Commercial Grade Item (CGI) Dedication for Leak Detection Relays

DOE Office of Scientific and Technical Information (OSTI.GOV)

KOCH, M.R.

1999-10-26

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping and Instrumentation Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

Commercial Grade Item (CGI) Dedication for Leak Detection Relays

DOE Office of Scientific and Technical Information (OSTI.GOV)

JOHNS, B.R.; KOCH, M.R.

2000-01-28

This Test Plan provides a test method to dedicate the leak detection relays used on the new Pumping Instrumentation and Control (PIC) skids. The new skids are fabricated on-site. The leak detection system is a safety class system per the Authorization Basis.

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND... promulgated under Title III of the Communications Act of 1934, as amended which vests authority in the Federal Communications Commission to regulate radio transmission and to issue licenses for radio stations. All rules in...

Evaluation of radiological dispersion/consequence codes supporting DOE nuclear facility SARs

DOE Office of Scientific and Technical Information (OSTI.GOV)

O`Kula, K.R.; Paik, I.K.; Chung, D.Y.

1996-12-31

Since the early 1990s, the authorization basis documentation of many U.S. Department of Energy (DOE) nuclear facilities has been upgraded to comply with DOE orders and standards. In this process, many safety analyses have been revised. Unfortunately, there has been nonuniform application of software, and the most appropriate computer and engineering methodologies often are not applied. A DOE Accident Phenomenology and Consequence (APAC) Methodology Evaluation Program was originated at the request of DOE Defense Programs to evaluate the safety analysis methodologies used in nuclear facility authorization basis documentation and to define future cost-effective support and development initiatives. Six areas, includingmore » source term development (fire, spills, and explosion analysis), in-facility transport, and dispersion/ consequence analysis (chemical and radiological) are contained in the APAC program. The evaluation process, codes considered, key results, and recommendations for future model and software development of the Radiological Dispersion/Consequence Working Group are summarized in this paper.« less

10 CFR 830.202 - Safety basis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Safety basis. 830.202 Section 830.202 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.202 Safety basis. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis...

10 CFR 830.202 - Safety basis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Safety basis. 830.202 Section 830.202 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.202 Safety basis. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis...

The Official Control beyond the Official Control. How To Plan And Schedule Controls Starting From Risk Assessment Along The Agro-Food Supply Chain.

PubMed

Panunzio, M F; Caporizzi, R; Lagravinese, D; Conversano, M

2015-01-01

Every year the Italian Ministry of Health, on the basis of regional data, draws up the "Report on Official Controls" to be submitted to the Parliament. The report contains abundant data, diagrams and charts and illustrates the number and type of official controls (OC) performed by the pertinent Bodies (Ministry of Health, Regional and Local Health Authorities) over the previous year on Food Business Operators (FBO), in accordance with the EC Regulation 882/2004. The trend - which has consolidated over the years - relates to the multiplicity of OC and shows a decrease of such controls compared to an increase in "non-conformities". OC frequency is established by the Regional Authorities on the basis of the categorisation of both a "generic risk" for companies calculated taking into account the probability of occurrence of a "non-conformity", and a "specific" risk, assessed on the basis of the results of the OC actually performed on a given "Operatore del Settore Alimentare" (Food Sector Operator, in Italian: OSA). Thus, categorisation (i.e. the probability of occurrence of non-conformities) is the main driver of the OC scheduling and planning process. We have been asking ourselves whether the current OC planning/scheduling method is still suitable for ensuring food safety in the face of internalisation of the food supply chain. As a matter of fact, food safety is now becoming increasingly variable due to the globalization of consumption where "farm to fork", rather than "border to fork", food safety must be ensured. On the basis of these considerations, a different OC planning /scheduling method is being proposed based on the assessment of risks and the estimation of the occurrence of the same along the agro-food chain.

The role of PRA in the safety assessment of VVER Nuclear Power Plants in Ukraine.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kot, C.

1999-05-10

Ukraine operates thirteen (13) Soviet-designed pressurized water reactors, VVERS. All Ukrainian plants are currently operating with annually renewable permits until they update their safety analysis reports (SARs), in accordance with new SAR content requirements issued in September 1995, by the Nuclear Regulatory Authority and the Government Nuclear Power Coordinating Committee of Ukraine. The requirements are in three major areas: design basis accident (DBA) analysis, probabilistic risk assessment (PRA), and beyond design-basis accident (BDBA) analysis. The last two requirements, on PRA and BDBA, are new, and the DBA requirements are an expanded version of the older SAR requirements. The US Departmentmore » of Energy (USDOE), as part of its Soviet-Designed Reactor Safety activities, is providing assistance and technology transfer to Ukraine to support their nuclear power plants (NPPs) in developing a Western-type technical basis for the new SARs. USDOE sponsored In-Depth Safety Assessments (ISAs) are in progress at three pilot nuclear reactor units in Ukraine, South Ukraine Unit 1, Zaporizhzhya Unit 5, and Rivne Unit 1, and a follow-on study has been initiated at Khmenytskyy Unit 1. The ISA projects encompass most areas of plant safety evaluation, but the initial emphasis is on performing a detailed, plant-specific Level 1 Internal Events PRA. This allows the early definition of the plant risk profile, the identification of risk significant accident sequences and plant vulnerabilities and provides guidance for the remainder of the safety assessments.« less

47 CFR 90.238 - Telemetry operations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... MHz band (as available in the Public Safety Pool for bio-medical telemetry operations). (i) For... with § 90.257 and subject to the rules governing the use of that band). (b) 154.45625, 154.46375, 154...-470 MHz band, telemetry operations will be authorized on a secondary basis with a transmitter output...

[Basic consideration on the security checking of sick travelers at airports].

PubMed

Felkai, Péter; Mártai, István

2012-09-02

The authorities guarantee the safety of passengers during air travel by strict ground security measures. All of these measures are restrictive and can affect the health status of both healthy and ill travelers. Patients who are in critical condition or confined to a stretcher and have to be repatriated by stretcher on a regular flight, must pass the airport security check as well. But the developers of security system should take into account the medical safety of patients during the procedure. The relevant medical principles are painfully missing not only in Hungary, but unfortunately also at most international airports. On the basis of principles reviewed in the present publication, an unambiguous, professionally reconciled regulation is necessary that would serve as a guideline for airport management and authorities, as well as for the involved medical personnel. Although setting principles into practice requires a different solution at each airport, yet, passenger safety and patient safety have to be harmonized as soon as possible.

[Recommendations for inspections of the French nuclear safety authority].

PubMed

Rousse, C; Chauvet, B

2015-10-01

The French nuclear safety authority is responsible for the control of radiation protection in radiotherapy since 2002. Controls are based on the public health and the labour codes and on the procedures defined by the controlled health care facility for its quality and safety management system according to ASN decision No. 2008-DC-0103. Inspectors verify the adequacy of the quality and safety management procedures and their implementation, and select process steps on the basis of feedback from events notified to ASN. Topics of the inspection are communicated to the facility at the launch of a campaign, which enables them to anticipate the inspectors' expectations. In cases where they are not physicians, inspectors are not allowed to access information covered by medical confidentiality. The consulted documents must therefore be expunged of any patient-identifying information. Exchanges before the inspection are intended to facilitate the provision of documents that may be consulted. Finally, exchange slots between inspectors and the local professionals must be organized. Based on improvements achieved by the health care centres and on recommendations from a joint working group of radiotherapy professionals and the nuclear safety authority, changes will be made in the control procedure that will be implemented when developing the inspection program for 2016-2019. Copyright © 2015. Published by Elsevier SAS.

[Strategic patient safety action plan for the anesthesiology and intensive care service of Ukraine: basic modules and their components].

PubMed

Федосюк, Роман Н

In recent years, the problem of patient safety has become top-priority in further improvement of national healthcare systems in all developed countries. To develop a modular structure and a component composition of the strategic patient safety action plan for the anesthesiology and intensive care service of Ukraine as a part of the National Action Plan. Major domestic priorities, substantiated and made public by the author in previous works, are taken as the basis for the modular structuring of the action plan. Existing foreign prototypes, evaluated for the patient safety effectiveness and the potential for the adaptation to domestic conditions, as well as author's own innovations are offered for a component filling-up of each module. Eight modules - infectious safety, surgical safety, pharmaceutical safety, infrastructural safety, incident monitoring and reporting, education and training, research and awards - have been proposed. Individual components for each of the modules are selected from a variety of foreign prototypes and author's own developments. Inter-modular stratification of the components into short-term perspective tools and long-term perspective tools, depending on the amount of resources needed for their implementation, is carried out. The strategic patient safety action plan for the anesthesiology and intensive care service of Ukraine is the embodiment, within a particular specialty, of the wider National Action Plan developed by the First National Congress on Patient Safety (Kiev, 2012) on the initiative of the Council of Europe and aimed at the fulfillment of international obligations of Ukraine in the healthcare sector. Its implementation will contribute to enhancing the safety of anesthesia and intensive care services in Ukraine and further development of the specialty.

Safety considerations for outpatient electroconvulsive therapy.

PubMed

Reti, Irving M; Walker, Melinda; Pulia, Kathy; Gallegos, Jesus; Jayaram, Geetha; Vaidya, Punit

2012-03-01

As electroconvulsive therapy (ECT) requires general anesthesia and is associated with both cognitive and non-cognitive side effects, careful consideration must be given to the safety aspects of providing ECT on an outpatient basis. Drawing upon published literature and their clinical experience administering outpatient ECT, the authors propose best practices for safely providing ECT to outpatients. They review criteria for selecting patients for outpatient ECT as well as treatment and programmatic issues. The authors highlight the importance of educating referring clinicians as well as patients and their families about factors involved in the safe delivery of ECT for outpatients. Fiscal considerations and the drive toward reduced length of stay are prompting insurers and caregivers to choose outpatient over inpatient ECT. For each patient, such a choice merits a careful analysis of the risks of outpatient ECT, as well as the implementation of measures to ensure patient safety.

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution. (section 2(b), Pub. L. 91-596; U.S. Constitution, Art. I, Sec. 8, Cl. 3; “United States v. Darby,” 312 U.S. 100.) The reach of the Commerce Clause extends beyond Federal regulation of the channels and...

29 CFR 1975.2 - Basis of authority.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Occupational Safety and Health Act of 1970, is derived mainly from the Commerce Clause of the Constitution. (section 2(b), Pub. L. 91-596; U.S. Constitution, Art. I, Sec. 8, Cl. 3; “United States v. Darby,” 312 U.S. 100.) The reach of the Commerce Clause extends beyond Federal regulation of the channels and...

47 CFR 101.81 - Future licensing in the 1850-1990 MHz, 2110-2150 MHz, and 2160-2200 MHz bands.

Code of Federal Regulations, 2011 CFR

2011-10-01

... two seconds); (d) Any data correction which does not involve a change in the location of an existing... COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Applications and Licenses... authorized on a secondary basis to ET systems. All other modifications will render the modified FMS license...

47 CFR 101.81 - Future licensing in the 1850-1990 MHz, 2110-2150 MHz, and 2160-2200 MHz bands.

Code of Federal Regulations, 2012 CFR

2012-10-01

... two seconds); (d) Any data correction which does not involve a change in the location of an existing... COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Applications and Licenses... authorized on a secondary basis to ET systems. All other modifications will render the modified FMS license...

47 CFR 101.81 - Future licensing in the 1850-1990 MHz, 2110-2150 MHz, and 2160-2200 MHz bands.

Code of Federal Regulations, 2013 CFR

2013-10-01

... two seconds); (d) Any data correction which does not involve a change in the location of an existing... COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Applications and Licenses... authorized on a secondary basis to ET systems. All other modifications will render the modified FMS license...

47 CFR 101.81 - Future licensing in the 1850-1990 MHz, 2110-2150 MHz, and 2160-2200 MHz bands.

Code of Federal Regulations, 2014 CFR

2014-10-01

... two seconds); (d) Any data correction which does not involve a change in the location of an existing... COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES FIXED MICROWAVE SERVICES Applications and Licenses... authorized on a secondary basis to ET systems. All other modifications will render the modified FMS license...

Advanced Test Reactor Safety Basis Upgrade Lessons Learned Relative to Design Basis Verification and Safety Basis Management

DOE Office of Scientific and Technical Information (OSTI.GOV)

G. L. Sharp; R. T. McCracken

The Advanced Test Reactor (ATR) is a pressurized light-water reactor with a design thermal power of 250 MW. The principal function of the ATR is to provide a high neutron flux for testing reactor fuels and other materials. The reactor also provides other irradiation services such as radioisotope production. The ATR and its support facilities are located at the Test Reactor Area of the Idaho National Engineering and Environmental Laboratory (INEEL). An audit conducted by the Department of Energy's Office of Independent Oversight and Performance Assurance (DOE OA) raised concerns that design conditions at the ATR were not adequately analyzedmore » in the safety analysis and that legacy design basis management practices had the potential to further impact safe operation of the facility.1 The concerns identified by the audit team, and issues raised during additional reviews performed by ATR safety analysts, were evaluated through the unreviewed safety question process resulting in shutdown of the ATR for more than three months while these concerns were resolved. Past management of the ATR safety basis, relative to facility design basis management and change control, led to concerns that discrepancies in the safety basis may have developed. Although not required by DOE orders or regulations, not performing design basis verification in conjunction with development of the 10 CFR 830 Subpart B upgraded safety basis allowed these potential weaknesses to be carried forward. Configuration management and a clear definition of the existing facility design basis have a direct relation to developing and maintaining a high quality safety basis which properly identifies and mitigates all hazards and postulated accident conditions. These relations and the impact of past safety basis management practices have been reviewed in order to identify lessons learned from the safety basis upgrade process and appropriate actions to resolve possible concerns with respect to the current ATR safety basis. The need for a design basis reconstitution program for the ATR has been identified along with the use of sound configuration management principles in order to support safe and efficient facility operation.« less

Energy efficiency in urban management: Russian and world experience

NASA Astrophysics Data System (ADS)

Pryadko, Igor

2017-10-01

The article discusses the role of energetics in creating a comfortable and safe environment of modern megacities, and the problem is considered in the socio-economic aspect. The object is the energy security of the city, and the subject is the influence of urban society on the formation of energy security. In particular, the problems are raised: ecological problems of urban energy supply, the condition of surface layer of the atmosphere near electric power lines. The author assesses the actions, implemented by the urban authorities in Mytischi, in the southwestern areas of New Moscow. The author assesses these sample areas on the basis of Ch. Landry’s concept of self-training, designated for municipal authorities and urban communities, and offers several successfully implemented self-study cases and in the light of modern methods of ensuring energy security. The forecasts of creation of energy-safe space, made by modern sociologist-urbanist Leo Hollis, are taken into account. The author also considers some of the economic aspects of biosphere safety. In particular, he insists that biosphere safety, convenience, and comfort have developed into competitive advantages in the housing market.

Statistical classification of drug incidents due to look-alike sound-alike mix-ups.

PubMed

Wong, Zoie Shui Yee

2016-06-01

It has been recognised that medication names that look or sound similar are a cause of medication errors. This study builds statistical classifiers for identifying medication incidents due to look-alike sound-alike mix-ups. A total of 227 patient safety incident advisories related to medication were obtained from the Canadian Patient Safety Institute's Global Patient Safety Alerts system. Eight feature selection strategies based on frequent terms, frequent drug terms and constituent terms were performed. Statistical text classifiers based on logistic regression, support vector machines with linear, polynomial, radial-basis and sigmoid kernels and decision tree were trained and tested. The models developed achieved an average accuracy of above 0.8 across all the model settings. The receiver operating characteristic curves indicated the classifiers performed reasonably well. The results obtained in this study suggest that statistical text classification can be a feasible method for identifying medication incidents due to look-alike sound-alike mix-ups based on a database of advisories from Global Patient Safety Alerts. © The Author(s) 2014.

An epistemology of patient safety research: a framework for study design and interpretation. Part 1. Conceptualising and developing interventions.

PubMed

Brown, C; Hofer, T; Johal, A; Thomson, R; Nicholl, J; Franklin, B D; Lilford, R J

2008-06-01

This is the first of a four-part series of articles examining the epistemology of patient safety research. Parts 2 and 3 will describe different study designs and methods of measuring outcomes in the evaluation of patient safety interventions, before Part 4 suggests that "one size does not fit all". Part 1 sets the scene by defining patient safety research as a challenging form of service delivery and organisational research that has to deal (although not exclusively) with some very rare events. It then considers two inter-related ideas: a causal chain that can be used to identify where in an organisation's structure and/or processes an intervention may impact; and the need for preimplementation evaluation of proposed interventions. Finally, the paper outlines the authors' pragmatist ontological stance to patient safety research, which sets the philosophical basis for the remaining three articles.

AP1000{sup R} nuclear power plant safety overview for spent fuel cooling

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gorgemans, J.; Mulhollem, L.; Glavin, J.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe class pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and costs. The AP1000 design uses passive features to mitigate design basis accidents. The passive safety systems are designed to function without safety-grade support systems such as AC power, component cooling water, service water or HVAC. Furthermore, these passive features 'fail safe' during a non-LOCA event such that DC power and instrumentation are not required. The AP1000 also has simple, active, defense-in-depth systems to support normal plant operations. These active systems provide the first levelmore » of defense against more probable events and they provide investment protection, reduce the demands on the passive features and support the probabilistic risk assessment. The AP1000 passive safety approach allows the plant to achieve and maintain safe shutdown in case of an accident for 72 hours without operator action, meeting the expectations provided in the U.S. Utility Requirement Document and the European Utility Requirements for passive plants. Limited operator actions are required to maintain safe conditions in the spent fuel pool via passive means. In line with the AP1000 approach to safety described above, the AP1000 plant design features multiple, diverse lines of defense to ensure spent fuel cooling can be maintained for design-basis events and beyond design-basis accidents. During normal and abnormal conditions, defense-in-depth and other systems provide highly reliable spent fuel pool cooling. They rely on off-site AC power or the on-site standby diesel generators. For unlikely design basis events with an extended loss of AC power (i.e., station blackout) or loss of heat sink or both, spent fuel cooling can still be provided indefinitely: - Passive systems, requiring minimal or no operator actions, are sufficient for at least 72 hours under all possible pool heat load conditions. - After 3 days, several different means are provided to continue spent fuel cooling using installed plant equipment as well as off-site equipment with built-in connections. Even for beyond design basis accidents with postulated pool damage and multiple failures in the passive safety-related systems and in the defense-in-depth active systems, the AP1000 multiple spent fuel pool spray and fill systems provide additional lines of defense to prevent spent fuel damage. (authors)« less

Baking soda as an abrasive in toothpastes: Mechanism of action and safety and effectiveness considerations.

PubMed

Hara, Anderson T; Turssi, Cecilia P

2017-11-01

Toothpastes can be formulated with different abrasive systems, depending on their intended clinical application. This formulation potentially affects their effectiveness and safety and, therefore, requires proper understanding. In this article, the authors focused on abrasive aspects of toothpastes containing sodium bicarbonate (baking soda), which have gained considerable attention because of their low abrasivity and good compatibility, while providing clinical effectiveness (further detailed in the other articles of this special issue). The authors first appraised the role of toothpaste abrasivity on tooth wear, exploring some underlying processes and the existing methods to determine toothpaste abrasivity. The authors reviewed the available data on the abrasivity of toothpastes containing baking soda and reported a summary of findings highlighting the clinical implications. On the basis of the collected evidence, baking soda has an intrinsic low-abrasive nature because of its comparatively lower hardness in relation to enamel and dentin. Baking soda toothpastes also may contain other ingredients, which can increase their stain removal effectiveness and, consequently, abrasivity. Even those formulations have abrasivity well within the safety limit regulatory agencies have established and, therefore, can be considered safe. Copyright © 2017 American Dental Association. Published by Elsevier Inc. All rights reserved.

16 CFR 1203.30 - Purpose, basis, and scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 1203.30 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SAFETY STANDARD FOR BICYCLE HELMETS Certification § 1203.30 Purpose, basis, and scope. (a) Purpose. The... of compliance in the form specified. (b) Basis. Section 14(a)(1) of the Consumer Product Safety Act...

Guiding principles of safety as a basis for developing a pharmaceutical safety culture.

PubMed

Edwards, Brian; Olsen, Axel K; Whalen, Matthew D; Gold, Marla J

2007-05-01

Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust.

Margin of Safety Definition and Examples Used in Safety Basis Documents and the USQ Process

DOE Office of Scientific and Technical Information (OSTI.GOV)

Beaulieu, R. A.

The Nuclear Safety Management final rule, 10 CFR 830, provides an undefined term, margin of safety (MOS). Safe harbors listed in 10 CFR 830, Table 2, such as DOE-STD-3009 use but do not define the term. This lack of definition has created the need for the definition. This paper provides a definition of MOS and documents examples of MOS as applied in a U.S. Department of Energy (DOE) approved safety basis for an existing nuclear facility. If we understand what MOS looks like regarding Technical Safety Requirements (TSR) parameters, then it helps us compare against other parameters that do notmore » involve a MOS. This paper also documents parameters that are not MOS. These criteria could be used to determine if an MOS exists in safety basis documents. This paper helps DOE, including the National Nuclear Security Administration (NNSA) and its contractors responsible for the safety basis improve safety basis documents and the unreviewed safety question (USQ) process with respect to MOS.« less

Bases of the scientific conception of the “green frame” designing in urban areas for providing ecological safety of the urban environment

NASA Astrophysics Data System (ADS)

Bespalov, V.; Kotlyarova, E.

2017-10-01

In modern conditions of a stable urban areas development special place is occupied by the problem of ecological security of built-up areas, including residential, recreational, industrial areas and objects of transport and engineering infrastructure. The main results of the study are to establish the basis of formation of the concept of choice of energy-efficient technologies and tools of forming an ecologically efficient “green frame” of urban areas on the basis of a single integrated scientific concept. Analysis allowed us to divide the measures for improvement into the following main groups: organizational and planning, engineering and technical and special engineering and environmental. The significance of these results for the construction industry, including transport infrastructure, is to increase the level of environmental safety in the construction and reconstruction of urban areas due to the organization of their improvement on the basis suggested by the authors scientific approach. Its basis is integrated accounting of the natural and climatic features of the landscaping territory, the types and level of environmental impact of negative anthropogenic factors, the features of architectural and planning solutions of the existing or projected on the studied area, the structure and types of green spaces and their functional ecological properties.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Roussel, G.

Leak-Before-Break (LBB) technology has not been applied in the first design of the seven Pressurized Water Reactors the Belgian utility is currently operating. The design basis of these plants required to consider the dynamic effects associated with the ruptures to be postulated in the high energy piping. The application of the LBB technology to the existing plants has been recently approved by the Belgian Safety Authorities but with a limitation to the primary coolant loop. LBB analysis has been initiated for the Doel 3 and Tihange 2 plants to allow the withdrawal of some of the reactor coolant pump snubbersmore » at both plants and not reinstall some of the restraints after steam generator replacement at Doel 3. LBB analysis was also found beneficial to demonstrate the acceptability of the primary components and piping to the new conditions resulting from power uprating and stretch-out operation. LBB analysis has been subsequently performed on the primary coolant loop of the Tihange I plant and is currently being performed for the Doel 4 plant. Application of the LBB to the primary coolant loop is based in Belgium on the U.S. Nuclear Regulatory Commission requirements. However the Belgian Safety Authorities required some additional analyses and put some restrictions on the benefits of the LBB analysis to maintain the global safety of the plant at a sufficient level. This paper develops the main steps of the safety evaluation performed by the Belgian Safety Authorities for accepting the application of the LBB technology to existing plants and summarizes the requirements asked for in addition to the U.S. Nuclear Regulatory Commission rules.« less

Learning the effects of psychotropic drugs during pregnancy using real-world safety data: a paradigm shift toward modern pharmacovigilance.

PubMed

Lupattelli, Angela; Spigset, Olav; Nordeng, Hedvig

2018-06-15

The growing evidence on psychotropic drug safety in pregnancy has been possible thanks to the increasing availability of real-world data, i.e. data not collected in conventional randomised controlled trials. Use of these data is a key to establish psychotropic drug effects on foetal, child, and maternal health. Despite the inherent limitations and pitfalls of observational data, these can still be informative after a critical appraisal of the collective body of evidence has been done. By valuing real-world safety data, and making these a larger part of the regulatory decision-making process, we move toward a modern pregnancy pharmacovigilance. The recent uptake of real-world safety data by health authorities has set the basis for an important paradigm shift, which is integrating such data into drug labelling. The recent safety assessment of sodium valproate in pregnant and childbearing women is probably one of the first examples of modern pregnancy pharmacovigilance.

Problem of unity of measurements in ensuring safety of hydraulic structures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kheifits, V.Z.; Markov, A.I.; Braitsev, V.V.

1994-07-01

Ensuring the safety of hydraulic structures (HSs) is not only an industry but also a national and global concern, since failure of large water impounding structures can entail large losses of lives and enormous material losses related to destruction downstream. The main information on the degree of safety of a structure is obtained by comparing information about the actual state of the structure obtained on the basis of measurements in key zones of the structure with the predicted state on basis of the design model used when designing the structure for given conditions of external actions. Numerous, from hundreds tomore » thousands, string type transducers are placed in large HSs. This system of transducers monitor the stress-strain rate, seepage, and thermal regimes. These measurements are supported by the State Standards Committee which certifies the accuracy of the checking methods. To improve the instrumental monitoring of HSs, the author recommends: Calibration of methods and means of reliable diagnosis for each measuring channel in the HS, improvements to reduce measurement error, support for the system software programs, and development of appropriate standards for the design and examination of HSs.« less

A Safety Case Approach for Deep Geologic Disposal of DOE HLW and DOE SNF in Bedded Salt - 13350

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sevougian, S. David; MacKinnon, Robert J.; Leigh, Christi D.

2013-07-01

The primary objective of this study is to investigate the feasibility and utility of developing a defensible safety case for disposal of United States Department of Energy (U.S. DOE) high-level waste (HLW) and DOE spent nuclear fuel (SNF) in a conceptual deep geologic repository that is assumed to be located in a bedded salt formation of the Delaware Basin [1]. A safety case is a formal compilation of evidence, analyses, and arguments that substantiate and demonstrate the safety of a proposed or conceptual repository. We conclude that a strong initial safety case for potential licensing can be readily compiled bymore » capitalizing on the extensive technical basis that exists from prior work on the Waste Isolation Pilot Plant (WIPP), other U.S. repository development programs, and the work published through international efforts in salt repository programs such as in Germany. The potential benefits of developing a safety case include leveraging previous investments in WIPP to reduce future new repository costs, enhancing the ability to effectively plan for a repository and its licensing, and possibly expediting a schedule for a repository. A safety case will provide the necessary structure for organizing and synthesizing existing salt repository science and identifying any issues and gaps pertaining to safe disposal of DOE HLW and DOE SNF in bedded salt. The safety case synthesis will help DOE to plan its future R and D activities for investigating salt disposal using a risk-informed approach that prioritizes test activities that include laboratory, field, and underground investigations. It should be emphasized that the DOE has not made any decisions regarding the disposition of DOE HLW and DOE SNF. Furthermore, the safety case discussed herein is not intended to either site a repository in the Delaware Basin or preclude siting in other media at other locations. Rather, this study simply presents an approach for accelerated development of a safety case for a potential DOE HLW and DOE SNF repository using the currently available technical basis for bedded salt. This approach includes a summary of the regulatory environment relevant to disposal of DOE HLW and DOE SNF in a deep geologic repository, the key elements of a safety case, the evolution of the safety case through the successive phases of repository development and licensing, and the existing technical basis that could be used to substantiate the safety of a geologic repository if it were to be sited in the Delaware Basin. We also discuss the potential role of an underground research laboratory (URL). (authors)« less

Beyond safety outcomes: An investigation of the impact of safety climate on job satisfaction, employee engagement and turnover using social exchange theory as the theoretical framework.

PubMed

Huang, Yueng-Hsiang; Lee, Jin; McFadden, Anna C; Murphy, Lauren A; Robertson, Michelle M; Cheung, Janelle H; Zohar, Dov

2016-07-01

Safety climate, a measure of the degree to which safety is perceived by employees to be a priority in their company, is often implicated as a key factor in the promotion of injury-reducing behavior and safe work environments. Using social exchange theory as a theoretical basis, this study hypothesized that safety climate would be related to employees' job satisfaction, engagement, and turnover rate, highlighting the beneficial effects of safety climate beyond typical safety outcomes. Survey data were collected from 6207 truck drivers from two U.S. trucking companies. The objective turnover rate was collected one year after the survey data collection. Results showed that employees' safety climate perceptions were linked to employees' level of job satisfaction, engagement, and objective turnover rate, thus supporting the application of social exchange theory. Job satisfaction was also a significant mediator between safety climate and the two human resource outcomes (i.e., employee engagement and turnover rate). This study is among the first to assess the impact of safety climate beyond safety outcomes among lone workers (using truck drivers as an exemplar). Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

The role of the ICRP in radiation protection--a view from industry.

PubMed

Henrichs, K

2003-01-01

It is the objective of this paper to discuss some aspects concerning the role and importance of the ICRP. Here, this is done with a background of practical radiation protection in industry. The author organises and controls radiation protection for a worldwide operating company, for which efficiently realised radiation safety is as relevant for its workplaces as for its products and services. According to the author's subjective observation, the ICRP has a decreasing importance in operational radiation protection. However, there are growing demands on the ICRP as it is the only basis for internationally compatible regulations and standards. It is the merit of the ICRP that an international comparison of legal protection systems and concepts should give a much more homogeneous picture than that for any other safety and protection issue. The most valuable asset of the ICRP is its credibility as a scientific authority solely committed to the effective protection of people. But its success also brings with it an obligation: there is an increasing need for more effective communication to non-experts. This and other expectations for the future are briefly discussed.

Flood hazard assessment for french NPPs

NASA Astrophysics Data System (ADS)

Rebour, Vincent; Duluc, Claire-Marie; Guimier, Laurent

2015-04-01

This paper presents the approach for flood hazard assessment for NPP which is on-going in France in the framework of post-Fukushima activities. These activities were initially defined considering both European "stress tests" of NPPs pursuant to the request of the European Council, and the French safety audit of civilian nuclear facilities in the light of the Fukushima Daiichi accident. The main actors in that process are the utility (EDF is, up to date, the unique NPP's operator in France), the regulatory authority (ASN) and its technical support organization (IRSN). This paper was prepared by IRSN, considering official positions of the other main actors in the current review process, it was not officially endorsed by them. In France, flood hazard to be considered for design basis definition (for new NPPs and for existing NPPs in periodic safety reviews conducted every 10 years) was revised before Fukushima-Daichi accident, due to le Blayais NPP December 1999 experience (partial site flooding and loss of some safety classified systems). The paper presents in the first part an overview of the revised guidance for design basis flood. In order to address design extension conditions (conditions that could result from natural events exceeding the design basis events), a set of flooding scenarios have been defined by adding margins on the scenarios that are considered for the design. Due to the diversity of phenomena to be considered for flooding hazard, the margin assessment is specific to each flooding scenario in terms of parameter to be penalized and of degree of variation of this parameter. The general approach to address design extension conditions is presented in the second part of the paper. The next parts present the approach for five flooding scenarios including design basis scenario and additional margin to define design extension scenarios.

Blood donor selection in European Union directives: room for improvement

PubMed Central

de Kort, Wim; Mayr, Wolfgang; Jungbauer, Christof; Vuk, Tomislav; Kullaste, Riin; Seifried, Erhard; Grazzini, Giuliano; de Wit, Jeroen; Folléa, Gilles

2016-01-01

Background Transfusion-transmissible infections have made both blood bankers and health authorities overly cautious. The general public expects and hence reinforces this policy. To obtain a high level of blood product safety, blood and plasma donors have to meet increasingly stringent eligibility criteria; however, it is not known whether this policy translates into improved outcomes for patients. There is a risk that the management of donors does not match the ambition of greater safety for patients. European directives related to the collection process and donor selection will probably be reconsidered in the next few years. Material and methods The development of European directives on donor selection and their basis in the literature were reviewed with an emphasis on the background and considerations for eligibility criteria to be included in the directives. Results The precautionary principle appears to be the predominant reason behind the set of eligibility criteria. However, the formal eligibility criteria, put into force in 2004, do not balance with the developments of the past decade in laboratory tests and measures that have substantially reduced actual infection risks. In no cases were the effects of eligibility criteria on the donor pool and donor well-being quantified. Regional differences in the epidemiology of transfusion-transmissible infections were not taken into consideration either. Discussion First, the Authors promote the collection of epidemiological data on the incidence and prevalence of conditions in the general population and in blood and plasma donors which could pose a risk for transfused patients, in order to use these data as a basis for decision-making in donor-selection policies. Second, the Authors suggest including allowance for differential deferral criteria throughout Europe, based on factual risk levels. There should be an accepted balance between donor and patient welfare, and also between risk to transfusion safety and risk of compromising the blood supply. PMID:26509824

Safety evaluation of cosmetics in the EU. Reality and challenges for the toxicologist.

PubMed

Pauwels, Marleen; Rogiers, Vera

2004-06-15

Council Directive 76/768/EEC, its seven amendments and 30 adaptations to technical progress form the basis of the cosmetic EU legislation today. There are actually four key principles for safety in the cosmetic legislation. (i) The full responsibility for the safety of cosmetics for human health is placed on the manufacturer, first importer in the EU or marketer. (ii) The safety evaluation of finished products is based on safety of individual ingredients, more specifically on their chemical structure, toxicological profile and their level of exposure. (iii) A compilation of information on each cosmetic product (dossier) must be kept readily available for inspection by the competent authorities of the Member State concerned. This information source, usually called a technical information file (TIF) or product information file/requirements (PIF(R)), contains, as the most important part, the safety assessment of the product undersigned by a competent safety assessor. (iv) The use of validated replacement alternative methods instead of animal testing forms the 4th key principle for safety of cosmetic products on the EU market. The 7th amendment imposes strict deadlines for the abolition of animal in vivo studies on cosmetic ingredients. These legal requirements induce a number of important challenges for the cosmetic industry and more specifically for the toxicologist involved as safety assessor.

Comparison of two drug safety signals in a pharmacovigilance data mining framework.

PubMed

Tubert-Bitter, Pascale; Bégaud, Bernard; Ahmed, Ismaïl

2016-04-01

Since adverse drug reactions are a major public health concern, early detection of drug safety signals has become a top priority for regulatory agencies and the pharmaceutical industry. Quantitative methods for analyzing spontaneous reporting material recorded in pharmacovigilance databases through data mining have been proposed in the last decades and are increasingly used to flag potential safety problems. While automated data mining is motivated by the usually huge size of pharmacovigilance databases, it does not systematically produce relevant alerts. Moreover, each detected signal requires appropriate assessment that may involve investigation of the whole therapeutic class. The goal of this article is to provide a methodology for comparing two detected signals. It is nested within the automated surveillance framework as (1) no extra information is required and (2) no simple inference on the actual risks can be extrapolated from spontaneous reporting data. We designed our methodology on the basis of two classical methods used for automated signal detection: the Bayesian Gamma Poisson Shrinker and the frequentist Proportional Reporting Ratio. A simulation study was conducted to assess the performances of both proposed methods. The latter were used to compare cardiovascular signals for two HIV treatments from the French pharmacovigilance database. © The Author(s) 2012.

Integrated therapy safety management system

PubMed Central

Podtschaske, Beatrice; Fuchs, Daniela; Friesdorf, Wolfgang

2013-01-01

Aims The aim is to demonstrate the benefit of the medico-ergonomic approach for the redesign of clinical work systems. Based on the six layer model, a concept for an ‘integrated therapy safety management’ is drafted. This concept could serve as a basis to improve resilience. Methods The concept is developed through a concept-based approach. The state of the art of safety and complexity research in human factors and ergonomics forms the basis. The findings are synthesized to a concept for ‘integrated therapy safety management’. The concept is applied by way of example for the ‘medication process’ to demonstrate its practical implementation. Results The ‘integrated therapy safety management’ is drafted in accordance with the six layer model. This model supports a detailed description of specific work tasks, the corresponding responsibilities and related workflows at different layers by using the concept of ‘bridge managers’. ‘Bridge managers’ anticipate potential errors and monitor the controlled system continuously. If disruptions or disturbances occur, they respond with corrective actions which ensure that no harm results and they initiate preventive measures for future procedures. The concept demonstrates that in a complex work system, the human factor is the key element and final authority to cope with the residual complexity. The expertise of the ‘bridge managers’ and the recursive hierarchical structure results in highly adaptive clinical work systems and increases their resilience. Conclusions The medico-ergonomic approach is a highly promising way of coping with two complexities. It offers a systematic framework for comprehensive analyses of clinical work systems and promotes interdisciplinary collaboration. PMID:24007448

Reliability enhancement of APR + diverse protection system regarding common cause failures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Oh, Y. G.; Kim, Y. M.; Yim, H. S.

2012-07-01

The Advanced Power Reactor Plus (APR +) nuclear power plant design has been developed on the basis of the APR1400 (Advanced Power Reactor 1400 MWe) to further enhance safety and economics. For the mitigation of Anticipated Transients Without Scram (ATWS) as well as Common Cause Failures (CCF) within the Plant Protection System (PPS) and the Emergency Safety Feature - Component Control System (ESF-CCS), several design improvement features have been implemented for the Diverse Protection System (DPS) of the APR + plant. As compared to the APR1400 DPS design, the APR + DPS has been designed to provide the Safety Injectionmore » Actuation Signal (SIAS) considering a large break LOCA accident concurrent with the CCF. Additionally several design improvement features, such as channel structure with redundant processing modules, and changes of system communication methods and auto-system test methods, are introduced to enhance the functional reliability of the DPS. Therefore, it is expected that the APR + DPS can provide an enhanced safety and reliability regarding possible CCF in the safety-grade I and C systems as well as the DPS itself. (authors)« less

[Storage of plant protection products in farms: minimum safety requirements].

