Transparency of nuclear regulatory activities

International Nuclear Information System (INIS)

2007-01-01

One of the main missions of nuclear regulators is to protect the public, and this cannot be completely achieved without public confidence. The more a regulatory process is transparent, the more such confidence will grow. Despite important cultural differences across countries, a number of common features characterise media and public expectations regarding any activity with an associated risk. A common understanding of transparency and main stakeholders' expectations in the field of nuclear safety were identified during this workshop, together with a number of conditions and practices aimed at improving the transparency of nuclear regulatory activities. These conditions and practices are described herein, and will be of particular interest to all those working in the nuclear regulatory field. Their implementation may, however, differ from one country to another depending on national context. (authors)

National legislative and regulatory activities

International Nuclear Information System (INIS)

2016-01-01

This section treats of the following National legislative and regulatory activities: 1 - France: General legislation, regulations and instruments; Nuclear trade (including non-proliferation); International co-operation; 2 - India: Licensing and regulatory infrastructure; Liability and compensation; 3 - Ireland: Nuclear safety and radiological protection (including nuclear emergency planning); Transport of radioactive material; Nuclear trade (including non-proliferation); 4 - Lithuania: Licensing and regulatory infrastructure; Nuclear safety and radiological protection (including nuclear emergency planning); Radioactive waste management; 5 - Luxembourg: Nuclear safety and radiological protection (including nuclear emergency planning); 6 - Slovak Republic: International co-operation; General legislation, regulations and instruments; 7 - Spain: Radioactive materials (including physical protection); Radioactive waste management; 8 - United States: Licensing and regulatory infrastructure

Rationales for regulatory activity

Energy Technology Data Exchange (ETDEWEB)

Perhac, R.M. [Univ. of Tennessee, Knoxville, TN (United States)

1997-02-01

The author provides an outline which touches on the types of concerns about risk evaluation which are addressed in the process of establishing regulatory guides. Broadly he says regulatory activity serves three broad constituents: (1) Paternalism (private risk); (2) Promotion of social welfare (public risks); (3) Protection of individual rights (public risks). He then discusses some of the major issues encountered in reaching a decision on what is an acceptable level of risk within each of these areas, and how one establishes such a level.

Activities relating to PSA in the regulatory process

International Nuclear Information System (INIS)

Campbell, J.F.; Grint, G.C.

1994-01-01

In addition to the IAEA activities concerning the use of PSA in the regulatory process there are two other international initiatives in this area by the European Commission and the OECD's Committee for Nuclear Regulatory Authorities (CRNA). The paper gives a brief outline of these activities as well as introducing an update on the regulatory use of PSA in the UK. 3 refs, 3 tabs

Regulatory Activities for Licensee's Safety Culture

International Nuclear Information System (INIS)

Choi, Young Sung; Choi, Kwang Sik

2008-01-01

Weaknesses in safety culture have contributed to a number of incidents/accidents in the nuclear and other high hazard sectors worldwide in the past. These events have fostered an increasing awareness of the need for licensees to develop a strong safety culture to support successful and sustainable nuclear safety performance. Regulatory bodies are taking a growing interest in this issue, and several are actively working to develop and implement approaches to maintaining regulatory oversight of licensee safety culture. However, these approaches are not yet well-established, and it was considered prudent to share experiences and developing methodologies in order to disseminate good practices and avoid potential pitfalls. This paper presents the findings, conclusions and recommendations of international meetings and other countries' activities on safety culture and gives some suggestions for regulators to consider when planning regulatory oversight for licensee's safety culture

National legislative and regulatory activities

International Nuclear Information System (INIS)

2014-01-01

This section of the Bulletin presents a summary of the recent national legislative and regulatory activities sorted by country and topic: - Algeria: Nuclear security. - France: Radioactive waste management; Nuclear safety and radiological protection; General legislation; International co-operation. - Germany: International trade. - Indonesia: Nuclear security, General legislation. - Ireland: Nuclear safety and radiological protection; General legislation. - Lithuania: Nuclear security; Nuclear safety and radiological protection. - Slovak Republic: International co-operation; Liability and compensation; Environmental protection. - Switzerland: Radioactive waste management. - United Arab Emirates: Liability and compensation. - United States: Radioactive waste management; Licensing and regulatory infrastructure

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2003-01-01

Among international regulatory activities we find resolutions adopted by the IAEA general conference (2003), through European Union we find proposals for directives on nuclear safety and radioactive waste management, new regulation on the application of EURATOM safeguards, control of high activity sealed radioactive sources, recommendation on the protection and information of the public with regard to the continued contamination of certain wild food products following the Chernobyl accident, proposals for decisions authorizing the Member states to sign and ratify the Protocol to amend the Paris convention, p)proposals for a directive on environment liability with regard to the prevention and remedying of environmental damage, proposal of a regulation on the law applicable to non-contractual obligation. (N.C.)

Organization of nuclear regulatory activities

International Nuclear Information System (INIS)

Blidaru, Valentin

2008-01-01

The paper presents the structure, missions and organizational aspects of the CNCAN, the National Commission for the control of nuclear activities in Romania. The paper addresses the following main issues: 1.General aspects; 2.Organizational structure of the NRA in Romania; 3.General description of the Division for Nuclear Safety Assessments; 4.Specific activities; 5.Regulatory approaches and practices. Under the title of 'General aspects' the following three basic statements are highlighted: 1.CNCAN is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and the licensing of nuclear facilities; 2.CNCAN is the national authority competent in exercising the regulatory activity, authorization and control in the nuclear field provided by the law No. 111/ 1996 republished in 1998; 3.The Commission exercises its functions independently of the ministries and other authorities of the public control administration being subordinated to the Romanian Government. The organizational structure is as follows: - President, the Managerial Council and the Advisory Council coordinating the four General Divisions that are responsible for: - Nuclear Safety with Division of Nuclear Safety Assessment and Division of Nuclear Objectives Surveillance; - Radiological Safety with Division of Radiological Safety Assessment and Division of Operational Radiation Protection; - Surveillance of Environmental Radioactivity with Division of Assessment and Analysis and Division of National Network; - Development and Resource with the Division of Economy and Division of Human Resources. In addition under direct coordination of the President operate the Division of Radiation Protection, Transport and Radioactive Waste and the Division of International Cooperation and Communication. Specific activities are listed describing among others the issues of: - Safety of nuclear installation; - Evaluation relating to licensing of nuclear

National legislative and regulatory activities

International Nuclear Information System (INIS)

2014-01-01

This section treats of the following activities sorted by country: 1 - Belarus: International cooperation, Organisation and structure, Licensing and regulatory infrastructure, Nuclear safety and radiological protection; 2 - France: Nuclear safety and radiological protection, Radioactive waste management, Environmental protection, Liability and compensation, International co-operation; 3 - Hungary: General legislation, Radioactive waste management, Nuclear security; 4 - Ireland: Nuclear safety and radiological protection (including emergency planning); 5 - Lithuania: Licensing and regulatory infrastructure; 6 - Moldova: Nuclear safety and radiological protection; 7 - Portugal: Radioactive waste management, Nuclear safety and radiological protection; 8 - Slovak Republic: Radioactive waste management, Liability and compensation; 9 - Spain: Radioactive waste management; 10 - Ukraine: Radioactive waste management; 11 - United Kingdom: Organisation and structure

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2002-01-01

Different international regulatory activities are presented: recommendation on the protection of the public against exposure to radon in drinking water supplies, amendment to the legislation implementing the regulation on imports of agricultural products originating in third countries following the Chernobyl accident, resolution on the commission green paper towards a European strategy for the security of energy supply, declaration of mandatory nature of the international code for the safe carriage of packaged irradiated nuclear fuel, plutonium and high level radioactive wastes on board ships, adoption of action plan against nuclear terrorism. (N.C.)

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA.

Science.gov (United States)

Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme

2014-06-01

Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type "gastrointestinal disorders" and "nervous system disorders". Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

Argentina's regulatory body: its communication activities

International Nuclear Information System (INIS)

Cesario, Pablo A.; Terigi, Gabriel E.

2008-01-01

Full text: The Nuclear Regulatory Authority of Argentina (ARN) is empowered to regulate and control the nuclear activity with regard to radiation and nuclear safety, physical protection and nuclear non-proliferation issues. It must also advise the Executive on issues under its purview. The objective of the Nuclear Regulatory Authority is to establish, develop and enforce a regulatory system applicable to all nuclear activities carried out in Argentina. Two of the goals of this regulatory system are to provide an appropriate standard of protection for individuals against the harmful effects of ionizing radiation, and to maintain a reasonable degree of radiological and nuclear safety in the nuclear activities performed in Argentina. The responsibility of the radiation protection community in performing the tasks to accomplish this goals is twofold. On one hand, it must ensure a high technical quality in performing these functions. It must also provide information on its activities which has to be accurate, comprehensive and understandable. The way a society understands the concept of 'risk' needs to be kept in mind. Risk perception is the subjective judgment that people make about the characteristics and severity of a risk. Cultural theory refers to theories of risk perception that focus on culture, rather than individual psychology as an explanation for differences in risk judgments. It is widely agreed that trust is a key factor in influencing people's perceptions of risk. It is understood there are two main ways trust may impact in risk perceptions: an activity is perceived as more risky if the people or agencies managing it are perceived as untrustworthy; and information presented by trusted sources is given more credibility than information from untrusted sources. One of the primary purposes of ARN's Communication Program is to provide a means whereby those engaged in radiation protection activities may communicate more readily with each other and the public and

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2009-01-01

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

Regulatory control of maintenance activities in Argentine nuclear power plants

International Nuclear Information System (INIS)

Calvo, J.C.; Caruso, G.

2000-01-01

The main maintenance objective is to assure that the safety features of structures, components and systems of nuclear power plants are kept as designed. Therefore, there is a direct relationship between safety and maintenance. Owing to the above mentioned, maintenance activities are considered a relevant regulatory issue for the Argentine Nuclear Regulatory Authority (ARN). This paper describes the regulatory control to maintenance activities of Argentine nuclear power plants. It also addresses essential elements for maintenance control, routine inspections, special inspections during planned outages, audits and license conditions and requirements. (author)

Semantic distance-based creation of clusters of pharmacovigilance terms and their evaluation.

Science.gov (United States)

Dupuch, Marie; Grabar, Natalia

2015-04-01

Pharmacovigilance is the activity related to the collection, analysis and prevention of adverse drug reactions (ADRs) induced by drugs or biologics. The detection of adverse drug reactions is performed using statistical algorithms and groupings of ADR terms from the MedDRA (Medical Dictionary for Drug Regulatory Activities) terminology. Standardized MedDRA Queries (SMQs) are the groupings which become a standard for assisting the retrieval and evaluation of MedDRA-coded ADR reports worldwide. Currently 84 SMQs have been created, while several important safety topics are not yet covered. Creation of SMQs is a long and tedious process performed by the experts. It relies on manual analysis of MedDRA in order to find out all the relevant terms to be included in a SMQ. Our objective is to propose an automatic method for assisting the creation of SMQs using the clustering of terms which are semantically similar. The experimental method relies on a specific semantic resource, and also on the semantic distance algorithms and clustering approaches. We perform several experiments in order to define the optimal parameters. Our results show that the proposed method can assist the creation of SMQs and make this process faster and systematic. The average performance of the method is precision 59% and recall 26%. The correlation of the results obtained is 0.72 against the medical doctors judgments and 0.78 against the medical coders judgments. These results and additional evaluation indicate that the generated clusters can be efficiently used for the detection of pharmacovigilance signals, as they provide better signal detection than the existing SMQs. Copyright © 2014. Published by Elsevier Inc.

National legislative and regulatory activities

International Nuclear Information System (INIS)

Anon.

2009-01-01

This part gathers the national legislative and regulatory activities. The subjects tackled are as follow: radiological protection (Belgium), transport of radioactive materials (Belgium, France), general legislation (Brazil, Ireland, Republic of Moldova, Serbia, Turkey), third part liability (Japan), radioactive waste management (Korea, Romania, Slovenia, Usa), regime of radioactive materials (Romania), organisation and structure (Switzerland), regime of nuclear installations (Usa), regulations on nuclear trade (Usa). (N.C)

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2010-01-01

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

17 CFR 1.59 - Activities of self-regulatory organization employees, governing board members, committee members...

Science.gov (United States)

2010-04-01

... 17 Commodity and Securities Exchanges 1 2010-04-01 2010-04-01 false Activities of self-regulatory... COMMODITY EXCHANGE ACT Miscellaneous § 1.59 Activities of self-regulatory organization employees, governing...) Self-regulatory organization means “self-regulatory organization,” as defined in Commission regulation...

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

Energy Technology Data Exchange (ETDEWEB)

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

2001-03-15

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

Program plan for future regulatory activity in nuclear-power-plant maintenance

International Nuclear Information System (INIS)

Badalamente, R.V.

1982-10-01

The intent of this paper is to describe the results of a study of nuclear power plant (NPP) maintenance conducted by Battelle's Pacific Northwest Laboratories (PNL) for the Nuclear Regulatory Commission (NRC). The purpose of the study for the NRC was to determine problems affecting human performance in NPP maintenance, pinpoint those which adversely affect public health and safety, review strategies for overcoming the problems, and suggest the direction that regulatory activities should take. Results of the study were presented to the NRC (Division of Human Factors Safety) in the form of a recommended program plan for future regulatory activity in NPP maintenance

Role of cooperation activities for capacity building of Romanian Regulatory Authority (CNCAN)

International Nuclear Information System (INIS)

Biro, L.; Ciurea-Ercau, C.

2010-01-01

With a slow but active nuclear development program of sector since 1980, Romanian regulatory authority had to permanently adapt to the changes in national and international environment in order ensure continuously increase of capacity building and effectiveness, commensurate with the growing nuclear sector. Limited human resources available at the national level put the Romanian Regulatory Authority in the position of building the Technical Support Organization as part of its on organization. International cooperation played an important role in capacity building of Romanian regulatory body and providing necessary assistance in performing regulatory activities or support in development of regulatory framework. Fellowships and technical visits, workshops and training courses provided through IAEA TC at national or regional level, technical assistance provided by European Commission (EC) through PHARE Projects, all provided valuable contribution in assuring training of regulatory staff and development of proper regulatory framework in Romania. Therefore, Romanian Regulatory Authority is putting a strong accent on strengthening and promoting international cooperation through IAEA Technical Cooperation Programme, Molls between regulatory bodies, as one of the key elements in supporting capacity building of regulatory authorities in countries having small or embarking on nuclear power program. Building networks between training centers and research facilities and establishments of regional training centers represent one of the future viable options in preserving knowledge in nuclear field. (author)

National legislative and regulatory activities

International Nuclear Information System (INIS)

2015-01-01

This section treats of the following National legislative and regulatory activities: 1 - Canada: Liability and compensation; 2 - France: Liability and compensation; Nuclear safety and radiological protection; 3 - Greece: Organisation and structure; 4 - Hungary: General legislation; 5 - India: Liability and compensation; 6 - Japan: Liability and compensation; 7 - Korea: Liability and compensation; 8 - Lithuania: General legislation; Transport of radioactive material; 9 - Slovak Republic: International co-operation; Liability and compensation; 10 - Slovenia: General legislation; 11 - Switzerland: Liability and compensation; 12 - United States: Radioactive waste management

MIRA: An R package for DNA methylation-based inference of regulatory activity.

Science.gov (United States)

Lawson, John T; Tomazou, Eleni M; Bock, Christoph; Sheffield, Nathan C

2018-03-01

DNA methylation contains information about the regulatory state of the cell. MIRA aggregates genome-scale DNA methylation data into a DNA methylation profile for independent region sets with shared biological annotation. Using this profile, MIRA infers and scores the collective regulatory activity for each region set. MIRA facilitates regulatory analysis in situations where classical regulatory assays would be difficult and allows public sources of open chromatin and protein binding regions to be leveraged for novel insight into the regulatory state of DNA methylation datasets. R package available on Bioconductor: http://bioconductor.org/packages/release/bioc/html/MIRA.html. nsheffield@virginia.edu.

Evaluating standard terminologies for encoding allergy information.

Science.gov (United States)

Goss, Foster R; Zhou, Li; Plasek, Joseph M; Broverman, Carol; Robinson, George; Middleton, Blackford; Rocha, Roberto A

2013-01-01

Allergy documentation and exchange are vital to ensuring patient safety. This study aims to analyze and compare various existing standard terminologies for representing allergy information. Five terminologies were identified, including the Systemized Nomenclature of Medical Clinical Terms (SNOMED CT), National Drug File-Reference Terminology (NDF-RT), Medication Dictionary for Regulatory Activities (MedDRA), Unique Ingredient Identifier (UNII), and RxNorm. A qualitative analysis was conducted to compare desirable characteristics of each terminology, including content coverage, concept orientation, formal definitions, multiple granularities, vocabulary structure, subset capability, and maintainability. A quantitative analysis was also performed to compare the content coverage of each terminology for (1) common food, drug, and environmental allergens and (2) descriptive concepts for common drug allergies, adverse reactions (AR), and no known allergies. Our qualitative results show that SNOMED CT fulfilled the greatest number of desirable characteristics, followed by NDF-RT, RxNorm, UNII, and MedDRA. Our quantitative results demonstrate that RxNorm had the highest concept coverage for representing drug allergens, followed by UNII, SNOMED CT, NDF-RT, and MedDRA. For food and environmental allergens, UNII demonstrated the highest concept coverage, followed by SNOMED CT. For representing descriptive allergy concepts and adverse reactions, SNOMED CT and NDF-RT showed the highest coverage. Only SNOMED CT was capable of representing unique concepts for encoding no known allergies. The proper terminology for encoding a patient's allergy is complex, as multiple elements need to be captured to form a fully structured clinical finding. Our results suggest that while gaps still exist, a combination of SNOMED CT and RxNorm can satisfy most criteria for encoding common allergies and provide sufficient content coverage.

Activities of Nuclear Regulatory Authority and safety of nuclear facilities in the Slovak Republic in 1993

International Nuclear Information System (INIS)

1994-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (NRA SR) in 1993 is presented. These activities are reported under the headings: (1) Introduction; (2) Regulatory activities at nuclear power plants units in operation; (2.1) Nuclear power plant SEP-EBO V-1; (4) Selected operation events and safety assessment in NPP SEP-EBO V-1; (2.2) Safety assessment of NPP SEP-EBO V-2; (3) Results of regulatory activities at the decommissioning of NPP A-1; (4) Regulatory activities at units under construction SEP-EMO - NPP Mochovce; (5) Further regulatory activities. (5.1) Preparation of designated personnel; (5.2) Inspection and accountancy of nuclear material; (5.3) Security provisions; (5.4) Accounted items and double use items; (5.5) Problem of radioactive wastes; (6.1) International co-operation activities of NRA; (6.2) Emergency planning; (6.3) International activities for quality enhancement of national supervision; (7) Conclusion [sk

National legislative and regulatory activities

International Nuclear Information System (INIS)

Anon.

2011-01-01

This chapter of Nuclear Law Bulletin gathers some documents about national legislative and regulatory activities: - Belgium: Amendment of the Act on classification and security clearances, certifications and security notifications; Czech Republic: Resolution of the government of the Czech Republic on the time schedule of preparatory works for enlarging the nuclear power plant Temelin; Finland: Temporary Amendment to the Nuclear Liability Act; Ireland: Merchant Shipping Act; Romania: Emergency Ordinance on the identification, designation and protection of critical infrastructures; Emergency Ordinance on the control regime of dual-use items; Amendment to the Act on the safe conduct of nuclear activities; Nuclear safety norms on design and construction of nuclear power plants and nuclear safety norms on siting of nuclear power plants; United Kingdom: Establishment of the Office for Nuclear Regulation; United States: Waste Confidence Decision and Rule Update; Response to recent events in Japan

Regulation of Federal radioactive waste activities. Report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

International Nuclear Information System (INIS)

1979-09-01

The report contains two recommendations for extending the Commission's regulatory authority: (1) NRC licensing authority should be extended to cover all new DOE facilities for disposal of transuranic (TRU) waste and nondefense low-level waste. (2) A pilot program, focused on a few specific DOE waste management activities, should be established to test the feasibility of extending NRC regulatory authority on a consultative basis to DOE waste management activities not now covered by NRC's licensing authority or its extension as recommended in Recommendation 1

The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2012

International Nuclear Information System (INIS)

2013-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2012 is presented. These activities are reported under the headings: Foreword; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Stress tests on the nuclear power plants; (5) Nuclear Materials in SR; (6) Building Authority; (7) Emergency planning and preparedness; (8) International activities; (9) Public communication; (10) Nuclear Regulatory Authority of the Slovak Republic; (11) Attachments; (12) Abbreviations used.

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

The contribution of the vaccine adverse event text mining system to the classification of possible Guillain-Barré syndrome reports.

Science.gov (United States)

Botsis, T; Woo, E J; Ball, R

2013-01-01

We previously demonstrated that a general purpose text mining system, the Vaccine adverse event Text Mining (VaeTM) system, could be used to automatically classify reports of an-aphylaxis for post-marketing safety surveillance of vaccines. To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). We used VaeTM to extract the key diagnostic features from the text of reports in VAERS. Then, we applied the Brighton Collaboration (BC) case definition for GBS, and an information retrieval strategy (i.e. the vector space model) to quantify the specific information that is included in the key features extracted by VaeTM and compared it with the encoded information that is already stored in VAERS as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs). We also evaluated the contribution of the primary (diagnosis and cause of death) and secondary (second level diagnosis and symptoms) diagnostic VaeTM-based features to the total VaeTM-based information. MedDRA captured more information and better supported the classification of reports for GBS than VaeTM (AUC: 0.904 vs. 0.777); the lower performance of VaeTM is likely due to the lack of extraction by VaeTM of specific laboratory results that are included in the BC criteria for GBS. On the other hand, the VaeTM-based classification exhibited greater specificity than the MedDRA-based approach (94.96% vs. 87.65%). Most of the VaeTM-based information was contained in the secondary diagnostic features. For GBS, clinical signs and symptoms alone are not sufficient to match MedDRA coding for purposes of case classification, but are preferred if specificity is the priority.

The Contribution of the Vaccine Adverse Event Text Mining System to the Classification of Possible Guillain-Barré Syndrome Reports

Science.gov (United States)

Botsis, T.; Woo, E. J.; Ball, R.

2013-01-01

Background We previously demonstrated that a general purpose text mining system, the Vaccine adverse event Text Mining (VaeTM) system, could be used to automatically classify reports of an-aphylaxis for post-marketing safety surveillance of vaccines. Objective To evaluate the ability of VaeTM to classify reports to the Vaccine Adverse Event Reporting System (VAERS) of possible Guillain-Barré Syndrome (GBS). Methods We used VaeTM to extract the key diagnostic features from the text of reports in VAERS. Then, we applied the Brighton Collaboration (BC) case definition for GBS, and an information retrieval strategy (i.e. the vector space model) to quantify the specific information that is included in the key features extracted by VaeTM and compared it with the encoded information that is already stored in VAERS as Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms (PTs). We also evaluated the contribution of the primary (diagnosis and cause of death) and secondary (second level diagnosis and symptoms) diagnostic VaeTM-based features to the total VaeTM-based information. Results MedDRA captured more information and better supported the classification of reports for GBS than VaeTM (AUC: 0.904 vs. 0.777); the lower performance of VaeTM is likely due to the lack of extraction by VaeTM of specific laboratory results that are included in the BC criteria for GBS. On the other hand, the VaeTM-based classification exhibited greater specificity than the MedDRA-based approach (94.96% vs. 87.65%). Most of the VaeTM-based information was contained in the secondary diagnostic features. Conclusion For GBS, clinical signs and symptoms alone are not sufficient to match MedDRA coding for purposes of case classification, but are preferred if specificity is the priority. PMID:23650490

Cis-regulatory RNA elements that regulate specialized ribosome activity.

Science.gov (United States)

Xue, Shifeng; Barna, Maria

2015-01-01

Recent evidence has shown that the ribosome itself can play a highly regulatory role in the specialized translation of specific subpools of mRNAs, in particular at the level of ribosomal proteins (RP). However, the mechanism(s) by which this selection takes place has remained poorly understood. In our recent study, we discovered a combination of unique RNA elements in the 5'UTRs of mRNAs that allows for such control by the ribosome. These mRNAs contain a Translation Inhibitory Element (TIE) that inhibits general cap-dependent translation, and an Internal Ribosome Entry Site (IRES) that relies on a specific RP for activation. The unique combination of an inhibitor of general translation and an activator of specialized translation is key to ribosome-mediated control of gene expression. Here we discuss how these RNA regulatory elements provide a new level of control to protein expression and their implications for gene expression, organismal development and evolution.

Peak-valley-peak pattern of histone modifications delineates active regulatory elements and their directionality

DEFF Research Database (Denmark)

Pundhir, Sachin; Bagger, Frederik Otzen; Lauridsen, Felicia Kathrine Bratt

2016-01-01

Formation of nucleosome free region (NFR) accompanied by specific histone modifications at flanking nucleosomes is an important prerequisite for enhancer and promoter activity. Due to this process, active regulatory elements often exhibit a distinct shape of histone signal in the form of a peak......-valley-peak (PVP) pattern. However, different features of PVP patterns and their robustness in predicting active regulatory elements have never been systematically analyzed. Here, we present PARE, a novel computational method that systematically analyzes the H3K4me1 or H3K4me3 PVP patterns to predict NFRs. We show...... four ENCODE cell lines and four hematopoietic differentiation stages, we identified several enhancers whose regulatory activity is stage specific and correlates positively with the expression of proximal genes in a particular stage. In conclusion, our results demonstrate that PVP patterns delineate...

77 FR 70846 - Regulatory Guide 1.182, “Assessing and Managing Risk Before Maintenance Activities at Nuclear...

Science.gov (United States)

2012-11-27

... NUCLEAR REGULATORY COMMISSION [NRC-2012-0285] Regulatory Guide 1.182, ``Assessing and Managing Risk Before Maintenance Activities at Nuclear Power Plants'' AGENCY: Nuclear Regulatory Commission... withdrawing Regulatory Guide (RG)1.182, Revision (Rev.) 0, ``Assessing and Managing Risk Before Maintenance...

Regulatory oversight of maintenance activities at nuclear power plants

International Nuclear Information System (INIS)

Pape, M.

1997-01-01

Regulation of nuclear safety in the UK is based on monitoring of compliance with licence conditions. This paper discusses legislation aspects, license conditions, license requirements for maintenance and maintenance activities in the UK. It also addresses the regulator utility interaction, the regulatory inspection of maintenance and the trends in maintenance. (author)

Role of in-house safety analysis and research activities in regulatory decision making

International Nuclear Information System (INIS)

Pradhan, Santosh K.; Nagrale, Dhanesh B.; Gaikwad, Avinash J.

2015-01-01

Achievement of an acceptable level of nuclear safety is an essential requirement for the peaceful utilization of nuclear energy. The success of Global Nuclear Safety Regime is built upon a foundation of research. Such research has been sponsored by Governments and industry and has led to improved designs, safer and more reliable plant operation, and improvements in operating plant efficiency. A key element of this research has been the nuclear safety research performed or sponsored by regulatory organizations. In part, it has been the safety research performed or sponsored by regulatory organizations that has contributed to improved safety and has laid the foundation for activities such as risk-informed regulation, plant life extension, improved plant performance (e.g. power uprates) and new plant designs. The regulatory research program is meant to improve the regulatory authority’s knowledge where uncertainty exists, where safety margins are not well-characterized, and where regulatory decisions need to be confirmed in existing or new designs and technologies. The regulatory body get research initiated either in-house or by the licensee or through technical support organizations (TSOs). Research and analysis carried out within the regulatory body is of immense value in this context. This could be in the form of analysis of safety significant events, analysis of severe accidents, review of operating experience, independent checks of critical designs and even review of operator responses under different situations towards arriving at modifications to training programmes and licensing procedures for operating personnel. A latent benefit of regulatory research carried out by the regulators themselves is that it improves their technical competence considerably which in turn leads to high quality safety reviews and improved regulation in general. The aim of the present paper is to provide an overview of role of regulatory research and the in-house regulatory safety

A HLA class I cis-regulatory element whose activity can be modulated by hormones.

Science.gov (United States)

Sim, B C; Hui, K M

1994-12-01

To elucidate the basis of the down-regulation in major histocompatibility complex (MHC) class I gene expression and to identify possible DNA-binding regulatory elements that have the potential to interact with class I MHC genes, we have studied the transcriptional regulation of class I HLA genes in human breast carcinoma cells. A 9 base pair (bp) negative cis-regulatory element (NRE) has been identified using band-shift assays employing DNA sequences derived from the 5'-flanking region of HLA class I genes. This 9-bp element, GTCATGGCG, located within exon I of the HLA class I gene, can potently inhibit the expression of a heterologous thymidine kinase (TK) gene promoter and the HLA enhancer element. Furthermore, this regulatory element can exert its suppressive function in either the sense or anti-sense orientation. More interestingly, NRE can suppress dexamethasone-mediated gene activation in the context of the reported glucocorticoid-responsive element (GRE) in MCF-7 cells but has no influence on the estrogen-mediated transcriptional activation of MCF-7 cells in the context of the reported estrogen-responsive element (ERE). Furthermore, the presence of such a regulatory element within the HLA class I gene whose activity can be modulated by hormones correlates well with our observation that the level of HLA class I gene expression can be down-regulated by hormones in human breast carcinoma cells. Such interactions between negative regulatory elements and specific hormone trans-activators are novel and suggest a versatile form of transcriptional control.

76 FR 18165 - Request for Public Comments Concerning Regulatory Cooperation Activities That Would Help...

Science.gov (United States)

2011-04-01

... DEPARTMENT OF COMMERCE International Trade Administration Request for Public Comments Concerning Regulatory Cooperation Activities That Would Help Eliminate or Reduce Unnecessary Regulatory Divergences in... ``Help'' tab.) All comments and recommendations submitted in response to this notice will be made...

National legislative and regulatory activities

International Nuclear Information System (INIS)

2015-01-01

This section treats of the following National legislative and regulatory activities: 1 - Australia: General legislation - Bill to amend the Australian Radiation Protection and Nuclear Safety Act 1998; 2 - France: General legislation - Law No. 2015-992 of 17 August 2015 on the energy transition for green growth; ASN Report on the state of nuclear safety and radiation protection in France in 2014; 3 - Germany: Radioactive waste management - First Ordinance to amend the 2005 Gorleben Development Freeze Ordinance (2015); 4 - Greece: Radioactive waste management - Joint Ministerial Decision establishing the national policy on the management of spent fuel and radioactive waste; 5 - Lithuania: Nuclear safety and radiological protection - Revised requirements for modifications, Plan for enhancement of nuclear safety, New requirements for the commissioning of nuclear power plants, Revised requirements regulating the provision of information on abnormal events; Radioactive waste management - Revised requirements for acceptance criteria for near surface repository; Nuclear security - Revised requirements for physical protection; 6 - Romania: Licensing and regulatory infrastructure - Government Decision No. 600/2014 for approval of National Nuclear Safety and Security; International co-operation - Government Decision No. 525/2014 for approval of the Co-operation Agreement on the radioactive waste management between the French National Radioactive Waste Management Agency (ANDRA) and Nuclear Agency and Radioactive Waste (ANDR) Strategy; Memorandum of Understanding for Co-operation and Exchange of Information in Nuclear Regulatory Matters between the National Commission for Nuclear Activities Control (CNCAN) of Romania and the President of National Atomic Energy Agency (PAA) of Poland; Government Decision No. 540/2015 for approval of the Agreement between the Government of Romania and the Government of the People's Republic of China regarding co-operation in the peaceful

As to achieve regulatory action, regulatory approaches

International Nuclear Information System (INIS)

Cid, R.; Encinas, D.

2014-01-01

The achievement of the effectiveness in the performance of a nuclear regulatory body has been a permanent challenge in the recent history of nuclear regulation. In the post-Fukushima era this challenge is even more important. This article addresses the subject from two complementary points of view: the characteristics of an effective regulatory body and the regulatory approaches. This work is based on the most recent studies carried out by the Committee on Nuclear Regulatory Activities, CNRA (OECD/NEA), as well as on the experience of the Consejo de Seguridad Nuclear, CSN, the Spanish regulatory body. Rafael Cid is the representative of CSN in these project: Diego Encinas has participated in the study on regulatory approaches. (Author)

National legislative and regulatory activities

International Nuclear Information System (INIS)

2013-01-01

- International co-operation: Law ratifying the agreement between the International Atomic Energy Agency and Greece in the area of education and training; - Nuclear safety and radiological protection: Ministerial decision establishing requirements for nuclear safety and regulatory control of research reactors; Moldova - General legislation: New comprehensive law governing nuclear and radiological activities; United States - Issuance of the 'Strategy for the Management and Disposal of Used Nuclear Fuel and High-Level Radioactive Waste'; - Ongoing activities: The Blue Ribbon Commission noted the need for near-term actions that can lay the groundwork for the next generation of nuclear waste policies and programmes included in its recommendations; - Physical protection of by-product material final rulemaking: On 19 March 2013, the NRC published a final rule amending its regulations to establish security requirements for the use and transport of category 1 and category 2 quantities of radioactive material; - Update on the NRC's response to the events at the Fukushima Daiichi nuclear site regarding filtered vents and consideration of economic consequences

National legislative and regulatory activities

International Nuclear Information System (INIS)

Anon.

2001-01-01

These columns treat of the legislative and regulatory activities of different OECD countries: Australia (environment protection and biodiversity conservation act and regulations, 1999-2000); Bulgaria (basic standards for radiation protection, 2000); France (decree on the standard tax charged on polluting activities due from operators of installations classified for environmental protection purposes, 2000; amendment of the orders on the transport of dangerous goods by road and by rail, 2000); Georgia (law on nuclear and radiation safety, 1998); Germany (amendments to nuclear legislation implementing EURATOM directives, 2000; amendment to the nuclear third party liability provisions of the atomic energy act, 2001; amendment to the foreign trade ordinance, 2000; ordinance on the treatment of foodstuffs with radiation, 2000; general administrative regulations on radioactivity limits in food and feeds); Ireland (European communities regulations on foodstuffs treated with ionizing radiations, 2000); Japan (law for nuclear sitting area development, 2000; Republic of Korea (amendments to the act on compensation for nuclear damage, 2001); Latvia (act on radiation safety and nuclear safety, 2000); Lithuania (resolution approving the decommissioning program for Unit 1, Ignalina NPP, 2001); Luxembourg (grand-ducal regulations on the protection of the public against the risks resulting from ionizing radiation, 2000; grand-ducal regulations relating to foods and food ingredients treated with ionizing radiation, 2000); Mexico (norm regarding selection, qualification and training requirements for staff of a NPP, 2000; norm regarding solid residue as radioactive waste, 2000); Mongolia (law on nuclear weapons free status and its implementing resolution, 2000); Netherlands (amendment to the nuclear energy act, 2000); Norway (act on radiation and use of radiation, 2000); Pakistan (nuclear authority ordinance, 2001); Poland (atomic energy act, 2000); Spain (royal decree on activities

STATE INSPECTION METHODOLOGY OF ENVIRONMENTAL REGULATORY ACTIVITY FOCUSED ON THE LIFE CYCLE PROCESSESES

Directory of Open Access Journals (Sweden)

Yuniey Quiala Armenteros

2016-10-01

Full Text Available The Cuban Environmental Regulatory Activity has on the Environmental State Inspection an instrument for control and monitoring of compliance of current legal standards regarding environmental protection and rational use of natural resources. In this research, a design methodology for effective implementation of environmental regulatory activity in Cuba directed to processes is proposed; based on the life cycle assessment and the applicable environmental management standards, including new performance indicators, which form a new tool based on scientific criterions for the Center of Environmental Inspection and Control.

Association between Selective Beta-adrenergic Drugs and Blood Pressure Elevation: Data Mining of the Japanese Adverse Drug Event Report (JADER) Database.

Science.gov (United States)

Ohyama, Katsuhiro; Inoue, Michiko

2016-01-01

Selective beta-adrenergic drugs are used clinically to treat various diseases. Because of imperfect receptor selectivity, beta-adrenergic drugs cause some adverse drug events by stimulating other adrenergic receptors. To examine the association between selective beta-adrenergic drugs and blood pressure elevation, we reviewed the Japanese Adverse Drug Event Reports (JADERs) submitted to the Japan Pharmaceuticals and Medical Devices Agency. We used the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Terms extracted from Standardized MedDRA queries for hypertension to identify events related to blood pressure elevation. Spontaneous adverse event reports from April 2004 through May 2015 in JADERs, a data mining algorithm, and the reporting odds ratio (ROR) were used for quantitative signal detection, and assessed by the case/non-case method. Safety signals are considered significant if the ROR estimates and lower bound of the 95% confidence interval (CI) exceed 1. A total of 2021 reports were included in this study. Among the nine drugs examined, significant signals were found, based on the 95%CI for salbutamol (ROR: 9.94, 95%CI: 3.09-31.93) and mirabegron (ROR: 7.52, 95%CI: 4.89-11.55). The results of this study indicate that some selective beta-adrenergic drugs are associated with blood pressure elevation. Considering the frequency of their indications, attention should be paid to their use in elderly patients to avoid adverse events.

Innate immune activity conditions the effect of regulatory variants upon monocyte gene expression.

Science.gov (United States)

Fairfax, Benjamin P; Humburg, Peter; Makino, Seiko; Naranbhai, Vivek; Wong, Daniel; Lau, Evelyn; Jostins, Luke; Plant, Katharine; Andrews, Robert; McGee, Chris; Knight, Julian C

2014-03-07

To systematically investigate the impact of immune stimulation upon regulatory variant activity, we exposed primary monocytes from 432 healthy Europeans to interferon-γ (IFN-γ) or differing durations of lipopolysaccharide and mapped expression quantitative trait loci (eQTLs). More than half of cis-eQTLs identified, involving hundreds of genes and associated pathways, are detected specifically in stimulated monocytes. Induced innate immune activity reveals multiple master regulatory trans-eQTLs including the major histocompatibility complex (MHC), coding variants altering enzyme and receptor function, an IFN-β cytokine network showing temporal specificity, and an interferon regulatory factor 2 (IRF2) transcription factor-modulated network. Induced eQTL are significantly enriched for genome-wide association study loci, identifying context-specific associations to putative causal genes including CARD9, ATM, and IRF8. Thus, applying pathophysiologically relevant immune stimuli assists resolution of functional genetic variants.

Key regulatory and safety issues emerging NEA activities. Lessons Learned from Fukushima Dai-ichi NPS Accident - Key Regulatory and Safety Issues

International Nuclear Information System (INIS)

Nakoski, John

2013-01-01

A presentation was provided on the key safety and regulatory issues and an update of activities undertaken by the NEA and its members in response to the accident at the Fukushima Daiichi nuclear power stations (NPS) on 11 March 2011. An overview of the accident sequence and the consequences was provided that identified the safety functions that were lost (electrical power, core cooling, and primary containment) that lead to units 1, 2, and 3 being in severe accident conditions with large off-site releases. Key areas identified for which activities of the NEA and member countries are in progress include accident management; defence-in-depth; crisis communication; initiating events; operating experience; deterministic and probabilistic assessments; regulatory infrastructure; radiological protection and public health; and decontamination and recovery. For each of these areas, a brief description of the on-going and planned NEA activities was provided within the three standing technical committees of the NEA with safety and regulatory mandates (the Committee on Nuclear Regulatory Activities - CNRA, the Committee on the Safety of Nuclear Installations - CSNI, and the Committee on Radiation Protection and Public Health - CRPPH). On-going activities of CNRA include a review of enhancement being made to the regulatory aspects for the oversight of on-site accident management strategies and processes in light of the lessons learned from the accident; providing guidance to regulators on crisis communication; and supporting the peer review of the safety assessments of risk-significant research reactor facilities in light of the accident. Within the scope of the CSNI mandate, activities are being undertaken to better understand accident progression; characteristics of new fuel designs; and a benchmarking study of fast-running software for estimating source term under severe accident conditions to support protective measure recommendations. CSNI also has ongoing work in human

The Evolution of Lineage-Specific Regulatory Activities in the Human Embryonic Limb

OpenAIRE

Cotney, Justin; Leng, Jing; Yin, Jun; Reilly, Steven K.; DeMare, Laura E.; Emera, Deena; Ayoub, Albert E.; Rakic, Pasko; Noonan, James P.

2013-01-01

The evolution of human anatomical features likely involved changes in gene regulation during development. However, the nature and extent of human-specific developmental regulatory functions remain unknown. We obtained a genome-wide view of cis-regulatory evolution in human embryonic tissues by comparing the histone modification H3K27ac, which provides a quantitative readout of promoter and enhancer activity, during human, rhesus, and mouse limb development. Based on increased H3K27ac, we find...

RNA-Seq of Bacillus licheniformis: active regulatory RNA features expressed within a productive fermentation

Science.gov (United States)

2013-01-01

Background The production of enzymes by an industrial strain requires a complex adaption of the bacterial metabolism to the conditions within the fermenter. Regulatory events within the process result in a dynamic change of the transcriptional activity of the genome. This complex network of genes is orchestrated by proteins as well as regulatory RNA elements. Here we present an RNA-Seq based study considering selected phases of an industry-oriented fermentation of Bacillus licheniformis. Results A detailed analysis of 20 strand-specific RNA-Seq datasets revealed a multitude of transcriptionally active genomic regions. 3314 RNA features encoded by such active loci have been identified and sorted into ten functional classes. The identified sequences include the expected RNA features like housekeeping sRNAs, metabolic riboswitches and RNA switches well known from studies on Bacillus subtilis as well as a multitude of completely new candidates for regulatory RNAs. An unexpectedly high number of 855 RNA features are encoded antisense to annotated protein and RNA genes, in addition to 461 independently transcribed small RNAs. These antisense transcripts contain molecules with a remarkable size range variation from 38 to 6348 base pairs in length. The genome of the type strain B. licheniformis DSM13 was completely reannotated using data obtained from RNA-Seq analyses and from public databases. Conclusion The hereby generated data-sets represent a solid amount of knowledge on the dynamic transcriptional activities during the investigated fermentation stages. The identified regulatory elements enable research on the understanding and the optimization of crucial metabolic activities during a productive fermentation of Bacillus licheniformis strains. PMID:24079885

RNA-Seq of Bacillus licheniformis: active regulatory RNA features expressed within a productive fermentation.

Science.gov (United States)

Wiegand, Sandra; Dietrich, Sascha; Hertel, Robert; Bongaerts, Johannes; Evers, Stefan; Volland, Sonja; Daniel, Rolf; Liesegang, Heiko

2013-10-01

The production of enzymes by an industrial strain requires a complex adaption of the bacterial metabolism to the conditions within the fermenter. Regulatory events within the process result in a dynamic change of the transcriptional activity of the genome. This complex network of genes is orchestrated by proteins as well as regulatory RNA elements. Here we present an RNA-Seq based study considering selected phases of an industry-oriented fermentation of Bacillus licheniformis. A detailed analysis of 20 strand-specific RNA-Seq datasets revealed a multitude of transcriptionally active genomic regions. 3314 RNA features encoded by such active loci have been identified and sorted into ten functional classes. The identified sequences include the expected RNA features like housekeeping sRNAs, metabolic riboswitches and RNA switches well known from studies on Bacillus subtilis as well as a multitude of completely new candidates for regulatory RNAs. An unexpectedly high number of 855 RNA features are encoded antisense to annotated protein and RNA genes, in addition to 461 independently transcribed small RNAs. These antisense transcripts contain molecules with a remarkable size range variation from 38 to 6348 base pairs in length. The genome of the type strain B. licheniformis DSM13 was completely reannotated using data obtained from RNA-Seq analyses and from public databases. The hereby generated data-sets represent a solid amount of knowledge on the dynamic transcriptional activities during the investigated fermentation stages. The identified regulatory elements enable research on the understanding and the optimization of crucial metabolic activities during a productive fermentation of Bacillus licheniformis strains.

Perceived success/failure and attributions associated with self-regulatory efficacy to meet physical activity recommendations for women with arthritis.

Science.gov (United States)

Spink, Kevin S; Brawley, Lawrence R; Gyurcsik, Nancy C

2016-10-01

The relationship between attributional dimensions women assign to the cause of their perceived success or failure at meeting the recommended physical activity dose and self-regulatory efficacy for future physical activity was examined among women with arthritis. Women (N = 117) aged 18-84 years, with self-reported medically-diagnosed arthritis, completed on-line questions in the fall of 2013 assessing endurance physical activity, perceived outcome for meeting the recommended levels of endurance activity, attributions for one's success or failure in meeting the recommendations, and self-regulatory efficacy to schedule/plan endurance activity over the next month. The main theoretically-driven finding revealed that the interaction of the stability dimension with perceived success/failure was significantly related to self-regulatory efficacy for scheduling and planning future physical activity (β = 0.35, p = .002). Outcomes attributed to more versus less stable factors accentuated differences in self-regulatory efficacy beliefs following perceived success and failure at being active. It appears that attributional dimensions were associated with self-regulatory efficacy in women with arthritis. This suggests that rather than objectively observed past mastery experience, women's subjective perceptions and explanations of their past experiences were related to efficacy beliefs, especially following a failure experience.

Regulation of Federal radioactive waste activities. Summary of report to Congress on extending the Nuclear Regulatory Commission's licensing or regulatory authority to Federal radioactive waste storage and disposal activities

International Nuclear Information System (INIS)

Smith, R.D.

