Science.gov

Sample records for achieve product safety

  1. Achieving Safety through Security Management

    NASA Astrophysics Data System (ADS)

    Ridgway, John

    Whilst the achievement of safety objectives may not be possible purely through the administration of an effective Information Security Management System (ISMS), your job as safety manager will be significantly eased if such a system is in place. This paper seeks to illustrate the point by drawing a comparison between two of the prominent standards within the two disciplines of security and safety management.

  2. Pork safety: achievements and challenges.

    PubMed

    Davies, P R

    2010-11-01

    Safepork is a biennial international symposium for researchers investigating the epidemiology and control of foodborne hazards in pork. Current research is heavily weighted towards enteric bacterial pathogens for which development of reliable practical interventions for farmers has proven frustrating. In contrast, modern production practices have greatly reduced the risk of parasitic foodborne pathogens. Better understanding of host adaptation of emerging agents is important for assessing their potential zoonotic and foodborne risks. PMID:21083812

  3. [Food safety achieved through herd management].

    PubMed

    Stärk, K D

    2000-12-01

    Most animal-derived food products originate from production chains consisting of a series of well-defined, separate production steps. Undesired events affecting food safety can principally occur at any point within the production chain. The principle of integrated food safety assurance from stable to table has therefore been established. The livestock holding has thus to be understood as a fix element of the production chain, and the producer has to accept a part of the responsibility for food safety. On a farm, food safety can be negatively affected by animal feed (microbiological or toxicological contamination), management (hygiene, stocking density, cleaning and disinfecting), veterinary treatments (use of antibiotics) and recycling of slurry. Most relevant practices can be summarised under the standard of "good farming practice". HACCP programmes as they are applied in the processing industries could in principle also be used at the farm level. Influential management steps would need to be identified and controlled. This approach is, however, still in its infancy at present. Using the current monitoring systems, microbiological and toxicological problems in food are difficult to be identified before the end of the production chain. As the cause of a problem can be found at the farm level, traceability of products through the production chain is essential. In Switzerland, traceability of animals is realised using compulsory animal identification and the animal movement database. Using this link, information on the health status of a herd could be made available to the slaughterhouse in order to classify animals into food-safety risk categories. This principle is a key element in the ongoing discussion about visual meat inspection in Europe and elsewhere. PMID:11189835

  4. Achievements and challenges of Space Station Freedom's safety review process

    NASA Technical Reports Server (NTRS)

    Robinson, David W.

    1993-01-01

    The most complex space vehicle in history, Space Station Freedom, is well underway to completion, and System Safety is a vital part of the program. The purpose is to summarize and illustrate the progress that over one-hundred System Safety engineers have made in identifying, documenting, and controlling the hazards inherent in the space station. To date, Space Station Freedom has been reviewed by NASA's safety panels through the first six assembly flights, when Freedom achieves a configuration known as Man Tended Capability. During the eight weeks of safety reviews spread out over a year and a half, over 200 preliminary hazard reports were presented. Along the way NASA and its contractors faced many challenges, made much progress, and even learned a few lessons.

  5. Results of scientific achievements for production

    SciTech Connect

    Primachenko, V.V.

    1988-07-01

    During recent years the Aluminosilicate Refractory Laboratory of the Ukrainian Scientific-Research Institute for Refractories together with refractory, metallurgical, and other plants has solved a number of problems on the technology and service of refractories. This paper reviews those achievements. A method for producing refractories, vibrocasting, was developed and was found to increase labor productivity by two or three times. The properties of vibrocast refractory parts and materials are discussed and compared to those of pressed and pneumatically rammed refractories. A number of new high-quality forms of refractory production were introduced for fused mullite and heat-resistant mullite-corundum refractories. Increasing the service life of coke oven doors by using an unreinforced block liner and mechanizing their installation and removal was also discussed. The economic savings obtained via these and other developments are cited.

  6. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 44 Emergency Management and Assistance 1 2010-10-01 2010-10-01 false Achieving production..., DEPARTMENT OF ENERGY, MARITIME ADMINISTRATION) § 321.4 Achieving production readiness. (a) In order to achieve a capability for maximum production of “urgent” items during the initial phase of war,...

  7. Achieving the Proper Balance between Crew & Public Safety

    NASA Astrophysics Data System (ADS)

    Wilde, P.; Gowan, J.; Silvestri, R.; Stahl, B.; Rosati, P.

    2012-01-01

    A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Crewed vehicle perspectives from the Federal Aviation Administration and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

  8. Achieving the Proper Balance Between Crew and Public Safety

    NASA Technical Reports Server (NTRS)

    Gowan, John; Silvestri, Ray; Stahl, Ben; Rosati, Paul; Wilde, Paul

    2011-01-01

    A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard, and the design engineers must give these requirements the same consideration as crew safety requirements. For human spaceflight, the primary purpose and operational concept for any flight safety system is to protect the public while maximizing the likelihood of crew survival. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. An overview of existing range and crew safety policy requirements will be presented. Application of these requirements and lessons learned from both the Space Shuttle and Constellation Programs will also be discussed. Using these past programs as examples, the paper will detail operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the Federal Aviation Administration (FAA) and Air Force organizations that oversee public safety will be summarized as well. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

  9. Achieving the Proper Balance Between Crew and Public Safety

    NASA Technical Reports Server (NTRS)

    Gowan, John; Rosati, Paul; Silvestri, Ray; Stahl, Ben; Wilde, Paul

    2011-01-01

    A paramount objective of all human-rated launch and reentry vehicle developers is to ensure that the risks to both the crew onboard and the public are minimized within reasonable cost, schedule, and technical constraints. Past experience has shown that proper attention to range safety requirements necessary to ensure public safety must be given early in the design phase to avoid additional operational complexities or threats to the safety of people onboard. This paper will outline the policy considerations, technical issues, and operational impacts regarding launch and reentry vehicle failure scenarios where crew and public safety are intertwined and thus addressed optimally in an integrated manner. Historical examples and lessons learned from both the Space Shuttle and Constellation Programs will be presented. Using these examples as context, the paper will discuss some operational, design, and analysis approaches to mitigate and balance the risks to people onboard and in the public. Manned vehicle perspectives from the FAA and Air Force organizations that oversee public safety will also be summarized. Finally, the paper will emphasize the need to factor policy, operational, and analysis considerations into the early design trades of new vehicles to help ensure that both crew and public safety are maximized to the greatest extent possible.

  10. Monitoring product safety in the postmarketing environment

    PubMed Central

    Dieck, Gretchen S

    2013-01-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries. PMID:25114782

  11. Consumer product safety: A systems problem

    NASA Technical Reports Server (NTRS)

    Clark, C. C.

    1971-01-01

    The manufacturer, tester, retailer, consumer, repairer disposer, trade and professional associations, national and international standards bodies, and governments in several roles are all involved in consumer product safety. A preliminary analysis, drawing on system safety techniques, is utilized to distinguish the inter-relations of these many groups and the responsibilities that they are or could take for product safety, including the slow accident hazards as well as the more commonly discussed fast accident hazards. The importance of interactive computer aided information flow among these groups is particularly stressed.

  12. Microbial bioinformatics for food safety and production

    PubMed Central

    Alkema, Wynand; Boekhorst, Jos; Wels, Michiel

    2016-01-01

    In the production of fermented foods, microbes play an important role. Optimization of fermentation processes or starter culture production traditionally was a trial-and-error approach inspired by expert knowledge of the fermentation process. Current developments in high-throughput ‘omics’ technologies allow developing more rational approaches to improve fermentation processes both from the food functionality as well as from the food safety perspective. Here, the authors thematically review typical bioinformatics techniques and approaches to improve various aspects of the microbial production of fermented food products and food safety. PMID:26082168

  13. [Viral safety of biological medicinal products].

    PubMed

    Stühler, A; Blümel, J

    2014-10-01

    Viral safety of blood donations, plasma products, viral vaccines and gene therapy medicinal products, biotechnical-derived products and tissue and cell therapy products is a particular challenge. These products are manufactured using a variety of human or animal-derived starting materials and reagents; therefore, extensive testing of donors and of cell banks established for production is required. Furthermore, the viral safety of reagents, such as bovine sera, porcine trypsin and human transferrin or albumin needs to be considered. Whenever possible, manufacturing steps for inactivation or removal of viruses should be introduced; however, sometimes it is not possible to introduce such steps for tissues or cell-based medicinal products as the activity and viability of cells will be compromised. It might be possible to implement steps for inactivation or removal of potential contaminating enveloped viruses only for production of small and stable non-enveloped viral gene vectors. PMID:25123140

  14. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains...

  15. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ...The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is issuing a notice of proposed rulemaking that would establish a publicly available consumer product safety information database (``database''). Section 212 of the Consumer Product Safety Improvement Act of 2008 (``CPSIA'') amended the Consumer Product Safety Act (``CPSA'') to require the Commission to establish and......

  16. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... achieve a capability for maximum production of “urgent” items during the initial phase of war, the... power, fuel, and water, or on long-distance communications; with spare replacements for...

  17. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... achieve a capability for maximum production of “urgent” items during the initial phase of war, the... power, fuel, and water, or on long-distance communications; with spare replacements for...

  18. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... achieve a capability for maximum production of “urgent” items during the initial phase of war, the... power, fuel, and water, or on long-distance communications; with spare replacements for...

  19. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... achieve a capability for maximum production of “urgent” items during the initial phase of war, the... power, fuel, and water, or on long-distance communications; with spare replacements for...

