretation of site 3D seismic reflection data suggests that much of the microseismicity is proximal to interpreted faults that extend from the basement up into the lowermost Mt. Simon strata. The faults proximally associated with microseismic activity are oriented parallel with respect to the maximum stress direction. The seismic monitoring of the IBDP indicate that the assessment of induced seismic potential associated with commercial-scale CCS requires not only identification of a suitable reservoir and its petrophysical characteristics, but also the extent and orientation of existing faults and their relation to regional stress orientation. Assessment of regional fault orientation using 3D seismic reflection data can be extremely useful to understanding the risks of induced seismicity

  20. The Nuclear Regulatory Commission's SPAR Model Development Plan

    International Nuclear Information System (INIS)

    O'Reilly, Patrick D.

    2003-01-01

    In order to provide the NRC staff with analytical tools to use in performing risk-informed activities, the Operating Experience Risk Analysis Branch (OERAB) in the Division of Risk Analysis and Applications began development of Standardized Plant Analysis Risk (SPAR) models. These probabilistic risk assessment (PRA) models span the following areas: Level 1 - internal events, full power operation, (2) Level 1 - internal events, low power and shutdown operations, (3) Level 1 - external events (including fires, floods, and seismic events), and (4) Level 2/Large Early Release Frequency (LERF). In September 1999, OERAB formed the interoffice SPAR Model Users Group (SMUG) to discuss, coordinate, and provide guidance on technical direction of methods and model development issues related to the Accident Sequence Precursor (ASP) Program and the routine assessment of events. The SMUG also supports the development of models for risk-informed regulatory activities performed by the members' organizations. They provide their organizations' input to the type of models to be produced, the level of detail that the models require, the model QA review process, and model development schedule priority. The SMUG prepared an integrated plan for the development of analytical tools for the staff to use in performing regulatory activities more efficiently and effectively. This Integrated SPAR Model Development Plan conforms to the specific modeling needs identified by the SMUG members and by key members of the NRC staff. Consistent with the schedule specified in the plan, OERAB is currently implementing the provisions of the approved plan in its technical assistance projects for model development that support the ASP Program. (author)

  1. UK regulatory expectations for the development of licensee organisational capability

    International Nuclear Information System (INIS)

    Gibson, S.; Reiersen, Craig

    2011-01-01

    The Nuclear Installations Inspectorate (NII) is responsible for the licensing and regulatory oversight of new nuclear power reactors in the UK. NII recognises that effective licensee leadership and management for safety are instrumental in the safety of new and existing nuclear installations. NII is consequently placing considerable emphasis on seeking assurance that prospective licensees develop an adequate organisational capability to manage and deliver nuclear safety in addition to constructing a design that has passed through a rigorous assessment process. In order to make NII's expectations clear, and support a consistent approach to interactions with prospective licensees, NII has produced a suite of related guidance to help its Inspectors assess and influence the development of licensee organisational capability. This includes: 1. The safety management prospectus; 2. The 'nuclear baseline'; 3. Intelligent Customer capability and use of contractors; 4. Design Authority; 5. Licence Condition Compliance Arrangements; 6. Development of Organisational Capability

  2. Hazard assessment of nitrosamine and nitramine by-products of amine-based CCS: Alternative approaches

    NARCIS (Netherlands)

    Buist, H.E.; Devito, S.; Goldbohm, R.A.; Stierum, R.H.; Venhorst, J.; Kroese, E.D.

    2015-01-01

    Carbon capture and storage (CCS) technologies are considered vital and economic elements for achieving global CO2 reduction targets, and is currently introduced worldwide (for more information on CCS, consult for example the websites of the International Energy Agency

  3. Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks.

    Science.gov (United States)

    Tsukamoto, Katusra; Carroll, Kelly A; Onishi, Taku; Matsumaru, Naoki; Brasseur, Daniel; Nakamura, Hidefumi

    2016-03-01

    A dearth in pediatric drug development often leaves pediatricians with no alternative but to prescribe unlicensed or off-label drugs with a resultant increased risk of adverse events. We present the current status of pediatric drug development and, based on our data analysis, clarify the problems in this area. Further action is proposed to improve the drug development that has pediatric therapeutic orphan status. We analyzed all Phase II/III and Phase III trials in ClinicalTrials.gov that only included pediatric participants (Japan, the European Union, and the United States. The European Union Clinical Trials Register and published reports from the European Medicines Agency were also surveyed to investigate the Paediatric Committee effect on pediatric clinical trials in the European Union. Mean difference of the performance index in prepremiums and postpremiums between Japan and the European Union were 0.296 (P Japan and the United States were 0.560 (P Japan was more active after the introduction of these premiums, even reaching the level of the European Union. The Pediatric Regulation and the Paediatric Committee promoted pediatric drug development in the European Union. The registered number of clinical trials that includes at least 1 participants 15% after 2008. Recruitment and ethical obstacles make conducting pediatric clinical trials challenging. An improved operational framework for conducting clinical trials should mirror the ever-improving regulatory framework that incentivizes investment in pediatric clinical trials. Technological approaches, enhancements in electronic medical record systems, and community approaches that actively incorporate input from physicians, researchers, and patients could offer a sustainable solution to recruitment of pediatric study participants. The key therefore is to improve pediatric pharmacotherapy collaboration among industry, government, academia, and community. Expanding the regulatory steps taken in the European Union

  4. Molecular and regulatory mechanisms controlling floral organ development.

    Science.gov (United States)

    Stewart, Darragh; Graciet, Emmanuelle; Wellmer, Frank

    2016-05-01

    The genetic and molecular mechanisms that underlie the formation of angiosperm flowers have been studied extensively for nearly three decades. This work has led to detailed insights into the gene regulatory networks that control this vital developmental process in plants. Here, we review some of the key findings in the field of flower development and discuss open questions that must be addressed in order to obtain a more comprehensive understanding of flower formation. In particular, we focus on the specification of the different types of floral organs and on how the morphogenesis of these organs is controlled to give rise to mature flowers. Central to this process are the floral organ identity genes, which encode members of the family of MADS-domain transcription factors. We summarize what is currently known about the functions of these master regulators and discuss a working model for the molecular mechanism that may underlie their activities. © 2016 Federation of European Biochemical Societies.

  5. Interleukin-2 and STAT5 in regulatory T cell development and function

    OpenAIRE

    Mahmud, Shawn A.; Manlove, Luke S.; Farrar, Michael A.

    2013-01-01

    Interleukin-2 and its downstream target STAT5 have effects on many aspects of immune function. This has been perhaps best documented in regulatory T cells. In this review we summarize the initial findings supporting a role for IL2 and STAT5 in regulatory T cell development and outline more recent studies describing how this critical signaling pathway entrains regulatory T cell differentiation and affects regulatory T cell function.

  6. Renewable energy and CCS in German and European power sector decarbonization scenarios

    Energy Technology Data Exchange (ETDEWEB)

    Ludig, Sylvie

    2013-11-06

    In order to avoid unmanageable impacts of anthropogenic climate change, it is necessary to achieve substantial CO{sub 2} emission reductions in all energy sectors. Due to salient decarbonization options such as renewable energy technologies and carbon capture and storage (CCS), the power sector plays a major role in climate change mitigation strategies. However, these options come with a set of challenges: the output of wind and solar energy varies in time and space and CCS faces technical challenges and public acceptance problems. This thesis develops power sector decarbonization scenarios for the EU and Germany while taking into account both the interplay of renewable energy technologies and CCS as mitigation options as well as the technical challenges of renewable energy integration. More specifically, a series of model based studies address the respective roles of CCS and renewable energy technologies in emission reduction strategies while evaluating technical integration options such as transmission, storage and balancing technologies. Results show that large-scale expansion of renewable energies will play the main role in power sector decarbonization scenarios, but the availability of CCS could lead to lower total costs and easier reaching of emission reduction targets through compensation of emissions generated by balancing technologies. Long-distance transmission enables better siting of renewable energy and thus higher achievable renewable shares in power generation and higher capacity factors. These indirect effects of delayed expansions induce additional power system costs, which are high relative to investment costs for new transmission lines. Results also reveal a preference for flexible technologies in combination with high shares of renewables for balancing purposes rather than inflexible baseload plants. A case study for the EU shows that a near-complete decarbonization is possible both with and without transmission expansions, but total power

  7. Contaminant screening of wastewater with HPLC-IM-qTOF-MS and LC+LC-IM-qTOF-MS using a CCS database.

    Science.gov (United States)

    Stephan, Susanne; Hippler, Joerg; Köhler, Timo; Deeb, Ahmad A; Schmidt, Torsten C; Schmitz, Oliver J

    2016-09-01

    Non-target analysis has become an important tool in the field of water analysis since a broad variety of pollutants from different sources are released to the water cycle. For identification of compounds in such complex samples, liquid chromatography coupled to high resolution mass spectrometry are often used. The introduction of ion mobility spectrometry provides an additional separation dimension and allows determining collision cross sections (CCS) of the analytes as a further physicochemical constant supporting the identification. A CCS database with more than 500 standard substances including drug-like compounds and pesticides was used for CCS data base search in this work. A non-target analysis of a wastewater sample was initially performed with high performance liquid chromatography (HPLC) coupled to an ion mobility-quadrupole-time of flight mass spectrometer (IM-qTOF-MS). A database search including exact mass (±5 ppm) and CCS (±1 %) delivered 22 different compounds. Furthermore, the same sample was analyzed with a two-dimensional LC method, called LC+LC, developed in our group for the coupling to IM-qTOF-MS. This four dimensional separation platform revealed 53 different compounds, identified over exact mass and CCS, in the examined wastewater sample. It is demonstrated that the CCS database can also help to distinguish between isobaric structures exemplified for cyclophosphamide and ifosfamide. Graphical Abstract Scheme of sample analysis and database screening.

  8. Air pollution impacts from carbon capture and storage (CCS)

    Energy Technology Data Exchange (ETDEWEB)

    Harmelen, T. van; Horssen, A. van; Jozwicka, M.; Pulles, T. (TNO, Delft (Netherlands)); Odeh, N. (AEA Technology, Harwell (United Kingdom)); Adams, M. (EEA, Copenhagen (Denmark))

    2011-11-15

    This report comprises two separate complementary parts that address the links between CCS implementation and its subsequent impacts on GHG and air pollutant emissions on a life-cycle basis: Part A discusses and presents key findings from the latest literature, focusing upon the potential air pollution impacts across the CCS life-cycle arising from the implementation of the main foreseen technologies. Both negative and positive impacts on air quality are presently suggested in the literature - the basis of scientific knowledge on these issues is rapidly advancing. Part B comprises a case study that quantifies and highlights the range of GHG and air pollutant life-cycle emissions that could occur by 2050 under a low-carbon pathway should CCS be implemented in power plants across the European Union under various hypothetical scenarios. A particular focus of the study was to quantify the main life-cycle emissions of the air pollutants taking into account the latest knowledge on air pollutant emission factors and life-cycle aspects of the CCS life-cycle as described in Part A of the report. Pollutants considered in the report were the main GHGs CO{sub 2}, methane (CH{sub 4}) and nitrous oxide (N{sub 2}O) and the main air pollutants with potential to harm human health and/or the environment - nitrogen oxides (NO{sub X}), sulphur dioxide (SO{sub 2}), ammonia (NH{sub 3}), non-methane volatile organic compounds (NMVOCs) and particulate matter (PM{sub 10}). (Author)

  9. Boron neutron capture therapy for clear cell sarcoma (CCS): Biodistribution study of p-borono-L-phenylalanine in CCS-bearing animal models

    Energy Technology Data Exchange (ETDEWEB)

    Andoh, T. [Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Cooperative Research Center of Life Sciences, Kobe Gakuin University, Kobe 650-8586 (Japan); Fujimoto, T. [Department of Orthopaedic Surgery, Hyogo Cancer Center, Akashi 673-0021 (Japan); Sudo, T. [Section of Translational Research, Hyogo Cancer Center, Akashi 673-0021 (Japan); Fujita, I.; Imabori, M. [Department of Orthopaedic Surgery, Hyogo Cancer Center, Akashi 673-0021 (Japan); Moritake, H. [Department of Pediatrics, Miyazaki University, Kiyotake 889-1692 (Japan); Sugimoto, T. [Department of Pediatrics, Saiseikai Shigaken Hospital, Ritto 520-3046 (Japan); Sakuma, Y. [Department of Pathology, Hyogo Cancer Center, Akashi 673-0021 (Japan); Takeuchi, T. [Department of Pathology, Kochi University, Nangoku 783-8505 (Japan); Kawabata, S. [Department of Neurosurgery, Osaka Medical College, Osaka 569-8686 (Japan); Kirihata, M. [Graduate School of Life and Environmental Sciences, Osaka Prefecture University, Sakai 599-8531 (Japan); Akisue, T. [Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Kobe 650-0017 (Japan); Yayama, K. [Laboratory of Cardiovascular Pharmacology, Faculty of Pharmaceutical Sciences and Cooperative Research Center of Life Sciences, Kobe Gakuin University, Kobe 650-8586 (Japan); Kurosaka, M. [Department of Orthopaedic Surgery, Kobe University Graduate School of Medicine, Kobe 650-0017 (Japan); Miyatake, S. [Department of Neurosurgery, Osaka Medical College, Osaka 569-8686 (Japan); Fukumori, Y. [Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Cooperative Research Center of Life Sciences, Kobe Gakuin University, Kobe 650-8586 (Japan); Ichikawa, H., E-mail: ichikawa@pharm.kobegakuin.ac.jp [Laboratory of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences and Cooperative Research Center of Life Sciences, Kobe Gakuin University, Kobe 650-8586 (Japan)

    2011-12-15

    Clear cell sarcoma (CCS) is a rare melanocytic malignant tumor with a poor prognosis. Our previous study demonstrated that in vitro cultured CCS cells have the ability to highly uptake L-BPA and thus boron neutron capture therapy could be a new option for CCS treatment. This paper proved that a remarkably high accumulation of {sup 10}B (45-74 ppm) in tumor was obtained even in a CCS-bearing animal with a well-controlled biodistribution followed by intravenous administration of L-BPA-fructose complex (500 mg BPA/kg).

  10. Boron neutron capture therapy for clear cell sarcoma (CCS): Biodistribution study of p-borono-L-phenylalanine in CCS-bearing animal models

    International Nuclear Information System (INIS)

    Andoh, T.; Fujimoto, T.; Sudo, T.; Fujita, I.; Imabori, M.; Moritake, H.; Sugimoto, T.; Sakuma, Y.; Takeuchi, T.; Kawabata, S.; Kirihata, M.; Akisue, T.; Yayama, K.; Kurosaka, M.; Miyatake, S.; Fukumori, Y.; Ichikawa, H.

    2011-01-01

    Clear cell sarcoma (CCS) is a rare melanocytic malignant tumor with a poor prognosis. Our previous study demonstrated that in vitro cultured CCS cells have the ability to highly uptake L-BPA and thus boron neutron capture therapy could be a new option for CCS treatment. This paper proved that a remarkably high accumulation of 10 B (45–74 ppm) in tumor was obtained even in a CCS-bearing animal with a well-controlled biodistribution followed by intravenous administration of L-BPA-fructose complex (500 mg BPA/kg).

  11. Mountaineer Commerical Scale Carbon Capture and Storage (CCS) Project

    Energy Technology Data Exchange (ETDEWEB)

    Deanna Gilliland; Matthew Usher

    2011-12-31

    The Final Technical documents all work performed during the award period on the Mountaineer Commercial Scale Carbon Capture & Storage project. This report presents the findings and conclusions produced as a consequence of this work. As identified in the Cooperative Agreement DE-FE0002673, AEP's objective of the Mountaineer Commercial Scale Carbon Capture and Storage (MT CCS II) project is to design, build and operate a commercial scale carbon capture and storage (CCS) system capable of treating a nominal 235 MWe slip stream of flue gas from the outlet duct of the Flue Gas Desulfurization (FGD) system at AEP's Mountaineer Power Plant (Mountaineer Plant), a 1300 MWe coal-fired generating station in New Haven, WV. The CCS system is designed to capture 90% of the CO{sub 2} from the incoming flue gas using the Alstom Chilled Ammonia Process (CAP) and compress, transport, inject and store 1.5 million tonnes per year of the captured CO{sub 2} in deep saline reservoirs. Specific Project Objectives include: (1) Achieve a minimum of 90% carbon capture efficiency during steady-state operations; (2) Demonstrate progress toward capture and storage at less than a 35% increase in cost of electricity (COE); (3) Store CO{sub 2} at a rate of 1.5 million tonnes per year in deep saline reservoirs; and (4) Demonstrate commercial technology readiness of the integrated CO{sub 2} capture and storage system.

  12. Biomass and CCS: The influence of technical change

    International Nuclear Information System (INIS)

    Laude, Audrey; Jonen, Christian

    2013-01-01

    The combination of bioenergy production and carbon capture and storage technologies (BECCS) provides an opportunity to create negative emissions of CO 2 in biofuel production. However, high capture costs reduce profitability. This paper investigates carbon price uncertainty and technological uncertainty through a real option approach. We compare the cases of early and delayed CCS deployments. An early technological progress may arise from aggressive R and D and pilot project programs, but the expected cost reduction remains uncertain. We show that this approach results in lower emissions and more rapid investment returns although these returns will not fully materialise until after 2030. In a second set of simulations, we apply an incentive that prioritises sequestered emissions rather than avoided emissions. In other words, this economic instrument does not account for CO 2 emissions from the CCS implementation itself, but rewards all the sequestered emissions. In contrast with technological innovations, this subsidy is certain for the investor. The resulting investment level is higher, and the project may become profitable before 2030. Negative emission in bioethanol production does not seem to be a short-term solution in our framework, whatever the carbon price drift. - Highlights: • Real option approach to assess CO 2 capture for bioethanol production. • Negative emissions opportunity but high capture costs. • Early CCS deployment increases investment probability. • Yet it is uncertain and costly: R and D and pilote programs required. • Rewarding stored emissions instead of avoided emissions is more efficient

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

    Directory of Open Access Journals (Sweden)

    T. I. Kryachko

    2017-01-01

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

  14. Development of regulatory technology for thermal-hydraulic safety analysis

    International Nuclear Information System (INIS)

    Bang, Young Seok; Lee, S. H.; Ryu, Y. H.

    2001-02-01

    The present study aims to develop the regulation capability in thermal-hydraulic safety analysis which was required for the reasonable safety regulation in the current NPP, the next generation reactors, and the future-type reactors. The fourth fiscal year of the first phase of the research was focused on the following research topics: Investigation on the current status of the thermal-hydraulic safety analysis technology outside and inside of the country; Review on the improved features of the thermal-hydraulic safety analysis regulatory audit code, RELAP5/MOD3; Assessments of code with LOFT L9-3 ATWS experiment and LSTF SB-SG-10 multiple SGTR experiment; Application of the RELAP5/CANDU code to analyses of SLB and LBLOCA and evaluation of its effect on safety; Application of the code to IAEA PHWR ISP analysis; Assessments of RELAP5 and TRAC with UPTF downcomer injection test and Analysis of LBLOCA with RELAP5 for the performance evaluation of KNGR DVI; Setup of a coupled 3-D kinetics and thermal-hydraulics and application it to a reactivity accident analysis; and Extension of database and improvement of plant input decks. For supporting the resolution of safety issues, loss of RHR event during midloop operation was analyzed for Kori Unit 3, issues on high burnup fuel were reviewed and performance of FRAPCON-3 assessed. Also MSLB was analyzed to figure out the sensitivity of downcomer temperature supporting the PTS risk evaluation of Kori Unit 1. Thermal stratification in pipe was analyzed using the method proposed. And a method predicting the thermal-hydraulic performance of IRWST of KNGR was explored. The PWR ECCS performance criteria was issued as a MOST Article 200-19.and a regulatory guide on evaluation methodology was improved to cover concerns raised from the related licensing review process

  15. Practice of Regulatory Science (Development of Medical Devices).

    Science.gov (United States)

    Niimi, Shingo

    2017-01-01

    Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.

  16. Experts Perception on Carbon Capture and Storage (CCS) in Spain; La Percepcion de la Captura y Almacenamiento de CO{sub 2} (CAC) por Parte de los Expertos Espanoles

    Energy Technology Data Exchange (ETDEWEB)

    Sola, R.; Oltra, C.

    2010-12-24

    This report presents the results from a survey on experts attitudes towards the development of CCS in Spain. This is the fi rst study carried out in Spain trying to report an empirical analysis of stake holders perception on the risks, challenges and barriers facing CCS deployment. Results show a positive attitude towards CCS implementation in Spain. Experts are concerned about the existence of suitable storage sites in Spain, safety of storage and costs from capture. They tend to support of CCS as a bridging solution to climate change and have a general low level of perceived risk from CCS. Experts risk perception is influenced, to some extent, by prior values and beliefs as well as by socio demographics and, to a lesser extent, by group membership. (Author) 15 refs.

  17. Development of Questionnaire for Self-Assessment of Regulatory Capture

    Energy Technology Data Exchange (ETDEWEB)

    Muhmood, Ul Hassan; Lee, Young Eal [Pakistan Nuclear Regulatory Authority, Islamabad (Pakistan); Choi, Kwang Sik [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-10-15

    Nuclear industry with its evolution in 60s came with a number of pros and cons. In order to avoid any accident or incident, highest safety standards and quality control mechanism were established. The relation of regulator with its licensee is critical in the sense of public safety and welfare. The situation when the regulator starts to work for the interests of the industry instead of the public interest and fails to cling with his mission is known as 'regulatory capture' which may cause a number of serious negative effects like radiological or radiation risk. According to George Stigler, as a rule regulation is acquired by the industry and is designed and operated primarily for its benefit. The phenomenon of regulatory capture may hamper the safety culture and can also be considered as regulatory failure. It is therefore necessary to clearly understand this type of government failure to avoid the happening of serious accidents like TMI and Fukushima in the future. This paper aims to explore whether the regulatory body works independently and effectively to achieve its assigned tasks and objectives. Hence we proposed a questionnaire for the self-assessment of regulatory capture within the regulatory body. It also includes the results of an experimental assessment which was carried out to check the relevance and reliability of the questions to this subject. This assessment survey was conducted with the officers and staff members of Pakistan Nuclear Regulatory Authority (PNRA). We checked the significance of the proposed questionnaire and found some of the questions like Q. 27, 30 and 33 (written in italic) are not directly related to the phenomenon of regulatory capture. However, the existence of the situation which has been asked in these questions may lead towards the hampering of regulatory culture.

  18. Echinoderm systems for gene regulatory studies in evolution and development.

    Science.gov (United States)

    Arnone, Maria Ina; Andrikou, Carmen; Annunziata, Rossella

    2016-08-01

    One of the main challenges in Evolutionary Developmental Biology is to understand to which extent developmental changes are driven by regulatory alterations in the genomic sequence. In the recent years, the focus of comparative developmental studies has moved towards a systems biology approach providing a better understanding of the evolution of gene interactions that form the so called Gene Regulatory Networks (GRN). Echinoderms provide a powerful system to reveal regulatory mechanisms and within the past decade, due to the latest technological innovations, a great number of studies have provided valuable information for comparative GRN analyses. In this review we describe recent advances in evolution of GRNs arising from echinoderm systems, focusing on the properties of conserved regulatory kernels, circuit co-option events and GRN topological rearrangements. Copyright © 2016 Elsevier Ltd. All rights reserved.

  19. A20 Restrains Thymic Regulatory T Cell Development.

    Science.gov (United States)

    Fischer, Julius Clemens; Otten, Vera; Kober, Maike; Drees, Christoph; Rosenbaum, Marc; Schmickl, Martina; Heidegger, Simon; Beyaert, Rudi; van Loo, Geert; Li, Xian Chang; Peschel, Christian; Schmidt-Supprian, Marc; Haas, Tobias; Spoerl, Silvia; Poeck, Hendrik

    2017-10-01

    Maintaining immune tolerance requires the production of Foxp3-expressing regulatory T (T reg ) cells in the thymus. Activation of NF-κB transcription factors is critically required for T reg cell development, partly via initiating Foxp3 expression. NF-κB activation is controlled by a negative feedback regulation through the ubiquitin editing enzyme A20, which reduces proinflammatory signaling in myeloid cells and B cells. In naive CD4 + T cells, A20 prevents kinase RIPK3-dependent necroptosis. Using mice deficient for A20 in T lineage cells, we show that thymic and peripheral T reg cell compartments are quantitatively enlarged because of a cell-intrinsic developmental advantage of A20-deficient thymic T reg differentiation. A20-deficient thymic T reg cells exhibit reduced dependence on IL-2 but unchanged rates of proliferation and apoptosis. Activation of the NF-κB transcription factor RelA was enhanced, whereas nuclear translocation of c-Rel was decreased in A20-deficient thymic T reg cells. Furthermore, we found that the increase in T reg cells in T cell-specific A20-deficient mice was already observed in CD4 + single-positive CD25 + GITR + Foxp3 - thymic T reg cell progenitors. T reg cell precursors expressed high levels of the tumor necrosis factor receptor superfamily molecule GITR, whose stimulation is closely linked to thymic T reg cell development. A20-deficient T reg cells efficiently suppressed effector T cell-mediated graft-versus-host disease after allogeneic hematopoietic stem cell transplantation, suggesting normal suppressive function. Holding thymic production of natural T reg cells in check, A20 thus integrates T reg cell activity and increased effector T cell survival into an efficient CD4 + T cell response. Copyright © 2017 by The American Association of Immunologists, Inc.

  20. Regulatory Reform as a Normative Concept: an Opportunity for the Development of Constitutive Policies

    Directory of Open Access Journals (Sweden)

    Ana Petek

    2008-01-01

    Full Text Available Regulatory reform, as part of public sector reform, concerns the change of the way of using regulation as a policy instrument. Since it started for the purpose of facilitating the operation of the business sector through simplifying the regulatory system in order to achieve increased competitiveness in the global market, it still has many opponents criticising its neoliberal background. This paper seeks to show how the regulatory reform programme has “transcended” its primary purpose because its reach has expanded even to noneconomic policy sectors – constitutive policies. Such broader interpretational framework of the objectives of regulatory reform allows access to the regulatory process for a much greater number of actors, particularly for noneconomic interest groups, and the benefits of the regulatory reform programme have spread among the broader ranks of the community. The implication of opening the regulatory process is an opportunity for other value systems, competing with neoliberalism, to affect regulatory reform. The paper especially emphasizes the governance approach to the research on regulatory reform, as the one which can outline and analyse its above-mentioned positive aspects. The essential thesis of the paper is that regulatory reform, as a specific normative concept, if understood within a broader interpretational framework, stimulates the development of constitutive policies in the sense that it places them higher on the policy priority scale of a regulatory state, and that this is exactly what should be the dominant logic of its introduction.

  1. Using renewables and the co-production of hydrogen and electricity from CCS-equipped IGCC facilities, as a stepping stone towards the early development of a hydrogen economy

    International Nuclear Information System (INIS)

    Haeseldonckx, Dries; D'haeseleer, William

    2010-01-01

    In this paper, specific cases for the interaction between the future electricity-generation mix and a newly-developing hydrogen-production infrastructure is modelled with the model E-simulate. Namely, flexible integrated-gasification combined-cycle units (IGCC) are capable of producing both electricity and hydrogen in different ratios. When these units are part of the electricity-generation mix and when they are not operating at full load, they could be used to produce a certain amount of hydrogen, avoiding the costly installation of new IGCC units for hydrogen production. The same goes for the massive introduction of renewable energies (especially wind), possibly generating excess electricity from time to time, which could then perhaps be used to produce hydrogen electrolytically. However, although contra-intuitive, the interaction between both 'systems' turns out to be almost negligible. Firstly, it is shown that it is more beneficial to use IGCC facilities to produce hydrogen with, rather than (excess) wind-generated electricity due to the necessary electrolyser investment costs. But even flexible IGCC facilities do not seem to contribute substantially to the early development of a hydrogen economy. Namely, in most scenarios - which are combinations of a wide range of fuel prices and carbon taxes - one primary-energy carrier (natural gas or coal) seems to be dominant, pushing the other, and the corresponding technologies such as reformers or IGCCs, out of the market. (author)

  2. ConocoPhillips Sweeny IGCC/CCS Project

    Energy Technology Data Exchange (ETDEWEB)

    Paul Talarico; Charles Sugg; Thomas Hren; Lauri Branch; Joseph Garcia; Alan Rezigh; Michelle Pittenger; Kathleen Bower; Jonathan Philley; Michael Culligan; Jeremy Maslen; Michele Woods; Kevin Elm

    2010-06-16

    Under its Industrial Carbon Capture and Sequestration (ICCS) Program, the United States (U.S.) Department of Energy (DOE) selected ConocoPhillips Company (ConocoPhillips) to receive funding through the American Recovery and Reinvestment Act (ARRA) of 2009 for the proposed Sweeny Integrated Gasification Combined Cycle (IGCC)/Carbon Capture and Storage (CCS) Project (Project) to be located in Brazoria County, Texas. Under the program, the DOE is partnering with industry to demonstrate the commercial viability and operational readiness of technologies that would capture carbon dioxide (CO{sub 2}) emissions from industrial sources and either sequester those emissions, or beneficially reuse them. The primary objective of the proposed Project was to demonstrate the efficacy of advanced technologies that capture CO{sub 2} from a large industrial source and store the CO{sub 2} in underground formations, while achieving a successful business venture for the entity (entities) involved. The Project would capture 85% of the CO{sub 2} produced from a petroleum coke (petcoke) fed, 703 MWnet (1,000 MWgross) IGCC power plant, using the ConocoPhillips (COP) proprietary and commercially proven E-Gas{trademark} gasification technology, at the existing 247,000 barrel per day COP Sweeny Refinery. In addition, a number of other commercially available technologies would be integrated into a conventional IGCC Plant in a unique, efficient, and reliable design that would capture CO{sub 2}. The primary destination for the CO{sub 2} would be a depleted natural gas field suitable for CO{sub 2} storage ('Storage Facility'). COP would also develop commercial options to sell a portion of the IGCC Plant's CO{sub 2} output to the growing Gulf Coast enhanced oil recovery (EOR) market. The IGCC Plant would produce electric power for sale in the Electric Reliability Council of Texas Houston Zone. The existing refinery effluent water would be treated and reused to fulfill all process

  3. Overview regarding the Romanian electricity sector regulatory framework development

    International Nuclear Information System (INIS)

    Bogdan, H.; Caracasian, L.

    2002-01-01

    The Romanian Electricity and Heat Regulatory Authority (ANRE) became operational in March 1999 and sector regulations came to render complete the specific primary legislation already adopted. The alignment to the international practice in the field, attracting investors while complying with the country's legitimate interests for a sustainable economic development and a sound social partnership among sector players were aimed at by ANRE in drawing out its regulations. The paper describes the progress Romania made in the last years in the transition towards a liberalised electricity sector. The key elements leading to such evolution are: 1. the development of the national legislation in accordance with the applicable EU legislation; 2. the establishment of an independent regulator to regulate monopolies where they remain, and to foster competition; 3. the splitting of the vertical integrated utility CONEL/RENEL in several independent companies, the establishment of the Transmission System Operator and the Market Operator within the National Grid Company T ranselectrica ; 4. the Romanian regulating system of authorizations and licenses; 5. the regulated access to the transmission and distribution networks; 6. the design of the wholesale market with two components: bilateral contracts between generators and suppliers and a day-ahead market to ensure the balance between demand and supply; 7. the gradual opening of the electricity market for eligible customers with minimum negative impact upon captive customers; 8. the improvements of the tariff methodologies in order to facilitate long-term decision making and to encourage the entering of potential investors on the market; 9. the introduction of performance standards for the supply activities. Financing resources were also ensured for investments in the modernisation of the national electricity transmission grid with a view to interconnection to the EU networks. Transparency of the process for the access to electricity

  4. Nuclear Versus Coal plus CCS. A Comparison of Two Competitive Base-Load Climate Control Options

    International Nuclear Information System (INIS)

    Tavoni, F.; Van der Zwaan, B.C.C.

    2011-01-01

    In this paper, we analyze the relative importance and mutual behavior of two competing base-load electricity generation options that each are capable of contributing significantly to the abatement of global CO2 emissions: nuclear energy and coal-based power production complemented with CO2 capture and storage (CCS). We also investigate how, in scenarios developed with an integrated assessment model that simulates the economics of a climate-constrained world, the prospects for nuclear energy would change if exogenous limitations on the spread of nuclear technology were relaxed. Using the climate change economics model World Induced Technical Change Hybrid, we find that until 2050 the growth rates of nuclear electricity generation capacity would become comparable to historical rates observed during the 1980s. Given that nuclear energy continues to face serious challenges and contention, we inspect how extensive the improvements of coal-based power equipped with CCS technology would need to be if our economic optimization model is to significantly scale down the construction of new nuclear power plants.

  5. Development methodology for the software life cycle process of the safety software

    International Nuclear Information System (INIS)

    Kim, D. H.; Lee, S. S.; Cha, K. H.; Lee, C. S.; Kwon, K. C.; Han, H. B.

    2002-01-01

    A methodology for developing software life cycle processes (SLCP) is proposed to develop the digital safety-critical Engineered Safety Features - Component Control System (ESF-CCS) successfully. A software life cycle model is selected as the hybrid model mixed with waterfall, prototyping, and spiral models and is composed of two stages , development stages of prototype of ESF-CCS and ESF-CCS. To produce the software life cycle (SLC) for the Development of the Digital Reactor Safety System, the Activities referenced in IEEE Std. 1074-1997 are mapped onto the hybrid model. The SLCP is established after the available OPAs (Organizational Process Asset) are applied to the SLC Activities, and the known constraints are reconciled. The established SLCP describes well the software life cycle activities with which the Regulatory Authority provides

  6. Ecological models for regulatory risk assessments of pesticides: Developing a strategy for the future.

    NARCIS (Netherlands)

    Thorbek, P.; Forbes, V.; Heimbach, F.; Hommen, U.; Thulke, H.H.; Brink, van den P.J.

    2010-01-01

    Ecological Models for Regulatory Risk Assessments of Pesticides: Developing a Strategy for the Future provides a coherent, science-based view on ecological modeling for regulatory risk assessments. It discusses the benefits of modeling in the context of registrations, identifies the obstacles that

  7. 77 FR 2556 - Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public...

    Science.gov (United States)

    2012-01-18

    ...] Ethical and Regulatory Challenges in the Development of Pediatric Medical Countermeasures; Public Workshop... Administration (FDA), Office of Pediatric Therapeutics, is announcing a public workshop entitled ``Ethical and... provide a forum for careful consideration of scientific, ethical, and regulatory issues confronting FDA...

  8. Breeding and regulatory opportunities and constraints for developing broccoli cultivars adapted to organic agriculture

    NARCIS (Netherlands)

    Renaud, E.N.C.

    2014-01-01

    This thesis is about the regulatory and technical challenges to the organic seed and breeding sector. This study specifically explored the mutual influence of the regulatory environment for organic seed sector development in the United States (US), Europe Union (EU) and Mexico, and the extent to

  9. Breeding and regulatory opportunities and constraints for developing broccoli cultivars adapted to organic agriculture

    NARCIS (Netherlands)

    Renaud, E.N.C.

    2014-01-01

    This thesis is about the regulatory and technical challenges to the organic seed and breeding sector. This study specifically explored the mutual influence of the regulatory environment for organic seed sector development in the United States (US), Europe Union (EU) and Mexico, and the extent to

  10. A survey on the public perception of CCS in France

    International Nuclear Information System (INIS)

    Minh, Ha-Duong; Campos, A.S.; Nadai, A.

    2007-12-01

    An awareness and opinion survey on Carbon Capture and Storage was conducted on a representative sample of French aged 15 years and above. About 6% of respondents were able to provide a satisfying definition of the technology. The key question about 'approval of or opposition to' the use of CCS in France was asked twice, first after presenting the technology, then after exposing the potential adverse consequences. Approval rates, 59% and 38%, show that there is no a priori rejection of the technology, but public trust needs to be build. The sample was split in two to test for a semantic effect: questioning one half about 'Stockage' (English: storage), the other about 'Sequestration'. Manipulating the vocabulary had no statistically significant effect on approval rates. Stockage is more meaningful, but does not convey the idea of permanent monitoring. (authors)

  11. Regulatory Consequences of "Brexit" for the Development of Medicinal Products.

    Science.gov (United States)

    Jackson, E L; Feldschreiber, P; Breckenridge, A

    2017-08-01

    The United Kingdom voted in a referendum in June 2016 to leave the European Union (EU) after 45 years of membership. Among the many political, social, and scientific consequences are those for the regulation of health care products. No longer will the efficacy, safety, and quality of medicines in the United Kingdom be subject to an EU regulatory framework. The European Medicines Agency (EMA), which is currently located in London, will move elsewhere in Europe. The pharmaceutical industry will reassess its commitment to the UK health scene. © 2017, ASCPT.

  12. CCS acceptability: social site characterization and advancing awareness at prospective storage sites in Poland and Scotland

    International Nuclear Information System (INIS)

    Brunsting, Suzanne; Mastop, Jessanne; Kaiser, Marta; Zimmer, Rene; Shackley, Simon; Mabon, Leslie; Howell, Rhys

    2015-01-01

    This paper summarizes the work on the social dimension conducted within the EU FP7 SiteChar project. The most important aim of the research was to advance public awareness and draw lessons for successful public engagement activities when developing a CO 2 storage permit application. To this end, social site characterization (e.g. representative surveys) and public participation activities (focus conference) were conducted at two prospective Carbon Capture and Storage (CCS) sites: an onshore site in Poland and an offshore site in Scotland. The research consisted of four steps over a time period of 1.5 year, from early 2011 to mid-2012. The first step consisted of four related qualitative and quantitative research activities to provide a social characterization of the areas: desk research, stakeholder interviews, media analyses, and a survey among representative samples of the local community. The aim was to identify: - stakeholders or interested parties; - factors that may drive their perceptions of and attitudes towards CCS. Results were used to as input for the second step, in which a new format for public engagement named 'focus conferences' was tested at both sites involving a small sample of the local community. The third step consisted of making available generic as well as site-specific information to the general and local public, by: - setting up a bilingual set of information pages on the project web site suitable for a lay audience; - organizing information meetings at both sites that were open to all who took interest. The fourth step consisted of a second survey among a new representative sample of the local community. The survey was largely identical to the survey in step 1 to enable the monitoring of changes in awareness, knowledge and opinions over time. Results provide insight in the way local CCS plans may be perceived by the local stakeholders, how this can be reliably assessed at early stage without raising unnecessary concerns, and how

  13. Development of the personnel training and qualification system of the Russian Federation Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    Kapralov, E.; Kapralov, Y.; Kozlov, V.

    2006-01-01

    The new personnel training and qualification system is being developed for russian regulatory body, having a very big number of employees and invited experts and widly territorially distributed structure. (author)

  14. Tackling CO2 reduction in India through use of CO2 capture and storage (CCS): Prospects and challenges

    International Nuclear Information System (INIS)

    Shackley, Simon; Verma, Preeti

    2008-01-01

    CO 2 capture and storage (CCS) is not currently a priority for the Government of India (GOI) because, whilst a signatory to the UNFCCC and Kyoto Protocol, there are no existing greenhouse gas emission reduction targets and most commentators do not envisage compulsory targets for India in the post-2012 phase. The overwhelming priority for the GOI is to sustain a high level of economic growth (8%+) and provision of secure, reliable energy (especially electricity) is one of the widely recognised bottlenecks in maintaining a high growth rate. In such a supply-starved context, it is not easy to envisage adoption of CCS-which increases overall generation capacity and demand for coal without increasing actual electricity supply-as being acceptable. Anything which increases costs-even slightly-is very unlikely to happen, unless it is fully paid for by the international community. The majority viewpoint of the industry and GOI interviewees towards CCS appears to be that it is a frontier technology, which needs to be developed further in the Annex-1 countries to bring down the cost through RD and D and deployment. More RD and D is required to assess in further detail the potential for CO 2 storage in geological reservoirs in India and the international community has an important role to play in cultivating such research

  15. The role of biomass and CCS in China in a climate mitigation perspective

    DEFF Research Database (Denmark)

    Lüthje, Mikael; Karlsson, Kenneth Bernard; Gregg, Jay Sterling

    2011-01-01

    that while both utilization of biomass and CCS are essential options for reducing emissions in China, BECCS is not the most cost effective option in China. CCS is nevertheless an important option for China; in the climate mitigation scenarios modeled, by 2050, China is projected to employ CCS on at least 70......As the world’s largest emitter of greenhouse gasses (GHGs), China plays a central role in the suite of options for climate change mitigation. To analyze the importance of biomass and carbon capture and storage (CCS) availability in China, varying levels of these parameters are created......, and bioenergy CCS (BECCS) in China under the constraint of meeting a climate stabilization target such that dangerous climate change (as defined by the Copenhagen Accord) is avoided. When considering hypothetical scenarios where GHG emissions are constrained, China consumes all available domestic biomass...

  16. System analysis of CO{sub 2} sequestration from biomass cogeneration plants (Bio-CHP-CCS). Technology, economic efficiency, sustainability; Systemanalyse der CO{sub 2}-Sequestrierung aus Biomasse-Heizkraftwerken (Bio-KWK-CCS). Technik, Wirtschaftlichkeit, Nachhaltigkeit

    Energy Technology Data Exchange (ETDEWEB)

    Hartmann, Claus

    2014-10-15

    In the present work a system analysis is carried out to determine the extent to which a combination of the three areas of energetic biomass use, combined heat and power (CHP) and CO{sub 2} sequestration (CCS - Carbon Capture and Storage) is fundamentally possible and meaningful. The term ''CO{sub 2} sequestration'' refers to the process chain from CO{sub 2} capture, CO{sub 2} transport and CO{sub 2} storage. While the use of biomass in combined heat and power plants is a common practice, CO{sub 2} sequestration (based on fossil fuels) is at the research and development stage. A combination of CCS with biomass has so far been little studied, a combination with combined heat and power plants has not been investigated at all. The two technologies for the energetic use of biomass and cogeneration represent fixed variables in the energy system of the future in the planning of the German federal government. According to the lead scenario of the Federal Ministry of the Environment, electricity generation from biomass is to be almost doubled from 2008 to 2020. At the same time, the heat generated in cogeneration is to be trebled [cf. Nitsch and Wenzel, 2009, p. 10]. At the same time, the CCS technology is to be used in half of all German coal-fired power plants until 2030 [cf. Krassuki et al., 2009, p. 17]. The combination of biomass and CCS also represents an option which is conceivable for the German federal policy [cf. Bundestag, 2008b, p. 4]. In addition, the CCS technology will provide very good export opportunities for the German economy in the future [cf. Federal Government, 2010, p. 20]. The combination of biomass combined heat and power plants with CCS offers the interesting opportunity to actively remove CO{sub 2} from the atmosphere as a future climate protection instrument by means of CO{sub 2} neutrality. Therefore, in the energy concept of the German federal government called for a storage project for industrial or biogenic CO{sub 2

  17. Coal-fired Power Plants with Flexible Amine-based CCS and Co-located Wind Power: Environmental, Economic and Reliability Outcomes

    Science.gov (United States)

    Bandyopadhyay, Rubenka

    Carbon Capture and Storage (CCS) technologies provide a means to significantly reduce carbon emissions from the existing fleet of fossil-fired plants, and hence can facilitate a gradual transition from conventional to more sustainable sources of electric power. This is especially relevant for coal plants that have a CO2 emission rate that is roughly two times higher than that of natural gas plants. Of the different kinds of CCS technology available, post-combustion amine based CCS is the best developed and hence more suitable for retrofitting an existing coal plant. The high costs from operating CCS could be reduced by enabling flexible operation through amine storage or allowing partial capture of CO2 during high electricity prices. This flexibility is also found to improve the power plant's ramp capability, enabling it to offset the intermittency of renewable power sources. This thesis proposes a solution to problems associated with two promising technologies for decarbonizing the electric power system: the high costs of the energy penalty of CCS, and the intermittency and non-dispatchability of wind power. It explores the economic and technical feasibility of a hybrid system consisting of a coal plant retrofitted with a post-combustion-amine based CCS system equipped with the option to perform partial capture or amine storage, and a co-located wind farm. A techno-economic assessment of the performance of the hybrid system is carried out both from the perspective of the stakeholders (utility owners, investors, etc.) as well as that of the power system operator. (Abstract shortened by ProQuest.).

  18. National system for regulatory body in the developing countries

    International Nuclear Information System (INIS)

    Othman, I.

    2001-01-01

    The status of radiation protection infrastructures varies from one region to another, and from one country to another in the same region. Some countries are very well advanced, others at an intermediate level, and others way behind. The Syrian Arab Republic is one of the countries using radiation generating machines, and sealed and unsealed radionuclide sources. The Atomic Energy Commission of Syria (AECS) has the direct responsibility of assuring proper safety for handling such sources on the basis of a solid regulatory infrastructure and conforming with the international standards. The AECS was approached by the IAEA to assist other countries in the area participating in the interregional Model Project on Upgrading Radiation Safety and Radiation Safety and Waste Management Infrastructure by providing them with the available facilities and experience in radiation safety. (author)

  19. Regulatory networks in pollen development under cold stress

    Directory of Open Access Journals (Sweden)

    Kamal Dev Sharma

    2016-03-01

    Full Text Available Cold stress modifies anthers’ metabolic pathways to induce pollen sterility. Cold-tolerant plants, unlike the susceptible ones, produce high proportion of viable pollen. Anthers in susceptible plants, when exposed to cold stress, increase abscisic acid (ABA metabolism and reduce ABA catabolism. Increased ABA negatively regulates expression of tapetum cell wall bound invertase and monosaccharide transport genes resulting in distorted carbohydrate pool in anther. Cold-stress also reduces endogenous levels of the bioactive gibberellins (GAs, GA4 and GA7, in susceptible anthers by repression of the GA biosynthesis genes. Here we discuss recent findings on mechanisms of cold susceptibility in anthers which determine pollen sterility. We also discuss differences in regulatory pathways between cold-stressed anthers of susceptible and tolerant plants that decide pollen sterility or viability.

  20. Innovative farmers and regulatory gatekeepers: Genetically modified crops regulation and adoption in developing countries.

    Science.gov (United States)

    Sinebo, Woldeyesus; Maredia, Karim

    2016-01-02

    The regulation of genetically modified (GM) crops is a topical issue in agriculture and environment over the past 2 decades. The objective of this paper is to recount regulatory and adoption practices in some developing countries that have successfully adopted GM crops so that aspiring countries may draw useful lessons and best practices for their biosafatey regulatory regimes. The first 11 mega-GM crops growing countries each with an area of more than one million hectares in 2014 were examined. Only five out of the 11 countries had smooth and orderly adoption of these crops as per the regulatory requirement of each country. In the remaining 6 countries (all developing countries), GM crops were either introduced across borders without official authorization, released prior to regulatory approval or unapproved seeds were sold along with the approved ones in violation to the existing regulations. Rapid expansion of transgenic crops over the past 2 decades in the developing world was a result of an intense desire by farmers to adopt these crops irrespective of regulatory roadblocks. Lack of workable biosafety regulatory system and political will to support GM crops encouraged unauthorized access to GM crop varieties. In certain cases, unregulated access in turn appeared to result in the adoption of substandard or spurious technology which undermined performance and productivity. An optimal interaction among the national agricultural innovation systems, biosafety regulatory bodies, biotech companies and high level policy makers is vital in making a workable regulated progress in the adoption of GM crops. Factoring forgone opportunities to farmers to benefit from GM crops arising from overregulation into biosafety risk analysis and decision making is suggested. Building functional biosafety regulatory systems that balances the needs of farmers to access and utilize the GM technology with the regulatory imperatives to ensure adequate safety to the environment and human

  1. Recent developments in the natural gas regulatory arena

    International Nuclear Information System (INIS)

    Hollis, S.S.

    1997-01-01

    The changes made by the US Federal Energy Regulatory Commission's (FERC) order no. 636 in traditional trading partner relationships, wherein contracts, not regulators have the most important role in defining the rights between the parties, were discussed. Implications of the unbundling of the natural gas industry were analyzed. While on the whole the policy appears to be a wise one, there are a number of questions yet to be answered about how well customers are served by the policy. The opinion of this author is that for a company to 'take charge of its energy destiny' will involve added costs in terms of having to re-engineer the company's organisation, or having to pay a middleman who is familiar with all the intricacies of gas procurement, trading and transmission. The restructuring of the gas market and the advent of customer oriented service also is driving the next wave of the energy business, namely the provision of integrated services which are the likely consequences of restructuring of the electric industry resulting from FERC orders 888 and 889. The integrated market encouraged by deregulation of the natural gas and electric industries will be one in which sellers will offer all forms of energy from a single source, and a marketplace where different forms of energy can be exchanged or converted. In such a market the role of regulators will be mainly to facilitate competition and to assure a level playing field for all players. 150 refs

  2. Breeding and regulatory opportunities and constraints for developing broccoli cultivars adapted to organic agriculture

    OpenAIRE

    Renaud, E.N.C.

    2014-01-01

    This thesis is about the regulatory and technical challenges to the organic seed and breeding sector. This study specifically explored the mutual influence of the regulatory environment for organic seed sector development in the United States (US), Europe Union (EU) and Mexico, and the extent to which cultivars performed differently under organic conditions compared to conventional conditions, measured by selected horticultural and phytochemical traits. Organic farming practices often differ ...

  3. “Nuclear energy sounded wonderful 40 years ago”: UK citizen views on CCS

    International Nuclear Information System (INIS)

    Lock, Simon J.; Smallman, Melanie; Lee, Maria; Rydin, Yvonne

    2014-01-01

    Around the world there is increasing interest from government and industry in the potential for Carbon Capture and Storage (CCS) technologies to play a part in decarbonisation. This paper examines how people with little previous exposure to CCS technology, frame and discuss it, and how in the absence of information, ideas, notions, values and experiences shape opinion. We present data from a series of focus groups held with environmental activists, planning councillors, and adult and youth community group members in London in 2012. We found that views on CCS are shaped strongly by wider factors, particularly trade offs between different energy futures. Lay-critiques were similar to those put forward by environmental groups and were strongly framed by conceptions of nuclear power. We argue that although there is little public disquiet concerning this technology in private opinions were generally negative. This, and the use of nuclear power as a framing device, may present a challenge to policy-makers and industry committed to implementing CCS while promoting education as the main mechanism for public acceptance. - highlights: • We present data from a series of focus groups held with lay-citizens in London in 2012. • We found that lay-critiques of CCS were similar to those negative views put forward by environmental groups. • Lay views on CCS were strongly framed by conceptions of nuclear power. • This framing may present a challenge to policy-makers and industry committed to implementing CCS

  4. The role of biomass and CCS in China in a climate mitigation perspective

    Energy Technology Data Exchange (ETDEWEB)

    Luethje, M.; Karlsson, K.; Gregg, J.; Foeyn, T.H.Y.; Balyk, O.