1979-09-01

The NRC Authorization Bill for FY 1979 directed NRC to conduct a study of extending the Commission's licensing or regulatory authority to include categories of existing and future Federal radioactive waste storage and disposal activities not presently subject to such authority. The report includes a complete listing and inventory of all radioactive waste storage and disposal activities now being conducted or planned by Federal agencies. The NRC study has attempted to present a general comparison of the relative hazards associated with defense-generated and commercial wastes. Options for extending Commission authority were developed and analyzed. The implications of NEPA were analyzed in the context of these options. The national security implications of extending NRC's regulatory authority over DOE programs are examined and evaluated. Costs and benefits are identified and assessed. The Commission's recommendations, based on the study, are to extend licensing authority over new DOE disposal activities involving transuranic wastes and non-defense low-level waste and to initiate a pilot program to test the feasibility of NRC playing a consultative role in the evaluation of existing DOE activities

National legislative and regulatory activities

International Nuclear Information System (INIS)

2016-01-01

This section treats of the following National legislative and regulatory activities: 1 - Argentina: Organisation and structure; 2 - France: Radioactive waste management (Act No. 2016-1015 of 25 July 2016 specifying the procedures for creating a reversible deep geological repository for long-lived medium and high-level radioactive waste), Liability and compensation (Decree No. 2016-333 of 21 March 2016 implementing Article L. 597-28 of the French Environmental Code and relating to third party liability in the field of nuclear energy; Ministerial Order of 19 August 2016 listing the sites benefiting from a reduced amount of liability pursuant to decree No. 2016-333 of 21 March 2016 implementing Article L. 597-28 of the French Environmental Code and relating to third party liability in the field of nuclear energy), Nuclear facilities (Decree No. 2016-846 of 28 June 2016 related to the modification, final shutdown and decommissioning of basic nuclear installations, and to subcontracting); 3 - Germany: Nuclear trade - including non-proliferation (Amendments to the Foreign Trade Act and the Foreign Trade Ordinance (2015)), Radioactive waste management (Act on the Organisational Restructuring in the Field of Radioactive Waste Management (2016); Final report of the Commission to Review the Financing for the Phase-out of Nuclear Energy; Draft Bill of an Act on the Reorganisation of the Responsibility of Nuclear Waste Disposal (2016)); 4 - Lithuania: Nuclear safety and radiological protection (including nuclear emergency planning), Nuclear security (Physical security of sources of ionising radiation), Radioactive waste management, Licensing and regulatory infrastructure (Enforcement measures); 5 - Luxembourg: Radioactive waste management (Agreement between the Grand Duchy of Luxembourg and the Kingdom of Belgium on the Management and Final Disposal of the Radioactive Waste of the Grand Duchy of Luxembourg on the Territory of the Kingdom of Belgium, signed on 4 July 2016); 6

National legislative and regulatory activities

International Nuclear Information System (INIS)

2013-01-01

This section reviews the recent National legislative and regulatory activities: Algeria (Establishment of a nuclear security centre); Armenia (Amendment to the Law of the Republic of Armenia on the Safe Utilization of Atomic Energy for Peaceful Purposes); Brazil (creation of a Support Centre for Safety and Radiation Protection - Centro de Apoio a Seguranca Fisica Nuclear e Radiologica - CENASF); Canada (enacting of the Nuclear Terrorism Act,4 which amends the Criminal Code, creating four new Criminal Code offences related to nuclear terrorism; proposal to replace the existing Nuclear Liability Act with the increase of the amount of compensation available to address civil nuclear damage); France (National plan for the management of radioactive materials and waste - PNGMDR; Law No.2013-580 of 4 July 2013 authorising approval of the agreement between France and Monaco on the management of Monegasque radioactive waste in the French territory; Decree No.2013-675 of 25 July 2013 publishing an agreement of co-operation between France and Saudi Arabia for the development of nuclear energy for peaceful purposes); Germany (Act for retrieving radioactive waste from and decommissioning the Asse II Mine); Greece (Decree transposing Council Directive 2011/70/Euratom); Ireland (Adoption of European Communities Regulations on Carriage of Dangerous Goods by Road and Use of Transportable Pressure Equipment); Luxembourg (Transposition of Council Directive 2011/70/Euratom of 19 July 2011 establishing a Community framework for the responsible and safe management of spent fuel and radioactive waste); Poland (New requirements for employees concerning radiological protection; New detailed requirements for nuclear facility siting, design, commissioning and operation, organisational unit commissioning, periodical safety assessment, decommissioning and fund contributions; New regulation on subsidies related to nuclear safety and radiological protection; New requirements on transparency of

Argentine influence on regulatory activities in Latin America

International Nuclear Information System (INIS)

Palacios, Elias

1998-01-01

An analysis of the nuclear regulatory systems and the nuclear regulations of many Latin American countries shows a substantial influence of the Argentine regulatory structure. This influence is attributed to the early Argentine development of a regulatory and control organization, the teaching of regional training courses and the advice of Argentine experts to Latin-American governments

Unexpected T cell regulatory activity of anti-histone H1 autoantibody: Its mode of action in regulatory T cell-dependent and -independent manners

Energy Technology Data Exchange (ETDEWEB)

Takaoka, Yuki [Department of Molecular Biotechnology, Graduate School of Advanced Sciences of Matter, Hiroshima University, Higashi-Hiroshima (Japan); Kawamoto, Seiji, E-mail: skawa@hiroshima-u.ac.jp [Department of Molecular Biotechnology, Graduate School of Advanced Sciences of Matter, Hiroshima University, Higashi-Hiroshima (Japan); Katayama, Akiko [Department of Molecular Biotechnology, Graduate School of Advanced Sciences of Matter, Hiroshima University, Higashi-Hiroshima (Japan); Nakano, Toshiaki [Liver Transplantation Program, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan (China); Yamanaka, Yasushi; Takahashi, Miki [Department of Molecular Biotechnology, Graduate School of Advanced Sciences of Matter, Hiroshima University, Higashi-Hiroshima (Japan); Shimada, Yayoi; Chiang, Kuei-Chen [Kazusa Institute for Drug Discovery, Josai International University, Kisarazu (Japan); Ohmori, Naoya [Kazusa Institute for Drug Discovery, Josai International University, Kisarazu (Japan); Faculty of Nursing, Josai International University, Togane (Japan); Aki, Tsunehiro [Department of Molecular Biotechnology, Graduate School of Advanced Sciences of Matter, Hiroshima University, Higashi-Hiroshima (Japan); Goto, Takeshi; Sato, Shuji [Kazusa Institute for Drug Discovery, Josai International University, Kisarazu (Japan); Faculty of Nursing, Josai International University, Togane (Japan); Goto, Shigeru [Liver Transplantation Program, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan (China); Iwao Hospital, Yufuin (Japan); Chen, Chao-Long [Liver Transplantation Program, Chang Gung Memorial Hospital-Kaohsiung Medical Center, Chang Gung University College of Medicine, Kaohsiung, Taiwan (China); Ono, Kazuhisa [Department of Molecular Biotechnology, Graduate School of Advanced Sciences of Matter, Hiroshima University, Higashi-Hiroshima (Japan)

2013-02-08

Highlights: ► Anti-histone H1 autoantibody (anti-H1) acts on T cells to inhibit their activation. ► Anti-H1 suppresses T cell activation in Treg cell-dependent and -independent manners. ► Suboptimal dose of anti-H1 enhances suppressor function of Treg cells. ► High dose of anti-H1 directly inhibits T cell receptor signaling. -- Abstract: Induction of anti-nuclear antibodies against DNA or histones is a hallmark of autoimmune disorders, but their actual contribution to disease predisposition remains to be clarified. We have previously reported that autoantibodies against histone H1 work as a critical graft survival factor in a rat model of tolerogeneic liver transplantation. Here we show that an immunosuppressive anti-histone H1 monoclonal antibody (anti-H1 mAb) acts directly on T cells to inhibit their activation in response to T cell receptor (TCR) ligation. Intriguingly, the T cell activation inhibitory activity of anti-H1 mAb under suboptimal dosages required regulatory T (Treg) cells, while high dose stimulation with anti-H1 mAb triggered a Treg cell-independent, direct negative regulation of T cell activation upon TCR cross-linking. In the Treg cell-dependent mode of immunosuppressive action, anti-H1 mAb did not induce the expansion of CD4{sup +}Foxp3{sup +} Treg cells, but rather potentiated their regulatory capacity. These results reveal a previously unappreciated T cell regulatory role of anti-H1 autoantibody, whose overproduction is generally thought to be pathogenic in the autoimmune settings.

Unexpected T cell regulatory activity of anti-histone H1 autoantibody: Its mode of action in regulatory T cell-dependent and -independent manners

International Nuclear Information System (INIS)

Takaoka, Yuki; Kawamoto, Seiji; Katayama, Akiko; Nakano, Toshiaki; Yamanaka, Yasushi; Takahashi, Miki; Shimada, Yayoi; Chiang, Kuei-Chen; Ohmori, Naoya; Aki, Tsunehiro; Goto, Takeshi; Sato, Shuji; Goto, Shigeru; Chen, Chao-Long; Ono, Kazuhisa

2013-01-01

Highlights: ► Anti-histone H1 autoantibody (anti-H1) acts on T cells to inhibit their activation. ► Anti-H1 suppresses T cell activation in Treg cell-dependent and -independent manners. ► Suboptimal dose of anti-H1 enhances suppressor function of Treg cells. ► High dose of anti-H1 directly inhibits T cell receptor signaling. -- Abstract: Induction of anti-nuclear antibodies against DNA or histones is a hallmark of autoimmune disorders, but their actual contribution to disease predisposition remains to be clarified. We have previously reported that autoantibodies against histone H1 work as a critical graft survival factor in a rat model of tolerogeneic liver transplantation. Here we show that an immunosuppressive anti-histone H1 monoclonal antibody (anti-H1 mAb) acts directly on T cells to inhibit their activation in response to T cell receptor (TCR) ligation. Intriguingly, the T cell activation inhibitory activity of anti-H1 mAb under suboptimal dosages required regulatory T (Treg) cells, while high dose stimulation with anti-H1 mAb triggered a Treg cell-independent, direct negative regulation of T cell activation upon TCR cross-linking. In the Treg cell-dependent mode of immunosuppressive action, anti-H1 mAb did not induce the expansion of CD4 + Foxp3 + Treg cells, but rather potentiated their regulatory capacity. These results reveal a previously unappreciated T cell regulatory role of anti-H1 autoantibody, whose overproduction is generally thought to be pathogenic in the autoimmune settings

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Iceland

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health and Social Security; Icelandic Radiation Protection Institute)

Guidance and methods for satisfying low specific activity material and surface contaminated object regulatory requirements

International Nuclear Information System (INIS)

Pope, R.B.; Shappert, L.B.; Michelhaugh, R.D.; Boyle, R.W.; Easton, E.P.; Coodk, J.R.

1998-01-01

The U.S. Department of Transportation (DOT) and the U.S. Nuclear Regulatory Commission (NRC) have prepared a comprehensive set of draft guidance for shippers and inspectors to use when applying the newly imposed regulatory requirements for low specific activity (LSA) material and surface contaminated objects (SCOs). These requirements represent significant departures in some areas from the manner in which these materials and objects were regulated by the earlier versions of the regulations. The proper interpretation and application of the regulatory criteria can require a fairly complex set of decisions be made. To assist those trying these regulatory requirements, a detailed set of logic-flow diagrams representing decisions related to multiple factors were prepared and included in the draft report for comment on Categorizing and Transporting Low Specific Activity Materials and Surface Contaminated Objects, (DOT/NRC, 1997). These logic-flow diagrams, as developed, are specific to the U.S. regulations, but were readily adaptable to the IAEA regulations. The diagrams have been modified accordingly and tied directly to specific paragraphs in IAEA Safety Series No. 6. This paper provides the logic-flow diagrams adapted in the IAEA regulations, and demonstrated how these diagrams can be used to assist consignors and inspectors in assessing compliance of shipments with the LSA material and SCO regulatory requirements. (authors)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Canada

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction (Licensing system; Offences, compliance and enforcement; Regulatory documents; Other relevant legislation); 2. Mining regime; 3. Nuclear substances and radiation devices; 4. Nuclear facilities; 5. Trade in nuclear materials and equipment (Exports, Other imports); 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Governor in council; Minister of natural resources; Other Ministerial authorities; Canadian Nuclear Safety Commission - CNSC); 2. Public and semi-public agencies (National Research Council - NRC; Natural Sciences and Engineering Research Council; Atomic Energy of Canada Ltd. - AECL)

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

DEFF Research Database (Denmark)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

2014-01-01

in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient's trial identification number. Using the patient's trial...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...... identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary...

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder

DEFF Research Database (Denmark)

Maund, Emma; Tendal, Britta; Hróbjartsson, Asbjørn

2014-01-01

OBJECTIVE: To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. DESIGN: Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events...... identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. SETTING: 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency...... for marketing approval. DATA SOURCES: Clinical study reports obtained from the EMA in 2011. RESULTS: Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly...

Regulatory T cells ameliorate tissue plasminogen activator-induced brain haemorrhage after stroke.

Science.gov (United States)

Mao, Leilei; Li, Peiying; Zhu, Wen; Cai, Wei; Liu, Zongjian; Wang, Yanling; Luo, Wenli; Stetler, Ruth A; Leak, Rehana K; Yu, Weifeng; Gao, Yanqin; Chen, Jun; Chen, Gang; Hu, Xiaoming

2017-07-01

Delayed thrombolytic treatment with recombinant tissue plasminogen activator (tPA) may exacerbate blood-brain barrier breakdown after ischaemic stroke and lead to lethal haemorrhagic transformation. The immune system is a dynamic modulator of stroke response, and excessive immune cell accumulation in the cerebral vasculature is associated with compromised integrity of the blood-brain barrier. We previously reported that regulatory T cells, which function to suppress excessive immune responses, ameliorated blood-brain barrier damage after cerebral ischaemia. This study assessed the impact of regulatory T cells in the context of tPA-induced brain haemorrhage and investigated the underlying mechanisms of action. The number of circulating regulatory T cells in stroke patients was dramatically reduced soon after stroke onset (84 acute ischaemic stroke patients with or without intravenous tPA treatment, compared to 115 age and gender-matched healthy controls). Although stroke patients without tPA treatment gradually repopulated the numbers of circulating regulatory T cells within the first 7 days after stroke, post-ischaemic tPA treatment led to sustained suppression of regulatory T cells in the blood. We then used the murine suture and embolic middle cerebral artery occlusion models of stroke to investigate the therapeutic potential of adoptive regulatory T cell transfer against tPA-induced haemorrhagic transformation. Delayed administration of tPA (10 mg/kg) resulted in haemorrhagic transformation in the ischaemic territory 1 day after ischaemia. When regulatory T cells (2 × 106/mouse) were intravenously administered immediately after delayed tPA treatment in ischaemic mice, haemorrhagic transformation was significantly decreased, and this was associated with improved sensorimotor functions. Blood-brain barrier disruption and tight junction damages were observed in the presence of delayed tPA after stroke, but were mitigated by regulatory T cell transfer. Mechanistic

Croatian energy regulatory council - independent Croatian regulatory body

International Nuclear Information System (INIS)

Klepo, M.

2002-01-01

By means of approving five energy laws, the Republic of Croatia established an appropriate legislative framework for energy sector regulation. A series of sub-law acts is presently being elaborated as well as some additional documents in order to bring about transparent and non-discriminatory provisions for the establishment of electric energy, gas, oil/oil derivatives and thermal energy markets, i.e. for the introduction and management of market activities and public services. A considerable share of these activities relates to the definition of transparent regulatory mechanisms that would guarantee the implementation of regulation rules based on the law, and be carried out by the independent regulatory body - Croatian Energy Regulatory Council. The Council's rights and obligations include firm executive functions, which present obligations to every energy entity. A dissatisfied party may set in motion a settlement of dispute, if it maintains that the decisions are not based on the law or reveal a flaw in the procedure. Therefore, it is the Council's priority to always make careful and law-abiding decisions. This paper gives insight into the regulatory framework elements based on the laws including the Council's organisational structure and non-profit entities that will prepare act proposals for the Council and perform other professional activities. (author)

Regulatory Activities on Civil Nuclear Safety Equipment in China

International Nuclear Information System (INIS)

Gaoshang, Lu; Choi, Kwang Sik

2011-01-01

It is stipulated in IAEA Fundamental Safety Principles (SF1) that the fundamental safety objective is to protect people and the environment from harmful effects of ionizing radiation. The fundamental safety objective applies for all facilities and activities and for all stages over the lifetime of a facility or radiation source, including planning, sitting, design, manufacturing, construction, commissioning and operation, as well as decommissioning and closure. So, according to the requirement, the related activities such as design, manufacturing, installation and non-destructive test that conducted on civil nuclear equipment should be well controlled by the vendors, the owner of the nuclear power plants and the regulatory body. To insure the quality of those equipment, Chinese government had taken a series of measures to regulate the related activities on them

Redefining the transcriptional regulatory dynamics of classically and alternatively activated macrophages by deepCAGE transcriptomics

KAUST Repository

Roy, S.; Schmeier, S.; Arner, E.; Alam, Tanvir; Parihar, S. P.; Ozturk, M.; Tamgue, O.; Kawaji, H.; de Hoon, M. J. L.; Itoh, M.; Lassmann, T.; Carninci, P.; Hayashizaki, Y.; Forrest, A. R. R.; Bajic, Vladimir B.; Guler, R.; Consortium, F.; Brombacher, F.; Suzuki, H.

2015-01-01

Classically or alternatively activated macrophages (M1 and M2, respectively) play distinct and important roles for microbiocidal activity, regulation of inflammation and tissue homeostasis. Despite this, their transcriptional regulatory dynamics

Research and regulatory review

International Nuclear Information System (INIS)

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

1979-01-01

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

Regulatory inspection activities related to inspection planning, plant maintenance and assessment of safety. Proceedings of an international workshop

International Nuclear Information System (INIS)

Van Binnebeek, J.J.; Aubrey, Richard; Grandame, Melvyn; Aro, Ilari; Balloffet, Yves; Klonk, Hartmut; Manzella, Pietro; Koizumi, Hiroyoshi; Bouvrie, E.C. des; Forsberg, Staffan; Lang, Hans-Guenter; Mehew, Robert; Warren, Thomas; Woodhouse, Paul; Gallo, Robert M.; Campbell, Rob; )

1997-01-01

The NEA Committee on Nuclear Regulatory Activities (CNRA) believes that an essential factor in ensuring the safety of nuclear installations is the continuing exchange and analysis of technical information and data. To facilitate this exchange the Committee has established Working Groups and Groups of Experts in specialised topics. CNRA believes that safety inspections are a major element in the regulatory authority's efforts to ensure the safe operation of nuclear facilities. Considering the importance of these issues, the Committee has established a special Working Group on Inspection Practices (WGIP). The purpose of WGIP, is to facilitate the exchange of information and experience related to regulatory safety inspections between CNRA Member countries. This was the 3. international workshop held by the WGIP on regulatory inspection activities. The focus of this workshop was on 3 main topics; Inspection Planning, Plant Maintenance and Assessment of Safety. This document presents the proceedings from the workshop, including: workshop programme, results and conclusions, papers and presentations and the list of participants. The main purpose of the Workshop is to provide a forum of exchange of information on the regulatory inspection activities

Regulatory inspection activities related to inspection planning, plant maintenance and assessment of safety. Proceedings of an international workshop

Energy Technology Data Exchange (ETDEWEB)

Van Binnebeek, J. J. [AIB-Vincotte Nuclear - AVN, Avenue du Roi, 157, B-1060 Brussels (Belgium); Aubrey, Richard; Grandame, Melvyn [Atomic Energy Control Board - AECB, P.O. Box 1046, Station B, 280 Slater Street, Ottawa, Ontario K1P 5S9 (Canada); Aro, Ilari [Finnish Centre for Radiation and Nuclear Safety - STUK, P.O. Box 14, FIN-00881 Helsinki (Finland); Balloffet, Yves [DRIRE Rhone Alpes, 146, rue Pierre Corneille, 69426 Lyon CEDEX 03 (France); Klonk, Hartmut [Bundesamt fuer Strahlenschutz - BfS, Federal Office for Radiation Protection, Postbox 10 01 49, 38201 Salzgitter 1 (Germany); Manzella, Pietro [A.N.P.A., Via V. Brancati, 48, 1-00144 Roma EUR (Italy); Koizumi, Hiroyoshi [Tech. Stan. Dept. - JAPEIC, Shin-Toranomon Bldg., 1-5-11, Akasaka, Minato-ku, Tokyo 107 (Japan); Bouvrie, E.C. des [Ministry of Social Affairs and Employment, Nuclear Safety Dept. KFD, P.O. Box 90804, 2509 LV The Hague (Netherlands); Forsberg, Staffan [Swedish Nuclear Power Inspectorate - SKI, Klarabergsviadukten 90, S-10658 Stockholm (Sweden); Lang, Hans-Guenter [Section Plant Coordination and Inspection, Swiss Federal Nuclear Safety Inspectorate - HSK, CH-5232 Villigen-HSK (Switzerland); Mehew, Robert; Warren, Thomas; Woodhouse, Paul [Health and Safety Executive - NII, St. Peter' s House, Balliol Road, Bootle, Merseyside L20 3LZ (United Kingdom); Gallo, Robert M. [Special Inspection Branch, US Nuclear Regulatory Commission - US NRC, Mail Stop 0-9A1, Washington, DC 20555 (United States); Campbell, Rob [International Atomic Energy Agency - IAEA, P.O. Box 100, A-1400 Vienna (International Atomic Energy Agency (IAEA))

1997-07-01

The NEA Committee on Nuclear Regulatory Activities (CNRA) believes that an essential factor in ensuring the safety of nuclear installations is the continuing exchange and analysis of technical information and data. To facilitate this exchange the Committee has established Working Groups and Groups of Experts in specialised topics. CNRA believes that safety inspections are a major element in the regulatory authority's efforts to ensure the safe operation of nuclear facilities. Considering the importance of these issues, the Committee has established a special Working Group on Inspection Practices (WGIP). The purpose of WGIP, is to facilitate the exchange of information and experience related to regulatory safety inspections between CNRA Member countries. This was the 3. international workshop held by the WGIP on regulatory inspection activities. The focus of this workshop was on 3 main topics; Inspection Planning, Plant Maintenance and Assessment of Safety. This document presents the proceedings from the workshop, including: workshop programme, results and conclusions, papers and presentations and the list of participants. The main purpose of the Workshop is to provide a forum of exchange of information on the regulatory inspection activities.

Self-Regulatory Imagery and Physical Activity in Middle-Aged and Older Adults: A Social-Cognitive Perspective.

Science.gov (United States)

Kosteli, Maria-Christina; Cumming, Jennifer; Williams, Sarah E

2018-01-01

Limited research has investigated exercise imagery use in middle-aged and older adults and its relationship with affective and behavioral correlates. The study examined the association between self-regulatory imagery and physical activity (PA) through key social cognitive variables. Middle-aged and older adults (N = 299; M age = 59.73 years, SD = 7.73, range = 50 to 80) completed self-report measures assessing self-regulatory imagery use, self-efficacy, outcome expectations, perceived barriers, self-regulatory behavior, enjoyment, and PA levels. Path analysis supported a model (χ² [14] = 21.76, p = .08, CFI = .99, TLI = .97, SRMR = .03, RMSEA = .04) whereby self-regulatory imagery positively predicted self-efficacy, outcome expectations, and self-regulatory behaviors. Furthermore, self-regulatory imagery indirectly predicted barriers, outcome expectations, self-regulation, enjoyment, and PA. This research highlights self-regulatory imagery as an effective strategy in modifying exercise-related cognitions and behaviors. Incorporating social cognitive constructs into the design of imagery interventions may increase PA engagement.

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies.

Science.gov (United States)

Nguyen, Diane; Seoane-Vazquez, Enrique; Rodriguez-Monguio, Rosa; Montagne, Michael

2013-01-22

The United States (US) Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA) and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation) to pharmaceutical companies. A regulatory letter represents the FDA's first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA.This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997-2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total), followed by the Office of Scientific Investigations (131; 5.3%), and the Office of Compliance (105; 4.3%). During the 2nd Clinton Administration (1997-2000) the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001-2008) it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009-2011) it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by administration: Clinton (122.3 ± 36.4), Bush (29.5�

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Slovak Republic

International Nuclear Information System (INIS)

2013-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances and Equipment; 4. Nuclear Installations (Licensing and Inspection, including Nuclear Safety; Emergency Response); 5. Trade in Nuclear Materials and Equipment; 6. Radiological Protection; 7. Radioactive Waste Management; 8. Non-proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities (Nuclear Regulatory Authority of the Slovak Republic - UJD; Ministry of Health; Ministry of the Environment; Ministry of the Interior; Ministry of Economy; Ministry of Labour and National Labour Inspectorate); 2. Public and Semi-Public Agencies

Upgrading of regulatory activities in Belarus

International Nuclear Information System (INIS)

Rozdyalovskaya, L.F.; Shabanov, V.V.

1998-01-01

Upgrading of the National regulatory regime in the Republic of Belarus started in fact in 1992 after the Interregional Nuclear and Radiation Safety Inspectorate had been established in the Gostekhnadzor of Belarus. In this connection, the Gostekhnadzor was transformed into the Gospromatomnadzor - the State Committee for Supervision of Industrial and Nuclear Safety. In 1993, by special decrees issued by the Council of Ministers the Gospromatomnadzor was designated a National Competent Body responsible for nuclear materials. Now the Committee is part of the Ministry for Emergencies. In the Committee, the issues of nuclear and radiation safety are dealt with by 6 departments among which the Department for Nuclear and Radiation Safety Regulation and the Interregional Nuclear and Radiation Safety inspectorate play major role. The created regulatory structure makes it possible to fully perform the control of situation at nuclear- and radiation-hazardous facilities and take adequate measures aimed at strengthening their safety. The priority directions of regulatory work by the Promatomnadzor include development and revision of regulations governing radiation and nuclear safety and upgrading of the training procedure to enhance the radiation safety and technical knowledge of the Promatomnadzor staff. (author)

Knowledge Management Tools in Application to Regulatory Body Activity

International Nuclear Information System (INIS)

Volkov, E.

2016-01-01

Full text: The paper presents the application of knowledge management tools to regulatory authority activity. Knowledge management tools are considered a means for improving the efficiency of regulator activities. Three case studies are considered: 1. a knowledge management audit procedure in the regulator (tools for knowledge management audit application, results and the audit outcomes); 2. the development of a guide to identify causes of discrepancies and shortcomings revealed during inspections in NPP maintenance (ontologies of factors influencing on a maintenance quality and causes of discrepancies and shortcoming development); 3. the development of a knowledge portal for regulator (regulator needs which could be covered by the portal, definition and basic function of the portal, it’s functioning principles, development goals and tasks, common model, development stages). (author)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Luxembourg

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Framework: 1. General; 2. Mining; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency measures); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. General Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health; Minister of Labour; Other Ministers competent); 2. Advisory bodies (Higher Health Council)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Slovenia

International Nuclear Information System (INIS)

2013-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Safeguards for nuclear material; 7. Radiation protection; 8. Radioactive waste management; 9. Nuclear security; 10. Transport; 11. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Slovenian Nuclear Safety Administration - SNSA; Slovenian Radiation Protection Administration - SRPA); 2. Advisory bodies; 3. Public and semi-public agencies; 4. Technical support organisations - approved experts

Waste management regulatory compliance issues related to D ampersand D activities at Oak Ridge National Laboratory (ORNL)

International Nuclear Information System (INIS)

Hitch, J.P.; Arnold, S.E.; Burwinkle, T.; Daugherty, D.

1994-01-01

The waste management activities at ORNL related to the decontamination and decommissioning (D ampersand D) of radioactively contaminated buildings are divided into four categories: Operational facilities, inactive or surplus facilities, future facilities planning, and D ampersand D activities. This paper only discusses regulatory issues related to inactive or surplus facilities. Additionally, rather than attempting to address all resulting waste streams and related regulations, this paper highlights only a few of the ORNL waste streams that present key regulatory issues

Assessment of regulatory effectiveness. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

1999-09-01

This report arises from the seventh series of peer discussions on regulatory practices entitled 'Assessment of Regulatory Effectiveness'. The term 'regulatory effectiveness' covers the quality of the work and level of performance of a regulatory body. In this sense, regulatory effectiveness applies to regulatory body activities aimed at preventing safety degradation and ensuring that an acceptable level of safety is being maintained by the regulated operating organizations. In addition, regulatory effectiveness encompasses the promotion of safety improvements, the timely and cost effective performance of regulatory functions in a manner which ensures the confidence of the operating organizations, the general public and the government, and striving for continuous improvements to performance. Senior regulators from 22 Member States participated in two peer group discussions during March and May 1999. The discussions were focused on the elements of an effective regulatory body, possible indicators of regulatory effectiveness and its assessment. This report presents the outcome of these meetings and recommendations of good practices identified by senior regulators, which do not necessarily reflect those of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. In order to protect people and the environment from hazards associated with nuclear facilities, the main objective of a nuclear regulatory body is to ensure that a high level of safety in the nuclear activities under its jurisdiction is achieved, maintained and within the control of operating organizations. Even if it is possible to directly judge objective safety levels at nuclear facilities, such safety levels would not provide an exclusive indicator of regulatory effectiveness. The way the regulatory body ensures the safety of workers and the public and the way it discharges its responsibilities also determine its effectiveness. Hence the

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - New Zealand

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive Substances and Equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities - National Radiation Laboratory - NRL; 2. Advisory bodies - Radiation Protection Advisory Council; 3. Public and semi-public agencies - Research institutes

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.

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.

Functional and topological characteristics of mammalian regulatory domains

Science.gov (United States)

Symmons, Orsolya; Uslu, Veli Vural; Tsujimura, Taro; Ruf, Sandra; Nassari, Sonya; Schwarzer, Wibke; Ettwiller, Laurence; Spitz, François

2014-01-01

Long-range regulatory interactions play an important role in shaping gene-expression programs. However, the genomic features that organize these activities are still poorly characterized. We conducted a large operational analysis to chart the distribution of gene regulatory activities along the mouse genome, using hundreds of insertions of a regulatory sensor. We found that enhancers distribute their activities along broad regions and not in a gene-centric manner, defining large regulatory domains. Remarkably, these domains correlate strongly with the recently described TADs, which partition the genome into distinct self-interacting blocks. Different features, including specific repeats and CTCF-binding sites, correlate with the transition zones separating regulatory domains, and may help to further organize promiscuously distributed regulatory influences within large domains. These findings support a model of genomic organization where TADs confine regulatory activities to specific but large regulatory domains, contributing to the establishment of specific gene expression profiles. PMID:24398455

Changes in FDA enforcement activities following changes in federal administration: the case of regulatory letters released to pharmaceutical companies

Directory of Open Access Journals (Sweden)

Nguyen Diane

2013-01-01

Full Text Available Abstract Background The United States (US Food and Drug Administration (FDA is responsible for the protection of the public health by assuring the safety, effectiveness and security of human drugs and biological products through the enforcement of the Federal Food, Drug and Cosmetic Act (FDCA and related regulations. These enforcement activities include regulatory letters (i.e. warning letters and notice of violation to pharmaceutical companies. A regulatory letter represents the FDA’s first official notification to a pharmaceutical company that the FDA has discovered a product or activity in violation of the FDCA. This study analyzed trends in the pharmaceutical-related regulatory letters released by the FDA during the period 1997–2011 and assessed differences in the average number and type of regulatory letters released during the last four federal administrations. Methods Data derived from the FDA webpage. Information about the FDA office releasing the letter, date, company, and drug-related violation was collected. Regulatory letters were classified by federal administration. Descriptive statistics were performed for the analysis. Results Between 1997 and 2011 the FDA released 2,467 regulatory letters related to pharmaceuticals. FDA headquarters offices released 50.6% and district offices 49.4% of the regulatory letters. The Office of Prescription Drug Promotion released the largest number of regulatory letters (850; 34.5% of the total, followed by the Office of Scientific Investigations (131; 5.3%, and the Office of Compliance (105; 4.3%. During the 2nd Clinton Administration (1997–2000 the average number of regulatory letters per year was 242.8 ± 45.6, during the Bush Administration (2001–2008 it was 120.4 ± 33.7, and during the first three years of the Obama administration (2009–2011 it was 177.7.0 ± 17.0. The average number of regulatory letters released by the Office of Prescription Drug Promotion also varied by

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.

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

Regulatory difficulties in a developing country

International Nuclear Information System (INIS)

Jacobs, W.R. Jr.

1978-01-01

The regulatory agency assigned the task of regulating the initial entry into the field of nuclear power generation by a developing country has a very difficult job. Based on the authors' experience during the start-up and initial operation of Ko-Ri Unit I, the first power reactor in the Republic of Korea, observations on regulatory difficulties and recommendations for improved regulatory effectiveness are offered. The problem areas can be loosely grouped into three general categories: (1) Lack of adequate technical knowledge which is the basis for all effective regulation; (2) Difficulties with understanding and utilization of the required regulatory documentation; (3) Failure to establish the proper regulatory environment. Examples are cited from actual experience during the Ko-Ri Unit I start-up to demonstrate the impact that regulatory activities can have on a plant construction and testing programme. The problems encountered are not unique to developing countries but also exist in the United States of America. Recommendations are offered which should be beneficial to either newly formed regulatory agencies or agencies wishing to improve their abilities and effectiveness. These include: (1) Additional training of regulatory inspectors in plant operations; (2) Additional experience gained by participation in regulatory activities in other countries; (3) Increased attention given to regulatory documents, especially plant technical specifications; (4) Establishment of formal lines of communication between the utility and the regulatory agency; (5) Clear definition of regulatory responsibilities to avoid areas of overlapping jurisdiction; (6) Active participation by the regulatory staff very early in the project. It is hoped that these and other recommendations offered will greatly improve regulatory effectiveness and at the same time demonstrate that when the decision is made to 'go nuclear', a strong commitment must be made to develop and support a technically

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.

A balance of activity in brain control and reward systems predicts self-regulatory outcomes.

Science.gov (United States)

Lopez, Richard B; Chen, Pin-Hao A; Huckins, Jeremy F; Hofmann, Wilhelm; Kelley, William M; Heatherton, Todd F

2017-05-01

Previous neuroimaging work has shown that increased reward-related activity following exposure to food cues is predictive of self-control failure. The balance model suggests that self-regulation failures result from an imbalance in reward and executive control mechanisms. However, an open question is whether the relative balance of activity in brain systems associated with executive control (vs reward) supports self-regulatory outcomes when people encounter tempting cues in daily life. Sixty-nine chronic dieters, a population known for frequent lapses in self-control, completed a food cue-reactivity task during an fMRI scanning session, followed by a weeklong sampling of daily eating behaviors via ecological momentary assessment. We related participants' food cue activity in brain systems associated with executive control and reward to real-world eating patterns. Specifically, a balance score representing the amount of activity in brain regions associated with self-regulatory control, relative to automatic reward-related activity, predicted dieters' control over their eating behavior during the following week. This balance measure may reflect individual self-control capacity and be useful for examining self-regulation success in other domains and populations. © The Author (2017). Published by Oxford University Press.

Future nuclear regulatory challenges

International Nuclear Information System (INIS)

Royen, J.

1998-01-01

In December 1996, the NEA Committee on Nuclear Regulatory Activities concluded that changes resulting from economic deregulation and other recent developments affecting nuclear power programmes have consequences both for licensees and regulatory authorities. A number of potential problems and issues which will present a challenge to nuclear regulatory bodies over the next ten years have been identified in a report just released. (author)

Case law. Administrative decisions. National legislative and regulatory activities. International regulatory activities

International Nuclear Information System (INIS)

Anon.

2007-01-01

(Romania), act on administrative and property management of the civilian nuclear energy sector (Russian Federation), amendment of the atomic act (Slovak Republic), regulation on monitoring of radioactivity (Slovenia), regulations on the contents of the annual public report, regulations on the keeping of records, regulations on safety standards and regulatory practices (South Africa), amendment to the act and ordinance on nuclear activities (Sweden), council directive on the supervision and control of shipments of radioactive waste and spent fuel (European Union). (N.C.)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Ireland

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection (Radiation protection standards; Emergency response); 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister for the Environment, Heritage and Local Government; Minister for Agriculture and Food; Minister for Communications, Marine and Natural Resources; Minister for Finance; Minister for Health and Children; Minister for Defence); 2. Public and semi-public agencies (Radiological Protection Institute of Ireland; Food Safety Authority of Ireland)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Turkey

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Prime Minister; Ministry of Energy and Natural Resources; Ministry of Health; Ministry of the Environment and Forestry); 2. Public and semi-public agencies (Turkish Atomic Energy Authority - TAEK; General Directorate for Mineral Research and Exploration - MTA; ETI Mine Works General Management; Turkish Electric Generation and Transmission Corporation - TEAS; Turkish Electricity Distribution Corporation - TEDAS)

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

Combinatorial binding leads to diverse regulatory responses: Lmd is a tissue-specific modulator of Mef2 activity.

Directory of Open Access Journals (Sweden)

Paulo M F Cunha

2010-07-01

Full Text Available Understanding how complex patterns of temporal and spatial expression are regulated is central to deciphering genetic programs that drive development. Gene expression is initiated through the action of transcription factors and their cofactors converging on enhancer elements leading to a defined activity. Specific constellations of combinatorial occupancy are therefore often conceptualized as rigid binding codes that give rise to a common output of spatio-temporal expression. Here, we assessed this assumption using the regulatory input of two essential transcription factors within the Drosophila myogenic network. Mutations in either Myocyte enhancing factor 2 (Mef2 or the zinc-finger transcription factor lame duck (lmd lead to very similar defects in myoblast fusion, yet the underlying molecular mechanism for this shared phenotype is not understood. Using a combination of ChIP-on-chip analysis and expression profiling of loss-of-function mutants, we obtained a global view of the regulatory input of both factors during development. The majority of Lmd-bound enhancers are co-bound by Mef2, representing a subset of Mef2's transcriptional input during these stages of development. Systematic analyses of the regulatory contribution of both factors demonstrate diverse regulatory roles, despite their co-occupancy of shared enhancer elements. These results indicate that Lmd is a tissue-specific modulator of Mef2 activity, acting as both a transcriptional activator and repressor, which has important implications for myogenesis. More generally, this study demonstrates considerable flexibility in the regulatory output of two factors, leading to additive, cooperative, and repressive modes of co-regulation.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities. Japan

International Nuclear Information System (INIS)

2017-01-01

The NEA has updated, in coordination with the Permanent Delegation of Japan to the OECD, the report on the Regulatory and Institutional Framework for Nuclear Activities in Japan. This country report provides comprehensive information on the regulatory and institutional framework governing nuclear activities in Japan. It provides a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. Content: I - General Regulatory Regime: Introduction; Mining regime; Radioactive substances and equipment; Nuclear installations (Reactor Regulation, Emergency response); Trade in nuclear materials and equipment; Radiological protection; Radioactive waste management; Nuclear safeguards and nuclear security; Transport; Nuclear third party liability. II - Institutional Framework: Regulatory and supervisory authorities (Cabinet Office, Nuclear Regulation Authority (NRA), Ministry of Economy, Trade and Industry (METI), The Agency for Natural Resources and Energy (ANRE), Ministry of Land, Infrastructure, Transport and Tourism (MLIT), Ministry of Education, Culture, Sports, Science and Technology (MEXT)); Advisory bodies (Atomic Energy Commission (AEC), Reactor Safety Examination Committee, Nuclear Fuel Safety Examination Committee, Radiation Council, Other advisory bodies); Public and semi-public agencies (Japan Atomic Energy Agency (JAEA), National Institutes for Quantum and Radiological Science and Technology (QST), Nuclear Damage Compensation and Decommissioning Facilitation Corporation (NDF), Nuclear Waste Management Organisation (NUMO))

Human Epidermal Langerhans Cells Maintain Immune Homeostasis in Skin by Activating Skin Resident Regulatory T Cells

Science.gov (United States)

Seneschal, Julien; Clark, Rachael A.; Gehad, Ahmed; Baecher-Allan, Clare M.; Kupper, Thomas S.

2013-01-01

Recent discoveries indicate that the skin of a normal individual contains 10-20 billion resident memory T cells ( which include various T helper, T cytotoxic, and T regulatory subsets, that are poised to respond to environmental antigens. Using only autologous human tissues, we report that both in vitro and in vivo, resting epidermal Langerhan cells (LC) selectively and specifically induced the activation and proliferation of skin resident regulatory T cells (Treg), a minor subset of skin resident memory T cells. In the presence of foreign pathogen, however, the same LC activated and induced proliferation of effector memory T (Tem) cells and limited Treg cells activation. These underappreciated properties of LC: namely maintenance of tolerance in normal skin, and activation of protective skin resident memory T cells upon infectious challenge, help clarify the role of LC in skin. PMID:22560445

Probabilistic risk analysis and its role in regulatory activity in a developing country

International Nuclear Information System (INIS)

Arredondo-Sanchez, C.

1985-01-01

The author discusses the criterion adopted for regulatory activity in a developing country with a nuclear power plant. He describes the problems that have to be overcome as a result of changes in the regulations during construction of the plant. There is discussion of the action taken by the regulatory body when introducing the method of probabilistic risk analysis. The part played by this form of analysis in quantifying the safety objectives proposed in the USA together with its limitations and the problems involved in this methodology are examined. Lastly, the author gives an opinion on the use that probabilistic risk analysis should be put to in developing countries such as Mexico. (author)

Systematic identification of regulatory variants associated with cancer risk.

Science.gov (United States)

Liu, Song; Liu, Yuwen; Zhang, Qin; Wu, Jiayu; Liang, Junbo; Yu, Shan; Wei, Gong-Hong; White, Kevin P; Wang, Xiaoyue

2017-10-23

Most cancer risk-associated single nucleotide polymorphisms (SNPs) identified by genome-wide association studies (GWAS) are noncoding and it is challenging to assess their functional impacts. To systematically identify the SNPs that affect gene expression by modulating activities of distal regulatory elements, we adapt the self-transcribing active regulatory region sequencing (STARR-seq) strategy, a high-throughput technique to functionally quantify enhancer activities. From 10,673 SNPs linked with 996 cancer risk-associated SNPs identified in previous GWAS studies, we identify 575 SNPs in the fragments that positively regulate gene expression, and 758 SNPs in the fragments with negative regulatory activities. Among them, 70 variants are regulatory variants for which the two alleles confer different regulatory activities. We analyze in depth two regulatory variants-breast cancer risk SNP rs11055880 and leukemia risk-associated SNP rs12142375-and demonstrate their endogenous regulatory activities on expression of ATF7IP and PDE4B genes, respectively, using a CRISPR-Cas9 approach. By identifying regulatory variants associated with cancer susceptibility and studying their molecular functions, we hope to help the interpretation of GWAS results and provide improved information for cancer risk assessment.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Poland

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Licensing; Registration and monitoring of nuclear materials and radioactive sources; High activity sources); 4. Nuclear facilities (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiological protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (The President of the National Atomic Energy Agency - Prezes Panstwowej Agencji Atomistyki (President of the PAA); Minister of Health; Minister of the Environment); 2. Advisory bodies (Council for Nuclear Safety and Radiological Protection); 3. Public and semi-public bodies (Radioactive Waste Management Plant); 4. Research institutes (Central Laboratory for Radiological Protection; National Centre for Nuclear Research; Institute of Nuclear Physics; Institute of Nuclear Chemistry and Technology; Institute of Plasma Physics and Laser Microfusion)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Finland

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations; (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Trade and Industry - KTM; Ministry of Social Affairs and Health; Ministry of the Interior; Ministry of the Environment; Ministry of Foreign Affairs); 2. Advisory bodies (Advisory Committee on Nuclear Energy; Advisory Committee on Nuclear Safety); 3. Public and semi-public agencies (Finnish Radiation and Nuclear Safety Authority - STUK; State Nuclear Waste Management Fund)

Information management systems for integrating the technical data and regulatory requirements of environmental restoration activities

International Nuclear Information System (INIS)

Geffen, C.A.; Garrett, B.A.; Walter, M.B.

1990-03-01

Current environmental regulations require that comprehensive planning be conducted before remediating a hazardous waste site to characterize the nature and extent of site contamination, calculate the risk to the public, and assess the effectiveness of various remediation technologies. Remediation of Department of Energy (DOE) sites contaminated with hazardous or mixed wastes will require the effective integration of scientific and engineering data with regulatory and institutional requirements. The information management challenge presented by waste site cleanup activities goes beyond merely dealing with the large quantity of data that will be generated. The information must be stored, managed, and presented in a way that provides some consistency in approach across sites, avoids duplication of effort, and facilitates responses to requests for information from the regulators and the public. This paper provides background information on the regulatory requirements for data gathering and analysis for environmental restoration activities, and outlines the data and information management requirements for completing the pre-remediation phases of an environmental restoration project. Information management systems for integrating the regulatory and institutional requirements of the environmental restoration process with the technical data and analysis requirements are also described. 7 refs

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Portugal

International Nuclear Information System (INIS)

2011-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Health; Minister of Science, Technology and Higher Education; Ministry of Economy and Innovation; Ministry of Environment and Territorial Planning; Other authorities); 2. Advisory bodies (Independent Commission for Radiological Protection and Nuclear Safety - CIPRSN; National Radiation Protection Commission - CNPCR; National Commission for Radiological Emergencies - CNER; Other advisory bodies); 3. Public and semi-public agencies

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Mexico

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; 11. Nuclear terrorism; II. Institutional Framework - The federal government: 1. Regulatory and supervisory authorities (Ministry of Energy; Ministry of Health; Ministry of Labour and Social Security; Ministry of the Environment and Natural Resources; Ministry of Communications and Transport); 2. Public and semi-public agencies: (National Nuclear Safety and Safeguards Commission; National Nuclear Research Institute)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Japan

International Nuclear Information System (INIS)

2011-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Cabinet Office; Minister of Economy, Trade and Industry - METI; Minister of Land, Infrastructure and Transport - MLIT; Minister of Education, Culture, Sports, Science and Technology - MEXT); 2. Advisory bodies (Atomic Energy Commission - AEC; Nuclear Safety Commission - NSC; Radiation Council; Special Committee on Energy Policy; Other advisory bodies); 3. Public and Semi-Public Agencies (Japan Atomic Energy Agency - JAEA)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Denmark

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Health; Minister for the Environment/Minister of Transport and Energy; Minister of Justice; Minister of Defence; National Board of Health; Emergency Management Agency); 2. Advisory bodies (The Danish Ministry of Energy, Supply and Climate and the Danish Energy Agency); 3. Public and semi-public agencies (Risoe National Laboratory)

THE ROLE OF SELF-REGULATORY AUDITING ASSOCIATIONS IN ARRANGEMENT OF AUDIT ACTIVITIES QUALITY CONTROL

Directory of Open Access Journals (Sweden)

Zinaida P. Arharova

2013-01-01

Full Text Available The role of self-regulatory organizations in audit activities quality control is revealed in this article. Creation of a united audit association is the basis of certain regulating and auditing functions transfer from the government to the public sector.

