Sample records for safety committee approved
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High committee for transparency and information on nuclear safety: meeting of September 10, 2010
International Nuclear Information System (INIS)
2010-01-01
After the approval of its rules of procedure and the designation of the High committee office, the members of the committee discuss the following topics: the High committee communication rules, various issues regarding radioactive wastes (activity of the low level waste work group, recent decisions made by the government on the process of selection of a low level waste storage site, perspectives and modalities of a public hearing organised by the committee according to the mission defined in the waste bill). Then, they discuss the environmental monitoring issue: organisation and strategy of radioactivity control in France by the French nuclear safety authority (ASN) and by the French institute for radiation protection and nuclear safety (IRSN), assessment of the radio-ecological status at the vicinity of basic nuclear installations
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76 FR 34139 - Northeast Corridor Safety Committee; Meeting Postponement
2011-06-10
.... 2] Northeast Corridor Safety Committee; Meeting Postponement AGENCY: Federal Railroad Administration... announced the first meeting of the Northeast Corridor Safety Committee, a Federal Advisory Committee... future date. DATES: The meeting of the Northeast Corridor Safety Committee scheduled to commence on...
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Ethics approval: responsibilities of journal editors, authors and research ethics committees.
Bain, Luchuo Engelbert
2017-01-01
Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.
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Committee on the safety of nuclear installations - Operating plan (2006 - 2009)
International Nuclear Information System (INIS)
2007-01-01
In 2004, NEA issued its Strategic Plan covering the period 2005-2009, addressing the NEA activities associated with nuclear safety and regulation. Committee on the Safety of Nuclear Installations (CSNI) and Committee on Nuclear Regulatory Activities (CNRA), which have the primary responsibility for activities in this area, have developed and issued a joint strategic plan covering this same time period. As requested in the Joint Strategic Plan, each committee is to prepare an operating plan which describes in more detail the committee's organisation, planned activities, priorities and operating procedures to be used to implement the Joint Strategic Plan. In effect, the Joint Strategic Plan defines what type of work CSNI should do, whereas the Operating Plan describes the overall work scope and how to accomplish it to meet the joint CSNI/CNRA Strategic Plan objectives and mission. The present Operating Plan follows and takes into account the outcome of a CSNI assessment group, which has evaluated the CSNI activities. The assessment group expressed appreciation for the CSNI role and activity, while making recommendations with regards to scope of work and way to operate in order to further improve efficiency. The main objectives of CSNI are to: - Keep all member countries involved in and abreast of developments in safety technology. - Review operating experience with the objective to identify safety issues that need to be addressed by new research. - Review the state-of-knowledge on selected topics of nuclear safety technology and safety assessment. - Promote training and research projects that serve to maintain competence in nuclear safety matters. - Promote research as needed to reach consensus on nuclear safety issues of common interest. - Consider the safety implications of scientific and technical developments. To accomplish these objectives, CSNI is organised into six permanent working groups (as described in Section II), each covering a different set of
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77 FR 3326 - Northeast Corridor Safety Committee; Notice of Meeting
2012-01-23
.... 3] Northeast Corridor Safety Committee; Notice of Meeting AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of Northeast Corridor Safety Committee Meeting. SUMMARY: FRA announced the first meeting of the Northeast Corridor Safety Committee, a Federal...
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76 FR 32391 - Northeast Corridor Safety Committee; Notice of Meeting
2011-06-06
.... 1] Northeast Corridor Safety Committee; Notice of Meeting AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of the Northeast Corridor Safety Committee Meeting. SUMMARY: FRA announces the first meeting of the Northeast Corridor Safety Committee, a...
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76 FR 24504 - National Offshore Safety Advisory Committee
2011-05-02
... DEPARTMENT OF HOMELAND SECURITY [Docket No. USCG-2011-0183] National Offshore Safety Advisory... Committee Meeting. SUMMARY: The National Offshore Safety Advisory Committee (NOSAC) will meet on May 19... completed its business. ADDRESSES: The meeting will be held at Wyndham Riverfront Hotel, Bacchus room, 701...
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76 FR 32390 - Motor Carrier Safety Advisory Committee Public Meeting
2011-06-06
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee (MCSAC) Meeting. SUMMARY...
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77 FR 46555 - Motor Carrier Safety Advisory Committee: Public Meeting
2012-08-03
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee: Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of meeting of Motor Carrier Safety Advisory Committee (MCSAC...
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75 FR 2923 - Motor Carrier Safety Advisory Committee Public Meeting
2010-01-19
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA...
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75 FR 29384 - Motor Carrier Safety Advisory Committee Public Meeting
2010-05-25
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee meeting. SUMMARY: FMCSA...
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75 FR 72863 - Motor Carrier Safety Advisory Committee Public Meeting
2010-11-26
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration, DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA announces...
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75 FR 50797 - Motor Carrier Safety Advisory Committee Public Meeting
2010-08-17
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2010-0143] Motor Carrier Safety Advisory Committee Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Motor Carrier Safety Advisory Committee Meeting. SUMMARY: FMCSA...
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78 FR 21977 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2013-04-12
... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and Health Administration (OSHA), Labor... Maritime Advisory Committee for Occupational Safety and Health. The Committee will better enable OSHA to...
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78 FR 23815 - Northeast Corridor Safety Committee; Notice of Meeting
2013-04-22
.... 6] Northeast Corridor Safety Committee; Notice of Meeting AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of the Northeast Corridor Safety Committee (NECSC) Meeting. [[Page 23816
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Nuclear Safety Research Review Committee
International Nuclear Information System (INIS)
Todreas, N.E.
1990-01-01
The Nuclear Safety Research Review Committee has had a fundamental difficulty because of the atmosphere that has existed since it was created. It came into existence at a time of decreasing budgets. For any Committee the easiest thing is to tell the Director what additional to do. That does not really help him a lot in this atmosphere of reduced budgets which he reviewed for you on Monday. Concurrently the research arm of Nuclear Regulatory Commission has recognized that the scope of its activity needed to be increased rather than decreased. In the last two-and-a-half-year period, human factors work was reinstated, radiation and health effects investigations were reinvigorated, research in the waste area was given significant acceleration. Further, accident management came into being, and the NRC finally got back into the TMI-2 area. So with all of those activities being added to the program at the same time that the research budget was going down, the situation has become very strained. What that leads to regarding Committee membership is a need for technically competent generalists who will be able to sit as the Division Directors come in, as the contractors come in, and sort the wheat from the chaff. The Committee needs people who are interested in and have a broad perspective on what regulatory needs are and specifically how safety research activities can contribute to them. The author summarizes the history of the Committee, the current status, and plans for the future
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Training for an effective health and safety committee in a small business setting.
Crollard, Allison; Neitzel, Richard L; Dominguez, Carlos F; Seixas, Noah S
2013-01-01
Health and safety committees are often heralded as a key element of successful health and safety programs, and are thought to represent a means of engaging workers in health and safety efforts. While the understanding of the factors that make these committees effective is growing, there are few resources for how to assist committees in developing these characteristics. This paper describes one approach to creating and implementing a training intervention aimed at improving health and safety committee function at one multilingual worksite. Short-term impacts were evaluated via questionnaire and qualitative observations of committee function. Results indicated high satisfaction with the training as well as modest increases in participation, cooperation, role clarity, and comfort with health and safety skills among committee members. The committee also made considerable achievements in establishing new processes for effective function. Similar interventions may be useful in other workplaces to increase health and safety committee success.
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Nuclear utility self-assessment as viewed by the corporate nuclear safety committee
International Nuclear Information System (INIS)
Corcoran, W.R.
1992-01-01
This paper discusses how corporate nuclear safety committees use the principles of self-assessment to enhance nuclear power plant safety performance. Corporate nuclear safety committees function to advise the senior nuclear power executive on matters affecting nuclear safety. These committees are required by the administrative controls section of the plant technical specifications which are part of the final safety analysis report and the operating license. Committee membership includes senior utility executives, executives from sister utilities, utility senior technical experts, and outside consultants. Current corporate nuclear safety committees often have a finely tuned intuitive feel for self-assessment that they use to probe the underlying opportunities for quality and safety enhancements. The questions prompted by the self-assessment orientation enable the utility line organization members to gain better perspectives on the characteristics of the organizational systems that they manage and work in
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77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2012-10-24
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... Use (ETASU) before CDER's Drug Safety and Risk Management Advisory Committee (DSaRM). The Agency plans...
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77 FR 73734 - Northeast Corridor Safety Committee; Notice of Meeting
2012-12-11
.... 5] Northeast Corridor Safety Committee; Notice of Meeting AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of a Northeast Corridor Safety... Committee is made up of stakeholders operating on the [[Page 73735
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77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2012-12-19
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug... being rescheduled due to the postponement of the October 29-30, 2012, Drug Safety and Risk Management... Committee: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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29 CFR 1912.5 - National Advisory Committee on Occupational Safety and Health.
2010-07-01
... Health. 1912.5 Section 1912.5 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND... Matters § 1912.5 National Advisory Committee on Occupational Safety and Health. (a) Section 7(a) of the Act established a National Advisory Committee on Occupational Safety and Health. The Committee is to...
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Lithuanian Nuclear Safety Advisory Committee - 1993-2003
International Nuclear Information System (INIS)
Medeliene, D.
2003-01-01
Brief overview of the Lithuanian Nuclear Safety Advisory Committee (LNSAC) activities is presented. LNSAC was established in May 1993, main task is to advise the Lithuanian government on industrial and regulatory matters of nuclear safety. One of the most of important tasks was to exert pressure on the Government so that it allocates sufficient funds from the national budget for setting up a national regulatory body. Statements of the members of LNSAC are presented. In the CD minutes of the meetings of the LNSAC in 1993-2003 and official documents regulating Committee activities are included
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75 FR 45591 - Pipeline Safety: Notice of Technical Pipeline Safety Advisory Committee Meetings
2010-08-03
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Committee Meetings AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA); DOT. ACTION... safety standards, risk assessments, and safety policies for natural gas pipelines and for hazardous...
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75 FR 28659 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2010-05-21
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH). SUMMARY: The National Advisory Committee on Occupational...
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75 FR 28661 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2010-05-21
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... Committee on Occupational Safety and Health (NACOSH). SUMMARY: The Assistant Secretary of Labor for...
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77 FR 46126 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2012-08-02
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0003] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and... Advisory Committee for Occupational Safety and Health. SUMMARY: OSHA invites interested persons to submit...
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75 FR 35090 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2010-06-21
... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and Health Administration (OSHA), Labor... for Occupational Safety and Health (MACOSH or Committee) was established under Section 7 of the...
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76 FR 54806 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2011-09-02
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0007] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and... Committee for Occupational Safety and Health (MACOSH) was established under Section 7 of the Occupational...
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2011-05-20
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No... Technical Hazardous Liquid Pipeline Safety Standards Committee AGENCY: Pipeline and Hazardous Materials... for natural gas pipelines and for hazardous liquid pipelines. Both committees were established under...
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78 FR 30929 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2013-05-23
...] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide... (REMS) with elements to assure safe use (ETASU) before its Drug Safety and Risk Management Advisory...
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Existing and future international standards for the safety of radioactive waste disposal
International Nuclear Information System (INIS)
Linsley, G.
1999-01-01
In this paper the essential features of the current international safety standards are summarised and the issues being raised for inclusion in future standards are discussed. The safety standards of the IAEA are used as the basis for the review and discussion. The IAEA has established a process for establishing international standards of safety for radioactive waste management through its Radioactive Waste Safety Standards (RADWASS) programme. The RADWASS documents are approved by a comprehensive process involving regulatory and other experts from all concerned IAEA Member States. A system of committees for approving the IAEAs safety standards has been established. For radioactive waste safety the committee for review and approval is the Waste Safety Standards Advisory Committee (WASSAC). In 1995 the IAEA published 'The Principles of Radioactive Waste Management' as the top level document in the RADWASS programme. The report sets out the basis principles which most experts believe are fundamental to the safe management of radioactive wastes
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Folb, Peter I.; Bernatowska, Ewa; Chen, Robert; Clemens, John; Dodoo, Alex N. O.; Ellenberg, Susan S.; Farrington, C. Patrick; John, T. Jacob; Lambert, Paul-Henri; MacDonald, Noni E.; Miller, Elizabeth; Salisbury, David; Schmitt, Heinz-J.; Siegrist, Claire-Anne; Wimalaratne, Omala
2004-01-01
Established in 1999, the Global Advisory Committee on Vaccine Safety advises the World Health Organization (WHO) on vaccine-related safety issues and enables WHO to respond promptly, efficiently, and with scientific rigor to issues of vaccine safety with potential global importance. The committee also assesses the implications of vaccine safety for practice worldwide and for WHO policies. We describe the principles on which the committee was established, its modus operandi, and the scope of the work undertaken, both present and future. We highlight its recent recommendations on major issues, including the purported link between the measles–mumps–rubella vaccine and autism and the safety of the mumps, influenza, yellow fever, BCG, and smallpox vaccines as well as that of thiomersal-containing vaccines. PMID:15514229
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77 FR 12863 - Towing Safety Advisory Committee; Meeting
2012-03-02
... DEPARTMENT OF HOMELAND SECURITY [Docket No. USCG-2012-0098] Towing Safety Advisory Committee... Airport, 9100 Gulf Freeway; Houston TX 77017. Hotel Web site: http://www.marriott.com/hotels/travel/houhh... the issues to be considered by the committee. Written comments must be identified by Docket No. USCG...
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Institutional glovebox safety committee (IGSC) annual report FY2010
Energy Technology Data Exchange (ETDEWEB)
Cournoyer, Michael E [Los Alamos National Laboratory; Roybal, Richard F [Los Alamos National Laboratory; Lee, Roy J [Los Alamos National Laboratory
2011-01-04
The Institutional Glovebox Safety Committee (IGSC) was chartered to minimize and/or prevent glovebox operational events. Highlights of the IGSC's third year are discussed. The focus of this working committee is to address glovebox operational and safety issues and to share Lessons Learned, best practices, training improvements, and glovebox glove breach and failure data. Highlights of the IGSC's third year are discussed. The results presented in this annual report are pivotal to the ultimate focus of the glovebox safety program, which is to minimize work-related injuries and illnesses. This effort contributes to the LANL Continuous Improvement Program by providing information that can be used to improve glovebox operational safety.
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2011-01-10
... duties imposed by the Occupational Safety and Health (OSH) Act of 1970 (29 U.S.C. 655, 656). Authority to...(b) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655(b)(1), 656(b)), the Federal... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for...
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78 FR 66801 - Motor Carrier Safety Advisory Committee; Charter Renewal
2013-11-06
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee; Charter Renewal AGENCY: Federal Motor Carrier Safety... and recommendations on motor carrier safety programs and motor carrier safety regulations through a...
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76 FR 27337 - Houston/Galveston Navigation Safety Advisory Committee
2011-05-11
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2010-1116] Houston/Galveston Navigation Safety...: The Houston/Galveston Navigation Safety Advisory Committee postponed its originally scheduled February... Houston Ship Channel, and various other navigation safety matters in the Galveston Bay area. The meeting...
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Work Plans 2011 – Norwegian Scientific Committee for Food Safety
Norwegian Scientific Committee for Food Safety
2011-01-01
The annual work plan for 2011 summaries activities for the Scientific Steering Committee and the 9 panels of the Norwegian Scientific Committee for Food Safety (VKM). VKM carries out independent risk assessments for the Norwegian Food Safety Authority across the Authority’s field of responsibility as well as environmental risk assessments of genetically modified organisms for the Directorate for Nature Management.
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75 FR 23793 - Houston/Galveston Navigation Safety Advisory Committee
2010-05-04
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2010-0032] Houston/Galveston... Houston/Galveston Navigation Safety Advisory Committee (``HOGANSAC'' or ``the Committee'') and its working groups will meet in Houston, Texas to discuss waterway improvements, aids to navigation, area projects...
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75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting
2010-05-04
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Drug Safety and Risk Management Advisory Committee. General Function of the Committee: To provide...
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Safety Review Committee - Annual Report 1991-1992
International Nuclear Information System (INIS)
1993-01-01
During the year under review. The Safety Review Committee (SRC) assessed the safety of ANSTO's operations. This was done by site visits, examination of documentation and briefing by ANSTO officers responsible for particular operations, and includes HIFAR and Moata reactors, radioisotope production, packing and dispatch, radioactive waste management practices, occupational health and safety activities and ANSTO's arrangements for public health and safety beyond the site. This report describes the activities and findings of the SRC during the year ending 30 June 1992. 8 figs., ills
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Safety Committees for Argentinean Research Reactor - Regulatory Issues
International Nuclear Information System (INIS)
Perrin, Carlos D.
2009-01-01
In the field of radiological and nuclear safety, the Nuclear Regulatory Authority (ARN) of Argentina controls three research reactors and three critical assemblies, by means of evaluations, audits and inspections, in order to ensure the fulfillment of the requirements established in the Licenses, in the Regulatory Standards and in the Mandatory Documentation in general. From the Nuclear Regulatory Authority's point of view, within the general process of research reactors safety management, the Operational Organization self verification of radiological and nuclear safety plays an outstanding role. In this aspect the ARN has established specific requirements in the Regulatory Standards, in the Operation Licenses and in the Operational Limits and Conditions. These requirements include the figure of different safety committees, which act as reviewers or advisers in diverse situations. This paper describes the main characteristics of the committees, their function, scope and the regulatory documents where the requirements are included. (author)
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2012-07-10
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH..., oxygen supply partnership, safety culture, occupational health and safety management systems, preventing...
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Report of the summative evaluation by the advisory committee on nuclear safety research
International Nuclear Information System (INIS)
2005-03-01
The Research Evaluation Committee of the Japan Atomic Energy Research Institute (JAERI) set up an Advisory Committee on Nuclear Safety Research in accordance with the 'Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations. The Advisory Committee on Nuclear Safety Research evaluated the adequacy of the plans of nuclear safety research to be succeeded from JAERI to a new research institute which will be established by integration of JAERI and the Japan Nuclear Cycle Development Institute (JNC). The Advisory Committee consisted of eight specialists from outside the JAERI conducted its activities from June 2004 to August 2004. The evaluation was performed on the basis of the materials submitted in advanced and of the oral presentations made at the Advisory Committee meeting which was held on July 27, 2004, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Advisory Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on December 1, 2004. This report describes the result of the evaluation by the Advisory Committee on Safety Research. (author)
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76 FR 8372 - Commercial Fishing Safety Advisory Committee; Meeting
2011-02-14
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2011-0070] Commercial Fishing Safety... Commercial Fishing Safety Advisory Committee (CFSAC) will meet in Portsmouth, Virginia to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to the public...
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The Role of Labor-Management Committees in Safeguarding Worker Safety and Health.
Ruttenberg, Ruth
There are thousands of labor-management committees for occupational safety and health in the United States. Most were established or activated after passage of the Occupational Safety and Health Act of 1970. Such committees can be an important tool when used as part of a comprehensive effort to achieve safety and health in the workplace. In the…
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77 FR 62248 - Commercial Fishing Safety Advisory Committee; Meeting
2012-10-12
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-0936] Commercial Fishing Safety.... SUMMARY: The Commercial Fishing Safety Advisory Committee (CFSAC) will meet in Washington, DC to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to the...
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78 FR 44958 - Commercial Fishing Safety Advisory Committee; Meeting
2013-07-25
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2013-0625] Commercial Fishing Safety.... SUMMARY: The Commercial Fishing Safety Advisory Committee (CFSAC) will meet in Washington, DC to discuss various issues relating to safety in the commercial fishing industry. This meeting will be open to the...
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Unions, Health and Safety Committees, and Workplace Accidents in the Korean Manufacturing Sector
Directory of Open Access Journals (Sweden)
Woo-Yung Kim
2016-06-01
Conclusion: Health and safety committees were found to reduce the incidence of accidents whereas unionized establishments have higher incidence of accidents than nonunionized establishments. We also found that health and safety committees can more effectively reduce accidents in nonunionized establishments. By contrast, nonexclusive joint committees can more effectively reduce accidents in unionized establishments.
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78 FR 41496 - Pipeline Safety: Meetings of the Gas and Liquid Pipeline Advisory Committees
2013-07-10
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2013-0156] Pipeline Safety: Meetings of the Gas and Liquid Pipeline Advisory Committees AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of advisory committee...
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75 FR 51473 - Houston/Galveston Navigation Safety Advisory Committee
2010-08-20
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2010-0656] Houston/Galveston... Houston/Galveston Navigation Safety Advisory Committee (HOGANSAC) and its working groups will meet in Houston, Texas, to discuss waterway improvements, aids to navigation, area projects impacting safety on...
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Alcohol addiction - the safety of available approved treatment options.
Antonelli, Mariangela; Ferrulli, Anna; Sestito, Luisa; Vassallo, Gabriele A; Tarli, Claudia; Mosoni, Carolina; Rando, Maria M; Mirijello, Antonio; Gasbarrini, Antonio; Addolorato, Giovanni
2018-02-01
Alcohol Use Disorders (AUD) is a leading cause of mortality and morbidity worldwide. At present disulfiram, naltrexone and acamprosate are approved for the treatment of AUD in U.S. and Europe. Nalmefene is approved in Europe and sodium oxybate is approved in Italy and Austria only. Baclofen received a 'temporary recommendation for use' in France. Areas covered: The safety of the above mentioned medications on liver, digestive system, kidney function, nervous system, pregnancy and lactation and their possible side effects are described and discussed. Expert opinion: Mechanism of action and metabolism of these drugs as well as patients' clinical characteristics can affect the safety of treatment. All approved medications are valid tools for the treatment of AUD in patients without advanced liver disease. For some drugs, attention should be paid to patients with renal failure and medications may be used with caution, adjusting the dosage according to kidney function. In patients with AUD and advanced liver disease, at present only baclofen has been formally tested in randomized controlled trials showing its safety in this population.
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Safety review and approval process for the TFTR
International Nuclear Information System (INIS)
Levine, J.D.; Howe, H.J.; Howe, K.E.
1983-01-01
The design, construction, and operation of the Tokamak Fusion Test Reactor (TFTR) has undergone an extensive safety and enviromental analysis involving Princeton Plasma Physics Laboratory (PPPL), the U.S. Department of Energy (DOE), the Ebasco/Grumman Industrial Subcontractor Team, and other organizations. This analysis, which is continuing during the TFTR operational phase, has been facilitated by the preparation, review and approval of several documents, including an Environmental Statement (Draft and Final), a Preliminary Safety Analysis Report (PSAR), a Final Safety Analysis Report (FSAR), Operations Safety Requirements (OSRs) and Safety Requirements (SRs), and various Operating and Maintenance Manuals. Through TFTR Safety Group participation in formal system design evaluations, change control boards, and reviews of project procurement and installation documentation, the TFTR Management Configuration Control System assures that all aspects of the project, including proposed design, installation and operational changes, receive prompt and thorough safety analyses. These efforts will continue as the TFTR Program moves into the neutral beam and D-T operational phases. The safety review and approval experience that has been acquired on the TFTR Project should serve as a foundation for similar efforts on future fusion devices
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[Experience feedback committee: a method for patient safety improvement].
François, P; Sellier, E; Imburchia, F; Mallaret, M-R
2013-04-01
An experience feedback committee (CREX, Comité de Retour d'EXpérience) is a method which contributes to the management of safety of care in a medical unit. Originally used for security systems of civil aviation, the method has been adapted to health care facilities and successfully implemented in radiotherapy units and in other specialties. We performed a brief review of the literature for studies reporting data on CREX established in hospitals. The review was performed using the main bibliographic databases and Google search results. The CREX is designed to analyse incidents reported by professionals. The method includes monthly meetings of a multi-professional committee that reviews the reported incidents, chooses a priority incident and designates a "pilot" responsible for investigating the incident. The investigation of the incident involves a systemic analysis method and a written synthesis presented at the next meeting of the committee. The committee agrees on actions for improvement that are suggested by the analysis and follows their implementation. Systems for the management of health care, including reporting systems, are organized into three levels: the medical unit, the hospital and the country as a triple loop learning process. The CREX is located in the base level, short loop of risk management and allows direct involvement of care professionals in patient safety. Safety of care has become a priority of health systems. In this context, the CREX can be a useful vehicle for the implementation of a safety culture in medical units. Copyright © 2013 Elsevier Masson SAS. All rights reserved.
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2013-07-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... Director, NIOSH, on priorities in mine safety and health research, including grants and contracts for such...
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77 FR 52393 - Railroad Safety Advisory Committee; Notice of Meeting
2012-08-29
... provided by the Engineering and System Safety Task Forces, and a presentation on headwear will be provided... Safety Board, and the Federal Transit Administration. The diversity of the Committee ensures the...
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2010-04-06
...] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory... Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This meeting was... Drug Safety and Risk Management Advisory Committee would be held on May 12, 2010. On page 10490, in the...
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76 FR 5424 - Motor Carrier Safety Advisory Committee; Request for Nominations
2011-01-31
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee; Request for Nominations AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Request for Nominations to the Motor Carrier Safety Advisory...
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2010-03-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee, National Institute for Occupational Safety and Health (MSHRAC, NIOSH... priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C...
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2011-04-28
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Emergency Response Interoperability Center Public Safety Advisory Committee Meeting AGENCY... Fullano, Associate Chief, Public Safety and Homeland Security Bureau, Federal Communications Commission...
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75 FR 52988 - National Advisory Committee on Occupational Safety and Health
2010-08-30
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health AGENCY: Occupational Safety and Health... Occupational Safety and Health (NACOSH) will meet September 14 and 15, 2010, in Washington, DC. In conjunction...
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77 FR 60507 - Motor Carrier Safety Advisory Committee (MCSAC): Public Subcommittee Meeting
2012-10-03
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee (MCSAC): Public Subcommittee Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Meeting of Compliance, Safety...
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77 FR 20690 - Northeast Corridor Safety Committee; Notice of Meeting
2012-04-05
.... 4] Northeast Corridor Safety Committee; Notice of Meeting AGENCY: Federal Railroad Administration (FRA), Department of Transportation (DOT). ACTION: Announcement of the Northeast Corridor Safety... NECSC is made up of stakeholders operating on the Northeast Corridor (NEC), and the purpose of the...
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Boden, L I; Hall, J A; Levenstein, C; Punnett, L
1984-11-01
In a study conducted to determine if the existence of a joint labor-management health and safety committee (HSC) was correlated with either the number of Occupational Safety and Health Administration (OSHA) complaints or hazardousness, as measured by OSHA serious citations, virtually no effect could be detected in a sample of 127 Massachusetts manufacturing firms. At a sample of 13 firms, interviews of HSC members were conducted. Committee attributes and perceptions about committee effectiveness were compared with the number of OSHA complaints and serious citations. There were fewer complaints and fewer serious citations at firms with HSCs that were perceived as effective. Results of the study suggest that the objective attributes of the committee may be less important to its success than the commitment of management and labor to solving workplace safety problems.
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76 FR 32374 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2011-06-06
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0065] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and NACOSH subgroups. SUMMARY: The National Advisory...
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75 FR 78775 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2010-12-16
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and NACOSH subgroup meetings. SUMMARY: The National...
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76 FR 60085 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2011-09-28
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0065] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... Assistant Secretary of Labor for Occupational Safety and Health requests nominations for membership on...
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76 FR 73689 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2011-11-29
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2011-0065] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and NACOSH Work Groups. SUMMARY: The National Advisory...
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77 FR 64549 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2012-10-22
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0019] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and a NACOSH Work Group. SUMMARY: NACOSH will meet...
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77 FR 43616 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2012-07-25
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0019] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... Assistant Secretary of Labor for Occupational Safety and Health requests nominations for membership on...
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76 FR 4128 - Establishment of the Ocean Energy Safety Advisory Committee
2011-01-24
... relating to offshore energy safety, including, but not limited to drilling and workplace safety, well... Federal Officer (DFO). BOEMRE will provide administrative and logistical support to the Committee. The..., including, but not limited to drilling and workplace safety, well intervention and containment, and oil...
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14 CFR 414.35 - Public notification of the criteria by which a safety approval was issued.
2010-01-01
... issued. For each grant of a safety approval, the FAA will publish in the Federal Register a notice of the... which a safety approval was issued. 414.35 Section 414.35 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING SAFETY APPROVALS Safety...
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77 FR 31398 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2012-05-25
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0019] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... on Occupational Safety and Health (NACOSH) and NACOSH Work Groups. SUMMARY: NACOSH will meet June 20...
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77 FR 33495 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2012-06-06
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0003] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and..., Docket No. OSHA- 2012-0003, U.S. Department of Labor, Occupational Safety and Health Administration, Room...
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76 FR 18798 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2011-04-05
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No OSHA-2011-0007] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and.... MACOSH will contribute to OSHA's performance of the duties imposed by the Occupational Safety and Health...
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77 FR 5577 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2012-02-03
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0003] Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and..., Docket No. OSHA- 2012-0003, U.S. Department of Labor, Occupational Safety and Health Administration, Room...
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75 FR 13783 - Maritime Advisory Committee for Occupational Safety and Health (MACOSH)
2010-03-23
... DEPARTMENT OF LABOR Occupational Safety and Health Administration Maritime Advisory Committee for Occupational Safety and Health (MACOSH) AGENCY: Occupational Safety and Health Administration (OSHA), Labor... Health (MACOSH) was established under Section 7 of the Occupational Safety and Health (OSH) Act of 1970...
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2012-10-04
... regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA...-0638] Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval... Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This...
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2010-09-17
...-2010-0074] The Future of Aviation Advisory Committee (FAAC) Aviation Safety Subcommittee; Notice of... Future of Aviation Advisory Committee (FAAC): Aviation Safety Subcommittee; Notice of Meeting. SUMMARY... of the FAAC Aviation Safety Subcommittee, which will be held September 28, 2010, via teleconference...
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2010-09-29
...-2010-0074] The Future of Aviation Advisory Committee (FAAC) Aviation Safety Subcommittee; Notice of... Future of Aviation Advisory Committee (FAAC): Aviation Safety Subcommittee; Notice of Meeting. SUMMARY... of the FAAC Aviation Safety Subcommittee, which will be held October 19, 2010, in Everett, Washington...
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78 FR 30937 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2013-05-23
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2013-0015] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... meeting is open to the public. Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH Act...
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Seeking ethical approval for an international study in primary care patient safety
Dovey, S.; Hall, K.; Makeham, M.; Rosser, W.; Kuzel, A.; Weel, C. van; Esmail, A.; Phillips, R.
2011-01-01
Seeking ethics committee approval for research can be challenging even for relatively simple studies occurring in single settings. Complicating factors such as multicentre studies and/or contentious research issues can challenge review processes, and conducting such studies internationally adds a
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2013-04-04
... Management Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice... of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management... Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee...
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77 FR 62536 - National Advisory Committee on Occupational Safety and Health (NACOSH)
2012-10-15
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2012-0019] National Advisory Committee on Occupational Safety and Health (NACOSH) AGENCY: Occupational Safety and... Section 7(a) of the Occupational Safety and Health Act of 1970 (OSH Act) (29 U.S.C. 651, 656) to advise...
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2011-10-14
...] Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and... Administration (FDA). The meeting will be open to the public. Name of Committees: Drug Safety and Risk Management... Safe Use (ETASU) before its Drug Safety and Risk Management Advisory Committee (DSaRM). On December 1...
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78 FR 5243 - Motor Carrier Safety Advisory Committee (MCSAC): Public Meeting of Subcommittees
2013-01-24
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration [Docket No. FMCSA-2006-26367] Motor Carrier Safety Advisory Committee (MCSAC): Public Meeting of Subcommittees AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of meeting of Motor Carrier Safety...
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A Safety Management Model for FAR 141 Approved Flight Schools
Mendonca, Flavio A. C.; Carney, Thomas Q
2017-01-01
The Safety Management Annex (Annex 19), which became applicable in November 2013, consolidates safety management provisions previously contained in six other International Civil Aviation Organization (ICAO) Annexes, and will serve as a resource for overarching state safety management responsibilities. Through Annex 19, ICAO has required that its member states develop and implement safety management systems (SMS) to improve safety. This mandate includes an approved training organization that i...
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75 FR 4904 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update
2010-01-29
... amend regulations protecting persons who work on, under, or between rolling equipment; and persons...-7257] Railroad Safety Advisory Committee (RSAC); Working Group Activity Update AGENCY: Federal Railroad... Committee (RSAC) Working Group Activities. SUMMARY: The FRA is updating its announcement of RSAC's Working...
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2013-11-26
... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration [Docket No. PHMSA-2009-0203] Pipeline Safety: Meeting of the Gas Pipeline Advisory Committee and the Liquid Pipeline Advisory Committee AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. [[Page...
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International Nuclear Information System (INIS)
Halme, Ville-Juhani
2015-01-01
Posiva is preparing geological final disposal in the Finnish bedrock in Olkiluoto, Eurajoki. The final disposal facility includes encapsulation plant and underground repository. Most of the main civil structures are concrete structures. STUK is the supervising authority in civil structures. The National Building Code of Finland and STUK's Regulatory Guide on nuclear safety (YVL) are the most important instructions when constructing concrete structures into nuclear installation. Posiva has classified concrete structures in two classes according STUK's YVL-guidance: EYT (non-nuclear) and Safety Class 3 (SC 3, nuclear safety significance). When building SC 3 concrete structures, specific protocol must be followed. Protocol includes planned routines for design, construction, supervision, quality control (QC) and quality assurance (QA) activities. Documents relating concrete structures must be approved by Posiva and STUK before construction work. After structures have been designed and actual building is ongoing, there are two main steps. Before concreting, readiness inspection for concreting must be arranged. Readiness inspection will be arranged according to a specific plan and the date must be informed to STUK. After establishing readiness for concreting, casting work can begin. Once concrete structures are done, inspected and approved, final documentation according to a quality control plan will be reviewed by Posiva. After Posiva's approval, final documentation will be sent for STUK's approval. In the end STUK will give the permission for commissioning of the concrete structures after approved commissioning inspection. The document is made up of an abstract and a poster
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78 FR 14314 - Towing Safety Advisory Committee; Meetings
2013-03-05
...: The Towing Safety Advisory Committee will meet in New York City, New York, March 21 and 22, 2013, to... the agenda in the SUPPLEMENTARY INFORMATION section below. The subcommittees will meet March 20, 2012, and work on seven assigned tasks listed in the referenced agenda. All meetings will be open to the...
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2011-08-19
... NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice (11-074)] NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel; Meeting AGENCY: National Aeronautics and Space... meeting of the NASA International Space Station Advisory Committee and the Aerospace Safety Advisory Panel...
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2010-03-08
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management Advisory... Drug Safety and Risk Management Advisory Committee. General Function of the Committees: To provide...
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International Nuclear Information System (INIS)
2001-06-01
The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Nuclear Safety Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Reactor Safety Research, Department of Fuel Cycle Safety Research, Department of Environmental Safety Research and Department of Safety Research Technical Support in Tokai Research Establishment at JAERI. The Ad Hoc Review Committee consisted of 11 specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 11, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. (author)
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1986 international meeting of nuclear reactor safety committees
International Nuclear Information System (INIS)
Moeller, D.W.
1987-01-01
During the week of Oct. 20-23, 1986, nuclear power-plant safety representatives from the Federal Republic of Germany (FRG), France, Japan, and the US assembled to discuss subjects of mutual interest. The meeting, the first of its kind, was organized under the leadership and direction of David A. Ward, Chairman, Advisory Committee on Reactor Safeguards, US Nuclear Regulatory Commission (NRC), and held at the Wingspread Conference Center of the Johnson Foundation in Racine, Wis. Approximately 40 representatives of the several countries attended. Discussions were candid and provided the participants an opportunity to share thoughts and information on nuclear safety concerns and solutions
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Safety regulation for the design approval of special form radioactive sources
International Nuclear Information System (INIS)
Cho, Woon-Kap
2009-01-01
Several kinds of special form radioactive sources for industrial, medical applications are being produced in Korea. Special form radioactive sources should meet strict safety requirements specified in the domestic safety regulations and the design of the sources should be certified by the regulatory authority, the Ministry of Education, Science and Technology (MEST). Several safety tests such as impact, percussion, heating, and leak tests are performed on the sources according to the domestic regulations and the international safety standards such as ANSI N542-1977 and ISO 2919-1999(E). As a regulatory expert body, Korea Institute of Nuclear Safety (KINS) assesses various types of application documents, such as safety analysis report, quality assurance program, and other documents evidencing fulfillment of requirements for design approval of the special form radioactive sources, submitted by a legal person who intends to produce special form radioactive sources and then reports the assessment result to MEST. A design approval certificate is issued to the applicant by MEST on the basis of a technical evaluation report presented by KINS.
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International Nuclear Information System (INIS)
2000-09-01
On the basis of the JAERI's Basic Guidelines for the Research Evaluation Methods and the Practices Manuals of the Institution Evaluation Committee and Research Evaluation Committee, the Ad Hoc Review Committee on Nuclear Safety Research composed of twelve experts was set up under the Research Evaluation Committee of the JAERI in order to review the R and D subjects to be implemented for five years starting in FY2000 in the Nuclear Safety Research Center (Department of Reactor Safety Research, Department of Fuel Cycle Safety Research and Department of Safety Research Technical Support). The Ad Hoc Review Committee meeting was held on January 20, 2000. According to the review methods including review items, points of review and review criteria, determined by the Research Evaluation Committee, the review was conducted based on the research plan documents submitted in advance and presentations by the Department Directors. The review report was submitted to the Research Evaluation Committee for further review and discussions in its meeting held on August 31, 2000. The Research Evaluation Committee recognized the review results as appropriate. This report describes the review results. (author)
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2011-09-23
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the...., [[Page 59143
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Energy Technology Data Exchange (ETDEWEB)
NONE
2001-06-01
The Research Evaluation Committee, which consisted of 14 members from outside of the Japan Atomic Energy Research Institute (JAERI), set up an Ad Hoc Review Committee on Nuclear Safety Research in accordance with the Fundamental Guideline for the Evaluation of Research and Development (R and D) at JAERI' and its subsidiary regulations in order to evaluate the R and D accomplishments achieved for five years from Fiscal Year 1995 to Fiscal Year 1999 at Department of Reactor Safety Research, Department of Fuel Cycle Safety Research, Department of Environmental Safety Research and Department of Safety Research Technical Support in Tokai Research Establishment at JAERI. The Ad Hoc Review Committee consisted of 11 specialists from outside of JAERI. The Ad Hoc Review Committee conducted its activities from December 2000 to February 2001. The evaluation was performed on the basis of the materials submitted in advance and of the oral presentations made at the Ad Hoc Review Committee meeting which was held on December 11, 2000, in line with the items, viewpoints, and criteria for the evaluation specified by the Research Evaluation Committee. The result of the evaluation by the Ad Hoc Review Committee was submitted to the Research Evaluation Committee, and was judged to be appropriate at its meeting held on March 16, 2001. This report describes the result of the evaluation by the Ad Hoc Review Committee on Nuclear Safety Research. (author)
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2010-10-29
... DEPARTMENT OF LABOR Occupational Safety and Health Administration [Docket No. OSHA-2010-0012] National Advisory Committee on Occupational Safety and Health (NACOSH), Charter Renewal AGENCY: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice of renewal of the NACOSH charter...