    2011-05-15

    As the world's largest emitter of greenhouse gasses (GHGs), China plays a central role in the suite of options for climate change mitigation. To analyze the importance of biomass and carbon capture and storage (CCS) availability in China, varying levels of these parameters are created and then global climate scenarios are simulated using TIAM (TIMES Integrated Assessment Model). TIAM is a 16-region global energy system optimization model that includes a climate module that calculates the global concentrations of GHGs in the atmosphere. We analyze the potential for using biomass, CCS, and bioenergy CCS (BECCS) in China under the constraint of meeting a climate stabilization target such that dangerous climate change (as defined by the Copenhagen Accord) is avoided. When considering hypothetical scenarios where GHG emissions are constrained, China consumes all available domestic biomass as a relatively inexpensive fuel source. However, while BECCS does have a small role to play, in general it is cheaper to use biomass for the transportation sector and CCS with fossil fuel in order to meet both the energy demand and emissions reduction goals in the cheapest way possible. Therefore, we find that while both utilization of biomass and CCS are essential options for reducing emissions in China, BECCS is not the most cost effective option in China. CCS is nevertheless an important option for China; in the climate mitigation scenarios modeled, by 2050, China is projected to employ CCS on at least 70% of fossil energy electricity generation. When CCS is excluded, the cost of mitigation is more than doubled compared to the scenarios where CCS is included as a mitigation option. (Author)

  5. Dose constraint for Industrial gammagraphy developed by regulatory authorities

    International Nuclear Information System (INIS)

    Salinas Mariaca, Rodrigo

    2008-01-01

    Aware that the dose limitation established by the Basic Safety Standards, is one of the radiation protection requirements necessary but not sufficient; and also aware that given the characteristics of the different practices and the culture of security already achieved in such practices, the workers occupationally exposed are far below from the respective limits. It becomes imperative to improve and exploit another of the requirements established by the referred standards, which is the Dose Constraint. This job takes as a basis the dose history having in the Bolivian Authority in nuclear issues, referred to the practices related to Nuclear Gauges, Well Logging, Radiotherapy and Industrial Gammagraphy (practices considered dangerous). This analysis is intended to be the pivot for the remainder practices and had as its goal, the establishment of a specific dose constraint value. The dose constraint suggested for every practices studied, were determined considering the percentile 95 and with the logic that if that 95% are able to achieve certain values of effective dose, the other 5% should be able to adapt their working conditions in order to decrease their doses. The spread of this work is intended not only aware, to other regulatory bodies to achieve a symbiosis between the different requirements of the Standard, but basically emphasize the fact that it is not convenient let the requirement of dose constraint exclusively in the hands of the regulated institutions and associated workers; making it, very subjective among those institutions according to their analysis (many times with no statistical support). Furthermore these dose constraint values should be determined previously to a new practice authorization or failing shortly after its implementation. (author)

  6. Radioactive and conventional toxic waste compared - An integrated approach, useful for an appraisal of carbon capture and storage (CCS)

    International Nuclear Information System (INIS)

    Flueeler, Thomas

    2014-01-01

    The interplay of nuclear and conventional toxic ('special') waste is investigated, using a novel integrated system assessment: material and system characteristics, risk assessment and regulatory approaches. The goal is to create profiles of strengths and weaknesses of wastes that are similar in their risk characteristics but dealt with differently in risk management and regulation. A further objective is to draw lessons from the comparison of different discourses and procedures of waste with a similar profile with regard to decision-making processes (the reasons for the different regulation of both waste systems are not investigated here). Finally, a side glance is ventured on carbon capture and storage (CCS) in view of the keynote lecture of Session 5. (authors)

  7. CO2 slurry pipeline to transport solid marketable products to improve CCS economics

    Energy Technology Data Exchange (ETDEWEB)

    Luhning, Richard

    2010-09-15

    Carbon dioxide pipelines are anticipated to be a key element in CCS (Carbon Capture and Sequestration) to transport the carbon dioxide to sequestration sites or to oil fields for use in enhanced oil recovery applications. However the economics of CCS are such that the operations are economically challenged. The concept of using super critical (liquid) carbon dioxide in a slurry pipeline is to use the pipeline constructed for environmental purposes to transport marketable products such as sulphur, petroleum coke, limestone and others to market thereby generating additional income to make CCS carbon dioxide transportation economically attractive.

  8. Management and share of regulatory information through web; development of regulatory information management system for Korea next generation reactors

    Energy Technology Data Exchange (ETDEWEB)

    Lee, J. S.; Lee, J. H.; Jeong, Y. H.; Lee, S. H. [KINS, Taejon (Korea, Republic of); Yun, Y. C.; Park, M. I. [LG-EDS Systems, Seoul (Korea, Republic of)

    2001-05-01

    The Regulatory Information Management System developed by the Korea Institute of Nuclear Safety supports researchers who are in charge of developing SRRG for the Korea Next Generation Reactors, manage the developed SRRG and development process, and make it possible to share the SRRG information and background knowledge through the internet with the nuclear-related personnel and the public. From the experience of the system operation, the search engine is repalced to manage the native SRRG files directly. This change eliminates the inconsistency between native files and database files and improve the search exactness by automatic indexing function. The user interface of the internet homepage (http://kngr.kins.re.kr) is completely rebuilded and allows SRRG developers to manage the search system and the atomic energy regulations database on the Web without the help of the client programs. General users are also able to utilize more convenient search function and additional information by the improved interface. The system is running under the backup system and firewall system for the data protection and security.

  9. UC Irvine CHRS Real-time Global Satellite Precipitation Monitoring System (G-WADI PERSIANN-CCS GeoServer) for Hydrometeorological Applications

    Science.gov (United States)

    Sorooshian, S.; Hsu, K. L.; Gao, X.; Imam, B.; Nguyen, P.; Braithwaite, D.; Logan, W. S.; Mishra, A.

    2015-12-01

    The G-WADI Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks-Cloud Classification System (PERSIANN-CCS) GeoServer has been successfully developed by the Center for Hydrometeorology and Remote Sensing (CHRS) at the University of California Irvine in collaboration with the UNESCO's International Hydrological Programme (IHP) and a number of its international centers. The system employs state-of-the-art technologies in remote sensing and artificial intelligence to estimate precipitation globally from satellite imagery in real-time and high spatiotemporal resolution (4km, hourly). It offers graphical tools and data service to help the user in emergency planning and management for natural disasters related to hydrological processes. The G-WADI PERSIANN-CCS GeoServer has been upgraded with new user-friendly functionalities. The precipitation data generated by the GeoServer is disseminated to the user community through support provided by ICIWaRM (The International Center for Integrated Water Resources Management), UNESCO and UC Irvine. Recently a number of new applications for mobile devices have been developed by our students. The RainMapper has been available on App Store and Google Play for the real-time PERSIANN-CCS observations. A global crowd sourced rainfall reporting system named iRain has also been developed to engage the public globally to provide qualitative information about real-time precipitation in their location which will be useful in improving the quality of the PERSIANN-CCS data. A number of recent examples of the application and use of the G-WADI PERSIANN-CCS GeoServer information will also be presented.

  10. A National Regulatory Authority set up in a developing country: case of Mali

    International Nuclear Information System (INIS)

    Kone, Nagantie

    2008-01-01

    Full text: The Republic of Mali is member of the International Atomic Energy Agency since 1961. Of since the creation of the IAEA, some African countries are members. The technical cooperation with the Agency started in the years 1975. Through that cooperation, many pacific uses of nuclear techniques have been introduced, then developed at different levels in many socio- economic domains as medicine, agriculture, research, and so on. That development of nuclear techniques use has occurred without legislation at all or in some limited cases with part of the legislation of the colonizing country), in a precise field (like radiography in medicine). Later the need of regulatory infrastructure implementation started. That implementation has followed several ways in the different African countries. Also, it started earlier in countries which had advanced activities in nuclear techniques and very later in others. Most if not all of these infrastructure (say regulatory board) were created by the greatest users of the nuclear techniques, the Ministry of Health in most cases or Energy Commission for Countries having a research reactor. After the years 90, the Agency has developed new vision in the implementation of Regulatory Authorities. The new innovation was: 1-) Development of Regulatory Authority with independent statute (decisions and finance); 2-) Assuming post graduate training in developing countries to come other the lack of human resources. That new strategy of the IAEA has facilitated the apparition and development of several new regulatory authorities. We are going to develop here the progress done by one of these new regulatory authorities, through five years being. (author)

  11. A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science

    DEFF Research Database (Denmark)

    Borup, Gitte; Bach, Karin Friis; Schmiegelow, Merete

    2016-01-01

    The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled “Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science......” that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status...... access to patient experience was proposed. A research and educational center such as CORS, which was founded on cross-sectorial and cross-disciplinary cooperation, is an example of an institution that could be a good starting point for hosting such a platform....

  12. Development of safety culture at Kozloduy NPP: The role of the regulatory body

    International Nuclear Information System (INIS)

    Miliovsky, Ventzislav

    2002-01-01

    An evolution is made upon external factor that accompany the development of safety culture at Kozloduy NPP (KNPP). The two basic stages and the major results achieved independently and with external assistance were considered in the process of development of safety culture. The areas in which the regulatory body insists on having active participation were defined. (author)

  13. Does the PI3K pathway promote or antagonize regulatory T cell development and function?

    Science.gov (United States)

    Soond, Dalya R.; Slack, Elizabeth C. M.; Garden, Oliver A.; Patton, Daniel T.; Okkenhaug, Klaus

    2012-01-01

    Regulatory T cells (Tregs) prevent autoimmunity and inflammation by suppressing the activation of other T cells and antigen presenting cells. The role of phosphoinositide 3-kinase (PI3K) signaling in Treg is controversial. Some studies suggest that inhibition of the PI3K pathway is essential for the development of Tregs whereas other studies have shown reduced Treg numbers and function when PI3K activity is suppressed. Here we attempt to reconcile the different studies that have explored PI3K and the downstream effectors Akt, Foxo, and mTOR in regulatory T cell development and function and discuss the implications for health and therapeutic intervention. PMID:22912633

  14. Socio-economic analysis of CCS/EOR in Denmark; Samfundsoekonomisk analyse af CCS/EOR i Danmark

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2012-12-15

    The Danish Energy Agency has initiated an analysis of the socio-economic sustainability of a CCS / EOR system based on CO{sub 2} capture from Danish sources and injected into selected Danish North Sea oil fields. The analysis shall assess the socioeconomic consequences of such a project as well as highlight the budgetary economic effects for the parties involved. Taking into account a realistic time frame for conversion of the cogeneration power plants and for the extent of the possible capture of CO{sub 2} in each of these plants, it has been chosen only to presuppose the establishment of CCS in three plants, namely Studstrupvaerket, Fynsvaerket and Nordjyllandsvaerket. Only the oil fields Dan, Halfdan and Gorm were selected for the analysis. The analysis shows that in the selected oil fields it is possible to increase the oil production by approx. 151 million. barrels of oil to the year 2049, which corresponds to approx. 40% of the estimated potential in these fields. The increased oil production requires that approx. 95 million. tonnes of CO{sub 2} is captured in the three power plants, which are subsequently transported and injected in the oil fields in the North Sea. The transport of CO{sub 2} from the CHP plants to the North Sea are assumed to be done by ship, since this solution is economically favorable and also offers logistical advantages and increased flexibility. The analysis shows that both the budget economic and the socio-economic analysis as a whole provide a positive economic net present value over a 30-year period. The socio-economic benefit is expected to be about. 3.5 billion DKK higher. This difference is due to especially the following conditions: a) CO{sub 2} emissions of CO{sub 2} transport are only included in the socio-economic analysis, since shipping is outside the quota system. In the socio-economic analysis, the estimated value of damage impact on the environment is included; b) The value of the oil produced after 2049 is included in

  15. Regulatory activities

    International Nuclear Information System (INIS)

    2001-01-01

    This publication, compiled in 8 chapters, presents the regulatory system developed by the Nuclear Regulatory Authority (NRA) of the Argentine Republic. The following activities and developed topics in this document describe: the evolution of the nuclear regulatory activity in Argentina; the Argentine regulatory system; the nuclear regulatory laws and standards; the inspection and safeguards of nuclear facilities; the emergency systems; the environmental systems; the environmental monitoring; the analysis laboratories on physical and biological dosimetry, prenatal irradiation, internal irradiation, radiation measurements, detection techniques on nuclear testing, medical program on radiation protection; the institutional relations with national and international organization; the training courses and meeting; the technical information

  16. The role of Life Cycle Assessment in identifying and reducing environmental impacts of CCS

    Energy Technology Data Exchange (ETDEWEB)

    Sathre, Roger; Masanet, Eric; Cain, Jennifer; Chester, Mikhail

    2011-04-20

    Life Cycle Assessment (LCA) should be used to assist carbon capture and sequestration (CCS) planners to reduce greenhouse gas (GHG) emissions and avoid unintended environmental trade-offs. LCA is an analytical framework for determining environmental impacts resulting from processes, products, and services. All life cycle stages are evaluated including raw material sourcing, processing, operation, maintenance, and component end-of-life, as well as intermediate stages such as transportation. In recent years a growing number of LCA studies have analyzed CCS systems. We reviewed 50+ LCA studies, and selected 11 studies that compared the environmental performance of 23 electric power plants with and without CCS. Here we summarize and interpret the findings of these studies. Regarding overall climatemitigation effectiveness of CCS, we distinguish between the capture percentage of carbon in the fuels, the net carbon dioxide (CO2) emission reduction, and the net GHG emission reduction. We also identify trade-offs between the climate benefits and the potential increased non-climate impacts of CCS. Emissions of non-CO2 flue gases such as NOx may increase due to the greater throughput of fuel, and toxicity issues may arise due to the use of monoethanolamine (MEA) capture solvent, resulting in ecological and human health impacts. We discuss areas where improvements in LCA data or methods are needed. The decision to implement CCS should be based on knowledge of the overall environmental impacts of the technologies, not just their carbon capture effectiveness. LCA will be an important tool in providing that knowledge.

  17. Preliminary Consideration for the Development of Regulatory Level 2 PSA Model

    International Nuclear Information System (INIS)

    Lee, Chang-Ju

    2006-01-01

    In order to assess the validity of PSA (probabilistic safety assessment) results and to establish regulatory requirements for relevant safety issues most of the regulators want to develop an independent and convenient risk assessment model including Level 2 PSA area. As this model and framework should be implicitly independent on the licensee's PSA model, it has a primary objective directly for applying to the risk-informed regulatory affairs and for supporting those kinds of works. According this, the regulator can take an objective view for the uncertainty of risk information made by the licensee and keep up the capability and decision-making framework for overall risk assessment results. In addition, the regulatory model may be used to verify and validate the operational risk levels of all engineered safety features of nuclear power plants (NPPs). An issue for plant-specific application of safety goals was previously identified in the US NRC's risk-informed regulatory guidance development activities, and discussed in many Commission papers, e. g. SECY-97-287, which identifies the goal for large early release frequency (LERF). LERF defines a containment performance criteria derived from the quantitative health objectives. As we know, the LERF was chosen to assess risk significance in Regulatory Guide 1.174 (2002) again, which provides one measure of the performance of the containment barrier, and represents a surrogate for early health effects

  18. Support in the development of Regulatory Procedures for licensing Lepse Waste Management Operations

    International Nuclear Information System (INIS)

    2001-05-01

    This report describes a project intended to assist Gosatomnadzor of Russia develop a set of documents defining the regulatory requirements for information to be submitted to Gosatomnadzor in support of any application for a licence relating to the removal of spent nuclear fuel from the depot ship Lepse. The project resulted in the development of three regulatory documents covering the documentation required in support of a licence application, the requirements for quality assurance arrangements and the safety analysis report. The working method adopted involved staged development of draft material and review at workshops involving a wide variety of relevant Russian and western organizations. The input and output of the workshops was fully documented to provide an audit trail for the document development and the rationale for what has been included and what is excluded and why. The availability of the regulatory documents in English should significantly assist in the use of the documents by western partners in the actual industrial project. Important experience and information was exchanged among participants in the project. The developing understanding is an important element in providing confidence, from a western perspective, that appropriate regulatory supervision can be applied to industrial projects supported by organizations such as the European Commission and national agencies. The same working methods could be used in the next phase of Lepse regulatory support, i.e., support in development of the procedures for the regulatory review of licence applications, and, subsequently, support in the application of the regulatory inspection process to ensure licence conditions are being complied with. Similarly, these working methods could be used in providing regulatory support for nuclear and radiation safety related to other industrial projects involving radioactive waste management. The participants in this sub-project described in this report were Norwegian

  19. Workshop on capture and sequestration of CO{sub 2} (CCS); Taller sobre captura y secuestro de CO{sub 2} (CCS)

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2008-07-15

    In this workshop diverse communications related to the capture and sequestration of CO{sub 2} are presented. This workshop was realized in the Technological Museum of the Comision Federal de Electricidad (CFE), in Mexico City on the ninth and tenth of July, 2008, and it had the objective of reflecting the necessity of considering in Mexico the application of the capture and sequestration technologies of CO{sub 2} (CCS), as well as to put in touch the technicians and managers of the Mexican institutions with the world-wide leaders in these technologies and with the managers of companies that are successfully applying CCS technologies. [Spanish] En este taller se presentan diversas ponencias relacionadas con la captura y secuestro de CO{sub 2}. Este taller se realizo en el Museo Tecnologico de la Comision Federal de Electricidad (CFE), en la Ciudad de Mexico, los dias 9 y 10 de julio de 2008 y tuvo como objetivo reflexionar sobre la necesidad de considerar en Mexico, la aplicacion de las tecnologias de captura y secuestro de CO{sub 2} (CCS), asi como poner en contacto a los tecnicos y directivos de las instituciones mexicanas con los lideres mundiales en estas tecnologias y con los directivos de empresas que estan aplicando con exito tecnologias de CCS.

  20. Regulatory circuitry governing fungal development, drug resistance, and disease.

    Science.gov (United States)

    Shapiro, Rebecca S; Robbins, Nicole; Cowen, Leah E

    2011-06-01

    Pathogenic fungi have become a leading cause of human mortality due to the increasing frequency of fungal infections in immunocompromised populations and the limited armamentarium of clinically useful antifungal drugs. Candida albicans, Cryptococcus neoformans, and Aspergillus fumigatus are the leading causes of opportunistic fungal infections. In these diverse pathogenic fungi, complex signal transduction cascades are critical for sensing environmental changes and mediating appropriate cellular responses. For C. albicans, several environmental cues regulate a morphogenetic switch from yeast to filamentous growth, a reversible transition important for virulence. Many of the signaling cascades regulating morphogenesis are also required for cells to adapt and survive the cellular stresses imposed by antifungal drugs. Many of these signaling networks are conserved in C. neoformans and A. fumigatus, which undergo distinct morphogenetic programs during specific phases of their life cycles. Furthermore, the key mechanisms of fungal drug resistance, including alterations of the drug target, overexpression of drug efflux transporters, and alteration of cellular stress responses, are conserved between these species. This review focuses on the circuitry regulating fungal morphogenesis and drug resistance and the impact of these pathways on virulence. Although the three human-pathogenic fungi highlighted in this review are those most frequently encountered in the clinic, they represent a minute fraction of fungal diversity. Exploration of the conservation and divergence of core signal transduction pathways across C. albicans, C. neoformans, and A. fumigatus provides a foundation for the study of a broader diversity of pathogenic fungi and a platform for the development of new therapeutic strategies for fungal disease.

  1. The use of critical loads in developing regulatory policy

    Energy Technology Data Exchange (ETDEWEB)

    Irwin, J.G.; Powlesland, C. [Environmental Agency, London (United Kingdom). National Centre for Risk Analysis and Options Appraisal

    1998-12-31

    Information on the spatial distribution of sensitive receptors may be incorporated into assessment of the potential benefits arising from reductions in sulphur dioxide emissions. Drawing on energy forecasts, illustrative future scenarios for black fossil fuel (coal and oil fired) power generation were developed and corresponding national sulphur dioxide emissions inventories constructed. These were used as input to a transport and deposition model. Total sulphur deposition was estimated taking account of other United Kingdom sources and European emissions. Model outputs were overlain on maps of critical loads for soil acidification. Environmental disbenefit was estimated from the number of squares exceeding the critical load and plotted against power station sulphur dioxide emission. These plots suggested that reductions in emissions below a sector total of about 200 to 300 k tonnes may result in proportionally smaller environmental benefit than reductions down to this value. Analyses of the impact of a unit source in different areas of the country showed that emissions in the North-West have over two times the impact on acid sensitive ecosystems than those in the Thames Valley. 6 refs., 4 figs., 1 tab.

  2. Challenges of development of regulatory control infrastructure for uranium mining in developing countries (Tanzania) to achieve regulatory compliance

    International Nuclear Information System (INIS)

    Kileo, A.; Mwalongo, D.; Mkilaha, I.; Mwaipopo, A.

    2014-01-01

    Managing radiation and waste in uranium mining is of paramount importance for the protection of occupational workers, the public and the environment. Responsibilities of the parties which are involved in the part of the Nuclear Fuel Cycle are outlined in the legislations and regulations governing uranium prospecting, mining and processing. The Tanzania Atomic Energy Commission, as the regulator for radiation and atomic energy, has developed regulations for exploration, construction, mining, milling, packaging, transport of yellow cake and decommissioning of uranium mine site in Tanzania. This paper outlines the development of these regulations and compares with the international standards. The paper also reviews and analyses gaps and shortcomings for safe uranium mining in United Republic of Tanzania. (author)

  3. Microfinance Institutions and Credit Unions in Albania : Regulatory, Supervisory and Market Development Issues

    OpenAIRE

    World Bank

    2008-01-01

    The objective of this report is to present an assessment of the current legal, regulatory, and supervisory framework in Albania for microfinance, as well as an assessment of institutions rendering microfinance services (MFIs), including the Savings and Credit Associations (SCAs) and credit unions (CUs), to identify future development priorities. Economic conditions have improved in Albania...

  4. Andrographolide Ameliorate Rheumatoid Arthritis by Promoting the Development of Regulatory T Cells

    Directory of Open Access Journals (Sweden)

    Muhaimin Rifa’i

    2010-10-01

    Full Text Available Andrographolide is important material present in Andrographis paniculata. This material can promote T cell to develop into regulatory T cell, CD4+CD25+. CD4+CD25+ regulatory T (Treg cells, a component of the innate immune response, which play a key role in the maintenance of self-tolerance, have become the focus of numerous studies over the last decade. These cells have the potential to be exploited to treat autoimmune disease. These cells inhibit the immune response in an Ag-nonspecific manner, interacting with other T cells. These T cell populations actively control the properties of other immune cells by suppressing their functional activity to prevent autoimmunity but also influence the immune response to allergens as well as against tumor cells and pathogens. In this experiment we showed that active compound from Andrographis paniculata namely andrographolide can induce active regulatory T cell that has an efficacy to cure rheumatoid arthritis mice model.

  5. Employee Development Capabilities of the Regulatory Authority in the Nuclear Field in Romania

    International Nuclear Information System (INIS)

    Ghinea, P.

    2016-01-01

    Full text: The paper provides information about CNCAN (general presentation of CNCAN responsibilities as a regulatory body) and about the general human resources management within our institution regarding the following: legal framework regarding resources; knowledge management; staff employment financial resources continuous focus on improvement of staff performances through dedicated training programmes. The process to develop and maintain the necessary competence and skills of staff of the regulatory body, as an element of knowledge management. Training for CNCAN staff is provided either in-house or through technical cooperation programmes with the IAEA. CNCAN has made arrangements for specific staff training using training courses and programmes provided by international organizations. The specific training is provided predominantly with the economic support from outside of the country. CNCAN has a process to develop and maintain the necessary competence and skills of staff of the regulatory body, as an element of knowledge management. To maintain an appropriate competence level, an annual plan for staff training is in place and each staff member has an individual training plan. Project supports CNCAN in the development of knowledge management and capacity building frameworks to secure long-term availability of regulatory competency. (author

  6. Development of PSA audit guideline and regulatory PSA model for SMART

    International Nuclear Information System (INIS)

    Cho, Namchul; Lee, Chang-Ju; Kim, I.S.

    2012-01-01

    SMART is under development for dual purposes of power generation and seawater desalination in Korea. It is an integral reactor type with a thermal power output of 330 MW and employs advanced design features such as a passive system for the removal of residual heat and also the setting of all the components of the primary system inside the reactor pressure vessel. It is essential to develop new probabilistic safety assessment (PSA) validation guidance for SMART. For the purpose of regulatory verification to the risk level of SMART, the insights and key issues on the PSA are identified with referring some worldwide safety guides as well as its design characteristics. Regulatory PSA model under the development for the design confirmation and its preliminary result are also described. (authors)

  7. Carbon Capture and Storage (CCS): Risk assessment focused on marine bacteria.

    Science.gov (United States)

    Borrero-Santiago, A R; DelValls, T A; Riba, I

    2016-09-01

    Carbon capture and storage (CCS) is one of the options to mitigate the negative effects of the climate change. However, this strategy may have associated some risks such as CO2 leakages due to an escape from the reservoir. In this context, marine bacteria have been underestimated. In order to figure out the gaps and the lack of knowledge, this work summarizes different studies related to the potential effects on the marine bacteria associated with an acidification caused by a CO2 leak from CSS. An improved integrated model for risk assessment is suggested as a tool based on the rapid responses of bacterial community. Moreover, this contribution proposes a strategy for laboratory protocols using Pseudomona stanieri (CECT7202) as a case of study and analyzes the response of the strain under different CO2 conditions. Results showed significant differences (p≤0.05) under six diluted enriched medium and differences about the days in the exponential growth phase. Dilution 1:10 (Marine Broth 2216 with seawater) was selected as an appropriate growth medium for CO2 toxicity test in batch cultures. This work provide an essential and a complete tool to understand and develop a management strategy to improve future works related to possible effects produced by potential CO2 leaks. Copyright © 2016 Elsevier Inc. All rights reserved.

  8. An Integrated User Interface Style Guide for the ESF-CCS, RPS and CPCS display design

    International Nuclear Information System (INIS)

    Park, Jae Kyu; Lee, Hyun Chul; Hwang, Seong Hwan; Jang, Tong Il; Kang, Suk Ho; Lee, Jung Woon; Lee, Yong Hee

    2009-01-01

    The human machine interface (HMI) design process is important to enhance the safety and reliability of a Nuclear Power Plant (NPP) operation. Various MMI activities are achieved with progress of MMI and environment of NPP. These activities are impossible to utilize when upgrade of environment because most of these activities emphasize hardware aspect. Also, the human factors guidelines mostly describe the human factors principles so the designer has to adapt them to apply them to his design. The design-specific guideline that is specially dedicated to a unique system and derived from the general guidelines is called style guide. The style guide provides easy to use templates to help the user interface design, and these templates help ensure a consistent look and behavior throughout the design products. However, it could be difficult for a designer to select the human factors guideline items related to a target system and to derive a style guide from the items. This paper describes human factors activities carried out to develop a style guide for the ESF-CCS, RPS and CPCS system

  9. Bio Energy with CCS (BECCS). Large potential for BioSNG at low CO2 avoidance cost

    Energy Technology Data Exchange (ETDEWEB)

    Carbo, M.C.; Smit, R.; Van der Drift, A.; Jansen, D. [ECN Biomass, Coal and Environment, Petten (Netherlands)

    2010-12-15

    The introduction slide of this presentation states that Bio Energy with CCS (BECCS) is conversion of biomass to electricity/heat/fuels/ products combined with CO2 capture and storage. The conclusions are formulated as follows: Incremental cost for CO2 capture and storage is low; CO2 separation equipment implemented regardless of application CCS; Retrofit application of CCS is straightforward; CO2 avoidance costs for BioSNG are competitive with CCS in fossil fired power plants; Accounting for net CO2-uptake from atmosphere lowers avoidance costs and accelerates deployment; Scale-up of indirect gasification technology is needed.

  10. Cell therapy medicinal product regulatory framework in Europe and its application for MSC based therapy development

    Directory of Open Access Journals (Sweden)

    Janis eAncans

    2012-08-01

    Full Text Available Advanced therapy medicinal products (ATMPs, including cell therapy products, form a new class of medicines in the European Union. Since ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT has been established at European Medicines Agency (EMA for centralized classification, certification and evaluation procedures, and other ATMP related tasks. Guidance documents, initiatives and interaction platforms are available to make the new framework more accessible for small and medium-sized enterprises, academia, hospitals and foundations. Good understanding of centralised and national components of the regulatory system is required to plan product development. It is in the best interests of cell therapy developers to utilise provided resources starting with the preclinical stage. Whilst there have not been mesenchymal stem cell (MSC based medicine authorisations in the EU, three MSC products have received marketing approval in other regions since 2011. Information provided on regulatory requirements, procedures and initiatives is aimed to facilitate MSC based medicinal product development and authorisation in the EU.

  11. Self-regulatory dimension of teachers' intercultural competence: Development and psychometric evaluation of new scales

    Directory of Open Access Journals (Sweden)

    Zlatković Blagica

    2017-01-01

    Full Text Available Self-regulation is a key issue for teachers. Self-regulatory competencies help teachers maintain both their well-being and professional commitment. This is of particular importance when it comes to teaching in culturally diverse classrooms. However, this facet is generally neglected when Teacher Education supports pre- and inservice teachers in the development of their intercultural competencies. Against this background, the current paper deals with the development of three scales for the assessment of self-regulatory aspects of teachers' intercultural competence - the Teacher Cultural Diversity Flexibility Scale (TCDFS, the Teacher Cultural Diversity Emotional Regulation Scale (TCDERS, and the Teacher Cultural Diversity Tolerance for Ambiguity Scale (TCDTAS. Each scale was developed and validated in two forms: one referring to minority students in general, and one referring specifically to Roma students. The results indicate generally good reliabilities (αs from .74 to .91 and a unifactorial structure for each of the proposed scales. Both forms (general and the one for the Roma of the TCDFS and the TCDERS also demonstrated concurrent validity. An assessment based on these scales may better inform training interventions aiming to develop self-regulatory aspect of teachers' intercultural competence and to measure the outcomes and efficacy of such interventions. However, correlation analyses have also revealed some weaknesses of the TCDTAS. In the light of these results, further efforts should be directed at reanalysing the construct of self-regulation in dealing with diversity.

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

    International Nuclear Information System (INIS)

    Khatoon, Abida

    2002-01-01

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

  13. Regulatory Technology Development Plan Sodium Fast Reactor. Mechanistic Source Term Development

    Energy Technology Data Exchange (ETDEWEB)

    Grabaskas, David S. [Argonne National Lab. (ANL), Argonne, IL (United States); Brunett, Acacia Joann [Argonne National Lab. (ANL), Argonne, IL (United States); Bucknor, Matthew D. [Argonne National Lab. (ANL), Argonne, IL (United States); Sienicki, James J. [Argonne National Lab. (ANL), Argonne, IL (United States); Sofu, Tanju [Argonne National Lab. (ANL), Argonne, IL (United States)

    2015-02-28

    Construction and operation of a nuclear power installation in the U.S. requires licensing by the U.S. Nuclear Regulatory Commission (NRC). A vital part of this licensing process and integrated safety assessment entails the analysis of a source term (or source terms) that represents the release of radionuclides during normal operation and accident sequences. Historically, nuclear plant source term analyses have utilized deterministic, bounding assessments of the radionuclides released to the environment. Significant advancements in technical capabilities and the knowledge state have enabled the development of more realistic analyses such that a mechanistic source term (MST) assessment is now expected to be a requirement of advanced reactor licensing. This report focuses on the state of development of an MST for a sodium fast reactor (SFR), with the intent of aiding in the process of MST definition by qualitatively identifying and characterizing the major sources and transport processes of radionuclides. Due to common design characteristics among current U.S. SFR vendor designs, a metal-fuel, pool-type SFR has been selected as the reference design for this work, with all phenomenological discussions geared toward this specific reactor configuration. This works also aims to identify the key gaps and uncertainties in the current knowledge state that must be addressed for SFR MST development. It is anticipated that this knowledge state assessment can enable the coordination of technology and analysis tool development discussions such that any knowledge gaps may be addressed. Sources of radionuclides considered in this report include releases originating both in-vessel and ex-vessel, including in-core fuel, primary sodium and cover gas cleanup systems, and spent fuel movement and handling. Transport phenomena affecting various release groups are identified and qualitatively discussed, including fuel pin and primary coolant retention, and behavior in the cover gas and

  14. Regulatory activities and their research and development support in the CSSR

    International Nuclear Information System (INIS)

    Klik, F.; Kriz, Z.

    1977-01-01

    According to the existing laws the Czechoslovak Atomic Energy Commission (CSAEC) is authorized to regulate the Czechoslovak nuclear activities with respect to the nuclear safety, waste management and accountability and control of nuclear materials. Its activity with respect to nuclear safety consists mainly of: preparation of safety code of practices supplemented by safety guides for nuclear facilities, assessment of nuclear safety and issuing of binding opinion on nuclear safety for licensing of nuclear facilities, inspection of nuclear safety during construction and operation of nuclear facilities. The first part of the paper deals with the regulatory implementation. This covers the first stage specified by the construction and operation of research reactors only, the second stage specified by the design, construction, commissioning and operation of the first prototype nuclear power plant and the present stage specified by the construction and commissioning of a number of industrially developed nuclear power reactors. The present stage of regulatory implementation is described in detail. This covers the development of regulatory documentation such as safety code of practices and safety guides and the main safety requirements included in the existing safety code of practices for the siting, design and operation of nuclear power plants equipped with pressure water reactors. Then the general licensing procedures and organization including the structure and contents of safety documentation required for the licensing of siting, construction and operation of nuclear power plants is also described. The paper deals also with the inspection practices applied during construction, commissioning and operation of nuclear power plant in order to verify that the licensing conditions and requirements are fulfilled. The paper gives also some basic information about coordination of CSAEC nuclear safety regulatory activity with the regulatory activities of other governmental bodies

  15. Modularity of gene-regulatory networks revealed in sea-star development.

    Science.gov (United States)

    McDougall, Carmel; Degnan, Bernard M

    2011-01-31

    Evidence that conserved developmental gene-regulatory networks can change as a unit during deutersostome evolution emerges from a study published in BMC Biology. This shows that genes consistently expressed in anterior brain patterning in hemichordates and chordates are expressed in a similar spatial pattern in another deuterostome, an asteroid echinoderm (sea star), but in a completely different developmental context (the animal-vegetal axis). This observation has implications for hypotheses on the type of development present in the deuterostome common ancestor.

  16. TANK FARM REMEDIATION TECHNOLOGY DEVELOPMENT PROJECT AN EXERCISE IN TECHNICAL & REGULATORY COLLABORATION

    Energy Technology Data Exchange (ETDEWEB)

    JARAYSI, M.N.

    2007-01-08

    The Tank Farm Remediation Technology Development Project at the Hanford Site focuses on waste storage tanks, pipelines and associated ancillary equipment that are part of the C-200 single-shell tank (SST) farm system located in the C Tank Farm. The purpose of the project is to obtain information on the implementation of a variety of closure activities and to answer questions on technical, operational and regulatory issues associated with closure.

  17. TANK FARM REMEDIATION TECHNOLOGY DEVELOPMENT PROJECT AN EXERCISE IN TECHNICAL and REGULATORY COLLABORATION

    International Nuclear Information System (INIS)

    JARAYSI, M.N.

    2007-01-01

    The Tank Farm Remediation Technology Development Project at the Hanford Site focuses on waste storage tanks, pipelines and associated ancillary equipment that are part of the C-200 single-shell tank (SST) farm system located in the C Tank Farm. The purpose of the project is to obtain information on the implementation of a variety of closure activities and to answer questions on technical, operational and regulatory issues associated with closure

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

    International Nuclear Information System (INIS)

    1980-01-01

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

  19. Recent Status of Indonesian Nuclear Regulatory System Development in Responding the Results of IRRS Mission

    International Nuclear Information System (INIS)

    Pramono, Y.

    2016-01-01

    BAPETEN as Nuclear Energy Regulatory Agency of Indonesia faces challenges in performing its tasks for assuring the safety, security, and safeguards in nuclear energy utilization through the regulatory system. Based on the recent IRRS mission to Indonesia, hosted by BAPETEN, several recommendations and suggestions shall require special attention to provide strategic action plans in following them up. Some of the recommendations include the necessity of the Government to develop and document a national policy and strategy for safety, to provide BAPETEN with human and financial resources to ensure adequate discharge of its statutory regulatory obligations, to ensure that prime responsibility of safety is assigned to the person or organization responsible for a facility or an activity through the legal framework, to ensure appropriate coordination and liaison between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. The suggestions cover, among others, the need of having a graded approach policy in implementing all regulatory functions, clarifying the responsibility of the individual reporting on the performance of the management system to senior management, establishing procedures for assessing the safety and appropriateness of the working environment and enhancing the implementation of self-assessments by including safety culture aspects. As part of the action plans, BAPETEN is currently drafting the national policy and strategy on nuclear and radiation safety. Furthermore, BAPETEN is revising the existing act on nuclear energy in order to assign the prime responsibility of safety to be borne by the licensees, to ensure the adequacy of its human and financial resources, and to provide clearer distinction of responsibilities between BAPETEN and other relevant authorities in the areas of medical application of radiation and transport of radioactive material. To counter the issue on

  20. [Contact and dialogue between drug companies and the global regulatory authorities throughout research and development phase].

    Science.gov (United States)

    Kock, Marianne; Thomsen, Mads Krogsgaard

    2003-04-14

    Contact between pharmaceutical companies and local as well as global regulatory authorities (Ministry of Health) takes place throughout the development phase and especially when a clinical study is to be initiated. This contact is important both for the company and for the authorities, as both parties are constantly kept informed about the development progress and about the potential unexpected findings in connection with development of a new drug. The authority dialogue secures that authorities and companies exploit their resources optimally and patients get access to new, safe and efficacious drugs without delay.

  1. 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

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

    International Nuclear Information System (INIS)

    Arndt, S. A.

    2006-01-01

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

  3. An overview of the gene regulatory network controlling trichome development in the model plant, Arabidopsis

    Directory of Open Access Journals (Sweden)

    Sitakanta ePattanaik

    2014-06-01

    Full Text Available Trichomes are specialized epidermal cells located on aerial parts of plants and are associated with a wide array of biological processes. Trichomes protect plants from adverse conditions including UV light and herbivore attack and are also an important source of a number of phytochemicals. The simple unicellular trichomes of Arabidopsis serve as an excellent model to study molecular mechanism of cell differentiation and pattern formation in plants. The emerging picture suggests that the developmental process is controlled by a transcriptional network involving three major groups of transcription factors: the R2R3 MYB, basic helix-loop-helix (bHLH and WD40 repeat (WDR protein. These regulatory proteins form a trimeric activator complex that positively regulates trichome development. The single repeat R3 MYBs act as negative regulators of trichome development. They compete with the R2R3 MYBs to bind the bHLH factor and form a repressor complex. In addition to activator-repressor mechanism, a depletion mechanism may operate in parallel during trichome development. In this mechanism, the bHLH factor traps the WDR protein which results in depletion of WDR protein in neighboring cells. Consequently, the cells with high levels of bHLH and WDR proteins are developed into trichomes. A group of C2H2 zinc finger TFs has also been implicated in trichome development. Phytohormones, including gibberellins and jasmonic acid, play significant roles in this developmental process. Recently, microRNAs have been shown to be involved in trichome development. Furthermore, it has been demonstrated that the activities of the key regulatory proteins involved in trichome development are controlled by the 26S/ubiquitin proteasome system (UPS, highlighting the complexity of the regulatory network controlling this developmental process. To complement several excellent recent relevant reviews, this review focuses on the transcriptional network and hormonal interplay

  4. Logics and properties of a genetic regulatory program that drives embryonic muscle development in an echinoderm.

    Science.gov (United States)

    Andrikou, Carmen; Pai, Chih-Yu; Su, Yi-Hsien; Arnone, Maria Ina

    2015-07-28

    Evolutionary origin of muscle is a central question when discussing mesoderm evolution. Developmental mechanisms underlying somatic muscle development have mostly been studied in vertebrates and fly where multiple signals and hierarchic genetic regulatory cascades selectively specify myoblasts from a pool of naive mesodermal progenitors. However, due to the increased organismic complexity and distant phylogenetic position of the two systems, a general mechanistic understanding of myogenesis is still lacking. In this study, we propose a gene regulatory network (GRN) model that promotes myogenesis in the sea urchin embryo, an early branching deuterostome. A fibroblast growth factor signaling and four Forkhead transcription factors consist the central part of our model and appear to orchestrate the myogenic process. The topological properties of the network reveal dense gene interwiring and a multilevel transcriptional regulation of conserved and novel myogenic genes. Finally, the comparison of the myogenic network architecture among different animal groups highlights the evolutionary plasticity of developmental GRNs.

  5. Development of Regulatory Framework on Decommissioning of Nuclear Facilities in the Philippines

    Energy Technology Data Exchange (ETDEWEB)

    Piqueroa, Ronald E. [Korea Advanced Institue of Science and Technology, Daejeon (Korea, Republic of); Lee, Jung Joon; Ahn, Sangmyeon [Radioactive Waste Safety Evaluation Dept., Daejeon (Korea, Republic of)

    2013-10-15

    The PRR-1 was obtained through the bilateral agreement between the Philippines and USA on July 25, 1955. The operation started in 1963 at 1 MW and converted to TRIGA type and shutdown on 1988. In 2005, the Philippine Nuclear Research Institute (PNRI) formally decided to decommission the reactor by internally regulating the process under the Nuclear Regulatory Division of PNRI based on PNRI Office Order in 2005 and granted authorization to start decommissioning in 2007. However, there are only few specific regulations and guidelines related to decommissioning of nuclear facilities. PRR-1 was accepted as a model reactor for the IAEA Research Reactor Decommissioning Demonstration Project (R2D2P) and currently receiving support and assistance from IAEA for the completion and implementation of decommissioning plan. Comparing with the IAEA Safety Standards, key points which are not present should be incorporated in developing the current regulatory framework on decommissioning of nuclear facilities in the Philippines.

  6. Regulatory challenges for GM crops in developing economies: the African experience.

    Science.gov (United States)

    Nang'ayo, Francis; Simiyu-Wafukho, Stella; Oikeh, Sylvester O

    2014-12-01

    Globally, transgenic or genetically modified (GM) crops are considered regulated products that are subject to regulatory oversight during trans-boundary movement, testing and environmental release. In Africa, regulations for transgenic crops are based on the outcomes of the historic Earth Summit Conference held in Rio, Brazil two decades ago, namely, the adoption of the Convention on Biological Diversity (CBD) and the subsequent adoption of the Cartagena Protocol on Biosafety. To exploit the potential benefits of transgenic crops while safeguarding the potential risks on human health and environment, most African countries have signed and ratified the CBD and the Cartagena Protocol on Biosafety. Consequently, these countries are required to take appropriate legal, administrative and other measures to ensure that the handling and utilization of living modified organisms are undertaken in a manner that reduces the risks to humans and the environment. These countries are also expected to provide regulatory oversight on transgenic crops through functional national biosafety frameworks (NBFs). While in principle this approach is ideal, NBFs in most African countries are steeped in a host of policy, legal and operational challenges that appear to be at cross-purposes with the noble efforts of seeking to access, test and deliver promising GM crops for use by resource-limited farmers in Africa. In this paper we discuss the regulatory challenges faced during the development and commercialization of GM crops based on experiences from countries in Sub-Saharan Africa.

  7. Thermal starless ammonia core surrounded by CCS in the Orion a cloud

    Energy Technology Data Exchange (ETDEWEB)

    Tatematsu, Ken' ichi; Hirota, Tomoya; Umemoto, Tomofumi; Kandori, Ryo; Mizuno, Norikazu [National Astronomical Observatory of Japan, 2-21-1 Osawa, Mitaka, Tokyo 181-8588 (Japan); Ohashi, Satoshi [Department of Astronomy, The University of Tokyo, Bunkyo-ku, Tokyo 113-0033 (Japan); Choi, Minho; Kang, Miju [Korea Astronomy and Space Science Institute, Daedeokdaero 776, Yuseong, Daejeon 305-348 (Korea, Republic of); Lee, Jeong-Eun [School of Space Research, Kyung Hee University, Seocheon-Dong, Giheung-Gu, Yongin-Si, Gyeonggi-Do 446-701 (Korea, Republic of); Yamamoto, Satoshi, E-mail: k.tatematsu@nao.ac.jp, E-mail: tomoya.hirota@nao.ac.jp, E-mail: umemoto.tomofumi@nao.ac.jp, E-mail: r.kandori@nao.ac.jp, E-mail: norikazu.mizuno@nao.ac.jp, E-mail: satoshi.ohashi@nao.ac.jp, E-mail: minho@kasi.re.kr, E-mail: mjkang@kasi.re.kr, E-mail: jeongeun.lee@khu.ac.kr, E-mail: yamamoto@taurus.phys.s.u-tokyo.ac.jp [Department of Physics, The University of Tokyo, Bunkyo-ku, Tokyo 113-0033 (Japan)

    2014-07-01

    We imaged two starless molecular cloud cores, TUKH083 and TUKH122, in the Orion A giant molecular cloud in the CCS and NH{sub 3} emission with the Very Large Array. TUKH122 contains one NH{sub 3} core 'TUKH122-n', which is elongated and has a smooth oval boundary. Where observed, the CCS emission surrounds the NH{sub 3} core. This configuration resembles that of the N{sub 2}H{sup +} and CCS distribution in the Taurus starless core L1544, a well-studied example of a dense prestellar core exhibiting infall motions. The linewidth of TUKH122-n is narrow (0.20 km s{sup –1}) in the NH{sub 3} emission line and therefore dominated by thermal motions. The smooth oval shape of the core boundary and narrow linewidth in N{sub 2}H{sup +} seem to imply that TUKH122-n is dynamically relaxed and quiescent. TUKH122-n is similar to L1544 in the kinetic temperature (10 K), linear size (0.03 pc), and virial mass (∼2 M {sub ☉}). Our results strongly suggest that TUKH122-n is on the verge of star formation. TUKH122-n is embedded in the 0.2 pc massive (virial mass ∼30 M {sub ☉}) turbulent parent core, while the L1544 NH{sub 3} core is embedded in the 0.2 pc less-massive (virial mass ∼10 M {sub ☉}) thermal parent core. TUKH083 shows complicated distribution in NH{sub 3}, but was not detected in CCS. The CCS emission toward TUKH083 appears to be extended, and is resolved out in our interferometric observations.

  8. Development of a novel regulatory pharmacovigilance prioritisation system: an evaluation of its performance at the UK Medicines and Healthcare products Regulatory Agency.

    Science.gov (United States)

    Seabroke, Suzie; Wise, Lesley; Waller, Patrick

    2013-10-01

    The prioritisation of drug safety issues for further evaluation or regulatory action is critical to ensure that acceptable timelines and appropriate resource allocation are defined to meet public health and regulatory obligations. Our objective was to develop, pilot and implement a novel tool for prioritising pharmacovigilance issues within the Medicines and Healthcare products Regulatory Agency (MHRA). An initial system was developed empirically and then piloted over a 10-month period in the pharmacovigilance signal management meeting at the MHRA that discusses potential pharmacovigilance issues, and determines, through consensus, their priority and a timescale for action. The priority assigned by the tool was compared with the priority decided by collective judgement at the meeting. Once an acceptable level of concordance between the tool and the meeting had been achieved, the finalised tool was implemented into routine use at the MHRA, with an evaluation of its performance conducted after the first year. The Regulatory Pharmacovigilance Prioritisation System (RPPS) tool prioritises pharmacovigilance issues according to the following four broad categories, each with four inputs: strength of evidence, public health implications, agency regulatory obligations and public perceptions. A weighted scoring system links the inputs to a pre-defined number of points where if a threshold is reached then the points are awarded. The overall priority is determined by the sum of all points obtained from each of the inputs. The pilot study included a total of 73 pharmacovigilance issues during the 10-month study period, with an overall exact agreement between the RPPS priority and the collective judgement of the meeting of 60.3 %. Where exact agreement was not obtained, the RPPS generally prioritised the issues slightly higher than the meeting. Over the first year following implementation, the RPPS achieved an overall exact agreement of 82.2 %. Following the pilot study and

  9. Recovery Act: 'Carbonsheds' as a Framework for Optimizing United States Carbon Capture and Storage (CCS) Pipeline Transport on a Regional to National Scale

    Energy Technology Data Exchange (ETDEWEB)

    Pratson, Lincoln

    2012-11-30

    Carbonsheds are regions in which the estimated cost of transporting CO{sub 2} from any (plant) location in the region to the storage site it encompasses is cheaper than piping the CO{sub 2} to a storage site outside the region. We use carbonsheds to analyze the cost of transport and storage of CO{sub 2} in deploying CCS on land and offshore of the continental U.S. We find that onshore the average cost of transport and storage within carbonsheds is roughly $10/t when sources cooperate to reduce transport costs, with the costs increasing as storage options are depleted over time. Offshore transport and storage costs by comparison are found to be roughly twice as expensive but t may still be attractive because of easier access to property rights for sub-seafloor storage as well as a simpler regulatory system, and possibly lower MMV requirements, at least in the deep-ocean where pressures and temperatures would keep the CO{sub 2} negatively buoyant. Agent-based modeling of CCS deployment within carbonsheds under various policy scenarios suggests that the most cost-effective strategy at this point in time is to focus detailed geology characterization of storage potential on only the largest onshore reservoirs where the potential for mitigating emissions is greatest and the cost of storage appears that it will be among the cheapest.

  10. A potential Italian CCS site: site characterization and monitoring of Sulcis Basin (Sardinia).

    Science.gov (United States)

    Chiara Tartarello, Maria; Bigi, Sabina; Beaubien, Stanley Eugene; De Angelis, Davide; Graziani, Stefano; Lombardi, Salvatore; Sacco, Pietro; Ruggiero, Livio

    2017-04-01

    The Sulcis Basin is an area situated in SW Sardinia (Italy) and is a potential site for the implementation of CCS in Italy. In fact, in the last years many studies were conducted to characterize the area and to define the baseline. The "Miliolitico" has been identified as the potential reservoir and is composed by fractured carbonate, while the "Produttivo Fm.", a sequence of clay, coal and marl, is the caprock. Above the "Produttivo Fm." there is a thick volcanic sequence (more than 800 m) that could be considered also a secondary caprock. In the area of Matzaccara, the "Miliolitico" is below an alluvial plain and it is estimates that could reach a depth of more than 800 m. To characterize the reservoir-caprock system there were conducted an extensive structural-geological survey, and more in detail a fracture analysis on all the Formation at the outcrop. With regard to the faults, it has been examined their architecture, and in particular the conduit-barrier behaviors. Moreover, to evaluate the theoretical capacity of the potential reservoir, we built a Discrete Fracture Model, using the fracture data collected at outcrop. So, we estimate a secondary porosity of about 3%. As regards to the definition of geochemical baseline, it has been conducted both discontinuous and continuous monitoring of CO2 and other gases. More in details, there were carried out a regional and a detailed survey, measuring the concentration and the flux of CO2. in that manner, it has been possible to identify potential migration pathways along faults and to define the position of continuous monitoring station. We developed small, low-power consuming, low-cost pCO2 "GasPro", to measure the CO2 both in soil and water. In the next months, it is planned to extend the monitoring network and to inject a little quantity of CO2 along a fault in the Matzaccara plain.

  11. Regulatory scientific advice in drug development: does company size make a difference?

    Science.gov (United States)

    Putzeist, Michelle; Mantel-Teeuwisse, Aukje K; Gispen-De Wied, Christine C; Hoes, Arno W; Leufkens, Hubert G

    2011-02-01

    To assess whether the content of Scientific Advice (SA) questions addressed to a national drug regulatory agency is associated with company size. This may help to increase understanding about the knowledge, strategic, and regulatory gaps companies face during drug development. A cross-sectional analysis was performed of SA provided by the Dutch Medicines Evaluation Board (MEB) in 2006-2008. Definition of company size was based on ranking by total revenues (Scrip's Pharmaceutical Company League Tables 2008). The content of each SA question was scored according to predefined domains (quality, nonclinical, clinical, regulatory, and product information), their subdomains (e.g., efficacy), and a selection of additional content variables (e.g., endpoints, choice of active comparator). In total, 201 SA documents including 1,087 questions could be identified. Small, medium-sized, and large companies asked for SA 110 (54.7%), 40 (19.9%), and 51 (25.4%) times, respectively. Clinical questions were asked most often (65.9%), mainly including efficacy (33.2%) and safety questions (24.0%). The most frequent topics were overall efficacy and safety strategy. Small companies asked quality and nonclinical questions more often (P companies (P = 0.004). Small companies asked significantly more clinical questions about pharmacokinetics, including bioequivalence, than medium-sized and large companies (P < 0.001). The array of topics addressed in SA provides an interesting outlook on what industry considers to be still unresolved in drug development and worthwhile to discuss with regulators. Company size is associated with the content of SA questions. MEB advice accommodates both innovative and noninnovative drug development.

  12. The verification methodologies for a software modeling of Engineered Safety Features- Component Control System (ESF-CCS)

    International Nuclear Information System (INIS)

    Lee, Young-Jun; Cheon, Se-Woo; Cha, Kyung-Ho; Park, Gee-Yong; Kwon, Kee-Choon

    2007-01-01

    The safety of a software is not guaranteed through a simple testing of the software. The testing reviews only the static functions of a software. The behavior, dynamic state of a software is not reviewed by a software testing. The Ariane5 rocket accident and the failure of the Virtual Case File Project are determined by a software fault. Although this software was tested thoroughly, the potential errors existed internally. There are a lot of methods to solve these problems. One of the methods is a formal methodology. It describes the software requirements as a formal specification during a software life cycle and verifies a specified design. This paper suggests the methods which verify the design to be described as a formal specification. We adapt these methods to the software of a ESF-CCS (Engineered Safety Features-Component Control System) and use the SCADE (Safety Critical Application Development Environment) tool for adopting the suggested verification methods

  13. CO2 abatement in the iron and steel industry - the case for carbon capture and storage (CCS

    Directory of Open Access Journals (Sweden)

    A.V. Todorut

    2017-01-01

    Full Text Available The steel industry is amongst the most energy-intensive industries also consuming large amounts of coal and emitting significant volumes of carbon dioxide (CO2. Studies indicate that steelmaking accounts for 6 - 7 % of world anthropogenic CO2 emissions, and 27 % of the total emissions of the world’s manufacturing sector. Steel manufacturers have responded to sustainable resource use and development adopting several measures attaining a reduction in energy consumption of 60 % in the last 50 years. The paper discusses Carbon Capture and Storage (CCS as a CO2 mitigation option, after the 2015 Paris Climate Conference (COP 21 and in relation to the European Regulation for CO2 measurement, reporting and verification.