PubMed

Dutto, Moreno; Alfonzo, Santo; Rubbiani, Maristella

2012-01-01

Failure to comply with requirements for proper storage and use of pesticides in farms can be extremely hazardous and the risk of accidents involving farm workers, other persons and even animals is high. There are still wide differences in the interpretation of the concept of "securing or making safe", by workers in this sector. One of the critical points detected, particularly in the fruit sector, is the establishment of an adequate storage site for plant protection products. The definition of "safe storage of pesticides" is still unclear despite the recent enactment of Legislative Decree 81/2008 regulating health and work safety in Italy. In addition, there are no national guidelines setting clear minimum criteria for storage of plant protection products in farms. The authors, on the basis of their professional experience and through analysis of recent legislation, establish certain minimum safety standards for storage of pesticides in farms.

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 10 Energy 4 2014-01-01 2014-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

10 CFR 830.200 - Scope.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Scope. 830.200 Section 830.200 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.200 Scope. This Subpart establishes safety basis requirements for hazard category 1, 2, and 3 DOE nuclear facilities. ...

The probability of transportation accidents

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brobst, W.A.

1972-11-10

We examined the relative safety of different modes of transportation from a statistical basis, rather than an emotional one. As we were collecting data and evaluating its applicability, we found that our own emotions came into play in judging which data would be useful and which data we should discard. We developed a methodology of simple data analysis that would lend itself to similar evaluations to questions. The author described that methodology, and demonstrated its application to shipments of radioactive materials. 31 refs., 7 tabs/

[International trend of guidance for nanomaterial risk assessment].

PubMed

Hirose, Akihiko

2013-01-01

In the past few years, several kinds of opinions or recommendations on the nanomaterial safety assessment have been published from international or national bodies. Among the reports, the first practical guidance of risk assessment from the regulatory body was published from the European Food Safety Authorities in May 2011, which included the determination of exposure scenario and toxicity testing strategy. In October 2011, European Commission (EC) adopted the definition of "nanomaterial" for regulation. And more recently, Scientific Committee on Consumer Safety of EC released guidance for assessment of nanomaterials in cosmetics in June 2012. A series of activities in EU marks an important step towards realistic safety assessment of nanomaterials. On the other hand, the US FDA announced a draft guidance for industry in June 2011, and then published draft guidance documents for both "Cosmetic Products" and "Food Ingredients and Food Contact Substances" in April 2012. These draft documents do not restrictedly define the physical properties of nanomaterials, but when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product, the products are treated as new products. Such international movements indicate that most of nanomaterials with any new properties would be assessed or regulated as new products by most of national authorities in near future, although the approaches are still case by case basis. We will introduce such current international activities and consideration points for regulatory risk assessment.

Thermal-hydraulic analysis capabilities and methods development at NYPA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Feltus, M.A.

1987-01-01

The operation of a nuclear power plant must be regularly supported by various thermal-hydraulic (T/H) analyses that may include final safety analysis report (FSAR) design basis calculations and licensing evaluations and conservative and best-estimate analyses. The development of in-house T/H capabilities provides the following advantages: (a) it leads to a better understanding of the plant design basis and operating characteristics; (b) methods developed can be used to optimize plant operations and enhance plant safety; (c) such a capability can be used for design reviews, checking vendor calculations, and evaluating proposed plant modifications; and (d) in-house capability reduces the cost ofmore » analysis. This paper gives an overview of the T/H capabilities and current methods development activity within the engineering department of the New York Power Authority (NYPA) and will focus specifically on reactor coolant system (RCS) transients and plant dynamic response for non-loss-of-coolant accident events. This paper describes NYPA experience in performing T/H analyses in support of pressurized water reactor plant operation.« less

Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.

PubMed

Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh

2015-01-01

Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.

Steam generator tubes integrity: In-service-inspection

DOE Office of Scientific and Technical Information (OSTI.GOV)

Comby, R.J.

1997-02-01

The author`s approach to tube integrity is in terms of looking for flaws in tubes. The basis for this approach is that no simple rules can be fixed to adopt a universal inspection methodology because of various concepts related to experience, leak acceptance, leak before break approach, etc. Flaw specific management is probably the most reliable approach as a compromise between safety, availability and economic issues. In that case, NDE capabilities have to be in accordance with information required by structural integrity demonstration. The author discusses the types of probes which can be used to search for flaws in additionmore » to the types of flaws which are being sought, with examples of specific analysis experiences. The author also discusses the issue of a reporting level as it relates to avoiding false calls, classifying faults, and allowing for automation in analysis.« less

Facts and Fallacies in the Debate on Glyphosate Toxicity.

PubMed

Mesnage, Robin; Antoniou, Michael N

2017-01-01

The safety profile of the herbicide glyphosate and its commercial formulations is controversial. Reviews have been published by individuals who are consultants and employees of companies commercializing glyphosate-based herbicides in support of glyphosate's reapproval by regulatory agencies. These authors conclude that glyphosate is safe at levels below regulatory permissible limits. In contrast, reviews conducted by academic scientists independent of industry report toxic effects below regulatory limits, as well as shortcomings of the current regulatory evaluation of risks associated with glyphosate exposures. Two authors in particular (Samsel and Seneff) have published a series of commentaries proposing that long-term exposure to glyphosate is responsible for many chronic diseases (including cancers, diabetes, neuropathies, obesity, asthma, infections, osteoporosis, infertility, and birth defects). The aim of this review is to examine the evidential basis for these claimed negative health effects and the mechanisms that are alleged to be at their basis. We found that these authors inappropriately employ a deductive reasoning approach based on syllogism. We found that their conclusions are not supported by the available scientific evidence. Thus, the mechanisms and vast range of conditions proposed to result from glyphosate toxicity presented by Samsel and Seneff in their commentaries are at best unsubstantiated theories, speculations, or simply incorrect. This misrepresentation of glyphosate's toxicity misleads the public, the scientific community, and regulators. Although evidence exists that glyphosate-based herbicides are toxic below regulatory set safety limits, the arguments of Samsel and Seneff largely serve to distract rather than to give a rational direction to much needed future research investigating the toxicity of these pesticides, especially at levels of ingestion that are typical for human populations.

Facts and Fallacies in the Debate on Glyphosate Toxicity

PubMed Central

Mesnage, Robin; Antoniou, Michael N.

2017-01-01

The safety profile of the herbicide glyphosate and its commercial formulations is controversial. Reviews have been published by individuals who are consultants and employees of companies commercializing glyphosate-based herbicides in support of glyphosate’s reapproval by regulatory agencies. These authors conclude that glyphosate is safe at levels below regulatory permissible limits. In contrast, reviews conducted by academic scientists independent of industry report toxic effects below regulatory limits, as well as shortcomings of the current regulatory evaluation of risks associated with glyphosate exposures. Two authors in particular (Samsel and Seneff) have published a series of commentaries proposing that long-term exposure to glyphosate is responsible for many chronic diseases (including cancers, diabetes, neuropathies, obesity, asthma, infections, osteoporosis, infertility, and birth defects). The aim of this review is to examine the evidential basis for these claimed negative health effects and the mechanisms that are alleged to be at their basis. We found that these authors inappropriately employ a deductive reasoning approach based on syllogism. We found that their conclusions are not supported by the available scientific evidence. Thus, the mechanisms and vast range of conditions proposed to result from glyphosate toxicity presented by Samsel and Seneff in their commentaries are at best unsubstantiated theories, speculations, or simply incorrect. This misrepresentation of glyphosate’s toxicity misleads the public, the scientific community, and regulators. Although evidence exists that glyphosate-based herbicides are toxic below regulatory set safety limits, the arguments of Samsel and Seneff largely serve to distract rather than to give a rational direction to much needed future research investigating the toxicity of these pesticides, especially at levels of ingestion that are typical for human populations. PMID:29226121

Model-Driven Development of Safety Architectures

NASA Technical Reports Server (NTRS)

Denney, Ewen; Pai, Ganesh; Whiteside, Iain

2017-01-01

We describe the use of model-driven development for safety assurance of a pioneering NASA flight operation involving a fleet of small unmanned aircraft systems (sUAS) flying beyond visual line of sight. The central idea is to develop a safety architecture that provides the basis for risk assessment and visualization within a safety case, the formal justification of acceptable safety required by the aviation regulatory authority. A safety architecture is composed from a collection of bow tie diagrams (BTDs), a practical approach to manage safety risk by linking the identified hazards to the appropriate mitigation measures. The safety justification for a given unmanned aircraft system (UAS) operation can have many related BTDs. In practice, however, each BTD is independently developed, which poses challenges with respect to incremental development, maintaining consistency across different safety artifacts when changes occur, and in extracting and presenting stakeholder specific information relevant for decision making. We show how a safety architecture reconciles the various BTDs of a system, and, collectively, provide an overarching picture of system safety, by considering them as views of a unified model. We also show how it enables model-driven development of BTDs, replete with validations, transformations, and a range of views. Our approach, which we have implemented in our toolset, AdvoCATE, is illustrated with a running example drawn from a real UAS safety case. The models and some of the innovations described here were instrumental in successfully obtaining regulatory flight approval.

Safety assessment of discharge chute isolation barrier preparation and installation. Revision 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Meichle, R.H.

1994-10-10

This revision responds to RL comments and increases the discussion of the ``effective hazard categorization`` and the readiness review basis. The safety assessment is made for the activities for the preparation and installation of the discharge chute isolation barriers. The safety assessment includes a hazard assessment and comparison of potential accidents/events to those addressed by the current safety basis documentation. No significant hazards were identified. An evaluation against the USQ evaluation questions were made and the determination made that the activities do not represent a USQ. Hazard categorization techniques were used to provide a basis for readiness review classification.

10 CFR 830.201 - Performance of work.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Performance of work. 830.201 Section 830.201 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.201 Performance of work. A contractor must perform work in accordance with the safety basis for a hazard category 1, 2, or 3 DOE nuclear...

Codex Alimentarius: food quality and safety standards for international trade.

PubMed

Randell, A W; Whitehead, A J

1997-08-01

Since 1962, the Codex Alimentarius Commission (CAC) of the Food and Agriculture Organisation/World Health Organisation has been responsible for developing standards, guidelines and other recommendations on the quality and safety of food to protect the health of consumers and to ensure fair practices in food trade. The mission of the CAC remains relevant, but a number of factors have shown the need for new techniques to form the basis of food standards, the most important of which is risk analysis. The authors give a brief description of the role and work of the CAC and the efforts deployed by the Commission to respond to the challenges posed by new approaches to government regulation, harmonisation of national requirements based on international standards and the role of civil society.

High-level waste tank farm set point document

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anthony, J.A. III

1995-01-15

Setpoints for nuclear safety-related instrumentation are required for actions determined by the design authorization basis. Minimum requirements need to be established for assuring that setpoints are established and held within specified limits. This document establishes the controlling methodology for changing setpoints of all classifications. The instrumentation under consideration involve the transfer, storage, and volume reduction of radioactive liquid waste in the F- and H-Area High-Level Radioactive Waste Tank Farms. The setpoint document will encompass the PROCESS AREA listed in the Safety Analysis Report (SAR) (DPSTSA-200-10 Sup 18) which includes the diversion box HDB-8 facility. In addition to the PROCESS AREASmore » listed in the SAR, Building 299-H and the Effluent Transfer Facility (ETF) are also included in the scope.« less

Use patterns among early adopters of adaptive cruise control.

PubMed

Xiong, Huimin; Boyle, Linda Ng; Moeckli, Jane; Dow, Benjamin R; Brown, Timothy L

2012-10-01

The objective of this study was to investigate use patterns among early adopters of adaptive cruise control (ACC). Extended use ofACC may influence a driver's behavior in the long-term, which can have unintended safety consequences. The authors examined the use of a motion-based simulator by 24 participants (15 males and 9 females). Cluster analysis was performed on drivers' use of ACC and was based on their gap settings, speed settings, number of warnings issued, and ACC disengaged. The data were then examined on the basis of driving performance measures and drivers' subjective responses to trust in ACC, understanding of system operations, and driving styles. Driving performance measures included minimum time headway, adjusted minimum time to collision, and drivers' reaction time to critical events. Three groups of drivers were observed on the basis of risky behavior, moderately risky behavior, and conservative behavior. Drivers in the conservative group stayed farther behind the lead vehicle than did drivers in the other two groups. Risky drivers responded later to critical events and had more ACC warnings issued. Safety consequences with ACC may be more prevalent in some driver groups than others. The findings suggest that these safety implications are related to trust in automation, driving styles, understanding of system operations, and personalities. Potential applications of this research include enhanced design for next-generation ACC systems and countermeasures to improve safe driving with ACC.

Canister Storage Building (CSB) Design Basis Accident Analysis Documentation

DOE Office of Scientific and Technical Information (OSTI.GOV)

CROWE, R.D.; PIEPHO, M.G.

2000-03-23

This document provided the detailed accident analysis to support HNF-3553, Spent Nuclear Fuel Project Final Safety Analysis Report, Annex A, ''Canister Storage Building Final Safety Analysis Report''. All assumptions, parameters, and models used to provide the analysis of the design basis accidents are documented to support the conclusions in the Canister Storage Building Final Safety Analysis Report.

Biosimilars: pharmacovigilance and risk management.

PubMed

Zuñiga, Leyre; Calvo, Begoña

2010-07-01

Biosimilars cannot be authorized based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorization clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk-benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit-risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialized with a brand name or the INN plus the manufacturer's name. (c) 2010 John Wiley & Sons, Ltd.

The European hospital exemption clause-new option for gene therapy?

PubMed

Buchholz, Christian J; Sanzenbacher, Ralf; Schüle, Silke

2012-01-01

Gene-therapy medicinal products are currently applied to patients enrolled in authorized clinical trials to demonstrate safety and efficacy. Given a positive outcome, marketing authorization can subsequently be achieved via the centralized procedure coordinated by the European Medicines Agency. With Regulation (EC) No. 1394/2007 in force, advanced therapy medicinal products, including gene- and cell-therapy products, can be excepted from the obligation of obtaining a marketing authorization via the centralized procedure under specific conditions (so-called "hospital exemption"). This hospital exemption allows the application of gene-therapy medicinal products prepared on a non-routine basis for an individual patient and used under the exclusive professional responsibility of a medical practitioner. Here, we explain the requirements to be fulfilled in order to fall under this exemption, the implementation of this regulation into the German national legislation, and its impact on gene-therapy product development in the future.

Debating the Controlled Substances Act.

PubMed

Spillane, Joseph F

2004-10-05

In the United States, the basis of modern drug regulation is the Controlled Substances Act (CSA) of 1970. The CSA laid out the authority of the federal government and provided a framework within which all existing and new substances could be regulated on their abuse potential, safety, and medical utility. The debates over the CSA centered on several critical issues: where to place the authority to make scheduling designations, the impact of scheduling on drug research, and defining what constituted drug "abuse" for purposes of scheduling. Passage of the CSA was aided by broad language that provided a kind of "big tent" which could accommodate diverse points of view. A retrospective assessment of the CSA shows it to have greatly expanded federal administrative authority over the nation's drug supply, much as its authors intended. Other impacts of the CSA, however, are much less certain. This article concludes by highlighting the issues and questions that should guide future retrospective research on the efficacy of drug control regimes.

Safety analysis report for the Waste Storage Facility. Revision 2

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bengston, S.J.

1994-05-01

This safety analysis report outlines the safety concerns associated with the Waste Storage Facility located in the Radioactive Waste Management Complex at the Idaho National Engineering Laboratory. The three main objectives of the report are: define and document a safety basis for the Waste Storage Facility activities; demonstrate how the activities will be carried out to adequately protect the workers, public, and environment; and provide a basis for review and acceptance of the identified risk that the managers, operators, and owners will assume.

"On a supposed right to lie [to the public] from benevolent motives": communicating health risks to the public.

PubMed

Shickle, D

2000-01-01

There are three main categories of rationale for withholding information or telling lies: if overwhelming harm can only be averted through deceit; complete triviality such that it is irrelevant whether the truth is told; a duty to protect the interests of others. Public health authorities are frequently having to form judgements about the public interest, whether to release information or issue warnings. In June 1992, routine surveillance detected patulin levels (a known carcinogen) in samples of apple juice exceeding safety threshold. Remedial actions were promptly taken and it was planned to subsequently publish the information in the routine way. However, the media portrayed the handling of the problem as a conspiracy and there was a short term reduction in juice sales. In October 1995, the UK Committee on Safety of Medicines issued a warning about certain brands of the contraceptive pill, based on the interim results of three unpublished studies. The increased risk of thromboembolism was small, but the resulting scare led to an increase in unwanted pregnancies. The handling of the B.S.E. crisis in the U.K. also led to accusations of incompetence or conspiracy. Public health authorities have to handle uncertainty and frequently have to form judgements for public safety on the basis of evidence of poor quantity and quality. Their task is not helped by the sometimes conflicting agenda of scientists and media. The public also have differing perceptions and interpretations of risk. The series of scares and crises are having a detrimental effect on public confidence in public health authorities.

AP1000{sup R} design robustness against extreme external events - Seismic, flooding, and aircraft crash

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pfister, A.; Goossen, C.; Coogler, K.

2012-07-01

Both the International Atomic Energy Agency (IAEA) and the U.S. Nuclear Regulatory Commission (NRC) require existing and new nuclear power plants to conduct plant assessments to demonstrate the unit's ability to withstand external hazards. The events that occurred at the Fukushima-Dai-ichi nuclear power station demonstrated the importance of designing a nuclear power plant with the ability to protect the plant against extreme external hazards. The innovative design of the AP1000{sup R} nuclear power plant provides unparalleled protection against catastrophic external events which can lead to extensive infrastructure damage and place the plant in an extended abnormal situation. The AP1000 plantmore » is an 1100-MWe pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance and safety. The plant's compact safety related footprint and protection provided by its robust nuclear island structures prevent significant damage to systems, structures, and components required to safely shutdown the plant and maintain core and spent fuel pool cooling and containment integrity following extreme external events. The AP1000 nuclear power plant has been extensively analyzed and reviewed to demonstrate that it's nuclear island design and plant layout provide protection against both design basis and extreme beyond design basis external hazards such as extreme seismic events, external flooding that exceeds the maximum probable flood limit, and malicious aircraft impact. The AP1000 nuclear power plant uses fail safe passive features to mitigate design basis accidents. The passive safety systems are designed to function without safety-grade support systems (such as AC power, component cooling water, service water, compressed air or HVAC). The plant has been designed to protect systems, structures, and components critical to placing the reactor in a safe shutdown condition within the steel containment vessel which is further surrounded by a substantial 'steel concrete' composite shield building. The containment vessel is not affected by external flooding, and the shield building design provides hazard protection beyond that provided by a comparable reinforced concrete structure. The intent of this paper is to demonstrate the robustness of the AP1000 design against extreme events. The paper will focus on the plants ability to withstand extreme external events such as beyond design basis flooding, seismic events, and malicious aircraft impact. The paper will highlight the robustness of the AP1000 nuclear island design including the protection provided by the unique AP1000 composite shield building. (authors)« less

Kombucha: a systematic review of the clinical evidence.

PubMed

Ernst, E

2003-04-01

Kombucha has become a popular complementary remedy. The aim of this systematic review was to critically evaluate the evidence related to its efficacy and safety. Computerised literature searches were carried out to locate all human medical investigations of kombucha regardless of study design. Data were extracted and validated by the present author and are reported in narrative form. No clinical studies were found relating to the efficacy of this remedy. Several case reports and case series raise doubts about the safety of kombucha. They include suspected liver damage, metabolic acidosis and cutaneous anthrax infections. One fatality is on record. On the basis of these data it was concluded that the largely undetermined benefits do not outweigh the documented risks of kombucha. It can therefore not be recommended for therapeutic use. Copyright 2003 S. Karger GmbH, Freiburg

Tobacco Industry Efforts to Defeat the Occupational Safety and Health Administration Indoor Air Quality Rule

PubMed Central

Bryan-Jones, Katherine; Bero, Lisa A.

2003-01-01

Objectives. We describe tobacco industry strategies to defeat the Occupational Safety and Health Administration (OSHA) Indoor Air Quality rule and the implementation of those strategies. Methods. We analyzed tobacco industry documents, public commentary on, and media coverage of the OSHA rule. Results. The tobacco industry had 5 strategies: (1) maintain scientific debate about the basis of the rule, (2) delay deliberation on the rule, (3) redefine the scope of the rule, (4) recruit and assist labor and business organizations in opposing the rule, and (5) increase media coverage of the tobacco industry position. The tobacco industry successfully implemented all 5 strategies. Conclusions. Our findings suggest that regulatory authorities must take into account the source, motivation, and validity of arguments used in the regulatory process in order to make accurately informed decisions. PMID:12660202

Healthcare databases in Europe for studying medicine use and safety during pregnancy.

PubMed

Charlton, Rachel A; Neville, Amanda J; Jordan, Sue; Pierini, Anna; Damase-Michel, Christine; Klungsøyr, Kari; Andersen, Anne-Marie Nybo; Hansen, Anne Vinkel; Gini, Rosa; Bos, Jens H J; Puccini, Aurora; Hurault-Delarue, Caroline; Brooks, Caroline J; de Jong-van den Berg, Lolkje T W; de Vries, Corinne S

2014-06-01

The aim of this study was to describe a number of electronic healthcare databases in Europe in terms of the population covered, the source of the data captured and the availability of data on key variables required for evaluating medicine use and medicine safety during pregnancy. A sample of electronic healthcare databases that captured pregnancies and prescription data was selected on the basis of contacts within the EUROCAT network. For each participating database, a database inventory was completed. Eight databases were included, and the total population covered was 25 million. All databases recorded live births, seven captured stillbirths and five had full data available on spontaneous pregnancy losses and induced terminations. In six databases, data were usually available to determine the date of the woman's last menstrual period, whereas in the remainder, algorithms were needed to establish a best estimate for at least some pregnancies. In seven databases, it was possible to use data recorded in the databases to identify pregnancies where the offspring had a congenital anomaly. Information on confounding variables was more commonly available in databases capturing data recorded by primary-care practitioners. All databases captured maternal co-prescribing and a measure of socioeconomic status. This study suggests that within Europe, electronic healthcare databases may be valuable sources of data for evaluating medicine use and safety during pregnancy. The suitability of a particular database, however, will depend on the research question, the type of medicine to be evaluated, the prevalence of its use and any adverse outcomes of interest. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Perceptions of health care professionals on the safety and security at Odi District Hospital, Gauteng, South Africa

PubMed Central

Okeke, Sunday O.

2017-01-01

Background For optimum delivery of service, an establishment needs to ensure a safe and secure environment. In 2011, the South African government promulgated the National Core Standards for Health Establishments for safety and security for all employees in all establishments. Little is known about whether these standards are being complied to. Aim and setting: To assess the perceptions of health care professionals (HCPs) on safety and security at Odi District Hospital. Methodology A sample of 181 out of a total of 341 HCPs was drawn through a systematic sampling method from each HCP category. Data were collected through a self-administered questionnaire. The SPSS® statistical software version 22 was used for data analysis. The level of statistical significance was set at < 0.05. Results There were more female respondents than male respondents (136; 75.10%). The dominant age group was 28–47 years (114; 57.46%). Perceptions on security personnel, their efficiency and the security system were significantly affirmed (p = 0.0001). The hospital infrastructure, surroundings and plan in emergencies were perceived to be safe (p < 0.0001). The hospital lighting system was perceived as inadequate (p = 0.0041). Only 36 (20.2%) HCPs perceived that hospital authorities were concerned about employees’ safety (p < 0.0001). Conclusion HCPs had positive perceptions regarding the hospital’s security system. Except for the negative perceptions of the lighting system and the perceived lack of hospital authorities’ concern for staff safety, perceptions of the HCPs on the hospital working environment were positive. The hospital authorities need to establish the basis of negative perceptions and enforce remedial measures to redress them. PMID:29113444

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2011 CFR

2011-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2011-10-01 2011-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2014 CFR

2014-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2014-10-01 2014-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2013 CFR

2013-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2013-10-01 2013-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

47 CFR 90.1 - Basis and purpose.

Code of Federal Regulations, 2012 CFR

2012-10-01

... licensed and used in the Public Safety, Industrial/Business Radio Pool, and Radiolocation Radio Services... 47 Telecommunication 5 2012-10-01 2012-10-01 false Basis and purpose. 90.1 Section 90.1 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND...

Implementation of Recommendations from the One System Comparative Evaluation of the Hanford Tank Farms and Waste Treatment Plant Safety Bases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Garrett, Richard L.; Niemi, Belinda J.; Paik, Ingle K.

2013-11-07

A Comparative Evaluation was conducted for One System Integrated Project Team to compare the safety bases for the Hanford Waste Treatment and Immobilization Plant Project (WTP) and Tank Operations Contract (TOC) (i.e., Tank Farms) by an Expert Review Team. The evaluation had an overarching purpose to facilitate effective integration between WTP and TOC safety bases. It was to provide One System management with an objective evaluation of identified differences in safety basis process requirements, guidance, direction, procedures, and products (including safety controls, key safety basis inputs and assumptions, and consequence calculation methodologies) between WTP and TOC. The evaluation identified 25more » recommendations (Opportunities for Integration). The resolution of these recommendations resulted in 16 implementation plans. The completion of these implementation plans will help ensure consistent safety bases for WTP and TOC along with consistent safety basis processes. procedures, and analyses. and should increase the likelihood of a successful startup of the WTP. This early integration will result in long-term cost savings and significant operational improvements. In addition, the implementation plans lead to the development of eight new safety analysis methodologies that can be used at other U.S. Department of Energy (US DOE) complex sites where URS Corporation is involved.« less

Variable dynamic testbed vehicle : safety plan

DOT National Transportation Integrated Search

1997-02-01

This safety document covers the entire safety process from inception to delivery of the Variable Dynamic Testbed Vehicle. In addition to addressing the process of safety on the vehicle , it should provide a basis on which to build future safety proce...

National Dam Safety Program Inspection Report. South Branch Root River. Lanesboro Dam, Fillmore County, Minnesota, Inventory Number 517.

DTIC Science & Technology

1978-07-01

CLASSIFICATION AUTHORITY 3 DISTRIBUTION /AVAILABILITY OF REPORT 2b DECLASSIFICATION /DOWNGRADING SCHEDULE ApproveI. foe ubl ic release; distributionunn mi e 4...TAYPOL ARM , STOP EQUAL .- maT9 PALLO-EkLTOMERA ’EDDY~ "IA WElp TO J NEMA CLOW NOCO 1000 1.0- ."L L- - AT. T D III SCCTSomm n2-2 24 P 21 -OOOW I-0 AIA a...material in the downstream channel and any other physical evidence, describe the foundation material. CI .4, r A ZAM ~ A .4,1 ic 3. Basis for

Process optimization of solid rad waste management at the Shelter object transformation to the ecologically safety system

DOE Office of Scientific and Technical Information (OSTI.GOV)

Batiy, V.G.; Stojanov, A.I.; Schmieman, E.

2007-07-01

Methodological approach of optimization of schemes of solid radwaste management of the Object Shelter (Shelter) and ChNPP industrial site during transformation to the ecologically safe system was developed. On the basis of the conducted models researches the ALARA-analysis was carried out for the choice of optimum variant of schemes and technologies of solid radwaste management. The criteria of choice of optimum schemes, which are directed on optimization of doses and financial expenses, minimization of amount of the formed radwaste etc, were developed for realization of this ALARA-analysis. (authors)

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2010 CFR

2010-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2010-01-01 2010-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

10 CFR 830.205 - Technical safety requirements.

Code of Federal Regulations, 2011 CFR

2011-01-01

... must: (1) Develop technical safety requirements that are derived from the documented safety analysis... 10 Energy 4 2011-01-01 2011-01-01 false Technical safety requirements. 830.205 Section 830.205 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.205 Technical...

Generic Safety Requirements for Developing Safe Insulin Pump Software

PubMed Central

Zhang, Yi; Jetley, Raoul; Jones, Paul L; Ray, Arnab

2011-01-01

Background The authors previously introduced a highly abstract generic insulin infusion pump (GIIP) model that identified common features and hazards shared by most insulin pumps on the market. The aim of this article is to extend our previous work on the GIIP model by articulating safety requirements that address the identified GIIP hazards. These safety requirements can be validated by manufacturers, and may ultimately serve as a safety reference for insulin pump software. Together, these two publications can serve as a basis for discussing insulin pump safety in the diabetes community. Methods In our previous work, we established a generic insulin pump architecture that abstracts functions common to many insulin pumps currently on the market and near-future pump designs. We then carried out a preliminary hazard analysis based on this architecture that included consultations with many domain experts. Further consultation with domain experts resulted in the safety requirements used in the modeling work presented in this article. Results Generic safety requirements for the GIIP model are presented, as appropriate, in parameterized format to accommodate clinical practices or specific insulin pump criteria important to safe device performance. Conclusions We believe that there is considerable value in having the diabetes, academic, and manufacturing communities consider and discuss these generic safety requirements. We hope that the communities will extend and revise them, make them more representative and comprehensive, experiment with them, and use them as a means for assessing the safety of insulin pump software designs. One potential use of these requirements is to integrate them into model-based engineering (MBE) software development methods. We believe, based on our experiences, that implementing safety requirements using MBE methods holds promise in reducing design/implementation flaws in insulin pump development and evolutionary processes, therefore improving overall safety of insulin pump software. PMID:22226258

System theory and safety models in Swedish, UK, Dutch and Australian road safety strategies.

PubMed

Hughes, B P; Anund, A; Falkmer, T

2015-01-01

Road safety strategies represent interventions on a complex social technical system level. An understanding of a theoretical basis and description is required for strategies to be structured and developed. Road safety strategies are described as systems, but have not been related to the theory, principles and basis by which systems have been developed and analysed. Recently, road safety strategies, which have been employed for many years in different countries, have moved to a 'vision zero', or 'safe system' style. The aim of this study was to analyse the successful Swedish, United Kingdom and Dutch road safety strategies against the older, and newer, Australian road safety strategies, with respect to their foundations in system theory and safety models. Analysis of the strategies against these foundations could indicate potential improvements. The content of four modern cases of road safety strategy was compared against each other, reviewed against scientific systems theory and reviewed against types of safety model. The strategies contained substantial similarities, but were different in terms of fundamental constructs and principles, with limited theoretical basis. The results indicate that the modern strategies do not include essential aspects of systems theory that describe relationships and interdependencies between key components. The description of these strategies as systems is therefore not well founded and deserves further development. Copyright © 2014 Elsevier Ltd. All rights reserved.

US Pharmacopeial Convention safety evaluation of menaquinone-7, a form of vitamin K.

PubMed

Marles, Robin J; Roe, Amy L; Oketch-Rabah, Hellen A

2017-07-01

Vitamin K plays important biological roles in maintaining normal blood coagulation, bone mineralization, soft tissue physiology, and neurological development. Menaquinone-7 is a form of vitamin K2 that occurs naturally in some animal-derived and fermented foods. It is also available as an ingredient of dietary supplements. Menaquinone-7 has greater bioavailability than other forms of vitamin K, which has led to increasing sales and use of menaquinone-7 supplements. This special article reviews the chemistry, nomenclature, dietary sources, intake levels, and pharmacokinetics of menaquinones, along with the nonclinical toxicity data available and the data on clinical outcomes related to safety (adverse events). In conclusion, the data reviewed indicate that menaquinone-7, when ingested as a dietary supplement, is not associated with any serious risk to health or with other public health concerns. On the basis of this conclusion, US Pharmacopeia monographs have been developed to establish quality standards for menaquinone-7 as a dietary ingredient and as a dietary supplement in various dosage forms. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Safety design approach for external events in Japan sodium-cooled fast reactor

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yamano, H.; Kubo, S.; Tani, A.

2012-07-01

This paper describes a safety design approach for external events in the design study of Japan sodium-cooled fast reactor. An emphasis is introduction of a design extension external condition (DEEC). In addition to seismic design, other external events such as tsunami, strong wind, abnormal temperature, etc. were addressed in this study. From a wide variety of external events consisting of natural hazards and human-induced ones, a screening method was developed in terms of siting, consequence, frequency to select representative events. Design approaches for these events were categorized on the probabilistic, statistical and deterministic basis. External hazard conditions were considered mainlymore » for DEECs. In the probabilistic approach, the DEECs of earthquake, tsunami and strong wind were defined as 1/10 of exceedance probability of the external design bases. The other representative DEECs were also defined based on statistical or deterministic approaches. (authors)« less

The FDA's role in medical device clinical studies of human subjects

NASA Astrophysics Data System (ADS)

Saviola, James

2005-03-01

This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.

[Safety evaluation of niuhuang jiedu tablet].

PubMed

Feng, Yu-Ling; Miao, Jia-wei; Li, Jing; Sung, An-Sheng; Liu, Jie

2014-09-01

Realgar-containing Niuhuang Jiedu tablet (NHJD) has been applied in clinic for more than 800 years. However, because realgar contains arsenic (As), it has aroused wide concerns and controversies both at home and abroad. Currently, there are two misunderstandings about realgar-containing Chinese patent medicines. First, some people exaggerated realgar's toxicity as that of arsenic. Second, they recommended to remove realgar from traditional Chinese medicine compounds. In this paper, the authors summarized the advance in studies on NHJD, and proposed different opinions: (1) It is inappropriate to take total As as the index in safety evaluation of NHJD. (2) The toxicity of NHJD is dependent on the dose and duration of administration. (3) Realgar is an active ingredient of NHJD, and shall be deeply studied. Classic realgar-containing traditional Chinese medicine prescriptions, such as Niuhuang Jiedu tablet, shall be evaluated with rigorous modern scientific basis, with the aim to guide rational and safe application.

Discussion on the Criterion for the Safety Certification Basis Compilation - Brazilian Space Program Case

NASA Astrophysics Data System (ADS)

Niwa, M.; Alves, N. C.; Caetano, A. O.; Andrade, N. S. O.

2012-01-01

The recent advent of the commercial launch and re- entry activities, for promoting the expansion of human access to space for tourism and hypersonic travel, in the already complex ambience of the global space activities, brought additional difficulties over the development of a harmonized framework of international safety rules. In the present work, with the purpose of providing some complementary elements for global safety rule development, the certification-related activities conducted in the Brazilian space program are depicted and discussed, focusing mainly on the criterion for certification basis compilation. The results suggest that the composition of a certification basis with the preferential use of internationally-recognized standards, as is the case of ISO standards, can be a first step toward the development of an international safety regulation for commercial space activities.

10 CFR 830.204 - Documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Documented safety analysis. 830.204 Section 830.204 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.204 Documented safety analysis... approval from DOE for the methodology used to prepare the documented safety analysis for the facility...

Simulation of Hydrogen Distribution in Ignalina NPP ALS Compartments During BDBA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Babilas, Egidijus; Urbonavicius, Egidijus; Rimkevicius, Sigitas

2006-07-01

Accident Localisation System (ALS) of Ignalina NPP is a 'pressure suppression' type confinement, which protects the population, employees and environment from the radiation hazards. According to the Safety Analysis Report for Ignalina NPP {approx}110 m{sup 3} of hydrogen is released to ALS compartments during the Maximum Design Basis Accident. However in case of beyond design basis accident, when the oxidation of zirconium starts, the amount of generated hydrogen could be significantly higher. If the volume concentration of hydrogen in the compartment reaches 4%, there is a possibility for a combustible mixture to appear. To prevent the possible hydrogen accumulation inmore » the ALS of the Ignalina NPP during an accident the H{sub 2} control system is installed. The results of the performed analysis derived the places of the possible H{sub 2} accumulation in the ALS compartments during the transient processes and assessed the mixture combustibility in these places for a beyond design basis accident scenario. Such analysis of H{sub 2} distribution in the ALS of Ignalina NPP in case of BDBA was not performed before. (authors)« less

10 CFR 830.206 - Preliminary documented safety analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Preliminary documented safety analysis. 830.206 Section 830.206 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.206 Preliminary documented safety analysis. If construction begins after December 11, 2000, the contractor...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2013 CFR

2013-01-01

... 14 Aeronautics and Space 2 2013-01-01 2013-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2012 CFR

2012-01-01

... 14 Aeronautics and Space 2 2012-01-01 2012-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2010 CFR

2010-01-01

... 14 Aeronautics and Space 2 2010-01-01 2010-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2014 CFR

2014-01-01

... 14 Aeronautics and Space 2 2014-01-01 2014-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

14 CFR 60.37 - FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA).

Code of Federal Regulations, 2011 CFR

2011-01-01

... 14 Aeronautics and Space 2 2011-01-01 2011-01-01 false FSTD qualification on the basis of a Bilateral Aviation Safety Agreement (BASA). 60.37 Section 60.37 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) AIRMEN FLIGHT SIMULATION TRAINING DEVICE INITIAL AND...

Corporate Functional Management Evaluation of the LLNL Radiation Safety Organization

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sygitowicz, L S

2008-03-20

A Corporate Assess, Improve, and Modernize review was conducted at Lawrence Livermore National Laboratory (LLNL) to evaluate the LLNL Radiation Safety Program and recommend actions to address the conditions identified in the Internal Assessment conducted July 23-25, 2007. This review confirms the findings of the Internal Assessment of the Institutional Radiation Safety Program (RSP) including the noted deficiencies and vulnerabilities to be valid. The actions recommended are a result of interviews with about 35 individuals representing senior management through the technician level. The deficiencies identified in the LLNL Internal Assessment of the Institutional Radiation Safety Program were discussed with Radiationmore » Safety personnel team leads, customers of Radiation Safety Program, DOE Livermore site office, and senior ES&H management. There are significant issues with the RSP. LLNL RSP is not an integrated, cohesive, consistently implemented program with a single authority that has the clear roll and responsibility and authority to assure radiological operations at LLNL are conducted in a safe and compliant manner. There is no institutional commitment to address the deficiencies that are identified in the internal assessment. Some of these deficiencies have been previously identified and corrective actions have not been taken or are ineffective in addressing the issues. Serious funding and staffing issues have prevented addressing previously identified issues in the Radiation Calibration Laboratory, Internal Dosimetry, Bioassay Laboratory, and the Whole Body Counter. There is a lack of technical basis documentation for the Radiation Calibration Laboratory and an inadequate QA plan that does not specify standards of work. The Radiation Safety Program lack rigor and consistency across all supported programs. The implementation of DOE Standard 1098-99 Radiological Control can be used as a tool to establish this consistency across LLNL. The establishment of a site wide ALARA Committee and administrative control levels would focus attention on improved processes. Currently LLNL issues dosimeters to a large number of employees and visitors that do not enter areas requiring dosimetry. This includes 25,000 visitor TLDs per year. Dosimeters should be issued to only those personnel who enter areas where dosimetry is required.« less

10 CFR 830.203 - Unreviewed safety question process.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Unreviewed safety question process. 830.203 Section 830.203 Energy DEPARTMENT OF ENERGY NUCLEAR SAFETY MANAGEMENT Safety Basis Requirements § 830.203 Unreviewed safety question process. (a) The contractor responsible for a hazard category 1, 2, or 3 DOE...