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Vinardell, M P
2015-03-01
In Europe, the safety evaluation of cosmetics is based on the safety evaluation of each individual ingredient. Article 3 of the Cosmetics Regulation specifies that a cosmetic product made available on the market is to be safe for human health when used normally or under reasonably foreseeable conditions. For substances that cause some concern with respect to human health (e.g., colourants, preservatives, UV-filters), safety is evaluated at the Commission level by a scientific committee, presently called the Scientific Committee on Consumer Safety (SCCS). According to the Cosmetics Regulations, in the EU, the marketing of cosmetics products and their ingredients that have been tested on animals for most of their human health effects, including acute toxicity, is prohibited. Nevertheless, any study dating from before this prohibition took effect is accepted for the safety assessment of cosmetics ingredients. The in vitro methods reported in the dossiers submitted to the SCCS are here evaluated from the published reports issued by the scientific committee of the Directorate General of Health and Consumers (DG SANCO); responsible for the safety of cosmetics ingredients. The number of studies submitted to the SCCS that do not involve animals is still low and in general the safety of cosmetics ingredients is based on in vivo studies performed before the prohibition. Copyright © 2014 Elsevier Inc. All rights reserved.
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76 FR 2916 - Houston/Galveston Navigation Safety Advisory Committee; Meetings
2011-01-18
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [USCG-2010-1116] Houston/Galveston Navigation Safety Advisory Committee; Meetings AGENCY: Coast Guard, DHS. ACTION: Notice of Meetings. SUMMARY: The Houston... will meet in Texas City, Texas and Houston, Texas to discuss waterway improvements, aids to navigation...
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International Nuclear Information System (INIS)
1982-01-01
A report to the Prime Minister by the Nuclear Safety Commission was presented concerning the safety in the installation alteration of the fuel reprocessing facilities, as PNC had requested its approval to the Prime Minister. The safety was confirmed. The items of examination on the safety made by the committee on Examination of Nuclear Fuel Safety of NSC were the aseismic design of liquid waste storage, uranium denitration facility, intermediate gate and radioactive solid waste storage; the criticality safety design of the denitration facility; the radiation shielding design of the liquid waste storage, denitration facility and solid waste storage; the function of radioactive material containment of the liquid waste storage and denitration facility; the radiation control in the liquid waste storage, denitration facility and solid waste storage; the waste management in the liquid waste storage and denitration facility; fire and explosion prevention in the liquid waste storage; exposure dose from the liquid waste storage and denitration facility. (Mori, K.)
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Energy Technology Data Exchange (ETDEWEB)
Evans, L.C.
1955-09-16
The Steering Committee approved 8 studies related to separation processes, analytical chemistry, waste handling, and recycle development. Safety and security issues were discussed. Appendices detail the financial status of the Technical Division and estimated man months for development studies approved for the Purex Process, tritium separations, thorium recycle, U-235 separations, and 100-, 200-, and 300-Area studies in analytical chemistry development. The status of 25 other Technical Division studies are listed along with their budget.
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2011-02-24
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal... Cybersecurity and Communications Reliability Public Safety and Homeland Security Bureau, Federal Communications...
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Health and safety education for joint occupational health and safety committees
Directory of Open Access Journals (Sweden)
Myriam Mahecha Angulo
2015-09-01
Full Text Available Objective: To build a proposal to develop the educational process in health and safety joint committees aimed at safety and health at work (copasst. Methodology: Qualitative, descriptive study in which an in-depth interview to 32 copasst assets was made. Each interview was transcribed and interpreted by applying check with participants, finding meaningful statements, organizing groups of subjects, exhaustive description and validation with participants. The information was placed in the categories planning, organization, development, evaluation and feedback, emerging the following categories: responsible for processes management; planning, place and frequency of educational sessions; topics; format of sessions; involving/ development of sessions; understanding of the issues; applicability to daily life and work environment; applicability to personal/professional life and to the organization. Results: From emerging categories and according to the conceptual framework on adult health education and health and safety for workers, a participatory methodology for the development of educational processes with copasst was built. Conclusions: According to the statement by the members of the copasst, educational processes in health and safety, as they are developed at present, preclude them from achieving necessary competences to perform its functions, thus they are irrelevant.
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2012-02-28
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal..., Associate Bureau Chief, Public Safety and Homeland Security Bureau, Federal Communications Commission, 445...
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2011-08-31
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal.... Postal Service Mail to Jeffery Goldthorp, Associate Bureau Chief, Public Safety and Homeland Security...
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Nuclear safety review requirements for launch approval
International Nuclear Information System (INIS)
Sholtis, J.A. Jr.; Winchester, R.O.
1992-01-01
Use of nuclear power systems in space requires approval which is preceded by extensive safety analysis and review. This careful study allows an informed risk-benefit decision at the highest level of our government. This paper describes the process as it has historically been applied to U.S. isotopic power systems. The Ulysses mission, launched in October 1990, is used to illustrate the process. Expected variations to deal with reactor-power systems are explained
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Developing international safety standards for the geological disposal of radioactive waste
International Nuclear Information System (INIS)
Metcalf, P.
2001-01-01
In the context of the International Atomic Energy Agency's (IAEA) programme to create a corpus of internationally accepted Radioactive Waste Safety Standards (RADWASS), focus is currently being placed on establishing standards for the 'geological disposal of radioactive waste'. This is a challenging task and to help the standards development process there is a need to stimulate discussion of some of the associated scientific and technical issues. A number of position papers developed in recent years by a subgroup of the Waste Safety Standards Committee (WASSC), the subgroup on Principles and Criteria for Radioactive Waste Disposal, address many of the relevant issues. These include a common safety based framework for radioactive waste disposal, appropriate time frames for safety assessment, different possible indicators of long-term safety, the safety implications of reversibility and retrievability, the assessment of possible human intrusion into the repository, the role and limitations of institutional control, establishing reference critical groups and biospheres for long-term assessment, and what is meant by 'compliance' with the standards. These papers will be discussed at a Specialists Meeting to be held at the IAEA in June 2001 as a means of establishing the extent to which they enjoy the general support of experts. In order to broaden that consensus, the conclusions reached at the Specialists Meeting on the issues listed above will be presented and discussed with participants at a number of international meetings. Later this year, a draft safety standard on the geological disposal of radioactive waste which takes account of the consensus positions reached through the various consultations will be submitted for the consideration of Waste Safety Standards Committee (WASSC), the officially approved body within the IAEA for the review and approval of waste safety standards. The Committee is made up of government appointed radioactive waste regulators
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Regulations of 19 August 1978 on the optional principles of the Nuclear Safety Committee
International Nuclear Information System (INIS)
1978-01-01
These regulations were published in the Turkish Official Gazette of 19 August 1978 and were made pursuant to Decree no. 7/9141 of 1975 on licensing of nuclear installations which established the Nuclear Safety Committee. They determine the duties and responsibilities of the Committee, its qualifications, its operating principles and its relations with the Nuclear Safety Assistance Service set up in the Turkish Atomic Energy Commission for the purposes of assisting its Secretary General. The regulations also lay down the procedures to be applied for consultations on granting licences. (NEA) [fr
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2010-03-04
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council; Notice of Public Meeting... Analysis Division, Public Safety and Homeland Security Bureau, Federal Communications Commission, 445 12th...
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2011-07-11
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... East, Adelphi, MD. The conference center telephone number is: 301 985-7300. Contact Person: Kalyani...
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Guidelines for nuclear reactor equipments safety-analysis
International Nuclear Information System (INIS)
1978-01-01
The safety analysis in approving the applications for nuclear reactor constructions (or alterations) is performed by the Committee on Examination of Reactor Safety in accordance with various guidelines prescribed by the Atomic Energy Commission. In addition, the above Committee set forth its own regulations for the safety analysis on common problems among various types of nuclear reactors. This book has collected and edited those guidelines and regulations. It has two parts: Part I includes the guidelines issued to date by the Atomic Energy Commission: and Part II - regulations of the Committee. Part I has collected 8 categories of guidelines which relate to following matters: nuclear reactor sites analysis guidelines and standards for their applications; standard exposure dose of plutonium; nuclear ship operation guidelines; safety design analysis guidelines for light-water type, electricity generating nuclear reactor equipments; safety evaluation guidelines for emergency reactor core cooling system of light-water type power reactors; guidelines for exposure dose target values around light-water type electricity generating nuclear reactor equipments, and guidelines for evaluation of above target values; and meteorological guidelines for the safety analysis of electricity generating nuclear reactor equipments. Part II includes regulations of the Committee concerning - the fuel assembly used in boiling-water type and in pressurized-water type reactors; techniques of reactor core heat designs, etc. in boiling-water reactors; and others
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International Nuclear Information System (INIS)
Saji, G.; Bartels, H.W.; Chuyanov, V.; Holland, D.; Kashirski, A.V.; Morozov, S.I.; Piet, S.J.; Poucet, A.; Raeder, J.; Rebut, P.H.; Topilski, L.N.
1995-01-01
International Thermonuclear Experimental Reactor (ITER) Engineering Design Activities (EDA) in safety and environment are approaching the point where conceptual safety design, topic studies and research will give way to project oriented engineering design activities. The Joint Central Team (JCT) is promoting safety design and analysis necessary for siting and regulatory approval. Scoping studies are underway at the general level, in terms of laying out the safety and environmental design framework for ITER. ITER must follow the nuclear regulations of the host country as the future construction site of ITER. That is, regulatory approval is required before construction of ITER. Thus, during the EDA, some preparations are necessary for the future application for regulatory approval. Notwithstanding the future host country's jurisdictional framework of nuclear regulations, the primary responsibility for safety and reliability of ITER rests with the legally responsible body which will operate ITER. Since scientific utilization of ITER and protection of the large investment depends on safe and reliable operation of ITER, we are highly motivated to achieve maximum levels of operability, maintainability, and safety. ITER will be the first fusion facility in which overall 'nuclear safety' provisions need to be integrated into the facility. For example, it will be the first fusion facility with significant decay heat and structural radiational damage. Since ITER is an experimental facility, it is also important that necessary experiments can be performed within some safety design limits without requiring extensive regulatory procedures. ITER will be designed with such a robust safety envelope compatible with the fusion power and the energy inventories. The basic approach to safety will be realized by 'defense-in-depth'. (orig.)
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76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability
2011-03-22
... Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of... Mr. James Berger, Associate Public Health Advisor for Blood, Organ and Tissue Safety; Office of... Public Health Advisor for Blood, Organ and Tissue Safety. Contact information for Mr. Berger is provided...
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2013-01-14
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... before February 7, 2013. Time allotted for each presentation may be limited. If the number of registrants...
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2011-09-23
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the..., Adelphi, MD. The conference center telephone number is 301-985-7300. Contact Person: Kalyani Bhatt, Center...
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2013-01-07
...] Petition for Positive Train Control Safety Plan Approval and System Certification of the Electronic Train... the Federal Railroad Administration (FRA) for Positive Train Control (PTC) Safety Plan (PTCSP) approval and system certification of the Electronic Train Management System (ETMS) as required by 49 U.S.C...
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International Nuclear Information System (INIS)
Birraux, Claude; Bataille, Christian; Sido, Bruno
2011-09-01
Following the Fukushima events, the Parliamentary Office for Scientific and Technological Assessment (OPECST) was officially asked at the end of March 2011 - jointly by the National Assembly Bureau and by the Senate Committee on the economy, sustainable development, territorial and regional planning - to carry out a study on nuclear safety, and the present and future outlook of the nuclear industry. To carry out this study, seven members of the National Assembly economic affairs and sustainable development committees were also involved, as well as eight members of the Senate Committee on the economy, sustainable development, territorial and regional planning. The first part of this study, devoted to nuclear safety, was completed on 30 June 2011 by the publication of an intermediate report. This report assembles and summarises the information collected during six public hearings and seven trips to nuclear sites. France is one of the nuclear countries where the management of safety is both the most demanding and the most transparent. In this respect, the independence of the Safety Authority is the best guarantee of strictness in the safety field and the existence of pluralistic bodies, such as the Local Information Committees, is the best guarantee of the transparency of safety. But no country can pride itself on being totally safe from a natural disaster of an unexpected scale. The French nuclear industry must therefore ratchet up one more notch its investment in safety and strengthen the means of university research. It must imagine events of even greater intensity, cascading accidents, with interactions between neighbouring industrial sites. Investment must be made by placing safety requirements above any economic consideration and in strict compliance with the specifications of public authorities supervising safety. (authors)
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2013-03-14
...] Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk... Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. General Function of the... presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably...
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Liu, Hangsheng; Burns, Rachel M; Schaefer, Agnes G; Ruder, Teague; Nelson, Christopher; Haviland, Amelia M; Gray, Wayne B; Mendeloff, John
2010-08-01
Since 1994, Pennsylvania, like several other states, has provided a 5% discount on workers' compensation insurance premiums for firms with a certified joint labor management safety committee. This study explored the factors affecting program participation and evaluated the effect of this program on work injuries. Using Pennsylvania unemployment insurance data (1996-2006), workers' compensation data (1998-2005), and the safety committee audit data (1999-2007), we conducted propensity score matching and regression analysis on the program's impact on injury rates. Larger firms, firms with higher injury rates, firms in high risk industries, and firms without labor unions were more likely to join the safety committee program and less likely to drop out of the program. The injury rates of participants did not decline more than the rates for non-participants; however, rates at participant firms with good compliance dropped more than the rates at participant firms with poor compliance. Firm size and prior injury rates are key predictors of program participation. Firms that complied with the requirement to train their safety committee members did experience reductions in injuries, but non-compliance with that and other requirements was so widespread that no overall impact of the program could be detected. Copyright 2010 Wiley-Liss, Inc.
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2010-06-17
... Committee (FAAC) Aviation Safety Subcommittee; Notice of Meeting AGENCY: Office of the Secretary of... Secretary of Transportation, announces a meeting of the FAAC Aviation Safety Subcommittee, which will be... of the global economy. The Aviation Safety Subcommittee will develop a list of priority safety issues...
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International Nuclear Information System (INIS)
2010-01-01
This document is the first activity report of the High committee for nuclear safety transparency and information (HCTISN), created on June 18, 2008. The HCTISN is a French authority of information, dialogue and debate about the risks linked with nuclear activities and about their impacts on public health, on the environment and on nuclear safety. The committee has the ability to express his opinion and recommendations about any question on the above topics and to propose any measure aiming at warranting or improving the transparency in the nuclear domain. This activity report offers a synthetic overview of the actions already undertaken: the plutonium imports from UK, the contamination incident at the Socatri facility (a Areva-Eurodif daughter company located at the Tricastin site), and the dismantling strategy of basic nuclear facilities. It presents the composition, organization, missions and means of the Committee, the different working groups and the follow-up of the different recommendations emitted so far by the Committee. (J.S.)
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75 FR 14609 - Commercial Fishing Industry Vessel Safety Advisory Committee; Vacancies
2010-03-26
... which Chapter 45 of Title 46, U.S.C. applies and persons representing the marine insurance industry... Industry Vessel Safety Advisory Committee; Vacancies AGENCY: Coast Guard, DHS. ACTION: Request for applications. SUMMARY: The Coast Guard seeks applications for membership on the Commercial Fishing Industry...
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Directory of Open Access Journals (Sweden)
Siriwardhana Chesmal
2008-02-01
Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.
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Källqvist, Torsten; Dirven, Hubert; Gjøen, Tor; Tronsmo, Arne; Yazdankhah, Siamak Pour; Rivedal, Edgar; Borgå, Katrine; Eklo, Ole Martin; Grung, Merete; Lyche, Jan Ludvig; Låg, Marit; Nilsen, Asbjørn Magne; Sverdrup, Line Emilie
2016-01-01
Bacillus thuringiensis are anaerobic, gram-positive bacteria that produce parasporal crystalline protein inclusions, δ-endotoxin, which are toxic to certain invertebrates, especially larvae belonging to the insect orders Coleoptera, Diptera and Lepidoptera. Different strains of Bacillus thuringiensis have therefore a long standing history as plant protective insecticides in many countries, but have not been approved for use in Norway. The Norwegian Scientific Committee for Food Safety (Vitens...
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Preparation, review, and approval of implementation plans for nuclear safety requirements
International Nuclear Information System (INIS)
1994-10-01
This standard describes an acceptable method to prepare, review, and approve implementation plans for DOE Nuclear Safety requirements. DOE requirements are identified in DOE Rules, Orders, Notices, Immediate Action Directives, and Manuals
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Standing Concertation Committee
HR Department
2008-01-01
ORDINARY MEETING ON 27 FEBRUARY 2008 The main items discussed at the meetings of the Standing Concertation Committee on 27 February 2008 included: Short-term Saved Leave Scheme The Committee noted that, by the end of February 2008, some 600 staff had enrolled in the short-term saved leave scheme: approx. 58% had signed up for 1 slice, 14% for two slices, 5% for three slices and 23% for four slices. Administrative Circular No. 4 (Rev. 4) - Unemployment Insurance Scheme The Committee agreed to recommend the Director-General to approve Administrative Circular No. 4 (Rev. 4) - Unemployment Insurance Scheme. Administrative Circular No. 30 (Rev. 2) - Financial benefits upon taking up appointment and termination of contract The Committee agreed to recommend the Director-General to approve Administrative Circular No. 30 (Rev. 2) - Financial Benefits upon taking up appointment and termination of contract. Progressive Retirement Programme The Progressive Retirement Programme (PR...
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Mission and work program of the Joint Committee on Structural Safety
Vrouwenvelder, A.C.W.M.; Faber, M.H.; Chryssanthopoulos, M.
2003-01-01
The Joint Committee on Structural Safety (JCSS for short) is concerned with fundamental and pre-normative research in the field of Structural Reliability and Risk Assessment, and is directly and indirectly involved in the development of ISO-standards and Eurocodes. The JCSS acts on behalf of five
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Reilly, J Patrick; Hirata, Akimasa
2016-06-21
This article treats unsettled issues in the use of numerical models of electrical dosimetry as applied to international limits on human exposure to low-frequency (typically IEEE-ICES (International Committee on Electromagnetic Safety) Technical Committee 95. The paper discusses 25 issues needing attention, fitting into three general categories: induction models; electrostimulation models; and human exposure limits. Of these, 9 were voted as 'high priority' by members of Subcommittee 6. The list is presented as a research agenda for refinements in numerical modeling with applications to human exposure limits. It is likely that such issues are also important in medical and electrical product safety design applications.
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76 FR 19176 - Shipping Coordinating Committee; Notice of Committee Meeting
2011-04-06
...) Maritime Safety Committee (MSC 89) to be held May 11-20, 2011. The primary matters to be considered at MSC... --Technical assistance sub-programme in maritime safety and security --Capacity-building for the... business --Report of the Maritime Safety Committee Members of the public may attend these two meetings up...
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International Nuclear Information System (INIS)
2009-11-01
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment, and, depending on the events, some extraordinary meetings. This document is the proceedings of an extraordinary meeting about the information and transparency in relation with the management of nuclear materials and wastes at all stages of the fuel cycle. The reason of this meeting is a request from the French Minister of ecology, energy, sustainable development and sea (MEEDDM) after the broadcast of a TV documentary entitled 'wastes: the nuclear industry nightmare' and the publication of a press article affirming that 'our nuclear wastes are hidden in Siberia'. The Minister expressed his wish to have the question of the international trade of nuclear materials examined by the HCTISN. The document is organized as follows: a first part presents the hearings of the general direction of energy and climate (DGEC), of the nuclear safety authority (ASN), of EdF, of Areva, of the CEA, of the senior official for the defense and security of the MEEDDM, of Rosatom company and of Greenpeace organisation. A second part examines the incident which took place in October 2009 at the plutonium technology workshop (ATPu) of Cadarache, where about 22 to 39 kg of plutonium powder were discovered in the gloveboxes of this facility, decommissioned in 2005 and undergoing dismantlement today. This part presents the hearings of the CEA, of AREVA, of the Institute of radiation protection and nuclear safety (IRSN), of the ASN, of the hygiene, safety and labour conditions committee (CHSCT) of Areva and CEA, and of the local information commission (CLI) of Cadarache, in relation with
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High committee for nuclear safety transparency and information. October 8, 2009 meeting
International Nuclear Information System (INIS)
2009-10-01
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment. This meeting was organized around 3 main points: 1 - the progress of the different working groups work: elaboration of a communication scale, comparable to the INES scale, for the evaluation of environmental radioactivity, the realisation of a web site for the HCTISN, the question of transparency and secrecy around the maritime transportation of radioactive materials after the visit by the High Committee of two ships from the British INS company; 2 - the management of radioactive wastes with the concept of storage reversibility: political, technical and decisional aspects, position of the National Evaluation Committee for the researches and studies relative to radioactive materials and wastes management (CNE), position of the ANCLI (French national association of local information commissions), debate; 3 - the shortage of radio-physicists in France and the information of populations and patients (declaration of incidents). Some miscellaneous points are reported as well: the first draft of the first annual report of the HCTISN, development of a societal approach for the research programs of the French institute of radiation protection and nuclear safety (IRSN), validation of a collaboration proposal with the ANCLI. (J.S.)
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78 FR 29201 - Shipping Coordinating Committee; Notice of Committee Meeting
2013-05-17
... the International Maritime Organization's (IMO) Marine Safety Committee to be held at the IMO... session of the Sub-Committee) Technical co-operation activities relating to maritime safety and security... amendments to mandatory instruments Measures to enhance maritime security Goal-based new ship construction...
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77 FR 57638 - Shipping Coordinating Committee; Notice of Committee Meeting
2012-09-18
... the International Maritime Organization's (IMO) Marine Safety Committee to be held at the IMO... seventeenth session of the Sub-Committee); Technical co-operation activities relating to maritime safety and... amendments to mandatory instruments; Measures to enhance maritime security; Goal-based new ship construction...
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75 FR 51525 - Railroad Safety Advisory Committee (RSAC); Working Group Activity Update
2010-08-20
.... The Working Group continues to work on after arrival orders, and at the September 25-26, 2008, meeting... protecting persons who work on, under, or between rolling equipment and persons applying, removing or.... 63] Railroad Safety Advisory Committee (RSAC); Working Group Activity Update AGENCY: Federal Railroad...
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International Nuclear Information System (INIS)
1976-01-01
The mandate of this Committee, appointed at the request of Parliament, is to make a broad analysis of the safety conditions connected with operation of land-based nuclear power plants and transport, storage and processing, if any, of radioactive materials so as to define the nuclear equipment policy in the 1980s. The analysis will be mainly concentrated on nuclear power but if it wishes, the Committee may make safety-related and environment-related comparisons with other forms of thermal generation. The Committee is composed of 21 members representing the different interested organisations and sectors and its work is scheduled to last approximately 2 years. (NEA) [fr
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2010-06-25
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice...
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78 FR 32699 - Shipping Coordinating Committee; Notice of Committee Meeting
2013-05-31
... Session of the International Maritime Organization's (IMO) Sub-Committee on Safety of Navigation to be... --Report to the Maritime Safety Committee Members of the public may attend this meeting up to the seating... system ``BeiDou'' in the maritime field --International Telecommunication Union (ITU) matters, including...
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Smith, T; Moore, E J; Tunstall-Pedoe, H
1997-05-31
To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. Tayside, Scotland (mixed rural and urban population). 30 research projects approved by Tayside local medical research ethics committee. Adherence to the agreed protocol, particularly for recruitment (obtaining and recording informed consent) and for specific requirements of the ethics committee, including notification of changes to the protocol and of adverse events. In one project only oral consent had been obtained, and in a quarter of the studies one or more consent forms were incorrectly completed. Inadequate filing of case notes in five studies and of consent forms in six made them unavailable for scrutiny. Adverse events were reported, but there was a general failure to report the abandoning or non-starting of projects in two studies the investigators failed to notify a change in the responsible researcher. Monitoring of medical research by local medical research ethics committees promotes and preserves ethical standards, protects subjects and researchers, discourages fraud, and has the support of investigators. We recommend that 10% of projects should undergo on-site review, with all others monitored by questionnaire. This would require about six person hours of time and a salary bill of 120 pounds per study monitored.
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2010-11-03
...-2010-0074] The Future of Aviation Advisory Committee (FAAC) Subcommittee on Aviation Safety; Notice of..., announces a meeting of the FAAC Subcommittee on Aviation Safety, which will be held at the offices [[Page... needs, challenges, and opportunities of the global economy. The Subcommittee on Aviation Safety will...
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2010-07-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2010-M-0068...
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2013-06-12
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0036... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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2011-06-02
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2011-M-0034... Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY...
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Design review report for modifications to RMCS safety class equipment
International Nuclear Information System (INIS)
Corbett, J.E.
1997-01-01
This report documents the completion of the formal design review for modifications to the Rotary Mode Core Sampling (RMCS) safety class equipment. These modifications are intended to support core sampling operations in waste tanks requiring flammable gas controls. The objective of this review was to approve the Engineering Change Notices affecting safety class equipment used in the RMCS system. The conclusion reached by the review committee was that these changes are acceptable
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Design review report for modifications to RMCS safety class equipment
Energy Technology Data Exchange (ETDEWEB)
Corbett, J.E.
1997-05-30
This report documents the completion of the formal design review for modifications to the Rotary Mode Core Sampling (RMCS) safety class equipment. These modifications are intended to support core sampling operations in waste tanks requiring flammable gas controls. The objective of this review was to approve the Engineering Change Notices affecting safety class equipment used in the RMCS system. The conclusion reached by the review committee was that these changes are acceptable.
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2013-03-21
... its decision. The regulations provide that FDA publish a quarterly list of available safety and..., FDA-2012-M-1183, and FDA-2012-M-1184] Medical Devices; Availability of Safety and Effectiveness.... SUMMARY: The Food and Drug Administration (FDA) is publishing a list of premarket approval applications...
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2013-08-19
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug... of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-M-0462...
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2010-06-24
... summaries of safety and effectiveness data to the Division of Dockets Management (HFA-305), Food and Drug...; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications AGENCY: Food and Drug... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2009-M-0317...
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Points from the September Committee Meetings
2002-01-01
After a turbulent year, the Committee meetings during the week beginning 16th September took a calmer nature, even if the follow-up of the cost-to-completion review was still a central topic of discussion. The detailed Action Plan and timetable for implementing the recommendations of the External Review Committee were among the principle items. The Plan is based on actions that address specific recommendations, from the redeployment of staff to the LHC to improved financial controls and budgetary tools. It was well received by the Committees and will be presented to the full CERN Council in December. In the meantime, many actions are underway, such as the restructuring of the Accelerator Sector, and the establishment of an external committee to review costs and progress of the LHC on an annual basis. The Finance Committee examined the proposed budget for 2003, which will also be presented to Council for approval in December. In addition, the Committee approved the volume of Industrial Support contracts for 20...
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2010-11-30
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal...) Communications Security, Reliability, and Interoperability Council (CSRIC) will hold its fourth meeting on...
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12 CFR 917.7 - Audit committees.
2010-01-01
... internal auditor and that the internal auditor may be removed only with the approval of the audit committee; (ii) Provide that the internal auditor shall report directly to the audit committee on substantive matters and that the internal auditor is ultimately accountable to the audit committee and board of...
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High committee for nuclear safety transparency and information. March 17, 2009 meeting
International Nuclear Information System (INIS)
2009-03-01
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment. This meeting was organized around 9 main topics: 1 - presentation by the French nuclear safety authority (ASN) of a dismantling strategy for nuclear facilities, in particular taking into account a final state for the site and the information of populations; 2 - status of the next campaign of iodine tablets distribution; 3 - the management of ancient uranium mines and in particular the long-term environmental and health impact of mine tailings; 4 - the implementation of the high committee's recommendations; 5 - work progress of the working group on information transparency; 6 - Areva's invitation of the working group on information transparency to assist to the organisation of a Mox fuel convoy between Cherbourg and Japan; 7 - progress of the working group on the elaboration of a 'communication scale' comparable to the INES scale; 8 - presentation of the meetings organized by the ANCLI (French national association of local information commissions) about the implementation of the Aarhus convention; 9 - presentation by the IRSN (Institute of radiation protection and nuclear safety) of its communication approach towards the public. (J.S.)
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2010-09-16
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal...) Communications Security, Reliability, and Interoperability Council (CSRIC) will hold its third meeting on October...
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2012-11-27
... FEDERAL COMMUNICATIONS COMMISSION Public Safety and Homeland Security Bureau; Federal Advisory Committee Act; Communications Security, Reliability, and Interoperability Council AGENCY: Federal... Security, Reliability, and Interoperability Council (CSRIC III) scheduled for December 5, 2012, at Federal...
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Action plan in response to March 1981 report to NFPQT Committee
International Nuclear Information System (INIS)
1981-03-01
This plan of action has been prepared at the direction of the Acting Under Secretary in response to the report of the Nuclear Facilities Personnel Qualifications and Training (NFPQT) Committee on A Safety Assessment of Department of Energy Nuclear Reactors. Senior Department officials with Headquarters responsibilities for the safety of nuclear facilities owned by and operated for the Department have developed this plan with input from the operations office managers having operational responsibility for such facilities. A summary of the plan's objectives and a cross-reference to the findings of the NFPQT Committee Report is attached to the plan. Appendix A contains implementing actions and Appendix B contains a summary of actions responsive to lessons learned from the TMI accident that have been completed or are well underway. Although the plan is written in definitive language, the specific actions (such as organization realignments and proposals) will be subject to appropriate review and approval. Also, other adjustments may be required as the actions are implemented
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International Nuclear Information System (INIS)
2010-01-01
After a description of the operation of the French 'High Committee for transparency and information on nuclear safety' (HCTISN), of its missions, its organisation and its means, the progress report presents the High Committee activity for 2010 with summaries of its report on the transparency of nuclear material and waste management, its meetings, its work groups, its visits and participations to other events
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Regulations for the safe transport of radioactive material, 2005 edition. Safety requirements
International Nuclear Information System (INIS)
2005-01-01
This publication includes amendments to the 1996 Edition (As Amended 2003) arising from the second cycle of the biennial review and revision process, as agreed by the Transport Safety Standards Committee (TRANSSC) at its ninth meeting in March 2004, as endorsed by the Commission on Safety Standards at its meeting in June 2004 and as approved by the IAEA Board of Governors in November 2004. Although this publication is identified as a new edition, there are no changes that affect the administrative and approval requirements in Section VIII. The fields covered are General Provisions (radiation protection; emergency response; quality assurance; compliance assurance; non-compliance; special arrangement and training); Activity Limits and Materials Restrictions, Requirement and Controls for Transport , Requirements for Radioactive Materials and for Packagings and Packages, Test Procedures, Approval and Administrative Requirements
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78 FR 66006 - Meeting of the Advisory Committee on Blood and Tissue Safety and Availability
2013-11-04
... decision making from donor to recipient. The Committee will also hear from the World Health Organization's... include: (1) Definition of public health parameters around safety and availability of blood and blood...
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Nuclear Safety advisory committee (NSAC)
International Nuclear Information System (INIS)
1999-01-01
The NNSA convened the 16th NSAC meeting in 1999. The Committee listened to the report by the NNSA relating to the fault of core barrel at the QNPP. And also the NNSA convened the 17th NSAC meeting in Beijing. The Committee listened to the report by the NNSA relating to the review and assessment on the application of CP at the JTNPP and discussed on the granting of CP and the related license conditions at the JTNPP. The Sub-Committee of NSAC of the NNSA on siting convened and enlarged meeting for a consulting with the domestic experts on the issue of seismic response spectrum in design at the JTNPP
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78 FR 28275 - Office of Commercial Space Transportation; Safety Approval Performance Criteria
2013-05-14
... provide as a service, scenario based physiology training, which includes hypobaric chamber training. BST may offer its scenario based physiology altitude training as a service to a prospective launch and...: Notification of criteria used to evaluate the Black Sky Training, Inc. (BST) safety approval application...
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A drug's life: the pathway to drug approval.
Keng, Michael K; Wenzell, Candice M; Sekeres, Mikkael A
2013-10-01
In the United States, drugs and medical devices are regulated by the US Food and Drug Administration (FDA). A drug must undergo rigorous testing prior to marketing to and medical use by the general public. The FDA grants marketing approval for drug products based on a comprehensive review of safety and efficacy data. This review article explains the history behind the establishment of the FDA and examines the historical legislation and approval processes for drugs, specifically in the fields of medical oncology and hematology. The agents imatinib (Gleevec, Novartis) and decitabine (Dacogen, Eisai) are used to illustrate both the current FDA regulatory process-specifically the orphan drug designation and accelerated approval process-and why decitabine failed to gain an indication for acute myeloid leukemia. The purpose and construct of the Oncologic Drugs Advisory Committee are also discussed, along with examples of 2 renal cell cancer drugs-axitinib (Inlyta, Pfizer) and tivozanib-that used progression-free survival as an endpoint. Regulatory approval of oncology drugs is the cornerstone of the development of new treatment agents and modalities, which lead to improvements in the standard of cancer care. The future landscape of drug development and regulatory approval will be influenced by the new breakthrough therapy designation, and choice of drug will be guided by genomic insights.
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Safety update on the use of recombinant activated factor VII in approved indications.
Neufeld, Ellis J; Négrier, Claude; Arkhammar, Per; Benchikh el Fegoun, Soraya; Simonsen, Mette Duelund; Rosholm, Anders; Seremetis, Stephanie
2015-06-01
This updated safety review summarises the large body of safety data available on the use of recombinant activated factor VII (rFVIIa) in approved indications: haemophilia with inhibitors, congenital factor VII (FVII) deficiency, acquired haemophilia and Glanzmann's thrombasthenia. Accumulated data up to 31 December 2013 from clinical trials as well as post-marketing data (registries, literature reports and spontaneous reports) were included. Overall, rFVIIa has shown a consistently favourable safety profile, with no unexpected safety concerns, in all approved indications. No confirmed cases of neutralising antibodies against rFVIIa have been reported in patients with congenital haemophilia, acquired haemophilia or Glanzmann's thrombasthenia. The favourable safety profile of rFVIIa can be attributed to the recombinant nature of rFVIIa and its localised mechanism of action at the site of vascular injury. Recombinant FVIIa activates factor X directly on the surface of activated platelets, which are present only at the site of injury, meaning that systemic activation of coagulation is avoided and the risk of thrombotic events (TEs) thus reduced. Nonetheless, close monitoring for signs and symptoms of TE is warranted in all patients treated with any pro-haemostatic agent, including rFVIIa, especially the elderly and any other patients with concomitant conditions and/or predisposing risk factors to thrombosis. Copyright © 2015 Elsevier Ltd. All rights reserved.
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77 FR 58607 - Office of Commercial Space Transportation Safety Approval Performance Criteria
2012-09-21
...: Notification of criteria used to evaluate the National Aerospace Training and Research (NASTAR) Center safety... approval for the ability of its Falcon 12/4 Altitude Chamber to replicate pressures experienced at altitude...). NASTAR's Falcon 12/4 Altitude Chamber is capable of replicating any pressure experienced at altitudes...
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Smith, T.; Moore, E. J.; Tunstall-Pedoe, H.
1997-01-01
OBJECTIVE: To monitor the conduct of medical research projects that have already been approved by the local medical research ethics committee. DESIGN: Follow up study of ethically approved studies (randomly selected from all the studies approved in the previous year) by examination of patients' case notes, consent forms, and research records and by interview of the researchers at their workplace. SETTING: Tayside, Scotland (mixed rural and urban population). SUBJECTS: 30 research projects app...
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75 FR 4108 - Sunshine Act Meeting Notice; Board of Directors and Five Committees of the Board
2010-01-26
... Part 1622 to remove from its requirements the Board's Governance & Performance Review Committee when it.... Audit Committee 11 a.m. 2. Governance & Performance Review Committee. 3. Provision for the Delivery of.... Governance and Performance Review Committee Agenda 1. Approval of Agenda. 2. Approval of Minutes of the...
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Italian ethical committee intervention in a case of embryo-fetal medicine.
Cannovo, Nunzia; Buccelli, Paola; Bryce, Jane
2011-06-01
Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.
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International Nuclear Information System (INIS)
Bikov, V.O.; Kyilochits'ka, T.P.; Bogorins'kij, P.; Vasil'chenko, V.M.; Kondrat'jev, S.M.; Smishlyajeva, S.P.; Troter, D.
2002-01-01
The main task of the technical support in the Shelter Implementation Plan (SIP) licensing process consists in Technical Evaluation of SIP projects and documents submitted by the Licensee to State Nuclear Regulatory Committee to substantiate the safety of Shelter-related work. The goal of this task is to evaluate the submitted materials whether they meet the requirements of nuclear and radiation safety
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1963-01-01
The following report highlights some of the work accomplished by the Aviation Safety Engineering and Research Division of the Flight Safety Foundations since the last report to the NASA Committee on Aircraft Operating Problems on 22 May 1963. The information presented is in summary form. Additional details may be provided upon request of the reports themselves may be obtained from AvSER.
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[Responsibilities of ethics committees].
von Bergmann, K
2000-05-01
Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.
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2012-07-19
... DEPARTMENT OF LABOR Occupational Safety and Health Administration 29 CFR Part 1952 [Docket ID. OSHA 2012-0029] RIN 1218-AC78 Hawaii State Plan for Occupational Safety and Health; Proposed Modification of 18(e) Plan Approval AGENCY: Occupational Safety and Health Administration (OSHA), Department of...