  14. Modularity of gene-regulatory networks revealed in sea-star development

    Directory of Open Access Journals (Sweden)

    Degnan Bernard M

    2011-01-01

    Full Text Available Abstract Evidence that conserved developmental gene-regulatory networks can change as a unit during deutersostome evolution emerges from a study published in BMC Biology. This shows that genes consistently expressed in anterior brain patterning in hemichordates and chordates are expressed in a similar spatial pattern in another deuterostome, an asteroid echinoderm (sea star, but in a completely different developmental context (the animal-vegetal axis. This observation has implications for hypotheses on the type of development present in the deuterostome common ancestor. See research article: http://www.biomedcentral.com/1741-7007/8/143/abstract

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

    International Nuclear Information System (INIS)

    Lee, C. J.; Park, J. Y.; Oh, K. M.

    2006-01-01

    In this study, the state-of-the art for estimating LERF is considered for the regulatory risk-informed decisions. The consideration is mainly focused on (1) the relationship between Level 2 PSA and LERF evaluation methodology, (2) the standard requirements in terms of modeling preparation and the acceptance criteria based on the application capability II of ASME PRA standard, and (3) some pending issues for developing and proposing a simplified LERF model. This study is preliminarily presented and will be updated for establishing detailed evaluation scheme of extended MPAS (multi-purpose probabilistic analysis of safety) model and preparing the technical basis

  16. An overview on development of safety culture of regulatory body in Korea

    International Nuclear Information System (INIS)

    Yoon, Myunghyun; Choi, Young Sung; Yi, Kyungjoo

    2015-01-01

    Fukushima accident revealed not only licensees but also regulatory bodies' (RBs) establishment of robust safety culture (SC) is crucial to implement effective safety regulation. Result of the IAEA IRRS held in 2011 required regulatory body in Korea to make improvement measure for the enhancement of safety culture of regulatory body (SCRB). Compared to works done to assess SC focused on working organizations of nuclear industry, not enough attention has been paid to assess the RBs. To achieve this goal, long-term comprehensive drive plan has to be made. The IAEA is putting great effort to establish and enhance SC in RBs. OECD/NEA CNRA is planning to produce Green Booklet on SCRB for regulatory guidance. SCRB is an organization's culture, RBs ultimately has to possess in order to assure secure use of nuclear energy. An organization's culture emerges from, and is manifested in, the interplay of its members' emotion, cognition, attitudes, behaviors and interaction patterns. As a result of this mechanism, organizational structures and culture influence individual's attitude and behavior when entered into a situation. Each organization has its strengths and weakness in SC. Safety culture defective components of the Fukushima accident was analyzed by JNES in 2012. According to the casual factors indicated in the investigation report, Nuclear Regulatory Organizations (NROs) of Korea also had weakness of the SCRB in terms of questioning attitude, continuous learning, issue identification and resolution and safety leadership. It doesn't have to be same but necessary for both NSSC and KINS to be consistent in building SC traits to carry out a coherent policy with synergy effect. NROs should communicated and convey consistent message to the stakeholders. Not limited to development of SCRB itself, influence of SCRB on licensee's SC is recommended for further study. Also, what behaviors are expected to make positive effects and whether they can

  17. An overview on development of safety culture of regulatory body in Korea

    Energy Technology Data Exchange (ETDEWEB)

    Yoon, Myunghyun; Choi, Young Sung; Yi, Kyungjoo [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2015-10-15

    Fukushima accident revealed not only licensees but also regulatory bodies' (RBs) establishment of robust safety culture (SC) is crucial to implement effective safety regulation. Result of the IAEA IRRS held in 2011 required regulatory body in Korea to make improvement measure for the enhancement of safety culture of regulatory body (SCRB). Compared to works done to assess SC focused on working organizations of nuclear industry, not enough attention has been paid to assess the RBs. To achieve this goal, long-term comprehensive drive plan has to be made. The IAEA is putting great effort to establish and enhance SC in RBs. OECD/NEA CNRA is planning to produce Green Booklet on SCRB for regulatory guidance. SCRB is an organization's culture, RBs ultimately has to possess in order to assure secure use of nuclear energy. An organization's culture emerges from, and is manifested in, the interplay of its members' emotion, cognition, attitudes, behaviors and interaction patterns. As a result of this mechanism, organizational structures and culture influence individual's attitude and behavior when entered into a situation. Each organization has its strengths and weakness in SC. Safety culture defective components of the Fukushima accident was analyzed by JNES in 2012. According to the casual factors indicated in the investigation report, Nuclear Regulatory Organizations (NROs) of Korea also had weakness of the SCRB in terms of questioning attitude, continuous learning, issue identification and resolution and safety leadership. It doesn't have to be same but necessary for both NSSC and KINS to be consistent in building SC traits to carry out a coherent policy with synergy effect. NROs should communicated and convey consistent message to the stakeholders. Not limited to development of SCRB itself, influence of SCRB on licensee's SC is recommended for further study. Also, what behaviors are expected to make positive effects and whether they can

  18. IL-2 and IL-15 dependent thymic development of Foxp3-expressing regulatory T lymphocytes.

    Science.gov (United States)

    Apert, Cécile; Romagnoli, Paola; van Meerwijk, Joost P M

    2018-04-01

    Immunosuppressive regulatory T lymphocytes (Treg) expressing the transcription factor Foxp3 play a vital role in the maintenance of tolerance of the immune-system to self and innocuous non-self. Most Treg that are critical for the maintenance of tolerance to self, develop as an independent T-cell lineage from common T cell precursors in the thymus. In this organ, their differentiation requires signals from the T cell receptor for antigen, from co-stimulatory molecules, as well as from cytokine-receptors. Here we focus on the cytokines implicated in thymic development of Treg, with a particular emphasis on the roles of interleukin-2 (IL-2) and IL-15. The more recently appreciated involvement of TGF-β in thymic Treg development is also briefly discussed. Finally, we discuss how cytokine-dependence of Treg development allows for temporal, quantitative, and potentially qualitative modulation of this process.

  19. Review of the Ikhil gas development and pipeline regulatory and environmental process : lessons learned

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2007-01-15

    This paper presented a case study of a gas development project in order to identify strengths and weaknesses in the environmental assessment process, permitting processes, and monitoring procedures related to Mackenzie Delta hydrocarbon developments. The Ikhil project is the sole oil and gas production and transportation facility situated within the Inuvialuit Settlement Region (ISR). The study involved interviews with members of the oil and gas industry, federal regulators and agencies, Inuvialuit agencies and organizations, and government agencies within the Northwest Territories (NT). Issues related to permitting requirements, regulatory approvals, assessment methodologies and environmental management plans were discussed. Results indicated that the majority of respondents approved of the regulatory process. However, respondents agreed that further guidelines are needed to assist project proponents in determining an approach for the collection and use of traditional knowledge and an understanding of cumulative effects. Other recommendations included clarifying the environmental review process for trans-boundary projects; the development of guidelines for the disposal of drilling wastes; and further refinement and clarifications of the roles of various agencies. 10 refs., 3 tabs., 1 fig.

  20. Clinical development and regulatory points for consideration for second-generation live attenuated dengue vaccines.

    Science.gov (United States)

    Vannice, Kirsten S; Wilder-Smith, Annelies; Barrett, Alan D T; Carrijo, Kalinka; Cavaleri, Marco; de Silva, Aravinda; Durbin, Anna P; Endy, Tim; Harris, Eva; Innis, Bruce L; Katzelnick, Leah C; Smith, Peter G; Sun, Wellington; Thomas, Stephen J; Hombach, Joachim

    2018-03-07

    Licensing and decisions on public health use of a vaccine rely on a robust clinical development program that permits a risk-benefit assessment of the product in the target population. Studies undertaken early in clinical development, as well as well-designed pivotal trials, allow for this robust characterization. In 2012, WHO published guidelines on the quality, safety and efficacy of live attenuated dengue tetravalent vaccines. Subsequently, efficacy and longer-term follow-up data have become available from two Phase 3 trials of a dengue vaccine, conducted in parallel, and the vaccine was licensed in December 2015. The findings and interpretation of the results from these trials released both before and after licensure have highlighted key complexities for tetravalent dengue vaccines, including concerns vaccination could increase the incidence of dengue disease in certain subpopulations. This report summarizes clinical and regulatory points for consideration that may guide vaccine developers on some aspects of trial design and facilitate regulatory review to enable broader public health recommendations for second-generation dengue vaccines. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. Ten years of biosimilars in Europe: development and evolution of the regulatory pathways

    Directory of Open Access Journals (Sweden)

    Schiestl M

    2017-05-01

    Full Text Available Martin Schiestl,1 Markus Zabransky,2 Fritz Sörgel3,4 1Sandoz GmbH, Kundl, Austria; 2Sandoz Biopharmaceuticals, Hexal AG, Holzkirchen, Germany; 3Institute for Biomedical and Pharmaceutical Research, Nürnberg-Heroldsberg, Germany; 4Institute of Pharmacology, Faculty of Medicine, University Duisburg-Essen, Essen, Germany Abstract: A biosimilar is defined by the European Medicines Agency as a biological medicine that is similar to another biological medicine that has already been authorized for use. A science-based regulatory framework to ensure high-quality biosimilars has been established in Europe since 2005 and is monitored and updated on an ongoing basis. The guiding principle of a biosimilar development program is to establish similarity between the biosimilar and the reference medicine by the best possible means, ensuring that the previously proven safety and efficacy of the reference medicinal product also applies to the biosimilar. Development of a biosimilar is underpinned by state-of-the-art analytical techniques to characterize both reference medicines and biosimilars. The extent and nature of the nonclinical in vivo studies and clinical studies to be performed depend on the level of evidence obtained in the previous step(s, including the robustness of the physicochemical, biological, and nonclinical in vitro data. Extrapolation is an important element of the biosimilarity concept. When biosimilar comparability has been demonstrated in one indication, extrapolation of the data package to other indications of the reference medicine could be acceptable, but needs to be scientifically justified and considered in light of the demonstrated level of sameness by all analytical, nonclinical, and clinical data. The credibility of the scientific basis behind the biosimilar concept, and quality of regulatory decision-making, is demonstrated by the successful approval and clinical use of 20 biosimilar medicines since 2006 when Omnitrope® was the

  2. Techno-economic analysis of integrated onshore and offshore UCG-CCS systems to produce electricity, SNG and urea

    Science.gov (United States)

    Nakaten, Natalie; Kapusta, Krzysztof; Burchart-Korol, Dorota; Kempka, Thomas

    2017-04-01

    profitable in view of the expected future development of natural gas prices. [1] Stanczyk, K., Howaniec, N., Smolinski, A., Swiadrowski, J., Kapusta, K., Wiatowski, M., Grabowski, J., Rogut, J. (2011): Gasification of lignite and hard coal with air and oxygen enriched air in a pilot scale ex-situ reactor for underground gasification. Fuel, 90, p. 1953-1962, doi:10.1016/j.fuel.2010.12.007. [2] Kempka, T., Schlüter, R., Hamann, J., Deowan, S., Azzam, R. (2011): Carbon dioxide utilisation for carbamide production by application of the coupled UCG-Urea process. Energy Procedia, 4, p. 2200-2205, doi.org/10.1016/j.egypro.2011.02.107. [3] Nakaten, N.C., Schlüter, R., Azzam, R. and Kempka, T. (2014): Development of a techno-economic model for dynamic calculation of COE, energy demand and CO2 emissions of an integrated UCG-CCS process. Energy, 66, p. 779-790, doi: 10.1016/j.energy.2014.01.014.

  3. Scientific and Regulatory Considerations in Solid Oral Modified Release Drug Product Development.

    Science.gov (United States)

    Li, Min; Sander, Sanna; Duan, John; Rosencrance, Susan; Miksinski, Sarah Pope; Yu, Lawrence; Seo, Paul; Rege, Bhagwant

    2016-11-01

    This review presents scientific and regulatory considerations for the development of solid oral modified release (MR) drug products. It includes a rationale for patient-focused development based on Quality-by-Design (QbD) principles. Product and process understanding of MR products includes identification and risk-based evaluation of critical material attributes (CMAs), critical process parameters (CPPs), and their impact on critical quality attributes (CQAs) that affect the clinical performance. The use of various biopharmaceutics tools that link the CQAs to a predictable and reproducible clinical performance for patient benefit is emphasized. Product and process understanding lead to a more comprehensive control strategy that can maintain product quality through the shelf life and the lifecycle of the drug product. The overall goal is to develop MR products that consistently meet the clinical objectives while mitigating the risks to patients by reducing the probability and increasing the detectability of CQA failures.

  4. Training related research and development conducted at Oak Ridge National Laboratory for the US Nuclear Regulatory Commission

    International Nuclear Information System (INIS)

    Haas, P.M.

    1985-01-01

    For a number of years Oak Ridge National Laboratory (ORNL) has conducted a sizeable program of human factors research and development in support of the Office of Nuclear Regulatory Research of the US Nuclear Regulatory Commission (NRC). The history of this effort has in many ways paralleled the growth of human factors R and D throughout the nuclear industry and the program has contributed to advances in the industry as well as to NRC regulatory and research programs. This paper reviews the major projects and products of the program relevant to training and concludes with an identification of future R and D needs

  5. CCS2, an Octatricopeptide-Repeat Protein, Is Required for Plastid Cytochrome c Assembly in the Green Alga Chlamydomonas reinhardtii

    Directory of Open Access Journals (Sweden)

    Sara G. Cline

    2017-08-01

    Full Text Available In bacteria and energy generating organelles, c-type cytochromes are a class of universal electron carriers with a heme cofactor covalently linked via one or two thioether bonds to a heme binding site. The covalent attachment of heme to apocytochromes is a catalyzed process, taking place via three evolutionarily distinct assembly pathways (Systems I, II, III. System II was discovered in the green alga Chlamydomonas reinhardtii through the genetic analysis of the ccs mutants (cytochrome csynthesis, which display a block in the apo- to holo- form conversion of cytochrome f and c6, the thylakoid lumen resident c-type cytochromes functioning in photosynthesis. Here we show that the gene corresponding to the CCS2 locus encodes a 1,719 amino acid polypeptide and identify the molecular lesions in the ccs2-1 to ccs2-5 alleles. The CCS2 protein displays seven degenerate amino acid repeats, which are variations of the octatricopeptide-repeat motif (OPR recently recognized in several nuclear-encoded proteins controlling the maturation, stability, or translation of chloroplast transcripts. A plastid site of action for CCS2 is inferred from the finding that GFP fused to the first 100 amino acids of the algal protein localizes to chloroplasts in Nicotiana benthamiana. We discuss the possible functions of CCS2 in the heme attachment reaction.

  6. Socio-economic impacts of future electricity generation scenarios in Europe : Potential costs and benefits of using CO2 Capture and Storage (CCS)

    NARCIS (Netherlands)

    Koelbl, B.S.; Wood, Richard; van den Broek, M.A.; Sanders, M.W.J.L.; Faaij, A.P.C.; van Vuuren, D.P.

    2015-01-01

    Carbon capture and storage (CCS) is a potential key-technology to mitigate greenhouse gas (GHG) emissions as its use can lead to lower mitigation cost. However, research on other economic impacts of using CCS is scarce. In this paper, we look into economic upstream impacts of CCS use in terms of

  7. EROI Analysis for Direct Coal Liquefaction without and with CCS: The Case of the Shenhua DCL Project in China

    Directory of Open Access Journals (Sweden)

    Zhaoyang Kong

    2015-01-01

    Full Text Available Currently, there are considerable discrepancies between China’s central government and some local governments in attitudes towards coal to liquids (CTL technology. Energy return on investment (EROI analysis of CTL could provide new insights that may help solve this dilemma. Unfortunately, there has been little research on this topic; this paper therefore analyses the EROI of China’s Shenhua Group Direct Coal Liquefaction (DCL project, currently the only DCL commercial project in the world. The inclusion or omission of internal energy and by-products is controversial. The results show that the EROIstnd without by-product and with internal energy is 0.68–0.81; the EROIstnd (the standard EROI without by-product and without internal energy is 3.70–5.53; the EROIstnd with by-product and with internal energy is 0.76–0.90; the EROIstnd with by-product and without internal energy is 4.13–6.14. Furthermore, it is necessary to consider carbon capture and storage (CCS as a means to control the CO2 emissions. Considering the added energy inputs of CCS at the plant level, the EROIs decrease to 0.65–0.77, 2.87–3.97, 0.72–0.85, and 3.20–4.40, respectively. The extremely low, even negative, net energy, which may be due to high investments in infrastructure and low conversion efficiency, suggests CTL is not a good choice to replace conventional energy sources, and thus, Chinese government should be prudent when developing it.

  8. Four essays on offshore wind power potential, development, regulatory framework, and integration

    Science.gov (United States)

    Dhanju, Amardeep

    Offshore wind power is an energy resource whose potential in the US has been recognized only recently. There is now growing interest among the coastal states to harness the resource, particularly in states adjacent to the Mid-Atlantic Bight where the shallow continental shelf allows installation of wind turbines using the existing foundation technology. But the promise of bountiful clean energy from offshore wind could be delayed or forestalled due to policy and regulatory challenges. This dissertation is an effort to identify and address some of the important challenges. Focusing on Delaware as a case study it calculates the extent of the wind resource; considers one means to facilitate resource development---the establishment of statewide and regional public power authorities; analyzes possible regulatory frameworks to manage the resource in state-controlled waters; and assesses the use of distributed storage to manage intermittent output from wind turbines. In order to cover a diversity of topics, this research uses a multi-paper format with four essays forming the body of work. The first essay lays out an accessible methodology to calculate offshore wind resource potential using publicly available data, and uses this methodology to access wind resources off Delaware. The assessment suggests a wind resource approximately four times the average electrical load in Delaware. The second essay examines the potential role of a power authority, a quasi-public institution, in lowering the cost of capital, reducing financial risk of developing and operating a wind farm, and enhancing regional collaboration on resource development and management issues. The analysis suggests that a power authority can lower the cost of offshore wind power by as much as 1/3, thereby preserving the ability to pursue cost-competitive development even if the current federal incentives are removed. The third essay addresses the existing regulatory void in state-controlled waters of Delaware

  9. Ecological models in support of regulatory risk assessments of pesticides: developing a strategy for the future.

    Science.gov (United States)

    Forbes, Valery E; Hommen, Udo; Thorbek, Pernille; Heimbach, Fred; Van den Brink, Paul J; Wogram, Jörn; Thulke, Hans-Hermann; Grimm, Volker

    2009-01-01

    This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract research organizations, and industry, representing Europe, the United States, and Asia, to discuss the role of ecological modeling in risk assessments of pesticides, particularly under the European regulatory framework. The following questions were addressed: What are the potential benefits of using ecological models in pesticide registration and risk assessment? What obstacles prevent ecological modeling from being used routinely in regulatory submissions? What actions are needed to overcome the identified obstacles? What recommendations should be made to ensure good modeling practice in this context? The workshop focused exclusively on population models, and discussion was focused on those categories of population models that link effects on individuals (e.g., survival, growth, reproduction, behavior) to effects on population dynamics. The workshop participants concluded that the overall benefits of ecological modeling are that it could bring more ecology into ecological risk assessment, and it could provide an excellent tool for exploring the importance of, and interactions among, ecological complexities. However, there are a number of challenges that need to be overcome before such models will receive wide acceptance for pesticide risk assessment, despite having been used extensively in other contexts (e.g., conservation biology). The need for guidance on Good Modeling Practice (on model development, analysis, interpretation, evaluation, documentation, and communication), as well as the need for case studies that can be used to explore the added value of ecological models for risk assessment, were identified as top priorities. Assessing recovery potential of exposed

  10. Regulatory and institutional issues for development of remedial action strategies at ORNL

    International Nuclear Information System (INIS)

    Kocher, D.C.

    1988-01-01

    This paper discusses a number of unresolved regulatory and institutional issues of fundamental importance to the development of strategies for cleanup of sites contaminated by the radioactive materials at Oak Ridge National Laboratory. These issues include the development of criteria for limiting radiation exposures of the public from remedial action sites, the time period to be assumed for active institutional controls over contaminated sites and the location at which such controls will be maintained, and the applicability of current standards for radioactivity in drinking water to surface waters and ground waters on the Oak Ridge Reservation. Proposals for resolution of these issues emphasize the need to protect public health, but in a cost-effective manner. 21 refs

  11. Weight Optimization for Distributed Average Consensus Algorithm in Symmetric, CCS & KCS Star Networks

    OpenAIRE

    Jafarizadeh, Saber; Jamalipour, Abbas

    2010-01-01

    This paper addresses weight optimization problem in distributed consensus averaging algorithm over networks with symmetric star topology. We have determined optimal weights and convergence rate of the network in terms of its topological parameters. In addition, two alternative topologies with more rapid convergence rates have been introduced. The new topologies are Complete-Cored Symmetric (CCS) star and K-Cored Symmetric (KCS) star topologies. It has been shown that the optimal weights for t...

  12. CCS on Offshore Oil and Gas Installation - Design of Post Combustion Capture System and Steam Cycle

    OpenAIRE

    Nord, Lars O.; Anantharaman, Rahul; Chikukwa, Actor; Mejdell, Thor

    2017-01-01

    Most of the released CO2 on offshore oil and gas installation originates from the gas turbines that power the installations. For certain offshore installations, CO2 capture and storage (CCS) could be an alternative to decrease the CO2 emissions. When opting for a chemical absorption CO2 capture system, a heat source for the stripper reboiler is needed. Since most offshore installations are powered by simple cycle GTs, there is typically no steam available that could be used for stripper reboi...

  13. The impact of parallel regulatory-health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations.

    Science.gov (United States)

    Tafuri, Giovanni; Lucas, Inês; Estevão, Steve; Moseley, Jane; d'Andon, Anne; Bruehl, Hannah; Gajraj, Elangovan; Garcia, Sonia; Hedberg, Niklas; Massari, Marco; Molina, Andrea; Obach, Mercè; Osipenko, Leeza; Petavy, Frank; Petschulies, Marco; Pontes, Caridad; Russo, Pierluigi; Schiel, Anja; Van de Casteele, Marc; Zebedin-Brandl, Eva-Maria; Rasi, Guido; Vamvakas, Spiros

    2018-01-25

    The parallel regulatory-health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought. Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint. In terms of uptake of comparator recommendations at the time of PSA in the actual development, our analysis showed that manufacturers implemented comparators to address both the needs of regulators and of at least one HTA body in 12 of 21 studies. For primary endpoints, in all included studies manufacturers addressed both the needs of the regulators and at least one HTA body. One of the key findings of this analysis is that manufacturers tend to implement changes to the development programme based on both regulatory and HTA advice with regards to the choice of primary endpoint and comparator. It also confirms the challenging choice of the study comparator, for which manufacturers seem to be more inclined to satisfy the regulatory advice. Continuous research efforts in this area are of paramount importance from a public health perspective. © 2018 The British Pharmacological Society.

  14. Coal and energy security for India: Role of carbon dioxide (CO2) capture and storage (CCS)

    International Nuclear Information System (INIS)

    Garg, Amit; Shukla, P.R.

    2009-01-01

    Coal is the abundant domestic energy resource in India and is projected to remain so in future under a business-as-usual scenario. Using domestic coal mitigates national energy security risks. However coal use exacerbates global climate change. Under a strict climate change regime, coal use is projected to decline in future. However this would increase imports of energy sources like natural gas (NG) and nuclear and consequent energy security risks for India. The paper shows that carbon dioxide (CO 2 ) capture and storage (CCS) can mitigate CO 2 emissions from coal-based large point source (LPS) clusters and therefore would play a key role in mitigating both energy security risks for India and global climate change risks. This paper estimates future CO 2 emission projections from LPS in India, identifies the potential CO 2 storage types at aggregate level and matches the two into the future using Asia-Pacific Integrated Model (AIM/Local model) with a Geographical Information System (GIS) interface. The paper argues that clustering LPS that are close to potential storage sites could provide reasonable economic opportunities for CCS in future if storage sites of different types are further explored and found to have adequate capacity. The paper also indicates possible LPS locations to utilize CCS opportunities economically in future, especially since India is projected to add over 220,000 MW of thermal power generation capacity by 2030.

  15. Reducing the energy penalty costs of postcombustion CCS systems with amine-storage.

    Science.gov (United States)

    Patiño-Echeverri, Dalia; Hoppock, David C

    2012-01-17

    Carbon capture and storage (CCS) can significantly reduce the amount of CO(2) emitted from coal-fired power plants but its operation significantly reduces the plant's net electrical output and decreases profits, especially during times of high electricity prices. An amine-based CCS system can be modified adding amine-storage to allow postponing 92% of all its energy consumption to times of lower electricity prices, and in this way has the potential to effectively reduce the cost of CO(2) capture by reducing the costs of the forgone electricity sales. However adding amine-storage to a CCS system implies a significant capital cost that will be outweighed by the price-arbitrage revenue only if the difference between low and high electricity prices is substantial. In this paper we find a threshold for the variability in electricity prices that make the benefits from electricity price arbitrage outweigh the capital costs of amine-storage. We then look at wholesale electricity markets in the Eastern Interconnect of the United States to determine profitability of amine-storage systems in this region. Using hourly electricity price data from years 2007 and 2008 we find that amine storage may be cost-effective in areas with high price variability.

  16. Carbon Sequestration and Carbon Capture and Storage (CCS) in Southeast Asia

    International Nuclear Information System (INIS)

    Muhd Nor, Nik Hisyamudin; Selamat, Siti Norhana; Abd Rashid, Muhammad Hanif; Ahmad, Mohd Fauzi; Jamian, Saifulnizan; Kiong, Sia Chee; Hassan, Mohd Fahrul; Mohamad, Fariza; Yokoyama, Seiji

    2016-01-01

    Southeast Asia is a standout amongst the most presented districts to unnatural weather change dangers even they are not principle worldwide carbon dioxide (CO 2 ) maker, its discharge will get to be significant if there is no move made. CO 2 wellsprings of Southeast Asia are mainly by fossil fuel through era of power and warmth generation, and also transportation part. The endeavors taken by these nations can be ordered into administrative and local level. This paper review the potential for carbon catch and capacity (CCS) as a part of the environmental change moderation system for the Malaysian power area utilizing an innovation appraisal structure. The country's recorded pattern of high dependence on fossil fuel for its power segment makes it a prime possibility for CCS reception. This issue leads to gradual increment of CO2 emission. It is evident from this evaluation that CCS can possibly assume a vital part in Malaysia's environmental change moderation methodology gave that key criteria are fulfilled. With the reason to pick up considerations from all gatherings into the earnestness of an Earth-wide temperature boost issue in Southeast Asia, assume that more efficient measures can be taken to effectively accomplish CO2 diminishment target. (paper)

  17. Final report for CCS cross-layer reliability visioning study

    Energy Technology Data Exchange (ETDEWEB)

    Quinn, Heather M [Los Alamos National Laboratory; Dehon, Andre [U. PENN; Carter, Nicj [INTEL

    2010-12-20

    solutions. For example, triple-modular redundancy masks errors by triplicating computations in either time or area. This mitigation methods imposes a 200% increase in energy consumption for every operation, not just the uncommon failure cases. At a time when computation is rapidly becoming part of our critical civilian and military infrastructure and decreasing costsfor computation are fueling our economy and our well being, we cannot afford increasingly unreliable electronics or a stagnation in capabilities per dollar, watt, or cubic meter. If researchers are able to develop techniques that tolerate the growing unpredictability of silicon devices, Moore's Law scaling should continue until at least 2022. During this 12-year time period, transistors, which are the building blocks of electronic devices, will scale their dimensions (feature sizes) from 45nm to 4.5nm.

  18. Development of neurodevelopmental disorders: a regulatory mechanism involving bromodomain-containing proteins

    Directory of Open Access Journals (Sweden)

    Li Junlin

    2013-02-01

    Full Text Available Abstract Neurodevelopmental disorders are classified as diseases that cause abnormal functions of the brain or central nervous system. Children with neurodevelopmental disorders show impaired language and speech abilities, learning and memory damage, and poor motor skills. However, we still know very little about the molecular etiology of these disorders. Recent evidence implicates the bromodomain-containing proteins (BCPs in the initiation and development of neurodevelopmental disorders. BCPs have a particular domain, the bromodomain (Brd, which was originally identified as specifically binding acetyl-lysine residues at the N-terminus of histone proteins in vitro and in vivo. Other domains of BCPs are responsible for binding partner proteins to form regulatory complexes. Once these complexes are assembled, BCPs alter chromosomal states and regulate gene expression. Some BCP complexes bind nucleosomes, are involved in basal transcription regulation, and influence the transcription of many genes. However, most BCPs are involved in targeting. For example, some BCPs function as a recruitment platform or scaffold through their Brds-binding targeting sites. Others are recruited to form a complex to bind the targeting sites of their partners. The regulation mediated by these proteins is especially critical during normal and abnormal development. Mutant BCPs or dysfunctional BCP-containing complexes are implicated in the initiation and development of neurodevelopmental disorders. However, the pathogenic molecular mechanisms are not fully understood. In this review, we focus on the roles of regulatory BCPs associated with neurodevelopmental disorders, including mental retardation, Fragile X syndrome (FRX, Williams syndrome (WS, Rett syndrome and Rubinstein-Taybi syndrome (RTS. A better understanding of the molecular pathogenesis, based upon the roles of BCPs, will lead to screening of targets for the treatment of neurodevelopmental disorders.

  19. Building a regulatory framework for geothermal energy development in the NWT

    Energy Technology Data Exchange (ETDEWEB)

    Holroyd, Peggy; Dagg, Jennifer [Pembina Institute (Canada)

    2011-03-15

    There is a high potential in Canada's Northwest Territories (NWT) for using geothermal energy, the thermal energy generated and stored in the Earth, and this could help the NWT meet their greenhouse gas emissions reduction targets. The Pembina Institute was engaged by the government of the NWT to perform a jurisdictional analysis of geothermal energy legislation and policy around the world; this report presents its findings. The jurisdictional review was carried out in 9 countries and interviews were conducted with various geothermal energy experts. Following this research, the Pembina Institute made recommendations to the NWT government on the development of a geothermal energy regulatory framework which would cover the need to define geothermal energy legislation and resource ownership as well as a plan and vision for geothermal energy use. This report highlighted that with an effective government policy in place, the use of geothermal energy in the NWT could provide the territories with a stable and secure energy supply.

  20. A Gene Regulatory Network Balances Neural and Mesoderm Specification during Vertebrate Trunk Development.

    Science.gov (United States)

    Gouti, Mina; Delile, Julien; Stamataki, Despina; Wymeersch, Filip J; Huang, Yali; Kleinjung, Jens; Wilson, Valerie; Briscoe, James

    2017-05-08

    Transcriptional networks, regulated by extracellular signals, control cell fate decisions and determine the size and composition of developing tissues. One example is the network controlling bipotent neuromesodermal progenitors (NMPs) that fuel embryo elongation by generating spinal cord and trunk mesoderm tissue. Here, we use single-cell transcriptomics to identify the molecular signature of NMPs and reverse engineer the mechanism that regulates their differentiation. Together with genetic perturbations, this reveals a transcriptional network that integrates opposing retinoic acid (RA) and Wnt signals to determine the rate at which cells enter and exit the NMP state. RA, produced by newly generated mesodermal cells, provides feedback that initiates NMP generation and induces neural differentiation, thereby coordinating the production of neural and mesodermal tissue. Together, the data define a regulatory network architecture that balances the generation of different cell types from bipotential progenitors in order to facilitate orderly axis elongation. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  1. ADMINISTRATIVE REGULATORY INSTRUMENTS OF SOCIO-ECONOMIC DEVELOPMENT OF SOLAR ENERGY IN UKRAINE

    Directory of Open Access Journals (Sweden)

    M. Rymkina

    2015-06-01

    Full Text Available The paper highlights the administrative regulatory instruments of socio-economic development of solar energy in Ukraine. This article considers that the current state of the energy market requires fundamental change. Analysis of international studies and publications indicates the balance between social, economic and environmental aspects that give rise to the development of alternative energy. Scientific originality of this article in a study of the dynamics of solar energy in Ukraine. International studies show that among the proposed renewable energy is the most environmentally friendly solar power. The practical significance of the study is to seek proposals for ensuring effective socio-economic development of enterprises in the industry for the future. For the implementation and development of the national energy strategy based on alternative energy in Ukraine has everything: raw materials, experience, technical and technological developments, training of highly qualified specialists in higher education. An important issue is the comprehensive state support, which will attract additional investment resources. As a result, at the macroeconomic level to mitigate the potential effects of the energy crisis.

  2. Uncoupling of complex regulatory patterning during evolution of larval development in echinoderms

    Directory of Open Access Journals (Sweden)

    Jennings Charlotte K

    2010-11-01

    Full Text Available Abstract Background Conservation of orthologous regulatory gene expression domains, especially along the neuroectodermal anterior-posterior axis, in animals as disparate as flies and vertebrates suggests that common patterning mechanisms have been conserved since the base of Bilateria. The homology of axial patterning is far less clear for the many marine animals that undergo a radical transformation in body plan during metamorphosis. The embryos of these animals are microscopic, feeding within the plankton until they metamorphose into their adult forms. Results We describe here the localization of 14 transcription factors within the ectoderm during early embryogenesis in Patiria miniata, a sea star with an indirectly developing planktonic bipinnaria larva. We find that the animal-vegetal axis of this very simple embryo is surprisingly well patterned. Furthermore, the patterning that we observe throughout the ectoderm generally corresponds to that of "head/anterior brain" patterning known for hemichordates and vertebrates, which share a common ancestor with the sea star. While we suggest here that aspects of head/anterior brain patterning are generally conserved, we show that another suite of genes involved in retinal determination is absent from the ectoderm of these echinoderms and instead operates within the mesoderm. Conclusions Our findings therefore extend, for the first time, evidence of a conserved axial pattering to echinoderm embryos exhibiting maximal indirect development. The dissociation of head/anterior brain patterning from "retinal specification" in echinoderm blastulae might reflect modular changes to a developmental gene regulatory network within the ectoderm that facilitates the evolution of these microscopic larvae.

  3. Recent developments in the Clean Water Act: Section 404 regulatory program

    Energy Technology Data Exchange (ETDEWEB)

    Kelsch, T. (EPA, Washington, DC (United States))

    1992-12-01

    Since the late 1970's and the 1980's, the Nation has become increasingly aware of the vital role wetlands play in providing habitat, protecting us from flooding and maintaining surface water quality. This public awakening came at the same time that the Fish and Wildlife Service's National Wetlands Inventory published reports indicating that less than one half of the wetlands that existed when the Europeans came to the US remain. The reports also indicated that the US was continuing to lose approximately 450,000 acres of our wetlands per year. Although recent data updating the status and trends of wetland losses for the 1980's indicate that the rate of loss has decreased, the Fish and Wildlife Service estimates indicate that approximately 290,000 acres of wetlands are still lost each year. Any loss in the natural functions provided by wetlands is not just felt in the environment; we simultaneously sustain, as a loss to our national economy, a decline in the income that could have been derived from the fisheries, recreation and other critical services performed by wetland systems. Clearly wetlands merit protection. However, in the US, where over 75 percent of our remaining wetlands are on private property, the protection of wetlands is often a difficult and sometimes contentious issue -- evoking debate about private property rights, economic development, the public interest in protecting wetland values, and the kind of world we wish to leave for future generations. Section 404 of the Clean Water Act establishes the primary Federal regulatory program providing protection for the Nation's remaining wetlands. The Section 404 permit program is recognized by both its supporters and critics as one of the strongest, yet often most contentious, Federal environmental protection programs. This presentation provides an overview of the Section 404 regulatory requirements and discusses some of the recent developments that have stirred considerable

  4. The Indonesia Carbon Capture Storage Capacity Building Program : CCS for Coal-fired Power Plants in Indonesia

    OpenAIRE

    World Bank

    2015-01-01

    In order to meet the growing Indonesian demand for electricity, while also constraining carbon dioxide (CO2) emissions, future coal power plants may have to include CO2 capture equipment with storage of that CO2. This study set out to define and evaluate the conditions under which fossil fuel power plants can be deemed as carbon capture and storage (CCS) ready (CCS-R). It considers the tec...

  5. A new equation of state for CCS pipeline transport: Calibration of mixing rules for binary mixtures of CO2 with N2, O2 and H2

    International Nuclear Information System (INIS)

    Demetriades, Thomas A.; Graham, Richard S.

    2016-01-01

    Highlights: • We develop a general framework for pressure-explicit equations of state for impure CO 2 . • For CCS modelling, we consider mixture data around the CO 2 critical point. • We generalise a pure CO 2 equation of state to mixtures with N 2 , O 2 and H 2 . • For N 2 and H 2 our model captures coexistence data more accurately than the GERG. - Abstract: One of the aspects currently holding back commercial scale deployment of carbon capture and storage (CCS) is an accurate understanding of the thermodynamic behaviour of carbon dioxide and relevant impurities during the pipeline transport stage. In this article we develop a general framework for deriving pressure-explicit EoS for impure CO 2 . This flexible framework facilitates ongoing development of custom EoS in response to new data and computational applications. We use our method to generalise a recent EoS for pure CO 2 (Demetriades et al., 2013) to binary mixtures with N 2 , O 2 and H 2 , obtaining model parameters by fitting to experiments made under conditions relevant to CCS-pipeline transport. Our model pertains to pressures up to 16 MPa and temperatures between 273 K and the critical temperature of pure CO 2 . In this region, we achieve close agreement with experimental data. When compared to the GERG EoS, our EoS has a comparable level of agreement with (CO 2 + N 2 ) VLE experiments and demonstrably superior agreement with the O 2 and H 2 VLE data. Finally, we discuss future options to improve the calibration of EoS and to deal with the sparsity of data for some impurities.

  6. Regulation – Do or Die: An Analysis of Factors Critical to New Product Development in a Regulatory Context

    Directory of Open Access Journals (Sweden)

    Clare O'Dwyer

    2017-04-01

    Full Text Available This study explores new product development in a strict regulatory and historically secretive environment. Adopting a systems perspective and a mixed methods approach in our research, we examine medical device development in Ireland. Findings indicate that the possession of a regulatory strategy expedites the rate of commercialization, so too does the generation of clear product definitions and marketing claims in the earliest developmental phases. Moreover, results suggest that if the regulated industry strengthens its culture for regulation by prioritizing regulation over speed to market, by encouraging cross-functional team collaborations, and by taking a more proactive approach in post-marketing surveillance activities, it has the potential to improve customer satisfaction and enhance product innovation. This study provides unique empirical data enriched by the homogeneity of its sample. It also contributes guidance to practitioners of new product development within a regulatory context.

  7. The Integration of Cognition and Emotion during Infancy and Early Childhood: Regulatory Processes Associated with the Development of Working Memory

    Science.gov (United States)

    Wolfe, Christy D.; Bell, Martha Ann

    2007-01-01

    This study was an attempt to integrate cognitive development (i.e., cognitive control) and emotional development (i.e., emotion regulation) in the first years of life. The construct of temperament was used to unify cognition and emotion because of its focus on attentional and regulatory behaviors. Children were seen at 8 months and 4 1/2-years of…

  8. Development of Regulatory Technical Requirements for the Advanced Integral Type Research Reactor

    International Nuclear Information System (INIS)

    Jo, Jong Chull; Yune, Young Gill; Kim, Woong Sik; Kim, Hho Jung

    2004-01-01

    This paper presents the current status of the study on the development of regulatory technical requirements for the licensing review of an advanced integral type research reactor of which the license application is expected in a few years. According to the Atomic Energy Act of Korea, both research and education reactors are subject to the technical requirements for power reactors in the licensing review. But, some of the requirements may not be applicable or insufficient for the licensing reviews of reactors with unique design features. Thus it is necessary to identify which review topics or areas can not be addressed by the existing requirements and to develop the required ones newly or supplement appropriately. Through the study performed so far, it has been identified that the following requirements need to be developed newly for the licensing review of SMART-P: the use of proven technology, the interfacial facility, the non-safety systems, and the metallic fuels. The approach and basis for the development of each of the requirements are discussed. (authors)

  9. Analyzing policy support instruments and regulatory risk factors for wind energy deployment-A developers' perspective

    International Nuclear Information System (INIS)

    Luethi, Sonja; Praessler, Thomas

    2011-01-01

    A transition to a renewable energy system is high on the policy agenda in many countries. A promising energy source for a low-carbon energy future is wind. Policy-makers can attract wind energy development by providing attractive policy frameworks. This paper argues that apart from the level of financial support, both the risks stemming from the regulatory environment (legal security, administrative process and grid access) and the ability to finance projects play a critical role in determining the attractiveness of the development environment. It sheds light on how project developers trade off these different aspects and to what extent the attractiveness of a certain policy framework increases with the introduction of specific measures. Conjoint analysis is employed to provide empirical evidence on the preference of wind energy developers in the EU and the US. The analysis shows that developers' preferences are very similar across the studied regions and for different types of developers. Which policy measures could be most valuable depends on the specific existing environment. In some southeastern European countries, a reduction of administrative process duration may yield the highest utility gains, whereas, in the US, improvements in grid access regulation and an increase in remuneration levels may be more effective. - Highlights: → Paper suggests conjoint analysis as scenario tool for estimating potential effects of specific policy measures. → It provides a quantitative, empirical dataset of 119 onshore wind energy developers' preferences. → Results suggest that the aspects 'Legal security' and 'Remuneration' are important attributes. → Cluster analyses yields slightly different preferences for developers from EU and US.

  10. Appreciating diversity: Regulatory reform and banking practices in the developed and developing worlds

    Directory of Open Access Journals (Sweden)

    Jayati Ghosh

    2012-12-01

    Full Text Available The homogenisation of finance that has dramatically increased the proclivity to instability and crisis is directly related to the very structure of regulations that have discouraged different types of institutions from emerging and/or and surviving. In developing countries they have the further limitation of preventing the necessary variation of financial institutions that is required for financing development and enlarging the spread of and access to institutional finance. The rules that apply to commercial banks or investment banks cannot and should not be applied to development banks, savings banks or co-operative banks. Diversity in the financial system can and should be encouraged at several levels and through several means.

  11. HAND2 Target Gene Regulatory Networks Control Atrioventricular Canal and Cardiac Valve Development.

    Science.gov (United States)

    Laurent, Frédéric; Girdziusaite, Ausra; Gamart, Julie; Barozzi, Iros; Osterwalder, Marco; Akiyama, Jennifer A; Lincoln, Joy; Lopez-Rios, Javier; Visel, Axel; Zuniga, Aimée; Zeller, Rolf

    2017-05-23

    The HAND2 transcriptional regulator controls cardiac development, and we uncover additional essential functions in the endothelial to mesenchymal transition (EMT) underlying cardiac cushion development in the atrioventricular canal (AVC). In Hand2-deficient mouse embryos, the EMT underlying AVC cardiac cushion formation is disrupted, and we combined ChIP-seq of embryonic hearts with transcriptome analysis of wild-type and mutants AVCs to identify the functionally relevant HAND2 target genes. The HAND2 target gene regulatory network (GRN) includes most genes with known functions in EMT processes and AVC cardiac cushion formation. One of these is Snai1, an EMT master regulator whose expression is lost from Hand2-deficient AVCs. Re-expression of Snai1 in mutant AVC explants partially restores this EMT and mesenchymal cell migration. Furthermore, the HAND2-interacting enhancers in the Snai1 genomic landscape are active in embryonic hearts and other Snai1-expressing tissues. These results show that HAND2 directly regulates the molecular cascades initiating AVC cardiac valve development. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  12. 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)

  13. Communicating CCS. Effects of text-only and text-and-visual depictions of CO2 storage on risk perceptions and attitudes

    Energy Technology Data Exchange (ETDEWEB)

    Brunsting, S.; De Best-Waldhober, M.; Brouwer, A.S. [ECN Policy Studies, Amsterdam (Netherlands); Riesch, H.; Reiner, D. [Cambridge University, Cambridge (United Kingdom)

    2013-05-01

    This experiment aims to increase understanding of the conditions under which combining textual and visual information on CO2 storage fosters comprehension of the technology. Specifically, it is investigated if and how precision in indicating the depth of CO2 injection in either text, visual, or combinations thereof influence estimates of CO2 injection depth and how this in turn influences perceived safety of and attitude towards CO2 injection. We used a 3x3 experimental design with two factors, resulting in 9 conditions: Textual description of depth of injection (absent, ambiguous, precise) X visualization of depth (absent, ambiguous, precise). Three texts were developed explaining the background and process of CCS. They were similar in every respect except for the accuracy of indication of depth: Absent ( 'underground'); Ambiguous ('deep underground'); Precise ('1,000 meters or deeper underground'). Three visual conditions were developed displaying the depth of CO2 injection. They were similar in every respect except for the accuracy of indication of depth: Absent (no visual displayed); Ambiguous (visual not to scale, injection obviously too shallow); Precise (visual to scale). Respondents were a representative sample of the adult UK population (n = 429). Each of them received one of the nine conditions, followed by a short questionnaire. Results indicate that estimates of depth are generally most accurate in text-only conditions and least accurate in visual-only conditions. Interestingly, the condition in which people are given no information about depth at all scores in-between with a mean estimate of 869 meters. Regarding textual depictions of CO2 injection depth, results indicate that the more precise indication of depth in the text the better respondents' estimate of depth, but this effect is only found for respondents who enjoy reading text. Regarding visual depictions of CO2 injection, results indicate that the presence of a visual worsens respondents

  14. Interpretaion of synthetic seismic time-lapse monitoring data for Korea CCS project based on the acoustic-elastic coupled inversion

    Science.gov (United States)

    Oh, J.; Min, D.; Kim, W.; Huh, C.; Kang, S.

    2012-12-01

    Recently, the CCS (Carbon Capture and Storage) is one of the promising methods to reduce the CO2 emission. To evaluate the success of the CCS project, various geophysical monitoring techniques have been applied. Among them, the time-lapse seismic monitoring is one of the effective methods to investigate the migration of CO2 plume. To monitor the injected CO2 plume accurately, it is needed to interpret seismic monitoring data using not only the imaging technique but also the full waveform inversion, because subsurface material properties can be estimated through the inversion. However, previous works for interpreting seismic monitoring data are mainly based on the imaging technique. In this study, we perform the frequency-domain full waveform inversion for synthetic data obtained by the acoustic-elastic coupled modeling for the geological model made after Ulleung Basin, which is one of the CO2 storage prospects in Korea. We suppose the injection layer is located in fault-related anticlines in the Dolgorae Deformed Belt and, for more realistic situation, we contaminate the synthetic monitoring data with random noise and outliers. We perform the time-lapse full waveform inversion in two scenarios. One scenario is that the injected CO2 plume migrates within the injection layer and is stably captured. The other scenario is that the injected CO2 plume leaks through the weak part of the cap rock. Using the inverted P- and S-wave velocities and Poisson's ratio, we were able to detect the migration of the injected CO2 plume. Acknowledgment This work was financially supported by the Brain Korea 21 project of Energy Systems Engineering, the "Development of Technology for CO2 Marine Geological Storage" program funded by the Ministry of Land, Transport and Maritime Affairs (MLTM) of Korea and the Korea CCS R&D Center (KCRC) grant funded by the Korea government (Ministry of Education, Science and Technology) (No. 2012-0008926).

  15. Dual-track CCS stakeholder engagement: Lessons learned from FutureGen in Illinois

    Science.gov (United States)

    Hund, G.; Greenberg, S.E.

    2011-01-01

    FutureGen, as originally planned, was to be the world's first coal-fueled, near-zero emissions power plant with fully integrated, 90% carbon capture and storage (CCS). From conception through siting and design, it enjoyed strong support from multiple stakeholder groups, which benefited the overall project. Understanding the stakeholder engagement process for this project provides valuable insights into the design of stakeholder programs for future CCS projects. FutureGen is one of few projects worldwide that used open competition for siting both the power plant and storage reservoir. Most site proposals were coordinated by State governments. It was unique in this and other respects relative to the site selection method used on other DOE-supported projects. At the time of site selection, FutureGen was the largest proposed facility designed to combine an integrated gasification combined cycle (IGCC) coal-fueled power plant with a CCS system. Stakeholder engagement by states and the industry consortium responsible for siting, designing, building, and operating the facility took place simultaneously and on parallel tracks. On one track were states spearheading state-wide site assessments to identify candidate sites that they wanted to propose for consideration. On the other track was a public-private partnership between an industry consortium of thirteen coal companies and electric utilities that comprised the FutureGen Alliance (Alliance) and the U.S. Department of Energy (DOE). The partnership was based on a cooperative agreement signed by both parties, which assigned the lead for siting to the Alliance. This paper describes the stakeholder engagement strategies used on both of these tracks and provides examples from the engagement process using the Illinois semi-finalist sites. ?? 2011 Published by Elsevier Ltd.

  16. Impact of a Fragmented Regulatory Environment on Sustainable Urban Development Design Management

    Directory of Open Access Journals (Sweden)

    Kerry Anne London

    2009-12-01

    Full Text Available The building project development approval process is increasingly complex and fraught with conflict due to the rise of the sustainable urban development movement and inclusive decision making. Coupled with this, government decision-making decentralization has resulted in a fragmented and over-regulated compliance system. Problems arising from the process include wasted resources, excessive time delays, increased holding and litigation costs, inadequate planning coordination, high levels of advocacy costs and a divisive politicized approval process. In Australia, despite attempts by government and industry associations, numerous problems are still unresolved. Design managers increasingly assume a liaison role during the approval phase. There is a long tradition of planning theory literature which provides context for understanding the knowledge-power-participation relationship for this paper. This study investigated the policy, process and practice conflicts during the approval stage in achieving sustainable urban developments. Three regional local government areas within one state jurisdiction and observations from detailed structured focus group interviews involving 23 stakeholders, proposers and assessors were analysed to explore this conflictual environment. As a result of regulatory fragmentation and excessive consultation, various persuasion tactics have been developed by all stakeholders of which `reciprocity' and `authority' were identified as the most common. Two challenges for design managers were thus identified: first, the emergence of the role of a by default central informal arbitrator across conflicting planning instruments; and, second, as a navigator through a set of persuasion tactics. An inclusive knowledge-based design management framework for sustainable urban development is proposed considering Habermas' communicative planning theory, Foucaltian governance and discursive powers thesis and Cialdini's persuasion theory, as

  17. Functional Development of the Human Gastrointestinal Tract: Hormone- and Growth Factor-Mediated Regulatory Mechanisms

    Directory of Open Access Journals (Sweden)

    Daniel Ménard

    2004-01-01

    Full Text Available The present review focuses on the control of gastrointestinal (GI tract development. The first section addresses the differences in general mechanisms of GI development in humans versus rodents, highlighting that morphogenesis of specific digestive organs and the differentiation of digestive epithelia occur not only at different stages of ontogeny but also at different rates. The second section provides an overview of studies from the author's laboratory at the Université de Sherbrooke pertaining to the development of the human fetal small intestine and colon. While both segments share similar morphological and functional characteristics, they are nevertheless modulated by distinct regulatory mechanisms. Using the organ culture approach, the author and colleagues were able to establish that hormones and growth factors, such as glucocorticoids, epidermal growth factor, insulin and keratinocyte growth factor, not only exert differential effects within these two segments, they can also trigger opposite responses in comparison with animal models. In the third section, emphasis is placed on the functional development of human fetal stomach and its various epithelial cell types; in particular, the glandular chief cells responsible for the synthesis and secretion of gastric enzymes such as pepsinogen-5 and gastric lipase. Bearing in mind that limitations of available cell models have, until now, greatly impeded the comprehension of molecular mechanisms regulating human gastric epithelial cell functions, the last section focuses on new human gastric epithelial cell models recently developed in the author's laboratory. These models comprise a novel primary culture system of human fetal gastric epithelium including, for the first time, functional chief cells, and human gastric epithelium cell lines cloned from the parental NCI-N87 strain. These new cells lines could serve important applications in the study of pathogenic action and epithelial

  18. [Regulatory science research to facilitate the development of cell/tissue-processed products].