  20. Safety of skin care products during pregnancy

    PubMed Central

    Bozzo, Pina; Chua-Gocheco, Angela; Einarson, Adrienne

    2011-01-01

    Abstract Question Many of my female patients complain about acne, unwanted hair growth, and other skin problems that have only developed since they became pregnant. Are products used for these types of benign skin conditions safe to use in pregnancy, as it is understandable that women want to look their best at this important time in their lives? Answer With the exception of hydroquinone, which has a relatively high systemic absorption rate, and tretinoin, for which the evidence is controversial, these products act locally and therefore produce minimal systemic levels. Consequently, in most cases women can deal with these cosmetically unappealing skin conditions without compromising the safety of their unborn children. PMID:21673209

  1. Parenteral nutrition product shortages: impact on safety.

    PubMed

    Holcombe, Beverly

    2012-03-01

    The drug shortage crisis continues in the United States and threatens the integrity of the pharmaceutical supply chain and compromises patient care, especially patients requiring parenteral nutrition (PN) therapy. The number of new drug shortages has increased rapidly over the past 5 years, with the most significant increase in sterile injectable products. The most common reason for a shortage of a sterile injectable medication is a product quality issue. Two surveys of healthcare professionals have assessed the impact of drug shortages on patient safety. Participants in one survey reported over 1000 medication errors or patient adverse events as the result of shortages. The American Society for Parenteral and Enteral Nutrition also conducted a survey of healthcare professionals regarding PN product shortages and the associated patient care implications. Safety risks were reported throughout the entire PN process, from procurement of PN products to patient outcomes. Providing PN therapy during product shortages requires vigilance and continuous assessment of the entire PN process to optimize patient care quality and avoid patient harm. PMID:22282871

  2. The likelihood of achieving quantified road safety targets: a binary logistic regression model for possible factors.

    PubMed

    Sze, N N; Wong, S C; Lee, C Y

    2014-12-01

    In past several decades, many countries have set quantified road safety targets to motivate transport authorities to develop systematic road safety strategies and measures and facilitate the achievement of continuous road safety improvement. Studies have been conducted to evaluate the association between the setting of quantified road safety targets and road fatality reduction, in both the short and long run, by comparing road fatalities before and after the implementation of a quantified road safety target. However, not much work has been done to evaluate whether the quantified road safety targets are actually achieved. In this study, we used a binary logistic regression model to examine the factors - including vehicle ownership, fatality rate, and national income, in addition to level of ambition and duration of target - that contribute to a target's success. We analyzed 55 quantified road safety targets set by 29 countries from 1981 to 2009, and the results indicate that targets that are in progress and with lower level of ambitions had a higher likelihood of eventually being achieved. Moreover, possible interaction effects on the association between level of ambition and the likelihood of success are also revealed. PMID:25255417

  3. Perceived School and Neighborhood Safety, Neighborhood Violence and Academic Achievement in Urban School Children.

    PubMed

    Aj, Milam; Cdm, Furr-Holden; Pj, Leaf

    2010-12-01

    Community and school violence continue to be a major public health problem, especially among urban children and adolescents. Little research has focused on the effect of school safety and neighborhood violence on academic performance. This study examines the effect of the school and neighborhood climate on academic achievement among a population of 3(rd)-5(th) grade students in an urban public school system. Community and school safety were assessed using the School Climate Survey, an annual city-wide assessment of student's perception of school and community safety. Community violence was measured using the Neighborhood Inventory for Environmental Typology, an objective observational assessment of neighborhood characteristics. Academic achievement was measured using the Maryland State Assessment (MSA), a standardized exam given to all Maryland 3(rd)-8(th) graders. School Climate Data and MSA data were aggregated by school and grade. Objective assessments of neighborhood environment and students' self-reported school and neighborhood safety were both strongly associated with academic performance. Increasing neighborhood violence was associated with statistically significant decreases from 4.2%-8.7% in math and reading achievement; increasing perceived safety was associated with significant increases in achievement from 16%-22%. These preliminary findings highlight the adverse impact of perceived safety and community violence exposure on primary school children's academic performance. PMID:21197388

  4. Product Safety, It's No Accident. A Consumer Product Safety Monthly Planning Guide for Community Organizations.

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

    A consumer product safety monthly planning guide for community organizations is provided. The material is organized into suggested monthly topics with seasonal emphasis. Each section highlights selected information about how to identify potential hazards associated with categories of products. Each section also includes recommendaitons of ways to…

  5. Chemical safety of meat and meat products.

    PubMed

    Andrée, Sabine; Jira, W; Schwind, K-H; Wagner, H; Schwägele, F

    2010-09-01

    Since the Second World War the consumer behaviour in developed countries changed drastically. Primarily there existed the demand for sufficient food after a period of starvation, afterwards the desire for higher quality was arising, whereas today most people ask for safe and healthy food with high quality. Therefore a united approach comprising consistent standards, sound science and robust controls is required to ensure consumers' health and to maintain consumers' confidence and satisfaction. Chemical analysis along the whole food chain downstream (tracking) from primary production to the consumer and upstream (tracing) from the consumer to primary production is an important prerequisite to ensure food safety and quality. In this frame the focus of the following paper is the "chemical safety of meat and meat products" taking into account inorganic as well as organic residues and contaminants, the use of nitrite in meat products, the incidence of veterinary drugs, as well as a Failure Mode and Effect Analysis (FMEA) system assessing (prioritizing) vulnerable food chain steps to decrease or eliminate vulnerability. PMID:20510527

  6. 78 FR 57570 - Safety Zone; Motion Picture Production; Chicago, Illinois

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... Safety Zone; Motion Picture Production; Chicago, IL (78 FR 20241, August 20, 2013). This updated schedule... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago....T09-0676 Safety Zone; Motion Picture Production; Chicago, IL and 5 U.S.C. 552(a). Because this...

  7. The Consumer Product Safety Commission: Benefit or Boondoggle?

    ERIC Educational Resources Information Center

    Feldman, Laurence P.

    1977-01-01

    The Consumer Product Safety Commission has been subject to the criticism of all parties involved in the regulation of the safety of consumer products. Evaluates the Commission's performance, examining both the sources of the Commission's regulatory problems and the extent to which recent amendments to the Consumer Product Safety Act will solve…

  8. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 4 2014-10-01 2014-10-01 false Product Safety Plan (PSP). 236.907 Section 236.907...-Based Signal and Train Control Systems § 236.907 Product Safety Plan (PSP). (a) What must a PSP contain... description of the product functionality and information flows; (4) A safety requirements document,...

  9. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  10. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  11. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 4 2012-10-01 2012-10-01 false Product Safety Plan (PSP). 236.907 Section 236.907...-Based Signal and Train Control Systems § 236.907 Product Safety Plan (PSP). (a) What must a PSP contain... description of the product functionality and information flows; (4) A safety requirements document,...

  12. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 4 2013-10-01 2013-10-01 false Product Safety Plan (PSP). 236.907 Section 236.907...-Based Signal and Train Control Systems § 236.907 Product Safety Plan (PSP). (a) What must a PSP contain... description of the product functionality and information flows; (4) A safety requirements document,...

  13. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  14. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... rulemaking for a product safety rule under any rulemaking authority administered by the Commission, assist... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL...

  15. Strategies for Science Student Achievement & Productive School Management

    ERIC Educational Resources Information Center

    Johnson, William L.

    2010-01-01

    There is an increasing literature pertaining to student achievement and school productivity. This session will present school and classroom strategies used in high school science classes at Robert E. Lee High School (5A) in Tyler, Texas. This year, 84% of the students at Lee passed the science TAKS test. Lee is also ranked in the top 1500 high…

  16. Perceived School and Neighborhood Safety, Neighborhood Violence and Academic Achievement in Urban School Children

    ERIC Educational Resources Information Center

    Milam, A. J.; Furr-Holden, C. D. M.; Leaf, P. J.

    2010-01-01

    Community and school violence continue to be a major public health problem, especially among urban children and adolescents. Little research has focused on the effect of school safety and neighborhood violence on academic performance. This study examines the effect of the school and neighborhood climate on academic achievement among a population…

  17. Achieving reimbursement for regenerative medicine products in the USA.

    PubMed

    Ginty, P J; Singh, P B; Smith, D; Hourd, P; Williams, D J

    2010-05-01

    Achieving reimbursement for regenerative medicine products is potentially a greater challenge than gaining US FDA approval, making it a decisive factor in the success or failure of small businesses. However, the mechanisms by which reimbursement is achieved are still seen as something of a 'black box', especially to those outside of the USA. This report aims to provide insights into the mechanisms of reimbursement and variety of payers in the USA, and to act as a starting point for a successful US reimbursement strategy. Fundamental concepts such as coverage, payment and coding are explained and linked with the factors that potentially determine the successful reimbursement of regenerative medicine products, including cost of goods and clinical study design. Finally, important considerations for the design of clinical studies that satisfy both the payers and the FDA are discussed and the key elements of a successful company strategy identified. PMID:20455656

  18. Automatic Production Planning System to Achieve Flexible Direct Machining

    NASA Astrophysics Data System (ADS)

    Nakamoto, Keiichi; Shirase, Keiichi; Wakamatsu, Hidefumi; Tsumaya, Akira; Arai, Eiji

    For shortening of production lead-time, it is needed to eliminate time and efforts for process and operation planning after product design. However, a conventional NC machine tool has no autonomy and intelligence to achieve direct machining operation or “Rapid Manufacturing”. Because CL data and cutting parameters for machining operation have to be determined precisely in process and operation planning. In this study, in order to realize an autonomous and intelligent machine tool, the digital copy milling system which allows to generate tool paths during machining operation, and the trouble free machining strategy which allows to adapt cutting parameters, have been developed. And, an automatic process and operation planning system has been developed to integrate with the functions mentioned. This planning system works on commercial CAD software, and a prototype of autonomous and intelligent machine tool can achieve direct machining operation or “Rapid Manufacturing” which does not require any effort to prepare an NC program.