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International Nuclear Information System (INIS)
Kataoka, Isao; Sekimoto, Hiroshi
2000-01-01
The Research Committee of Nuclear Safety carried out a research on criticality accident at the JCO plant according to statement of president of the Japan Atomic Energy Society on October 8, 1999, of which results are planned to be summarized by the constitutions shown as follows, for a report on the 'Questionnaires of criticality accident in the Uranium Fuel Processing Plant of the JCO, Inc.': general criticality safety, fuel cycle and the JCO, Inc.; elucidation on progress and fact of accident; cause analysis and problem picking-up; proposals on improvement; and duty of the Society. Among them, on last two items, because of a conclusion to be required for members of the Society at discussions of the Committee, some questionnaires were send to more than 1800 of them on April 5, 2000 with name of chairman of the Committee. As results of the questionnaires contained proposals and opinions on a great numbers of fields, some key-words like words were found on a shape of repeating in most questionnaires. As they were thought to be very important nuclei in these two items, they were further largely classified to use for summarizing proposals and opinions on the questionnaires. This questionnaire had a big characteristic on the duty of the Society in comparison with those in the other organizations. (G.K.)
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75 FR 27614 - Shipping Coordinating Committee; Notice of Committee Meeting
2010-05-17
... Environment Protection Committee. --Consideration of the report of the Maritime Safety Committee... Session of the International Maritime Organization (IMO) Council to be held at the IMO headquarters in... HNS Convention. --World Maritime University: --IMO International Maritime Law Institute: --Protection...
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RADWASS update. Radioactive Waste Safety Standards Programme
International Nuclear Information System (INIS)
Delattre, D.
2000-01-01
By the late 1980s, the issue of radioactive wastes and their management was becoming increasingly politically important. The IAEA responded by establishing a high profile family of safety standards, the Radioactive Waste Safety Standards (RADWASS). By this means, the IAEA intended to draw attention to the fact that well-established procedures for the safe management of radioactive wastes already were in place. The programme was intended to establish an ordered structure for safety documents on waste management and to ensure comprehensive coverage of all relevant subject areas. RADWASS documents are categorized under four subject areas - discharges, predisposal, disposal, and environmental restoration. The programme is overseen through a formalized review and approval mechanism that was established in 1996 for all safety standards activities. The Waste Safety Standards Committee (WASSC) is a standing body of senior regulatory officials with technical expertise in radioactive waste safety. To date, three Safety Requirements and seven Safety Guides have been issued
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Committee on Scientific Values | Initiatives | Indian Academy of ...
Indian Academy of Sciences (India)
Academy Committee on Scientific Values. The Council of the Academy had in 2003 constituted a Committee to consider and submit a report on ethical guidelines which the fellowship of the Academy should follow. The Committee submitted its report to the Council, which at its meeting in December 2005 approved this report ...
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77 FR 47490 - Shipping Coordinating Committee; Notice of Committee Meeting
2012-08-08
...: --Adoption of the agenda --Decisions of other IMO bodies --Global Maritime Distress and Safety System (GMDSS... facilities --Consideration of operational and technical coordination provisions of maritime safety... Vice-Chairman for 2014 --Any other business --Report to the Maritime Safety Committee Members of the...
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77 FR 28923 - Shipping Coordinating Committee; Notice of Committee Meeting
2012-05-16
... Session of the International Maritime Organization's (IMO) Sub-Committee on Safety of Navigation to be... --Election of Chairman and Vice-Chairman for 2013 --Any other business --Report to the Maritime Safety...
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Fong, Allan; Harriott, Nicole; Walters, Donna M; Foley, Hanan; Morrissey, Richard; Ratwani, Raj R
2017-08-01
Many healthcare providers have implemented patient safety event reporting systems to better understand and improve patient safety. Reviewing and analyzing these reports is often time consuming and resource intensive because of both the quantity of reports and length of free-text descriptions in the reports. Natural language processing (NLP) experts collaborated with clinical experts on a patient safety committee to assist in the identification and analysis of medication related patient safety events. Different NLP algorithmic approaches were developed to identify four types of medication related patient safety events and the models were compared. Well performing NLP models were generated to categorize medication related events into pharmacy delivery delays, dispensing errors, Pyxis discrepancies, and prescriber errors with receiver operating characteristic areas under the curve of 0.96, 0.87, 0.96, and 0.81 respectively. We also found that modeling the brief without the resolution text generally improved model performance. These models were integrated into a dashboard visualization to support the patient safety committee review process. We demonstrate the capabilities of various NLP models and the use of two text inclusion strategies at categorizing medication related patient safety events. The NLP models and visualization could be used to improve the efficiency of patient safety event data review and analysis. Copyright © 2017 Elsevier B.V. All rights reserved.
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78 FR 12062 - Nominations to the Advisory Committee on Blood and Tissue Safety and Availability
2013-02-21
... Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of... Mr. James Berger, Senior Advisor for Blood Policy; Division of Blood and Tissue Safety and...: (240) 453-8803. FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Senior Advisor for Blood Policy...
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77 FR 47491 - Shipping Coordinating Committee; Notice of Committee Meeting
2012-08-08
... to the Maritime Safety Committee Members of the public may attend this meeting up to the seating... Session of the International Maritime Organization's (IMO) Sub-Committee on Dangerous Goods, Solid Cargoes... --Amendment 37-14 to the International Maritime Dangerous Goods (IMDG) Code and supplements, including...
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MO-AB-201-00: Radiation Safety Officer Update
Energy Technology Data Exchange (ETDEWEB)
NONE
2015-06-15
The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35
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MO-AB-201-00: Radiation Safety Officer Update
International Nuclear Information System (INIS)
2015-01-01
The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35
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77 FR 72431 - Shipping Coordinating Committee; Notice of Committee Meeting
2012-12-05
... other IMO bodies --Global Maritime Distress and Safety System (GMDSS): --Review and modernization of the... operational and technical coordination provisions of maritime safety information (MSI) services, including the... business --Report to the Maritime Safety Committee Members of the public may attend this meeting up to the...
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Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F
2017-06-26
Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to
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100th meeting of the Finance Committee
CERN PhotoLab
1969-01-01
The Finance Committee is an advisory committee to the CERN Council. It has the exacting job of supervising CERN’s finances, being concerned with such things as examining budget proposals, salary structures and cost variation formulae and with approving the award of major contracts to industry.
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Energy Technology Data Exchange (ETDEWEB)
NONE
1988-03-01
The environmental safety evaluation sub-committee has held two meeting in the current fiscal year as described below. The first sub-committee meeting (August 25, 1987) was held for the agenda of the summary of future test plans, the result of overseas surveys in fiscal 1986, the results of tests in fiscal 1986, and the summary of the test plan for fiscal 1987. The major agendum of the second sub-committee meeting (February 23) was the interim reports on the overseas survey results and the safety tests in fiscal 1987. NEDO intends to ensure the labor hygiene for workers in coal liquefying plants, the effect of liquefied oil on users' health, and social acceptability of liquefied oil. Therefore, a safety test for liquefied oil in the primary hydrogenation process was performed provisionally on brown coal PP in the initial stage of operation, in addition to bituminous coal liquefied oil at the existing 1-t/d PDU. The main contents of the test performed by NEDO are based on the labor safety and hygiene law and the law related to regulation on the deliberation and manufacture of chemical materials. Different tests using guinea pigs were carried out on the total fraction mixed at the 1-t/d PDU, and each fraction of light and heavy oils, where the liquefied oil was verified to have minor degree of toxicity. (NEDO)
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2010-03-12
..., information about changes to the safety culture of the affected workplaces will be used as one of several data...: RITA-2008-0002] Notice of Request for Approval To Collect New Information: Collection of Safety Culture.... mail to Federal offices in Washington, DC, we recommend that persons consider an alternative method...
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Millán-González, Ricardo
2012-03-01
Delirium is an acute alteration of consciousness and cognition. Atypical antipsychotics (AA) have recently become a main part of its treatment. Studies in this population generate a series of ethical dilemmas concerning the voluntary participation of patients and their state of vulnerability since their mental faculties are, by definition, compromised. To assess whether studies with AA for the treatment of delirium obtained an approval by an ethics committee on human research (ECHR), if an informed consent (IC) was obtained, whether the IC was verbal or written, and who gave the approval to participate. Systematic review of Medline for studies of delirium where quetiapine and olanzapine were the main treatment, assessing the existence of an ECHR approval and implementation of an IC. 11 studies were identified (6 of quetiapine and 5 of olanzapine). 5 had an ECHR approval. Most studies examining the treatment of delirium with quetiapine or olanzapine were not subject to approval by an ECHR and most of them did not obtain an IC from the patient's legal guardian. It is essential that future studies of antipsychotics and other drugs for the treatment of delirium have the protocol approved by an ECHR and a written IC signed by the patient's legal representative, since by definition delirium is a condition that compromises superior mental processes. Copyright © 2012 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.
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Approaches to the safety of future nuclear power plants. Report of a technical committee meeting
International Nuclear Information System (INIS)
1996-09-01
The Technical Committee Meeting on Approaches to Safety of Future Nuclear Power Plants in Different Countries, held from 29 May to 2 June 1995, contributed to this process. Experts from 14 different countries and two international organizations participated in the meeting, which provided the opportunity to exchange information and to review the answers developed to date to these issues (primarily form the IAEA's technical document ''Development of Safety Principles for the Design of Future Nuclear Power Plants'' IAEA-TECDOC-801) and the report of the International Nuclear Safety Advisory Group ''Basic Safety Principles for Nuclear Power Plants'' (INSAG-3). These references were then used as a starting point for answering the question ''to what degree does general agreement (or harmonization) exist on these desired safety approaches for future reactors, and what opportunities remain for further harmonization? 11 refs, 1 tab
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Reporting ethics committee approval in public administration research.
Jordan, Sara R; Gray, Phillip W
2014-03-01
While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.
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International Nuclear Information System (INIS)
2000-08-01
Safety in the transport of radioactive material is dependent on packaging appropriate for the contents being shipped, rather than on operational and/or administrative actions required on the package. The grater the radiological risk posed by the material being moved, the more stringent become the performance for the packaging that can be authorised to contain it. These principles have been expanded since 1061 into a set of regulations that are responsible for safety moving the ever-growing number and complexity of radioactive material shipments throughout the world. The IAEA Regulations for the Safe Transport of Radioactive Material are incorporated into UN regulations, as well as the requirements of other international transport organizations. This is the eleventh report published by the IAEA since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Transport safety Standards Advisory Committee (TRANSSAC). Through the PACKTRAM database, the IAEA collects administrative and technical information provided by the issuing competent authority about package approval certificates
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2011-04-27
... communication of information from knowledgeable and independent perspectives regarding transit rail safety... evaluated mainly on academic experience but also the following factors: Leadership and organizational skills... committee member's name and organizational affiliation, a cover letter describing the nominee's...
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Safety of Therapeutic Fever Induction in Cancer Patients Using Approved PAMP Drugs
Directory of Open Access Journals (Sweden)
Uwe Rudolf Max Reuter
2018-04-01
Full Text Available William Coley, between 1895 and 1936, treated hundreds of cancer patients using infusions of fever inducing bacerial extracts. Similar experiments were done by Klyuyeva and co-workers in the 1940ies in Russia using trypanosoma extracts. Many remissions and cures were reported. We have conjectured that pathogen associated molecular pattern substances (PAMP are the molecular explanation for the beneficial treatments in both groups. We could show that a combination of PAMP can eradicate solid tumours in cancer mice if applied several times. Accordingly, we suggested to combine PAMP containing approved drugs to treat cancer patients using a protocol similar to the old fever induction regimen. In this retrospective phase-1 study we report on the fever induction capacity and safety of applications of bacterial extracts, combinations of bacterial extracts with approved drugs, and combinations of approved drugs in 131 mainly cancer patients. Adverse reactions were those which can be expected during a feverish infection and mild. Over 523 fever inductions, no severe adverse reaction was observed.
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Directory of Open Access Journals (Sweden)
Raghavendra Charan P Makam
Full Text Available Direct oral anticoagulants (DOACs have emerged as promising alternatives to vitamin K antagonists (VKAs for patients with non-valvular atrial fibrillation (NVAF or venous thromboembolism (VTE. Few meta-analyses have included all DOACs that have received FDA approval for these cardiovascular indications, and their overall comparisons against VKAs have shortcomings in data and methods. We provide an updated overall assessment of the efficacy and safety of those DOACs at dosages currently approved for NVAF or VTE, in comparison with VKAs.We used data from Phase 3 randomized trials that compared an FDA-approved DOAC with VKA for primary prevention of stroke in patients with NVAF or for treatment of acute VTE.Among trial participants with NVAF, DOAC recipients had a lower risk of stroke or systemic embolism [Pooled Odds Ratio (OR 0.76, 95% Confidence Interval (CI (0.68-0.84], any stroke (0.80, 0.73-0.88, systemic embolism (0.56, 0.34-0.93, and total mortality (0.89, 0.84-0.95. Safety outcomes also showed a lower risk of fatal, major, and intracranial bleeding but higher risk for gastrointestinal bleeding (GIB. Patients with acute VTE randomized to DOACs had comparable risk of recurrent VTE and death (OR 0.88, 95% CI 0.75-1.03, recurrent DVT (0.83, 0.66-1.05, recurrent non-fatal PE (0.97, 0.75-1.25, and total mortality (0.94, 0.79-1.12. Safety outcomes for DOACs showed a lower risk of major, fatal, and intracranial bleeding, but similar risk of GIB.Patients receiving DOACs for NVAF had predominantly superior efficacy and safety. Patients who were treated with DOACs for acute VTE had non-inferior efficacy, but an overall superior safety profile.
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Maximum tolerable radiation doses recommended by the Israel Advisory Committee on nuclear safety
International Nuclear Information System (INIS)
Tadmor, J.; Litai, D.; Lubin, E.
1978-01-01
Maximum tolerable doses have been recommended by the Israel Advisory Committee on Nuclear Safety. The recommendations which are based on a comparison with risks tolerated in other human activities, are for doses to radiation workers, for individual members of the population at the fence of a nuclear installation, and for the population at large, for both normal operating and accident conditions. Tolerable whole-body doses and doses to different critical organs are listed
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Navigating the Process of Ethical Approval: A methodological note
Directory of Open Access Journals (Sweden)
Eileen Carey, RNID, BSc. (hons, MSc.
2010-12-01
Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.
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29 CFR 1960.37 - Committee organization.
2010-07-01
... 29 Labor 9 2010-07-01 2010-07-01 false Committee organization. 1960.37 Section 1960.37 Labor... MATTERS Occupational Safety and Health Committees § 1960.37 Committee organization. (a) For agencies which... organization of the agency and its collective bargaining configuration. The agency shall form committees at the...
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Energy Technology Data Exchange (ETDEWEB)
NONE
1993-03-01
This paper reports the activities of the environmental safety evaluation sub-committee for the coal liquefaction plant in fiscal 1992. The sub-committee, upon having received reports on the result of environmental safety evaluation tests performed in fiscals 1991 and 1992 by NEDO, deliberated and discussed carefully the contents thereof. In order to ensure labor hygiene for coal liquefaction plant workers, health influence on liquefied oil users, and social acceptability of the liquefied oil, NEDO has performed the comprehensive brown coal pilot plant operation and oil safety tests. The tests are in accordance with the labor safety and hygiene law, the chemicals examination law, and the MPD issued by OECD, and performed on each fraction produced in the pilot plant and the whole fraction mixing the former fractions, using rats, rabbits, and guinea pigs. The test items included: acute inhalation toxicity and oral repeated administration (using rats); eye stimulation, repeated coating and skin stimulation (using rabbits); photo-toxicity (using guinea pigs); mutagenicity tests (microorganisms, bacteria and chromosome anomaly); resolution tests; fish toxicity; concentration degrees; algae growth obstruction; and water flea breeding obstruction. As the result, the toxicity was found light. (NEDO)
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DEFF Research Database (Denmark)
Regnier, Stephane A; Larsen, Michael; Bezlyak, Vladimir
2015-01-01
OBJECTIVE: To compare the efficacy and safety of approved treatments for macular oedema secondary to branch retinal vein occlusion (BRVO). DESIGN: Randomised controlled trials (RCTs) evaluating the efficacy and safety of approved treatments for macular oedema secondary to BRVO were identified from...... an updated systematic review. SETTING: A Bayesian network meta-analysis of RCTs of treatments for macular oedema secondary to BRVO. INTERVENTIONS: Ranibizumab 0.5 mg pro re nata, aflibercept 2 mg monthly (2q4), dexamethasone 0.7 mg implant, laser photocoagulation, ranibizumab+laser, or sham intervention...... pressure (IOP)/ocular hypertension (OH). RESULTS: 8 RCTs were identified for inclusion with 1743 adult patients. The probability of being the most efficacious treatment at month 6 or 12 based on letters gained was 54% for ranibizumab monotherapy, 30% for aflibercept, 16% for ranibizumab plus laser...
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75 FR 64390 - Shipping Coordinating Committee; Notice of Committee Meeting
2010-10-19
...-eighth Session of the International Maritime Organization's (IMO) Maritime Safety Committee to be held at... --Technical assistance sub-programme in maritime safety and security --Capacity-building for the... --Measures to enhance maritime security --Goal-based new ship construction standards --LRIT-related matters...
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76 FR 58330 - Shipping Coordinating Committee; Notice of Committee Meeting
2011-09-20
... bodies --Global Maritime Distress and Safety System (GMDSS) --ITU maritime radiocommunication matters... for 2013 --Any other business --Report to the Maritime Safety Committee Finally, an open meeting will... events at the International Maritime Organization (IMO) in London, United Kingdom. Two of these meetings...
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77 FR 21619 - Shipping Coordinating Committee; Notice of Committee Meeting
2012-04-10
... of the International Maritime Organization's (IMO) Marine Safety Committee to be held at the IMO... gases; Implementation of the STCW Convention; Technical assistance sub-programme in maritime safety and...: Consideration and adoption of amendments to mandatory instruments; Measures to enhance maritime security; Goal...
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International Nuclear Information System (INIS)
1983-04-01
The Safety Evaluation Report for the application filed by General Electric Company for the Final Design Approval for the General Electric Standard Safety Analysis Report (GESSAR II FSAR) has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report summarizes the results of the staff's safety review of the GESSAR II BWR/6 Nuclear Island Design. Subject to favorable resolution of items discussed in the Safety Evaluation Report, the staff concludes that the facilities referencing GESSAR II, subject to approval of the balance-of-plant design, can conform with the provisions of the Act and the regulations of the Nuclear Regulatory Commission
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Implementation of the new regulation on radiological safety in Peru
International Nuclear Information System (INIS)
Medina Gironzini, E.
1997-01-01
Since its creation in 1975, the Peruvian Institute of Nuclear Energy (IPEN) has enacted three regulations of national importance on the norms of protection against ionizing radiation. The first regulation, which is called regulation of radiological protection (1980) approved by a resolution of IPEN, is the result of the work of a committee constituted by IPEN and the Ministry of Health. Its implementation caused some problems as result of which, in 1989, a new regulation on radiological protection was enacted through a supreme decree. Taking into account the new recommendation of the International Commission on Radiological Protection and the International Basic Safety Standard for Protection against Ionizing Radiation and for the Safety of Radiation Sources, approved in May 1997, the regulation of radiological safety also considers evolving aspects in the Project ARCAL XVII/IAEA. This regulation includes various topics such as exclusions, requirements of protection (medical exposure, occupational exposure, public exposure, chronic exposure), requirements of source safety, interventions and emergencies, control of sources and practices (exemptions, authorizations, inspections) etc. The implementation of this regulation at the national level falls to IPEN, the unique authority commissioned to control nuclear installations, radioactivity and x ray facilities in medicine, industry and research
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Magnuson, Bernadene; Munro, Ian; Abbot, Peter; Baldwin, Nigel; Lopez-Garcia, Rebeca; Ly, Karen; McGirr, Larry; Roberts, Ashley; Socolovsky, Susan
2013-01-01
This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods. PMID:23781843
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High committee for nuclear safety transparency and information. December 18, 2008 meeting
International Nuclear Information System (INIS)
2008-12-01
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment. This meeting was organized around 6 main topics: 1 - a presentation of nuclear medicine by Prof. Devaux, of its domains of application and the respect of radiation protection rules; 2 - the launching of a working group on the transparency/secrecy problem with nuclear activities; 3 - the elaboration of an environmental radioactivity index by the nuclear safety authority (ASN); 4 - the order addressed to the Cruas nuclear facility for the lack of standardized marking and maintenance of pipes used for the transport of explosive fluids; 5 - the consequences of the blocking of 2 fuel assemblies (out of 157) in the Tricastin reactor core; 6 - the flood at the Tricastin site, its origin and consequences. (J.S.)
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International Nuclear Information System (INIS)
1997-01-01
The aim of the Technical Committee Meeting (TCM) was to review developed systems and methods in diagnostics in the scope of their impacts and importance to the safety of Nuclear Power Plants. Papers presented on TCM came from different sources, from developers, from manufacturers, from licensing authorities and from NPP personal. They reflect up to date status in the given subject. Participants of TCM formulated three working groups to elaborate different questions which were raised during the discussions. Their results are reflected in the three chapter titles of the given material. Annex 1 to this document contains presentations made at the Technical Committee Meeting. Refs, figs, tabs
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Carpenter, Daniel; Chattopadhyay, Jacqueline; Moffitt, Susan; Nall, Clayton
2012-01-01
Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.
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International Nuclear Information System (INIS)
Anspaugh, L.R.; Hendrickson, S.M.
1991-01-01
This report contains brief summaries of the status of projects of the Environmental Transport Group of the US-USSR Joint Coordinating Committee of Civilian Nuclear Reactor Safety. Projects reported on include: Management and Administration; Atmospheric Transport; Resuspension; External Dose; Terrestrial Food Chains; Aquatic Food Chains; Hydrological Transport; and Intercalibration
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2010-08-12
...] Baseline Safety and Health Practices; Office of Management and Budget's (OMB) Approval of Information... health practices of private sector establishments in agriculture (with 10 or more workers) and non... monitor and more effectively implement practices to mitigate workplace hazards, thereby reducing the...
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International Nuclear Information System (INIS)
1999-08-01
This is the tenth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Transport Safety Standards Advisory Committee (TRANSSAC), formerly known as the Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The reporting format was established at consecutive meetings of SAGSTRAM and endorsed by TRANSSAC, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last complete calendar year. The 1985 Edition of IAEA Safety Series No. 6, the 'Regulations for the Safe Transport of Radioactive Material' highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material
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K Basins Spent Nuclear Fuel (SNF) Project Safety Analysis Report for Packaging (SARP) approval plan
International Nuclear Information System (INIS)
1995-01-01
This document delineates the plan for preparation, review, and approval of the K Basins Spent Nuclear Fuel (SNF) Packaging Design Criteria (PDC) document and the on-site Safety Analysis Report for Packaging (SARP). The packaging addressed in these documents is used to transport SNF in a Multi- canister Overpack (MCO) configuration
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Energy Technology Data Exchange (ETDEWEB)
NONE
1990-07-01
At the invitation of the Government of the Union of Soviet Socialist Republics, the Eleventh International Conference on the HTGR and the IAEA Technical Committee Meeting on Gas-Cooled Reactor Technology, Safety and Siting were held in Dimitrovgrad, USSR, on June 21-23, 1989. The Technical Committee Meeting provided the Soviet delegates with an opportunity to display the breadth of their program on HTGRs to an international audience. Nearly one-half of the papers were presented by Soviet participants. Among the highlights of the meeting were the following: the diverse nature and large magnitude of the Soviet research and development program on high temperature gas-cooled reactors; the Government approval of the budget for the construction of the 30 MWt High Temperature Test Reactor (HTTR) in Japan (The schedule contemplates a start of construction in spring 1990 on a site at the Oarai Research Establishment and about a five year construction period.); disappointment in the announced plans to shutdown both the Fort St. Vrain (FSV) plant in the United States (US) and the Thorium High Temperature Reactor (THTR-300) in Germany (These two reactors presently represent the only operating HTGRs in the world since the AVR plant in Juelich, Germany, was also shutdown at the end of 1988.); the continuing negotiations between Germany and the USSR on the terms of the co-operation between the two countries for the construction of a HTR Module supplemented by joint research and development activities aimed at increasing coolant outlet temperatures from 750 deg. C to 950 deg. C; the continued enthusiasm displayed by both the US and German representatives for the potential of the small modular designs under development in both countries and the ability for these designs to meet the stringent requirements demanded for the future expansion of nuclear power; the combining of the HTGR technology interest of ABB-Atom and Siemens in Germany into a joint enterprise, HTR GmbH, in May 1989
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International Nuclear Information System (INIS)
1990-01-01
At the invitation of the Government of the Union of Soviet Socialist Republics, the Eleventh International Conference on the HTGR and the IAEA Technical Committee Meeting on Gas-Cooled Reactor Technology, Safety and Siting were held in Dimitrovgrad, USSR, on June 21-23, 1989. The Technical Committee Meeting provided the Soviet delegates with an opportunity to display the breadth of their program on HTGRs to an international audience. Nearly one-half of the papers were presented by Soviet participants. Among the highlights of the meeting were the following: the diverse nature and large magnitude of the Soviet research and development program on high temperature gas-cooled reactors; the Government approval of the budget for the construction of the 30 MWt High Temperature Test Reactor (HTTR) in Japan (The schedule contemplates a start of construction in spring 1990 on a site at the Oarai Research Establishment and about a five year construction period.); disappointment in the announced plans to shutdown both the Fort St. Vrain (FSV) plant in the United States (US) and the Thorium High Temperature Reactor (THTR-300) in Germany (These two reactors presently represent the only operating HTGRs in the world since the AVR plant in Juelich, Germany, was also shutdown at the end of 1988.); the continuing negotiations between Germany and the USSR on the terms of the co-operation between the two countries for the construction of a HTR Module supplemented by joint research and development activities aimed at increasing coolant outlet temperatures from 750 deg. C to 950 deg. C; the continued enthusiasm displayed by both the US and German representatives for the potential of the small modular designs under development in both countries and the ability for these designs to meet the stringent requirements demanded for the future expansion of nuclear power; the combining of the HTGR technology interest of ABB-Atom and Siemens in Germany into a joint enterprise, HTR GmbH, in May 1989
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International Nuclear Information System (INIS)
Anon.
1979-01-01
The main objective of holding these hearings is to help the committee, and the Congress, and members of the public to understand the questions associated with nuclear powerplant safety. Also, to help the committee and the Congress to take what steps it feels necessary in assuring that our nuclear powerplants will be even safer in the future than they are today. Learning the lessons from Three Mile Island, asking the tough questions, and providing responsible answers to them will be part of the functioning of this committee. This committee has the responsibility for energy research, development, and demonstration associated with our nuclear powerplant research, development, and demonstration programs which ultimately will lead to commercialization. In conducting these hearings, the subcommittee intends to explore every aspect of safety technology and to conduct a thorough review of the status of the technology. The subcommittee wants to develop a detailed understanding of nuclear safety and operating philosophy as well as the implications of the Three Mile Island accident and any other accident
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High committee for nuclear safety transparency and information. July 1, 2009 meeting
International Nuclear Information System (INIS)
2009-07-01
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment. This meeting was organized around 5 main points: 1 - radioactive waste management: status and steps of the June 28, 2006 law, ANDRA's projects of deep geologic disposal for long living/high-medium activity wastes and of low depth disposal for long living/low activity wastes, French nuclear safety authority (ASN) opinion about the sites choice, implementation of article 10 of the June 28, 2006 law relative to public information; 2 - progress of the working groups' works on transparency and secrecy, on the development of a communication scale, and on the creation of an Internet portal for the radio-ecological follow-up of nuclear sites; 3 - comments of the ASN's report on the nuclear safety and radiation protection in France in 2008; 4 - procedure of management of the radio-physicists shortage in order to warrant the patients' safety and information; 5 - miscellaneous points: project of European directive on nuclear safety, organisation of a visit day onboard of a ship for nuclear materials transportation, comments about the by-law from May 5, 2009, relative to the exemption to informing consumers about the addition of radionuclides to consumption and construction products. (J.S.)
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New technology planning and approval: critical factors for success.
Haselkorn, Ateret; Rosenstein, Alan H; Rao, Anil K; Van Zuiden, Michele; Coye, Molly J
2007-01-01
The steady evolution of technology, with the associated increased costs, is a major factor affecting health care delivery. In the face of limited capital resources, it is important for hospitals to integrate technology management with the strategic plan, mission, and resource availability of the organization. Experiences in technology management have shown that having a well-organized, consistent approach to technology planning, assessment, committee membership, approval, evaluation, implementation, and monitoring are key factors necessary to ensure a successful program. We examined the results of a survey that assessed the structure, processes, and cultural support behind hospital committees for new technology planning and approval.
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12 CFR 630.6 - Funding Corporation committees.
2010-01-01
... in its minutes its agreement or disagreement with the item(s) under review. (ii) External auditors... and plans for senior officers and employees. The compensation committee must approve the overall...
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[Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].
Jeong, Ihn Sook
2015-06-01
This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.
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General re-evaluation of the safety on the nuclear ship 'Mutsu' and its repair work
International Nuclear Information System (INIS)
1980-01-01
According to the proposition by the Committee for Investigation Radiation Leak on Mutsu, the works of the general re-evaluation of safety were started after the approval by the Committee for Investigating General Re-evaluation and Repair Techniques for Mutsu. The contents of the general re-evaluation of safety are the inspection of the machines and equipments in the nuclear reactor plant, the review of the design of the nuclear reactor plant, the analysis of the nuclear reactor plant behavior in accidents, and the related experimental researches. These works have been carried out for five years, and problem did not arise at all regarding the nuclear reactor so far, but from the viewpoint of improving the safety and reliability further, it was decided to carry out the repair work based on the general re-evaluation of safety. The contents of the repair work are the improvement of the emergency core-cooling system, the improvement of the safety protection system, the improvement of the radiation monitoring equipments, the improvement of the containment vessel boundary, the improvement of the actuators for technological safety facilities, the improvement of the method controlling secondary water quality, and other repair works. The progress of the general re-evaluation of safety is reported. (Kako, I.)
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STANDING CONCERTATION COMMITTEE: ORDINARY MEETINGS IN NOVEMBER & DECEMBER 2003
2004-01-01
Original: English These meetings were devoted to the main topics summarised below. 1-Follow-up of the meetings of TREF in October and the Finance Committee in November, and preparation for the Committee meetings in December The Chairman reported that the Management's proposals to adjust, on 1 January 2004, the salaries by 1.1%, on the basis of the calculated salary index, and the pensions by 0.7%, corresponding to the Geneva cost-of-living index, had received the support of TREF and would now be proposed by the Finance Committee for approval by Council in December. TREF had taken note of a factual status report regarding the first phase of recruitment of Local Staff and looked forward to a final report on overall implementation in June next year. TREF also gave its support to the Management's proposed modification to the Progressive Retirement Programme. Subject to some amendments and clarifications made at TREF and at the SCC, this proposal will be submitted for approval at the Finance Committee and Counci...
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International Nuclear Information System (INIS)
Marcus, F.
1990-01-01
Joint Nordic research programmes in nuclear safety have been conducted since 1977 under the direction of the Nordic Liaison Committee for Atomic Energy. Each of these four-year programmes is evaluated according to a procedure established by the Nordic Committee for Safety Research, NKS. The latest programme covered the period 1985-89 and included items that are of interest to countries that have nuclear power plants (Finland and Sweden) as well as to countries without (Denmark, Iceland and Norway). This last programme has been evaluated in 1990. The first area (AKT) deals with phenomena that might occur within the reactor containment during accidents. It also deals with potential pathways of radioactive material that could be released, as well as effects in the environment and possible counter-measures. The second area (KAV) investigates several topics related to waste management, such as waste arising in Scandinavia from power plant operation and decommissioning, and related transportation needs. It also deals with the methods used for modelling possible leaks from waste repositories and the uncertainty related to such calculations. The third area (RAS) deals with risk management - how decisions on safety issues are made, and what is the relative risk of nuclear activities. It also deals with methods for safety calculations that are based on a probabilistic approach. In the fourth area (MAT), the tendency of materials to develop cracks under tough external conditions is examined together with corrosion issues relevant to nuclear plants. Finally, the fifth area (INF) deals with the possibility of using modern information technology to support communication and decision making during emergency situations at compelx industrial plants. (author)
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International Nuclear Information System (INIS)
2008-01-01
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment. This meeting was organized around 3 main topics: 1 - the organization and stakes of nuclear safety and radiation protection in France, 2 - the plutonium imports and transports from England to France and their conformability with respect to the maritime, nuclear safety and nuclear security regulations, 3 - the role and operation of the HCTISN. This document is the proceedings of this meeting. (J.S.)
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Standing Concertation Committee
2007-01-01
Ordinary meeting on 30 January 2007 The main items discussed at the meeting of the Standing Concertation Committee on 30 January 2007 included: Administrative Circular No. 26: with the introduction of the merit recognition system in the framework of the 5-yearly review of CERN employment conditions, Administrative Circular No. 26 has been revised. The committee took note of the revised document which is being finalized for submission to the Director-General for approval in the near future. Technical analysis of CERN Health Insurance Scheme: the Committee was informed that a group has been set up by the Director-General to analyse the financial situation of the CERN Health Insurance Scheme in the short and long term, and to propose measures to ensure that the Scheme remains in financial balance, with adequate cover, over the medium term. The group's terms of reference and membership were communicated. Voluntary programmes It was announced that the programmes: 'part-time work as a pre-retirement measure...
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Standing Concertation Committee
2007-01-01
ORDINARY MEETING ON 30 JANUARY 2007 The main items discussed at the meeting of the Standing Concertation Committee on 30 January 2007 included: Administrative Circular No. 26: with the introduction of the merit recognition system in the framework of the 5-yearly review of CERN employment conditions, Administrative Circular No. 26 has been revised. The Committee took note of the revised document which is being finalized for submission to the Director-General for approval in the near future. Technical analysis of CERN Health Insurance Scheme: the Committee was informed that a group has been set up by the Director-General to analyse the financial situation of the CERN Health Insurance Scheme in the short and long term, and to propose measures to ensure that the Scheme remains in financial balance, with adequate cover, over the medium term. The group's terms of reference and membership were communicated. Voluntary programmes It was announced that the programmes: 'part-time work as a pre-retirement mea...
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International Nuclear Information System (INIS)
Brisbin, S.A.
1996-01-01
This document delineates the plan for preparation, review, and approval of the Packaging Design Crieteria for the K Basin Sludge Transportation System and the Associated on-site Safety Analysis Report for Packaging. The transportation system addressed in the subject documents will be used to transport sludge from the K Basins using bulk packaging
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International Nuclear Information System (INIS)
1996-09-01
This is the seventh annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificated (PACKTRAM) at the recommendation of the then Standing Advisory Group on the Sate Transport of Radioactive Material (SAGSTRAM). The functions of SAGSTRAM were taken over in 1996 by the Transport Safety Standards Advisory Committee (TRANSSAC). The reporting format was established at consecutive meetings of SAGSTRAM, whose membership consists of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who have shown a keen interest in the IAEA's transport safety programme. Through the PACKTRAM database, the Secretariat collects administrative and technical information on package approval certificates to assist national competent authorities in regulating radioactive material movements in their country. The database carries information on extant certificates and those that expired within the last complete calendar year. The 1985 Edition of IAEA Safety Series No. 6, the ''Regulations for the Safe Transport of Radioactive Material'', highlights the role of competent authorities in assuring regulatory compliance in their own countries. Package approval certificates are an important aspect of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material. 6 tabs
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International Nuclear Information System (INIS)
1994-01-01
A Technical Committee Meeting (TCM) was organized between 5-8 December 1994 to discuss and review the international situation in connection with the use made, whether formally or informally, by regulatory bodies of probabilistic safety assessment (PSA) in the course of their work, and the related question of the use and value of adopting probabilistic safety criteria (PSC) as an aid to judging the results of PSAs. The document includes the output from the four working groups, as well as 11 papers from the 12 papers presented to the TCM. A separate abstract was prepared for each paper. Refs, figs, tabs
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International Nuclear Information System (INIS)
1983-03-01
Supplement No. 1 to the Safety Evaluation Report for the application filed by Combustion Engineering, Inc. for a Final Design Approval for the Combustion Engineering Standard Safety Analysis Report (STN 50-470) has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. The purpose of this supplement is to update the Safety Evaluation by providing: (1) the evaluation of additional information submitted by the applicant since the Safety Evaluation Report was issued, (2) the evaluation of the matters the staff had under review when the Safety Evaluation Report was issued, and (3) the response to comments made by the Advisory Committee on Reactor Safeguards
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Jeffs, Lianne; Abramovich, Ilona Alex; Hayes, Chris; Smith, Orla; Tregunno, Deborah; Chan, Wai-Hin; Reeves, Scott
2013-11-01
Effective teamwork and interprofessional collaboration are vital for healthcare quality and safety; however, challenges persist in creating interprofessional teamwork and resilient professional teams. A study was undertaken to delineate perceptions of individuals involved with the implementation of an interprofessional patient safety competency-based intervention and intervention participants. The study employed a qualitative study design that triangulated data from interviews with six steering committee members and five members of the project team who developed and monitored the intervention and six focus groups with clinical team members who participated in the intervention and implemented local patient safety projects within a large teaching hospital in Canada. Our study findings reveal that healthcare professionals and support staff acquired patient safety competencies in an interprofessional context that can result in improved patient and work flow processes. However, key challenges exist including managing projects amidst competing priorities, lacking physician engagement and sustaining projects. Our findings point to leaders to provide opportunities for healthcare teams to engage in interprofessional teamwork and patient safety projects to improve quality of patient care. Further research efforts should examine the sustainability of interprofessional safety projects and how leaders can more fully engage the participation of all professions, specifically physicians.