    Science.gov (United States)

    Sato, Yoji; Tsutsumi, Hideki; Sawada, Rumi; Suzuki, Takayoshi; Yasuda, Satoshi

    2013-01-01

    Regenerative medicine is regarded as innovative therapy for severe diseases and damages caused by tissue loss and functional impairment. In Japan, regenerative medicine is one of the most important subjects issued by Council for Science and Technology Policy and also referred to in Medical Innovation of New Growth Strategy. Cell/tissue-processed products are living cells, which have been manipulated or processed for the purpose of regenerative medicine, and are extensively developing. Human somatic cells, somatic stem cells, embryonic stem cells, and induced pluripotent stem cells are cell sources used for regenerative medicine. Since we lack in experiences with cell/tissue-processed products, technical development of safety and quality assessment is urgently needed. National Institute of Health Sciences has carried out a mission of Regulatory Science and worked on safety assessment of pharmaceuticals and medical devices and their guideline development. The objective of our study is to develop safety and quality assessment methods for cell/tissue-processed products derived from stem cells, based on recent progresses in life science. We are currently developing methods to evaluate products as follows; a) useful and quantitative tumorigenicity tests to detect contamination of undifferentiated and/or abnormal cells in products, b) quality assessment by gene expression analysis and detection of genetic stability in a manufacturing process, and c) analysis of quality attributes associated with propensity of undifferentiated cells to set acceptable criteria of cell banks. We will be able to provide indicators to control the quality, efficacy and safety of stem cell-processed products and support efficient and economical promotion of the products. Especially, this study would help translate stem cell science into therapeutic products to patients with severe and life-threatening diseases, consequently contributing to administrative policy of Ministry of Health, Labor and

  19. Unraveling multifaceted contributions of small regulatory RNAs to photomorphogenic development in Arabidopsis.

    Science.gov (United States)

    Lin, Meng-Chun; Tsai, Huang-Lung; Lim, Sim-Lin; Jeng, Shih-Tong; Wu, Shu-Hsing

    2017-07-24

    Post-transcriptional control of gene expression mediated by small regulatory RNAs (sRNAs) is vital for growth and development of diverse organisms. The biogenesis of sRNAs is regulated by both positive and negative regulators known to regulate photomorphogenic development. Two microRNAs (miRNAs), miR157 and miR319, also regulate photomorphogenesis. However, genome-wide profiling of sRNAs and their regulation of target genes during photomorphogenesis has been missing. We provide a comprehensive view of sRNA-controlled gene expression in this developmental process. By profiling sRNAs and the 5' ends of degraded mRNAs during the first 24 h of photomorphogenic development in Arabidopsis, we identified 335 sRNA-mediated mRNA cleavage events in de-etiolating seedlings. These cleavage events are primarily resulted from actions of highly expressed miRNAs and irrelevant to the abundance of target mRNAs. In the light, the expression of the slicer protein gene ARGONAUTE1 in the miRNA functioning pathway could be fine-tuned by miRNA168a/b. We also found that miR396a/b positively regulates de-etiolation by suppressing GROWTH REGULATING FACTORs. Our results suggest that the miRNAs are required to tune down the target mRNAs and regulate photomorphogenesis. sRNAs may have a broad impact on gene expression regulation for optimized photomorphogenic development. With both positive and negative regulators under the control of sRNAs, young Arabidopsis seedlings can have a timely but not exaggerated developmental adaptation to light.

  20. U.S. Department of Energy & Nuclear Regulatory Commission Advanced Fuel Cycle Research & Development Seminar Series FY 2007 & 2008

    Energy Technology Data Exchange (ETDEWEB)

    Grandy, Christopher [Argonne National Lab. (ANL), Argonne, IL (United States)

    2008-08-01

    In fiscal year 2007, the Advanced Burner Reactor project initiated an educational seminar series for the Department of Energy (DOE) and Nuclear Regulatory Commission (NRC) personnel on various aspects of fast reactor fuel cycle closure technologies. This important work was initiated to inform DOE and NRC personnel on initial details of sodium-cooled fast reactor, separations, waste form, and safeguard technologies being considered for the Advanced Fuel Cycle Research and Development program, and to learn the important lesson from the licensing process for the Clinch River Breeder Reactor Plant that educating the NRC staff early in the regulatory process is very important and critical to a project success.

  1. The wider use of fixed-dose combinations emphasizes the need for a global approach to regulatory guideline development

    DEFF Research Database (Denmark)

    Gautam, Yvonne; Bjerrum, Ole Jannik; Schmiegelow, Merete

    2015-01-01

    in the EU and US. A review of the FDC guidelines set forth by the EMA, FDA, and ICH, followed by interviews of key informants in industry, identified 5 main industry concerns related to development of FDCs. These concerns were presented to key informants from both the EU and US regulatory authorities...

  2. Impact of the Serbian Banking Regulatory Framework Development on the Economic Growth of Serbia

    Directory of Open Access Journals (Sweden)

    Nenad Milojević

    2013-04-01

    Full Text Available The dynamic relationship between the banking regulatory framework and Basel capital standards, on the one side and economic growth and other macroeconomic indicators on the other side, attracts international academic and business circles for many years. Perceived from the Serbian perspective, the impact of the banking regulation development, or the Basel standards application, on economic growth is one of the most actual issues, especially since Serbia starting from December 31st 2011, began the Basel II application. The fact that the National Bank of Serbia and the Serbian commercial banks, gradually directed attention to more actual Basel III standard, further increasing the importance of the topic that this paper will be addressed. Quantitative and qualitative analyzes that were performed during the research presented in this paper indicate a significant potential for further positive effects, including economic growth, due to the implementation of Basel standards in Serbia. Positive results of application largely depend on adequate preparation, analysis and actions of all relevant parties in Basel standards implementation.

  3. [Future Regulatory Science through a Global Product Development Strategy to Overcome the Device Lag].

    Science.gov (United States)

    Tsuchii, Isao

    2016-01-01

    Environment that created "medical device lag (MDL)" has changed dramatically, and currently that term is not heard often. This was mainly achieved through the leadership of three groups: government, which determined to overcome MDL and took steps to do so; medical societies, which exhibited accountability in trial participation; and MD companies, which underwent a change in mindset that allowed comprehensive tripartite cooperation to reach the current stage. In particular, the global product development strategy (GPDS) of companies in a changing social environment has taken a new-turn with international harmonization trends, like Global Harmonization Task Force and International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. As a result, this evolution has created opportunities for treatment with cutting-edge MDs in Japanese society. Simultaneously, it has had a major impact on the planning process of GPDS of companies. At the same time, the interest of global companies has shifted to emerging economies for future potential profit since Japan no longer faces MDL issue. This economic trend makes MDLs a greater problem for manufacturers. From the regulatory science viewpoint, this new environment has not made it easy to plan a global strategy that will be adaptable to local societies. Without taking hasty action, flexible thinking from the global point of view is necessary to enable the adjustment of local strategies to fit the situation on the ground so that the innovative Japanese medical technology can be exported to a broad range of societies.

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

    International Nuclear Information System (INIS)

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

    1987-01-01

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

  5. Effects of regulatory reforms in the electricity supply industry on electricity prices in developing countries

    International Nuclear Information System (INIS)

    Nagayama, Hiroaki

    2007-01-01

    Electric power sector reforms in the electricity supply industry have had an impact on industrial and household prices in developing countries in Latin America, the former Soviet Union, and Eastern Europe. Using original panel data for 83 countries during the period from 1985 to 2002, we examine how each policy instrument of the reform measures influenced electricity prices for countries in the above regions. We found that variables such as entry of independent power producers (IPP), unbundling of generation and transmission, establishment of a regulatory agency, and the introduction of a wholesale spot market have had a variety of impacts on electricity prices, some of which were not always consistent with expected results. The research findings suggest that neither unbundling nor introduction of a wholesale pool market on their own necessarily reduces the electric power price. In fact, contrary to expectations, there was a tendency for the price to rise. However, coexistent with an independent regulator, unbundling may work to reduce electricity prices. Privatization and the introduction of foreign IPP and retail competition lower electricity prices in some regions, but not all

  6. Recovery Act: Understanding the Impact of CO2 Injection on the Subsurface Microbial Community in an Illinois Basin CCS Reservoir: Integrated Student Training in Geoscience and Geomicrobiology

    Energy Technology Data Exchange (ETDEWEB)

    Fouke, Bruce [Univ. of Illinois, Champaign, IL (United States)

    2013-03-31

    An integrated research and teaching program was developed to provide cross--disciplinary training opportunities in the emerging field of carbon capture and storage (CCS) for geobiology students attending the University of Illinois Urbana-­Champaign (UIUC). Students from across the UIUC campus participated, including those from the departments of Geology, Microbiology, Biochemistry, Civil and Environmental Engineering, Animal Sciences and the Institute for Genomic Biology. The project took advantage of the unique opportunity provided by the drilling and sampling of the large-­scale Phase III CCS demonstration Illinois Basin - Decatur Project (IBDP) in the central Illinois Basin at nearby Decatur, Illinois. The IBPD is under the direction of the Illinois State Geological Survey (ISGS, located on the UIUC campus) and the Midwest Geological Sequestration Consortium (MGSC). The research component of this project focused on the subsurface sampling and identification of microbes inhabiting the subsurface Cambrian-­age Mt. Simon Sandstone. In addition to formation water collected from the injection and monitoring wells, sidewall rock cores were collected and analyzed to characterize the cements and diagenetic features of the host Mt. Simon Sandstone. This established a dynamic geobiological framework, as well as a comparative baseline, for future studies of how CO2 injection might affect the deep microbial biosphere at other CCS sites. Three manuscripts have been prepared as a result of these activities, which are now being finalized for submission to top-­tier international peer-­reviewed research journals. The training component of this project was structured to ensure that a broad group of UIUC students, faculty and staff gained insight into CCS issues. An essential part of this training was that the UIUC faculty mentored and involved undergraduate and graduate students, as well as postdocs and research scientists, at all stages of the project in order

  7. Evaluating the development of carbon capture and storage technologies in the United States

    International Nuclear Information System (INIS)

    van Alphen, Klaas; Noothout, Paul M.; Hekkert, Marko P.; Turkenburg, Wim C.

    2010-01-01

    Carbon capture and storage (CCS) is seen as an important solution to solve the twin challenge of reducing GHG emissions, while utilizing fossil fuel reserves to meet future energy requirements. In this study an innovation systems perspective is applied to review the development of CCS technologies in the US between 2000 and 2009 and to come up with policy recommendations for technology managers that wish to accelerate the deployment of CCS. The analysis describes the successful built-up of an innovation system around CCS and pinpoints the key determinants for this achievement. However, the evaluation of the system's performance also indicates that America's leading role in the development of CCS should not be taken for granted. It shows that the large CCS R and D networks, as well as the extensive CCS knowledge base, which have been accumulated over the past decade, have not yet been valorized by entrepreneurs to explore the market for integrated CCS concepts linked to power generation. Therefore, it is argued that the build-up of the innovation system has entered a critical phase that is decisive for a further thriving development of CCS technologies in the US. This study provides a clear understanding of the current barriers to the technology's future deployment and outlines a policy strategy that (1) stimulates technological learning; (2) facilitates collaboration and coordination in CCS actor networks; (3) creates financial and market incentives for the technology; and (4) provides supportive regulation and sound communication on CCS. (author)

  8. Deletion of Foxp3+ regulatory T cells in genetically targeted mice supports development of intestinal inflammation

    Directory of Open Access Journals (Sweden)

    Boehm Franziska

    2012-07-01

    Full Text Available Abstract Background Mice lacking Foxp3+ regulatory T (Treg cells develop severe tissue inflammation in lung, skin, and liver with premature death, whereas the intestine remains uninflamed. This study aims to demonstrate the importance of Foxp3+ Treg for the activation of T cells and the development of intestinal inflammation. Methods Foxp3-GFP-DTR (human diphtheria toxin receptor C57BL/6 mice allow elimination of Foxp3+ Treg by treatment with Dx (diphtheria toxin. The influence of Foxp3+ Treg on intestinal inflammation was tested using the CD4+ T-cell transfer colitis model in Rag−/− C57BL/6 mice and the acute DSS-colitis model. Results Continuous depletion of Foxp3+ Treg in Foxp3-GFP-DTR mice led to dramatic weight loss and death of mice by day 28. After 10 days of depletion of Foxp3+ Treg, isolated CD4+ T-cells were activated and produced extensive amounts of IFN-γ, IL-13, and IL-17A. Transfer of total CD4+ T-cells isolated from Foxp3-GFP-DTR mice did not result in any changes of intestinal homeostasis in Rag−/− C57BL/6 mice. However, administration of DTx between days 14 and 18 after T-cell reconstitution, lead to elimination of Foxp3+ Treg and to immediate weight loss due to intestinal inflammation. This pro-inflammatory effect of Foxp3+ Treg depletion consecutively increased inflammatory cytokine production. Further, the depletion of Foxp3+ Treg from Foxp3-GFP-DTR mice increased the severity of acute dSS-colitis accompanied by 80% lethality of Treg-depleted mice. CD4+ effector T-cells from Foxp3+ Treg-depleted mice produced significantly more pro-inflammatory cytokines. Conclusion Intermittent depletion of Foxp3+ Treg aggravates intestinal inflammatory responses demonstrating the importance of Foxp3+ Treg for the balance at the mucosal surface of the intestine.

  9. [The Innovation Office of the Paul-Ehrlich-Institut. Regulatory support during the scientific development of ATMP].

    Science.gov (United States)

    Ziegele, B; Dahl, L; Müller, A T

    2011-07-01

    In conformity with Regulation (EC) No. 1394/2007, advanced therapy medicinal products (ATMP) are now subject to the centralized marketing authorization procedure. This also applies to most medicinal products in regenerative medicine. ATMP that have been marketed in a member state by the end of 2008 must be centrally authorized by the end of 2012 at the latest. In exceptional cases, a national authorization is acceptable. Developers of these medicinal products are usually academic institutions or small- and medium-sized enterprises (SME). They focus on scientific aspects and usually have little experience with pharmaceutical law. The Innovation Office of the Paul-Ehrlich-Institut (PEI) is designed to support developers of medicinal products in the areas between research and development, on the one hand, and regulatory requirements, on the other. Its main role is supportive advice in the regulatory field with an emphasis on ATMP. For this purpose, the Innovation Office makes use of core competences from various experts at the PEI in order to provide a quality consulting service to those companies who are seeking advice as early as possible and hand in hand with the development process. The aim is to support the developer to identify the appropriate regulatory pathway and to provide advice for each individual medicinal product at its corresponding stage of development in order to develop a high-quality ATMP manufactured on the basis of positive nonclinical results and appropriate clinical studies that meet all the necessary requirements for the application of a marketing authorization.

  10. PRA research and the development of risk-informed regulation at the U.S. nuclear regulatory commission

    International Nuclear Information System (INIS)

    Siu, Nathan; Collins, Dorothy

    2008-01-01

    Over the years, Probabilistic Risk Assessment (PRA) research activities conducted at the U.S. Nuclear Regulatory Commission (NRC) have played an essential role in support of the agency's move towards risk-informed regulation. These research activities have provided the technical basis for NRC's regulatory activities in key areas; provided PRA methods, tools, and data enabling the agency to meet future challenges; supported the implementation of NRC's 1995 PRA Policy Statement by assessing key sources of risk; and supported the development of necessary technical and human resources supporting NRC's risk-informed activities. PRA research aimed at improving the NRC's understanding of risk can positively affect the agency's regulatory activities, as evidenced by three case studies involving research on fire PRA, Human Reliability Analysis (HRA), and Pressurized Thermal Shock (PTS) PRA. These case studies also show that such research can take a considerable amount of time, and that the incorporation of research results into regulatory practice can take even longer. The need for sustained effort and appropriate lead time is an important consideration in the development of a PRA research program aimed at helping the agency address key sources of risk for current and potential future facilities

  11. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

    Science.gov (United States)

    Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

    Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory

  12. GPM Ground Validation Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks Cloud Classification System (PERSIANN-CCS) IFloodS V1

    Data.gov (United States)

    National Aeronautics and Space Administration — The GPM Ground Validation Precipitation Estimation from Remotely Sensed Information using Artificial Neural Networks Cloud Classification System (PERSIANN-CCS)...

  13. Development of a Quantitative Framework for Regulatory Risk Assessments: Probabilistic Approaches

    International Nuclear Information System (INIS)

    Wilmot, R.D.

    2003-11-01

    The Swedish regulators have been active in the field of performance assessment for many years and have developed sophisticated approaches to the development of scenarios and other aspects of assessments. These assessments have generally used dose as the assessment end-point and have been based on deterministic calculations. Recently introduced Swedish regulations have introduced a risk criterion for radioactive waste disposal: the annual risk of harmful effects after closure of a disposal facility should not exceed 10 -6 for a representative individual in the group exposed to the greatest risk. A recent review of the overall structure of risk assessments in safety cases concluded that there are a number of decisions and assumptions in the development of a risk assessment methodology that could potentially affect the calculated results. Regulatory understanding of these issues, potentially supported by independent calculations, is important in preparing for review of a proponent's risk assessment. One approach to evaluating risk in performance assessments is to use the concept of probability to express uncertainties, and to propagate these probabilities through the analysis. This report describes the various approaches available for undertaking such probabilistic analyses, both as a means of accounting for uncertainty in the determination of risk and more generally as a means of sensitivity and uncertainty analysis. The report discusses the overall nature of probabilistic analyses and how they are applied to both the calculation of risk and sensitivity analyses. Several approaches are available, including differential analysis, response surface methods and simulation. Simulation is the approach most commonly used, both in assessments for radioactive waste disposal and in other subject areas, and the report describes the key stages of this approach in detail. Decisions relating to the development of input PDFs, sampling methods (including approaches to the treatment

  14. Maternal allergic disease history affects childhood allergy development through impairment of neonatal regulatory T-cells.

    Science.gov (United States)

    Meng, Shan-Shan; Gao, Rong; Yan, Bing-di; Ren, Jin; Wu, Fei; Chen, Peng; Zhang, Jie; Wang, Li-Fang; Xiao, Yuan-Ming; Liu, Jing

    2016-09-20

    Maternal allergic disease history and impaired regulatory T-cells (Tregs) are critical risk factors for allergy development in children. However, the mechanisms that underlie these risk factors remain poorly defined. Therefore, the aim of this study was to assess whether maternal allergies affect the Tregs of offspring and lead to allergy development in childhood. A total of 332 mothers of healthy newborns (234 from no allergic mothers, 98 from allergic mothers) were recruited to this study. Detailed questionnaires were administered yearly to determine the allergy status of the mothers and the newborns from birth to 3 years of age. Cord blood samples obtained at the time of birth were analysed for Treg counts, as well Treg activity, based on their response to Toll-like receptor (TLR) stimuli such as lipid A (LPA) and peptidoglycans (PPG). Surface markers, associated genes, suppressive capacity, and cytokine levels of Tregs were also measured. Possible correlations between Treg activity and maternal or neonate allergies were assessed. In addition, environmental microbial content and other known risk factors for allergies were measured. Cord blood mononuclear cells (CBMCs) from offspring with allergic mothers showed fewer CD4(+)CD25(+)FOXP3(+) T cells, lower expression levels of associated genes, and reduced cytokine production of interleukin (IL)-10 and interferon-γ (P allergies was impaired, especially IL-13 production by Type 2 T helper (Th2) cells (P = 0.026). Children who developed allergies in the first 3 years of life had lower numbers of CD4(+)CD25(+)FOXP3(+) T cells and reduced FOXP3 expression and IL-10 production as newborns (P allergy development in the children (Odds ratio (OR) = 2.46, 95 % CI = 1.05-5.79); while declining Treg numbers, IL-10 production, and FOXP3 expression in neonates (PPG and LPA stimulated) were identified as independent risk factors for allergic diseases in offspring at 3 years of age after adjusting for

  15. Policy and Regulatory Roadmaps for the Integration of Distributed Generation and the Development of Sustainable Electricity Networks. Final Report of the SUSTELNET project

    Energy Technology Data Exchange (ETDEWEB)

    Scheepers, M.J.J. [ECN Policy Studies, Petten (Netherlands)

    2004-08-01

    The SUSTELNET project has been created to identify criteria for a regulatory framework for future electricity markets and network structures that create a level playing field between centralised and decentralised generation and facilitate the integration of renewable energy sources (RES). Furthermore, the objective of the project was to develop regulatory roadmaps for the transition to a sustainable electricity market and network structure. This report summarizes the results of the project. These results consist of: criteria, guidelines and rationales for a future electricity policy and regulatory framework, an outline for the development of regulatory roadmaps and nine national regulatory roadmaps (for Denmark, Germany, Italy, the Netherlands, United Kingdom, Czech Republic, Poland, Hungary and Slovakia), recommendations for a European regulatory policy on distributed generation and a benchmark study of current Member States policies towards distributed generation.

  16. Regulatory Technology Development Plan - Sodium Fast Reactor: Mechanistic Source Term - Trial Calculation

    International Nuclear Information System (INIS)

    Grabaskas, David

    2016-01-01

    The potential release of radioactive material during a plant incident, referred to as the source term, is a vital design metric and will be a major focus of advanced reactor licensing. The U.S. Nuclear Regulatory Commission has stated an expectation for advanced reactor vendors to present a mechanistic assessment of the potential source term in their license applications. The mechanistic source term presents an opportunity for vendors to realistically assess the radiological consequences of an incident, and may allow reduced emergency planning zones and smaller plant sites. However, the development of a mechanistic source term for advanced reactors is not without challenges, as there are often numerous phenomena impacting the transportation and retention of radionuclides. This project sought to evaluate U.S. capabilities regarding the mechanistic assessment of radionuclide release from core damage incidents at metal fueled, pool-type sodium fast reactors (SFRs). The purpose of the analysis was to identify, and prioritize, any gaps regarding computational tools or data necessary for the modeling of radionuclide transport and retention phenomena. To accomplish this task, a parallel-path analysis approach was utilized. One path, led by Argonne and Sandia National Laboratories, sought to perform a mechanistic source term assessment using available codes, data, and models, with the goal to identify gaps in the current knowledge base. The second path, performed by an independent contractor, performed sensitivity analyses to determine the importance of particular radionuclides and transport phenomena in regards to offsite consequences. The results of the two pathways were combined to prioritize gaps in current capabilities.

  17. Pulmonary CCR2+CD4+T cells are immune regulatory and attenuate lung fibrosis development.

    Science.gov (United States)

    Milger, Katrin; Yu, Yingyan; Brudy, Eva; Irmler, Martin; Skapenko, Alla; Mayinger, Michael; Lehmann, Mareike; Beckers, Johannes; Reichenberger, Frank; Behr, Jürgen; Eickelberg, Oliver; Königshoff, Melanie; Krauss-Etschmann, Susanne

    2017-11-01

    Animal models have suggested that CCR2-dependent signalling contributes to the pathogenesis of pulmonary fibrosis, but global blockade of CCL2 failed to improve the clinical course of patients with lung fibrosis. However, as levels of CCR2 + CD4 + T cells in paediatric lung fibrosis had previously been found to be increased, correlating with clinical symptoms, we hypothesised that distinct CCR2 + cell populations might either increase or decrease disease pathogenesis depending on their subtype. To investigate the role of CCR2 + CD4 + T cells in experimental lung fibrosis and in patients with idiopathic pulmonary fibrosis and other fibrosis. Pulmonary CCR2 + CD4 + T cells were analysed using flow cytometry and mRNA profiling, followed by in silico pathway analysis, in vitro assays and adoptive transfer experiments. Frequencies of CCR2 + CD4 + T cells were increased in experimental fibrosis-specifically the CD62L - CD44 + effector memory T cell phenotype, displaying a distinct chemokine receptor profile. mRNA profiling of isolated CCR2 + CD4 + T cells from fibrotic lungs suggested immune regulatory functions, a finding that was confirmed in vitro using suppressor assays. Importantly, adoptive transfer of CCR2 + CD4 + T cells attenuated fibrosis development. The results were partly corroborated in patients with lung fibrosis, by showing higher percentages of Foxp3 + CD25 + cells within bronchoalveolar lavage fluid CCR2 + CD4 + T cells as compared with CCR2 - CD4 + T cells. Pulmonary CCR2 + CD4 + T cells are immunosuppressive, and could attenuate lung inflammation and fibrosis. Therapeutic strategies completely abrogating CCR2-dependent signalling will therefore also eliminate cell populations with protective roles in fibrotic lung disease. This emphasises the need for a detailed understanding of the functions of immune cell subsets in fibrotic lung disease. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights

  18. Acid Sphingomyelinase (ASM is a Negative Regulator of Regulatory T Cell (Treg Development

    Directory of Open Access Journals (Sweden)

    Yuetao Zhou

    2016-08-01

    Full Text Available Background/Aims: Regulatory T cell (Treg is required for the maintenance of tolerance to various tissue antigens and to protect the host from autoimmune disorders. However, Treg may, indirectly, support cancer progression and bacterial infections. Therefore, a balance of Treg function is pivotal for adequate immune responses. Acid sphingomyelinase (ASM is a rate limiting enzyme involved in the production of ceramide by breaking down sphingomyelin. Previous studies in T-cells have suggested that ASM is involved in CD28 signalling, T lymphocyte granule secretion, degranulation, and vesicle shedding similar to the formation of phosphatidylserine-exposing microparticles from glial cells. However, whether ASM affects the development of Treg has not yet been described. Methods: Splenocytes, isolated Naive T lymphocytes and cultured T cells were characterized for various immune T cell markers by flow cytometery. Cell proliferation was measured by Carboxyfluorescein succinimidyl ester (CFSE dye, cell cycle analysis by Propidium Iodide (PI, mRNA transcripts by q-RT PCR and protein expression by Western Blotting respectively. Results: ASM deficient mice have higher number of Treg compared with littermate control mice. In vitro induction of ASM deficient T cells in the presence of TGF-β and IL-2 lead to a significantly higher number of Foxp3+ induced Treg (iTreg compared with control T-cells. Further, ASM deficient iTreg has less AKT (serine 473 phosphorylation and Rictor levels compared with control iTreg. Ceramide C6 led to significant reduction of iTreg in both ASM deficient and WT mice. The reduction in iTreg leads to induction of IL-1β, IL-6 and IL-17 but not IFN-γ mRNA levels. Conclusion: ASM is a negative regulator of natural and iTreg.

  19. Regulatory Technology Development Plan - Sodium Fast Reactor: Mechanistic Source Term – Trial Calculation

    Energy Technology Data Exchange (ETDEWEB)

    Grabaskas, David [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Bucknor, Matthew [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Jerden, James [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Brunett, Acacia J. [Argonne National Lab. (ANL), Argonne, IL (United States). Nuclear Engineering Division; Denman, Matthew [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). Nuclear Engineering Division; Clark, Andrew [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States). Nuclear Engineering Division; Denning, Richard S. [Consultant, Columbus, OH (United States)

    2016-10-01

    The potential release of radioactive material during a plant incident, referred to as the source term, is a vital design metric and will be a major focus of advanced reactor licensing. The U.S. Nuclear Regulatory Commission has stated an expectation for advanced reactor vendors to present a mechanistic assessment of the potential source term in their license applications. The mechanistic source term presents an opportunity for vendors to realistically assess the radiological consequences of an incident, and may allow reduced emergency planning zones and smaller plant sites. However, the development of a mechanistic source term for advanced reactors is not without challenges, as there are often numerous phenomena impacting the transportation and retention of radionuclides. This project sought to evaluate U.S. capabilities regarding the mechanistic assessment of radionuclide release from core damage incidents at metal fueled, pool-type sodium fast reactors (SFRs). The purpose of the analysis was to identify, and prioritize, any gaps regarding computational tools or data necessary for the modeling of radionuclide transport and retention phenomena. To accomplish this task, a parallel-path analysis approach was utilized. One path, led by Argonne and Sandia National Laboratories, sought to perform a mechanistic source term assessment using available codes, data, and models, with the goal to identify gaps in the current knowledge base. The second path, performed by an independent contractor, performed sensitivity analyses to determine the importance of particular radionuclides and transport phenomena in regards to offsite consequences. The results of the two pathways were combined to prioritize gaps in current capabilities.

  20. Acid Sphingomyelinase (ASM) is a Negative Regulator of Regulatory T Cell (Treg) Development.

    Science.gov (United States)

    Zhou, Yuetao; Salker, Madhuri S; Walker, Britta; Münzer, Patrick; Borst, Oliver; Gawaz, Meinrad; Gulbins, Erich; Singh, Yogesh; Lang, Florian

    2016-01-01

    Regulatory T cell (Treg) is required for the maintenance of tolerance to various tissue antigens and to protect the host from autoimmune disorders. However, Treg may, indirectly, support cancer progression and bacterial infections. Therefore, a balance of Treg function is pivotal for adequate immune responses. Acid sphingomyelinase (ASM) is a rate limiting enzyme involved in the production of ceramide by breaking down sphingomyelin. Previous studies in T-cells have suggested that ASM is involved in CD28 signalling, T lymphocyte granule secretion, degranulation, and vesicle shedding similar to the formation of phosphatidylserine-exposing microparticles from glial cells. However, whether ASM affects the development of Treg has not yet been described. Splenocytes, isolated Naive T lymphocytes and cultured T cells were characterized for various immune T cell markers by flow cytometery. Cell proliferation was measured by Carboxyfluorescein succinimidyl ester (CFSE) dye, cell cycle analysis by Propidium Iodide (PI), mRNA transcripts by q-RT PCR and protein expression by Western Blotting respectively. ASM deficient mice have higher number of Treg compared with littermate control mice. In vitro induction of ASM deficient T cells in the presence of TGF-β and IL-2 lead to a significantly higher number of Foxp3+ induced Treg (iTreg) compared with control T-cells. Further, ASM deficient iTreg has less AKT (serine 473) phosphorylation and Rictor levels compared with control iTreg. Ceramide C6 led to significant reduction of iTreg in both ASM deficient and WT mice. The reduction in iTreg leads to induction of IL-1β, IL-6 and IL-17 but not IFN-γ mRNA levels. ASM is a negative regulator of natural and iTreg. © 2016 The Author(s) Published by S. Karger AG, Basel.

  1. Progress in research and regulatory development by the Materials Engineering Branch, RES Engineering Division

    International Nuclear Information System (INIS)

    Serpan, C.Z. Jr.

    1988-01-01

    Much activity has been underway In NRC this past year on definition of aging Issues for nuclear power plants that will be applicable to the regulatory considerations of applications for license renewals following the Initial 40-year operating period. The Materials Engineering Branch has been reviewing its program to assure that aging Issues are prominent, and to identify regulatory documents that will have to be validated or revised to provide a proper basis for license renewal safety evaluation. A report on the branch plan for aging and needs for extended life review is under preparation and should be available early in 1988

  2. Identification of novel regulatory genes in development of the avian reproductive tracts.

    Directory of Open Access Journals (Sweden)

    Whasun Lim

    Full Text Available The chicken reproductive system is unique in maintaining its functions including production of eggs or sperm, fertilization of the egg by sperm maintained in sperm nests, production of hormones regulating its growth, development and function, and reproduction. Development of the reproductive organs is a highly regulated process that results in differentiation and proliferation of germ cells in response to predominant regulatory factors such as hormones and transcription factors. However, only a few genes are known to determine morphogenesis of the chicken reproductive tract and their mechanisms are unknown. Therefore, in the present study, we investigated the expression patterns of four genes including SNCA, TOM1L1, TTR and ZEB1 in the gonads at embryonic days 14 and 18, and in immature (12-week-old and mature (50-week-old chickens, as well as the reproductive tract including ovary, oviduct and testes of the respective sexes by qRT-PCR, in situ hybridization and immunofluorescence analyses. The expression of SNCA, TOM1L1 and ZEB1 genes was higher in immature and mature female reproductive tracts than expression of TTR. In addition, different temporal and spatial patterns of expression of the four genes were observed during maturation of testis in chickens. Specifically, SNCA, TOM1L1 and TTR were highly expressed in testes of 12-week-old chickens. Moreover, several chicken specific microRNAs (miRs were demonstrated to affect expression of target gene mRNAs by directly binding to the 3'-UTR of their target genes through actions at the post-transcriptional level as follows: miR-153 and miR-1643 for SNCA; miR-1680* for TTR; and miR-200b and miR-1786 for ZEB1. These results suggest that four-selected genes play an important role in development of the male and female reproductive tract in chickens and expression of most candidate genes is regulated at the post-transcriptional level through specific microRNAs.

  3. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development

    Science.gov (United States)

    Ancans, Janis

    2012-01-01

    Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU. PMID:22912639

  4. Biorefineries of carbon dioxide: From carbon capture and storage (CCS) to bioenergies production.

    Science.gov (United States)

    Cheah, Wai Yan; Ling, Tau Chuan; Juan, Joon Ching; Lee, Duu-Jong; Chang, Jo-Shu; Show, Pau Loke

    2016-09-01

    Greenhouse gas emissions have several adverse environmental effects, like pollution and climate change. Currently applied carbon capture and storage (CCS) methods are not cost effective and have not been proven safe for long term sequestration. Another attractive approach is CO2 valorization, whereby CO2 can be captured in the form of biomass via photosynthesis and is subsequently converted into various form of bioenergy. This article summarizes the current carbon sequestration and utilization technologies, while emphasizing the value of bioconversion of CO2. In particular, CO2 sequestration by terrestrial plants, microalgae and other microorganisms are discussed. Prospects and challenges for CO2 conversion are addressed. The aim of this review is to provide comprehensive knowledge and updated information on the current advances in biological CO2 sequestration and valorization, which are essential if this approach is to achieve environmental sustainability and economic feasibility. Copyright © 2016 Elsevier Ltd. All rights reserved.

  5. Regulatory response to the financial crisis in Europe : Recent developments (2010-2013)

    NARCIS (Netherlands)

    Carbo Valverde, S.; Benink, H.A.; Berglund, T.; Wihlborg, C.

    2015-01-01

    Purpose – The purpose of this paper by the European Shadow Financial Regulatory Committee (ESFRC) is to provide an account of the financial crisis in Europe during the period 2010-2013 and an analysis of how the relevant authorities reacted to the crisis. Design/methodology/approach – These actions

  6. Ecological Models in Support of Regulatory Risk Assessments of Pesticides: Developing a Strategy for the Future

    NARCIS (Netherlands)

    Forbes, V.E.; Hommen, U.; Thorbek, P.; Heimbach, F.; Brink, van den P.J.; Wogram, J.; Thulke, H.H.; Grimm, V.

    2009-01-01

    This brief communication reports on the main findings of the LEMTOX workshop, held from 9 to 12 September 2007, at the Helmholtz Centre for Environmental Research (UFZ) in Leipzig, Germany. The workshop brought together a diverse group of stakeholders from academia, regulatory authorities, contract

  7. Leak-Before-Break: Further developments in regulatory policies and supporting research

    International Nuclear Information System (INIS)

    Wilkowski, G.M.; Chao, K.-S.

    1990-02-01

    The fourth in a series of international Leak-Before-Break (LBB) Seminars supported in part by the US Nuclear Regulatory Commission was held at the National Central Library in Taipei, Taiwan on May 11 and 12, 1989. The seminar updated the international polices and supporting research on LBB. Attendees included representatives from regulatory agencies, electric utilities, nuclear power plant fabricators, research organizations, and academic institutions. Regulatory policy was the subject of presentations by Mr. G. Arlotto (US NRC, USA) Dr. B. Jarman (AECB, Canada), Dr.P. Milella (ENEA-DISP, Italy), Dr. C. Faidy (EDF/Septen, France ), and Dr. K. Takumi (NUPEC, Japan). A paper by Mr. K. Wichman and Mr. A. Lee of the US NRC Office of Nuclear Reactor Regulation is included as background material to these proceedings; it discusses the history and status of LBB applications in US nuclear power plants. In addition, several papers on the supporting research programs described regulatory policy or industry standards for flaw evaluations, e.g., the ASME Section XI code procedures. Supporting research programs were reviewed on the first and second day by several participants from Taiwan, US, Japan, Canada, Italy, and France. Each individual paper has been cataloged separately

  8. Teacher Self-Regulatory Climate: Conceptualizing an Indicator of Leader Support for Teacher Learning and Development

    Science.gov (United States)

    Ford, Timothy G.; Ware, Jordan K.

    2018-01-01

    Few studies that examine organizational conditions conducive to teacher learning utilize social-psychological theory to explain how leader actions specifically support teachers' psychological needs as learners. We apply self-determination theory to the conceptualization of a new construct, Teacher Self-Regulatory Climate (TSRC), defined as a set…

  9. An otx/nodal regulatory signature for posterior neural development in ascidians.

    Directory of Open Access Journals (Sweden)

    Agnès Roure

    2014-08-01

    Full Text Available In chordates, neural induction is the first step of a complex developmental process through which ectodermal cells acquire a neural identity. In ascidians, FGF-mediated neural induction occurs at the 32-cell stage in two blastomere pairs, precursors respectively of anterior and posterior neural tissue. We combined molecular embryology and cis-regulatory analysis to unveil in the ascidian Ciona intestinalis the remarkably simple proximal genetic network that controls posterior neural fate acquisition downstream of FGF. We report that the combined action of two direct FGF targets, the TGFβ factor Nodal, acting via Smad- and Fox-binding sites, and the transcription factor Otx suffices to trigger ascidian posterior neural tissue formation. Moreover, we found that this strategy is conserved in the distantly related ascidian Phallusia mammillata, in spite of extreme sequence divergence in the cis-regulatory sequences involved. Our results thus highlight that the modes of gene regulatory network evolution differ with the evolutionary scale considered. Within ascidians, developmental regulatory networks are remarkably robust to genome sequence divergence. Between ascidians and vertebrates, major fate determinants, such as Otx and Nodal, can be co-opted into different networks. Comparative developmental studies in ascidians with divergent genomes will thus uncover shared ascidian strategies, and contribute to a better understanding of the diversity of developmental strategies within chordates.

  10. KAEC experience in development of the regulatory framework for training and qualification

    International Nuclear Information System (INIS)

    Kim, A.; Idrissova, M.; Kossilov, Al.; Pryakhin, A.

    2002-01-01

    Full text: Since 1991, after getting of the sovereignty, Kazakhstan started developing of its own legislative and regulatory system in the field of atomic energy use. In accordance with the Decrees of the President appropriate structures in Kazakhstan were created. They are: Atomic Energy Committee, as a main supervising governmental body, National Nuclear Centre combining all nuclear related scientific institutes, and National Atomic Company Kazatomprom. On 14 February 1994 Kazakhstan joined the International Atomic Energy Agency. Also a lot of enterprises use radioactive sources for the different application in medicine, research, industry, agriculture and etc. Infrastructure of the using of atomic energy in Kazakhstan includes: One power fast reactor BN-350 (now it is shut down and prepared for the decommissioning); Four Research reactors of the National Nuclear Centre; Uranium mining and milling enterprises; Fuel fabrication plant; Storage facilities for nuclear materials, radiation substances and radioactive waste; Organizations using radiation sources; Transport organizations. According to this the Republic of Kazakhstan needs the effective system for the assurance and guarantees for protection of population and environment against the possible negative influence of atomic energy usage. One of the important parts of that is a system of training and qualification of personnel involved in the nuclear activity. In the legislative field of the safely use of nuclear energy several Laws of the Republic of Kazakhstan have been elaborated and adopted. They are: Law on Atomic Energy Use (14 April 1997, Law on Radiation Protection of Population (23 April 1998), Law on Licensing. Those documents formed the first level of the structure of the national system for reliable training, qualification and authorization of the personnel involved in the nuclear activities. The second level is formed by the Legal Acts of the Government of Kazakhstan. The other levels of the

  11. The Adult Life After Childhood Cancer in Scandinavia (ALiCCS) Study: Design and Characteristics.

    Science.gov (United States)

    Asdahl, Peter H; Winther, Jeanette F; Bonnesen, Trine G; De Fine Licht, Sofie; Gudmundsdottir, Thorgerdur; Anderson, Harald; Madanat-Harjuoja, Laura; Tryggvadottir, Laufey; Småstuen, Milada Cvancarova; Holmqvist, Anna Sällfors; Hasle, Henrik; Olsen, Jørgen H

    2015-12-01

    During the last five decades, survival of childhood cancer has increased from 25% to 80%. At the same time, however, it has become evident that survivors experience a broad range of therapy-related late adverse health effects. The aim of the Adult Life after Childhood Cancer in Scandinavia (ALiCCS) study is to investigate long-term health consequences of past and current therapies in order to improve follow-up care of survivors and to reduce treatment-related morbidity of future patients. Childhood cancer survivors were identified through the five Nordic cancer registries and a comparison cohort was established through random selection of cancer-free individuals from the civil registration systems. A unique personal identification number was used to link between different health registries. Abstraction of treatment information for a subset of survivors allows investigation of the association between the various components of cancer therapy and late occurring comorbidity. The childhood cancer survivor cohort comprises 33,160 1-year survivors and the comparison cohort comprises 212,892 cancer free individuals from the general population. In the childhood cancer survivor cohort, all types of childhood cancer are represented including leukemia (21%), lymphoma (14%), central nervous system tumors (24%), sarcomas (5%), retinoblastoma (3%), and neuroblastoma (4%). Among the survivors, 22% have been followed beyond the age of 40 years. The ALiCCS study constitutes a new large resource for research on late effects of childhood cancers that include all types of childhood malignancies and has followed a large proportion of the survivors well into late adulthood. © 2015 Wiley Periodicals, Inc.

  12. Perfluorooctanoic acid (PFOA) - main concerns and regulatory developments in Europe from an environmental point of view

    Energy Technology Data Exchange (ETDEWEB)

    Vierke, Lena [Federal Environment Agency, Dessau-Rosslau (Germany); Leuphana University of Lueneburg, Lueneburg (Germany); Staude, Claudia; Biegel-Engler, Annegret; Drost, Wiebke; Schulte, Christoph [Federal Environment Agency, Dessau-Rosslau (Germany)

    2012-12-15

    Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) are the most investigated substances of the group of per- and polyfluorinated chemicals (PFCs). Whereas for PFOS regulatory measures are already in force on international level (inclusion in Stockholm Convention on Persistent Organic Pollutants) such activities are missing for PFOA. The environmental concerns of PFOA, which are summarized in the present study, underline the necessity of regulatory measures on an international level for PFOA. Since it seems more likely to agree on a regulation within the European Union first, a regulatory strategy based on the European chemicals regulation REACH (EC No. 1907/2006), is discussed in the present study. PFOA is persistent in the environment, ubiquitous present in surface waters, and subject to long-range transport. It accumulates in biota, especially in top predators. PFOA is increasingly analyzed in food items, and in drinking water. PFOA's intrinsic properties such as its persistency (P), its potential for bioaccumulation (B) and its toxicity (T) suggest that PFOA is a promising candidate for being identified as a Substance of Very High Concern (SVHC) under REACH. Because of the dispersive occurrence of PFOA in the environment, the presence in imported products, and the use of PFCs, which can degrade to PFOA in various consumer products, a restriction under REACH seems to be the most effective regulatory measure to minimize human and environmental exposure to PFOA in the European Union. Due to its intrinsic properties, PFOA fulfills the REACH PBT-criteria. The next regulatory step will be the identification of PFOA and its ammonium salt (APFO) as SVHC according to REACH and the addition to the REACH Candidate List. As a second step, a restriction proposal will be prepared to include both substances and precursors into REACH Annex XVII. (orig.)

  13. Pitx2 is a critical early regulatory gene in normal cecal development.

    Science.gov (United States)

    Nichol, Peter F; Saijoh, Yukio

    2011-09-01

    The murine cecum is a critical digestive structure. Morphogenesis of the cecum involves several key genes, including Homeobox (Hox) d12. Ectopic expression of Hoxd12 has been shown to result in cecal agenesis and a down-regulation of both Fibroblast growth factor 10 (Fgf10) and the Pituitary homeobox 2 gene (Pitx2). Homozygous null mutation of Fgf10 or its cognate receptor Fgfr2IIIb results in severe cecal defects where there is the initiation of mesodermal budding, but a failure of the endoderm to grow and extend into this structure. We examined the expression of Pitx2 in the cecum and hypothesized that homozygous null mutation of Pitx2 would result in cecal agenesis. IACUC approval was obtained for these studies. Whole mount in situ hybridizations for Pitx2 were performed on wild-type embryos between embryonic d (E)11.0 and E12.5. Pitx2 -/- and Fgfr2IIIb -/- embryos were generated from n/+ heterozygote breedings and harvested at E10.5, E11.5, and E13.5. Genotypes were confirmed by PCR. Morphology of Pitx2 -/- cecae were compared with those of wild-type littermates and Fgfr2IIIb -/- embryos at identical stages. Embryos were fixed overnight and photographed the following day. Pitx2 is expressed in the cecal mesoderm and endoderm as early as E11.0. Expression becomes increasingly more robust by E12.5. Homozygous null mutation of Pitx2 results in agenesis of the cecum. In contrast to Fgfr2IIIb -/- embryos, which demonstrate a persistent mesodermal bud as late as E18.5, no mesodermal bud is present in Pitx2 -/- embryos. Our findings demonstrate that Pitx2 is a critical regulatory gene in cecal morphogenesis and suggest that Pitx2 is required for initiation of mesodermal budding and likely resides upstream of Fgf10-Fgfr2IIIb signaling in the normal development of this structure. Copyright © 2011 Elsevier Inc. All rights reserved.

  14. Gene and metabolite regulatory network analysis of early developing fruit tissues highlights new candidate genes for the control of tomato fruit composition and development.

    Science.gov (United States)

    Mounet, Fabien; Moing, Annick; Garcia, Virginie; Petit, Johann; Maucourt, Michael; Deborde, Catherine; Bernillon, Stéphane; Le Gall, Gwénaëlle; Colquhoun, Ian; Defernez, Marianne; Giraudel, Jean-Luc; Rolin, Dominique; Rothan, Christophe; Lemaire-Chamley, Martine

    2009-03-01

    Variations in early fruit development and composition may have major impacts on the taste and the overall quality of ripe tomato (Solanum lycopersicum) fruit. To get insights into the networks involved in these coordinated processes and to identify key regulatory genes, we explored the transcriptional and metabolic changes in expanding tomato fruit tissues using multivariate analysis and gene-metabolite correlation networks. To this end, we demonstrated and took advantage of the existence of clear structural and compositional differences between expanding mesocarp and locular tissue during fruit development (12-35 d postanthesis). Transcriptome and metabolome analyses were carried out with tomato microarrays and analytical methods including proton nuclear magnetic resonance and liquid chromatography-mass spectrometry, respectively. Pairwise comparisons of metabolite contents and gene expression profiles detected up to 37 direct gene-metabolite correlations involving regulatory genes (e.g. the correlations between glutamine, bZIP, and MYB transcription factors). Correlation network analyses revealed the existence of major hub genes correlated with 10 or more regulatory transcripts and embedded in a large regulatory network. This approach proved to be a valuable strategy for identifying specific subsets of genes implicated in key processes of fruit development and metabolism, which are therefore potential targets for genetic improvement of tomato fruit quality.

  15. Modular and coordinated expression of immune system regulatory and signaling components in the developing and adult nervous system.

    Science.gov (United States)

    Monzón-Sandoval, Jimena; Castillo-Morales, Atahualpa; Crampton, Sean; McKelvey, Laura; Nolan, Aoife; O'Keeffe, Gerard; Gutierrez, Humberto

    2015-01-01

    During development, the nervous system (NS) is assembled and sculpted through a concerted series of neurodevelopmental events orchestrated by a complex genetic programme. While neural-specific gene expression plays a critical part in this process, in recent years, a number of immune-related signaling and regulatory components have also been shown to play key physiological roles in the developing and adult NS. While the involvement of individual immune-related signaling components in neural functions may reflect their ubiquitous character, it may also reflect a much wider, as yet undescribed, genetic network of immune-related molecules acting as an intrinsic component of the neural-specific regulatory machinery that ultimately shapes the NS. In order to gain insights into the scale and wider functional organization of immune-related genetic networks in the NS, we examined the large scale pattern of expression of these genes in the brain. Our results show a highly significant correlated expression and transcriptional clustering among immune-related genes in the developing and adult brain, and this correlation was the highest in the brain when compared to muscle, liver, kidney and endothelial cells. We experimentally tested the regulatory clustering of immune system (IS) genes by using microarray expression profiling in cultures of dissociated neurons stimulated with the pro-inflammatory cytokine TNF-alpha, and found a highly significant enrichment of immune system-related genes among the resulting differentially expressed genes. Our findings strongly suggest a coherent recruitment of entire immune-related genetic regulatory modules by the neural-specific genetic programme that shapes the NS.

  16. Zinc recovery from the water-jacket furnace flue dusts by leaching and electrowinning in a SEC-CCS cell

    CSIR Research Space (South Africa)

    Mukongo, T

    2009-01-01

    Full Text Available electrolysis in a symmetric electrolysis current–continuous circulating system, SEC-CCS. Electrolysis current efficiency higher than 94% and 3.5 kWh/ kg of specific energy consumption was achieved under 500–600 A/m2 at 35 to 40 °C in the presence of gelatine....

  17. Offshore CCS and ocean acidification : A global long-term probabilistic cost-benefit analysis of climate change mitigation

    NARCIS (Netherlands)

    van der Zwaan, B.C.C.; Gerlagh, Reyer

    Public fear over environmental and health impacts of CO2 storage, or over potential leakage of CO2 from geological reservoirs, is among the reasons why over the past decade CCS has not yet been deployed on a scale large enough so as to meaningfully contribute to mitigate climate change. Storage of

  18. A regulatory network modeled from wild-type gene expression data guides functional predictions in Caenorhabditis elegans development

    Directory of Open Access Journals (Sweden)

    Stigler Brandilyn

    2012-06-01

    Full Text Available Abstract Background Complex gene regulatory networks underlie many cellular and developmental processes. While a variety of experimental approaches can be used to discover how genes interact, few biological systems have been systematically evaluated to the extent required for an experimental definition of the underlying network. Therefore, the development of computational methods that can use limited experimental data to define and model a gene regulatory network would provide a useful tool to evaluate many important but incompletely understood biological processes. Such methods can assist in extracting all relevant information from data that are available, identify unexpected regulatory relationships and prioritize future experiments. Results To facilitate the analysis of gene regulatory networks, we have developed a computational modeling pipeline method that complements traditional evaluation of experimental data. For a proof-of-concept example, we have focused on the gene regulatory network in the nematode C. elegans that mediates the developmental choice between mesodermal (muscle and ectodermal (skin cell fates in the embryonic C lineage. We have used gene expression data to build two models: a knowledge-driven model based on gene expression changes following gene perturbation experiments, and a data-driven mathematical model derived from time-course gene expression data recovered from wild-type animals. We show that both models can identify a rich set of network gene interactions. Importantly, the mathematical model built only from wild-type data can predict interactions demonstrated by the perturbation experiments better than chance, and better than an existing knowledge-driven model built from the same data set. The mathematical model also provides new biological insight, including a dissection of zygotic from maternal functions of a key transcriptional regulator, PAL-1, and identification of non-redundant activities of the T-box genes

  19. Benefits of coal-fired power generation with flexible CCS in a future northwest European power system with large scale wind power

    NARCIS (Netherlands)

    Van der Wijk, Pieter Cornelis; Brouwer, Anne Sjoerd|info:eu-repo/dai/nl/330822748; Van den Broek, Machteld|info:eu-repo/dai/nl/092946895; Slot, Thijs; Stienstra, Gerard; Van der Veen, Wim; Faaij, André P C

    Coal-fired power generation with carbon capture and storage (CCS) is projected as a cost-effective technology to decarbonize the power sector. Intermittent renewables could reduce its load factor and revenues, so flexible capture unit operation strategies (flexible CCS) have been suggested to

  20. Regulatory use of risk information - initial developments at Slovenian Nuclear Safety Administration

    International Nuclear Information System (INIS)

    Muehleisen, A.; Koncar, M.; Vojnovic, D.; Persic, A.

    2004-01-01

    Similarly to other regulators worldwide, the SNSA intends to enhance the use of PSA and risk insights in its activities in order to ensure a better and more focused regulatory oversight as well as improved interface with a licensee. The main aim of the SNSA is to establish PSA as a standard tool to complement the deterministic based regulation for a variety of regulatory tasks. The PSA applications should, in particular, support the decision making process as well as the interactions with the Krsko NPP. As a first step in the internal use of PSA, PSA event analysis and risk based performance indicators are being introduced. In 2004, the SNSA will start introducing risk follow up and risk informed inspections. By mid 2005 the legal basis for the use of PSA will be also established in Slovenian legislation. (author)

  1. Managing the Risks of Shale Gas Development Using Innovative Legal and Regulatory Approaches

    OpenAIRE

    Olmstead, Sheila; Richardson, Nathan

    2014-01-01

    Booming production of oil and gas from shale, enabled by hydraulic fracturing technology, has led to tension between hoped-for economic benefits and feared environmental and other costs, with great associated controversy. Study of how policy can best react to these challenges and how it can balance risk and reward has focused on prescriptive regulatory responses and, to a somewhat lesser extent, voluntary industry best practices. While there is undoubtedly room for improved regulation, innova...

  2. [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.

  3. Adenylyl cyclase plays a regulatory role in development, stress resistance and secondary metabolism in Fusarium fujikuroi.

    Directory of Open Access Journals (Sweden)

    Jorge García-Martínez

    Full Text Available The ascomycete fungus Fusarium fujikuroi (Gibberella fujikuroi MP-C produces secondary metabolites of biotechnological interest, such as gibberellins, bikaverin, and carotenoids. Production of these metabolites is regulated by nitrogen availability and, in a specific manner, by other environmental signals, such as light in the case of the carotenoid pathway. A complex regulatory network controlling these processes is recently emerging from the alterations of metabolite production found through the mutation of different regulatory genes. Here we show the effect of the targeted mutation of the acyA gene of F. fujikuroi, coding for adenylyl cyclase. Mutants lacking the catalytic domain of the AcyA protein showed different phenotypic alterations, including reduced growth, enhanced production of unidentified red pigments, reduced production of gibberellins and partially derepressed carotenoid biosynthesis in the dark. The phenotype differs in some aspects from that of similar mutants of the close relatives F. proliferatum and F. verticillioides: contrary to what was observed in these species, ΔacyA mutants of F. fujikuroi showed enhanced sensitivity to oxidative stress (H(2O(2, but no change in heavy metal resistance or in the ability to colonize tomato tissue, indicating a high versatility in the regulatory roles played by cAMP in this fungal group.