  19. Health, safety, and productivity in a manufacturing environment.

    PubMed

    Bunn, W B; Pikelny, D B; Slavin, T J; Paralkar, S

    2001-01-01

    The Health and Productivity Management model at International Truck and Engine Corporation includes the measurement, analysis, and management of the individual component programs affecting employee safety, health, and productivity. The key to the success of the program was the iterative approach used to identify the opportunities, develop interventions, and achieve targets through continuous measurement and management. In addition, the integration of multiple disciplines and the overall emphasis on employee productivity and its cost are key foci of the International Model. The program was instituted after economic and clinical services' analyses of data on International employees showed significant excess costs and a high potential for health care cost reductions based on several modifiable health risk factors. The company also faced significant challenges in the safety, workers' compensation, and disability areas. The program includes safety, workers' compensation, short-term disability, long-term disability, health care, and absenteeism. Monthly reports/analyses are sent to senior management, and annual goals are set with the board of directors. Economic impact has been documented in the categories after intervention. For example, a comprehensive corporate wellness effort has had a significant impact in terms of reducing both direct health care cost and improving productivity, measured as absenteeism. Workers' compensation and disability program interventions have had an impact on current costs, resulting in a significant reduction of financial liability. In the final phase of the program, all direct and indirect productivity costs will be quantified. The impact of the coordinated program on costs associated with employee health will be analyzed initially and compared with a "silo" approach. PMID:11201769

  20. 16 CFR 1115.8 - Compliance with product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... 1115.8 Section 1115.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... Commission generally encourage the private sector development of, and compliance with voluntary consumer... consumer products. To support the development of such consensus standards, Commission staff participates...

  1. The Pentagon-S process: A systematic approach for achieving high confidence in high-consequence products

    SciTech Connect

    D`Antonio, P.E.; Covan, J.M.; Ekman, M.E.

    1997-10-01

    Sandia National Laboratories has developed a systematic approach for achieving high confidence in major products requiring high reliability for use in high-consequence applications. A high-consequence application is one in which product failure could result in significant loss of life, damage to major systems or to the environment, financial loss, or political repercussions. The application of this process has proven to be of significant benefit in the early identification, verification, and correction of potential product design and manufacturing process failure modes. Early identification and correction of these failures modes and the corresponding controls placed on safety-critical features, ensures product adherence to safety-critical design requirements, and enhances product quality, reliability, and the cost effectiveness of delivered products. Safety-critical features include design features such as materials and dimensions, as well as manufacturing features such as assembly processes, inspections, and testing.

  2. The importance of safety in achieving the widespread use of hydrogen as a fuel

    SciTech Connect

    Edeskuty, F.J.

    1997-09-01

    The advantages of hydrogen fuel have been adequately demonstrated on numerous occasions. However, two major disadvantages have prevented any significant amount of corresponding development. These disadvantages have been in the economics of producing sufficient quantities of hydrogen and in the safety (both real and perceived) of its use. To date work has mostly been properly centered on solving the economic problems. However, a greater effort on the safety of new hydrogen systems now being proposed also deserves consideration. To achieve the greatest safety in the expansion of the use of hydrogen into its wide-spread use as a fuel, attention must be given to four considerations. These are, obtaining knowledge of all the physical principles involved in the new uses, having in place the regulations that allow the safe interfacing of the new systems, designing and constructing the new systems with safety in mind, and the training of the large number of people that will become the handlers of the hydrogen. Existing organizations that produce, transport, or use hydrogen on a large scale have an excellent safety record. This safety record comes as a consequence of dedicated attention to the above-mentioned principles. However, where these principles were not closely followed, accidents have resulted. Some examples can be cited. As the use of hydrogen becomes more widespread, there must be a mechanism for assuring the universal application of these principles. Larger and more numerous fleet operations with hydrogen fuel may be the best way to begin the indoctrination of the general public to the more general use of hydrogen fuel. Demonstrated safe operation with hydrogen is vital to its final acceptance as the fuel of choice.

  3. Product Safety: "An Ounce of Prevention". Health and the Consumer.

    ERIC Educational Resources Information Center

    Florida State Dept. of Education, Tallahassee. Div. of Elementary and Secondary Education.

    Secondary level students learn about product safety in this consumer education learning activity package, which is one of a series. While the majority of products are safe, there remains a small percentage of consumer goods which reach the market place containing a real or potential hazard to the consumer's safety. This module is designed to make…

  4. Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

    NASA Technical Reports Server (NTRS)

    Hill, Janice; Victor, Daniel

    2008-01-01

    When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

  5. Can the Academic Achievement of Korean Students Be Portrayed as a Product of "Shadow Achievement"?

    ERIC Educational Resources Information Center

    Kim, Hyunjin

    2015-01-01

    The purpose of this study was to investigate the effects of private tutoring expenditure on two types of Korean students' academic achievements as measured by standardized test achievement and by school performance achievement, applying 5-year data from Korean Educational Longitudinal Study (KELS). It was found that private tutoring…

  6. Achieving safety/risk goals for less ATR backup power upgrades

    SciTech Connect

    Atkinson, S.A.

    1995-10-01

    The Advanced Test Reactor probabilistic risk assessment for internal fire and flood events defined a relatively high risk for a total loss of electric power possibly leading to core damage. Backup power sources were disabled due to fire and flooding in the diesel generator area with propagation of the flooding to a common switchgear room. The ATR risk assessment was employed to define options for relocation of backup power system components to achieve needed risk reduction while minimizing costs. The risk evaluations were performed using sensitivity studies and importance measures. The risk-based evaluations of relocation options for backup power systems saved over $3 million from what might have been otherwise considered {open_quotes}necessary{close_quotes} for safety/risk improvement. The ATR experience shows that the advantages of a good risk assessment are to define risk significance, risk specifics, and risk solutions which enable risk goals to be achieved at the lowest cost.

  7. Harmonization of legislation and regulations to achieve food safety: US and Canada perspective.

    PubMed

    Keener, Larry; Nicholson-Keener, Sophia M; Koutchma, Tatiana

    2014-08-01

    Trade in food and food ingredients among the nations of the world is rapidly expanding and, with this expansion, new supply chain partners, from globally disparate geographic regions, are being enrolled. Food and food ingredients are progressively sourced more from lesser developed nations. Food safety incidents in the USA and Canada show a high unfavorable correlation between illness outbreaks and imported foods. In the USA, for example, foodborne disease outbreaks caused by imported food appeared to rise in 2009 and 2010, and nearly half of the outbreaks, associated with imported food, implicated foods imported from areas which previously had not been associated with outbreaks. Projecting supply chains into new geographical regions raises serious questions about the capacity of the new supply chain partners to provide the requisite regulatory framework and sufficiently robust public health measures for ensuring the safety of the foods and foodstuffs offered for international trade. The laws, regulation and legislation among the many nations participating in the global food trade are, at best, inconsistent. These inconsistencies frequently give rise to trade disputes and cause large quantities of food to be at risk of destruction on the often dubious pretext that they are not safe. Food safety is often viewed through a political or normative lens. Often as not, this lens has been wrought absent scientific precision. Harmonization of food safety legislation around sound scientific principles, as advocated by the US Food Safety Modernization Act (FSMA), would ultimately promote trade and likely provide for incremental improvement in public health. Among the priority roles of most national governments are the advancement of commerce and trade, preservation of public health and ensuring domestic tranquility. Achieving these priorities is fundamental to creating and preserving the wealth of nations. Countries such as the Netherlands, Canada, Germany, Japan and the USA

  8. The Stories Clinicians Tell: Achieving High Reliability and Improving Patient Safety

    PubMed Central

    Cohen, Daniel L; Stewart, Kevin O

    2016-01-01

    The patient safety movement has been deeply affected by the stories patients have shared that have identified numerous opportunities for improvements in safety. These stories have identified system and/or human inefficiencies or dysfunctions, possibly even failures, often resulting in patient harm. Although patients’ stories tell us much, less commonly heard are the stories of clinicians and how their personal observations regarding the environments they work in and the circumstances and pressures under which they work may degrade patient safety and lead to harm. If the health care industry is to function like a high-reliability industry, to improve its processes and achieve the outcomes that patients rightly deserve, then leaders and managers must seek and value input from those on the front lines—both clinicians and patients. Stories from clinicians provided in this article address themes that include incident identification, disclosure and transparency, just culture, the impact of clinical workload pressures, human factors liabilities, clinicians as secondary victims, the impact of disruptive and punitive behaviors, factors affecting professional morale, and personal failings. PMID:26580146

  9. Consumer Product Safety Commission. Consumer Education Efforts for Revised Children's Sleepwear Safety Standard.

    ERIC Educational Resources Information Center

    General Accounting Office, Washington, DC. Health, Education, and Human Services Div.

    A study examined the type and extent of consumer education that occurred since the Consumer Product Safety Commission (CPSC) amended the 1972 federal safety standards (effective January 1997) to permit marketing of snug-fitting, nonflame-resistant cotton garments as sleepwear. Three voluntary point-of-sale (POS) practices recognized as important…

  10. Evaluation of Safety, Quality and Productivity in Construction

    NASA Astrophysics Data System (ADS)

    Usmen, M. A.; Vilnitis, M.

    2015-11-01

    This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

  11. [Viral safety concept: application to blood and blood products].

    PubMed

    Trouvin, Jean-Hugues

    2005-11-30

    Safety of blood and its derivatives, with regards to the risk of transmission of infectious agents such as viruses or non conventional agents, relies on a series of general principles for which national and European guidance and regulations have been drawn and regularly updated. Three main criteria contribute to the safety of these products: knowledge and control of the quality of blood or plasma as the starting material, the efficiency of the manufacturing process to remove/inactivate adventitious agents, and the testing done during the production process. In addition, vigilance routinely exercised on the products used in daily practice increases the confidence in these health products. PMID:16419908

  12. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a)...

  13. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a)...

  14. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a)...

  15. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a)...

  16. 42 CFR 3.204 - Privilege of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a)...