Phenotype specific analyses reveal distinct regulatory mechanism for chronically activated p53.

Directory of Open Access Journals (Sweden)

Kristina Kirschner

2015-03-01

Full Text Available The downstream functions of the DNA binding tumor suppressor p53 vary depending on the cellular context, and persistent p53 activation has recently been implicated in tumor suppression and senescence. However, genome-wide information about p53-target gene regulation has been derived mostly from acute genotoxic conditions. Using ChIP-seq and expression data, we have found distinct p53 binding profiles between acutely activated (through DNA damage and chronically activated (in senescent or pro-apoptotic conditions p53. Compared to the classical 'acute' p53 binding profile, 'chronic' p53 peaks were closely associated with CpG-islands. Furthermore, the chronic CpG-island binding of p53 conferred distinct expression patterns between senescent and pro-apoptotic conditions. Using the p53 targets seen in the chronic conditions together with external high-throughput datasets, we have built p53 networks that revealed extensive self-regulatory 'p53 hubs' where p53 and many p53 targets can physically interact with each other. Integrating these results with public clinical datasets identified the cancer-associated lipogenic enzyme, SCD, which we found to be directly repressed by p53 through the CpG-island promoter, providing a mechanistic link between p53 and the 'lipogenic phenotype', a hallmark of cancer. Our data reveal distinct phenotype associations of chronic p53 targets that underlie specific gene regulatory mechanisms.

Regulatory behavior and frontal activity: Considering the role of revised-BIS in relative right frontal asymmetry.

Science.gov (United States)

Gable, Philip A; Neal, Lauren B; Threadgill, A Hunter

2018-01-01

Essential to human behavior are three core personality systems: approach, avoidance, and a regulatory system governing the two motivational systems. Decades of research has linked approach motivation with greater relative left frontal-cortical asymmetry. Other research has linked avoidance motivation with greater relative right frontal-cortical asymmetry. However, past work linking withdrawal motivation with greater relative right frontal asymmetry has been mixed. The current article reviews evidence suggesting that activation of the regulatory system (revised Behavioral Inhibition System [r-BIS]) may be more strongly related to greater relative right frontal asymmetry than withdrawal motivation. Specifically, research suggests that greater activation of the r-BIS is associated with greater relative right frontal activity, and reduced r-BIS activation is associated with reduced right frontal activity (greater relative left frontal activity). We review evidence examining trait and state frontal activity using EEG, source localization, lesion studies, neuronal stimulation, and fMRI supporting the idea that r-BIS may be the core personality system related to greater relative right frontal activity. In addition, the current review seeks to disentangle avoidance motivation and r-BIS as substrates of relative right frontal asymmetry. © 2017 Society for Psychophysiological Research.

Annual Report 2013. 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 seven parts and eight annexes the activities developed by the organism during 2013. 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 has annexes with the following content: regulatory documents; inspections to medical; presentations of publications from ARN staff; measurement and evaluation of the drinking water of Ezeiza; international expert report on the implementation of international standards on radiation protection in the Ezeiza Atomic Center; Code of Ethics of the Nuclear Regulatory Authority.

Guidelines for IAEA International Regulatory Review Teams (IRRTs)

International Nuclear Information System (INIS)

1993-04-01

This document is intended to be used by International regulatory review teams in reviewing the activities of a regulatory body as applicable to the regulation of nuclear power plants. The mission will, however, take note of any other activities of the regulatory body when drawing up the review report. The document does not specifically deal with the functions of a regulatory body responsible for other types of nuclear facilities or related nuclear activities, but it is intended that the concepts presented in the document could be applied where appropriate. Refs

Heterogeneous but “Standard” Coding Systems for Adverse Events: Issues in Achieving Interoperability between Apples and Oranges

Science.gov (United States)

Richesson, Rachel L.; Fung, Kin Wah; Krischer, Jeffrey P.

2008-01-01

Monitoring adverse events (AEs) is an important part of clinical research and a crucial target for data standards. The representation of adverse events themselves requires the use of controlled vocabularies with thousands of needed clinical concepts. Several data standards for adverse events currently exist, each with a strong user base. The structure and features of these current adverse event data standards (including terminologies and classifications) are different, so comparisons and evaluations are not straightforward, nor are strategies for their harmonization. Three different data standards - the Medical Dictionary for Regulatory Activities (MedDRA) and the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) terminologies, and Common Terminology Criteria for Adverse Events (CTCAE) classification - are explored as candidate representations for AEs. This paper describes the structural features of each coding system, their content and relationship to the Unified Medical Language System (UMLS), and unsettled issues for future interoperability of these standards. PMID:18406213

Experience and regulatory activities on advanced instrumentation and control systems applied to nuclear power plants in Korea

International Nuclear Information System (INIS)

Kim, B.R.

1995-01-01

This paper describes the status for applying microprocessor-based systems to nuclear power plants in Korea and the regulatory activities performed by Korea Institute of Nuclear Safety (KINS). And this presents the development of safety and regulatory technology for advanced I and C systems that has been carried out as a part of the next generation reactor development program in Korea. (author). 3 refs, 4 figs, 1 tab

Regulatory support activities of JNES by thermal-hydraulic and safety analyses

International Nuclear Information System (INIS)

Kasahara, Fumio

2008-01-01

Current status and some related topics on regulatory support activities of Japan Nuclear Energy Safety Organization (JNES) by thermal-hydraulic and safety analyses are reported. The safety of nuclear facilities is secured primarily by plant owners and operators. However, the regulatory body NISA (Nuclear and Industrial Safety Agency) has conducted a strict regulation to confirm the adequacy of the site condition as well as the basic and detailed design. The JNES has been conducting independent analyses from applicants (audit analyses, etc.) by direction of NISA and supporting its review. In addition to the audit analysis, thermal-hydraulic and safety analyses are used in such areas as analytical evaluation for investigation of causes of accidents and troubles, level 2 PSA for risk informed regulation, etc. Recent activities of audit analyses are for the application of Tsuruga 3 and 4 (APWR), the spent fuel storage facility for the establishment, and the LMFBR Monju for the core change. For the trouble event evaluation, the criticality accident analysis of Sika1 was carried out and the evaluation of effectiveness of accident management (AM) measure for Tomari 3 (PWR) and Monju was performed. The analytical codes for these evaluations are continuously revised by reflecting the state-of-art technical information and validated using the information provided by the data from JAEA, OECD project, etc. (author)

Overview of maintenance principles and regulatory supervision of maintenance activities at nuclear power plants in Slovakia

International Nuclear Information System (INIS)

Rohar, S.; Cepcek, S.

1997-01-01

The maintenance represents one of the most important tools to ensure safe and reliable operation of nuclear power plants. The emphasis of Nuclear Regulatory Authority of the Slovak Republic to the maintenance issue is expressed by requirements in the regulations. The current practice of maintenance management in operated nuclear power plants in Slovak Republic is presented. Main aspects of maintenance, as maintenance programme, organization of maintenance, responsibilities for maintenance are described. Activities of nuclear regulatory authority in maintenance process are presented too. (author)

The conduct of regulatory activities

International Nuclear Information System (INIS)

Wright, H.A.

1975-01-01

The main emphasis is placed on the legal responsibility of the utility in UK to build and operate its plant to avoid any nuclear hazard. The regulatory practices have endeavoured to inculcate a proper emphasis towards safety by the people who comprise the management of the utility, and to avoid any erosion of their legal responsibility as the best and possibly only practical means to achieve adequate safety standards. (orig./HP) [de

WAVE regulatory complex activation by cooperating GTPases Arf and Rac1

DEFF Research Database (Denmark)

Koronakis, Vassilis; Hume, Peter J; Humphreys, Daniel

2011-01-01

The WAVE regulatory complex (WRC) is a critical element in the control of actin polymerization at the eukaryotic cell membrane, but how WRC is activated remains uncertain. While Rho GTPase Rac1 can bind and activate WRC in vitro, this interaction is of low affinity, suggesting other factors may...... be important. By reconstituting WAVE-dependent actin assembly on membrane-coated beads in mammalian cell extracts, we found that Rac1 was not sufficient to engender bead motility, and we uncovered a key requirement for Arf GTPases. In vitro, Rac1 and Arf1 were individually able to bind weakly to recombinant...... be central components in WAVE signalling, acting directly, alongside Rac1....

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

International Nuclear Information System (INIS)

2016-01-01

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

TU-AB-204-00: CDRH/FDA Regulatory Processes and Device Science Activities

Energy Technology Data Exchange (ETDEWEB)

NONE

2016-06-15

The responsibilities of the Food and Drug Administration (FDA) have increased since the inception of the Food and Drugs Act in 1906. Medical devices first came under comprehensive regulation with the passage of the 1938 Food, Drug, and Cosmetic Act. In 1971 FDA also took on the responsibility for consumer protection against unnecessary exposure to radiation-emitting devices for home and occupational use. However it was not until 1976, under the Medical Device Regulation Act, that the FDA was responsible for the safety and effectiveness of medical devices. This session will be presented by the Division of Radiological Health (DRH) and the Division of Imaging, Diagnostics, and Software Reliability (DIDSR) from the Center for Devices and Radiological Health (CDRH) at the FDA. The symposium will discuss on how we protect and promote public health with a focus on medical physics applications organized into four areas: pre-market device review, post-market surveillance, device compliance, current regulatory research efforts and partnerships with other organizations. The pre-market session will summarize the pathways FDA uses to regulate the investigational use and commercialization of diagnostic imaging and radiation therapy medical devices in the US, highlighting resources available to assist investigators and manufacturers. The post-market session will explain the post-market surveillance and compliance activities FDA performs to monitor the safety and effectiveness of devices on the market. The third session will describe research efforts that support the regulatory mission of the Agency. An overview of our regulatory research portfolio to advance our understanding of medical physics and imaging technologies and approaches to their evaluation will be discussed. Lastly, mechanisms that FDA uses to seek public input and promote collaborations with professional, government, and international organizations, such as AAPM, International Electrotechnical Commission (IEC

Future nuclear regulatory challenges. A report by the NEA Committee on Nuclear Regulatory Activities

International Nuclear Information System (INIS)

1998-01-01

Future challenges are considered that may arise from technical, socio-economic and political issues; organizational, management and human aspects; and international issues. The perceived challenges have been grouped into four categories, each covered by a chapter. Technical issues are addressed that many present regulatory challenges in the future: ageing nuclear power plants. External changes to industry are considered next that have an effect on regulators, privatization, cost reduction consequences, commercialization etc. It is followed by the impacts of internal changes: organizational, managerial, human-resources, licensing, staff training etc. Finally, international issues are discussed with potential regulatory impact. (R.P.)

The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2011

International Nuclear Information System (INIS)

2012-05-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2011 is presented. These activities are reported under the headings: Foreword; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Nuclear Materials in SR; (5) Nuclear materials and physical protection of nuclear materials; (6) Scope of powers of the office building; (7) Emergency planning and preparedness; (8) International activities; (9) Public communication; (10) Nuclear Regulatory Authority of the Slovak Republic; (11) UJD SR organization chart; The International Nuclear Event Scale (INES); (12) Abbreviations.

A balance of activity in brain control and reward systems predicts self-regulatory outcomes

OpenAIRE

Lopez, Richard B.; Chen, Pin-Hao A.; Huckins, Jeremy F.; Hofmann, Wilhelm; Kelley, William M.; Heatherton, Todd F.

2017-01-01

Abstract Previous neuroimaging work has shown that increased reward-related activity following exposure to food cues is predictive of self-control failure. The balance model suggests that self-regulation failures result from an imbalance in reward and executive control mechanisms. However, an open question is whether the relative balance of activity in brain systems associated with executive control (vs reward) supports self-regulatory outcomes when people encounter tempting cues in daily lif...

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Norway

International Nuclear Information System (INIS)

2001-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances, Nuclear Fuel and Equipment; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in Nuclear Materials and Equipment (Trade governed by nuclear energy legislation; Trade governed by radiation protection legislation; Trade governed by export/import control legislation); 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities: A. Ministerial Level (Ministry of Health and Social Affairs; Ministry of Trade and Industry; Ministry of Foreign Affairs; Other Ministries); B. Subsidiary Level: (The Norwegian Radiation Protection Authority - NRPA; The Norwegian Nuclear Emergency Organisation); 2. Public and Semi-Public Agencies - Institute for Energy Technology - IFE

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

International Nuclear Information System (INIS)

2012-01-01

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

Regulatory effects of fisetin on microglial activation.

Science.gov (United States)

Chuang, Jing-Yuan; Chang, Pei-Chun; Shen, Yi-Chun; Lin, Chingju; Tsai, Cheng-Fang; Chen, Jia-Hong; Yeh, Wei-Lan; Wu, Ling-Hsuan; Lin, Hsiao-Yun; Liu, Yu-Shu; Lu, Dah-Yuu

2014-06-26

Increasing evidence suggests that inflammatory processes in the central nervous system that are mediated by microglial activation play a key role in neurodegeneration. Fisetin, a plant flavonol commonly found in fruits and vegetables, is frequently added to nutritional supplements due to its antioxidant properties. In the present study, treatment with fisetin inhibited microglial cell migration and ROS (reactive oxygen species) production. Treatment with fisetin also effectively inhibited LPS plus IFN-γ-induced nitric oxide (NO) production, and inducible nitric oxide synthase (iNOS) expression in microglial cells. Furthermore, fisetin also reduced expressions of iNOS and NO by stimulation of peptidoglycan, the major component of the Gram-positive bacterium cell wall. Fisetin also inhibited the enhancement of LPS/IFN-γ- or peptidoglycan-induced inflammatory mediator IL (interlukin)-1 β expression. Besides the antioxidative and anti-inflammatory effects of fisetin, our study also elucidates the manner in fisetin-induced an endogenous anti-oxidative enzyme HO (heme oxygenase)-1 expression. Moreover, the regulatory molecular mechanism of fisetin-induced HO-1 expression operates through the PI-3 kinase/AKT and p38 signaling pathways in microglia. Notably, fisetin also significantly attenuated inflammation-related microglial activation and coordination deficit in mice in vivo. These findings suggest that fisetin may be a candidate agent for the development of therapies for inflammation-related neurodegenerative diseases.

Regulatory Effects of Fisetin on Microglial Activation

Directory of Open Access Journals (Sweden)

Jing-Yuan Chuang

2014-06-01

Full Text Available Increasing evidence suggests that inflammatory processes in the central nervous system that are mediated by microglial activation play a key role in neurodegeneration. Fisetin, a plant flavonol commonly found in fruits and vegetables, is frequently added to nutritional supplements due to its antioxidant properties. In the present study, treatment with fisetin inhibited microglial cell migration and ROS (reactive oxygen species production. Treatment with fisetin also effectively inhibited LPS plus IFN-γ-induced nitric oxide (NO production, and inducible nitric oxide synthase (iNOS expression in microglial cells. Furthermore, fisetin also reduced expressions of iNOS and NO by stimulation of peptidoglycan, the major component of the Gram-positive bacterium cell wall. Fisetin also inhibited the enhancement of LPS/IFN-γ- or peptidoglycan-induced inflammatory mediator IL (interlukin-1 β expression. Besides the antioxidative and anti-inflammatory effects of fisetin, our study also elucidates the manner in fisetin-induced an endogenous anti-oxidative enzyme HO (heme oxygenase-1 expression. Moreover, the regulatory molecular mechanism of fisetin-induced HO-1 expression operates through the PI-3 kinase/AKT and p38 signaling pathways in microglia. Notably, fisetin also significantly attenuated inflammation-related microglial activation and coordination deficit in mice in vivo. These findings suggest that fisetin may be a candidate agent for the development of therapies for inflammation-related neurodegenerative diseases.

Regulatory inspection of nuclear facilities and enforcement by the regulatory body. Safety guide

International Nuclear Information System (INIS)

2002-01-01

The purpose of this Safety Guide is to provide recommendations for regulatory bodies on the inspection of nuclear facilities, regulatory enforcement and related matters. The objective is to provide the regulatory body with a high level of confidence that operators have the processes in place to ensure compliance and that they do comply with legal requirements, including meeting the safety objectives and requirements of the regulatory body. However, in the event of non-compliance, the regulatory body should take appropriate enforcement action. This Safety Guide covers regulatory inspection and enforcement in relation to nuclear facilities such as: enrichment and fuel manufacturing plants; nuclear power plants; other reactors such as research reactors and critical assemblies; spent fuel reprocessing plants; and facilities for radioactive waste management, such as treatment, storage and disposal facilities. This Safety Guide also covers issues relating to the decommissioning of nuclear facilities, the closure of waste disposal facilities and site rehabilitation. Section 2 sets out the objectives of regulatory inspection and enforcement. Section 3 covers the management of regulatory inspections. Section 4 covers the performance of regulatory inspections, including internal guidance, planning and preparation, methods of inspection and reports of inspections. Section 5 deals with regulatory enforcement actions. Section 6 covers the assessment of regulatory inspections and enforcement activities. The Appendix provides further details on inspection areas for nuclear facilities

Self-discrepancy and regulatory fit in avatar-based exergames.

Science.gov (United States)

Jin, Seung-A Annie

2012-12-01

Drawing from Higgins's self-discrepancy theory and regulatory focus theory, this study examined the use of activated selves and regulatory foci in health games. Utilizing the Wii's avatar-creating and exergaming features, a 2 (activated self: actual self versus ideal self) x 2 (regulatory focus: promotion versus prevention) x 2 (efficacy appeals: self-efficacy versus response-efficacy) between-subjects experiment tested the interactions of activated selves, regulatory foci, and efficacy appeals on low-calorie dieting intentions after health game playing. Results from an experiment with 156 participants demonstrated that a fit between regulatory focus and efficacy appeals induced greater dieting intentions when the actual self was activated while the opposite effect occurred when the ideal self was activated. Theoretical contributions to basic and applied social psychology as well as managerial implications for consumer behavior research are considered.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Sweden

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects (The Environmental Code, Environmental impact statement, Permit under the Environmental Code)); 5. Trade in nuclear materials and equipment; 6. Radiological protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability (The Nuclear Liability Act; Chernobyl legislation); II. Institutional Framework: 1. Ministries with responsibilities concerning nuclear activities (Ministry of the Environment; Ministry of Enterprise, Energy and Communications; Ministry of Justice; Ministry of Foreign Affairs); 2. Swedish Radiation Safety Authority

Evaluation of the safety culture in the regulatory activity in Camaguey province

International Nuclear Information System (INIS)

Naranjo Lopez, A.M.; Barreras Caballero, A.; Damera Martinez, A.

1999-01-01

Previous studied accomplished in the country have permitted to evaluate the activity of the regulatory body in nuclear safety matter in part of the national territory. These studies did not encompass the Camaguey province. In the work are shown the results of the study in this part of the territory, accomplished as of the survey elaborated by the National Nuclear Safety Center using guides it ASCOT and other documents of the IAEA

A study on the influence of the regulatory requirements of a nuclear facility during decommissioning activities

Energy Technology Data Exchange (ETDEWEB)

Park, Hee Seong; Park, Seung Kook; Park, Kook Nam; Hong, Yun Jeong; Park, Jang Jin; Choi, Jong Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

2016-10-15

The preliminary decommissioning plan should be written with various chapters such as a radiological characterization, a decommissioning strategy and methods, a design for decommissioning usability, a safety evaluation, decontamination and dismantling activities, radioactive waste management, an environmental effect evaluation, and fire protection. The process requirements of the decommissioning project and the technical requirements and technical criteria should comply with regulatory requirements when dismantling of a nuclear facility. The requirements related to safety in the dismantling of a nuclear facility refer to the IAEA safety serious. The present paper indicates that a decommissioning design and plan, dismantling activities, and a decommissioning project will be influenced by the decommissioning regulatory requirements when dismantling of a nuclear facility. We hereby paved the way to find the effect of the regulatory requirements on the decommissioning of a whole area from the decommissioning strategy to the radioactive waste treatment when dismantling a nuclear facility. The decommissioning requirements have a unique feature in terms of a horizontal relationship as well as a vertical relationship from the regulation requirements to the decommissioning technical requirements. The decommissioning requirements management will be conducted through research that can recognize a multiple relationship in the next stage.

Physical Activity in the Transition to University: The Role of Past Behavior and Concurrent Self-Regulatory Efficacy

Science.gov (United States)

Crozier, Alyson J.; Gierc, Madelaine S. H.; Locke, Sean R.; Brawley, Lawrence R.

2015-01-01

Objective: Two studies were conducted to examine the relationship between past physical activity, concurrent self-regulatory efficacy (CSRE), and current physical activity during the transition to university. Participants: Study 1 included 110 first-year undergraduate students recruited during October/November of 2012. Study 2 involved 86…

Annual Report 2010. 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 six chapters and seven annexes the activities developed by the organism during 2010. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

Annual Report 2011. Nuclear Regulatory Authority

International Nuclear Information System (INIS)

2011-01-01

The present Annual Report of Activities of the Nuclear Regulatory Authority (ARN), prepared regularly from the creation as independent institution, describes across six chapters and seven annexes the activities developed by the organism during 2011. The main topic are: institutional issues; regulatory guides and standards; argentinean nuclear regulatory system; quality assurance of the ARN; the institutional communications; the licensing and inspection of nuclear power plants and critical facilities; the emergency systems; the safeguards and the physical protection; the environmental control; the institutional relations; the training and the public information. Also, this publication have annexes with the following content: the regulatory framework; regulatory documents; inspections to medical, industrial and training installations; measurement and evaluation of the drinking water of Ezeiza; international expert's report on the application of the international standards of radiological protection of the public in the zone of the Ezeiza Atomic Center; ethical code

Perampanel with concomitant levetiracetam and topiramate: Post hoc analysis of adverse events related to hostility and aggression.

Science.gov (United States)

Chung, Steve; Williams, Betsy; Dobrinsky, Cindy; Patten, Anna; Yang, Haichen; Laurenza, Antonio

2017-10-01

In 4 Phase III registration trials (3 in patients with partial seizures, N=1480; 1 in patients with PGTCS, N=163), perampanel administered to patients already receiving 1-3 concomitant antiepileptic drugs (AEDs) demonstrated statistically superior efficacy compared to placebo in reducing seizure frequency. However, use of perampanel in these studies was associated with a risk of psychiatric and behavioral adverse reactions, including aggression, hostility, irritability, anger, and homicidal ideation and threats. The present study is a post hoc analysis of pooled data from these 4 trials to determine if concomitant treatment with levetiracetam and/or topiramate increased the risk of hostility- and aggression-related AEs. Treatment-emergent AEs (TEAEs) were determined using a "Narrow & Broad" search based on the Medical Dictionary for Regulatory Activities (MedDRA) standard MedDRA query (SMQ) for hostility- and aggression-related events. The rate of hostility- and aggression-related TEAEs was observed to be similar among perampanel-treated patients: a) receiving levetiracetam (N=340) compared to those not receiving levetiracetam (N=779); b) receiving topiramate (N=223) compared to those not receiving topiramate (N=896); and c) receiving both levetiracetam and topiramate (N=47) compared to those not receiving levetiracetam and topiramate (N=1072). Severe and serious TEAEs related to hostility and aggression were rare and occurred at a similar rate regardless of concomitant levetiracetam and/or topiramate therapy. Taken together, these results suggest that concomitant treatment with levetiracetam and/or topiramate has no appreciable effect on the occurrence of hostility- or aggression-related TEAEs in patients receiving perampanel. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

78 FR 54502 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2013-09-04

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of a Proposed Rule... Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or ``Commission... or manipulative motivation for the trading activity at issue.\\4\\ Specifically, proposed Supplementary...

REFORM OF REGULATORY POLICY IN THE FIELD OF SUPERVISION OF AUDIT ACTIVITY

Directory of Open Access Journals (Sweden)

Iryna Kantsir

2017-12-01

Full Text Available Reforming the regulatory system and supervision of audit activity in Ukraine is a basic condition for Ukraine’s accession to the European Community, and the introduction of international standards in the field of audit and supervision of audit activity and quality assurance of audit services should be correlated with the standards of European and world audit practice. The dominant factor in the effective functioning of independent control is the choice of a model of supervision of the mechanism for its implementation; effectiveness of the system of monitoring the quality of audit services; effectiveness of legal and regulatory framework of audit activity. The regulation of audit activity is to coordinate direct and indirect actions aimed at the subject of audit activity with the purpose of ensuring the quality of audit services and minimizing the level of audit risk. The purpose of the research is: analysis of the basic models of regulation of audit activity aimed at improving the legal regulation of economic relations in general and subjects of audit activity in particular. Determination of expediency of implementation of public oversight as monitoring of the process of implementation of audit activity in the context of granting the right to conduct audit activities to individuals, implementation of standards of professional ethics and quality control of audit services, permanence of education and imposing sanctions for non-compliance by auditors with the requirements of the current legislation. Method (methodology. In the process of research, general scientific and special methods of scientific knowledge are used: abstract-logical (in the disclosure of theoretical and methodological foundations of public oversight; synthesis and system analysis (substantiation of the essential characteristics of the system of public oversight; system analysis and theoretical generalization (definition of institutional prerequisites for the introduction of

Status on the regulatory aspects in NORM/TENORM activities and waste in Malaysia

International Nuclear Information System (INIS)

Hassan, Hasmadi

2005-01-01

In Malaysia, waste associated with TENORM are generated mostly in the tin mining and smelting, processing of minerals, and oil and gas industry. As one of a major tin producer in the world and the country current activities in oil production, the amount of waste generated in this kind of activities is quite substantial. Currently the government of Malaysia did not provide any provision in the law specifically for the exclusion of TENORM waste, however, the government did imposed the criteria for exclusion of this waste by adopting the guideline limit established by the IAEA safety series 26, which is very vital for the regulatory body i.e. Atomic Energy Licensing Board (AELB) to overcome the problems in managing some of waste related to TENORM industries. As one example, this guideline has been applied to one of the mineral processing industries in the country on decommissioning and disposing of their waste. Furthermore, due to economic reason and price of tin and its by-product is not viable and profitable so much, making this industry not significant in business and trade industries, several practices have been exempted from the regulatory control under the Atomic Energy Licensing Act, 1984. (author)

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

78 FR 68893 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Science.gov (United States)

2013-11-15

... that the size of the BBO equals the minimum quote size. Number of market makers actively quoting...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Extend the Tier Size Pilot of FINRA Rule 6433 (Minimum Quotation Size...

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...

Activation of counter-regulatory mechanisms in a rat renal acute rejection model

Directory of Open Access Journals (Sweden)

Salomon Daniel R

2008-02-01

Full Text Available Abstract Background Microarray analysis provides a powerful approach to identify gene expression alterations following transplantation. In patients the heterogeneity of graft specimens, co-morbidity, co-medications and the challenges in sample collection and preparation complicate conclusions regarding the underlying mechanisms of graft injury, rejection and immune regulation. Results We used a rat kidney transplantation model with strict transplant and sample preparation procedures to analyze genome wide changes in gene expression four days after syngeneic and allogeneic transplantation. Both interventions were associated with substantial changes in gene expression. After allogeneic transplantation, genes and pathways related to transport and metabolism were predominantly down-regulated consistent with rejection-mediated graft injury and dysfunction. Up-regulated genes were primarily related to the acute immune response including antigen presentation, T-cell receptor signaling, apoptosis, interferon signaling and complement cascades. We observed a cytokine and chemokine expression profile consistent with activation of a Th1-cell response. A novel finding was up-regulation of several regulatory and protective genes after allogeneic transplantation, specifically IL10, Bcl2a1, C4bpa, Ctla4, HO-1 and the SOCS family. Conclusion Our data indicate that in parallel with the predicted activation of immune response and tissue injury pathways, there is simultaneous activation of pathways for counter regulatory and protective mechanisms that would balance and limit the ongoing inflammatory/immune responses. The pathophysiological mechanisms behind and the clinical consequences of alterations in expression of these gene classes in acute rejection, injury and dysfunction vs. protection and immunoregulation, prompt further analyses and open new aspects for therapeutic approaches.

Extensive evolutionary changes in regulatory element activity during human origins are associated with altered gene expression and positive selection.

Directory of Open Access Journals (Sweden)

Yoichiro Shibata

2012-06-01

Full Text Available Understanding the molecular basis for phenotypic differences between humans and other primates remains an outstanding challenge. Mutations in non-coding regulatory DNA that alter gene expression have been hypothesized as a key driver of these phenotypic differences. This has been supported by differential gene expression analyses in general, but not by the identification of specific regulatory elements responsible for changes in transcription and phenotype. To identify the genetic source of regulatory differences, we mapped DNaseI hypersensitive (DHS sites, which mark all types of active gene regulatory elements, genome-wide in the same cell type isolated from human, chimpanzee, and macaque. Most DHS sites were conserved among all three species, as expected based on their central role in regulating transcription. However, we found evidence that several hundred DHS sites were gained or lost on the lineages leading to modern human and chimpanzee. Species-specific DHS site gains are enriched near differentially expressed genes, are positively correlated with increased transcription, show evidence of branch-specific positive selection, and overlap with active chromatin marks. Species-specific sequence differences in transcription factor motifs found within these DHS sites are linked with species-specific changes in chromatin accessibility. Together, these indicate that the regulatory elements identified here are genetic contributors to transcriptional and phenotypic differences among primate species.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Netherlands

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Fissionable materials, ores, radioactive materials and equipment (Fissionable materials and ores; Radioactive materials and equipment); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection (Protection of workers; Protection of the public; Protection of individuals undergoing medical exposure); 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister for Housing, Spatial Planning and the Environment; Minister for Economic Affairs; Minister for Social Affairs and Employment; Minister for Health, Welfare and Sports; Minister for Finance; Minister for Foreign Affairs); 2. Advisory body - Health Council of the Netherlands; 3. Public and semi-public agencies (Nuclear Research and Consultancy Group - NRG; Central Organisation for Radioactive Waste - COVRA)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Spain

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trading in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection (Safeguards and non-proliferation; Physical protection); 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Ministry of Industry, Tourism and Trade - MITYC; Ministry of the Interior - MIR; Ministry of Economy and the Exchequer - MEH; Ministry of the Environment and Rural and Marine Affairs - MARM); 2. Public and semi-public agencies (Nuclear Safety Council - CSN; Centre for Energy-related, Environmental and Technological Research - CIEMAT; National Energy Commission - CNE; 3. Public capital companies (Enusa Industrias Avanzadas, s.a. - ENUSA; Empresa Nacional de Residuos Radiactivos, s.a. - ENRESA)

The diabetes type 1 locus Idd6 modulates activity of CD4+CD25+ regulatory T-cells.

Science.gov (United States)

Rogner, Ute Christine; Lepault, Françoise; Gagnerault, Marie-Claude; Vallois, David; Morin, Joëlle; Avner, Philip; Boitard, Christian

2006-01-01

The genetic locus Idd6 confers susceptibility to the spontaneous development of type 1 diabetes in the NOD mouse. Our studies on disease resistance of the congenic mouse strain NOD.C3H 6.VIII showed that Idd6 influences T-cell activities in the peripheral immune system and suggest that a major mechanism by which the Idd6 locus modifies diabetes development is via modulation of regulatory T-cell activities. Our transfer experiments using total splenocytes and purified T-cells demonstrated that the locus specifically controls the efficiency of disease protection mediated by the regulatory CD4(+)CD25(+) T-cell subset. Our data also implicate the Idd6 locus in controlling the balance between infiltrating lymphocytes and antigen-presenting cells within the pancreatic islet.

Direct activation of a notochord cis-regulatory module by Brachyury and FoxA in the ascidian Ciona intestinalis.

Science.gov (United States)

Passamaneck, Yale J; Katikala, Lavanya; Perrone, Lorena; Dunn, Matthew P; Oda-Ishii, Izumi; Di Gregorio, Anna

2009-11-01

The notochord is a defining feature of the chordate body plan. Experiments in ascidian, frog and mouse embryos have shown that co-expression of Brachyury and FoxA class transcription factors is required for notochord development. However, studies on the cis-regulatory sequences mediating the synergistic effects of these transcription factors are complicated by the limited knowledge of notochord genes and cis-regulatory modules (CRMs) that are directly targeted by both. We have identified an easily testable model for such investigations in a 155-bp notochord-specific CRM from the ascidian Ciona intestinalis. This CRM contains functional binding sites for both Ciona Brachyury (Ci-Bra) and FoxA (Ci-FoxA-a). By combining point mutation analysis and misexpression experiments, we demonstrate that binding of both transcription factors to this CRM is necessary and sufficient to activate transcription. To gain insights into the cis-regulatory criteria controlling its activity, we investigated the organization of the transcription factor binding sites within the 155-bp CRM. The 155-bp sequence contains two Ci-Bra binding sites with identical core sequences but opposite orientations, only one of which is required for enhancer activity. Changes in both orientation and spacing of these sites substantially affect the activity of the CRM, as clusters of identical sites found in the Ciona genome with different arrangements are unable to activate transcription in notochord cells. This work presents the first evidence of a synergistic interaction between Brachyury and FoxA in the activation of an individual notochord CRM, and highlights the importance of transcription factor binding site arrangement for its function.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Czech Republic

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear items and spent fuel (Ionising radiation sources; Nuclear items; Spent fuel); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response; Decommissioning); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (State Office for Nuclear Safety - SUJB; Ministry of Industry and Trade; Ministry of the Interior; Ministry of the Environment); 2. Public and semi-public agencies (CEZ, a.s.; National Radiation Protection Institute - NRPI; Radioactive Waste Repository Authority - RAWRA; Diamo; Nuclear Physics Institute - NPI; National Institute for Nuclear, Chemical and Biological Protection; Nuclear Research Institute Rez, a.s. - NRI)

Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2015

International Nuclear Information System (INIS)

2016-01-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2015 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Safety of nuclear installations; (4) Nuclear Materials; (5) Competence of the building authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public relations; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) Abbreviations.

Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2016

International Nuclear Information System (INIS)

2017-01-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2016 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear installations; (4) Nuclear Materials; (5) Competence of the building authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public relations; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) Abbreviations.

Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2013

International Nuclear Information System (INIS)

2014-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2013 is presented. These activities are reported under the headings: Foreword by the Chairperson; (1) Legislative activities; (2) Regulatory Activities; (3) Nuclear safety of nuclear power plants; (4) Nuclear Materials in SR; (5) Building Authority; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Annexes; (11) (12) Abbreviations.

Cooperation of Ukrainian regulatory authorities in the SIP

Energy Technology Data Exchange (ETDEWEB)

Kutina, L.; Bachner, D.; Bykov, V.; Erickson, L.; Kondralyev, S.; Redko, V.; Simonov, I.; Vasilchenko, V. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)

2003-07-01

The State Nuclear Regulatory Committee of Ukraine (SNRCU) supported by the State Scientific and Technical Center (SSTC) and the Licensing consultant (LC - RISKAUDIT/SCIENTECH) coordinates the activities of other regulatory authorities (RA) within the Shelter Implementation Plan (SIP) licensing. A protocol on cooperation and differentiation of competence in the SIP has been agreed between SNRCU and other RA (Ecology, Health, Construction, Occupational safety, Fire). The RA intended to carry out their activities such that SIP be implemented in the most efficient way by: - providing the Chernobyl NPP with a possibility to choose optimal variants for Shelter transformation; - minimizing required regulatory steps for SIP; - reviewing SIP documents at the initial stages of development of SIP designs; - providing consultative support by technical support organizations (TSO) on the SIP designs; - relating regulatory decisions on safety issues to the competence of the inspection at the Chernobyl NPP site. Coordination of regulatory activity and cooperation in safety areas are presented.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Australia

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I) - General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection (Bilateral safeguards agreements; International Atomic Energy Agency Safeguards Agreement; The South Pacific Nuclear Free Zone Treaty Act; The Comprehensive Nuclear Test-Ban Treaty Act; The Nuclear Non-Proliferation (Safeguards) Act); 9. Transport; 10. Nuclear third party liability; II) - Institutional Framework: 1. Regulatory and supervisory authorities (Minister for Health and Ageing; Minister for Foreign Affairs; Minister for the Environment, Heritage and the Arts; Minister for, Resources, Energy and Tourism); 2. Advisory bodies (Radiation Health and Safety Advisory Council; Advisory Committees); 3. Public and semi-public agencies (Australian Radiation Protection and Nuclear Safety Agency (ARPANSA); Australian Safeguards and Non-Proliferation Office; Australian Nuclear Science and Technology Organisation (ANSTO); Supervising Scientist)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Hungary

International Nuclear Information System (INIS)

2008-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Atomic Energy Co-ordination Council; Hungarian Atomic Energy Authority - HAEA; Minister for Health; Minister for Local Government and Regional Development and Minister for Justice and Law Enforcement; Minister for Agriculture and Rural Development; Minister for Economy and Transport; Minister of Environment Protection and Water Management; Minister for Defence; Minister for Education; President of the Hungarian Mining and Geological Authority; Governmental Co-ordination Committee); 2. Advisory bodies (Scientific Board); 3. Public and semi-public agencies (Institute for Electric Power Research - VEIKI; Atomic Energy Research Institute - AEKI; Institute of Isotopes; Department of Physical Chemistry of the University of Pannon; Hungarian Power Companies Ltd - MVM Zrt.)

LWRS II&C Industry and Regulatory Engagement Activities for FY 11

Energy Technology Data Exchange (ETDEWEB)

Ken Thomas

2011-09-01

To ensure broad industry support and coordination for the Advanced Instrumentation, Information, and Controls (II&C) Systems Technologies research pathway, an engagement process will be continually pursued with nuclear asset owners, vendors, and suppliers, Nuclear Regulatory Commission (NRC), and the major industry support organizations of Electric Power Research Institute (EPRI), Institute of Nuclear Power Operations (INPO), and Nuclear Energy Institute (NEI). Nuclear asset owner engagement is a necessary and enabling activity to obtain data and accurate characterization of long-term operational challenges, assess the suitability of proposed research for addressing long-term needs, and gain access to data and representative infrastructure and expertise needed to ensure success of the proposed research and development (R&D) activities. Engagement with vendors and suppliers will ensure that vendor expectations and needs can be translated into requirements that can be met through technology commercialization.

Chronic lymphocytic leukemia cells acquire regulatory B-cell properties in response to TLR9 and CD40 activation.

Science.gov (United States)

Ringelstein-Harlev, Shimrit; Avivi, Irit; Fanadka, Mona; Horowitz, Netanel A; Katz, Tami

2018-02-15

Circulating chronic lymphocytic leukemia (CLL) cells share phenotypic features with certain subsets of regulatory B-cells (Bregs). The latter cells have been reported to negatively regulate immune cell responses, mostly by provision of IL-10. The purpose of the current study was to identify and delineate Breg properties of CLL cells. B-cells and T-cells were obtained from the peripheral blood of untreated CLL patients diagnosed according to the 2008 Guidelines of the International Workshop on Chronic Lymphocytic Leukemia. Co-culture assays were used to examine the ability of CLL cells to suppress autologous T-cell immune responses. IL-10 potency of CLL cells was assessed following stimulation with activators of the toll-like receptor 9 (TLR9) or CD40 and was correlated with the inhibitory activity of the cells. TLR9-activated CLL cells were found to increase the frequency of CD4 + CD25 hi FOXp3 + regulatory T-cells (Tregs) and to inhibit autologous CD4 + T-cell proliferation. This signaling cascade proved to control IL-10 generation in CLL cells, which in turn promoted the inhibition of T-cell proliferation by CLL cells. However, CD40 activation of CLL cells, while exhibiting a similar ability to augment Treg frequency, did not either affect IL-10 generation or T-cell proliferation. In conclusion, CLL cells demonstrate a unique clonal quality of adopting Breg properties which promote modulation of T-cell characteristics. TLR9 appears to be a potent activator of regulatory abilities in CLL cells, possibly contributing to preferential immune escape of TLR9-responsive cells.

TLR5 signaling enhances the proliferation of human allogeneic CD40-activated B cell induced CD4hiCD25+ regulatory T cells.

Directory of Open Access Journals (Sweden)

Ping-Lung Chan

Full Text Available Although diverse functions of different toll-like receptors (TLR on human natural regulatory T cells have been demonstrated recently, the role of TLR-related signals on human induced regulatory T cells remain elusive. Previously our group developed an ex vivo high-efficient system in generating human alloantigen-specific CD4(hiCD25(+ regulatory T cells from naïve CD4(+CD25(- T cells using allogeneic CD40-activated B cells as stimulators. In this study, we investigated the role of TLR5-related signals on the generation and function of these novel CD4(hiCD25(+ regulatory T cells. It was found that induced CD4(hiCD25(+ regulatory T cells expressed an up-regulated level of TLR5 compared to their precursors. The blockade of TLR5 using anti-TLR5 antibodies during the co-culture decreased CD4(hiCD25(+ regulatory T cells proliferation by induction of S phase arrest. The S phase arrest was associated with reduced ERK1/2 phosphorylation. However, TLR5 blockade did not decrease the CTLA-4, GITR and FOXP3 expressions, and the suppressive function of CD4(hiCD25(+ regulatory T cells. In conclusion, we discovered a novel function of TLR5-related signaling in enhancing the proliferation of CD4(hiCD25(+ regulatory T cells by promoting S phase progress but not involved in the suppressive function of human CD40-activated B cell-induced CD4(hiCD25(+ regulatory T cells, suggesting a novel role of TLR5-related signals in the generation of induced regulatory T cells.

Regulatory activities in the area of fuel safety and performance

International Nuclear Information System (INIS)

Viktorov, A.; Couture, M.

2005-01-01

Generic Action Item 94G02 'Impact of Fuel Bundle Condition on Reactor Safety' in many ways determined the present priorities in regulatory activities related to fuel performance. As one of the closure criteria it required that all licensees establish 'an effective formal and systematic process for integrating fuel design, fuel and channel inspection, laboratory examination, research, operating limits and safety analysis'. To date, such a process has been, to a large extent, put in place by all licensees. To assure that such processes remain operational and effective after the GAI closure, CNSC required, through S-99, to report annually on fuel performance and major activities in the fuel safety area. The scope of reported information has been defined to allow CNSC staff evaluation of key events and trends in fuel performance. To compliment reporting by the industry, CNSC staff has conducted targeted inspections of fuel compliance programs at all sites. Combined together, these activities provide the regulator with the confidence that CANDU fuel is robust and operates with safety margins. The scrutiny, to which fuel performance has been subjected lately, has allowed identification of certain programmatic weaknesses and gaps in the knowledge concerning the fuel behaviour under various conditions. It has become apparent that top-level strategies for assessment of fuel performance may have been inadequate and far from systematic; fuel inspection practices and capabilities have varied significantly from site to site; certain issues were identified but remained unaddressed for significant time; priorities in experimental or design support activities were not assigned consistently. The presentation gives examples of areas where, in the opinion of the CNSC staff, further work is required to support fuel design and safety envelopes. The implementation of new CANFLEX fuel designs is currently being considered by the industry and CNSC staff has been engaged in the review

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

The Regulatory Independence of FANR

Energy Technology Data Exchange (ETDEWEB)

ALNuaimi, Fatema; Choi, Kwang Shik [Korea Advanced Institute of Science and Technology, Daejeon (Korea, Republic of)

2012-05-15

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

Inference of cancer-specific gene regulatory networks using soft computing rules.

Science.gov (United States)

Wang, Xiaosheng; Gotoh, Osamu

2010-03-24

Perturbations of gene regulatory networks are essentially responsible for oncogenesis. Therefore, inferring the gene regulatory networks is a key step to overcoming cancer. In this work, we propose a method for inferring directed gene regulatory networks based on soft computing rules, which can identify important cause-effect regulatory relations of gene expression. First, we identify important genes associated with a specific cancer (colon cancer) using a supervised learning approach. Next, we reconstruct the gene regulatory networks by inferring the regulatory relations among the identified genes, and their regulated relations by other genes within the genome. We obtain two meaningful findings. One is that upregulated genes are regulated by more genes than downregulated ones, while downregulated genes regulate more genes than upregulated ones. The other one is that tumor suppressors suppress tumor activators and activate other tumor suppressors strongly, while tumor activators activate other tumor activators and suppress tumor suppressors weakly, indicating the robustness of biological systems. These findings provide valuable insights into the pathogenesis of cancer.

Information system fur the management of a regulatory programme

International Nuclear Information System (INIS)

Ortiz, P.; Mrabit, K.; Miaw, S.

1998-01-01

A Regulatory Programme to monitor safety of activities involving radiation sources, implies the existence of a Regulatory Authority empowered by legislation to issue radiation protection regulations and to monitor compliance with those regulations. The core element of the programme is a system of notification and authorization (registration and licensing), inspection and enforcement. The efficiency of this system is largely dependent on the availability of reliable information on the inventory of radiation sources and installations, the administrative status of the facilities (authorization), prompt processing of inspection reports and follow up of regulatory actions, including monitoring deadlines. Essential data relevant to safety, such as personal dosimetry for occupationally exposed individuals, inspection findings and incident reports would provide, in addition, an insight on the overall safety of the country. A simple but comprehensive Regulatory Authority Information System (RAIS) linked to the authorization and inspection process will largely facilitate regulatory decisions and actions. A readily available and reliable information from the various regulatory activities will facilitate planning, optimization of resources, monitoring safety related data, disseminating safety information, making decisions and follow up regulatory actions including monitoring dead lines. The implementation of the system in more than 50 countries will contribute to experience exchange and harmonization of regulatory activities. (author)

Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2007. Annual report

International Nuclear Information System (INIS)

2007-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2007 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) Abbreviations

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

International Nuclear Information System (INIS)

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

1991-01-01

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

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Republic of Korea

International Nuclear Information System (INIS)

2009-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection) (Protection of workers; Protection of the public); 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Minister of Education, Science and Technology, including the Nuclear Energy Bureau; Minister of Knowledge Economy); 2. Advisory bodies (Atomic Energy Commission; Atomic Energy Safety Commission); 3. Public and semi-public agencies (Korean Atomic Energy Research Institute - KAERI; Korean Institute for Nuclear Safety - KINS; Korean Electric Power Company - KEPCO; Korean Hydro and Nuclear Power - KHNP)

Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2008. Annual report

International Nuclear Information System (INIS)

Zemanova, D.; Pirozekova, M.