  4. Regulatory agencies and regulatory risk

    OpenAIRE

    Knieps, Günter; Weiß, Hans-Jörg

    2008-01-01

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

  5. 2001 in review: recent Canadian regulatory developments affecting natural gas pipelines

    International Nuclear Information System (INIS)

    Sanderson, C.W.

    2002-01-01

    The natural gas delivery system witnessed unprecedented bottlenecks and frenzied markets as a result of the unprecedented prices for natural gas at the beginning of 2001. This situation was especially serious in Western Canada. It brought to light, to both producers and consumers, that transportation constraints have a major impact on the industry. The importance of the regulatory framework governing natural gas transmission was re-emphasized with this heightened awareness. The author reviewed and outlined the significant regulatory decisions and the events of 2001 and early 2002 which had an impact on the regulation of natural gas pipelines in Canada. Some important federal decisions made by the National Energy Board, which in turn led to provincial decisions, are summarized in this paper, with special emphasis placed on the situation of both British Columbia and Alberta. On the federal side, the author reviewed pipeline harmonization; guidelines for negotiated traffic, tolls, and tariffs; and consultation with Aboriginal Peoples. The major gas pipelines applications and decisions mentioned are: Multi-pipeline cost of capital, Maritimes and North-East Pipeline Limited, TransCanada, Westcoast, and Petro-Canada Medicine Hat Pipeline. The next section of the presentation deals with potential Northern pipelines and the last section deals with the provincial picture in Alberta and British Columbia. refs., figs

  6. U.S. Department of Energy's regional carbon sequestration partnership initiative: Update on validation and development phases

    Science.gov (United States)

    Rodosta, T.; Litynski, J.; Plasynski, S.; Spangler, L.; Finley, R.; Steadman, E.; Ball, D.; Gerald, H.; McPherson, B.; Burton, E.; Vikara, D.

    2011-01-01

    The U.S. Department of Energy (DOE) is the lead federal agency for the development and deployment of carbon sequestration technologies. The Regional Carbon Sequestration Partnerships (RCSPs) are the mechanism DOE utilizes to prove the technology and to develop human capital, stakeholder networks, information for regulatory policy, best practices documents and training to work toward the commercialization of carbon capture and storage (CCS). The RCSPs are tasked with determining the most suitable technologies, regulations, and infrastructure for carbon capture, transport, and storage in their respective geographic areas of responsibility. The seven partnerships include more than 400 state agencies, universities, national laboratories, private companies, and environmental organizations, spanning 43 states and four Canadian provinces. The Regional Partnerships Initiative is being implemented in three phases: Characterization, Validation, and Development. The initial Characterization Phase began in 2003 and was completed in 2005 and focused on characterization of CO2 storage potential within each region. It was followed by the Validation Phase, which began in 2005 and is nearing completion in 2011. The focus of the Validation Phase has been on small-scale field tests throughout the seven partnerships in various formation types such as saline, oil-bearing, and coal seams. The Validation Phase has characterized suitable CO2 storage reservoirs and identified the need for comprehensive legal and regulatory frameworks to enable commercial-scale CCS deployment. Finally, the Development Phase will consist of a series of large-scale, one-million-ton, injection tests throughout the United States and Canada. The objective of these large-scale tests is to identify the regulatory path or challenges in permitting CCS projects, to demonstrate the technology can inject CO2 safely, and to verify its permanence in geologic formations in preparation for the commercialization of geologic

  7. Conceptual design of multi-source CCS pipeline transportation network for Polish energy sector

    Science.gov (United States)

    Isoli, Niccolo; Chaczykowski, Maciej

    2017-11-01

    The aim of this study was to identify an optimal CCS transport infrastructure for Polish energy sector in regards of selected European Commission Energy Roadmap 2050 scenario. The work covers identification of the offshore storage site location, CO2 pipeline network design and sizing for deployment at a national scale along with CAPEX analysis. It was conducted for the worst-case scenario, wherein the power plants operate under full-load conditions. The input data for the evaluation of CO2 flow rates (flue gas composition) were taken from the selected cogeneration plant with the maximum electric capacity of 620 MW and the results were extrapolated from these data given the power outputs of the remaining units. A graph search algorithm was employed to estimate pipeline infrastructure costs to transport 95 MT of CO2 annually, which amount to about 612.6 M€. Additional pipeline infrastructure costs will have to be incurred after 9 years of operation of the system due to limited storage site capacity. The results show that CAPEX estimates for CO2 pipeline infrastructure cannot be relied on natural gas infrastructure data, since both systems exhibit differences in pipe wall thickness that affects material cost.

  8. Conceptual design of multi-source CCS pipeline transportation network for Polish energy sector

    Directory of Open Access Journals (Sweden)

    Isoli Niccolo

    2017-01-01

    Full Text Available The aim of this study was to identify an optimal CCS transport infrastructure for Polish energy sector in regards of selected European Commission Energy Roadmap 2050 scenario. The work covers identification of the offshore storage site location, CO2 pipeline network design and sizing for deployment at a national scale along with CAPEX analysis. It was conducted for the worst-case scenario, wherein the power plants operate under full-load conditions. The input data for the evaluation of CO2 flow rates (flue gas composition were taken from the selected cogeneration plant with the maximum electric capacity of 620 MW and the results were extrapolated from these data given the power outputs of the remaining units. A graph search algorithm was employed to estimate pipeline infrastructure costs to transport 95 MT of CO2 annually, which amount to about 612.6 M€. Additional pipeline infrastructure costs will have to be incurred after 9 years of operation of the system due to limited storage site capacity. The results show that CAPEX estimates for CO2 pipeline infrastructure cannot be relied on natural gas infrastructure data, since both systems exhibit differences in pipe wall thickness that affects material cost.

  9. Cutting edge: the Foxp3 target miR-155 contributes to the development of regulatory T cells.

    Science.gov (United States)

    Kohlhaas, Susan; Garden, Oliver A; Scudamore, Cheryl; Turner, Martin; Okkenhaug, Klaus; Vigorito, Elena

    2009-03-01

    Foxp3 is a transcription factor that is essential for the normal development of regulatory T cells (Tregs). In the absence of microRNAs (miRNAs), Foxp3(+) Tregs develop but fail to maintain immune homeostasis, leading to a scurfy-like disease. Global analysis of the network of genes regulated by Foxp3 has identified the miRNA miR-155, which is highly expressed in Tregs, as a direct target of Foxp3. In this study we report that miR-155-deficient mice have reduced numbers of Tregs, both in the thymus and periphery, due to impaired development. However, we found no evidence for defective suppressor activity of miR-155-deficient Tregs, either in vitro or in vivo. Our results indicate that miR-155 contributes to Treg development, but that additional miRNAs control Treg function.

  10. CCS2, an Octatricopeptide-Repeat Protein, Is Required for Plastid CytochromecAssembly in the Green AlgaChlamydomonas reinhardtii.

    Science.gov (United States)

    Cline, Sara G; Laughbaum, Isaac A; Hamel, Patrice P

    2017-01-01

    In bacteria and energy generating organelles, c -type cytochromes are a class of universal electron carriers with a heme cofactor covalently linked via one or two thioether bonds to a heme binding site. The covalent attachment of heme to apocytochromes is a catalyzed process, taking place via three evolutionarily distinct assembly pathways (Systems I, II, III). System II was discovered in the green alga Chlamydomonas reinhardtii through the genetic analysis of the ccs mutants ( c ytochrome c s ynthesis), which display a block in the apo- to holo- form conversion of cytochrome f and c 6 , the thylakoid lumen resident c -type cytochromes functioning in photosynthesis. Here we show that the gene corresponding to the CCS2 locus encodes a 1,719 amino acid polypeptide and identify the molecular lesions in the ccs2-1 to ccs2-5 alleles. The CCS2 protein displays seven degenerate amino acid repeats, which are variations of the o ctatrico p eptide- r epeat motif (OPR) recently recognized in several nuclear-encoded proteins controlling the maturation, stability, or translation of chloroplast transcripts. A plastid site of action for CCS2 is inferred from the finding that GFP fused to the first 100 amino acids of the algal protein localizes to chloroplasts in Nicotiana benthamiana . We discuss the possible functions of CCS2 in the heme attachment reaction.

  11. [Defects in TOR regulatory complexes retard aging and carbonyl/oxidative stress development in yeast Saccharomyces cerevisiae].

    Science.gov (United States)

    Homza, B V; Vasyl'kovs'ka, R A; Semchyshyn, H M

    2014-01-01

    TOR signaling pathway first described in yeast S. cerevisiae is the highly conserved regulator of eukaryotic cell growth, aging and stress resistance. The effect of nitrogen sources, in particular amino acids, on the activity of TOR signaling pathway is well studied, however its relation to carbohydrates is poor understood. The aim of the present study is expanding of our understanding of potential role of TOR regulatory complexes in development of carbonyl/oxidative stress that can result from yeast cultivation on glucose and fructose. It has been shown that the level of alpha-dicarbonyl compounds and protein carbonyl groups increased with time of yeast cultivation and was higher in cells grown on fructose that demonstrated their accelerated aging and carbonyl/oxidative stress development as compared with cells grown on glucose. The strains defective in TOR proteins cultivated in the presence of glucose as well as fructose demonstrated lower markers of the stress and aging than parental strain. Thus these data confirmed the previous conclusion on fructose more potent ability to cause carbonyl/oxidative stress and accelerated aging in S. cerevisiae as compared with glucose. However, defects in TOR regulatory complexes retard aging and development of the stress in yeast independent on the type of carbohydrate in the cultivation medium.

  12. A set of regulatory genes co-expressed in embryonic human brain is implicated in disrupted speech development.

    Science.gov (United States)

    Eising, Else; Carrion-Castillo, Amaia; Vino, Arianna; Strand, Edythe A; Jakielski, Kathy J; Scerri, Thomas S; Hildebrand, Michael S; Webster, Richard; Ma, Alan; Mazoyer, Bernard; Francks, Clyde; Bahlo, Melanie; Scheffer, Ingrid E; Morgan, Angela T; Shriberg, Lawrence D; Fisher, Simon E

    2018-02-20

    Genetic investigations of people with impaired development of spoken language provide windows into key aspects of human biology. Over 15 years after FOXP2 was identified, most speech and language impairments remain unexplained at the molecular level. We sequenced whole genomes of nineteen unrelated individuals diagnosed with childhood apraxia of speech, a rare disorder enriched for causative mutations of large effect. Where DNA was available from unaffected parents, we discovered de novo mutations, implicating genes, including CHD3, SETD1A and WDR5. In other probands, we identified novel loss-of-function variants affecting KAT6A, SETBP1, ZFHX4, TNRC6B and MKL2, regulatory genes with links to neurodevelopment. Several of the new candidates interact with each other or with known speech-related genes. Moreover, they show significant clustering within a single co-expression module of genes highly expressed during early human brain development. This study highlights gene regulatory pathways in the developing brain that may contribute to acquisition of proficient speech.

  13. Mapping Gene Regulatory Networks in Drosophila Eye Development by Large-Scale Transcriptome Perturbations and Motif Inference

    Directory of Open Access Journals (Sweden)

    Delphine Potier

    2014-12-01

    Full Text Available Genome control is operated by transcription factors (TFs controlling their target genes by binding to promoters and enhancers. Conceptually, the interactions between TFs, their binding sites, and their functional targets are represented by gene regulatory networks (GRNs. Deciphering in vivo GRNs underlying organ development in an unbiased genome-wide setting involves identifying both functional TF-gene interactions and physical TF-DNA interactions. To reverse engineer the GRNs of eye development in Drosophila, we performed RNA-seq across 72 genetic perturbations and sorted cell types and inferred a coexpression network. Next, we derived direct TF-DNA interactions using computational motif inference, ultimately connecting 241 TFs to 5,632 direct target genes through 24,926 enhancers. Using this network, we found network motifs, cis-regulatory codes, and regulators of eye development. We validate the predicted target regions of Grainyhead by ChIP-seq and identify this factor as a general cofactor in the eye network, being bound to thousands of nucleosome-free regions.

  14. Regulatory odour model development: Survey of modelling tools and datasets with focus on building effects

    DEFF Research Database (Denmark)

    Olesen, H. R.; Løfstrøm, P.; Berkowicz, R.

    A project within the framework of a larger research programme, Action Plan for the Aquatic Environment III (VMP III) aims towards improving an atmospheric dispersion model (OML). The OML model is used for regulatory applications in Denmark, and it is the candidate model to be used also in future...... in relation to odour problems due to animal farming. However, the model needs certain improvements and validation in order to be fully suited for that purpose. The report represents a survey of existing literature, models and data sets. It includes a brief overview of the state-of-the-art of atmospheric...... dispersion models for estimating local concentration levels in general. However, the report focuses on some particular issues, which are relevant for subsequent work on odour due to animal production. An issue of primary concern is the effect that buildings (stables) have on flow and dispersion. The handling...

  15. A draft of guidance from the scientific Research Programme GEOTECHNOLOGIEN to underpin the implementation of the CCS Directive in Germany

    Science.gov (United States)

    Streibel, Martin; Schoebel, Birgit

    2015-04-01

    In 2004 the Federal Ministry of Education and Research of Germany launched the programme GEOTECHNOLOGIEN with one key aspect being the development of technologies for sustainable storage of carbon dioxide in geological formations. Within this research field more than 30 projects in three consecutive programme phases have been funded up to the end of 2014. In order to benefit from the gathered knowledge and use the experiences for the policy/law making process the umbrella project AUGE has been launched in October 2012 with a life time of three years. The aim of the project is to review and compile all results of projects funded during the three phases to underpin the appendices of the German transposition of the EC Directive 2009/31/EC the "Carbon Dioxide Storage Law" (KSpG). The results of the projects have been structured along the lines of the two appendices of the KSpG which are similar to the ones of the EC Directive. The detailed structure follows the CSA Z741, Canada's first CCS standard for the geological storage of carbon emissions deep underground. This document also serves as the draft version for the ISO Technical Committee 265 "Carbon dioxide capture, transportation, and geological storage". From the risk management perspective, according to ISO 31000, most of the research performed in the above mentioned scientific programme dealt with contextual background of geological CO2 storage asking the question which physical, chemical and biological interactions of CO2 are most important to understand to evaluate if CO2 storage in general is feasible. This lead to risk identification, risk analysis and risk evaluation. Major topics of the scientific programme were • site characterisation with development and optimisation of laboratory procedures and implementation amongst other activities at the pilot site at Ketzin; • optimization of seismic procedures for site characterisation and the detection of injected CO2; • physical, chemical and microbiological

  16. Carbon dioxide capture and storage. Public perception, policy and regulatory issues in the Netherlands

    Energy Technology Data Exchange (ETDEWEB)

    De Coninck, H.C. [ECN Policy Studies, Amsterdam (Netherlands); Huijts, N.M.A. [Human Technology Interactions, Eindhoven University of Technology TUE, Eindhoven (Netherlands)

    2004-07-01

    While CO2 capture and storage (CCS) projects are quickly emerging all over the world, uncertainty is prevailing on the public acceptance, a legal framework, and the policy incentives for CCS. Fulfilment of these requirements is essential for CCS deployment. This paper discusses the state of affairs in the Netherlands. The reported public perception study highlights the results of an inquiry on the perception of CCS with 112 people in the city of Alkmaar and surroundings in the Northwest of the Netherlands. Alkmaar is located above a gas storage field, which in the past has caused several small earthquakes. It can be concluded that the average attitude towards CO2 capture and storage is not positive but also not rejecting, although the drawbacks of the technology were regarded greater than the benefits, and significant NIMBY feelings could be distinguished. The public's feelings associated with storage of CO2 seem to be dominated by concern. Besides public perception of CCS, the legal and policy framework are key to implementation of CCS. The legal framework in the Netherlands is developing with a big step taken by the coming into force of a Mining Act allowing storage of CO2 in the underground under conditions for safety and environmental impacts. Policy incentives include the European Union Emissions Trading System, Joint Implementation, and an electricity subsidy of 7 eurocents/kWh for a Zero Emission Power Plant. All things combined, CCS appears to have good chances, even of short-term commercial implementation in the Netherlands. The occurrence of NIMBY feelings, however, should be taken into account when CCS is planned in populated areas.

  17. Performance Analysis of Cold Energy Recovery from CO2 Injection in Ship-Based Carbon Capture and Storage (CCS

    Directory of Open Access Journals (Sweden)

    Hwalong You

    2014-11-01

    Full Text Available Carbon capture and storage (CCS technology is one of the practical solutions for mitigating the effects of global warming. When captured CO2 is injected into storage sites, the CO2 is subjected to a heating process. In a conventional CO2 injection system, CO2 cold energy is wasted during this heating process. This study proposes a new CO2 injection system that takes advantage of the cold energy using the Rankine cycle. The study compared the conventional system with the new CO2 injection system in terms of specific net power consumption, exergy efficiency, and life-cycle cost (LCC to estimate the economic effects. The results showed that the new system reduced specific net power consumption and yielded higher exergy efficiency. The LCC of the new system was more economical. Several cases were examined corresponding to different conditions, specifically, discharge pressure and seawater temperature. This information may affect decision-making when CCS projects are implemented.

  18. Component Functional Allocations of the ESF Multi-loop Controller for the KNICS ESF-CCS Design

    International Nuclear Information System (INIS)

    Hur, Seop; Choi, Jong Kyun; Kim, Dong Hoon; Kim, Ho; Kim, Seong Tae

    2006-01-01

    The safety related components in nuclear power plants are traditionally controlled by single-loop controllers. Traditional single-loop controller systems utilize dedicated processors for each component but that components independence is compromised through a sharing of power supplies, auxiliary logic modules and auxiliary I/O cards. In the new design of the ESF-CCS, the multi-loop controllers with data networks are widely used. Since components are assigned to ESF-CCS functional groups in a manner consistent with their process relationship, the effects of the failures are predictable and manageable. Therefore, the key issues for the design of multi-loop controller is to allocate the components to the each multi-loop controller through plant and function analysis and grouping. This paper deals with an ESF component functional allocation which is performed through allocation criteria and a fault analysis

  19. Consideration of the Development of the Gastrointestinal Tract in the Choice of Species for Regulatory Juvenile Studies.

    Science.gov (United States)

    Downes, Noel John

    2018-01-15

    Although the rat is close to being the automatic choice for regulatory juvenile toxicity studies, there are several shortcomings in this model. Choosing a species should take into serious consideration the importance of gastrointestinal tract development in the period before weaning as this may have a major effect on exposure. A comparison of the anatomical changes in the stomach and small intestine of mini-pig and rat show that the mini-pig is a far closer model for man than is the rat, although there are a few unusual aspects of small intestinal development in the mini-pig. Considerations of the development of the gastrointestinal tract and choice of species have the potential to affect safety assessment and should be a prime consideration when planning an investigation. Birth Defects Research 110:56-62, 2018. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

  20. Techno-economic evaluation of significant CO2 emission reductions in the iron and steel industry with CCS

    OpenAIRE

    Arasto, Antti

    2015-01-01

    The iron and steel industry is one of the largest emitters of industrial CO2, accounting for around 6% of global anthropogenic CO2 emissions each year. In Europe, the recently proposed stricter emission reduction targets for 2030 are likely to increase the price for CO2 emission allowances. Various different GHG emission mitigation alternatives have been considered to enable decarbonisation of the iron and steel industry, such as energy efficiency, biogenic reducing agents, hydrogen and CCS. ...

  1. Experience of regulatory body functioning in energy industry of Ukraine: Prospects for future development of state regulation of energy

    International Nuclear Information System (INIS)

    Oruskaya, M.

    2002-01-01

    Materials collected (presented) in the paper introduce to (familiarise) the audience with the main forms, methods and phases of the state regulation of energy industry in Ukraine in the period of transition to market economy. Special attention was paid to the following aspects: 1. Necessity and history of establishment of special regulatory body in Ukraine - The National Electricity Regulatory Commission (NERC); 2. The main tasks and authorities of NERC according to the Ukraine Law on Energy Sector; 3. Regulation mechanisms of the main processes in the energy industry used by the Commission on the current level of energy sector development and economic results of its introduction; 4. Problems with functioning of the wholesale energy market specifically as the main component of the Ukraine energy industry and trends of future development (improvement of energy industry's financial situation, intensification of competition between energy producers and suppliers, improvement of tariff and investment policies, etc.); 5. Necessity and ways of future improvement of the standards and legal basis for regulation in Ukraine. (author)

  2. Regulatory RNAs in Planarians.

    Science.gov (United States)

    Pawlicka, Kamila; Perrigue, Patrick M; Barciszewski, Jan

    2016-01-01

    The full scope of regulatory RNA evolution and function in epigenetic processes is still not well understood. The development of planarian flatworms to be used as a simple model organism for research has shown a great potential to address gaps in the knowledge in this field of study. The genomes of planarians encode a wide array of regulatory RNAs that function in gene regulation. Here, we review planarians as a suitable model organism for the identification and function of regulatory RNAs.

  3. Effects of carbon and nitrogen in austenitic stainless steel on sensitization behavior through TTS and CCS diagram

    International Nuclear Information System (INIS)

    Borah, D.; Roychowdhury, S.; Kain, V.; Ghosh Acharyya, S.

    2012-01-01

    Intergranular Corrosion (IGC) and Intergranular Stress Corrosion Cracking (IGSCC) are important corrosion issues for austenitic stainless steels (SS) used in nuclear, chemical process and power industries etc. Time-temperature-sensitisation (TTS) and continuous-cooling-sensitization (CCS) diagrams represent the susceptibility to sensitisation. TTS and CCS diagrams for ditch microstructure also can be used to predict the operations/heat treatments which are to be avoided to prevent component materials from IGC degradation. In the present study austenitic SS grades 304, SS 304L, 304LN and SS 304L (NAG) were subjected to heat treatment at a temperature range of 550 ℃ to 850 ℃ for different time durations ranging from 2 min to 300 h. This was followed by double loop potentiodynamic reactivation testing (DL-EPR) on all the materials in all the different heat treated conditions for correlating to the susceptibility to IGC and IGSCC. The TTS and CCS diagrams for 'ditch' microstructure and DL-EPR value of 1 were derived for all the studied materials. In addition, a comprehensive analysis of the effect of alloying additions e.g. C and N etc. on the sensitization kinetics and susceptibility to IGC and IGSCC has been established in this study. (author

  4. Adoption of Agricultural Conservation Practices in the Ignacio Agramonte Cooperative of Credits and Services (CCS, Nuevitas, Camaguey

    Directory of Open Access Journals (Sweden)

    Arelys Valido Tomé

    2016-09-01

    Full Text Available The adoption of sustainable technologies, like Agriculture Conservation Practices in drought-stricken suburban areas is a must for land sustainable management. In order to contribute with the inclusion of this technology at the Ignacio Agramonte CCS, in El Carmen, municipality of Nuevitas, Camaguey, Agricultural Extension tools were used, like systemic diagnostic and participatory orientation. The SWOT matrix was created after three workshops, where agricultural conservation practices were identified for adoption, based on actual conditions at the CCS. As a result, five key problems were identified: lack of water for irrigation, saline waters, saline soils, use of inappropriate management technologies, deforestation and poor training in agriculture. The most critical impact found in the matrix was in Weaknesses - Threats (81.3%. Furthermore, local farmers, inhabitants and public officials agreed on the use of agricultural extension tools to provide positive elements and an effective way to help increase motivation and knowledge about agricultural conservation technology, as an alternative to mitigate the degradation state of lands at the CCS.

  5. Development of default uncertainties for the value/benefit attributes in the regulatory analysis technical evaluation handbook

    International Nuclear Information System (INIS)

    Gallucci, Raymond H.V.

    2016-01-01

    Highlights: • Uncertainties for values/benefits. • Upper bound four times higher than mean. • Distributional histograms. - Abstract: NUREG/BR-0184, Regulatory Analysis Technical Evaluation (RATE) Handbook, was produced in 1997 as an update to the original NUREG/CR-3568, A Handbook for Value-Impact Assessment (1983). Both documents, especially the later RATE Handbook, have been used extensively by the USNRC and its contractors not only for regulatory analyses to support backfit considerations but also for similar applications, such as Severe Accident Management Alternative (SAMA) analyses as part of license renewals. While both provided high-level guidance on the performance of uncertainty analyses for the various value/benefit attributes, detailed quantification was not of prime interest at the times of the Handbooks’ development, defaulting only to best estimates with low and high bounds on these attributes. As the USNRC examines the possibility of updating the RATE Handbook, renewed interest in a more quantitative approach to uncertainty analyses for the attributes has surfaced. As the result of an effort to enhance the RATE Handbook to permit at least default uncertainty analyses for the value/benefit attributes, it has proven feasible to assign default uncertainties in terms of 95th %ile upper bounds (and absolute lower bounds) on the five dominant value/benefit attributes, and their sum, when performing a regulatory analysis via the RATE Handbook. Appropriate default lower bounds of zero (no value/benefit) and an upper bound (95th %ile) that is four times higher than the mean (for individual value/benefit attributes) or three times higher (for their summation) can be recommended. Distributions in the form of histograms on the summed value/benefit attributes are also provided which could be combined, after appropriate scaling and most likely via simulation, with their counterpart(s) from the impact/cost analysis to yield a final distribution on the net

  6. Developing a regulatory framework for the financial, management performance and social reporting systems for co-operatives in developing countries: A case study of South Africa

    OpenAIRE

    Gideon Nieman; Karel Fouché

    2016-01-01

    Purpose: This report is on a team effort to advise the Department of Trade and Industry on the development of a regulatory framework for the auditing of Financial, Management. Performance and Social Reporting Systems for co-operatives.  Orientation: There was no framework in place prescribing requirements for reporting on financial, management and social performance of co-operatives. As a result, the team assisted the Department of Trade and Industry with the development of a proposed repo...

  7. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    International Nuclear Information System (INIS)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral; Rocha, Bruna Oliveira; Santos-Oliveira, Ralph

    2014-01-01

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  8. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Directory of Open Access Journals (Sweden)

    Maryelle Moreira Lima Gamboa

    2014-04-01

    Full Text Available Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ or positrons emitter (β+, linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64. In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs.

  9. Development and Delivery of Coursework: The Legal/Regulatory/Policy Environment of Cyberforensics

    Directory of Open Access Journals (Sweden)

    John W. Bagby

    2006-06-01

    Full Text Available This paper describes a cyber-forensics course that integrates important public policy and legal issues as well as relevant forensic techniques. Cyber-forensics refers to the amalgam of multi-disciplinary activities involved in the identification, gathering, handling, custody, use and security of electronic files and records, involving expertise from the forensic domain, and which produces evidence useful in the proof of facts for both commercial and legal activities. The legal and regulatory environment in which electronic discovery takes place is of critical importance to cyber-forensics experts because the legal process imposes both constraints and opportunities for the effective use of evidence gathered through cyber-forensic techniques. This paper discusses different pedagogies that can be used (including project teams, research and writing assignments, student presentations, case analyses, class activities and participation and examinations, evaluation methods, problem-based learning approaches and critical thinking analysis. A survey and evaluation is provided of the growing body of applicable print and online materials that can be utilized. Target populations for such a course includes students with majors, minors or supporting elective coursework in law, information sciences, information technology, computer science, computer engineering, financial fraud, security and information assurance, forensic aspects of cyber security, privacy, and electronic commerce.

  10. Obligations, precautions and pending issues in regulatory development for radiopharmaceuticals in Brazil

    Energy Technology Data Exchange (ETDEWEB)

    Gamboa, Maryelle Moreira Lima; Roesch, Heveline Rayane Moura; Lemos, Vanessa Pinheiro Amaral, E-mail: maryellelg@hotmail.com [PPG BioSaude, Universidade Luterana do Brasil, Canoas, RS (Brazil); Rocha, Bruna Oliveira [Faculty of Biology, Universidade Luterana do Brasil, Canoas, RS (Brazil); Santos-Oliveira, Ralph [Institute of Radiopharmacy Research, Universidade Estadual da Zona Oeste, Rio de Janeiro, RJ (Brazil)

    2014-04-15

    Radiopharmaceuticals are compounds that have a radionuclide and may be gamma-radiation emitter (γ) or positrons emitter (β+), linked to a molecule with specific diagnostic and therapeutic purposes. The progress in the use of radiopharmaceuticals has culminated to a sector in common with other types of drugs: regulation and surveillance. >From 2006 on, production, marketing and use of these drugs were open to the Brazilian market granting much more freedom due to the Constitutional Amendment 49, resulting from the previous Constitutional Amendment 199/03 which removes the Union monopoly for this kind of manipulation and granted this production to other nuclear medicine. From this date on, the amount of this type of sold product have been greatly increased, and the nucleus of surveillance and regulation in Brazil have also advanced in the legislative processes, creating documents that are now more focused on radiopharmaceuticals in the national territory (Resolutions No. 63 and No. 64). In international overview, there is too much to be done in regulatory terms in Brazil, such as adding mainly issues of drugs surveillance to pharmacovigilance practice in radiopharmaceuticals drugs. (author)

  11. THE MEDICO-SCIENTIFIC MARGINALISATION OF HOMEOPATHY: INTERNATIONAL LEGAL AND REGULATORY DEVELOPMENTS.

    Science.gov (United States)

    Freckelton, Ian

    2015-09-01

    The 2010 report of the United Kingdom Science and Technology Committee of the House of Commons and the 2015 report of the Australian National Health and Medical Research Council have overtaken in significance the uncritical Swiss report of 2012 and have gone a long way to changing the environment of tolerance toward proselytising claims of efficacy in respect of homeopathy. The inquiry being undertaken in the United States by the Food and Drug Administration during 2015 may accelerate this trend. An outcome of the reports and inquiries has been a series of decisions from advertising regulators and by courts rejecting medically unjustifiable claims in respect of the efficacy of homeopathy. Class actions have also been initiated in North America against manufacturers of homeopathic products. The changing legal and regulatory environment is generating an increasingly scientifically marginalised existence for homeopathy. That new environment is starting to provide effective inhibition of assertions on behalf of homeopathy and other health modalities whose claims to therapeutic efficacy cannot be justified by reference to the principles of evidence-based health care. This has the potential to reduce the financial support that is provided by insurers and governments toward homeopathy and to result in serious liability exposure for practitioners, manufacturers and those who purvey homeopathic products, potentially including pharmacists. In addition, it may give a fillip to a form of regulation of homeopaths if law reform to regulate unregistered health practitioners gathers momentum, as is taking place in Australia.

  12. Standardization of nuclear power plants in the United States: recent regulatory developments

    International Nuclear Information System (INIS)

    Cowan, B.Z.; Tourtellotte, J.R.

    1992-01-01

    On April 18, 1989, the United States (U.S.) Nuclear Regulatory Commission (NRC) amended the regulations governing the process for licensing nuclear power plants in the United States to provide for issuance of early site permits, standard design certifications and combined construction permits and operating licenses for nuclear power reactors. The new regulations are designed to achieve early resolution of licensing issues and facilitate standardization of nuclear power plants in the United States. The program for design standardization is central to efforts mounted by the U.S. government and industry to ensure that there will be a next generation of nuclear power facilities in the U.S. The most significant changes are provisions for certification of standard designs and for issuance prior to start of construction of combined licenses which incorporate a construction permit and an operating license with conditions. Such certifications and combined licenses must contain tests, inspections and analyses, and acceptance criteria, which are necessary and sufficient to provide reasonable assurance that the facility has been constructed and will operate in accordance with the combined license. A number of significant implementation issues have arisen. In addition a major court case brought by several anti-nuclear groups is pending, challenging NRC authority to issue combined licenses. It is the goal of the U.S. nuclear industry to have the first of the next generation of standardized nuclear power plants ordered, licensed, constructed and on-line by the year 2000. (author)

  13. Development of the sinus venosus myocardium from the posterior second heart field : implications for sinoatrial and atrioventricular mode development

    NARCIS (Netherlands)

    Vicente Steijn, Rebecca

    2011-01-01

    While the embryonic heart is developing and maturing towards its four-chambered form, the cardiac conduction system (CCS) is developing as well. The CCS will provide the heart with the required wiring system to ensure the properly orchestrated contraction of the myocardial chambers. In both the

  14. Coal reserves and resources as well as potentials for underground coal gasification in connection with carbon capture and storage (CCS)

    Science.gov (United States)

    Ilse, Jürgen

    2010-05-01

    Coal is the energy source with the largest geological availability worldwide. Of all non-renewable energies coal and lignite accounting for 55 % of the reserves and some 76 % of the resources represent the largest potential. Reserves are those geological quantities of a mineral which can currently be mined under technically and economically viable conditions. Resources are those quantities which are either proven but currently not economically recoverable or quantities which can still be expected or explored on the basis of geological findings. The global availability of energy source does not only depend on geological and economic factors. The technical availability, e.g. mining and preparation capacities, the sufficient availability of land and sea-borne transportation as well as transloading capacities and also a political availability are required likewise. The latter may be disturbed by domestic-policy disputes like strikes or unrest or by foreign-policy disputes like embargos, trade conflicts or even tensions and wars in the producing regions. In the energy-economic discussion the reach of fossil primary energies plays a central role with the most important questions being: when will which energy source be exhausted, which impact will future developments have on the energy price, what does the situation of the other energies look like and which alternatives are there? The reach of coal can only be estimated because of the large deposits on the one hand and the uncertain future coal use and demand on the other. The stronger growth of population and the economic catching-up process in the developing and threshold countries will result in a shift of the production and demand centres in the global economy. However, also in case of further increases the geological potential will be sufficient to reliably cover the global coal demand for the next 100 years. The conventional mining of seams at great depths or of thin seams reaches its technical and economic limits

  15. CCS in the North Sea region: A comparison on the cost-effectiveness of storing CO2 in the Utsira formation at regional and national scales

    DEFF Research Database (Denmark)

    Strachan, N.; Hoefnagels, R.; Ramirez, A.

    2011-01-01

    modelling at the national level (ensuring country-specific technical, economic and policy detail), and the regional level (ensuring transboundary electricity and CO2 trade). Analysis at alternate model scales investigates the full range of drivers on the feasibility and trade-offs in using the Utsira......The potential scale of carbon dioxide capture and storage (CCS) under long-term decarbonisation scenarios means that analysis on the contribution of large international CO2 storage reservoirs is critical. This paper compares the potentially key role of CCS within cost-optimizing energy systems...... formation as a common North Sea CO2 storage resource. A robust finding is that low carbon electricity is a primary decarbonisation pathway and that CCS plays a key role (32–40%) within this portfolio. This paper confirms that the overall driver of the amount of CCS utilized is the climate policy...

  16. Quality of alcohol-based hand disinfectants and their regulatory status. Development and marketing authorisation.

    Science.gov (United States)

    Stengele, Michael

    2008-10-01

    A 2005 survey showed that there are at least four legal product classifications for hand disinfectants in the European Union: medicinal products, biocidal products, cosmetics and medical devices. An internationally harmonized classification does not exist. The regulatory status of those products is defined at national level. In order to assure compliance with the regulations these four classifications provide different levels of official surveillance varying from product-specific marketing authorisations and production site audits to the obligation to just work in accordance with certain general guidelines. Biocidal product regulations cover eco-toxicological and toxicological aspects, but do not very much address to the customers' quality and efficacy expectations. In contrast, the medicinal product legislation is the most ambitious one claiming quality, safety, efficacy, and an independent benefit risk-assessment by an authority. In respect of ambition, the two remaining product categories--cosmetics and medical devices--rank between the both classifications mentioned above. For medical devices, it is the responsibility of the manufacturer to make sure the products meet defined essential requirements regarding quality, safety and performance and to have an appropriate quality assurance system implemented under third party control. For cosmetics there are some legal restrictions, but within these it is the sole responsibility of the manufacturer to ensure that the products are safe and fulfil their claims. This paper describes one way out of this increasingly complex situation, the definition of a single quality standard meeting the users' expectations as well as all legal requirements regardless of the specific sales country. This international quality standard for products would take priority over any individual national standard, to the benefit of users.

  17. Managing and understanding risk perception of surface leaks from CCS sites: risk assessment for emerging technologies and low-probability, high-consequence events

    Science.gov (United States)

    Augustin, C. M.

    2015-12-01

    Carbon capture and storage (CCS) has been suggested by the Intergovernmental Panel on Climate Change as a partial solution to the greenhouse gas emissions problem. As CCS has become mainstream, researchers have raised multiple risk assessment issues typical of emerging technologies. In our research, we examine issues occuring when stored carbon dioxide (CO2) migrates to the near-surface or surface. We believe that both the public misperception and the physical reality of potential environmental, health, and commercial impacts of leak events from such subsurface sites have prevented widespread adoption of CCS. This paper is presented in three parts; the first is an evaluation of the systemic risk of a CCS site CO2 leak and models indicating potential likelihood of a leakage event. As the likelihood of a CCS site leak is stochastic and nonlinear, we present several Bayesian simulations for leak events based on research done with other low-probability, high-consequence gaseous pollutant releases. Though we found a large, acute leak to be exceptionally rare, we demonstrate potential for a localized, chronic leak at a CCS site. To that end, we present the second piece of this paper. Using a combination of spatio-temporal models and reaction-path models, we demonstrate the interplay between leak migrations, material interactions, and atmospheric dispersion for leaks of various duration and volume. These leak-event scenarios have implications for human, environmental, and economic health; they also have a significant impact on implementation support. Public acceptance of CCS is essential for a national low-carbon future, and this is what we address in the final part of this paper. We demonstrate that CCS remains unknown to the general public in the United States. Despite its unknown state, we provide survey findings -analyzed in Slovic and Weber's 2002 framework - that show a high unknown, high dread risk perception of leaks from a CCS site. Secondary findings are a

  18. Competition and Synergy of Different Technologies in the Subsurface: A Case Study for CCS vs. Geothermal Energy Production

    Science.gov (United States)

    Kissinger, Alexander; Juan-Lien Ramírez, Alina; Class, Holger

    2013-04-01

    Global climate change, shortage of resources and the resulting turn towards renewable sources of energy lead to a growing demand for the utilization of subsurface systems. Among these competing uses are Carbon Capture and Storage (CCS), geothermal energy, nuclear waste disposal, "renewable" methane or hydrogen storage as well as the ongoing production of fossil resources like oil, gas, and coal. The different uses of the subsurface can result in competition for the limited subsurface space, but in some cases there may also be synergetic effects, if the technologies are combined in a clever way. The idea behind this case study is to investigate the effects of a CCS site on a geothermal power plant operated in its vicinity and present both positive and negative impacts. During CCS operations large quantities of carbon dioxide (CO2) are injected into a storage formation. This causes a pressure increase as the brine in the formation is displaced by CO2. These elevations in pressure can have an extent of several tens of kilometers from the injection well in contrast to the much smaller extent of the CO2 plume. If geothermal power plants operate in the range influenced by pressure evaluation, this may have an impact on their performance. For example: Increased discharge of "warm" brine could be favorable for geothermal power plants as the time until thermal depletion of the reservoir may also increase Early breakthrough of the cold water front between an injection and an extraction well due to a brine discharge "pushing" the cold water front towards the extraction well may lead to a decrease in performance of the power plant Of course, there is a huge number of possible hydrogeological settings and technical configurations for geothermal power production that may be combined to an even larger number of possible scenarios. In this work however we use a simple model setup in which we incorporate and vary the parameters that we think are crucial. Only porous (not fractured

  19. A Cellular MicroRNA Facilitates Regulatory T Lymphocyte Development by Targeting the FOXP3 Promoter TATA-Box Motif.

    Science.gov (United States)

    Zhang, Yiwen; Liu, Weiwei; Chen, Yingshi; Liu, Jun; Wu, Kang; Su, Lishi; Zhang, Wanying; Jiang, Yawen; Zhang, Xu; Zhang, Yijun; Liu, Chao; Tao, Liang; Liu, Bingfeng; Zhang, Hui

    2018-02-01

    The CD4 + CD25 + FOXP3 + regulatory T cells (Tregs) mediate immunological self-tolerance and suppress various immune responses. FOXP3 is a key transcriptional factor for the generation and development of Tregs. Its expression is regulated by various cytokines including TGF-β, IL-2, and IL-10. It is important to further identify the regulatory factors for Tregs. Given that many microRNAs (miRNAs) could specifically interact with the core promoter region and specifically enhance the transcription of many target genes, we searched for any possible miRNA(s) targeting the core promoter region of the FOXP3 gene. We found that miR-4281, an miRNA specifically expressed in hominids, can potently and specifically upregulate FOXP3 expression by directly interacting with the TATA-box motif in the human FOXP3 promoter. Consequently, miR-4281 significantly accelerated the differentiation of human naive cells to induced Tregs (iTregs) that possess immune suppressor functions and weaken the development of graft-versus-host disease in a humanized mouse model. Interestingly, iTregs induced by the combination of TGF-β, IL-2, and chemically synthesized miR-4281 were more stable and functional than those induced by TGF-β and IL-2 alone. Moreover, we found that the IL-2/STAT5 signal transduction upregulates FOXP3 expression not only through the classical pathway, but also by enhancing the expression of the miR-4281 precursor gene ( SNCB ) and, correspondingly, miR-4281. This study reveals a novel mechanism regulating FOXP3 expression and human iTreg development and, therefore, offers a new therapeutic target to manipulate immunosuppressive system. Copyright © 2018 by The American Association of Immunologists, Inc.

  20. Profligate Biotin Synthesis in α-Proteobacteria – A Developing or Degenerating Regulatory System?

    Science.gov (United States)

    Feng, Youjun; Zhang, Huimin; Cronan, John E.

    2013-01-01

    Summary Biotin (vitamin H) is a key enzyme cofactor required in all three domains of life. Although this cofactor was discovered over 70 years ago and has long been recognized as an essential nutrient for animals, our knowledge of the strategies bacteria use to sense biotin demand is very limited. The paradigm mechanism is that of Escherichia coli in which BirA protein, the prototypical bi-functional biotin protein ligase, both covalently attaches biotin to the acceptor proteins of central metabolism and represses transcription of the biotin biosynthetic pathway in response to biotin demand. However, in other bacteria the biotin protein ligase lacks a DNA-binding domain which raises the question of how these bacteria regulate the synthesis of biotin, an energetically expensive molecule. A bioinformatic study by Rodionov and Gelfand (FEMS Microbiol Lett. (2006) 255:102–107) identified a protein termed BioR in α-proteobacteria and predicted that BioR would have the biotin operon regulatory role that in most other bacteria is fulfilled by the BirA DNA-binding domain. We have now tested this prediction in the plant pathogen Agrobacterium tumefaciens. As predicted the A. tumefaciens biotin protein ligase is a fully functional ligase that has no role in regulation of biotin synthesis whereas BioR represses transcription of the biotin synthesis genes. Moreover, as determined by electrophoretic mobility shift assays, BioR binds the predicted operator site, which is located downstream of the mapped transcription start site. qPCR measurements indicated that deletion of BioR resulted in a ca.15-fold increase of bio operon transcription in the presence of high biotin levels. Effective repression of a plasmid-borne bioB-lacZ reporter was seen only upon the overproduction of BioR. In contrast to E. coli and Bacillus subtilis where biotin synthesis is tightly controlled, A. tumefaciens synthesizes much more biotin than needed for modification of the biotin-requiring enzymes

  1. Eddy Covariance Method for CO2 Emission Measurements: CCS Applications, Principles, Instrumentation and Software

    Science.gov (United States)

    Burba, George; Madsen, Rod; Feese, Kristin

    2013-04-01

    and technical papers. A free open-source software package with a user-friendly interface was developed accordingly for computing final fully corrected CO2 emission numbers [10]. The presentation covers highlights of the eddy covariance method, its application to geological carbon sequestration, key requirements, instrumentation and software, and reviews educational resources particularly useful for carbon sequestration research. References: [1] Aubinet, M., T. Vesala, and D. Papale (Eds.), 2012. Eddy Covariance: A Practical Guide to Measurement and Data Analysis. Springer-Verlag, 442 pp. [2] Foken T., 2008. Micrometeorology. Springer-Verlag, 308 pp. [4] Finley, R., 2009. An Assessment of Geological Carbon Sequestration in the Illinois Basin Overview of the Decatur-Illinois Basin Site. MGSC, http://www.istc.illinois.edu/info/govs_awards_docs/2009-GSA-1100-Finley.pdf [5] Liu, G. (Ed.), 2012. Greenhouse Gases: Capturing, Utilization and Reduction. Intech, 338 pp. [6] LI-COR Biosciences, 2011. Surface Monitoring for Geologic Carbon Sequestration Monitoring: Methods, Instrumentation, and Case Studies. LI-COR Biosciences, Pub. 980-11916, 15 pp. [7] Benson, S., 2006. Monitoring carbon dioxide sequestration in deep geological formations for inventory verification and carbon credits, SPE-102833, Presentation [8] Lewicki, J., G. Hilley, M. Fischer, L. Pan, C. Olden-burg, C. Dobeck, and L. Spangler, 2009.Eddy covariance observations of leakage during shallow subsurface CO2 releases. Journal of Geophys Res, 114: D12302 [9] Burba, G., 2013. Eddy Covariance Method for Scientific, Industrial, Agricultural and Regulatory Applications. LI-COR Biosciences, 328 pp. [10] LI-COR Biosciences, 2012. EddyPro 4.0: Help and User's Guide. Lincoln, NE, 208 pp.

  2. On the Basic Principles of Creating a Regulatory Framework for Strategic Planning of Innovative Development of the Russian Economy

    Directory of Open Access Journals (Sweden)

    Yu. V. Mishin

    2017-01-01

    Full Text Available Purpose: the aim of the work is to substantiate methodological approaches to create the most important component of strategic planning – its regulatory framework. The relevance of the chosen topic of this article is due to the fact that in modern conditions, strategic planning is an important tool for ensuring sustainable development and increasing the competitiveness of the domestic economy. It allows you to identify the most important and priority areas of activity, distribute and ensure the effective use of available limited labor, material and, most importantly, financial resources. Today, domestic strategic planning has a number of significant shortcomings, the main one of which, in our opinion, is the lack of reliable initial information for forecasting and analytical calculations. Methods: the methodological basis is the dialectical method of scientific cognition, the systemic and institutional approach to building an effective information base of strategic planning. In the course of research of the current state and level of industrial rationing, methods of analysis and synthesis, comparisons and analogies were used. As a methodological basis of this article, regulatory legal documents were used in the field of strategic planning in Russia, as well as methodological documents that previously operated in the USSR on the regulation of resource consumption. Results: the result of the work are the goals, tasks and requirements for the strategic planning base proposed by the author. The relationship of production rationing with the basic principles of strategic planning is shown - balance and consistency in priorities, goals, objectives, activities, resources and timing; The effectiveness of methods and methods for achieving goals with the least expenditure of resources used. The possibility of the existence of a standardization of labor costs, the consumption of material and production resources, regardless of the form of ownership of the

  3. Discovery of transcription factors and regulatory regions driving in vivo tumor development by ATAC-seq and FAIRE-seq open chromatin profiling.

    Directory of Open Access Journals (Sweden)

    Kristofer Davie

    2015-02-01

    Full Text Available Genomic enhancers regulate spatio-temporal gene expression by recruiting specific combinations of transcription factors (TFs. When TFs are bound to active regulatory regions, they displace canonical nucleosomes, making these regions biochemically detectable as nucleosome-depleted regions or accessible/open chromatin. Here we ask whether open chromatin profiling can be used to identify the entire repertoire of active promoters and enhancers underlying tissue-specific gene expression during normal development and oncogenesis in vivo. To this end, we first compare two different approaches to detect open chromatin in vivo using the Drosophila eye primordium as a model system: FAIRE-seq, based on physical separation of open versus closed chromatin; and ATAC-seq, based on preferential integration of a transposon into open chromatin. We find that both methods reproducibly capture the tissue-specific chromatin activity of regulatory regions, including promoters, enhancers, and insulators. Using both techniques, we screened for regulatory regions that become ectopically active during Ras-dependent oncogenesis, and identified 3778 regions that become (over-activated during tumor development. Next, we applied motif discovery to search for candidate transcription factors that could bind these regions and identified AP-1 and Stat92E as key regulators. We validated the importance of Stat92E in the development of the tumors by introducing a loss of function Stat92E mutant, which was sufficient to rescue the tumor phenotype. Additionally we tested if the predicted Stat92E responsive regulatory regions are genuine, using ectopic induction of JAK/STAT signaling in developing eye discs, and observed that similar chromatin changes indeed occurred. Finally, we determine that these are functionally significant regulatory changes, as nearby target genes are up- or down-regulated. In conclusion, we show that FAIRE-seq and ATAC-seq based open chromatin profiling

  4. How Adverse Outcome Pathways Can Aid the Development and Use of Computational Prediction Models for Regulatory Toxicology

    Energy Technology Data Exchange (ETDEWEB)

    Wittwehr, Clemens; Aladjov, Hristo; Ankley, Gerald; Byrne, Hugh J.; de Knecht, Joop; Heinzle, Elmar; Klambauer, Günter; Landesmann, Brigitte; Luijten, Mirjam; MacKay, Cameron; Maxwell, Gavin; Meek, M. E. (Bette); Paini, Alicia; Perkins, Edward; Sobanski, Tomasz; Villeneuve, Dan; Waters, Katrina M.; Whelan, Maurice

    2016-12-19

    Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumulated mechanistic understanding. The adverse outcome pathway (AOP) framework has emerged as a systematic approach for organizing knowledge that supports such inference. We argue that this systematic organization of knowledge can inform and help direct the design and development of computational prediction models that can further enhance the utility of mechanistic and in silico data for chemical safety assessment. Examples of AOP-informed model development and its application to the assessment of chemicals for skin sensitization and multiple modes of endocrine disruption are provided. The role of problem formulation, not only as a critical phase of risk assessment, but also as guide for both AOP and complementary model development described. Finally, a proposal for actively engaging the modeling community in AOP-informed computational model development is made. The contents serve as a vision for how AOPs can be leveraged to facilitate development of computational prediction models needed to support the next generation of chemical safety assessment.

  5. Current regulatory developments concerning the implementation of probabilistic safety analyses for external hazards in Germany

    International Nuclear Information System (INIS)

    Krauss, Matias; Berg, Heinz-Peter

    2014-01-01

    Ministry for Environment, Nature Conservation and Nuclear Safety (BMU). This expert group, led by the Federal Office for Radiation Protection (BfS), has the task to advise the BMU on all methodological issues for the implementation of probabilistic safety analyses and has elaborated two publications on methods and data for PSA with the aim to support a unified application of the PSA in Germany. With the publication 'Safety requirements for nuclear power plants', a modern version of a German nuclear safety regulations has been published. In this regulation the broad experience of the application of the periodic safety reviews have been incorporated as a key element of regulatory supervision. Further key findings from the European safety review of nuclear power plants were taken into account after the accident at Fukushima. The revision also paid special attention to the requirements and recommendations of WENRA and IAEA. In addition, the recommendations and guidelines of the Nuclear Safety Standards Commission (KTA) and the expert group on Probabilistic Safety Analysis (PSA FAK) have also been updated. The activities of the updates have been focused the natural external hazards 'earthquake' and 'flooding' in the German regulations: - Probabilistic assessment for retrofit measures in individual cases for all operating modes and the PSA level 1 and level 2 is possible. - Deterministic and probabilistic site hazard analysis for the events 'earthquake' and 'flood' are required. - For the event 'earthquake' according to IAEA plants receives a minimum design comparable to 0.1 g >concept. - Furthermore, a seismic instrumentation independent of the location of intensity is required for each installation. - The importance of quality assured plant walk downs to determine the specified plant conditions was explicitly emphasized and required measures to ensure. - Furthermore, the existing methods for their applicability verified the associated generic data base for PSA updated. - The

  6. Nuclear Regulatory Authority Personnel Educating and Training within the National Nuclear Program Development

    International Nuclear Information System (INIS)

    Potapov, V.; Goryaeva, T.; Moiseenko, A.; Kapralov, E.; Museridze, A.