  17. Offshore Production and Safety Act of 2011

    THOMAS, 112th Congress

    Sen. McConnell, Mitch [R-KY

    2011-05-11

    05/18/2011 Motion to proceed to consideration of measure, under the order of 5/16/2011, not having achieved 60 votes in the affirmative, withdrawn in Senate. (consideration: CR S3086) (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  18. Food Safety Practices in the Egg Products Industry.

    PubMed

    Viator, Catherine L; Cates, Sheryl C; Karns, Shawn A; Muth, Mary K; Noyes, Gary

    2016-07-01

    We conducted a national census survey of egg product plants (n = 57) to obtain information on the technological and food safety practices of the egg products industry and to assess changes in these practices from 2004 to 2014. The questionnaire asked about operational and sanitation practices, microbiological testing practices, food safety training for employees, other food safety issues, and plant characteristics. The findings suggest that improvements were made in the industry's use of food safety technologies and practices between 2004 and 2014. The percentage of plants using advanced pasteurization technology and an integrated, computerized processing system increased by almost 30 percentage points. Over 90% of plants voluntarily use a written hazard analysis and critical control point (HACCP) plan to address food safety for at least one production step. Further, 90% of plants have management employees who are trained in a written HACCP plan. Most plants (93%) conduct voluntary microbiological testing. The percentage of plants conducting this testing on egg products before pasteurization has increased by almost 30 percentage points since 2004. The survey findings identify strengths and weaknesses in egg product plants' food safety practices and can be used to guide regulatory policymaking and to conduct required regulatory impact analysis of potential regulations. PMID:27357041

  19. Perspectives on achieving sustainable energy production and use

    EPA Science Inventory

    The traditional definition of sustainability calls for polices and strategies that meet society's present needs without compromising the ability of future generations to meet their own needs. Achieving operational sustainability requires three critical elements: advances in scien...

  20. The Managerial Grid; Key Orientations for Achieving Production through People.

    ERIC Educational Resources Information Center

    Blake, Robert R; Mouton, Jane S.

    The Managerial Grid arranges a concern for production on the horizontal axis and a concern for people on the vertical axis of a coordinate system: 1,1 shows minimum concern for production and people; 9,1 shows major production emphasis and minimum human considerations; 1,9 shows maximum concern for friendly working conditions and minimum…

  1. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ..., MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES Standards for Processor-Based Signal and Train Control Systems § 236.907 Product Safety Plan (PSP). (a) What must a PSP contain... railroad operation or categories of operations on which the product is designed to be used, including...

  2. Blood donation in China: sustaining efforts and challenges in achieving safety and availability.

    PubMed

    Yin, Yong-Hua; Li, Chang-Qing; Liu, Zhong

    2015-10-01

    China has entered a new phase in blood safety and availability through persistent efforts in the past decades. Based on national data from 2008 to 2012, we present a comprehensive review on the blood services ranging from policy and organization, supply, donors, screening and processing, and clinical use to government response in contemporary China. Current evidence suggests that the Chinese blood industries, after continual efforts in reforms on the legal framework and national management system, have been in a relatively steady but bottleneck stage. Although the blood industries have had an impressive track record on management and resolving problems, such as low availability, limited donors, deficient laboratory tests, shortage of blood products, and unnecessary clinical usage of blood still exist nationwide. While medical technology and services have seen a rapid increase in progress in recent years, they have not coordinated with the development of the national health care system. This article presents an analysis with detailed data, rich contents, and recent response from the Chinese government, allowing readers to appreciate how China, a country with more than 19.13% of the world's population, has long endeavored to improve safety and availability of blood. Meantime, the article sincerely welcomes the guidance on policymaking and technical assistance from the international community. Data in this article do not include those of Hong Kong, Macao, or Taiwan. PMID:26111254

  3. 42 CFR 3.208 - Continued protection of patient safety work product.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Continued protection of patient safety work product... GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.208 Continued protection of patient safety...

  4. 42 CFR 3.208 - Continued protection of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Continued protection of patient safety work product... GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.208 Continued protection of patient safety...

  5. Health and safety risks in production agriculture.

    PubMed Central

    Von Essen, S G; McCurdy, S A

    1998-01-01

    Production agriculture is associated with a variety of occupational illnesses and injuries. Agricultural workers are at higher risk of death or disabling injury than most other workers. Traumatic injury commonly occurs from working with machinery or animals. Respiratory illness and health problems from exposures to farm chemicals are major concerns, and dermatoses, hearing loss, certain cancers, and zoonotic infections are important problems. Innovative means of encouraging safe work practices are being developed. Efforts are being made to reach all groups of farmworkers, including migrant and seasonal workers, farm youth, and older farmers. PMID:9795581

  6. 77 FR 22602 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-16

    ... paperwork requirements in the regulations under Subpart O, ``Well Control and Production Safety Training... Bureau of Safety and Environmental Enforcement (BSEE) Information Collection Activities: Well Control and Production Safety Training, Submitted for Office of Management and Budget (OMB) Review; Comment...

  7. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... production-safety systems. 250.802 Section 250.802 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL... SHELF Oil and Gas Production Safety Systems § 250.802 Design, installation, and operation of surface production-safety systems. (a) General. All production facilities, including separators,...

  8. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... production-safety systems. 250.802 Section 250.802 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL... SHELF Oil and Gas Production Safety Systems § 250.802 Design, installation, and operation of surface production-safety systems. (a) General. All production facilities, including separators,...

  9. Food Production Worker. Dietetic Support Personnel Achievement Test.

    ERIC Educational Resources Information Center

    Oklahoma State Dept. of Vocational and Technical Education, Stillwater.

    This guide contains a series of multiple-choice items and guidelines to assist instructors in composing criterion-referenced tests for use in the food production worker component of Oklahoma's Dietetic Support Personnel training program. Test items addressing each of the following occupational duty areas are provided: human relations; hygiene and…

  10. Lean Production as Promoter of Thinkers to Achieve Companies' Agility

    ERIC Educational Resources Information Center

    Alves, Anabela C.; Dinis-Carvalho, Jose; Sousa, Rui M.

    2012-01-01

    Purpose: This paper aims to explore the lean production paradigm as promoter of workers' creativity and thinking potential, and recognize this human potential as a fundamental asset for companies' growth and success, being a major factor to face the disturbing and unpredictable needs of current markets, providing companies with the necessary…

  11. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false Safety Zone; BW PIONEER Floating... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  12. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false Safety Zone; BW PIONEER Floating... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is...

  13. A modular modulation method for achieving increases in metabolite production.

    PubMed

    Acerenza, Luis; Monzon, Pablo; Ortega, Fernando

    2015-01-01

    Increasing the production of overproducing strains represents a great challenge. Here, we develop a modular modulation method to determine the key steps for genetic manipulation to increase metabolite production. The method consists of three steps: (i) modularization of the metabolic network into two modules connected by linking metabolites, (ii) change in the activity of the modules using auxiliary rates producing or consuming the linking metabolites in appropriate proportions and (iii) determination of the key modules and steps to increase production. The mathematical formulation of the method in matrix form shows that it may be applied to metabolic networks of any structure and size, with reactions showing any kind of rate laws. The results are valid for any type of conservation relationships in the metabolite concentrations or interactions between modules. The activity of the module may, in principle, be changed by any large factor. The method may be applied recursively or combined with other methods devised to perform fine searches in smaller regions. In practice, it is implemented by integrating to the producer strain heterologous reactions or synthetic pathways producing or consuming the linking metabolites. The new procedure may contribute to develop metabolic engineering into a more systematic practice. PMID:25683235

  14. A Public-Private Consortium Advances Cardiac Safety Evaluation: Achievements of the HESI Cardiac Safety Technical Committee

    EPA Science Inventory

    The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues have been and continue to be a major cause of attrition and withdrawal due to Adverse Drug Reactions (ADRs) in pharmaceutical drug developm...

  15. Achieving health, safety, and performance improvements through enhanced cost visibility and workplace partnerships.

    PubMed

    Grant, Katharyn A; Garland, John G; Joachim, Todd C; Wallen, Andrew; Vital, Twyla

    2003-01-01

    Reduction in the environment, safety, and occupational health (ESOH) component of operational costs requires not only a better understanding of ESOH costs and requirements, but also the formation of effective partnerships between ESOH professionals, financial analysts, and shop workers to identify viable improvements to current practices. This article presents two case studies of efforts to enhance productivity and ESOH in corrosion control facilities at Randolph Air Force Base (AFB), Texas, and Robins AFB, Ga. At each site, activity-based cost models were created to increase the visibility of ESOH-related costs and target improvement opportunities. Analysis of the strip-and-paint processes for the T-38 aircraft at Randolph and the F-15 radome and C-141 aft cowl at Robins revealed that a large proportion of operating costs were tied to ESOH requirements and practices (22 and 39%, respectively). In each case ESOH professionals teamed with shop personnel to identify potential improvements in personal protective equipment use, waste disposal, tool selection, and work methods. This approach yielded alternatives projected to reduce total shop costs by 5 to 7%. This case study demonstrates how workplaces can identify cost-saving and efficiency-enhancing practices by partnering with ESOH professionals in planning and decision-making activities. PMID:14521429

  16. 78 FR 51064 - Safety Zone; Motion Picture Production; Chicago, IL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking TFR Temporary Final... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago, IL... hazards include falling wreckage, as well as injuries associated with debris propelled by helicopter...

  17. Voluntary Product Standard PS 72-76: Toy Safety.

    ERIC Educational Resources Information Center

    National Bureau of Standards (DOC), Washington, DC.

    The purpose of this voluntary product standard is to establish nationally recognized safety requirements and test methods for toys intended for use by children in age groups through 14 years. The standard relates to possible hazards that may not be readily recognized and which may be encountered in,normal use or after reasonably foreseeable abuse.…

  18. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... in § 236.909 and appendix B to this part; (8) A hazard mitigation analysis, including a complete and... principles and assumptions; (11) A human factors analysis, including a complete description of all human... product to enhance or preserve safety, and an analysis in accordance with appendix E to this part or...