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International Nuclear Information System (INIS)
1997-08-01
This is the eighth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the then Standing Advisory Group on the Safe Transport of Radioactive Material (SAGSTRAM). The functions of SAGSTRAM were taken over in 1996 by the Transport Safety Standards Advisory Committee (TRANSSAC). The reporting format was established at consecutive meetings of SAGSTRAM, whose membership consisted of national competent authorities responsible for the transport of radioactive material from those Member States who have a nuclear industry and others who showed a keen interest in the IAEA's transport safety programme. TRANSSAC underscores the importance of data collecting activities and recommends the continued publication of this annual report. The 1985 Edition of Safety Series No. 6, the ''Regulations for the Safe Transport of Radioactive Material'', highlights the role of competent authorities in assuring regulatory compliance in their own countries. The issuance of package approval certificates is an important aspects of that function. This document aims to be a useful reference for competent authorities as well as for manufacturers and shippers of radioactive material. 6 tabs
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International Nuclear Information System (INIS)
Holdren, J.P.; Berwald, D.H.; Budnitz, R.J.
1987-01-01
The Senior Committee on Environmental, Safety, and Economic Aspects of Magnetic Fusion Energy (ESECOM) has assessed magnetic fusion energy's prospects for providing energy with economic, environmental, and safety characteristics that would be attractive compared with other energy sources (mainly fission) available in the year 2015 and beyond. ESECOM gives particular attention to the interaction of environmental, safety, and economic characteristics of a variety of magnetic fusion reactors, and compares them with a variety of fission cases. Eight fusion cases, two fusion-fission hybrid cases, and four fission cases are examined, using consistent economic and safety models. These models permit exploration of the environmental, safety, and economic potential of fusion concepts using a wide range of possible materials choices, power densities, power conversion schemes, and fuel cycles. The ESECOM analysis indicates that magnetic fusion energy systems have the potential to achieve costs-of-electricity comparable to those of present and future fission systems, coupled with significant safety and environmental advantages. 75 refs., 2 figs., 24 tabs
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Energy Technology Data Exchange (ETDEWEB)
Wurster, R.; Vandendungen, G.; Guichard, J.; Molag, M.; Barron, J.; Reijalt, M.; Hill, H.J.; Landinger, H.
2007-05-15
The EU-funded project HyApproval [www.hyapproval.org] aims at developing a universal Handbook to facilitate the approval process of Hydrogen Refuelling Stations (HRS) in Europe. The main goal of the HyApproval partnership with 22 partners from Europe and one each from China, Japan and the USA is to provide a Handbook of technical and regulatory requirements to assist authorisation officials, companies and organisations in the safe implementation and operation of HRS. Achievements during the first 15 months: analyses of HRS technology concepts and of equipment and safety distances/ Intermediate Design Paper/ Regulations, Codes and Standards (RCS) review and comparison/ first Handbook draft and first review sessions with HySafe experts/ safety matrix/ identification of accident scenarios/ agreement on safety documentation/ critical review of reliability data from collections and risk studies/ risk assessment (RA) criteria definition and RA/ matrix of acceptability and awareness levels/ database of Fire Associations and First Responders/ calendar of hydrogen events/ general description of CGH{sub 2} interfaces. (au)
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Osman-Hicks, Victoria; Graham, Hannah; Leadbetter, Peter; Brittlebank, Andrew
2015-01-01
Aims and method This paper intends to analyse the number of applications, trainee demographic and approval rate of those applying for out of programme training (OOPT) or out of programme research (OOPR) between January 2008 and April 2013 using the committee’s anonymised database. We also describe the process of application and approval by the Quality Assurance Committee. Results There were 90 applications, including 10 resubmissions during the 64-month period. Most applicants (77%) were higher trainees; 53% of applicants were from the London deanery; 60% of applications were for research posts and higher degrees (OOPR). Overall, 64% were approved by the committee: 70% for OOPRs and 53% for OOPTs. Clinical implications This paper shows with transparency the breakdown of applications to the Quality Assurance Committee. Around two-thirds of applications to the committee are supported (64%). Relatively few psychiatry trainees (2.5%) have applied for an OOPT or an OOPR over the past 5 years. PMID:26191450
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Safety of and regulations for nuclear fuel cycle facilities. Report of a technical committee meeting
International Nuclear Information System (INIS)
2001-05-01
In order to compile information on the nature of the safety concerns and current status of the regulations concerning nuclear fuel cycle facilities in Member States, an IAEA Technical Committee meeting on this topic was convened from 8 to 12 May 2000 in Vienna. The present publication contains the results of this meeting. The contributions of the participants in Annex 3 exemplify the work done in some Member States to develop an adequate regulatory framework to oversee the safe operation of these facilities
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Castleden, C M; Pickles, H
1988-01-01
1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age grou...
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International Nuclear Information System (INIS)
Batchelor, K.
1996-03-01
The National Synchrotron Light Source Safety Analysis Reports (1), (2), (3), BNL reports number-sign 51584, number-sign 52205 and number-sign 52205 (addendum) describe the basic Environmental Safety and Health issues associated with the department's operations. They include the operating envelope for the Storage Rings and also the rest of the facility. These documents contain the operational limits as perceived prior or during construction of the facility, much of which still are appropriate for current operations. However, as the machine has matured, the experimental program has grown in size, requiring more supervision in that area. Also, machine studies have either verified or modified knowledge of beam loss modes and/or radiation loss patterns around the facility. This document is written to allow for these changes in procedure or standards resulting from their current mode of operation and shall be used in conjunction with the above reports. These changes have been reviewed by NSLS and BNL ES and H committee and approved by BNL management
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MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223
Energy Technology Data Exchange (ETDEWEB)
Phillips, L. [Stanford University (United States)
2015-06-15
The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35
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MO-AB-201-01: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223
International Nuclear Information System (INIS)
Phillips, L.
2015-01-01
The role of the Radiation Safety Officer at a medical facility can be complicated. The complexity of the position is based on the breadth of services provided at the institution and the nature of the radioactive materials license. Medical practices are constantly changing and the use of ionizing radiation continues to rise in this area. Some of the newer medical applications involving radiation have unique regulatory and safety issues that must be addressed. Oversight of the uses of radiation start at the local level (radiation safety officer, radiation safety committee) and are heavily impacted by outside agencies (i.e. Nuclear Regulatory Commission, State Radiologic Health, The Joint Commission (TJC), etc). This session will provide both an overview of regulatory oversight and essential compliance practices as well as practical ways to assess and introduce some of the new applications utilizing radioactive materials into your medical facility. Learning Objectives: Regulatory Compliance and Safety with New Radiotherapies: Spheres and Ra-223 (Lance Phillips) Understand the radioactive materials license amendment process to add new radiotherapies (i.e., SIR-Spheres, Therasphere, Xofigo). Understand the AU approval process for microspheres and Xofigo. Examine the training and handling requirements for new procedures. Understand the process involved with protocol development, SOP in order to define roles and responsibilities. The RSO and The RSC: Challenges and Opportunities (Colin Dimock) Understand how to form an effective Committee. Examine what the Committee does for the Program and the RSO. Understand the importance of Committee engagement. Discuss the balance of the complimentary roles of the RSO and the Committee. The Alphabet Soup of Regulatory Compliance: Being Prepared for Inspections (Linda Kroger) Recognize the various regulatory bodies and organizations with oversight or impact in Nuclear Medicine, Radiology and Radiation Oncology. Examine 10CFR35
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Energy Technology Data Exchange (ETDEWEB)
Conover, David R.
2014-09-11
The purpose of this document is to identify laws, rules, model codes, codes, standards, regulations, specifications (CSR) related to safety that could apply to stationary energy storage systems (ESS) and experiences to date securing approval of ESS in relation to CSR. This information is intended to assist in securing approval of ESS under current CSR and to identification of new CRS or revisions to existing CRS and necessary supporting research and documentation that can foster the deployment of safe ESS.
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Analysis of time to regulatory and ethical approval of SATVI TB ...
African Journals Online (AJOL)
Background. Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Aim. Our aim was to ...
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International Nuclear Information System (INIS)
2003-10-01
This is the fourteenth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Transport Safety Standards Committee (TRANSSC). It supersedes IAEA-TECDOC-1302 'Directory of National Competent Authorities' Approval Certificates for Package Design, Special Form Material and Shipment of Radioactive Material, 2002 Edition'. Through the database, the Secretariat collects administrative and technical information provided by the issuing competent authority about package approval certificates. Such data are used mainly by national competent authorities and port and customs officials to assist in regulating radioactive material movements in their country, and also by manufacturers and shippers of radioactive material. The database carries information on extant certificates and those that expired within the last complete calendar year. The PACKTRAM database only contains information that has been provided to the IAEA. The data are not complete nor guaranteed to be accurate. If detailed information is required, the original package approval certificates must be consulted. If information is required about package approval certificates that are not contained in the database, the issuing competent authority must be consulted
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Energy Technology Data Exchange (ETDEWEB)
NONE
2003-10-01
This is the fourteenth annual report being published by the Secretariat of the International Atomic Energy Agency since implementing its database on package approval certificates (PACKTRAM) at the recommendation of the Transport Safety Standards Committee (TRANSSC). It supersedes IAEA-TECDOC-1302 'Directory of National Competent Authorities' Approval Certificates for Package Design, Special Form Material and Shipment of Radioactive Material, 2002 Edition'. Through the database, the Secretariat collects administrative and technical information provided by the issuing competent authority about package approval certificates. Such data are used mainly by national competent authorities and port and customs officials to assist in regulating radioactive material movements in their country, and also by manufacturers and shippers of radioactive material. The database carries information on extant certificates and those that expired within the last complete calendar year. The PACKTRAM database only contains information that has been provided to the IAEA. The data are not complete nor guaranteed to be accurate. If detailed information is required, the original package approval certificates must be consulted. If information is required about package approval certificates that are not contained in the database, the issuing competent authority must be consulted.
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2000-04-18
This document amends OSHA's regulations to reflect the Assistant Secretary's decision granting final approval to the Nevada State plan. As a result of this affirmative determination under section 18(e) of the Occupational Safety and Health Act of 1970, Federal OSHA's standards and enforcement authority no longer apply to occupational safety and health issues covered by the Nevada plan, and authority for Federal concurrent jurisdiction is relinquished. Federal enforcement jurisdiction is retained over any private sector maritime employment, private sector employers on Indian land, and any contractors or subcontractors on any Federal establishment where the land is exclusive Federal jurisdiction. Federal jurisdiction remains in effect with respect to Federal government employers and employees. Federal OSHA will also retain authority for coverage of the United States Postal Service (USPS), including USPS employees, contract employees, and contractor-operated facilities engaged in USPS mail operations.
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International Nuclear Information System (INIS)
Pouleur, Y.; Krs, P.
2010-01-01
This paper intends to present the key issues of the directive (council directive 2009/71/EURATOM establishing a Community framework for the nuclear safety of nuclear installations, approved by the Permanent Representatives Committee (C.O.R.E.P.E.R. 2) on 24. June and by the Council of Ministers on 25. June in the environment Council. It was published on 2. July in the Official Journal, O.J. L 172:18 and is to be transposed by 22. July 2011): a summary of the institutional context, the international framework in the field of nuclear safety developed in fora such as the International Atomic energy Agency (IAEA), the basic principles of nuclear safety and the compromises that were necessary to finally reach the consensus on the text. The goal of the authors is to offer an objective and accurate analysis that could be used for the interpretation and better understanding of the directive. (N.C.)
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12 CFR 1710.12 - Committees of board of directors.
2010-01-01
... AND URBAN DEVELOPMENT SAFETY AND SOUNDNESS CORPORATE GOVERNANCE Corporate Practices and Procedures...) Compensation committee; and (3) Nominating/corporate governance committee. [67 FR 38370, June 4, 2002...
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Safety Design Approach for the Development of Safety Requirements for Design of Commercial HTGR
International Nuclear Information System (INIS)
Ohashi, Hirofumi; Sato, Hiroyuki; Nakagawa, Shigeaki; Tachibana, Yukio; Nishihara, Tetsuo; Yan, Xing; Sakaba, Nariaki; Kunitomi, Kazuhiko
2014-01-01
The research committee on “Safety requirements for HTGR design” was established in 2013 under the Atomic Energy Society of Japan to develop the draft safety requirements for the design of commercial High Temperature Gas-cooled Reactors (HTGRs), which incorporate the HTGR safety features demonstrated using the High Temperature Engineering Test Reactor (HTTR), lessons learned from the accident of Fukushima Daiichi Nuclear Power Station and requirements for the integration of the hydrogen production plants. The safety design approach for the commercial HTGRs which is a basement of the safety requirements is determined prior to the development of the safety requirements. The safety design approaches for the commercial HTGRs are to confine the radioactive materials within the coated fuel particles not only during normal operation but also during accident conditions, and the integrity of the coated fuel particles and other requiring physical barriers are protected by the inherent and passive safety features. This paper describes the main topics of the research committee, the safety design approaches and the safety functions of the commercial HTGRs determined in the research committee. (author)
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Staples, J Erin; Bocchini, Joseph A; Rubin, Lorry; Fischer, Marc
2015-06-19
On February 26, 2015, the Advisory Committee on Immunization Practices (ACIP) voted that a single primary dose of yellow fever vaccine provides long-lasting protection and is adequate for most travelers. ACIP also approved recommendations for at-risk laboratory personnel and certain travelers to receive additional doses of yellow fever vaccine (Box). The ACIP Japanese Encephalitis and Yellow Fever Vaccines Workgroup evaluated published and unpublished data on yellow fever vaccine immunogenicity and safety. The evidence for benefits and risks associated with yellow fever vaccine booster doses was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. This report summarizes the evidence considered by ACIP and provides the updated recommendations for yellow fever vaccine booster doses.
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Energy Technology Data Exchange (ETDEWEB)
NONE
2008-09-15
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment. This meeting was organized around 6 main points: 1 - the terms of the High Committee operation and the internal rules for the meetings; 2 - the plutonium imports and transportation between Great Britain and France (contracts status, ship safety report, plutonium grade, return of plutonium-derived wastes): hearing of Areva, of the general direction of infrastructures, transports and sea (DGITM), of Greenpeace organisation, debate; 3 - the follow-up of the July 7, 2008 incident at the Socatri facility (Tricastin site (France)) where the overflow of a storage tank led to the spillage of a uraniferous solution on the ground: hearing of Areva (remedial action, re-start up of the facility, environmental monitoring, communication and transparency), hearing of the nuclear safety authority (ASN), of the institute of radiation protection and nuclear safety (IRSN), of the local commission of information (CIGEET), of the hygiene, safety and labour conditions committee (CHSCT) of Socatri company, of the direction of civil safety (DSC), debate about the information dissemination around this incident; 4 - Opinion of the High Committee about the plutonium transportation between Great Britain and France, and about the Socatri incident; 5 - referral to the High Committee of the radioecological follow up of all nuclear sites and of the quality of the information given to the public: ASN's reports about the radioecological follow-up of surface and ground waters and of the ancient radioactive waste storage sites, ASND's answer (Nuclear safety authority of defense), IRSN
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High committee for transparency and information on nuclear safety: meeting of April 29, 2010
International Nuclear Information System (INIS)
2010-01-01
The committee members first discuss the report project concerning the State minister's and OPECST (parliamentary office of scientific and technological choices) chairman's submission regarding the transparency of the nuclear fuel cycle. They discuss the project of a portal web site gathering information on French nuclear power plant operations. They comment the 2009 ASN assessment on medical nuclear activities, the implementation of the Cancer Plan (presentation by the minister of public health, statements by the French nuclear safety authority or ASN, the French institute for radiation protection and nuclear safety or IRSN, and by associations of patients). They discuss the presentation by the ASN of a return on experience after the ATPu event and the presentation by the IRSN of technical form on the criticality risk. Other topics are addressed: extensions of storage sites under construction in La Hague, modification of the Grenelle II bill to improve public consultation in some procedures regarding base nuclear installations
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International Nuclear Information System (INIS)
2000-01-01
The Nuclear Safety Commission was received a decision on thorough investigations of accident reason on criticality accident at the Tokai-mura uranium processing factory of the JCO Incorporation occurred on September 30, 1999, to establish the Committee of Uranium Processing Factory Criticality Accident Survey to elucidate its reason thoroughly and contribute to set up a sufficient reforming prevention countermeasure. This Committee judged that it was important to propose a countermeasure directly obtainable by grasping some fact relations clarified before now as soon as possible and intended to conduct this meantime report of 'emergent proposal' by arrangement of such fact relations. Here were described on accidental conditions and their effects, response to the accident (on prevention of the accident), its reasons and their relating conditions, and some emergent proposals. In the last items, safety security at accidental site, health countermeasures to residents and others, establishment of safety security for nuclear business workers and others, and reconstruction on safety regulation in national government. (G.K.)
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Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo, Richard A
2004-01-01
Despite many successes, drug approval at the Food and Drug Administration (FDA) is subject to gaps, internal tensions, and conflicts of interest. Recalls of drugs and devices and studies demonstrating advantages of older drugs over newer ones highlight the importance of these limitations. The FDA does not compare competing drugs and rarely requires tests of clinical efficacy for new devices. It does not review advertisements before use, assess cost-effectiveness, or regulate surgery (except for devices). Many believe postmarketing surveillance of drugs and devices is inadequate. A source of tension within the agency is pressure for speedy approvals. This may have resulted in "burn-out" among medical officers and has prompted criticism that safety is ignored. Others argue, however, that the agency is unnecessarily slow and bureaucratic. Recent reports identify conflicts of interest (stock ownership, consulting fees, research grants) among some members of the FDA's advisory committees. FDA review serves a critical function, but physicians should be aware that new drugs may not be as effective as old ones; that new drugs are likely to have undiscovered side effects at the time of marketing; that direct-to-consumer ads are sometimes misleading; that new devices generally have less rigorous evidence of efficacy than new drugs; and that value for money is not considered in approval.
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LLNL Electrical Safety Committee Summary report for 1993 and 1994
Energy Technology Data Exchange (ETDEWEB)
Niven, W.A.; Trost, S.R.
1995-03-01
The ESC is presently organized with three subcommittees: Guidelines and Regulations, Programs and Training, and Performance Measurement and Analysis. Current membership is attached for information, as well as the charters of the three subcommittees. The committee at large meets once a quarter, the Executive Committee, comprised of the Committee Chair, the Executive Secretary and the Subcommittee Chairs meets twice quarterly, and the subcommittees meet once or twice per month. Minutes of meetings are distributed to the ES&H Working Group and senior Laboratory management.
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International Nuclear Information System (INIS)
1997-01-01
The document presents the status as of 17 March 1997 of signature, ratification, acceptance, approval or accession by Member States of the Convention on Nuclear Safety adopted on 17 June 1994 by the Diplomatic Conference convened by the IAEA at its Headquarters between 14-17 June 1994. The Convention entered into force on 24 October 1996. There are 65 signatories and 35 parties. Reservations/declarations deposited upon signature are also included
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International Nuclear Information System (INIS)
1997-02-01
DOE 5480.23, Nuclear Safety Analysis Reports, requires that the US Department of Energy conduct an independent, defensible, review in order to approve a Safety Analysis Report (SAR). That review and the SAR approval basis is documented in this formal Safety Evaluation Report (SER). This SER documents the DOE's review of the Waste Isolation Pilot Plant SAR and provides the Carlsbad Area Office Manager, the WIPP SAR approval authority, with the basis for approving the safety document. It concludes that the safety basis documented in the WIPP SAR is comprehensive, correct, and commensurate with hazards associated with planned waste disposal operations
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2011-06-28
..., as Modified by Amendment No. 1, to Reduce the Minimum Size of the Nominating and Governance Committee... proposed rule change to reduce the minimum size of the Nominating and Governance Committee (``NGC'') from... the original proposed rule change, it had not yet obtained formal approval from its Board of Directors...
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Applying for ethical approval for research: the main issues.
Gelling, Leslie
2016-01-13
The need to obtain research ethical approval is common to all research involving human participants. This approval must be obtained before research participants can be approached and before data collection can begin. The process of ethical review is one way that research participants can be confident that possible risks have been considered, minimised and deemed acceptable. This article outlines some of the main issues researchers should consider when planning an application for research ethical approval by answering the following six questions: 'Do I need research ethical approval?', 'How many applications will I need to make?', 'Where should I apply for research ethical approval?', 'What do I need to include in my application?', 'What do research ethics committees look for?' and 'What other approvals might I need?' Answering these questions will enable researchers to navigate the ethical review process.
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MDEP Position Paper - PP-STC-01 - MDEP Steering Technical Committee Position Paper on Safety Goals
International Nuclear Information System (INIS)
2011-01-01
In considering the acceptability of a nuclear facility in relation to safety, Governments and regulatory bodies define a range of legal, mandatory requirements which are supplemented by regulatory requirements and expectations which may not have a mandatory nature. The term 'safety goals' is used to cover all health and safety requirements and expectations which must be met: these may be deterministic rules and/or probabilistic targets. They should cover the safety of workers, public and the environment in line with the IAEA's Basic Safety Objective encompassing safety in normal operation through to severe plant states. Although all regulators have safety goals, these are expressed in many different ways and exercises in comparing them frequently are done at a very low level e.g. specific temperature limits in the reactor core. The differences in the requirements from different regulators are difficult to resolve as the goals are derived using different principles and assumptions and are usually for a specific technology. Therefore the Multinational Design Evaluation Programme (MDEP) set up a sub-committee to investigate a different approach. This approach was to start with the high level safety goals and try to derive a structure and means of deriving lower level safety goals that can be seen to be clearly related to the higher level ones. The work will greatly assist in the process of harmonisation of regulatory requirements and enhance coherence and consistency between goals for different technologies. MDEP expects that higher levels of safety will be achieved in the design and operation of new reactors. MDEP strongly supports the structure of safety goals and targets, as set out in this paper, for consideration of its members and IAEA and other organisations, in moving towards international harmonisation of regulatory requirements. MDEP strongly supports the use of integrated decision-making for design evaluation and operational safety. MDEP recognises the need
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U.S. Department of Health & Human Services — Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An...
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Goebel, Joel A
2016-03-01
Ménière's disease is a disorder of the inner ear that causes attacks of vertigo and hearing loss, tinnitus, aural fullness in the involved ear. Over the past 4 decades, the Equilibrium Committee of the AAO-HNS has issued guidelines for diagnostic criteria, with the latest version being published in 1995. These criteria were reviewed in 2015 by the Equilibrium Committee, and revisions were approved at the recent meeting of the committee at the 2015 AAO-HNSF Annual Meeting. The following commentary outlines the amended and approved criteria. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2016.
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International Nuclear Information System (INIS)
2011-01-01
One of the aims of MDEP is to work towards greater harmonisation of regulatory requirements. To achieve this aim, it is necessary that there is a degree of convergence on the safety goals that are required to be met by designers and operators. The term 'safety goals' is defined to cover all health and safety requirements which must be met: these may be deterministic rules and/or probabilistic targets. They should cover the safety of workers, public and the environment in line with the IAEA's Basic Safety Objective; encompassing safety in normal operation through to severe accidents. All regulators have safety goals, but these are expressed in many different ways and exercises in comparing them frequently are done at a very low level eg specific temperatures in the reactor vessel. The differences in the requirements from different regulators are difficult to resolve as the goals are derived using different principles and assumptions and are for a specific technology. Therefore MDEP set up a sub-committee to investigate a different approach. This approach was to start with the top level goals and to derive a structure and means of deriving lower tier goals that can be seen to be clearly related to the higher level ones. This approach has the potential to greatly assist in the process of harmonisation of regulatory requirements. The paper reviews the high level goals used in MDEP countries and the relevant work of international groups. From these it draws broad conclusions that the form of the framework should be an Hierarchical Structure of Safety Goals, incorporating an extended Defense-in-Depth approach. The basis concept is that the higher level safety goals can then developed, in a coherent and consistent manner, into lower level safety goals and targets that can be applied within the design and operation of reactors, with a clear connection between the different levels. This structured approach is technology-neutral and is sufficiently flexible that it can be
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The Incentive Effect of Scores: Randomized Evidence from Credit Committees
Daniel Paravisini; Antoinette Schoar
2013-01-01
We design a randomized controlled trial to evaluate the adoption of credit scoring with a bank that uses soft information in small businesses lending. We find that credit scores improve the productivity of credit committees, reduce managerial involvement in the loan approval process, and increase the profitability of lending. Credit committee members' effort and output also increase when they anticipate the score becoming available, indicating that scores improve incentives to use existing in...
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Safety assessment of Department of Energy nuclear reactors
International Nuclear Information System (INIS)
1981-03-01
One of the first tasks of the NFPQT Committee was to determine which DOE reactors would be assessed. The Committee determined that in view of the limited time available to conduct the assessment, 13 DOE reactors were of such size (physical, power or fission product inventory) to warrant review. This determination was approved by the Under Secretary. A decision was also made in the cases of three weapons material production reactors, C, K and P, to concentrate on the K reactor only, since all three are of the same basic design, have the same operating features, are all at the same site, and are all operated by the same contractor. The assessment was accomplished in the following ways: reviewing the results of assessments conducted by the DOE organizations with reactor safety responsibilities, which were undertaken in compliance with the request of the various program directors; reviewing selected documents that were requested by the Committee and assembled at DOE Headquarters; interviewing DOE Headquarters and Field Office personnel; and conducting on-site reviews of four reactors located at four different sites. The four reactors for on-site reviews were: Advanced Test Reactor (ATR); K Production Reactor; High Flux Beam Reactor (HFBR); and High Flux Isotope Reactor (HFIR). Specific findings and recommendations from the assessment are presented
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75 FR 41795 - Tehama County Resource Advisory Committee
2010-07-19
...) will meet in Red Bluff, California. Agenda items to be covered include: (1) Introductions, (2) Approval of Minutes, (3) Public Comment, (4) Chairman's Perspective, (5) Project Voting, (6) Discuss Meeting... wishing to speak or propose agenda items must send their names and proposals to Randy Jero, Committee...
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2010-03-04
The Federal Transit Administration (FTA) conducted an on-site audit of the safety program implemented by the Washington Metropolitan Area Transit Authority (WMATA) and overseen by the Tri-State Oversight Committee (TOC) between December 14 and 17, 20...
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Second step report of the National Committee for the follow-up of radiotherapy
International Nuclear Information System (INIS)
Maraninchi, D.; Houssin, D.; Podeur, A.; Lacoste, A.C.; Marimbert, J.; Degos, L.; Mazeron, J.J.; Sarrazin, T.; Saout, C.; Renody, N.; Depenweiller, C.; Goinere, R.
2010-01-01
In a first part, this report presents the outcome of the ministerial road-map for the national improvement of radiotherapy activities. Then, a second part presents the actions undertaken in 2009 to support the evolution of radiotherapy professions and care organization (accompanying the evolution of radiotherapy activities, increasing manpower, improving the vigilance system, accompanying care organization up to the implementation of approvals criteria, considering the possible R and D pathways in radiotherapy) The third part addresses some actions of the 2009-2013 Cancer Plan (support for practice quality and safety in authorized radiotherapy centres, strengthening of human means in these centres, updating good practice recommendations). The last part is a list of the publications resulting from the works of the national committee for the follow up of the national measures for radiotherapy
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... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...
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The Ethics and Politics of Ethics Approval
Battin, Tim; Riley, Dan; Avery, Alan
2014-01-01
The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…
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Report of the Committee to review safeguards requirements at power reactors
International Nuclear Information System (INIS)
1983-05-01
In October 1982, NRC's Executive Director for Operations appointed a five-member Committee to review NRC security requirements at nuclear power plants with a view toward evaluating the impact of these requirements on operational safety. During visits to five power reactor sites and more than a dozen days of meetings over a period of four months, the Committee observed plant operating conditions and obtained views from abut 100 persons representing 16 nuclear utilities and industry organizations. They also interviewed about 40 NRC employees, including Resident Inspectors, and members of the Regional and Headquarters staffs. Overall, the Committee did not identify any clear operational safety problems associated with implementation of the NRC's security requirements. However, they did find that the potential existed, to varying degrees, at licensed facilities. The Committee's report, dated February 28, 1983, contains five basic findings and a number of associated recommendations intended to minimize the potential impact of security on safety
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International Nuclear Information System (INIS)
Rajdeep; Jayarajan, K.; Taly, Y.K.
2016-01-01
Bhabha Atomic Research Centre is involved in multidisciplinary research and developmental activities, related to peaceful use of nuclear energy and its societal benefits. In order to achieve high level of performance of these facilities, the best efforts are made to maintain good health of the plant personnel and good working conditions. BARC Safety Council (BSC), which is the regulatory body for BARC facilities, regulates radiation safety, industrial safety and surveillance of occupational health, by implementing various rules and guidelines in BARC facilities. BARC Safety framework consists of various committees in a 3-tier system. The first tier is BSC, which is the apex body authorized for issuing directives, permissions, consents and authorizations. It is having responsibility of ensuring protection and safety of public, environment, personnel and facilities of BARC through enforcement of radiation protection and industrial safety programmes. Besides the 18 committees in 2"n"d tier, there are 6 other expert committees which assist in functioning of BSC. (author)
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77 FR 13512 - National Advisory Committee on Meat and Poultry Inspection
2012-03-07
... Poultry Inspection AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice of committee meeting... Committee Act, that the National Advisory Committee on Meat and Poultry Inspection (NACMPI) will hold a public meeting on Wednesday, March 21, 2012, to discuss the proposed rule on the Modernization of Poultry...
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STANDING CONCERTATION COMMITTEE - ORDINARY MEETING ON 25 NOVEMBER 2002
2002-01-01
Original : English This meeting was devoted to follow-up from the Committee meetings in November and to the other main topics summarised below. 1. Follow-up from the meetings of the Finance Committee and TREF in November and preparation for the Committee meetings in December 2002 The SCC took note that the Finance Committee, held on 6 November, had recommended to apply the 2003 calculated salary adjustment index of 1.2%, and to approve the Management's proposed measures for containing the cost of hospital treatment within the CERN Health Insurance Scheme (CHIS). Related amendments to the CHIS Rules are being drawn up by the CHIS Supervisory Board in preparation for implementation next year. At its meeting on 15 November, TREF had expressed appreciation for the Management's preview of the Human Resources Plan 2003-2010 that is submitted to the Committees in December. The Forum had also discussed the Management's proposal document on Local Staff, as described below. 2. Local Staff After extensive debate at its ...
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Barsebaeck power plant - safety and emergency measures
International Nuclear Information System (INIS)
Anon.
1981-01-01
A Swedish-Danish Committee on safety at the Swedish nuclear power plant Barsebaeck was established in 1979 in order to evaluate the nuclear safety at Barsebaeck with a view to the reactor accident at the Three-Mile-Island nuclear power plant March 28, 1979. According to the committees mandate the investigations of the Kemeny Commission, the Rogouin investigation, investigations of the American Nuclear Regulatory Commission, and the Swedish report ''Safe nuclear power'' have been taken into consideration by the Committee. Furthermore, it has formed the basis for the Committees work that the authority responsibility for the safety at Barsebaeck lies with the Swedish authorities, and that these authorities have evaluated the safety aspects before the permissions for operation of the Barsebaeck power plant were given and hereafter currently in connection with the inspection of the power plant. The report prepared by the Commission treats aspects as: a) Nuclear safety at the Barsebaeck power plant, b) reactor safety and emergency provisions, c) common elements in the emergency provision situation in Sweden and Denmark, d) ongoing investigations on course of events during accidents and release limiting safety systems. (BP)
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Energy Technology Data Exchange (ETDEWEB)
NONE
2010-07-01
The discussion between members dealt with the following topics: the committee' program and implication with respect to the ACN approach (Aarhus Convention and Nuclear), the main orientations of the Transparency and Secret work group, the hearing of actors involved in a Tritium contamination incident in Valduc. These actors belonged to the CEA, to the 2M Process company, to the Nuclear safety authority or ASN, to the Institute for radiation protection and nuclear safety or IRSN, or to the Delegate to radiation protection and nuclear safety for installations of interest for the defence or DSND. Then the committee addressed the issue of old uranium mines and of places of use of uranium mining tailings. The committee members discuss the results of investigations performed around the Tricastin site (studies on cancers, on the presence of uranium in underground water sheets). Other topics are addressed: waste transportation to Germany, the French-British nuclear cooperation, the creation of a web site
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78 FR 77643 - National Advisory Committee of Meat and Poultry Inspection
2013-12-24
... Advisory Committee of Meat and Poultry Inspection AGENCY: Food Safety and Inspection Service, USDA. ACTION... of the National Advisory Committee on Meat and Poultry Inspection (NACMPI). The Committee is being... label on meat and poultry packages. With this input, the Agency will consider whether or not the current...
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75 FR 35873 - Meeting; Shipping Coordinating Committee
2010-06-23
... Report. --Status of Constituent and Other Instruments. --Global Maritime Distress and Safety Systems... Vice-Chairman for 2012. --Any other business. --Report to the Maritime Safety Committee. The primary... purpose of the July 28 SHC meeting is to prepare for the fifty-third Session of the International Maritime...
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Transportation Safety Excellence in Operations Through Improved Transportation Safety Document
International Nuclear Information System (INIS)
Dr. Michael A. Lehto; MAL
2007-01-01
A recent accomplishment of the Idaho National Laboratory (INL) Materials and Fuels Complex (MFC) Nuclear Safety analysis group was to obtain DOE-ID approval for the inter-facility transfer of greater-than-Hazard-Category-3 quantity radioactive/fissionable waste in Department of Transportation (DOT) Type A drums at MFC. This accomplishment supported excellence in operations through safety analysis by better integrating nuclear safety requirements with waste requirements in the Transportation Safety Document (TSD); reducing container and transport costs; and making facility operations more efficient. The MFC TSD governs and controls the inter-facility transfer of greater-than-Hazard-Category-3 radioactive and/or fissionable materials in non-DOT approved containers. Previously, the TSD did not include the capability to transfer payloads of greater-than-Hazard-Category-3 radioactive and/or fissionable materials using DOT Type A drums. Previous practice was to package the waste materials to less-than-Hazard-Category-3 quantities when loading DOT Type A drums for transfer out of facilities to reduce facility waste accumulations. This practice allowed operations to proceed, but resulted in drums being loaded to less than the Waste Isolation Pilot Plant (WIPP) waste acceptance criteria (WAC) waste limits, which was not cost effective or operations friendly. An improved and revised safety analysis was used to gain DOE-ID approval for adding this container configuration to the MFC TSD safety basis. In the process of obtaining approval of the revised safety basis, safety analysis practices were used effectively to directly support excellence in operations. Several factors contributed to the success of MFC's effort to obtain approval for the use of DOT Type A drums, including two practices that could help in future safety basis changes at other facilities. (1) The process of incorporating the DOT Type A drums into the TSD at MFC helped to better integrate nuclear safety
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2011-06-29
... No. 1, To Reduce the Minimum Size of the Nominating and Governance Committee June 22, 2011. I... size of the Nominating and Governance Committee (``NGC'') from seven to five. On May 18, 2011, the..., it had not yet obtained formal approval from its Board of Directors for the specific Bylaw changes...
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10 CFR 1.19 - Other committees, boards, and panels.
2010-01-01
... philosophy of nuclear regulatory research. The committee conducts specialized studies when requested by the... Mile Island, Unit 2. (c) The Nuclear Safety Research Review Committee (NSRRC) was established by the... of Nuclear Regulatory Research on important management matters in the direction of the Commission's...
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9 CFR 317.4 - Labeling approval.
2010-01-01
... undue economic hardship; and (iv) An unfair competitive advantage would not result from the granting of... Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY... approval to the Food Labeling Division, Regulatory Programs, Food Safety and Inspection Service, and...
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Investigation of nuclear power safety objects
International Nuclear Information System (INIS)
2003-09-01
It is a report of ground and concept of nuclear safety objects and future issues in Japan, which has investigated by the Committee of Experts on Investigation of Nuclear Safety Objects in the Nuclear Safety Research Association. The report consisted of member of committee, main conclusions and five chapters. The first chapter contains construction of safety objects and range of object, the second chapter qualitative safety objects, the third chapter quantitative safety objects, the forth subsiding objects and the fifth other items under consideration. The qualitative safety objects on individual and society, the quantitative one on effects on health and social cost, aspect of safety objects, relation between radiation protection and safety objects, practical objective values and earthquake are stated. (S.Y.)
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Regulatory measures of BARC Safety Council to control radiation exposure in BARC Facilities
International Nuclear Information System (INIS)
Rajdeep; Jolly, V.M.; Jayarajan, K.
2018-01-01
Bhabha Atomic Research Centre is involved in multidisciplinary research and developmental activities, related to peaceful use of nuclear energy including societal benefits. BARC facilities at different parts of India include nuclear fuel fabrication facilities, research reactors, nuclear recycle facilities and various Physics, Chemistry and Biological laboratories. BARC Safety Council (BSC) is the regulatory body for BARC facilities and takes regulatory measures for radiation protection. BSC has many safety committees for radiation protection including Operating Plants Safety Review Committee (OPSRC), Committee to Review Applications for Authorization of Safe Disposal of Radioactive Wastes (CRAASDRW) and Design Safety Review Committees (DSRC) in 2 nd tier and Unit Level Safety Committees (ULSCs) in 3 rd tier under OPSRC
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International Nuclear Information System (INIS)
1996-04-01
The meeting covered the following topics: Developments in design of safety-related heat removal components and systems for advanced water cooled reactors; status of test programmes on heat removal components and systems of new designs; range of validity and extrapolation of test results for the qualification of design/licensing computer models and codes for advanced water cooled reactors; future needs and trends in testing of safety systems for advanced water cooled reactors. Tests of heat removal safety systems have been conducted by various groups supporting the design, testing and certification of advanced water cooled reactors. The Technical Committee concluded that the reported test results generally confirm the predicted performance features of the advanced designs. Refs, figs, tabs
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Energy Technology Data Exchange (ETDEWEB)
NONE
1996-04-01
The meeting covered the following topics: Developments in design of safety-related heat removal components and systems for advanced water cooled reactors; status of test programmes on heat removal components and systems of new designs; range of validity and extrapolation of test results for the qualification of design/licensing computer models and codes for advanced water cooled reactors; future needs and trends in testing of safety systems for advanced water cooled reactors. Tests of heat removal safety systems have been conducted by various groups supporting the design, testing and certification of advanced water cooled reactors. The Technical Committee concluded that the reported test results generally confirm the predicted performance features of the advanced designs. Refs, figs, tabs.