    2014-01-01

    International Cooperation for Nuclear Education and Knowledge: Aims: •Creation of system of continuous personnel training for EvrAzES states in the field of nuclear power applications based on the international standards; •Development of educational service export as following of export of Russian nuclear technology; • Development of educational and scientific contacts to IAEA, WNU, ENEN, ANENT, biggest scientific centers and universities of USA, EU and Asia. Directions of activities: • Education. Transfer of knowledge to new generation, to new developing countries and cooperation with the nuclear education of leading powers; • Scientific enlightening activity – students, specialists, decision makers; • Informational and analytical work

  7. Regulatory Physiology

    Science.gov (United States)

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

    1999-01-01

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

  8. Conserved regulatory mechanism controls the development of cells with rooting functions in land plants

    Science.gov (United States)

    Tam, Thomas Ho Yuen; Catarino, Bruno; Dolan, Liam

    2015-01-01

    Land plants develop filamentous cells—root hairs, rhizoids, and caulonemata—at the interface with the soil. Members of the group XI basic helix–loop–helix (bHLH) transcription factors encoded by LOTUS JAPONICUS ROOTHAIRLESS1-LIKE (LRL) genes positively regulate the development of root hairs in the angiosperms Lotus japonicus, Arabidopsis thaliana, and rice (Oryza sativa). Here we show that auxin promotes rhizoid and caulonema development by positively regulating the expression of PpLRL1 and PpLRL2, the two LRL genes in the Physcomitrella patens genome. Although the group VIII bHLH proteins, AtROOT HAIR DEFECTIVE6 and AtROOT HAIR DEFECTIVE SIX-LIKE1, promote root-hair development by positively regulating the expression of AtLRL3 in A. thaliana, LRL genes promote rhizoid development independently of PpROOT HAIR DEFECTIVE SIX-LIKE1 and PpROOT HAIR DEFECITVE SIX-LIKE2 (PpRSL1 and PpRSL2) gene function in P. patens. Together, these data demonstrate that both LRL and RSL genes are components of an ancient auxin-regulated gene network that controls the development of tip-growing cells with rooting functions among most extant land plants. Although this network has diverged in the moss and the angiosperm lineages, our data demonstrate that the core network acted in the last common ancestor of the mosses and angiosperms that existed sometime before 420 million years ago. PMID:26150509

  9. Analyzing policy support instruments and regulatory risk factors for wind energy deployment-A developers' perspective

    Energy Technology Data Exchange (ETDEWEB)

    Luethi, Sonja, E-mail: sonja.luethi@unisg.ch [University of St. Gallen, 9000 St. Gallen (Switzerland); Praessler, Thomas [Potsdam Institute for Climate Impact Research (Germany)

    2011-09-15

    A transition to a renewable energy system is high on the policy agenda in many countries. A promising energy source for a low-carbon energy future is wind. Policy-makers can attract wind energy development by providing attractive policy frameworks. This paper argues that apart from the level of financial support, both the risks stemming from the regulatory environment (legal security, administrative process and grid access) and the ability to finance projects play a critical role in determining the attractiveness of the development environment. It sheds light on how project developers trade off these different aspects and to what extent the attractiveness of a certain policy framework increases with the introduction of specific measures. Conjoint analysis is employed to provide empirical evidence on the preference of wind energy developers in the EU and the US. The analysis shows that developers' preferences are very similar across the studied regions and for different types of developers. Which policy measures could be most valuable depends on the specific existing environment. In some southeastern European countries, a reduction of administrative process duration may yield the highest utility gains, whereas, in the US, improvements in grid access regulation and an increase in remuneration levels may be more effective. - Highlights: > Paper suggests conjoint analysis as scenario tool for estimating potential effects of specific policy measures. > It provides a quantitative, empirical dataset of 119 onshore wind energy developers' preferences. > Results suggest that the aspects 'Legal security' and 'Remuneration' are important attributes. > Cluster analyses yields slightly different preferences for developers from EU and US.

  10. Key issues in food processing by irradiation in developing countries and the ensuing regulatory aspects

    International Nuclear Information System (INIS)

    Mossel, D. A. A.

    1985-01-01

    Food irradiation offers tremendous potential as a means of food preservation, particularly for developing countries. Irradiating food on a commercial scale has distinct advantages. Through irradiation, the keeping quality of a variety of food will be increased, insect infestation will be controlled, and dangerous intestinal pathogens will be eliminated. It will also facilitate export of food, which will aid national economic development, provide employment opportunities and foster the development of personnel trained in the technology. While food irradiation may be of importance and use in developing countries, it is equally important that developing countries are not used as 'testing grounds' for commercial food irradiation. By and large, public reluctance to accept food irradiation is deep-rooted. Fears need to be allayed through exposure to research results and extensive talks by experts and individuals from research institutions and the United Nations. If such attempts fail, it may be necessary for the government to embark on a program of introducing alternative food processes or technologies, e.g. food dehydration, fermentation, thermal or chemical treatments. In the eventual adoption of food irradiation, inspection of plants and manufacturing and distribution practices, monitoring of production lines, and testing of final product samples will be necessary

  11. Influence of early regulatory problems in infants on their development at 12 months: a longitudinal study in a high-risk sample.

    Science.gov (United States)

    Sidor, Anna; Fischer, Cristina; Eickhorst, Andreas; Cierpka, Manfred

    2013-10-12

    This study examined the extent to which regulatory problems in infants at 4 and 6 months influence childhood development at 12 months. The second aim of the study was to examine the influence maternal distress has on 4-month-old children's subsequent development as well as gender differences with regard to regulatory problems and development. 153 mother-child dyads enrolled in the family support research project "Nobody slips through the net" constituted the comparison group. These families faced psychosocial risks (e.g. poverty, excessive demands on the mother, and mental health disorders of the mother, measured with the risk screening instrument Heidelberger Belastungsskala - HBS) and maternal stress, determined with the Parental Stress Index (PSI-SF). The children's developmental levels and possible early regulatory problems were evaluated by means of the Ages and Stages Questionnaires (ASQ) and a German questionnaire assessing problems of excessive crying along with sleeping and feeding difficulties (SFS). A statistically significant but only low, inverse association between excessive crying, whining and sleep problems at 4 and 6 months and the social development of one-year-olds (accounting for 5% and 8% of the variance respectively) was found. Feeding problems had no effect on development. Although regulatory problems in infants were accompanied by increased maternal stress level, these did not serve as a predictor of the child's social development at 12 months. One-year-old girls reached a higher level of development in social and fine motor skills. No gender differences were found with regard to regulatory problems, nor any moderating effect of gender on the relation between regulatory problems and level of development. Our results reinforce existing knowledge pertaining to the transactional association between regulatory problems in infants, maternal distress and dysfunctionality of mother-child interactions. They also provide evidence of a slight but

  12. Geothermal energy development in Washington State. A guide to the federal, state and local regulatory process

    Energy Technology Data Exchange (ETDEWEB)

    Bloomquist, R.G.; Simpson, S.J.

    1986-03-01

    Washington State's geothermal potential is wide spread. Hot springs and five strato volcanoes existing throughout the Cascade Range, limited hot spring activity on the Olympic Peninsula, and broad reaching, low temperature geothermal resources found in the Columbia Basin comprise the extent of Washington's known geothermal resources. Determination of resource ownership is the first step in proceeding with geothermal exploration and development activities. The federal and state processes are examined from pre-lease activity through leasing and post-lease development concerns. Plans, permits, licenses, and other requirements are addressed for the federal, state, and local level. Lease, permit, and other forms for a number of geothermal exploration and development activities are included. A map of public lands and another displaying the measured geothermal resources throughout the state are provided.

  13. Motivation and Career-Development Training Programs: Use of Regulatory Focus to Determine Program Effectiveness

    Science.gov (United States)

    Anthony, Peter J.; Weide, Jeffrey

    2015-01-01

    The purpose of this study was to focus on the relationship between career-development training programs and the motivation of employees. The study used a qualitative method and a phenomenological design using semistructured interviews conducted with a script of open-ended questions. Two main components of the research design were the modified van…

  14. Implications of Danish Regulatory Policies for Technologies Supporting Sustainable Energy Development

    DEFF Research Database (Denmark)

    Meyer, Niels I

    1997-01-01

    The goal of the official Danish energy plans is to establish a sustainable energy development.This goal has been promoted by government programmes and regulations in different ways. Thus, the government has established test stations to secure a high quality of the new technologies and to certify ...

  15. A Paradigm for Developing Sediment Toxicity Bioassays for the Regulatory Evaluation of Dredged Material

    Science.gov (United States)

    1994-06-01

    dredging program and has direct application to the develop- meat of sediment toxicity bioassays. Federal statutes (MPRSA and CWA) require "no...assessing interspecific differences in xenobiotic metab- olism for major contaminants. Cost and logistics. By this point, the technical community should

  16. Press Coverage of CCS: A New Technology in the Media; Analisis de la Cobertura de la Tecnologia de Captura y Almacenamiento de CO{sub 2} (CAC) en la Prensa Escrita: Una Nueva Tecnologia en los Medios de Comunicacion

    Energy Technology Data Exchange (ETDEWEB)

    Sola, R.; Oltra, C.; Sala, R.; Di Masso, M.

    2009-12-19

    Public knowledge of Carbon Capture and Storage (CCS) technology is very low among the Spanish population. Only 17% of the Spanish said to have heard about CCS. There is also an important percentage of the population who is not sure about the use of CCS as a mitigation option for climate change. In that sense, the media could play an important role in the formation of public attitudes of CCS. The objective of the present work is to identify the picture of CCS transmitted in the Spanish press from January 2005 to July 2008. We carried out a quantitative analysis of a total of 139 press articles, considering different dimensions as the general attitude to CCS, the actors mentioned and their attitude, benefits and risks related to CCS, or the link with climate change. Data show a significant increase of CCS coverage in the Spanish press from 2007. The CCS technology is framed in the climate change context, as a possible solution to reduce CO{sub 2} emissions. The general attitude transmitted is positive: the benefits of the technology are emphasized versus the risks. Nevertheless, data show an important polarization in the attitudes through CCS between environmental NGOs (against it) and all the other actors (in favour). (Author) 5 refs.

  17. HADES : A Mission Concept for the Identification of New Saline Aquifer Sites Suitable for Carbon Capture & Storage (CCS)

    Science.gov (United States)

    Pechorro, Ed; Lecuyot, Arnaud; Bacon, Andrew; Chalkley, Simon; Milnes, Martin; Williams, Ivan; Williams, Stuart; Muthu, Kavitha

    2014-05-01

    The Hidden Aquifer & Deep Earth Sounder (HADES) is a ground penetrating radar mission concept for identifying new saline aquifer sites suitable for Carbon Capture & Storage (CCS). HADES uses a newly proposed type of Earth Observation technique, previously deployed in Mars orbit to search for water. It has been proposed to globally map the sub-surface layers of Earth's land area down to a maximum depth of 3km to detect underground aquifers of suitable depth and geophysical conditions for CCS. We present the mission concept together with the approach and findings of the project from which the concept has arisen, a European Space Agency (ESA) study on "Future Earth Observation Missions & Techniques for the Energy Sector" performed by a consortium of partners comprising CGI and SEA. The study aims to improve and increase the current and future application of Earth Observation in provision of data and services to directly address long term energy sector needs for a de-carbonised economy. This is part of ESA's cross-agency "Space and Energy" initiative. The HADES mission concept is defined by our specification of (i) mission requirements, reflecting the challenges and opportunities with identifying CCS sites from space, (ii) the observation technique, derived from ground penetrating radar, and (iii) the preliminary system concept, including specification of the resulting satellite, ground and launch segments. Activities have also included a cost-benefit analysis of the mission, a defined route to technology maturation, and a preliminary strategic plan towards proposed implementation. Moreover, the mission concept maps to a stakeholder analysis forming the initial part of the study. Its method has been to first identify the user needs specific to the energy sector in the global transition towards a de-carbonised economy. This activity revealed the energy sector requirements geared to the identification of suitable CCS sites. Subsequently, a qualitative and quantitative

  18. Model for gas hydrates applied to CCS systems part III. Results and implementation in TREND 2.0

    Czech Academy of Sciences Publication Activity Database

    Jäger, A.; Vinš, Václav; Span, R.; Hrubý, Jan

    2016-01-01

    Roč. 429, December (2016), s. 55-66 ISSN 0378-3812 R&D Projects: GA MŠk LG13056; GA ČR(CZ) GJ15-07129Y Institutional support: RVO:61388998 Keywords : CCS * gas hydrate * enthalpy Subject RIV: BJ - Thermodynamics Impact factor: 2.473, year: 2016 http://ac.els-cdn.com/S0378381216304010/1-s2.0-S0378381216304010-main.pdf?_tid=80a68084-7436-11e6-87c5-00000aacb362&acdnat=1473168991_07d2c8c0551e59d0997fee5d98ccc2d0

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

    International Nuclear Information System (INIS)

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

    2006-01-01

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

  20. Quantitative Profiling Identifies Potential Regulatory Proteins Involved in Development from Dauer Stage to L4 Stage in Caenorhabditis elegans.

    Science.gov (United States)

    Kim, Sunhee; Lee, Hyoung-Joo; Hahm, Jeong-Hoon; Jeong, Seul-Ki; Park, Don-Ha; Hancock, William S; Paik, Young-Ki

    2016-02-05

    When Caenorhabditis elegans encounters unfavorable growth conditions, it enters the dauer stage, an alternative L3 developmental period. A dauer larva resumes larval development to the normal L4 stage by uncharacterized postdauer reprogramming (PDR) when growth conditions become more favorable. During this transition period, certain heterochronic genes involved in controlling the proper sequence of developmental events are known to act, with their mutations suppressing the Muv (multivulva) phenotype in C. elegans. To identify the specific proteins in which the Muv phenotype is highly suppressed, quantitative proteomic analysis with iTRAQ labeling of samples obtained from worms at L1 + 30 h (for continuous development [CD]) and dauer recovery +3 h (for postdauer development [PD]) was carried out to detect changes in protein abundance in the CD and PD states of both N2 and lin-28(n719). Of the 1661 unique proteins identified with a proteomic approach identifies and quantitates the regulatory proteins potentially involved in PDR in C. elegans, which safeguards the overall lifecycle in response to environmental changes.

  1. Practical, regulatory and clinical considerations for development of inhalation drug products

    Directory of Open Access Journals (Sweden)

    Shuguang Hou

    2015-12-01

    Full Text Available The formulation and device collectively constitute an inhalation drug product. Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical performance and usability of the product to improve patient compliance with treatment instruction. From the points of formulation, device and patient use, this article summarizes the inhalation drugs, including pressurized metered dose inhaler (pMDI, dry powder inhaler (DPI, and nebulizer that are currently available in the US and UK markets. It also discusses the practical considerations for the development of inhalers and provides an update on the corresponding regulations of the FDA (U.S. Food and Drug Administration and the EMA (European Medicines Agency.

  2. Conserved regulatory mechanism controls the development of cells with rooting functions in land plants

    OpenAIRE

    Tam, Thomas Ho Yuen; Catarino, Bruno; Dolan, Liam

    2015-01-01

    This work describes the discovery of an ancient genetic mechanism that was used to build rooting systems when plants colonized the relatively dry continental surfaces >470 million years ago. We demonstrate that a group of basic helix–loop–helix transcription factors—the LOTUS JAPONICUS ROOTHAIRLESS1-LIKE proteins—is part of a conserved auxin-regulated gene network that controls the development of tip-growing cells with rooting functions among extant land plants. This result suggests that this...

  3. Dynamic and modular gene regulatory networks drive the development of gametogenesis.

    Science.gov (United States)

    Che, Dongxue; Wang, Yang; Bai, Weiyang; Li, Leijie; Liu, Guiyou; Zhang, Liangcai; Zuo, Yongchun; Tao, Shiheng; Hua, Jinlian; Liao, Mingzhi

    2017-07-01

    Gametogenesis is a complex process, which includes mitosis and meiosis and results in the production of ovum and sperm. The development of gametogenesis is dynamic and needs many different genes to work synergistically, but it is lack of global perspective research about this process. In this study, we detected the dynamic process of gametogenesis from the perspective of systems biology based on protein-protein interaction networks (PPINs) and functional analysis. Results showed that gametogenesis genes have strong synergistic effects in PPINs within and between different phases during the development. Addition to the synergistic effects on molecular networks, gametogenesis genes showed functional consistency within and between different phases, which provides the further evidence about the dynamic process during the development of gametogenesis. At last, we detected and provided the core molecular modules of different phases about gametogenesis. The gametogenesis genes and related modules can be obtained from our Web site Gametogenesis Molecule Online (GMO, http://gametsonline.nwsuaflmz.com/index.php), which is freely accessible. GMO may be helpful for the reference and application of these genes and modules in the future identification of key genes about gametogenesis. Summary, this work provided a computational perspective and frame to the analysis of the gametogenesis dynamics and modularity in both human and mouse. © The Author 2016. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  4. Drosophila Protein Kinase CK2: Genetics, Regulatory Complexity and Emerging Roles during Development

    Directory of Open Access Journals (Sweden)

    Mohna Bandyopadhyay

    2016-12-01

    Full Text Available CK2 is a Ser/Thr protein kinase that is highly conserved amongst all eukaryotes. It is a well-known oncogenic kinase that regulates vital cell autonomous functions and animal development. Genetic studies in the fruit fly Drosophila are providing unique insights into the roles of CK2 in cell signaling, embryogenesis, organogenesis, neurogenesis, and the circadian clock, and are revealing hitherto unknown complexities in CK2 functions and regulation. Here, we review Drosophila CK2 with respect to its structure, subunit diversity, potential mechanisms of regulation, developmental abnormalities linked to mutations in the gene encoding CK2 subunits, and emerging roles in multiple aspects of eye development. We examine the Drosophila CK2 “interaction map” and the eye-specific “transcriptome” databases, which raise the prospect that this protein kinase has many additional targets in the developing eye. We discuss the possibility that CK2 functions during early retinal neurogenesis in Drosophila and mammals bear greater similarity than has been recognized, and that this conservation may extend to other developmental programs. Together, these studies underscore the immense power of the Drosophila model organism to provide new insights and avenues to further investigate developmentally relevant targets of this protein kinase.

  5. Dosage effects of cohesin regulatory factor PDS5 on mammalian development: implications for cohesinopathies.

    Directory of Open Access Journals (Sweden)

    Bin Zhang

    Full Text Available Cornelia de Lange syndrome (CdLS, a disorder caused by mutations in cohesion proteins, is characterized by multisystem developmental abnormalities. PDS5, a cohesion protein, is important for proper chromosome segregation in lower organisms and has two homologues in vertebrates (PDS5A and PDS5B. Pds5B mutant mice have developmental abnormalities resembling CdLS; however the role of Pds5A in mammals and the association of PDS5 proteins with CdLS are unknown. To delineate genetic interactions between Pds5A and Pds5B and explore mechanisms underlying phenotypic variability, we generated Pds5A-deficient mice. Curiously, these mice exhibit multiple abnormalities that were previously observed in Pds5B-deficient mice, including cleft palate, skeletal patterning defects, growth retardation, congenital heart defects and delayed migration of enteric neuron precursors. They also frequently display renal agenesis, an abnormality not observed in Pds5B(-/- mice. While Pds5A(-/- and Pds5B(-/- mice die at birth, embryos harboring 3 mutant Pds5 alleles die between E11.5 and E12.5 most likely of heart failure, indicating that total Pds5 gene dosage is critical for normal development. In addition, characterization of these compound homozygous-heterozygous mice revealed a severe abnormality in lens formation that does not occur in either Pds5A(-/- or Pds5B(-/- mice. We further identified a functional missense mutation (R1292Q in the PDS5B DNA-binding domain in a familial case of CdLS, in which affected individuals also develop megacolon. This study shows that PDS5A and PDS5B functions other than those involving chromosomal dynamics are important for normal development, highlights the sensitivity of key developmental processes on PDS5 signaling, and provides mechanistic insights into how PDS5 mutations may lead to CdLS.

  6. Managing Regulatory Body Competence

    International Nuclear Information System (INIS)

    2013-01-01

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

  7. Consistent Regulatory Policy under Uncertainty

    OpenAIRE

    Michael J. Brennan; Eduardo S. Schwartz

    1982-01-01

    This article is concerned with the effects of regulation on the risk and value of the regulated firm in a dynamic context. Current regulatory practice is shown to be logically deficient, since it ignores the effect of regulatory policy on the cost of capital and therefore on the appropriate allowed rate of return. A notion of consistency in regulatory policy is developed, and it is shown how consistent regulatory policies may be implemented once the valuation problem is solved.

  8. Role of the Bulgarian nuclear regulatory body on the development of the Novi Han repository

    International Nuclear Information System (INIS)

    Batandjieva, B.

    2000-01-01

    The state control over the safe atomic energy utilisation and nuclear material accounting, storage and transportation is carried out by the Committee on the Use of Atomic Energy for Peaceful Purposes, through the Inspectorate on Safe Use of Atomic Energy. The main responsibilities of the Bulgarian Nuclear Safety Authority in the field of radioactive waste management as: state policy; development of concept and programmes; co-ordination and financing of research studies; definition of requirements on the safe use of atomic energy; collection and provision of information on events, related to the radiation protection and nuclear safety; co-ordination of the control over the use of atomic energy; definition of measurements and leading remediation actions are described. The main achievements and the future challenges related to the Novi Han repository are also given

  9. Complexity of cis-regulatory organization of six3a during forebrain and eye development in zebrafish

    Directory of Open Access Journals (Sweden)

    Wang Horng-Dar

    2010-03-01

    Full Text Available Abstract Background Six3a belongs to the SIX family of homeodomain proteins and is expressed in the most anterior neural plate at the beginning of neurogenesis in various species. Though the function of Six3a as a crucial regulator of eye and forebrain development has been thoroughly investigated, the transcriptional regulation of six3a is not well understood. Results To elucidate the transcriptional regulation of six3a, we performed an in vivo reporter assay. Alignment of the 21-kb region surrounding the zebrafish six3a gene with the analogous region from different species identified several conserved non-coding modules. Transgenesis in zebrafish identified two enhancer elements and one suppressor. The D module drives the GFP reporter in the forebrain and eyes at an early stage, while the A module is responsible for the later expression. The A module also works as a repressor suppressing ectopic expression from the D module. Mutational analysis further minimized the A module to four highly conserved elements and the D module to three elements. Using electrophoresis mobility shift assays, we also provided evidence for the presence of DNA-binding proteins in embryonic nuclear extracts. The transcription factors that may occupy those highly conserved elements were also predicted. Conclusion This study provides a comprehensive view of six3a transcription regulation during brain and eye development and offers an opportunity to establish the gene regulatory networks underlying neurogenesis in zebrafish.

  10. Long-Term Time Series of Remote Sensing Observations for Development of Regulatory Water Quality Standards

    Science.gov (United States)

    Blonski, Slawomir; Spiering, Bruce A.; Holekamp, Kara L.

    2010-01-01

    Water quality standards in the U.S. consist of: designated uses (the services that a water body provides; e.g., drinking water, aquatic life, harvestable species, recreation) . criteria that define the environmental conditions that must be maintained to support the uses For estuaries and coastal waters in the Gulf of Mexico, there are no numeric (quantitative) criteria to protect designated uses from effects of nutrients. This is largely due to the absence of adequate data that would quantitatively link biological conditions to nutrient concentrations. The Gulf of Mexico Alliance, an organization fostering collaboration between the Gulf States and U.S. Federal agencies, has identified the development of the numeric nutrient criteria as a major step leading to reduction in MODIS Products Figure 6. Map of the Mobile Bay with a yellow patch indicating the Bon Secour Bay area selected in this study for averaging water clarity parameters retrieved from MODIS datasets. nutrient inputs to coastal ecosystems. Nutrient enrichment in estuaries and coastal waters can be quantified based on response variables that measure phytoplankton biomass and water clarity. Long-term, spatially and temporally resolved measurements of chlorophyll a concentration, total concentration of suspended solids, and water clarity are needed to establish reference conditions and to quantify stressor-response relationships.

  11. Motivation and career-development training programs: Use of regulatory focus to determine program effectiveness

    Directory of Open Access Journals (Sweden)

    Peter John Anthony

    2015-06-01

    Full Text Available The purpose of this study was to focus on the relationship between career-development training programs and the motivation of employees. The study used a qualitative method and a phenomenological design using semistructured interviews conducted with a script of open-ended questions. Two main components of the research design were the modified van Kaam method for exploration of experiences and the purposive selection of the participants. The 20 participants in the sample were project managers and consultants from south-central Texas, all of whom had experience with governmental projects. Based on interview responses, the findings of this study highlighted a concern from the participants that training programs have a major influence on workplace productivity and morale. Furthermore, the findings suggest the training program’s quality may influence workplace productivity. The authors conclude by pointing out the analysis of the answers showed that not only does workplace productivity decline from the changes in a training program, but employee motivation is altered as well. DOI: 10.18870/hlrc.v5i2.214 

  12. Science in regulatory policy making: case studies in the development of workplace smoking restrictions

    Science.gov (United States)

    Bero, L.; Montini, T.; Bryan-Jones, K.; Mangurian, C.

    2001-01-01

    OBJECTIVE—To study the role of science related and other arguments in the development of workplace smoking regulations.
DESIGN—Case study, content analysis
SUBJECTS—Written commentaries and hearing transcripts on proposed indoor air regulations in Maryland and Washington.
MAIN OUTCOME MEASURES—We coded each written commentary and hearing testimony for position toward the regulation, affiliation of the person submitting it, criteria used to evaluate science and scientific, ideological, economic, political, engineering and procedural arguments.
RESULTS—In both states, opposition to the regulations came primarily from the tobacco industry, small businesses, and business organisations and appeared to be coordinated. There was little coordination of public health support for the regulations. Arguments about science were used more often by those opposed to the regulations than by those in favour. Supporters emphasised the quantity of the evidence, while opponents criticised its reliability, validity, and quality. Arguments not related to science (61% of total arguments; 459/751), were more common than scientific arguments (39% of total arguments; 292/751). Economic and ideological arguments were used to a similar extent by regulation supporters and opponents.
CONCLUSIONS—Advocates can support health related regulations by submitting commentary emphasising the sound research base for regulation and countering criticisms of research. National coordination of these efforts could avoid duplication of effort and make more efficient use of limited public health resources.


Keywords: workplace smoking regulations; science based arguments PMID:11740023

  13. Heat Shock Protein A2 (HSPA2): Regulatory Roles in Germ Cell Development and Sperm Function.

    Science.gov (United States)

    Nixon, Brett; Bromfield, Elizabeth G; Cui, Jinwei; De Iuliis, Geoffry N

    2017-01-01

    Among the numerous families of heat shock protein (HSP) that have been implicated in the regulation of reproductive system development and function, those belonging to the 70 kDa HSP family have emerged as being indispensable for male fertility. In particular, the testis-enriched heat shock 70 kDa protein 2 (HSPA2) has been shown to be critical for the progression of germ cell differentiation during spermatogenesis in the mouse model. Beyond this developmentally important window, mounting evidence has also implicated HSPA2 in the functional transformation of the human sperm cell during their ascent of the female reproductive tract. Specifically, HSPA2 appears to coordinate the remodelling of specialised sperm domains overlying the anterior region of the sperm head compatible with their principle role in oocyte recognition. The fact that levels of the HSPA2 protein in mature spermatozoa tightly correlate with the efficacy of oocyte binding highlight its utility as a powerful prognostic biomarker of male fertility. In this chapter, we consider the unique structural and biochemical characteristics of HSPA2 that enable this heat shock protein to fulfil its prominent roles in orchestrating the morphological differentiation of male germ cells during spermatogenesis as well as their functional transformation during post-testicular sperm maturation.

  14. Structured Development and Promotion of a Research Field: Hormesis in Biology, Toxicology, and Environmental Regulatory Science.

    Science.gov (United States)

    Mushak, Paul; Elliott, Kevin C

    2015-12-01

    The ability of powerful and well-funded interest groups to steer scientific research in ways that advance their goals has become a significant social concern. This steering ability is increasingly being recognized in the peer-reviewed scientific literature and in findings of deliberative scientific bodies. This paper provides a case study that illustrates some of the major strategies that can be used to structure and advance a controversial research field. It focuses on hormesis, described as a type of dose-response relationship in toxicology and biology showing low-dose stimulation but high-dose inhibition, or the reverse. Hormesis proponents tout its significance, arguing that substances toxic at high doses and beneficial at lower doses should be regulated less stringently. We identify five strategies employed by hormesis proponents to foster its acceptance: (1) creating institutions focused on supporting hormesis; (2) developing terminology, study designs, and data interpretations that cast it in a favorable light; (3) using bibliometric techniques and surveys to attract attention; (4) aggressively advocating for the phenomenon and challenging critics; and (5) working with outside interest groups to apply the hormesis phenomenon in the economic and political spheres. We also suggest a number of oversight strategies that can be implemented to help promote credible and socially responsible research in cases like this one.

  15. Establishing a Regulatory Framework for the Development & Operations of Sub-Orbital & Orbital Aircraft (SOA) in the EU

    Science.gov (United States)

    Marciacq, Jean-Bruno; Tomasello, Filippo; Erdelyi, Zsuzsanna; Gerhard, Michael

    2013-09-01

    The Treaty of the European Union allows for the development of common policies for all sectors of transport, including aviation, and its safety. To this end, the European legislator established in 2002 the European Aviation Safety Agency (EASA), located in Cologne, Germany, and gave it responsibility for the regulation of aviation safety, successively encompassing airworthiness, air operations and Flight Crew Licensing (FCL), Air Traffic Management (ATM), Air Navigation Systems (ANS), as well as Aerodromes (ADR).The Annexes 6 and 8 of the International Civil Aviation Organization (ICAO) to the Chicago Convention define an aircraft as "any machine that can derive support in the atmosphere from the reactions of the air other than the reactions of the air against the earth's surface". The aerodynamic lift generated during the atmospheric part of the flight is commonly used to sustain and control the vehicle, that is to take-off, climb, pull-up, perform manoeuvres, fly back to the airport and land. Thus, Sub- orbital and Orbital Aircraft (SOA) are considered to be aircraft, as opposed to rockets which are symmetrical bodies not generating lift, and solely sustained by their rocket engine(s).Consequently, the regulation of SOA airworthiness, their crew, operations, insertion into the traffic and utilisation of aerodromes would in principle fall under the remit of EASA, which would have to fulfil its role of protection of the European citizens in relation to civil suborbital and orbital flights, that is to certify SOAs and their operations before they would be operated for Commercial Transport in the EU.Since EASA was first contacted by potential applicants in 2007, many projects have developed and the context has evolved. Thus, this paper intends to update the approach initially proposed at the 3rd IAASS in Rome in October 2008 and complemented at the 4th IAASS in Huntsville in May 2010 to accommodate sub-orbital and orbital aircraft into the EU regulatory system, and

  16. Research and development and related capabilities for safety and licensing of nuclear power reactors: a regulatory perspective

    International Nuclear Information System (INIS)

    Newland, D.B.

    2001-01-01

    In today's increasingly competitive environment within the electrical power generation industry, the nuclear power utilities are constantly striving for greater efficiency and lower operating costs. Economic de-regulation costs. Economic de-regulation of the electrical market is occurring in a number of countries, including Canada, and this places additional pressure on utilities to be economically competitive. The industry examines all its business activities critically to determine if they provide benefit and good value for money. In these circumstances there can be a tendency for the longer term strategic activities to be treated as lower priority and have reduced funding. Such activities include research and development, design authority, corporate knowledge, and technical expertise, and their associated infrastructure. This paper discusses how the situation with regard to funding of research and development (R and D) has evolved in Canada over the past 5 years, and how the Canadian Nuclear Safety Commission (CNSC) has responded to the changing environment. Of particular interest is a R and D capability review that the industry undertook, the results of which are briefly described. Other related infrastructure aspects such as technical expertise, design authority, education and their inter-relationship with R and D. are also discussed. There are a number of important elements that are needed for a successful way forward: recognition of the depth of the problem by stakeholders; clarification of the roles and responsibilities of these stakeholders; strong leadership within the power reactor industry; improved co-ordinating amongst the industry partners; effective international co-operation; and succession planning in the broadest sense. It is finally concluded that the issue of R and D funding and expertise maintenance is one that will not go away and will inevitably worsen. It is a difficult issue to tackle and there are no simple solutions. The situation has

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

    Energy Technology Data Exchange (ETDEWEB)

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

    2001-03-15

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

  18. Regulatory Technology Development Plan - Sodium Fast Reactor. Mechanistic Source Term - Metal Fuel Radionuclide Release

    Energy Technology Data Exchange (ETDEWEB)

    Grabaskas, David [Argonne National Lab. (ANL), Argonne, IL (United States); Bucknor, Matthew [Argonne National Lab. (ANL), Argonne, IL (United States); Jerden, James [Argonne National Lab. (ANL), Argonne, IL (United States)

    2016-02-01

    The development of an accurate and defensible mechanistic source term will be vital for the future licensing efforts of metal fuel, pool-type sodium fast reactors. To assist in the creation of a comprehensive mechanistic source term, the current effort sought to estimate the release fraction of radionuclides from metal fuel pins to the primary sodium coolant during fuel pin failures at a variety of temperature conditions. These release estimates were based on the findings of an extensive literature search, which reviewed past experimentation and reactor fuel damage accidents. Data sources for each radionuclide of interest were reviewed to establish release fractions, along with possible release dependencies, and the corresponding uncertainty levels. Although the current knowledge base is substantial, and radionuclide release fractions were established for the elements deemed important for the determination of offsite consequences following a reactor accident, gaps were found pertaining to several radionuclides. First, there is uncertainty regarding the transport behavior of several radionuclides (iodine, barium, strontium, tellurium, and europium) during metal fuel irradiation to high burnup levels. The migration of these radionuclides within the fuel matrix and bond sodium region can greatly affect their release during pin failure incidents. Post-irradiation examination of existing high burnup metal fuel can likely resolve this knowledge gap. Second, data regarding the radionuclide release from molten high burnup metal fuel in sodium is sparse, which makes the assessment of radionuclide release from fuel melting accidents at high fuel burnup levels difficult. This gap could be addressed through fuel melting experimentation with samples from the existing high burnup metal fuel inventory.

  19. RNA-seq analysis identifies an intricate regulatory network controlling cluster root development in white lupin.

    Science.gov (United States)

    Secco, David; Shou, Huixia; Whelan, James; Berkowitz, Oliver

    2014-03-25

    Highly adapted plant species are able to alter their root architecture to improve nutrient uptake and thrive in environments with limited nutrient supply. Cluster roots (CRs) are specialised structures of dense lateral roots formed by several plant species for the effective mining of nutrient rich soil patches through a combination of increased surface area and exudation of carboxylates. White lupin is becoming a model-species allowing for the discovery of gene networks involved in CR development. A greater understanding of the underlying molecular mechanisms driving these developmental processes is important for the generation of smarter plants for a world with diminishing resources to improve food security. RNA-seq analyses for three developmental stages of the CR formed under phosphorus-limited conditions and two of non-cluster roots have been performed for white lupin. In total 133,045,174 high-quality paired-end reads were used for a de novo assembly of the root transcriptome and merged with LAGI01 (Lupinus albus gene index) to generate an improved LAGI02 with 65,097 functionally annotated contigs. This was followed by comparative gene expression analysis. We show marked differences in the transcriptional response across the various cluster root stages to adjust to phosphate limitation by increasing uptake capacity and adjusting metabolic pathways. Several transcription factors such as PLT, SCR, PHB, PHV or AUX/IAA with a known role in the control of meristem activity and developmental processes show an increased expression in the tip of the CR. Genes involved in hormonal responses (PIN, LAX, YUC) and cell cycle control (CYCA/B, CDK) are also differentially expressed. In addition, we identify primary transcripts of miRNAs with established function in the root meristem. Our gene expression analysis shows an intricate network of transcription factors and plant hormones controlling CR initiation and formation. In addition, functional differences between the

  20. γδ T Cell-Dependent Regulatory T Cells Prevent the Development of Autoimmune Keratitis1

    Science.gov (United States)

    Huang, Yafei; Yang, Zhifang; Huang, Chunjian; McGowan, Jessica; Casper, Tamara; Sun, Deming; Born, Willi K.; O’Brien, Rebecca L.

    2015-01-01

    To prevent potentially damaging inflammatory responses, the eye actively promotes local immune tolerance via a variety of mechanisms. Due to trauma, infection, or other ongoing autoimmunity, these mechanisms sometimes fail, and an autoimmune disorder may develop in the eye. In mice of the C57BL/10 (B10) background, autoimmune keratitis often develops spontaneously, particularly in the females. Its incidence is greatly elevated in the absence of γδ T cells, such that about 80% of female B10.TCRδ−/− mice develop keratitis by 18 weeks of age. Here, we show that CD8+ αβ T cells are the drivers of this disease, because adoptive transfer of CD8+ but not CD4+ T cells to keratitis-resistant B10.TCRβ/δ−/− hosts induced a high incidence of keratitis. This was unexpected because in other autoimmune diseases, more often CD4+ αβ T cells, or both CD4+ and CD8+ αβ T cells, mediate the disease. Compared to wildtype B10 mice, B10.TCRδ−/− mice also show increased percentages of peripheral memory phenotype CD8+ αβ T cells, along with an elevated frequency of CD8+ αβ T cells biased to produce inflammatory cytokines. B10.TCRδ−/− mice in addition have fewer peripheral CD4+ CD25+ FoxP3+ regulatory αβ T cells (Tregs), which express lower levels of receptors needed for Treg development and function. Together, these observations suggest that in B10 background mice, γδ T cells are required to generate adequate numbers of CD4+ CD25+ FoxP3+ Tregs, and that in B10.TCRδ−/− mice a Treg deficiency allows dysregulated effector or memory CD8+ αβ T cells to infiltrate the cornea and provoke an autoimmune attack. PMID:26566677

  1. The function of the RNA-binding protein TEL1 in moss reveals ancient regulatory mechanisms of shoot development.

    Science.gov (United States)

    Vivancos, Julien; Spinner, Lara; Mazubert, Christelle; Charlot, Florence; Paquet, Nicolas; Thareau, Vincent; Dron, Michel; Nogué, Fabien; Charon, Céline

    2012-03-01

    The shoot represents the basic body plan in land plants. It consists of a repeated structure composed of stems and leaves. Whereas vascular plants generate a shoot in their diploid phase, non-vascular plants such as mosses form a shoot (called the gametophore) in their haploid generation. The evolution of regulatory mechanisms or genetic networks used in the development of these two kinds of shoots is unclear. TERMINAL EAR1-like genes have been involved in diploid shoot development in vascular plants. Here, we show that disruption of PpTEL1 from the moss Physcomitrella patens, causes reduced protonema growth and gametophore initiation, as well as defects in gametophore development. Leafy shoots formed on ΔTEL1 mutants exhibit shorter stems with more leaves per shoot, suggesting an accelerated leaf initiation (shortened plastochron), a phenotype shared with the Poaceae vascular plants TE1 and PLA2/LHD2 mutants. Moreover, the positive correlation between plastochron length and leaf size observed in ΔTEL1 mutants suggests a conserved compensatory mechanism correlating leaf growth and leaf initiation rate that would minimize overall changes in plant biomass. The RNA-binding protein encoded by PpTEL1 contains two N-terminus RNA-recognition motifs, and a third C-terminus non-canonical RRM, specific to TEL proteins. Removal of the PpTEL1 C-terminus (including this third RRM) or only 16-18 amino acids within it seriously impairs PpTEL1 function, suggesting a critical role for this third RRM. These results show a conserved function of the RNA-binding PpTEL1 protein in the regulation of shoot development, from early ancestors to vascular plants, that depends on the third TEL-specific RRM.

  2. Intradermal application of vitamin D3 increases migration of CD14 (+) dermal dendritic cells and promotes the development of Foxp3 (+) regulatory T cells

    NARCIS (Netherlands)

    Bakdash, G.; Schneider, L.P.; Capel, T.M. van; Kapsenberg, M.L.; Teunissen, M.B.M.; Jong, E.C. de

    2013-01-01

    The active form of vitamin D3 (VitD) is a potent immunosuppressive drug. Its effects are mediated in part through dendritic cells (DCs) that promote the development of regulatory T cells (Tregs). However, it remains elusive how VitD would influence the different human skin DC subsets, e.g., CD1a (+)

  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...

  4. Developing the Regulatory Utility of the Exposome: Mapping Exposures for Risk Assessment through Lifestage Exposome Snapshots (LEnS).

    Science.gov (United States)

    Shaffer, Rachel M; Smith, Marissa N; Faustman, Elaine M

    2017-08-07

    Exposome-related efforts aim to document the totality of human exposures across the lifecourse. This field has advanced rapidly in recent years but lacks practical application to risk assessment, particularly for children's health. Our objective was to apply the exposome to children's health risk assessment by introducing the concept of Lifestage Exposome Snapshots (LEnS). Case studies are presented to illustrate the value of the framework. The LEnS framework encourages organization of exposome studies based on windows of susceptibility for particular target organ systems. Such analyses will provide information regarding cumulative impacts during specific critical periods of the life course. A logical extension of this framework is that regulatory standards should analyze exposure information by target organ, rather than for a single chemical only or multiple chemicals grouped solely by mechanism of action. The LEnS concept is a practical refinement to the exposome that accounts for total exposures during particular windows of susceptibility in target organ systems. Application of the LEnS framework in risk assessment and regulation will improve protection of children's health by enhancing protection of sensitive developing organ systems that are critical for lifelong health and well-being. https://doi.org/10.1289/EHP1250.

  5. Why are investors not interested in my radiotracer? The industrial and regulatory constraints in the development of radiopharmaceuticals

    International Nuclear Information System (INIS)

    Zimmermann, Richard G.

    2013-01-01

    Four criteria are essential in the acceptance by investors of new radiopharmaceuticals: the existence of a market and a medical need, the quality of the science and technology behind the new molecule, the feasibility and compliance with regulations and the limited competitive landscape. Potential investors need to get more convincing market evidence, largely beyond the nice preclinical data generated to the point of first discussion. A properly protected compound not jeopardized by earlier published results is a must. A guarantee of an easy and secured source of the ligand is obvious. A safe access to the radionuclide in volumes corresponding to the targeted market is rarely taken into account, but of utmost importance. The evaluation of new drugs by investors will include the evaluation of the real market size for the targeted indication and the position of the drug in the healthcare environment at the time to market. This includes the potential competition with other radiopharmaceuticals, but also with conventional drugs or competitive modalities also at time to market. Both criteria are usually not easily accessible to researchers whose acquaintance remains limited to the scientific and technical part. Starting from this set of information, a first business plan can be deduced based on a best estimate for price per dose and a rough evaluation about the chance and level of reimbursement. In the following most of the events are covered that could jeopardize the development of the drug, focusing on the industrial, economic and regulatory aspects, comprehending the detailed analysis of the currently best available radionuclides

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

    International Nuclear Information System (INIS)

    Oh, Se Ki; Shin, Y. K.; Kim, J. S.; Yu, Y. J.; Lee, Y. J.

    2001-03-01

    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

  7. Hemoglobin-Based Oxygen Carrier (HBOC) Development in Trauma: Previous Regulatory Challenges, Lessons Learned, and a Path Forward.

    Science.gov (United States)

    Keipert, Peter E

    2017-01-01

    Historically, hemoglobin-based oxygen carriers (HBOCs) were being developed as "blood substitutes," despite their transient circulatory half-life (~ 24 h) vs. transfused red blood cells (RBCs). More recently, HBOC commercial development focused on "oxygen therapeutic" indications to provide a temporary oxygenation bridge until medical or surgical interventions (including RBC transfusion, if required) can be initiated. This included the early trauma trials with HemAssist ® (BAXTER), Hemopure ® (BIOPURE) and PolyHeme ® (NORTHFIELD) for resuscitating hypotensive shock. These trials all failed due to safety concerns (e.g., cardiac events, mortality) and certain protocol design limitations. In 2008 the Food and Drug Administration (FDA) put all HBOC trials in the US on clinical hold due to the unfavorable benefit:risk profile demonstrated by various HBOCs in different clinical studies in a meta-analysis published by Natanson et al. (2008). During standard resuscitation in trauma, organ dysfunction and failure can occur due to ischemia in critical tissues, which can be detected by the degree of lactic acidosis. SANGART'S Phase 2 trauma program with MP4OX therefore added lactate >5 mmol/L as an inclusion criterion to enroll patients who had lost sufficient blood to cause a tissue oxygen debt. This was key to the successful conduct of their Phase 2 program (ex-US, from 2009 to 2012) to evaluate MP4OX as an adjunct to standard fluid resuscitation and transfusion of RBCs. In 2013, SANGART shared their Phase 2b results with the FDA, and succeeded in getting the FDA to agree that a planned Phase 2c higher dose comparison study of MP4OX in trauma could include clinical sites in the US. Unfortunately, SANGART failed to secure new funding and was forced to terminate development and operations in Dec 2013, even though a regulatory path forward with FDA approval to proceed in trauma had been achieved.

  8. Filtering, transport and long-term storage of carbon dioxide in licensing law and national planning law. Implementation of the 2009/31 EG directive via a CCS law; Abscheidung, Transport und dauerhafte Speicherung von Kohlenstoffdioxid im Genehmigungs- und nationalen Planungsrecht. Umsetzung der Richtlinie 2009/31 EG durch ein CCS-Gesetz

    Energy Technology Data Exchange (ETDEWEB)

    Kuznik, Christoph

    2012-07-01

    The book discusses the legal boundary conditions of the CCS technology in licensing law and national planning law against the background of RL/ 2009/31 EG and the various drafts of a German CCS law between 2009 and 2011. The legal situation is outlined as of June 2011, when the original dissertation was submitted; the draft acts are analyzed critically in a comparative evaluation. Publications of a later date are considered as far as possible.

  9. Public Perception of CCS Technology. The Effects of Information on Attitude; Percepcion Publica de la Tecnologia de CAC. El Efecto de la Informacion en la Actitud

    Energy Technology Data Exchange (ETDEWEB)

    Oltra, C.; Marin, R.; Sala, R.

    2011-11-10

    This report examines the public perception of Carbon Capture and Storage technology and the impacts of information on perception. We analyze, from an electronic questionnaire with technical and contextual information, dimensions such as the initial reaction to the technology, the acceptance of CO{sub 2} storage, the perception of risk of storage and the degree of antagonism toward the organizations involved. The determinants of attitudes and reactions to CCS are also analyzed. A favorable initial reaction to CCS is found after some information and contextualization of CCS as well as significant risk perception. The type of information transmitted appears to influence the attitude of participants to the technology. The broader positive impact on attitude occurs when transmitting the idea of CO{sub 2} as a natural resource. (Author) 4 refs.

  10. Osteoprotegerin-Mediated Homeostasis of Rank+ Thymic Epithelial Cells Does Not Limit Foxp3+ Regulatory T Cell Development.

    Science.gov (United States)

    McCarthy, Nicholas I; Cowan, Jennifer E; Nakamura, Kyoko; Bacon, Andrea; Baik, Song; White, Andrea J; Parnell, Sonia M; Jenkinson, Eric J; Jenkinson, William E; Anderson, Graham

    2015-09-15

    In the thymus, medullary thymic epithelial cells (mTEC) regulate T cell tolerance via negative selection and Foxp3(+) regulatory T cell (Treg) development, and alterations in the mTEC compartment can lead to tolerance breakdown and autoimmunity. Both the receptor activator for NF-κB (RANK)/RANK ligand (RANKL)/osteoprotegerin (OPG) axis and expression of the transcriptional regulator Aire are involved in the regulation of thymus medullary microenvironments. However, their impact on the mechanisms controlling mTEC homeostasis is poorly understood, as are the processes that enable the thymus medulla to support the balanced production of mTEC-dependent Foxp3(+) Treg. In this study, we have investigated the control of mTEC homeostasis and examined how this process impacts the efficacy of Foxp3(+) Treg development. Using newly generated RANK Venus reporter mice, we identify distinct RANK(+) subsets that reside within both the mTEC(hi) and mTEC(lo) compartments and that represent direct targets of OPG-mediated control. Moreover, by mapping OPG expression to a subset of Aire(+) mTEC, our data show how cis- and trans-acting mechanisms are able to control the thymus medulla by operating on multiple mTEC targets. Finally, we show that whereas the increase in mTEC availability in OPG-deficient (Tnfrsf11b(-/-)) mice impacts the intrathymic Foxp3(+) Treg pool by enhancing peripheral Treg recirculation back to the thymus, it does not alter the number of de novo Rag2pGFP(+)Foxp3(+) Treg that are generated. Collectively, our study defines patterns of RANK expression within the thymus medulla, and it shows that mTEC homeostasis is not a rate-limiting step in intrathymic Foxp3(+) Treg production. Copyright © 2015 The Authors.

  11. An iterative genetic and dynamical modelling approach identifies novel features of the gene regulatory network underlying melanocyte development.

    Science.gov (United States)

    Greenhill, Emma R; Rocco, Andrea; Vibert, Laura; Nikaido, Masataka; Kelsh, Robert N

    2011-09-01

    The mechanisms generating stably differentiated cell-types from multipotent precursors are key to understanding normal development and have implications for treatment of cancer and the therapeutic use of stem cells. Pigment cells are a major derivative of neural crest stem cells and a key model cell-type for our understanding of the genetics of cell differentiation. Several factors driving melanocyte fate specification have been identified, including the transcription factor and master regulator of melanocyte development, Mitf, and Wnt signalling and the multipotency and fate specification factor, Sox10, which drive mitf expression. While these factors together drive multipotent neural crest cells to become specified melanoblasts, the mechanisms stabilising melanocyte differentiation remain unclear. Furthermore, there is controversy over whether Sox10 has an ongoing role in melanocyte differentiation. Here we use zebrafish to explore in vivo the gene regulatory network (GRN) underlying melanocyte specification and differentiation. We use an iterative process of mathematical modelling and experimental observation to explore methodically the core melanocyte GRN we have defined. We show that Sox10 is not required for ongoing differentiation and expression is downregulated in differentiating cells, in response to Mitfa and Hdac1. Unexpectedly, we find that Sox10 represses Mitf-dependent expression of melanocyte differentiation genes. Our systems biology approach allowed us to predict two novel features of the melanocyte GRN, which we then validate experimentally. Specifically, we show that maintenance of mitfa expression is Mitfa-dependent, and identify Sox9b as providing an Mitfa-independent input to melanocyte differentiation. Our data supports our previous suggestion that Sox10 only functions transiently in regulation of mitfa and cannot be responsible for long-term maintenance of mitfa expression; indeed, Sox10 is likely to slow melanocyte differentiation in the

  12. Regulatory guidance document

    International Nuclear Information System (INIS)

    1994-05-01

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

  13. CO2leakage from carbon dioxide capture and storage (CCS) systems affects organic matter cycling in surface marine sediments.

    Science.gov (United States)

    Rastelli, Eugenio; Corinaldesi, Cinzia; Dell'Anno, Antonio; Amaro, Teresa; Greco, Silvestro; Lo Martire, Marco; Carugati, Laura; Queirós, Ana M; Widdicombe, Stephen; Danovaro, Roberto

    2016-12-01

    Carbon dioxide capture and storage (CCS), involving the injection of CO 2 into the sub-seabed, is being promoted worldwide as a feasible option for reducing the anthropogenic CO 2 emissions into the atmosphere. However, the effects on the marine ecosystems of potential CO 2 leakages originating from these storage sites have only recently received scientific attention, and little information is available on the possible impacts of the resulting CO 2 -enriched seawater plumes on the surrounding benthic ecosystem. In the present study, we conducted a 20-weeks mesocosm experiment exposing coastal sediments to CO 2 -enriched seawater (at 5000 or 20,000 ppm), to test the effects on the microbial enzymatic activities responsible for the decomposition and turnover of the sedimentary organic matter in surface sediments down to 15 cm depth. Our results indicate that the exposure to high-CO 2 concentrations reduced significantly the enzymatic activities in the top 5 cm of sediments, but had no effects on subsurface sediment horizons (from 5 to 15 cm depth). In the surface sediments, both 5000 and 20,000 ppm CO 2 treatments determined a progressive decrease over time in the protein degradation (up to 80%). Conversely, the degradation rates of carbohydrates and organic phosphorous remained unaltered in the first 2 weeks, but decreased significantly (up to 50%) in the longer term when exposed at 20,000 ppm of CO 2 . Such effects were associated with a significant change in the composition of the biopolymeric carbon (due to the accumulation of proteins over time in sediments exposed to high-pCO 2 treatments), and a significant decrease (∼20-50% at 5000 and 20,000 ppm respectively) in nitrogen regeneration. We conclude that in areas immediately surrounding an active and long-lasting leak of CO 2 from CCS reservoirs, organic matter cycling would be significantly impacted in the surface sediment layers. The evidence of negligible impacts on the deeper sediments should be

  14. Identification of a novel Leucine-rich repeat protein and candidate PP1 regulatory subunit expressed in developing spermatids

    Directory of Open Access Journals (Sweden)

    Sperry Ann O

    2008-01-01

    . TLRR is homologous to a class of regulatory subunits for PP1, a central phosphatase in the reversible phosphorylation of proteins that is key to modulation of many intracellular processes. TLRR may serve to target this important signaling molecule near the nucleus of developing spermatids in order to control the cellular rearrangements of spermiogenesis.