2009-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2008 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Activity of Building Office; (9) Emergency planning and preparedness; (10) International activities; (11) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Switzerland

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Nuclear fuels; Radioactive substances and equipment generating ionising radiation); 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment; 6. Radiation protection; 7. Radioactive waste management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear third party liability; 11. Environmental protection; II. Institutional Framework: 1. Regulatory and supervisory authorities (Federal Council; Federal Assembly; Federal Department of the Environment, Transport, Energy and Communications - DETEC; Federal Office of Energy - SFOE; Swiss Federal Nuclear Safety Inspectorate - IFSN; Federal Department of Home Affairs - FDHA; Federal Office of Public Health - FOPH; State Secretariat for Education and Research - SER; Other authorities); 2. Advisory bodies (Swiss Federal Nuclear Safety Commission - KNS; Federal Commission for Radiological Protection and Monitoring of the Radioactivity in the Environment; Federal Emergency Organisation on Radioactivity); 3. Public and semi-public agencies (Paul-Scherrer Institute - PSI; Fund for the decommissioning of nuclear installations and for the waste disposal; National Co-operative for the

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Belgium

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Nuclear facilities (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response; Decommissioning); 4. Trade in nuclear materials and equipment; 5. Radiological protection; 6. Radioactive waste management; 7. Non-proliferation of nuclear weapons and physical protection of nuclear material (International aspects; National control and security measures); 8. Transport; 9. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Federal Agency for Nuclear Control - FANC; Federal Public Service for Home Affairs; Federal Public Service for Economy, SME's, Self-Employed and Energy; Federal Public Service for Employment, Labour and Social Dialogue; Federal Public Service for Defence; Federal Public Service for Foreign Affairs, Foreign Trade and Development Co-operation; Federal Public Planning Service for Science Policy); 2. Advisory bodies (Scientific Council for Ionizing Radiation of the Federal Agency for Nuclear Control; Superior Health Council; Superior Council for Safety, Hygiene and Enhancement of Workplaces; Advisory Committee for the Non-Proliferation of Nuclear Weapons; Commission for Electricity and Gas Regulation - CREG)

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Austria

International Nuclear Information System (INIS)

2003-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I) - General Regulatory Regime - General Outline: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances, Nuclear Fuel and Equipment; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Emergency response); 5. Trade in Nuclear Materials and Equipment; 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II) - Institutional Framework: 1. Regulatory and Supervisory Authorities: A. Federal Authorities - Bund (The Federal Chancellery; The Federal Minister for Women's Affairs and Consumer Protection; The Federal Minister of the Interior; The Federal Minister for Economic Affairs; The Federal Minister of Finance; The Federal Minister of Labour, Health and Social Affairs; The Federal Minister of Science and Transport; The Federal Minister of Justice; The Federal Minister for the Environment; The Federal Minister for Foreign Affairs) B. Regional Authorities - Laender; C. District Authorities - Bezirksverwaltungsbehorden; 2. Advisory Bodies (Forum for Nuclear Questions, Radiation Protection Commission - SSK); 3. Public and Semi-Public Agencies (The Seibersdorf Austrian Research Centre; The Graz Nuclear Institute; The Nuclear Institute of the Austrian Universities; The Institute of Risk Research, University of Vienna)

Rac1 GTPase activates the WAVE regulatory complex through two distinct binding sites

Science.gov (United States)

Brautigam, Chad A; Xing, Wenmin; Yang, Sheng; Henry, Lisa; Doolittle, Lynda K; Walz, Thomas

2017-01-01

The Rho GTPase Rac1 activates the WAVE regulatory complex (WRC) to drive Arp2/3 complex-mediated actin polymerization, which underpins diverse cellular processes. Here we report the structure of a WRC-Rac1 complex determined by cryo-electron microscopy. Surprisingly, Rac1 is not located at the binding site on the Sra1 subunit of the WRC previously identified by mutagenesis and biochemical data. Rather, it binds to a distinct, conserved site on the opposite end of Sra1. Biophysical and biochemical data on WRC mutants confirm that Rac1 binds to both sites, with the newly identified site having higher affinity and both sites required for WRC activation. Our data reveal that the WRC is activated by simultaneous engagement of two Rac1 molecules, suggesting a mechanism by which cells may sense the density of active Rac1 at membranes to precisely control actin assembly. PMID:28949297

Etonogestrel implant migration to the vasculature, chest wall, and distant body sites: cases from a pharmacovigilance database.

Science.gov (United States)

Kang, Sarah; Niak, Ali; Gada, Neha; Brinker, Allen; Jones, S Christopher

2017-12-01

To describe clinical outcomes of etonogestrel implant patients with migration to the vasculature, chest wall and other distant body sites spontaneously reported to the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. We performed a standardized Medical Dictionary for Regulatory Activities (MedDRA) query in the FAERS database (through November 15, 2015), with reports coded with one or more MedDRA preferred terms that indicate complications with device placement or migration of the device from the original site of insertion to the vasculature, chest wall and other distant body sites. We excluded any cases previously described in the medical literature. We identified 38 cases of pronounced etonogestrel implant migration. Migration locations included the lung/pulmonary artery (n=9), chest wall (n=1), vasculature at locations other than the lung/pulmonary artery (n=14) and extravascular migrations (n=14) to other body sites (e.g., the axilla and clavicle/neck line/shoulder). The majority of cases were asymptomatic and detected when the patient desired implant removal; however, seven cases reported symptoms such as pain, discomfort and dyspnea in association with implant migration. Three cases also describe pulmonary fibrosis and skin reactions as a result of implant migration to the vasculature, chest wall and other distant body sites. Sixteen cases reported surgical removal in an operating room setting. Our FAERS case series demonstrates etonogestrel implant migration to the vasculature, chest wall and other body sites distant from the site of original insertion. As noted by the sponsor in current prescribing information, a key determinant in the risk for etonogestrel contraceptive implant migration appears to be improper insertion technique. Although migration of etonogestrel implants to the vasculature is rare, awareness of migration and education on proper insertion technique may reduce the risk. Published by Elsevier Inc.

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

Global transcriptional regulatory network for Escherichia coli robustly connects gene expression to transcription factor activities

Science.gov (United States)

Fang, Xin; Sastry, Anand; Mih, Nathan; Kim, Donghyuk; Tan, Justin; Lloyd, Colton J.; Gao, Ye; Yang, Laurence; Palsson, Bernhard O.

2017-01-01

Transcriptional regulatory networks (TRNs) have been studied intensely for >25 y. Yet, even for the Escherichia coli TRN—probably the best characterized TRN—several questions remain. Here, we address three questions: (i) How complete is our knowledge of the E. coli TRN; (ii) how well can we predict gene expression using this TRN; and (iii) how robust is our understanding of the TRN? First, we reconstructed a high-confidence TRN (hiTRN) consisting of 147 transcription factors (TFs) regulating 1,538 transcription units (TUs) encoding 1,764 genes. The 3,797 high-confidence regulatory interactions were collected from published, validated chromatin immunoprecipitation (ChIP) data and RegulonDB. For 21 different TF knockouts, up to 63% of the differentially expressed genes in the hiTRN were traced to the knocked-out TF through regulatory cascades. Second, we trained supervised machine learning algorithms to predict the expression of 1,364 TUs given TF activities using 441 samples. The algorithms accurately predicted condition-specific expression for 86% (1,174 of 1,364) of the TUs, while 193 TUs (14%) were predicted better than random TRNs. Third, we identified 10 regulatory modules whose definitions were robust against changes to the TRN or expression compendium. Using surrogate variable analysis, we also identified three unmodeled factors that systematically influenced gene expression. Our computational workflow comprehensively characterizes the predictive capabilities and systems-level functions of an organism’s TRN from disparate data types. PMID:28874552

Inference of Cancer-specific Gene Regulatory Networks Using Soft Computing Rules

Directory of Open Access Journals (Sweden)

Xiaosheng Wang

2010-03-01

Full Text Available Perturbations of gene regulatory networks are essentially responsible for oncogenesis. Therefore, inferring the gene regulatory networks is a key step to overcoming cancer. In this work, we propose a method for inferring directed gene regulatory networks based on soft computing rules, which can identify important cause-effect regulatory relations of gene expression. First, we identify important genes associated with a specific cancer (colon cancer using a supervised learning approach. Next, we reconstruct the gene regulatory networks by inferring the regulatory relations among the identified genes, and their regulated relations by other genes within the genome. We obtain two meaningful findings. One is that upregulated genes are regulated by more genes than downregulated ones, while downregulated genes regulate more genes than upregulated ones. The other one is that tumor suppressors suppress tumor activators and activate other tumor suppressors strongly, while tumor activators activate other tumor activators and suppress tumor suppressors weakly, indicating the robustness of biological systems. These findings provide valuable insights into the pathogenesis of cancer.

The mass media role in acceptance activities of Slovak Republic's Nuclear Regulatory Authority

International Nuclear Information System (INIS)

Seliga, Mojmir

1998-01-01

Communication is the vital link between Nuclear Regulatory Authority and the public. If people do not know and understand the facts on which optimal a safety energy choice decisions should be based they cannot make informed decisions on how their own objectives can be met. The following ten commandments of communications are pointed out: be yourself; be comfortable and confident; be honest; be brief; be human; be personal; be positive and consistent; be attentive; be energetic; be committed and sincere. The important aspect is to test whether the nuclear energy in the Slovak Republic is acceptable according to mandatory rules and if its operation is regulated by the state through the independent institution - the Nuclear Regulatory Authority of the Slovak Republic (UJD). The media in Slovakia has on important power. Many organizations are therefore apprehensive when dealing with the press, radio and television. Many people would simply prefer not to get panicked when the dreaded microphones and cameras do appear. UJD considers the whole area of public relations as an essential component of its activity. UJD intends to offer the public true, systematic, qualified, understandable and independent information, regarding the safety of nuclear power plants, as well as regarding the methods and results of UJD work. Generally, public information is considered a significant contribution to the creation of confidence into the regulatory work. The paper presents the UJD communication program and relations with media as well as the preparedness of public information in case of emergency

Regulatory research for waste disposal - Objectives and international approaches

International Nuclear Information System (INIS)

Wanner, Hans; Fischer-Appelt, Klaus; Pescatore, Claudio

2011-01-01

The question of active involvement of nuclear regulatory and supervisory bodies in research and development (R and D) projects has become a topic of increasing interest in recent years. The way in which research is included in regulatory activities varies from country to country, ranging from countries with no regulatory R and D activities to countries with extensive activities which are often carried out by independent research organisations acting on behalf of the regulatory body. The present report outlines (part 1) the potential merits of R and D work carried out by the regulator, and summarizes (part 2) the results of a questionnaire that was circulated among the members of the Regulators' Forum of NEA's Radioactive Waste Management Committee in 2009. Part 3 presents the conclusions of discussions within the RWMC-RF. The detailed answers to the questionnaire are also provided

Creating a safety culture in the regulatory authority: The Cuban experience

International Nuclear Information System (INIS)

Ferro Fernandez, R.; Guillen Campos, A.

2002-01-01

The Cuban regulatory authority has been working during several years for the fostering and development of a high Safety Culture level in nuclear activities in the country. As starting point to achieve this objective the assessment of the Safety Culture level in the regulatory authority performance was considered an important issue. For this purpose a preliminary diagnosis was carried out by means of a national survey that allowed identifying some areas of the regulatory activity that required improvements in order to achieve a higher Safety Culture and to immediately implement appropriate actions. Two of the most important actions undertaken were: the statement of the regulatory authority Safety Policy which governs and determines the performance of this organization and its staff and also the implementation of a new interaction practice at top level between the regulatory authority and the utilities of the nuclear sector through the Annual Regulatory Conference. The present paper summarizes these two introduced practices into the Cuban regulatory activity. (author)

Regulatory Audit Activities on Nuclear Design of Reactor Cores

International Nuclear Information System (INIS)

Yang, Chae-Yong; Lee, Gil Soo; Lee, Jaejun; Kim, Gwan-Young; Bae, Moo-Hun

2016-01-01

Regulatory audit analyses are initiated on the purpose of deep knowledge, solving safety issues, being applied in the review of licensee's results. The current most important safety issue on nuclear design is to verify bias and uncertainty on reactor physics codes to examine the behaviors of high burnup fuel during rod ejection accident (REA) and LOCA, and now regulatory audits are concentrated on solving this issue. KINS develops regulatory audit tools on its own, and accepts ones verified from foreign countries. The independent audit tools are sometimes standardized through participating the international programs. New safety issues on nuclear design, reactor physics tests, advanced reactor core design are steadily raised, which are mainly drawn from the independent examination tools. It is some facing subjects for the regulators to find out the unidentified uncertainties in high burnup fuels and to systematically solve them. The safety margin on nuclear design might be clarified by precisely having independent tools and doing audit calculations by using them. SCALE-PARCS/COREDAX and the coupling with T-H code or fuel performance code would be certainly necessary for achieving these purposes

Regulatory Audit Activities on Nuclear Design of Reactor Cores

Energy Technology Data Exchange (ETDEWEB)

Yang, Chae-Yong; Lee, Gil Soo; Lee, Jaejun; Kim, Gwan-Young; Bae, Moo-Hun [Korea Institute of Nuclear Safety, Daejeon (Korea, Republic of)

2016-10-15

Regulatory audit analyses are initiated on the purpose of deep knowledge, solving safety issues, being applied in the review of licensee's results. The current most important safety issue on nuclear design is to verify bias and uncertainty on reactor physics codes to examine the behaviors of high burnup fuel during rod ejection accident (REA) and LOCA, and now regulatory audits are concentrated on solving this issue. KINS develops regulatory audit tools on its own, and accepts ones verified from foreign countries. The independent audit tools are sometimes standardized through participating the international programs. New safety issues on nuclear design, reactor physics tests, advanced reactor core design are steadily raised, which are mainly drawn from the independent examination tools. It is some facing subjects for the regulators to find out the unidentified uncertainties in high burnup fuels and to systematically solve them. The safety margin on nuclear design might be clarified by precisely having independent tools and doing audit calculations by using them. SCALE-PARCS/COREDAX and the coupling with T-H code or fuel performance code would be certainly necessary for achieving these purposes.

GITR ligand-costimulation activates effector and regulatory functions of CD4+ T cells

International Nuclear Information System (INIS)

Igarashi, Hanna; Cao, Yujia; Iwai, Hideyuki; Piao, Jinhua; Kamimura, Yosuke; Hashiguchi, Masaaki; Amagasa, Teruo; Azuma, Miyuki

2008-01-01

Engagement of glucocorticoid-induced TNFR-related protein (GITR) enables the costimulation of both CD25 - CD4 + effector (Teff) and CD25 + CD4 + regulatory (Treg) cells; however, the effects of GITR-costimulation on Treg function remain controversial. In this study, we examined the effects of GITR ligand (GITRL) binding on the respective functions of CD4 + T cells. GITRL-P815 transfectants efficiently augmented anti-CD3-induced proliferation and cytokine production by Teff cells. Proliferation and IL-10 production in Treg were also enhanced by GITRL transfectants when exogenous IL-2 and stronger CD3 stimulation was provided. Concomitant GITRL-costimulation of Teff and Treg converted the anergic state of Treg into a proliferating state, maintaining and augmenting their function. Thus, GITRL-costimulation augments both effector and regulatory functions of CD4 + T cells. Our results suggest that highly activated and increased ratios of Treg reverse the immune-enhancing effects of GITRL-costimulation in Teff, which may be problematic for therapeutic applications using strong GITR agonists

Report on activities of Nuclear Regulatory Authority of the Slovak Republic and safety of nuclear installations in the Slovak Republic in 2009. Annual report

International Nuclear Information System (INIS)

2010-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2009 is presented. These activities are reported under the headings: (1) Foreword; (2) Legislation; (3) Issuance of authorizations, assessment, supervisory activities and enforcement; (4) Nuclear safety of nuclear installations in the Slovak Republic; (5) Safety of other nuclear installations; (6) Management of radioactive waste; (7) Nuclear materials and physical protection of nuclear materials; (8) Emergency planning and preparedness; (9) International activities; (10) Public communication; (11) Nuclear Regulatory Authority of the Slovak Republic; (12) UJD SR organization chart; (13) Abbreviations.

The Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2010

International Nuclear Information System (INIS)

2010-05-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic (UJD SR) in 2010 is presented. These activities are reported under the headings: Address of the Chairperson; (1) Legislative activities; (2) Issuance of authorizations, assessment, supervisory activities and enforcement; (3) Nuclear safety of nuclear power plants; (4) Nuclear materials and physical protection of nuclear materials; (5) Powers of the office building; (6) Emergency planning and preparedness; (7) International activities; (8) Public communication; (9) Nuclear Regulatory Authority of the Slovak Republic; (10) Appendix: UJD SR organization chart; The International Nuclear Event Scale (INES); Abbreviations.

Automated Identification of Core Regulatory Genes in Human Gene Regulatory Networks.

Directory of Open Access Journals (Sweden)

Vipin Narang

Full Text Available Human gene regulatory networks (GRN can be difficult to interpret due to a tangle of edges interconnecting thousands of genes. We constructed a general human GRN from extensive transcription factor and microRNA target data obtained from public databases. In a subnetwork of this GRN that is active during estrogen stimulation of MCF-7 breast cancer cells, we benchmarked automated algorithms for identifying core regulatory genes (transcription factors and microRNAs. Among these algorithms, we identified K-core decomposition, pagerank and betweenness centrality algorithms as the most effective for discovering core regulatory genes in the network evaluated based on previously known roles of these genes in MCF-7 biology as well as in their ability to explain the up or down expression status of up to 70% of the remaining genes. Finally, we validated the use of K-core algorithm for organizing the GRN in an easier to interpret layered hierarchy where more influential regulatory genes percolate towards the inner layers. The integrated human gene and miRNA network and software used in this study are provided as supplementary materials (S1 Data accompanying this manuscript.

Sociotechnical systems as a framework for regulatory system design and evaluation: Using Work Domain Analysis to examine a new regulatory system.

Science.gov (United States)

Carden, Tony; Goode, Natassia; Read, Gemma J M; Salmon, Paul M

2017-03-15

Like most work systems, the domain of adventure activities has seen a series of serious incidents and subsequent calls to improve regulation. Safety regulation systems aim to promote safety and reduce accidents. However, there is scant evidence they have led to improved safety outcomes. In fact there is some evidence that the poor integration of regulatory system components has led to adverse safety outcomes in some contexts. Despite this, there is an absence of methods for evaluating regulatory and compliance systems. This article argues that sociotechnical systems theory and methods provide a suitable framework for evaluating regulatory systems. This is demonstrated through an analysis of a recently introduced set of adventure activity regulations. Work Domain Analysis (WDA) was used to describe the regulatory system in terms of its functional purposes, values and priority measures, purpose-related functions, object-related processes and cognitive objects. This allowed judgement to be made on the nature of the new regulatory system and on the constraints that may impact its efficacy following implementation. Importantly, the analysis suggests that the new system's functional purpose of ensuring safe activities is not fully supported in terms of the functions and objects available to fulfil them. Potential improvements to the design of the system are discussed along with the implications for regulatory system design and evaluation across the safety critical domains generally. Copyright © 2017 Elsevier Ltd. All rights reserved.

Role of regulatory subunits and protein kinase inhibitor (PKI) in determining nuclear localization and activity of the catalytic subunit of protein kinase A.

Science.gov (United States)

Wiley, J C; Wailes, L A; Idzerda, R L; McKnight, G S

1999-03-05

Regulation of protein kinase A by subcellular localization may be critical to target catalytic subunits to specific substrates. We employed epitope-tagged catalytic subunit to correlate subcellular localization and gene-inducing activity in the presence of regulatory subunit or protein kinase inhibitor (PKI). Transiently expressed catalytic subunit distributed throughout the cell and induced gene expression. Co-expression of regulatory subunit or PKI blocked gene induction and prevented nuclear accumulation. A mutant PKI lacking the nuclear export signal blocked gene induction but not nuclear accumulation, demonstrating that nuclear export is not essential to inhibit gene induction. When the catalytic subunit was targeted to the nucleus with a nuclear localization signal, it was not sequestered in the cytoplasm by regulatory subunit, although its activity was completely inhibited. PKI redistributed the nuclear catalytic subunit to the cytoplasm and blocked gene induction, demonstrating that the nuclear export signal of PKI can override a strong nuclear localization signal. With increasing PKI, the export process appeared to saturate, resulting in the return of catalytic subunit to the nucleus. These results demonstrate that both the regulatory subunit and PKI are able to completely inhibit the gene-inducing activity of the catalytic subunit even when the catalytic subunit is forced to concentrate in the nuclear compartment.

Inspection activities of the Mexican regulatory body during the construction stage of the first unit of Laguna Verde Nuclear Power Plant

International Nuclear Information System (INIS)

Salgado Gonzalez, Julio Ricardo

1996-01-01

The paper addresses the regulatory framework established for the design, construction and operation of the NPP. The regulatory bases of the inspection program are mentioned.A summary of the inspection and reviewing activities carried out by the former Nuclear Safety Management Construction area during the construction stage, taking the year 1977 as the beginning of regular inspection activities for this construction stage, and up to the year 1987, when this one is considered as practically completed, and a stage of pre-operational tests has been started. Finally, the main inspection areas are described, and a summary is given of the classification of deficiencies detected during the inspections

Implementation of a Quality Management System in regulatory inspection activities

International Nuclear Information System (INIS)

Pires do Rio, Monica; Ferreira, Paulo Roberto; Cunha, Paulo G. da; Acar, Maria Elizabeth

2005-01-01

The Institute for Radioprotection and Dosimetry - IRD -, of the Brazilian National Nuclear Energy Commission, CNEN, started in 2001, the implementation of a quality management system (SGQ), in the inspection, testing and calibration activities. The SGQ was an institutional guideline and is inserted in a larger system of management of the IRD started in 1999, with the adoption of the National Quality Award criteria - PNQ, within the Project for Excellence in Technological Research of Associacao Brasileira das Instituicoes de Pesquisas Tecnologicas - ABIPTI (Brazilian Association of Technological Research institutions). The proposed quality management system and adopted at the IRD was developed and implemented in accordance with the requirements of NBR ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, and ISO/IEC 17020 - General criteria for operation of various types of bodies performing inspections. For regulatory inspection activities, the quality system was implemented on three program inspection services of radiological protection led, respectively, by clinics and hospitals that operate radiotherapy services; industries that use nuclear gauges in their control or productive processes and power reactor operators (CNAAA) - just the environmental part. It was formed a pioneering team of inspectors for standardizing the processes, procedures and starting the implementation of the system in the areas. This work describes the implementation process steps, including difficulties, learning and advantages of the adoption of a quality management system in inspection activities

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - United States

International Nuclear Information System (INIS)

2015-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Special nuclear material; Source material; By-product material; Agreement state programmes); 4. Nuclear installations (Initial licensing; Operation and inspection, including nuclear safety; Operating licence renewal; Decommissioning; Emergency response); 5. Radiological protection (Protection of workers; Protection of the public); 6. Radioactive waste management (High-level waste; Low-level waste; Disposal at sea; Uranium mill tailings; Formerly Utilized Sites Remedial Action Program - FUSRAP); 7. Non-proliferation and exports (Exports of source material, special nuclear material, production or utilisation facilities and sensitive nuclear technology; Exports of components; Exports of by-product material; Exports and imports of radiation sources; Conduct resulting in the termination of exports or economic assistance; Subsequent arrangements; Technology exports; Information and restricted data); 8. Nuclear security; 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Nuclear Regulatory Commission - NRC; Department of Energy - DOE; Department of Labor - DOL; Department of Transportation - DOT; Environmental Protection Agency - EPA); 2. Public and semi-public agencies: A. Cabinet-level departments (Department of

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - United Kingdom

International Nuclear Information System (INIS)

2003-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Regime: 1. Introduction; 2. Mining Regime; 3. Radioactive Substances; 4. Nuclear Installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in Nuclear Materials and Equipment; 6. Radiation Protection; 7. Radioactive Waste Management; 8. Non-Proliferation and Physical Protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and Supervisory Authorities (Department of Trade and Industry - DTI; Secretary of State for Environment, Food and Rural Affairs and the Secretary of State for Health; Secretary of State for Transport; Secretary of State for Education); 2. Advisory Bodies (Medical Research Council - MRC; Nuclear Safety Advisory Committee; Radioactive Waste Management Advisory Committee); 3. Public and Semi-Public Agencies (United Kingdom Atomic Energy Authority - UKAEA; Health and Safety Commission and Executive - HSC/HSE; National Radiological Protection Board - NRPB; Environment Agencies; British Nuclear Fuels plc. - BNFL; Amersham International plc.; The National Nuclear Corporation Ltd. - NNC; United Kingdom Nirex Ltd.; Magnox Electric plc.; British Energy Generation Ltd.; Scottish Electricity Generator Companies; British Energy Generation Ltd.; Regional Electricity Companies in England and Wales)

Regulatory activity based risk model identifies survival of stage II and III colorectal carcinoma.

Science.gov (United States)

Liu, Gang; Dong, Chuanpeng; Wang, Xing; Hou, Guojun; Zheng, Yu; Xu, Huilin; Zhan, Xiaohui; Liu, Lei

2017-11-17

Clinical and pathological indicators are inadequate for prognosis of stage II and III colorectal carcinoma (CRC). In this study, we utilized the activity of regulatory factors, univariate Cox regression and random forest for variable selection and developed a multivariate Cox model to predict the overall survival of Stage II/III colorectal carcinoma in GSE39582 datasets (469 samples). Patients in low-risk group showed a significant longer overall survival and recurrence-free survival time than those in high-risk group. This finding was further validated in five other independent datasets (GSE14333, GSE17536, GSE17537, GSE33113, and GSE37892). Besides, associations between clinicopathological information and risk score were analyzed. A nomogram including risk score was plotted to facilitate the utilization of risk score. The risk score model is also demonstrated to be effective on predicting both overall and recurrence-free survival of chemotherapy received patients. After performing Gene Set Enrichment Analysis (GSEA) between high and low risk groups, we found that several cell-cell interaction KEGG pathways were identified. Funnel plot results showed that there was no publication bias in these datasets. In summary, by utilizing the regulatory activity in stage II and III colorectal carcinoma, the risk score successfully predicts the survival of 1021 stage II/III CRC patients in six independent datasets.

A flexible regulatory framework

International Nuclear Information System (INIS)

Silvennoinen, T.

2000-01-01

Regulatory reform of the Finnish electricity market meant opening up potentially competitive parts of the electricity sector to competition and eliminating all unnecessary forms of regulation covering generation, wholesale supply, retail supply, and foreign trade in electricity. New types of control and regulatory mechanisms and institutions were set up for those parts of the electricity industry that were excluded from competition, such as network operations. Network activities now have to be licensed, whereas no licence is needed for generation or supply. A new sector-specific regulatory authority was established in 1995 to coincide with the implementation of the Electricity Market Act, known as the Electricity Market Authority. This is responsible for regulating network activities and retail supply to captive customers. The core function of the authority, which employs some 14 people, is to promote the smooth operation of the Finnish electricity market and to oversee the implementation of the Electricity Market Act and its provisions. Its most important duties are linked to overseeing the process by which network companies price their electricity. As price regulation no longer exists, all the companies in the electricity sector set their tariffs independently, even network companies. The job of controlling the pricing of network services is handed by the Electricity Market Authority, following the principles of competition control. Pricing control takes place ex post - after a pricing system has been adopted by a company and concentrates on individual cases and companies. There is no ex ante system of setting or approving prices and tariffs by the regulator. The tariffs and pricing of network services can be evaluated, however, by both the Electricity Market Authority and the Finnish Competition Authority, which have overlapping powers as regards the pricing of network activities. The Finnish regulatory framework can be described as a system of light

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Greece

International Nuclear Information System (INIS)

2015-01-01

In Greece, there are no nuclear power plants and nuclear energy is not considered as an option in the foreseeable future. There is, however, one nuclear research reactor (in extended shutdown since 2014) and one sub-critical assembly. Radioactive waste originating from medicine, research and industry is classified as low level. Although there is no framework act dealing comprehensively with the different aspects of nuclear energy, there are various laws, decrees and regulations of a more specific nature governing several aspects of nuclear activities. This paper gives information on the general regulatory regime (mining regime, radioactive substances, nuclear fuel and equipment, nuclear installations (licensing and inspection, including nuclear safety, emergency response, trade in nuclear materials and equipment, radiation protection, radioactive waste management, nuclear security, transport, nuclear third party liability) and on the institutional framework with the regulatory and supervisory authorities (Greek Atomic Energy Commission (EEAE))

Characterization of a putative cis-regulatory element that controls transcriptional activity of the pig uroplakin II gene promoter

International Nuclear Information System (INIS)

Kwon, Deug-Nam; Park, Mi-Ryung; Park, Jong-Yi; Cho, Ssang-Goo; Park, Chankyu; Oh, Jae-Wook; Song, Hyuk; Kim, Jae-Hwan; Kim, Jin-Hoi

2011-01-01

Highlights: → The sequences of -604 to -84 bp of the pUPII promoter contained the region of a putative negative cis-regulatory element. → The core promoter was located in the 5F-1. → Transcription factor HNF4 can directly bind in the pUPII core promoter region, which plays a critical role in controlling promoter activity. → These features of the pUPII promoter are fundamental to development of a target-specific vector. -- Abstract: Uroplakin II (UPII) is a one of the integral membrane proteins synthesized as a major differentiation product of mammalian urothelium. UPII gene expression is bladder specific and differentiation dependent, but little is known about its transcription response elements and molecular mechanism. To identify the cis-regulatory elements in the pig UPII (pUPII) gene promoter region, we constructed pUPII 5' upstream region deletion mutants and demonstrated that each of the deletion mutants participates in controlling the expression of the pUPII gene in human bladder carcinoma RT4 cells. We also identified a new core promoter region and putative negative cis-regulatory element within a minimal promoter region. In addition, we showed that hepatocyte nuclear factor 4 (HNF4) can directly bind in the pUPII core promoter (5F-1) region, which plays a critical role in controlling promoter activity. Transient cotransfection experiments showed that HNF4 positively regulates pUPII gene promoter activity. Thus, the binding element and its binding protein, HNF4 transcription factor, may be involved in the mechanism that specifically regulates pUPII gene transcription.

Nuclear regulatory communication with the public: 10 years of progress

International Nuclear Information System (INIS)

Gauvain, J.; Jorle, A.; Chanial, L.

2008-01-01

The NEA has an acknowledged role to assist its member countries in maintaining and developing, through international co-operation, the scientific, technological and legal bases required for a safe, environmentally friendly and economical use of nuclear energy. In this context, the NEA Committee on Nuclear Regulatory Activities (CNRA) provides a forum for senior representatives from nuclear regulatory bodies to exchange information and experience on nuclear regulatory policies and practices in NEA member countries and to review developments which could affect regulatory requirements. Public confidence in government and in risk management structures is important to all developed countries with an open society. The use of nuclear power in a democracy is built upon a certain trust in the political system and the national authorities. To foster and maintain such trust in a period of greater public scrutiny of nuclear activities, a number of nuclear regulatory organisations (NROs) initiated various processes to pro-actively inform the public about their supervision and control of nuclear activities, or when appropriate to involve the public in decision making. In 1998 the question was raised within the CNRA of whether public trust in the regulator might be very different from one country to another, and an activity was started among member countries to exchange experience and best practices and to learn lessons about NRO communication with their publics. Three workshops were organised by the NEA, and a Working Group on Public Communication of Nuclear Regulatory Organisations was set up in 2001. The activities and findings are summarised below. (author)

Insect growth regulatory activity of Vitex trifolia and Vitex agnus-castus essential oils against Spilosoma obliqua.

Science.gov (United States)

Tandon, Shishir; Mittal, Ashutosh K; Pant, A K

2008-06-01

Essential oils of Vitex trifolia and Vitex agnus-castus were evaluated against Vth instar larvae of Spilosoma obliqua, when applied topically on the dorsal side of mesothoracic region, for insect growth regulatory activity. This treatment caused extended larval period and pupal period, increase in larval mortality and adult deformity and decrease in adult emergence, fecundity of female and egg fertility of test insect.

RMOD: a tool for regulatory motif detection in signaling network.

Directory of Open Access Journals (Sweden)

Jinki Kim

Full Text Available Regulatory motifs are patterns of activation and inhibition that appear repeatedly in various signaling networks and that show specific regulatory properties. However, the network structures of regulatory motifs are highly diverse and complex, rendering their identification difficult. Here, we present a RMOD, a web-based system for the identification of regulatory motifs and their properties in signaling networks. RMOD finds various network structures of regulatory motifs by compressing the signaling network and detecting the compressed forms of regulatory motifs. To apply it into a large-scale signaling network, it adopts a new subgraph search algorithm using a novel data structure called path-tree, which is a tree structure composed of isomorphic graphs of query regulatory motifs. This algorithm was evaluated using various sizes of signaling networks generated from the integration of various human signaling pathways and it showed that the speed and scalability of this algorithm outperforms those of other algorithms. RMOD includes interactive analysis and auxiliary tools that make it possible to manipulate the whole processes from building signaling network and query regulatory motifs to analyzing regulatory motifs with graphical illustration and summarized descriptions. As a result, RMOD provides an integrated view of the regulatory motifs and mechanism underlying their regulatory motif activities within the signaling network. RMOD is freely accessible online at the following URL: http://pks.kaist.ac.kr/rmod.

Annual Report 2007. Nuclear Regulatory Authority; Informe Anual 2007. Autoridad Regulatoria Nuclear

Energy Technology Data Exchange (ETDEWEB)

NONE

2008-07-01

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.

Annual Report 2008. Nuclear Regulatory Authority; Informe Anual 2008. Autoridad Regulatoria Nuclear

Energy Technology Data Exchange (ETDEWEB)

NONE

2009-07-01

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.

Improving regulatory oversight of maintenance programs

International Nuclear Information System (INIS)

Cook, S.

2008-01-01

Safe nuclear power plant operation requires that risks due to failure or unavailability of Structures, Systems and Components (SSCs) be minimized. Implementation of an effective maintenance program is a key means for achieving this goal. In its regulatory framework, the important relationship between maintenance and safety is acknowledged by the CNSC. A high level maintenance program requirement is included in the Class I Facilities Regulations. In addition, the operating licence contains a condition based on the principle that the design function and performance of SSCs needs to remain consistent with the plant's design and analysis documents. Nuclear power plant licensees have the primary responsibility for safe operation of their facilities and consequently for implementation of a successful maintenance program. The oversight role of the Canadian Nuclear Safety Commission (CNSC) is to ensure that the licensee carries out that responsibility. The challenge for the CNSC is how to do this consistently and efficiently. Three opportunities for improvement to regulatory maintenance oversight are being pursued. These are related to the regulatory framework, compliance verification inspection activities and monitoring of self-reporting. The regulatory framework has been improved by clarifying expectations through the issuance of S-210 'Maintenance Programs for Nuclear Power Plants'. Inspection activities have been improved by introducing new maintenance inspections into the baseline program. Monitoring is being improved by making better use of self-reported and industry produced maintenance related performance indicators. As with any type of program change, the challenge is to ensure the consistent and optimal application of regulatory activities and resources. This paper is a summary of the CNSC's approach to improving its maintenance oversight strategy. (author)

Status report on NRC's current below regulatory concern activities

International Nuclear Information System (INIS)

Dragonette, K.S.

1988-01-01

The concept of below regulatory concern (BRC) is not new to the Nuclear Regulatory Commission (NRC) or its predecessor agency, the Atomic Energy Commission. The regulations and licensing decisions have involved limited and de facto decisions on BRC since the beginning. For example, consumer products containing radioactive materials have been approved for distribution to persons exempt from licensing for some time and procedures for survey and release of equipment have traditionally been a part of many licensees' radiation safety programs. However, these actions have generally been ad hoc decisions in response to specific needs and have not been necessarily consistent. The need to deal with this regulatory matter has been receiving attention from both Congress and the NRC Commissioners. NRC response has grown from addressing specific waste streams, to generic rulemaking for wastes, and finally to efforts to develop a broad generic BRC policy. Section 10 of the Low-Level Radioactive Waste Policy Amendments Act of 1985 addressed NRC actions on specific waste streams. In response, NRC issued guidance on rulemaking petitions for specific wastes. NRC also issued an advance notice of proposed rulemaking indicating consideration of Commission initiated regulations to address BRC wastes in a generic manner. The Commissioners have directed staff to develop an umbrella policy for all agency decisions concerning levels of risk or dose that do not require government regulation

Nuclear regulatory developments in Canada

International Nuclear Information System (INIS)

Binder, M.

2012-01-01

This paper from CNSC discusses nuclear regulatory developments in Canada. It starts with the Fukushima accident and the effect on the nuclear sector. It summarises what CNSC has done, what it has learned and their plans going forward. It has made recommendations to IAEA for international enhancements to regulatory procedures. It outline the activities of Canada's nuclear power plants, Canada's uranium projects, deep geological repository and waste management as well as nuclear research in Canada.

Regulatory Assistance, Stakeholder Outreach, and Coastal and Marine Spatial Planning Activities in Support of Marine and Hydrokinetic Energy Deployment

Energy Technology Data Exchange (ETDEWEB)

Geerlofs, Simon H. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Copping, Andrea E. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Van Cleve, Frances B. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Blake, Kara M. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States); Hanna, Luke A. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

2011-09-01

This fiscal year 2011 progress report summarizes activities carried out under DOE Water Power Task 2.1.7, Permitting and Planning. Activities under Task 2.1.7 address the concerns of a wide range of stakeholders with an interest in the development of the marine and hydrokinetic (MHK) energy industry, including regulatory and resource management agencies, tribes, nongovernmental organizations, and industry.

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

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

International regulatory activities

International Nuclear Information System (INIS)

Anon.

2004-01-01

The 48. session of the IAEA general conference was held in Vienna from 20 to 24 september 2004 with the participation of delegates from 125 members states and representatives of various international organisations. A number of resolutions were adopted by the conference in the following fields: nuclear safety, radiation, transport and waste safety. The general conference also adopted a resolution on measures to protect against nuclear terrorism. The Director General decided in 2003 to appoint a group of experts to explore and advise on issues related to nuclear liability. This group called the International Expert Group on Nuclear Liability (I.N.L.E.X.) consists of 20 experts members from nuclear power and non nuclear power countries and from shipping and non shipping states. It serves three major functions: to create a forum of expertise to explore and advise on issues related to nuclear liability; to enhance global adherence by nuclear and non nuclear states to an effective nuclear liability regime, inter alia, on the basis of the convention on supplementary compensation for nuclear damage and the annex thereto, the Vienna convention on civil liability for nuclear damage, the Paris convention on third party liability in the field of nuclear energy, the joint protocol relating to the application of the vienna convention and the paris convention and the amendments thereto; and to assist in the development and strengthening of the national nuclear liability legal frameworks in IAEA members states to protect the public and the environment and to enhance nuclear safety. The second part of international regulatory concerns a directive on public access to environmental information made by the European Parliament. (N.C.)

Safety performance indicators used by the Russian Safety Regulatory Authority in its practical activities on nuclear power plant safety regulation

International Nuclear Information System (INIS)

Khazanov, A.L.

2005-01-01

The Sixth Department of the Nuclear, Industrial and Environmental Regulatory Authority of Russia, Scientific and Engineering Centre for Nuclear and Radiation Safety process, analyse and use the information on nuclear power plants (NPPs) operational experience or NPPs safety improvement. Safety performance indicators (SPIs), derived from processing of information on operational violations and analysis of annual NPP Safety Reports, are used as tools to determination of trends towards changing of characteristics of operational safety, to assess the effectiveness of corrective measures, to monitor and evaluate the current operational safety level of NPPs, to regulate NPP safety. This report includes a list of the basic SPIs, those used by the Russian safety regulatory authority in regulatory activity. Some of them are absent in list of IAEA-TECDOC-1141 ('Operational safety performance indicators for nuclear power plants'). (author)

Regulatory inspection activities on nuclear power plant sites during construction in the United Kingdom

International Nuclear Information System (INIS)

Jeffery, J.V.

1977-01-01

The work of regulatory inspection of the construction of the plant on the site is performed not only by the inspector who has been allocated to inspection duties for that site but also by the specialist staff who are involved with the safety assessment of the plant. The co-ordination of this work is described in the paper and examples are given of inspection activities associated with the enforcement requirements of licence conditions as well as those related to the inspection of the plant itself. (author)

Reactor aging research. United States Nuclear Regulatory Commission

International Nuclear Information System (INIS)

Vassilaros, M.G.

1998-01-01

The reactor ageing research activities in USA described, are focused on the research of reactor vessel integrity, including regulatory issues and technical aspects. Current emphasis are described for fracture analysis, embrittlement research, inspection capabilities, validation od annealing rule, revision of regulatory guide

Nuclear Regulatory Commission probabilistic risk assessment implementation program: A status report

International Nuclear Information System (INIS)

Rubin, M.P.; Caruso, M.A.

1996-01-01

The US Nuclear Regulatory Commission (NRC) is undertaking a number of activities intended to increase the consideration of risk significance in its decision processes and the effective use of risk-based technologies in its regulatory activities. Although the NRC is moving toward risk-informed regulation throughout its areas of responsibilities, this paper focuses primarily on those issues associated with reactor regulation. As the NRC completed significant milestones in its development of probabilistic risk assessment (PRA) methodology and gained considerable experience in the limited application of risk assessment to selected regulatory activities, it became evident that a much broader use of risk informed approaches offered advantages to both the NRC and the US commercial nuclear industry. This desire to enhance the use of risk assessment is driven by the clear belief that application of PRA methods will result in direct improvements in nuclear power plant operational safety from the perspective of both the regulator and the plant operator. The NRC believed that an overall policy on the use of PRA methods in nuclear regulatory activities should be established so that the many potential applications of PRA could be implemented in a consistent and predictable manner that would promote regulatory stability and efficiency. This paper describes the key activities that the NRC has undertaken to implement the initial stages of an integrated risk-informed regulatory framework

Robustness and accuracy in sea urchin developmental gene regulatory networks

Directory of Open Access Journals (Sweden)

Smadar eBen-Tabou De-Leon

2016-02-01

Full Text Available Developmental gene regulatory networks robustly control the timely activation of regulatory and differentiation genes. The structure of these networks underlies their capacity to buffer intrinsic and extrinsic noise and maintain embryonic morphology. Here I illustrate how the use of specific architectures by the sea urchin developmental regulatory networks enables the robust control of cell fate decisions. The Wnt-βcatenin signaling pathway patterns the primary embryonic axis while the BMP signaling pathway patterns the secondary embryonic axis in the sea urchin embryo and across bilateria. Interestingly, in the sea urchin in both cases, the signaling pathway that defines the axis controls directly the expression of a set of downstream regulatory genes. I propose that this direct activation of a set of regulatory genes enables a uniform regulatory response and a clear cut cell fate decision in the endoderm and in the dorsal ectoderm. The specification of the mesodermal pigment cell lineage is activated by Delta signaling that initiates a triple positive feedback loop that locks down the pigment specification state. I propose that the use of compound positive feedback circuitry provides the endodermal cells enough time to turn off mesodermal genes and ensures correct mesoderm vs. endoderm fate decision. Thus, I argue that understanding the control properties of repeatedly used regulatory architectures illuminates their role in embryogenesis and provides possible explanations to their resistance to evolutionary change.

Regulatory Models and the Environment: Practice, Pitfalls, and Prospects

Energy Technology Data Exchange (ETDEWEB)

Holmes, K. John; Graham, Judith A.; McKone, Thomas; Whipple, Chris

2008-06-01

Computational models support environmental regulatory activities by providing the regulator an ability to evaluate available knowledge, assess alternative regulations, and provide a framework to assess compliance. But all models face inherent uncertainties, because human and natural systems are always more complex and heterogeneous than can be captured in a model. Here we provide a summary discussion of the activities, findings, and recommendations of the National Research Council's Committee on Regulatory Environmental Models, a committee funded by the US Environmental Protection Agency to provide guidance on the use of computational models in the regulatory process. Modeling is a difficult enterprise even outside of the potentially adversarial regulatory environment. The demands grow when the regulatory requirements for accountability, transparency, public accessibility, and technical rigor are added to the challenges. Moreover, models cannot be validated (declared true) but instead should be evaluated with regard to their suitability as tools to address a specific question. The committee concluded that these characteristics make evaluation of a regulatory model more complex than simply comparing measurement data with model results. Evaluation also must balance the need for a model to be accurate with the need for a model to be reproducible, transparent, and useful for the regulatory decision at hand. Meeting these needs requires model evaluation to be applied over the"life cycle" of a regulatory model with an approach that includes different forms of peer review, uncertainty analysis, and extrapolation methods than for non-regulatory models.

Needs of research for regulatory purposes

International Nuclear Information System (INIS)

Wanner, H.

2010-01-01

Hans Wanner, Swiss Federal Nuclear Safety Inspectorate (ENSI), presented a general overview of regulatory research at the international level based on a preliminary input from international colleagues and observed that the question of active involvement of nuclear regulatory and supervisory bodies in R and D projects has become a topic of increasing interest in recent years even if the way in which research is included in regulatory activities varies from country to country. The range spans from countries with no regulatory R and D activities to countries with extensive activities that are often carried out by independent research organisations acting on behalf of the regulatory body. In a few countries, the regulator and implementer have their research carried out by the same research institutes. As an example H. Wanner explained the organisation of R and D work in Switzerland. He presented the potential merits of R and D work carried out by the regulator and introduced a number of questions that would gain from being addressed at an international level. He stressed that the R and D work performed by the implementer must be comprehensive and there should be, in principle, no need for complementary work by the regulatory body. Nevertheless, R and D work of the regulator has still several merits. It improves the regulator's necessary competence to review the safety case allowing it to rely on the scientific community. It provides the regulator's independence, allowing a different view on the safety case from the implementer's view. By bringing to the fore the scientific and technical ability of the regulator, R and D work by the regulator provides additional confidence to the stakeholders in the credibility of the regulator. There may exist further motivations for the regulator to carry out its own R and D projects, among which is the verification of key safety issues or the investigation of topics not addressed by the implementer, i.e., to fill scientific gaps. The

Annual Report 2009. Nuclear Regulatory Authority; Informe Anual 2009. Autoridad Regulatoria Nuclear

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-07-01

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.