  19. Relationships among School Climate, School Safety, and Student Achievement and Well-Being: A Review of the Literature

    ERIC Educational Resources Information Center

    Kutsyuruba, Benjamin; Klinger, Don A.; Hussain, Alicia

    2015-01-01

    School climate, safety and well-being of students are important antecedents of academic achievement. However, school members do not necessarily experience school climate in the same way; rather, their subjective perceptions of the environment and personal characteristics influence individual outcomes and behaviours. Therefore, a closer look at the…

  20. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of...

  1. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 42 Public Health 1 2012-10-01 2012-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of...

  2. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of...

  3. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 42 Public Health 1 2013-10-01 2013-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of...

  4. 42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of...

  5. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 2 2011-07-01 2011-07-01 false Production safety-system testing and records... SHELF Oil and Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a...-controlled subsurface safety device installed in a well, including such devices in shut-in and...

  6. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 1 2011-10-01 2011-10-01 false Confidentiality of patient safety work product. 3.206 Section 3.206 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product §...

  7. [Safety monitoring of cell-based medicinal products (CBMPs)].

    PubMed

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved. PMID:26391098

  8. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    PubMed Central

    Vlachojannis, Christian

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  9. A Collection Scheme for Tracing Information of Pig Safety Production

    NASA Astrophysics Data System (ADS)

    Luo, Qingyao; Xiong, Benhai; Yang, Liang

    This study takes one main production pattern of smallhold pig farming in Tianjin as a study prototype, deeply analyzes characters of informations about tracing inputs including vaccines,feeds,veterinary drugs and supervision test in pig farming, proposesinputs metadata, criteria for integrating inputs event and interface norms for data transmision, developes and completes identification of 2D ear tags and traceability information collection system of pig safety production based on mobile PDA. The system has implemented functions including setting and invalidate of 2D ear tags, collection of tracing inputs and supervision in the mobile PDA and finally integration of tracing events (the epidemic event,feed event,drug event and supervision event) on the traceability data center (server). The PDA information collection system has been applied for demonstration in Tianjin, the collection is simple, convenient and feasible. It could meet with requirements of traceability information system of pig safety production

  10. Safety and risk assessment of ceramide 3 in cosmetic products.

    PubMed

    Choi, Seul Min; Lee, Byung-Mu

    2015-10-01

    Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. PMID:26206496

  11. 78 FR 59754 - Notice of Application for Approval of Railroad Safety Program Plan and Product Safety Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... published on April 11, 2000 (65 FR 19477). Robert C. Lauby, Deputy Associate Administrator for Regulatory... railroad productivity and significantly improving the safety of train operations, roadway workers,...

  12. Adjusting the Passing Scores for Gearing up for Safety: Production Agriculture Safety Training for Youth Curriculum Test Instruments

    ERIC Educational Resources Information Center

    Hoover, William Brian; French, Brian F.; Field, William E.; Tormoehlen, Roger L.

    2012-01-01

    Minimum passing scores for the Gearing Up for Safety: Production Agriculture Safety Training for Youth curriculum (Gearing Up for Safety) were set in 2006 with widely used and established procedures by efforts of subject matter experts (French, Breidenbach et al., 2007; French, Field, and Tormoehlen, 2006, 2007). While providing a research-based…

  13. Scrubber and remote control system improves productivity and safety

    SciTech Connect

    Kost, J.

    1984-07-01

    The paper describes the development of a scrubber and remote control system for a continuous miner. Test results using the system and a greater depth of cut showed that productivity was increased without any sacrifice to health and safety. Approval has been obtained from MSHA for operation under a ventilation plan which allows a 40 aft cut and a face-to-brattice distance of 40 ft when the scrubber is in operation.

  14. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... production-safety systems. 250.802 Section 250.802 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT... Gas Production Safety Systems § 250.802 Design, installation, and operation of surface production-safety systems. (a) General. All production facilities, including separators, treaters,...

  15. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... production-safety systems. 250.802 Section 250.802 Mineral Resources BUREAU OF OCEAN ENERGY MANAGEMENT... OUTER CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.802 Design, installation, and operation of surface production-safety systems. (a) General. All production facilities, including...

  16. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA acceptance of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as...

  17. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA listing of equivalent non-MSHA product... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they...

  18. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

    ... Cosmetic Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The... ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic...

  19. An occupational health and safety intervention research agenda for production agriculture: does safety education work?

    PubMed

    Murphy, D J; Kiernan, N E; Chapman, L J

    1996-04-01

    It is clear that agriculture has not kept pace with other hazardous industries in reducing its injury rate. For example, between 1960 and 1990 the work death rate for agriculture decreased only 28% while the work death rates decreased 65% for mining and 55% for construction [Purschwitz (1992)]. A national conference in Iowa in 1988 came to the forceful conclusion that "America's most productive workforce was being systematically liquidated by an epidemic of occupational disease and traumatic death and injury" [NCASH (1988)]. In 1991, the nation's top public health officer, the U.S. Surgeon General, convened a conference titled "FarmSafe 2000-A National Coalition for Local Action," to formally address agricultural safety and health issues. Importantly, conferees recognized that preventing injury and disease was superior to trying to rehabilitate people after an injury occurred. But does participation in farm safety and health educational programs lead to a reduction in risk of injury from farm work? Questions are being raised about the value of farm safety and health educational information, campaigns, programs, and related activities. The questions have identified a critical gap in the literature of farm safety and health education. There is currently no good evidence demonstrating that farm safety and health education, campaigns, programs, or related activities lead to a relatively stable reduction of risk on the farm. In other words, do farmers and their families actually put to use, in a relatively permanent or stable manner, the educational information regarding elimination, reduction, or control of physical hazards and the modification of work behavior that may cause injury? PMID:8728146

  20. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 30 Mineral Resources 2 2014-07-01 2014-07-01 false Production safety-system testing and records... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a) Inspection... installed in a well, including such devices in shut-in and injection wells, shall be tested in place...

  1. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 30 Mineral Resources 2 2012-07-01 2012-07-01 false Production safety-system testing and records... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a) Inspection... installed in a well, including such devices in shut-in and injection wells, shall be tested in place...

  2. 76 FR 67201 - Information Collection Activities: Oil and Gas Production Safety Systems; Submitted for Office of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-31

    ... Production Safety Systems; Submitted for Office of Management and Budget (OMB) Review; Comment Request ACTION... the paperwork requirements in the regulations under Subpart H, ``Oil and Gas Production Safety Systems... H, Oil and Gas Production Safety Systems. Abstract: The Outer Continental Shelf (OCS) Lands Act,...

  3. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Production safety-system testing and records... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a) Inspection and testing. The...

  4. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product...

  5. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product...

  6. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product...

  7. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG... Technical Electronic Products Radiation Safety Standards Committee § 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). The Technical Electronic Product...

  8. The Simultaneous Production of Educational Achievement and Popularity: How Do Some Pupils Accomplish It?

    ERIC Educational Resources Information Center

    Francis, Becky; Skelton, Christine; Read, Barbara

    2010-01-01

    In spite of research showing that pupils--particularly boys--tend to experience tension between high academic achievement and popularity with peers at school, some pupils continue to maintain simultaneous production of both. This article focuses on a sample of 12-13 year-old pupils, identified as high achieving and popular, to examine classroom…

  9. Achieving high dependability and safety in sluice automation by using a fuzzy-logic-based control system

    SciTech Connect

    1998-07-01

    This paper describes how sluice automation was realized, achieving the customer requirements of dependability and safety. The analysis of both the managerial and technical problems has lead ENEL-PIN to develop an innovative sluice barrage control system, whose control algorithm is fuzzy-logic-based, that can be easily configured for each plant belonging to the identified sluice barrage class. APOS 1 achieves the automation requirements of dependability and safety by using a strong and continuous H/W and S/W self-testing and plant diagnosis, implementing particular techniques in order to realize a valid protection against electromagnetic interferences and climatic influences, and implementing suited command strategies to apply safety measures in case of hazardous situations. Its main tasks are to operate up to seven sluice-gates, suited for regulation, for controlling the river level near the sluices, and to perform a broadly diagnostic activity over the whole plant and on itself, to be used both on-line and for plant maintenance. APOS application software was designed in a general way for a class of plants, so that it may be configured by the plant expert personnel by means of a simple setting of some numeric parameters, during the plant installation. The core of the control system is a fuzzy-logic-based algorithm, that proved to be fast, reliable, and easily configurable to operate on different plants, because of the natural way in which the operation personnel's knowledge can be expressed. 1 APOS - Programmable Sluice Control System.

  10. IV and V Issues in Achieving High Reliability and Safety in Critical Control System Software

    NASA Technical Reports Server (NTRS)

    Nikora, A. P.; Schneidewind, N. F.; Munson, J. C.

    1997-01-01

    Risk analysis and integrated verification and validation are two important elements in a plan for ensuring the safety of critical software systems. We describe an approach we are currently developing for integrating risk analysis, and metrics analysis, and propose a fault predictor that would integrate the results of these activities. Practical difficulties associated with our approach are also discussed, as are limitations of the proposed predictor. We conclude with a discussion of what as been learned to date, and with suggestions for future work.

  11. Scrubber and remote control system improves productivity and safety

    SciTech Connect

    Kust, J.

    1984-07-01

    The test program conducted at NREC No. 1 Mine clearly indicated that methane levels did not increase with greater depths of cut (up to 40 ft) and corresponding increases in the face-to-brattice distance and methane and respirable dust levels remained well within acceptable levels. By using the scrubber, remote control, and greater depth of cut, productivity is increased without any sacrifice to miner health and safety. Based on the test results, NREC recently received approval from MSHA to operate under a ventilation plan which allows a 40-ft cut and face-to-brattice distance of 40 ft when the scrubber is in operation.