A site of communication among enterprises for supporting occupational health and safety management system.

PubMed

Velonakis, E; Mantas, J; Mavrikakis, I

2006-01-01

The occupational health and safety management constitutes a field of increasing interest. Institutions in cooperation with enterprises make synchronized efforts to initiate quality management systems to this field. Computer networks can offer such services via TCP/IP which is a reliable protocol for workflow management between enterprises and institutions. A design of such network is based on several factors in order to achieve defined criteria and connectivity with other networks. The network will be consisted of certain nodes responsible to inform executive persons on Occupational Health and Safety. A web database has been planned for inserting and searching documents, for answering and processing questionnaires. The submission of files to a server and the answers to questionnaires through the web help the experts to make corrections and improvements on their activities. Based on the requirements of enterprises we have constructed a web file server. We submit files in purpose users could retrieve the files which need. The access is limited to authorized users and digital watermarks authenticate and protect digital objects. The Health and Safety Management System follows ISO 18001. The implementation of it, through the web site is an aim. The all application is developed and implemented on a pilot basis for the health services sector. It is all ready installed within a hospital, supporting health and safety management among different departments of the hospital and allowing communication through WEB with other hospitals.

49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...

The power of simplification: Operator interface with the AP1000{sup R} during design-basis and beyond design-basis events

DOE Office of Scientific and Technical Information (OSTI.GOV)

Williams, M. G.; Mouser, M. R.; Simon, J. B.

2012-07-01

The AP1000{sup R} plant is an 1100-MWe pressurized water reactor with passive safety features and extensive plant simplifications that enhance construction, operation, maintenance, safety and cost. The passive safety features are designed to function without safety-grade support systems such as component cooling water, service water, compressed air or HVAC. The AP1000 passive safety features achieve and maintain safe shutdown in case of a design-basis accident for 72 hours without need for operator action, meeting the expectations provided in the European Utility Requirements and the Utility Requirement Document for passive plants. Limited operator actions may be required to maintain safe conditionsmore » in the spent fuel pool (SFP) via passive means. This safety approach therefore minimizes the reliance on operator action for accident mitigation, and this paper examines the operator interaction with the Human-System Interface (HSI) as the severity of an accident increases from an anticipated transient to a design basis accident and finally, to a beyond-design-basis event. The AP1000 Control Room design provides an extremely effective environment for addressing the first 72 hours of design-basis events and transients, providing ease of information dissemination and minimal reliance upon operator actions. Symptom-based procedures including Emergency Operating Procedures (EOPs), Abnormal Operating Procedures (AOPs) and Alarm Response Procedures (ARPs) are used to mitigate design basis transients and accidents. Use of the Computerized Procedure System (CPS) aids the operators during mitigation of the event. The CPS provides cues and direction to the operators as the event progresses. If the event becomes progressively worse or lasts longer than 72 hours, and depending upon the nature of failures that may have occurred, minimal operator actions may be required outside of the control room in areas that have been designed to be accessible using components that have been designed to be reliable in these conditions. The primary goal of any such actions is to maintain or refill the passive inventory available to cool the core, containment and spent fuel pool in the safety-related and seismically qualified Passive Containment Cooling Water Storage Tank (PCCWST). The seismically-qualified, ground-mounted Passive Containment Cooling Ancillary Water Storage Tank (PCCAWST) is also available for this function as appropriate. The primary effect of these actions would be to increase the coping time for the AP1000 during design basis events, as well as events such as those described above, from 72 hours without operator intervention to 7 days with minimal operator actions. These Operator actions necessary to protect the health and safety of the public are addressed in the Post-72 Hour procedures, as well as some EOPs, AOPs, ARPs and the Severe Accident Management Guidelines (SAMGs). Should the event continue to become more severe and plant conditions degrade further with indications of inadequate core cooling, the SAMGs provide guidance for strategies to address these hypothetical severe accident conditions. The AP1000 SAMG diagnoses and actions are prioritized to first utilize the AP1000 features that are expected to retain a damaged core inside the reactor vessel. Only one strategy is undertaken at any time. This strategy will be followed and its effectiveness evaluated before other strategies are undertaken. This is a key feature of both the symptom-oriented AP1000 EOPs and the AP1000 SAMGs which maximizes the probability of retaining a damaged core inside the reactor vessel and containment while minimizing the chances for confusion and human errors during implementation. The AP1000 SAMGs are simple and straight-forward and have been developed with considerable input from human factors and plant operations experts. Most importantly, and different from severe accident management strategies for other plants, the AP1000 SAMGs do not require diagnosis of the location of the core (i.e., whether reactor vessel failure has occurred). This is a fundamental consequence of the AP1000 In-Vessel Retention approach, which allows severe accident management to be based on fundamental principles (e.g. provide coolant as close as possible to the core) that do not change during a specific event. This eliminates the need for one of the more difficult diagnostic requirements, since reactor vessel failure does not directly relate to any measurable plant parameter, and differs from other designs in that an engineered failure of the pressure vessel' (e.g. core catcher) is never required. (authors)« less

eBASIS (Bioactive Substances in Food Information Systems) and Bioactive Intakes: Major Updates of the Bioactive Compound Composition and Beneficial Bioeffects Database and the Development of a Probabilistic Model to Assess Intakes in Europe.

PubMed

Plumb, Jenny; Pigat, Sandrine; Bompola, Foteini; Cushen, Maeve; Pinchen, Hannah; Nørby, Eric; Astley, Siân; Lyons, Jacqueline; Kiely, Mairead; Finglas, Paul

2017-03-23

eBASIS (Bioactive Substances in Food Information Systems), a web-based database that contains compositional and biological effects data for bioactive compounds of plant origin, has been updated with new data on fruits and vegetables, wheat and, due to some evidence of potential beneficial effects, extended to include meat bioactives. eBASIS remains one of only a handful of comprehensive and searchable databases, with up-to-date coherent and validated scientific information on the composition of food bioactives and their putative health benefits. The database has a user-friendly, efficient, and flexible interface facilitating use by both the scientific community and food industry. Overall, eBASIS contains data for 267 foods, covering the composition of 794 bioactive compounds, from 1147 quality-evaluated peer-reviewed publications, together with information from 567 publications describing beneficial bioeffect studies carried out in humans. This paper highlights recent updates and expansion of eBASIS and the newly-developed link to a probabilistic intake model, allowing exposure assessment of dietary bioactive compounds to be estimated and modelled in human populations when used in conjunction with national food consumption data. This new tool could assist small- and medium-sized enterprises (SMEs) in the development of food product health claim dossiers for submission to the European Food Safety Authority (EFSA).

The American compensation phenomenon.

PubMed

Bale, A

1990-01-01

In this article, the author defines the occupational safety and health domain, characterizes the distinct compensation phenomenon in the United States, and briefly reviews important developments in the last decade involving Karen Silkwood, intentional torts, and asbestos litigation. He examines the class conflict over the value and meaning of work-related injuries and illnesses involved in the practical activity of making claims and turning them into money through compensation inquiries. Juries, attributions of fault, and medicolegal discourse play key roles in the compensation phenomenon. This article demonstrates the extensive, probing inquiry through workers' bodies constituted by the American compensation phenomenon into the moral basis of elements of the system of production.

[Stevia in the fight against dental caries].

PubMed

Ma, M S; Blanksma, N G

2015-01-01

Stevia is a natural, non-caloric sweetener of plant origin. The sweetening power of stevia is several hundred times larger than that of table sugar (sucrose). On the basis of available research, the European Food Safety Authority concluded that stevia is safe for human consumption. Since then, stevia has been approved as a sweetener for the European market. As a substitute for sucrose, stevia can contribute to a reduced caloric intake and can play a role in the prevention and/or treatment of metabolic disorders. In addition, stevia is non-cariogenic and is, moreover, affordable. Promoting the consumption of stevia can therefore be a preventive means of fighting dental caries.

Efficacy and safety of pilocarpine for radiation-induced xerostomia in patients with head and neck cancer: A systematic review and meta-analysis.

PubMed

Cheng, Cai-Qi; Xu, Hao; Liu, Ling; Wang, Rui-Nan; Liu, Yu-Ting; Li, Jing; Zhou, Xi-Kun

2016-04-01

Pilocarpine has been used widely in the treatment of dry mouth and glaucoma. In this review, the authors assessed the efficacy and safety of pilocarpine for patients with head and neck cancer who have radiation-induced xerostomia. The authors conducted a systematic search including meta-analyses and randomized controlled trials in the following databases: MEDLINE, Embase, Cochrane Library, and Science Citation Index Expanded. The primary outcome was the severity of xerostomia (measured using visual analog scale [VAS] scores). Adverse events were other outcomes of interest. The authors performed meta-analyses where appropriate. The authors used the Cochrane Collaboration's tool for assessing risk of bias to assess the quality of the study. The authors identified 6 studies (including 752 patients in total). The results of a meta-analysis of 3 articles showed that pilocarpine was associated with a 12-point increase in VAS score (mean difference, 12.00; 95% confidence interval [CI], 1.93-22.08; P = .02) and higher rates of adverse events compared with placebo in terms of sweating (odds ratio [OR], 3.71; 95% CI, 2.34-5.86; P < .00001). There were no differences in rhinitis (OR, 1.21; 95% CI, 0.68-2.16; P = .52) and nausea (OR, 1.44; 95% CI, 0.83-2.49; P = .19). On the basis of the best available evidence, the results of this meta-analysis provide evidence that pilocarpine offers statistically significant clinical benefits for the symptomatic treatment of radiation-induced xerostomia in patients with head and neck cancer. However, the authors of this systematic review found the best available evidence in the meta-analysis in 3 studies, 1 of which showed no effect. The authors of this systematic review suggest that these patients take 5 milligrams of pilocarpine 3 times daily, and that there is need for further study. Copyright © 2016 American Dental Association. Published by Elsevier Inc. All rights reserved.

10 CFR 35.50 - Training for Radiation Safety Officer.

Code of Federal Regulations, 2011 CFR

2011-01-01

... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

10 CFR 35.50 - Training for Radiation Safety Officer.

Code of Federal Regulations, 2014 CFR

2014-01-01

... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

10 CFR 35.50 - Training for Radiation Safety Officer.

Code of Federal Regulations, 2012 CFR

2012-01-01

... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

10 CFR 35.50 - Training for Radiation Safety Officer.

Code of Federal Regulations, 2013 CFR

2013-01-01

... authorized nuclear pharmacist identified on the licensee's license and has experience with the radiation... Radiation Safety Officer, authorized medical physicist, authorized nuclear pharmacist, or authorized user...

New challenges in assuring vaccine quality.

PubMed Central

Dellepiane, N.; Griffiths, E.; Milstien, J. B.

2000-01-01

In the past, quality control of vaccines depended on use of a variety of testing methods to ensure that the products were safe and potent. These methods were developed for vaccines whose safety and efficacy were based on several years worth of data. However, as vaccine production technologies have developed, so have the testing technologies. Tests are now able to detect potential hazards with a sensitivity not possible a few years ago, and an increasing array of physicochemical methods allows a much better characterization of the product. In addition to sophisticated tests, vaccine regulation entails a number of other procedures to ensure safety. These include characterization of starting materials by supplier audits, cell banking, seed lot systems, compliance with the principles of good manufacturing practices, independent release of vaccines on a lot-by-lot basis by national regulatory authorities, and enhanced pre- and post-marketing surveillance for possible adverse events following immunization. These procedures help assure vaccine efficacy and safety, and some examples are given in this article. However, some contaminants of vaccines that can be detected by newer assays raise theoretical safety concerns but their presence may be less hazardous than not giving the vaccines. Thus risk-benefit decisions must be well informed and based on scientific evidence. PMID:10743279

Current Sports: Medicine Issues. Annual Safety Education Review--1973.

ERIC Educational Resources Information Center

Craig, Timothy T., Ed.

This document is a collection of papers whose theme is sports safety. Section one, "Government Interest in Sports Safety," includes an article on Washington, D.C.'s focus on sports safety. Section two, "Medical Aspects of Safety in Sports," includes articles regarding the medical basis of restriction from athletics, orthopaedic restrictions, and…

The Dread Factor: How Hazards and Safety Training Influence Learning and Performance

ERIC Educational Resources Information Center

Burke, Michael J.; Salvador, Rommel O.; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous…

Transportation Safety Information Report : Second Quarter 1984

DOT National Transportation Integrated Search

1984-01-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Transportation Safety Information Report : Second Quarter 1985

DOT National Transportation Integrated Search

1985-10-01

The "Transportation Safety Information Report" is a compendium of selected national-level transportation safety statistics for all modes of transportation. The report presents and compares data on a monthly and quarterly basis for transportation fata...

Natural radioactivity in building materials in the European Union: a database and an estimate of radiological significance.

PubMed

Trevisi, R; Risica, S; D'Alessandro, M; Paradiso, D; Nuccetelli, C

2012-02-01

The authors set up a database of activity concentration measurements of natural radionuclides (²²⁶Ra, ²³²Th and ⁴⁰K) in building material. It contains about 10,000 samples of both bulk material (bricks, concrete, cement, natural- and phosphogypsum, sedimentary and igneous bulk stones) and superficial material (igneous and metamorphic stones) used in the construction industry in most European Union Member States. The database allowed the authors to calculate the activity concentration index I--suggested by a European technical guidance document and recently used as a basis for elaborating the draft Euratom Basic Safety Standards Directive--for bricks, concrete and phosphogypsum used in the European Union. Moreover, the percentage could be assessed of materials possibly subject to restrictions, if either of the two dose criteria proposed by the technical guidance were to be adopted. Copyright © 2011 Elsevier Ltd. All rights reserved.

RELEASE OF DRIED RADIOACTIVE WASTE MATERIALS TECHNICAL BASIS DOCUMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

KOZLOWSKI, S.D.

2007-05-30

This technical basis document was developed to support RPP-23429, Preliminary Documented Safety Analysis for the Demonstration Bulk Vitrification System (PDSA) and RPP-23479, Preliminary Documented Safety Analysis for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Facility. The main document describes the risk binning process and the technical basis for assigning risk bins to the representative accidents involving the release of dried radioactive waste materials from the Demonstration Bulk Vitrification System (DBVS) and to the associated represented hazardous conditions. Appendices D through F provide the technical basis for assigning risk bins to the representative dried waste release accident and associated represented hazardous conditionsmore » for the Contact-Handled Transuranic Mixed (CH-TRUM) Waste Packaging Unit (WPU). The risk binning process uses an evaluation of the frequency and consequence of a given representative accident or represented hazardous condition to determine the need for safety structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls. A representative accident or a represented hazardous condition is assigned to a risk bin based on the potential radiological and toxicological consequences to the public and the collocated worker. Note that the risk binning process is not applied to facility workers because credible hazardous conditions with the potential for significant facility worker consequences are considered for safety-significant SSCs and/or TSR-level controls regardless of their estimated frequency. The controls for protection of the facility workers are described in RPP-23429 and RPP-23479. Determination of the need for safety-class SSCs was performed in accordance with DOE-STD-3009-94, Preparation Guide for US. Department of Energy Nonreactor Nuclear Facility Documented Safety Analyses, as described below.« less

Health Care Worker Fatigue.

PubMed

Gardner, Lea Anne; Dubeck, Deborah

2016-08-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, birthing centers, and abortion facilities must file information on incidents and serious events.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

Molecular commonality detection using an artificial enzyme membrane for in situ one-stop biosurveillance.

PubMed

Ikeno, Shinya; Asakawa, Hitoshi; Haruyama, Tetsuya

2007-08-01

Biodetection and biosensing have been developed based on the concept of sensitivity toward specific molecules. However, current demand may require more levelheaded or far-sighted methods, especially in the field of biological safety and security. In the fields of hygiene, public safety, and security including fighting bioterrorism, the detection of biological contaminants, e.g., microorganisms, spores, and viruses, is a constant challenge. However, there is as yet no sophisticated method of detecting such contaminants in situ without oversight. The authors focused their attention on diphosphoric acid anhydride, which is a structure common to all biological phosphoric substances. Interestingly, biological phosphoric substances are peculiar substances present in all living things and include many different substances, e.g., ATP, ADP, dNTP, pyrophosphate, and so forth, all of which have a diphosphoric acid anhydride structure. The authors took this common structure as the basis of their development of an artificial enzyme membrane with selectivity for the structure common to all biological phosphoric substances and studied the possibility of its application to in situ biosurveillance sensors. The artificial enzyme membrane-based amperometric biosensor developed by the authors can detect various biological phosphoric substances, because it has a comprehensive molecular selectivity for the structure of these biological phosphoric substances. This in situ detection method of the common diphosphoric acid anhydride structure brings a unique advantage to the fabrication of in situ biosurveillance sensors for monitoring biological contaminants, e.g., microorganism, spores, and viruses, without an oversight, even if they were transformed.

76 FR 63988 - Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-14

...-0097] Pilot Project on NAFTA Trucking Provisions; Pre-Authorization Safety Audits AGENCY: Federal Motor... public comment on data and information concerning the Pre-Authorization Safety Audits (PASAs) for two motor carriers that applied to participate in the Agency's long-haul pilot program to test and...

Risk evaluation and monitoring in multiple sclerosis therapeutics.

PubMed

Clanet, Michel C; Wolinsky, Jerry S; Ashton, Raymond J; Hartung, Hans-Peter; Reingold, Stephen C

2014-09-01

Risk for multiple sclerosis (MS) disease-modifying therapies (DMT) must be assessed on an ongoing basis. Early concerns regarding the first-approved DMTs for MS have been mitigated, but recently licensed therapies have been linked to possibly greater risks. The objective of this review is to discuss risk assessment in MS therapeutics based on an international workshop and comprehensive literature search and recommend strategies for risk assessment/monitoring. Assessment and perception of therapeutic risks vary between patients, doctors and regulators. Acceptability of risk depends on the magnitude of risk and the demonstrated clinical benefits of any agent. Safety signals must be distinguishable from chance occurrences in a clinical trial and in long-term use of medications. Post-marketing research is crucial for assessing longer-term safety in large patient cohorts. Reporting of adverse events is becoming more proactive, allowing more rapid identification of risks. Communication about therapeutic risks and their relationship to clinical benefit must involve patients in shared decision making. It is difficult to produce a general risk-assessment algorithm for all MS therapies. Specific algorithms are required for each DMT in every treated-patient population. New and evolving risks must be evaluated and communicated rapidly to allow patients and physicians to be well informed and able to share treatment decisions. © The Author(s) 2013.

41 CFR 102-5.75 - What circumstances do not establish a basis for authorizing home-to-work transportation for field...

Code of Federal Regulations, 2010 CFR

2010-07-01

... not establish a basis for authorizing home-to-work transportation for field work? 102-5.75 Section 102... (Continued) FEDERAL MANAGEMENT REGULATION GENERAL 5-HOME-TO-WORK TRANSPORTATION Authorizing Home-to-Work Transportation § 102-5.75 What circumstances do not establish a basis for authorizing home-to-work transportation...

42 CFR 87.4 - For what purposes may grants be awarded?

Code of Federal Regulations, 2013 CFR

2013-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH... Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority...

42 CFR 87.4 - For what purposes may grants be awarded?

Code of Federal Regulations, 2012 CFR

2012-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH... Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority...

42 CFR 87.4 - For what purposes may grants be awarded?

Code of Federal Regulations, 2014 CFR

2014-10-01

... SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH... Safety and Health Act authorizes grants for research, experiments, and demonstrations relating to occupational safety and health, including studies of the psychological factors involved. This authority...

"My love-hate relationship": Ethical issues associated with nurses' interactions with industry.

PubMed

Grundy, Quinn

2014-08-01

Ethical issues associated with nurses' interactions with industry have implications for the safety, quality, and cost of healthcare. To date, little work has explored nurse-industry interactions and their associated ethical issues empirically. A phenomenological study was conducted to explore registered nurses' interactions with industry in clinical practice. Five registered nurses working in direct patient care were recruited and individual, in-depth interviews were conducted. The University's Committee on Human Research approved the study. Nurses frequently interacted with industry in their practice and felt ambivalent about these interactions. Nurses described systemic cuts to multiple "goods" central to nursing practice, including patient support, but paradoxically relied on industry resources to deliver these "goods." They relied on a particular conception of trust to navigate these interactions but were left to do so individually on the basis of their experience. Conflicts of interest arose as a result of multiple competing interests, and were frequently mediated through nurses' superiors. Nursing as a profession requires a guiding narrative to aid nurses in interpreting and navigating interactions with industry. A conception of trust that incorporates both the work of caring and attention to social justice could form the basis of these interactions, but would require that nursing take a much more critical stance toward marketing interactions. © The Author(s) 2013.

Recent findings relating to firefighter safety zones

Treesearch

Bret Butler; Russ Parsons; William Mell

2015-01-01

Designation of safety zones is a primary duty of all wildland firefighters. Unfortunately, information regarding what constitutes an adequate safety zone is inadequately defined. Measurements of energy release from wildland fires have been used to develop an empirically based safety zone guideline. The basis for this work is described here.

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2011 CFR

2011-01-01

... occurrences, design basis accidents, external events, and natural phenomena for which the plant must be... important to safety, (2) protection of electric equipment important to safety against other natural phenomena and external events, and (3) environmental qualification of electric equipment important to safety...

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

PubMed

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices

PubMed Central

Kraft, Marc

2008-01-01

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority. PMID:20204095

Caring for class III obese patients.

PubMed

Gardner, Lea Anne

2013-11-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, and birthing centers, as well as some abortion facilities, must file information on medical errors.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

2016 Traffic Safety Culture Index

MedlinePlus

... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ... for Traffic Safety. For media inquiries, contact: Tamra Johnson 202-942-2079 TRJohnson@national.aaa.com Authors ...

Application of gas chromatography-mass spectrometry/combustion/isotope ratio mass spectrometry (GC-MS/C/IRMS) to detect the abuse of 17β-estradiol in cattle.

PubMed

Janssens, Geert; Mangelinckx, Sven; Courtheyn, Dirk; Prévost, Stéphanie; De Poorter, Geert; De Kimpe, Norbert; Le Bizec, Bruno

2013-07-31

Although the ability to differentiate between endogenous steroids and synthetic homologues on the basis of their (13)C/(12)C isotopic ratio has been known for over a decade, this technique has been scarcely implemented for food safety purposes. In this study, a method was developed using gas chromatography-mass spectrometry/combustion/isotope ratio mass spectrometry (GC-MS/C/IRMS) to demonstrate the abuse of 17β-estradiol in cattle, by comparison of the (13)C/(12)C ratios of the main metabolite 17α-estradiol and an endogenous reference compound (ERC), 5-androstene-3β,17α-diol, in bovine urine. The intermediate precisions were determined as 0.46 and 0.26‰ for 5-androstene-3β,17α-diol and 17α-estradiol, respectively. This is, to the authors' knowledge, the first reported use of GC-MS/C/IRMS for the analysis of steroid compounds for food safety issues.

New York Metropolitan Transportation Authority safety investigation

DOT National Transportation Integrated Search

1993-06-01

The Federal Transit Administration (FTA) conducted an intensive investigation of passenger and employee safety on the New York Metropolitan Transportation Authority (MTA) and its operating elements. The investigation stressed the system safety concep...

Safety and tolerability of bilastine 10 mg administered for 12 weeks in children with allergic diseases.

PubMed

Novák, Zoltán; Yáñez, Anahí; Kiss, Ildikó; Kuna, Piotr; Tortajada-Girbés, Miguel; Valiente, Román

2016-08-01

Regulations on medicinal products for paediatric use require that pharmacokinetics and safety be characterized specifically in the paediatric population. A previous study established that a 10-mg dose of bilastine in children aged 2 to <12 years provided an equivalent systemic exposure as 20 mg in adults. The current study assessed the safety and tolerability of bilastine 10 mg in children with allergic rhinoconjunctivitis and chronic urticaria. In this phase III, multicentre, double-blind study, children were randomized to once-daily treatment with bilastine 10-mg oral dispersible table (n = 260) or placebo (n = 249) for 12 weeks. Safety evaluations included treatment-emergent adverse events (TEAEs), laboratory tests, cardiac safety (ECG recordings) and somnolence/sedation using the Pediatric Sleep Questionnaire (PSQ). The primary hypothesis of non-inferiority between bilastine 10 mg and placebo was demonstrated on the basis of a near-equivalent proportion of children in each treatment arm without TEAEs during 12 weeks' treatment (31.5 vs. 32.5%). No clinically relevant differences between bilastine 10 mg and placebo were observed from baseline to study end for TEAEs or related TEAEs, ECG parameters and PSQ scores. The majority of TEAEs were mild or moderate in intensity. TEAEs led to discontinuation of two patients treated with bilastine 10 mg and one patient treated with placebo. Bilastine 10 mg had a safety and tolerability profile similar to that of placebo in children aged 2 to <12 years with allergic rhinoconjunctivitis or chronic urticaria. © 2016 The Authors. Pediatric Allergy and Immunology Published by John Wiley & Sons Ltd.

23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

23 CFR 1200.4 - State Highway Safety Agency-Authority and functions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... is suitably equipped and organized to carry out the State's highway safety program. (b) Authority... safety and projects administered by other State and local agencies; (3) Maintain or have ready access to information contained in State highway safety data systems, including crash, citation, adjudication, emergency...

76 FR 52231 - Restrictions on Operators Employing Former Flight Standards Service Aviation Safety Inspectors

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-22

... Standards Service Aviation Safety Inspectors AGENCY: Federal Aviation Administration (FAA), DOT. ACTION... responsible for the oversight of, a Flight Standards Service Aviation Safety Inspector, and had direct... . SUPPLEMENTARY INFORMATION: Authority for This Rulemaking The FAA's authority to issue rules on aviation safety...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2012 CFR

2012-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2014 CFR

2014-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2013 CFR

2013-01-01

... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., safety, and health into work planning and execution (48 CFR 970.5223-1, Integration of Environment...) Using the method in DOE-STD-1120-98, Integration of Environment, Safety, and Health into Facility...

10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

Code of Federal Regulations, 2011 CFR

2011-01-01

..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

Code of Federal Regulations, 2014 CFR

2014-01-01

..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

Code of Federal Regulations, 2012 CFR

2012-01-01

..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

Code of Federal Regulations, 2013 CFR

2013-01-01

..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

10 CFR 35.57 - Training for experienced Radiation Safety Officer, teletherapy or medical physicist, authorized...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., teletherapy or medical physicist, authorized medical physicist, authorized user, nuclear pharmacist, and authorized nuclear pharmacist. 35.57 Section 35.57 Energy NUCLEAR REGULATORY COMMISSION MEDICAL USE OF... pharmacist, and authorized nuclear pharmacist. (a)(1) An individual identified as a Radiation Safety Officer...

Volcanic hazards of North Island, New Zealand-overview

NASA Astrophysics Data System (ADS)

Dibble, R. R.; Nairn, I. A.; Neall, V. E.

1985-10-01

In October 1980, a National Civil Defence Planning Committee on Volcanic Hazards was formed in New Zealand, and solicited reports on the likely areas and types of future eruptions, the risk to public safety, and the need for special precautions. Reports for eight volcanic centres were received, and made available to the authors. This paper summarises and quantifies the type and frequency of hazard, the public risk, and the possibilities for mitigation at the 7 main volcanic centres: Northland, Auckland, White Island, Okataina, Taupo, Tongariro, and Egmont. On the basis of Recent tephrostratigraphy, eruption probabilities up to 20% per century (but commonly 5%), and tephra volumes up to 100 km 3 are credible.

eBASIS (Bioactive Substances in Food Information Systems) and Bioactive Intakes: Major Updates of the Bioactive Compound Composition and Beneficial Bioeffects Database and the Development of a Probabilistic Model to Assess Intakes in Europe

PubMed Central

Plumb, Jenny; Pigat, Sandrine; Bompola, Foteini; Cushen, Maeve; Pinchen, Hannah; Nørby, Eric; Astley, Siân; Lyons, Jacqueline; Kiely, Mairead; Finglas, Paul

2017-01-01

eBASIS (Bioactive Substances in Food Information Systems), a web-based database that contains compositional and biological effects data for bioactive compounds of plant origin, has been updated with new data on fruits and vegetables, wheat and, due to some evidence of potential beneficial effects, extended to include meat bioactives. eBASIS remains one of only a handful of comprehensive and searchable databases, with up-to-date coherent and validated scientific information on the composition of food bioactives and their putative health benefits. The database has a user-friendly, efficient, and flexible interface facilitating use by both the scientific community and food industry. Overall, eBASIS contains data for 267 foods, covering the composition of 794 bioactive compounds, from 1147 quality-evaluated peer-reviewed publications, together with information from 567 publications describing beneficial bioeffect studies carried out in humans. This paper highlights recent updates and expansion of eBASIS and the newly-developed link to a probabilistic intake model, allowing exposure assessment of dietary bioactive compounds to be estimated and modelled in human populations when used in conjunction with national food consumption data. This new tool could assist small- and medium-sized enterprises (SMEs) in the development of food product health claim dossiers for submission to the European Food Safety Authority (EFSA). PMID:28333085

Thermal injury through intraradicular heat transfer using ultrasonic devices: precautions and practical preventive strategies.

PubMed

Gluskin, Alan H; Ruddle, Clifford J; Zinman, Edwin J

2005-09-01

The use of ultrasonic energy is a highly efficient method of removing obstructions and cements within the root canal space when re-treatment or rehabilitation of that ultrasonic energy dislodges and removes cemented objects from the bonded interface of the canal wall. When using this method, there is less potential for structural loss or root damage and significantly less operator stress than when using other methods. There is little evidence in published research of the considerable heat transfer that occurs during use of ultrasonic devices to remove posts, pastes and separated instruments in teeth. The authors present three cases of patients who experienced serious burn injuries during application of ultrasonic energy for restorative dentistry. The authors also offer techniques and strategies for safe and effective use of ultrasonic devices. On the basis of the best available evidence, the authors recommend strategies to provide safe and effective therapy while using ultrasonic devices in intraradicular obstruction removal. The intent of the suggested protocols is to provide advanced and sophisticated therapies in a safe and regulated manner with patient safety as an overriding priority.

Vehicle fires and fire safety in tunnels

DOT National Transportation Integrated Search

2002-09-20

Tunnels present what is arguably the most hazardous environment, from the point of view of fire safety, that members of the public ever experience. The fire safety design of tunnels is carried out by tunnel engineers on the basis of a potential fire ...

47 CFR 0.392 - Authority delegated.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 1 2011-10-01 2011-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

47 CFR 0.392 - Authority delegated.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 1 2010-10-01 2010-10-01 false Authority delegated. 0.392 Section 0.392 Telecommunication FEDERAL COMMUNICATIONS COMMISSION GENERAL COMMISSION ORGANIZATION Delegations of Authority Public Safety and Homeland Security Bureau § 0.392 Authority delegated. The Chief, Public Safety and Homeland...

Experiences of frontline nursing staff on workplace safety and occupational health hazards in two psychiatric hospitals in Ghana.

PubMed

Alhassan, Robert Kaba; Poku, Kwabena Adu

2018-06-06

Psychiatric hospitals need safe working environments to promote productivity at the workplace. Even though occupational health and safety is not completely new to the corporate society, its scope is largely limited to the manufacturing/processing industries which are perceived to pose greater dangers to workers than the health sector. This paper sought to explore the experiences of frontline nursing personnel on the occupational health and safety conditions in two psychiatric hospitals in Ghana. This is an exploratory cross-sectional study among 296 nurses and nurse-assistants in Accra (n = 164) and Pantang (n = 132) psychiatric hospitals using the proportional stratified random sampling technique. Multivariate Ordinary Least Squares (OLS) regression test was conducted to ascertain the determinants of staff exposure to occupational health hazards and the frequency of exposure to these occupational health hazards on daily basis. Knowledge levels on occupational health hazards was high in Accra and Pantang psychiatric hospitals (i.e. 92 and 81% respectively), but barely 44% of the 296 interviewed staff in the two hospitals said they reported their most recent exposure to an occupational health hazard to hospital management. It was found that staff who worked for more years on the ward had higher likelihood of exposure to occupational health hazards than those who worked for lesser years (p = 0.002). The category of occupational health hazards reported most were the physical health hazards. Psychosocial hazards were the least reported health hazards. Frequency of exposure to occupational health hazards on daily basis was positively associated with work schedules of staff particularly, staff on routine day schedule (Coef = 4.49, p = 0.011) and those who alternated between day and night schedules (Coef = 4.48, p = 0.010). Occupational health and safety conditions in the two hospitals were found to be generally poor. Even though majority of the staff knew about occupational health and safety, less than half of them reported exposure to workplace health hazards. Key stakeholders such as the Ministry of Health in collaboration with the Mental Health Authority should intensify efforts towards effective enforcement of existing policies on safety in healthcare institutions, particularly psychiatric hospitals where exposure to occupational health hazards is more prevalent.

Setting quality and safety priorities in a target-rich environment: an academic medical center's challenge.

PubMed

Mort, Elizabeth A; Demehin, Akinluwa A; Marple, Keith B; McCullough, Kathryn Y; Meyer, Gregg S

2013-08-01

Hospitals are continually challenged to provide safer and higher-quality patient care despite resource constraints. With an ever-increasing range of quality and safety targets at the national, state, and local levels, prioritization is crucial in effective institutional quality goal setting and resource allocation.Organizational goal-setting theory is a performance improvement methodology with strong results across many industries. The authors describe a structured goal-setting process they have established at Massachusetts General Hospital for setting annual institutional quality and safety goals. Begun in 2008, this process has been conducted on an annual basis. Quality and safety data are gathered from many sources, both internal and external to the hospital. These data are collated and classified, and multiple approaches are used to identify the most pressing quality issues facing the institution. The conclusions are subject to stringent internal review, and then the top quality goals of the institution are chosen. Specific tactical initiatives and executive owners are assigned to each goal, and metrics are selected to track performance. A reporting tool based on these tactics and metrics is used to deliver progress updates to senior hospital leadership.The hospital has experienced excellent results and strong organizational buy-in using this effective, low-cost, and replicable goal-setting process. It has led to improvements in structural, process, and outcomes aspects of quality.

77 FR 37252 - Delegations of Authority for the Office of Housing-Federal Housing Administration (FHA...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-20

... Secretary, Office of Single Family Housing Authority is redelegated, on a nationwide basis, to take all... Authority is redelegated, on a nationwide basis, to take all actions necessary to the conduct of single... redelegated, on a nationwide basis, to take all actions necessary to the conduct of single family housing...

The Evolution of System Safety at NASA

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Everett, Chris; Groen, Frank

2014-01-01

The NASA system safety framework is in the process of change, motivated by the desire to promote an objectives-driven approach to system safety that explicitly focuses system safety efforts on system-level safety performance, and serves to unify, in a purposeful manner, safety-related activities that otherwise might be done in a way that results in gaps, redundancies, or unnecessary work. An objectives-driven approach to system safety affords more flexibility to determine, on a system-specific basis, the means by which adequate safety is achieved and verified. Such flexibility and efficiency is becoming increasingly important in the face of evolving engineering modalities and acquisition models, where, for example, NASA will increasingly rely on commercial providers for transportation services to low-earth orbit. A key element of this objectives-driven approach is the use of the risk-informed safety case (RISC): a structured argument, supported by a body of evidence, that provides a compelling, comprehensible and valid case that a system is or will be adequately safe for a given application in a given environment. The RISC addresses each of the objectives defined for the system, providing a rational basis for making informed risk acceptance decisions at relevant decision points in the system life cycle.

Good practices on cost - effective road infrastructure safety investments.

PubMed

Yannis, George; Papadimitriou, Eleonora; Evgenikos, Petros; Dragomanovits, Anastasios

2016-12-01

The paper presents the findings of a research project aiming to quantify and subsequently classify several infrastructure-related road safety measures, based on the international experience attained through extensive and selected literature review and additionally on a full consultation process including questionnaire surveys addressed to experts and relevant workshops. Initially, a review of selected research reports was carried out and an exhaustive list of road safety infrastructure investments covering all types of infrastructure was compiled. Individual investments were classified according to the infrastructure investment area and the type of investment and were thereafter analysed on the basis of key safety components. These investments were subsequently ranked in relation to their safety effects and implementation costs and on the basis of this ranking, a set of five most promising investments was selected for an in-depth analysis. The results suggest that the overall cost effectiveness of a road safety infrastructure investment is not always in direct correlation with the safety effect and is recommended that cost-benefit ratios and safety effects are always examined in conjunction with each other in order to identify the optimum solution for a specific road safety problem in specific conditions and with specific objectives.

26 CFR 1.187-1 - Amortization of certain coal mine safety equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 3 2010-04-01 2010-04-01 false Amortization of certain coal mine safety... (continued) § 1.187-1 Amortization of certain coal mine safety equipment. (a) Allowance of deduction—(1) In... respect to the amortization of the adjusted basis (for determining gain) of any certified coal mine safety...

76 FR 22812 - Safety Zone; Sea World Fireworks; Mission Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-25

...-AA00 Safety Zone; Sea World Fireworks; Mission Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION... navigable waters of Mission Bay in support of the Sea World Fireworks. This safety zone is necessary to... impracticable, because immediate action is needed to ensure the public's safety. Basis and Purpose Sea World is...

29 CFR 1952.365 - Level of Federal enforcement.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION... Mexico occupational health and safety plan, discretionary Federal enforcement authority under section 18... authority fully or effectively; (7) Enforcement of occupational safety and health standards at all Federal...

Rational and irrational clinical strategies for collaborative medicine.