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.

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

Regulatory activities related with the modification of the frequency of the programmed stoppings of the Argentine nuclear centrals

International Nuclear Information System (INIS)

Marino, E.; Calvo, J.; Waldman, R.; Navarro, R.

2006-01-01

The mandatory character documentation of the Argentinean nuclear power stations in Embalse and Atucha I, required the realization of a programmed stoppings every twelve months to execute that settled down in the maintenance and surveillance programs for each installation. Nucleoelectrica Argentina S.A., in it character of Responsible Entity of the operation of these power stations, requested to the Argentinean Nuclear Regulatory Authority, in 2003 and 2005 respectively, the authorization to change the period of the repetitive tests and of the preventive maintenance of the systems related with the safety, to extend them from twelve to eighteen months. The mentioned applications were founded in economic aspects and in inclining to a decrease in the doses of the workers that perform in the activities that are carried out in the programmed stops. The adopted position by the Nuclear Regulatory Authority to decide on these applications was based on the result of diverse evaluations that included the use of the Probabilistic Analysis of Safety specific of each power station, the operative experience resultant of the execution of the preventive maintenance program, and of the results of the repetitive tests and of the inspections in service. The regulatory decisions were different in each case. Indeed, the Embalse nuclear power station was authorized by the Regulatory Authority to modify from twelve to eighteen months the period among the realization of the repetitive tests and of the preventive maintenance, conditioned to the execution of some specific regulatory requirements. On the other hand, the Atucha I nuclear power station was not authorized to modify this period. In this presentation that is detailed the acted by the Nuclear Regulatory Authority in both cases, the used analysis tools, and the foundation of the adopted decisions. (Author)

Evolution of nuclear security regulatory activities in Brazil

International Nuclear Information System (INIS)

Mello, Luiz A. de; Monteiro Filho, Joselio S.; Belem, Lilia M.J.; Torres, Luiz F.B.

2009-01-01

The changing of the world scenario in the last 15 years has increased worldwide the concerns about overall security and, as a consequence, about the nuclear and radioactive material as well as their associated facilities. Considering the new situation, in February 2004, the Brazilian National Nuclear Energy Commission (CNEN), decided to create the Nuclear Security Office. This Office is under the Coordination of Nuclear Safeguards and Security, in the Directorate for Safety, Security and Safeguards (Regulatory Directorate). Before that, security regulation issues were dealt in a decentralized manner, within that Directorate, by different licensing groups in specific areas (power reactors, fuel cycle facilities, radioactive facilities, transport of nuclear material, etc.). This decision was made in order to allow a coordinated approach on the subject, to strengthen the regulation in nuclear/radioactive security, and to provide support to management in the definition of institutional security policies. The CNEN Security Office develops its work based in the CNEN Physical Protection Regulation for Nuclear Operational Units - NE-2.01, 1996, the Convention on the Physical Protection of Nuclear Material and the IAEA Nuclear Security Series . This paper aims at presenting the activities developed and the achievements obtained by this new CNEN office, as well as identifying the issues and directions for future efforts. (author)

Regulatory heterochronies and loose temporal scaling between sea star and sea urchin regulatory circuits.

Science.gov (United States)

Gildor, Tsvia; Hinman, Veronica; Ben-Tabou-De-Leon, Smadar

2017-01-01

It has long been argued that heterochrony, a change in relative timing of a developmental process, is a major source of evolutionary innovation. Heterochronic changes of regulatory gene activation could be the underlying molecular mechanism driving heterochronic changes through evolution. Here, we compare the temporal expression profiles of key regulatory circuits between sea urchin and sea star, representative of two classes of Echinoderms that shared a common ancestor about 500 million years ago. The morphologies of the sea urchin and sea star embryos are largely comparable, yet, differences in certain mesodermal cell types and ectodermal patterning result in distinct larval body plans. We generated high resolution temporal profiles of 17 mesodermally-, endodermally- and ectodermally-expressed regulatory genes in the sea star, Patiria miniata, and compared these to their orthologs in the Mediterranean sea urchin, Paracentrotus lividus. We found that the maternal to zygotic transition is delayed in the sea star compared to the sea urchin, in agreement with the longer cleavage stage in the sea star. Interestingly, the order of gene activation shows the highest variation in the relatively diverged mesodermal circuit, while the correlations of expression dynamics are the highest in the strongly conserved endodermal circuit. We detected loose scaling of the developmental rates of these species and observed interspecies heterochronies within all studied regulatory circuits. Thus, after 500 million years of parallel evolution, mild heterochronies between the species are frequently observed and the tight temporal scaling observed for closely related species no longer holds.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Germany

International Nuclear Information System (INIS)

2011-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment (Definitions; Licensing requirements); 4. Nuclear installations (Licensing regime; Protection of the environment against radiation effects; Emergency response; Surveillance of installations and activities); 5. Trade in nuclear materials and equipment; 6. Radiation protection (General; Principal elements of the Radiation Protection Ordinance; Additional radiation protection norms); 7. Radioactive waste management (Atomic Energy Act 2002; Radiation Protection Ordinance; International obligations); 8. Non-proliferation and physical protection (Non-proliferation regime; Physical protection regime); 9. Transport; 10. Nuclear third party liability; II. Institutional Framework: 1. Regulatory and supervisory authorities: Federal authorities (Federal Minister for the Environment, Nature Conservation and Nuclear Safety, Federal Minister for Education and Research, Federal Minister of Finance, Federal Minister of Transport, Building and Urban Affairs, Federal Minister for Economy and Technology, Federal Minister of Defence, Federal Office for Radiation Protection - BfS, Federal Office of Economics and Export Control); Authorities of the Laender; 2. Advisory bodies (Reactor Safety Commission - RSK; Radiation Protection Commission - SSK; Disposal Commission - ESK; Nuclear Technology

National legislative and regulatory activities

International Nuclear Information System (INIS)

2017-01-01

This section treats of the following National legislative and regulatory activities: 1 - Algeria, Nuclear safety and radiological protection, Executive Decree No. 17-126 of 27 March 2017; 2 - Belgium, Liability and compensation, Law of 7 December 2016 modifying the law of 22 July 1985 on third party liability in the field of nuclear energy; 3 - Canada, Liability and compensation, Ratification by Canada of the Convention on Supplementary Compensation for Nuclear Damage; 4 - France, Radioactive waste management: Decree No. 2017-231 of 23 February 2017 implementing Article L. 542-1-2 of the French Environmental Code (Code de l'environnement) and setting out the provisions of the National Radioactive Material and Waste Management Plan; and Order of 23 February 2017 implementing Decree No. 2017-231 of 23 February 2017 implementing Article L. 542-1-2 of the French Environmental Code setting out the provisions of the National Radioactive Material and Waste Management Plan; Liability and compensation: Order of 10 November 2016 amending the Appendix to the Order of 19 August 2016, setting the list of reduced liability amount sites pursuant to Decree No. 2016-333 of 21 March 2016 implementing Article L. 597-28 of the Environmental Code and relating to third party liability in the nuclear energy field; International co-operation: Decree No. 2016-1225 of 16 September 2016 making public the Protocol to the Co-operation Agreement between the Government of the French Republic and the Government of the Hashemite Kingdom of Jordan for the Development of the Pacific Uses of Nuclear Energy, signed in Paris on 27 August 2008; 5 - Germany, Transport of radioactive materials: New Versions of Ordinances on the Transport of Dangerous Goods (2017); Radioactive Waste Management: Act on the Reorganisation of the Responsibility of Nuclear Waste Disposal (2017); 6 - Lithuania, Nuclear security: Cyber security; Nuclear installations: Free release criteria of buildings and site of nuclear

Self-Regulatory Strategies as Correlates of Physical Activity Behavior in Persons With Multiple Sclerosis.

Science.gov (United States)

Cederberg, Katie L; Balto, Julia M; Motl, Robert W

2018-05-01

To examine self-regulation strategies as correlates of physical activity in persons with multiple sclerosis (MS). Cross-sectional, or survey, study. University-based research laboratory. Convenience sample of persons with MS (N=68). Not applicable. Exercise Self-Efficacy Scale (EXSE), 12-item Physical Activity Self-Regulation Scale (PASR-12), and Godin Leisure-Time Exercise Questionnaire (GLTEQ). Correlation analyses indicated that GLTEQ scores were positively and significantly associated with overall self-regulation (r=.43), self-monitoring (r=.45), goal-setting (r=.27), reinforcement (r=.30), time management (r=.41), and relapse prevention (r=.53) PASR-12 scores. Regression analyses indicated that relapse prevention (B=5.01; SE B=1.74; β=.51) and self-monitoring (B=3.65; SE B=1.71; β=.33) were unique predictors of physical activity behavior, and relapse prevention demonstrated a significant association with physical activity behavior that was accounted for by EXSE. Our results indicate that self-regulatory strategies, particularly relapse prevention, may be important correlates of physical activity behavior that can inform the design of future behavioral interventions in MS. Published by Elsevier Inc.

Survey by senior NRC management to obtain veiwpoints on the safety impact of regulatory activities from representative utilities operating and constructing nuclear power plants

International Nuclear Information System (INIS)

1981-08-01

A survey of licensee staff members representing the several organizational elements in different licensee corporate and plant staffs was conducted by senior NRC management to obtain licensee views on the potential safety consequences and impact of NRC regulatory activities. The comments received addressed the full scope of NRC activities and the negative impact of agency actions on licensee resources, staff performance, planning and scheduling, and organizational effectiveness. The findings of the survey is that the pace and nature of regulatory actions have created a potential safety problem which deserves further evaluation by the agency

Oncogenes Activate an Autonomous Transcriptional Regulatory Circuit That Drives Glioblastoma

Directory of Open Access Journals (Sweden)

Dinesh K. Singh

2017-01-01

Full Text Available Efforts to identify and target glioblastoma (GBM drivers have primarily focused on receptor tyrosine kinases (RTKs. Clinical benefits, however, have been elusive. Here, we identify an SRY-related box 2 (SOX2 transcriptional regulatory network that is independent of upstream RTKs and capable of driving glioma-initiating cells. We identified oligodendrocyte lineage transcription factor 2 (OLIG2 and zinc-finger E-box binding homeobox 1 (ZEB1, which are frequently co-expressed irrespective of driver mutations, as potential SOX2 targets. In murine glioma models, we show that different combinations of tumor suppressor and oncogene mutations can activate Sox2, Olig2, and Zeb1 expression. We demonstrate that ectopic co-expression of the three transcription factors can transform tumor-suppressor-deficient astrocytes into glioma-initiating cells in the absence of an upstream RTK oncogene. Finally, we demonstrate that the transcriptional inhibitor mithramycin downregulates SOX2 and its target genes, resulting in markedly reduced proliferation of GBM cells in vivo.

Nuclear knowledge management system in the regulatory activity

International Nuclear Information System (INIS)

Nosovskij, A.V.; Klevtsov, A.L.; Kravchenko, N.A.

2010-01-01

Important issues on collection, storage and spread of knowledge among organisation dealing with the use of nuclear technologies, role of close cooperation between enterprises and organizations in developing knowledge management, general requirements for creating a nuclear knowledge management system are considered. Recommendations and the main mechanisms are identified to create the knowledge management system in technical support organizations of the regulatory authority.

An activating mutation of interferon regulatory factor 4 (IRF4) in adult T cell leukemia.

Science.gov (United States)

Cherian, Mathew A; Olson, Sydney; Sundaramoorthi, Hemalatha; Cates, Kitra; Cheng, Xiaogang; Harding, John; Martens, Andrew; Challen, Grant A; Tyagi, Manoj; Ratner, Lee; Rauch, Daniel

2018-03-14

The human T cell leukemia virus-1 (HTLV-1) oncoprotein Tax drives cell proliferation and resistance to apoptosis early in the pathogenesis of adult T-cell leukemia (ATL). Subsequently, likely as a result of specific immuno-editing, Tax expression is downregulated and functionally replaced by somatic driver mutations of the host genome. Both amplification and point mutations of interferon regulatory factor 4 (IRF4) have been previously detected in ATL, and the K59R mutation is the most common single-nucleotide variation in IRF4 and is found exclusively in ATL. Here high throughput whole-exome sequencing revealed recurrent activating genetic alterations in the T cell receptor, CD28, and NF-kB pathways. Moreover, we found that IRF4, which is transcriptionally activated downstream of these pathways, is frequently mutated in ATL. IRF4 RNA, protein, and IRF4 transcriptional targets are uniformly elevated in HTLV transformed cells and ATL cell lines, and IRF4 was bound to genomic regulatory DNA of many of these transcriptional targets in HTLV-1 transformed cell lines. We further noted that the K59R IRF4 mutant is expressed at higher levels in the nucleus than is wild-type IRF4, and is transcriptionally more active. Expression of both wild-type and the K59R mutant of IRF4 from a constitutive promoter in retrovirally transduced murine bone marrow cells increased the abundance of T lymphocytes but not myeloid cells or B lymphocytes in mice. IRF4 may represent a therapeutic target in ATL since ATL cells select for a mutant of IRF4 with higher nuclear expression and transcriptional activity, and over-expression of IRF4 induces the expansion of T lymphocytes in vivo. Published under license by The American Society for Biochemistry and Molecular Biology, Inc.

Computational Studies of the Active and Inactive Regulatory Domains of Response Regulator PhoP Using Molecular Dynamics Simulations.

Science.gov (United States)

Qing, Xiao-Yu; Steenackers, Hans; Venken, Tom; De Maeyer, Marc; Voet, Arnout

2017-11-01

The response regulator PhoP is part of the PhoP/PhoQ two-component system, which is responsible for regulating the expression of multiple genes involved in controlling virulence, biofilm formation, and resistance to antimicrobial peptides. Therefore, modulating the transcriptional function of the PhoP protein is a promising strategy for developing new antimicrobial agents. There is evidence suggesting that phosphorylation-mediated dimerization in the regulatory domain of PhoP is essential for its transcriptional function. Disruption or stabilization of protein-protein interactions at the dimerization interface may inhibit or enhance the expression of PhoP-dependent genes. In this study, we performed molecular dynamics simulations on the active and inactive dimers and monomers of the PhoP regulatory domains, followed by pocket-detecting screenings and a quantitative hot-spot analysis in order to assess the druggability of the protein. Consistent with prior hypothesis, the calculation of the binding free energy shows that phosphorylation enhances dimerization of PhoP. Furthermore, we have identified two different putative binding sites at the dimerization active site (the α4-β5-α5 face) with energetic "hot-spot" areas, which could be used to search for modulators of protein-protein interactions. This study delivers insight into the dynamics and druggability of the dimerization interface of the PhoP regulatory domain, and may serve as a basis for the rational identification of new antimicrobial drugs. © 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Weinheim.

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

Barcoded DNA-tag reporters for multiplex cis-regulatory analysis.

Directory of Open Access Journals (Sweden)

Jongmin Nam

Full Text Available Cis-regulatory DNA sequences causally mediate patterns of gene expression, but efficient experimental analysis of these control systems has remained challenging. Here we develop a new version of "barcoded" DNA-tag reporters, "Nanotags" that permit simultaneous quantitative analysis of up to 130 distinct cis-regulatory modules (CRMs. The activities of these reporters are measured in single experiments by the NanoString RNA counting method and other quantitative procedures. We demonstrate the efficiency of the Nanotag method by simultaneously measuring hourly temporal activities of 126 CRMs from 46 genes in the developing sea urchin embryo, otherwise a virtually impossible task. Nanotags are also used in gene perturbation experiments to reveal cis-regulatory responses of many CRMs at once. Nanotag methodology can be applied to many research areas, ranging from gene regulatory networks to functional and evolutionary genomics.

77 FR 58022 - Montana Regulatory Program

Science.gov (United States)

2012-09-19

... precludes in situ gasification projects from including carbon capture and sequestration (CCS) under the... Conservation as the regulatory authority for CCS activities within the State. SB498 generally established that..., the Board would regulate any proposed CCS activities appropriately. CCS operations have potential...

Regulatory control of nuclear power plants

International Nuclear Information System (INIS)

2002-01-01

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

Generation of dTALEs and Libraries of Synthetic TALE-Activated Promoters for Engineering of Gene Regulatory Networks in Plants.

Science.gov (United States)

Schreiber, Tom; Tissier, Alain

2017-01-01

Transcription factors with programmable DNA-binding specificity constitute valuable tools for the design of orthogonal gene regulatory networks for synthetic biology. Transcription activator-like effectors (TALEs), as natural transcription regulators, were used to design, build, and test libraries of synthetic TALE-activated promoters (STAPs) that show a broad range of expression levels in plants. In this chapter, we present protocols for the construction of artificial TALEs and corresponding STAPs.

Regulatory framework for the management of radioactive wastes in Argentina

International Nuclear Information System (INIS)

D'Amato, E.; Siraky, G.; Petraitis, E.; Novo, R.

2000-01-01

The legal and regulatory framework within which the radioactive waste management is carried out in Argentina are exposed. The activities of the Nuclear Regulatory Authority (ARN) in relation to facility inspections, safety assessments and collaboration with international agencies in the matter are also presented. Further, the regulatory criteria applied to waste management are reported. (author)

Deficient regulatory T cell activity and low frequency of IL-17-producing T cells correlate with the extent of cardiomyopathy in human Chagas' disease.

Directory of Open Access Journals (Sweden)

Paulo Marcos Matta Guedes

Full Text Available BACKGROUND: Myocardium damage during Chagas' disease results from the immunological imbalance between pro- and production of anti-inflammatory cytokines and has been explained based on the Th1-Th2 dichotomy and regulatory T cell activity. Recently, we demonstrated that IL-17 produced during experimental T. cruzi infection regulates Th1 cells differentiation and parasite induced myocarditis. Here, we investigated the role of IL-17 and regulatory T cell during human Chagas' disease. METHODOLOGY/PRINCIPAL FINDINGS: First, we observed CD4(+IL-17(+ T cells in culture of peripheral blood mononuclear cells (PBMC from Chagas' disease patients and we evaluated Th1, Th2, Th17 cytokine profile production in the PBMC cells from Chagas' disease patients (cardiomyopathy-free, and with mild, moderate or severe cardiomyopathy cultured with T. cruzi antigen. Cultures of PBMC from patients with moderate and severe cardiomyopathy produced high levels of TNF-α, IFN-γ and low levels of IL-10, when compared to mild cardiomyopathy or cardiomyopathy-free patients. Flow cytometry analysis showed higher CD4(+IL-17(+ cells in PBMC cultured from patients without or with mild cardiomyopathy, in comparison to patients with moderate or severe cardiomyopathy. We then analyzed the presence and function of regulatory T cells in all patients. All groups of Chagas' disease patients presented the same frequency of CD4(+CD25(+ regulatory T cells. However, CD4(+CD25(+ T cells from patients with mild cardiomyopathy or cardiomyopathy-free showed higher suppressive activity than those with moderate and severe cardiomyopathy. IFN-γ levels during chronic Chagas' disease are inversely correlated to the LVEF (P = 0.007, r = -0.614, while regulatory T cell activity is directly correlated with LVEF (P = 0.022, r = 0.500. CONCLUSION/SIGNIFICANCE: These results indicate that reduced production of the cytokines IL-10 and IL-17 in association with high levels of IFN-γ and TNF

Protection of people and environment from radiation risk through good regulatory practice

Science.gov (United States)

Jais, Azlina Mohammad; Hassan, Najwa

2017-01-01

The term "good regulatory practice" has seen growing frequency of usage worldwide, especially since the 2011 Fukushima nuclear incident. However, the term appears quite ambiguous as it may mean differently to different people. This leads us to the first important question: what does "good regulatory practice" actually mean? When used in conjunction with the Fukushima incident, do we imply that there is an absence of "good regulatory practice" in the Japanese' Nuclear and Industry Safety Agency (NISA)? This is quite troubling. It is clear that the term should be defined formally so that our understanding of "good regulatory practice" can be standardized. There is still another important question beyond agreeing on what "good regulatory practice" is: is "good regulatory practice" specific to a region, or is it global? And is it applicable only to nuclear regulators, or to all types of regulators per se? This paper aims to deliberate on the above mentioned questions. Specifically, we hope to discuss the "good regulatory practice" for atomic energy activities in order to protect the people and the environment from radiation risk of such activities. By understanding what "good regulatory practice" truly means, a newcomer country such as Malaysia can quickly learn and adopt these practices so as to assure a competent national nuclear regulatory authority who will be responsible in ensuring the safety, security and safeguards of peaceful atomic energy activities in the country including nuclear liability. In understanding this concept, a holistic approach will be taken by looking into example of advanced and newcomer countries of various nuclear regulatory authorities all around the world. Then the paper will focus on the challenges that the current nuclear regulatory authority in Malaysia which is Atomic Energy Licensing Board has, its challenges to follow the concept of "good regulatory practice" and its ways to overcome it. This study explore the initiatives could be

Targeting regulatory T cells in cancer.

LENUS (Irish Health Repository)

Byrne, William L

2012-01-31

Infiltration of tumors by regulatory T cells confers growth and metastatic advantages by inhibiting antitumor immunity and by production of receptor activator of NF-kappaB (RANK) ligand, which may directly stimulate metastatic propagation of RANK-expressing cancer cells. Modulation of regulatory T cells can enhance the efficacy of cancer immunotherapy. Strategies include depletion, interference with function, inhibition of tumoral migration, and exploitation of T-cell plasticity. Problems with these strategies include a lack of specificity, resulting in depletion of antitumor effector T cells or global interruption of regulatory T cells, which may predispose to autoimmune diseases. Emerging technologies, such as RNA interference and tetramer-based targeting, may have the potential to improve selectivity and efficacy.

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - Italy

International Nuclear Information System (INIS)

2010-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General regulatory regime: 1. Introduction; 2. Mining regime; 3. Radioactive substances, nuclear fuel and equipment; 4. Nuclear installations (Licensing and inspection, including nuclear safety; Protection of the environment against radiation effects; Emergency response); 5. Trade in nuclear materials and equipment (General provisions; Patents); 6. Radiation Protection (Protection of workers; Protection of the public; Protection of the environment); 7. Radioactive Waste Management; 8. Non-proliferation and physical protection; 9. Transport; 10. Nuclear Third Party Liability; II. Institutional Framework: 1. Regulatory and supervisory authorities (Interdepartmental Committee for Economic Planning; Nuclear Safety Agency; Prime Minister; Minister for Economic Development; Minister for Labour and Social Security; Minister for Health; Minister for the Environment; Minister for the Interior; Minister for Transport and Navigation; Minister for Foreign Trade (now incorporated in Ministry for Economic Development); Minister for Education; Treasury Minister; Minister for Universities and for Scientific and Technical Research; Minister for Foreign Affairs; State Advocate General); 2. Advisory bodies (Inter-ministerial Council for Consultation and Co-ordination; Coordinating Committee for Radiation Protection of Workers and the Public; Regional and Provincial Commissions for Public Health Protection

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

International Nuclear Information System (INIS)

Johnson, R.L.

1994-01-01

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

Environmental Regulatory Update Table, May/June 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number sign}.

Environmental Regulatory Update Table, May/June 1992

Energy Technology Data Exchange (ETDEWEB)

Houlberg, L.M.; Hawkins, G.T.; Lewis, E.B.; Salk, M.S.

1992-07-01

This report contains a bi-monthly update of environmental regulatory activity that is of interest to the Department of Energy. It is provided to DOE operations and contractor staff to assist and support environmental management programs by tracking regulatory developments. Any proposed regulation that raises significant issues for any DOE operation should be reported to the Office of Environmental Guidance (EH-23) as soon as possible so that the Department can make its concerns known to the appropriate regulatory agency. Items of particular interest to EH-23 are indicated by a shading of the RU{number_sign}.

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

ChIP-Seq-Annotated Heliconius erato Genome Highlights Patterns of cis-Regulatory Evolution in Lepidoptera

Directory of Open Access Journals (Sweden)

James J. Lewis

2016-09-01

Full Text Available Uncovering phylogenetic patterns of cis-regulatory evolution remains a fundamental goal for evolutionary and developmental biology. Here, we characterize the evolution of regulatory loci in butterflies and moths using chromatin immunoprecipitation sequencing (ChIP-seq annotation of regulatory elements across three stages of head development. In the process we provide a high-quality, functionally annotated genome assembly for the butterfly, Heliconius erato. Comparing cis-regulatory element conservation across six lepidopteran genomes, we find that regulatory sequences evolve at a pace similar to that of protein-coding regions. We also observe that elements active at multiple developmental stages are markedly more conserved than elements with stage-specific activity. Surprisingly, we also find that stage-specific proximal and distal regulatory elements evolve at nearly identical rates. Our study provides a benchmark for genome-wide patterns of regulatory element evolution in insects, and it shows that developmental timing of activity strongly predicts patterns of regulatory sequence evolution.

Measuring and Modeling the U.S. Regulatory Ecosystem

Science.gov (United States)

Bommarito, Michael J., II; Katz, Daniel Martin

2017-09-01

Over the last 23 years, the U.S. Securities and Exchange Commission has required over 34,000 companies to file over 165,000 annual reports. These reports, the so-called "Form 10-Ks," contain a characterization of a company's financial performance and its risks, including the regulatory environment in which a company operates. In this paper, we analyze over 4.5 million references to U.S. Federal Acts and Agencies contained within these reports to measure the regulatory ecosystem, in which companies are organisms inhabiting a regulatory environment. While individuals across the political, economic, and academic world frequently refer to trends in this regulatory ecosystem, far less attention has been paid to supporting such claims with large-scale, longitudinal data. In this paper, in addition to positing a model of regulatory ecosystems, we document an increase in the regulatory energy per filing, i.e., a warming "temperature." We also find that the diversity of the regulatory ecosystem has been increasing over the past two decades. These findings support the claim that regulatory activity and complexity are increasing, and this framework contributes an important step towards improving academic and policy discussions around legal complexity and regulation.

Enabling legislation and regulatory determinations for a nuclear power programme

International Nuclear Information System (INIS)

Ha Vinh Phuong

1977-01-01

General remarks on objectives and scope of enabling legislation, on the regulatory body and on the IAEA activities and assistance in regulatory matters e.g. the IAEA Safety Guides which are in preparation. (HP) [de

The regulatory control of radioactive sources in Argentina

International Nuclear Information System (INIS)

Rojkind, Roberto Hector

1997-01-01

Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author)

GARP (LRRC32) is essential for the surface expression of latent TGF-β on platelets and activated FOXP3+ regulatory T cells

OpenAIRE

Tran, Dat Q.; Andersson, John; Wang, Rui; Ramsey, Heather; Unutmaz, Derya; Shevach, Ethan M.

2009-01-01

TGF-β family members are highly pleiotropic cytokines with diverse regulatory functions. TGF-β is normally found in the latent form associated with latency-associated peptide (LAP). This latent complex can associate with latent TGFβ-binding protein (LTBP) to produce a large latent form. Latent TGF-β is also found on the surface of activated FOXP3+ regulatory T cells (Tregs), but it is unclear how it is anchored to the cell membrane. We show that GARP or LRRC32, a leucine-rich repeat molecule ...

Localizing potentially active post-transcriptional regulations in the Ewing's sarcoma gene regulatory network

Directory of Open Access Journals (Sweden)

Delyon Bernard

2010-11-01

Full Text Available Abstract Background A wide range of techniques is now available for analyzing regulatory networks. Nonetheless, most of these techniques fail to interpret large-scale transcriptional data at the post-translational level. Results We address the question of using large-scale transcriptomic observation of a system perturbation to analyze a regulatory network which contained several types of interactions - transcriptional and post-translational. Our method consisted of post-processing the outputs of an open-source tool named BioQuali - an automatic constraint-based analysis mimicking biologist's local reasoning on a large scale. The post-processing relied on differences in the behavior of the transcriptional and post-translational levels in the network. As a case study, we analyzed a network representation of the genes and proteins controlled by an oncogene in the context of Ewing's sarcoma. The analysis allowed us to pinpoint active interactions specific to this cancer. We also identified the parts of the network which were incomplete and should be submitted for further investigation. Conclusions The proposed approach is effective for the qualitative analysis of cancer networks. It allows the integrative use of experimental data of various types in order to identify the specific information that should be considered a priority in the initial - and possibly very large - experimental dataset. Iteratively, new dataset can be introduced into the analysis to improve the network representation and make it more specific.

Safety research programs sponsored by Office of Nuclear Regulatory Research

International Nuclear Information System (INIS)

Weiss, A.J.; Azarm, A.; Baum, J.W.

1989-07-01

This progress report describes current activities and technical progress in the programs at Brookhaven National Laboratory sponsored by the Division of Regulatory Applications, Division of Engineering, Division of Safety Issue Resolution, and Division of Systems Research of the US Nuclear Regulatory Commission, Office of Nuclear Regulatory Research following the reorganization in July 1988. The previous reports have covered the period October 1, 1976 through September 30, 1988

CD147 (Basigin/Emmprin) identifies FoxP3+CD45RO+CTLA4+-activated human regulatory T cells.

Science.gov (United States)

Solstad, Therese; Bains, Simer Jit; Landskron, Johannes; Aandahl, Einar Martin; Thiede, Bernd; Taskén, Kjetil; Torgersen, Knut Martin

2011-11-10

Human CD4(+)FoxP3(+) T cells are functionally and phenotypically heterogeneous providing plasticity to immune activation and regulation. To better understand the functional dynamics within this subset, we first used a combined strategy of subcellular fractionation and proteomics to describe differences at the protein level between highly purified human CD4(+)CD25(+) and CD4(+)CD25(-) T-cell populations. This identified a set of membrane proteins highly expressed on the cell surface of human regulatory T cells (Tregs), including CD71, CD95, CD147, and CD148. CD147 (Basigin or Emmprin) divided CD4(+)CD25(+) cells into distinct subsets. Furthermore, CD147, CD25, FoxP3, and in particular CTLA-4 expression correlated. Phenotypical and functional analyses suggested that CD147 marks the switch between resting (CD45RA(+)) and activated (CD45RO(+)) subsets within the FoxP3(+) T-cell population. Sorting of regulatory T cells into CD147(-) and CD147(+) populations demonstrated that CD147 identifies an activated and highly suppressive CD45RO(+) Treg subset. When analyzing CD4(+) T cells for their cytokine producing potential, CD147 levels grouped the FoxP3(+) subset into 3 categories with different ability to produce IL-2, TNF-α, IFN-γ, and IL-17. Together, this suggests that CD147 is a direct marker for activated Tregs within the CD4(+)FoxP3(+) subset and may provide means to manipulate cells important for immune homeostasis.

Using the IRRS to Strengthen Regulatory Competence in Ireland

International Nuclear Information System (INIS)

Smith, K.

2016-01-01

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

Nuclear regulatory organisations: Learning from stakeholders to enhance communication

International Nuclear Information System (INIS)

Lorin, Aurelie

2015-01-01

Since its creation 15 years ago, the NEA Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) has been addressing a broad range of communication issues, with two reports recently issued on Nuclear Regulatory Organisations, the Internet and Social Media: The What, How and Why of Their Use as Communication Tools and on Nuclear Regulatory Organisations and Communication Strategies. After the Fukushima Daiichi nuclear power plant accident in 2011, nuclear regulatory organisations around the world reaffirmed the need to strengthen stakeholder outreach and communication, and to create more robust avenues for stakeholder involvement in regulatory matters. The WGPC proposed a means for stakeholders to play a more active role in the group by holding one-day workshops in conjunction with regular meetings. These workshops offer a platform for stakeholder exchange with communication experts from nuclear regulatory organisations (NROs). The objective is to stimulate co-operation and improve communication by better understanding stakeholder perceptions, needs and expectations, and by discussing how to use traditional and social media more effectively. While nuclear regulatory organisations may have a common willingness to improve their communication methods and to build constructive relationships with stakeholders, every country has its own practices and cultural background, and thus its own challenges. Following the first workshop in Paris, which brought together European stakeholders, and the second in North America, the NEA is now organising a third workshop in Asia (Japan) to be held in April 2016. This third workshop will enable the NEA to gather stakeholder views from a third continent. A report on the workshops' findings will be issued after the completion of this third workshop, thus giving a broader idea of how to improve the overall communication methods of nuclear regulatory

Regulatory review of safety cases and safety assessments for near surface

International Nuclear Information System (INIS)

Nys, V.

2003-01-01

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

Regulatory framework for nuclear power plant operation

International Nuclear Information System (INIS)

Perez Alcaniz, T.; Esteban Barriendos, M.

1995-01-01

As the framework of standards and requirements covering each phase of nuclear power plant project and operation developed, plant owners defined their licensing commitments (codes, rules and design requirements) during the project and construction phase before start-up and incorporated regulatory requirements imposed by the regulatory Body during the licensing process prior to operation. This produces a regulatory framework for operating a plant. It includes the Licensing Basis, which is the starting point for analyzing and incorporating new requirements, and for re-evaluation of existing ones. This presentation focuses on the problems of applying this regulatory framework to new operating activities, in particular to new projects, analyzing new requirements, and reconsidering existing ones. Clearly establishing a plant's licensing basis allows all organizations involved in plant operation to apply the requirements in a more rational way. (Author)

Current and future applications of PRA in regulatory activities

Energy Technology Data Exchange (ETDEWEB)

Speis, T.P.; Murphy, J.A.; Cunningham, M.A. [Nuclear Regulatory Commission, Washington, DC (United States)] [and others

1995-04-01

Probabilistic Risk Assessments (PRAs) have proven valuable in providing the regulators, the nuclear plant operators, and the reactor designers insights into plant safety, reliability, design and operation. Both the NRC Commissioners and the staff have grown to appreciate the valuable contributions PRAs can have in the regulatory arena, though I will admit the existence of some tendencies for strict adherence to the deterministic approach within the agency and the public at large. Any call for change, particularly one involving a major adjustment in approach to the regulation of nuclear power, will meet with a certain degree of resistance and retrenchment. Change can appear threatening and can cause some to question whether the safety mission is being fulfilled. This skepticism is completely appropriate and is, in fact, essential to a proper transition towards risk and performance-based approaches. Our task in the Office of Nuclear Regulatory Research is to increase the PRA knowledge base within the agency and develop appropriate guidance and methods needed to support the transitioning process.

Dual regulatory switch confers tighter control on HtrA2 proteolytic activity.

Science.gov (United States)

Singh, Nitu; D'Souza, Areetha; Cholleti, Anuradha; Sastry, G Madhavi; Bose, Kakoli

2014-05-01

High-temperature requirement protease A2 (HtrA2), a multitasking serine protease that is involved in critical biological functions and pathogenicity, such as apoptosis and cancer, is a potent therapeutic target. It is established that the C-terminal post-synaptic density protein, Drosophila disc large tumor suppressor, zonula occludens-1 protein (PDZ) domain of HtrA2 plays pivotal role in allosteric modulation, substrate binding and activation, as commonly reported in other members of this family. Interestingly, HtrA2 exhibits an additional level of functional modulation through its unique N-terminus, as is evident from 'inhibitor of apoptosis proteins' binding and cleavage. This phenomenon emphasizes multiple activation mechanisms, which so far remain elusive. Using conformational dynamics, binding kinetics and enzymology studies, we addressed this complex behavior with respect to defining its global mode of regulation and activity. Our findings distinctly demonstrate a novel N-terminal ligand-mediated triggering of an allosteric switch essential for transforming HtrA2 to a proteolytically competent state in a PDZ-independent yet synergistic activation process. Dynamic analyses suggested that it occurs through a series of coordinated structural reorganizations at distal regulatory loops (L3, LD, L1), leading to a population shift towards the relaxed conformer. This precise synergistic coordination among different domains might be physiologically relevant to enable tighter control upon HtrA2 activation for fostering its diverse cellular functions. Understanding this complex rheostatic dual switch mechanism offers an opportunity for targeting various disease conditions with tailored site-specific effector molecules. © 2014 FEBS.

Regulatory barriers for activating flexibility in the Nordic-Baltic electricity market

DEFF Research Database (Denmark)

Bergaentzlé, Claire; Skytte, Klaus; Soysal, Emilie Rosenlund

2017-01-01

to flexibility. We find that the most restrictive barriers against flexibility are emitted by public authorities as part of broader policy strategies. Overall, we find that current regulatory and market framework conditions do not hinder flexibility. However, despite that, flexibility remains limited due......, load adjustment or to a greater coupling to other energy sectors. In this paper, we identify the framework conditions that influence the provision of VRE-friendly flexibility in the Nordic and Baltic electricity sector, i.e., the market and regulatory settings that act as drivers or barriers...... to a lack of coherent instruments intended to both the demand and supply-side to effectively act flexibly....

Regulatory coiled-coil domains promote head-to-head assemblies of AAA+ chaperones essential for tunable activity control.

Science.gov (United States)

Carroni, Marta; Franke, Kamila B; Maurer, Michael; Jäger, Jasmin; Hantke, Ingo; Gloge, Felix; Linder, Daniela; Gremer, Sebastian; Turgay, Kürşad; Bukau, Bernd; Mogk, Axel

2017-11-22

Ring-forming AAA+ chaperones exert ATP-fueled substrate unfolding by threading through a central pore. This activity is potentially harmful requiring mechanisms for tight repression and substrate-specific activation. The AAA+ chaperone ClpC with the peptidase ClpP forms a bacterial protease essential to virulence and stress resistance. The adaptor MecA activates ClpC by targeting substrates and stimulating ClpC ATPase activity. We show how ClpC is repressed in its ground state by determining ClpC cryo-EM structures with and without MecA. ClpC forms large two-helical assemblies that associate via head-to-head contacts between coiled-coil middle domains (MDs). MecA converts this resting state to an active planar ring structure by binding to MD interaction sites. Loss of ClpC repression in MD mutants causes constitutive activation and severe cellular toxicity. These findings unravel an unexpected regulatory concept executed by coiled-coil MDs to tightly control AAA+ chaperone activity.

The regulatory control of radioactive sources in Argentina

International Nuclear Information System (INIS)

Rojkind, R.H.

1998-01-01

Argentina has been conducting nuclear activities for more than forty years, and had established a Regulatory Authority as early as in 1956. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations were in force in Argentina before the accident in Goiania. The conclusions drawn from the Goiania accident encouraged the Argentine authorities to improve some regulatory procedures and helped to enhance the quality of the regulatory process. As a result, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain have improved. Lessons learned in Argentina from the accident in Goiania are presented as well as the main characteristics of an effective enforcement programme to prevent radiological accidents when radioactive sources are used for industrial, medical, research and teaching purposes. (author)

Summary of worldwide pediatric malignancies reported after exposure to etanercept

Directory of Open Access Journals (Sweden)

Chernyukhin Nataliya

2010-06-01

Full Text Available Abstract Background Concerns have been raised about a potential link between the use of TNF inhibitors and development of malignancy in the pediatric population. We examined the worldwide experience of etanercept use in pediatric patients and the occurrence of malignancies as reported from clinical trials, registry studies, post-marketing surveillance, and published scientific literature. Methods All reports of "malignancy" in pediatric patients (including subjects who received etanercept before age 18 and developed a malignancy before age 22 were collected from the etanercept clinical trials database and global safety database using the Medical Dictionary for Regulatory Activities (MedDRA; v12.0 standardized MedDRA query "Malignancies" from 1998 to August 2009. Cases were collected irrespective of treatment indication. All cases were included regardless of exposure to other TNF blockers or other biologics and whether the other exposure was before or after etanercept. Results A total of 18 potential malignancies were identified: 4 leukemias, 7 lymphomas, and 7 solid tumors. Three of the 18 malignancies remain unconfirmed. No malignancies were reported from clinical trials or the open-label extension studies in any indication in children. Conclusion The data suggest that there does not appear to be an increased risk of malignancy overall with the use of etanercept. Among etanercept-exposed patients aged 4 to 17 years, the estimated worldwide and US reporting rates for lymphoma were approximately 0.01 per 100 patient-years (1 in 10,000 pt-yrs. While the reported rate of lymphoma is higher in pediatric patients treated with etanercept than in normal children, the expected rate of lymphoma in biologic naïve JIA patients is currently unknown. The risk of TNF inhibitors in the development of malignancies in children and adolescents is difficult to assess because of the rarity of malignant events, the absence of knowledge of underlying frequency of

Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

Science.gov (United States)

Fukuda, Akiho; Tahara, Kohei; Hane, Yuuki; Matsui, Toshinobu; Sasaoka, Sayaka; Hatahira, Haruna; Motooka, Yumi; Hasegawa, Shiori; Naganuma, Misa; Abe, Junko; Nakao, Satoshi; Takeuchi, Hirofumi; Nakamura, Mitsuhiro

2017-01-01

Doxorubicin (DOX) is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS) databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS). This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA) and the standardized MedDRA Queries (SMQ) database. We also calculated the reporting odds ratios (RORs) of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX). The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI) from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68), 6.43 (5.81-7.13), and 14.73 (11.42-18.99), respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI) for palmar-plantar erythrodysesthesia (PPE) associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07), 64.77 (56.84-73.80), and 28.76 (15.77-52.45), respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

Comparison of the adverse event profiles of conventional and liposomal formulations of doxorubicin using the FDA adverse event reporting system.

Directory of Open Access Journals (Sweden)

Akiho Fukuda

Full Text Available Doxorubicin (DOX is an anthracycline widely used for the treatment of solid and hematological tumors. The aim of this study was to assess the adverse event profiles of conventional DOX and liposomal DOX. This is the first study to evaluate the effect of a liposomal formulation of DOX using spontaneous reporting system (SRS databases. The SRS used was the US Food and Drug Administration Adverse Event Reporting System (FAERS. This study relied on definitions of preferred terms provided by the Medical Dictionary for Regulatory Activities (MedDRA and the standardized MedDRA Queries (SMQ database. We also calculated the reporting odds ratios (RORs of suspected drugs (conventional DOX; PEGylated-liposome DOX; non-PEGylated-liposome DOX. The FAERS database contained 7,561,254 reports from January 2004 to December 2015. The number of reported AE cases for conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX was 5039, 3780, and 349, respectively. Conventional DOX and liposomal DOX have potential risks of causing myelosuppression, cardiotoxicity, alopecia, nausea, and vomiting, among other effects. The RORs (95% CI from SMQ for haematopoietic leucopenia associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 12.75 (11.89-13.68, 6.43 (5.81-7.13, and 14.73 (11.42-18.99, respectively. Liposomal DOX formulations were associated with lower RORs with regard to myelosuppression, cardiotoxicity, and alopecia than the conventional DOX was. The RORs (95% CI for palmar-plantar erythrodysesthesia (PPE associated with conventional DOX, PEGylated-liposome DOX, and non-PEGylated-liposome DOX were 6.56 (4.74-9.07, 64.77 (56.84-73.80, and 28.76 (15.77-52.45, respectively. This study is the first to evaluate the relationship between DOX liposomal formulations and their adverse event profiles. The results indicate that careful observation for PPE is recommended with the use of liposomal DOX, especially PEGylated

Regulatory Inspection of Nuclear Power Plants in NEA Member Countries

International Nuclear Information System (INIS)

1978-01-01

Based on the replies to a questionnaire, this report gives a description and comparative evaluation of the regulatory inspection activities in several NEA Member countries. The questionnaire which was circulated to all Member countries requested details on the organisation, system, scope and objectives of nuclear regulatory inspection and the effort required throughout all stages of the life of a nuclear plant including the use of independent bodies or consultants. Additional information was requested on the documentation concerned with regulatory inspections, incident and accident reporting procedures, and the duties, powers and bases for recruitment of regulatory personnel with the object of covering all related aspects. However, because of the differences in national practices and perhaps in the interpretation of the questionnaire, it proved to be extremely difficult to make an evaluation and comparison of inspection activities and effort involved in these Member countries. This report, which includes a section on the nuclear power programme in Member countries, should therefore only be regarded as an initial review but it provides a useful contribution to the exchange of experience and views on regulatory inspection practices

A gene regulatory network armature for T-lymphocyte specification

Energy Technology Data Exchange (ETDEWEB)

Fung, Elizabeth-sharon [Los Alamos National Laboratory

2008-01-01

Choice of a T-lymphoid fate by hematopoietic progenitor cells depends on sustained Notch-Delta signaling combined with tightly-regulated activities of multiple transcription factors. To dissect the regulatory network connections that mediate this process, we have used high-resolution analysis of regulatory gene expression trajectories from the beginning to the end of specification; tests of the short-term Notchdependence of these gene expression changes; and perturbation analyses of the effects of overexpression of two essential transcription factors, namely PU.l and GATA-3. Quantitative expression measurements of >50 transcription factor and marker genes have been used to derive the principal components of regulatory change through which T-cell precursors progress from primitive multipotency to T-lineage commitment. Distinct parts of the path reveal separate contributions of Notch signaling, GATA-3 activity, and downregulation of PU.l. Using BioTapestry, the results have been assembled into a draft gene regulatory network for the specification of T-cell precursors and the choice of T as opposed to myeloid dendritic or mast-cell fates. This network also accommodates effects of E proteins and mutual repression circuits of Gfil against Egr-2 and of TCF-l against PU.l as proposed elsewhere, but requires additional functions that remain unidentified. Distinctive features of this network structure include the intense dose-dependence of GATA-3 effects; the gene-specific modulation of PU.l activity based on Notch activity; the lack of direct opposition between PU.l and GATA-3; and the need for a distinct, late-acting repressive function or functions to extinguish stem and progenitor-derived regulatory gene expression.

Pain acceptance, psychological functioning, and self-regulatory fatigue in temporomandibular disorder.

Science.gov (United States)

Eisenlohr-Moul, Tory A; Burris, Jessica L; Evans, Daniel R

2013-12-01

A growing body of evidence suggests that chronic pain patients suffer from chronic self-regulatory fatigue: difficulty controlling thoughts, emotions, and behavior. Pain acceptance, which involves responding to pain and related experiences without attempts to control or avoid them (pain willingness), and pursuit of valued life activities regardless of pain (activity engagement) has been associated with various favorable outcomes in chronic pain patients, including better psychological functioning. The study presented here tested the hypotheses that pain acceptance is associated with less psychological distress, higher psychological well-being, and reduced self-regulatory fatigue in temporomandibular disorder (TMD) patients, particularly for those with longer pain duration. Cross-sectional data were provided by 135 TMD patients during an initial evaluation at a university-based tertiary orofacial pain clinic. Results of hierarchical linear regression models indicated that, controlling for pain severity, pain willingness is associated with less psychological distress and lower self-regulatory fatigue, and activity engagement is associated with greater psychological well-being. Furthermore, the effect of pain willingness on psychological distress was moderated by pain duration such that pain willingness was more strongly associated with less psychological distress in patients with longer pain duration; this moderating effect was fully mediated by self-regulatory fatigue. These findings suggest pain willingness may buffer against self-regulatory fatigue in those with longer pain duration, and such conservation of self-regulatory resources may protect against psychological symptoms.