  12. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...-identification at 45 CFR 164.514(a) through (c). ... 42 Public Health 1 2012-10-01 2012-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

  13. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...-identification at 45 CFR 164.514(a) through (c). ... 42 Public Health 1 2011-10-01 2011-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

  14. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...-identification at 45 CFR 164.514(a) through (c). ... 42 Public Health 1 2013-10-01 2013-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

  15. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...-identification at 45 CFR 164.514(a) through (c). ... 42 Public Health 1 2014-10-01 2014-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

  16. 30 CFR 250.804 - Production safety-system testing and records.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Production safety-system testing and records. 250.804 Section 250.804 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.804...

  17. 42 CFR 3.212 - Nonidentification of patient safety work product.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-identification at 45 CFR 164.514(a) through (c). ... 42 Public Health 1 2010-10-01 2010-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and...

  18. Westinghouse independent safety review of Savannah River production reactors

    SciTech Connect

    Leggett, W.D.; McShane, W.J. ); Liparulo, N.J.; McAdoo, J.D.; Strawbridge, L.E. . Nuclear and Advanced Technology Div.); Toto, G. . Nuclear Services Div.); Fauske, H.K. ); Call, D.W. (Westinghouse Savannah R

    1989-04-01

    Westinghouse Electric Corporation has performed a safety assessment of the Savannah River production reactors (K,L, and P) as requested by the US Department of Energy. This assessment was performed between November 1, 1988, and April 1, 1989, under the transition contract for the Westinghouse Savannah River Company's preparations to succeed E.I. du Pont de Nemours Company as the US Department of Energy contractor for the Savannah River Project. The reviewers were drawn from several Westinghouse nuclear energy organizations, embody a combination of commercial and government reactor experience, and have backgrounds covering the range of technologies relevant to assessing nuclear safety. The report presents the rationale from which the overall judgment was drawn and the basis for the committee's opinion on the phased restart strategy proposed by E.I. du Pont de Nemours Company, Westinghouse, and the US Department of Energy-Savannah River. The committee concluded that it could recommend restart of one reactor at partial power upon completion of a list of recommended upgrades both to systems and their supporting analyses and after demonstration that the organization had assimilated the massive changes it will have undergone.

  19. Impact of sedating antihistamines on safety and productivity.

    PubMed

    Kay, G G; Quig, M E

    2001-01-01

    The use of sedating antihistamines by allergy sufferers remains common, and physicians continue to prescribe these older antihistamines with great frequency. Precautionary statements warning of possible drowsiness and the need for caution when driving or operating machinery, which are required for sedating antihistamines, don't appear to be having much impact. Sedating antihistamines are frequently found to be a causal factor in fatal traffic accidents and are the leading medication found on autopsy of pilots who have crashed their aircraft. Patients taking sedating antihistamines frequently don't feel sleepy, yet they have difficulty staying awake and their brain functioning is impaired. The impact on safety is found in the increased risk of traumatic work-related injuries, driving accidents, and aviation fatalities. The cognitive and psychomotor deficits translate into losses in worker productivity and student learning. PMID:11715216

  20. Vector Design for Improved DNA Vaccine Efficacy, Safety and Production

    PubMed Central

    Williams, James A.

    2013-01-01

    DNA vaccination is a disruptive technology that offers the promise of a new rapidly deployed vaccination platform to treat human and animal disease with gene-based materials. Innovations such as electroporation, needle free jet delivery and lipid-based carriers increase transgene expression and immunogenicity through more effective gene delivery. This review summarizes complementary vector design innovations that, when combined with leading delivery platforms, further enhance DNA vaccine performance. These next generation vectors also address potential safety issues such as antibiotic selection, and increase plasmid manufacturing quality and yield in exemplary fermentation production processes. Application of optimized constructs in combination with improved delivery platforms tangibly improves the prospect of successful application of DNA vaccination as prophylactic vaccines for diverse human infectious disease targets or as therapeutic vaccines for cancer and allergy. PMID:26344110

  1. Impact of irradiation on the safety and quality of poultry and meat products: a review.

    PubMed

    O'Bryan, Corliss A; Crandall, Philip G; Ricke, Steven C; Olson, Dennis G

    2008-05-01

    For more than 100 years research on food irradiation has demonstrated that radiation will make food safer and improve the shelf life of irradiated foods. Using the current food safety technology, we may have reached the point of diminishing returns even though recent figures from the CDC show a significant drop in the number of foodborne illnesses. However, too many people continue to get sick and die from eating contaminated food. New and under utilized technologies such as food irradiation need to be re-examined to achieve new levels of safety for the food supply. Effects of irradiation on the safety and quality of meat and poultry are discussed. Irradiation control of the principle microbial pathogens including viruses, the differences among at-risk sub-populations, factors affecting the diminished rate of improvement in food safety and published D values for irradiating raw meat and poultry are presented. Currently permitted levels of irradiation are probably not sufficient to control pathogenic viruses. Typical gram-negative spoilage organisms are very sensitive to irradiation. Their destruction leads to a significant increase in the acceptable shelf life. In addition, the destruction of these normal spoilage organisms did not provide a competitive growth advantage for irradiation injured food pathogens. Another of the main focuses of this review is a detailed compilation of the effects of most of the food additives that have been proposed to minimize the negative quality effect of irradiation. Most of the antimicrobials and antioxidants used singly or in combination produced an increased lethality of irradiation and a decrease in oxidation by-products. Combinations of dosage, temperature, dietary and direct additives, storage temperature and packaging atmosphere can produce meats that the average consumer will find indistinguishable from non-irradiated meats. A discussion of the production of unique radiological by-products is also included. PMID:18464033

  2. 77 FR 74196 - Draft Guidance for Industry on Safety Considerations for Product Design To Minimize Medication...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-13

    ... Product Design To Minimize Medication Errors; Availability AGENCY: Food and Drug Administration, HHS... guidance for industry entitled ``Safety Considerations for Product Design to Minimize Medication Errors... using a systems approach to minimize medication errors relating to product design. The draft...

  3. 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)

  4. 16 CFR 1115.5 - Reporting of failures to comply with a voluntary consumer product safety standard relied upon by...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... voluntary consumer product safety standard relied upon by the Commission under section 9 of the CPSA. 1115.5 Section 1115.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT... with a voluntary consumer product safety standard relied upon by the Commission under section 9 of...

  5. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... of the paperwork requirements in the regulations under Subpart O, ``Well Control and Production... 250, Subpart O, Well Control and Production Safety Training. OMB Control Number: 1014-0008. Abstract... 30 CFR part 250, subpart O, Well Control and Production Safety Training. Responses are mandatory...

  6. The Readership of Liquor Ads Employing Appeals to Affiliation, Achievement, and Product-Attributes.

    ERIC Educational Resources Information Center

    Reid, Leonard N.; And Others

    A study examined whether advertising appeals based on product affiliation, achievement, and attributes would account for differences in male readership of liquor advertisements. The investigation focused on the relationship between the content of alcholic beverage advertisements and attention engagement, the first state in consumer information…

  7. Influence of School Climate on Students' Achievement and Teachers' Productivity for Sustainable Development

    ERIC Educational Resources Information Center

    Adeogun, A. A.; Olisaemeka, Blessing U.

    2011-01-01

    The study covers ten secondary schools in Lagos State of Nigeria. The purpose is to ascertain the relationship between school climate and student achievements and teachers' productivity for sustainable development. A total sample of 150 respondents was taken. Ten principals, seven teachers and seven students were randomly picked per school. This…

  8. Addendum: Factor Analysis of Explanatory Variables in an Achievement Production Function

    ERIC Educational Resources Information Center

    Phelps, James L.

    2011-01-01

    Combining explanatory variables into factors instead of using individual variables in an achievement production function is advocated in several of the articles in this special issue. This article provides a brief overview of factor analysis explaining and illustrating the reasoning for this technique. There is a linchpin: Factor analysis is an…

  9. Evaluation of the efficiency and safety in cosmetic products.

    PubMed

    Uckaya, Meryem; Uckaya, Fatih; Demir, Nazan; Demir, Yasar

    2016-02-29

    Chemicals used in cosmetics have to interact with enzymes for beneficial or destroy purpose after they enter in our body. Active sections of enzymes that catalyze reactions have three dimensions and they are active optically. When these limitations of catalytic sections are considered, it may be considered that defining geometric specifications of chemical materials and functional groups they contain may contribute on safety evaluations of cosmetic products. In this study, defining similarities and differences of geometric structures of chemicals that are prohibited to be used in cosmetic products and chemical that are allowed to be used by using group theory and analyze of functional groups that are often encountered in these chemicals are aimed. Molecule formulas related to chemical material of, 276 pieces chemicals that are prohibited to be used in cosmetic products and 65 pieces chemicals that are allowed, are used as the material. Two and three-dimension structures of these formulas are drawn and types and quantity of functional groups they contain are defined. And as a method, freeware (Free Trial) version of "Chem-BioOffice Ultra 13.0 Suite" chemical drawing program to draw two and three-dimension of formulas, "Campus-Licensed" version that are provided for use by our university of "Autodesk 3DS Max" for three-dimension drawings are used. In order to analyze geometric specifications of drawn molecules according to Group Theory and define type and quantity of available functional groups, Excel applications developed by Prof. Dr. Yaşar Demir are used. PMID:26773597

  10. [Discussion on agricultural product quality and safety problem from ecological view].