  15. 75 FR 52046 - Development of U.S. Nuclear Regulatory Commission Safety Culture Policy Statement: Public Meeting

    Science.gov (United States)

    2010-08-24

    ...The NRC plans to hold a public meeting on September 28, 2010, in its Las Vegas, Nevada hearing facility to solicit comments on the revision of its draft safety culture policy statement, including the revised definition and traits. The revision has been developed as a result of the NRC staff's evaluation of the public comments submitted in response to the draft policy statement (74 FR 57525, November 6, 2009; ML093030375), the results of the NRC's February 2010 workshop (February workshop) on safety culture, and additional comments that stakeholders and other interested parties have provided to the staff at the various outreach activities that have occurred since February. The draft policy statement focuses on the unique aspects of nuclear safety and security and highlights the Commission's expectations that the policy applies to individuals and organizations performing or overseeing NRC-regulated activities. As part of the NRC staff's outreach activities which have focused on engaging a broad range of stakeholders including the Agreement States, the NRC held a 3-day Safety Culture Workshop in February 2010 at NRC headquarters in which participants were asked to reach alignment on (1) a common definition of safety culture and (2) high level descriptions or traits of areas important to safety culture. The February workshop also provided an additional venue for interested parties to provide comments on the draft policy statement that had been published in the Federal Register. Workshop panelists successfully aligned on a common definition of safety culture and developed a list of traits that they believe exist in a positive safety culture. Following the February workshop, the NRC staff participated in various industry forums in order to obtain additional input from stakeholders and other interested parties to confirm that the draft definition and traits developed at the February workshop reflect a broad consensus view. In preparation for the February workshop, the

  16. Development of an environmental performance assessment tool for carbon capture & storage chains

    NARCIS (Netherlands)

    Koornneef, J.; Florentinus, A.; Brandsma, R.; Hendriks, C.; Horssen, A. van; Harmelen, A.K. van; Ramirez, A.; Talaei, A.; Plomp, A.; Deurzen, J. van; Smekens, K.

    2013-01-01

    This paper reports the development of a tool to assess the environmental performance of carbon dioxide capture and storage (CCS) chains. The environmental assessment is done for the whole CCS chain. The tool has been designed to produce transparent and traceable results and is easy to work with. The

  17. Speech and Language Development in Cri Du Chat Syndrome: A Critical Review

    Science.gov (United States)

    Kristoffersen, Kristian Emil

    2008-01-01

    This article reviews research on speech and language abilities in people with cri du chat syndrome (CCS). CCS is a rare genetic disorder, with an estimated incidence between 1 in 15,000 and 1 in 50,000 births, resulting from a deletion on the short arm of chromosome 5. In general, individuals have delayed speech and language development, and some…

  18. MiReCOL: developing corrective measures for CO2 storage

    NARCIS (Netherlands)

    Neele, F.P.; Grimstadt, A.A.; Fleury, M.; Liebscher, A.; Korre, A.; Wilkinson, M.

    2014-01-01

    CO2 capture, transport and storage (CCS) has the potential to significantly reduce the carbon emission that follows from the use of fossil fuels in power production and industry. Integrated demo-scale projects are currently being developed to demonstrate the feasibility of CCS and the first such

  19. Evaluating the development of carbon capture and storage technologies in the United States

    NARCIS (Netherlands)

    Alphen, K. van; Noothout, P.M.; Hekkert, M.P.; Turkenburg, W.C.

    2010-01-01

    Carbon capture and storage (CCS) is seen as an important solution to solve the twin challenge of reducing GHG emissions, while utilizing fossil fuel reserves to meet future energy requirements. In this study an innovation systems perspective is applied to review the development of CCS technologies

  20. Multiple cis-regulatory elements are involved in the complex regulation of the sieve element-specific MtSEO-F1 promoter from Medicago truncatula.

    Science.gov (United States)

    Bucsenez, M; Rüping, B; Behrens, S; Twyman, R M; Noll, G A; Prüfer, D

    2012-09-01

    The sieve element occlusion (SEO) gene family includes several members that are expressed specifically in immature sieve elements (SEs) in the developing phloem of dicotyledonous plants. To determine how this restricted expression profile is achieved, we analysed the SE-specific Medicago truncatula SEO-F1 promoter (PMtSEO-F1) by constructing deletion, substitution and hybrid constructs and testing them in transgenic tobacco plants using green fluorescent protein as a reporter. This revealed four promoter regions, each containing cis-regulatory elements that activate transcription in SEs. One of these segments also contained sufficient information to suppress PMtSEO-F1 transcription in the phloem companion cells (CCs). Subsequent in silico analysis revealed several candidate cis-regulatory elements that PMtSEO-F1 shares with other SEO promoters. These putative sieve element boxes (PSE boxes) are promising candidates for cis-regulatory elements controlling the SE-specific expression of PMtSEO-F1. © 2012 German Botanical Society and The Royal Botanical Society of the Netherlands.

  1. Development of Off-take Model, Subcooled Boiling Model, and Radiation Heat Transfer Input Model into the MARS Code for a Regulatory Auditing of CANDU Reactors

    International Nuclear Information System (INIS)

    Yoon, C.; Rhee, B. W.; Chung, B. D.; Ahn, S. H.; Kim, M. W.

    2009-01-01

    Korea currently has four operating units of the CANDU-6 type reactor in Wolsong. However, the safety assessment system for CANDU reactors has not been fully established due to a lack of self-reliance technology. Although the CATHENA code had been introduced from AECL, it is undesirable to use a vendor's code for a regulatory auditing analysis. In Korea, the MARS code has been developed for decades and is being considered by KINS as a thermal hydraulic regulatory auditing tool for nuclear power plants. Before this decision, KINS (Korea Institute of Nuclear Safety) had developed the RELAP5/MOD3/CANDU code for CANDU safety analyses by modifying the model of the existing PWR auditing tool, RELAP5/MOD3. The main purpose of this study is to transplant the CANDU models of the RELAP5/MOD3/CANDU code to the MARS code including a quality assurance of the developed models

  2. Development of regulatory criteria applicable to control of radiation exposures to the population from products containing radioactive material

    International Nuclear Information System (INIS)

    Rogers, L.R.; Western, F.

    1969-01-01

    Under the Atomic Energy Act of 1954 as amended, the Atomic Energy Commission is responsible for regulating the possession, use and transfer of byproduct, source and special nuclear materials in accordance with safety standards established by rule of the Commission to protect health and minimize danger to life and property. This paper describes some of the basic considerations in establishing safety criteria and regulations for authorizing the transfer and use of byproduct material (radioisotopes) in products for distribution to the general public. It discusses problems encountered in extending the broad guidance provided by the Federal Radiation Council (FRC) and by the International Commission of Radiological Protection and the National Council on Radiation Protection and Measurements (ICRP-NCRP), which is limited to total exposures of individuals and population groups to radiation from many sources, to appropriate controls on radioactivity in an individual consumer product which represents only one source of population exposures. The paper also discusses possible approaches to accomplishing the regulatory objectives of providing reasonable assurance that (1) the contribution of an individual product to total exposures that might be permitted under FRC and ICRP-NCRP guidance should not be disproportionate to the benefits to be derived, and (2) appropriate efforts are made to limit exposures to the population from individual classes of sources of exposure as far as practicable. Existing criteria and regulations pertaining to the control of radiation exposure to the population from products into which radioactive material is purposely introduced are described, and additional considerations which must be taken into account for the development of further criteria and regulations which are applicable to the possible wide-scale distribution of products containing radioactive material as a result of the Plowshare Programs are explored. (author)

  3. Radionuclide migration at sites of temporary storage of SNF and RW in North-West Russia - Contribution to regulatory development

    International Nuclear Information System (INIS)

    Sneve, M.K.; Shandala, N.K.; Orlova, E.I.; Titov, A.V.; Kochetkov, O.A.; Smith, G.M.; Barraclough, I.M.

    2007-01-01

    Two technical bases of the Northern Fleet were created in the Russian northwest in the 1960s at Andreeva in the Kola Bay and Gremikha village on the coast of the Barents Sea. They maintained nuclear submarines, performing receipt and storage of radioactive waste and spent nuclear fuel. No further stored material was received after 1985. These technical bases have since been re-categorised as sites of temporary storage. It is necessary to note that, during the storage of RW and SNF, certain conditions arose which resulted in failure of the storage barrier system, resulting in release of radionuclides. Remediation activities at the site focus on reduction of major risks associated with most hazardous radioactive source terms. In addition, the long term management of the sites includes consideration of how to remediate contaminated areas, not only because they affect continuing work at the site, but also because this work will influence final radiological status of the sites. The optimum approach to remediation will be affected by how quickly radionuclides could move, both during the remediation works and, so far as any residual activity is concerned, after the works are completed. Present investigations reported here are directed to determination of sorption-desorption parameters of radionuclides in the studied areas, which will affect their underground migration, with the purpose of accounting for regional peculiarities in optimization process of the STSs remediation. The work is being carried out by the TSO State Research Centre - Institute of Biophysics, of Russian Federation, with assistance from western experts. The work forms part of a regulatory collaboration programme on-going between the Norwegian Radiation Protection Authority and the Federal Medical-Biological Agency which is designed to support the development of norms and standards to be applied in the remediation of these sites of temporary storage. (author)

  4. The identification and characterization of specific ARF-Aux/IAA regulatory modules in plant growth and development.

    Science.gov (United States)

    Krogan, Naden T; Berleth, Thomas

    2015-01-01

    The current model of auxin-inducible transcription describes numerous regulatory interactions between AUXIN RESPONSE FACTORs (ARFs) and Aux/IAAs. However, specific relationships between individual members of these families in planta remain largely uncharacterized. Using a systems biology approach, the entire suite of Aux/IAA genes directly regulated by the developmentally pivotal ARF MONOPTEROS (MP) was recently determined for multiple Arabidopsis tissue types. This study showed that MP directly targets distinct subclades of Aux/IAAs, revealing potential regulatory modules of redundantly acting Aux/IAAs involved in MP-dependent processes. Further, functional analyses indicated that the protein products of these targeted Aux/IAAs negatively feedback on MP. Thus, comprehensive identification of Aux/IAAs targeted by individual ARFs will generate biologically meaningful networks of ARF-Aux/IAA regulatory modules controlling distinct plant pathways.

  5. An arthropod cis-regulatory element functioning in sensory organ precursor development dates back to the Cambrian

    Directory of Open Access Journals (Sweden)

    Simpson Pat

    2010-09-01

    Full Text Available Abstract Background An increasing number of publications demonstrate conservation of function of cis-regulatory elements without sequence similarity. In invertebrates such functional conservation has only been shown for closely related species. Here we demonstrate the existence of an ancient arthropod regulatory element that functions during the selection of neural precursors. The activity of genes of the achaete-scute (ac-sc family endows cells with neural potential. An essential, conserved characteristic of proneural genes is their ability to restrict their own activity to single or a small number of progenitor cells from their initially broad domains of expression. This is achieved through a process called lateral inhibition. A regulatory element, the sensory organ precursor enhancer (SOPE, is required for this process. First identified in Drosophila, the SOPE contains discrete binding sites for four regulatory factors. The SOPE of the Drosophila asense gene is situated in the 5' UTR. Results Through a manual comparison of consensus binding site sequences we have been able to identify a SOPE in UTR sequences of asense-like genes in species belonging to all four arthropod groups (Crustacea, Myriapoda, Chelicerata and Insecta. The SOPEs of the spider Cupiennius salei and the insect Tribolium castaneum are shown to be functional in transgenic Drosophila. This would place the origin of this regulatory sequence as far back as the last common ancestor of the Arthropoda, that is, in the Cambrian, 550 million years ago. Conclusions The SOPE is not detectable by inter-specific sequence comparison, raising the possibility that other ancient regulatory modules in invertebrates might have escaped detection.

  6. The safety, efficacy and regulatory triangle in drug development: Impact for animal models and the use of animals.

    Science.gov (United States)

    van Meer, Peter J K; Graham, Melanie L; Schuurman, Henk-Jan

    2015-07-15

    Nonclinical studies in animals are conducted to demonstrate proof-of-concept, mechanism of action and safety of new drugs. For a large part, in particular safety assessment, studies are done in compliance with international regulatory guidance. However, animal models supporting the initiation of clinical trials have their limitations, related to uncertainty regarding the predictive value for a clinical condition. The 3Rs principles (refinement, reduction and replacement) are better applied nowadays, with a more comprehensive application with respect to the original definition. This regards also regulatory guidance, so that opportunities exist to revise or reduce regulatory guidance with the perspective that the optimal balance between scientifically relevant data and animal wellbeing or a reduction in animal use can be achieved. In this manuscript we review the connections in the triangle between nonclinical efficacy/safety studies and regulatory aspects, with focus on in vivo testing of drugs. These connections differ for different drugs (chemistry-based low molecular weight compounds, recombinant proteins, cell therapy or gene therapy products). Regarding animal models and their translational value we focus on regulatory aspects and indications where scientific outcomes warrant changes, reduction or replacement, like for, e.g., biosimilar evaluation and safety testing of monoclonal antibodies. On the other hand, we present applications where translational value has been clearly demonstrated, e.g., immunosuppressives in transplantation. Especially for drugs of more recent date like recombinant proteins, cell therapy products and gene therapy products, a regulatory approach that allows the possibility to conduct combined efficacy/safety testing in validated animal models should strengthen scientific outcomes and improve translational value, while reducing the numbers of animals necessary. Copyright © 2015 Elsevier B.V. All rights reserved.

  7. Recent advances in the dissection of drought-stress regulatory networks and strategies for development of drought-tolerant transgenic rice plants.

    Science.gov (United States)

    Todaka, Daisuke; Shinozaki, Kazuo; Yamaguchi-Shinozaki, Kazuko

    2015-01-01

    Advances have been made in the development of drought-tolerant transgenic plants, including cereals. Rice, one of the most important cereals, is considered to be a critical target for improving drought tolerance, as present-day rice cultivation requires large quantities of water and as drought-tolerant rice plants should be able to grow in small amounts of water. Numerous transgenic rice plants showing enhanced drought tolerance have been developed to date. Such genetically engineered plants have generally been developed using genes encoding proteins that control drought regulatory networks. These proteins include transcription factors, protein kinases, receptor-like kinases, enzymes related to osmoprotectant or plant hormone synthesis, and other regulatory or functional proteins. Of the drought-tolerant transgenic rice plants described in this review, approximately one-third show decreased plant height under non-stressed conditions or in response to abscisic acid treatment. In cereal crops, plant height is a very important agronomic trait directly affecting yield, although the improvement of lodging resistance should also be taken into consideration. Understanding the regulatory mechanisms of plant growth reduction under drought stress conditions holds promise for developing transgenic plants that produce high yields under drought stress conditions. Plant growth rates are reduced more rapidly than photosynthetic activity under drought conditions, implying that plants actively reduce growth in response to drought stress. In this review, we summarize studies on molecular regulatory networks involved in response to drought stress. In a separate section, we highlight progress in the development of transgenic drought-tolerant rice plants, with special attention paid to field trial investigations.

  8. Regulatory Governance

    DEFF Research Database (Denmark)

    Kjær, Poul F.; Vetterlein, Antje

    2018-01-01

    , legal and cultural, on a global scale. Against this background, this special issue sets out to explore the multifaceted meaning, potential and impact as well as the social praxis of regulatory governance. Under the notions rules, resistance and responsibility the special issue pins out three overall......Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political...

  9. Supporting and Developing Self-Regulatory Behaviours in Early Childhood in Young Children with High Levels of Impulsive Behaviour

    Science.gov (United States)

    Dan, Aviva

    2016-01-01

    Deficits in self-regulatory skills underlie or contribute to a range of adverse developmental problems and disorders, including ADHD (Barkley, 1997), eating disorders (Attie & Brooks-Gunn, 1995) and risk -taking behaviour (Cantor & Sanderson 1998; Eisenberg et al., 2005). Self-regulation has been recognised as an important factor in aiding…

  10. 76 FR 78173 - Options for Developing the Regulatory Basis for Streamlining Non-Power Reactor License Renewal...

    Science.gov (United States)

    2011-12-16

    ... the Regulatory Basis for Streamlining Non- Power Reactor License Renewal and Non-Power Reactor... non-power reactor license renewal and non-power reactor emergency preparedness. This meeting is a... establishing the technical basis for proposing rulemaking to streamline the non-power reactor license renewal...

  11. How adverse outcome pathways can aid the development and use of computational prediction models for regulatory toxicology

    Science.gov (United States)

    Efforts are underway to transform regulatory toxicology and chemical safety assessment from a largely empirical science based on direct observation of apical toxicity outcomes in whole organism toxicity tests to a predictive one in which outcomes and risk are inferred from accumu...

  12. Developing a strategy and closure criteria for radioactive and mixed waste sites in the ORNL remedial action program: Regulatory interface

    International Nuclear Information System (INIS)

    Trabalka, J.R.

    1987-09-01

    Some options for stabilization and treatment of contaminated sites can theoretically provide a once-and-for-all solution (e.g., removal or destruction of contaminants). Most realizable options, however, leave contaminants in place (in situ), potentially isolated by physical or chemical, but more typically, by hydrologic measures. As a result of the dynamic nature of the interactions between contaminants, remedial measures, and the environment, in situ stablization measures are likely to have limited life spans, and maintenance and monitoring of performance become an essential part of the scheme. The length of formal institutional control over the site and related questions about future uses of the land and waters are of paramount importance. Unique features of the ORNL site and environs appear to be key ingredients in achieving the very long term institutional control necessary for successful financing and implementation of in situ stabilization. Some formal regulatory interface is necessary to ensure that regulatory limitations and new guidance which can affect planning and implementation of the ORNL Remedial Action Program are communicated to ORNL staff and potential technical and financial limitations which can affect schedules or alternatives for achievement of long-term site stabilization and the capability to meet environmental regulations are provided to regulatory bodies as early as possible. Such an interface should allow decisions on closure criteria to be based primarily on technical merit and protection of human health and the environment. A plan for interfacing with federal and state regulatory authorities is described. 93 refs., 1 fig., 4 tabs

  13. A comparison of electricity and hydrogen production systems with CO2 capture and storage. Part B: Chain analysis of promising CCS options

    NARCIS (Netherlands)

    Damen, K.J.; van Troost, M.M.; Faaij, A.P.C.; Turkenburg, W.C.

    2007-01-01

    Promising electricity and hydrogen production chains with CO2 capture, transport and storage (CCS) and energy carrier transmission, distribution and end-use are analysed to assess (avoided) CO2 emissions, energy production costs and CO2 mitigation costs. For electricity chains, the performance is

  14. Regulatory Anatomy

    DEFF Research Database (Denmark)

    Hoeyer, Klaus

    2015-01-01

    , legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to explore the types of “safety” produced...... they arise. In short, I expose the regulatory anatomy of the policy landscape....

  15. Lessons Learned in Performing and Implementing the Results of TNA in a Newly Developed Regulatory Body with a Mandate to Regulate the Country's Expanding Nuclear Power Programme: A Case Study of PNRA no. 97

    International Nuclear Information System (INIS)

    Shahzad, Moazzam

    2014-01-01

    Conclusion: → It is essential that regulatory bodies apply a systematic approach to training need assessment; → Education and training requires capital investment, time and effort; it must be planned long in advance to be effective; → It is essential for a country considering a nuclear power programme to establish and implement a corresponding manpower development programme for its regulatory body

  16. Perceptions of regulatory approaches

    International Nuclear Information System (INIS)

    Halin, Magnus; Leinonen, Ruusaliisa

    2012-01-01

    Ms. Ruusaliisa Leinonen and Mr. Magnus Halin from Fortum gave a joint presentation on industry perceptions of regulatory oversight of LMfS/SC. It was concluded that an open culture of discussion exists between the regulator (STUK) and the licensee, based on the common goal of nuclear safety. An example was provided of on how regulatory interventions helped foster improvements to individual and collective dose rate trends, which had remained static. Regulatory interventions included discussions on the ALARA concept to reinforce the requirement to continuously strive for improvements in safety performance. Safety culture has also been built into regulatory inspections in recent years. Training days have also been organised by the regulatory body to help develop a shared understanding of safety culture between licensee and regulatory personnel. Fortum has also developed their own training for managers and supervisors. Training and ongoing discussion on LMfS/SC safety culture is considered particularly important because both Fortum and the regulatory body are experiencing an influx of new staff due to the demographic profile of their organisations. It was noted that further work is needed to reach a common understanding of safety culture on a practical level (e.g., for a mechanic setting to work), and in relation to the inspection criteria used by the regulator. The challenges associated with companies with a mix of energy types were also discussed. This can make it more difficult to understand responsibilities and decision making processes, including the role of the parent body organisation. It also makes communication more challenging due to increased complexity and a larger number of stakeholders

  17. Scientific and Regulatory Policy Committee Points to Consider Review: Inclusion of Reproductive and Pathology End Points for Assessment of Reproductive and Developmental Toxicity in Pharmaceutical Drug Development.

    Science.gov (United States)

    Halpern, Wendy G; Ameri, Mehrdad; Bowman, Christopher J; Elwell, Michael R; Mirsky, Michael L; Oliver, Julian; Regan, Karen S; Remick, Amera K; Sutherland, Vicki L; Thompson, Kary E; Tremblay, Claudine; Yoshida, Midori; Tomlinson, Lindsay

    2016-08-01

    Standard components of nonclinical toxicity testing for novel pharmaceuticals include clinical and anatomic pathology, as well as separate evaluation of effects on reproduction and development to inform clinical development and labeling. General study designs in regulatory guidances do not specifically mandate use of pathology or reproductive end points across all study types; thus, inclusion and use of these end points are variable. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology (STP) formed a Working Group to assess the current guidelines and practices on the use of reproductive, anatomic pathology, and clinical pathology end points in general, reproductive, and developmental toxicology studies. The Working Group constructed a survey sent to pathologists and reproductive toxicologists, and responses from participating organizations were collected through the STP for evaluation by the Working Group. The regulatory context, relevant survey results, and collective experience of the Working Group are discussed and provide the basis of each assessment by study type. Overall, the current practice of including specific end points on a case-by-case basis is considered appropriate. Points to consider are summarized for inclusion of reproductive end points in general toxicity studies and for the informed use of pathology end points in reproductive and developmental toxicity studies. © 2016 by The Author(s) 2016.

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

    International Nuclear Information System (INIS)

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

    2005-01-01

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

  19. Boolean modelling reveals new regulatory connections between transcription factors orchestrating the development of the ventral spinal cord.

    KAUST Repository

    Lovrics, Anna

    2014-11-14

    We have assembled a network of cell-fate determining transcription factors that play a key role in the specification of the ventral neuronal subtypes of the spinal cord on the basis of published transcriptional interactions. Asynchronous Boolean modelling of the network was used to compare simulation results with reported experimental observations. Such comparison highlighted the need to include additional regulatory connections in order to obtain the fixed point attractors of the model associated with the five known progenitor cell types located in the ventral spinal cord. The revised gene regulatory network reproduced previously observed cell state switches between progenitor cells observed in knock-out animal models or in experiments where the transcription factors were overexpressed. Furthermore the network predicted the inhibition of Irx3 by Nkx2.2 and this prediction was tested experimentally. Our results provide evidence for the existence of an as yet undescribed inhibitory connection which could potentially have significance beyond the ventral spinal cord. The work presented in this paper demonstrates the strength of Boolean modelling for identifying gene regulatory networks.

  20. Regulatory framework and development perspectives of the mechanism of public participation in the management of Russia’s forests

    Directory of Open Access Journals (Sweden)

    Nikolay Mikhaylovich Shmatkov

    2014-03-01

    Full Text Available The article dwells on the current state of the regulatory framework of the Russian Federation and the mechanism of public participation in forest management. The examples of addressing the problems of public participation in forest management in individual regions are disclosed. The article deals with the issues concerning the provision of in-interests of the local population through the voluntary forest certification system under the FSC scheme. Recommendations on improving the mechanism of public participation in solving the forest management issues are suggested

  1. Environmental Regulatory Compliance Plan for Site Characterization; Yucca Mountain Site, Nevada Research and Development Area, Nevada: Revision 1

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1988-12-01

    The DOE is committed to conduct its operations in an environmentally safe and sound manner, and will comply with applicable environmental statutes and regulations. These objectives are described in DOE Order 5400.1 (Environmental Protection Program Requirements). This document -- the Environmental Regulatory Compliance Plan (ERCP) -- is one method of implementing the policy set forth in DOE Order 5400.1 and the NWPA. The ERCP describes the plan by which the DOE will comply with applicable Federal environmental statutes and regulations. The ERCP also discusses how DOE will address State and local environmental statutes and regulations. 180 refs., 27 figs., 1 tab.

  2. Meeting CCS communication challenges head-on: Integrating communications, planning, risk assessment, and project management

    Science.gov (United States)

    Greenberg, S.; Gauvreau, L.; Hnottavange-Telleen, K.; Finley, R.; Marsteller, S.

    2011-01-01

    The Midwest Geological Sequestration Consortium, Schlumberger Carbon Services, and Archer Daniels Midland has implemented a comprehensive communications plan at the Illinois Basin - Decatur Project (IBDP), a one million metric tonne Carbon Capture and Storage project in Decatur, IL, USA funded by the U.S. Department of Energy's National Energy Technology Laboratory. The IBDP Communication Plan includes consortium information, funding and disclaimer citations, description of target audiences, media communications guidelines, paper and presentations guidelines, site visit information, crisis communication, on-site photography regulations, and other components. The creation, development, and implementation processes for the IBDP Communication Plan (the Plan) are shared in this paper. New communications challenges, such as how to address add-on research requests, data sharing and management, scope increase, and contract agreements have arisen since the Plan was completed in January 2009, resulting in development of new policies and procedures by project management. Integrating communications planning, risk assessment, and project management ensured that consistent, factual information was developed and incorporated into project planning, and constitutes the basis of public communications. Successful integration has allowed the IBDP to benefit from early identification and mitigation of the potential project risks, which allows more time to effectively deal with unknown and unidentified risks that may arise. Project risks and risks associated with public perception can be managed through careful planning and integration of communication strategies into project management and risk mitigation. ?? 2011 Published by Elsevier Ltd.

  3. Current and new developments in transport and regulatory issues concerning radioisotopes: managing change for minimum business impact

    International Nuclear Information System (INIS)

    Bennett, Neil; Coppell, David; Rogers, David; Schrader, John

    2004-01-01

    Changes in the regulatory framework governing the Radiation Processing Industry have the potential to make a real business impact on day-to-day profitability. Many areas of the Radiation Processing Industry are affected by changes in the regulatory framework within which these areas are managed. When planning for such changes the transportation element in the shipment of sealed cobalt radiation sources is an area that is often neglected by some parts of the distribution chain. A balance must be struck between the cobalt supplier and the facility operator/customer that rests upon how much the customer needs to know about the intricacies of cobalt shipment. The objective of this paper is to highlight areas of possible business impact and reassure the users of sealed radiation sources that the global suppliers of these products are used to negotiating local variations in regulations governing the physical transportation of radiation sources, changes in regulations governing the design, manufacture and use of transportation containers and changes in the availability of commercial shippers and shipping routes. The major suppliers of industrial quantities of cobalt-60 are well placed to lead their customers through this complex process as a matter of routine

  4. Current and new developments in transport and regulatory issues concerning radioisotopes: managing change for minimum business impact

    Energy Technology Data Exchange (ETDEWEB)

    Bennett, Neil; Coppell, David; Rogers, David; Schrader, John

    2004-10-01

    Changes in the regulatory framework governing the Radiation Processing Industry have the potential to make a real business impact on day-to-day profitability. Many areas of the Radiation Processing Industry are affected by changes in the regulatory framework within which these areas are managed. When planning for such changes the transportation element in the shipment of sealed cobalt radiation sources is an area that is often neglected by some parts of the distribution chain. A balance must be struck between the cobalt supplier and the facility operator/customer that rests upon how much the customer needs to know about the intricacies of cobalt shipment. The objective of this paper is to highlight areas of possible business impact and reassure the users of sealed radiation sources that the global suppliers of these products are used to negotiating local variations in regulations governing the physical transportation of radiation sources, changes in regulations governing the design, manufacture and use of transportation containers and changes in the availability of commercial shippers and shipping routes. The major suppliers of industrial quantities of cobalt-60 are well placed to lead their customers through this complex process as a matter of routine.

  5. CCS-DTN: Clustering and Network Coding-Based Efficient Routing in Social DTNs

    Directory of Open Access Journals (Sweden)

    Zhenjing Zhang

    2014-12-01

    Full Text Available With the development of mobile Internet, wireless communication via mobile devices has become a hot research topic, which is typically in the form of Delay Tolerant Networks (DTNs. One critical issue in the development of DTNs is routing. Although there is a lot research work addressing routing issues in DTNs, they cannot produce an advanced solution to the comprehensive challenges since only one or two aspects (nodes’ movements, clustering, centricity and so on are considered when the routing problem is handled. In view of these defects in the existing works, we propose a novel solution to address the routing issue in social DTNs. By this solution, mobile nodes are divided into different clusters. The scheme, Spray and Wait, is used for the intra-cluster communication while a new forwarding mechanism is designed for the inter-cluster version. In our solution, the characteristics of nodes and the relation between nodes are fully considered. The simulation results show that our proposed scheme can significantly improve the performance of the routing scheme in social DTNs.

  6. Regulatory and licensee surveys

    International Nuclear Information System (INIS)

    2009-01-01

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

  7. Cell-intrinsic role for NF-kappa B-inducing kinase in peripheral maintenance but not thymic development of Foxp3+ regulatory T cells in mice.

    Directory of Open Access Journals (Sweden)

    Susan E Murray

    Full Text Available NF-κB inducing kinase (NIK, MAP3K14 is a key signaling molecule in non-canonical NF-κB activation, and NIK deficient mice have been instrumental in deciphering the immunologic role of this pathway. Global ablation of NIK prevents lymph node development, impairs thymic stromal development, and drastically reduces B cells. Despite altered thymic selection, T cell numbers are near normal in NIK deficient mice. The exception is CD4(+ regulatory T cells (Tregs, which are reduced in the thymus and periphery. Defects in thymic stroma are known to contribute to impaired Treg generation, but whether NIK also plays a cell intrinsic role in Tregs is unknown. Here, we compared intact mice with single and mixed BM chimeric mice to assess the intrinsic role of NIK in Treg generation and maintenance. We found that while NIK expression in stromal cells suffices for normal thymic Treg development, NIK is required cell-intrinsically to maintain peripheral Tregs. In addition, we unexpectedly discovered a cell-intrinsic role for NIK in memory phenotype conventional T cells that is masked in intact mice, but revealed in BM chimeras. These results demonstrate a novel role for NIK in peripheral regulatory and memory phenotype T cell homeostasis.

  8. Defects in tor regulatory complexes retard aging and carbonyl/oxidative stress development in yeast Sассharomyces cerevisiae

    Directory of Open Access Journals (Sweden)

    B. V. Homza

    2014-02-01

    Full Text Available TOR signaling pathway first described in yeast S. сerevisiae is the highly conserved regulator of eukaryotic cell growth, aging and stress resistance. The effect of nitrogen sources, in particular amino acids, on the activity of TOR signaling pathway is well studied, however its relation to carbohydrates is poor understood. The aim of the present study is expanding of our understanding of potential role of TOR regulatory complexes in development of carbonyl/oxidative stress that can result from yeast cultivation on glucose and fructose. It has been shown that the level of α-dicarbonyl compounds and protein carbonyl groups increased with time of yeast cultivation and was higher in cells grown on fructose that demonstrated their accelerated aging and carbonyl/oxidative stress development as compared with cells grown on glucose. The strains defective in TOR proteins cultivated in the presence of glucose as well as fructose demonstrated lower markers of the stress and aging than parental strain. Thus these data confirmed the previous conclusion on fructose more potent ability to cause carbonyl/oxidative stress and accelerated aging in S. cerevisiae as compared with glucose. However, defects in TOR regulatory complexes retard aging and development of the stress in yeast independent on the type of carbohydrate in the cultivation medium.

  9. Assessing innovation in emerging energy technologies: Socio-technical dynamics of carbon capture and storage (CCS) and enhanced geothermal systems (EGS) in the USA

    International Nuclear Information System (INIS)

    Stephens, Jennie C.; Jiusto, Scott

    2010-01-01

    This study applies a socio-technical systems perspective to explore innovation dynamics of two emerging energy technologies with potential to reduce greenhouse gas emissions from electrical power generation in the United States: carbon capture and storage (CCS) and enhanced geothermal systems (EGS). The goal of the study is to inform sustainability science theory and energy policy deliberations by examining how social and political dynamics are shaping the struggle for resources by these two emerging, not-yet-widely commercializable socio-technical systems. This characterization of socio-technical dynamics of CCS and EGS innovation includes examining the perceived technical, environmental, and financial risks and benefits of each system, as well as the discourses and actor networks through which the competition for resources - particularly public resources - is being waged. CCS and EGS were selected for the study because they vary considerably with respect to their social, technical, and environmental implications and risks, are unproven at scale and uncertain with respect to cost, feasibility, and life-cycle environmental impacts. By assessing the two technologies in parallel, the study highlights important social and political dimensions of energy technology innovation in order to inform theory and suggest new approaches to policy analysis.

  10. Development of a Carbon Management Geographic Information System (GIS) for the United States

    Energy Technology Data Exchange (ETDEWEB)

    Howard Herzog; Holly Javedan

    2009-12-31

    In this project a Carbon Management Geographical Information System (GIS) for the US was developed. The GIS stored, integrated, and manipulated information relating to the components of carbon management systems. Additionally, the GIS was used to interpret and analyze the effect of developing these systems. This report documents the key deliverables from the project: (1) Carbon Management Geographical Information System (GIS) Documentation; (2) Stationary CO{sub 2} Source Database; (3) Regulatory Data for CCS in United States; (4) CO{sub 2} Capture Cost Estimation; (5) CO{sub 2} Storage Capacity Tools; (6) CO{sub 2} Injection Cost Modeling; (7) CO{sub 2} Pipeline Transport Cost Estimation; (8) CO{sub 2} Source-Sink Matching Algorithm; and (9) CO{sub 2} Pipeline Transport and Cost Model.

  11. Regulatory Control of Radiation Sources. Safety Guide

    International Nuclear Information System (INIS)

    2009-01-01

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

  12. Study of the olfactory epithelium in the developing sturgeon. Characterization of the crypt cells.

    Science.gov (United States)

    Camacho, Susana; Ostos-Garrido, M V; Domezain, A; Carmona, R

    2010-02-01

    In acipenserids, crypt cells (CCs) have only been observed in juvenile specimens, and it has not been clarified whether they differentiate along with olfactory receptor neurons (ORNs) during the lecithotrophic stage or during later development stages. Furthermore, no detailed optical microscopy (OM) or electron microscopy study on the development of CCs has been published to date. In the present study, we used OM and electron microscopy to follow the development of CCs in Acipenser naccarii from hatching to the establishment of exogenous feeding. Based on these observations, we can affirm that CCs are present from the first few posthatching (PH) days. CCs appear with their nucleus close to the basal lamina of the epithelium and enveloped by supporting cells. In addition, from the beginning of day 2 PH, we observed cells with highly similar characteristics to those of CCs (absence of knob, abundant mitochondria and filamentous material in apical cytoplasm, numerous microtubules, and envelopment by supporting cells) but with cilia still remaining on their noninvaginated apical surface. We conclude that these cells may correspond to immature CCs in which the crypt, the final feature of their morphological differentiation, has not yet formed.

  13. Quantification of tumor infiltrating Foxp3+ regulatory T cells enables the identification of high-risk patients for developing synchronous cancers over upper aerodigestive tract.

    Science.gov (United States)

    Wang, Wen-Lun; Chang, Wei-Lun; Yang, Hsiao-Bai; Chang, I-Wei; Lee, Ching-Tai; Chang, Chi-Yang; Lin, Jaw-Town; Sheu, Bor-Shyang

    2015-07-01

    Patients with squamous cell carcinomas (SCC) of upper aerodigestive tract, either over head and neck (HNSCC) or esophagus (ESCC), frequently developed synchronous multiple cancers, leading to worse prognosis. This study validated whether suppression of host cancer immunosurveillance mediated by regulatory T cells (Treg) may predispose to the development of synchronous cancers. Tumor tissues of 200 patients (100 ESCC only, 50 HNSCC only, and 50 synchronous SCCs) were quantitatively accessed for the tumor infiltrating Treg by immunohistochemistry. The density of Treg was also correlated to the level of Treg-associated inhibitory cytokines (IL-10, IL-35 and TGF-β1), and chemokine (CCL22). The density of tumor infiltrating Treg in the index tumor (i.e. the first malignancy diagnosed) of synchronous SCC group was higher than those of HNSCC or ESCC only (prisk of synchronous cancer development to initiate a proper surveillance program. Copyright © 2015 Elsevier Ltd. All rights reserved.

  14. Regulatory aspects, an important factor for geothermal energy application for district heating development. European insurance scheme to cover geological risk related to geothermal operations

    International Nuclear Information System (INIS)

    Popovski, Kiril

    2000-01-01

    District heating is one of the most interesting fields of geothermal energy application development in Europe. However, besides the technical/technological/economical and organizational aspects of the problem in question, the related legal and regulatory aspects influence very much the real possibilities for wider introduction of this energy source in the state energy balances in most of the countries. Based on the official EU report for the State-of-the-art of the problem of the insurance to cover geological risks and necessary aspects to be developed and resolved in a better and 'common' way in order to enable higher investments in bigger projects (district heating) development, the paper presents the situation in different European countries in relation to the Macedonian one. Conclusions extracted should give a positive contribution to the process of the Macedonian laws accommodation to the common EU practice. (Author)

  15. Science in bullet points: How to compile scientific results to underpin guidelines for CO2 storage for the German transposition of the European CCS Directive

    Science.gov (United States)

    Streibel, Martin

    2015-04-01

    In 2012 the German Parliament passed the transposition of the EC Directive 2009/31/EC the "Carbon Dioxide Storage Law" (KSpG). The law focuses on the demonstration of the CO2 storage technology and mainly regulates the storage part of the Carbon Capture and Storage (CCS) chain. As the law has a conceptual character, appendix 1 provides a description of criteria for the characterisation and assessment of a potential CO2 storage site starting with field data ending with requirements for dynamic modelling of the storage complex. Appendix 2 describes the expected monitoring system during all relevant phases of a life cycle of a CO2 storage site. The criteria given in the appendices are of general nature, which reflects on one hand that the CO2 storage technology is still being developed and on the other hand that site specific aspects needs to be considered. In 2004 the Federal Ministry of Education and Research of Germany launched the programme GEOTECHNOLOGIEN with one key aspect being the development of technologies for a sustainable storage of carbon dioxide in geological formations. Within this research field more than 30 projects in three phases have been funded until the end of 2014. In order to benefit from the gathered knowledge and use the experiences for the policy/law making process the umbrella project AUGE has been launched in October 2012 with a life time of three years. The aim of the project is to review and compile all results of projects funded during the three phases to underpin the appendices of the KSpG. In the first part of the paper the most important findings of the project with regard to the overall risk of a geological CO2 storage and the procedure of compiling the guidance document will be discussed. Milestones of this project were • the compilation of the results of national, European and international projects; • interviews with stakeholders; • a workshops to define state of the art for certain involved technologies and existing gaps

  16. 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) The...

  17. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving?

    Science.gov (United States)

    Boráň, Tomáš; Menezes-Ferreira, Margarida; Reischl, Ilona; Celis, Patrick; Ferry, Nicolas; Gänsbacher, Bernd; Krafft, Hartmut; Lipucci di Paola, Michele; Sladowski, Dariusz; Salmikangas, Paula

    2017-09-01

    The research and development of advanced therapy medicinal products (ATMPs) has been active in Europe and worldwide during recent years. Yet, the number of licensed products remains low. The main expected legal change in the near future in the European Union (EU) concerns the regulation on clinical trials (536/2014), which will come into force in 2018. With this new framework, a more harmonized and swift process for approval of clinical trials is anticipated, which is expected to support the entry of new innovations into the EU market. A survey on ATMPs in clinical trials during 2010-2015 in the EU was conducted in order to study the trends of ATMP development since the earlier survey published in 2012. According to the results, the number of clinical trials using ATMPs is slowly increasing in the EU. Yet, the focus is still in early development, and the projects are mainly carried out by small and medium-sized enterprises, academia, and hospitals. Oncology is the main area of clinical development. Yet, the balance between cell-based products and gene therapy medicinal products in this area may be changing in the future due to the new T-cell technologies. Many limitations and challenges are identified for ATMP development, requiring proportionate regulatory requirements. On the other hand, for such a novel field, the developers should be active in considering possible constraints and actively engage with authorities to look for solutions. This article provides up to-date information on forthcoming regulatory improvements and discusses the main challenges hampering the commercialization of ATMPs in the EU.

  18. Virginia Power's regulatory reduction program

    International Nuclear Information System (INIS)

    Miller, G.D.

    1996-01-01

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

  19. 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...

  20. Regulatory facility guide for Ohio

    Energy Technology Data Exchange (ETDEWEB)

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

    1994-02-28

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

  1. Proteomics analysis of global regulatory cascades involved in clavulanic acid production and morphological development in Streptomyces clavuligerus.

    Science.gov (United States)

    Ferguson, Nicole L; Peña-Castillo, Lourdes; Moore, Marcus A; Bignell, Dawn R D; Tahlan, Kapil

    2016-04-01

    The genus Streptomyces comprises bacteria that undergo a complex developmental life cycle and produce many metabolites of importance to industry and medicine. Streptomyces clavuligerus produces the β-lactamase inhibitor clavulanic acid, which is used in combination with β-lactam antibiotics to treat certain β-lactam resistant bacterial infections. Many aspects of how clavulanic acid production is globally regulated in S. clavuligerus still remains unknown. We conducted comparative proteomics analysis using the wild type strain of S. clavuligerus and two mutants (ΔbldA and ΔbldG), which are defective in global regulators and vary in their ability to produce clavulanic acid. Approximately 33.5 % of the predicted S. clavuligerus proteome was detected and 192 known or putative regulatory proteins showed statistically differential expression levels in pairwise comparisons. Interestingly, the expression of many proteins whose corresponding genes contain TTA codons (predicted to require the bldA tRNA for translation) was unaffected in the bldA mutant.

  2. TpF1 from Treponema pallidum activates inflammasome and promotes the development of regulatory T cells.

    Science.gov (United States)

    Babolin, Chiara; Amedei, Amedeo; Ozolins, Dzintars; Zilevica, Aija; D'Elios, Mario Milco; de Bernard, Marina

    2011-08-01

    Human syphilis is a multistage disease, with diverse and wide-ranging manifestations caused by Treponema pallidum. Despite the fact that a cell-mediated immune response takes part in the course of syphilis, T. pallidum often manages to evade host immunity and, in untreated individuals, may trigger chronic infection. With this study, we demonstrate for the first time, to our knowledge, that Treponema pallidum induces a regulatory T (Treg) response in patients with secondary syphilis and we found that the miniferritin TpF1, produced by the bacterium, is able to expand this response and promote the production of TGF-β. Accordingly, TpF1 stimulates monocytes to release IL-10 and TGF-β, the key cytokines in driving Treg cell differentiation. Interestingly, we also found that TpF1 stimulates monocytes to synthesize and release several proinflammatory cytokines, such as TNF-α, IL-6, and IL-1β, the latter following the activation of the multiprotein complex inflammasome. Collectively, these data strongly support a central role for TpF1 both in the inflammation process, which occurs in particular during the early stage of syphilis, and in the long-term persistence of the spirochete within the host by promoting Treg response and TGF-β production.

  3. New policy and regulatory developments in satellite communications: Innovations by the German Ministry of Posts and Telecommunications

    Science.gov (United States)

    Boettcher, Christian D.

    Since the beginning of the 1990s the Ministry of Posts and Telecommunications has embarked on a course in cooperation with the European Commission to further the cause of regulatory reform in telecommunications through the furtherance of competition at the national and international level. This has been particularly true in the field of satellite communications. To date, 39 foreign and domestic countries have been given licenses to engage in satellite communications in some form in Germany. Currently, there are some 2300 transmitting or receive-only earth stations in operation. As a result of this policy significant new investment in satellite communications is expected with perhaps 530 million DM or US $350 million being spent on private networks by 1998. Currently the ministry is seeking competition in satellite communications in several areas. These include: (1) competition in the earth segment, nationally and internationally; (2) competitive access to the space segment of international satellite organizations (e.g., Intelsat, Inmarsat, Eutelsat); and (3) competitive space segment offerings. This report indicates the current status of these activities and plans for the future.

  4. Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.

    Science.gov (United States)

    Grabowski, Henry G; Guha, Rahul; Salgado, Maria

    2014-06-01

    In March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class-including "biobetters," which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors. Project HOPE—The People-to-People Health Foundation, Inc.

  5. Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part I. Biotherapeutics.

    Science.gov (United States)

    Frazier, Kendall S; Engelhardt, Jeffery A; Fant, Pierluigi; Guionaud, Silvia; Henry, Scott P; Leach, Michael W; Louden, Calvert; Scicchitano, Marshall S; Weaver, James L; Zabka, Tanja S

    2015-10-01

    Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. Although DIVI in laboratory animal species has been well characterized for vasoactive small molecules, there is little available information regarding DIVI associated with biotherapeutics such as peptides/proteins or antibodies. Because of the uncertainty about whether DIVI in preclinical studies is predictive of effects in humans and the lack of robust biomarkers of DIVI, preclinical DIVI findings can cause considerable delays in or even halt development of promising new drugs. This review discusses standard terminology, characteristics, and mechanisms of DIVI associated with biotherapeutics. Guidance and points to consider for the toxicologist and pathologist facing preclinical cases of biotherapeutic-related DIVI are outlined, and examples of regulatory feedback for each of the mechanistic types of DIVI are included to provide insight into risk assessment. © 2015 by The Author(s).

  6. Reconstruction of the gene regulatory network involved in the sonic hedgehog pathway with a potential role in early development of the mouse brain.

    Directory of Open Access Journals (Sweden)

    Jinhua Liu

    2014-10-01

    Full Text Available The Sonic hedgehog (Shh signaling pathway is crucial for pattern formation in early central nervous system development. By systematically analyzing high-throughput in situ hybridization data of E11.5 mouse brain, we found that Shh and its receptor Ptch1 define two adjacent mutually exclusive gene expression domains: Shh+Ptch1- and Shh-Ptch1+. These two domains are associated respectively with Foxa2 and Gata3, two transcription factors that play key roles in specifying them. Gata3 ChIP-seq experiments and RNA-seq assays on Gata3-knockdown cells revealed that Gata3 up-regulates the genes that are enriched in the Shh-Ptch1+ domain. Important Gata3 targets include Slit2 and Slit3, which are involved in the process of axon guidance, as well as Slc18a1, Th and Qdpr, which are associated with neurotransmitter synthesis and release. By contrast, Foxa2 both up-regulates the genes expressed in the Shh+Ptch1- domain and down-regulates the genes characteristic of the Shh-Ptch1+ domain. From these and other data, we were able to reconstruct a gene regulatory network governing both domains. Our work provides the first genome-wide characterization of the gene regulatory network involved in the Shh pathway that underlies pattern formation in the early mouse brain.

  7. Strengthening Regulatory Competence in Pakistan

    International Nuclear Information System (INIS)

    Sadiq, M.

    2016-01-01

    Capacity building of Pakistan Nuclear Regulatory Authority is considered an essential element in pursuit of its vision to become a world class regulatory body. Since its inception in 2001, PNRA has continuously endeavoured to invest in its people, develop training infrastructure and impart sound knowledge and professional skills with the aim to improve its regulatory effectiveness. The use of nuclear and radioactive material in Pakistan has increased manifold in recent years, thus induction of more manpower was needed for regulatory oversight. PNRA adopted two pronged approach for meeting the manpower demand (a) employment of university graduates through fast track recruitment drive and (b) induction of graduates by offering fellowships for Master degree programs. Although, the newly employed staff was selected on the basis of their excellent academic qualifications in basic and applied sciences, but they required rigorous knowledge and skills in regulatory perspectives. In order to implement a structured training program, PNRA conducted Training Needs Assessment (TNA) and identified competency gaps of the regulatory staff in legal, technical, regulatory practice and behavioural domains. PNRA took several initiatives for capacity building which included establishment of a training centre for sustainability of trainings, initiation of a fellowship scheme for Master program, attachment of staff at local institutes for on-the-job training and placement at foreign regulatory bodies and organizations for technical development with the assistance of IAEA. The above strategies have been very beneficial in competence building of the PNRA staff to perform all regulatory activities indigenously for nuclear power plants, research reactors and radiation facilities. Provision of vibrant technical support to IAEA and Member States in various programs by PNRA is a landmark of these competence development efforts. This paper summarizes PNRA initiatives and the International Atomic

  8. Regulatory body contribution to the development of an integrated radioactive waste management system in the Slovak Republic

    International Nuclear Information System (INIS)

    Konecny, L.; Burclova, J.

    2002-01-01

    The nuclear energy is a very important part of electricity production in the Slovak Republic. Slovakia currently operates 6 nuclear units in two sites and their share on total power production is about 55%. Original soviet design of NPPs operated in Slovakia was based on storage strategy of non-treated solid waste and evaporated liquid waste until decommissioning of the plant. A new approach to the waste management at the end of the 1980s resulted in a strategy to install technologies able to transform in principle all radioactive waste into a form suitable for disposal. The technological part of radioactive waste management was supported in the late 1990s by respective legislation namely by a new act on peaceful use of nuclear energy and by regulation on radioactive waste and spent fuel management. Thus the basis for an integrated radioactive waste management system was created and technical short and long term solutions for the management of all kinds of radioactive waste were prepared. A comprehensive combination of individual components such as legal framework, regulation, overall organization, technology etc. in a single functional system is required for an effective and safe waste management system. Although the waste management system in the Slovak Republic is influenced by historical, socio-political, economic and other factors, a strong regulatory body is one of the key elements of an integrated approach to a generic national system for management of all types of wastes. UJD SR which was appointed as the central state authority for nuclear safety supervision took great effort in its legislative, licensing, assessment and inspection activities with the aim to support this integrated approach. (author)

  9. Characterizing near-surface CO2 conditions before injection - Perspectives from a CCS project in the Illinois Basin, USA

    Science.gov (United States)

    Locke, R.A.; Krapac, I.G.; Lewicki, J.L.; Curtis-Robinson, E.

    2011-01-01

    The Midwest Geological Sequestration Consortium is conducting a large-scale carbon capture and storage (CCS) project in Decatur, Illinois, USA to demonstrate the ability of a deep saline formation to store one million tonnes of carbon dioxide (CO2) from an ethanol facility. Beginning in early 2011, CO2 will be injected at a rate of 1,000 tonnes/day for three years into the Mount Simon Sandstone at a depth of approximately 2,100 meters. An extensive Monitoring, Verification, and Accounting (MVA) program has been undertaken for the Illinois Basin Decatur Project (IBDP) and is focused on the 0.65 km2 project site. Goals include establishing baseline conditions to evaluate potential impacts from CO2 injection, demonstrating that project activities are protective of human health and the environment, and providing an accurate accounting of stored CO2. MVA efforts are being conducted pre-, during, and post- CO2 injection. Soil and net CO2 flux monitoring has been conducted for more than one year to characterize near-surface CO2 conditions. More than 2,200 soil CO2 flux measurements have been manually collected from a network of 118 soil rings since June 2009. Three ring types have been evaluated to determine which type may be the most effective in detecting potential CO 2 leakage. Bare soil, shallow-depth rings were driven 8 cm into the ground and were prepared to minimize surface vegetation in and near the rings. Bare soil, deep-depth rings were prepared similarly, but were driven 46 cm. Natural-vegetation, shallow-depth rings were driven 8 cm and are most representative of typical vegetation conditions. Bare-soil, shallow-depth rings had the smallest observed mean flux (1.78 ??mol m-2 s-1) versus natural-vegetation, shallow-depth rings (3.38 ??mol m-2 s-1). Current data suggest bare ring types would be more sensitive to small CO2 leak signatures than natural ring types because of higher signal to noise ratios. An eddy covariance (EC) system has been in use since June

  10. Development of measures to assess the safety of existing NPPs and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches). Peer discussions on regulatory practices

    International Nuclear Information System (INIS)

    1996-09-01

    This report arises from the fourth series of peer discussions on regulatory practices entitled D evelopment of measures to assess the safety of existing nuclear power plants and the effectiveness of regulations and regulatory actions (including 'prescriptive' and 'performance based' approaches) . Senior regulators from 23 Member States participated in four peer group discussions during 1995-1996. This report presents the outcome of these meetings and recommendations of good practices identified by these senior regulators. The purpose of this report is to disseminate the views which the senior regulators presented at the meetings relating to measures used for assessing the safety of existing nuclear power plants and evaluating the effectiveness of regulators and regulatory actions. The intention in doing this is to assist Member States in the enhancement of their regulatory practices by identifying commonly accepted good practices. This report is structured so that it covers the subject matter under the following main headings: 'Prescriptive and Performance Based' Approaches to Regulation; Common Features of Regulatory Approaches; Effectiveness of the Regulator and Regulatory Actions; Recommendations of Good Practice. It is important to note that recommendations of good practice are included if they have been identified by at least one of the groups. It does not follow that all of the groups or individual Member States would necessarily endorse all of the recommendations. However, it is considered that if a single group of senior regulators judge that a particular practice is worthy of recommendation then it should be included for serious consideration. In some cases the same recommendations arise from all of the Groups

  11. Transcriptomic Analysis of Long Non-Coding RNAs and Coding Genes Uncovers a Complex Regulatory Network That Is Involved in Maize Seed Development

    Directory of Open Access Journals (Sweden)

    Ming Zhu

    2017-10-01

    Full Text Available Long non-coding RNAs (lncRNAs have been reported to be involved in the development of maize plant. However, few focused on seed development of maize. Here, we identified 753 lncRNA candidates in maize genome from six seed samples. Similar to the mRNAs, lncRNAs showed tissue developmental stage specific and differential expression, indicating their putative role in seed development. Increasing evidence shows that crosstalk among RNAs mediated by shared microRNAs (miRNAs represents a novel layer of gene regulation, which plays important roles in plant development. Functional roles and regulatory mechanisms of lncRNAs as competing endogenous RNAs (ceRNA in plants, particularly in maize seed development, are unclear. We combined analyses of consistently altered 17 lncRNAs, 840 mRNAs and known miRNA to genome-wide investigate potential lncRNA-mediated ceRNA based on “ceRNA hypothesis”. The results uncovered seven novel lncRNAs as potential functional ceRNAs. Functional analyses based on their competitive coding-gene partners by Gene Ontology (GO and KEGG biological pathway demonstrated that combined effects of multiple ceRNAs can have major impacts on general developmental and metabolic processes in maize seed. These findings provided a useful platform for uncovering novel mechanisms of maize seed development and may provide opportunities for the functional characterization of individual lncRNA in future studies.