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International Nuclear Information System (INIS)
Wittmann, R.
1998-01-01
In Germany the mandate for preparing nuclear safety standards is given to the KTA (Nuclear Safety Standards Commission) which has restrictive procedures to definitely ensure consensus principle. The KTA was up to now not in a position to approve comprehensive fire safety relevant standards, although its corresponding program is now 22 years old. KTA 2101.1 ''Basic Principles of Fire Protection in NPPs'' (12/85) is the only one published as valid safety standard. Drafts for 3 additional standards referring fire protection of structural elements, electrical and mechanical components as well as for rescue routes have been agreed upon in working groups, supervised and accepted by the responsible KTA subcommittee, but have not been approved by the full committee of the KTA up to now. Some of these drafts are already more than 5 years old. From the today's point of view the earliest possibility to have a comprehensive and actual set of fire relevant KTA standards will be in the second half of the year 1999. This would then be 24 years after the first KTA decision to start such a program. (author)
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International Nuclear Information System (INIS)
Oh, B. J.; Ahn, H. Z.; Kim, S. W.; Yoo, S. O.; Kang, S. C.; Yang, S. H.; Han, S. J.; Kim, H. S.; Kim, H. J.
2002-01-01
In accordance with 2001 amendment of the Atomic Energy Act(AEA), KINS also amended its internal 'Regulation on Implementation of Entrusted AEA-related Work'. Up to now the nuclear safety-specialized institute has used its internally developed guidelines in the safety regulation. From now on, however, the institute will enhance the objectivity and transparency by having the instruments approved by the Ministry of Science ad Technology. In this paper, we introduced the major points and directions to be considered to the development of the safety regulatory guides on Inspection for the quality assurance of the nuclear reactor facilities and the use of radioisotopes, and review and inspection for dosimeter reading
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Status of the IAEA safety standards programme
International Nuclear Information System (INIS)
2002-01-01
This presentation describes the status of the IAEA safety standards program to May 2002. The safety standards program overcome whole main nuclear implementations as General safety, Nuclear safety, Radiation safety, Radioactive waste safety, and Transport safety. Throughout this report the first column provides the list of published IAEA Safety Standards. The second gives the working identification number (DS) of standards being developed or revised. The bold type indicates standard issued under the authority the Board of Governors, others are issued under authority of the Director General. The last column provides the list of Committees, the first Committee listed has the lead in the preparation and review of the particular standard
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A viewpoint on the approval context of strategic environmental assessments
International Nuclear Information System (INIS)
Kontić, Branko; Kontić, Davor
2012-01-01
A reflection on the last report from the Commission to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions on the application and effectiveness of the Directive on Strategic Environmental Assessment (SEA) is provided. It covers the inadequacies of the approval/permitting context of SEA, which appears to be increasingly applied by a significant number of Member States in recent years. A viewpoint is provided on the main deficiencies of such praxis. As a practical defence of the planning context of SEA, the authors propose that the EC should consider a clear recommendation to Member States to cease performing SEA in the approval/permitting context until proper amendments to the SEA Directive are made and implemented. - Highlights: ► Administrative and permitting context of SEA, has ousted the primary environmental impact assessment goal. ► The approval context moves from the environmental protection to the area of political power and economy. ► SEA and EIA are misused. ► Environmental evaluations should be used for improving the projects/plans/programmes and not for permitting them.
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47 CFR 400.5 - Approval and award.
2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false Approval and award. 400.5 Section 400.5 Telecommunication NATIONAL TELECOMMUNICATIONS AND INFORMATION ADMINISTRATION, DEPARTMENT OF COMMERCE, AND NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION E-911 GRANT PROGRAM § 400.5 Approval...
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Informed consent in Sri Lanka: A survey among ethics committee members
Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin
2008-01-01
Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical ap...
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Report of the Design Approval and the Safety Issues of the Ion Accelerator for Manufacturing
Energy Technology Data Exchange (ETDEWEB)
Min, Yi Sub; Lee, Chan Young [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)
2013-05-15
The application of ion implantation technology has been extended to the field of semiconductor, as well as of metals, ceramics and polymers. A change in the characteristics of the surface that is required in industries is various. To manufacture these devices which are by requirements of industrial, anyone must be licensed by nuclear law; producing permit. And that device must be certified to safety through the design approval. For the first time in domestic, Korea Multipurpose Accelerator Complex (KOMAC) has finished the producing facility inspection as well as the producing permit in August 2012 that can produce four types of radiation generator(RG)
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76 FR 14372 - Glenn/Colusa County Resource Advisory Committee
2011-03-16
... Committee (RAC) will meet in Willows, California. Agenda items covered include: (1) Introductions, (2) Approve Minutes, (3) RAC Admin Updates, (4) Public Comment, (5) New Project Proposals, (6) Project Updates... Office, 825 N. Humboldt Ave., Willows, CA 95988. Individuals who wish to speak or propose a project or...
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75 FR 27287 - Glenn/Colusa County Resource Advisory Committee
2010-05-14
... Committee (RAC) will meet in Willows, California. Agenda items covered include: (1) Introductions, (2) Approve Minutes, (3) RAC Admin Updates, (4) Public Comment, (5) FY08 and FY09 New Project Presentations... to speak or propose agenda items send their names and proposals to Eduardo Olmedo, DFO, 825 N...
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Yanagawa, Hiroaki; Katashima, Rumi; Takeda, Noriaki
2015-01-01
The first Japanese ethics committee for biomedical research involving human subjects was established at Tokushima University in 1982. Although this committee was not formed as a response to national directives, the government eventually developed ethical guidelines, such as the Ethical Guidelines for Clinical Studies that were established in 2003. The practical impact of such guidelines was a rapid increase in the number of protocols seeking ethics committee approval and, accordingly, an increase in the workload of ethics committees. This review describes the activity of the ethics committee at Tokushima University during the last thirty years and discusses the infrastructure that best supports the activities of this committee. In addition, we address the issues that ethics committees now face and discuss future directions. J. Med. Invest. 62: 114-118, August, 2015.
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75 FR 8916 - Glenn/Colusa County Resource Advisory Committee
2010-02-26
...) Introductions, (2) Approve Minutes, (3) RAC Admin Updates, (4) Public Comment, (5) FY08 and FY09 New Project... National Forest Supervisor's Office, 825 N. Humboldt Ave., Willows, CA 95988. Individuals who wish to speak... . SUPPLEMENTARY INFORMATION: The meeting will be open to the public. Committee discussion is limited to Forest...
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75 FR 63436 - Glenn/Colusa County Resource Advisory Committee
2010-10-15
... Committee (RAC) will meet in Willows, California. Agenda items covered include: (1) Introductions, (2) Approve Minutes, (3) RAC Admin Updates, (4) Public Comment, (5) Project Updates FY 08, 09, 10, (6) General... who wish to speak or propose agenda items send their names and proposals to Eduardo Olmedo, DFO, 825 N...
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USAR managing and updating process
International Nuclear Information System (INIS)
Prah, M.; Spiler, J.
1996-01-01
In this paper basis and background of the FSAR (Final Safety Analysis Report) document and its conversion process to the USAR (Updated Safety Analysis Report) document are described. In addition, there are internal and external reviews as approval process presented. The following is included in our new approach to manage USAR changes: initiating the USAR change, technical reviewing, preparing a safety evaluation, KSC (Krsko Safety Committee) and KOC (Krsko Operating Committee) review, ESD Director approval, and the Regulatory Body review or approval. The intensive technological modification activities started in the year 1992 when the NEK Engineering Services Division was established. These activities are one of the most important reason for a very intensive USAR items change. The other reason for its conversation to an electronic format is a possibility for easier and faster searching, updating and changing process and introducing a new systematic USAR managing approach as mentioned above. (author)
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Delivering the International Olympic Committee's mandate on Youth ...
African Journals Online (AJOL)
The International Olympic Committee (IOC) is currently planning the historic Youth Olympic Games (YOG), an international mul ti-sport event that will be inaugurated in Singapore in 2010. On the 6t h of July 2007, the establishment of the YOG was approved and will feature 14 to 18 year-old athletes. The purpose of the YOG ...
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WHO Expert Committee on Biological Standardization. Sixty-fifth report.
2015-01-01
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1) followed by the above three WHO documents adopted on the advice of the Committee (Annexes 2-4). All additions and discontinuations made during the 2014 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
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Safety, health and environmental committee (JKSHE): Establishing chemical hazard management
International Nuclear Information System (INIS)
Shyen, A.K.S.; Noriah Mod Ali; Sangau, J.K.
2012-01-01
Most of the laboratories in Malaysian Nuclear Agency are using chemicals in their research activities. However, it is known that using of chemicals without proper knowledge especially on the material characteristics as well as safe handling procedure may cause great harm to the workers. Therefore, Safety, Health and Environmental Committee (JKSHE) sees the need to establish a good chemical hazard management to ensure that a safe and healthy workplace and environment is provided. One of the elements in chemical hazard management is to carry out Chemical Hazard Risk Assessment (CHRA). The assessment was done so that decision can be made on suitable control measures upon use of such chemicals, such as induction and training courses to be given to the workers and health surveillance activities that may be needed to protect the workers. For this, JKSHE has recommended to conduct CHRA for one of the laboratories at Secondary Standard Dosimetry Laboratory (SSDL) namely Film Dosimeter Processing Room (dark room) as the initial effort towards a better chemical hazard management. This paper presents the case study where CHRA was conducted to identify the chemical hazards at the selected laboratory, the adequacy of existing control measures and finally the recommendation for more effective control measures. (author)
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Introduction of the activity of the radiation safety for KOMAC
Energy Technology Data Exchange (ETDEWEB)
Min, Yi Sub; Park, Sung Kyun; Park, Jeong Min; Cho, Yong Sub [KAERI, Daejeon (Korea, Republic of)
2016-05-15
The 100 MeV linear proton accelerator as well as the various types of the ion accelerator have been operated and developed in KOMAC. These accelerators are classified as a radiation generator by the nuclear law of Korea. The operation of these accelerators included in the KOMAC site should be approved by Nuclear Safety and Security Committee (NSSC). This paper introduces the activity in terms of the radiation safety for these accelerator operations and their future plan. The model of the ion beam accelerator for analysis installed in KOMAC is a 5SDH-2, produced by National Electrostatics Corporation. This ion beam accelerator, devolved from Korea Institute of Geoscience and Mineral Resources (KIGAM), consists of two ion source, accelerating tanks and four beamlines. Ions in the ion beam accelerator are accelerated using a tandem method, that is, ions accelerated have been drawn out by the negative ions from the ion source and then changed into positive ions in the acceleration tube intermediate.
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International Nuclear Information System (INIS)
1995-03-01
Computer based technology is increasingly used in order to perform safety functions. In some recently designed nuclear power plants the whole safety system is computerized. In older plants replacement of conventional technology based system is seen to be of benefit. If the new technology is to be used, it must meet at least the same level of quality and reliability requirements as specified for conventional technology. However, there is a potential for enhancing the safety of nuclear power plants if the full power of computer technology is applied correctly through well designed, engineered and tested systems which are properly installed and maintained. It is essential that areas where reliability and quality can be improved are identified and that methods for assessing and assuring reliability are developed. The results of the Technical Committee Meeting on Reliability of Computerized Safety Systems at Nuclear Power Plants presented in this report are a step on the road to this goal of improved nuclear safety. Refs, figs and tabs
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2006-01-01
As announced in Weekly Bulletin No. 43/2006, a new approach to the implementation of Safety at CERN has been decided, which required taking some managerial decisions. The guidelines of the new approach are described in the document 'New approach to Safety implementation at CERN', which also summarizes the main managerial decisions I have taken to strengthen compliance with the CERN Safety policy and Rules. To this end I have also reviewed the mandates of the Safety Commission and the Safety Policy Committee (SAPOCO). Some details of the document 'Safety Policy at CERN' (also known as SAPOCO42) have been modified accordingly; its essential principles, unchanged, remain the basis for the safety policy of the Organisation. I would also like to inform you that I have appointed Dr M. Bona as the new Head of the Safety Commission until 31.12.2008, and that I will proceed soon to the appointment of the members of the new Safety Policy Committee. All members of the personnel are deemed to have taken note of the d...
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Standing Concertation Committee - Ordinary Meeting on 3 September 2008
HR Department
2008-01-01
The main items discussed at the meeting of the Standing Concertation Committee on 3 September 2008 included: Education fees: Indexation of the amounts for accommodation and meals The Committee approved the indexation calculations for accommodation and meals for the academic year 2008-2009. With the indexation of the lump sum payments, accommodation costs for the academic year 2007-2008 will be reimbursed at 529 CHF per month (previously CHF 500). Meals will be reimbursed at 17.50 CHF per meal (unchanged). The ceiling for school transport has been increased from 600 CHF to 622 CHF. Administrative Circular No. 26 (Rev. 8) The Committee took note of the modifications to Administrative Circular No. 26 (Rev. 8) ‘Recognition of merit of staff members’, concerning provision for the award of exceptional advancement outside the annual advancement exercise to recognize, for example, the completion of a major project. HR Survey The Committee took note of the Head of HR Department...
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Standing Concertation Committee - Ordinary meeting on 25 June 2008
HR Department
2008-01-01
The main items discussed at the meetings of the Standing Concertation Committee on 25 June 2008 included: Mutual Aid Fund The committee took note of the annual report for 2007 by the chairman of the Mutual Aid Fund and approved contributions to the Fund’s 2008 budget from the Management and the Staff Association. Results of 2008 MARS exercise and LHC achievement awards The committee took note of the Head of HR Department’s presentation of the results of the 2008 MARS exercise and the distribution of LHC achievement awards. It was noted that these awards would be granted with effect from 1 October 2008 (see Bulletin 18&19). The results show agreement with the 2008 MARS guidelines (see Bulletin 10&11) for the advancement ceilings per career path, the number of awards for extraordinary service, as well as the distribution of steps for the recognition of merit as shown in the SCC of 27 February (see Bulletin 14&15). Follow-up of Finance Committee and Council...
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Safety objectives for nuclear activities in Canada
International Nuclear Information System (INIS)
1982-04-01
This report by the Advisory Committee on Nuclear Safety presents a concise statement of the basic safety objectives which the Committee considers underlie, or should underlie, the regulations and the licensing and compliance practices of the Atomic Energy Control Board. The report also includes a number of general criteria for achieving these objectives
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The VGB 'Plant Engineering' Special Committee
International Nuclear Information System (INIS)
Pamme, Hartmut
2009-01-01
The ''Plant Engineering'' Special Committee deals with technical issue of reliable and safe operation of German nuclear power plants. The activities of the expert network of VGB PowerTech e.V. serve to find technical solutions to questions of detail and, in addition, harmonize the work of more than 30 working parties of the Nuclear Power Plants Competence Center. This function makes the Committee also a hub of nuclear activities in VGB. Besides consulting on problems of plant technology, the Committee now also processes or writes opinions and decisions in particular to help industries in negotiating with authorities, the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU), and other institutions. (orig.)
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Kiesewetter, Jan; Drossard, Sabine; Gaupp, Rainer; Baschnegger, Heiko; Kiesewetter, Isabel; Hoffmann, Susanne
2018-01-01
The topic of patient safety is of fundamental interest for the health care sector. In view of the realisation of the National Competence-Based Learning Objectives Catalogue for Undergraduate Medical Education (NKLM) this topic now has to be prepared for medical education. For a disciplinary and content-related orientation the GMA Committee developed the Learning Objectives Catalogue Patient Safety for Undergraduate Medical Education (GMA-LZK). To ensure an optimal implementation of the GMA-LZK we recommend a longitudinal embedding into the existing curriculum. This position paper supports the implementation of the GMA-LZK and is aimed at everyone who wants to establish teaching courses on the topic patient safety and embed them in the curriculum. In light of this, we will initially describe the key features for a structured analysis of the current situation. Based on three best-practice-examples, as seen in the faculties of Freiburg, Bonn and Munich, different approaches to the implementation of the GMA-LZK will be illustrated. Lastly, we will outline the methodical requirements regarding the curriculum development as well as the disciplinary and methodical competences that the lecturers will have to hold or develop to fulfil the requirements.
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75 FR 51500 - Advisory Committee on Reactor Safeguards
2010-08-20
..., October 14, 2009 (74 FR 52829-52830). Thursday, September 9, 2010, Conference Room T2-B1, Two White Flint... Fabrication Facility and the Associated Safety Evaluation Report (Open/ Closed)--The Committee will hold... the MOX Fuel Fabrication Facility and the associated Safety Evaluation Report. [Note: A portion of...
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STANDING CONCERTATION COMMITTEE: ORDINARY MEETINGS ON 5 & 12 MARCH 2004
2004-01-01
Original: English These meetings were devoted to the main topics summarised below. 1-Procedure for the award of Long-term Contracts After discussion at several sessions of the SCC, the Committee concluded that a thorough examination of contract policy is required, along the lines of the recommendations presented last year by Internal Task Force 4. However, this study and related changes to the Staff Rules and Regulations will not be completed until the latter part of this year. In the mean time, the Management has proposed to introduce simplified procedures concerning the award of long-term contracts, within the existing Staff Rules and Regulations. The Committee approved these simplified procedures in principle. After final editing of modifications to Administrative Circular no.2 - Guidelines and procedures concerning recruitment and probation period of staff members - and Administrative Circular no.9 - Staff members contracts, they will be submitted to the next meeting of the SCC for approval. 2- MAPS ...
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76 FR 62817 - National Offshore Safety Advisory Committee
2011-10-11
... will man and operate large OSVs. (6) Offshore Operators Committee (OOC) update regarding medical... Officer, on evaluating the various requirements for licensing mariners who will man and operate large OSVs, and to make recommendations on same. Dated: October 3, 2011. F. J. Sturm, Deputy Director of...
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International Nuclear Information System (INIS)
1988-10-01
The Technical Committee Meeting considered the current effort in the implementation and use of PSA information for day-to-day operational safety management on Personal Computers. Due to the very recent development of the necessary hardware and software for Personal Computers, the application of PSA information for day-to-day operational safety management on PCs is essentially still in a pioneering stage. There is at present only one such system for end users existing, the PRISIM (Plant Risk Status Information Management) program for which a limited practical application experience is available. Others are still in the development stage. The main aim of the Technical Committee Meeting was to discuss the present status of PSA based systems for operational safety management support on small computers, to consider practical aspects when implementing these systems into a nuclear installation and to address problems related to the further work in the area. A separate abstract was prepared for the summary of the Technical Committee Meeting and for the 8 papers presented by the participants. Refs, figs and tabs
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Report on the PWR-radiation protection/ALARA Committee
Energy Technology Data Exchange (ETDEWEB)
Malone, D.J. [Consumers Power Co., Covert, MI (United States)
1995-03-01
In 1992, representatives from several utilities with operational Pressurized Water Reactors (PWR) formed the PWR-Radiation Protection/ALARA Committee. The mission of the Committee is to facilitate open communications between member utilities relative to radiation protection and ALARA issues such that cost effective dose reduction and radiation protection measures may be instituted. While industry deregulation appears inevitable and inter-utility competition is on the rise, Committee members are fully committed to sharing both positive and negative experiences for the benefit of the health and safety of the radiation worker. Committee meetings provide current operational experiences through members providing Plant status reports, and information relative to programmatic improvements through member presentations and topic specific workshops. The most recent Committee workshop was facilitated to provide members with defined experiences that provide cost effective ALARA performance.
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International Nuclear Information System (INIS)
1980-03-01
In July 1979 the Ontario Advisory Committee on Radiology was formed to develop a comprehensive strategy for x-ray safety in the province. At its hearings the committee recieved submissions from groups representing physicians, dentists, chiropractors, radiological technicians, physiotherapists, podiatrists, and consumers, among others; these briefs are included as appendices to the report. The report surveys the historical background and the current situation in Ontario, and makes recommendations for an organized safety program. (L.L.)
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Gonorazky, Sergio E
2008-01-01
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.
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22 CFR 214.31 - A.I.D. Advisory Committee Representative.
2010-04-01
.... Advisory Committee Representative. (b) The designated A.I.D. employee performs functions required by section 10 of the Act and assigned herein. Such functions include: (1) Calling, or giving advance approval... Administrator; (4) Assuring that advance notices of each meeting (whether open or closed) are published in the...
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76 FR 5330 - Bridger-Teton National Forest Resource Advisory Committee
2011-01-31
... Schools and Community Self-Determination Act (Pub. L. 110- 343) and in compliance with the Federal Advisory Committee Act. The purpose is to listen to proposed project presentations. DATES: The meeting will...) Approve minutes from February 14, 2011 meeting; (2) Listen to proposed project presentations; (3) Vote on...
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Energy Technology Data Exchange (ETDEWEB)
NONE
1995-01-01
There is considerable interest in many countries in the partitioning and transmutation of long lived radionuclides as a potential complement to the closed fuel cycle. Recognizing this, the IAEA organized a Technical Committee Meeting on Safety and Environmental Aspects of Partitioning and Transmutation of Actinides and Fission Products, to review the current status of progress of national and international programmes and identify the most important directions of co-operation. The results of the Technical Committee meeting are presented in this document. Refs, figs and tabs.
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International Nuclear Information System (INIS)
1995-01-01
There is considerable interest in many countries in the partitioning and transmutation of long lived radionuclides as a potential complement to the closed fuel cycle. Recognizing this, the IAEA organized a Technical Committee Meeting on Safety and Environmental Aspects of Partitioning and Transmutation of Actinides and Fission Products, to review the current status of progress of national and international programmes and identify the most important directions of co-operation. The results of the Technical Committee meeting are presented in this document. Refs, figs and tabs
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77 FR 75118 - National Advisory Committee on Meat and Poultry Inspection
2012-12-19
... Advisory Committee on Meat and Poultry Inspection AGENCY: Food Safety and Inspection Service, USDA. ACTION... Inspection Service (FSIS) is announcing a meeting of the National Advisory Committee on Meat and Poultry... strengthening Agency verification activities and guidance concerning sanitary dressing and antimicrobial...
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National Machine Guarding Program: Part 2. Safety management in small metal fabrication enterprises.
Parker, David L; Yamin, Samuel C; Brosseau, Lisa M; Xi, Min; Gordon, Robert; Most, Ivan G; Stanley, Rodney
2015-11-01
Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem. The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers. Insurance safety consultants collected baseline data in 221 business using a 33-question safety management audit. Audits were completed during an interview with the business owner or manager. Most measures of safety management improved with an increasing number of employees. This trend was particularly strong for lockout/tagout. However, size was only significant for businesses without a safety committee. Establishments with a safety committee scored higher (55% vs. 36%) on the safety management audit compared with those lacking a committee (P < 0.0001). Critical safety management programs were frequently absent. A safety committee appears to be a more important factor than business size in accounting for differences in outcome measures. © 2015 The Authors. American Journal of Industrial Medicine Published by Wiley Periodicals, Inc.
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International cooperation for operating safety
International Nuclear Information System (INIS)
Dupuis, M.C.
1989-03-01
The international-cooperation organization in nuclear safety domain is discussed. The nuclear energy Direction Committee is helped by the Security Committee for Nuclear Power Plants in the cooperation between security organizations of member countries and in the safety and nuclear activity regulations. The importance of the cooperation between experts in human being and engine problems is underlined. The applied methods, exchange activities and activity analysis, and the cooperation of the Nuclear Energy Agency and international organizations is analysed [fr
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Australian Radiation Protection and Nuclear Safety Act 1998. Act No 133
International Nuclear Information System (INIS)
1999-01-01
A set of legislation consisting of three Acts in the field of radiation protection and nuclear safety was passed by both Houses of Parliament on 10 December 1998 and was proclaimed on 5 February 1999. Act No. 133 - Australian Radiation Protection and Nuclear Safety Act, which is a framework Law, established the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) as the regulatory body for radiation protection and nuclear safety, in place of the Nuclear Safety Bureau. The Chief Executive Officer of ARPANSA, who is appointed by the Governor-General for a term of up to 5 years, is obliged to submit annual and quarterly reports to the Minister on the operations of the Chief Executive Officer, ARPANSA, the Council, the Radiation Health Committee and the Nuclear Safety Committee. The Council is a consultative body which examines issues relating to radiation protection and nuclear safety and advises the Chief Executive Officer on these issues as well as on the adoption of recommendations, policies and codes. The Radiation Health Committee and the Nuclear Safety Committee are to be established as advisory committees to the Chief Executive Officer or the Council. Both committees should draft national policies, codes and standards in their respective fields and review their effectiveness periodically. The second in this series of legislation, Act No. 134, Australian Radiation Protection and Nuclear Safety (License Charges) Act requires holders of both facility and source licenses to pay an annual charge, to be prescribed by the regulations. The third, Act No. 135 , Australian Radiation Protection and Nuclear Safety (Consequential Amendments) Act repeals those provisions of the 1987 Australian Nuclear Science and Technology Organisation Act which concern the Nuclear Safety Bureau, and the 1978 Environment Protection Act as a whole
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Australian Radiation Protection and Nuclear Safety Act 1998. Act No 133
Energy Technology Data Exchange (ETDEWEB)
NONE
1999-11-01
A set of legislation consisting of three Acts in the field of radiation protection and nuclear safety was passed by both Houses of Parliament on 10 December 1998 and was proclaimed on 5 February 1999. Act No. 133 - Australian Radiation Protection and Nuclear Safety Act, which is a framework Law, established the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) as the regulatory body for radiation protection and nuclear safety, in place of the Nuclear Safety Bureau. The Chief Executive Officer of ARPANSA, who is appointed by the Governor-General for a term of up to 5 years, is obliged to submit annual and quarterly reports to the Minister on the operations of the Chief Executive Officer, ARPANSA, the Council, the Radiation Health Committee and the Nuclear Safety Committee. The Council is a consultative body which examines issues relating to radiation protection and nuclear safety and advises the Chief Executive Officer on these issues as well as on the adoption of recommendations, policies and codes. The Radiation Health Committee and the Nuclear Safety Committee are to be established as advisory committees to the Chief Executive Officer or the Council. Both committees should draft national policies, codes and standards in their respective fields and review their effectiveness periodically. The second in this series of legislation, Act No. 134, Australian Radiation Protection and Nuclear Safety (License Charges) Act requires holders of both facility and source licenses to pay an annual charge, to be prescribed by the regulations. The third, Act No. 135 , Australian Radiation Protection and Nuclear Safety (Consequential Amendments) Act repeals those provisions of the 1987 Australian Nuclear Science and Technology Organisation Act which concern the Nuclear Safety Bureau, and the 1978 Environment Protection Act as a whole
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Trial endpoints for drug approval in oncology: Chemoprevention.
Beitz, J
2001-04-01
As with other drugs, new drug applications for marketing approval of chemopreventive drugs must include data from adequate and well-controlled clinical trials that demonstrate effectiveness and safety for the intended use. This article summarizes the regulatory requirements for traditional marketing approval, as well as for approval under the accelerated approval regulations. Unlike traditional approval, accelerated approval is based on a surrogate endpoint that is reasonably likely to predict clinical benefit. Discussions with the Food and Drug Administration (FDA) regarding the validity of trial endpoints that may serve as surrogates for clinical benefit for accelerated approval should take place as early as possible in drug development. Meetings with the FDA to discuss these issues may be requested throughout the clinical development of a new drug.
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21 CFR 14.22 - Meetings of an advisory committee.
2010-04-01
... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Meetings of an advisory committee. 14.22 Section... of, and with an agenda approved by, the designated Federal employee or alternate. No meeting may be held in the absence of the designated Federal employee. (1) If any matter is added to the agenda after...
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Chin, Lisa Judy; Rifai-Bashjawish, Hoda; Kleinert, Kelly; Saltman, Alexandra; Leu, Cheng-Shiun; Klitzman, Robert
2011-09-01
We explored how often journal articles reporting HIV research sponsored by a developed country, but conducted in a developing country, mention research ethics committee (REC) approval from both countries, and what factors are involved. Of all such 2007 articles on Medline conducted in one of four developing countries (N = 154), only 52% mentioned such dual approval. Mention of dual vs. single approval was more likely among articles with ≥ 50% sponsor country authors, and the United States as the sponsor country. Also, dual approval was more likely among articles that mentioned informed consent and funding, had ≥ 50% sponsor country authors, were biomedical (vs. psychosocial), and appeared in journals adopting International Committee Medical Journal Editors (ICMJE) guidelines. Dual approval was thus obtained in only half of the articles and was associated with ethical and logistic issues, indicating the need for clearer and more universally accepted guidelines.
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Regulating nuclear and radiation safety in the frame of the Chernobyl shelter Implementation Plan
Energy Technology Data Exchange (ETDEWEB)
Bykov, V.; Demchyuk, A.; Kilochitska, T.; Redko, V. [State Nuclear Regulatory Committee of Ukraine, SNRCU, Arsenalna St. 9/11, Kyiv (Ukraine); Bogorinski, P. [GRS/IPSN-RISKAUDIT, Gesellschaft fuer Anlagen- und Reaktorsicherheit (GRS) mbH, Koeln (Germany); Vasilchenko, V.; Erickson, L.; Kadkin, E.; Kondratyev, S.; Kutina, L.; Smyshliaeva, S. [SSTC NRS, Stusa St. 35-37, 03142, Kyiv (Ukraine)
2003-07-01
Since 1998 the Shelter Implementation Plan (SIP) has been carried out on the Chernobyl NPP Unit 4 (the object Shelter - OS). The State Nuclear Regulatory Committee of Ukraine (SNRCU) recognizes the exceptional importance of successful and efficient SIP implementation and acts accordingly in regulation, licensing, and inspection. Technical support of the SNRCU in SIP licensing are provided by the State Scientific and Technical Center for Nuclear and Radiation Safety (SSTC) and the SIP Licensing Consultant (LC) representing RISKAUDIT IPSN/GRS International and SCIENTECH, Inc. Support of the SNRCU is also provided by the International Consultative Committee of Regulatory Bodies (ICCRB). ICCRB members represent regulatory authorities from nine European countries, Canada and the U.S. Summarizing the information above, it can be stated that a sound basis has been created for the licensing process for SIP. The approach for using the regulatory base has been determined. It ensures the establishment of safety objectives and gives ChNPP the freedom of optimal choice of specific technical decisions. The License has been issued for OS-related activities and a number of documents have been developed to conduct an effective and high quality authorization process: the Licensing Process; Recommendations on single SSR, Licensing Plan for SIP. The Order of State Safety Supervision for SIP has been approved. Working groups are functioning, whose purposes are to coordinate actions of participants in authorization activities, including ChNPP, SNRCU, and other RA.
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Regulating nuclear and radiation safety in the frame of the Chernobyl shelter Implementation Plan
International Nuclear Information System (INIS)
Bykov, V.; Demchyuk, A.; Kilochitska, T.; Redko, V.; Bogorinski, P.; Vasilchenko, V.; Erickson, L.; Kadkin, E.; Kondratyev, S.; Kutina, L.; Smyshliaeva, S.
2003-01-01
Since 1998 the Shelter Implementation Plan (SIP) has been carried out on the Chernobyl NPP Unit 4 (the object Shelter - OS). The State Nuclear Regulatory Committee of Ukraine (SNRCU) recognizes the exceptional importance of successful and efficient SIP implementation and acts accordingly in regulation, licensing, and inspection. Technical support of the SNRCU in SIP licensing are provided by the State Scientific and Technical Center for Nuclear and Radiation Safety (SSTC) and the SIP Licensing Consultant (LC) representing RISKAUDIT IPSN/GRS International and SCIENTECH, Inc. Support of the SNRCU is also provided by the International Consultative Committee of Regulatory Bodies (ICCRB). ICCRB members represent regulatory authorities from nine European countries, Canada and the U.S. Summarizing the information above, it can be stated that a sound basis has been created for the licensing process for SIP. The approach for using the regulatory base has been determined. It ensures the establishment of safety objectives and gives ChNPP the freedom of optimal choice of specific technical decisions. The License has been issued for OS-related activities and a number of documents have been developed to conduct an effective and high quality authorization process: the Licensing Process; Recommendations on single SSR, Licensing Plan for SIP. The Order of State Safety Supervision for SIP has been approved. Working groups are functioning, whose purposes are to coordinate actions of participants in authorization activities, including ChNPP, SNRCU, and other RA
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The UK Committee on Radioactive Waste Management
International Nuclear Information System (INIS)
Baverstock, Keith; Ball, David J
2005-01-01
The UK Committee on Radioactive Waste Management is charged with recommending to Government, by July 2006, options for the long term management of the UK's radioactive waste legacy. These options should inspire public confidence. Now, more than halfway into the time allotted, we, as two former members of the Committee, express our concerns at the wayward approach that has been adopted. The Committee has placed emphasis on gaining public confidence but this has been done at the expense of recruiting the best scientific expertise in the management of radioactive waste, an act which we believe will actually undermine public confidence. Furthermore, given also the immense importance of this decision to public safety, national security and the national interest, we believe urgent steps should be taken to review the Committee's process, its management and its sponsorship. (opinion)
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REVIEW OF NRC APPROVED DIGITAL CONTROL SYSTEMS ANALYSIS
International Nuclear Information System (INIS)
Markman, D.W.
1999-01-01
Preliminary design concepts for the proposed Subsurface Repository at Yucca Mountain indicate extensive reliance on modern, computer-based, digital control technologies. The purpose of this analysis is to investigate the degree to which the U. S. Nuclear Regulatory Commission (NRC) has accepted and approved the use of digital control technology for safety-related applications within the nuclear power industry. This analysis reviews cases of existing digitally-based control systems that have been approved by the NRC. These cases can serve as precedence for using similar types of digitally-based control technologies within the Subsurface Repository. While it is anticipated that the Yucca Mountain Project (YMP) will not contain control systems as complex as those required for a nuclear power plant, the review of these existing NRC approved applications will provide the YMP with valuable insight into the NRCs review process and design expectations for safety-related digital control systems. According to the YMP Compliance Program Guidance, portions of various NUREGS, Regulatory Guidelines, and nuclear IEEE standards the nuclear power plant safety related concept would be applied to some of the designs on a case-by-case basis. This analysis will consider key design methods, capabilities, successes, and important limitations or problems of selected control systems that have been approved for use in the Nuclear Power industry. An additional purpose of this analysis is to provide background information in support of further development of design criteria for the YMP. The scope and primary objectives of this analysis are to: (1) Identify and research the extent and precedence of digital control and remotely operated systems approved by the NRC for the nuclear power industry. Help provide a basis for using and relying on digital technologies for nuclear related safety critical applications. (2) Identify the basic control architecture and methods of key digital control
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30 CFR 90.206 - Approved sampling devices; equivalent concentrations.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; equivalent... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.206 Approved sampling devices; equivalent...
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7 CFR 1436.9 - Loan amount and loan application approvals.
2010-01-01
... approving authority to be ineligible for loan. (c) The maximum total principal amount of the farm storage... facility; (ii) By a yield determined reasonable by the county committee; (iii) Multiply by two (for 2 years... first time. (e) When a storage structure has a larger capacity than the applicant's needed capacity, as...
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International Nuclear Information System (INIS)
1971-01-01
This Order approves the General Regulations for Health and Safety at Work in Industrial Establishments. Section V which concerns ionizing radiations lays down that radiation protection measures currently in force must be observed in all premises where radioactive substances are stored, handled or used and where devices producing ionizing radiations are operated. (NEA) [fr
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OIE philosophy, policy and procedures for the development of food safety standards.
Droppers, W F G L
2006-08-01
Food safety was identified as a high priority area in the 2001-2005 World Organisation for Animal Health (OIE) Strategic Plan. Member Countries of the OIE considered that the organisation should be more active in issues of public health and consumer protection and that this should include more involvement in the area of diseases or pathogens transmissible through food, whether or not animals are affected by such diseases or pathogens. A permanent Working Group on Animal Production Food Safety was established in 2002 to coordinate the OIE's activities in food safety. The Working Group was requested to focus on food safety measures applicable at farm level and to monitor the ongoing cooperation between the OIE and Codex Alimentarius. More emphasis is now placed on the public health aspects of a disease when OIE standards are developed or revised. For example, the revised chapter on bovine tuberculosis in the Terrestrial Animal Health Code includes food safety recommendations for meat and meat products and for milk and milk products. The revised chapter was approved by the OIE International Committee of Member Countries at their 73rd General Session in May 2005. More chapters will follow, beginning with a chapter addressing bovine brucellosis.
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EFSA Scientific Committee; Scientific Opinion on Risk Assessment Terminology
DEFF Research Database (Denmark)
Hald, Tine
of improving the expression and communication of risk and/or uncertainties in the selected opinions. The Scientific Committee concluded that risk assessment terminology is not fully harmonised within EFSA. In part this is caused by sectoral legislation defining specific terminology and international standards......The Scientific Committee of the European Food Safety Authority (EFSA) reviewed the use of risk assessment terminology within its Scientific Panels. An external report, commissioned by EFSA, analysed 219 opinions published by the Scientific Committee and Panels to recommend possible ways......, the Scientific Committee concludes that particular care must be taken that the principles of CAC, OIE or IPPC are followed strictly. EFSA Scientific Panels should identify which specific approach is most useful in dealing with their individual mandates. The Scientific Committee considered detailed aspects...
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[Reporting ethics board approval in German medical theses and journals].
Zenz, Michael; Zenz, Julia; Grieger, Maximilian
2018-06-05
Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.
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Nuclear committee plays it straight: and draws criticism from all quarters
International Nuclear Information System (INIS)
Lanouette, W.J.
1981-01-01
The Nuclear Safety Oversight Committee appointed after the 1979 accident at Three Mile Island angered everyone, but succeeded in highlighting many of the operating and regulatory problems plaguing nuclear power. The now defunct committee received mixed reviews, some calling it a waste of time and money, and others seeing it as a model for solving policy disputes. A review of the committee members and their two controversial studies describes the areas of disagreement
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Payment of research participants: current practice and policies of Irish research ethics committees.
LENUS (Irish Health Repository)
Roche, Eric
2013-09-01
Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.
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75 FR 56502 - National Advisory Committee on Meat and Poultry Inspection
2010-09-16
... Advisory Committee on Meat and Poultry Inspection AGENCY: Food Safety and Inspection Service, USDA. ACTION... and Poultry Inspection (NACMPI) will hold a public meeting on September 29-30, 2010, to review and... disks or CD-ROMs: Send to National Advisory Committee on Meat and Poultry Inspection, USDA, FSIS, 14th...