U.S. Nuclear Regulatory Commission Role and Activities Related to U.S. Department of Energy Incidental Waste Determinations

International Nuclear Information System (INIS)

Bradford, A.H.; Esh, D.W.; Ridge, A.C.

2006-01-01

Section 3116 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 (NDAA) requires the U.S. Department of Energy (DOE) to consult with the U.S. Nuclear Regulatory Commission (NRC) for certain non-high level waste (HLW) determinations. Under the NDAA, NRC performs consultative technical reviews of DOE's waste determinations and monitors DOE's disposal actions for such waste, but the NRC does not have regulatory authority over DOE's waste disposal activities. The NDAA provides the criteria that must be met to determine that waste is not HLW. The criteria require that the waste does not need to be disposed of in a geologic repository, that highly radioactive radionuclides be removed to the maximum extent practical, and that the performance objectives of 10 CFR 61, Subpart C, be met. 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. This paper describes NRC's approach to implementing its responsibilities under the NDAA, as well as similar activities being performed for sites not covered by the NDAA. (authors)

Expression of GARP selectively identifies activated human FOXP3+ regulatory T cells.

Science.gov (United States)

Wang, Rui; Kozhaya, Lina; Mercer, Frances; Khaitan, Alka; Fujii, Hodaka; Unutmaz, Derya

2009-08-11

The molecules that define human regulatory T cells (Tregs) phenotypically and functionally remain to be fully characterized. We recently showed that activated human Tregs express mRNA for a transmembrane protein called glycoprotein A repetitions predominant (GARP, or LRRC32). Here, using a GARP-specific mAb, we demonstrate that expression of GARP on activated Tregs correlates with their suppressive capacity. However, GARP was not induced on T cells activated in the presence of TGFbeta, which expressed high levels of FOXP3 and lacked suppressive function. Ectopic expression of FOXP3 in conventional T cells was also insufficient for induction of GARP expression in most donors. Functionally, silencing GARP in Tregs only moderately attenuated their suppressive activity. CD25+ T cells sorted for high GARP expression displayed more potent suppressive activity compared with CD25+GARP- cells. Remarkably, CD25+GARP- T cells expanded in culture contained 3-5 fold higher IL-17-secreting cells compared with either CD25+GARP+ or CD25-GARP- cells, suggesting that high GARP expression can potentially discriminate Tregs from those that have switched to Th17 lineage. We also determined whether GARP expression correlates with FOXP3-expressing T cells in human immunodeficiency virus (HIV) -infected subjects. A subset of HIV+ individuals with high percentages of FOXP3+ T cells did not show proportionate increase in GARP+ T cells. This finding suggests that higher FOXP3 levels observed in these HIV+ individuals is possibly due to immune activation rather than to an increase in Tregs. Our findings highlight the significance of GARP both in dissecting duality of Treg/Th17 cell differentiation and as a marker to identify bona fide Tregs during diseases with chronic immune activation.

Regulatory Office for Network Industries

International Nuclear Information System (INIS)

2005-01-01

The main goal of the economic regulation of network industries is to ensure a balance between the interests of consumers and investors and to encourage providing high-quality goods and services. The task of the regulatory authority is to protect the interests of consumers against monopolistic behaviour of regulated enterprises. At the same time, the regulatory office has to protect the interests of investors by giving them an opportunity to achieve an adequate return on their investments. And last, but not least, the regulatory office has to provide regulated enterprises with appropriate incentives to make them function in an efficient and effective manner and to guarantee the security of delivery of energies and related services. All this creates an efficient regulatory framework that is capable of attracting the required amount and type of investments. This also means providing third party access to the grids, the opening of energy markets, the un-bundling of accounts according to production, distribution, transmission and other activities and the establishment of a transparent and stable legislative environment for regulated companies, investors and consumers. Otherwise, in the long run consumers may suffer from a serious deterioration of service quality, although in the short run they are protected against increased prices. Under the Act No. 276/2001 Coll. on Regulation of Network Industries and on amendment of some acts the Office for Regulation of Network Industries has been commissioned to implement the main objectives of regulation of network industries. By network industries the Act No. 276/2001 Coll. on Regulation means the following areas: (a) Production, purchase, transit and distribution of electricity; (b) Production, purchase, transit and distribution of gas; (c) Production, purchase and distribution of heat; (d) Water management activities relating to the operation of the public water supply system or the public sewerage system; (e) Water management

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

Science.gov (United States)

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

2017-07-01

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

The waste isolation pilot plant regulatory compliance program

International Nuclear Information System (INIS)

Mewhinney, J.A.; Kehrman, R.F.

1996-01-01

The passage of the WIPP Land Withdrawal Act of 1992 (LWA) marked a turning point for the Waste Isolation Pilot Plant (WIPP) program. It established a Congressional mandate to open the WIPP in as short a time as possible, thereby initiating the process of addressing this nation's transuranic (TRU) waste problem. The DOE responded to the LWA by shifting the priority at the WIPP from scientific investigations to regulatory compliance and the completion of prerequisites for the initiation of operations. Regulatory compliance activities have taken four main focuses: (1) preparing regulatory submittals; (2) aggressive schedules; (3) regulator interface; and (4) public interactions

Mission Risk Reduction Regulatory Change Management

Science.gov (United States)

Scroggins, Sharon

2007-01-01

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

Regulatory Competition in Global Financial Markets

DEFF Research Database (Denmark)

Ringe, Georg

2015-01-01

competition are a reality in today’s global financial market, and the financial sector is different from their traditional fields of application: the ease of arbitrage, the fragility of banking and the risks involved are exceptional. Most importantly, regulatory arbitrage does not or only rarely occurs......The decades-long discussion on the merits of regulatory competition appears in a new light on the global financial market. There are a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of shifting trading abroad or else relocating activities...

Safety and regulatory requirements of nuclear power plants

International Nuclear Information System (INIS)

Kumar, S.V.; Bhardwaj, S.A.

2000-01-01

A pre-requisite for a nuclear power program in any country is well established national safety and regulatory requirements. These have evolved for nuclear power plants in India with participation of the regulatory body, utility, research and development (R and D) organizations and educational institutions. Prevailing international practices provided a useful base to develop those applicable to specific system designs for nuclear power plants in India. Their effectiveness has been demonstrated in planned activities of building up the nuclear power program as well as with unplanned activities, like those due to safety related incidents etc. (author)

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the US Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issuance of the guidance in 1997

Development of guidance on applications of regulatory requirements for low specific activity materials and surface contaminated objects

International Nuclear Information System (INIS)

Pope, R.B.; Easton, E.P.; Shankman, S.F.; Boyle, R.W.

1997-01-01

In 1985, the International Atomic Energy Agency issued revised regulations for the safe transport of radioactive material. Significant among the changes were major revisions to requirements for Low Specific Activity (LSA) material and Surface Contaminated Objects (SCOs). In preparation for the adoption of these requirements into regulations in the United States, it became apparent that guidance on how to apply these requirements, clarifying technical uncertainties and ensuring proper implementation, would be needed both by the regulators and those regulated. Thus, the US Department of Transportation and the U.S. Nuclear Regulatory Commission, with the assistance of staff from Oak Ridge National Laboratory, are preparing regulatory guidance for LSA material and SCO transport. The guidance will present examples of acceptable methods for demonstrating compliance with the revised rules. Ideas being investigated for inclusion in the pending guidance are discussed in this paper. Under current plans, the guidance will be issued for public comment prior to final issue of the guidance in 1997. (Author)

Building Nuclear Safety and Security Culture Within Regulatory Body

International Nuclear Information System (INIS)

Huda, K.

2016-01-01

To achieve a higher level of nuclear safety and security, it needs to develop the safety and security culture not only in the facility but also in the regulatory body. The regulatory body, especially needs to develop the safety and security culture within the organization, because it has a function to promote and oversee the culture in the facilities. In this sense, the regulatory body should become a role model. Development of the nuclear safety and security culture should be started by properly understanding its concept and awakening the awareness of individual and organization on the importance of nuclear safety and security. For effectiveness of the culture development in the regulatory body, the following steps are suggested to be taken: setting up of the regulatory requirements, self-assessment, independent assessment review, communication with the licensee, oversight of management system implementation, and integration with regulatory activities. The paper discusses those steps in the framework of development of nuclear safety and security culture in the regulatory body, as well as some important elements in building of the culture in the nuclear facilities. (author)

PNRA: Practically Improving Safety Culture within the Regulatory Body

International Nuclear Information System (INIS)

Bhatti, S.A.N.; Habib, M.A.

2016-01-01

The prevalence of a good safety culture is equally important for all kind of organizations involved in nuclear business including operating organizations, designers, regulator, etc., and this should be reflected through the processes and activities of these organizations. The need for inculcating safety culture into regulatory processes and practices is gradually increasing since the major nuclear accident of Fukushima, Japan. Accordingly, several international fora in last few years repeatedly highlighted the importance of prevalence of safety culture in regulatory bodies as well. The utilisation of concept of safety culture remained applicable in regulatory activities of PNRA in the form of core values. After the Fukushima accident, PNRA considered it important to check the extent of utilisation of safety culture concept in organizational activities and decided to conduct its “Safety Culture Self-Assessment (SCSA)” for presenting itself as role model in-order to endorse the fact that safety culture at regulatory authority plays an important role to influence safety culture at licenced facilities. Considering the complexity of cultural assessment starting from visual manifestations to the basic assumptions at the deeper level, PNRA decided to utilise IAEA emerging methodology for assessment of culture and then used modified IAEA normative framework (made it applicable for regulatory body) for assessing safety culture at a regulatory body. PNRA SCSA team utilised safety culture assessment tools (observations, focus groups, surveys, interviews and document analysis) for collecting cultural facts by including all level of personnel involved in different activities and functions in the organization. Different challenges were encountered during implementation of these tools which were tackled with the background of training on SCSA and with the help of experts during support missions arranged by IAEA. Before formally starting the SCSA process, pre-launch activities

Mutational robustness of gene regulatory networks.

Directory of Open Access Journals (Sweden)

Aalt D J van Dijk

Full Text Available Mutational robustness of gene regulatory networks refers to their ability to generate constant biological output upon mutations that change network structure. Such networks contain regulatory interactions (transcription factor-target gene interactions but often also protein-protein interactions between transcription factors. Using computational modeling, we study factors that influence robustness and we infer several network properties governing it. These include the type of mutation, i.e. whether a regulatory interaction or a protein-protein interaction is mutated, and in the case of mutation of a regulatory interaction, the sign of the interaction (activating vs. repressive. In addition, we analyze the effect of combinations of mutations and we compare networks containing monomeric with those containing dimeric transcription factors. Our results are consistent with available data on biological networks, for example based on evolutionary conservation of network features. As a novel and remarkable property, we predict that networks are more robust against mutations in monomer than in dimer transcription factors, a prediction for which analysis of conservation of DNA binding residues in monomeric vs. dimeric transcription factors provides indirect evidence.

2015 Summary Report on Industrial and Regulatory Engagement Activities

Energy Technology Data Exchange (ETDEWEB)

Thomas, Kenneth David [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2015-09-01

activities and future plans were made to Arizona Public Service, Exelon, Duke Energy, Pacific Gas & Electric, SCANA, Southern Nuclear, South Texas Project, STARS Alliance, Tennessee Valley Authority, and Xcel. Discussions were also held on the pathway goals and activities with major industry support organizations during FY 2102, including the Institute of Nuclear Power Operations (INPO), the Nuclear Information Technology Strategic Leadership (NITSL), the Nuclear Energy Institute (NEI), and the Electric Power Research Institute. The Advanced II&C Pathway work was presented at five major industry conferences and Informal discussions were held with key NRC managers at industry conferences. In addition, discussions were held with NRC senior managers on digital regulatory issues through participation on the NEI Digital I&C Working Group. Meetings were held with major industry suppliers and consultants, to explore opportunities for collaboration and to provide a means of pilot project technology transfer. In the international area, discussions were held with Electricite’ de France (EdF) concerning possible collaboration in the area NPP configuration control using intelligent wireless devices.

2015 Summary Report on Industrial and Regulatory Engagement Activities

International Nuclear Information System (INIS)

Thomas, Kenneth David

2015-01-01

activities and future plans were made to Arizona Public Service, Exelon, Duke Energy, Pacific Gas & Electric, SCANA, Southern Nuclear, South Texas Project, STARS Alliance, Tennessee Valley Authority, and Xcel. Discussions were also held on the pathway goals and activities with major industry support organizations during FY 2102, including the Institute of Nuclear Power Operations (INPO), the Nuclear Information Technology Strategic Leadership (NITSL), the Nuclear Energy Institute (NEI), and the Electric Power Research Institute. The Advanced II&C Pathway work was presented at five major industry conferences and Informal discussions were held with key NRC managers at industry conferences. In addition, discussions were held with NRC senior managers on digital regulatory issues through participation on the NEI Digital I&C Working Group. Meetings were held with major industry suppliers and consultants, to explore opportunities for collaboration and to provide a means of pilot project technology transfer. In the international area, discussions were held with Electricite de France (EdF) concerning possible collaboration in the area NPP configuration control using intelligent wireless devices.

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.

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

The regulatory control of radioactive sources in Argentina

Energy Technology Data Exchange (ETDEWEB)

Rojkind, Roberto Hector [Autoridade Regulatoria Nuclear, Buenos Aires (Argentina)

1997-12-31

Argentina has been conducting nuclear activities for more than forty years, and as early as in 1956 established a Regulatory Authority. Procedures for compliance monitoring and enforcement have been in use in the regulatory control of radioactive sources, and regulatory standards and regulations had been set in Argentina, before the accident in Goiania. The conclusions drawn from that accident encouraged in Argentina the improvement of some regulatory procedures and helped to enhance the quality of the regulatory process. Therefore, the effectiveness of the control of spent radioactive sources has gradually increased, and enforcement actions to prevent radioactive sources ending up in the public domain improved. Some lessons learned in Argentina from the accident in Goiania and the main characteristics of an effective enforcement program helpful to prevent radiological accidents in industrial, medical, research and teaching uses of radioactive sources are presented. (author) 9 refs; e-mail: rrojkind at sede.arn.gov.br

Diagnosis of the Brazilian Nuclear Regulatory body

International Nuclear Information System (INIS)

Santos Gomes, Rogerio dos; Magalhaes Ennes Ennes, Edson Carlos

2008-01-01

This work has the objective to present the diagnosis of the existing structure in the Brazilian Government to ensure the radioprotection and nuclear safety in the country, being compared the current situation with the conclusions presented in another studies, carried through in last 30 years, with special attention in the existence of the necessary available to support and independence of the national regulatory body for the development of the regulatory inspections activities in the radioprotection and nuclear safety. (author)

Regulation for continuous improvements - the new regulatory strategy of SKI

International Nuclear Information System (INIS)

Hoegberg, L.; Svensson, G.; Viktorsson, C.

1998-01-01

This paper describes the new regulatory objectives and strategy of the Swedish Nuclear Power Inspectorate. Factors that have influenced the development of the regulatory strategy, including an international peer review, are discussed. In addition to general technical requirements for a defence in depth, the new strategy strongly focuses on the quality of plant safety management processes, to be monitored by process-oriented inspections. Also, quality assurance of regulatory activities is stressed. Experience gained so far shows that the regulatory approach chosen in Sweden promotes utility self assessment, quality of safety management and ownership of safety work within the utility staff. (author)

Politically Induced Regulatory Risk and Independent Regulatory Agencies

OpenAIRE

Strausz, Roland

2015-01-01

Uncertainty in election outcomes generates politically induced regulatory risk. Political parties' risk attitudes towards such risk depend on a fluctuation effect that hurts both parties and an output--expansion effect that benefits at least one party. Notwithstanding the parties' risk attitudes, political parties have incentives to negotiate away all regulatory risk by pre-electoral bargaining. Efficient pre-electoral bargaining outcomes fully eliminate politically induced regulatory risk. P...

Redefining the transcriptional regulatory dynamics of classically and alternatively activated macrophages by deepCAGE transcriptomics

KAUST Repository

Roy, S.

2015-06-27

Classically or alternatively activated macrophages (M1 and M2, respectively) play distinct and important roles for microbiocidal activity, regulation of inflammation and tissue homeostasis. Despite this, their transcriptional regulatory dynamics are poorly understood. Using promoter-level expression profiling by non-biased deepCAGE we have studied the transcriptional dynamics of classically and alternatively activated macrophages. Transcription factor (TF) binding motif activity analysis revealed four motifs, NFKB1_REL_RELA, IRF1,2, IRF7 and TBP that are commonly activated but have distinct activity dynamics in M1 and M2 activation. We observe matching changes in the expression profiles of the corresponding TFs and show that only a restricted set of TFs change expression. There is an overall drastic and transient up-regulation in M1 and a weaker and more sustainable up-regulation in M2. Novel TFs, such as Thap6, Maff, (M1) and Hivep1, Nfil3, Prdm1, (M2) among others, were suggested to be involved in the activation processes. Additionally, 52 (M1) and 67 (M2) novel differentially expressed genes and, for the first time, several differentially expressed long non-coding RNA (lncRNA) transcriptome markers were identified. In conclusion, the finding of novel motifs, TFs and protein-coding and lncRNA genes is an important step forward to fully understand the transcriptional machinery of macrophage activation.

Experience Transformed into Nuclear Regulatory Improvements in Russia

International Nuclear Information System (INIS)

Sapozhnikov, A.

2016-01-01

The third International Conference on Effective Nuclear Regulatory Systems (Canada, 2013) identified the main action items that should be addressed, implemented and followed up. The key technical and organizational areas important to strengthening reactor and spent fuel safety have been determined as following: • Regulatory lessons learned and actions taken (since the accident at the Fukushima Daiichi NPP); • Waste management and spent fuel safety; • Emergency management; • Emerging programmes; • Human and organizational factors, safety and security culture. Over time many activities based on results of the IAEA Integrated Regulatory Review Service in the Russian Federation, 2019, and post-mission, 2013, have been implemented. At present there is progress for the national action plan on nuclear safety, preparation and conducting of long term spent fuel management, complementary reviews for nuclear facilities other than Nuclear Power Plants, emergency exercises with the regulatory body participation, improving communication, development of national regulations and improvement of regulatory system in the whole. The regulatory body ensures assistance in development of national regulatory infrastructure, safety culture to the countries planning to construct Russian design facilities (NPPs, RRs). The report outlines the results and future actions to improve nuclear regulation based on systematic approach to safety and particularly reflects the specificity of taking measures for the research reactors. (author)

Report on Activities of the Nuclear Regulatory Authority of the Slovak Republic and on Safety of Nuclear Installations in the Slovak Republic in 2005. Annual report 2005

International Nuclear Information System (INIS)

Zemanova, D.; Seliga, M.; Sladek, V.

2006-04-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2005 is presented. These activities are reported under the headings: Foreword; (1) Vision, Mission and Principles of Activities; (2) Legislation; (3) Issuance of Authorisations, Safety Assessment and Enforcement; (4) Nuclear Safety of Nuclear Installations in the Slovak Republic; (4.1) Nuclear installations in operation in the Slovak Republic; (4.2) Nuclear Installations under construction in the Slovak Republic; (4.3) Decommissioning of nuclear installations in the Slovak Republic; (5) Spent Fuel and Radioactive Waste Management and Safety of other Nuclear Installations in the Slovak Republic; (5.1) Generation and minimisation of radioactive waste; (5.2) Management of radioactive waste; (5.3) Pre-disposal management of radioactive waste; (5.4) Disposal of radioactive waste; (5.5) Shipment of radioactive waste; (5.6) Safety of other nuclear installations in the Slovak Republic; (6) Personnel Qualification and Training; (7) Nuclear Materials and Physical Protection of Nuclear installations; (8) Emergency Preparedness; (9) International Co-operation; (10) Public Communication; (11) UJD SR; (11.1) UJD SR organizational chart; (11.2) UJD SR organizational chart; (11.3) Human resources and training; (11.4) Internal system of quality assurance; (11.5) Development of UJD SR regulatory activities; Appendix: Abbreviations; Development of UJD SR regulatory activities

Activation of the aryl hydrocarbon receptor reduces the number of precursor and effector T cells, but preserves thymic CD4(+)CD25(+)Foxp3(+) regulatory T cells

NARCIS (Netherlands)

Schulz, V.J.; Smit, J.J.; Bol-Schoenmakers, M.; van Duursen, M.B.M.; van den Berg, M.; Pieters, R.H.H.

2012-01-01

Aryl hydrocarbon receptor (AhR) activation suppresses immune responses, including allergic sensitization, by increasing the percentage of regulatory (Treg) cells. Furthermore, AhR activation is known to affect thymic precursor T cells. However, the effect of AhR activation on intrathymic

Compliance. Regulatory policy P-211

International Nuclear Information System (INIS)

2001-05-01

This regulatory policy describes the basic principles and directives for establishing and conducting the Canadian Nuclear Safety Commission (CNSC) Compliance Program. The program is aimed at securing compliance by regulated persons with regulatory requirements made under the Nuclear Safety and Control Act ('the Act'). The policy applies to persons who are regulated by the CNSC through the Act, regulations and licences, as well as by decisions and orders made under the Act. The policy applies to officers and employees of the CNSC, and its authorized representatives or agents, who are involved in developing and carrying out compliance activities. Compliance, in the context of this policy, means conformity by regulated persons with the legally binding requirements of the Act, and the CNSC regulations, licences, decisions, and orders made under the Act. Compliance activities are CNSC measures of promotion, verification and enforcement aimed at securing compliance by regulated person with the applicable legally binding requirements. (author)

Regulatory regime and its influence in the nuclear safety

International Nuclear Information System (INIS)

Laaksonen, J.

1999-01-01

Main elements of nuclear regulatory regime in general is presented. These elements are: national rules and safety regulations, system of nuclear facility licensing, activities of regulatory body. Regulatory body is needed to specify the national safety regulations, review and assess the safety documentation presented to support license application, make inspections to verify fulfilment of safety regulations and license conditions, monitor the quality of work processes of user organization, and to assess whether these processes provide a high safety level, promote high safety culture, promote maintenance and development of national infrastructure relevant to nuclear safety, etc

Hijacking Complement Regulatory Proteins for Bacterial Immune Evasion.

Science.gov (United States)

Hovingh, Elise S; van den Broek, Bryan; Jongerius, Ilse

2016-01-01

The human complement system plays an important role in the defense against invading pathogens, inflammation and homeostasis. Invading microbes, such as bacteria, directly activate the complement system resulting in the formation of chemoattractants and in effective labeling of the bacteria for phagocytosis. In addition, formation of the membrane attack complex is responsible for direct killing of Gram-negative bacteria. In turn, bacteria have evolved several ways to evade complement activation on their surface in order to be able to colonize and invade the human host. One important mechanism of bacterial escape is attraction of complement regulatory proteins to the microbial surface. These molecules are present in the human body for tight regulation of the complement system to prevent damage to host self-surfaces. Therefore, recruitment of complement regulatory proteins to the bacterial surface results in decreased complement activation on the microbial surface which favors bacterial survival. This review will discuss recent advances in understanding the binding of complement regulatory proteins to the bacterial surface at the molecular level. This includes, new insights that have become available concerning specific conserved motives on complement regulatory proteins that are favorable for microbial binding. Finally, complement evasion molecules are of high importance for vaccine development due to their dominant role in bacterial survival, high immunogenicity and homology as well as their presence on the bacterial surface. Here, the use of complement evasion molecules for vaccine development will be discussed.

Increased T-regulatory cells within lymphocyte follicles in moderate COPD

DEFF Research Database (Denmark)

Plumb, J; Smyth, L J C; Adams, H R

2009-01-01

Lymphoid follicles in the lung parenchyma are a characteristic feature of chronic obstructive pulmonary disease (COPD). There are reports of altered CD4 T-regulatory cell numbers in COPD lungs, but the location of these cells within COPD lung tissue specific follicles has not been investigated......, as well as lymphoid clusters lacking organisation. The percentage of CD4 cells that were T-regulatory cells were significantly increased (p = 0.02) within COPD (16%) follicles compared with smokers (10%) and nonsmokers (8%). In contrast, there was no change (p>0.05) in the percentage of T-regulatory cells...... in clusters or the subepithelium between groups. Lymphoid follicles in COPD patients have increased T-regulatory cells. Therefore, T-regulatory activity may be altered within COPD lymphoid follicles....

A unified architecture of transcriptional regulatory elements

DEFF Research Database (Denmark)

Andersson, Robin; Sandelin, Albin Gustav; Danko, Charles G.

2015-01-01

Gene expression is precisely controlled in time and space through the integration of signals that act at gene promoters and gene-distal enhancers. Classically, promoters and enhancers are considered separate classes of regulatory elements, often distinguished by histone modifications. However...... and enhancers are considered a single class of functional element, with a unified architecture for transcription initiation. The context of interacting regulatory elements and the surrounding sequences determine local transcriptional output as well as the enhancer and promoter activities of individual elements....

Nuclear Regulatory Commission Information Digest 1992 edition

International Nuclear Information System (INIS)

Olive, K.

1992-03-01

The Nuclear Regulatory Commission Information Digest provides a summary of information about the US Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. This digest is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and industry it regulates. In general, the data cover 1975 through 1991, with exceptions noted. Information on generating capacity and average capacity factor for operating US commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed

A dataset of 200 structured product labels annotated for adverse drug reactions.

Science.gov (United States)

Demner-Fushman, Dina; Shooshan, Sonya E; Rodriguez, Laritza; Aronson, Alan R; Lang, Francois; Rogers, Willie; Roberts, Kirk; Tonning, Joseph

2018-01-30

Adverse drug reactions (ADRs), unintended and sometimes dangerous effects that a drug may have, are one of the leading causes of morbidity and mortality during medical care. To date, there is no structured machine-readable authoritative source of known ADRs. The United States Food and Drug Administration (FDA) partnered with the National Library of Medicine to create a pilot dataset containing standardised information about known adverse reactions for 200 FDA-approved drugs. The Structured Product Labels (SPLs), the documents FDA uses to exchange information about drugs and other products, were manually annotated for adverse reactions at the mention level to facilitate development and evaluation of text mining tools for extraction of ADRs from all SPLs. The ADRs were then normalised to the Unified Medical Language System (UMLS) and to the Medical Dictionary for Regulatory Activities (MedDRA). We present the curation process and the structure of the publicly available database SPL-ADR-200db containing 5,098 distinct ADRs. The database is available at https://bionlp.nlm.nih.gov/tac2017adversereactions/; the code for preparing and validating the data is available at https://github.com/lhncbc/fda-ars.

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

International Nuclear Information System (INIS)

Bacon, Mick; Ilett, Doug; Whittall, Andy

2009-01-01

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

CD8+CD122+CD49dlow regulatory T cells maintain T-cell homeostasis by killing activated T cells via Fas/FasL-mediated cytotoxicity.

Science.gov (United States)

Akane, Kazuyuki; Kojima, Seiji; Mak, Tak W; Shiku, Hiroshi; Suzuki, Haruhiko

2016-03-01

The Fas/FasL (CD95/CD178) system is required for immune regulation; however, it is unclear in which cells, when, and where Fas/FasL molecules act in the immune system. We found that CD8(+)CD122(+) cells, which are mostly composed of memory T cells in comparison with naïve cells in the CD8(+)CD122(-) population, were previously shown to include cells with regulatory activity and could be separated into CD49d(low) cells and CD49d(high) cells. We established in vitro and in vivo experimental systems to evaluate the regulatory activity of CD122(+) cells. Regulatory activity was observed in CD8(+)CD122(+)CD49d(low) but not in CD8(+)CD122(+)CD49d(high) cells, indicating that the regulatory cells in the CD8(+)CD122(+) population could be narrowed down to CD49d(low) cells. CD8(+)CD122(-) cells taken from lymphoproliferation (lpr) mice were resistant to regulation by normal CD122(+) Tregs. CD122(+) Tregs taken from generalized lymphoproliferative disease (gld) mice did not regulate wild-type CD8(+)CD122(-) cells, indicating that the regulation by CD122(+) Tregs is Fas/FasL-dependent. CD122(+) Tregs taken from IL-10-deficient mice could regulate CD8(+)CD122(-) cells as equally as wild-type CD122(+) Tregs both in vitro and in vivo. MHC class I-missing T cells were not regulated by CD122(+) Tregs in vitro. CD122(+) Tregs also regulated CD4(+) cells in a Fas/FasL-dependent manner in vitro. These results suggest an essential role of Fas/FasL as a terminal effector of the CD122(+) Tregs that kill activated T cells to maintain immune homeostasis.

The regulatory process of the Visual and Technological Education teachers' activity: analysis of the impact of the 2012 Curricular Restructure in Portugal

Directory of Open Access Journals (Sweden)

Cláudia Pereira

2017-12-01

Full Text Available This paper aims at exploring a case study of a group of teachers of the 2 nd Cycle of Basic Education, for pupils aged 10 and 11 according to the Portuguese Education System, who belong to the disciplinary group of Visual and Technological Education. The analysis is twofold: it focuses on the one hand on understanding the changes in the work activity and the constraints that resulted from changes in education implemented at national level; and on the other hand on the identification of regulatory strategies developed by the teachers. Based on the fieldwork (individual interviews, activity analysis, documentary analysis there is evidence of variations and constraints, as a result from the changes, both in the teachers' activity (e.g. increase in the workload and in their health (e.g. tiredness, anxiety, disappointment. In order to face the constraints they were experiencing, the teachers developed individual, but also group regulatory strategies, demonstrating the protective and supportive effect the group had in the continuity of the work and in the preservation of these teachers' health.

GARP (LRRC32) is essential for the surface expression of latent TGF-β on platelets and activated FOXP3+ regulatory T cells

Science.gov (United States)

Tran, Dat Q.; Andersson, John; Wang, Rui; Ramsey, Heather; Unutmaz, Derya; Shevach, Ethan M.

2009-01-01

TGF-β family members are highly pleiotropic cytokines with diverse regulatory functions. TGF-β is normally found in the latent form associated with latency-associated peptide (LAP). This latent complex can associate with latent TGFβ-binding protein (LTBP) to produce a large latent form. Latent TGF-β is also found on the surface of activated FOXP3+ regulatory T cells (Tregs), but it is unclear how it is anchored to the cell membrane. We show that GARP or LRRC32, a leucine-rich repeat molecule of unknown function, is critical for tethering TGF-β to the cell surface. We demonstrate that platelets and activated Tregs co-express latent TGF-β and GARP on their membranes. The knockdown of GARP mRNA with siRNA prevented surface latent TGF-β expression on activated Tregs and recombinant latent TGF-β1 is able to bind directly with GARP. Confocal microscopy and immunoprecipitation strongly support their interactions. The role of TGF-β on Tregs appears to have dual functions, both for Treg-mediated suppression and infectious tolerance mechanism. PMID:19651619

GARP (LRRC32) is essential for the surface expression of latent TGF-beta on platelets and activated FOXP3+ regulatory T cells.

Science.gov (United States)

Tran, Dat Q; Andersson, John; Wang, Rui; Ramsey, Heather; Unutmaz, Derya; Shevach, Ethan M

2009-08-11

TGF-beta family members are highly pleiotropic cytokines with diverse regulatory functions. TGF-beta is normally found in the latent form associated with latency-associated peptide (LAP). This latent complex can associate with latent TGFbeta-binding protein (LTBP) to produce a large latent form. Latent TGF-beta is also found on the surface of activated FOXP3(+) regulatory T cells (Tregs), but it is unclear how it is anchored to the cell membrane. We show that GARP or LRRC32, a leucine-rich repeat molecule of unknown function, is critical for tethering TGF-beta to the cell surface. We demonstrate that platelets and activated Tregs co-express latent TGF-beta and GARP on their membranes. The knockdown of GARP mRNA with siRNA prevented surface latent TGF-beta expression on activated Tregs and recombinant latent TGF-beta1 is able to bind directly with GARP. Confocal microscopy and immunoprecipitation strongly support their interactions. The role of TGF-beta on Tregs appears to have dual functions, both for Treg-mediated suppression and infectious tolerance mechanism.

Regulatory aspects of NPP safety

International Nuclear Information System (INIS)

Stuller, J.; Brandejs, P.; Miasnikov, A.; Svab, M.

1999-01-01

In beginning, a history of legislative process regulating industrial utilisation of nuclear energy is given, including detailed list of decrees issued by the first regulatory body supervising Czech nuclear installations - Czechoslovak Atomic Energy Commission (CSKAE). Current status of nuclear regulations and radiation protection, especially in connection with Atomic Act (Act No 18/1997 Coll.), is described. The Atomic Act transfers into the Czech legal system a number of obligations following from the Vienna Convention on Civil Liability for Nuclear Damage and Joint Protocol relating to the Application of the Vienna and Paris Convention, to which the Czech Republic had acceded. Actual duties and competence of current nuclear regulatory body - State Office for Nuclear Safety (SUJB) - are given in detail. Execution of the State supervision of peaceful utilisation of nuclear energy and ionising radiation is laid out in several articles of the Act, which comprises: control activities of the SUJB, remedial measures, penalties. Material and human resources are sufficient for fulfilment of the basic functions for which SUJB is authorised by the law. For 1998, the SUJB allotted staff of 149, approximately 2/3 of that number are nuclear safety and radiation protection inspectors. The SUJB budget for 1998 is approximately 180 million Czech crowns (roughly 6 million US dollars). Inspection activity of SUJB is carried out in three different ways: routine inspections, planned specialised inspections, inspections as a response to a certain situation (ad-hoc inspections). Approach to the licensing of major plant upgrades and backfittings are mainly illustrated on the Temelin NPP licensing. Regulatory position and practices concerning review activities are presented. (author)

Methodology For Evaluation Of Regulatory Effectiveness In Physical Protection

International Nuclear Information System (INIS)

Izmaylov, Alexander; Valente, John; Griggs, James R.; Rexroth, Paul; Piskarev, Alexander; Babkin, Vladimir; Sokolov, Egor; Melton, Ronald B.; Cunningham, Mitchel E.; Baker, Kathryn A.; Brothers, Alan J.

2005-01-01

Material protection, control, and accounting (MPC and A) regulatory documents play an important role in securing and protecting nuclear material by regulating a variety of activities at different hierarchical levels. The development, implementation, and practical application of these regulatory documents requires a significant investment of financial and material resources. Therefore, it is important to evaluate the effectiveness of the regulatory development process and the extent to which regulations improve the effectiveness of MPC and A at nuclear sites. The joint Russian and U.S. Regulatory Development Project has a goal of evaluating the effectiveness of regulatory documents developed for MPC and A. As part of this joint Project, a methodology for evaluating effectiveness has been developed. This methodology was developed around physical protection objectives. The developed methodology specifies physical protection objectives to be accomplished through the implementation of a regulatory system based on the physical protection goals at the nuclear sites. It includes approaches to assessing regulatory effectiveness, the hierarchical structure of physical protection objectives to be accomplished through implementing regulations, a 'mapping' of the physical protection objectives to the regulatory framework, a list of criteria for evaluating the effectiveness of physical protection regulations and effectiveness indicators, as well as means and methods for gathering information and implementation of this evaluation.

Regulatory dendritic cells in autoimmunity: A comprehensive review.

Science.gov (United States)

Liu, Juan; Cao, Xuetao

2015-09-01

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

Modular arrangement of regulatory RNA elements.

Science.gov (United States)

Roßmanith, Johanna; Narberhaus, Franz

2017-03-04

Due to their simple architecture and control mechanism, regulatory RNA modules are attractive building blocks in synthetic biology. This is especially true for riboswitches, which are natural ligand-binding regulators of gene expression. The discovery of various tandem riboswitches inspired the design of combined RNA modules with activities not yet found in nature. Riboswitches were placed in tandem or in combination with a ribozyme or temperature-responsive RNA thermometer resulting in new functionalities. Here, we compare natural examples of tandem riboswitches with recently designed artificial RNA regulators suggesting substantial modularity of regulatory RNA elements. Challenges associated with modular RNA design are discussed.

Heart rate variability reflects self-regulatory strength, effort, and fatigue.

Science.gov (United States)

Segerstrom, Suzanne C; Nes, Lise Solberg

2007-03-01

Experimental research reliably demonstrates that self-regulatory deficits are a consequence of prior self-regulatory effort. However, in naturalistic settings, although people know that they are sometimes vulnerable to saying, eating, or doing the wrong thing, they cannot accurately gauge their capacity to self-regulate at any given time. Because self-regulation and autonomic regulation colocalize in the brain, an autonomic measure, heart rate variability (HRV), could provide an index of self-regulatory strength and activity. During an experimental manipulation of self-regulation (eating carrots or cookies), HRV was elevated during high self-regulatory effort (eat carrots, resist cookies) compared with low self-regulatory effort (eat cookies, resist carrots). The experimental manipulation and higher HRV at baseline independently predicted persistence at a subsequent anagram task. HRV appears to index self-regulatory strength and effort, making it possible to study these phenomena in the field as well as the lab.

Regulatory controls for NORM contamination: Emerging issues and strategies

International Nuclear Information System (INIS)

Wennerberg, Linda

1992-01-01

Naturally occurring and accelerator-produced radioactive material (NORM) faces the increasing likelihood of federal or state regulatory control. Public concern and limited preliminary survey data fuel the debate over the necessity, approach, and jurisdiction of a NORM regulatory strategy. This debate requires the resolution of technical controversies and potentially competing state and federal agency interests. An additional facet of the debate is the impact of regulation upon traditionally non-nuclear industries, such as oil and gas production. Regulatory response has been initiated in several states, such as Louisiana's controls on equipment used in oil and gas production, to control specific industrial activities which generate NORM. A more comprehensive, generic federal strategy to control NORM contamination is also under review by the Environmental Protection Agency. This paper will detail the emerging technical issues, federal and state regulatory strategies under consideration, and evaluate the efficacy of selected regulatory approaches. (author)

FDA's Activities Supporting Regulatory Application of "Next Gen" Sequencing Technologies.

Science.gov (United States)

Wilson, Carolyn A; Simonyan, Vahan

2014-01-01

Applications of next-generation sequencing (NGS) technologies require availability and access to an information technology (IT) infrastructure and bioinformatics tools for large amounts of data storage and analyses. The U.S. Food and Drug Administration (FDA) anticipates that the use of NGS data to support regulatory submissions will continue to increase as the scientific and clinical communities become more familiar with the technologies and identify more ways to apply these advanced methods to support development and evaluation of new biomedical products. FDA laboratories are conducting research on different NGS platforms and developing the IT infrastructure and bioinformatics tools needed to enable regulatory evaluation of the technologies and the data sponsors will submit. A High-performance Integrated Virtual Environment, or HIVE, has been launched, and development and refinement continues as a collaborative effort between the FDA and George Washington University to provide the tools to support these needs. The use of a highly parallelized environment facilitated by use of distributed cloud storage and computation has resulted in a platform that is both rapid and responsive to changing scientific needs. The FDA plans to further develop in-house capacity in this area, while also supporting engagement by the external community, by sponsoring an open, public workshop to discuss NGS technologies and data formats standardization, and to promote the adoption of interoperability protocols in September 2014. Next-generation sequencing (NGS) technologies are enabling breakthroughs in how the biomedical community is developing and evaluating medical products. One example is the potential application of this method to the detection and identification of microbial contaminants in biologic products. In order for the U.S. Food and Drug Administration (FDA) to be able to evaluate the utility of this technology, we need to have the information technology infrastructure and

Regulatory Endorsement Activities for ASME Nuclear Codes and Standards

International Nuclear Information System (INIS)

West, Raymond A.

2006-01-01

The ASME Board on Nuclear Codes and Standards (BNCS) has formed a Task Group on Regulatory Endorsement (TG-RE) that is currently in discussions with the United States Nuclear Regulatory Commission (NRC) to look at suggestions and recommendations that can be used to help with the endorsement of new and revised ASME Nuclear Codes and Standards (NC and S). With the coming of new reactors in the USA in the very near future we need to look at both the regulations and all the ASME NC and S to determine where we need to make changes to support these new plants. At the same time it is important that we maintain our operating plants while addressing ageing management needs of our existing reactors. This is going to take new thinking, time, resources, and money. For all this to take place the regulations and requirements that we use must be clear concise and necessary for safety and to that end both the NRC and ASME are working together to make this happen. Because of the influence that the USA has in the world in dealing with these issues, this paper is written to inform the international nuclear engineering community about the issues and what actions are being addressed under this effort. (author)

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

International Nuclear Information System (INIS)

Ng, Ching Hang; Chen, Pei-Ying

2009-01-01

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

IAEA Mission Says Chile Committed to Enhancing Safety, Sees Regulatory Challenges

International Nuclear Information System (INIS)

2018-01-01

An International Atomic Energy Agency (IAEA) team of experts said Chile is committed to strengthening its regulatory framework for nuclear and radiation safety. To help achieve this aim, the team said the country should address challenges in some areas, including the need to ensure effective independence in regulatory decision-making. The Integrated Regulatory Review Service (IRRS) team today concluded a 12-day mission to assess the regulatory safety framework in Chile. The mission was conducted at the request of the Government and hosted by the Chilean Nuclear Energy Commission (CCHEN), which is responsible for regulatory supervision together with the Ministry of Health (MINSAL). The review mission covered all civilian nuclear and radiation source facilities and activities regulated in Chile.

Activation of Salmonella Typhi-specific regulatory T cells in typhoid disease in a wild-type S. Typhi challenge model.

OpenAIRE

Monica A McArthur; Stephanie Fresnay; Laurence S Magder; Thomas C Darton; Claire Jones; Claire S Waddington; Christoph J Blohmke; Gordon Dougan; Brian Angus; Myron M Levine; Andrew J Pollard; Marcelo B Sztein

2015-01-01

Salmonella Typhi (S. Typhi), the causative agent of typhoid fever, causes significant morbidity and mortality worldwide. Currently available vaccines are moderately efficacious, and identification of immunological responses associated with protection or disease will facilitate the development of improved vaccines. We investigated S. Typhi-specific modulation of activation and homing potential of circulating regulatory T cells (Treg) by flow and mass cytometry using specimens obtained from a h...

Approach for assessing the effectiveness of regulatory control in Peru using performance indicators

International Nuclear Information System (INIS)

Ramirez Quijada, R.

1998-01-01

The paper is intended to make an approach for assessing the effectiveness of regulatory activities in Peru by using of performance indicators for each of the activities developed pursuant their responsibilities. So inspections, authorizations, enforcement and regulation activities are qualified by levels of attainments and then assessed independently to rise specific issues. The general conclusion is that regulatory activities seems to be acceptable but some improvements are needed in order to reach a good level of performance. (author)

Regulatory capture by default: Offshore exploratory drilling for oil and gas

International Nuclear Information System (INIS)

Portman, Michelle E.

2014-01-01

This article examines a form of regulatory capture that occurs when significant ambiguity exists regarding the environmental protection standards for new types of activities in the marine environment. To begin with, there is little research that categorizes the typologies of regulatory capture despite the ubiquity of the phenomenon. After a discussion of theoretical approaches to regulatory capture, I describe the operative definition and theory appropriate to the situation related to authorization of oil and natural gas production in Israel following the discovery of large offshore reserves in 2010. This approach, embodying several facets of existing typologies, is applied to decisions made authorizing construction of the Gabriella offshore exploratory drilling platform. The analysis highlights the nature of capture in the absence of clear agency jurisdiction over new activities located in offshore environs organized as temporal and spatial “vacuums”. I conclude that comprehensive marine spatial planning would result in less capture and the development of more capture-resistant regulations. - Highlights: • Regulatory capture occurs when ambiguity exists about environmental protection standards for new types of activities in the marine environment. • A typology is developed from theories of regulatory capture (RC) and applied to cases of offshore exploratory drilling. • The typology is applied to offshore natural gas reserves discovered in 2010 offshore of Israel in the Mediterranean Sea. • Temporal aspects (anachronistic laws and regulations) and spatial aspects (jurisdictional ambiguity) have created regulatory vacuums leading to RC. • Comprehensive marine spatial planning would result in less capture and the development of more capture-resistant regulations

Regulatory proteins (inhibitors or activators) affect estimates of Msub(r) of enzymes and receptors by radiation inactivation

International Nuclear Information System (INIS)

Potier, M.; Giroux, S.

1985-01-01

The radiation-inactivation method allows the determination of the Msub(r) of enzymes and receptors by monitoring the decay of biological activity as a function of absorbed dose. The presence of regulatory or effector proteins (inhibitors or activators) associated with an enzyme or receptor, or released in the preparation after tissue homogenization, may affect the decay of biological activity. How the activity is affected, however, will depend on the type of inhibition (competitive or non-competitive), the inhibitor or activator concentration, the dissociation constant of the enzyme-effector system, and the effector Msub(r) relative to that of the enzyme. Since little is known on how effector proteins influence radiation inactivation of enzymes and receptors, we have considered a theoretical model in an effort to provide a framework for the interpretation of experimentally obtained data. Our model predicts that competitive and non-competitive inhibitors of enzymes could be distinguished by analysing irradiated samples with various substrate concentrations. Inhibitors will decrease whereas activators will increase the apparent target size of enzymes or receptors. (author)

The regulatory mechanism in the U.S. lessons learned

International Nuclear Information System (INIS)

Roberts, T.M.

1987-01-01

The U.S. Nuclear Regulatory Commission is responsible for the regulation of the commercial uses of nuclear power in the United States in order to protect the public health and safety. The NRC has undertaken a number of initiatives to incorporate the experience gained from the over 25 years of commercial nuclear power plant operation. These initiatives are aimed at improving the regulatory structure currently in place by providing for a more predictable and stable regulatory environment and by more efficiently and effectively focusing the activities of utilities on the safe operation of their facilities. (author)

Phosphorylation of protein kinase A (PKA) regulatory subunit RIα by protein kinase G (PKG) primes PKA for catalytic activity in cells.