PubMed

Hammerly, Milt

2002-01-01

Individual practitioners and health care systems/organizations increasingly understand the rationale for collaborative medicine. An absence of collaboration can compromise the quality and safety of patient care. But having a rationale to provide collaborative medicine without also having a rational clinical strategy can be equally compromising to the quality and safety of patient care. Reasonable evidentiary criteria must be used to determine whether specific therapies merit inclusion or exclusion in a collaborative medicine model. Ranking therapies hierarchically on the basis of their risk-benefit ratio simplifies matching of therapies with the needs of the patient. A unifying taxonomy that categorizes all therapies (complementary/alternative and conventional) on the basis of how we think they work (presumed mechanisms of action) facilitates development of a clinical strategy for collaborative medicine. On the basis of these principles, a rational clinical strategy for collaborative medicine is described to help optimize the quality and safety of patient care.

77 FR 62466 - Airworthiness Directives; GA200 (Pty) Ltd Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

... Aviation Safety Authority (CASA), which is the aviation authority for the Commonwealth of Australia, has...) Related Information Refer to MCAI Civil Aviation Safety Authority (CASA) AD AD/ GA200/1, Amendment 1...

78 FR 28897 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-16

...] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the... CFR 2.104, 2.105, 2.300, 2.309, 2.313, 2.318, and 2.321, notice is hereby given that an Atomic Safety... comprised of the following administrative judges: Alex S. Karlin, Chairman, Atomic Safety and Licensing...

The utility of injury narratives for prioritising future prevention activities in small and medium enterprises in rural Vietnam.

PubMed

Marucci-Wellman, Helen; Willetts, Joanna L; Diep, Nguyen Bich; Binh, Ta Thi Tuyet

2013-04-01

Injuries are a leading cause of work-related disability and death in rapidly developing countries such as Vietnam. The authors' objective was to demonstrate the utility of detailed injury narratives, derived from a household survey, in providing information on the determinants of work-related injuries to inform potential intervention targets. In a cross-sectional survey administered to 2615 households of a rapidly developing community of Vietnam where many workers engage in both agriculture and industrial work, the authors collected information about self-reported work-related injuries, annual hours worked in each industry and narrative text describing the circumstances of each injury. The authors used a customised coding taxonomy to describe injury scenarios. Several intervention themes emerged, including the implementation of machine guarding, the use of cut resistant gloves and safety glasses which would benefit the small- and medium-sized enterprises. Calculation of incidence rates using full-time equivalents, stratified by work group, provided some unexpected observations of the risks of working in agriculture; workers who work in agriculture in addition to another industry are at an increased risk of fatigue or overexertion and other consequences of working too hard in their agricultural activities. A lack of aggregate injury statistics makes it difficult for the owners of small- and medium-sized enterprises to recognise a priori the most effective safety interventions. This analysis of detailed injury narratives with an appropriate taxonomic basis offers the ability to focus on the level of cause, activity and source and may inform the choice of various potential interventions at the workplace or enterprise level.

Aviation and healthcare: a comparative review with implications for patient safety.

PubMed

Kapur, Narinder; Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2016-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing.

Aviation and healthcare: a comparative review with implications for patient safety

PubMed Central

Parand, Anam; Soukup, Tayana; Reader, Tom; Sevdalis, Nick

2015-01-01

Safety in aviation has often been compared with safety in healthcare. Following a recent article in this journal, the UK government set up an Independent Patient Safety Investigation Service, to emulate a similar well-established body in aviation. On the basis of a detailed review of relevant publications that examine patient safety in the context of aviation practice, we have drawn up a table of comparative features and a conceptual framework for patient safety. Convergence and divergence of safety-related behaviours across aviation and healthcare were derived and documented. Key safety-related domains that emerged included Checklists, Training, Crew Resource Management, Sterile Cockpit, Investigation and Reporting of Incidents and Organisational Culture. We conclude that whilst healthcare has much to learn from aviation in certain key domains, the transfer of lessons from aviation to healthcare needs to be nuanced, with the specific characteristics and needs of healthcare borne in mind. On the basis of this review, it is recommended that healthcare should emulate aviation in its resourcing of staff who specialise in human factors and related psychological aspects of patient safety and staff wellbeing. Professional and post-qualification staff training could specifically include Cognitive Bias Avoidance Training, as this appears to play a key part in many errors relating to patient safety and staff wellbeing. PMID:26770817

Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.

PubMed

Reisinger, Keith S; Block, Stanley L; Izu, Allen; Groth, Nicola; Holmes, Sandra J

2009-09-15

This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV). Adult subjects (n = 613; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates. There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines. The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.

Nuclear power and probabilistic safety assessment (PSA): past through future applications

NASA Astrophysics Data System (ADS)

Stamatelatos, M. G.; Moieni, P.; Everline, C. J.

1995-03-01

Nuclear power reactor safety in the United States is about to enter a new era -- an era of risk- based management and risk-based regulation. First, there was the age of `prescribed safety assessment,' during which a series of design-basis accidents in eight categories of severity, or classes, were postulated and analyzed. Toward the end of that era, it was recognized that `Class 9,' or `beyond design basis,' accidents would need special attention because of the potentially severe health and financial consequences of these accidents. The accident at Three Mile Island showed that sequences of low-consequence, high-frequency events and human errors can be much more risk dominant than the Class 9 accidents. A different form of safety assessment, PSA, emerged and began to gain ground against the deterministic safety establishment. Eventually, this led to the current regulatory requirements for individual plant examinations (IPEs). The IPEs can serve as a basis for risk-based regulation and management, a concept that may ultimately transform the U.S. regulatory process from its traditional deterministic foundations to a process predicated upon PSA. Beyond the possibility of a regulatory environment predicated upon PSA lies the possibility of using PSA as the foundation for managing daily nuclear power plant operations.

Comparative safety assessment of plant-derived foods.

PubMed

Kok, E J; Keijer, J; Kleter, G A; Kuiper, H A

2008-02-01

The second generation of genetically modified (GM) plants that are moving towards the market are characterized by modifications that may be more complex and traits that more often are to the benefit of the consumer. These developments will have implications for the safety assessment of the resulting plant products. In part of the cases the same crop plant can, however, also be obtained by 'conventional' breeding strategies. The breeder will decide on a case-by-case basis what will be the best strategy to reach the set target and whether genetic modification will form part of this strategy. This article discusses important aspects of the safety assessment of complex products derived from newly bred plant varieties obtained by different breeding strategies. On the basis of this overview, we conclude that the current process of the safety evaluation of GM versus conventionally bred plants is not well balanced. GM varieties are elaborately assessed, yet at the same time other crop plants resulting from conventional breeding strategies may warrant further food safety assessment for the benefit of the consumer. We propose to develop a general screening frame for all newly developed plant varieties to select varieties that cannot, on the basis of scientific criteria, be considered as safe as plant varieties that are already on the market.

47 CFR 95.1400 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 47 Telecommunication 5 2010-10-01 2010-10-01 false Basis and purpose. 95.1400 Section 95.1400 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PERSONAL RADIO SERVICES Personal Locator Beacons (PLB). § 95.1400 Basis and purpose. The rules in this subpart are...

77 FR 42638 - Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... 1625-AA00 Safety Zone: Sea World San Diego Fireworks, Mission Bay; San Diego, CA AGENCY: Coast Guard... navigable waters of Mission Bay in support of the Sea World San Diego Fireworks. This safety zone is..., since immediate action is needed to ensure the public's safety. B. Basis and Purpose Sea World is...

A Risk-Based Strategy for Evaluating Mitigation Options for Process-Formed Compounds in Food: Workshop Proceedings.

PubMed

Hanlon, Paul; Brorby, Gregory P; Krishan, Mansi

2016-05-01

Processing (eg, cooking, grinding, drying) has changed the composition of food throughout the course of human history; however, awareness of process-formed compounds, and the potential need to mitigate exposure to those compounds, is a relatively recent phenomenon. In May 2015, the North American Branch of the International Life Sciences Institute (ILSI North America) Technical Committee on Food and Chemical Safety held a workshop on the risk-based process for mitigation of process-formed compounds. This workshop aimed to gain alignment from academia, government, and industry on a risk-based process for proactively assessing the need for and benefit of mitigation of process-formed compounds, including criteria to objectively assess the impact of mitigation as well as research needed to support this process. Workshop participants provided real-time feedback on a draft framework in the form of a decision tree developed by the ILSI North America Technical Committee on Food and Chemical Safety to a panel of experts, and they discussed the importance of communicating the value of such a process to the larger scientific community and, ultimately, the public. The outcome of the workshop was a decision tree that can be used by the scientific community and could form the basis of a global approach to assessing the risks associated with mitigation of process-formed compounds. © The Author(s) 2016.

78 FR 54280 - Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-09-03

... safety-related batteries would remain operable if all the inter-cell and terminal connections were at the... new acceptance criteria for total battery connection resistance to ensure that the safety-related batteries can perform their specified safety function. Basis for proposed no significant hazards...

29 CFR 1952.160 - Description of the plan as initially approved.

Code of Federal Regulations, 2010 CFR

2010-07-01

... include both occupational safety and occupational health, the latter on a developmental basis. The plan defines the covered occupational safety and health issues as defined by the Secretary of Labor in 29 CFR... Section 1952.160 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.160 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... include both occupational safety and occupational health, the latter on a developmental basis. The plan defines the covered occupational safety and health issues as defined by the Secretary of Labor in 29 CFR... Section 1952.160 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH...

29 CFR 1952.210 - Description of the plan as initially approved.

Code of Federal Regulations, 2011 CFR

2011-07-01

... throughout the State. The plan defines the covered occupational safety and health issues on the basis of... Section 1952.210 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH... standards will be considered by the State Occupational Safety and Health Advisory Board which will make...

Liquefied natural gas (LNG) safety

NASA Technical Reports Server (NTRS)

Ordin, P. M.

1977-01-01

Bibliography, assembled from computer search of NASA Aerospace Safety Data Bank, including title of report, author, abstract, source, description of figures, key references, and key words or subject terms. Publication is indexed by key subjects and by authors. Items are relevant to design engineers and safety specialists.

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products...

A system safety model for developmental aircraft programs

NASA Technical Reports Server (NTRS)

Amberboy, E. J.; Stokeld, R. L.

1982-01-01

Basic tenets of safety as applied to developmental aircraft programs are presented. The integration of safety into the project management aspects of planning, organizing, directing and controlling is illustrated by examples. The basis for project management use of safety and the relationship of these management functions to 'real-world' situations is presented. The rationale which led to the safety-related project decision and the lessons learned as they may apply to future projects are presented.

The application of consequence models in risk assessment: A regulator`s view

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nussey, C.; Carter, D.A.; Cassidy, K.

1995-12-31

Quantified risk assessment (QRA) is a technique for aiding decision making. The UK Health and Safety Executive (HSE) uses QRA in the Major Hazards (MH) area to formulate advice to Local Planning Authorities (LPAs) on the siting of MH installations and the development of land in the vicinity of existing MH installations. The region around UK MH sites within which LPAs are required to consult HSE on land-use planning matters (i.e. the Consultation Distance (CD)) is increasingly being redefined by adopting a risk based approach. The authors are now in the process of conducting or updated site specific QRAs tomore » redefine CDs. This process enables them to identify risk reduction measures and discuss them with companies, taking into consideration the ALARP--as low as is reasonably practicable--philosophy. The paper outlines the basis of the QRAs and the role of consequence assessment models and procedures in this process, and illustrates by examples the setting of CDs and the application of the ALARP philosophy.« less

Index to Nuclear Safety. A technical progress review by chronology, permuted title, and author. Vol. 11, No. 1--Vol. 17, No. 6

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cottrell, W.B.; Klein, A.

1977-02-23

This index to Nuclear Safety covers articles in Nuclear Safety Vol. 11, No. 1 (Jan.-Feb. 1970), through Vol. 17, No. 6 (Nov.-Dec. 1976). The index includes a chronological list of articles (including abstract) followed by KWIC and Author Indexes. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. The index lists over 350 technical articles in the last six years of publication.

FLAMMABLE GAS TECHNICAL BASIS DOCUMENT

DOE Office of Scientific and Technical Information (OSTI.GOV)

KRIPPS, L.J.

2005-02-18

This document describes the qualitative evaluation of frequency and consequences for double shell tank (DST) and single shell tank (SST) representative flammable gas accidents and associated hazardous conditions without controls. The evaluation indicated that safety-significant SSCs and/or TSRS were required to prevent or mitigate flammable gas accidents. Discussion on the resulting control decisions is included. This technical basis document was developed to support of the Tank Farms Documented Safety Analysis (DSA) and describes the risk binning process for the flammable gas representative accidents and associated represented hazardous conditions. The purpose of the risk binning process is to determine the needmore » for safety-significant structures, systems, and components (SSC) and technical safety requirement (TSR)-level controls for a given representative accident or represented hazardous condition based on an evaluation of the event frequency and consequence.« less

The role and functionality of Veterinary Services in food safety throughout the food chain.

PubMed

McKenzie, A I; Hathaway, S C

2006-08-01

Both national Veterinary Services and international standard-setting organisations have now embraced risk assessment as an essential tool for achieving their goals. Veterinarians have key roles in all aspects of the control of food-borne hazards of animal origin, but additional specialist skills are necessary for assessing, managing and communicating risk. Further, the deployment of Veterinary Services must reflect the multi-functional aspects of public and animal health activities. A generic risk management framework provides a systematic process whereby food safety standards and other measures are chosen and implemented on the basis of knowledge of risk and evaluation of other factors relevant to protecting human health and promoting non-discriminatory trade practices. In this context, a number of countries are exploring new administrative and structural arrangements for competent authorities. The traditional focus of veterinary involvement in food safety has been in meat hygiene at the level of the slaughterhouse. While this role continues, the emerging 'risk-based' approach to food control requires increased involvement in other segments of the meat food chain, as well as other areas such as production of milk and fish. This more extensive role requires a wider skill base and establishment of effective networks with a different range of stakeholders.

The assessment of exploitation process of power for access control system

NASA Astrophysics Data System (ADS)

Wiśnios, Michał; Paś, Jacek

2017-10-01

The safety of public utility facilities is a function not only of effectiveness of the electronic safety systems, used for protection of property and persons, but it also depends on the proper functioning of their power supply systems. The authors of the research paper analysed the power supply systems, which are used in buildings for the access control system that is integrated with the closed-circuit TV. The Access Control System is a set of electronic, electromechanical and electrical devices and the computer software controlling the operation of the above-mentioned elements, which is aimed at identification of people, vehicles allowed to cross the boundary of the reserved area, to prevent from crossing the reserved area and to generate the alarm signal informing about the attempt of crossing by an unauthorised entity. The industrial electricity with appropriate technical parameters is a basis of proper functioning of safety systems. Only the electricity supply to the systems is not equivalent to the operation continuity provision. In practice, redundant power supply systems are used. In the carried out reliability analysis of the power supply system, various power circuits of the system were taken into account. The reliability and operation requirements for this type of system were also included.

Critical features of an auditable management system for an ISO 9000-compatible occupational health and safety standard.

PubMed

Levine, S; Dyjack, D T

1997-04-01

An International Organization for Standardization (ISO) 9001: 1994-harmonized occupational health and safety (OHS) management system has been written at the University of Michigan, and reviewed, revised, and accepted under the direction of the American Industrial Hygiene Association (AIHA) Occupational Health and Safety Management Systems (OHSMS) Task Force and the Board of Directors. This system is easily adaptable to the ISO 14001 format and to both OHS and environmental management system applications. As was the case with ISO 9001: 1994, this system is expected to be compatible with current production quality and OHS quality systems and standards, have forward compatibility for new applications, and forward flexibility, with new features added as needed. Since ISO 9001: 1987 and 9001: 1994 have been applied worldwide, the incorporation of harmonized OHS and environmental management system components should be acceptable to business units already performing first-party (self-) auditing, and second-party (contract qualification) auditing. This article explains the basis of this OHS management system, its relationship to ISO 9001 and 14001 standards, the philosophy and methodology of an ISO-harmonized system audit, the relationship of these systems to traditional OHS audit systems, and the authors' vision of the future for application of such systems.

A nomogram for interpreting slope stability of fine-grained deposits in modern and ancient-marine environments.

USGS Publications Warehouse

Booth, J.S.; Sangrey, D.A.; Fugate, J.K.

1985-01-01

This nomogram was designed to aid in interpreting the causes of mass movement in modern and ancient settings, to provide a basis for evaluating and predicting slope stability under given conditions and to further the understanding of the relationships among the several key factors that control slope stability. Design of the nomogram is based on effective stress and combines consolidation theory as applicable to depositional environments with the infinite-slope model of slope-stability analysis. If infinite-slope conditions are assumed to exist, the effective overburden stress can be used to derive a factor of safety against static slope failure by using the angle of internal friction and the slope angle. -from Authors

77 FR 32136 - Agency Information Collection Activities:

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-31

... Fire Safety Authority of Storage of Explosive Materials. (3) Agency form number, if any, and the... safety of emergency response personnel responding to fires at sites where explosives are stored. The information is provided both orally and in writing to the authority having jurisdiction for fire safety in the...

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2011 CFR

2011-01-01

... for the design and construction of a new DOE nuclear facility or a major modification to an existing... acceptable nuclear safety design criteria for use in preparing a preliminary documented safety analysis. As a... mitigate hazards to workers, the public, or the environment. They include (1) physical, design, structural...

49 CFR Appendix A to Part 385 - Explanation of Safety Audit Evaluation Criteria

Code of Federal Regulations, 2010 CFR

2010-10-01

... safety management controls in place, is included in Appendix B, VII. List of Acute and Critical... having similar characteristics are combined together into six regulatory areas called “factors.” The regulatory factors, evaluated on the basis of the adequacy of the carrier's safety management controls, are...

76 FR 4420 - OSRAM SYLVANIA Products, Inc., Receipt of Petition for Decision of Inconsequential Noncompliance

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-25

... basis that this noncompliance is inconsequential to motor vehicle safety. This notice of receipt of... petition OSRAM SYLVANIA argues that the noncompliance is inconsequential to motor vehicle safety for the... conforming to all applicable Federal motor vehicle safety standards. Subject ``H11 C'' light sources are...

Safe Schools Report 2004-2005

ERIC Educational Resources Information Center

New Mexico Public Education Department, 2006

2006-01-01

Safety in New Mexico's schools is one of the most important issues facing our communities. Every school and school district in the state make it a priority to identify and implement ways to increase the safety, security and integrity of students, teachers, staff, parents and visitors at our schools on a daily basis. Safety is critical for…

76 FR 23708 - Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-28

...-AA00 Safety Zone; Pierce County Department of Emergency Management Regional Water Exercise, East... the Regional Water Rescue Exercise. Basis and Purpose The Pierce County, Washington, Department of... to read as follows: Sec. 165.T13-0251 Safety Zone; Pierce County Department of Emergency Management...

ITS logical architecture : volume 3, data dictionary.

DOT National Transportation Integrated Search

1981-01-01

The objective of the research effort was to develop an empirically and experiencially based model pedestrian safety program which cities can use as guidelines for pedestrian safety program planning, implementation, and evaluation. The basis of these ...

Safety review of Washington Metropolitan Area Transit Authority (WMATA) metrorail operations

DOT National Transportation Integrated Search

1997-09-01

A recent series of accidents and incidents at the Washington Metropolitan Area Transit Authority (WMATA) have raised concerns about the Authority's commitment to safety as its top priority. In January 1996, a train operator was killed at an end-of-th...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2014 CFR

2014-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2013 CFR

2013-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

10 CFR 50.49 - Environmental qualification of electric equipment important to safety for nuclear power plants.

Code of Federal Regulations, 2010 CFR

2010-01-01

... following design basis events to ensure— (A) The integrity of the reactor coolant pressure boundary; (B) The...) Design basis events are defined as conditions of normal operation, including anticipated operational occurrences, design basis accidents, external events, and natural phenomena for which the plant must be...

Secondary school accident reporting in one education authority.

PubMed

Williams, W R; Latif, A H A; Sibert, J

2002-01-01

Secondary schools appear to have very different accident rates when they are compared on the basis of accident report returns. The variation may be as a result of real differences in accident rates or different reporting procedures. This study investigates accident reporting from secondary schools and, in particular, the role of the school nurse. Accident form returns covering a 2-year period were collected for statistical analysis from 13 comprehensive schools in one local education authority in Wales. School sites were visited in the following school year to obtain information about accident records held on site and accident reporting procedures. The main factors determining the number of school accident reports submitted to the education authority relate to differences in recording and reporting procedures, such as the employment of a nurse and the policy of the head teacher/safety officer on submitting accident returns. Accident and emergency department referrals from similar schools may show significant differences in specific injuries and their causes. The level of school accident activity cannot be gauged from reports submitted to the education authority. Lack of incentives for collecting good accident data, in conjunction with the degree of complacency in the current system, suggest that future accident rates and reporting activity are unlikely to change.

28 CFR 32.16 - Payment.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) more than one individual, on the basis of being a public safety officer's parent as his mother, or on that basis as his father. If more than one parent qualifies as the officer's mother, or as his father...

Index to Nuclear Safety: a technical progress review by chronology, permuted title, and author, Volume 18 (1) through Volume 22 (6)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cottrell, W.B.; Passiakos, M.

This index to Nuclear Safety covers articles published in Nuclear Safety, Volume 18, Number 1 (January-February 1977) through Volume 22, Number 6 (November-December 1981). The index is divided into three section: a chronological list of articles (including abstracts), a permuted-title (KWIC) index, and an author index. Nuclear Safety, a bimonthly technical progress review prepared by the Nuclear Safety Information Center, covers all safety aspects of nuclear power reactors and associated facilities. Over 300 technical articles published in Nuclear Safety in the last 5 years are listed in this index.

Factors influencing mine rescue team behaviors.

PubMed

Jansky, Jacqueline H; Kowalski-Trakofler, K M; Brnich, M J; Vaught, C

2016-01-01

A focus group study of the first moments in an underground mine emergency response was conducted by the National Institute for Occupational Safety and Health (NIOSH), Office for Mine Safety and Health Research. Participants in the study included mine rescue team members, team trainers, mine officials, state mining personnel, and individual mine managers. A subset of the data consists of responses from participants with mine rescue backgrounds. These responses were noticeably different from those given by on-site emergency personnel who were at the mine and involved with decisions made during the first moments of an event. As a result, mine rescue team behavior data were separated in the analysis and are reported in this article. By considering the responses from mine rescue team members and trainers, it was possible to sort the data and identify seven key areas of importance to them. On the basis of the responses from the focus group participants with a mine rescue background, the authors concluded that accurate and complete information and a unity of purpose among all command center personnel are two of the key conditions needed for an effective mine rescue operation.

Balancing public health and practitioner accountability in cases of medical manslaughter: reconsidering the tests for criminal negligence-related offences in Australia after R v Patel.

PubMed

Tuckett, Nikita

2011-12-01

In 2010 Dr Jayant Patel was convicted of several offences on the basis of criminal negligence. Following the Queensland Court of Appeal's 2011 endorsement of the trial judge's decision, the case provides a timely opportunity to review prosecutions for medical negligence criminal offences throughout Australia and to critically examine the tests in assessing whether the balance has been correctly struck. The author argues that the thresholds required for prosecutions for criminal negligence for medical manslaughter are problematic and unduly onerous, and do not adequately strike the balance between the utilitarian value in health care and patient safety, on the one hand, and practitioner accountability and deterrence, on the other. This article considers reforms to remedy the imbalance, including a reformulation of the Criminal Code (Qld) and common law thresholds, proposals for the enactment of a separate offence of criminally negligent manslaughter and the utilisation of corporate prosecutions for manslaughter liability to broaden accountability in health care and promote patient safety on a systemic level.

Basis for standards: ICRP activities.

PubMed

Vano, E

2015-07-01

The purpose of this chapter is to describe work achieved recently by the International Commission on Radiological Protection (ICRP) and especially by Committee 3 (Protection in Medicine) and its use for standards. In March 1960, the Board of Governors of the International Atomic Energy Agency approved the Agency's 'Health and Safety Measures', stating that the Agency's 'Basic Safety Standards' (BSS) would be based, to the extent possible, on the recommendations of the ICRP. In a similar way, the Council of the European Union took into account the new recommendations of the ICRP when adopting the new Directive 2013/59/EURATOM that laid down BSS for protection against the dangers arising from exposure to ionising radiation. The new limit for the lens of the eyes for occupational exposures has been incorporated into these international standards and several articles dealing with medical exposures: justification, optimisation, recording patient doses, the use of diagnostic reference levels, training, accidental and unintended exposures, etc. have also been included in agreement with the ICRP recommendations. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Development and implementation of an HSE management system in E and P companies

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bentley, P.D.; Mundhenk, D.L.; Jones, M.G.

1995-01-01

This paper describes the experience to date with safety management systems (SMS's) and describes their implementation after the Piper Alpha disaster and Lord Cullen's report. It also shows the gradual expansion of these systems toward fully integrated health, safety, and environment (HSE) management systems. The authors' company policy, which was clearly stated before publication of Lord Cullen's report, is that work should not start until the appropriate controls are in place. Work based on this policy and on objective-setting SMS's within Shell Intl. Petroleum Mij. (SIPM) E and P coordination started in earnest soon after the publication of the reportmore » in Nov. 1990 and has continued without interruption since that time. Objective-setting systems may be defined as systems where the company management sets its own objectives or goals on the basis of functional rather than prescriptive requirements and then goes on to demonstrate how such goals have been, or are being, met. The paper ends with a projection of what may be expected in the future.« less

Working towards a detection of bullying related morbidity.

PubMed

Srabstein, Jorge

2011-12-09

Physicians are being confronted with the responsibility of detecting bullying related health and safety risks in different clinical settings. Recommendations are being made on the basis of research evidence of a significant link of bullying with a wide array of health and safety problems; the author's clinical routine practice of ascertaining patients' participation in bullying and a recommended role for clinical detection of bullying within a whole-community base strategy for its prevention. There is a need to develop a standardized strategy for detection of bullying related morbidity which could be utilized in all clinical settings with sensitivity to developmental and cultural differences in the understanding of what is meant by bullying. Such an approach should ascertain the exposure of different types of bullying across social settings and its symptomatic repercussions. Its results should be used for clinical decisions to procure intervention and treatment, within a three-tier bullying prevention strategy. The present paper is the result of a work-in-progress which will contribute to efforts to develop a clinical practice guideline providing a standardized strategy for the detection and intervention of bullying related health and safety problems, within a primary or specialty pediatric setting. Bullying is at the intersection of many health and safety risks and health practitioners are challenged with the critical public health responsibility of their detection, prevention, and intervention. It would be expected that the recommendations contained in this article should facilitate the development of strategies to fulfill such a responsibility.

49 CFR 451.3 - Action by Approval Authority.

Code of Federal Regulations, 2013 CFR

2013-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

49 CFR 451.3 - Action by Approval Authority.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

49 CFR 451.3 - Action by Approval Authority.

Code of Federal Regulations, 2014 CFR

2014-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

49 CFR 451.3 - Action by Approval Authority.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

49 CFR 451.3 - Action by Approval Authority.

Code of Federal Regulations, 2012 CFR

2012-10-01

... SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of Existing Containers § 451.3 Action by Approval Authority. (a) The Approval Authority (or the Chief, Office of... affix a safety approval plate to each container after an examination of each container concerned has...

75 FR 56662 - Proposed Information Collection (Application for Authority To Close Loans on an Automatic Basis...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-16

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0252] Proposed Information Collection (Application for Authority To Close Loans on an Automatic Basis--Nonsupervised Lenders) Activity: Comment... on an automatic basis. DATES: Written comments and recommendations on the proposed collection of...

48 CFR 50.205-3 - Authorization of offers contingent upon SAFETY Act designation or certification before contract...

Code of Federal Regulations, 2010 CFR

2010-10-01

...; (2) To the contracting officer's knowledge, the Government has not provided advance notice so that... competition without SAFETY Act protections or the subject technology would be sold to the Government only with SAFETY Act protections. (b) Contracting officers shall not authorize offers contingent upon obtaining a...

Safety and Security Interface Technology Initiative

DOE Office of Scientific and Technical Information (OSTI.GOV)

Dr. Michael A. Lehto; Kevin J. Carroll; Dr. Robert Lowrie

Safety and Security Interface Technology Initiative Mr. Kevin J. Carroll Dr. Robert Lowrie, Dr. Micheal Lehto BWXT Y12 NSC Oak Ridge, TN 37831 865-576-2289/865-241-2772 carrollkj@y12.doe.gov Work Objective. Earlier this year, the Energy Facility Contractors Group (EFCOG) was asked to assist in developing options related to acceleration deployment of new security-related technologies to assist meeting design base threat (DBT) needs while also addressing the requirements of 10 CFR 830. NNSA NA-70, one of the working group participants, designated this effort the Safety and Security Interface Technology Initiative (SSIT). Relationship to Workshop Theme. “Supporting Excellence in Operations Through Safety Analysis,” (workshop theme)more » includes security and safety personnel working together to ensure effective and efficient operations. One of the specific workshop elements listed in the call for papers is “Safeguards/Security Integration with Safety.” This paper speaks directly to this theme. Description of Work. The EFCOG Safety Analysis Working Group (SAWG) and the EFCOG Security Working Group formed a core team to develop an integrated process involving both safety basis and security needs allowing achievement of the DBT objectives while ensuring safety is appropriately considered. This effort garnered significant interest, starting with a two day breakout session of 30 experts at the 2006 Safety Basis Workshop. A core team was formed, and a series of meetings were held to develop that process, including safety and security professionals, both contractor and federal personnel. A pilot exercise held at Idaho National Laboratory (INL) in mid-July 2006 was conducted as a feasibility of concept review. Work Results. The SSIT efforts resulted in a topical report transmitted from EFCOG to DOE/NNSA in August 2006. Elements of the report included: Drivers and Endstate, Control Selections Alternative Analysis Process, Terminology Crosswalk, Safety Basis/Security Documentation Integration, Configuration Control, and development of a shared ‘tool box’ of information/successes. Specific Benefits. The expectation or end state resulting from the topical report and associated implementation plan includes: (1) A recommended process for handling the documentation of the security and safety disciplines, including an appropriate change control process and participation by all stakeholders. (2) A means to package security systems with sufficient information to help expedite the flow of that system through the process. In addition, a means to share successes among sites, to include information and safety basis to the extent such information is transportable. (3) Identification of key security systems and associated essential security elements being installed and an arrangement for the sites installing these systems to host an appropriate team to review a specific system and determine what information is exportable. (4) Identification of the security systems’ essential elements and appropriate controls required for testing of these essential elements in the facility. (5) The ability to help refine and improve an agreed to control set at the manufacture stage.« less

National Environmental Policy Act Hazards Assessment for the TREAT Alternative

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boyd D. Christensen; Annette L. Schafer

2013-11-01

This document provides an assessment of hazards as required by the National Environmental Policy Act for the alternative of restarting the reactor at the Transient Reactor Test (TREAT) facility by the Resumption of Transient Testing Program. Potential hazards have been identified and screening level calculations have been conducted to provide estimates of unmitigated dose consequences that could be incurred through this alternative. Consequences considered include those related to use of the TREAT Reactor, experiment assembly handling, and combined events involving both the reactor and experiments. In addition, potential safety structures, systems, and components for processes associated with operating TREAT andmore » onsite handling of nuclear fuels and experiments are listed. If this alternative is selected, a safety basis will be prepared in accordance with 10 CFR 830, “Nuclear Safety Management,” Subpart B, “Safety Basis Requirements.”« less

National Environmental Policy Act Hazards Assessment for the TREAT Alternative

DOE Office of Scientific and Technical Information (OSTI.GOV)

Christensen, Boyd D.; Schafer, Annette L.

2014-02-01

This document provides an assessment of hazards as required by the National Environmental Policy Act for the alternative of restarting the reactor at the Transient Reactor Test (TREAT) facility by the Resumption of Transient Testing Program. Potential hazards have been identified and screening level calculations have been conducted to provide estimates of unmitigated dose consequences that could be incurred through this alternative. Consequences considered include those related to use of the TREAT Reactor, experiment assembly handling, and combined events involving both the reactor and experiments. In addition, potential safety structures, systems, and components for processes associated with operating TREAT andmore » onsite handling of nuclear fuels and experiments are listed. If this alternative is selected, a safety basis will be prepared in accordance with 10 CFR 830, “Nuclear Safety Management,” Subpart B, “Safety Basis Requirements.”« less

The Development of Project Orion Ground Safety Requirements

NASA Technical Reports Server (NTRS)

Kirkpatrick, Paul; Condzella, Bill; Williams, Jeff

2011-01-01

In spite of a very compressed schedule, Project Orion's AFT safety team was able to pull together a comprehensive set of ground safety requirements using existing requirements and subject matter experts. These requirements will serve as the basis for the design of GSE and ground operations. Using the above lessons as a roadmap, new Projects can produce the same results. A rigorous set of ground safety requirements is required to assure ground support equipment (GSE) and associated flight hardware ground operations are conducted safety

Medication safety.

PubMed

Keohane, Carol A; Bates, David W

2008-03-01

Patient safety is a state of mind, not a technology. The technologies used in the medical setting represent tools that must be properly designed, used well, and assessed on an on-going basis. Moreover, in all settings, building a culture of safety is pivotal for improving safety, and many nontechnologic approaches, such as medication reconciliation and teaching patients about their medications, are also essential. This article addresses the topic of medication safety and examines specific strategies being used to decrease the incidence of medication errors across various clinical settings.

31 CFR 586.515 - Payments for services rendered by the Government of the FRY (S&M) to aircraft authorized...

Code of Federal Regulations, 2010 CFR

2010-07-01

... Government of the FRY (S&M) to aircraft authorized; aircraft and maritime safety. 586.515 Section 586.515... services rendered by the Government of the FRY (S&M) to aircraft authorized; aircraft and maritime safety... maritime traffic in international waters. ...

78 FR 76191 - Operational Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-16

... Tests and Inspections for Compliance With Maximum Authorized Train Speeds and Other Speed Restrictions... safety advisory; Operational tests and inspections for compliance with maximum authorized train speeds and other speed restrictions. SUMMARY: FRA is issuing Safety Advisory 2013-08 to stress to railroads...

77 FR 64411 - Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... 1625-AA00 Safety Zone; Cooper T. Smith Fireworks Event; Mobile River; Mobile, AL AGENCY: Coast Guard.... Smith Fireworks Event. Entry into, transiting or anchoring in this zone is prohibited to all vessels... safety hazards associated with a fireworks display. B. Basis and Purpose Cooper T. Smith Corp. has hired...

Barriers to Safety Event Reporting in an Academic Radiology Department: Authority Gradients and Other Human Factors.

PubMed

Siewert, Bettina; Swedeen, Suzanne; Brook, Olga R; Eisenberg, Ronald L; Hochman, Mary

2018-05-15

Purpose To investigate barriers to reporting safety concerns in an academic radiology department and to evaluate the role of human factors, including authority gradients, as potential barriers to safety concern reporting. Materials and Methods In this institutional review board-approved, HIPAA-compliant retrospective study, an online questionnaire link was emailed four times to all radiology department staff members (n = 648) at a tertiary care institution. Survey questions included frequency of speaking up about safety concerns, perceived barriers to speaking up, and the annual number of safety concerns that respondents were unsuccessful in reporting. Respondents' sex, role in the department, and length of employment were recorded. Statistical analysis was performed with the Fisher exact test. Results The survey was completed by 363 of the 648 employees (56%). Of those 363 employees, 182 (50%) reported always speaking up about safety concerns, 134 (37%) reported speaking up most of the time, 36 (10%) reported speaking up sometimes, seven (2%) reported rarely speaking up, and four (1%) reported never speaking up. Thus, 50% of employees spoke up about safety concerns less than 100% of the time. The most frequently reported barriers to speaking up included high reporting threshold (69%), reluctance to challenge someone in authority (67%), fear of disrespect (53%), and lack of listening (52%). Conclusion Of employees in a large academic radiology department, 50% do not attain 100% reporting of safety events. The most common human barriers to speaking up are high reporting threshold, reluctance to challenge authority, fear of disrespect, and lack of listening, which suggests that existing authority gradients interfere with full reporting of safety concerns. © RSNA, 2018.

IRQN award paper: Operational rounds: a practical administrative process to improve safety and clinical services in radiology.

PubMed

Donnelly, Lane F; Dickerson, Julie M; Lehkamp, Todd W; Gessner, Kevin E; Moskovitz, Jay; Hutchinson, Sally

2008-11-01

As part of a patient safety program in the authors' department of radiology, operational rounds have been instituted. This process consists of radiology leaders' visiting imaging divisions at the site of imaging and discussing frontline employees' concerns about patient safety, the quality of care, and patient and family satisfaction. Operational rounds are executed at a time to optimize the number of attendees. Minutes that describe the issues identified, persons responsible for improvement, and updated improvement plan status are available to employees online. Via this process, multiple patient safety and other issues have been identified and remedied. The authors believe that the process has improved patient safety, the quality of care, and the efficiency of operations. Since the inception of the safety program, the mean number of days between serious safety events involving radiology has doubled. The authors review the background around such walk rounds, describe their particular program, and give multiple illustrative examples of issues identified and improvement plans put in place.

Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

PubMed

Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

2017-12-01

The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants <18 years old) conducted in South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

Results from a Nationwide Cohort Temporary Utilization Authorization (ATU) survey of patients in france treated with Pheburane(®) (Sodium Phenylbutyrate) taste-masked granules.

PubMed

Kibleur, Yves; Dobbelaere, Dries; Barth, Magalie; Brassier, Anaïs; Guffon, Nathalie

2014-10-01

The aim of this study was to describe a nationwide system for pre-marketing follow-up (cohort temporary utilization authorization [ATU] protocol; i.e., 'therapeutic utilization') of a new taste-masked formulation of sodium phenylbutyrate (NaPB) granules (Pheburane(®)) in France and to analyze safety and efficacy in this treated cohort of patients with urea cycle disease (UCD). In October 2012, a cohort ATU was established in France to monitor the use of Pheburane(®) on a named-patient basis. All treated UCD patients were included in a follow-up protocol developed by the Laboratory (Lucane Pharma) and the French Medicines Agency (ANSM), which recorded demographics, dosing characteristics of NaPB, concomitant medications, adverse events, and clinical outcome during the period of treatment. Following the granting of the Marketing Authorization in Europe, the cohort ATU was terminated approximately 1 year after its initiation, as the product was launched on the French market. The ease of administration and acceptability were much better with the new taste-masked formulation than with the previous treatment. No episodes of metabolic decompensation were observed over a treatment period ranging from 3 to 11 months with Pheburane(®) and the range of ammonia and glutamine plasma levels improved and remained within the normal range. In all, no adverse events were reported with Pheburane(®) treatment. The recently developed taste-masked formulation of NaPB granules improved the quality of life for UCD patients. This may translate into improved compliance, efficacy, and safety, which may be demonstrated either in further studies or in the post-marketing use of the product.