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NCRP Program Area Committee 3: Nuclear and Radiological Security and Safety.
Taylor, Tammy P; Buddemeier, Brooke
2016-02-01
Program Area Committee (PAC) 3 provides guidance and recommendations for response to nuclear and radiological incidents of both an accidental and deliberate nature. Leadership of PAC 3 was transitioned in March 2015, and the newly composed PAC has been working to delineate and then prioritize the landscape of possible activities for PAC 3. The major activity of PAC 3 during the past year was the establishment of Scientific Committee 3-1 to begin producing a report on Guidance for Emergency Responder Dosimetry.
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Minimum qualifications for nuclear criticality safety professionals
International Nuclear Information System (INIS)
Ketzlach, N.
1990-01-01
A Nuclear Criticality Technology and Safety Training Committee has been established within the U.S. Department of Energy (DOE) Nuclear Criticality Safety and Technology Project to review and, if necessary, develop standards for the training of personnel involved in nuclear criticality safety (NCS). The committee is exploring the need for developing a standard or other mechanism for establishing minimum qualifications for NCS professionals. The development of standards and regulatory guides for nuclear power plant personnel may serve as a guide in developing the minimum qualifications for NCS professionals
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Congress of the U.S., Washington, DC. House Committee on Merchant Marine and Fisheries.
The publication consists of Congressional hearings before the Ad Hoc Committee on Maritime Education and Training: (1) June 26, 1974 hearing pertaining to officer requirements and (2) November 19, 1974 hearing on maritime education regarding safety at sea. Estimated cost per graduate for the U. S. Merchant Marine 1973 class was $31,100. Supply and…
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National machine guarding program: Part 2. Safety management in small metal fabrication enterprises
Yamin, Samuel C.; Brosseau, Lisa M.; Xi, Min; Gordon, Robert; Most, Ivan G.; Stanley, Rodney
2015-01-01
Background Small manufacturing businesses often lack important safety programs. Many reasons have been set forth on why this has remained a persistent problem. Methods The National Machine Guarding Program (NMGP) was a nationwide intervention conducted in partnership with two workers' compensation insurers. Insurance safety consultants collected baseline data in 221 business using a 33‐question safety management audit. Audits were completed during an interview with the business owner or manager. Results Most measures of safety management improved with an increasing number of employees. This trend was particularly strong for lockout/tagout. However, size was only significant for businesses without a safety committee. Establishments with a safety committee scored higher (55% vs. 36%) on the safety management audit compared with those lacking a committee (P management programs were frequently absent. A safety committee appears to be a more important factor than business size in accounting for differences in outcome measures. Am. J. Ind. Med. 58:1184–1193, 2015. © 2015 The Authors. American Journal of Industrial Medicine Published by Wiley Periodicals, Inc. PMID:26345591
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Tsuda, Shawn; Oleynikov, Dmitry; Gould, Jon; Azagury, Dan; Sandler, Bryan; Hutter, Matthew; Ross, Sharona; Haas, Eric; Brody, Fred; Satava, Richard
2015-10-01
The da Vinci(®) Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) is a computer-assisted (robotic) surgical system designed to enable and enhance minimally invasive surgery. The Food and Drug Administration (FDA) has cleared computer-assisted surgical systems for use by trained physicians in an operating room environment for laparoscopic surgical procedures in general, cardiac, colorectal, gynecologic, head and neck, thoracic and urologic surgical procedures. There are substantial numbers of peer-reviewed papers regarding the da Vinci(®) Surgical System, and a thoughtful assessment of evidence framed by clinical opinion is warranted. The SAGES da Vinci(®) TAVAC sub-committee performed a literature review of the da Vinci(®) Surgical System regarding gastrointestinal surgery. Conclusions by the sub-committee were vetted by the SAGES TAVAC Committee and SAGES Executive Board. Following revisions, the document was evaluated by the TAVAC Committee and Executive Board again for final approval. Several conclusions were drawn based on expert opinion organized by safety, efficacy, and cost for robotic foregut, bariatric, hepatobiliary/pancreatic, colorectal surgery, and single-incision cholecystectomy. Gastrointestinal surgery with the da Vinci(®) Surgical System is safe and comparable, but not superior to standard laparoscopic approaches. Although clinically acceptable, its use may be costly for select gastrointestinal procedures. Current data are limited to the da Vinci(®) Surgical System; further analyses are needed.
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2010-09-16
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Joint Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety... and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk Management Advisory...
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ASTM Committee D-7 : Wood : promoting safety and standardization for 100 years
David W. Green; Robert L. Ethington
2004-01-01
In October 2004, Committee D-7 on Wood of the American Society for Testing and Materials (ASTM) is celebrating 100 years of contributions to the safe and efficient use of wood as a building material. Born during a period of rapid social, economic, and technological change, the Committee faced controversial issues and the challenge of a changing forest resource. This...
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International Nuclear Information System (INIS)
Smith, P.D.; Bernreuter, D.L.; Bohn, M.P.; Chuang, T.Y.; Cummings, G.E.; Dong, R.G.; Johnson, J.J.; Wells, J.E.
1981-01-01
The January 29-30, 1981, meeting of the Advisory Committee on Reactor Safeguards (ACRS), Subcommittee on Extreme External Phenomena, mark the close of Phase I efforts on the Seismic Safety Margins Research Program (SSMRP). Presentations at the meeting focused on results produced. These included computer codes, response computations, failure and release probabilities, data bases, and fragilities and parameter characteristics
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Energy Technology Data Exchange (ETDEWEB)
NONE
2009-11-15
The high committee for the nuclear safety transparency and information (HCTISN) is an information, consultation and debate authority devoted to the assessment of the risks linked with nuclear activities and to the analysis of their impact on public health, on the environment and on nuclear safety. Each year, the HCTISN organizes several ordinary meetings in order to analyze some specific topics of the moment, and, depending on the events, some extraordinary meetings. This document is the proceedings of an extraordinary meeting about the information and transparency in relation with the management of nuclear materials and wastes at all stages of the fuel cycle. The reason of this meeting is a request from the French Minister of ecology, energy, sustainable development and sea (MEEDDM) after the broadcast of a TV documentary entitled 'wastes: the nuclear industry nightmare' and the publication of a press article affirming that 'our nuclear wastes are hidden in Siberia'. The Minister expressed his wish to have the question of the international trade of nuclear materials examined by the HCTISN. The document is organized as follows: a first part presents the hearings of the general direction of energy and climate (DGEC), of the nuclear safety authority (ASN), of EdF, of Areva, of the CEA, of the senior official for the defense and security of the MEEDDM, of Rosatom company and of Greenpeace organisation. A second part examines the incident which took place in October 2009 at the plutonium technology workshop (ATPu) of Cadarache, where about 22 to 39 kg of plutonium powder were discovered in the gloveboxes of this facility, decommissioned in 2005 and undergoing dismantlement today. This part presents the hearings of the CEA, of AREVA, of the Institute of radiation protection and nuclear safety (IRSN), of the ASN, of the hygiene, safety and labour conditions committee (CHSCT) of Areva and CEA, and of the local information commission (CLI) of Cadarache
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Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees
Hoecht, Andreas
2011-01-01
Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…
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2010-09-02
... Revised Terms of Reference (TOR)--Discussion--Review/ Approval New Business. Other Business. Review Action... Advisory Committee. [FR Doc. 2010-21927 Filed 9-1-10; 8:45 am] BILLING CODE 4910-13-P ...
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Examination on the safety of handling the fuel elements in the nuclear ship 'Mutsu'
International Nuclear Information System (INIS)
1977-01-01
This is the report of the Examination Committee on Total Inspection and Repair Technologies for Mutsu to the Director of Science and Technology Agency and the Minister of Transport dated July 29, 1977. The committee concluded before that the total inspection on safety and the repair of shielding can be carried out as the fuel elements are loaded, and the safety can be secured sufficiently. It was decided at the meeting of ministers concerned with Mutsu on May 17 that the safety concerning handling the fuel elements of Mutsu should be examined by the committee. Under the premise that the fuel elements are loaded again and used after the total inspection on safety and the repair of shielding, the committee examined the methods and the basic concept of safety about the taking-out, transport and preservation of the fuel elements, and the conclusions obtained are reported. The contents of the examination are the outline of the fuel elements, the present condition of the fuel elements, the safety concerning taking-out, transport and preservation of the fuel elements, and the other measures required for securing safety. The committee thinks that the safety can be secured sufficiently if the works are carried out carefully. (Kako, I.)
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Report of the meeting of the INES advisory committee, 16-17 October 1995
International Nuclear Information System (INIS)
1995-01-01
The INES advisory committee discussed at its meeting the following issues: report on results from questionnaires, review of events, proposed simplification of the user's manual, guidance on relationship between initiators and safety functions, computerized rating procedure, future work of the advisory committee
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75 FR 1831 - Seeks Qualified Candidates for the Advisory Committee on Reactor Safeguards
2010-01-13
... NUCLEAR REGULATORY COMMISSION Seeks Qualified Candidates for the Advisory Committee on Reactor... Regulatory Commission (NRC) seeks qualified candidates for the Advisory Committee on Reactor Safeguards (ACRS... amended. ACRS provides independent expert advice on matters related to the safety of existing and proposed...
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Report of the meeting of the INES advisory committee, 16-17 October 1995
Energy Technology Data Exchange (ETDEWEB)
NONE
1996-12-31
The INES advisory committee discussed at its meeting the following issues: report on results from questionnaires, review of events, proposed simplification of the user`s manual, guidance on relationship between initiators and safety functions, computerized rating procedure, future work of the advisory committee.
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International Nuclear Information System (INIS)
1990-01-01
The purpose of the Australian Nuclear Science and Technology Organization's Safety Handbook is to outline simply the fundamental procedures and safety precautions which provide an appropriate framework for safe working with any potential hazards, such as fire and explosion, welding, cutting, brazing and soldering, compressed gases, cryogenic liquids, chemicals, ionizing radiations, non-ionising radiations, sound and vibration, as well as safety in the office. It also specifies the organisation for safety at the Lucas Heights Research Laboratories and the responsibilities of individuals and committees. It also defines the procedures for the scrutiny and review of all operations and the resultant setting of safety rules for them. ills
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Effectiveness and safety of abatacept in moderate to severe rheumatoid arthritis.
Cortejoso-Fernández, Lucía; Romero-Jiménez, Maria Rosa; Pernía-López, María Sagrario; Montoro-Álvarez, María; Sanjurjo-Sáez, María
2012-01-01
Abatacept was approved in our hospital by the Pharmacy and Therapeutics Committee for treatment of moderate to severe rheumatoid arthritis (RA) in adult patients with inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs), including at least one anti-tumour necrosis factor (anti-TNF). The objectives of this study were to analyze compliance with our protocol and to evaluate effectiveness and safety of abatacept in our patients. We performed a descriptive longitudinal study of patients with RA treated with abatacept between August 2008 and May 2010 in our day care unit. We reviewed clinical records and recorded the following data: sex, age, weight, year of diagnosis, previous antirheumatic treatments and reasons for withdrawal of anti-TNFs, indication for abatacept, dose and date of administration, Disease Activity Score (DAS28) and adverse events. Effectiveness was evaluated using the European League Against Rheumatism (EULAR) criteria. We recruited 16 patients. Mean follow-up time was 10.4 (SD: 6.1) months. All patients had been previously treated with DMARDs, including at least one anti-TNF, and the mean dose of abatacept was 9.4 (SD: 1.4) mg/kg. During the first 6 months of treatment, 11/16 of patients experienced a decrease in their DAS28 value, but only 5/16 achieved a satisfactory response. Dyspnea was the most frequent adverse event (7/16), followed by fatigue and asthenia (6/16) and dry skin (5/16). The indication for abatacept in our hospital complied with the protocol approved by the Pharmacy and Therapeutics Committee. Only 5/16 of patients achieved a satisfactory response; however, it should be noted that these patients had moderate to severe RA that was refractory to other treatments. Adverse reactions were consistent with those described in the summary of product characteristics. Further studies with larger cohorts are needed to analyze the long-term safety and effectiveness profile in clinical practice.
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Ethics committees and the changed clinical research environment in India in 2016: A perspective!
Davis, Sanish; Sule, Poonam; Bughediwala, Murtuza; Pandya, Vrunda; Sinha, Shilpi
2017-01-01
Institutional and Independent Ethics Committees (ECs) have as their primary mission the protection of human research subjects. The Central Drugs Standard Control Organization has in the period 2013-2016 introduced several new regulations and amendments to existing regulations overseeing the conduct of Research in India. Several of these have direct effect on the functioning of the EC from a review, approval, and oversight mechanism. The Ethics Council of Indian Society for Clinical Research conducted a questionnaire survey among EC members to understand the impact of these changes in their functioning. The domains surveyed included awareness about recent changes/amendments and impacts, serious adverse events (SAEs) and compensation, informed consent and audio-video recording, monitoring and auditing of research, and future working of ECs. Seventy-nine percent of ECs are of the opinion that the new regulations/guidelines will add to their existing burden in the process of review and approval, providing subject protection and research oversight. Even though 68% of ECs stated that they are comfortable with SAE assessment and compensation determination, they state that there is variability in calculation of compensation amount using the formulae. An overwhelming majority (80%) of ECs stated that they were not in favor of centralized EC for providing review, approval, and oversight of clinical studies. Ethics Committees act as local regulator for clinical trials at sites providing Human Subject protection. The survey captures the contemporary issues faced by the ECs and also raises important questions on the ease of doing research, oversight of approved research, and administrative burden on the EC. Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.
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Safety-related control air systems - approved 1977
International Nuclear Information System (INIS)
Anon.
1978-01-01
This standard applies to those portions of the control air system that furnish air required to support, control, or operate systems or portions of systems that are safety related in nuclear power plants. This standard relates only to the air supply system(s) for safety-related air operated devices and does not apply to the safety-related air operated device or to air operated actuators for such devices. The objectives of this standard are to provide (1) minimum system design requirements for equipment, piping, instruments, controls, and wiring that constitute the air supply system; and (2) the system and component testing and maintenance requirements
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30 CFR 75.600-1 - Approved cables; flame resistance.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved cables; flame resistance. 75.600-1 Section 75.600-1 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE... cables; flame resistance. Cables shall be accepted or approved by MSHA as flame resistant. [57 FR 61223...
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ITER technical advisory committee meeting
International Nuclear Information System (INIS)
Fujiwara, M.
1999-01-01
The ITER Technical Advisory Committee (TAC) meeting took place on December 20-22, 1999 at the Naka Joint Work Site. The objective of this meeting was to review the document 'Technical Basis for ITER-FEAT Outline Design (ODR)' issued by the Director on December 10. It was also aimed at providing the ITER Meeting scheduled for January 19-20, 2000 in Tokyo with a technical assessment of ODR and recommendations for the optimization of the anticipated plasma performance and engineering design, based on the guidelines approved by the Council in June 1998 and recommendations of the last TAC meeting
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STANDING CONCERTATION COMMITTEE ORDINARY MEETINGS IN NOVEMBER & DECEMBER 2003
2003-01-01
Original: English La version française de cet article paraîtra dans le prochain Bulletin hebdomadaire. These meetings were devoted to the main topics summarised below. 1-Follow-up of the meetings of TREF in October and the Finance Committee in November, and preparation for the Committee meetings in December The Chairman reported that the Management's proposals to adjust, on 1 January 2004, the salaries by 1.1%, on the basis of the calculated salary index, and the pensions by 0.7%, corresponding to the Geneva cost-of-living index, had received the support of TREF and would now be proposed by the Finance Committee for approval by Council in December. TREF had taken note of a factual status report regarding the first phase of recruitment of Local Staff and looked forward to a final report on overall implementation in June next year. TREF also gave its support to the Management's proposed modification to the Progressive Retirement Programme. Subject to some amendments and clarifications m...
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77 FR 25781 - Twenty-First Meeting: RTCA Special Committee 203, Unmanned Aircraft Systems
2012-05-01
.../Administrative Remarks Approval of Twentieth Plenary Summary Chairperson/Leadership Updates Designated Federal... Workgroup Back Briefs Other Business Closing Plenary Session Other Business Date, Place, and Time for... the committee at any time. Issued in Washington, DC, on April 24, 2012. John Raper, Manager, Business...
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Kim, David K; Riley, Laura E; Hunter, Paul
2018-02-09
In October 2017, the Advisory Committee on Immunization Practices (ACIP) voted to approve the Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2018. The 2018 adult immunization schedule summarizes ACIP recommendations in two figures and a table of contraindications and precautions for vaccines recommended for adults, and is intended is to assist health care providers in implementing the current ACIP recommendations for vaccinating adults. The schedule can be found at https://www.cdc.gov/vaccines/schedules.* The full ACIP recommendations for each vaccine are available at https://www.cdc.gov/vaccines/hcp/acip-recs/index.html. The 2018 adult immunization schedule has also been approved by the American College of Physicians (https://www.acponline.org), the American Academy of Family Physicians (https://www.aafp.org), the American College of Obstetricians and Gynecologists (https://www.acog.org), and the American College of Nurse-Midwives (http://www.midwife.org). The ACIP-recommended use of each vaccine is developed after an in-depth review of vaccine-related data, including data on disease epidemiology, vaccine efficacy and effectiveness, vaccine safety, feasibility of program implementation, and economic aspects of immunization policy (1).
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The approval process for biosimilar erythropoiesis-stimulating agents.
Wish, Jay B
2014-09-05
A biosimilar drug or follow-on biologic drug is defined by the Public Health Service Act as a product that is "highly similar to the reference product notwithstanding minor differences in clinically active components and there are no clinically meaningful differences between the biologic product and the reference product in terms of the safety, purity and potency of the product." The advantage of biosimilar drugs is that they are significantly less expensive than the reference products, allowing for increased accessibility and cost savings. Recognizing these advantages, the US Congress passed the Biologics Price Competition and Innovation Act in 2009 as part of health care reform. The Biologics Price Competition and Innovation Act allows sponsors of biosimilar agents to seek approval by showing structural and functional similarity to the reference agent, with the extent of required clinical studies to be determined on the basis of the degree of biosimilarity with the reference product. The goal is to bring biosimilar agents to the market more efficiently while still protecting the safety of the public. The European Union has had such a process in place for a number of years. Two biosimilar epoetin agents have been approved in the European Union since 2007, and their companies are conducting trials to seek approval in the United States, because Amgen's patent protection for epoetin alfa expires in 2014. Trials completed for European Union approval of both agents showed similar efficacy and safety to the reference epoetin alfa. As with all biologics, immunogenicity concerns may persist because of the fragility of the manufacturing process and the worldwide experience with pure red cell aplasia as a result of epoetin therapy. The uptake of biosimilar epoetins after approval in the United States will depend on the balance of cost advantage against safety concerns. Competition in the marketplace will likely decrease the cost of the reference agent as well. Copyright
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76 FR 20434 - Notice of Sunshine Act Meeting
2011-04-12
..., 1101 Market Street, Chattanooga, Tennessee, to consider the matters listed below. The public may.... Nuclear Safety Review. Old Business Approval of minutes of February 18, 2011, Board Meeting. New Business... Relations Committee. 8. Report of the People and Performance Committee. 9. Report of the Finance, Rates, and...
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Informed consent in Sri Lanka: a survey among ethics committee members.
Sumathipala, Athula; Siribaddana, Sisira; Hewage, Suwin; Lekamwattage, Manura; Athukorale, Manjula; Siriwardhana, Chesmal; Murray, Joanna; Prince, Martin
2008-05-20
Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research.However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Twenty-nine members from ethics committees participated. Majority of participants (23), believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%), believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52%) believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. The number of themes generated for the consent form (N = 18) is as many as for the information leaflet (N = 19) and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and consent forms proved to be similar with WHO checklist on informed
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The transport system approval concept
International Nuclear Information System (INIS)
Pettersson, B.G.
1991-01-01
The needs for, and merits of, a new concept for the safety assessment and approval of shipments of radioactive materials is introduced and discussed. The purpose of the new concept is to enable and encourage integration of analysis and review of transport safety with similar safety analysis and review of the handling operations involving the radioactive material at the despatching and receiving ends of a shipment. Safety contributing elements or functions of the means of transport (the Transport System) can thus readily be taken into account in the assessment. The objective is to avoid constraints -experienced or potential - introduced by the package functional provisions contained in the transport regulations, whilst maintaining safety during transport, as well as during facility handling operations, at least at the level at the level currently established. (author)
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78 FR 62002 - Railroad Safety Advisory Committee; Notice of Meeting
2013-10-10
... Working Groups. Status reports will also be provided by the Engineering Task Force. This agenda is subject... Transit Administration. The diversity of the Committee ensures the requisite range of views and expertise...
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30 CFR 90.204 - Approved sampling devices; maintenance and calibration.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; maintenance and... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.204 Approved sampling devices; maintenance and...
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Directory of Open Access Journals (Sweden)
Str
2015-05-01
Full Text Available Vibeke Strand,1 Louis F McIntyre,2 William R Beach,3 Larry E Miller,4,5 Jon E Block5 1Stanford University School of Medicine, Palo Alto, CA, USA; 2New York University Medical Center, White Plains, NY, USA; 3Tuckahoe Orthopaedics, Richmond, VA, USA; 4Miller Scientific Consulting, Inc., Asheville, NC, USA; 5The Jon Block Group, San Francisco, CA, USA Background: Intra-articular injection of hyaluronic acid is a common, yet controversial, therapeutic option for patients with knee osteoarthritis (OA. The purpose of this research was to determine the safety and efficacy of US-approved viscosupplements for symptomatic knee OA. Methods: We searched MedLine and EMBase for randomized, sham-controlled trials evaluating safety and/or clinical efficacy of US-approved viscosupplements in patients with symptomatic knee OA. Knee pain severity and knee joint function were assessed at 4 to 13 weeks and 14 to 26 weeks. Safety outcomes included serious adverse events, treatment-related serious adverse events, patient withdrawal, and adverse event-related patient withdrawal occurring at any time during follow-up. Results: A total of 29 studies representing 4,866 unique patients (active: 2,673, control: 2,193 were included. All sham-controlled trials used saline injections as a control. Viscosupplementation resulted in very large treatment effects between 4 and 26 weeks for knee pain and function compared to preinjection values, with standardized mean difference values ranging from 1.07 to 1.37 (all P<0.001. Compared to controls, standardized mean difference with viscosupplementation ranged from 0.38 to 0.43 for knee pain and 0.32 to 0.34 for knee function (all P<0.001. There were no statistically significant differences between viscosupplementation and controls for any safety outcome, with absolute risk differences of 0.7% (95% confidence interval [CI]: –0.2 to 1.5% for serious adverse events, 0% (95% CI: –0.4 to 0.4% for treatment-related serious adverse
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2011-09-26
... Meeting (RTCA Paper No. 166-11/SC 135-685). Review Approved Revised SC135 TOR (Terms of Reference..., RTCA Advisory Committee. [FR Doc. 2011-24637 Filed 9-23-11; 8:45 am] BILLING CODE 4910-13-P ...
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Energy Technology Data Exchange (ETDEWEB)
Bourassa, H. [Centre d' expertise hydrique du Quebec, Quebec, PQ (Canada)
2009-07-01
Fourty public dams are managed on a real-time basis by the Centre d'expertise hydrique du Quebec (CEHQ). This presentation described the public dams owned by the CEHQ and discussed the public safety measures at the dams. The dams serve various purposes, including protection against floods; industrial or drinking water supply; resort or recreational activities; hydroelectric development; and wildlife conservation. Trigger events were also discussed, such as the complaint at Rapides-des-Cedres dam and deaths that occurred in 2004 when water from a dam was released without warning. Several photographs were presented to illustrate that people were unaware of the danger. Initiatives aimed at raising awareness and studying public safety issues were discussed. A pilot project was launched and a permanent committee was created to evaluate all aspects of public safety at the dams owned by CEHQ. The first tasks of the committee were to establish requirements for waterway safety barriers, both upstream and downstream, for all public dams; to establish requirements for safety signage for all public dams; and to develop criteria to decide on safety signage at each dam. figs.
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Energy Technology Data Exchange (ETDEWEB)
Bourassa, H [Centre d' expertise hydrique du Quebec, Quebec, PQ (Canada)
2009-07-01
Fourty public dams are managed on a real-time basis by the Centre d'expertise hydrique du Quebec (CEHQ). This presentation described the public dams owned by the CEHQ and discussed the public safety measures at the dams. The dams serve various purposes, including protection against floods; industrial or drinking water supply; resort or recreational activities; hydroelectric development; and wildlife conservation. Trigger events were also discussed, such as the complaint at Rapides-des-Cedres dam and deaths that occurred in 2004 when water from a dam was released without warning. Several photographs were presented to illustrate that people were unaware of the danger. Initiatives aimed at raising awareness and studying public safety issues were discussed. A pilot project was launched and a permanent committee was created to evaluate all aspects of public safety at the dams owned by CEHQ. The first tasks of the committee were to establish requirements for waterway safety barriers, both upstream and downstream, for all public dams; to establish requirements for safety signage for all public dams; and to develop criteria to decide on safety signage at each dam. figs.
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Safety issues at the defense production reactors
International Nuclear Information System (INIS)
1987-01-01
The United States produces plutonium and tritium for use in nuclear weapons at the defense production reactors endash the N Reactor in Washington and the Savannah River reactors in South Carolina. This report reaches general conclusions about the management of those reactors and highlights a number of safety and technical issues that should be resolved. The report provides an assessment of the safety management, safety review, and safety methodology employed by the Department of Energy and the private contractors who operate the reactors for the federal government. The report is necessarily based on a limited review of the defense production reactors. It does not address whether any of the reactors are ''safe,'' because such an analysis would involve a determination of acceptable risk endash a matter of obvious importance, but one that was beyond the purview of the committee. It also does not address whether the safety of the production reactors is comparable to that of commercial nuclear power stations, because even this narrower question extended beyond the charge to the committee and would have involved detailed analyses that the committee could not undertake
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International Nuclear Information System (INIS)
2008-01-01
The NEA Committee on the Safety of Nuclear Installations (CSNI) has recently completed a study on the availability and utilisation of facilities supporting safety studies for current and advanced nuclear power reactors. The study showed that significant steps had been undertaken in the past several years in support of safety test facilities, mainly by conducting multinational joint projects centered on the capability of unique test facilities worldwide. Given the positive experience of the safety research projects, it has been recommended that efforts be made to prioritize technical issues associated with advanced (Generation IV) reactor designs and to develop options on how to efficiently obtain the necessary data through internationally co-ordinated research, preparing a gradual extension of safety research beyond the needs set by currently operating reactors. This statement constitutes a reference for future CSNI activities and for safety authorities, R and D centres and industry for internationally co-ordinated research initiatives in the nuclear safety research area. (author)
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78 FR 29780 - Fees for Testing, Evaluation, and Approval of Mining Products
2013-05-21
... Approval of Mining Products AGENCY: Mine Safety and Health Administration, Labor. ACTION: Notice. SUMMARY..., and approval of mining products; it allows MSHA to collect fees up to $2,499,000 for the testing, evaluation, and approval of certain mining equipment. MSHA is continuing to collect these fees for 2013 as...
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Committees review activities at December meetings
The Education and Human Resources Committee reported having approved participation in the Association for Women Geoscientist's (AWG) national survey. During the summer of 1983 the AWG designed a 75-question survey targeted to women but also applicable to men. The survey consisted of five sections (in addition to such demographics as age, salary, education, job area, and society membership): feelings and attitude toward job, career/family balance, sexual harassment and discrimination, opinions on national energy and conservation policy, and attitude toward AWG. The questionnaire was mailed to AWG members (just over 1000) and to AGU female members (about 1300). Survey participants were asked to give copies to their male colleagues to create a comparison group. About 25% of the 800 responses were from men. The responses were split about 50/50 between AWG and AGU members. The Education and Human Resources Committee will have the results from the survey presented at their next meeting in Cincinnati, May 15.
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30 CFR 90.205 - Approved sampling devices; operation; air flowrate.
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Approved sampling devices; operation; air... LABOR COAL MINE SAFETY AND HEALTH MANDATORY HEALTH STANDARDS-COAL MINERS WHO HAVE EVIDENCE OF THE DEVELOPMENT OF PNEUMOCONIOSIS Sampling Procedures § 90.205 Approved sampling devices; operation; air flowrate...
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Stepping Up Occupational Safety and Health Through Employee Participation.
Vaughan, Gary R.
1986-01-01
The effectiveness of the Occupational Safety and Health Act of 1970 is examined, and it is suggested that employee participation could help improve occupational safety and health in the future, through safety committees, safety circles, safety teams, and individual participation. (MSE)
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Number of patients studied prior to approval of new medicines
DEFF Research Database (Denmark)
Duijnhoven, Ruben G; Straus, Sabine M J M; Raine, June M
2013-01-01
length of time), whereas 67 (79.8%) of the medicines met the criteria for 12-mo patient exposure (at least 100 participants studied for 12 mo). CONCLUSIONS: For medicines intended for chronic use, the number of patients studied before marketing is insufficient to evaluate safety and long-term efficacy....... Both safety and efficacy require continued study after approval. New epidemiologic tools and legislative actions necessitate a review of the requirements for the number of patients studied prior to approval, particularly for chronic use, and adequate use of post-marketing studies. Please see later...
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Internal safety review team at Comanche Peak SES
Energy Technology Data Exchange (ETDEWEB)
Davis, D [Comanche Peak Steam Electric Staion, Texas Utilities, TX (United States)
1997-09-01
The presentations describes the following issues: levels of defense in depth; internal safety review organizations; methods used to perform safety assessment; safety committee review; quality verification; root cause analysis; human performance program; industry operating experience.
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Kimemia, David; van Niekerk, Ashley; Govender, Rajen; Seedat, Mohamed
2018-06-01
This study is a follow-on to an intervention project that implemented South African Bureau of Standards approved kerosene stoves and safety education in 150 households of a Johannesburg informal settlement. An investigation conducted 12 months later established that 43 stoves had operational defects, yet 23 households continued using the faulty appliances. This study focuses on (1) the psychological and behavioural factors associated with continued use of faulty stoves by the 23 households, and (2), the specific technical failures of these stoves. The study involved one-on-one recall interviews with the households using defective stoves (N=21) and laboratory-based stove tests for seven of the affected appliances. The results indicate that the stoves had defects in critical safety features such as flame control and the self-extinguishing mechanism. Four stove malfunctions of minor burn affect were reported in the study. Continued use of the damaged stoves was significantly associated with the time from receipt of the stove to detection of first failure: stoves that failed later on were more significantly likely to remain in use as compared to those that failed sooner. The findings point to the need for strengthening enforcement of appliance standards, public education on kerosene stove use, and structural change for the energy-poor. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.
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75 FR 49536 - Petitions for Modification of Existing Mandatory Safety Standards
2010-08-13
... wells utilizing the following terms and conditions: 1. District Manager Approval; (a) a safety barrier.... After District Manager approval, the mine operator will then mine within the safety barrier of the well... DEPARTMENT OF LABOR Mine Safety and Health Administration Petitions for Modification of Existing...
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Safety assessment of research reactors and preparation of the safety analysis report
International Nuclear Information System (INIS)
1994-01-01
This Safety Guide presents guidelines, approved by international consensus, for the preparation, review and assessment of safety documentation for research reactors such as the Safety Analysis Report. While the Guide is most applicable to research reactors in the design and construction stage, it is also recommended for use during relicensing or reassessment of existing reactors
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Arnardottir, Arna H.; Haaijer-Ruskamp, Flora M.; Straus, Sabine M. J.; de Graeff, Pieter A.; Mol, Peter G. M.
2011-01-01
Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required >= 1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval. Objective:
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IRT‑Sofia, HEU to LEU conversion: regulatory approval tasks solution overview
International Nuclear Information System (INIS)
Mitev, Mladen; Belousov, Sergey; Dimitrov, Dobromir
2014-01-01
The HEU to LEU conversion of the IRT–Sofia research reactor of the Institute for Nuclear Research and Nuclear Energy of the Bulgarian Academy of Sciences was jointly studied with the Argonne National Laboratory as a part of the RERTR Programme. The main purpose of the collaboration consisted in accomplishment of safety analyses and preparation of documents used for regulatory approval tasks solution. The main steps and results which are fundamental for the preparation of IRT–Sofia Safety Analyses Report including Operating Limits and Conditions are presented in this paper. The documents prepared by INRNE in accordance with the European nuclear safety requirements and IAEA recommendations were submitted for approval to the Bulgarian Nuclear Regulatory Agency at the end of 2010. Key words: research reactor, safety analyses report, Nuclear Regulatory Agency
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Safety aspects of nuclear plant licensing in Canada
International Nuclear Information System (INIS)
Jennekens, J.H.F.
1975-01-01
The legislative authority is laid down in the Atomic Energy Control Act, 1946, declaring atomic energy a matter of national interest and establishing the Atomic Energy Control Board (AECB) as the competent body for regulating all aspects of atomic energy. The Act also vests a Minister designated by the Government with research and exploitation functions; thus, by Ministerial order, Atomic Energy of Canada Limited was established in 1952 as a State-owned company. The Nuclear Liability Act, 1970, channels all liability for nuclear damage to the operator of a nuclear installation and requires him to obtain insurance in the amount of $75 million, part of which may be re-insured by the Government. The licensing requirements comprise the issuance of a site approval, a construction licence and an operating licence. The AECB is assisted in its licensing functions by its Nuclear Plant Licensing Directorate and by the Reactor Safety Advisory Committee co-operating with each other in making extensive safety assessments of a licence application. A site evaluation report, a preliminary safety report and a final safety report are required in relation to the siting, construction and operation of a nuclear power plant. The Canadian reactor safety philosophy is based on the concept of defence in depth, implemented through a multi-step approach, which includes avoidance of malfunctions, provision of special safety systems, periodic inspection and testing, and avoidance of human errors. Specific criteria and principles have evolved in applying this basic safety philosophy and radiation protection standards are derived from international recommendations. Stringent control is exercised over the management of radioactive waste and management facilities must meet the engineering and procedural requirements of AECB before they can be placed in operation. (author)
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Castleden, C M; Pickles, H
1988-10-01
1. Spontaneous reports of suspected adverse drug reactions (ADRs) reported to the Committee on Safety of Medicines (CSM) have been studied in relation to patient age. 2. The proportion of reports received for the elderly increased between 1965 and 1983. 3. There was a correlation between the use of drugs and the number of ADR reports. Thus age-related prescription figures for two non-steroidal anti-inflammatory drugs (NSAI) and co-trimoxazole matched ADR reports for each drug in each age group. 4. The reported ADR was more likely to be serious or fatal in the elderly. 5. The commonest ADRs reported for the elderly affected the gastrointestinal (GIT) and haemopoietic systems, where more reports were received than would be expected from prescription figures. 6. The drug suspected of causing a GIT reaction was a NSAI in 75% of the reports. 7. Ninety-one per cent of fatal reports of GIT bleeds and perforations associated with NSAI drugs were in patients over 60 years of age.
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Regulatory considerations for computational requirements for nuclear criticality safety
International Nuclear Information System (INIS)
Bidinger, G.H.
1995-01-01
As part of its safety mission, the U.S. Nuclear Regulatory Commission (NRC) approves the use of computational methods as part of the demonstration of nuclear criticality safety. While each NRC office has different criteria for accepting computational methods for nuclear criticality safety results, the Office of Nuclear Materials Safety and Safeguards (NMSS) approves the use of specific computational methods and methodologies for nuclear criticality safety analyses by specific companies (licensees or consultants). By contrast, the Office of Nuclear Reactor Regulation approves codes for general use. Historically, computational methods progressed from empirical methods to one-dimensional diffusion and discrete ordinates transport calculations and then to three-dimensional Monte Carlo transport calculations. With the advent of faster computational ability, three-dimensional diffusion and discrete ordinates transport calculations are gaining favor. With the proper user controls, NMSS has accepted any and all of these methods for demonstrations of nuclear criticality safety
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International Nuclear Information System (INIS)
Agarwal, K.
2017-01-01
Regulatory Inspection (RI) of BARC facilities and projects are carried out under the guidance of BARC Safety Council (BSC) Secretariat. Basically facilities and projects have been divided into two board categories viz. radiological facilities and non-radiological facilities. The Rls of radiological facilities should be carried out under OPSRC and of non-radiological facilities under CFSRC. Periodicity of inspection shall be at least once in a year. The RI of projects is carried out under concerned DSRC. RI practices with industrial safety which includes electrical, mechanical, material handling and conventional aspect for these facilities starts with check lists. The inspection areas are prepared in the form of checklists which includes availability of approved documents, compliance status of previous RIT and various safety committee's recommendations, radiological status of facilities, prompt reporting of safety related unusual occurrences, major incident, site visit for verification of actual status of system/plant. The practices for inspection in the area of electrical safety shall include checking of maintenance procedure for all critical class IV system equipment's such as HT panel, LT panel, transformer and motors. Load testing of Class III system such as D.G. set etc. shall be carried out as technical specification surveillance schedule. Status of aviation lights, number of qualified staff, availability of qualified staff etc. shall be form of inspection
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ACOG Committee Opinion Number 542: Access to emergency contraception.
2012-11-01
Emergency contraception includes contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to access to emergency contraception remain. The purpose of this Committee Opinion is to examine the barriers to the use of oral emergency contraception methods and to highlight the importance of increasing access.
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International Nuclear Information System (INIS)
Kouts, H.J.C.; Apostolakis, G.; Kastenberg, W.E.; Birkhofer, E.H.A.; Hoegberg, L.G.; LeSage, L.G.; Rasmussen, N.C.; Teague, H.J.; Taylor, J.J.