Science.gov (United States)

Haushalter, Kristofer J; Casteel, Darren E; Raffeiner, Andrea; Stefan, Eduard; Patel, Hemal H; Taylor, Susan S

2018-03-23

cAMP-dependent protein kinase (PKAc) is a pivotal signaling protein in eukaryotic cells. PKAc has two well-characterized regulatory subunit proteins, RI and RII (each having α and β isoforms), which keep the PKAc catalytic subunit in a catalytically inactive state until activation by cAMP. Previous reports showed that the RIα regulatory subunit is phosphorylated by cGMP-dependent protein kinase (PKG) in vitro , whereupon phosphorylated RIα no longer inhibits PKAc at normal (1:1) stoichiometric ratios. However, the significance of this phosphorylation as a mechanism for activating type I PKA holoenzymes has not been fully explored, especially in cellular systems. In this study, we further examined the potential of RIα phosphorylation to regulate physiologically relevant "desensitization" of PKAc activity. First, the serine 101 site of RIα was validated as a target of PKGIα phosphorylation both in vitro and in cells. Analysis of a phosphomimetic substitution in RIα (S101E) showed that modification of this site increases PKAc activity in vitro and in cells, even without cAMP stimulation. Numerous techniques were used to show that although Ser 101 variants of RIα can bind PKAc, the modified linker region of the S101E mutant has a significantly reduced affinity for the PKAc active site. These findings suggest that RIα phosphorylation may be a novel mechanism to circumvent the requirement of cAMP stimulus to activate type I PKA in cells. We have thus proposed a model to explain how PKG phosphorylation of RIα creates a "sensitized intermediate" state that is in effect primed to trigger PKAc activity.

Strengthening Regulatory Competence in a Changing Nuclear Regulatory Environment

International Nuclear Information System (INIS)

Illizastigui, P.F.

2016-01-01

The paper addresses the approach followed by the Cuban National Center for Nuclear Safety for the management of current and new competences of its regulatory staff with the aim of allowing those staff to effectively fulfill their core regulatory functions. The approach is realized through an Integrated System for Competence Building, which is based on the IAEA recommendations, shown to be effective in ensuring the necessary competence in the relevant areas. In the author’s opinion, competence of the regulatory staff in the area of human and organizational factors is of paramount importance and needs to be further strengthened in order to be able to assess safety performance at the facilities and detect early signs of deteriorating safety performance. The former is defined by the author as the core regulatory function “Analysis” which covers the entire spectrum of assessment tasks carried out by the regulatory staff to: a) detect declining safety performance, b) diagnose latent weaknesses (root causes) and c) make effective safety culture interventions. The author suggests that competence associated with the fulfillment of the analysis function is distinctly identified and dealt with separately in the current system of managing regulatory competence. (author)

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

International Nuclear Information System (INIS)

2011-01-01

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

CD4+ CD25+ CD127low Regulatory T Cells as Indicator of Rheumatoid Arthritis Disease Activity.

Science.gov (United States)

Khattab, Sahar S; El-Saied, Amany M; Mohammed, Rehab A; Mohamed, Eman E

2016-06-01

Rheumatoid arthritis (RA) is an autoimmune disease characterized by disturbed immune regulation, inducing a progressive cartilage and bone destruction. Despite enrichment of T regulatory cell (T-regs) in synovial fluid, conflicting results are reported concerning T-regs in peripheral blood (PB) of RA patients. To determine possible correlation between the frequency of PB CD4+ CD25+CD127low (T-regs) with RA disease activity. Forty females with RA, classified according to the Disease Activity Score 28 (DAS-28), as highly active, mild-moderate or low disease activity; and 20 age and sex matched healthy controls, were enrolled to study CD4+ CD25+ CD127low T- regs in PB by flow cytometry. Active RA patients had lower frequency of the CD4+ CD25+ CD127low T- regs compared to those with mild-moderate or low disease activity (P <0.001). The frequencies of the T- regs showed negative correlation with the DAS-28 (P<0.01). In conclusion, CD4+ CD25+ CD127low T-regs is significantly lower in highly active RA patients compared to patients with lower activity or controls. Copyright© by the Egyptian Association of Immunologists.

Effect of Simulated Microgravity on the Activity of Regulatory Enzymes of Glycolysis and Gluconeogenesis in Mice Liver

Science.gov (United States)

Ramirez, Joaquin; Periyakaruppan, Adaikkappan; Sarkar, Shubhashish; Ramesh, Govindarajan T.; Sharma, S. Chidananda

2014-02-01

Gravity supports all the life activities present on earth. Microgravity environments have effect on the biological functions and physiological status of an individual. The present study was undertaken to investigate the effect of simulated microgravity on important regulatory enzymes of carbohydrate metabolism in liver using HLS mice model. Following hind limb unloading of mice for 11 days the animal's average body weights were found to be not different, while the liver weights were decreased and found to be significantly different ( p gluconeogenesis in liver and reciprocally regulated.

Human Factors Regulatory Research Program Plan, FY 1989--FY 1992

International Nuclear Information System (INIS)

Coffman, F.; Persensky, J.; Ryan, T.; Ramey-Smith, A.; Goodman, C.; Serig, D.; Trager, E; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

1989-10-01

This report describes the currently ongoing (FY 1989) and planned (FY 1989-1992) Human Factors Regulatory Research Program in the NRC Office of Nuclear Regulatory Research (RES). Examples of the influence of human factors on nuclear safety are presented, and the role of personnel is discussed. Current regulatory issues associated with human factors in the nuclear system and the purpose of the research plan are provided. The report describes the research process applied to the human factors research issues and the program activities: Personnel Performance Measurement, Personnel Subsystem, Human-System Interface. Organization and Management, and Reliability Assessment. The research being conducted within each activity is summarized along with the objectives, background information, and expected regulatory products. Budget and personnel forecasts are provided along with a summary of contractors performing some of the ongoing research. Appendices contain a chronology of human factors research at NRC, a description of the research approach, an update on human factors programs and initiatives in RES and other NRC offices, and the integration among these programs. 46 refs., 5 tabs

Nuclear Regulatory Commission Information Digest: 1993 edition

International Nuclear Information System (INIS)

1993-03-01

The Nuclear Regulatory Commission Information Digest (digest) provides a summary of information about the U.S. Nuclear Regulatory Commission (NRC), NRC's regulatory responsibilities, the activities NRC licenses, and general information on domestic and worldwide nuclear energy. The digest, published annually, is a compilation of nuclear- and NRC-related data and is designed to provide a quick reference to major facts about the agency and the industry it regulates. In general, the data cover 1975 through 1992, with exceptions noted. Information on generating capacity and average capacity factor for operating U.S. commercial nuclear power reactors is obtained from monthly operating reports that are submitted directly to the NRC by the licensee. This information is reviewed by the NRC for consistency only and no independent validation and/or verification is performed. Comments and/or suggestions on the data presented are welcomed and should be directed to Karen Olive, United States Nuclear Regulatory Commission, Office of the Controller, Division of Budget and Analysis, Washington, D.C. 20555. For detailed and complete information about tables and figures, refer to the source publications

Regulatory networks, legal federalism, and multi-level regulatory systems

OpenAIRE

Kerber, Wolfgang; Wendel, Julia

2016-01-01

Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insight...

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

Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 3

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-12-31

On July, 1993, a Regulatory Oversight (RO) organization was established within the US DOE, Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the OR program was to ensure continued plant safety, safeguards and security while the plants were transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). Volume 3 contains copies of two reports that document the DOE/ORO regulatory oversight inspection and enforcement history for each gaseous diffusion plant site. Each report provides a formal mechanism by which DOE/ORO could communicate the inspection and enforcement history to NRC. The reports encompass the inspection activities that occurred during July 1, 1993 through March 2, 1997.

RNA SURVEILLANCE– AN EMERGING ROLE FOR RNA REGULATORY NETWORKS IN AGING

OpenAIRE

Montano, Monty; Long, Kimberly

2010-01-01

In this review, we describe recent advances in the field of RNA regulatory biology and relate these advances to aging science. We introduce a new term, RNA surveillance, an RNA regulatory process that is conserved in metazoans, and describe how RNA surveillance represents molecular cross-talk between two emerging RNA regulatory systems – RNA interference and RNA editing. We discuss how RNA surveillance mechanisms influence mRNA and microRNA expression and activity during lifespan. Additionall...

Regulatory elements of the floral homeotic gene AGAMOUS identified by phylogenetic footprinting and shadowing.

Energy Technology Data Exchange (ETDEWEB)

Hong, R. L., Hamaguchi, L., Busch, M. A., and Weigel, D.

2003-06-01

OAK-B135 In Arabidopsis thaliana, cis-regulatory sequences of the floral homeotic gene AGAMOUS (AG) are located in the second intron. This 3 kb intron contains binding sites for two direct activators of AG, LEAFY (LFY) and WUSCHEL (WUS), along with other putative regulatory elements. We have used phylogenetic footprinting and the related technique of phylogenetic shadowing to identify putative cis-regulatory elements in this intron. Among 29 Brassicaceae, several other motifs, but not the LFY and WUS binding sites previously identified, are largely invariant. Using reporter gene analyses, we tested six of these motifs and found that they are all functionally important for activity of AG regulatory sequences in A. thaliana. Although there is little obvious sequence similarity outside the Brassicaceae, the intron from cucumber AG has at least partial activity in A. thaliana. Our studies underscore the value of the comparative approach as a tool that complements gene-by-gene promoter dissection, but also highlight that sequence-based studies alone are insufficient for a complete identification of cis-regulatory sites.

Regulatory control, legislation and framework

International Nuclear Information System (INIS)

Parthasarathy, K.S.

1998-01-01

The legislation and regulations, a regulatory authority to authorise and inspect the regulated activities and to enforce the legislation and regulations, sufficient financial and man-power resources are the essential parts of a national infrastructure to implement the Basic Safety Standards. The legal framework consists of legislation (Act passed by Parliament) and the regulations (framed by the government and endorsed by the Parliament). This paper is primarily deals with the the legal framework set up in India for atomic energy activities

Nuclear Regulatory Authority of the Slovak Republic. Annual Report 1999

International Nuclear Information System (INIS)

Seliga, M.

2000-01-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 1999 is presented. These activities are reported under the headings: (1) Foreword; (2) Mission of the Nuclear Regulatory Authority; (3) Legislation; (4) Assessment and inspection of safety at nuclear installations; (4) Safety analyses; (5) Nuclear materials; (6) Radioactive waste; (7) Quality assurance; (8) Personnel qualification and training; (9) Emergency preparedness; (10) International co-operation; (11) Public information; (12) Conclusions; (13) Appendices: Economic and personnel data; Abbreviations; The International nuclear event scales - INES

Regulatory control of radiation sources and radioactive materials in the Czech Republic

International Nuclear Information System (INIS)

Drabova, D.; Prouza, Z.

2001-01-01

The paper describes legal and regulatory provisions for radiation protection and safe use of sources of ionizing radiation in the Czech Republic with special emphasis on aspects of bringing activities under regulatory control and releasing them from it. It covers the development of a new legal framework, the work of the regulatory body, an overview of sources in use and provisions to achieve effective regulatory control of facilities and releases of radioactive material into the environment. Also, it describes reported unusual events with a proposed scheme for their classification and evaluation. (author)

Regulatory and law framework of agricultural methanization and composting activities. User's guide

International Nuclear Information System (INIS)

2008-08-01

After a presentation of the general context of organic waste management (its techniques, materials, legal and regulatory sources, i.e. European and French laws), this guide indicates the main regulatory and law aspects to those wishing to implement a project of methanization or composting of organic by-products in the agricultural sector. Several aspects are therefore discussed and presented in practical sheets. They concern the health and environment regulation, but not the professional risk prevention (explosion, fire, and so on). These aspects are the project setting up, input materials (animal by-products, organic materials coming from agricultural production or from out of it), waste collection and transport, process steps, organic product valorization, biogas valorization, solid and liquid release management

Safety culture as a matter of regulatory control and regulatory effectiveness

International Nuclear Information System (INIS)

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

2002-01-01

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

Regulatory control of the use of contractors by operating organizations. Peer discussions on regulatory practices

International Nuclear Information System (INIS)

2000-09-01

This report arises from the eighth series of peer discussions on regulatory practices entitled 'Regulatory control of the use of contractors by operating organizations'. Senior regulators from 19 Member States participated in two peer group discussions in March 2000 and May 2000. This report gives an account of the outcomes of these meetings and of practical suggestions put forward by senior regulators. These suggestions do not necessarily reflect the views of the governments of the nominating Member States, the organizations they belong to, or the International Atomic Energy Agency. The objective of this document is to share experience between regulatory bodies and provide practical suggestions for controlling the use of contractors and subcontractors by the operating organizations during all stages, especially operation, of a nuclear power plant, so as to ensure that the quality of work and services delivered is commensurate with the safety importance of the activities and that these are carried out in a manner that will not adversely affect the safe or reliable operation of the facility. These documented practical suggestions and experiences are the result of a series of peer discussions at the IAEA in 2000. It is considered that the manner in which control is exercised, and the various challenges connected to this control, are highly dependent upon the legislative framework, maturity of the nuclear programme, the size of the national nuclear industry and the culture in each country. The report is structured so that it covers the subject matter under the following main headings: Legal Provisions, Regulatory Strategy and Requirements; Regulatory Approaches for Controlling the Use of Contractors; Types of Contracts; Practical Suggestions

The Romanian nuclear regulatory body as a nuclear communicator

International Nuclear Information System (INIS)

Cluculescu, Cristina

2000-01-01

A comprehensive nuclear law environment could be a relevant tool to promote greater confidence in the nuclear energy. Romania has had laws in place governing the regulation of nuclear activities since 1974, which remained in force throughout and subsequent to the national constitutional changes. Up to December 1996, the CNCAN activities were based on Law No. 61/1974 for the development of the nuclear activities in Romania and Law No. 61982 on the quality assurance of the nuclear facilities and nuclear power plants. The Nuclear Safety legislation has been enacted in November 1974 (Law No. 61/1974) and it followed as closely as possible (for that time) the US Atomic Energy Act of 1954, as amended subsequently. The Romanian nuclear regulatory body, called National Commission for Nuclear Activities Control (CNCAN) is a governmental organization responsible for the development of the regulatory framework, the control of its implementation and for the licensing of nuclear facilities. An important issue of CNCAN is to provide the correct and reasoning information to the public. The most important topics focused on nuclear activities for the interest of mass media in Romania are: Radioactive waste management; The cost and benefit of nuclear energy compared by conventional energy; The conditions for transportation of radioactive materials; The consequences of a suppositional nuclear accidents; The safety in operation for nuclear installations. The information provided to press and public by regulatory body is clearly and well structured. The target is to clearly explain to mass media and the public should understand very well the difference between the meaning of a nuclear accident, nuclear incident or nuclear event. CNCAN monitories and surveys the operation in safe conditions the nuclear facilities and plants, the protection against nuclear radiation of the professionally exposed personnel, of the population, of the environment and the material goods. It is also

Regulatory Oversight Program, July 1, 1993 - March 3, 1997. Volume 1

International Nuclear Information System (INIS)

1997-09-01

On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation

Regulatory Oversight Program, July 1, 1993--March 3, 1997. Volume 1

Energy Technology Data Exchange (ETDEWEB)

NONE

1997-09-01

On July 1, 1993, a Regulatory Oversight (RO) organization was established within the United States Department of Energy (DOE), Oak Ridge Operations (ORO) to provide regulatory oversight of the DOE uranium enrichment facilities leased to the United States Enrichment Corporation (USEC). The purpose of the RO program was to ensure continued plant safety, safeguards and security while the Paducah and Portsmouth gaseous diffusion plants (GDPs) transitioned to regulatory oversight by the Nuclear Regulatory Commission (NRC). These activities were performed under the authority of the lease agreement between DOE and USEC until NRC issued a Certificate of Compliance or approved a Compliance Plan pursuant to Section 1701 of the Atomic Energy Act of 1954, as amended, and assumed regulatory responsibility. This report chronicles the formal development, operation and key activities of the RO organization from its beginning in July 1993, until the turnover of the regulatory oversight responsibility to the NRC on March 3, 1997. Through its evolution to closure, the RO program was a formal, proceduralized effort designed to provide consistent regulation and to facilitate transition to NRC. The RO Program was also a first-of-a-kind program for DOE. The process, experience, and lessons learned summarized herein should be useful as a model for transition of other DOE facilities to privatization or external regulation.

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

International Nuclear Information System (INIS)

2011-01-01

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

77 FR 61449 - Self-Regulatory Organizations; EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness...

Science.gov (United States)

2012-10-09

..., regulatory and other risks of this business activity. These controls include financial risk management... entry of erroneous orders. In addition, the Market Access Rule requires certain regulatory risk... authorized by the broker-dealer. These regulatory risk management controls also include measures designed to...

Safety culture in regulatory expert organization : analysis result of survey for KINS employees

International Nuclear Information System (INIS)

Choi, G. S.; Choi, Y. S.

2003-01-01

Much has been discussed on safety culture of operating organizations, however, little has been done on that of regulatory organization. Current issues and activities related to nuclear safety culture at IAEA, OECD/NEA, etc. were investigated and relevant literatures were reviewed. Elements essential for safety culture of regulatory organization were proposed and survey questionnaire for employees of regulatory expert organization, KINS, was developed based on the elements proposed. The survey result was presented and its implications were discussed. Based on the result, elements of safety culture in regulatory organization were proposed. The result of this survey can be used in developing safety culture model of regulatory organization, measurement method and also promotion of safety culture in regulatory organization

Office of Nuclear Regulatory Research summary of advanced reactors activities, June 4, 2001

International Nuclear Information System (INIS)

2001-01-01

Pre-application interactions with potential licensee applicants will help NRC prepare for future submittals, through the development of the infrastructure necessary for licensing application reviews. RES has the lead for non-LWR advanced reactor pre-application initiatives and longer-range new technology initiatives. An advanced reactor group has been formed in REAHFB, and is currently performing a pre-application review of Exelon's Pebble Bed Modular Reactor. Recent industry requests for future pre application interaction include General Atomics' Gas Turbine-Modular Helium Reactor (GT-MHR) and Westinghouse International Reactor Innovative and Secure (IRIS) design. RES advanced reactors activities also include participation as an observer in DOE's Generation IV initiative. Pre-Application review objectives include the development of regulatory guidance, licensing approach, and technology-basis expectations for licensing advanced designs, including identifying significant technology, design, safety, licensing and policy issues that would need to be addressed in the licensing process. The presentation described the pre-application process for the Exelon PBMR. NRC first identifies additional information following topical meetings with Exelon, and Exelon formally documents and submits required topical Information. The staff then develops a preliminary assessment and drafts a response which is followed by stakeholder input and comments at a public workshop. Preliminary assessments are discussed with ACRS and ACNW, and Commission papers are written which provide staff positions and recommendations on proposed policy decisions. Some of the significant areas for the PBMR include: Process Issues, Legal and Financial Issues; Regulatory Framework; Fuel Performance and Qualification; Traditional Engineering Design (e.g, Nuclear, Thermal-Fluid, Materials); Fuel Cycle Safety Areas; PRA, SSC Safety Classification; PBMR Prototype Testing

Design reviews from a regulatory perspective

International Nuclear Information System (INIS)

Foster, B.D.

1991-01-01

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

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.

76 FR 21932 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting...

Science.gov (United States)

2011-04-19

... statement therein, as follows: I. Introduction On February 4, 2011, the Financial Industry Regulatory...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Granting Approval of a... Financial Industry Regulatory Authority, Inc. (``FINRA'') to amend Rule 13806 of the Code of Arbitration...

A transcription factor collective defines the HSN serotonergic neuron regulatory landscape.

Science.gov (United States)

Lloret-Fernández, Carla; Maicas, Miren; Mora-Martínez, Carlos; Artacho, Alejandro; Jimeno-Martín, Ángela; Chirivella, Laura; Weinberg, Peter; Flames, Nuria

2018-03-22

Cell differentiation is controlled by individual transcription factors (TFs) that together activate a selection of enhancers in specific cell types. How these combinations of TFs identify and activate their target sequences remains poorly understood. Here, we identify the cis -regulatory transcriptional code that controls the differentiation of serotonergic HSN neurons in Caenorhabditis elegans . Activation of the HSN transcriptome is directly orchestrated by a collective of six TFs. Binding site clusters for this TF collective form a regulatory signature that is sufficient for de novo identification of HSN neuron functional enhancers. Among C. elegans neurons, the HSN transcriptome most closely resembles that of mouse serotonergic neurons. Mouse orthologs of the HSN TF collective also regulate serotonergic differentiation and can functionally substitute for their worm counterparts which suggests deep homology. Our results identify rules governing the regulatory landscape of a critically important neuronal type in two species separated by over 700 million years. © 2018, Lloret-Fernández et al.

Regulatory Activities to the Natural Hazard

International Nuclear Information System (INIS)

Choi, Kangryong; Jung, Raeyoung

2008-01-01

The safety of the Nuclear Power Plants(NPPs) against the natural hazards has been investigated focused on earthquake and tsunami. Since the mass media and general people have high interests on nuclear safety whenever the natural hazards occur, earthquake and tsunami are not only technical safety concern, but also psychological issues in terms of public acceptance of nuclear energy. The Korean peninsula has been considered as a safe zone compared to neighboring countries against natural hazard, but the historical documents which state severely damaged events due to the strong earthquake make US paying careful attention to assure the safety against natural phenomenon. The potential and characteristics of earthquake and tsunami have been examined, and the status of seismic and tsunami safety of the NPPs in Korea is described. the follow-up action after disastrous huge earthquake and tsunami occurred in neighboring countries is summarized as well. The assessment results show that the NPPs in Korea are well designed, constructed and maintained with certain amount of safety margin against natural hazards, and the utility and the regulatory body are continuously doing an effort to enhance the safety with consideration of lessons learned from big events in other countries

Emotion: The Self-regulatory Sense.

Science.gov (United States)

Peil, Katherine T

2014-03-01

While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system-perhaps the first sensory system to have emerged, serving the ancient autopoietic function of "self-regulation." Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of "self-relevant" sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes-evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health.

Emotion: The Self-regulatory Sense

Science.gov (United States)

2014-01-01

While emotion is a central component of human health and well-being, traditional approaches to understanding its biological function have been wanting. A dynamic systems model, however, broadly redefines and recasts emotion as a primary sensory system—perhaps the first sensory system to have emerged, serving the ancient autopoietic function of “self-regulation.” Drawing upon molecular biology and revelations from the field of epigenetics, the model suggests that human emotional perceptions provide an ongoing stream of “self-relevant” sensory information concerning optimally adaptive states between the organism and its immediate environment, along with coupled behavioral corrections that honor a universal self-regulatory logic, one still encoded within cellular signaling and immune functions. Exemplified by the fundamental molecular circuitry of sensorimotor control in the E coli bacterium, the model suggests that the hedonic (affective) categories emerge directly from positive and negative feedback processes, their good/bad binary appraisals relating to dual self-regulatory behavioral regimes—evolutionary purposes, through which organisms actively participate in natural selection, and through which humans can interpret optimal or deficit states of balanced being and becoming. The self-regulatory sensory paradigm transcends anthropomorphism, unites divergent theoretical perspectives and isolated bodies of literature, while challenging time-honored assumptions. While suppressive regulatory strategies abound, it suggests that emotions are better understood as regulating us, providing a service crucial to all semantic language, learning systems, evaluative decision-making, and fundamental to optimal physical, mental, and social health. PMID:24808986

Costs of regulatory compliance: categories and estimating techniques

International Nuclear Information System (INIS)

Schulte, S.C.; McDonald, C.L.; Wood, M.T.; Cole, R.M.; Hauschulz, K.

1978-10-01

Use of the categorization scheme and cost estimating approaches presented in this report can make cost estimates of regulation required compliance activities of value to policy makers. The report describes a uniform assessment framework that when used would assure that cost studies are generated on an equivalent basis. Such normalization would make comparisons of different compliance activity cost estimates more meaningful, thus enabling the relative merits of different regulatory options to be more effectively judged. The framework establishes uniform cost reporting accounts and cost estimating approaches for use in assessing the costs of complying with regulatory actions. The framework was specifically developed for use in a current study at Pacific Northwest Laboratory. However, use of the procedures for other applications is also appropriate

IFN regulatory factor 1 restricts hepatitis E virus replication by activating STAT1 to induce antiviral IFN-stimulated genes.

Science.gov (United States)

Xu, Lei; Zhou, Xinying; Wang, Wenshi; Wang, Yijin; Yin, Yuebang; Laan, Luc J W van der; Sprengers, Dave; Metselaar, Herold J; Peppelenbosch, Maikel P; Pan, Qiuwei

2016-10-01

IFN regulatory factor 1 (IRF1) is one of the most important IFN-stimulated genes (ISGs) in cellular antiviral immunity. Although hepatitis E virus (HEV) is a leading cause of acute hepatitis worldwide, how ISGs counteract HEV infection is largely unknown. This study was conducted to investigate the effect of IRF1 on HEV replication. Multiple cell lines were used in 2 models that harbor HEV. In different HEV cell culture systems, IRF1 effectively inhibited HEV replication. IRF1 did not trigger IFN production, and chromatin immunoprecipitation sequencing data analysis revealed that IRF1 bound to the promoter region of signal transducers and activators of transcription 1 (STAT1). Functional assay confirmed that IRF1 could drive the transcription of STAT1, resulting in elevation of total and phosphorylated STAT1 proteins and further activating the transcription of a panel of downstream antiviral ISGs. By pharmacological inhibitors and RNAi-mediated gene-silencing approaches, we revealed that antiviral function of IRF1 is dependent on the JAK-STAT cascade. Furthermore, induction of ISGs and the anti-HEV effect of IRF1 overlapped that of IFNα, but was potentiated by ribavirin. We demonstrated that IRF1 effectively inhibits HEV replication through the activation of the JAK-STAT pathway, and the subsequent transcription of antiviral ISGs, but independent of IFN production.-Xu, L., Zhou, X., Wang, W., Wang, Y., Yin, Y., van der Laan, L. J. W., Sprengers, D., Metselaar, H. J., Peppelenbosch, M. P., Pan, Q. IFN regulatory factor 1 restricts hepatitis E virus replication by activating STAT1 to induce antiviral IFN-stimulated genes. © FASEB.

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

International Nuclear Information System (INIS)

2010-01-01

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

The Safety Culture of an Effective Nuclear Regulatory Body

International Nuclear Information System (INIS)

Carlsson, Lennart; Bernard, Benoit; Lojk, Robert; Koskinen, Kaisa; Rigail, Anne-Cecile; Stoppa, Gisela; Lorand, Ferenc; Aoki, Masahiro; Fujita, Kenichi; Takada, Hiroko; Kurasaki, Takaaki; Choi, Young Sung; Smit, Martin; Bogdanova, Tatiana; Sapozhnikov, Alexander; Smetnik, Alexander; Cid Campo, Rafael; Axelsson, Lars; Carlsson, Lennart; Edland, Anne; Ryser, Cornelia; Cohen, Miriam; Ficks, Ben; Valentin, Andrea; Nicic, Adriana; Lorin, Aurelie; Nezuka, Takayoshi; Creswell, Len

2016-01-01

The fundamental objective of all nuclear safety regulatory bodies is to ensure that activities related to the peaceful use of nuclear energy are carried out in a safe manner within their respective countries. In order to effectively achieve this objective, the nuclear regulatory body requires specific characteristics, one of which is a healthy safety culture. This regulatory guidance report describes five principles that support the safety culture of an effective nuclear regulatory body. These principles concern leadership for safety, individual responsibility and accountability, co-operation and open communication, a holistic approach, and continuous improvement, learning and self-assessment. The report also addresses some of the challenges to a regulatory body's safety culture that must be recognised, understood and overcome. It provides a unique resource to countries with existing, mature regulators and can be used for benchmarking as well as for training and developing staff. It will also be useful for new entrant countries in the process of developing and maintaining an effective nuclear safety regulator. (authors)

Commensal-induced regulatory T cells mediate protection against pathogen-stimulated NF-kappaB activation.

Directory of Open Access Journals (Sweden)

Caitlin O'Mahony

Full Text Available Host defence against infection requires a range of innate and adaptive immune responses that may lead to tissue damage. Such immune-mediated pathologies can be controlled with appropriate T regulatory (Treg activity. The aim of the present study was to determine the influence of gut microbiota composition on Treg cellular activity and NF-kappaB activation associated with infection. Mice consumed the commensal microbe Bifidobacterium infantis 35624 followed by infection with Salmonella typhimurium or injection with LPS. In vivo NF-kappaB activation was quantified using biophotonic imaging. CD4+CD25+Foxp3+ T cell phenotypes and cytokine levels were assessed using flow cytometry while CD4+ T cells were isolated using magnetic beads for adoptive transfer to naïve animals. In vivo imaging revealed profound inhibition of infection and LPS induced NF-kappaB activity that preceded a reduction in S. typhimurium numbers and murine sickness behaviour scores in B. infantis-fed mice. In addition, pro-inflammatory cytokine secretion, T cell proliferation, and dendritic cell co-stimulatory molecule expression were significantly reduced. In contrast, CD4+CD25+Foxp3+ T cell numbers were significantly increased in the mucosa and spleen of mice fed B. infantis. Adoptive transfer of CD4+CD25+ T cells transferred the NF-kappaB inhibitory activity. Consumption of a single commensal micro-organism drives the generation and function of Treg cells which control excessive NF-kappaB activation in vivo. These cellular interactions provide the basis for a more complete understanding of the commensal-host-pathogen trilogue that contribute to host homeostatic mechanisms underpinning protection against aberrant activation of the innate immune system in response to a translocating pathogen or systemic LPS.

NRC [Nuclear Regulatory Commission] safety research in support of regulation, 1987

International Nuclear Information System (INIS)

1988-05-01

This report, the third in a series of annual reports, was prepared in response to congressional inquiries concerning how nuclear regulatory research is used. It summarizes the accomplishments of the Office of Nuclear Regulatory Research during 1987. The goal of this office is to ensure that research provides the technical bases for rulemaking and for related decisions in support of NRC licensing and inspection activities. This report describes both the direct contributions to scientific and technical knowledge with regard to nuclear safety and their regulatory applications

Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

International Nuclear Information System (INIS)

Coleman, Justin Leigh; Kammerer, Annie M.; Whittaker, Andrew S.

2016-01-01

Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, 'Licenses, Certifications, and Approvals for Nuclear Power Plants,' interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report that investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, 'Seismic Analysis of Safety Related Nuclear Structures.' The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design

Proposed Activities to Address Regulatory Gaps and Challenges for Licensing Advanced Reactors Using Seismic Isolation

Energy Technology Data Exchange (ETDEWEB)

Coleman, Justin Leigh [Idaho National Lab. (INL), Idaho Falls, ID (United States); Kammerer, Annie M. [Idaho National Lab. (INL), Idaho Falls, ID (United States); Whittaker, Andrew S. [Idaho National Lab. (INL), Idaho Falls, ID (United States)

2016-12-01

Over the last decade, particularly since implementation of the certified design regulatory approaches outlined in 10 CFR 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants,” interest has been increasing in the use of seismic isolation (SI) technology to support seismic safety in nuclear facilities. In 2009, the United States (U.S.) Nuclear Regulatory Commission (NRC) initiated research activities to develop new guidance targeted at isolated facilities because SI is being considered for nuclear power plants in the U.S. One product of that research, which was developed around a risk-informed regulatory approach, is a draft NRC NUREG series (NUREG/CR) report that investigates and discusses considerations for use of SI in otherwise traditionally founded large light water reactors (LWRs). A coordinated effort led to new provisions for SI of LWRs in the American Society of Civil Engineers standard ASCE/SEI 4-16, “Seismic Analysis of Safety Related Nuclear Structures.” The risk-informed design philosophy that underpinned development of the technical basis for these documents led to a set of proposed performance objectives and acceptance criteria intended to serve as the foundation for future NRC guidance on the use of SI and related technology. Although the guidance provided in the draft SI NUREG/CR report and ASCE/SEI 4 16 provides a sound basis for further development of nuclear power plant designs incorporating SI, these initial documents were focused on surface-founded or near-surface-founded LWRs and were, necessarily, limited in scope. For example, there is limited information in both the draft NUREG/CR report and ASCE/SEI 4-16 related to nonlinear analysis of soil-structure systems for deeply-embedded reactors, the isolation of components, and the use of vertical isolation systems. Also not included in the draft SI NUREG/CR report are special considerations for licensing of isolated facilities using the certified design approach in 10 CFR

Initiating Knowledge Management Project in a Regulatory Body in Thailand

International Nuclear Information System (INIS)

Pakdee, K.; Apichaibukol, A.

2016-01-01

Full text: Thailand is one of countries that have adopted the use of nuclear technology in various applications such as medical, agricultural, industrial and research applications. Recognizing this enormous potential in many applications, the Office of Atoms for Peace (OAP) as a regulatory body under the Ministry of Science and Technology, carries out a variety of activities to disseminate and promote youth, entrepreneurs and public on the awareness of the atomic energy in Thailand. In recent years, “knowledge management” is one of the key factors that contribute to safe, secure and efficient operation of nuclear activities and facilities but also for the regulatory processes as well. In this regards, the OAP is aware and recognize of the importance of studying and initiating nuclear knowledge and human resource development programme in the regulatory body. Even though, the OAP has been initiating the project on nuclear knowledge and human resources for several years but the present status of the projects still remain in primarily stage of the initiating. This paper describes the initiating of nuclear knowledge in the past and present status for knowledge management project in regulatory body in Thailand. (author

Nuclear Regulatory Authority of the Slovak Republic. Annual Report 2000

International Nuclear Information System (INIS)

Seliga, M.

2001-01-01

A brief account of activities carried out by the Nuclear Regulatory Authority of the Slovak Republic in 2000 is presented. These activities are reported under the headings: (1) Foreword and organisation structure; (2) Mission of the Nuclear Regulatory Authority; (3) Legislation; (4) Assessment and inspection of nuclear installations; (5) Safety analyses; (6) Nuclear materials and physical protection of nuclear installations; (7) Radioactive waste; (8) Quality assurance; (9) Personnel qualification and training; (10) Emergency preparedness; (11) International co-operation; (12) Public information; (13) Personnel and economic data of the UJD; (14) Conclusion; (15) Attachments: Abbreviations; Radiation safety

Regulatory supervision of industrial waste containing very low activities of man-made radionuclides at SevRAO facility

International Nuclear Information System (INIS)

Sneve, Malgorzata K.; Kochetkov, Oleg; Monastyrskaya, Svetlana; Barchukov, Valerie; Romanov, Vladimir

2008-01-01

Full text: Large amounts of waste and materials with very low activity level are generated during operation and especially during decommissioning of nuclear facilities. Selection of the optimum economic and ecologically safe management option of such material is complicated by its specific features: very low level radiation exposure to individuals but rather large initial amounts of waste. On the one hand, it is a poor use of limited resources to em place such low activity waste into expensive facilities for radioactive waste storage and disposal if the radiological impact would be very small even for a much less expensive option; on the other hand, there is some apprehension regarding safety both about its disposal to landfills for conventional (non-radioactive) waste disposal, and about its limited or unlimited re-use or re-cycling. To regulate such waste management, a special waste category is introduced - very low level waste (VLLW). This category includes waste containing radionuclides with specific activity levels, which are higher than clearance levels, but do not need high containment and isolation. This paper discusses experience of regulatory development for VLLW control during remediation of radiation hazardous facilities in northwest Russia. The work has promoted identification of some challenges, whose solution has affected the waste management strategy at the sites. One of the main problems resolved was the selection of criteria according to which waste is allocated to the VLLW category. These is turn were partly determined by the radiological criteria chosen for protection of the public during this waste disposal. Elaboration of safe VLLW management strategy depends upon a source of waste generation and of its radiological composition. The VLLW management strategy at an operating enterprise, e.g. a nuclear power plant is rather different from the strategy implemented at the plant under decommissioning, or at storage facilities for the legacy waste

Identification and Functional Analysis of Gene Regulatory Sequences Interacting with Colorectal Tumor Suppressors

DEFF Research Database (Denmark)

Dahlgaard, Katja; Troelsen, Jesper

2018-01-01

Several tumor suppressors possess gene regulatory activity. Here, we describe how promoter and promoter/enhancer reporter assays can be used to characterize a colorectal tumor suppressor proteins’ gene regulatory activity of possible target genes. In the first part, a bioinformatic approach...... of the quick and efficient In-Fusion cloning method, and how to carry out transient transfections of Caco-2 colon cancer cells with the produced luciferase reporter plasmids using polyethyleneimine (PEI). A plan describing how to set up and carry out the luciferase expression assay is presented. The luciferase...... to identify relevant gene regulatory regions of potential target genes is presented. In the second part, it is demonstrated how to prepare and carry out the functional assay. We explain how to clone the bioinformatically identified gene regulatory regions into luciferase reporter plasmids by the use...

Quantitative inference of dynamic regulatory pathways via microarray data

Directory of Open Access Journals (Sweden)

Chen Bor-Sen

2005-03-01

Full Text Available Abstract Background The cellular signaling pathway (network is one of the main topics of organismic investigations. The intracellular interactions between genes in a signaling pathway are considered as the foundation of functional genomics. Thus, what genes and how much they influence each other through transcriptional binding or physical interactions are essential problems. Under the synchronous measures of gene expression via a microarray chip, an amount of dynamic information is embedded and remains to be discovered. Using a systematically dynamic modeling approach, we explore the causal relationship among genes in cellular signaling pathways from the system biology approach. Results In this study, a second-order dynamic model is developed to describe the regulatory mechanism of a target gene from the upstream causality point of view. From the expression profile and dynamic model of a target gene, we can estimate its upstream regulatory function. According to this upstream regulatory function, we would deduce the upstream regulatory genes with their regulatory abilities and activation delays, and then link up a regulatory pathway. Iteratively, these regulatory genes are considered as target genes to trace back their upstream regulatory genes. Then we could construct the regulatory pathway (or network to the genome wide. In short, we can infer the genetic regulatory pathways from gene-expression profiles quantitatively, which can confirm some doubted paths or seek some unknown paths in a regulatory pathway (network. Finally, the proposed approach is validated by randomly reshuffling the time order of microarray data. Conclusion We focus our algorithm on the inference of regulatory abilities of the identified causal genes, and how much delay before they regulate the downstream genes. With this information, a regulatory pathway would be built up using microarray data. In the present study, two signaling pathways, i.e. circadian regulatory

CRISPR-Cas9 epigenome editing enables high-throughput screening for functional regulatory elements in the human genome.

Science.gov (United States)

Klann, Tyler S; Black, Joshua B; Chellappan, Malathi; Safi, Alexias; Song, Lingyun; Hilton, Isaac B; Crawford, Gregory E; Reddy, Timothy E; Gersbach, Charles A

2017-06-01

Large genome-mapping consortia and thousands of genome-wide association studies have identified non-protein-coding elements in the genome as having a central role in various biological processes. However, decoding the functions of the millions of putative regulatory elements discovered in these studies remains challenging. CRISPR-Cas9-based epigenome editing technologies have enabled precise perturbation of the activity of specific regulatory elements. Here we describe CRISPR-Cas9-based epigenomic regulatory element screening (CERES) for improved high-throughput screening of regulatory element activity in the native genomic context. Using dCas9 KRAB repressor and dCas9 p300 activator constructs and lentiviral single guide RNA libraries to target DNase I hypersensitive sites surrounding a gene of interest, we carried out both loss- and gain-of-function screens to identify regulatory elements for the β-globin and HER2 loci in human cells. CERES readily identified known and previously unidentified regulatory elements, some of which were dependent on cell type or direction of perturbation. This technology allows the high-throughput functional annotation of putative regulatory elements in their native chromosomal context.

Regulatory inspection of nuclear power plants in NEA member countries

International Nuclear Information System (INIS)

Gronow, W.S.; Ilani, O.

1977-01-01

The increasing use of nuclear power and public interest in the safety controls led to the proposal by the sub-Committe on Licensing of the NEA Committee on the Safety of Nuclear Installations for a specialist meeting on regulatory inspection practices. This report which was prepared at the request of the sub-Committee to assist in the exchange of views and experience at the meeting reviews the response to a questionnaire on the systems employed, the scope and objectives and the effort involved in regulatory inspection throughout all stages of the life of a nuclear power plant. Other aspects of regulatory inspection activities are discussed including documentation, procedures for changes in technical specification and modifications to plant, powers and duties of regulatory inspection personnel and actions to be taken in the event of an accident or emergency. The report concludes with some comments on those aspects of regulatory inspection practices where further information and an exchange of experience might prove to be beneficial to Member countries. (author)

Criteria of exemption of regulatory control for radioactive material

International Nuclear Information System (INIS)

Marco A. Medrano Lopez

1991-01-01

Being based on the information contained in the 10 CFR Part 20, of the section 20.301 until the 20.306 where the mechanisms by means of which can prepare the waste of low level are indicated. While the Nuclear Regulatory Commission (NRC) it amended in the year of 1985 the Act of Politics on Low level Wastes, in particular the section 10 of the amendment of the Act, relative to the concept BRC treats those groups of radioactive waste in that their activity contents are so low that they could be exempt of the regulatory control, either liberating them toward the environment or to exempt people or organizations of the regulatory control

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

International Nuclear Information System (INIS)

Woodhouse, P.A.

1995-01-01

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

Crisis Communication of Nuclear Regulatory Organisations: Towards global thinking

International Nuclear Information System (INIS)

Martell, Meritxell; Menendez, Susan; Calvo, Marina

2013-01-01

The OECD Nuclear Energy Agency (NEA) Committee on Nuclear Regulatory Activities (CNRA) Working Group on Public Communication of Nuclear Regulatory Organisations (WGPC) organised the workshop 'Crisis communication: facing the challenges' on 9-10 May 2012 in Madrid to address the international dimension of the communicative responses to crises by assessing the experience of Nuclear Regulatory Organisations of the NEA member countries and their stakeholders. The CNRA/WGPC also prepared in 2011, before the Fukushima-Daiichi nuclear accident occurred, a Road Map for Crisis Communication of Nuclear Regulatory Organisations which focused only on national aspects. This 'road map' had not considered the international dimension. CNRA mandated the WGPC to expand the Road Map so as to conclude the follow-up activity on crisis communication. The objective of the present document is to firstly, identify the key messages which can be extracted from three surveys carried out among the WGPC members after Fukushima-Daiichi's accident (Appendices II, III and IV), and incorporate them into the Road Map for Crisis Communication. Secondly, the good practices on public communication of NROs, which were presented during the OECD/NEA Workshop on Crisis Communication: Facing the Challenges, are reported. Following the structure of the road map for public communication responses during crisis included in the NEA report entitled 'Road Map for Crisis Communication of Nuclear Regulatory Organisations - National aspects', the good practices on communication before, during and after a crisis are provided. Overall, the emphasis of this report is on the international aspects of crisis communication, rather than the national dimension. (authors)

Establishing a regulatory value chain model: An innovative approach to strengthening medicines regulatory systems in resource-constrained settings.

Science.gov (United States)

Chahal, Harinder Singh; Kashfipour, Farrah; Susko, Matt; Feachem, Neelam Sekhri; Boyle, Colin

2016-05-01

Medicines Regulatory Authorities (MRAs) are an essential part of national health systems and are charged with protecting and promoting public health through regulation of medicines. However, MRAs in resource-constrained settings often struggle to provide effective oversight of market entry and use of health commodities. This paper proposes a regulatory value chain model (RVCM) that policymakers and regulators can use as a conceptual framework to guide investments aimed at strengthening regulatory systems. The RVCM incorporates nine core functions of MRAs into five modules: (i) clear guidelines and requirements; (ii) control of clinical trials; (iii) market authorization of medical products; (iv) pre-market quality control; and (v) post-market activities. Application of the RVCM allows national stakeholders to identify and prioritize investments according to where they can add the most value to the regulatory process. Depending on the economy, capacity, and needs of a country, some functions can be elevated to a regional or supranational level, while others can be maintained at the national level. In contrast to a "one size fits all" approach to regulation in which each country manages the full regulatory process at the national level, the RVCM encourages leveraging the expertise and capabilities of other MRAs where shared processes strengthen regulation. This value chain approach provides a framework for policymakers to maximize investment impact while striving to reach the goal of safe, affordable, and rapidly accessible medicines for all.

[Physico-chemical characteristics of endogenous regulatory oligopeptides].

Science.gov (United States)

Zamiatnin, A A

1990-01-01

Analysis of amino acid residue content in endogenous regulatory oligopeptides possessing a preset spectrum of functional activity has been made. It has been shown that compared to proteins the oligopeptides contain a greater number of positively charged and cyclic radicals. All 525 oligopeptides with the preset spectrum of functional activity contained in EROP-Moscow data bank were found to have the same physicochemical characteristics.

Perspectives on Regulatory T Cell Therapies.

Science.gov (United States)

Probst-Kepper, Michael; Kröger, Andrea; Garritsen, Henk S P; Buer, Jan

2009-01-01

Adoptive transfer in animal models clearly indicate an essential role of CD4+ CD25+ FOXP3+ regulatory T (T(reg)) cells in prevention and treatment of autoimmune and graft-versus-host disease. Thus, T(reg) cell therapies and development of drugs that specifically enhance T(reg) cell function and development represent promising tools to establish dominant tolerance. So far, lack of specific markers to differentiate human T(reg) cells from activated CD4+ CD25+ effector T cells, which also express FOXP3 at different levels, hampered such an approach. Recent identification of the orphan receptor glycoprotein-A repetitions predominant (GARP or LRRC32) as T(reg) cell-specific key molecule that dominantly controls FOXP3 via a positive feedback loop opens up new perspectives for molecular and cellular therapies. This brief review focuses on the role of GARP as a safeguard of a complex regulatory network of human T(reg) cells and its implications for regulatory T cell therapies in autoimmunity and graft-versus-host disease.

Role of technical and scientific support organization In Indonesian regulatory body

International Nuclear Information System (INIS)

Yusri Heni, N.A.; Zarkasih, A.S.; Liliana, Y.P.; Salman, S.