    PubMed

    Xiao, Ming; Dong, Nan; Lyu, Xin

    2015-08-01

    There are many different perspectives about the sustainable agriculture, which had been proposed since the last three decades in the world. While China's ecologists and agronomists proposed a similar concept named 'ecological agriculture'. Although ecological agriculture in China has achieved substantial progress, including theory, models and supporting technologies nearly several decades of practice and development, its application guidance still is not yet clear. The organic agriculture model proposed by European Union is popular, but it is limited in the beneficiary groups and the social and ecological responsibility. In this context, the article based on an ecological point of view, analyzed the shortcomings of ecological imbalance caused by a single mode of agricultural production and the negative impact on the quality of agricultural products, and discussed the core values of ecological agriculture. On this basis, we put forward the concept of sustainable security of agricultural products. Based on this concept, an agricultural platform was established under the healthy ecosysphere environment, and from this agricultural platform, agricultural products could be safely and sustainably obtained. Around the central value of the concept, we designed the agricultural sustainable and security production model. Finally, we compared the responsibility, benefiting groups, agronomic practices selection and other aspects of sustainable agriculture with organic agriculture, and proved the advancement of sustainable agricultural model in agricultural production quality and safety. PMID:26685623

  11. Safety Observations Achieve Results

    Energy Science and Technology Software Center (ESTSC)

    2000-01-16

    The SOAR web application provides a multi-checklist capability where focused observations can be created to address risk-likely work environments, tasks, etc. The SOAR web application has numerous reports to sort the data by key word, multiple factors (i.e., location, team, behavior, checklist, work environment, etc.), and the highest frequency of behaviors and error-likely predecessors, etc. Other performance indicators are also provided.

  12. [Ecological and food safety considerations about products of vegetable origin].

    PubMed

    Tapia de Daza, M S; Díaz, R V

    1994-12-01

    Media have paid much attention in recent years to emerging microbiological problems in foods of plant origin. The potential for contamination of fruits and vegetables is high because of the wide variety of conditions to which produce is exposed during growth, harvest, processing and distribution. These considerations acquire great significance in the current scenario of the new processing techniques that offer attributes of convenience and fresh-likeness in response to changes in consumption patterns and increased demand of fresh and minimally processed fruits and vegetables. Thus, reliance on low temperature storage and on improved packaging materials/techniques have increased. Even if produce had not been considered a major vector for foodborne diseases, technologies that extend shelf-life by decreasing the rate of product deterioration might increase the risks associated with pathogenic microorganisms, especially of psychotropic nature, by allowing sufficient time for their growth when retarding the development of competitive spoilage organisms. Processing steps that modify the food microenvironment open new possibilities to support pathogens that, for ecological reason, would have never been naturally present in produce. Ecological and safety aspects related to fruits and vegetables as well as foodborne disease outbreaks traceable to produce and reportedly due to Salmonella and Shigella spp., Listeria monocytogenes, Clostridium botulinum, Aeromonas hydrophila, Campylobacter jejuni are reviewed. PMID:8984963

  13. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

    ... From the Federal Register Online via the Government Publishing Office NUCLEAR REGULATORY COMMISSION Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...) is considering the issuance of a license to International Isotopes Fluorine Products, Inc., (IIFP...

  14. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 30 Mineral Resources 2 2013-07-01 2013-07-01 false Design, installation, and operation of surface production-safety systems. 250.802 Section 250.802 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production...

  15. 77 FR 61513 - Information Disclosure Under Section 6(b) of the Consumer Product Safety Act

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1101 Information Disclosure Under Section 6(b) of the Consumer Product Safety Act CFR..., on page 147, in Sec. 1101.25 (a) and (b), the words ``5 working'' are corrected to read...

  16. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA acceptance of equivalent non-MSHA product safety standards. 7.10 Section 7.10 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING BY APPLICANT OR THIRD PARTY General § 7.10 MSHA acceptance of equivalent...

  17. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Findings Under the Consumer Product Safety Act Appendix to Part 1213 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER...

  18. Improving Student Concern for Safety in a Production Technology Lab through the Use of Teambuilding.

    ERIC Educational Resources Information Center

    Lacina, Dale Robert

    The effectiveness of team building as a strategy for improving students' concern for safety in a production technology laboratory was examined in a study involving a group of grade 9 and 10 production technology students from an urban, lower-middle-class community in western Illinois. Students' safety test scores, teacher checklists, and…

  19. Evaluation of the safety assurance level for Salmonella spp. throughout the food production chain in Switzerland.

    PubMed

    Sauli, I; Danuser, J; Wenk, C; Stärk, K D C

    2003-07-01

    In Switzerland. the safeguarding of food is the responsibility of industry, organizations, and governmental authorities. The dispersion of the tasks and the diversity of implemented safety measures among involved stakeholders do not allow a general overview of the national safety assurance level provided. A comprehensive evaluation of the level of safety assurance provided for foodborne pathogens such as Salmonella spp. is therefore lacking, and the prevalence of Salmonella spp. at various points in the food production chain is not known. The objectives of this study were to (i) collect data on safety measures implemented throughout the food production chain in Switzerland regarding Salmonella spp.; (ii) evaluate the safety assurance level for Salmonella spp. at each step of the production chain for chicken meat, pork, beef, and milk and dairy products (bovine origin); and (iii) gather data on the prevalence of the pathogen at each step. Data on implemented safety assurance measures for Salmonella spp. were gathered from the various stakeholders in the food production chain. The data were analyzed by a semiquantitative method that considered the quality and relevance of the implemented safety measures for Salmonella spp. The safety assurance level for Salmonella spp. was evaluated from "no safety assurance" to "very good safety assurance." Available results of testing for Salmonella spp. from 1998 to 2000 were used for calculating the prevalence of the pathogen throughout the food production chain. The results showed a varying safety assurance level for Salmonella spp. throughout the food production chain. Strengths (e.g., feed production for chickens) and weaknesses (e.g., pork production) were observed. These results serve as a basis for a rational optimization of the system. PMID:12870745

  20. Gross domestic product, science interest, and science achievement: a person × nation interaction.

    PubMed

    Tucker-Drob, Elliot M; Cheung, Amanda K; Briley, Daniel A

    2014-11-01

    Maximizing science achievement is a critical target of educational policy and has important implications for national and international economic and technological competitiveness. Previous research has identified both science interest and socioeconomic status (SES) as robust predictors of science achievement, but little research has examined their joint effects. In a data set drawn from approximately 400,000 high school students from 57 countries, we documented large Science Interest × SES and Science Interest × Per Capita Gross Domestic Product (GDP) interactions in the prediction of science achievement. Student interest in science is a substantially stronger predictor of science achievement in higher socioeconomic contexts and in higher-GDP nations. Our results are consistent with the hypothesis that in higher-opportunity contexts, motivational factors play larger roles in learning and achievement. They add to the growing body of evidence indicating that substantial cross-national differences in psychological effect sizes are not simply a logical possibility but, in many cases, an empirical reality. PMID:25304883

  1. Preventative safety management supported by an emergency response system for sour gas production in North Germany

    SciTech Connect

    Grossmann, U.M.; Schoenbach, H.C.

    1996-12-31

    In general, the onshore production of oil and gas in North place in densely populated areas. Approximately 800 MMSCFD of gas are produced from sour gas reservoirs, with H{sub 2}S-concentrations of up to 20 Vol.-% being involved. Despite a high technical safety standard and different organizational measures in the production of sour gas, emergency cases cannot be absolutely ruled out. H{sub 2}S concentrations of more than 700 ppm will cause immediate death. In Germany the production of hydrocarbons is regulated by the Federal Mining Law. According to these regulations an extensive gas protection plan and gas alarm plan have to be set up for sour gas operations. This includes establishing an emergency response organization and a gas alarm management guide. Beyond the legal requirements Mobil Erdgas-Erdoel GmbH (MEEG) has implemented an emergency response management system in compliance with Mobil Oil`s worldwide safety philosophy to minimize the risk for the population, the employees and the environment. The installation of two electronic data systems enables the crisis management team to respond faster, more safely and in a less complicated manner to accidental sour gas releases. The introduction of the Emergency Information and Response System (EMIS) makes possible the display and manipulation of maps in different scales and geographically oriented data. The expansion of the process master computer by installing an H{sub 2}S-Gas alarm system has achieved the online measurements of H{sub 2}S concentrations, wind direction and wind velocity at sour gas production facilities. The system, which is operated at the gas dispatcher center, gives the crisis response team the opportunity to predict the location of sour gas release and the area being impacted. Consequently rescue parties will be directed to the location in a safe manner and, if necessary, measures will be managed for evacuating the residents living in the danger zones around sour gas facilities.

  2. Spatio-temporal elements of articulation work in the achievement of repeat prescribing safety in UK general practice.

    PubMed

    Grant, Suzanne; Mesman, Jessica; Guthrie, Bruce

    2016-02-01

    Prescribing is the most common healthcare intervention, and is both beneficial and risky. An important source of risk in UK general practice is the management of 'repeat prescriptions', which are typically requested from and issued by non-clinically trained reception staff with only intermittent reauthorisation by a clinical prescriber. This paper ethnographically examines the formal and informal work employed by GPs and receptionists to safely conduct repeat prescribing work in primary care using Strauss's (1985, 1988, 1993) concept of 'articulation work' across eight UK general practices. The analytical lens of articulation work provided an investigative framing to contextually map the informal, invisible resources of resilience and strength employed by practice team members in the achievement of repeat prescribing safety, where risk and vulnerability were continually relocated across space and time. In particular, the paper makes visible the micro-level competencies and collaborative practices that were routinely employed by both GPs and receptionists across different socio-cultural contexts, with informal, cross-hierarchical communication usually considered more effective than the formal structures of communication that existed (e.g. protocols). While GPs held formal prescribing authority, this paper also examines the key role of receptionists in both the initiation and safe coordination of the repeat prescribing routine. PMID:26283462

  3. Production of Biodiesel at Kinetic Limit Achieved in a Centrifugal Reactor/Separator

    SciTech Connect

    McFarlane, Joanna; Tsouris, Costas; Birdwell Jr, Joseph F; Lee, Denise L; Jennings, Hal L; Pahmer Boitrago, Amy M; Terpstra, Sarah M

    2010-01-01

    The kinetics of the transesterification of soybean oil has been investigated in a centrifugal reactor at temperatures from 45 to 80 C and pressures up to 2.6 bar using gas chromatography flame ionization detection (GC-FID) and infrared (IR) spectroscopy. The yields of product methyl esters were quantified using IR, proton Nuclear Magnetic Resonance (H1NMR), and viscosity measurements and were found to achieve 90% of the yield in 2 min; however, to meet ASTM specifications with one pass through the reactor, a 15 min residence time was needed. Performance was improved by sequential reactions, allowing separation of by-product glycerine and injection of additional small aliquots of methanol. The kinetics was modeled using a three-step mechanism of reversible reactions, which was used to predict performance at commercial scale. The mechanism correctly predicted the exponential decline in reaction rate as the concentration of the products allowed significant reverse reactions to occur.