Long-Term Follow-Up on a Cohort Temporary Utilization Authorization (ATU) Survey of Patients Treated with Pheburane (Sodium Phenylbutyrate) Taste-Masked Granules.

PubMed

Kibleur, Yves; Guffon, Nathalie

2016-04-01

The aim was to describe the status of patients with urea cycle disorders (UCD) at the latest long-term clinical follow-up of treatment with a new taste-masked formulation of sodium phenylbutyrate (NaPB) granules (Pheburane). These patients are a subset of those treated under a cohort temporary utilisation study (ATU) previously reported and now followed for 2 years. From a French cohort temporary utilization authorization (ATU) set up to monitor the use of Pheburane on a named-patient basis in UCD patients in advance of its marketing authorization, a subset of patients were followed up in the long term. Data on demographics, dosing characteristics of NaPB, concomitant medications, adverse events and clinical outcomes were collected at a follow-up visit after 1-2 years of treatment with the drug administered under marketing conditions. This paper reports on the subset of patients who were included in further long-term follow-up at the principal recruiting metabolic reference center involved in the original cohort. No episode of metabolic decompensation was observed over a treatment period ranging from 8 to 30 months with Pheburane, and the range of ammonia and glutamine levels continued to improve and remained within the normal range, thus adding valuable longer-term feedback to the original ATU report. In all, no adverse events were reported with Pheburane treatment. These additional data demonstrate the maintenance of the safety and efficacy of Pheburane over time. The recently developed taste-masked formulation of NaPB granules (Pheburane) improved the quality of life for UCD patients. The present post-marketing report on the use of the product confirms the original observations of improved compliance, efficacy and safety with this taste-masked formulation of NaPB.

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

9 CFR 592.24 - Basis of service.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Basis of service. 592.24 Section 592.24 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS INSPECTION VOLUNTARY INSPECTION OF EGG PRODUCTS General § 592.24 Basis of service. (a) Products shall be inspected in accordance with such...

Most common road safety engineering deficiencies in South Eastern Europe as a part of safe system approach

NASA Astrophysics Data System (ADS)

Jovanov, D.; Vollpracht, H. J.; Beles, H.; Popa, V.; Tolea, B. A.

2017-10-01

Most common road safety engineering deficiencies identified by the authors in South Eastern Europe, including Romania, have been collected together and presented in this paper as a part of road safety unbreakably connected to the safe system approach (driver-vehicle-road). In different South Eastern Europe countries Road Safety Audit (RSA), Road Safety Inspection (RSI), as well as Black Spot Management (BSM) was introduced and practical implementation experience enabled the authors to analyze the road safety problems. Typical road safety engineering deficiencies have been presented in 8 different subsections, based on PIARC (World Road Association) RSA approach. This paper presents collected common road safety problems with relevant illustrations (real pictures) with associated accident risks.

Fire safety in transit systems fault tree analysis

DOT National Transportation Integrated Search

1981-09-01

Fire safety countermeasures applicable to transit vehicles are identified and evaluated. This document contains fault trees which illustrate the sequences of events which may lead to a transit-fire related casualty. A description of the basis for the...

Pilot Construction Project for Granular Shoulder Stabilization

DOT National Transportation Integrated Search

2013-09-30

Granular shoulders need to be maintained on a regular basis because edge ruts and potholes develop, posing a safety hazard to motorists. The successful mitigation of edge-rut issues for granular shoulders would increase safety and reduce the number o...

14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

Code of Federal Regulations, 2011 CFR

2011-01-01

... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety... nonconstruction contracts as they are subject to the Conract Work Hours and Safety Standards Act, in regards to...

14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

Code of Federal Regulations, 2010 CFR

2010-01-01

... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety... nonconstruction contracts as they are subject to the Conract Work Hours and Safety Standards Act, in regards to...

Scientific evaluation of the safety factor for the acceptable daily intake (ADI). Case study: butylated hydroxyanisole (BHA).

PubMed

Würtzen, G

1993-01-01

The principles of 'data-derived safety factors' are applied to toxicological and biochemical information on butylated hydroxyanisole (BHA). The calculated safety factor for an ADI is, by this method, comparable to the existing internationally recognized safety evaluations. Relevance for humans of forestomach tumours in rodents is discussed. The method provides a basis for organizing data in a way that permits an explicit assessment of its relevance.

Simulation of data safety components for corporative systems

NASA Astrophysics Data System (ADS)

Yaremko, Svetlana A.; Kuzmina, Elena M.; Savchuk, Tamara O.; Krivonosov, Valeriy E.; Smolarz, Andrzej; Arman, Abenov; Smailova, Saule; Kalizhanova, Aliya

2017-08-01

The article deals with research of designing data safety components for corporations by means of mathematical simulations and modern information technologies. Simulation of threats ranks has been done which is based on definite values of data components. The rules of safety policy for corporative information systems have been presented. The ways of realization of safety policy rules have been proposed on the basis of taken conditions and appropriate class of valuable data protection.

The European ASAMPSA_E project : towards guidance to model the impact of high amplitude natural hazards in the probabilistic safety assessment of nuclear power plants. Information on the project progress and needs from the geosciences.

NASA Astrophysics Data System (ADS)

Raimond, Emmanuel; Decker, Kurt; Guigueno, Yves; Klug, Joakim; Loeffler, Horst

2015-04-01

The Fukushima nuclear accident in Japan resulted from the combination of two correlated extreme external events (earthquake and tsunami). The consequences, in particular flooding, went beyond what was considered in the initial engineering design design of nuclear power plants (NPPs). Such situations can in theory be identified using probabilistic safety assessment (PSA) methodology. PSA results may then lead industry (system suppliers and utilities) or Safety Authorities to take appropriate decisions to reinforce the defence-in-depth of the NPP for low probability event but high amplitude consequences. In reality, the development of such PSA remains a challenging task. Definitions of the design basis of NPPs, for example, require data on events with occurrence probabilities not higher than 10-4 per year. Today, even lower probabilities, down to 10-8, are expected and typically used for probabilistic safety analyses (PSA) of NPPs and the examination of so-called design extension conditions. Modelling the combinations of natural or man-made hazards that can affect a NPP and affecting some meaningful probability of occurrence seems to be difficult. The European project ASAMPSAE (www.asampsa.eu) gathers more than 30 organizations (industry, research, safety control) from Europe, US and Japan and aims at identifying some meaningful practices to extend the scope and the quality of the existing probabilistic safety analysis developed for nuclear power plants. It offers a framework to discuss, at a technical level, how "extended PSA" can be developed efficiently and be used to verify if the robustness of Nuclear Power Plants (NPPs) in their environment is sufficient. The paper will present the objectives of this project, some first lessons and introduce which type of guidance is being developed. It will explain the need of expertise from geosciences to support the nuclear safety assessment in the different area (seismotectonic, hydrological, meteorological and biological hazards, …).

78 FR 46419 - Proposed Information Collection (Application for Authority To Close Loans on an Automatic Basis...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0252] Proposed Information Collection (Application for Authority To Close Loans on an Automatic Basis--Nonsupervised Lenders) Activity: Comment... solicits comments for information needed to authorize nonsupervised lenders to close loans on an automatic...

Stochastic Modeling of Radioactive Material Releases

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andrus, Jason; Pope, Chad

2015-09-01

Nonreactor nuclear facilities operated under the approval authority of the U.S. Department of Energy use unmitigated hazard evaluations to determine if potential radiological doses associated with design basis events challenge or exceed dose evaluation guidelines. Unmitigated design basis events that sufficiently challenge dose evaluation guidelines or exceed the guidelines for members of the public or workers, merit selection of safety structures, systems, or components or other controls to prevent or mitigate the hazard. Idaho State University, in collaboration with Idaho National Laboratory, has developed a portable and simple to use software application called SODA (Stochastic Objective Decision-Aide) that stochastically calculatesmore » the radiation dose associated with hypothetical radiological material release scenarios. Rather than producing a point estimate of the dose, SODA produces a dose distribution result to allow a deeper understanding of the dose potential. SODA allows users to select the distribution type and parameter values for all of the input variables used to perform the dose calculation. SODA then randomly samples each distribution input variable and calculates the overall resulting dose distribution. In cases where an input variable distribution is unknown, a traditional single point value can be used. SODA was developed using the MATLAB coding framework. The software application has a graphical user input. SODA can be installed on both Windows and Mac computers and does not require MATLAB to function. SODA provides improved risk understanding leading to better informed decision making associated with establishing nuclear facility material-at-risk limits and safety structure, system, or component selection. It is important to note that SODA does not replace or compete with codes such as MACCS or RSAC, rather it is viewed as an easy to use supplemental tool to help improve risk understanding and support better informed decisions. The work was funded through a grant from the DOE Nuclear Safety Research and Development Program.« less

14 CFR 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

Code of Federal Regulations, 2013 CFR

2013-01-01

... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... authority to take action regarding “liquidated damage” assessments under the Contract Work Hours and Safety Standards Act, and associated labor statutes. (a) Delegation of authority. The Director, Industrial...

49 CFR 831.3 - Authority of Directors.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

49 CFR 831.3 - Authority of Directors.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

49 CFR 831.3 - Authority of Directors.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

49 CFR 831.3 - Authority of Directors.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this...

Rail Safety/Equipment Crashworthiness : Volume 1. A Systems Analysis of Injury Minimization in Rail Systems

DOT National Transportation Integrated Search

1978-07-01

The Department of Transportation, Transportation Systems Center (TSC), is providing technical assistance to the Federal Railroad Administration (FRA) in a program to improve railroad safety and efficiency by providing a technological basis for improv...

76 FR 55796 - Safety Zone; TriRock Triathlon, San Diego Bay, San Diego, CA

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-09

...-AA00 Safety Zone; TriRock Triathlon, San Diego Bay, San Diego, CA AGENCY: Coast Guard, DHS. ACTION.... Basis and Purpose Competitor Group is sponsoring the TriRock Triathlon, consisting of 2000 swimmers.... 165.T11-431 to read as follows: Sec. 165.T11-431 Safety Zone; TriRock Triathlon, San Diego Bay, San...

Underreporting of maritime accidents to vessel accident databases.

PubMed

Hassel, Martin; Asbjørnslett, Bjørn Egil; Hole, Lars Petter

2011-11-01

Underreporting of maritime accidents is a problem not only for authorities trying to improve maritime safety through legislation, but also to risk management companies and other entities using maritime casualty statistics in risk and accident analysis. This study collected and compared casualty data from 01.01.2005 to 31.12.2009, from IHS Fairplay and the maritime authorities from a set of nations. The data was compared to find common records, and estimation of the true number of occurred accidents was performed using conditional probability given positive dependency between data sources, several variations of the capture-recapture method, calculation of best case scenario assuming perfect reporting, and scaling up a subset of casualty information from a marine insurance statistics database. The estimated upper limit reporting performance for the selected flag states ranged from 14% to 74%, while the corresponding estimated coverage of IHS Fairplay ranges from 4% to 62%. On average the study results document that the number of unreported accidents makes up roughly 50% of all occurred accidents. Even in a best case scenario, only a few flag states come close to perfect reporting (94%). The considerable scope of underreporting uncovered in the study, indicates that users of statistical vessel accident data should assume a certain degree of underreporting, and adjust their analyses accordingly. Whether to use correction factors, a safety margin, or rely on expert judgment, should be decided on a case by case basis. Copyright © 2011 Elsevier Ltd. All rights reserved.

The 7-day contraceptive hormone-free interval should be consigned to history.

PubMed

MacGregor, E Anne; Guillebaud, John

2018-06-26

This review summarises the available data on the disadvantages of the 7-day contraceptive-free interval (CFI) of combined oral contraceptives (COCs), in contrast to shorter CFIs or continuous use - including flexible regimens - and provides recommendations for practice. Relevant papers were identified by Medline and PubMed. The final reference list was generated on the basis of relevance to the review, with priority given to systematic reviews and randomised controlled trials. There is considerable inter- and intra-individual variation in the absorption and metabolism of COCs. Even with perfect use, the loss of endocrine suppression during the standard 7-day CFI allows follicular development with the risk of escape ovulation in a vulnerable minority. This risk increases in typical users whenever the CFI is prolonged: late restarts are a common reason for pill omissions. Shortening or eliminating the CFI improves contraceptive efficacy using the lowest doses available, without evidence to date of compromised safety. There is no scientific evidence to support a 7-day CFI and it should be replaced either by a continuous flexible regimen, or extended regimens with a shortened CFI, prescribed first-line. In women preferring a monthly 'bleed', a 4-day CFI similarly provides a greater safety margin when pills are omitted. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Auditory midbrain implant: a review.

PubMed

Lim, Hubert H; Lenarz, Minoo; Lenarz, Thomas

2009-09-01

The auditory midbrain implant (AMI) is a new hearing prosthesis designed for stimulation of the inferior colliculus in deaf patients who cannot sufficiently benefit from cochlear implants. The authors have begun clinical trials in which five patients have been implanted with a single shank AMI array (20 electrodes). The goal of this review is to summarize the development and research that has led to the translation of the AMI from a concept into the first patients. This study presents the rationale and design concept for the AMI as well a summary of the animal safety and feasibility studies that were required for clinical approval. The authors also present the initial surgical, psychophysical, and speech results from the first three implanted patients. Overall, the results have been encouraging in terms of the safety and functionality of the implant. All patients obtain improvements in hearing capabilities on a daily basis. However, performance varies dramatically across patients depending on the implant location within the midbrain with the best performer still not able to achieve open set speech perception without lip-reading cues. Stimulation of the auditory midbrain provides a wide range of level, spectral, and temporal cues, all of which are important for speech understanding, but they do not appear to sufficiently fuse together to enable open set speech perception with the currently used stimulation strategies. Finally, several issues and hypotheses for why current patients obtain limited speech perception along with several feasible solutions for improving AMI implementation are presented.

Chinese plasma-derived products supply under the lot release management system in 2007-2011.

PubMed

Zhang, Xuejun; Ye, Shengliang; Du, Xi; Yuan, Jing; Zhao, Chaoming; Li, Changqing

2013-11-01

In 2007, the Chinese State Food and Drug Administration (SFDA) implemented a management system for lot release of all plasma-derived products. Since then, there have been only a few systematic studies of the blood supply, which is a concern when considering the small amount of plasma collected per capita (approximately 3 L/1000 people). As a result, there may be a threat to the safety of the available blood supply. In this study, we examined the characteristics of the supply of Chinese plasma-derived products. We investigated the reports of lot-released biological products derived from all 8 national or regional regulatory authorities in China from 2007 to 2011. The market supply characteristics of Chinese plasma-derived products were analyzed by reviewing the changes in supply varieties, the batches of lot-released plasma-derived products and the actual supply. As a result, the national regulatory authorities can more accurately develop a specific understanding of the production and quality management information provided by Chinese plasma product manufacturers. The implementation of the lot release system further ensures the clinical validity of the plasma-derived products in China and improves the safety of using plasma-derived products. This work provides an assessment of the future Chinese market supply of plasma-derived products and can function as a theoretical basis for the establishment of hemovigilance. Copyright © 2013 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

The Regulation of Energy Medicine

NASA Astrophysics Data System (ADS)

Kosovich, Judy; Esq

This paper describes the laws and regulations that affect the practice of energy medicine. State law often has more impact on a health care practice than federal law, but federal law provides a common denominator among states. Device law is emphasized here because practitioners of energy medicine are more likely to use devices than drugs. For purposes of this paper, energy medicine is defined as practices that measure or benefit energy flow and overall energy in the body. This broad definition encompasses things as diverse as certain forms of exercise, measurement of meridian resistance, the use of electrical current or magnetic pulses to relieve pain, and the use of light, sound, scent, touch, position, or movement to stimulate the body's own electrical systems. What is of greatest importance in determining legal implications of a practice is whether there are any health-related claims. Two federal entities are pivotal. The Food and Drug Administration ("FDA") is authorized to protect health and safety and the Federal Trade Commission ("FTC") is authorized to protect consumers from false or misleading advertising. There are 5 things that FDA looks at: 1) intended use, 2) claims made in advertising and in labeling, 3) substantial equivalence to a predicate, 4) safety, and 5) effectiveness. A concern regarding any one of these can be the basis for denying clearance to market a device. The FTC looks at whether statements are true and substantiated and whether they might be misleading. The FTC often consults with the FDA on the interpretation of technical information.

A systematic review of the psychological literature on interruption and its patient safety implications.

PubMed

Li, Simon Y W; Magrabi, Farah; Coiera, Enrico

2012-01-01

To understand the complex effects of interruption in healthcare. As interruptions have been well studied in other domains, the authors undertook a systematic review of experimental studies in psychology and human-computer interaction to identify the task types and variables influencing interruption effects. 63 studies were identified from 812 articles retrieved by systematic searches. On the basis of interruption profiles for generic tasks, it was found that clinical tasks can be distinguished into three broad types: procedural, problem-solving, and decision-making. Twelve experimental variables that influence interruption effects were identified. Of these, six are the most important, based on the number of studies and because of their centrality to interruption effects, including working memory load, interruption position, similarity, modality, handling strategies, and practice effect. The variables are explained by three main theoretical frameworks: the activation-based goal memory model, prospective memory, and multiple resource theory. This review provides a useful starting point for a more comprehensive examination of interruptions potentially leading to an improved understanding about the impact of this phenomenon on patient safety and task efficiency. The authors provide some recommendations to counter interruption effects. The effects of interruption are the outcome of a complex set of variables and should not be considered as uniformly predictable or bad. The task types, variables, and theories should help us better to identify which clinical tasks and contexts are most susceptible and assist in the design of information systems and processes that are resilient to interruption.

Bias in benefit-risk appraisal in older products: the case of buflomedil for intermittent claudication.

PubMed

De Backer, Tine L M; Vander Stichele, Robert H; Van Bortel, Luc M

2009-01-01

Benefit-risk assessment should be ongoing during the life cycle of a pharmaceutical agent. New products are subjected to rigorous registration laws and rules, which attempt to assure the availability and validity of evidence. For older products, bias in benefit-risk assessment is more likely, as a number of safeguards were not in place at the time these products were registered. This issue of bias in benefit-risk assessment of older products is illustrated here with an example: buflomedil in intermittent claudication. Data on efficacy were retrieved from a Cochrane systematic review. Data on safety were obtained by comparing the number of reports of serious adverse events and fatalities published in the literature with those reported in postmarketing surveillance databases. In the case of efficacy, the slim basis of evidence for the benefit of buflomedil is undermined by documented publication bias. In the case of safety, bias in reporting to international safety databases is illustrated by the discrepancy between the number of drug-related deaths published in the literature (20), the potentially drug-related deaths in the WHO database (20) and deaths attributed to buflomedil in the database of the international marketing authorization holder (11). In older products, efficacy cannot be evaluated without a thorough search for publication bias. For safety, case reporting of drug-related serious events and deaths in the literature remains a necessary instrument for risk appraisal of older medicines, despite the existence of postmarketing safety databases. The enforcement of efficient communication between healthcare workers, drug companies, national centres of pharmacovigilance, national poison centers and the WHO is necessary to ensure the validity of postmarketing surveillance reporting systems. Drugs considered obsolete because of unfavourable benefit-risk assessment should not be allowed to stay on the market.

Continuous Improvement and the Safety Case for the Waste Isolation Pilot Plant Geologic Repository - 13467

DOE Office of Scientific and Technical Information (OSTI.GOV)

Van Luik, Abraham; Patterson, Russell; Nelson, Roger

2013-07-01

The Waste Isolation Pilot Plant (WIPP) is a geologic repository 2150 feet (650 m) below the surface of the Chihuahuan desert near Carlsbad, New Mexico. WIPP permanently disposes of transuranic waste from national defense programs. Every five years, the U.S. Department of Energy (DOE) submits an application to the U.S. Environmental Protection Agency (EPA) to request regulatory-compliance re-certification of the facility for another five years. Every ten years, DOE submits an application to the New Mexico Environment Department (NMED) for the renewal of its hazardous waste disposal permit. The content of the applications made by DOE to the EPA formore » re-certification, and to the NMED for permit-renewal, reflect any optimization changes made to the facility, with regulatory concurrence if warranted by the nature of the change. DOE points to such changes as evidence for its having taken seriously its 'continuous improvement' operations and management philosophy. Another opportunity for continuous improvement is to look at any delta that may exist between the re-certification and re-permitting cases for system safety and the consensus advice on the nature and content of a safety case as being developed and published by the Nuclear Energy Agency's Integration Group for the Safety Case (IGSC) expert group. DOE at WIPP, with the aid of its Science Advisor and teammate, Sandia National Laboratories, is in the process of discerning what can be done, in a reasonably paced and cost-conscious manner, to continually improve the case for repository safety that is being made to the two primary regulators on a recurring basis. This paper will discuss some aspects of that delta and potential paths forward to addressing them. (authors)« less

SLUDGE TREATMENT PROJECT KOP DISPOSITION - THERMAL AND GAS ANALYSIS FOR THE COLD VACUUM DRYING FACILITY

DOE Office of Scientific and Technical Information (OSTI.GOV)

SWENSON JA; CROWE RD; APTHORPE R

2010-03-09

The purpose of this document is to present conceptual design phase thermal process calculations that support the process design and process safety basis for the cold vacuum drying of K Basin KOP material. This document is intended to demonstrate that the conceptual approach: (1) Represents a workable process design that is suitable for development in preliminary design; and (2) Will support formal safety documentation to be prepared during the definitive design phase to establish an acceptable safety basis. The Sludge Treatment Project (STP) is responsible for the disposition of Knock Out Pot (KOP) sludge within the 105-K West (KW) Basin.more » KOP sludge consists of size segregated material (primarily canister particulate) from the fuel and scrap cleaning process used in the Spent Nuclear Fuel process at K Basin. The KOP sludge will be pre-treated to remove fines and some of the constituents containing chemically bound water, after which it is referred to as KOP material. The KOP material will then be loaded into a Multi-Canister Overpack (MCO), dried at the Cold Vacuum Drying Facility (CVDF) and stored in the Canister Storage Building (CSB). This process is patterned after the successful drying of 2100 metric tons of spent fuel, and uses the same facilities and much of the same equipment that was used for drying fuel and scrap. Table ES-l present similarities and differences between KOP material and fuel and between MCOs loaded with these materials. The potential content of bound water bearing constituents limits the mass ofKOP material in an MCO load to a fraction of that in an MCO containing fuel and scrap; however, the small particle size of the KOP material causes the surface area to be significantly higher. This relatively large reactive surface area represents an input to the KOP thermal calculations that is significantly different from the calculations for fuel MCOs. The conceptual design provides for a copper insert block that limits the volume available to receive KOP material, enhances heat conduction, and functions as a heat source and sink during drying operations. This use of the copper insert represents a significant change to the thermal model compared to that used for the fuel calculations. A number of cases were run representing a spectrum of normal and upset conditions for the drying process. Dozens of cases have been run on cold vacuum drying of fuel MCOs. Analysis of these previous calculations identified four cases that provide a solid basis for judgments on the behavior of MCO in drying operations. These four cases are: (1) Normal Process; (2) Degraded vacuum pumping; (3) Open MCO with loss of annulus water; and (4) Cool down after vacuum drying. The four cases were run for two sets of input parameters for KOP MCOs: (1) a set of parameters drawn from safety basis values from the technical data book and (2) a sensitivity set using parameters selected to evaluate the impact of lower void volume and smaller particle size on MCO behavior. Results of the calculations for the drying phase cases are shown in Table ES-2. Cases using data book safety basis values showed dry out in 9.7 hours and heat rejection sufficient to hold temperature rise to less than 25 C. Sensitivity cases which included unrealistically small particle sizes and corresponding high reactive surface area showed higher temperature increases that were limited by water consumption. In this document and in the attachment (Apthorpe, R. and M.G. Plys, 2010) cases using Technical Databook safety basis values are referred to as nominal cases. In future calculations such cases will be called safety basis cases. Also in these documents cases using parameters that are less favorable to acceptable performance than databook safety values are referred to as safety cases. In future calculations such cases will be called sensitivity cases or sensitivity evaluations Calculations to be performed in support of the detailed design and formal safety basis documentation will expand the calculations presented in this document to include: additional features of the drying cycle, more realistic treatment of uranium metal consumption during oxidation, larger water inventory, longer time scales, and graphing of results of hydrogen gas concentration.« less

Note on evaluating safety performance of road infrastructure to motivate safety competition.

PubMed

Han, Sangjin

2016-01-01

Road infrastructures are usually developed and maintained by governments or public sectors. There is no competitor in the market of their jurisdiction. This monopolic feature discourages road authorities from improving the level of safety with proactive motivation. This study suggests how to apply a principle of competition for roads, in particular by means of performance evaluation. It first discusses why road infrastructure has been slow in safety oriented development and management in respect of its business model. Then it suggests some practical ways of how to promote road safety between road authorities, particularly by evaluating safety performance of road infrastructure. These are summarized as decision of safety performance indicators, classification of spatial boundaries, data collection, evaluation, and reporting. Some consideration points are also discussed to make safety performance evaluation on road infrastructure lead to better road safety management.

77 FR 11353 - Defense Federal Acquisition Regulation Supplement: Award Fee Reduction or Denial for Health or...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-24

... Denial for Health or Safety Issues (DFARS Case 2011-D033) AGENCY: Defense Acquisition Regulations System... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government... authorities to reduce or deny award fees to companies found to jeopardize the health or safety of Government...

75 FR 57659 - Airworthiness Directives Eurocopter France (ECF) Model SA-365N1, AS-365N2, AS 365 N3, EC 155B...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-22

... aviation authority of the European Aviation Safety Agency (EASA). The MCAI AD reports the separation and...: DOT/FAA Southwest Region, Gary Roach, ASW-111, Aviation Safety Engineer, Rotorcraft Directorate... Rulemaking Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety...

7 CFR 2.51 - Deputy Under Secretary for Food Safety.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 1 2010-01-01 2010-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

7 CFR 2.51 - Deputy Under Secretary for Food Safety.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 1 2011-01-01 2011-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

7 CFR 2.51 - Deputy Under Secretary for Food Safety.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 1 2014-01-01 2014-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

7 CFR 2.51 - Deputy Under Secretary for Food Safety.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 1 2012-01-01 2012-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

7 CFR 2.51 - Deputy Under Secretary for Food Safety.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 1 2013-01-01 2013-01-01 false Deputy Under Secretary for Food Safety. 2.51 Section 2.51 Agriculture Office of the Secretary of Agriculture DELEGATIONS OF AUTHORITY BY THE SECRETARY OF AGRICULTURE AND GENERAL OFFICERS OF THE DEPARTMENT Delegations of Authority by the Under Secretary for Food Safety § 2.51 Deputy Under Secretary for...

Safe Physical Activity Environments--To What Extent Are Local Government Authorities Auditing the Safety of Grassed Sporting Grounds?

ERIC Educational Resources Information Center

Otago, Leonie; Swan, Peter; Donaldson, Alex; Payne, Warren; Finch, Caroline

2009-01-01

Physical activity (PA) participation is influenced by the safety of the settings in which it is undertaken. This study describes the grounds assessment practices of Local Government Authorities (LGAs) in Victoria, Australia to ensure the safety of grassed sporting grounds. It also makes recommendations for improving these practices to maximise the…

Multiprocessor shared-memory information exchange

DOE Office of Scientific and Technical Information (OSTI.GOV)

Santoline, L.L.; Bowers, M.D.; Crew, A.W.

1989-02-01

In distributed microprocessor-based instrumentation and control systems, the inter-and intra-subsystem communication requirements ultimately form the basis for the overall system architecture. This paper describes a software protocol which addresses the intra-subsystem communications problem. Specifically the protocol allows for multiple processors to exchange information via a shared-memory interface. The authors primary goal is to provide a reliable means for information to be exchanged between central application processor boards (masters) and dedicated function processor boards (slaves) in a single computer chassis. The resultant Multiprocessor Shared-Memory Information Exchange (MSMIE) protocol, a standard master-slave shared-memory interface suitable for use in nuclear safety systems, ismore » designed to pass unidirectional buffers of information between the processors while providing a minimum, deterministic cycle time for this data exchange.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

Stickney, R.G.

This report presents the results of a systematic evaluation conducted to identify miscellaneous TWRS facilities, tanks and components with potential needed authorization basis upgrades. It provides the Authorization Basis upgrade plan for those miscellaneous TWRS facilities, tanks and components identified.

Occupational Safety Review of High Technology Facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee Cadwallader

2005-01-31

This report contains reviews of operating experiences, selected accident events, and industrial safety performance indicators that document the performance of the major US DOE magnetic fusion experiments and particle accelerators. These data are useful to form a basis for the occupational safety level at matured research facilities with known sets of safety rules and regulations. Some of the issues discussed are radiation safety, electromagnetic energy exposure events, and some of the more widespread issues of working at height, equipment fires, confined space work, electrical work, and other industrial hazards. Nuclear power plant industrial safety data are also included for comparison.

Safety Assessment of Synthetic Fluorphlogopite as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-01-01

The Cosmetic Ingredient Review Expert Panel (the Panel) reviewed the safety of synthetic fluorphlogopite as used in cosmetics. Synthetic fluorphlogopite functions as a bulking agent and a viscosity-increasing agent. The Panel reviewed available animal and human data related to this ingredient along with a previous safety assessment of other magnesium silicates. The Panel concluded that synthetic fluorphlogopite was safe as cosmetic ingredients in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

Highway Safety Program Manual: Volume 14: Pedestrian Safety.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 14 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on pedestrian safety. The purpose and objectives of a pedestrian safety program are outlined. Federal authority in the area of pedestrian safety and policies regarding a safety program…

Study on the Rule of Super Strata Movement and Subsidence

NASA Astrophysics Data System (ADS)

Yao, Shunli; Yuan, Hongyong; Jiang, Fuxing; Chen, Tao; Wu, Peng

2018-01-01

The movement of key strata is related to the safety of the whole earth’s surface for coal mining under super strata. Based on the key strata theory, the paper comprehensively analyzes the characteristics of the subsidence before and after the instability of the super strata by studing through FLAC3D and microseismic dynamic monitoring of the surface rock movement observation. The stability of the super strata movement is analyzed according to the characteristic value of the subsidence. The subsidence law and quantitative indexes under the control of the super rock strata that provides basis for the prevention and control of surface risk, optimize mining area and face layout and reasonably set mining boundary around mining area. It provides basis for the even growth of mine safety production and regional public safety.

77 FR 76232 - Airworthiness Directives; GA200 (Pty) Ltd Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-12-27

..., Amendment 39-17187 (77 FR 55686, September 11, 2012), the Civil Aviation Safety Authority (CASA), which is...-200. (h) Related Information Refer to MCAI Civil Aviation Safety Authority (CASA) AD AD/ GA200/1...

14 CFR § 1204.509 - Delegation of authority to take action regarding “liquidated damage” assessments under the...

Code of Federal Regulations, 2014 CFR

2014-01-01

... regarding âliquidated damageâ assessments under the Contract Work Hours and Safety Standards Act, and... Hours and Safety Standards Act, and associated labor statutes. (a) Delegation of authority. The Director, Industrial Relations Office, is hereby delegated the authority to act for the Administrator in all matters...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2010 CFR

2010-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2014 CFR

2014-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2011 CFR

2011-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2012 CFR

2012-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

46 CFR 50.01-15 - Scope of regulations.

Code of Federal Regulations, 2013 CFR

2013-10-01

... choice of materials for machinery, boilers, pressure vessels, safety valves, and piping systems upon which safety of life is dependent. (b) Since this subchapter contains the marine engineering details, it... COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) MARINE ENGINEERING GENERAL PROVISIONS Basis and...

Egg processing plant sanitation, SSOPs, and GMPs.

USDA-ARS?s Scientific Manuscript database

The basis of food safety programs in processing facilities is prerequisite programs such as sanitation and good manufacturing practices. Thoughtful, thorough, and complete sanitation programs are necessary to enhance the food safety of products and reduce the likelihood of foodborne illness. Egg p...

Large trucks involved in fatal crashes : the North Carolina data 1993-1997

DOT National Transportation Integrated Search

1999-03-01

An analysis of large, truck-involved crash outcomes in North Carolina for the period 1993-1997 was conducted by the UNC Highway Safety Research Center (HSRC) for the purpose of establishing an empirical basis for subsequent Governor's Highway Safety ...

Further Analysis of Motorcycle Helmet Effectiveness Using CODES Linked Data

DOT National Transportation Integrated Search

1998-01-01

Linked data from the Crash Outcome Data Evaluation System (CODES) in seven : states was used by the National Highway Traffic Safety Administration as the : basis of a 1996 Report to Congress on the Benefits of Safety Belts and : Motorcycle Helmets (D...

1998 motor vehicle occupant safety survey. Volume 1, methodology report

DOT National Transportation Integrated Search

2000-03-01

This is the Methodology Report for the 1998 Motor Vehicle Occupant Safety Survey. The survey is conducted on a biennial basis (initiated in 1994), and is administered by telephone to a randomly selected national sample. Two questionnaires are used, e...

47 CFR 101.1305 - Private internal service.

Code of Federal Regulations, 2010 CFR

2010-10-01

... business purposes or public safety communications and not on a for-hire or for-profit basis. ... 47 Telecommunication 5 2010-10-01 2010-10-01 false Private internal service. 101.1305 Section 101.1305 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES...

Trends in public information within the Fairfax Alcohol Safety Action Project, 1975.

DOT National Transportation Integrated Search

1976-01-01

To assess current trends in the effectiveness of the public information and education countermeasure of the Fairfax Alcohol Safety Action Project, two pieces of survey type research are conducted on a periodic basis. The roadside survey has been cond...

49 CFR 831.3 - Authority of Directors.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety, and Office of Pipeline and Hazardous Materials Safety, subject to the provisions of § 831.2 and part 800 of this... Transportation Other Regulations Relating to Transportation (Continued) NATIONAL TRANSPORTATION SAFETY BOARD...

Materials Safety Data Sheets: the basis for control of toxic chemicals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ketchen, E.E.; Porter, W.E.

1979-09-01

The Material Safety Data Sheets contained in this volume are the basis for the Toxic Chemical Control Program developed by the Industrial Hygiene Department, Health Division, ORNL. The three volumes are the update and expansion of ORNL/TM-5721 and ORNL/TM-5722 Material Safety Data Sheets: The Basis for Control of Toxic Chemicals, Volume I and Volume II. As such, they are a valuable adjunct to the data cards issued with specific chemicals. The chemicals are identified by name, stores catalog number where appropriate, and sequence numbers from the NIOSH Registry of Toxic Effects of Chemical Substances, 1977 Edition, if available. The datamore » sheets were developed and compiled to aid in apprising the employees of hazards peculiar to the handling and/or use of specific toxic chemicals. Space limitation necessitate the use of descriptive medical terms and toxicological abbreviations. A glossary and an abbreviation list were developed to define some of those sometimes unfamiliar terms and abbreviations. The page numbers are keyed to the catalog number in the chemical stores at ORNL.« less

Materials Safety Data Sheets: the basis for control of toxic chemicals

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ketchen, E.E.; Porter, W.E.

The Material Safety Data Sheets contained in this volume are the basis for the Toxic Chemical Control Program developed by the Industrial Hygiene Department, Health Division, ORNL. The three volumes are the update and expansion of ORNL/TM-5721 and ORNL/TM-5722 Material Safety Data Sheets: The Basis for Control of Toxic Chemicals, Volume I and Volume II. As such, they are a valuable adjunct to the data cards issued with specific chemicals. The chemicals are identified by name, stores catalog number where appropriate, and sequence numbers from the NIOSH Registry of Toxic Effects of Chemical Substances, 1977 Edition, if available. The datamore » sheets were developed and compiled to aid in apprising the employees of hazards peculiar to the handling and/or use of specific toxic chemicals. Space limitation necessitate the use of descriptive medical terms and toxicological abbreviations. A glossary and an abbreviation list were developed to define some of those sometimes unfamiliar terms and abbreviations. The page numbers are keyed to the catalog number in the chemical stores at ORNL.« less

A smartphone app to communicate child passenger safety: an application of theory to practice.

PubMed

Gielen, A C; McDonald, E M; Omaki, E; Shields, W; Case, J; Aitken, M

2015-10-01

Child passenger safety remains an important public health problem because motor vehicle crashes are the leading cause of death for children, and the majority of children ride improperly restrained. Using a mobile app to communicate with parents about injury prevention offers promise but little information is available on how to create such a tool. The purpose of this article is to illustrate a theory-based approach to developing a tailored, smartphone app for communicating child passenger safety information to parents. The theoretical basis for the tailoring is the elaboration likelihood model, and we utilized the precaution adoption process model (PAPM) to reflect the stage-based nature of behavior change. We created assessment items (written at ≤6th grade reading level) to determine the child's proper type of car seat, the parent's PAPM stage and beliefs on selected constructs designed to facilitate stage movement according to the theory. A message library and template were created to provide a uniform structure for the tailored feedback. We demonstrate how messages derived in this way can be delivered through new m-health technology and conclude with recommendations for the utility of the methods used here for other m-health, patient education interventions. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Regulatory considerations on new adjuvants and delivery systems.