1990-08-01
In April 1989, the Nuclear Regulatory Commission's (NRC) Office of Nuclear Regulatory Research (RES) published a draft report ''Severe Accident Risks: An Assessment for Five US Nuclear Power Plants,'' NUREG-1150. This report updated, extended and improved upon the information presented in the 1974 ''Reactor Safety Study,'' WASH-1400. Because the information in NUREG-1150 will play a significant role in implementing the NRC's Severe Accident Policy, its quality and credibility are of critical importance. Accordingly, the Commission requested that the RES conduct a peer review of NUREG-1150 to ensure that the methods, safety insights and conclusions presented are appropriate and adequately reflect the current state of knowledge with respect to reactor safety. To this end, RES formed a special committee in June of 1989 under the provisions of the Federal Advisory Committee Act. The Committee, composed of a group of recognized national and international experts in nuclear reactor safety, was charged with preparing a report reflecting their review of NUREG-1150 with respect to the adequacy of the methods, data, analysis and conclusions it set forth. The report which precedes reflects the results of this peer review
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Workshop on safety analysis reports and licensing procedures. Pt. 2
International Nuclear Information System (INIS)
Burkart, K.
1981-01-01
The present paper deals with the document ''Single Failure Concept-Principles for the Application of the Single Failure Criterion'' approved by the Federal States Committee for Nuclear Energy (Federal Republic of Germany). (RW)
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Timms, Olinda
2018-01-01
Soon after the Surrogacy (Regulation) Bill, 2016 was approved by the Cabinet for introduction into Parliament in 2016, it was submitted for review to a Parliamentary Standing Committee on Health and Family Welfare. The report of this committee, The 102nd Report on the Surrogacy (Regulation) Bill, 2016 was laid on the table of the Lok Sabha and presented to the Rajya Sabha on August 10, 2017. It contains hearings with stakeholders and witnesses and a review of relevant documents and related legislation. The comments of the Parliamentary Standing Committee are wide ranging and pertinent, seeking to fill the gaps and explain and rationalise the statute and includes responses from the Department of Health Research. This commentary seeks to analyse the recommendations of the Committee, exploring some of the ethical, legal, and social implications of surrogacy arrangements in our country, where diverse viewpoints and strong sentiments can encounter difficult ground realities.
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Committee Opinion No 707: Access to Emergency Contraception.
2017-07-01
Emergency contraception refers to contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to emergency contraception remain. The purpose of this Committee Opinion is to examine barriers to the use of emergency contraception, emphasize the importance of increasing access, and review new methods of emergency contraception and limitations in efficacy in special populations.
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The Agency's Safety Standards and Measures
International Nuclear Information System (INIS)
1976-04-01
The Agency's Health and Safety Measures were first, approved by the Board of Governors on 31 March 1960 in implementation of Articles III.A.6 and XII of the Statute of the Agency. On the basis of the experience gained from applying those measures to projects carried out by Members under agreements concluded with the Agency, the Agency's Health and Safety Measures were revised in 1975 and approved by the Board of Governors on 25 February 1976. The Agency's Safety Standards and Measures as revised are reproduced in this document for the information of all Members
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Review of experiments for research reactors - approved 1974
International Nuclear Information System (INIS)
Anon.
1977-01-01
This standard establishes guidelines for the review and approval of experiments performed at research reactor facilities. This standard identifies the major areas that shall be reviewed for each experiment to ensure that it (a) falls within the limits delineated in the technical specifications, (b) does not present an unreviewed safety question as defined in 10 CFR Section 50.59 π2-, (c) does not constitute a threat to the health and safety of any individual or group of individuals, and (d) does not constitute a hazard to the reactor facility or other equipment. In addition, this standard recommends a system for classifying experiments to establish levels of review and approval commensurate with the level of risk inherent in the experiment
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International Nuclear Information System (INIS)
JONES GL
2008-01-01
The objective is to describe the process used by the Office of River Protection (ORP) for evaluating and implementing Contractor-initiated changes to the Waste Treatment and Immobilization Plant (WTP) Authorization Basis (AB). The WTP Project's history has provided a unique challenge for establishing and maintaining an ORP-approved AB during design and construction. Until operations begin, the project cannot implement the classic Unreviewed Safety Question (USQ) process to determine when ORP approval of Contractor-initiated changes is required. A 'quasiUSQ' process has been implemented that defines when AB changes could occur. The three types of AB changes are (1) Limited Scope Changes, (2) Authorization Basis Deviations, and (3) Authorization Basis Amendment Request (ABAR). DOE RL/REG 97-13, 'Office of River Protection Position on Contractor-Initiated Changes to the Authorization Basis', describes the process the WTP Contractor must follow to make changes to the AB, with and without ORP approval. The process uses a 'safety evaluation' process that is similar to the USQ process but at a more qualitative level. The maturation of the WTP Contractor's facility design and activities, and other changing conditions, resulted in a process that allows the Contractor to make changes to the AB without ORP approval; however, those changes that may significantly affect nuclear safety do require ORP approval. This process balances the WTP regulatory principle of efficiency with assurance that adequate safety will not be compromised. The process has reduced the number of ABARs requiring ORP approval and reduced the potential for delays in design and procurement activities
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Miracle drug: Brazil approves never-tested cancer medicine.
Kuchenbecker, Ricardo S; Mota, Daniel M
2017-07-01
Background Brazil recently approved synthetic phosphoetanolamine, a popularly dubbed 'cancer pill', a substance that has been shown to kill cancer cells in lab animal models but was not yet formally accessed in humans, and thus despite the existence of any evidence of its efficacy and safety. Methods The authors describe the recent decision of Brazil to aprove phosphoetanolamine in the context of growing 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty. Results The approval of phosphoetanolamine despite the existence of any evidence of its efficacy and safety represents to the authors one of the saddest and surrealistic episodes in Brazil's recent public health history. Brazil's current economic crisis is fueling the 'judicialization' to promote access to medicines and thus reinforcing a growing sense of legal uncertainty in the context of rising economic constrains and a progressive failing state. The authors state that the Phosphoetanolamine's approval bill violates current legal prohibition of commercialisation of drugs without the Brazilian national drug regulatory agency's approval and thus may represent a potential menace to Brazil's pharmacogovernance and the country's governance to health technology assessment at the Brazilian national health systems. Conclusion Phosphoetanolamine's approval illustrates that the combination of flawed decision making, economic crisis and political interference may threaten weak governance mechanisms for drug regulation and health technology assessment and thus representing an extra burden in the sustainability of universal access-based national health systems.
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30 CFR 71.301 - Respirable dust control plan; approval by District Manager and posting.
2010-07-01
... District Manager and posting. 71.301 Section 71.301 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION... plan; approval by District Manager and posting. (a) The District Manager will approve respirable dust control plans on a mine-by-mine basis. When approving respirable dust control plans, the District Manager...
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Proceedings of the first technical committee meeting held in Vienna, Austria, 17-20 November 1987
International Nuclear Information System (INIS)
1987-01-01
This was the first Technical Committee meeting organized by the International Atomic Energy Agency on reactivity transient accidents as a response to recommendations made during the Chernobyl Post Accident Review Meeting (25-29 August 1986) and the subsequent Member States Experts meeting to review the IAEA expanded nuclear safety programme. The Technical Committee meeting was attended by 46 representatives from 28 countries and 1 international organization. The objectives of the Technical Committee meeting were: to review the state of knowledge and to assess the remaining safety questions relating to reactivity initiated accidents (RIAs); to share experience and information on RIA assessment and relevant fuel experiments; to formulate conclusions on what the consensus might be on safety aspects of the RIAs; and to provide recommendations for sharing the technical information and for IAEA assistance to Member States. A separate abstract was prepared for each of the 17 presentations of this meeting. Refs, figs and tabs
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Directory of Open Access Journals (Sweden)
M.J. Bernardes
2012-11-01
Full Text Available Introduction: Reporting of ethical committee (EC approval and patient consent in publications involving human subjects may be lower than recommended. In this paper this ethical issue was analysed in the Portuguese Journal of Pulmonology and in the other two Portuguese medical journals with impact factor indexed in the ISI Web of Knowledge. Methods: Reporting of EC approval and patient consent was searched in all publications involving human subjects published in the Acta Médica Portuguesa, Acta Reumatológica Portuguesa and Portuguese Journal of Pulmonology, from the 1st July 2010 until the 30th June 2011. The search also looked for the involvement of vulnerable and potentially identifiable subjects. Results: Most of the analysed publications, which included a considerable proportion of vulnerable (23% and of potentially identifiable case reports (14%, were case reports (49%. Overall EC approval ranged from 0% to 28%, in case reports and prospective studies, respectively, whereas overall patient consent ranged from 0% to 26%. There were not statistically significant differences in results among the selected journals. Conclusions: Reporting of EC approval and patient consent in the three leading Portuguese medical journals has been lower than in their leading world counterparts. This should be taken into account and further audited in future, not only for the protection of the research subjects but also to maintain public trust in the process. Resumo: Introdução: A referência a aprovação de comissão de ética (CE e a consentimento dos doentes, nas publicações que envolvem humanos, poderá ser inferior à recomendada. Neste artigo, esta situação foi analisada na Revista Portuguesa de Pneumologia e nas outras 2 revistas médicas portuguesas com fator de impacto indexadas na ISI Web of Knowledge. Métodos: A referência a aprovação de CE e a consentimento dos doentes foi pesquisada em todas as publicações que envolveram humanos na
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International Nuclear Information System (INIS)
Mutic, Sasa; Palta, Jatinder R.; Butker, Elizabeth K.; Das, Indra J.; Huq, M. Saiful; Loo, Leh-Nien Dick; Salter, Bill J.; McCollough, Cynthia H.; Van Dyk, Jacob
2003-01-01
This document presents recommendations of the American Association of Physicists in Medicine (AAPM) for quality assurance of computed-tomography- (CT) simulators and CT-simulation process. This report was prepared by Task Group No. 66 of the AAPM Radiation Therapy Committee. It was approved by the Radiation Therapy Committee and by the AAPM Science Council
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Why should ethics approval be required prior to publication of health promotion research?
Newson, Ainsley J; Lipworth, Wendy
2015-12-01
Most academic journals that publish studies involving human participants require evidence that the research has been approved by a human research ethics committee (HREC). Yet journals continue to receive submissions from authors who have failed to obtain such approval. In this paper, we provide an ethical justification of why journals should not, in general, publish articles describing research that has no ethics approval, with particular attention to the health promotion context. Using theoretical bioethical reasoning and drawing on a case study, we first rebut some potential criticisms of the need for research ethics approval. We then outline four positive claims to justify a presumption that research should, in most instances, be published only if it has been undertaken with HREC approval. We present four justifications for requiring ethics approval before publication: (1) HREC approval adds legitimacy to the research; (2) the process of obtaining HREC approval can improve the quality of an intervention being investigated; (3) obtaining HREC approval can help mitigate harm; and (4) obtaining HREC approval demonstrates respect for persons. This paper provides a systematic and comprehensive assessment of why research ethics approval should generally be obtained before publishing in the health promotion context. So what? Journals such as the Health Promotion Journal of Australia have recently begun to require research ethics approval for publishing research. Health promotion researchers will be interested in learning the ethical justification for this change.
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International Nuclear Information System (INIS)
Little, C.A.
1995-01-01
The government of Ukraine, a now-independent former member of the Soviet Union, has asked the United States to assist its State Committee for Nuclear and Radiation Safety (SCNRS) in improving its regulatory control in technical fields for which it has responsibility. The US Nuclear Regulatory Commission (NRC) is providing this assistance in several areas, including management of radioactive waste and spent fuel. Radioactive wastes resulting from nuclear power plant operation, maintenance, and decommissioning must be stored and ultimately disposed of appropriately. In addition, radioactive residue from radioisotopes used in various industrial and medical applications must be managed. The objective of this program is to provide the Ukrainian SCNRS with the information it needs to establish regulatory control over uranium mining and milling activities in the Zheltye Vody (Yellow Waters) area and radioactive waste disposal in the Pripyat (Chernobyl) area among others. The author of this report, head of the Environmental Technology Section, Health Sciences Research Division of Oak Ridge National Laboratory, accompanied NRC staff to Ukraine to meet with SCNRS staff and visit sites in question. The report highlights problems at the sites visited and recommends license conditions that SCNRS can require to enhance safety of handling mining and milling wastes. The author's responsibility was specifically for the visit to Zheltye Vody and the mining and milling waste sites associated with that facility. An itinerary for the Zheltye Vody portion of the trip is included as Appendix A
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International Nuclear Information System (INIS)
Petti, D.A.; Haire, J.C.
1993-12-01
The International Thermonuclear Experimental Reactor (ITER) is the first fusion machine that will have sufficient decay heat and activation product inventory to pose potential nuclear safety concerns. As a result, nuclear safety and environmental issues will be much more important in the approval process for the design, siting, construction, and operation of ITER in the United States than previous fusion devices, such as the Tokamak Fusion Test Reactor. The purpose of this report is (a) to provide an overview of the regulatory approval process for a Department of Energy (DOE) nuclear facility; (b) to present the dose limits used by DOE to protect workers, the public, and the environment from the risks of exposure to radiation and hazardous materials; (c) to discuss some key nuclear safety-related issues that must be addressed early in the Engineering Design Activities (EDA) to obtain regulatory approval; and (d) to provide general guidelines to the ITER Joint Central Team (JCT) concerning the development of a regulatory framework for the ITER project
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Fritschi, Lin; Kelsall, Helen L; Loff, Bebe; Slegers, Claudia; Zion, Deborah; Glass, Deborah C
2015-07-01
Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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76 FR 64326 - National Construction Safety Team Advisory Committee Meeting
2011-10-18
... update the Committee on the status of the National Institute of Standards and Technology (NIST) Disaster... business. The final agenda will be posted on the NIST Web site at http://www.nist.gov/el/disasterstudies... INFORMATION section of this notice. FOR FURTHER INFORMATION CONTACT: Eric Letvin, Director, Disaster and...
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Marketing Approval of Ethical Kampo Medicines.
Hakamatsuka, Takashi
2017-01-01
Kampo medicine is an original traditional medicine in Japan. Currently, 148 ethical Kampo formulations (Kampo prescription drugs) are registered in the National Health Insurance Price List. Kampo medicines can be prescribed under the national insurance system, which shows that they are part of conventional medicine in Japan. Japan has a unified drug approval system that does not distinguish between Western and Kampo medicines, and both are subject to the same regulations. The application for the market approval of ethical Kampo medicines is based on the general notification for drugs, i.e., "Handling of Ethical Combination Drugs" in "Precautions Necessary When Applying for Drug Marketing Approval" (Yakushokushinsa Notification No. 1121-12 of November 21, 2014). Furthermore, applications for the market approval of ethical Kampo medicines should follow the Kampo-specific notification of "Handling of Ethical Kampo Medicines" (Yakushin Notification No. 804 of June 25, 1980). Data from comparative studies with standard decoctions must be submitted with approval applications according to Yakushin 2 Notification No. 120 of May 31, 1985. The safety, efficacy, and quality of Kampo medicines are comprehensively assured by the Japanese Pharmacopoeia, Good Manufacturing Practice, Good Agricultural and Collection Practices, marketing approval certificate, approval standard, and pharmacovigilance. I believe that the basic framework for the market approval of ethical Kampo medicines has been established as described above. The key factors for the practical application of superior manufacturing technology and research achievements and the promotion of drug development are the specific guidelines for the approval of drugs of herbal origin.
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14 CFR 415.117 - Ground safety.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Ground safety. 415.117 Section 415.117... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.117 Ground safety. (a) General. An applicant's safety review...
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14 CFR 415.115 - Flight safety.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Flight safety. 415.115 Section 415.115... TRANSPORTATION LICENSING LAUNCH LICENSE Safety Review and Approval for Launch of an Expendable Launch Vehicle From a Non-Federal Launch Site § 415.115 Flight safety. (a) Flight safety analysis. An applicant's...
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75 FR 8038 - Fruit and Vegetable Industry Advisory Committee
2010-02-23
... Agricultural Commodities Act program, marketing agreements, food safety, local farmer/education initiatives... DEPARTMENT OF AGRICULTURE Agricultural Marketing Service [Doc. No. AMS-FV-10-0017; FV-09-378] Fruit and Vegetable Industry Advisory Committee AGENCY: Agricultural Marketing Service, USDA. ACTION...
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Periodic safety review of the HTR-10 safety analysis
International Nuclear Information System (INIS)
Chen Fubing; Zheng Yanhua; Shi Lei; Li Fu
2015-01-01
Designed by the Institute of Nuclear and New Energy Technology (INET) of Tsinghua University, the 10 MW High Temperature Gas-cooled Reactor-Test Module (HTR-10) is the first modular High Temperature Gas-cooled Reactor (HTGR) in China. According to the nuclear safety regulations of China, the periodic safety review (PSR) of the HTR-10 was initiated by INET after approved by the National Nuclear Safety Administration (NNSA) of China. Safety analysis of the HTR-10 is one of the key safety factors of the PSR. In this paper, the main contents in the review of safety analysis are summarized; meanwhile, the internal evaluation on the review results is presented by INET. (authors)
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2012-09-27
... account for any future changes to the emission model, projection model and other input data. \\2\\ A safety... changes in the emissions model and vehicle miles traveled (VMT) projection model. EPA is approving this... Regional Office's official hours of business are Monday through Friday, 8:30 to 4:30, excluding federal...
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Operation safety at Ignalina NPP
International Nuclear Information System (INIS)
Zheltobriukh, G.
1999-01-01
An improvement of operational safety at Ignalina NPP covers: improvement of management structure and safety culture; symptom-based emergency operating procedures; staff training and full scope simulator; program of components ageing; metal inspection; improvement of fire safety. The first plan of Ignalina NPP Safety culture development for 1997 purposed to the SAR recommendation implementation was prepared and approved by the General Director
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77 FR 63849 - National Offshore Safety Advisory Committee
2012-10-17
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2012-0855] National Offshore Safety... November 7 and 8, 2012, in Houston, TX to discuss various issues related to safety of operations and other... public comments. ADDRESSES: The meetings will be held at the Marriott South Hobby Airport Hotel, 9100...
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The in-depth safety assessment (ISA) pilot projects in Ukraine
International Nuclear Information System (INIS)
Kot, C. A.
1998-01-01
Ukraine operates pressurized water reactors of the Soviet-designed type, VVER. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs). After approval of the SARS by the Ukrainian Nuclear Regulatory Authority, the plants will be granted longer-term operating licenses. In September 1995, the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine issued a new contents requirement for the safety analysis reports of VVERs in Ukraine. It contains requirements in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The DBA requirements are an expanded version of the older SAR requirements. The last two requirements, on PRA and BDBA, are new. The US Department of Energy (USDOE), through the International Nuclear Safety Program (INSP), has initiated an assistance and technology transfer program to Ukraine to assist their nuclear power stations in developing a Western-type technical basis for the new SARS. USDOE sponsored In-Depth Safety Assessments (ISAs) have been initiated at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1. USDOE/INSP have structured the ISA program in such a way as to provide maximum assistance and technology transfer to Ukraine while encouraging and supporting the Ukrainian plants to take the responsibility and initiative and to perform the required assessments
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International Nuclear Information System (INIS)
1972-09-01
Under the Terms of Reference of the International Nuclear Data Committee (INDC) , hereinafter referred to as the Committee, approved by the Director General of the IAEA in October 1967, the Committee is authorized to determine its own Methods of Work, including preparation of its agenda, establishment of working groups, keeping of records and other procedures. The Committee will have the dual purpose of serving as a means of promoting international cooperation in all phases of nuclear data activity of general usefulness to nuclear energy programmes, and of advising the Director General of the IAEA in this field. The Committee shall be concerned with the collection, exchange and dissemination of basic nuclear data generally relevant to nuclear energy programmes, with the various aspects of measurements and interpretation of nuclear cross sections and other nuclear constants, and the instrumentation and techniques related thereto.
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A comparison of some Mexican/U.S. safety regulations
Energy Technology Data Exchange (ETDEWEB)
Bunner, W.R. [Training Associates, Columbus, OH (United States)
1994-12-31
In the US, safety and hygiene began to be enforced broadly with the formation of the US Department of Labor`s, Occupational Safety and Health Administration (OSHA) in 1970. In Mexico, the 1917 Constitution required companies to protect their workers against safety and hygiene hazards in the workplace. Additional requirements were added with the Federal Labor Law of 1931. General safety and hygiene regulations were added in 1934. Modern-day federal labor law in Mexico requires the creation of mixed safety and hygiene commissions in all industries. However, only about 114,000 workplaces have registered mixed commissions. In a similar vein, the most favored OSHA reform bill in the US proposes to require safety and health committees in all work places. At this time such committees are common in larger companies but not in smaller ones.
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75 FR 57019 - Pesticide Product Registrations; Conditional Approval
2010-09-17
..., the Agency was able to make basic health and safety determinations which show that use of flutriafol... unreasonable adverse effects to man and the environment. III. Conditional Approval Form EPA issued a notice...
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Pharmacovigilance of biologicals : dynamics in post-approval safety learning
Vermeer, N.S.
2015-01-01
Regulatory decisions to allow new drugs on the market by definition have to accept a certain level of uncertainty about the full benefit-risk balance. Pre-approval studies typically provide information on a limited number of patients over a relative short follow-up period, and handle strict
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2011-01-31
... consisting of amendments to Rule A-3, on membership on the Board, in order to establish a Nominating... Independent Public Finance Advisors to discuss the proposed rule change among other matters. See Memorandum... to the creation of the Nominating Committee of the MSRB. On September 30, 2010, the SEC approved MSRB...
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Tomazoni, Andréia; Rocha, Patrícia Kuerten; de Souza, Sabrina; Anders, Jane Cristina; de Malfussi, Hamilton Filipe Correia
2014-01-01
OBJECTIVE: to verify the assessment of the patient safety culture according to the function and length of experience of the nursing and medical teams at Neonatal Intensive Care Units. METHOD: quantitative survey undertaken at four Neonatal Intensive Care Units in Florianópolis, Brazil. The sample totaled 141 subjects. The data were collected between February and April 2013 through the application of the Hospital Survey on Patient Safety Culture. For analysis, the Kruskal-Wallis and Chi-Square tests and Cronbach's Alpha coefficient were used. Approval for the research project was obtained from the Ethics Committee, CAAE: 05274612.7.0000.0121. RESULTS: differences in the number of positive answers to the Hospital Survey on Patient Safety Culture, the safety grade and the number of reported events were found according to the professional characteristics. A significant association was found between a shorter Length of work at the hospital and Length of work at the unit and a larger number of positive answers; longer length of experience in the profession represented higher grades and less reported events. The physicians and nursing technicians assessed the patient safety culture more positively. Cronbach's alpha demonstrated the reliability of the instrument. CONCLUSION: the differences found reveal a possible relation between the assessment of the safety culture and the subjects' professional characteristics at the Neonatal Intensive Care Units. PMID:25493670
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Informed consent in Sri Lanka: A survey among ethics committee members
Directory of Open Access Journals (Sweden)
Siriwardhana Chesmal
2008-05-01
Full Text Available Abstract Background Approval of the research proposal by an ethical review committee from both sponsoring and host countries is a generally agreed requirement in externally sponsored research. However, capacity for ethics review is not universal. Aim of this study was to identify opinions and views of the members serving in ethical review and ethics committees in Sri Lanka on informed consent, essential components in the information leaflet and the consent form. Methods We obtained ethical approval from UK and Sri Lanka. A series of consensus generation meetings on the protocol were conducted. A task oriented interview guide was developed. The interview was based on open-ended questionnaire. Then the participants were given a WHO checklist on informed consent and requested to rate the items on a three point scale ranging from extremely important to not important. Results Twenty-nine members from ethics committees participated. Majority of participants (23, believed a copy of the information leaflet and consent form, should accompany research proposal. Opinions about the items that should be included in the information leaflets varied. Participants identified 18 criteria as requirements in the information leaflet and 19 for the consent form. The majority, 20 (69%, believed that all research need ethical approval but identified limited human resource, time and inadequate capacity as constraints. Fifteen (52% believed that written consent is not required for all research. Verbal consent emerged as an alternative to written consent. The majority of participants rated all components of the WHO checklist as important. Conclusion The number of themes generated for the consent form (N = 18 is as many as for the information leaflet (N = 19 and had several overlaps. This suggests that the consent form should be itemized to reflect the contents covered in the information leaflet. The participants' opinion on components of the information leaflets and
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HSE statement on the approval of dosimetry services
International Nuclear Information System (INIS)
1992-09-01
This statement is intended to assist dosimetry services who may wish to be approved by the U.K. Health and Safety Executive under Regulation 15 of the Ionising Radiations Regulations 1985. It also serves to inform approved dosimetry services of changes in the arrangements which HSE makes for approval and reassessment of dosimetry services. A general description of the administrative arrangements for making application is given and the subsequent processing of such applications by the HSE is outlined. Background notes on the requirements of the Regulations are given in Appendix I. The fees which are chargeable from 20/8/92 are given in Appendix II. (Author)
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76 FR 21936 - Aviation Rulemaking Advisory Committee-New Task
2011-04-19
... assignment for the Aviation Rulemaking Advisory Committee (ARAC). SUMMARY: The FAA assigned the Aviation... the evolving transportation needs, challenges and opportunities of the United States and global... influence the need to consider rulemaking; e.g., safety, capacity, cost, environmental impacts...
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Pitt, Penelope
2014-01-01
This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…
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78 FR 18614 - National Offshore Safety Advisory Committee
2013-03-27
... DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2013-0182] National Offshore Safety... April 17 and 18, 2013, in New Orleans, LA, to discuss various issues related to safety of operations and... comments. ADDRESSES: The meetings will be held at the Wyndham Garden New Orleans Baronne Plaza Hotel, 201...
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Contributions of the food irradiation technology to the nutritional and alimentary safety
International Nuclear Information System (INIS)
Ferreira, Sonia Regina Schauffert
1999-01-01
This work is a bibliographic review about the contributions of the food irradiation technology on nutritional and alimentary safety. Subjected to research and development for more than 60 years, these technology was approved by a jointly FAO/WHO/IAEA Expert Committees in 1980 with the conclusion that the irradiation of food up to an overall average dose of 10 kGy present no toxicological hazard and introduce no special nutritional or microbiological problems. Following these conclusions general standards and practices for food irradiation were adopted by the Codex Alimentarium Commission in 1983, opening the possibilities for internal applications and international commerce of irradiated food in many countries. Radiation from radioisotopes sources, electron accelerators or X-ray generators can be applied to food in order to reduce the microbial load, insect disinfestation, improving the shelf life extension of the products. Absorbed doses up to 10 kGy level do not introduce significant alterations in the macro or micro nutrients contents or in the sensorial characteristic of irradiated food. Although food safety can be related with many other important topics, irradiation technology improving food quality, reducing food spoilage during preservation and preventing problems related with food borne disease present a good potential to contribute with the foment and guaranty of the nutritional and alimentary safety. (author)
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International Nuclear Information System (INIS)
1988-06-01
On December 8, 1986, the Committee on Nuclear Safety Research of the National Research Council submitted its report, ''Revitalizing Nuclear Safety Research,'' to the US Nuclear Regulatory Commission (NRC). The Commission and its staff have carefully reviewed the Committee's report and have extensively examined the planning, implementation, and management of NRC research programs in order to respond most effectively to the Committee's recommendations. This report presents the Commission's view of the Committee's report and describes the actions that are under way in response to its recommendations
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Larkins, Erin; Blumenthal, Gideon M; Chen, Huanyu; He, Kun; Agarwal, Rajiv; Gieser, Gerlie; Stephens, Olen; Zahalka, Eias; Ringgold, Kimberly; Helms, Whitney; Shord, Stacy; Yu, Jingyu; Zhao, Hong; Davis, Gina; McKee, Amy E; Keegan, Patricia; Pazdur, Richard
2016-11-01
On December 11, 2015, the FDA granted accelerated approval to alectinib (Alecensa; Genentech) for the treatment of patients with anaplastic lymphoma receptor tyrosine kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This approval was based on two single-arm trials including 225 patients treated with alectinib 600 mg orally twice daily. The objective response rates (ORR) by an independent review committee in these studies were 38% [95% confidence interval (CI), 28-49] and 44% (95% CI, 36-53); the median durations of response (DOR) were 7.5 months and 11.2 months. In a pooled analysis of 51 patients with measurable disease in the central nervous system (CNS) at baseline, the CNS ORR was 61% (95% CI, 46-74); the CNS DOR was 9.1 months. The primary safety analysis population included 253 patients. The most common adverse reactions were fatigue (41%), constipation (34%), edema (30%), and myalgia (29%). The most common laboratory abnormalities were anemia (56%), increased aspartate aminotransferase (51%), increased alkaline phosphatase (47%), increased creatine phosphokinase (43%), hyperbilirubinemia (39%), hyperglycemia (36%), increased alanine aminotransferase (34%), and hypocalcemia (32%). Dose reductions due to adverse reactions occurred in 12% of patients, whereas 27% of patients had alectinib dosing interrupted for adverse reactions. Permanent discontinuation of alectinib due to adverse reactions occurred in only 6% of patients. With the clinically meaningful ORR and DOR as well as the safety profile observed in these trials, alectinib was determined to have a favorable benefit-risk profile for the treatment of the indicated population. Clin Cancer Res; 22(21); 5171-6. ©2016 AACR. ©2016 American Association for Cancer Research.
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A compilation of reports of the Advisory Committee on Nuclear Waste, July 1992--June 1993
International Nuclear Information System (INIS)
1993-08-01
This compilation contains 17 reports issued by the Advisory Committee on Nuclear Waste (ACNW) during the fifth year of its operation. The reports were submitted to the Chairman and Commissioners of the US Nuclear Regulatory Commission, the Executive Director for Operations, the Director, Office of Nuclear Material Safety and Safeguards, or to the Director, Division of High Level Waste Management, Office of Nuclear Material Safety and Safeguards. All reports prepared by the Committee have been made available to the public through the NRC Public document Room and the US Library of Congress
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International Nuclear Information System (INIS)
Gordon, C.W.; Bartels, H.-W.; Honda, T.; Raeder, J.; Topilski, L.; Iseli, M.; Moshonas, K.; Taylor, N.; Gulden, W.; Kolbasov, B.; Inabe, T.; Tada, E.
2001-01-01
Safety has been an integral part of the design process for ITER since the Conceptual Design Activities of the project. The safety approach adopted in the ITER-FEAT design and the complementary assessments underway, to be documented in the Generic Site Safety Report (GSSR), are expected to help demonstrate the attractiveness of fusion and thereby set a good precedent for future fusion power reactors. The assessments address ITER's radiological hazards taking into account fusion's favourable safety characteristics. The expectation that ITER will need regulatory approval has influenced the entire safety design and assessment approach. This paper summarises the ITER-FEAT safety approach and assessments underway. (author)
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Hawaii State Plan for Occupational Safety and Health. Final rule.
2012-09-21
This document announces the Occupational Safety and Health Administration's (OSHA) decision to modify the Hawaii State Plan's ``final approval'' determination under Section 18(e) of the Occupational Safety and Health Act (the Act) and to transition to ``initial approval'' status. OSHA is reinstating concurrent federal enforcement authority over occupational safety and health issues in the private sector, which have been solely covered by the Hawaii State Plan since 1984.
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International Nuclear Information System (INIS)
D. Kokkinos
2005-01-01
The purpose of this letter is to request Naval Reactors comments on the nuclear reactor high tier requirements for the PROMETHEUS space flight reactor design, pre-launch operations, launch, ascent, operation, and disposal, and to request Naval Reactors approval to transmit these requirements to Jet Propulsion Laboratory to ensure consistency between the reactor safety requirements and the spacecraft safety requirements. The proposed PROMETHEUS nuclear reactor high tier safety requirements are consistent with the long standing safety culture of the Naval Reactors Program and its commitment to protecting the health and safety of the public and the environment. In addition, the philosophy on which these requirements are based is consistent with the Nuclear Safety Policy Working Group recommendations on space nuclear propulsion safety (Reference 1), DOE Nuclear Safety Criteria and Specifications for Space Nuclear Reactors (Reference 2), the Nuclear Space Power Safety and Facility Guidelines Study of the Applied Physics Laboratory
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Committee Opinion No. 707 Summary: Access to Emergency Contraception.
2017-07-01
Emergency contraception refers to contraceptive methods used to prevent pregnancy in the first few days after unprotected intercourse, sexual assault, or contraceptive failure. Although the U.S. Food and Drug Administration approved the first dedicated product for emergency contraception in 1998, numerous barriers to emergency contraception remain. The purpose of this Committee Opinion is to examine barriers to the use of emergency contraception, emphasize the importance of increasing access, and review new methods of emergency contraception and limitations in efficacy in special populations.
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Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide
Energy Technology Data Exchange (ETDEWEB)
NONE
2012-07-15
This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.
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Safety in the Utilization and Modification of Research Reactors. Specific Safety Guide
International Nuclear Information System (INIS)
2012-01-01
This Safety Guide is a revision of Safety Series No. 35-G2 on safety in the utilization and modification of research reactors. It provides recommendations on meeting the requirements for the categorization, safety assessment and approval of research reactor experiments and modification projects. Specific safety considerations in different phases of utilization and modification projects are covered, including the pre-implementation, implementation and post-implementation phases. Guidance is also provided on the operational safety of experiments, including in the handling, dismantling, post-irradiation examination and disposal of experimental devices. Examples of the application of the safety categorization process for experiments and modification projects and of the content of the safety analysis report for an experiment are also provided. Contents: 1. Introduction; 2. Management system for the utilization and modification of a research reactor; 3. Categorization, safety assessment and approval of an experiment or modification; 4. Safety considerations for the design of an experiment or modification; 5. Pre-implementation phase of a modification or utilization project; 6. Implementation phase of a modification or utilization project; 7. Post-implementation phase of a utilization or modification project; 8. Operational safety of experiments at a research reactor; 9. Safety considerations in the handling, dismantling, post-irradiation examination and disposal of experimental devices; 10. Safety aspects of out-of-reactor-core installations; Annex I: Example of a checklist for the categorization of an experiment or modification at a research reactor; Annex II: Example of the content of the safety analysis report for an experiment at a research reactor; Annex III: Examples of reasons for a modification at a research reactor.
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Setting clear expectations for safety basis development
International Nuclear Information System (INIS)
MORENO, M.R.
2003-01-01
DOE-RL has set clear expectations for a cost-effective approach for achieving compliance with the Nuclear Safety Management requirements (10 CFR 830, Nuclear Safety Rule) which will ensure long-term benefit to Hanford. To facilitate implementation of these expectations, tools were developed to streamline and standardize safety analysis and safety document development resulting in a shorter and more predictable DOE approval cycle. A Hanford Safety Analysis and Risk Assessment Handbook (SARAH) was issued to standardized methodologies for development of safety analyses. A Microsoft Excel spreadsheet (RADIDOSE) was issued for the evaluation of radiological consequences for accident scenarios often postulated for Hanford. A standard Site Documented Safety Analysis (DSA) detailing the safety management programs was issued for use as a means of compliance with a majority of 3009 Standard chapters. An in-process review was developed between DOE and the Contractor to facilitate DOE approval and provide early course correction. As a result of setting expectations and providing safety analysis tools, the four Hanford Site waste management nuclear facilities were able to integrate into one Master Waste Management Documented Safety Analysis (WM-DSA)
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The Nordic Nuclear Safety Research (NKS) programme. Nordic cooperation on nuclear safety
Energy Technology Data Exchange (ETDEWEB)
Andersson, Kasper G. [Technical Univ. of Denmark, Roskilde (Denmark). National Lab. for Sustainable Energy; Ekstroem, Karoliina [Fortum Power and Heat, Fortum (Finland); Gwynn, Justin P. [Norwegian Radiation Protection Authority, Tromsoe (Norway). Fram Centre; Magnusson, Sigurdur M. [Icelandic Radiation Safety Authority, Reykjavik (Iceland); Physant, Finn C. [NKS-Sekretariatet, Roskilde (Denmark)
2012-07-01
The roots of the current Nordic Nuclear Safety Research (NKS) programme can be traced back to the recommendation by the Nordic Council in the late 1950s for the establishment of joint Nordic committees on the issues of nuclear research and radiation protection. One of these joint Nordic committees, the 'Kontaktorgan', paved the way over its 33 years of existence for the future of Nordic cooperation in the field of nuclear safety, through the formation of Nordic groups on reactor safety, nuclear waste and environmental effects of nuclear power in the late 1960s and early 1970s. With an increased focus on developing nuclear power in the wake of the energy crisis on the 1970s, the NKS was established by the Nordic Council to further develop the previous strands of Nordic cooperation in nuclear safety. NKS started its first programme in 1977, funding a series of four year programmes over the next 24 years covering the areas of reactor safety, waste management, emergency preparedness and radioecology. Initially funded directly from the Nordic Council, ownership of NKS was transferred from the political level to the national competent authorities at the beginning of the 1990s. This organizational and funding model has continued to the present day with additional financial support from a number of co-sponsors in Finland, Norway and Sweden. (orig.)
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2012-01-17
... advise the public of the eighteenth meeting of RTCA Special Committee 216: Aeronautical Systems Security... Agenda Overview and Approval Split Plenary Session (9:15 a.m.--12 p.m.) SC 216 Review of the Summary of....--12 p.m.) WG-72 Introduction, Report about publications and relations EUROCAE Document Discussions, e...
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2009-01-01
Safety is an integral part of our working lives, and should be in our minds whatever job we do at CERN. Ultimately, safety is the responsibility of the Director General – your safety is my concern. That’s why I have this week appointed a new Safety Policy Committee (SAPOCO) that reflects the new Organizational structure of CERN. CERN’s Staff Rules and Regulations clearly lay out in chapter 3 the scope of safety at CERN as well as my responsibilities and yours in safety matters. At CERN, safety is considered in the broadest sense, encompassing occupational Health and Safety, environmental protection, and the safety of equipment and installations. It is my responsibility to put appropriate measures in place to ensure that these conditions are met. And it is the responsibility of us all to ensure that we are fully conversant with safety provisions applicable in our areas of work and that we comply with them. The appointment of a n...
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Safety management of radioisotopes and others in educational institutions
International Nuclear Information System (INIS)
1981-01-01
Radioisotopes are extensively used in the fields of research in various educational institutions. While considerable progress has been seen in the safety management of RI utilization, such accidents as the loss of radioisotopes and radioactive contamination occurred. Under the situation, the safety management of RIs and others in RI-using facilities provided by the law has been examined by the ad hoc committee. A report by the committee is described as follows: need for a RI safety management organization, defining the responsibility of the chief technicians handling radiation, need for the practices of using RIs, etc. in education and traininng, planned RI-handling facilities, cautions for the loss of RIs and the contamination, centralization in RI safety management, improvement of remuneration for the chief technicians handling radiation, occasional restudy on the safety management of RIs, etc. (J.P.N.)