  12. The application of transformational leadership theory to parenting: questionnaire development and implications for adolescent self-regulatory efficacy and life satisfaction.

    Science.gov (United States)

    Morton, Katie L; Barling, Julian; Rhodes, Ryan E; Mâsse, Louise C; Zumbo, Bruno D; Beauchamp, Mark R

    2011-10-01

    We draw upon transformational leadership theory to develop an instrument to measure transformational parenting for use with adolescents. First, potential items were generated that were developmentally appropriate and evidence for content validity was provided through the use of focus groups with parents and adolescents. We subsequently provide evidence for several aspects of construct validity of measures derived from the Transformational Parenting Questionnaire (TPQ). Data were collected from 857 adolescents (M(age) = 14.70 years), who rated the behaviors of their mothers and fathers. The results provided support for a second-order measurement model of transformational parenting. In addition, positive relationships between mothers' and fathers' transformational parenting behaviors, adolescents' self-regulatory efficacy for physical activity and healthy eating, and life satisfaction were found. The results of this research support the application of transformational leadership theory to parenting behaviors, as well as the construct validity of measures derived from the TPQ.

  13. [Regulatory science researches of nanomedicines].

    Science.gov (United States)

    Sakai-Kato, Kumiko; Goda, Yukihiro

    2014-01-01

    Recently, the development of nanomedicines is progressing. These are designed to ensure high stability and to optimize the pharmacokinetics in vivo. The polymeric micelles and lipid nanoparticles are typical such examples. Because the unique size-specific interaction with biological systems or biodistribution may have significant impacts on the efficacy and safety of nanomedicines, regulatory science researches of nanomedicines are required. In this review, the authors introduce our initiatives of the regulatory science researches of nanomedicines.

  14. Early Childhood Curriculum Development: The Role of Play in Building Self-Regulatory Capacity in Young Children

    Science.gov (United States)

    Kroll, Linda R.

    2017-01-01

    This case study examines the development of self-regulation, socially, cognitively and emotionally, through the use of play in the curriculum in five preschool classrooms for children ages 2-5 years old at a university laboratory school. Five teachers were interviewed about their deliberate use of play to support the development of self-regulation…

  15. CD4+CD25+Foxp3+ regulatory T cells depletion may attenuate the development of silica-induced lung fibrosis in mice.

    Directory of Open Access Journals (Sweden)

    Fangwei Liu

    Full Text Available BACKGROUND: Silicosis is an occupational lung disease caused by inhalation of silica dust characterized by lung inflammation and fibrosis. Previous study showed that Th1 and Th2 cytokines are involved in silicosis, but Th1/Th2 polarization during the development of silicosis is still a matter of debate. Regulatory T cells (Treg cells represent a crucial role in modulation of immune homeostasis by regulating Th1/Th2 polarization, but their possible implication in silicosis remains to be explored. METHODOLOGY/PRINCIPAL FINDINGS: To evaluate the implication of Treg cells in the development of silicosis, we generated the Treg-depleted mice model by administration of anti-CD25 mAbs and mice were exposed to silica by intratracheal instillation to establish experimental model of silica-induced lung fibrosis. The pathologic examinations show that the Treg-depleted mice are susceptive to severer inflammation in the early stage, with enhanced infiltration of inflammatory cells. Also, depletion of Treg cells causes a delay of the progress of silica-induced lung fibrosis in mice model. Further study of mRNA expression of cytokines reveals that depletion of Tregs leads to the increased production of Th1-cytokines and decreased production of Th2-cytokine. The Flow Cytometry and realtime PCR study show that Treg cells exert the modulation function both directly by expressing CTLA-4 at the inflammatory stage, and indirectly by secreting increasing amount of IL-10 and TGF-β during the fibrotic stage in silica-induced lung fibrosis. CONCLUSION/SIGNIFICANCE: Our study suggests that depletion of Tregs may attenuate the progress of silica-induced lung fibrosis and enhance Th1 response and decelerate Th1/Th2 balance toward a Th2 phenotype in silica-induced lung fibrosis. The regulatory function of Treg cells may depend on direct mechanism and indirect mechanism during the inflammatory stage of silicosis.

  16. Positional mapping and candidate gene analysis of the mouse Ccs3 locus that regulates differential susceptibility to carcinogen-induced colorectal cancer.

    Directory of Open Access Journals (Sweden)

    Charles Meunier

    Full Text Available The Ccs3 locus on mouse chromosome 3 regulates differential susceptibility of A/J (A, susceptible and C57BL/6J (B6, resistant mouse strains to chemically-induced colorectal cancer (CRC. Here, we report the high-resolution positional mapping of the gene underlying the Ccs3 effect. Using phenotype/genotype correlation in a series of 33 AcB/BcA recombinant congenic mouse strains, as well as in groups of backcross populations bearing unique recombinant chromosomes for the interval, and in subcongenic strains, we have delineated the maximum size of the Ccs3 physical interval to a ∼2.15 Mb segment. This interval contains 12 annotated transcripts. Sequencing of positional candidates in A and B6 identified many either low-priority coding changes or non-protein coding variants. We found a unique copy number variant (CNV in intron 15 of the Nfkb1 gene. The CNV consists of two copies of a 54 bp sequence immediately adjacent to the exon 15 splice site, while only one copy is found in CRC-susceptible A. The Nfkb1 protein (p105/p50 expression is much reduced in A tumors compared to normal A colonic epithelium as analyzed by immunohistochemistry. Studies in primary macrophages from A and B6 mice demonstrate a marked differential activation of the NfκB pathway by lipopolysaccharide (kinetics of stimulation and maximum levels of phosphorylated IκBα, with a more robust activation being associated with resistance to CRC. NfκB has been previously implicated in regulating homeostasis and inflammatory response in the intestinal mucosa. The interval contains another positional candidate Slc39a8 that is differentially expressed in A vs B6 colons, and that has recently been associated in CRC tumor aggressiveness in humans.

  17. A Novel Sucrose-Regulatory MADS-Box Transcription Factor GmNMHC5 Promotes Root Development and Nodulation in Soybean (Glycine max [L.] Merr.).

    Science.gov (United States)

    Liu, Wei; Han, Xiangdong; Zhan, Ge; Zhao, Zhenfang; Feng, Yongjun; Wu, Cunxiang

    2015-08-31

    The MADS-box protein family includes many transcription factors that have a conserved DNA-binding MADS-box domain. The proteins in this family were originally recognized to play prominent roles in floral development. Recent findings, especially with regard to the regulatory roles of the AGL17 subfamily in root development, have greatly broadened their known functions. In this study, a gene from soybean (Glycine max [L.] Merr.), GmNMHC5, was cloned from the Zigongdongdou cultivar and identified as a member of the AGL17 subfamily. Real-time fluorescence quantitative PCR analysis showed that GmNMHC5 was expressed at much higher levels in roots and nodules than in other organs. The activation of expression was first examined in leaves and roots, followed by shoot apexes. GmNMHC5 expression levels rose sharply when the plants were treated under short-day conditions (SD) and started to pod, whereas low levels were maintained in non-podding plants under long-day conditions (LD). Furthermore, overexpression of GmNMHC5 in transgenic soybean significantly promoted lateral root development and nodule building. Moreover, GmNMHC5 is upregulated by exogenous sucrose. These results indicate that GmNMHC5 can sense the sucrose signal and plays significant roles in lateral root development and nodule building.

  18. A Novel Sucrose-Regulatory MADS-Box Transcription Factor GmNMHC5 Promotes Root Development and Nodulation in Soybean (Glycine max [L.] Merr.

    Directory of Open Access Journals (Sweden)

    Wei Liu

    2015-08-01

    Full Text Available The MADS-box protein family includes many transcription factors that have a conserved DNA-binding MADS-box domain. The proteins in this family were originally recognized to play prominent roles in floral development. Recent findings, especially with regard to the regulatory roles of the AGL17 subfamily in root development, have greatly broadened their known functions. In this study, a gene from soybean (Glycine max [L.] Merr., GmNMHC5, was cloned from the Zigongdongdou cultivar and identified as a member of the AGL17 subfamily. Real-time fluorescence quantitative PCR analysis showed that GmNMHC5 was expressed at much higher levels in roots and nodules than in other organs. The activation of expression was first examined in leaves and roots, followed by shoot apexes. GmNMHC5 expression levels rose sharply when the plants were treated under short-day conditions (SD and started to pod, whereas low levels were maintained in non-podding plants under long-day conditions (LD. Furthermore, overexpression of GmNMHC5 in transgenic soybean significantly promoted lateral root development and nodule building. Moreover, GmNMHC5 is upregulated by exogenous sucrose. These results indicate that GmNMHC5 can sense the sucrose signal and plays significant roles in lateral root development and nodule building.

  19. The changing regulatory environment

    International Nuclear Information System (INIS)

    Caron, G.

    1999-01-01

    The role and value of regulation in the energy sector was discussed, demonstrating how, despite common perception, regulation is an essential part of Canada's strategy to find and develop new opportunities. The future vision of regulation for industry participants was presented with particular focus on issues related to streamlining the regulatory process. As far as pipelines are concerned, regulatory actions are necessary to facilitate capacity increases and to ensure the line's integrity, safety and environmental record. Furthermore, regulation provides economic solutions where market forces cannot provide them, as for example where business has elements of monopoly. It arbitrates interests of landowners, business, consumers, and environmental groups. It looks for ways to ensure conditions under which competition can flourish. It acts as the guardian of citizens' rights in a democratic society by providing citizens with an opportunity to be heard on the building or expansion of pipelines and associated facilities. As citizens become more and more concerned about their property and the land that surrounds them, citizen involvement in decision making about how industry activity affects their quality of life will become correspondingly more important. Regulatory agencies are committed to facilitate this engagement by flexible hearing procedures and by making use of evolving communication and information technology

  20. Quality assurance within regulatory bodies

    International Nuclear Information System (INIS)

    1999-06-01

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

  1. Expression pattern of inflammatory response genes and their regulatory micrornas in bovine oviductal cells in response to lipopolysaccharide: implication for early embryonic development.

    Directory of Open Access Journals (Sweden)

    Sally Ibrahim

    Full Text Available In the present study, we used an in vitro model to investigate the response of the oviduct with respect to inflammatory mediators and their regulatory microRNAs in case of bacterial infection and subsequent association with embryo survival. For this, we conducted two experiments. In the first experiment, cultured primary bovine oviductal cells (BOEC were challenged with lipopolysaccharide (LPS for 24h and the temporal expression pattern of inflammatory mediators and their regulatory microRNAs were measured at 0, 3, 6, 12, 24 and 48h after LPS treatment. Intriguingly, the temporal patterns of all miRNAs except miR-21 were significantly up-regulated at 6h after LPS treatment. Whereas, we observed significant overexpression of pro-inflammatory mediators as tumor necrosis factor alpha (TNFα and interleukin-1 beta (IL1β after LPS challenge for 24h. On the other hand, the expression level of essential elements like oviductal glycoprotein 1 (OVGP1 and insulin-like growth factor 2 (IGF2 was significantly decreased in challenged groups compared with control. Moreover, miR-155, miR-146a, miR-223, miR-21, miR-16 and miR-215 have shown a clear suppression in challenged group after LPS treatment. In the 2nd experiment there were four groups of blastocysts produced, namely embryo+LPS free media, embryo+LPS, BOEC+embryo and BOEC+embryo+LPS. The suboptimal oviduct environment due to LPS challenge is found to have a significant influence on the expression of inflammatory response genes (TNFα and CSF1, stress response genes (SOD and CAT, mitochondrial activity, reactive oxygen species (ROS accumulation and apoptotic level either in cultured or co-cultured blastocysts. Collectively, LPS challenge led to aberrant changes in oviductal transcriptome profile, which could lead to a suboptimal environment for embryo development.

  2. Importance of B cells to development of regulatory T cells and prolongation of tissue allograft survival in recipients receiving autologous bone marrow transplantation.

    Science.gov (United States)

    Gorczynski, Reginald M; Farrokhi, Kaveh; Gorczynski, Christopher; Sadozai, Hassan; Zhu, Fang; Khatri, Ismat

    2018-01-16

    We previously showed that congenic bone marrow transplantation (BMTx) post myeloablation augmented tissue allograft survival in association with increased regulatory T (Treg) cells of both host and bone marrow donor origin. Regulatory B (Breg) cells can also modulate T-cell immunity and B cells may be implicated in the development of Treg cells. Accordingly, we explored the effect of B-cell depletion in vivo on augmented graft survival post BMTx. C57BL/6 mice received BALB/c skin allografts followed 7 days later by myeloablation using cyclophosphamide and busulphan. Mice then received T-cell-depleted bone marrow from CD45.1 congenic donors, and ongoing immunosuppression with rapamycin (to day 28 after BMTx). Control mice received cyclophosphamide and busulphan followed by rapamycin, but not congenic bone marrow. At different times post BMTx, mice received B-cell-depleting antibody treatment, and the effect on both skin graft survival, and induction of Treg cells was assessed. BMTx resulted in significantly prolonged skin graft survival versus control mice, in association with attenuated donor-specific alloreactivity relative to controls, increased splenic Treg cells and significantly diminished anti-donor IgG. In mice receiving infusion of B-depleting antibodies for 12 days from day 15 post BMTx, both graft survival and Treg cell activity were diminished, particularly for functional Treg cells of donor origin. Adoptive transfer of Breg cells from mice harvested at 15 days post BMTx prolonged survival in naive transplanted mice and increased Treg cell levels. Thus, autologous BMTx augmentation of graft survival is dependent in part upon a population of Breg cells that can modulate the function of donor-derived Treg cells. © 2018 John Wiley & Sons Ltd.

  3. State Child Care Regulatory, Monitoring and Evaluation Systems as a Means for Ensuring Quality Child Development Programs.

    Science.gov (United States)

    Fiene, Richard

    The development of a checklist for use in monitoring and evaluating the quality of child care services, and the implications of use of the checklist by day care providers, are discussed. Several research studies that used the indicator checklist model have attempted to determine whether compliance with state child care regulations has a positive…

  4. Analysis of new drugs whose clinical development and regulatory approval were hampered during their introduction in Japan.

    Science.gov (United States)

    Asada, R; Shimizu, S; Ono, S; Ito, T; Shimizu, A; Yamaguchi, T

    2013-08-01

    Many drugs fail during development. However, detailed reasons for failure during drug development are almost never disclosed. We focused on the drugs whose clinical development and registration were initially hampered, but which were finally approved to identify reasons that delayed their marketing approval in Japan. We analysed 727 new drug applications (NDAs) approved in Japan between 2001 and 2011. Fifty-three NDAs had serious and identifiable problems during drug development. Of these, 43 NDAs had 'problem related to clinical data'. We found that the problems for withdrawal of these NDAs could be ascribed largely to inappropriate clinical data package and study design for supporting the intended indications and usage and to unclear clinical results for defining dosage regimen or efficacy of the drugs. Our results indicate the importance of careful determination of the optimal dosage regimen and the choice of objective endpoints in clinical trials. Further, it is important to establish a clear strategy for generating the clinical data package, to include careful design of clinical trials on the basis of the nature of the target disease and target population. For drugs marketed in Japan, there is a need to include sufficient numbers of Japanese patients in the trials. © 2013 John Wiley & Sons Ltd.

  5. Fast weathering of olivine in high-energy shallow seas for cost-effective CO2 capture as a cheap alternative for CCS, and effective mitigation of ocean acidification

    Science.gov (United States)

    De Boer, P. L.; Schuiling, R. D.

    2013-12-01

    Spreading of olivine in high-energy shelf seas can counteract human CO2 emissions and ocean acidification against a price well below that of CCS and other methods. In the reaction: Mg(Fe)2SiO4 (olivine) + 4 H2O --> 2 Mg(Fe)2+ + 4 OH- + H4SiO4 followed by 4 OH- + 4 CO2 --> 4 HCO3-, CO2 is consumed, while Mg2+, Fe2+, H4SiO4 and HCO3- are produced. Contrary to the paradigm that olivine weathering in nature is a slow process, flume experiments mimicking high-energy shallow marine environments show a fast reaction, consuming CO2, and raising the pH at short notice. This must be because under immobile conditions a silica coating develops and retards or stops the reaction. In high-energy shallow marine environments such silica coatings are abraded so that the chemical reaction can continue. When kept in motion also large olivine grains and gravels rubbing and bumping against each other and against other sediment grains weather quickly. The experiments also show that fine micron- to silt-sized olivine particles are produced, and that the chemical reaction is fast. The chemical weathering of 7 km3 olivine would be needed on a yearly basis in order to compensate the human CO2 emissions. This seems very much. It is, however, of the same order of magnitude as the volume of fossil fuels (in oil equivalents ~10 km3) that are burnt annually. Olivine is readily available at the Earth' surface on all continents, and past mining efforts show that such volume of 7 km3 is exceeded by existing mines; e.g. the Bingham Canyon open pit mine in Utah has an excavated volume of 25 km3. Hydrocarbons, on the other hand, are commonly retrieved with great efforts, from great depths, and often at remote locations. The annual spreading of large amounts of olivine (and/or serpentinite) in high-energy shelf seas where coarse sand and gravel can be transported, will counteract human CO2 production by fossil fuel burning and ocean acidification against a price well below that of other methods. For

  6. Immunoregulatory changes induced by total lymphoid irradiation. II. Development of thymus-leukemia antigen-positive and -negative suppressor T cells that differ in their regulatory function

    International Nuclear Information System (INIS)

    King, D.P.; Strober, S.

    1981-01-01

    BALB/c mice treated with total lymphoid irradiation (TLI) develop non-antigen-specific suppressor cells of the adoptive secondary antibody response and of the mixed leukocyte reaction. Suppressors of the adoptive anti-DNP response were eliminated by incubation of spleen cells with anti-Thy-1.2 or anti-thymus-leukemia (TL) antiserum and complement before cell transfer. Thymectomy before TLI prevented the appearance of the latter suppressor cells. On the other hand, suppressors of the MLR were eliminated by incubation of spleen cells with anti-Thy-1.2 but not anti-TL antiserum and complement. Thymectomy before TLI did not prevent their subsequent development. Thus, two subpopulations of suppressor T cells that differ in the expression of the TL surface antigen, dependence on the presence of the thymus, and in regulatory functions develop after TLI. The TL+, thymus-dependent cell suppresses the adoptive antibody response, and the TL-, thymus-independent cell suppresses the MLR

  7. Comparative Analysis of mRNA Isoform Expression in Cardiac Hypertrophy and Development Reveals Multiple Post-Transcriptional Regulatory Modules

    Science.gov (United States)

    Park, Ji Yeon; Li, Wencheng; Zheng, Dinghai; Zhai, Peiyong; Zhao, Yun; Matsuda, Takahisa; Vatner, Stephen F.; Sadoshima, Junichi; Tian, Bin

    2011-01-01

    Cardiac hypertrophy is enlargement of the heart in response to physiological or pathological stimuli, chiefly involving growth of myocytes in size rather than in number. Previous studies have shown that the expression pattern of a group of genes in hypertrophied heart induced by pressure overload resembles that at the embryonic stage of heart development, a phenomenon known as activation of the “fetal gene program”. Here, using a genome-wide approach we systematically defined genes and pathways regulated in short- and long-term cardiac hypertrophy conditions using mice with transverse aortic constriction (TAC), and compared them with those regulated at different stages of embryonic and postnatal development. In addition, exon-level analysis revealed widespread mRNA isoform changes during cardiac hypertrophy resulting from alternative usage of terminal or internal exons, some of which are also developmentally regulated and may be attributable to decreased expression of Fox-1 protein in cardiac hypertrophy. Genes with functions in certain pathways, such as cell adhesion and cell morphology, are more likely to be regulated by alternative splicing. Moreover, we found 3′UTRs of mRNAs were generally shortened through alternative cleavage and polyadenylation in hypertrophy, and microRNA target genes were generally de-repressed, suggesting coordinated mechanisms to increase mRNA stability and protein production during hypertrophy. Taken together, our results comprehensively delineated gene and mRNA isoform regulation events in cardiac hypertrophy and revealed their relations to those in development, and suggested that modulation of mRNA isoform expression plays an importance role in heart remodeling under pressure overload. PMID:21799842

  8. Development of a modelling framework in response to new European energy-efficiency regulatory obligations: The Irish experience

    International Nuclear Information System (INIS)

    Hull, David; O Gallachoir, Brian P.; Walker, Neil

    2009-01-01

    Momentum has been building for an EU-wide approach to energy policy in which energy end-use efficiency is regarded as one of the main planks. Member States are already obliged to plan for the achievement of energy savings targets in respect of the period 2008-2016 and they now face additional economy-wide targets for 2020. Efficiency investments are widely regarded as capable of improving industrial competitiveness, security of energy supply and the abatement of greenhouse gas emissions. Nevertheless, the design of policy packages may involve trade-offs between these objectives. The challenge for energy modellers is to quantify future energy savings associated with combinations of efficiency measures. This paper draws on the international experience in energy modelling and tracks recent progress that has been made towards a harmonised European framework for verification of savings. It points to the significant development work that remains to be done, particularly to enable an increased reliance on bottom-up evaluation methods. One significant gap in our knowledge relates to the required adjustment of technical savings due to behavioural factors such as rebound effects. The paper uses one country (Ireland) as a case study to demonstrate how a framework is being developed to respond to these new requirements.

  9. Gut microbiota and lipopolysaccharide content of the diet influence development of regulatory T cells: studies in germ-free mice.

    Science.gov (United States)

    Hrncir, Tomas; Stepankova, Renata; Kozakova, Hana; Hudcovic, Tomas; Tlaskalova-Hogenova, Helena

    2008-11-06

    Mammals are essentially born germ-free but the epithelial surfaces are promptly colonized by astounding numbers of bacteria soon after birth. The most extensive microbial community is harbored by the distal intestine. The gut microbiota outnumber ~10 times the total number of our somatic and germ cells. The host-microbiota relationship has evolved to become mutually beneficial. Studies in germ-free mice have shown that gut microbiota play a crucial role in the development of the immune system. The principal aim of the present study was to elucidate whether the presence of gut microbiota and the quality of a sterile diet containing various amounts of bacterial contaminants, measured by lipopolysaccharide (LPS) content, can influence maturation of the immune system in gnotobiotic mice. We have found that the presence of gut microbiota and to a lesser extent also the LPS-rich sterile diet drive the expansion of B and T cells in Peyer's patches and mesenteric lymph nodes. The most prominent was the expansion of CD4+ T cells including Foxp3-expressing T cells in mesenteric lymph nodes. Further, we have observed that both the presence of gut microbiota and the LPS-rich sterile diet influence in vitro cytokine profile of spleen cells. Both gut microbiota and LPS-rich diet increase the production of interleukin-12 and decrease the production of interleukin-4. In addition, the presence of gut microbiota increases the production of interleukin-10 and interferon-gamma. Our data clearly show that not only live gut microbiota but also microbial components (LPS) contained in sterile diet stimulate the development, expansion and function of the immune system. Finally, we would like to emphasize that the composition of diet should be regularly tested especially in all gnotobiotic models as the LPS content and other microbial components present in the diet may significantly alter the outcome of experiments.

  10. Development of targeted therapy for ovarian cancer mediated by a plasmid expressing diphtheria toxin under the control of H19 regulatory sequences

    Directory of Open Access Journals (Sweden)

    Birman Tatiana

    2009-08-01

    Full Text Available Abstract Background Ovarian cancer ascites fluid (OCAF, contains malignant cells, is usually present in women with an advanced stage disease and currently has no effective therapy. Hence, we developed a new therapy strategy to target the expression of diphtheria toxin gene under the control of H19 regulatory sequences in ovarian tumor cells. H19 RNA is present at high levels in human cancer tissues (including ovarian cancer, while existing at a nearly undetectable level in the surrounding normal tissue. Methods H19 gene expression was tested in cells from OCAF by the in-situ hybridization technique (ISH using an H19 RNA probe. The therapeutic potential of the toxin vector DTA-H19 was tested in ovarian carcinoma cell lines and in a heterotopic animal model for ovarian cancer. Results H19 RNA was detected in 90% of patients with OCAF as determined by ISH. Intratumoral injection of DTA-H19 into ectopically developed tumors caused 40% inhibition of tumor growth. Conclusion These observations may be the first step towards a major breakthrough in the treatment of human OCAF, while the effect in solid tumors required further investigation. It should enable us to identify likely non-responders in advance, and to treat patients who are resistant to all known therapies, thereby avoiding treatment failure.

  11. Vision from next generation sequencing: multi-dimensional genome-wide analysis for producing gene regulatory networks underlying retinal development, aging and disease.

    Science.gov (United States)

    Yang, Hyun-Jin; Ratnapriya, Rinki; Cogliati, Tiziana; Kim, Jung-Woong; Swaroop, Anand

    2015-05-01

    Genomics and genetics have invaded all aspects of biology and medicine, opening uncharted territory for scientific exploration. The definition of "gene" itself has become ambiguous, and the central dogma is continuously being revised and expanded. Computational biology and computational medicine are no longer intellectual domains of the chosen few. Next generation sequencing (NGS) technology, together with novel methods of pattern recognition and network analyses, has revolutionized the way we think about fundamental biological mechanisms and cellular pathways. In this review, we discuss NGS-based genome-wide approaches that can provide deeper insights into retinal development, aging and disease pathogenesis. We first focus on gene regulatory networks (GRNs) that govern the differentiation of retinal photoreceptors and modulate adaptive response during aging. Then, we discuss NGS technology in the context of retinal disease and develop a vision for therapies based on network biology. We should emphasize that basic strategies for network construction and analyses can be transported to any tissue or cell type. We believe that specific and uniform guidelines are required for generation of genome, transcriptome and epigenome data to facilitate comparative analysis and integration of multi-dimensional data sets, and for constructing networks underlying complex biological processes. As cellular homeostasis and organismal survival are dependent on gene-gene and gene-environment interactions, we believe that network-based biology will provide the foundation for deciphering disease mechanisms and discovering novel drug targets for retinal neurodegenerative diseases. Published by Elsevier Ltd.

  12. Scientific and Regulatory Policy Committee Points-to-consider Paper*: Drug-induced Vascular Injury Associated with Nonsmall Molecule Therapeutics in Preclinical Development: Part 2. Antisense Oligonucleotides.

    Science.gov (United States)

    Engelhardt, Jeffery A; Fant, Pierluigi; Guionaud, Silvia; Henry, Scott P; Leach, Michael W; Louden, Calvert; Scicchitano, Marshall S; Weaver, James L; Zabka, Tanja S; Frazier, Kendall S

    2015-10-01

    Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. In recent years, DIVI has been occasionally observed in nonhuman primates given RNA-targeting therapeutics such as antisense oligonucleotide therapies (ASOs) during chronic toxicity studies. While DIVI in laboratory animal species has been well characterized for vasoactive small molecules, and immune-mediated responses against large molecule biotherapeutics have been well described, there is little published information regarding DIVI induced by ASOs to date. Preclinical DIVI findings in monkeys have caused considerable delays in development of promising new ASO therapies, because of the uncertainty about whether DIVI in preclinical studies is predictive of effects in humans, and the lack of robust biomarkers of DIVI. This review of DIVI discusses clinical and microscopic features of vasculitis in monkeys, their pathogenic mechanisms, and points to consider for the toxicologist and pathologist when confronted with ASO-related DIVI. Relevant examples of regulatory feedback are included to provide insight into risk assessment of ASO therapies. © 2015 by The Author(s).

  13. Annual Report 2008. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2009-01-01

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

  14. Annual Report 2009. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2010-01-01

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

  15. Stage-Specific Fatty Acid Fluxes Play a Regulatory Role in Glycerolipid Metabolism during Seed Development in Jatropha curcas L.

    Science.gov (United States)

    Chaitanya, Bharatula Sri Krishna; Kumar, Sumit; Kaki, Shiva Shanker; Balakrishna, Marrapu; Karuna, Mallampalli Sri Lakshmi; Prasad, Rachapudi Badari Narayana; Sastry, Pidaparty Seshadri; Reddy, Attipalli Ramachandra

    2015-12-23

    The present study describes the changes in lipid profile as well as fatty acid fluxes during seed development in Jatropha curcas L. Endosperm from 34, 37, and 40 days after anthesis (DAA), incubated with [(14)C]acetate, showed significant synthesis of phosphatidylcholine (PC) at seed maturation. The fatty acid methyl ester profile showed PC from 34 DAA was rich in palmitic acid (16:0), whereas PC from 37 and 40 DAA was rich in oleic acid (18:1n-9). Molecular species analysis of diacylglycerol (DAG) indicated DAG (16:0/18:2n-6) was in abundance at 34 DAA, whereas DAG (18:1n-9/18:2n-6) was significantly high at 40 DAA. Triacylglycerol (TAG) analysis revealed TAG (16:0/18:2n-6/16:0) was abundant at 34 DAA, whereas TAG (18:1n-9/18:2n-6/18:1n-9) formed the majority at 40 DAA. Expression of two types of diacylglycerol acyltransferases varied with seed maturation. These data demonstrate stage-specific distinct pools of PC and DAG synthesis during storage TAG accumulation in Jatropha seed.

  16. Opportunities for Energy Development in Water Conduits: A Report Prepared in Response to Section 7 of the Hydropower Regulatory Efficiency Act of 2013

    Energy Technology Data Exchange (ETDEWEB)

    Sale, Michael J. [BCS, Incorporated, Laurel, MD (United States); Bishop, Norman A. [Knight Piesold, Chicago, IL (United States); Reiser, Sonya L. [Knight Piesold, Chicago, IL (United States); Johnson, Kurt [Telluride Energy LLC, Grand Junction, CO (United States); Bailey, Andrea C. [BCS, Incorporated, Laurel, MD (United States); Frank, Anthony [BCS, Incorporated, Laurel, MD (United States); Smith, Brennan T. [Oak Ridge National Lab. (ORNL), Oak Ridge, TN (United States). Environmental Sciences Division

    2014-09-01

    In Section 7 of the Hydropower Regulatory Efficiency Act (HREA) of 2013 (P.L. 113-23), Congress directed the U.S. Department of Energy (DOE) to prepare an analysis of conduit hydropower opportunities available in the United States and to present case studies that describe the potential energy generation from these types of hydropower projects. Those analyses have been included in a new DOE report to Congress, and this ORNL/TM provides additional technical details supporting that report. Conduit hydropower offers important new ways to enhance renewable energy portfolios in the United States, as well as to increase the energy efficiency of water delivery systems. Conduit hydropower projects are constructed on existing water-conveyance structures, such as irrigation canals or pressurized pipelines that deliver water to municipalities, industry, or agricultural water users. Although water conveyance infrastructures are usually designed for non-power purposes, new renewable energy can often be harvested from them without affecting their original purpose and without the need to construct new dams or diversions. Conduit hydropower differs from more conventional hydropower development in that it is generally not located on natural rivers or waterways and therefore does not involve the types of environmental impacts that are associated with hydropower. The addition of hydropower to existing water conduits can provide valuable new revenue sources from clean, renewable energy. The new energy can be used within the existing water distribution systems to offset other energy demands, or it can be sold into regional transmission systems.

  17. Foxp3+ CD25+ regulatory T cells specific for a neo-self-antigen develop at the double-positive thymic stage

    Science.gov (United States)

    Cabarrocas, Julie; Cassan, Cécile; Magnusson, Fay; Piaggio, Eliane; Mars, Lennart; Derbinski, Jens; Kyewski, Bruno; Gross, David-Alexandre; Salomon, Benoit L.; Khazaie, Khashayarsha; Saoudi, Abdelhadi; Liblau, Roland S.

    2006-01-01

    Thymus-derived regulatory T cells (Tregs) expressing CD4, CD25, and the transcription factor Foxp3 play major roles in preventing autoimmunity. The Treg population is enriched in T cells expressing high-avidity self-reactive T cell receptors, and thymic epithelial cells expressing self-antigens (Ag) have been implicated in their induction and/or selection. However, the thymic selection events leading to Treg lineage commitment remain unclear. We followed the thymic development of self-Ag-specific Tregs in double-transgenic mice coexpressing a neo-self-Ag, hemagglutinin (HA) under the control of a neural tissue-specific promoter, and a transgenic class II-restricted T cell antigen receptor specific for HA111-119. Our data show that the promiscuous expression of the HA transgene in thymic epithelial cells is involved in the selective induction and/or expansion of HA-specific Foxp3+ Treg thymic precursors as early as the double-positive stage. PMID:16709665

  18. Regulatory on the corporate social responsibility in the context of sustainable development by mandatory in the world trade organization law perspective (case study in Indonesia

    Directory of Open Access Journals (Sweden)

    SH. M. Hum. TAUFIQURRAHMAN

    2013-12-01

    Full Text Available Regulatory on the Corporate Social Responsibility (CSR by mandatory in Indonesia as stipulated in Article 74 of Law No. 40/2007 on the Limited Liability Company (hereafter the Company Law raises a contradiction. Those who agree argue that the company is not solely for profit, but more than that are participating in social issues and the preservation of the environment within the framework of sustainable development. Conversely, those who disagree view that social issues and the environment are the full responsibility of state. The involvement of a corporation in social and environmental activities is voluntary. Verdict of the Indonesian Constitutional Court in case no. 53/PUU-VI / / 2008 dated 13 April 2009 which rejected a requesting of material test of the Article 74 paragraph (1, (2 and (3 of the Company Law confirms the existence of the CSR by mandatory in international trade traffic today. The analytical results indicates that mandatory CSR regulation in the Company Law is not a form of a state intervention to the private activities. In addition, the arrangement is not contrary to the principles of free trade within the framework of the General Agreement on Tariffs and Trade (GATT / World Trade Organization (WTO.

  19. Development of a regulatory guide about the content and criteria for the elaboration of the radioactive waste management plans in Spanish nuclear facilities

    International Nuclear Information System (INIS)

    Lopez de la Higuera, Julia; Alvarez Alonso, M. Angeles; Simon Cirujano, Maria I.; Suarez Llorente, Beatriz

    2008-01-01

    Full text:The Spanish legislation requires the licensees to develop, among other documents, a Radioactive Waste Management Plan (RWMP) as an official report in the application for the operation and for the dismantling and decommissioning of a nuclear facility. These Plans should describe the types of waste, inventory, characterization, treatment, conditioning and storage of wastes. The Spanish regulatory body, Consejo de Seguridad Nuclear (CSN), promoted a working group to analyze the content and scope of the RWMP, bringing together the electric power industry association (UNESA), the waste management organisation (ENRESA) and the nuclear fuel industry (ENUSA). The objective of the RWMP is to establish the criteria and instructions to ensure a safe and optimized management, taking into account the normative and technological developments. The Plan is based on support Studies that contain the basic information for the analysis of the waste management options and deals with: (1) Actual generation and management options in the facility; (2) Classification of the facility in waste generation zones; (3) Experience analysis and identification of potential management improvements; (4) Selection, justification and introduction of new management modes. The RWMP will develop the following issues: a) Waste generation and management (for each waste type, information in terms of the origin, physico-chemical and radiological properties, volume of production and implemented management routes); b) Classification of the facility in waste zones. The facility will differentiate those areas where contaminated or activated wastes can be produced (Radioactive Waste Zone - RWZ) or not (Conventional Waste Zone - CWZ). To avoid mixing and allow this separation, two lines of defense will be established. The first one is the classification and setting marks in the Zones and the second one the controls on the non-radioactive wastes at the exit of the facility: a) Selection of foreseen lines

  20. The Bright Elusive Butterfly of Value in Health Technology Development Comment on "Providing Value to New Health Technology: The Early Contribution of Entrepreneurs, Investors, and Regulatory Agencies".

    Science.gov (United States)

    Greenhalgh, Trisha; Fahy, Nick; Shaw, Sara

    2017-05-29

    The current system of health technology development is characterised by multiple misalignments. The "supply" side (innovation policy-makers, entrepreneurs, investors) and the "demand" side (health policy-makers, regulators, health technology assessment, purchasers) operate under different - and conflicting - logics. The system is less a "pathway" than an unstable ecosystem of multiple interacting sub-systems. "Value" means different things to each of the numerous actors involved. Supply-side dynamics are built on fictions; regulatory checks and balances are designed to assure quality, safety and efficacy, not to ensure that technologies entering the market are either desirable or cost-effective. Assessment of comparative and cost-effectiveness usually comes too late in the process to shape an innovation's development. We offer no simple solutions to these problems, but in the spirit of commencing a much-needed public debate, we suggest some tentative ways forward. First, universities and public research funders should play a more proactive role in shaping the system. Second, the role of industry in forging long-term strategic partnerships for public benefit should be acknowledged (though not uncritically). Third, models of "responsible innovation" and public input to research priority-setting should be explored. Finally, the evidence base on how best to govern inter-sectoral health research partnerships should be developed and applied. © 2018 The Author(s); Published by Kerman University of Medical Sciences. This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

  1. Earth 2075 (CO2) - can Ocean-Amplified Carbon Capture (oacc) Impart Atmospheric CO2-SINKING Ability to CCS Fossil Energy?

    Science.gov (United States)

    Fry, R.; Routh, M.; Chaudhuri, S.; Fry, S.; Ison, M.; Hughes, S.; Komor, C.; Klabunde, K.; Sethi, V.; Collins, D.; Polkinghorn, W.; Wroobel, B.; Hughes, J.; Gower, G.; Shkolnik, J.

    2017-12-01

    Previous attempts to capture atmospheric CO2 by algal blooming were stalled by ocean viruses, zooplankton feeding, and/or bacterial decomposition of surface blooms, re-releasing captured CO2 instead of exporting it to seafloor. CCS fossil energy coupling could bypass algal bloom limits—enabling capture of 10 GtC/yr atmospheric CO2 by selective emiliania huxleyi (EHUX) blooming in mid-latitude open oceans, far from coastal waters and polar seas. This could enable a 500 GtC drawdown, 350 ppm restoration by 2050, 280 ppm CO2 by 2075, and ocean pH 8.2. White EHUX blooms could also reflect sunlight back into outer space and seed extra ocean cloud cover, via DMS release, to raise albedo 1.8%—restoring preindustrial temperature (ΔT = 0°C) by 2030. Open oceans would avoid post-bloom anoxia, exclusively a coastal water phenomenon. The EHUX calcification reaction initially sources CO2, but net sinking prevails in follow-up equilibration reactions. Heavier-than-water EHUX sink captured CO2 to the sea floor before surface decomposition occurs. Seeding EHUX high on their nonlinear growth curve could accelerate short-cycle secondary open-ocean blooming—overwhelming mid-latitude viruses, zooplankton, and competition from other algae. Mid-latitude "ocean deserts" exhibit low viral, zooplankton, and bacterial counts. Thermocline prevents nutrient upwelling that would otherwise promote competing algae. Adding nitrogen nutrient would foster exclusive EHUX blooming. Elevated EHUX seed levels could arise from sealed, pH-buffered, floating, seed-production bioreactors infused with 10% CO2 from carbon feedstock supplied by inland CCS fossil power plants capturing 90% of emissions as liquid CO2. Deep-water SPAR platforms extract natural gas from beneath the sea floor. On-platform Haber and pH processing could convert extracted CH4 to buffered NH4+ nutrient, enabling ≥0.7 GtC/yr of bioreactor seed production and 10 GtC/yr of amplified secondary open-ocean CO2 capture—making CCS

  2. Global Summit on Regulatory Science 2013.

    Science.gov (United States)

    Howard, Paul C; Tong, Weida; Weichold, Frank; Healy, Marion; Slikker, William

    2014-12-01

    Regulatory science has been defined as the science that is used to develop regulatory decisions by government bodies. Regulatory science encompasses many scientific disciplines that oversee many studies producing a wide array of data. These may include fundamental research into the cellular interaction or response to a particular chemical or substance, hazard-assessment and dose-response studies in animal species, neurophysiological or neurobehavioral studies, best practices for the generation and analysis of genomics data, bioinformatics approaches, and mathematical modeling of risk. The Global Summit on Regulatory Science is an international conference with a mission to explore emerging and innovative technologies, and provide a platform to enhance translation of basic science into regulatory applications. The Third Global Summit on Regulatory Science which focused on nanotechnology is discussed. Published by Elsevier Inc.

  3. Annual Report 2007. Nuclear Regulatory Authority

    International Nuclear Information System (INIS)

    2008-01-01

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

  4. Steroidogenic acute regulatory protein (StAR) gene expression construct: Development, nanodelivery and effect on reproduction in air-breathing catfish, Clarias batrachus.

    Science.gov (United States)

    Rathor, Pravesh Kumar; Bhat, Irfan Ahmad; Rather, Mohd Ashraf; Gireesh-Babu, Pathakota; Kumar, Kundan; Purayil, Suresh Babu Padinhate; Sharma, Rupam

    2017-11-01

    Steroidogenic acute regulatory protein (StAR) is responsible for the relocation of cholesterol across mitochondrial membrane in vertebrates and is, therefore, a key factor in regulating the rate and timing of steroidogenesis. In the present study, we developed chitosan nanoparticle (CNP) conjugated StAR gene construct (CNP-pcDNA4-StAR) in a eukaryotic expression vector, pcDNA4/HisMax A. CNPs of 135.4nm diameter, 26.7mV zeta potential and 0.381 polydispersity index were used for conjugation. The loading efficiency (LE) of pcDNA4-StAR construct with CNPs was found to be 86%. After the 24h of intramuscular injection, the CNP-pcDNA4-StAR plasmid could be detected from testis, brain, kidney and muscle tissues of Clarias batrachus. The transcript levels of important reproductive genes viz. cyp11a1, cyp17a1, 3β-hsd, 17β-hsd and cyp19a1 in CNP-pcDNA4-StAR treated group were initially low up to 24h, but significantly increased subsequently up to 120h. In naked pcDNA4-StAR treated group, the mRNA level of 3β-hsd, 17β-hsd and cyp19a1 increased initially up to 24h, while cyp11a1 and cyp17a1 increased up to 48h and then started declining. Similar results were obtained for 11-Ketotestosterone and 17β-estradiol. The results indicate relatively long lasting effects of nano-conjugated construct compared to the construct alone. Furthermore, the histopathology of gonads and liver authenticates its possible role in the gonadal development in fish without any adverse effect. Copyright © 2017 Elsevier B.V. All rights reserved.

  5. A Comparison of national CCS strategies for Northwest Europe, with a focus on the potential of common CO2 storage at the Utsira formation

    DEFF Research Database (Denmark)

    Ramirez, Andrea; Hoefnagels, Ric; van den Broek, Machteld

    2011-01-01

    distance to Utsira while the Netherlands utilise the Utsira formation due to limited domestic low cost storage fields and the use of the country as a regional hub for CO2. In Germany and Denmark, the competitiveness of CO2storage in Utsira is determined by the availability of domestic onshore saline......Mega structures for CO2 storage, such as the Utsira formation in the North Sea, could theoretically supply CO2 storage capacity for several countries for a period of several decades. Their use could increase the cost-effectiveness of CCS in a region while minimizing opposition from the public to CO......2 storage. However, this will not only depend on their potential available capacity to store CO2 flows but also on the cost effectiveness of such an option within national portfolios of mitigation measures. This article shows key results of a research project aiming to assess the potentials...

  6. Regulatory actions post - Fukushima

    International Nuclear Information System (INIS)

    Ciurea Ercau, C.

    2013-01-01

    The paper presents the results of the safety reviews performed in Romania after the Fukushima accident and the resulting actions for improving the safety. The actions taken by the National Commission for Nuclear Activities Control (CNCAN) to improve the regulatory framework include the development of new regulations and the enhancement of inspection practices, taking account of the lessons learned from the Fukushima accident. A regulation on the response to transients, accidents and emergency situations at nuclear power plants has been developed, which includes requirements on transient and accident scenarios that have to be covered by the Emergency Operating Procedures (EOPs), accident scenarios to be covered by the Severe Accident Management Guidelines (SAMGs), emergency situations to be covered by the on-site emergency response plan and emergency response procedures. (authors)

  7. The Regulatory Independence of FANR

    International Nuclear Information System (INIS)

    ALNuaimi, Fatema; Choi, Kwang Shik

    2012-01-01

    Regulatory independence is meant to provide a conservative system of policy making in order to comply with the problems that are forecasted upon the basis of assumptions. The Federal Authorization of Nuclear Regulation (FANR) is a regulatory commission that was formed to be regulatory body that governs the generation of nuclear power in United Arab Emirates. It was established under the UAE nuclear law (9/2009) as an independent regulatory body that was tasked with the regulation of all nuclear activities in the United Arab Emirates. As an independent body, FANR was tasked with ensuring that the regulation of the nuclear sector is done in effective and transparent manner to ensure its accountability to the people. Being independent, the regulatory body develops national nuclear regulations based on laid down safety standards by the International Atomic Energy Agency, ensuring that they are based on scientific and proven technologies The role of FANR is to ensure that the all corporations that undertake nuclear activities follow the laid down procedures and objectives and ensure safety measures are taken keenly to ensure the safety of the workers and the general public while at the same time ensuring the environment is free from nuclear radiations

  8. Regulatory Expectations for Safety Culture

    International Nuclear Information System (INIS)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung

    2014-01-01

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety

  9. Regulatory Expectations for Safety Culture

    Energy Technology Data Exchange (ETDEWEB)

    Jung, Su Jin; Oh, Jang Jin; Choi, Young Sung [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

    2014-05-15

    The oversight of licensee's safety culture becomes an important issue that attracts great public and political concerns recently in Korea. Beginning from the intended violation of rules, a series of corruptions, documents forgery and disclosure of wrong-doings made the public think that the whole mindset of nuclear workers has been inadequate. Thus, they are demanding that safety culture shall be improved and that regulatory body shall play more roles and responsibilities for the improvements and oversight for them. This paper introduces, as an effort of regulatory side, recent changes in the role of regulators in safety culture, regulatory expectations on the desired status of licensee's safety culture, the pilot inspection program for safety culture and research activity for the development of oversight system. After the Fukushima accident in Japan 2011, many critics has searched for cultural factors that caused the unacceptable negligence pervaded in Japan nuclear society and the renewed emphasis has been placed on rebuilding safety culture by operators, regulators, and relevant institutions globally. Significant progress has been made in how to approach safety culture and led to a new perspective different from the existing normative assessment method both in operators and regulatory side. Regulatory expectations and oversight of them are based on such a new holistic concept for human, organizational and cultural elements to maintain and strengthen the integrity of defense in depth and consequently nuclear safety.

  10. Regulatory Circuits Linking Energy Status to Growth

    NARCIS (Netherlands)

    Jansen, W.M.

    2017-01-01

    Plant growth and development critically depend on carbon nutrient status. Over the past years several core regulatory systems that link plant carbon status to growth have emerged. The core regulatory systems studied include the trehalose 6-phosphate (T6P) signaling system and the Target of Rapamycin

  11. 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. Published by Elsevier Inc.

  12. Regulatory authority information system RAIS

    International Nuclear Information System (INIS)

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

    2000-01-01

    In this lecture the principles of the regulatory authority information system (RAIS) are presented. RAIS is a tool currently being developed by the IAEA for the Regulatory Authorities. It is a part of a set of supporting actions designed to assist member states in achieving the objectives of the Model project on radiation and waste safety infrastructure. RAIS is a tool that provides the management of the Regulatory Authority with the key information needed for the planning and implementation of activities and to ensure confidence that resources are optimally used. The RAIS contains five modules: Inventory of installations and radiation sources; Authorization process; Inspection and follow-up actions; Information on personal dosimetry; Assessment of effectiveness by means of performance indicators

  13. Incorporating patient preferences into drug development and regulatory decision making: Results from a quantitative pilot study with cancer patients, carers, and regulators.

    Science.gov (United States)

    Postmus, D; Mavris, M; Hillege, H L; Salmonson, T; Ryll, B; Plate, A; Moulon, I; Eichler, H-G; Bere, N; Pignatti, F

    2016-05-01

    Currently, patient preference studies are not required to be included in marketing authorization applications to regulatory authorities, and the role and methodology for such studies have not been agreed upon. The European Medicines Agency (EMA) conducted a pilot study to gain experience on how the collection of individual preferences can inform the regulatory review. Using a short online questionnaire, ordinal statements regarding the desirability of different outcomes in the treatment of advanced cancer were elicited from 139 participants (98 regulators, 29 patient or carers, and 12 healthcare professionals). This was followed by face-to-face meetings to gather feedback and validate the individual responses. In this article we summarize the EMA pilot study and discuss the role of patient preference studies within the regulatory review. Based on the results, we conclude that our preference elicitation instrument was easy to implement and sufficiently precise to learn about the distribution of the participants' individual preferences. © 2015 American Society for Clinical Pharmacology and Therapeutics.

  14. Identification of a novel conserved mixed-isoform B56 regulatory subunit and spatiotemporal regulation of protein phosphatase 2A during Xenopus laevis development

    Directory of Open Access Journals (Sweden)

    Seeling Joni M

    2007-12-01

    Full Text Available Abstract Background Wnt signaling is a key regulator of development and tumorigenesis. Protein phosphatase 2A (PP2A, which consists of a catalytic C, a structural A, and a regulatory B subunit, plays diverse roles in Wnt signaling through its B56 subunits. B56 is a multigene family encoding for proteins with a conserved core domain and divergent amino- and carboxy-termini. Ectopic B56α and B56γ reduce β-catenin abundance and B56α reduces Wnt-dependent transcription, suggesting that B56α and B56γ inhibit Wnt signaling. In contrast, B56ε is required for Wnt signaling. Knowledge of where and when B56 subunits are expressed during Xenopus development will aid in our understanding of their roles in Wnt signaling. Results We have undertaken expression analyses of B56α and B56γ in Xenopus laevis. We cloned Xenopus B56α; it is 88% identical to human B56α. Xenopus B56γ is 94% identical with human B56γ, however, a novel evolutionarily conserved mixed-isoform transcript was identified that contains a B56δ-like amino-terminal domain and a B56γ core domain. The B56δ-like variable domain exon is located upstream of the B56γ variable domain exon at the human B56γ locus, suggesting that the mixed-isoform transcript is due to alternative splicing. B56γ transcripts with different 3' ends were identified that lack or possess a 35 base pair sequence, resulting in either a transcript similar to human B56γ1, or an uncharacterized evolutionarily conserved sequence. Real time RT-PCR analyses revealed that B56α is expressed at moderate levels before the midblastula transition (MBT, at reduced levels during gastrulation and neurulation, and at high levels during organogenesis, while B56γ is expressed at low levels until organogenesis. B56α is enriched in the ventral hemisphere pre-MBT, while B56γ is ventrally enriched post-MBT. Aα, Aβ, Cα and Cβ are expressed in early Xenopus development, suggesting the presence of a functional heterotrimer

  15. Carbon Capture and Storage: Legal and Regulatory Review

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2010-07-01

    The International Energy Agency (IEA) considers carbon capture and storage (CCS) a crucial part of worldwide efforts to limit global warming by reducing greenhouse-gas emissions. The IEA has estimated that the broad deployment of low-carbon energy technologies could reduce projected 2050 emissions to half 2005 levels -- and that CCS could contribute about one-fifth of those reductions. Reaching that goal, however, would require around 100