PubMed

Sesardic, D

2006-04-12

New and improved vaccines and delivery systems are increasingly being developed for prevention, treatment and diagnosis of human diseases. Prior to their use in humans, all new biological products must undergo pre-clinical evaluation. These pre-clinical studies are important not only to establish the biological properties of the material and to evaluate its possible risk to the public, but also to plan protocols for subsequent clinical trials from which safety and efficacy can be evaluated. For vaccines, evaluation in pre-clinical studies is particularly important as information gained may also contribute to identifying the optimum composition and formulation process and provide an opportunity to develop suitable indicator tests for quality control. Data from pre-clinical and laboratory evaluation studies, which continue during clinical studies, is used to support an application for marketing authorisation. Addition of a new adjuvant and exploration of new delivery systems for vaccines presents challenges to both manufacturers and regulatory authorities. Because no adjuvant is licensed as a medicinal product in its own right, but only as a component of a particular vaccine, pre-clinical and appropriate toxicology studies need to be designed on a case-by-case basis to evaluate the safety profile of the adjuvant and adjuvant/vaccine combination. Current regulatory requirements for the pharmaceutical and pre-clinical safety assessment of vaccines are insufficient and initiatives are in place to develop more specific guidelines for evaluation of adjuvants in vaccines.

26 CFR 1.9200-1 - Deduction for motor carrier operating authority.

Code of Federal Regulations, 2010 CFR

2010-04-01

... less within which such 80 percent of the acquired corporation's stock was purchased. The election to... election, Y may allocate to the basis of the authority the amount of X's basis in Y stock that would have... Y makes the election under § 1.9200-1(e)(2), then for purposes of allocating X's basis in Y stock, X...

Radiation Protection, Safety and Security Issues in Ghana.

PubMed

Boadu, Mary; Emi-Reynolds, Geoffrey; Amoako, Joseph Kwabena; Akrobortu, Emmanuel; Hasford, Francis

2016-11-01

Although the use of radioisotopes in Ghana began in 1952, the Radiation Protection Board of Ghana was established in 1993 and served as the national competent authority for authorization and inspection of practices and activities involving radiation sources until 2015. The law has been superseded by an Act of Parliament, Act 895 of 2015, mandating the Nuclear Regulatory Authority of Ghana to take charge of the regulation of radiation sources and their applications. The Radiation Protection Institute in Ghana provided technical support to the regulatory authority. Regulatory and service activities that were undertaken by the Institute include issuance of permits for handling of a radiation sources, authorization and inspection of radiation sources, radiation safety assessment, safety assessment of cellular signal towers, and calibration of radiation-emitting equipment. Practices and activities involving application of radiation are brought under regulatory control in the country through supervision by the national competent authority.

Lawn Care Pesticides. Risks Remain Uncertain While Prohibited Safety Claims Continue

DTIC Science & Technology

1990-03-23

Trade Commission (FrC), under its own legislative authority to protect consumers against false and deceptive advertising , can take enforcement action...vides to the public about the safety of its products, federal enforcement actions taken against lawn care pesticide safety advertising claims, and...in reassessing the risks of these pesticides. FIFRA also authorizes EPA to take enforcement action against advertising claims made by pesticide

Transsexualism and Flight Safety

DTIC Science & Technology

1987-05-08

Security Classification) Transsexualism and Flight Safety 12. PERSONAL AUTHOR(S) Clements, Thomas I. and Wicks, Roland E. 13a. TYPE OF REPORT 13b. TIME... transsexual pilot with questionable judgment affecting flight safety is reported. The definition, etiology, and presenting symptoms are discussed. Three...involve all the phases of therapy and can be significant. Though the transsexual tends to have more episodes of anxiety and depression than the norm

Integrated deterministic and probabilistic safety analysis for safety assessment of nuclear power plants

DOE PAGES

Di Maio, Francesco; Zio, Enrico; Smith, Curtis; ...

2015-07-06

The present special issue contains an overview of the research in the field of Integrated Deterministic and Probabilistic Safety Assessment (IDPSA) of Nuclear Power Plants (NPPs). Traditionally, safety regulation for NPPs design and operation has been based on Deterministic Safety Assessment (DSA) methods to verify criteria that assure plant safety in a number of postulated Design Basis Accident (DBA) scenarios. Referring to such criteria, it is also possible to identify those plant Structures, Systems, and Components (SSCs) and activities that are most important for safety within those postulated scenarios. Then, the design, operation, and maintenance of these “safety-related” SSCs andmore » activities are controlled through regulatory requirements and supported by Probabilistic Safety Assessment (PSA).« less

The dread factor: how hazards and safety training influence learning and performance.

PubMed

Burke, Michael J; Salvador, Rommel O; Smith-Crowe, Kristin; Chan-Serafin, Suzanne; Smith, Alexis; Sonesh, Shirley

2011-01-01

On the basis of hypotheses derived from social and experiential learning theories, we meta-analytically investigated how safety training and workplace hazards impact the development of safety knowledge and safety performance. The results were consistent with an expected interaction between the level of engagement of safety training and hazardous event/exposure severity in the promotion of safety knowledge and performance. For safety knowledge and safety performance, highly engaging training was considerably more effective than less engaging training when hazardous event/exposure severity was high, whereas highly and less engaging training had comparable levels of effectiveness when hazardous event/exposure severity was low. Implications of these findings for theory testing and incorporating information on objective risk into workplace safety research and practice are discussed.

47 CFR 80.1103 - Equipment authorization.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 47 Telecommunication 5 2011-10-01 2011-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

47 CFR 80.1103 - Equipment authorization.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 5 2014-10-01 2014-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

47 CFR 80.1103 - Equipment authorization.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 5 2012-10-01 2012-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

47 CFR 80.1103 - Equipment authorization.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 5 2013-10-01 2013-10-01 false Equipment authorization. 80.1103 Section 80.1103 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Global Maritime Distress and Safety System (GMDSS) Equipment Requirements...

77 FR 29929 - Safety Zone; Town of Cape Charles Fireworks, Cape Charles Harbor, Cape Charles, VA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-21

... section of this notice. Basis and Purpose On July 4, 2012 the Town of Cape Charles will sponsor a...-AA00 Safety Zone; Town of Cape Charles Fireworks, Cape Charles Harbor, Cape Charles, VA AGENCY: Coast... temporary safety zone on the waters of Cape Charles City Harbor in Cape Charles, VA in support of the Fourth...

76 FR 18672 - Safety Zone; Big Rock Blue Marlin Air Show; Bogue Sound, Morehead City, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-05

...-AA00 Safety Zone; Big Rock Blue Marlin Air Show; Bogue Sound, Morehead City, NC AGENCY: Coast Guard... Safety Zone for the ``Big Rock Blue Marlin Air Show'', an aerial demonstration to be held over the waters... Register. Basis and Purpose On June 11, 2011 from 7 p.m. to 8 p.m., the Big Rock Blue Marlin Tournament...

77 FR 35850 - Safety Zone; F/V Deep Sea, Penn Cove, WA

Federal Register 2010, 2011, 2012, 2013, 2014

2012-06-15

... 1625-AA00 Safety Zone; F/V Deep Sea, Penn Cove, WA AGENCY: Coast Guard, DHS. ACTION: Temporary final rule. SUMMARY: The Coast Guard is establishing a safety zone around the Fishing Vessel (F/V) Deep Sea... with the sunken F/V Deep Sea. B. Basis and Purpose On the evening of May 13, 2012, the F/V Deep Sea...

School Safety, Severe Disciplinary Actions, and School Characteristics: A Secondary Analysis of the School Survey on Crime and Safety

ERIC Educational Resources Information Center

Han, Seunghee; Akiba, Motoko

2011-01-01

On the basis of a secondary analysis of survey data collected from 1,872 secondary school principals in the 2005-2006 School Survey on Crime and Safety, we examined the frequency of and reasons for severe disciplinary actions and the relationship between school characteristics and severe disciplinary actions. We found that severe disciplinary…

Towards an Inclusive Occupational Health and Safety For Informal Workers.

PubMed

Lund, Francie; Alfers, Laura; Santana, Vilma

2016-08-01

Large numbers of workers worldwide work informally. Yet the discipline and practice of occupational health and safety covers largely only formal workers, in formal work places. A comprehensive approach would have to take into account specific hazards faced by those in different occupations, working in "atypical" work places. Local authorities exert significant influence in the provision of infrastructure that impacts on health and safety, such as water and sanitation. Examples from Brazil and Ghana show that positive interventions are possible so long as informal workers are recognized as contributing to the economy. A more inclusive occupational health and safety is most likely to happen in contexts where informal workers have an organized voice and where there are responsive health and safety personnel who understand that the world of work has changed. Some policy interventions that impact on healthy and safe work will need to involve multiple stakeholders and institutions. © The Author(s) 2016.

Highway Safety Program Manual: Volume 3: Motorcycle Safety.

ERIC Educational Resources Information Center

National Highway Traffic Safety Administration (DOT), Washington, DC.

Volume 3 of the 19-volume Highway Safety Program Manual (which provides guidance to State and local governments on preferred highway safety practices) concentrates on aspects of motorcycle safety. The purpose and specific objectives of a State motorcycle safety program are outlined. Federal authority in the highway safety area and general policies…

42 CFR 498.100 - Basis, timing, and authority for reopening an ALJ or Board decision.

Code of Federal Regulations, 2010 CFR

2010-10-01

..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND CERTIFICATION APPEALS PROCEDURES FOR... Law Judges or the Departmental Appeals Board § 498.100 Basis, timing, and authority for reopening an...

16 CFR 1034.110 - Self-evaluation.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Self-evaluation. 1034.110 Section 1034.110 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER PRODUCT SAFETY COMMISSION § 1034.110...

Prediction of main factors’ values of air transportation system safety based on system dynamics

NASA Astrophysics Data System (ADS)

Spiridonov, A. Yu; Rezchikov, A. F.; Kushnikov, V. A.; Ivashchenko, V. A.; Bogomolov, A. S.; Filimonyuk, L. Yu; Dolinina, O. N.; Kushnikova, E. V.; Shulga, T. E.; Tverdokhlebov, V. A.; Kushnikov, O. V.; Fominykh, D. S.

2018-05-01

On the basis of the system-dynamic approach [1-8], a set of models has been developed that makes it possible to analyse and predict the values of the main safety indicators for the operation of aviation transport systems.

76 FR 53072 - Certification; Importation of Vehicles and Equipment Subject to Federal Safety, Bumper, and Theft...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-25

... used as a basis for the non-automatic suspension of an RI registration, deletes redundant text from... Part 592 as a Basis for the Non-Automatic Suspension or Revocation of an RI Registration B. Deletion of... violations of the regulations in part 592 as a basis for the non-automatic suspension or revocation of an RI...

High-reliability emergency response teams in the hospital: improving quality and safety using in situ simulation training.

PubMed

Wheeler, Derek S; Geis, Gary; Mack, Elizabeth H; LeMaster, Tom; Patterson, Mary D

2013-06-01

In situ simulation training is a team-based training technique conducted on actual patient care units using equipment and resources from that unit, and involving actual members of the healthcare team. We describe our experience with in situ simulation training in a major children's medical centre. In situ simulations were conducted using standardised scenarios approximately twice per month on inpatient hospital units on a rotating basis. Simulations were scheduled so that each unit participated in at least two in situ simulations per year. Simulations were conducted on a revolving schedule alternating on the day and night shifts and were unannounced. Scenarios were preselected to maximise the educational experience, and frequently involved clinical deterioration to cardiopulmonary arrest. We performed 64 of the scheduled 112 (57%) in situ simulations on all shifts and all units over 21 months. We identified 134 latent safety threats and knowledge gaps during these in situ simulations, which we categorised as medication, equipment, and/or resource/system threats. Identification of these errors resulted in modification of systems to reduce the risk of error. In situ simulations also provided a method to reinforce teamwork behaviours, such as the use of assertive statements, role clarity, performance of frequent updating, development of a shared mental model, performance of independent double checks of high-risk medicines, and overcoming authority gradients between team members. Participants stated that the training programme was effective and did not disrupt patient care. In situ simulations can identify latent safety threats, identify knowledge gaps, and reinforce teamwork behaviours when used as part of an organisation-wide safety programme.

The AP1000{sup R} nuclear power plant innovative features for extended station blackout mitigation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vereb, F.; Winters, J.; Schulz, T.

2012-07-01

Station Blackout (SBO) is defined as 'a condition wherein a nuclear power plant sustains a loss of all offsite electric power system concurrent with turbine trip and unavailability of all onsite emergency alternating current (AC) power system. Station blackout does not include the loss of available AC power to buses fed by station batteries through inverters or by alternate AC sources as defined in this section, nor does it assume a concurrent single failure or design basis accident...' in accordance with Reference 1. In this paper, the innovative features of the AP1000 plant design are described with their operation inmore » the scenario of an extended station blackout event. General operation of the passive safety systems are described as well as the unique features which allow the AP1000 plant to cope for at least 7 days during station blackout. Points of emphasis will include: - Passive safety system operation during SBO - 'Fail-safe' nature of key passive safety system valves; automatically places the valve in a conservatively safe alignment even in case of multiple failures in all power supply systems, including normal AC and battery backup - Passive Spent Fuel Pool cooling and makeup water supply during SBO - Robustness of AP1000 plant due to the location of key systems, structures and components required for Safe Shutdown - Diverse means of supplying makeup water to the Passive Containment Cooling System (PCS) and the Spent Fuel Pool (SFP) through use of an engineered, safety-related piping interface and portable equipment, as well as with permanently installed onsite ancillary equipment. (authors)« less

Post-marketing surveillance of sertindole.

PubMed

Toumi, Mondher

2002-01-01

The atypical antipsychotic drug, sertindole, like several other drugs, causes QT interval prolongation. Prolongation of the QT interval on the electrocardiogram has been associated with an increased risk of ventricular arrhythmia, including the more serious form, torsades de pointes, and is thus a safety concern for the authorities. In the case of sertindole, however, the available pharmacoepidemiological studies gathering data from about 10 000 patients documented the lack of increased risk associated to sertindole in comparison to other atypical antipsychotics. On the basis of these data, as well as non-clinical and clinical safety data, the CPMP expert group concluded that, although sertindole has the potential to prolong the QT interval, ¤ ¤ QT interval prolongation does not seem to be a reliable proxy for the risk of severe cardiac arrhythmias'', and there are no clinical data suggesting that sertindole is more arrhythmogenic than are other atypical antipsychotics. To further substantiate this conclusion, two post-marketing surveillance studies have been initiated. One is a randomized comparison of sertindole and risperidone under normal conditions of use. Randomization minimizes selection bias and the intention is that allocation to the two treatment arms will yield comparable treatment groups. While the two drugs will be given in an open-label fashion, all safety data will be blinded and reviewed by an independent safety committee. The other study is an observational study that includes all patients prescribed sertindole who, for whatever reason, will not be included in the randomized study. In all, 10 000 patients are expected to take part in the studies, which will run for at least 1 year.

75 FR 11574 - Draft Regulatory Guide: Issuance, Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-11

... agency's ``Regulatory Guide'' series. This series was developed to describe and make available to the... protection during plant operation and maintenance activities. For plants that have a design basis that... coatings be qualified and capable of surviving a design-basis accident without adversely affecting safety...

16 CFR 1034.130 - General prohibitions against discrimination.

Code of Federal Regulations, 2010 CFR

2010-01-01

.... 1034.130 Section 1034.130 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE CONSUMER... handicapped person shall, on the basis of handicap, be excluded from participation in, be denied the benefits...

47 CFR 87.1 - Basis and purpose.

Code of Federal Regulations, 2010 CFR

2010-10-01

... Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES AVIATION SERVICES... purpose for which this part is issued. (a) Basis. The rules for the aviation services in this part are... Regulations). (3) The Convention on International Civil Aviation—(ICAO Convention). (b) Purpose. This part...

Toys and confectionery--a legally hazardous combination?

PubMed

Eldred, J S; Pape, S M

1998-01-01

"What kind of magic has Nestlé worked on FDA?" Many in the confectionery business were asking this very question after seeing the company introduce onto the market in July 1997 - without any immediate agency intervention - a chocolate product surrounding an inedible plastic sphere enclosing a toy, bearing the moniker Nestlé Magic(R). A spate of recent publicity 1 on the controversy engendered by the new product has focused public attention on a little-known provision of the Federal Food, Drug, and Cosmetic Act (FDCA), specifically section 402(d)(1). Adding fuel to the proverbial regulatory fire was the Food and Drug Administration's (FDA's) signaling of a possible reversal of its long-standing policy prohibiting the marketing of combination "confectionery and toy" products that contain nonfunctional, nonnutritive objects. After the product was launched, FDA, in response to a petition filed by Nestlé USA, stated its intention to 1) issue a guidance document that would purport to sanction such products on an interim basis, and 2) promulgate a regulation setting safety standards for such products and thereby authorize their marketing. Although Nestlé subsequently announced its withdrawal of the product,2 questions remain about the applicable law and FDA's authority. This article critically examines the agency's authority to authorize marketing of such products through a regulation that addresses the criteria set forth in section 402(d)(1).

[Information and consensus for an appropriate medical-legal management of nosocomial infections, also in the light of the recommendations of the Joint Commission International Accreditation and the directions of the Supreme Court].

PubMed

Buzzi, Fabio

2010-01-01

The author, underlined the general importance of the information towards the persons who receive hospital assistance and recalled also the historical bases and the international inquiry upon this matter, precises the reasons that need particular information procedure regarding the hospital infections, because the problems raised by these infections and the safety measures against them request to involve also all people entering the hospital as visitors. On the basis of some specific items fixed by the Joint Commission International Accreditation in order of the duties of the hospital directions, well applicable on this matter, the author suggests that the material impossibility to zeroing occurrence of the hospital infections, in case of litigations between hospitals and patients needs alternative dispute solutions. In this respect the author mentions the opportunities created by law in France and, very recently, in Italy too. Finally, the author points out the pretentions of the Italian Supreme Court about the completeness and the precision that must caractherize the procedure of informed consent about all risks of every medical activity, otherwise the liability of the hospitals and the members of their care staffs is quite presumed--even from the point of view of the penal aforethought--while the medical performance has been proper.

49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

Code of Federal Regulations, 2012 CFR

2012-10-01

... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

Code of Federal Regulations, 2011 CFR

2011-10-01

... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

Code of Federal Regulations, 2014 CFR

2014-10-01

... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

49 CFR Appendix A to Subpart E of... - Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico-Domiciled Motor...

Code of Federal Regulations, 2013 CFR

2013-10-01

... Evaluation Criteria for Mexico-Domiciled Motor Carriers A Appendix A to Subpart E of Part 365 Transportation... OPERATING AUTHORITY Special Rules for Certain Mexico-domiciled Carriers Pt. 365, Subpt. E, App. A Appendix A to Subpart E of Part 365—Explanation of Pre-Authorization Safety Audit Evaluation Criteria for Mexico...

49 CFR 1.53 - Delegations to the Administrator of the Pipeline and Hazardous Materials Safety Administration.

Code of Federal Regulations, 2010 CFR

2010-10-01

... following: (a) Pipelines. (1) Exercise the authority and carry out the functions vested in the Secretary by the Federal pipeline safety laws (49 U.S.C. 60101 et seq.). (2) Exercise the authority and carry out....C. 185). (3) Exercise the authority and carry out the functions vested in the Secretary under...

49 CFR 1.53 - Delegations to the Administrator of the Pipeline and Hazardous Materials Safety Administration.

Code of Federal Regulations, 2011 CFR

2011-10-01

... following: (a) Pipelines. (1) Exercise the authority and carry out the functions vested in the Secretary by the Federal pipeline safety laws (49 U.S.C. 60101 et seq.). (2) Exercise the authority and carry out....C. 185). (3) Exercise the authority and carry out the functions vested in the Secretary under...

Explanation and elaboration of the SQUIRE (Standards for Quality Improvement Reporting Excellence) Guidelines, V.2.0: examples of SQUIRE elements in the healthcare improvement literature

PubMed Central

Goodman, Daisy; Ogrinc, Greg; Davies, Louise; Baker, G Ross; Barnsteiner, Jane; Foster, Tina C; Gali, Kari; Hilden, Joanne; Horwitz, Leora; Kaplan, Heather C; Leis, Jerome; Matulis, John C; Michie, Susan; Miltner, Rebecca; Neily, Julia; Nelson, William A; Niedner, Matthew; Oliver, Brant; Rutman, Lori; Thomson, Richard

2016-01-01

Since its publication in 2008, SQUIRE (Standards for Quality Improvement Reporting Excellence) has contributed to the completeness and transparency of reporting of quality improvement work, providing guidance to authors and reviewers of reports on healthcare improvement work. In the interim, enormous growth has occurred in understanding factors that influence the success, and failure, of healthcare improvement efforts. Progress has been particularly strong in three areas: the understanding of the theoretical basis for improvement work; the impact of contextual factors on outcomes; and the development of methodologies for studying improvement work. Consequently, there is now a need to revise the original publication guidelines. To reflect the breadth of knowledge and experience in the field, we solicited input from a wide variety of authors, editors and improvement professionals during the guideline revision process. This Explanation and Elaboration document (E&E) is a companion to the revised SQUIRE guidelines, SQUIRE 2.0. The product of collaboration by an international and interprofessional group of authors, this document provides examples from the published literature, and an explanation of how each reflects the intent of a specific item in SQUIRE. The purpose of the guidelines is to assist authors in writing clearly, precisely and completely about systematic efforts to improve the quality, safety and value of healthcare services. Authors can explore the SQUIRE statement, this E&E and related documents in detail at http://www.squire-statement.org. PMID:27076505

Qualification of Simulation Software for Safety Assessment of Sodium Cooled Fast Reactors. Requirements and Recommendations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Brown, Nicholas R.; Pointer, William David; Sieger, Matt

2016-04-01

The goal of this review is to enable application of codes or software packages for safety assessment of advanced sodium-cooled fast reactor (SFR) designs. To address near-term programmatic needs, the authors have focused on two objectives. First, the authors have focused on identification of requirements for software QA that must be satisfied to enable the application of software to future safety analyses. Second, the authors have collected best practices applied by other code development teams to minimize cost and time of initial code qualification activities and to recommend a path to the stated goal.

[Do residents and nurses communicate safety relevant concerns? : simulation study on the influence of the authority gradient].

PubMed

St Pierre, M; Scholler, A; Strembski, D; Breuer, G

2012-10-01

Due to the negative impact on decision-making too steep authority gradients in teams represent a risk factor for patient safety. As residents and nursing staff may fear sanctions they may be reluctant to forward critical information to or challenge planned actions of attending physicians. In the setting of a simulation course it was investigated whether and to what extent team members would challenge decisions of familiar attending physicians. In each case where participants did not voice an opinion the underlying motives for the behavior were investigated. A total of 59 physicians and 18 nursing staff participated in the scenario. During a rapid sequence induction they were confronted with 7 critical situations created by the attending physician who had been instructed by the simulation team. Recommendations of the German Society of Anaesthesiology were ignored as well as clinical standard operating procedures (SOPs) and two potentially fatal drug administrations were ordered. An attempt was made to determine whether team members were aware of the safety threat at all and if so how they would solve the resulting conflicts. The level of verbal challenge was scored. During debriefing participants were asked to verbalize the motives which they thought might account for their silence or level of challenge. In situations where non-verbal conflict resolution was possible 65% of the participants pursued that strategy whereas 35% voiced an opinion. Situations necessitating verbal intervention were identified in 66% but 72% of the participants chose to remain silent. Team members decided to challenge the attending physician in only 28% of the situations. In 35% their statement was oblique, in 25% the problem was addressed but not further pursued and only in 40% did participants show crisp advocacy and assertiveness and initiated discussion. Asked why they had refrained from challenging the attending physician 37% had no answer, in 35% of situations participants observed a discrepancy between their own knowledge and the intended course of action yet they decided not to address the problem, 12% explained their behavior with the perceived authority of the attending physician and 8% stated that in their opinion attending physicians violated SOPs on a daily basis. None of the participants had the feeling that the simulation setting had provoked a response different to what they might have done in everyday life. The authority gradient can have a major negative impact on perioperative patient care. Residents and nursing staff are seldom able to challenge the attending physicians when patient safety is at risk. However, even attending physicians who normally accept feedback and criticism from team members can fail to receive support.

[Safety evaluation and risk control measures of Cassiae Semen].

PubMed

Zhao, Yi-Meng; Wu, Li; Zhang, Shuo; Zhang, Li; Gao, Xue-Min; Sun, Xiao-Bo; Wang, Chun

2017-11-01

In this study, the authors reviewed domestic and foreign literatures, conducted the textual research on origin and development of Cassia Semen, studied records in ancient books and ancient and modern literatures, clinical adverse reactions and relevant experimental studies in recent years, and summarized the clinical features and influencing factors related to the safety of Cassiae Semen. According to the findings,Cassia Semen's safety risks are mainly liver and kidney system damages, with the main clinical features of fatigue, anorexia, disgusting of oil, yellow urine and gray stool; digestive system injury, with the main clinical features of diarrhea, abdominal distension, nausea and loose stool; reproductive system damage, with the main clinical features of vaginal bleeding. Allergic reactions and clinical adverse events, with the main clinical features for numb mouth, itching skin, nausea and vomiting, diarrhea, wheezing and lip cyanosis were also reported. The toxicological studies on toxic components of Cassiae Semen obtusifolia were carried out through acute toxicity test, subacute toxicity test, subchronic toxicity test and chronic toxicity test. Risk factors might include patients, compatibility and physicians. Physicians should strictly abide by the medication requirements in the Pharmacopoeia, pay attention to rational compatibility, appropriate dosage,correct usage and appropriate processing, control the dosage below 15 g to avoid excessive intake, strictly control the course of treatment to avoid accumulated poisoning caused by long-term administration. At the same time, clinicians should pay attention to the latest research progress, update the knowledge structure, quickly find the latest and useful materials from clinical practice, scientific research and drug information and other literatures, make evaluation and judgment for the materials, establish a traditional Chinese medicine intelligence information library, and strengthen the control over adverse effects with a pre-warning consciousness. The authors suggested standardizing clinical medication of Cassiae Semen, and avoiding misuse or excessive use; clinicians should prescribe it in strict accordance with there commended usage and dosage in the Pharmacopoeia, and focus on the safety signal accumulation in clinic, while strengthening studies for toxic substance basis and toxicity mechanism, in order to give full play to Cassiae Semen's clinical efficacy and reduce its adverse reactions. Copyright© by the Chinese Pharmaceutical Association.

The dental safety net in Connecticut.

PubMed

Beazoglou, Tryfon; Heffley, Dennis; Lepowsky, Steven; Douglass, Joanna; Lopez, Monica; Bailit, Howard

2005-10-01

Many poor, medically disabled and geographically isolated populations have difficulty accessing private-sector dental care and are considered underserved. To address this problem, public- and voluntary-sector organizations have established clinics and provide care to the underserved. Collectively, these clinics are known as "the dental safety net." The authors describe the dental safety net in Connecticut and examine the capacity and efficiency of this system to provide care to the noninstitutionalized underserved population of the state. The authors describe Connecticut's dental safety net in terms of dentists, allied health staff members, operatories, patient visits and patients treated per dentist per year. The authors compare the productivity of safety-net dentists with that of private practitioners. They also estimate the capacity of the safety net to treat people enrolled in Medicaid and the State Children's Health Insurance Program. The safety net is made up of dental clinics in community health centers, hospitals, the dental school and public schools. One hundred eleven dentists, 38 hygienists and 95 dental assistants staff the clinics. Safety-net dentists have fewer patient visits and patients than do private practitioners. The Connecticut safety-net system has the capacity to treat about 28.2 percent of publicly insured patients. The dental safety net is an important community resource, and greater use of allied dental personnel could substantially improve the capacity of the system to care for the poor and other underserved populations.

Safety Education--An Essential Element of Technical Training

ERIC Educational Resources Information Center

Glazener, Everett R.; Comstock, Thomas W.

1978-01-01

After tracing the background of the safety movement, provisions of recent safety legislation, and the ecological and environmental impact of industrial processes, the author stresses the need for safety education in technical education programs to prepare future employees for industrial safety requirements. (MF)

Safety assessment of Vitis vinifera (grape)-derived ingredients as used in cosmetics.

PubMed

Fiume, Monice M; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2014-01-01

The Cosmetic Ingredient Review Expert Panel (Panel) assessed the safety of 24 Vitis vinifera (grape)-derived ingredients and found them safe in the present practices of use and concentration in cosmetics. These ingredients function in cosmetics mostly as skin-conditioning agents, but some function as antioxidants, flavoring agents, and/or colorants. The Panel reviewed the available animal and clinical data to determine the safety of these ingredients. Additionally, some constituents of grapes have been assessed previously for safety as cosmetic ingredients by the Panel, and others are compounds that have been discussed in previous Panel safety assessments. © The Author(s) 2014.

Response Time Analysis and Test of Protection System Instrument Channels for APR1400 and OPR1000

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, Chang Jae; Han, Seung; Yun, Jae Hee

2015-07-01

Safety limits are required to maintain the integrity of physical barriers designed to prevent the uncontrolled release of radioactive materials in nuclear power plants. The safety analysis establishes two critical constraints that include an analytical limit in terms of a measured or calculated variable, and a specific time after the analytical limit is reached to begin protective action. Keeping with the nuclear regulations and industry standards, satisfying these two requirements will ensure that the safety limit will not be exceeded during the design basis event, either an anticipated operational occurrence or a postulated accident. Various studies on the setpoint determinationmore » methodology for the safety-related instrumentation have been actively performed to ensure that the requirement of the analytical limit is satisfied. In particular, the protection setpoint methodology for the advanced power reactor 1400 (APP1400) and the optimized power reactor 1000 (OPR1000) has been recently developed to cover both the design basis event and the beyond design basis event. The developed setpoint methodology has also been quantitatively validated using specific computer programs and setpoint calculations. However, the safety of nuclear power plants cannot be fully guaranteed by satisfying the requirement of the analytical limit. In spite of the response time verification requirements of nuclear regulations and industry standards, it is hard to find the studies on the systematically integrated methodology regarding the response time evaluation. In cases of APR1400 and OPR1000, the response time analysis for the plant protection system is partially included in the setpoint calculation and the response time test is separately performed via the specific plant procedure. The test technique has a drawback which is the difficulty to demonstrate completeness of timing test. The analysis technique has also a demerit of resulting in extreme times that not actually possible. Thus, the establishment of the systematic response time evaluation methodology is needed to justify the conformance to the response time requirement used in the safety analysis. This paper proposes the response time evaluation methodology for APR1400 and OPR1000 using the combined analysis and test technique to confirm that the plant protection system can meet the analytical response time assumed in the safety analysis. In addition, the results of the quantitative evaluation performed for APR1400 and OPR1000 are presented in this paper. The proposed response time analysis technique consists of defining the response time requirement, determining the critical signal path for the trip parameter, allocating individual response time to each component on the signal path, and analyzing the total response time for the trip parameter, and demonstrates that the total analyzed response time does not exceed the response time requirement. The proposed response time test technique is composed of defining the response time requirement, determining the critical signal path for the trip parameter, determining the test method for each component on the signal path, performing the response time test, and demonstrates that the total test result does not exceed the response time requirement. The total response time should be tested in a single test that covers from the sensor to the final actuation device on the instrument channel. When the total channel is not tested in a single test, separate tests on groups of components or single components including the total instrument channel shall be combined to verify the total channel response. For APR1400 and OPR1000, the ramp test technique is used for the pressure and differential pressure transmitters and the step function testing technique is applied to the signal processing equipment and final actuation device. As a result, it can be demonstrated that the response time requirement is satisfied by the combined analysis and test technique. Therefore, the proposed methodology in this paper plays a crucial role in guaranteeing the safety of the nuclear power plants systematically satisfying one of two critical requirements from the safety analysis. (authors)« less

Nursing workload, patient safety incidents and mortality: an observational study from Finland

PubMed Central

Kinnunen, Marina; Saarela, Jan

2018-01-01

Objective To investigate whether the daily workload per nurse (Oulu Patient Classification (OPCq)/nurse) as measured by the RAFAELA system correlates with different types of patient safety incidents and with patient mortality, and to compare the results with regressions based on the standard patients/nurse measure. Setting We obtained data from 36 units from four Finnish hospitals. One was a tertiary acute care hospital, and the three others were secondary acute care hospitals. Participants Patients’ nursing intensity (249 123 classifications), nursing resources, patient safety incidents and patient mortality were collected on a daily basis during 1 year, corresponding to 12 475 data points. Associations between OPC/nurse and patient safety incidents or mortality were estimated using unadjusted logistic regression models, and models that adjusted for ward-specific effects, and effects of day of the week, holiday and season. Primary and secondary outcome measures Main outcome measures were patient safety incidents and death of a patient. Results When OPC/nurse was above the assumed optimal level, the adjusted odds for a patient safety incident were 1.24 (95% CI 1.08 to 1.42) that of the assumed optimal level, and 0.79 (95% CI 0.67 to 0.93) if it was below the assumed optimal level. Corresponding estimates for patient mortality were 1.43 (95% CI 1.18 to 1.73) and 0.78 (95% CI 0.60 to 1.00), respectively. As compared with the patients/nurse classification, models estimated on basis of the RAFAELA classification system generally provided larger effect sizes, greater statistical power and better model fit, although the difference was not very large. Net benefits as calculated on the basis of decision analysis did not provide any clear evidence on which measure to prefer. Conclusions We have demonstrated an association between daily workload per nurse and patient safety incidents and mortality. Current findings need to be replicated by future studies. PMID:29691240

77 FR 48856 - Safety Zone; Superior Bay, Duluth, MN

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-15

... participants, event safety personnel, boaters and spectators during the Superior Man Triathlon. DATES: This..., spectators, and vessels from the hazards associated with the Superior Man Triathlon, which are discussed... interest. B. Basis and Purpose On August 26, 2012, the inaugural Superior Man Triathlon will occur along...

2007 motor vehicle occupant safety survey : use of and support for emergency medical services systems.

DOT National Transportation Integrated Search

2009-09-01

The Motor Vehicle Occupant Safety Survey (MVOSS) is a national telephone survey administered by NHTSA on a periodic basis to obtain data on attitudes, knowledge, and self-reported behavior primarily in areas of occupant protection. The sample is comp...

Equivalent Safety Basis for Evaluation of On-Site Packages for US DOE Facilities

DOE Office of Scientific and Technical Information (OSTI.GOV)

Smith, A.C.

Packages for transport of radioactive material within the boundaries of a Department of Energy facility (on-site) must conform to the requirements for packages shipped in normal commerce, or must provide equivalent safety. Equivalence is achieved if the frequency of severe on-site accidents, which could result in a release of radioactive material, is less than or equal to the frequency of Beyond-HAC accidents for packages in commerce. This is shown to be achieved it the rate of on-site accident is 22 per 100 MVM or lower. For equivalence to Normal Conditions of Transport, for on-site packages, appropriate, defensible Design Basis Conditionsmore » can be established and the ability of the package to meet the reduced requirements shown in the On-site Safety Assessment.« less

49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

Code of Federal Regulations, 2012 CFR

2012-10-01

... 49 Transportation 7 2012-10-01 2012-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

Code of Federal Regulations, 2014 CFR

2014-10-01

... 49 Transportation 7 2014-10-01 2014-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

Code of Federal Regulations, 2013 CFR

2013-10-01

... 49 Transportation 7 2013-10-01 2013-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

Code of Federal Regulations, 2011 CFR

2011-10-01

... 49 Transportation 7 2011-10-01 2011-10-01 false Delegation to the Directors of Office of Aviation... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority...

49 CFR 800.25 - Delegation to the Directors of Office of Aviation Safety, Office of Railroad Safety, Office of...

Code of Federal Regulations, 2010 CFR

2010-10-01

... Office of Aviation Safety, Office of Railroad Safety, Office of Highway Safety, Office of Marine Safety... Offices of Aviation, Railroad, Highway, Marine, and Pipeline and Hazardous Materials Safety, the authority... 49 Transportation 7 2010-10-01 2010-10-01 false Delegation to the Directors of Office of Aviation...

WHO informal consultation on quality, safety and efficacy specifications for live attenuated rotavirus vaccines Mexico City, Mexico, 8-9 February 2005.

PubMed

Wood, David

2005-12-01

Rotavirus vaccines are at an advanced stage of development but there are as yet no WHO recommendations on production and quality control to provide regulatory guidance. A meeting of experts was convened by WHO and PAHO/AMRO to review the scientific basis for production and quality control of rotavirus vaccines, and to discuss specific measures to assure the safety and efficacy of rotavirus vaccines. The meeting was attended by 25 experts from 14 countries, drawn from academia, public health, national regulatory authorities and vaccine producers. It was agreed that existing guidance for other live virus vaccines provides a very good basis for product characterization, especially for source materials and control of production. The basis for attenuation of current vaccines or vaccine candidates is not known but, at least for the vaccines based on the Jennerian approach of using animal (bovine) rotaviruses, is likely to be multigenic. The risk of intussusception in humans is influenced by genetic background and age. Recent analyzes of large vaccine safety trials found that certain strains of vaccine virus were not associated with intussusception, although in these trials the first dose of vaccine was not administered to children over 3 months of age. Since age is a risk factor for intussusception, this may suggest that early delivery of the first dose of vaccine is desirable. However, maternal antibodies may mitigate against early delivery of the first vaccine dose. Factors which could affect vaccine efficacy or safety include strain diversity, malnutrition, other enteric infections, parasitic infection or immune suppression. It was concluded that data from clinical trials conducted in one part of the world would not necessarily be predictive of vaccine efficacy in other places. It was agreed that in nonclinical evaluations there was a need to use oral dosing for toxicity studies and, because rotavirus is non-neurovirulent, that there was no need for an animal neurovirulence test. For clinical evaluations there was a need for a standard definition of severe disease as the clinical endpoint, a need for studies in diverse geographical regions, and the need to control for possible interference by factors such as other oral vaccinations, intercurrent infections and breast feeding. There is no accepted correlate of protection. Secretory IgA is the most satisfactory laboratory parameter currently available and for a period after vaccination much of the specific serum IgA is of this type, so that serum IgA levels can act as measure of seroconversion. The need for standardization of the potency assay for release of vaccine was identified, as was a need to develop guidance on standardized approaches to post-marketing surveillance for rotavirus vaccines.

10 CFR 820.61 - Secretarial officer.

Code of Federal Regulations, 2012 CFR

2012-01-01

... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

10 CFR 820.61 - Secretarial officer.

Code of Federal Regulations, 2010 CFR

2010-01-01

... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

10 CFR 820.61 - Secretarial officer.

Code of Federal Regulations, 2014 CFR

2014-01-01

... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

10 CFR 820.61 - Secretarial officer.

Code of Federal Regulations, 2013 CFR

2013-01-01

... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

10 CFR 820.61 - Secretarial officer.

Code of Federal Regulations, 2011 CFR

2011-01-01

... environment, safety and health matters shall exercise this authority with respect to provisions relating to radiological protection of workers, the public and the environment. This authority may not be further delegated. ... Safety Requirement relates may grant a temporary or permanent exemption from that requirement as...