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Disposal of radioactive waste: can long-term safety be evaluated
International Nuclear Information System (INIS)
1991-01-01
The long-term safety of any hazardous waste disposal system must be convincingly shown prior to its implementation. For radioactive wastes, safety assessments over timescales far beyond the normal horizon of social and technical planning have already been conducted in many countries. These assessments provide the principal means to investigate, quantify, and explain long-term safety of each selected disposal concept and site for the appropriate authorities and the public. Such assessments are based on four main elements: definition of the disposal system and its environment, identification of possible processes and events that may affect the integrity of the disposal system, quantification of the radiological impact by predictive modelling, and description of associated uncertainties. The NEA Radioactive Waste Management Committee and the IAEA International Radioactive Waste Management Advisory Committee have carefully examined the current scientific methods for safety assessments of radioactive waste disposal systems, as briefly summarized in this report. The Committees have also reviewed the experience now available from using safety assessment methods in many countries, for different disposal concepts and formations, and in the framework of both nationally and internationally conducted studies, as referenced in this report [fr
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International Nuclear Information System (INIS)
2012-01-01
This activity report first describes the Committee operation (missions, composition, organization and operation rules, and means). Then, it reports the Committee's activity during 2011: works related to the Fukushima accident, report and recommendations on transparency and secrets in the nuclear sector, report and recommendations on the search for a storage site for long life and low activity wastes, meetings and work-groups, and visits
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International Nuclear Information System (INIS)
1985-01-01
Supplement 3 to the Safety Evaluation Report (SER) for the application filed by General Electric Company for the final design approval for the GE BWR/6 nuclear island design has been prepared by the Office of Nuclear Reactor Regulation of the Nuclear Regulatory Commission. This report supplements the GESSAR II SER (NUREG-0979), issued in April 1983, summarizing the results of the staff's safety review of the GESSAR II BWR/6 nuclear island design. Subject to favorable resolution of the items discussed in this supplement, the staff concludes that the GESSAR II design satisfactorily addresses the severe-accident concerns described in draft NUREG-1070
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The strategic plan for the Committee on the Safety of Nuclear Installations
International Nuclear Information System (INIS)
2000-01-01
Following the request from the NEA that all the committees should develop Strategic Plans and the report of the Effectiveness Review Group (ERG) on the effectiveness of CSNI's activities, CSNI created a Strategic Planning Group to review their working processes. In developing a five year rolling Strategic Plan, the Group has considered the need for more top-down direction by CSNI, stricter control on time limited Task Groups and improved communications including timely review and publication of reports. The Strategic Planning Group, after reviewing the current work structure of CSNI and the current technical issues as laid out in the SESAR series of reports and the CNRA report on Regulatory Effectiveness, have made the following recommendations. The basic elements of the CSNI will continue to be the Principal Working Groups, which will be known in future simply as Working Groups. The number of Working Groups and their areas of expertise will be reviewed periodically when the strategic plan undergoes a review. It is recommended that this Plan be reviewed every five years. In order to provide better top-down direction by the CSNI, it is recommended that a small Programme Review Group (PRG) be created. The PRG will assist the CSNI Bureau to review proposals from the Working Groups, and enable the review of major reports to ensure high quality. To ensure timely management of projects and reviews of proposals and reports it is recommended that CSNI have a second full meeting in early summer. It is recommended that Special Expert Groups (SEGs) be created reporting directly to CSNI. These Groups would deal with issues that cut across the disciplines of more than one Working Group and be assigned clear time-limited mandates. The creation of SEGs on Fuel Safety Margins and on Human and Organisational Factors is proposed at this time. Restructuring of the five Principal Working Groups into four Working Groups is recommended. This would be accomplished by merging the former
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[Ethic review on clinical experiments of medical devices in medical institutions].
Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining
2011-07-01
Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.
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14 CFR 431.33 - Safety organization.
2010-01-01
... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Safety organization. 431.33 Section 431.33... Launch and Reentry of a Reusable Launch Vehicle § 431.33 Safety organization. (a) An applicant shall maintain a safety organization and document it by identifying lines of communication and approval authority...
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Findings From the National Machine Guarding Program-A Small Business Intervention: Machine Safety.
Parker, David L; Yamin, Samuel C; Xi, Min; Brosseau, Lisa M; Gordon, Robert; Most, Ivan G; Stanley, Rodney
2016-09-01
The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 to 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of Occupational Safety and Health Administration (OSHA) citations and may result in serious traumatic injury. Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits, and a 12-month follow-up evaluation. The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10% point increase in business-level machine scores (P increase in LOTO program scores (P < 0.0001). Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees.
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Inter-Society Research Committee
International Nuclear Information System (INIS)
Akiyama, Mamoru; Higuchi, Masahisa.
1996-01-01
World-wide tendencies and circumstances for nuclear power cannot be said to be moving full of sail with a favorable wind, due to nuclear power plant accidents and comparatively little economical benefit. The present Nuclear Power Plant situation is that some personnel understand a need for the development from the viewpoint of efficient energy usage in the world and environmental problems like global warming. At the same time others oppose future nuclear development from the viewpoint of safety problems and economic cost. These issues may end nuclear development worldwide. Nuclear development must be considered from an international viewpoint and other various aspects. Therefore, all countries concerned should cooperative in the adjustment of research carried out by each country. Nuclear power's future must be efficient in the utilization of limited resources (money, manpower and facilities). It is concluded that the ISRC should only discuss technical matters on nuclear engineering, independent from political influence. Societies agreeing to this idea, provide the ISRC with money and/or manpower and/or facilities. The ISRC will consist of a research program committee and research task forces. Members of the Research Program Committee are the chairmen of the research task forces who are also society representatives. The Committee will discuss research programs and resources. The research task forces will consist of one society representative chairman and specialists on the program
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Hazarika, Maitreyee; Chuk, Meredith K; Theoret, Marc R; Mushti, Sirisha; He, Kun; Weis, Shawna L; Putman, Alexander H; Helms, Whitney S; Cao, Xianhua; Li, Hongshan; Zhao, Hong; Zhao, Liang; Welch, Joel; Graham, Laurie; Libeg, Meredith; Sridhara, Rajeshwari; Keegan, Patricia; Pazdur, Richard
2017-07-15
On December 22, 2014, the FDA granted accelerated approval to nivolumab (OPDIVO; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received 3 mg/kg of nivolumab intravenously every 2 weeks with at least 6-month follow-up in an ongoing, randomized, open-label, active-controlled clinical trial. The ORR as assessed by a blinded independent review committee per RECIST v1.1 was 31.7% (95% confidence interval, 23.5-40.8). Ongoing responses were observed in 87% of responding patients, ranging from 2.6+ to 10+ months. In 13 patients, the response duration was 6 months or longer. The risks of nivolumab, including clinically significant immune-mediated adverse reactions (imARs), were assessed in 268 patients who received at least one dose of nivolumab. The FDA review considered whether the ORR and durations of responses were reasonably likely to predict clinical benefit, the adequacy of the safety database, and systematic approaches to the identification, description, and patient management for imARs in product labeling. Clin Cancer Res; 23(14); 3484-8. ©2017 AACR . ©2017 American Association for Cancer Research.
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International Nuclear Information System (INIS)
1989-01-01
The International Atomic Energy Agency Safety Series No. 75-INSAG--3, 'Basic Safety Principles for Nuclear Power Plants' is reviewed in the light of the Advisory Committee on Nuclear Safety reports ACNS--2, 'Safety Objectives for Nuclear Activities in Canada', and ACNS--4, 'Recommended General Safety Requirements for Nuclear Power Plants'. The INSAG safety objectives are consistent with the safety objectives stated in ACNS--2 but are less general, applying only to nuclear power plants. The INSAG safety principles are, in general, consistent with the requirements stated in ACNS--4 but put more emphasis on 'safety culture'. They give little attention to reactor plant effluents, waste management, or decommissioning. (fig., 5 refs.)
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Rotary mode core sampling approved checklist: 241-TX-113
International Nuclear Information System (INIS)
Fowler, K.D.
1998-01-01
The safety assessment for rotary mode core sampling was developed using certain bounding assumptions, however, those assumptions were not verified for each of the existing or potential flammable gas tanks. Therefore, a Flammable Gas/Rotary Mode Core Sampling Approved Checklist has been completed for tank 241-TX-113 prior to sampling operations. This transmittal documents the dispositions of the checklist items from the safety assessment
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Rotary mode core sampling approved checklist: 241-TX-116
International Nuclear Information System (INIS)
FOWLER, K.D.
1999-01-01
The safety assessment for rotary mode core sampling was developed using certain bounding assumptions, however, those assumptions were not verified for each of the existing or potential flammable gas tanks. Therefore, a Flammable Gas/Rotary Mode Core Sampling Approved Checklist has been completed for tank 241-TX-116 prior to sampling operations. This transmittal documents the dispositions of the checklist items from the safety assessment
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Radiation protection and safety of radiation sources international basic safety standards
International Atomic Energy Agency. Vienna
2014-01-01
The Board of Governors of the IAEA first approved Basic Safety Standards in June 1962; they were published by the IAEA as IAEA Safety Series No. 9. A revised edition was issued in 1967. A third revision was published by the IAEA as the 1982 Edition of IAEA Safety Series No. 9 ; this edition was jointly sponsored by the IAEA, ILO, OECD/NEA and the WHO. The next edition was International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources, published by the IAEA as IAEA Safety Series No. 115 in February 1996, and jointly sponsored by the FAO, IAEA, ILO, OECD/NEA, PAHO and the WHO.
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International Nuclear Information System (INIS)
Whittemore, G.F.
1986-01-01
The National Committee on Radiation Protection is a private, self-perpetuating body of radiation experts founded in 1928 which, except during World War II, has established the basic guidelines for radiation safety in the United States. This dissertation examines three themes in its history from 1928 to 1960. On an intellectual level, how do scientists make judgments when called upon to perform a legal function, instead of conduct research? On an institutional level, how does a scientific committee develop when it serves a medical, industrial, and legal constituency larger than the research community of the scientist themselves? On a political level, how has the development of atomic energy influenced both the intellectual content of the radiation safety standards and the institutional form of the NCRP? Institutional and political concerns were found to play a significant role in the NCRP's intellectual work from 1928 to 1960. The time span can be divided into three periods, revealing a growing politicization of radiation safety: professional self-regulation (1928-1941), government advisory committee (1946-1954), and public controversy and increasing legislation (1954-1960). In 1959, political controversy led to the establishment of the Federal Radiation Council, a government agency which was to replace the NCRP
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The safety of Ontario's nuclear reactors
International Nuclear Information System (INIS)
1980-06-01
A Select Committee of the Legislature of Ontario was established to examine the affairs of Ontario Hydro, the provincial electrical utility. Extensive public hearings were held on several topics including the safety of nuclear power reactors operating in Ontario. The Committee found that these reactors are acceptably safe. Many of the 24 recommendations in this report deal with the licensing process and public access to information. (O.T.)
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75 FR 74735 - Food Advisory Committee; Notice of Meeting
2010-12-01
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001... Person: Carolyn Jeletic, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug... the committee. Written submissions may be made to the contact person on or before March 23, 2011. Oral...
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75 FR 82074 - Fee Adjustment for Testing, Evaluation, and Approval of Mining Products
2010-12-29
..., and Approval of Mining Products AGENCY: Mine Safety and Health Administration (MSHA), Labor. ACTION..., evaluating, and approving mining products as provided by 30 CFR part 5. MSHA charges applicants a fee to... materials manufactured for use in the mining industry. The new fee schedule, effective January 1, 2011, is...
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76 FR 37371 - Ocean Energy Safety Advisory Committee; Notice of Meeting
2011-06-27
... Advisory Committee will meet at the Astor Crowne Plaza Hotel in New Orleans, Louisiana. DATES: Wednesday...: The Astor Crowne Plaza Hotel, 739 Canal Street, New Orleans, Louisiana 70130, telephone (504) 962-0500... Budget's Circular No. A-63, Revised. Dated: June 22, 2011. Michael R. Bromwich, Director, Bureau of Ocean...
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NCRP Program Area Committee 7: Radiation Education, Risk Communication, Outreach, and Policy.
Becker, S M; Locke, P A
2016-02-01
Recognizing the central importance of effective communication, education, and policy across all of the domains of radiation safety and radiation protection, the National Council on Radiation Protection and Measurements (NCRP) established a new committee in 2013. Program Area Committee 7 (PAC 7) was created to develop projects and provide guidance on "Radiation Education, Risk Communication, Outreach, and Policy." After identifying individuals with relevant expertise who were willing to serve, the Committee held its inaugural meeting in 2014. In 2015, the Committee increased its membership and began carrying out an expanded program of activities. One area of activity has involved providing input and feedback on risk communication issues to NCRP and other agencies. Another area of work has involved liaising with other NCRP committees (e.g., Council Committee 1 and PAC 3) to help incorporate psychosocial and risk communication issues into projects. Future efforts of NCRP's newest PAC are expected to include the development of authoritative reports and commentaries dealing with critical issues and challenges in radiation risk communication, education, and policy.
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77 FR 22358 - Occupational Safety and Health Administration
2012-04-13
... DEPARTMENT OF LABOR Occupational Safety and Health Administration Preparations for the 23rd Session of the UN Sub-Committee of Experts on the Globally Harmonized System of Classification and...: Occupational Safety and Health Administration (OSHA), Labor. ACTION: Notice of public meeting. SUMMARY: OSHA...
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Directory of Open Access Journals (Sweden)
Yi-hua An
2016-01-01
Trial registration: ClinicalTrials.gov identifier: NCT01489267; registered on 30 October 2011. The study protocol has been approved by the ethics committee of the General Hospital of Chinese Armed Police Forces, China (approval No. 201117.
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International Nuclear Information System (INIS)
2008-10-01
The IAEA Safety Glossary defines and explains technical terms used in the IAEA Safety Standards and other safety related IAEA publications, and provides information on their usage.The publication is multilingual and covers the six official IAEA languages,, Arabic, Chinese, English, French, Russian and Spanish. It has been in use since April 2000. The 2007 Edition is a revised and updated version. The primary purpose of the publication is to harmonize terminology and usage in the IAEA Safety Standards. It is a source of information for users of the IAEA Safety Standards and other safety related IAEA publications and provides guidance for the drafters and reviewers of publications, including IAEA technical officers and consultants, and members of technical committees, advisory groups, working groups and bodies for the endorsement of safety standards
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International Nuclear Information System (INIS)
Anon.
1980-01-01
Statements concerning the safety of air transport of hazardous and radioactive materials presented before a Subcommittee of the Committee on Government Operations of the House of Representatives are presented. Statements of various personnel involved in air transport including the Air Line Pilots Association and the US Postal Service and the Professional Air Traffic Controllers Organization are presented for the record. Also included are appendices concerning the Minneapolis-Saint Paul Metropolitan Airport Commission Ordinance number 44, Air Line Pilots Association procedures for the safe transportation of passengers, and a personal statement concerning the handling procedures of radioactive materials by the US Postal Service
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Evaluation of experience and trends in international co-operation in nuclear safety and licensing
International Nuclear Information System (INIS)
Stadie, K.B.; Strohl, P.
1977-01-01
The paper traces the development of co-operation in nuclear safety technology between the OECD Member countries which began as early as 1965 and is now organised under the auspices of the Committee on the Safety of Nuclear Installations of the OECD Nuclear Energy Agency. The principal objective is to exchange and evaluate information on relevant R and D and hence broaden the technical basis for decision-making by licensing authorities in the different countries. The membership of the Committee on the Safety of Nuclear Installations combines expertise in nuclear safety R and D and in licensing questions so that licensing procedures in the different countries may be exposed continuously to the influence of overall technological progress. The Committee actively seeks to narrow the differences between administrative procedures and traditional legal practices in Member countries as these affect the licensing of nuclear installations, primarily by assessing and comparing the methods employed. The paper shows how the Committee's working arrangements provide for maximum flexibility: the various co-ordinated programmes are selected after in-depth evaluation of potential areas of priority and are implemented through ad hoc Working Groups, specialist meetings or task forces, or in the form of special studies involving all interested countries. The results, conclusions and recommendations emerging from each programme are reviewed by the Committee before dissemination. Hitherto the greater part of the Committee's activities has been concerned with the safety of light water reactors and related subjects, but more attention is now being given to other topics such as LMFBR safety technology and the safety of fuel cycle facilities, particularly those at the end of the process, the so-called ''back-end'' plants. The paper discusses certain problems and constraints encountered in implementing the programme, some of which stem from Member countries' different degrees of penetration
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French butane propane committee. 2003 activity report
International Nuclear Information System (INIS)
2003-01-01
This activity report presents the French butane-propane committee (CFBP), an association for the promotion of liquefied petroleum gases (LPG), the characteristics of LPG fuels, the LPG market and its evolution, the CFBP's missions and the 2003 highlights: representation of subscribing companies, participation to standardization works, making techniques and regulations change, improving the safety of equipments and installations, training and information, promoting LPG products. (J.S.)
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French butane propane committee. 2004 activity report
International Nuclear Information System (INIS)
2004-01-01
This activity report presents the French butane-propane committee (CFBP), an association for the promotion of liquefied petroleum gases (LPG), the characteristics of LPG fuels, the LPG market and its evolution, the CFBP's missions and the 2004 highlights: representation of subscribing companies, participation to standardization works, making techniques and regulations change, improving the safety of equipments and installations, training and information, promoting LPG products. (J.S.)
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75 FR 65551 - Shipping Coordinating Committee; Notice of Subcommittee Meeting
2010-10-25
... from passenger ships. --Review of damage stability regulations for ro-ro passenger ships. --Legal and... SOLAS chapter II-1 subdivision and damage stability regulations. --Consideration of IACS unified... 2012. --Any other business. --Report to the Maritime Safety Committee. Members of the public may attend...
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International Nuclear Information System (INIS)
Busche, D.M.
1995-09-01
During Fiscal Year 1992, the US Department of Energy, Richland Operations Office (RL) separately transmitted the following US Department of Energy (DOE) Orders to Westinghouse Hanford Company (WHC) for compliance: DOE 5480.21, ''Unreviewed Safety Questions,'' DOE 5480.22, ''Technical Safety Requirements,'' and DOE 5480.23, ''Nuclear Safety Analysis Reports.'' WHC has proceeded with its impact assessment and implementation process for the Orders. The Orders are closely-related and contain some requirements that are either identical, similar, or logically-related. Consequently, WHC has developed a strategy calling for an integrated implementation of the three Orders. The strategy is comprised of three primary objectives, namely: Obtain DOE approval of a single list of DOE-owned and WHC-managed Nuclear Facilities, Establish and/or upgrade the ''Safety Basis'' for each Nuclear Facility, and Establish a functional Unreviewed Safety Question (USQ) process to govern the management and preservation of the Safety Basis for each Nuclear Facility. WHC has developed policy-revision and facility-specific implementation plans to accomplish near-term tasks associated with the above strategic objectives. This plan, which as originally submitted in August 1993 and approved, provided an interpretation of the new DOE Nuclear Facility definition and an initial list of WHC-managed Nuclear Facilities. For each current existing Nuclear Facility, existing Safety Basis documents are identified and the plan/status is provided for the ISB. Plans for upgrading SARs and developing TSRs will be provided after issuance of the corresponding Rules
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International Nuclear Information System (INIS)
2001-01-01
Just after the Hyogoken-Nanbu Earthquake occurred, Nuclear Safety Commission of Japan established a committee to examine the validity or related guidelines on the seismic design to be used for the safety examination. After the 8 months study, the committee confirmed that the validity of guidelines regulating the seismic design of nuclear facilities is not impaired even though on the basis of the Hyogoken-Nanbu earthquake. This report is the outline of the Committee's study results. (author)
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International Nuclear Information System (INIS)
1987-01-01
The Technical Committee on Thermal Reactor Safety Research held its sixth meeting from 8-11 June 1987 at the Agency's Headquarters in Vienna. It was attended by 25 participants representing 18 countries and 2 international organizations. With respect to exchange on national research activities the committee members presented their most recent achievements in the area of nuclear safety research. A separate abstract was prepared for each of their presentations. Refs, figs and tabs
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The international state of affairs in marine safety
International Nuclear Information System (INIS)
Benkert, W.M.
1978-01-01
The three-fold objective of marine safety is examined with emphasis on international cooperation as a means of achievement. In this respect, the recent and present activities of the Intergovernmental Maritime Consultative organization are reviewed by looking at the accomplishments and goals of several subcommittees of the Maritime Safety Committee. The United States program for commercial vessel safety is briefly discussed along with a comment on the recent Tanker Safety initiatives
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Findings from the National Machine Guarding Program–A Small Business Intervention: Machine Safety
Yamin, Samuel C.; Xi, Min; Brosseau, Lisa M.; Gordon, Robert; Most, Ivan G.; Stanley, Rodney
2016-01-01
Objectives The purpose of this nationwide intervention was to improve machine safety in small metal fabrication businesses (3 – 150 employees). The failure to implement machine safety programs related to guarding and lockout/tagout (LOTO) are frequent causes of OSHA citations and may result in serious traumatic injury. Methods Insurance safety consultants conducted a standardized evaluation of machine guarding, safety programs, and LOTO. Businesses received a baseline evaluation, two intervention visits and a twelve-month follow-up evaluation. Results The intervention was completed by 160 businesses. Adding a safety committee was associated with a 10-percentage point increase in business-level machine scores (p< 0.0001) and a 33-percentage point increase in LOTO program scores (p <0.0001). Conclusions Insurance safety consultants proved effective at disseminating a machine safety and LOTO intervention via management-employee safety committees. PMID:26716850
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STANDING CONCERTATION COMMITTEE ORDINARY MEETING ON 14 FEBRUARY 2001
2001-01-01
This meeting was mainly devoted to the items summarised below. The Director-General attended for discussion of item 2. 1. Membership of SCC and its Sub-Groups The Chairman welcomed K-H. Schindl, new member of the SCC nominated by the Management. The President of the Staff Association, confirming that M. Aymon and M. Vitasse are nominated as its Vice-Presidents, announced its new members of the SCC, namely : Ch. Petit-Jean-Genaz and Ph. Defert. The Committee also agreed on the membership of three Sub-Groups working on : the implementation of the new career structure, the draft Guide of career path descriptions, as well as amendments to Staff Rules & Regulations and various circulars. 2. Follow-up from the meetings of the Finance Committee and Council in December 2000 Having analysed the detailed implications of implementing the package of measures approved by Council last December, the SCC identified a small discrepancy in the salary adjustment which is a secondary effect due to the redistribution of c...
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Contrast media. Safety issues and ESUR guidelines. 3. ed.
International Nuclear Information System (INIS)
Thomsen, Henrik S.; Webb, Judith A.W.
2014-01-01
Fully updates the previous edition and includes new chapters on various complex topics. Represents a unique and unparalleled source of information on the many safety issues relating to different contrast media. Includes chapters on acute and delayed non-renal adverse reactions and on renal adverse reactions. Presented in a handy, easy-to-use format. In 1994 the European Society of Urogenital Radiology (ESUR) set up a committee to consider the safety of contrast media used for diagnostic imaging. Subsequently the committee questioned ESUR members, reviewed the literature, proposed guidelines, and discussed these proposals with participants at the annual symposia of the society. The end result of this work was the successful first edition of this book, published in 2006, which was followed by an equally successful second edition in 2009. This third edition not only fully updates the previous edition, but also includes new chapters on complex topics such as use of contrast media in children and practical aspects of off-label contrast media use. The authorship includes members, past members, and non-members of the Contrast Media Safety Committee.
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National Committee for the follow-up of measures for radiotherapy 2008-2011 - Final report
International Nuclear Information System (INIS)
Buzyn, A.; Grall, J.Y; Selleret, F.X.; Lacoste, A.C.; Maraninchi, D.; Harousseau, J-L.; Chauvet, B.; LE DU, D.; Saout, C.; Renody, N.; Depenweiller, C.; Goinere, R.
2012-06-01
As always more patients suffering from cancer are treated by radiotherapy, and as several over-irradiation events occurred in 2007, measures have been implemented to guarantee radiotherapy practice quality and safety. This document reports the work and actions performed by the national follow-up committee and its work groups to define, implement and follow-up these measures. They encompassed information actions towards patients, public, physicians and establishment managers, and new authorization measures. The committee also addressed radiotherapy professions involved in manipulation, dosimetry, as well as radio-physicists and radiotherapists. It introduced measures regarding vigilance in radiation, the improvement of quality and safety in radiation therapy centres, research and development, and the financing of these measures
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Specialist committee's review reports for experimental fast reactor JOYO' MK-III performance tests
International Nuclear Information System (INIS)
Yamashita, Kiyonobu; Okubo, Toshiyuki; Kamide, Hideki
2004-02-01
Performance tests (startup-physics tests and power elevation tests) were planed for experimental fast reactor 'JOYO' MK-III where irradiation performances were upgraded by power increase from 100 to 140 MW. The reactor safety committee of O-arai Engineering Center has established a specialist committee for 'JOYO' MK-III Performance Tests at the first meeting of 2003 on 23th. April 2003, to accomplish the tests successfully. Subjects of the specialist committee were reviews of following items covering a wide range. 1) Contents of modification works. 2) Reflections of functional test results to the plant and facilities. 3) Reflections of safety rule modification to instruction and manual for operation. 4) Quality assurances and pre-calculation for performance test. 5) Inspection plan and its results. 6) Adequacy of performance test plan. 7) Confirmation of performance test results. Before test-starts, the specialist committee has confirmed by reviewing the items from 1) to 6) based on explanations and documents of the Division of Experimental Reactor, that the test plan and pre-inspections are adequate. After the tests, the specialist committee had confirmed by reviewing the item 7) in the same way, that the each test result satisfies the corresponding criterion. The specialist committee has concluded from these review's results before and after the tests that the 'JOYO' MK-III Performance Tests were carried out appropriately. Besides, the first criticality of the JOYO MK-III was achieved on 2nd. July 2003, and the continuous full power operation was carried on 20th. Nov. 2003. Finally, all performance tests were completed by the pass of the last governmental pre-serviced inspection (dose rate measurement during the shut down condition). (author)
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International Nuclear Information System (INIS)
Prah, M.; Spiler, J.; Vojnovic, D.; Pristavec, M.
1998-01-01
The article presents the approach to nuclear licensing in Slovenia. The paper describes, the initialization, internal authorization and review process in the Krsko NPP. The overall process includes preparation, internal independent evaluation, the Krsko Operating Committee and the Krsko Safety Committee review and internal approval. In addition, the continuation of the licensing process is discussed which includes independent evaluation by an authorized institution and a regulatory body approval process. This regulatory body approval process includes official hearing of the licensee, communication with the licensee, and final issuance of a license amendment. The internal evaluation, which follows the methodology of US NRC (defined in 10 CFR 50.59 and NUMARC 125) is described. This concept is partially implemented in domestic legislation.(author)
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78 FR 69991 - Advisory Committee; Veterinary Medicine Advisory Committee; Termination
2013-11-22
.... FDA-2013-N-1380] Advisory Committee; Veterinary Medicine Advisory Committee; Termination AGENCY: Food... announcing the termination of the Veterinary Medicine Advisory Committee. This document removes the Veterinary Advisory Committee from the Agency's list of standing advisory committees. DATES: This rule is...
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National nuclear safety report 1998. Convention on nuclear safety
International Nuclear Information System (INIS)
1998-01-01
The Argentine Republic subscribed the Convention on Nuclear Safety, approved by a Diplomatic Conference in Vienna, Austria, in June 17th, 1994. According to the provisions in Section 5th of the Convention, each Contracting Party shall submit for its examination a National Nuclear Safety Report about the measures adopted to comply with the corresponding obligations. This Report describes the actions that the Argentine Republic is carrying on since the beginning of its nuclear activities, showing that it complies with the obligations derived from the Convention, in accordance with the provisions of its Article 4. The analysis of the compliance with such obligations is based on the legislation in force, the applicable regulatory standards and procedures, the issued licenses, and other regulatory decisions. The corresponding information is described in the analysis of each of the Convention Articles constituting this Report. The present National Report has been performed in order to comply with Article 5 of the Convention on Nuclear Safety, and has been prepared as much as possible following the Guidelines Regarding National Reports under the Convention on Nuclear Safety, approved in the Preparatory Meeting of the Contracting Parties, held in Vienna in April 1997. This means that the Report has been ordered according to the Articles of the Convention on Nuclear Safety and the contents indicated in the guidelines. The information contained in the articles, which are part of the Report shows the compliance of the Argentine Republic, as a contracting party of such Convention, with the obligations assumed
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Public safety and sour gas quarterly progress report October - December 2002
Energy Technology Data Exchange (ETDEWEB)
Sikora, V.; Lillo, H.; Craig, M.; Neilson, G.
2003-01-01
This third quarterly progress report for the business year 2002-2003 on the Alberta Energy and Utilities Board (EUB) Public Safety and Sour Gas initiative covers projects based on the 87 recommendations made by the Provincial Advisory Committee on Public Safety and Sour Gas (Advisory Committee) in December 2000. As of December 2002, work has been completed on 16 recommendations and is proceeding on 50 recommendations. This report includes several tables indicating the status of recommendations as either complete or ongoing. The recommendation categories include: (1) sour gas development, planning and approval, (2) sour gas operations, (3) emergency preparedness, and (4) information, communication and consultation. The report also summarizes the health effects and sour gas research. Recommendations completed as of December 2002 include: plant proliferation; pre-license review of critical well license applications; license application training/certification information requirement; increase sour gas inspections; increase inspections of new and noncompliant operators; implement 100 per cent inspection rate for critical wells near people; response to sour gas complaints; enhance EUB capability to monitor for complaint response/compliance; complaint/incident response program for Aboriginal communities; interim policy on ERP review and reduced EPZs; infrastructure and resources for Aboriginal community ERP; field staff in industry-landowner discussions; EUB involvement in mediation of application issues; and, timely and meaningful public consultation for First Nations and Metis. Alberta Health and Wellness is currently evaluating the health effects of H{sub 2}S and SO{sub 2} and the work is near completion. Other ongoing work includes the development of a draft protocol to address the involvement of regional health authorities (RHAs), the early involvement of RHAs and other local government bodies, and a process for communication between the EUB field staff and
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U.S. Nuclear Regulatory Commission Safety Culture Oversight
International Nuclear Information System (INIS)
Sieracki, D. J.
2016-01-01
The NRC recognises that it is important for all organizations performing or overseeing regulated activities to establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. The NRC’s approach to safety culture is based on the premise that licencees bear the primary responsibility for safety. The NRC provides oversight of safety culture through expectations detailed in policy statements, safety culture assessor training for NRC inspectors, the oversight process, and the Allegations and Enforcement Programs. The NRC’s Safety Culture Policy Statement (SCPS) sets forth the Commission’s expectation that individuals and organizations establish and maintain a positive safety culture commensurate with the safety and security significance of their activities and the nature and complexity of their organizations and functions. The SCPS is not a regulation. It applies to all licencees, certificate holders, permit holders, authorisation holders, holders of quality assurance program approvals, vendors and suppliers of safety-related components, and applicants for a licence, certificate, permit, authorisation, or quality assurance program approval, subject to NRC authority.
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International Nuclear Information System (INIS)
2005-01-01
This report satisfies the annual reporting requirements of the ARPANS Act in addition to the Department of Prime Minister and Cabinet requirements for annual reporting by Agencies. The report includes: details of the operations of the CEO and details of directions given by the Minister under section 16 at Part 1; details of the operations of ARPANSA at Part 3; details of the operations of the Radiation Health Advisory Council, the Radiation Health Committee and the Nuclear Safety Committee and details of all reports received from the Radiation Health and Safety Advisory Council on matters related to radiation protection and nuclear safety or the Nuclear Safety Committee on matters related to nuclear safety and the safety of controlled facilities at Part 4; details of any breach of licence conditions by a licensee at Appendix 4; an index of compliance with the annual reporting requirements at Appendix 8
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Directory of Open Access Journals (Sweden)
Subhrojyoti Bhowmick
2014-01-01
Full Text Available Purpose of study: The vital responsibility of Institutional Ethics Committee (IEC members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. Materials and Methods: A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals in Kolkata conducting active clinical research and having functional Ethics Committees (ECs in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors′ collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Results: Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43% was found to be more than that of the medical members (68.75%, though the figure was not statistically significant. Majority of the members (75% felt that EC should decide compensation in case of a serious adverse event. Conclusion: The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding
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2012-03-22
... Monitoring System and the Food Safety Mobile Questionnaire) AGENCY: Food Safety and Inspection Service, USDA... Safety Mobile questionnaire. The approval for this information collection is due to expire. FSIS is... post their personal contact information--mailing address, email address, and telephone number-- on the...
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Summary of findings of the R&D committee
Energy Technology Data Exchange (ETDEWEB)
Kenley, C.R. [Lockheed Martin Idaho Technologies, Idaho Falls (United States); Kokenge, B.R. [BRK Associates Inc., Farmersville, OH (United States)
1996-05-01
In March 1995, the Department of Energy`s (DOE) Nuclear Materials Stabilization Task Group (NMST) chartered a committee to formulate a research and development (R&D) plan in response to Sub-recommendation (2) of Defense Nuclear Facilities Safety Board (DNFSB) Recommendation 94-1. The NMSTG was established as an organizational unit operating under the auspices of the DOE Office of the Environmental Management. As a result of its efforts, the Research Committee concluded that, in general, the technology needs for stabilizing 94-1 nuclear materials are being adequately met by existing or planned DOE programs. At the same time, the committee, in the form of recommendations, noted specific R&D program areas that should be addressed by the NMSTG. These recommendations are documented in the R&D plan and formulated based on: (1) existing {open_quotes}gaps{close_quotes} in DOE`s R&D stabilization program, (2) the relative maturity of various technologies, and (3) other important R&D program issues that, in the judgement of the committee, should be addressed by the NMSTG. A systems engineering approach, derived form the aerospace industry, was applied to the various stabilization technologies to assess their relative maturity and availability for use in treating 94-1 nuclear materials.
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DARHT: INTEGRATION OF AUTHORIZATION BASIS REQUIREMENTS AND WORKER SAFETY
International Nuclear Information System (INIS)
MC CLURE, D. A.; NELSON, C. A.; BOUDRIE, R. L.
2001-01-01
This document describes the results of consensus agreements reached by the DARHT Safety Planning Team during the development of the update of the DARHT Safety Analysis Document (SAD). The SAD is one of the Authorization Basis (AB) Documents required by the Department prior to granting approval to operate the DARHT Facility. The DARHT Safety Planning Team is lead by Mr. Joel A. Baca of the Department of Energy Albuquerque Operations Office (DOE/AL). Team membership is drawn from the Department of Energy Albuquerque Operations Office, the Department of Energy Los Alamos Area Office (DOE/LAAO), and several divisions of the Los Alamos National Laboratory. Revision 1 of the DARHT SAD had been written as part of the process for gaining approval to operate the Phase 1 (First Axis) Accelerator. Early in the planning stage for the required update of the SAD for the approval to operate both Phase 1 and Phase 2 (First Axis and Second Axis) DARHT Accelerator, it was discovered that a conflict existed between the Laboratory approach to describing the management of facility and worker safety
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Report of Committee for JAEA Internationalization Initiative
International Nuclear Information System (INIS)
2013-03-01
In global circumstances surrounding nuclear energy, the role expected to Japan Atomic Energy Agency (JAEA) is becoming increasingly important. JAEA has been promoted an initiative for the international hub in order to increase the scientific competitiveness of Japan and make international contributions, by gathering excellent researchers from the entire world with the latest facilities. Also, JAEA established 'Committee for JAEA Internationalization Initiative', which will discuss issues such as environmental improvement for accepted foreigners, direction of efforts for internationalization initiative and strategies to improve current situation. This report mentions the results of the committee's discussion including current issues for the initiative and recommendations for their solution, as well as the issues to be discussed in order to enhance international awareness of JAEA staff. The following is the summary of the recommendations for the initiative: Set up local teams that focus on the situation of each site in order to provide detailed support for foreigners from diversified backgrounds. Develop systems for emergency situations to provide information for safety swiftly for foreigners and confirm their safety, in addition to preparing emergency goods. Prepare bilingual documents and systems that foreigners need to use for their work based on importance and frequency of use of such systems and documents. (author)
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76 FR 67020 - Railroad Safety Advisory Committee; Notice of Meeting
2011-10-28
... Device Distraction, Critical Incident, Track Safety Standards, Dark Territory, Passenger Safety, and... requisite range of views and expertise necessary to discharge its responsibilities. See the RSAC Web site...
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Fire Safety Trianing in Health Care Institutions.
American Hospital Association, Chicago, IL.
The manual details the procedures to be followed in developing and implementing a fire safety plan. The three main steps are first, to organize; second, to set up a procedure and put it in writing; and third, to train and drill employees and staff. Step 1 involves organizing a safety committee, appointing a fire marshall, and seeking help from…
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2011-06-06
...) Program--Quality Assurance Protocol for the Safety Inspection Program in Non-I/M Counties AGENCY... approve revisions to the Pennsylvania State Implementation Plan (SIP). The revision consists of a change... prior SIP-approved I/M program to change the duration of the timing of quality assurance audits...
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2012-08-06
... CONSUMER PRODUCT SAFETY COMMISSION Proposed Extension of Approval of Information Collection; Comment Request--Baby Bouncers and Walker-Jumpers AGENCY: Consumer Product Safety Commission. ACTION... information collection requirements for manufacturers and importers of children's articles known as baby...
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77 FR 73734 - Railroad Safety Advisory Committee; Notice of Meeting
2012-12-11
... by the Engineering and System Safety Task Forces. This agenda is subject to change, including the... National Transportation Safety Board, and the Federal Transit Administration. The diversity of the...
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78 FR 26423 - Railroad Safety Advisory Committee; Notice of Meeting
2013-05-06
... Engineering and System Safety Task Forces. This agenda is subject to change, including the possible addition... National Transportation Safety Board, and the Federal Transit Administration. The diversity of the...
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Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.
Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark
2017-06-01
An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post