2007-01-01

Indonesian Nuclear Energy Regulatory Agency (BAPETEN) has the function in controlling the utility of nuclear energy through regulation, licensing and inspection, with the aim, interalia, to ensure the welfare, the security and the peace of people, to assure the safety and the health of workers and public, and the environmental protection, and to prevent diversion of purpose of the nuclear material utilization (Article 14 and 15 of Act no 10, 1997 on Nuclear Energy). The role and quality of technical and scientific expertise in supporting regulatory systems are importance increase the effectiveness and public confidence. The Center for Regulatory Assessment of Nuclear Installation and Nuclear Material and Center for Regulatory Assessment of Radiation Facilities and Radioactive Sources as part of BAPETEN organization has a function as technical and scientific support for regulatory systems. The purpose of this function is to provide technical and scientific basis for decisions and activities regarding nuclear and radiation safety during regulatory processes, such as in the developing and establishing regulation, technical verification for licensing, assessment of inspection funding and enforcement. In order to meet the quality and effectiveness of technical and scientific result activity, those two centers for regulatory assesment used internal and external technical experts and joint cooperation with universities, research institutes or laboratories. The development of technical and scientific strategic planning in enhancing nuclear and radiation safety is done by the following increasing of : Human resources and expertise by internal and external training or on the job training; number for computer code to perform safety analysis, capability and quality for review and assessment, national and international cooperation, etc. (author)

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

International Nuclear Information System (INIS)

2011-01-01

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

Structural classification of endogenous regulatory oligopeptides.

Science.gov (United States)

Zamyatnin, A A

1991-07-01

Based on the criteria of 50% identity in the amino acid sequence, a new method for grouping endogenous regulatory oligopeptides into structural families is presented. Data from the EROP-Moscow data bank on 579 oligopeptides fitting a preset spectrum of functional activities revealed 73 structural oligopeptide groups, 36 of which were called families.

Competitive mindsets, creativity, and the role of regulatory focus

NARCIS (Netherlands)

Bittner, Jenny; Heidemeier, Heike

2013-01-01

We examined how regulatory focus and intentions to compete rather than cooperate with group members relate to creativity. Study 1 showed that a promotion focus (i.e., a focus on ideals) activated a cooperative mindset, whereas a prevention focus (i.e., a focus on responsibilities) activated a

A regulatory perspective on design and performance requirements for engineered systems in high-level waste

International Nuclear Information System (INIS)

Bernero, R.M.

1992-01-01

For engineered systems, this paper gives an overview of some of the current activities at the U.S. Nuclear Regulatory Commission (NRC), with the intent of elucidating how the regulatory process works in the management of high-level waste (HLW). Throughout the waste management cycle, starting with packaging and transportation, and continuing to final closure of a repository, these activities are directed at taking advantage of the prelicensing consultation period, a period in which the NRC, DOE and others can interact in ways that will reduce regulatory, technical and institutional uncertainties, and open the path to development and construction of a deep geologic repository for permanent disposal of HLW. Needed interactions in the HLW program are highlighted. Examples of HLW regulatory activities are given in discussions of a multipurpose-cask concept and of current NRC work on the meaning of the term substantially complete containment

75 FR 11166 - Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission...

Science.gov (United States)

2010-03-10

... the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission; Notice of Joint Meeting of the Nuclear Regulatory Commission and the Federal Energy Regulatory Commission March 2, 2010. The Federal Energy Regulatory Commission (FERC) and the Nuclear Regulatory Commission (NRC) will hold...

Regulatory Safety Requirements for Operating Nuclear Installations

International Nuclear Information System (INIS)

Gubela, W.

2017-01-01

The National Nuclear Regulator (NNR) is established in terms of the National Nuclear Regulator Act (Act No 47 of 1999) and its mandate and authority are conferred through sections 5 and 7 of this Act, setting out the NNR's objectives and functions, which include exercising regulatory control over siting, design, construction etc of nuclear installations through the granting of nuclear authorisations. The NNR's responsibilities embrace all those actions aimed at providing the public with confidence and assurance that the risks arising from the production of nuclear energy remain within acceptable safety limits -> Therefore: Set fundamental safety standards, conducting pro-active safety assessments, determining licence conditions and obtaining assurance of compliance. The promotional aspects of nuclear activities in South Africa are legislated by the Nuclear Energy Act (Act No 46 of 1999). The NNR approach to regulations of nuclear safety and security take into consideration, amongst others, the potential hazards associated with the facility or activity, safety related programmes, the importance of the authorisation holder's safety related processes as well as the need to exercise regulatory control over the technical aspects such as of the design and operation of a nuclear facility in ensuring nuclear safety and security. South Africa does not have national nuclear industry codes and standards. The NNR is therefore non-prescriptive as it comes to the use of industry codes and standards. Regulatory framework (current) provide for the protection of persons, property, and environment against nuclear damage, through Licensing Process: Safety standards; Safety assessment; Authorisation and conditions of authorisation; Public participation process; Compliance assurance; Enforcement

Regulatory aspects of the radioactive waste management in Argentina

International Nuclear Information System (INIS)

Siraky, Graciela

2000-01-01

This paper describes briefly the legislative and regulatory framework in which the radioactive waste management is carried out in Argentina. The activities of the Nuclear Regulatory Authority (NRA) and the applied approaches in relation to inspection of facilities, safety assessments of associated systems and collaboration in the matter with international agencies are also exposed. The 'National Law of the Nuclear Activity' (No. 24804), in force since April 1997, assigns to NRA the following functions: to regulate and to inspect nuclear activities regarding radiological and nuclear safety, physical protection of nuclear materials, in order to verify that such materials are used exclusively with peaceful purposes and also, to advise the National Executive Power in matters of its competence. For the fulfilment of these functions the Law grants to NRA the necessary legal competence to develop, to establish and to apply a regulatory system to all nuclear activities carried out in Argentina. The activity of NRA is carried out in the framework of a regulatory system whose fundamental aspect in the approach adopted to establish the requirements of safety, which is know as 'of performance'. This system has a group of rules known as 'AR Standards' (AR: abbreviation of Regulatory Authority) that, among other requirements, establish that the construction, operation and decommissioning of a nuclear installation can not start without the corresponding construction, operation or decommissioning license. In that sense, besides having the legal competence in the topic, NRA has developed its necessary technical competence to evaluate, with own criteria, all radiological and nuclear safety aspects involved in the grant of licenses and to guarantee an appropriate level of control in the facilities. In relation to the radioactive waste management, NRA has developed some basic criteria. These criteria underline the requirements put to the 'Responsible Entity' that generates or manages

Nuclear Legislation in OECD and NEA Countries. Regulatory and Institutional Framework for Nuclear Activities - France

International Nuclear Information System (INIS)

2011-01-01

This country profile provide comprehensive information on the regulatory and Institutional Framework governing nuclear activities as well as a detailed review of a full range of nuclear law topics, including: mining regime; radioactive substances; nuclear installations; trade in nuclear materials and equipment; radiation protection; radioactive waste management; non-proliferation and physical protection; transport; and nuclear third party liability. The profile is complemented by reproductions of the primary legislation regulating nuclear activities in the country. Content: I. General Regulatory Framework: 1. General (The French nuclear power programme and its main players; French nuclear law); 2. Mining Regime; 3. Radioactive Substances and Nuclear Equipment (Regulatory diversity; Radioactive sources; Medical activities); 4. Trade in Nuclear Materials and Equipment (Basic nuclear installations - INB; Tax on basic nuclear installations, Additional taxes, Funding nuclear costs; Installations classified for environmental protection purposes (ICPE) using radioactive substances; Nuclear pressure equipment - ESPN; Defence-related nuclear installations and activities - IANID; Emergency plans); 5. Trade in Nuclear Materials and Equipment (General provisions; Patents); 6. Radiation protection (Protection of the public; Protection of workers; Radiation protection inspectors; Labour inspectors; Protection of individuals in a radiological emergency); 7. Radioactive Waste Management (General regulations; Radioactive waste regulations; Discharge of effluents); 8. Non-proliferation and physical protection (Materials not used for the nuclear deterrent; Materials used for the nuclear deterrent); 9. Transport (Licensing and notification regime: Transport of radioactive materials, Transport of nuclear materials, Transport of radioactive substances between member states of the European Union; Methods of transport: Land transport, Sea transport, Air transport, Transport by post); 10

Oncogenic MYC Activates a Feedforward Regulatory Loop Promoting Essential Amino Acid Metabolism and Tumorigenesis.

Science.gov (United States)

Yue, Ming; Jiang, Jue; Gao, Peng; Liu, Hudan; Qing, Guoliang

2017-12-26

Most tumor cells exhibit obligatory demands for essential amino acids (EAAs), but the regulatory mechanisms whereby tumor cells take up EAAs and EAAs promote malignant transformation remain to be determined. Here, we show that oncogenic MYC, solute carrier family (SLC) 7 member 5 (SLC7A5), and SLC43A1 constitute a feedforward activation loop to promote EAA transport and tumorigenesis. MYC selectively activates Slc7a5 and Slc43a1 transcription through direct binding to specific E box elements within both genes, enabling effective EAA import. Elevated EAAs, in turn, stimulate Myc mRNA translation, in part through attenuation of the GCN2-eIF2α-ATF4 amino acid stress response pathway, leading to MYC-dependent transcriptional amplification. SLC7A5/SLC43A1 depletion inhibits MYC expression, metabolic reprogramming, and tumor cell growth in vitro and in vivo. These findings thus reveal a MYC-SLC7A5/SLC43A1 signaling circuit that underlies EAA metabolism, MYC deregulation, and tumorigenesis. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Environment and T regulatory cells in allergy.

Science.gov (United States)

Braga, M; Schiavone, C; Di Gioacchino, G; De Angelis, I; Cavallucci, E; Lazzarin, F; Petrarca, C; Di Gioacchino, M

2012-04-15

The central role of T regulatory cells in the responses against harmless environmental antigens has been confirmed by many studies. Impaired T regulatory cell function is implicated in many pathological conditions, particularly allergic diseases. The "hygiene hypothesis" suggests that infections and infestations may play a protective role for allergy, whereas environmental pollutants favor the development of allergic diseases. Developing countries suffer from a variety of infections and are also facing an increasing diffusion of environmental pollutants. In these countries allergies increase in relation to the spreading use of xenobiotics (pesticides, herbicides, pollution, etc.) with a rate similar to those of developed countries, overcoming the protective effects of infections. We review here the main mechanisms of non-self tolerance, with particular regard to relations between T regulatory cell activity, infections and infestations such as helminthiasis, and exposure to environmental xenobiotics with relevant diffusion in developing countries. Copyright © 2010 Elsevier B.V. All rights reserved.

75 FR 63878 - Self-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate...

Science.gov (United States)

2010-10-18

...-Regulatory Organizations; Self-Regulatory Organizations; Notice of Filing and Immediate Effectiveness of...(b)(1). \\2\\ 17 CFR 240.19b-4. I. Self-Regulatory Organization's Statement of the Terms of Substance... Public Reference Room. II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory...

Regulatory issues in the maintenance of Argentine nuclear power plants

International Nuclear Information System (INIS)

Castro, E.; Caruso, G.

1997-01-01

The influence of maintenance activities upon nuclear safety and their relevance as means to detect and prevent aging make them play an outstanding role among the fields of interest of the Argentine nuclear regulatory body (ENREN). Such interest is reinforced by the fact that the data obtained during maintenance are used - among other - as inputs in the Probabilistic Safety Analyses required for those nuclear power plants. This paper provides a brief description of the original requirements by the regulatory body concerning maintenance, of the factors that led to review the criteria involved in such requirements and of the key items identified during the reviewing process. The latter shall be taken into account in the maintenance regulatory policy, for the consequent issue of new requirements from the utilities and for the eventual publication of a specific regulatory standard. (author)

Developing self-regulation for dietary temptations: intervention effects on physical, self-regulatory and psychological outcomes.

Science.gov (United States)

McKee, Heather C; Ntoumanis, Nikos

2014-12-01

We aimed to investigate whether a self-regulatory skills intervention can improve weight loss-related outcomes. Fifty-five participants (M BMI = 32.60 ± 4.86) were randomized into self-regulation training and advice groups and received two training workshops and weekly practice tasks. The self-regulation training group was trained to use six self-regulatory skills: Delayed gratification, thought control, goal setting, self-monitoring, mindfulness, and coping. The advice group received dietary and physical activity advice for weight loss. Physical, self-regulatory, and psychological measures were taken at baseline, end of intervention (week 8) and at follow-up (week 12). Using intention-to-treat analysis, weight, waist circumference, body fat and body mass index (BMI) were significantly reduced at follow-up for both groups. There were significant increases in all six self-regulatory skills and the psychological measures of self-efficacy, self-regulatory success, and physical self-worth for both groups. Results indicate that self-regulatory skills training might be as effective as dietary and physical activity advice in terms of weight loss and related outcomes.

Protein Kinase A Regulatory Subunits in Human Adipose Tissue

Science.gov (United States)

Mantovani, Giovanna; Bondioni, Sara; Alberti, Luisella; Gilardini, Luisa; Invitti, Cecilia; Corbetta, Sabrina; Zappa, Marco A.; Ferrero, Stefano; Lania, Andrea G.; Bosari, Silvano; Beck-Peccoz, Paolo; Spada, Anna

2009-01-01

OBJECTIVE—In human adipocytes, the cAMP-dependent pathway mediates signals originating from β-adrenergic activation, thus playing a key role in the regulation of important metabolic processes, i.e., lipolysis and thermogenesis. Cyclic AMP effects are mainly mediated by protein kinase A (PKA), whose R2B regulatory isoform is the most expressed in mouse adipose tissue, where it protects against diet-induced obesity and fatty liver development. The aim of the study was to investigate possible differences in R2B expression, PKA activity, and lipolysis in adipose tissues from obese and nonobese subjects. RESEARCH DESIGN AND METHODS—The expression of the different PKA regulatory subunits was evaluated by immunohistochemistry, Western blot, and real-time PCR in subcutaneous and visceral adipose tissue samples from 20 nonobese and 67 obese patients. PKA activity and glycerol release were evaluated in total protein extract and adipocytes isolated from fresh tissue samples, respectively. RESULTS—Expression techniques showed that R2B was the most abundant regulatory protein, both at mRNA and protein level. Interestingly, R2B mRNA levels were significantly lower in both subcutaneous and visceral adipose tissues from obese than nonobese patients and negatively correlated with BMI, waist circumference, insulin levels, and homeostasis model assessment of insulin resistance. Moreover, both basal and stimulated PKA activity and glycerol release were significantly lower in visceral adipose tissue from obese patients then nonobese subjects. CONCLUSIONS—Our results first indicate that, in human adipose tissue, there are important BMI-related differences in R2B expression and PKA activation, which might be included among the multiple determinants involved in the different lipolytic response to β-adrenergic activation in obesity. PMID:19095761

Evolution of Cis-Regulatory Elements and Regulatory Networks in Duplicated Genes of Arabidopsis.

Science.gov (United States)

Arsovski, Andrej A; Pradinuk, Julian; Guo, Xu Qiu; Wang, Sishuo; Adams, Keith L

2015-12-01

Plant genomes contain large numbers of duplicated genes that contribute to the evolution of new functions. Following duplication, genes can exhibit divergence in their coding sequence and their expression patterns. Changes in the cis-regulatory element landscape can result in changes in gene expression patterns. High-throughput methods developed recently can identify potential cis-regulatory elements on a genome-wide scale. Here, we use a recent comprehensive data set of DNase I sequencing-identified cis-regulatory binding sites (footprints) at single-base-pair resolution to compare binding sites and network connectivity in duplicated gene pairs in Arabidopsis (Arabidopsis thaliana). We found that duplicated gene pairs vary greatly in their cis-regulatory element architecture, resulting in changes in regulatory network connectivity. Whole-genome duplicates (WGDs) have approximately twice as many footprints in their promoters left by potential regulatory proteins than do tandem duplicates (TDs). The WGDs have a greater average number of footprint differences between paralogs than TDs. The footprints, in turn, result in more regulatory network connections between WGDs and other genes, forming denser, more complex regulatory networks than shown by TDs. When comparing regulatory connections between duplicates, WGDs had more pairs in which the two genes are either partially or fully diverged in their network connections, but fewer genes with no network connections than the TDs. There is evidence of younger TDs and WGDs having fewer unique connections compared with older duplicates. This study provides insights into cis-regulatory element evolution and network divergence in duplicated genes. © 2015 American Society of Plant Biologists. All Rights Reserved.

Identification of a new gene regulatory circuit involving B cell receptor activated signaling using a combined analysis of experimental, clinical and global gene expression data

Science.gov (United States)

Schrader, Alexandra; Meyer, Katharina; Walther, Neele; Stolz, Ailine; Feist, Maren; Hand, Elisabeth; von Bonin, Frederike; Evers, Maurits; Kohler, Christian; Shirneshan, Katayoon; Vockerodt, Martina; Klapper, Wolfram; Szczepanowski, Monika; Murray, Paul G.; Bastians, Holger; Trümper, Lorenz; Spang, Rainer; Kube, Dieter

2016-01-01

To discover new regulatory pathways in B lymphoma cells, we performed a combined analysis of experimental, clinical and global gene expression data. We identified a specific cluster of genes that was coherently expressed in primary lymphoma samples and suppressed by activation of the B cell receptor (BCR) through αIgM treatment of lymphoma cells in vitro. This gene cluster, which we called BCR.1, includes numerous cell cycle regulators. A reduced expression of BCR.1 genes after BCR activation was observed in different cell lines and also in CD10+ germinal center B cells. We found that BCR activation led to a delayed entry to and progression of mitosis and defects in metaphase. Cytogenetic changes were detected upon long-term αIgM treatment. Furthermore, an inverse correlation of BCR.1 genes with c-Myc co-regulated genes in distinct groups of lymphoma patients was observed. Finally, we showed that the BCR.1 index discriminates activated B cell-like and germinal centre B cell-like diffuse large B cell lymphoma supporting the functional relevance of this new regulatory circuit and the power of guided clustering for biomarker discovery. PMID:27166259

Use of PRA in the nuclear regulatory field in South Africa

International Nuclear Information System (INIS)

Hill, T.F.

1994-01-01

The nuclear regulatory authority in South Africa (since 1988 the Council for Nuclear Safety (CNS)), established in 1973 nuclear safety criteria against which to assess the level of safety of any facility using radioactive material. It is a regulatory requirement in South Africa to develop and maintain a living PRA for each facility and thereby to provide the necessary information to demonstrate compliance against these criteria. All safety submissions to the CNS must include at least a risk statement based on an accepted PRA study. The function of the CNS is to regulate all activities in South Africa involving the use of radioactive material and posing a significant risk to the public or plant personnel. This includes most aspects of the nuclear fuel cycle and the Koeberg NPS (two 2775 MW(th) PWRs). A PRA study including source terms for the two Koeberg units was presented by the contractor in 1979. This included the risk due to power and shutdown states and non reactor related accidents involving spent fuel storage, fuel handling and waste treatment related activities. At least 20 PRA studies have been performed for other nuclear facilities in the country. The CNS maintains an in-house PRA capability to perform independent assessments of licensee submission, to participate in developments of PRA methodology in the regulatory field, to perform pro-active safety work and to assist in regulatory decision making. Present ongoing work includes the development of a risk monitor, a risk management system, improvement in PRA codes, models, data collection and analysis, off-site risk assessment methodology and associated regulatory policy. (author). 1 fig

Modulation of redox regulatory molecules and electron transport chain activity in muscle of air breathing fish Heteropneustes fossilis under air exposure stress.

Science.gov (United States)

Paital, Biswaranjan

2014-01-01

Responses of redox regulatory system to long-term survival (>18 h) of the catfish Heteropneustes fossilis in air are not yet understood. Lipid and protein oxidation level, oxidant (H2O2) generation, antioxidative status (levels of superoxide dismutase, catalase, glutathione peroxidase and reductase, ascorbic acid and non-protein sulfhydryl) and activities of respiratory complexes (I, II, III and IV) in mitochondria were investigated in muscle of H. fossilis under air exposure condition (0, 3, 6, 12 and 18 h at 25 °C). The increased levels of both H2O2 and tissue oxidation were observed due to the decreased activities of antioxidant enzymes in muscle under water deprivation condition. However, ascorbic acid and non-protein thiol groups were the highest at 18 h air exposure time. A linear increase in complex II activity with air exposure time and an increase up to 12 h followed by a decrease in activity of complex I at 18 h were observed. Negative correlation was observed for complex III and V activity with exposure time. Critical time to modulate the above parameters was found to be 3 h air exposure. Dehydration induced oxidative stress due to modulation of electron transport chain and redox metabolizing enzymes in muscle of H. fossilis was clearly observed. Possible contribution of redox regulatory system in muscle tissue of the fish for long-term survival in air is elucidated. Results of the present study may be useful to understand the redox metabolism in muscle of fishes those are exposed to air in general and air breathing fishes in particular.

Construction of the Database for Tomorrow's Regulatory Activities

International Nuclear Information System (INIS)

Lee, Il S.; Kim, Min C.; Kim, Sang J.; Yu, Seon O.; Lee, Kyung W.; Kim, Ji T.; Koo, Bon H.; Lee, Durk H.

2010-01-01

KINS has launched a top brand project since early 2007, which called the 'Tracking System for the Implementation of Nuclear Regulation: RTRACER' The one of main contents of RTRACER is promoting nuclear safety by interconnecting the information of the events and that of safety review and regulatory inspection. R-TRACER is composed of three parts. One is the CATS(Corrective Action Tracking System) to carry out the related affairs and to exchange information between organizations concerned efficiently. Another is the SIMS(Safety Issue Management System) to coordinate the safety issues program and to implement the operating experience feedback in a real-time basis. And the other is the DIOS to supply above both systems with core information. This paper is focused on the database structure of the DIOS

Current Status of Regulatory Science Education in Faculties of Pharmaceutical Science in Japan.

Science.gov (United States)

Tohkin, Masahiro

2017-01-01

I introduce the current pharmaceutical education system in Japan, focusing on regulatory science. University schools or faculties of pharmaceutical science in Japan offer two courses: a six-year course for pharmacists and a four-year course for scientists and technicians. Students in the six-year pharmaceutical course receive training in hospitals and pharmacies during their fifth year, and those in the four-year life science course start research activities during their third year. The current model core curriculum for pharmaceutical education requires them to "explain the necessity and significance of regulatory science" as a specific behavior object. This means that pharmacists should understand the significance of "regulatory science", which will lead to the proper use of pharmaceuticals in clinical practice. Most regulatory science laboratories are in the university schools or faculties of pharmaceutical sciences; however, there are too few to conduct regulatory science education. There are many problems in regulatory science education, and I hope that those problems will be resolved not only by university-based regulatory science researchers but also by those from the pharmaceutical industry and regulatory authorities.

Systematisation of the use of experience feedback from NPP's in the regulatory field

International Nuclear Information System (INIS)

Vandewalle, A.

2004-01-01

Operating experience activities are important to maintain and to improve nuclear safety for nuclear power plant installations. Although with somewhat other objectives, the same kind of activities has to be performed by the regulatory organisations to support their functions, responsibilities and missions, without duplications and wastage of resources. International cooperation to share experience gained from events is also essential in this improvement process and each regulatory organisation should participate to this fundamental support to nuclear safety. (orig.)

The core to regulatory reform

International Nuclear Information System (INIS)

Partridge, J.W. Jr.

1993-01-01

Federal Energy Regulatory Commission (FERC) Orders 436, 500, and 636, the Clean Air Act Amendments of 1990, Public Utility Holding Company Act reform, and the 1992 Energy Policy Act all can have significant effects on an LDC's operations. Such changes in an LDC's environments must be balanced by changes within the utility, its marketplace, and its state regulatory environment. The question is where to start. For Columbia Gas Distribution Cos., based in Columbus, OH, the new operating foundation begins with each employee. Internal strength is critical in designing initiatives that meet the needs of the marketplace and are well-received by regulators. Employees must understand not only the regulatory environment in which the LDC operates, but also how their work contributes to a positive regulatory relationship. To achieve this, Columbia initiated the COntinuing Regulatory Education program, or CORE, in 1991. CORE is a regulatory-focused, information-initiative program coordinated by Columbia's Regulatory Policy, Planning, and Government Affairs Department. The CORE programs can take many forms, such as emerging issue discussions, dialogues with regulators and key parties, updates on regulatory fillings, regulatory policy meetings, and formal training classes. The speakers and discussion facilitators can range from human resource department trainers to senior officers, from regulatory department staff members to external experts, or from state commissioners to executives from other LDCs. The goals of CORE initiatives are to: Support a professional level of regulatory expertise through employee participation in well-developed regulatory programs presented by credible experts. Encourage a constructive state regulatory environment founded on communication and cooperation. CORE achieves these goals via five program levels: introductory basics, advanced learning, professional expertise, crossfunctional dialogues, and external idea exchanges

76 FR 66344 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2011-10-26

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... 31, 2011, Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a National Association of... consolidation process, see Information Notice, March 12, 2008 (Rulebook Consolidation Process). For convenience...

75 FR 17456 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2010-04-06

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change..., Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission... terms. For more information about the rulebook consolidation process, see Information Notice, March 12...

Gene regulatory and signaling networks exhibit distinct topological distributions of motifs

Science.gov (United States)

Ferreira, Gustavo Rodrigues; Nakaya, Helder Imoto; Costa, Luciano da Fontoura

2018-04-01

The biological processes of cellular decision making and differentiation involve a plethora of signaling pathways and gene regulatory circuits. These networks in turn exhibit a multitude of motifs playing crucial parts in regulating network activity. Here we compare the topological placement of motifs in gene regulatory and signaling networks and observe that it suggests different evolutionary strategies in motif distribution for distinct cellular subnetworks.

78 FR 62784 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Science.gov (United States)

2013-10-22

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer... 5210 (Publication of Transactions and Quotations) October 4, 2013. I. Introduction On August 15, 2013, Financial Industry Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission...

Computational methods to dissect cis-regulatory transcriptional ...

Indian Academy of Sciences (India)

The formation of diverse cell types from an invariant set of genes is governed by biochemical and molecular processes that regulate gene activity. A complete understanding of the regulatory mechanisms of gene expression is the major function of genomics. Computational genomics is a rapidly emerging area for ...

Antidiabetic activity of Ganoderma lucidum polysaccharides F31 down-regulated hepatic glucose regulatory enzymes in diabetic mice.

Science.gov (United States)

Xiao, Chun; Wu, Qingping; Zhang, Jumei; Xie, Yizhen; Cai, Wen; Tan, Jianbin

2017-01-20

Ganoderma lucidum (Lin Zhi) has been used to treat diabetes in Chinese folk for centuries. Our laboratory previously demonstrated that Ganoderma lucidum polysaccharides (GLPs) had hypoglycemic effects in diabetic mice. Our aim was to identify the main bioactives in GLPs and corresponding mechanism of action. Four polysaccharide-enriched fraction were isolated from GLPs and the antidiabetic activities were evaluated by type 2 diabetic mice. Fasting serum glucose (FSG), fasting serum insulin (FSI) and epididymal fat/BW ratio were measured at the end of the experiment. In liver, the mRNA levels of hepatic glucose regulatory enzymes were determined by quantitative polymerase chain reaction (qPCR) and the protein levels of phospho-AMP-activated protein kinase (p-AMPK)/AMPK were determined by western blotting test. In epididymal fat tissue, the mRNA and protein levels GLUT4, resistin, fatty acid synthase (FAS) and acetyl-CoA carboxylase (ACC1) were determined by qPCR and immuno-histochemistry. The structure of polysaccharide F31 was obtained from GPC, FTIR NMR and GC-MS spectroscopy, RESULTS: F31 significantly decreased FSG (P<0.05), FSI and epididymal fat/BW ratio (P<0.01). In liver, F31 decreased the mRNA levels of hepatic glucose regulatory enzymes, and up-regulated the ratio of phospho-AMP-activated protein kinase (p-AMPK)/AMPK. In epididymal fat tissue, F31 increased the mRNA levels of GLUT4 but decreased fatty acid synthase (FAS), acetyl-CoA carboxylase (ACC1) and resistin. Immuno-histochemistry results revealed F31 increased the protein levels of GLUT4 and decreased resistin. Data suggested that the main bioactives in GLPs was F31, which was determined to be a β-heteropolysaccharide with the weight-average molecular weight of 15.9kDa. The possible action mechanism of F31 may be associated with down-regulation of the hepatic glucose regulated enzyme mRNA levels via AMPK activation, improvement of insulin resistance and decrease of epididymal fat/BW ratio. These

Nuclear Regulatory Infrastructure in the Philippines

International Nuclear Information System (INIS)

Leonin, Teofilo V. Jr.

2015-01-01

Regulating the use of radioactive materials in the Philippines involves the adherence to legislation, regulations, standards and regulatory guides. It is based on a detailed review and assessment of the radiation safety program of owners and users of these materials and associated equipment against safety requirements and on additional verification of the operating practices and procedures. Republic Acts 5207 and 2067, both as amended, are implemented through the regulations which are titled Code of PNRI Regulations or CPRs are developed and issued together with supporting regulatory guides, Bulletins and other documents detailing the safety requirements. These issuance adhere to internationally accepted requirements on radiation protection, and nuclear safety and security, as well as safeguards. Design documents and technical Specifications of important radioactive materials, equipment and components are required to be submitted and reviewed by the PNRI before the issuance of an authorization in the form of a license Verification of adherence to regulations and safety requirements are periodically checked through the implementation of an inspection and enforcement program. The ISO certified regulatory management system of PNRI is documented in a QMS manual that provides guidance on all work processes. It involves systematic planning and evaluation of activities, multiple means of getting feedback on the work processes, and continuous efforts to improve its effectiveness. Efforts are implemented in order to strengthen the transparency openness, independence, technical competence and effectiveness of the regulatory body. (author)

Radiation safety in educational, medical and research institutions. Regulatory guide G-121

International Nuclear Information System (INIS)

2000-05-01

This regulatory guide is intended to help educational, medical and research institutions design and implement radiation protection programs that meed regulatory requirements. This guide applied to educational, medical or research institutions that require a licence from the CNSC to posses or use radioactive materials. It describes programs to assure that radioactive materials are used safely during licensed activities. (author)

Governmental, Legal and Regulatory Framework for Safety. General Safety Requirements. Part 1

Energy Technology Data Exchange (ETDEWEB)

NONE

2010-09-15

The objective of this publication is to establish requirements in respect of the governmental, legal and regulatory framework for safety. It covers the essential aspects of the framework for establishing a regulatory body and taking other actions necessary to ensure the effective regulatory control of facilities and activities utilized for peaceful purposes. Other responsibilities and functions, such as liaison within the global safety regime and on support services for safety (including radiation protection), emergency preparedness and response, nuclear security, and the State system of accounting for and control of nuclear material, are also covered.

A study on the implement of regulatory issue problems about service business

International Nuclear Information System (INIS)

Kim, In Hwan; Shim, H. S.; Yoon, K. H.; Jun, I. Y.; Kang, W. S.; Chang, J. H.

2004-12-01

This study is intended to derive a proposal for revision of the Atomic Energy Law, with understanding of differences between regulatory requirements and current issues based on findings during safety review and regular inspection. The contents and scope of this study is as follows: - Deep review for service business in 'the rationalization of the radiation protection system related with use of radionuclide', studied by Korea Isotope Association and presentation in the Korea Association for radiation protection, - Efficient regulatory activity through pre-finding of current regulatory issues to be derived during safety review and regular inspection

75 FR 21686 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of...

Science.gov (United States)

2010-04-26

... to pay arbitration awards to remain in the securities industry presents regulatory risks and is...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing of Proposed Rule... Regulatory Authority, Inc. (``FINRA'') filed with the Securities and Exchange Commission (``SEC'' or...

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)

Pharmaceutical Cocrystals: Regulatory and Strategic Aspects, Design and Development

Directory of Open Access Journals (Sweden)

Dipak Dilip Gadade

2016-12-01

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

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

Science.gov (United States)

Gadade, Dipak Dilip; Pekamwar, Sanjay Sudhakar

2016-12-01

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

A distinct regulatory region of the Bmp5 locus activates gene expression following adult bone fracture or soft tissue injury.

Science.gov (United States)

Guenther, Catherine A; Wang, Zhen; Li, Emma; Tran, Misha C; Logan, Catriona Y; Nusse, Roel; Pantalena-Filho, Luiz; Yang, George P; Kingsley, David M

2015-08-01

Bone morphogenetic proteins (BMPs) are key signaling molecules required for normal development of bones and other tissues. Previous studies have shown that null mutations in the mouse Bmp5 gene alter the size, shape and number of multiple bone and cartilage structures during development. Bmp5 mutations also delay healing of rib fractures in adult mutants, suggesting that the same signals used to pattern embryonic bone and cartilage are also reused during skeletal regeneration and repair. Despite intense interest in BMPs as agents for stimulating bone formation in clinical applications, little is known about the regulatory elements that control developmental or injury-induced BMP expression. To compare the DNA sequences that activate gene expression during embryonic bone formation and following acute injuries in adult animals, we assayed regions surrounding the Bmp5 gene for their ability to stimulate lacZ reporter gene expression in transgenic mice. Multiple genomic fragments, distributed across the Bmp5 locus, collectively coordinate expression in discrete anatomic domains during normal development, including in embryonic ribs. In contrast, a distinct regulatory region activated expression following rib fracture in adult animals. The same injury control region triggered gene expression in mesenchymal cells following tibia fracture, in migrating keratinocytes following dorsal skin wounding, and in regenerating epithelial cells following lung injury. The Bmp5 gene thus contains an "injury response" control region that is distinct from embryonic enhancers, and that is activated by multiple types of injury in adult animals. Copyright © 2015 Elsevier Inc. All rights reserved.

Regulatory Competition in Global Financial Markets

DEFF Research Database (Denmark)

Ringe, Georg

2016-01-01

Regulatory arbitrage in financial markets refers to a number of strategies that market participants use to avoid the reach of regulation, in particular by virtue of moving trading abroad or relocating activities or operations of financial institutions to other jurisdictions. Where this happens...... institutions' excessive risk-taking. If such risk-taking would be judged by market discipline instead of posing a risk to global financial stability, the main downside of regulatory competition could be restrained. Within the boundaries of such a system, competition could then operate and contribute...... their standards solely to attract business and thereby impose externalities on the worldwide financial market by undermining financial stability as a global public good. Policymakers worldwide are experimenting with remedies to respond to the phenomenon. I introduce the importance of an effective special...

Team structure and regulatory focus: the impact of regulatory fit on team dynamic.

Science.gov (United States)

Dimotakis, Nikolaos; Davison, Robert B; Hollenbeck, John R

2012-03-01

We report a within-teams experiment testing the effects of fit between team structure and regulatory task demands on task performance and satisfaction through average team member positive affect and helping behaviors. We used a completely crossed repeated-observations design in which 21 teams enacted 2 tasks with different regulatory focus characteristics (prevention and promotion) in 2 organizational structures (functional and divisional), resulting in 84 observations. Results suggested that salient regulatory demands inherent in the task interacted with structure to determine objective and subjective team-level outcomes, such that functional structures were best suited to (i.e., had best fit with) tasks with a prevention regulatory focus and divisional structures were best suited to tasks with a promotion regulatory focus. This contingency finding integrates regulatory focus and structural contingency theories, and extends them to the team level with implications for models of performance, satisfaction, and team dynamics.

Proton Pump Inhibitors and the Risk for Fracture at Specific Sites: Data Mining of the FDA Adverse Event Reporting System.

Science.gov (United States)

Wang, Liwei; Li, Mei; Cao, Yuying; Han, Zhengqi; Wang, Xueju; Atkinson, Elizabeth J; Liu, Hongfang; Amin, Shreyasee

2017-07-17

Proton pump inhibitors (PPIs) are widely used to treat gastric acid-related disorders. Concerns have been raised about potential fracture risk, especially at the hip, spine and wrist. However, fracture risk at other bone sites has not been as well studied. We investigated the association between PPIs and specific fracture sites using an aggregated knowledge-enhanced database, the Food and Drug Administration Adverse Event Reporting System Data Mining Set (AERS-DM). Proportional reporting ratio (PRR) was used to detect statistically significant associations (signals) between PPIs and fractures. We analyzed both high level terms (HLT) and preferred terms (PT) for fracture sites, defined by MedDRA (Medical Dictionary for Regulatory Activities). Of PPI users reporting fractures, the mean age was 65.3 years and the female to male ratio was 3.4:1. Results revealed signals at multiple HLT and PT fracture sites, consistent for both sexes. These included fracture sites with predominant trabecular bone, not previously reported as being associated with PPIs, such as 'rib fractures', where signals were detected for overall PPIs as well as for each of 5 generic ingredients (insufficient data for dexlansoprazole). Based on data mining from AERS-DM, PPI use appears to be associated with an increased risk for fractures at multiple sites.

Differential Delivery of Genomic Double-Stranded RNA Causes Reovirus Strain-Specific Differences in Interferon Regulatory Factor 3 Activation.

Science.gov (United States)

Stuart, Johnasha D; Holm, Geoffrey H; Boehme, Karl W

2018-05-01

Serotype 3 (T3) reoviruses induce substantially more type 1 interferon (IFN-I) secretion than serotype 1 (T1) strains. However, the mechanisms underlying differences in IFN-I production between T1 and T3 reoviruses remain undefined. Here, we found that differences in IFN-I production between T1 and T3 reoviruses correlate with activation of interferon regulatory factor 3 (IRF3), a key transcription factor for the production of IFN-I. T3 strain rsT3D activated IRF3 more rapidly and to a greater extent than the T1 strain rsT1L, in simian virus 40 (SV40) immortalized endothelial cells (SVECs). Differences in IRF3 activation between rsT1L and rsT3D were observed in the first hours of infection and were independent of de novo viral RNA and protein synthesis. NF-κB activation mirrored IRF3 activation, with rsT3D inducing more NF-κB activity than rsT1L. We also found that IRF3 and NF-κB are activated in a mitochondrial antiviral-signaling protein (MAVS)-dependent manner. rsT1L does not suppress IRF3 activation, as IRF3 phosphorylation could be induced in rsT1L-infected cells. Transfected rsT1L and rsT3D RNA induced IRF3 phosphorylation, indicating that genomic RNA from both strains has the capacity to activate IRF3. Finally, bypassing the normal route of reovirus entry by transfecting in vitro -generated viral cores revealed that rsT1L and rsT3D core particles induced equivalent IRF3 activation. Taken together, our findings indicate that entry-related events that occur after outer capsid disassembly, but prior to deposition of viral cores into the cytoplasm, influence the efficiency of IFN-I responses to reovirus. This work provides further insight into mechanisms by which nonenveloped viruses activate innate immune responses. IMPORTANCE Detection of viral nucleic acids by the host cell triggers type 1 interferon (IFN-I) responses, which are critical for containing and clearing viral infections. Viral RNA is sensed in the cytoplasm by cellular receptors that initiate

Regulatory T cell activity in immunosuppresive mice model of pseudomonas aeruginosa pneumonia.

Science.gov (United States)

Li, Jun-Lu; Chen, Ting-Sang; Yuan, Cong-Cong; Zhao, Guo-Qiang; Xu, Min; Li, Xiao-Yan; Cao, Jie; Xing, Li-Hua

2017-08-01

Pseudomonas aeruginosa (PA) pneumonia is a refractory, even lethal complication in immunosuppressive individuals and immune disturbances may promote the pathological process. We aimed to investigate the regulatory T (Treg) cell activity in an immunosuppressive mice model of PA pneumonia by estimating levels of main transcription factor and the main effector of Treg cells, i.e., Forkhead box protein 3 (FOXP3) and interleukine-10 (IL-10). Seventy-two BALB/c mice were divided into four groups randomly: control (A), PA pneumonia (B), immunosuppression (C) and immunosuppression with PA pneumonia (D). Mice were sacrificed at 4, 8 and 24 h after establishing experimental models. The pathological changes of lung tissue were graded, and the FOXP3 mRNA and serum IL-10 levels were detected. Histological analysis of lung tissues showed there were no significantly pathological changes in groups A and C, but significantly pathological changes were found in groups B and D, especially in group D at 8 h (Ppneumonia in immunosuppressive individuals worsens rapidly, which may be associated with Treg cells function disturbance. And Treg cells may be promising as adjuvant therapeutics for PA pneumonia in immunosuppressive individuals.

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

75 FR 5157 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving...

Science.gov (United States)

2010-02-01

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Proposed Rule Change... Consolidated FINRA Rulebook January 25, 2010. On December 2, 2009, the Financial Industry Regulatory Authority... later in the rulebook consolidation process. It is therefore ordered, pursuant to Section 19(b)(2) of...

77 FR 47470 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Science.gov (United States)

2012-08-08

...-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Withdrawal of Proposed Rule Change To Adopt FINRA Rule 2231 (Customer Account Statements) in the Consolidated FINRA Rulebook August 2, 2012. On April 22, 2009, the Financial Industry Regulatory Authority, Inc. (``FINRA'') (f/k/a...

76 FR 21084 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of...

Science.gov (United States)

2011-04-14

... Securities April 8, 2011. I. Introduction On March 3, 2011, the Financial Industry Regulatory Authority, Inc... SECURITIES AND EXCHANGE COMMISSION [Release No. 34-64283; File No. SR-FINRA-2011-012] Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer...

Overview of NRC's human factors regulatory research program

International Nuclear Information System (INIS)

Coffman, F.D. Jr.

1989-01-01

The human factors research program is divided into distinct and interrelated program activities: (1) Personnel Performance measurement, (2) Personnel Subsystem, (3) Human-System Interface, (4) Organization and Management, and (5) a group of Reliability Assessment activities. The purpose of the Personnel Performance Measurement activity is to improve the Agency's understanding of the factors influencing personnel performance and the effects on the safety of nuclear operations and maintenance by developing improvements to methods for collecting and managing personnel performance data. Personnel Subsystem research will broaden the understanding of such factors as staffing, qualifications, and training that influence human performance in the nuclear system and will develop the technical basis for regulatory guidance to reduce any adverse impact of these influences on nuclear safety. Research in the Human-System Interface activity will provide the technical basis for ensuring that the interface between the system and the human user supports safe operations and maintenance. Organization and Management research will result in the development of tools for evaluating organization and management issues within the nuclear industry. And finally, the Reliability Assessment group of activities includes multidisciplinary research that will integrate human and hardware considerations for evaluating reliability and risk in NRC licensing, inspection, and regulatory decisions

Industry perceptions of the impact of the U.S. Nuclear Regulatory Commission on nuclear power plant activities. Draft report

Energy Technology Data Exchange (ETDEWEB)

Davis, A Bert; Pederson, Cynthia D

1990-03-01

Teams of senior managers from the U.S. Nuclear Regulatory Commission (NRC) surveyed licensee staff members representing 13 nuclear power utilities from across the country to obtain their candid views of the effectiveness and impact of NRC regulatory activities. Licensee comments addressed the full scope of NRC activities and the impact of agency actions on licensee resources, staff performance, planning and scheduling, and organizational effectiveness. The principal themes of the survey respondents' comments are that (1) licensees acquiesce to NRC requests to avoid poor ratings on NRC Systematic Assessment of Licensee Performance (SALP) reports and the consequent financial and public perception problems that result, even if the requests require the expenditure of significant resources on matters of marginal safety significance, and (2) NRC so dominates licensee resources through its existing and changing formal and informal requirements that licensees believe that their plants, though not unsafe, would have better reliability, and may even achieve a higher degree of safety, if licensees were freer to manage their own resources. This draft report does not attempt to defend any NRC position; endorse or refute licensee perceptions; or explain any action taken by NRC in fulfilling its responsibilities to protect the health and safety of the public. Senior RC managers have made a preliminary evaluation of the information in this report and have made recommendations to address licensee concerns in some areas. The final evaluation and recommendations will be published at a later date as the final NUREG. (author)

Regulatory BC1 RNA in Cognitive Control

Science.gov (United States)

Iacoangeli, Anna; Dosunmu, Aderemi; Eom, Taesun; Stefanov, Dimitre G.; Tiedge, Henri

2017-01-01

Dendritic regulatory BC1 RNA is a non-protein-coding (npc) RNA that operates in the translational control of gene expression. The absence of BC1 RNA in BC1 knockout (KO) animals causes translational dysregulation that entails neuronal phenotypic alterations including prolonged epileptiform discharges, audiogenic seizure activity in vivo, and…

Regulatory activity of azabisphosphonate-capped dendrimers on human CD4+ T cell proliferation enhances ex-vivo expansion of NK cells from PBMCs for immunotherapy

Directory of Open Access Journals (Sweden)

Caminade Anne-Marie

2009-09-01

Full Text Available Abstract Background Adoptive cell therapy with allogenic NK cells constitutes a promising approach for the treatment of certain malignancies. Such strategies are currently limited by the requirement of an efficient protocol for NK cell expansion. We have developed a method using synthetic nanosized phosphonate-capped dendrimers allowing such expansion. We are showing here that this is due to a specific inhibitory activity towards CD4+ T cell which could lead to further medical applications of this dendrimer. Methods Mononuclear cells from human peripheral blood were used to investigate the immunomodulatory effects of nanosized phosphonate-capped dendrimers on interleukin-2 driven CD4+T cell expansion. Proliferation status was investigated using flow cytometry analysis of CFSE dilution and PI incorporation experiments. Magnetic bead cell sorting was used to address activity towards individual or mixed cell sub-populations. We performed equilibrium binding assay to assess the interaction of fluorescent dendrimers with pure CD4+ T cells. Results Phosphonate-capped dendrimers are inhibiting the activation, and therefore the proliferation; of CD4+ T cells in IL-2 stimulated PBMCs, without affecting their viability. This allows a rapid enrichment of NK cells and further expansion. We found that dendrimer acts directly on T cells, as their regulatory property is maintained when stimulating purified CD4+ T cells with anti-CD3/CD28 microbeads. Performing equilibrium binding assays using a fluorescent analogue, we show that the phosphonate capped-dendrimers are specifically interacting with purified CD4+ T cells. Ultimately, we found that our protocol prevents the IL-2 related expansion of regulatory T cells that would be deleterious for the activity of infused NK cells. Conclusion High yield expansion of NK cells from human PBMCs by phosphonate-capped dendrimers and IL-2 occurs through the specific inhibition of the CD4+ lymphocyte compartment. Given the