29 CFR 1952.125 - Changes to approved plans.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR..., concerning an internal occupational safety and health program on the Colville reservation. Under this... authority set forth in its State plan. (Federal OSHA will exercise enforcement authority over Indian-owned...

29 CFR 1952.125 - Changes to approved plans.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR..., concerning an internal occupational safety and health program on the Colville reservation. Under this... authority set forth in its State plan. (Federal OSHA will exercise enforcement authority over Indian-owned...

49 CFR 392.9a - Operating authority.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 49 Transportation 5 2010-10-01 2010-10-01 false Operating authority. 392.9a Section 392.9a Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS DRIVING OF COMMERCIAL MOTOR...

75 FR 63774 - Pipeline Safety: Safety of On-Shore Hazardous Liquid Pipelines

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-18

... DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Part... Pipelines AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of... Gas Pipeline Safety Act of 1968, Public Law 90-481, delegated to DOT the authority to develop...

48 CFR 923.7001 - Nuclear safety.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Nuclear safety. 923.7001... Efficiency, Renewable Energy Technologies, and Occupational Safety Programs 923.7001 Nuclear safety. The DOE regulates the nuclear safety of its major facilities under its own statutory authority derived from the...

Differences in Hospital Managers', Unit Managers', and Health Care Workers' Perceptions of the Safety Climate for Respiratory Protection.

PubMed

Peterson, Kristina; Rogers, Bonnie M E; Brosseau, Lisa M; Payne, Julianne; Cooney, Jennifer; Joe, Lauren; Novak, Debra

2016-07-01

This article compares hospital managers' (HM), unit managers' (UM), and health care workers' (HCW) perceptions of respiratory protection safety climate in acute care hospitals. The article is based on survey responses from 215 HMs, 245 UMs, and 1,105 HCWs employed by 98 acute care hospitals in six states. Ten survey questions assessed five of the key dimensions of safety climate commonly identified in the literature: managerial commitment to safety, management feedback on safety procedures, coworkers' safety norms, worker involvement, and worker safety training. Clinically and statistically significant differences were found across the three respondent types. HCWs had less positive perceptions of management commitment, worker involvement, and safety training aspects of safety climate than HMs and UMs. UMs had more positive perceptions of management's supervision of HCWs' respiratory protection practices. Implications for practice improvements indicate the need for frontline HCWs' inclusion in efforts to reduce safety climate barriers and better support effective respiratory protection programs and daily health protection practices. © 2016 The Author(s).

Criticality Safety Evaluation of the LLNL Inherently Safe Subcritical Assembly (ISSA)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Percher, Catherine

2012-06-19

The LLNL Nuclear Criticality Safety Division has developed a training center to illustrate criticality safety and reactor physics concepts through hands-on experimental training. The experimental assembly, the Inherently Safe Subcritical Assembly (ISSA), uses surplus highly enriched research reactor fuel configured in a water tank. The training activities will be conducted by LLNL following the requirements of an Integration Work Sheet (IWS) and associated Safety Plan. Students will be allowed to handle the fissile material under the supervision of LLNL instructors. This report provides the technical criticality safety basis for instructional operations with the ISSA experimental assembly.

Prioritisation of allergenic foods with respect to public health relevance: Report from an ILSI Europe Food Allergy Task Force Expert Group.

PubMed

Houben, Geert; Burney, Peter; Chan, Chun-Han; Crevel, René; Dubois, Anthony; Faludi, Roland; Klein Entink, Rinke; Knulst, André; Taylor, Steve; Ronsmans, Stefan

2016-03-01

Regulators and risk managers in general need to decide whether an allergenic food or ingredient is of such public health importance that it needs to be actively managed. There is therefore a need to scale the relative allergenicity of foods and ingredients according to the hazards they pose. Objective criteria increase transparency and trust in this decision-making process and its conclusions. This paper proposes a framework that allows categorisation and prioritisation of allergenic foods according to their public health importance. The challenge is to find a basis on which the allergenicity of foods can best be described and a method to combine the relevant measures of allergenicity into a scoring system that prioritises allergenic foods on the basis of their public health relevance. The framework is designed in accordance with the generic risk analysis principles used in food safety and can be used by regulators to decide whether or not a specific allergenic food or ingredient is of sufficient public health importance that it warrants regulation (i.e. mandatory labelling) when used in the production of food products. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

DTIC Science & Technology

More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

Assessing safety climate in acute hospital settings: a systematic review of the adequacy of the psychometric properties of survey measurement tools.

PubMed

Alsalem, Gheed; Bowie, Paul; Morrison, Jillian

2018-05-10

The perceived importance of safety culture in improving patient safety and its impact on patient outcomes has led to a growing interest in the assessment of safety climate in healthcare organizations; however, the rigour with which safety climate tools were developed and psychometrically tested was shown to be variable. This paper aims to identify and review questionnaire studies designed to measure safety climate in acute hospital settings, in order to assess the adequacy of reported psychometric properties of identified tools. A systematic review of published empirical literature was undertaken to examine sample characteristics and instrument details including safety climate dimensions, origin and theoretical basis, and extent of psychometric evaluation (content validity, criterion validity, construct validity and internal reliability). Five questionnaire tools, designed for general evaluation of safety climate in acute hospital settings, were included. Detailed inspection revealed ambiguity around concepts of safety culture and climate, safety climate dimensions and the methodological rigour associated with the design of these measures. Standard reporting of the psychometric properties of developed questionnaires was variable, although evidence of an improving trend in the quality of the reported psychometric properties of studies was noted. Evidence of the theoretical underpinnings of climate tools was limited, while a lack of clarity in the relationship between safety culture and patient outcome measures still exists. Evidence of the adequacy of the psychometric development of safety climate questionnaire tools is still limited. Research is necessary to resolve the controversies in the definitions and dimensions of safety culture and climate in healthcare and identify related inconsistencies. More importance should be given to the appropriate validation of safety climate questionnaires before extending their usage in healthcare contexts different from those in which they were originally developed. Mixed methods research to understand why psychometric assessment and measurement reporting practices can be inadequate and lacking in a theoretical basis is also necessary.

49 CFR 807.151 - Program accessibility: New construction and alterations.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) NATIONAL TRANSPORTATION SAFETY BOARD ENFORCEMENT OF NONDISCRIMINATION ON THE BASIS OF HANDICAP IN PROGRAMS OR ACTIVITIES CONDUCTED BY THE NATIONAL TRANSPORTATION SAFETY BOARD § 807.151 Program accessibility... the Architectural Barriers Act (42 U.S.C. 4151-4157), as established in 41 CFR 101-19.600 to 101-19...

47 CFR 90.528 - Public safety broadband license.

Code of Federal Regulations, 2010 CFR

2010-10-01

... financial and operational information. The Public Safety Broadband Licensee shall submit, on a quarterly basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing Agreement, and as approved by the Commission. Such quarterly financial reports shall be filed with the...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

21 CFR 202.1 - Prescription-drug advertisements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... scientific training and experience to evaluate the safety and effectiveness of such drugs; or (b) For which... evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and... descriptive of a drug and references published (for example, the “Physicians Desk Reference”) for use by...

75 FR 39197 - Safety Zone; Fireworks Display, Portland, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-08

...-AA00 Safety Zone; Fireworks Display, Portland, OR AGENCY: Coast Guard, DHS. ACTION: Notice of proposed..., and the shoreline to the east and west in support of the Oregon Symphony Celebration Fireworks Display... Register. Basis and Purpose The Oregon Symphony Celebration Fireworks display is an annual event. The...

School Safety Project: Product Evaluation, 1990-1991.

ERIC Educational Resources Information Center

Saginaw Public Schools, MI. Dept. of Evaluation Services.

A districtwide school safety project implemented in Saginaw, Michigan, in 1990-91, the third year of its operation, is evaluated in this report. The project is evaluated on the basis of the following objectives: employment and training of home-school liaison officers; establishment of an advisory council; development and implementation of…

10 CFR Appendix A to Subpart B of... - General Statement of Safety Basis Policy

Code of Federal Regulations, 2010 CFR

2010-01-01

... Analysis Reports for Nuclear Power Plants, or successor document. (2) A DOE nonreactor nuclear facility... with DOE Policy 450.2A, “Identifying, Implementing and Complying with Environment, Safety and Health..., the public and the environment from adverse consequences. These analyses and hazard controls...

29 CFR 1926.1418 - Authority to stop operation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 29 Labor 8 2011-07-01 2011-07-01 false Authority to stop operation. 1926.1418 Section 1926.1418 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Cranes and Derricks in...

Bibliography on Liquefied Natural Gas (LNG) safety

NASA Technical Reports Server (NTRS)

Ordin, P. M.

1976-01-01

Approximately 600 citations concerning safety of liquefied natural gas and liquid methane are presented. Each entry includes the title, author, abstract, source, description of figures, key references, and major descriptors for retrieving the document. An author index is provided as well as an index of descriptors.

77 FR 1975 - Safety Advisory: Unauthorized Marking of Compressed Gas Cylinders

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-12

... Jackson Plaza, Ann Arbor, MI improperly requalified and marked high pressure compressed gas cylinders... DOT specification cylinders after its authority to requalifiy high pressure cylinders expired on... that Spears Fire & Safety continued to requalify and mark high pressure cylinders after their authority...

A Daily Diary Approach to the Examination of Chronic Stress, Daily Hassles and Safety Perceptions in Hospital Nursing.

PubMed

Louch, Gemma; O'Hara, Jane; Gardner, Peter; O'Connor, Daryl B

2017-12-01

Stress is a significant concern for individuals and organisations. Few studies have explored stress, burnout and patient safety in hospital nursing on a daily basis at the individual level. This study aimed to examine the effects of chronic stress and daily hassles on safety perceptions, the effect of chronic stress on daily hassles experienced and chronic stress as a potential moderator. Utilising a daily diary design, 83 UK hospital nurses completed three end-of-shift diaries, yielding 324 person days. Hassles, safety perceptions and workplace cognitive failure were measured daily, and a baseline questionnaire included a measure of chronic stress. Hierarchical multivariate linear modelling was used to analyse the data. Higher chronic stress was associated with more daily hassles, poorer perceptions of safety and being less able to practise safely, but not more workplace cognitive failure. Reporting more daily hassles was associated with poorer perceptions of safety, being less able to practise safely and more workplace cognitive failure. Chronic stress did not moderate daily associations. The hassles reported illustrate the wide-ranging hassles nurses experienced. The findings demonstrate, in addition to chronic stress, the importance of daily hassles for nurses' perceptions of safety and the hassles experienced by hospital nurses on a daily basis. Nurses perceive chronic stress and daily hassles to contribute to their perceptions of safety. Measuring the number of daily hassles experienced could proactively highlight when patient safety threats may arise, and as a result, interventions could usefully focus on the management of daily hassles.

49 CFR 195.452 - Pipeline integrity management in high consequence areas.

Code of Federal Regulations, 2011 CFR

2011-10-01

... engineering evaluation and provides an equivalent level of public safety and environmental protection. (c... situations—(i) Engineering basis. An operator may be able to justify an engineering basis for a longer assessment interval on a segment of line pipe. The justification must be supported by a reliable engineering...

[Applications of near infrared reflectance spectroscopy technique to determination of forage mycotoxins].

PubMed

Xu, Qing-Fang; Han, Jian-Guo; Yu, Zhu; Yue, Wen-Bin

2010-05-01

The near infrared reflectance spectroscopy technique (NIRS) has been explored at many fields such as agriculture, food, chemical, medicine, and so on, due to its rapid, effective, non-destructive, and on-line characteristics. Fungi invasion in forage materials during processing and storage would generate mycotoxins, which were harmful for people and animal through food chains. The determination of mycotoxins included the overelaborated pretreatments such as milling, extracting, chromatography and subsequent process such as enzyme linked immunosorbent assay, high performance liquid chromatography, and thin layer chromatography. The authors hope that high precision and low detection limit spectrum instrument, and software technology and calibration model of mycotoxins determination, will fast measure accurately the quality and quantity of mycotoxins, which will provide basis for reasonable process and utilization of forage and promote the application of NIRS in the safety livestock product.

Consumers’ Attitude Towards Fish Meat

PubMed Central

Passantino, Annamaria; Longo, Sabrina; Voslářová, Eva

2014-01-01

The overall aim of this paper is to show the factors that may affect consumers’ attitude towards farmed fish products. Consumers ask new products on the basis of different quality attributes: stability, safety, composition, better health effects, environment protection, etc. Different and controversial opinions on farmed and wild fish are also explored by literature review. The authors pay attention also to fish welfare as an emerging issue and effective information about fish products as a factor exerting a positive influence on consumers’ decision of purchase. Some relevant legislative notes on the paper’s topics are also cited. The qualitative aspects of aquaculture fish and the consumers’ demand and choice need further studies, according to some factors, such as the changing consumers’ attitudes towards fish products, the different fish quality perception and the development in the aquaculture systems. PMID:27800359

TA-55 and Sigma Overview

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spearing, Dane Robert

These are slides from a facility overview presentation for visiting agencies to Los Alamos National Laboratory (LANL). The TA-55 Plutonium Facility (PF-4) is discussed in detail. PF-4 is a unique resource for US plutonium programs. The basic design is flexible and has adapted to changing national needs. It is a robust facility with strong safety and security implementation. It supports a variety of national programs. It will continue for many years into the future. Sigma is then discussed in detail, which handles everything from hydrogen to uranium. It has been in long term service to the Nation (nearly 60 years).more » It has a flexible authorization basis to handle almost the entire periodic table. It has a wide breadth of prototyping and characterization capabilities. It has integrated program and line management.« less

Identification of adverse events in ground transport emergency medical services.

PubMed

Patterson, P Daniel; Weaver, Matthew D; Abebe, Kaleab; Martin-Gill, Chris; Roth, Ronald N; Suyama, Joseph; Guyette, Francis X; Rittenberger, Jon C; Krackhardt, David; Arnold, Robert; Yealy, Donald M; Lave, Judith

2012-01-01

The purpose of this study was to develop a method to define and rate the severity of adverse events (AEs) in emergency medical services (EMS) safety research. They used a modified Delphi technique to develop a consensus definition of an AE. The consensus definition was as follows: "An adverse event in EMS is a harmful or potentially harmful event occurring during the continuum of EMS care that is potentially preventable and thus independent of the progression of the patient's condition." Physicians reviewed 250 charts from 3 EMS agencies for AEs. The authors examined physician agreement using κ, Fleiss's κ, and corresponding 95% confidence intervals (CIs). Overall physician agreement on presence of an AE per chart was fair (κ = 0.24; 95% CI = 0.19, 0.29). These findings should serve as a basis for refining and implementing an AE evaluation instrument.

GPs' compliance with health and safety legislation and their occupational health needs in one London health authority.

PubMed Central

Kennedy, Ioanna; Williams, Siân; Reynolds, Anne; Cockcroft, Anne; Solomon, Jack; Farrow, Stephen

2002-01-01

This survey assessed general practitioners' (GPs') knowledge of and compliance with, health and safety legislation and occupational health guidance in one London health authority. The response rate was 85%. Although the majority of practices were aware of the most important piece of legislation--The Management of Health and Safety at Work Regulations, 1992--less than one in ten practices had carried out the required systematic risk assessments. Compliance with other health and safety legislation and related employment issues was also poor. The health of GPs and their staff may be at risk and these general practices may be vulnerable to prosecution by the Health and Safety Executive. PMID:12236278

Laboratory Safety in the Biology Lab.

ERIC Educational Resources Information Center

Ritch, Donna; Rank, Jane

2001-01-01

Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

Safety and health concerns in forestry operations

Treesearch

Robert B. Rummer

1997-01-01

The author discusses several safety models, including the "Three E?s": engineering, education, and enforcement; the Heinrich-Lateiner model; the organizational model; and the behavioral safety model. Rummer encourages approaching safety from a broader perspective, enabling the industry to track changes in all aspects and to keep leading the safety target....

Commonwealth of Virginia, Department of Transportation Safety, transportation safety plan for the period July 1, 1981-June 30, 1982.

DOT National Transportation Integrated Search

1981-01-01

Senate Bill 85, passed by the General Assembly in 1978, renamed the Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to participate in the evaluation of current safety measures in all modes of trans...

To make or buy patient safety solutions: a resource dependence and transaction cost economics perspective.

PubMed

Fareed, Naleef; Mick, Stephen S

2011-01-01

For almost a decade, public and private organizations have pressured hospitals to improve their patient safety records. Since 2008, the Centers for Medicare & Medicaid Services has no longer been reimbursing hospitals for secondary diagnoses not reported during the point of admission. This ruling has motivated some hospitals to engage in safety-oriented programs to decrease adverse events. This study examined which hospitals may engage in patient safety solutions and whether they create these patient safety solutions within their structures or use suppliers in the market. We used a theoretical model that incorporates the key constructs of resource dependence theory and transaction cost economics theory to predict a hospital's reaction to Centers for Medicare & Medicaid Services "never event" regulations. We present propositions that speculate on how forces conceptualized from the resource dependence theory may affect adoption of patient safety innovations and, when they do, whether the adopting hospitals will do so internally or externally according to the transaction cost economics theory. On the basis of forces identified by the resource dependence theory, we predict that larger, teaching, safety net, horizontally integrated, highly interdependent, and public hospitals in concentrated, high public payer presence, competitive, and resource-rich environments will be more likely to engage in patient safety innovations. Following the logic of the transaction cost economics theory, we predict that of the hospitals that react positively to the never event regulation, most will internalize their innovations in patient safety solutions rather than approach the market, a choice that helps hospitals economize on transaction costs. This study helps hospital managers in their strategic thinking and planning in relation to current and future regulations related to patient safety. For researchers and policy analysts, our propositions provide the basis for empirical testing.

9 CFR 592.10 - Authority.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Authority. 592.10 Section 592.10 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE EGG PRODUCTS... this part. The Food Safety Inspection Service and its officers and employees shall not be liable in...

49 CFR 365.507 - FMCSA action on the application.

Code of Federal Regulations, 2011 CFR

2011-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES... databases of the governments of Mexico and the United States. (c) Pre-authorization safety audit. Every...

49 CFR 365.507 - FMCSA action on the application.

Code of Federal Regulations, 2010 CFR

2010-10-01

... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS RULES... databases of the governments of Mexico and the United States. (c) Pre-authorization safety audit. Every...

Safety Assessment of Pentaerythrityl Tetraesters as Used in Cosmetics.

PubMed

Becker, Lillian C; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2015-09-01

The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 16 pentaerythrityl tetraester compounds as used in cosmetics. These ingredients mostly function as hair-conditioning agents, skin-conditioning agents-miscellaneous and binders, skin-conditioning agents-occlusive, viscosity-increasing agents-nonaqueous, and skin-conditioning agents-emollient. The Panel reviewed the available animal and human data related to these ingredients and previous safety assessments of the fatty acid moieties. The Panel concluded that pentaerythrityl tetraisostearate and the other pentaerythrityl tetraester compounds were safe in the practices of use and concentration as given in this safety assessment. © The Author(s) 2015.

Hazards in the hospital.

PubMed

Seibert, P J

1994-02-01

In an earlier article (JAVMA, Jan 15, 1994), the author outlined some of the first steps necessary in establishing a hospital safety program that will comply with current Occupational Safety and Health Administration (OSHA) guidelines. One of the main concerns of the OSHA guidelines is that there be written plans for managing hazardous materials, performing dangerous jobs, and dealing with other potential safety problems. In this article, the author discusses potentially hazardous situations commonly found in veterinary practices and provides details on how to minimize the risks associated with those situations and how to implement safety procedures that will comply with the OSHA guidelines.

European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety.

PubMed

Coppens, Patrick; da Silva, Miguel Fernandes; Pettman, Simon

2006-04-03

This article describes the legislation that is relevant in the marketing of functional foods in the European Union (EU), how this legislation was developed as well as some practical consequences for manufacturers, marketers and consumers. It also addresses some concrete examples of how the EU's safety requirements for food products have impacted a range of product categories. In the late nineties, research into functional ingredients was showing promising prospects for the use of such ingredients in foodstuffs. Due mainly to safety concerns, these new scientific developments were accompanied by an urgent call for legislation. The European Commission 2000 White Paper on Food Safety announced some 80 proposals for new and improved legislation in this field. Among others, it foresaw the establishment of a General Food Law Regulation, laying down the principles of food law and the creation of an independent Food Authority endowed with the task of giving scientific advice on issues based upon scientific risk assessment with clearly separated responsibilities for risk assessment, risk management and risk communication. Since then, more than 90% of the White Paper proposals have been implemented. However, there is not, as such, a regulatory framework for 'functional foods' or 'nutraceuticals' in EU Food Law. The rules to be applied are numerous and depend on the nature of the foodstuff. The rules of the general food law Regulation are applicable to all foods. In addition, legislation on dietetic foods, on food supplements or on novel foods may also be applicable to functional foods depending on the nature of the product and on their use. Finally, the two proposals on nutrition and health claims and on the addition of vitamins and minerals and other substances to foods, which are currently in the legislative process, will also be an important factor in the future marketing of 'nutraceuticals' in Europe. The cornerstone of EU legislation on food products, including functional foods and nutraceuticals is 'safety'. Decisions on the safety-basis of legislation are based on risk analysis, in which scientific risk assessment is performed by the European Food Safety Authority and risk management is performed by the European Commission, the Member States, and in case of legislation, together with the European Parliament. In the risk management phase, both the precautionary principle and other legitimate factors may be considered in choosing the best way of dealing with an issue. Due to the numerous pieces of legislation applying and to the different procedures to be followed, the process of having 'functional foods' ready for the market is certainly a costly and time-consuming task. However, it may also be clearly worth it in terms of market success and improved consumer health.

Findings From the National Machine Guarding Program

PubMed Central

Parker, David L.; Yamin, Samuel; Xi, Min; Gordon, Robert; Most, Ivan; Stanley, Rod

2017-01-01

Objectives: This manuscript assesses safety climate data from the National Machine Guarding Program (NMGP)—a nationwide intervention to improve machine safety. Methods: Baseline safety climate surveys were completed by 2161 employees and 341 owners or managers at 115 businesses. A separate onsite audit of safety management practices and machine guarding equipment was conducted at each business. Results: Safety climate measures were not correlated with machine guarding or safety management practices. The presence of a safety committee was correlated with higher scores on the safety management audit when contrasted with those without one. Conclusions: The presence of a safety committee is easily assessed and provides a basis on which to make recommendations with regard to how it functions. Measures of safety climate fail to provide actionable information. Future research on small manufacturing firms should emphasize the presence of an employee-management safety committee. PMID:28930801

TWRS authorization basis configuration control summary

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mendoza, D.P.

This document was developed to define the Authorization Basis management functional requirements for configuration control, to evaluate the management control systems currently in place, and identify any additional controls that may be required until the TWRS [Tank Waste Remediation System] Configuration Management system is fully in place.

OSHA Laboratory Standard: Driving Force for Laboratory Safety!

ERIC Educational Resources Information Center

Roy, Kenneth R.

2000-01-01

Discusses the Occupational Safety and Health Administration's (OSHA's) Laboratory Safety Standards as the major driving force in establishing and maintaining a safe working environment for teachers and students. (Author)

[Study on "multi-dimensional structure and process dynamics quality control system" of Danshen infusion solution based on component structure theory].

PubMed

Feng, Liang; Zhang, Ming-Hua; Gu, Jun-Fei; Wang, Gui-You; Zhao, Zi-Yu; Jia, Xiao-Bin

2013-11-01

As traditional Chinese medicine (TCM) preparation products feature complex compounds and multiple preparation processes, the implementation of quality control in line with the characteristics of TCM preparation products provides a firm guarantee for the clinical efficacy and safety of TCM preparation products. Danshen infusion solution is a preparation commonly used in clinic, but its quality control is restricted to indexes of finished products, which can not guarantee its inherent quality. Our study group has proposed "multi-dimensional structure and process dynamics quality control system" on the basis of "component structure theory", for the purpose of controlling the quality of Danshen infusion solution at multiple levels and in multiple links from the efficacy-related material basis, the safety-related material basis, the characteristics of dosage form to the preparation process. This article, we bring forth new ideas and models to the quality control of TCM preparation products.

77 FR 17504 - Agency Information Collection Activities: Proposed Collection; Comments Requested: Notification...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-26

...: Notification to Fire Safety Authority of Storage of Explosive Materials. (3) Agency form number, if any, and... provided both orally and in writing to the authority having jurisdiction for fire safety in the locality in...] Agency Information Collection Activities: Proposed Collection; Comments Requested: Notification to Fire...

14 CFR Special Federal Aviation... - Robinson R-22/R-44 Special Training and Experience Requirements

Code of Federal Regulations, 2010 CFR

2010-01-01

..., may obtain an endorsement from an FAA aviation safety inspector in lieu of completing the awareness... authorized by endorsement from an FAA aviation safety inspector or authorized designated examiner that the... Experience Requirements Federal Special Federal Aviation Regulation No. 73 Aeronautics and Space FEDERAL...

33 CFR 96.490 - What further obligations exist for an organization if the Coast Guard terminates its authorization?

Code of Federal Regulations, 2010 CFR

2010-07-01

... and Navigable Waters COAST GUARD, DEPARTMENT OF HOMELAND SECURITY VESSEL OPERATING REGULATIONS RULES FOR THE SAFE OPERATION OF VESSELS AND SAFETY MANAGEMENT SYSTEMS Authorization of Recognized... companies and vessels must do to have their safety management systems transferred to another organization...

77 FR 64450 - Hazardous Materials: Incorporation of Certain Special Permits and Competent Authorities Into...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-22

... varies from the regulations provided an equivalent level of safety is maintained. An approval is a... materials regulations (HMR) provided an equivalent level of safety is maintained. A competent authority (CA... drums. Transportation of spent bleaching earth. Requalification of non-DOT specification cylinders in...

School Bus Fleet Safety: Planning and Development.

ERIC Educational Resources Information Center

Bieber, Robert M.

1984-01-01

To ensure worker safety, fleet safety managers need professional staffs, good access to top management, and sufficient authority to discharge their duties. Safety programs should include careful driver hiring; training, including orientation, testing, and practice; comprehensive accident reporting; and cooperative compliance programs with…

The development of a methodology for transportation safety planning in Virginia.

DOT National Transportation Integrated Search

1980-01-01

Senate Bill 85, passed by the General Assembly in 1978, renamed the former Highway Safety Division of Virginia the Department of Transportation Safety (VDTS) and authorized it to assume control over safety activities in all modes of transportation. T...

Developing a smartphone based warning system application to enhance the safety at work zones : final report.

DOT National Transportation Integrated Search

2016-05-01

Collisions in the work zone have always been a contributing factor to compromising safety on urban roadways. The National Highway Traffic Safety Administration (NHTSA) and the State Transportation Authorities have implemented many safety countermeasu...

75 FR 77675 - AREVA NP, Inc.; Confirmatory Order (Effective Immediately)

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-13

..., appropriate notification of regulatory authorities, safety culture and safety conscious work environment...., outside the global AREVA organization), safety culture assessment in accordance with an accepted nuclear....e., outside the global AREVA organization), safety culture assessment in accordance with an accepted...

75 FR 38716 - Safety Zone; Vietnam Veterans of America Fireworks Display, Brookings, OR

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-06

...-AA00 Safety Zone; Vietnam Veterans of America Fireworks Display, Brookings, OR AGENCY: Coast Guard, DHS... waters of Pelican Bay and the Pacific Ocean for the Vietnam Veterans of America Fireworks Display near... period will have passed. Basis and Purpose The Vietnam Veterans of America are holding a fireworks...

Developing a Model on Improving Maritime English Training for Maritime Transportation Safety

ERIC Educational Resources Information Center

Yercan, Funda; Fricke, Donna; Stone, Laurie

2005-01-01

Maritime services form an integral part of what regulatory agencies requires for the safe navigation and operation of vessels. Therefore, the maritime industry's compliance with governmental regulations and international protocols has been essential for maritime safety management. As a basis to this aspect, the preparation of maritime students as…

75 FR 37720 - Safety Zone; New Bern Air Show, Neuse River, NC

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... would be contrary to public interest, since immediate action is needed to ensure the safety of human life and property from the hazards associated with air show operations. Basis and Purpose Coast Guard... effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g...

76 FR 38568 - Safety Zone; Bullhead City Regatta, Bullhead City, AZ

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-01

...-AA00 Safety Zone; Bullhead City Regatta, Bullhead City, AZ AGENCY: Coast Guard, DHS. ACTION: Temporary... the Colorado River in Bullhead City, Arizona for the Bullhead City Regatta on August 13, 2011. This... the waterway during the Regatta event. Basis and Purpose The City of Bullhead is sponsoring the...

Safety recommendation component of mobile information assistant of the tourist

NASA Astrophysics Data System (ADS)

Savchuk, Valeriya V.; Kunanec, Natalia E.; Pasichnyk, Volodymyr V.; Popiel, Piotr; Weryńska-Bieniasz, RóŻa; Kashaganova, Gulzhamal; Kalizhanova, Aliya

2017-08-01

The goal of article is to introduce and justify the need for the safety system components of Mobile Information of the tourist (MIAT). One of the objectives of the system is to determine the level of risk in a particular tourist destination on the basis of available information in the knowledge base.

Safety in the Air: A Curriculum About Flight and Air Traffic Control Designed for Middle School Students

DOT National Transportation Integrated Search

1983-01-01

Safety in the Air is designed to be taught as a six-lesson unit to middle school : students, preferably sixth, seventh, or eighth grade level. : This curriculum is designed first of all to familiarize both the teacher and the : student with some basi...

47 CFR 90.528 - Public safety broadband license.

Code of Federal Regulations, 2012 CFR

2012-10-01

... basis, a full financial accounting to the Commission, in a format to be set forth in the Network Sharing... Commission, with a copy to the Chiefs of the Wireless Telecommunications and the Public Safety and Homeland Security Bureaus. [72 FR 48860, Aug. 24, 2007, as amended at 74 FR 8879, Feb. 27, 2009] ...

47 CFR 90.20 - Public Safety Pool.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 47 Telecommunication 5 2014-10-01 2014-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

47 CFR 90.20 - Public Safety Pool.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 47 Telecommunication 5 2013-10-01 2013-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

47 CFR 90.20 - Public Safety Pool.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 47 Telecommunication 5 2012-10-01 2012-10-01 false Public Safety Pool. 90.20 Section 90.20 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES PRIVATE LAND MOBILE RADIO SERVICES Public Safety Radio Pool § 90.20 Public Safety Pool. (a) Eligibility. The following are eligible to hold authorizations in...

Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.

ERIC Educational Resources Information Center

Renfrew, Malcolm M., Ed.; Palladino, George F.

1980-01-01

Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)

77 FR 21782 - International Conference on Harmonisation; Draft Guidance for Industry on E2C(R2) Periodic...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-11

... electronic submission of individual case safety reports to regulatory authorities, automated data mining... Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (E2C guidance) and ``Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs'' (addendum...

FY2017 Updates to the SAS4A/SASSYS-1 Safety Analysis Code

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fanning, T. H.

The SAS4A/SASSYS-1 safety analysis software is used to perform deterministic analysis of anticipated events as well as design-basis and beyond-design-basis accidents for advanced fast reactors. It plays a central role in the analysis of U.S. DOE conceptual designs, proposed test and demonstration reactors, and in domestic and international collaborations. This report summarizes the code development activities that have taken place during FY2017. Extensions to the void and cladding reactivity feedback models have been implemented, and Control System capabilities have been improved through a new virtual data acquisition system for plant state variables and an additional Block Signal for a variablemore » lag compensator to represent reactivity feedback for novel shutdown devices. Current code development and maintenance needs are also summarized in three key areas: software quality assurance, modeling improvements, and maintenance of related tools. With ongoing support, SAS4A/SASSYS-1 can continue to fulfill its growing role in fast reactor safety analysis and help solidify DOE’s leadership role in fast reactor safety both domestically and in international collaborations.« less

Teen worker safety training: methods used, lessons taught, and time spent.

PubMed

Zierold, Kristina M

2015-05-01

Safety training is strongly endorsed as one way to prevent teens from performing dangerous tasks at work. The objective of this mixed methods study was to characterize the safety training that teenagers receive on the job. From 2010 through 2012, focus groups and a cross-sectional survey were conducted with working teens. The top methods of safety training reported were safety videos (42 percent) and safety lectures (25 percent). The top lessons reported by teens were "how to do my job" and "ways to spot hazards." Males, who were more likely to do dangerous tasks, received less safety training than females. Although most teens are getting safety training, it is inadequate. Lessons addressing safety behaviors are missing, training methods used are minimal, and the time spent is insignificant. More research is needed to understand what training methods and lessons should be used, and the appropriate safety training length for effectively preventing injury in working teens. In addition, more research evaluating the impact of high-quality safety training compared to poor safety training is needed to determine the best training programs for teens. © The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 42 Public Health 1 2012-10-01 2012-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 42 Public Health 1 2011-10-01 2011-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 42 Public Health 1 2013-10-01 2013-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 42 Public Health 1 2014-10-01 2014-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

42 CFR 3.402 - Basis for a civil money penalty.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Basis for a civil money penalty. 3.402 Section 3... money penalty. (a) General rule. A person who discloses identifiable patient safety work product in knowing or reckless violation of the confidentiality provisions shall be subject to a civil money penalty...

9 CFR 307.6 - Basis of billing for overtime and holiday services.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Basis of billing for overtime and holiday services. 307.6 Section 307.6 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND TERMINOLOGY; MANDATORY MEAT AND POULTRY PRODUCTS INSPECTION...

Collapse Mechanisms Of Masonry Structures

NASA Astrophysics Data System (ADS)

Zuccaro, G.; Rauci, M.

2008-07-01

The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of one of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.

Collapse Mechanisms Of Masonry Structures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zuccaro, G.; Rauci, M.

2008-07-08

The paper outlines a possible approach to typology recognition, safety check analyses and/or damage measuring taking advantage by a multimedia tool (MEDEA), tracing a guided procedure useful for seismic safety check evaluation and post event macroseismic assessment. A list of the possible collapse mechanisms observed in the post event surveys on masonry structures and a complete abacus of the damages are provided in MEDEA. In this tool a possible combination between a set of damage typologies and each collapse mechanism is supplied in order to improve the homogeneity of the damages interpretation. On the other hand recent researches of onemore » of the author have selected a number of possible typological vulnerability factors of masonry buildings, these are listed in the paper and combined with potential collapse mechanisms to be activated under seismic excitation. The procedure takes place from simple structural behavior models, derived from the Umbria-Marche earthquake observations, and tested after the San Giuliano di Puglia event; it provides the basis either for safety check analyses of the existing buildings or for post-event structural safety assessment and economic damage evaluation. In the paper taking advantage of MEDEA mechanisms analysis, mainly developed for the post event safety check surveyors training, a simple logic path is traced in order to approach the evaluation of the masonry building safety check. The procedure starts from the identification of the typological vulnerability factors to derive the potential collapse mechanisms and their collapse multipliers and finally addresses the simplest and cheapest strengthening techniques to reduce the original vulnerability. The procedure has been introduced in the Guide Lines of the Regione Campania for the professionals in charge of the safety check analyses and the buildings strengthening in application of the national mitigation campaign introduced by the Ordinance of the Central Government n. 3362/03. The main cases of out of plane mechanisms are analyzed and a possible innovative theory for masonry building vulnerability assessment, based on limit state analyses, is outlined. The paper report the first step of a research granted by the Department of the Civil Protection to Reluis within the research program of Line 10.« less

Electronic nicotine delivery systems: a research agenda.

PubMed

Etter, Jean-François; Bullen, Chris; Flouris, Andreas D; Laugesen, Murray; Eissenberg, Thomas

2011-05-01

Electronic nicotine delivery systems (ENDS, also called electronic cigarettes or e-cigarettes) are marketed to deliver nicotine and sometimes other substances by inhalation. Some tobacco smokers report that they used ENDS as a smoking cessation aid. Whether sold as tobacco products or drug delivery devices, these products need to be regulated, and thus far, across countries and states, there has been a wide range of regulatory responses ranging from no regulation to complete bans. The empirical basis for these regulatory decisions is uncertain, and more research on ENDS must be conducted in order to ensure that the decisions of regulators, health care providers and consumers are based on science. However, there is a dearth of scientific research on these products, including safety, abuse liability and efficacy for smoking cessation. The authors, who cover a broad range of scientific expertise, from basic science to public health, suggest research priorities for non-clinical, clinical and public health studies. They conclude that the first priority is to characterize the safety profile of these products, including in long-term users. If these products are demonstrated to be safe, their efficacy as smoking cessation aids should then be tested in appropriately designed trials. Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health. Potentially, this research effort, contributing to the safety and efficacy of new smoking cessation devices and to the withdrawal of dangerous products, could save many lives.

Electronic nicotine delivery systems: a research agenda

PubMed Central

Etter, Jean-François; Bullen, Chris; Flouris, Andreas D; Laugesen, Murray; Eissenberg, Thomas

2011-01-01

Electronic nicotine delivery systems (ENDS, also called electronic cigarettes or e-cigarettes) are marketed to deliver nicotine and sometimes other substances by inhalation. Some tobacco smokers report that they used ENDS as a smoking cessation aid. Whether sold as tobacco products or drug delivery devices, these products need to be regulated, and thus far, across countries and states, there has been a wide range of regulatory responses ranging from no regulation to complete bans. The empirical basis for these regulatory decisions is uncertain, and more research on ENDS must be conducted in order to ensure that the decisions of regulators, health care providers and consumers are based on science. However, there is a dearth of scientific research on these products, including safety, abuse liability and efficacy for smoking cessation. The authors, who cover a broad range of scientific expertise, from basic science to public health, suggest research priorities for non-clinical, clinical and public health studies. They conclude that the first priority is to characterize the safety profile of these products, including in long-term users. If these products are demonstrated to be safe, their efficacy as smoking cessation aids should then be tested in appropriately designed trials. Until these studies are conducted, continued marketing constitutes an uncontrolled experiment and the primary outcome measure, poorly assessed, is user health. Potentially, this research effort, contributing to the safety and efficacy of new smoking cessation devices and to the withdrawal of dangerous products, could save many lives. PMID:21415064

A Survey of Workplace Violence Across 65 U.S. Emergency Departments

PubMed Central

Kansagra, Susan M.; Rao, Sowmya R.; Sullivan, Ashley F.; Gordon, James A.; Magid, David J.; Kaushal, Rainu; Camargo, Carlos A.; Blumenthal, David

2012-01-01

Objectives Workplace violence is a concerning issue. Healthcare workers represent a significant portion of the victims, especially those who work in the emergency department (ED). The objective of this study was to examine ED workplace violence and staff perceptions of physical safety. Methods Data were obtained from the National Emergency Department Safety Study (NEDSS), which surveyed staff across 69 U.S. EDs including physicians, residents, nurses, nurse practitioners, and physician assistants. The authors also conducted surveys of key informants (one from each site) including ED chairs, medical directors, nurse managers, and administrators. The main outcome measures included physical attacks against staff, frequency of guns or knives in the ED, and staff perceptions of physical safety. Results A total of 5,695 staff surveys were distributed, and 3,518 surveys from 65 sites were included in the final analysis. One-fourth of surveyed ED staff reported feeling safe sometimes, rarely, or never. Key informants at the sampled EDs reported a total of 3,461 physical attacks (median of 11 attacks per ED) over the 5-year period. Key informants at 20% of EDs reported that guns or knives were brought to the ED on a daily or weekly basis. In multivariate analysis, nurses were less likely to feel safe “most of the time” or “always” when compared to other surveyed staff. Conclusions This study showed that violence and weapons in the ED are common, and nurses were less likely to feel safe than other ED staff. PMID:18976337

An examination of the impact of five grade crossing safety factors on driver decision making

DOT National Transportation Integrated Search

2014-04-01

The authors applied signal detection theory to model the impact : of five grade-crossing safety factors to understand their impact : on driver decision making. The safety factors were improving : commercial motor vehicle (CMV) driver safety through f...

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nicholson, J. C.

Performance metrics for evaluating commercial fixatives are often not readily available for important parameters that must be considered per the facility safety basis and the facility Basis for Interim Operations (BIO). One such parameter is the behavior of such materials in varied, “non-ideal” conditions where ideal is defined as 75 °F, 40% RH. Coupled with the inherent flammable nature of the fixative materials that can act to propagate flame along surfaces that are otherwise fireproof (concrete, sheet metal), much is left unknown when considering the safety basis implications for introducing these materials into nuclear facilities. Through SRNL’s efforts, three (3)more » fixatives, one (1) decontamination gel, and six (6) intumescent coatings were examined for their responses to environmental conditions to determine whether these materials were impervious to non-nominal temperatures and humidities that may be found in nuclear facilities. Characteristics that were examined included set-to-touch time, dust free time, and adhesion testing of the fully cured compounds. Of these ten materials, three were two-part epoxy materials while the other seven consisted of only one constituent. The results show that the epoxies tested are unable to cure in sub-freezing temperatures, with the low temperatures inhibiting crosslinking to a very significant degree. These efforts show significant inhibiting of performance for non-nominal environmental conditions, something that must be addressed both in the decision process for a fixative material to apply and per the safety basis to ensure the accurate flammability and material at risk is calculated.« less

Training in quality and safety: the current landscape.

PubMed

Karasick, Andrew S; Nash, David B

2015-01-01

The current US health care environment requires and encourages the development and implementation of training programs focusing on quality improvement and patient safety. This article offers a new resource that details the basic characteristics of such physician-inclusive training programs. Specifically, program type, objectives, eligibility, cost, training length, and modality are aggregated and displayed to provide health care professionals with a new tool to facilitate individual education in the field of quality improvement and patient safety. © The Author(s) 2014.

Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics.

PubMed

Fiume, Monice M; Heldreth, Bart; Bergfeld, Wilma F; Belsito, Donald V; Hill, Ronald A; Klaassen, Curtis D; Liebler, Daniel C; Marks, James G; Shank, Ronald C; Slaga, Thomas J; Snyder, Paul W; Andersen, F Alan

2016-07-01

The Cosmetic Ingredient Review Expert Panel assessed the safety of 34 microbial polysaccharide gums for use in cosmetics, finding that these ingredients are safe in cosmetic formulations in the present practices of use and concentration. The microbial polysaccharide gums named in this report have a variety of reported functions in cosmetics, including emulsion stabilizer, film former, binder, viscosity-increasing agent, and skin-conditioning agent. The Panel reviewed available animal and clinical data in making its determination of safety. © The Author(s) 2016.

Cognitive decision errors and organization vulnerabilities in nuclear power plant safety management: Modeling using the TOGA meta-theory framework

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cappelli, M.; Gadomski, A. M.; Sepiellis, M.

In the field of nuclear power plant (NPP) safety modeling, the perception of the role of socio-cognitive engineering (SCE) is continuously increasing. Today, the focus is especially on the identification of human and organization decisional errors caused by operators and managers under high-risk conditions, as evident by analyzing reports on nuclear incidents occurred in the past. At present, the engineering and social safety requirements need to enlarge their domain of interest in such a way to include all possible losses generating events that could be the consequences of an abnormal state of a NPP. Socio-cognitive modeling of Integrated Nuclear Safetymore » Management (INSM) using the TOGA meta-theory has been discussed during the ICCAP 2011 Conference. In this paper, more detailed aspects of the cognitive decision-making and its possible human errors and organizational vulnerability are presented. The formal TOGA-based network model for cognitive decision-making enables to indicate and analyze nodes and arcs in which plant operators and managers errors may appear. The TOGA's multi-level IPK (Information, Preferences, Knowledge) model of abstract intelligent agents (AIAs) is applied. In the NPP context, super-safety approach is also discussed, by taking under consideration unexpected events and managing them from a systemic perspective. As the nature of human errors depends on the specific properties of the decision-maker and the decisional context of operation, a classification of decision-making using IPK is suggested. Several types of initial situations of decision-making useful for the diagnosis of NPP operators and managers errors are considered. The developed models can be used as a basis for applications to NPP educational or engineering simulators to be used for training the NPP executive staff. (authors)« less

One-year safety and efficacy study of bilastine treatment in Japanese patients with chronic spontaneous urticaria or pruritus associated with skin diseases.

PubMed

Yagami, Akiko; Furue, Masutaka; Togawa, Michinori; Saito, Akihiro; Hide, Michihiro

2017-04-01

A number of second-generation non-sedating antihistamines are used in clinical practices over the world. However, long-term safety and efficacy have not been proved high level evidence based medicine. We have performed an open-label, multicenter, phase III study to evaluate the long-term safety and efficacy of bilastine, a novel non-sedating H 1 -antihistamine for patients with chronic spontaneous urticaria (CSU) or pruritus associated with skin diseases (trial registration no. JapicCTI-142528). Patients aged 18-74 years were treated with bilastine 20 mg once daily for up to 52 weeks. Safety and tolerability were assessed on the basis of adverse events (AE), bilastine-related AE, laboratory tests and vital signs. Efficacy was assessed based on rash score, itch score, overall improvement and quality of life. One hundred and ninety-eight patients enrolled, 122 of whom (61.6%) completed the 52-week treatment period. AE were reported in 64.5% and bilastine-related AE in 2.5% of patients throughout the 52-week treatment period. All AE were mild to moderate in severity. AE associated with the nervous system occurred in 10 patients (5.1%) including seven patients (3.6%) with headache. Somnolence reported in two of these patients (1.0%) was related to bilastine. All efficacy variables improved during treatment with bilastine. In conclusion, long-term treatment with bilastine 20 mg once daily for 52 weeks is safe and well tolerated in Japanese patients with CSU or pruritus associated with skin diseases. Bilastine improved disease symptoms of both conditions early in treatment, and the efficacy was maintained throughout the treatment. © 2016 The Authors. The Journal of Dermatology published by John Wiley & Sons Australia, Ltd on behalf of Japanese Dermatological Association.

Constructing a safety and security system by medical applications of a fast face recognition optical parallel correlator

NASA Astrophysics Data System (ADS)

Watanabe, Eriko; Ishikawa, Mami; Ohta, Maiko; Murakami, Yasuo; Kodate, Kashiko

2006-01-01

Medical errors and patient safety have always received a great deal of attention, as they can be critically life-threatening and significant matters. Hospitals and medical personnel are trying their utmost to avoid these errors. Currently in the medical field, patients' record is identified through their PIN numbers and ID cards. However, for patients who cannot speak or move, or who suffer from memory disturbances, alternative methods would be more desirable, and necessary in some cases. The authors previously proposed and fabricated a specially-designed correlator called FARCO (Fast Face Recognition Optical Correlator) based on the Vanderlugt Correlator1, which operates at the speed of 1000 faces/s 2,3,4. Combined with high-speed display devices, the four-channel processing could achieve such high operational speed as 4000 faces/s. Running trial experiments on a 1-to-N identification basis using the optical parallel correlator, we succeeded in acquiring low error rates of 1 % FMR and 2.3 % FNMR. In this paper, we propose a robust face recognition system using the FARCO for focusing on the safety and security of the medical field. We apply our face recognition system to registration of inpatients, in particular children and infants, before and after medical treatments or operations. The proposed system has recorded a higher recognition rate by multiplexing both input and database facial images from moving images. The system was also tested and evaluated for further practical use, leaving excellent results. Hence, our face recognition system could function effectively as an integral part of medical system, meeting these essential requirements of safety, security and privacy.

Probabilistic design of fibre concrete structures

NASA Astrophysics Data System (ADS)

Pukl, R.; Novák, D.; Sajdlová, T.; Lehký, D.; Červenka, J.; Červenka, V.

2017-09-01

Advanced computer simulation is recently well-established methodology for evaluation of resistance of concrete engineering structures. The nonlinear finite element analysis enables to realistically predict structural damage, peak load, failure, post-peak response, development of cracks in concrete, yielding of reinforcement, concrete crushing or shear failure. The nonlinear material models can cover various types of concrete and reinforced concrete: ordinary concrete, plain or reinforced, without or with prestressing, fibre concrete, (ultra) high performance concrete, lightweight concrete, etc. Advanced material models taking into account fibre concrete properties such as shape of tensile softening branch, high toughness and ductility are described in the paper. Since the variability of the fibre concrete material properties is rather high, the probabilistic analysis seems to be the most appropriate format for structural design and evaluation of structural performance, reliability and safety. The presented combination of the nonlinear analysis with advanced probabilistic methods allows evaluation of structural safety characterized by failure probability or by reliability index respectively. Authors offer a methodology and computer tools for realistic safety assessment of concrete structures; the utilized approach is based on randomization of the nonlinear finite element analysis of the structural model. Uncertainty of the material properties or their randomness obtained from material tests are accounted in the random distribution. Furthermore, degradation of the reinforced concrete materials such as carbonation of concrete, corrosion of reinforcement, etc. can be accounted in order to analyze life-cycle structural performance and to enable prediction of the structural reliability and safety in time development. The results can serve as a rational basis for design of fibre concrete engineering structures based on advanced nonlinear computer analysis. The presented methodology is illustrated on results from two probabilistic studies with different types of concrete structures related to practical applications and made from various materials (with the parameters obtained from real material tests).

Acute And Long-Term Bioeffects And Lamp Safety

NASA Astrophysics Data System (ADS)

Andersen, F. Alan

1980-10-01

Knowledge of both acute and chronic biological effects is currently used to evaluate lamp safety. In some cases, a quantitative basis for avoiding exposures greater than a certain value can be stated. In other cases, however, only a qualitative estimate of the hazard is available. In a discussion that uses mercury vapor lamps, tanning booths, and sodium vapor lamps as examples, the interplay between the two types of data leading to an evaluation of lamp safety is described.

State safety oversight program : audit of the tri-state oversight committee and the Washington metropolitan area transit authority, final audit report, March 4, 2010.

DOT National Transportation Integrated Search

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...

Integration into Civil Airspace Airworthiness and Safety

DTIC Science & Technology

2003-09-02

Integration into Civil Airspace Airworthiness and Safety 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER......into civil airspace lPurpose : n to explore and propose French process and means for integrating UAV into civil airspace. lMethod based on : n first

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2013 CFR

2013-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2010 CFR

2010-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2012 CFR

2012-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2011 CFR

2011-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 451.13 - Action by approval authority-approval by design type.

Code of Federal Regulations, 2014 CFR

2014-10-01

...) COAST GUARD, DEPARTMENT OF HOMELAND SECURITY SAFETY APPROVAL OF CARGO CONTAINERS TESTING AND APPROVAL OF CONTAINERS Approval of New Containers § 451.13 Action by approval authority-approval by design type. (a) The... of safety approval plates to the containers. Absence of individual inspections will not relieve the...

49 CFR 1.95 - Delegations to the National Highway Traffic Safety Administrator.

Code of Federal Regulations, 2014 CFR

2014-10-01

...-related aspects of pedestrian and bicycle safety. (e) Carry out the functions and exercise the authority...) Carry out the functions and exercise the authority vested in the Secretary for the following provisions of Title 23, U.S.C. (with respect to matters within the primary responsibility of the National...

Anger and Pedagogy

ERIC Educational Resources Information Center

Mayo, Cris

2016-01-01

In his discussion of safety on campus, Eamonn Callan (2016) suggests a way to distinguish between two sorts of safety: "dignity safety" and "intellectual safety." As much as this author has some concerns that student activists should think more about pedagogy, she is not sure that "dignity" is the best approach to…

75 FR 59658 - Airworthiness Directives; SOCATA Model TBM 700 Airplanes

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

... drive assemblies. The European Aviation Safety Agency (EASA), which is the Technical Agent for the... United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section... Part 39 Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety. The Proposed...

[Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)].

PubMed

Eckhardt, K; Cremer-Schaeffer, P; König, J; Paeschke, N

2005-02-01

With the 12th Law Amending the German Drug Law and the Ordinance on GCP (GCPV), new legal provisions for clinical trials came into force in August 2004. These include specific definitions and differentiated reporting obligations affecting investigators, sponsors, authorities and ethics committees concerning pharmacovigilance in clinical trials. The definitions according to section sign3 (6-8) GCP-V make clear that these provisions focus on those adverse events and adverse drug reactions, which are related to investigational medicinal products. In the GCP-V for the first time legally binding provisions for investigators are laid down defining obligations to report all serious adverse events to the sponsor. The sponsor of clinical trials plays a decisive role concerning the evaluation, documentation and reporting to the competent higher authorities, ethics committees and investigators involved in the clinical trial. In the GCP-V different time limits concerning the reporting for sponsors are laid down. The requirements concerning expedited reporting focus on suspected unexpected serious adverse reactions (SUSARs), i. e. those adverse serious reactions, which are not described in the information on the investigational medicinal product. The time limit for reporting SUSARs leading to death or life-threatening SUSARs is 7 days, while for other SUSARs the time limit is 15 days. Besides the responsibilities on expedited reporting the sponsor has to submit a line listing of all serious adverse reactions which occurred during the clinical trial and a report on the safety of the trial subjects on an annual basis or on request. On the European level the harmonisation concerning the provisions on pharmacovigilance in clinical trials according to the Directive 2001/20/EC and the Eudravigilance database should contribute to reach a faster and more effective exchange of safety information related to clinical trials between the different competent authorities of the EU member states.

The Strategy for Safety: Preventing Crises through Safety Audits

ERIC Educational Resources Information Center

Schwartz, Sara Goldsmith

2013-01-01

In this article the author demonstrates the importance of school safety audits and describes what schools should focus on in a safety audit. Ultimately, each school should determine its own safety audit strategy based on its unique circumstances, including the type of community within which it is located, the age of the students it serves, and the…

Nuclear Safety Information Center, Its Products and Services

ERIC Educational Resources Information Center

Buchanan, J. R.

1970-01-01

The Nuclear Safety Information Center (NSIC) serves as a focal point for the collection, analysis and dissemination of information related to safety problems encountered in the design, analysis, and operation of nuclear facilities. (Author/AB)

Alcohol/safety public information materials catalog. Number 5

DOT National Transportation Integrated Search

1981-06-01

Author's abstract: The Alcohol/Safety Public Information Materials Catalog is designed for use by persons developing public information programs on alcohol and highway safety. It lists materials produced for campaigns along with journal articles and ...

A prioritization of generic safety issues. Supplement 19, Revision insertion instructions

DOE Office of Scientific and Technical Information (OSTI.GOV)

None

1995-11-01

The report presents the safety priority ranking for generic safety issues related to nuclear power plants. The purpose of these rankings is to assist in the timely and efficient allocation of NRC resources for the resolution of those safety issues that have a significant potential for reducing risk. The safety priority rankings are HIGH, MEDIUM, LOW, and DROP, and have been assigned on the basis of risk significance estimates, the ratio of risk to costs and other impacts estimated to result if resolution of the safety issues were implemented, and the consideration of uncertainties and other quantitative or qualitative factors.more » To the extent practical, estimates are quantitative. This document provides revisions and amendments to the report.« less

NSR&D Program Fiscal Year 2015 Funded Research Stochastic Modeling of Radioactive Material Releases Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andrus, Jason P.; Pope, Chad; Toston, Mary

2016-12-01

Nonreactor nuclear facilities operating under the approval authority of the U.S. Department of Energy use unmitigated hazard evaluations to determine if potential radiological doses associated with design basis events challenge or exceed dose evaluation guidelines. Unmitigated design basis events that sufficiently challenge dose evaluation guidelines or exceed the guidelines for members of the public or workers, merit selection of safety structures, systems, or components or other controls to prevent or mitigate the hazard. Idaho State University, in collaboration with Idaho National Laboratory, has developed a portable and simple to use software application called SODA (Stochastic Objective Decision-Aide) that stochastically calculatesmore » the radiation dose distribution associated with hypothetical radiological material release scenarios. Rather than producing a point estimate of the dose, SODA produces a dose distribution result to allow a deeper understanding of the dose potential. SODA allows users to select the distribution type and parameter values for all of the input variables used to perform the dose calculation. Users can also specify custom distributions through a user defined distribution option. SODA then randomly samples each distribution input variable and calculates the overall resulting dose distribution. In cases where an input variable distribution is unknown, a traditional single point value can be used. SODA, developed using the MATLAB coding framework, has a graphical user interface and can be installed on both Windows and Mac computers. SODA is a standalone software application and does not require MATLAB to function. SODA provides improved risk understanding leading to better informed decision making associated with establishing nuclear facility material-at-risk limits and safety structure, system, or component selection. It is important to note that SODA does not replace or compete with codes such as MACCS or RSAC; rather it is viewed as an easy to use supplemental tool to help improve risk understanding and support better informed decisions. The SODA development project was funded through a grant from the DOE Nuclear Safety Research and Development Program.« less

NSR&D Program Fiscal Year 2015 Funded Research Stochastic Modeling of Radioactive Material Releases Final Report

DOE Office of Scientific and Technical Information (OSTI.GOV)

Andrus, Jason P.; Pope, Chad; Toston, Mary

Nonreactor nuclear facilities operating under the approval authority of the U.S. Department of Energy use unmitigated hazard evaluations to determine if potential radiological doses associated with design basis events challenge or exceed dose evaluation guidelines. Unmitigated design basis events that sufficiently challenge dose evaluation guidelines or exceed the guidelines for members of the public or workers, merit selection of safety structures, systems, or components or other controls to prevent or mitigate the hazard. Idaho State University, in collaboration with Idaho National Laboratory, has developed a portable and simple to use software application called SODA (Stochastic Objective Decision-Aide) that stochastically calculatesmore » the radiation dose distribution associated with hypothetical radiological material release scenarios. Rather than producing a point estimate of the dose, SODA produces a dose distribution result to allow a deeper understanding of the dose potential. SODA allows users to select the distribution type and parameter values for all of the input variables used to perform the dose calculation. Users can also specify custom distributions through a user defined distribution option. SODA then randomly samples each distribution input variable and calculates the overall resulting dose distribution. In cases where an input variable distribution is unknown, a traditional single point value can be used. SODA, developed using the MATLAB coding framework, has a graphical user interface and can be installed on both Windows and Mac computers. SODA is a standalone software application and does not require MATLAB to function. SODA provides improved risk understanding leading to better informed decision making associated with establishing nuclear facility material-at-risk limits and safety structure, system, or component selection. It is important to note that SODA does not replace or compete with codes such as MACCS or RSAC; rather it is viewed as an easy to use supplemental tool to help improve risk understanding and support better informed decisions. The SODA development project was funded through a grant from the DOE Nuclear Safety Research and Development Program.« less

Unstoppable The Gap Between Public Safety and Traffic Safety in the Age of Driverless Cars

DTIC Science & Technology

2017-03-01

themselves, what will the increase in traffic safety cost society in terms of public safety? • What can public safety and homeland security...industry. Safer products are more marketable products, and companies that work with law enforcement for the benefit of public safety may have an...secondary public safety benefit of crime suppression. Reasonable suspicion to stop a vehicle would be an infrequent occurrence, and the legal authority

Description of basic mining legal principles.

PubMed

Schmidt, Reinhard

2014-01-01

The Federal Mining Act manages access, via the system of mining concessions, to areas free for mining natural resources that do not belong to the surface property and deposits' owner. These cover especially important natural resources for the economy, including coal, ore, salt, crude oil and natural gas, and also terrestrial heat. For mining operations there exist, however, the same decrees for natural resources in the property of the surface owners, which are predominantly higher-value industrial minerals such as roofing slate, basalt, quartz sand, and clays for the fireproofing industry. In the case of mining laws, administrative procedures such as issuing mining concessions, approving operating plans, and issuing permits or licenses to explore according to water rights or the Federal Immission Control Act, those authorities and departments in whose remit the projects fall are dealt with by the Mining Authority. This means that the Mining Authority is the only state point of contact for the applicant, essentially an "all-in-one" service as it will itself instigate any further participation procedures required. The classic licensing procedure of mining is the operations plan procedure, whereby the operator submits an operating plan to the Mining Authority, which then examines it to ensure it fulfills mandatory legal safety objectives. If necessary these safety objectives can be met during licensing of the operating plans by stipulating additional requirements, Depending on the subject and validity period there are overall operating plans having the widest possible remit with comprehensive participation by the authorities and basic operating plans that form the basis for every mining works. There are also special operating plans, which owing to the dynamics of mining, resolve matters that suddenly become necessary or when the basic operating plans as originally conceived were not relevant. The closing-down operating plan is the designated tool for closing down works and for the rehabilitation of the land; in the case of underground mining and mine boreholes an operating history must also be submitted. For those projects that have a significant effect on the environment, an obligatory overall operations plan with mining law project approval procedure and integrated Environmental Risk Assessment (UVP) are necessary. The point at which this is required is stipulated in the UVP-mining decree, for example if the mining area of an open-cast pit is more than 25 ha. Alongside the UVP, the procedure is also equipped with public participation and through its "concentrating effect" replaces further licensing procedures according to other laws. The Mining Authority combines supervision and licensing, which are usually inseparable due to the operations plan procedure, as well as aspects of occupational safety and of the protection of the environment. In view of this administrative concentration these should not be fragmented. The "all-in-one" service meets the requirements of a modern public-oriented administration, has only a few points of contact, and can therefore work efficiently.

California Guide for Pedestrian Safety Education. Volumes I-III.

ERIC Educational Resources Information Center

California State Dept. of Education, Sacramento.

This guide is designed to serve as the basis for a pedestrian safety education program for pupils in kindergarten through grade two. The basic printed materials for use in the program are provided in three volumes, each of which is intended for a different audience. Volume I, directed to school administrators and teachers, contains information for…

Study on Safety Monitoring System for Submarine Power Cable on the Basis of AIS and Radar Technology

NASA Astrophysics Data System (ADS)

Jie, Wang; Yao-Tian, Fan

Through analyzing the risks of submarine power cable, the highest risk to damage the cable identified is from ship. Based on concept of Vessel Traffic Management Information Systems, the three core sub-systems of safety monitoring system for submarine power cable were studied and described, also some suggestions were given.

78 FR 78362 - National Institute for Occupational Safety and Health Personal; Notice of public meeting in...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-26

... public commenter has spoken, whichever occurs first. ADDRESSES: First United Methodist Church, 53..., first served basis. The meeting will end at 8:30PM EST or after the last public commenter has spoken... Institute for Occupational Safety and Health Personal; Notice of public meeting in Endicott, New York AGENCY...

31 CFR 538.519 - Aircraft and maritime safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft and maritime safety. 538.519..., Authorizations, and Statements of Licensing Policy § 538.519 Aircraft and maritime safety. Specific licenses may... aircraft, and to ensure the safety of ocean-going maritime traffic in international waters. ...

31 CFR 560.528 - Aircraft safety.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

14 CFR 431.33 - Safety organization.

Code of Federal Regulations, 2010 CFR

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...

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-01-01

... the feed mill to the pork production site. Food Safety and Inspection Service (FSIS). The Food Safety... Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any individual employed by or acting as an agent on behalf of the Food Safety and...

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-01-01

... the feed mill to the pork production site. Food Safety and Inspection Service (FSIS). The Food Safety... Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any individual employed by or acting as an agent on behalf of the Food Safety and...

9 CFR 149.1 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-01-01

... the feed mill to the pork production site. Food Safety and Inspection Service (FSIS). The Food Safety... Administrator, Food Safety and Inspection Service, or any person authorized to act for the Administrator. FSIS program employee. Any individual employed by or acting as an agent on behalf of the Food Safety and...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 4 2011-10-01 2011-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 4 2014-10-01 2014-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 4 2012-10-01 2012-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

46 CFR 115.910 - Passenger Ship Safety Certificate.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 4 2013-10-01 2013-10-01 false Passenger Ship Safety Certificate. 115.910 Section 115... Ship Safety Certificate. (a) A vessel that carries more than 12 passengers on an international voyage must have a valid SOLAS Passenger Ship Safety Certificate. The Commandant authorizes the cognizant...

31 CFR 560.528 - Aircraft safety.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Aircraft safety. 560.528 Section 560..., Authorizations and Statements of Licensing Policy § 560.528 Aircraft safety. Specific licenses may be issued on a... the safety of civil aviation and safe operation of U.S.-origin commercial passenger aircraft. ...

[Comment to DPR 177/011].

PubMed

De Santis, Anna Elisa

2012-01-01

The subject of this study is the analysis of DPR 177/2011 regarding occupational safety in confined environments suspected of pollution The study wishes to represent a platform for the knowledge of the relevant principles and issues that are the functional basis for occupational health professionals, to offer a scheme in which it is possible to implement local actions of occupational prevention in the confined spaces and to help Italian intervention plans Italian within the European area, such, e.g., the present "Healthy workplaces campaign working together for risk prevention" promoted by the European Agency for Safety and Health at Work. The interiorization of this behavioural scheme is needed for professionals and authorities in the occupational safety systems, both public and private, who have the institutional duty to obtain trheir effectiveness. To observe the safety system in the specific matter of confined spaces, their essential elements were considered. These elements were identified both in the DPR 177/2011 and in other pertinent documents. This study doesn't pretend to identify all relevant documents, but wishes to underline the open structure of the system for acquiring non strictly juridical documents, such as ICOH guidelines and International code of ethics for occupational health professionals and pertinent authorities. A specific matter of the study is the different role of rules and ethical principles in verifying the adequacy of the safety system. The role of guidelines and ethic principles in the internal evaluation of legal value was examined for their relevance in order to decide on adequacy of the employer's management in safety matter adequacy which can by evaluated looking at his effective knowledge of spaces and good selection of managers and professionals. Furthermore, the study establishes how central--in reaching the safety--is the method based on effectiveness in managing the prevention in occupational health. The managerial method, not based on formal interpretation but on the effective situation of the spaces and of the human resources, is a critical element in safety systems and represents an acceptable scheme for the conduct of the subjects in charge for the production cycle. They are those who effectively decide on the site, except for some situations, as it is for example the prevision of managerial liability for activity in outsourcing. It has been stressed in this study the dynamicity of safety system in confined spaces which can be derived by the employer's duty of vigilance for interference risks between his activity and the activity of other enterprises operating in outsourcing. This duty it is permanent in every space and moment of production cycle. This context of functional responsibility, and liability when it exists, based on reality as well as on the knowledge of the spaces and human resources, shows the central function of qualified MD and his functionality in both aspects. In the first, he is able to understand various risks existing for health. In the second, for the many strict contacts with workers, he can participate in developing their information and formation, which have educational importance for the safety system of the occupational health. To conclude about the occupational safety system, this study stresses that the activity of qualified MD is not a simple surveillance carried out by medical examinations as a routine, but it is a strategic issue for the realization of organizational wellness at work, which is functional to respect both the human rights and an efficient production cycle.

Safety profile: fifteen years of clinical experience with ibuprofen.

PubMed

Royer, G L; Seckman, C E; Welshman, I R

1984-07-13

Since its introduction in the United States in 1974, ibuprofen (Motrin, Upjohn) has been shown to be safe and effective for the treatment of pain, dysmenorrhea, inflammation, and fever. A careful review of pre-registration and postmarketing data from both patients and normal subjects clearly indicates ibuprofen's remarkable safety profile compared with that of aspirin and other commonly prescribed nonsteroidal anti-inflammatory agents. Continued safety can be anticipated on the basis of the past 15 years of review experience.

29 CFR 1908.1 - Purpose and scope.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Agreements between states and the Federal Occupational Safety and Health Administration (OSHA) under sections... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR...), the Occupational Safety and Health Administration Compliance Assistance Authorization Act of 1998...

29 CFR 1908.1 - Purpose and scope.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Agreements between states and the Federal Occupational Safety and Health Administration (OSHA) under sections... Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR...), the Occupational Safety and Health Administration Compliance Assistance Authorization Act of 1998...

Worker Health and Safety: An Area of Conflicts

ERIC Educational Resources Information Center

Ashford, Nicholas A.

1975-01-01

The article outlines four basic conflicts concerning occupational health and safety, discusses the nature and dimensions of health and safety problems, examines the generation of information and its diffusion, and deals briefly with some economic issues. (Author)

The Impact of Language and Culture Diversity in Occupational Safety.

PubMed

De Jesus-Rivas, Mayra; Conlon, Helen Acree; Burns, Candace

2016-01-01

Occupational health nursing plays a critical part in improving the safety of foreign labor workers. The development and implementation of safety training programs do not always regularly take into account language barriers, low literacy levels, or cultural elements. This oversight can lead to more injuries and fatalities among this group. Despite established health and safety training programs, a significant number of non-native English speakers are injured or killed in preventable, occupation-related accidents. Introducing safety programs that use alternative teaching strategies such as pictograms, illustrations, and hands-on training opportunities will assist in addressing challenges for non-English laborers. Occupational health nursing has an opportunity to provide guidance on this subject and assist businesses in creating a safer and more productive work environment. © 2015 The Author(s).

Research on the method of information system risk state estimation based on clustering particle filter

NASA Astrophysics Data System (ADS)

Cui, Jia; Hong, Bei; Jiang, Xuepeng; Chen, Qinghua

2017-05-01

With the purpose of reinforcing correlation analysis of risk assessment threat factors, a dynamic assessment method of safety risks based on particle filtering is proposed, which takes threat analysis as the core. Based on the risk assessment standards, the method selects threat indicates, applies a particle filtering algorithm to calculate influencing weight of threat indications, and confirms information system risk levels by combining with state estimation theory. In order to improve the calculating efficiency of the particle filtering algorithm, the k-means cluster algorithm is introduced to the particle filtering algorithm. By clustering all particles, the author regards centroid as the representative to operate, so as to reduce calculated amount. The empirical experience indicates that the method can embody the relation of mutual dependence and influence in risk elements reasonably. Under the circumstance of limited information, it provides the scientific basis on fabricating a risk management control strategy.

How to design and write a clinical research protocol in Cosmetic Dermatology*

PubMed Central

Bagatin, Ediléia; Miot, Helio A.

2013-01-01

Cosmetic Dermatology is a growing subspecialty. High-quality basic science studies have been published; however, few double-blind, randomized controlled clinical trials, which are the major instrument for evidence-based medicine, have been conducted in this area. Clinical research is essential for the discovery of new knowledge, improvement of scientific basis, resolution of challenges, and good clinical practice. Some basic principles for a successful researcher include interest, availability, persistence, and honesty. It is essential to learn how to write a protocol research and to know the international and national regulatory rules. A complete clinical trial protocol should include question, background, objectives, methodology (design, variable description, sample size, randomization, inclusion and exclusion criteria, intervention, efficacy and safety measures, and statistical analysis), consent form, clinical research form, and references. Institutional ethical review board approval and financial support disclosure are necessary. Publication of positive or negative results should be an authors' commitment. PMID:23539006

A human reliability based usability evaluation method for safety-critical software

DOE Office of Scientific and Technical Information (OSTI.GOV)

Boring, R. L.; Tran, T. Q.; Gertman, D. I.

2006-07-01

Boring and Gertman (2005) introduced a novel method that augments heuristic usability evaluation methods with that of the human reliability analysis method of SPAR-H. By assigning probabilistic modifiers to individual heuristics, it is possible to arrive at the usability error probability (UEP). Although this UEP is not a literal probability of error, it nonetheless provides a quantitative basis to heuristic evaluation. This method allows one to seamlessly prioritize and identify usability issues (i.e., a higher UEP requires more immediate fixes). However, the original version of this method required the usability evaluator to assign priority weights to the final UEP, thusmore » allowing the priority of a usability issue to differ among usability evaluators. The purpose of this paper is to explore an alternative approach to standardize the priority weighting of the UEP in an effort to improve the method's reliability. (authors)« less

Regulation of Health Policy: Patient Safety and the States

DTIC Science & Technology

2005-05-01

the consumer perspective about patient safety. Advances in Patient Safety: Vol 1 420 Note See e.g., Public Citizen, Inc. v. U.S. Dept. of Health ...405 Regulation of Health Policy: Patient Safety and the States Joanna Weinberg, Lee H. Hilborne, Quang-Tuyen Nguyen Abstract In its 1999...regulating patient safety. The authors suggest that State patient safety regulation illustrates ongoing tensions in U.S. health policy, and conclude that

Convoy Active Safety Technology - Environmental Understanding and Navigation With Use of Low Cost Sensors

DTIC Science & Technology

2012-08-01

ACTIVE SAFETY TECHNOLOGY – ENVIRONMENTAL UNDERSTANDING AND NAVIGATION WITH USE OF LOW COST SENSORS David Simon Lockheed Martin MFC, Grand Prairie, TX...Understanding and Navigation with use of low cost sensors 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) David Simon ; Bernard

75 FR 3946 - Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-25

... NUCLEAR REGULATORY COMMISSION [Docket Nos. 50-438-CP, 50-439-CP; ASLBP No. 10-896-01-CP-BD01] Tennessee Valley Authority; Establishment of Atomic Safety and Licensing Board Pursuant to delegation by the Commission dated December 29, 1972, published in the Federal Register, 37 FR 28,710 (1972), and the...

76 FR 38457 - Reports, Forms and Record Keeping Requirements Agency Information Collection Activity Under OMB...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-30

..., and 30117 of the National Traffic and Motor Vehicle Safety Act of 1996, authorizes the issuance of Federal Motor Vehicle Safety Standards (FMVSS). The Secretary is authorized to issue, amend, and revoke... designed to be carried mandatory in buses and trucks that have a gross vehicle weight rating (GVWR) greater...

Assessing Explosives Safety Risks, Deviations, And Consequences

DTIC Science & Technology

2009-07-31

Technical Paper 23 31 July 2009 DDESB Assessing Explosives Safety Risks, Deviations, And Consequences ...Deviations, And Consequences 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e. TASK NUMBER...and approaches to assist warfighters in executing their mission, conserving resources, and maximizing operational effectiveness . When mission risk

The Introduction of "Safety Science" into an Undergraduate Nursing Programme at a Large University in the United Kingdom.

PubMed

White, Nick; Clark, Deborah; Lewis, Robin; Robson, Wayne

2016-04-13

Implementing safety science {a term adopted by the authors which incorporates both patient safety and human factors (Sherwood, G. (2011). Integrating quality and safety science in nursing education and practice. Journal of Research in Nursing, 16(3), 226-240. doi: 10.1177/1744987111400960)} into healthcare programmes is a major challenge facing healthcare educators worldwide (National Advisory Group on the Safety of Patients in England, 2013; World Health Organisation, 2009). Patient safety concerns relating to human factors have been well-documented over the years, and the root cause(s) of as many as 65-80 % of these events are linked to human error (Dunn et al., 2007; Reason, 2005). This paper will describe how safety science education was embedded into a pre-registration nursing programme at a large UK university. The authors argue that the processes described in this paper, may be successfully applied to other pre-registration healthcare programmes in addition to nursing.

Regulatory environment for allergen-specific immunotherapy.

PubMed

Kaul, S; May, S; Lüttkopf, D; Vieths, Stefan

2011-06-01

Products for specific immunotherapy (SIT) are medicinal products according to the European Regulations. To obtain a marketing authorization (MA) within the European Community, the quality, safety and efficacy have to be proven. During the development phase of a medicinal product, applicants have the opportunity to apply for scientific advice by national competent authorities or the European Medicines Agency (EMA) to compile a suitable development plan for the examination of quality and performance of nonclinical and clinical trials. Moreover, a paediatric investigation plan has to be submitted to the Paediatric Committee of the EMA and has to be approved before submission of an application for MA. Several regulatory procedures exist for obtaining a MA in the European Community. The national procedure leads only to marketability in one country whereas the Mutual Recognition, the Decentralized and Centralized Procedures (CP) are intended for MA in several or all member states of the European Union. The CP is mandatory for certain medicinal products, for example for drug substances derived by biotechnological processes such as recombinant allergens. Named Patient Products for SIT are a specialty because they are manufactured on the basis of an individual prescription and marketed without a MA. © 2011 John Wiley & Sons A/S.

10 CFR 35.14 - Notifications.

Code of Federal Regulations, 2014 CFR

2014-01-01

... licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, or an... nuclear pharmacist, a Radiation Safety Officer, or an authorized medical physicist permanently...