  4. Safety Issues at the Defense Production Reactors. A Report to the U.S. Department of Energy.

    ERIC Educational Resources Information Center

    National Academy of Sciences - National Research Council, Washington, DC. Commission on Physical Sciences, Mathematics, and Resources.

    This report provides an assessment of safety management, safety review, and safety methodology employed by the Department of Energy (DOE) and private contractors. Chapter 1, "The DOE Safety Framework," examines safety objectives for production reactors and processes to implement the objectives. Chapter 2, "Technical Issues," focuses on a variety…

  5. Part I. Fuel-motion diagnostics in support of fast-reactor safety experiments. Part II. Fission product detection system in support of fast reactor safety experiments

    SciTech Connect

    Devolpi, A.; Doerner, R.C.; Fink, C.L.; Regis, J.P.; Rhodes, E.A.; Stanford, G.S.; Braid, T.H.; Boyar, R.E.

    1986-05-01

    In all destructive fast-reactor safety experiments at TREAT, fuel motion and cladding failure have been monitored by the fast-neutron/gamma-ray hodoscope, providing experimental results that are directly applicable to design, modeling, and validation in fast-reactor safety. Hodoscope contributions to the safety program can be considered to fall into several groupings: pre-failure fuel motion, cladding failure, post-failure fuel motion, steel blockages, pretest and posttest radiography, axial-power-profile variations, and power-coupling monitoring. High-quality results in fuel motion have been achieved, and motion sequences have been reconstructed in qualitative and quantitative visual forms. A collimated detection system has been used to observe fission products in the upper regions of a test loop in the TREAT reactor. Particular regions of the loop are targeted through any of five channels in a rotatable assembly in a horizontal hole through the biological shield. A well-type neutron detector, optimized for delayed neutrons, and two GeLi gamma ray spectrometers have been used in several experiments. Data are presented showing a time history of the transport of Dn emitters, of gamma spectra identifying volatile fission products deposited as aerosols, and of fission gas isotopes released from the coolant.

  6. 78 FR 59632 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-27

    ... proposed rulemaking on production safety systems on August 22, 2013 (78 FR 52240). The proposed rule would... Bureau of Safety and Environmental Enforcement 30 CFR Part 250 RIN 1014-AA10 Oil and Gas and Sulphur Operations on the Outer Continental Shelf--Oil and Gas Production Safety Systems AGENCY: Bureau of Safety...

  7. Health, safety, and ecological implications of using biobased floor-stripping products.

    PubMed

    Massawe, Ephraim; Geiser, Kenneth; Ellenbecker, Michael; Marshall, Jason

    2007-05-01

    The main objective of the study reported here was to investigate the ecological, health, and safety (EHS) implications of using biobased floor strippers as alternatives to solvent-based products such as Johnson Wax Professional (Pro Strip). The authors applied a quick EHS-scoring technique developed by the Surface Solution Laboratory (SSL) of the Toxics Use Reduction Institute (TURI) to some alternative, biobased products that had previously performed as well as or close to as well as the currently used product. The quick technique is considered an important step in EHS assessment, particularly for toxics use reduction planners and advocates who may not have the resources to subject many alternative products or processes at once to detailed EHS analysis. Taking this step narrows available options to a manageable number. (Technical-performance experiments were also conducted, but the results are not discussed or reported in this paper). The cost of switching to biobased floor strippers was assessed and compared with the cost of using the traditional product, both at full strength and at the dilution ratios recommended by the respective manufacturers. The EHS analysis was based on a framework consisting of five parameters: volatile organic compounds (VOCs); pH; global-warming potential (GWP); ozone depletion potential (ODP); and safety scores in areas such as flammability, stability, and special hazards, based on ratings from the Hazardous Material Classification System (HMIS) and the National Fire Protection Association (NFPA). Total EHS scores were calculated with data derived from the material safety data sheets. For most cleaning products previously investigated by the TURI SSL, the investigators have demonstrated that the five key parameters used in the study reported here can successfully be used for quick screening of the EHS impacts of cleaning alternatives. All eight biobased, or green, products evaluated in the study had better EHS-screening scores than did

  8. Toward an understanding of the impact of production pressure on safety performance in construction operations.

    PubMed

    Han, Sanguk; Saba, Farzaneh; Lee, Sanghyun; Mohamed, Yasser; Peña-Mora, Feniosky

    2014-07-01

    It is not unusual to observe that actual schedule and quality performances are different from planned performances (e.g., schedule delay and rework) during a construction project. Such differences often result in production pressure (e.g., being pressed to work faster). Previous studies demonstrated that such production pressure negatively affects safety performance. However, the process by which production pressure influences safety performance, and to what extent, has not been fully investigated. As a result, the impact of production pressure has not been incorporated much into safety management in practice. In an effort to address this issue, this paper examines how production pressure relates to safety performance over time by identifying their feedback processes. A conceptual causal loop diagram is created to identify the relationship between schedule and quality performances (e.g., schedule delays and rework) and the components related to a safety program (e.g., workers' perceptions of safety, safety training, safety supervision, and crew size). A case study is then experimentally undertaken to investigate this relationship with accident occurrence with the use of data collected from a construction site; the case study is used to build a System Dynamics (SD) model. The SD model, then, is validated through inequality statistics analysis. Sensitivity analysis and statistical screening techniques further permit an evaluation of the impact of the managerial components on accident occurrence. The results of the case study indicate that schedule delays and rework are the critical factors affecting accident occurrence for the monitored project. PMID:24184131

  9. Hyperspectral imaging for safety inspection of food and agricultural products

    NASA Astrophysics Data System (ADS)

    Lu, Renfu; Chen, Yud-Ren

    1999-01-01

    Development of effective food inspection systems is critical in successful implementation of the hazard analysis and critical control points (HACCP) program. Hyperspectral imaging or imaging spectroscopy, which combines techniques of imaging and spectroscopy to acquire spatial and spectral information simultaneously, has great potential in food quality and safety inspection. This paper reviewed the basic principle and features of hyperspectral imaging and its hardware and software implementation. The potential areas of application for hyperspectral imaging in food quality and safety inspection were identified and its limitations were discussed. A hyperspectral imaging system developed for research in food quality and safety inspection was described. Experiments were performed to acquire hyperspectral images from four classes of poultry carcasses: normal, cadaver, septicemia, and tumor. Noticeable differences in the spectra of the relative reflectance and its second difference in the wavelengths between 430 nm and 900 nm were observed between wholesome and unwholesome carcasses. Differences among the three classes of unwholesome carcasses were also observed from their respective spectra. These results showed that hyperspectral imaging can be an effective tool for safety inspection of poultry carcasses.

  10. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  11. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  12. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  13. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... CFR part 1212. This definition includes products that are referred to as micro-torches. Multi-purpose... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the...

  14. Technical Communications and the Law: Product Liability and Safety Labels.

    ERIC Educational Resources Information Center

    Smith, Herb

    1990-01-01

    Suggests that the product liability issues of inadequate warnings and inadequate instructions are particularly important to technical communicators. Examines the relationship between warranties and product liability. Discusses American National Standards Institute (ANSI) guidelines and other resources that provide information on product liability…

  15. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 14 Aeronautics and Space 4 2011-01-01 2011-01-01 false Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety System A Appendix A to Part 417 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Pt. 417, App....

  16. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety System A Appendix A to Part 417 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Pt. 417, App....

  17. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety System A Appendix A to Part 417 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Pt. 417, App....

  18. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety System A Appendix A to Part 417 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING LAUNCH SAFETY Pt. 417, App....

  19. Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

    PubMed

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

    Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system. PMID:27357039

  20. Achieving waste to energy through sewage sludge gasification using hot slags: syngas production

    NASA Astrophysics Data System (ADS)

    Sun, Yongqi; Nakano, Jinichiro; Liu, Lili; Wang, Xidong; Zhang, Zuotai

    2015-06-01

    To relieve the environmental issues of sewage sludge (SS) disposal and greenhouse gas (GHG) emission in China, we proposed an integrated method for the first time to simultaneously deal with these two problems. The hot slags below 920 °C could act as a good heat carrier for sludge gasification and the increasing CO2 concentration in CO2/O2 atmospheres enhanced the production of CO and H2 at 400-800 °C. Three stages of syngas release were clearly identified by Gaussian fittings, i.e., volatile release, char transformation and fixed carbon reaction. Additionally, the effect of sulfur retention of slags and the synergy effect of the stabilization of toxic elements in the solid residuals were discovered in this study. Furthermore, a novel prototype of multiple industrial and urban systems was put forward, in which the produced CO + H2 could be utilized for direct reduced iron (DRI) production and the solid residuals of sludge ash and glassy slags would be applied as cementitious materials. For a steel plant with an annual production of crude steel of 10 million tons in China, the total annual energy saving and GHG emission reduction achieved are 3.31*105 tons of standard coal and 1.74*106 tons of CO2, respectively.

  1. Achieving waste to energy through sewage sludge gasification using hot slags: syngas production.

    PubMed

    Sun, Yongqi; Nakano, Jinichiro; Liu, Lili; Wang, Xidong; Zhang, Zuotai

    2015-01-01

    To relieve the environmental issues of sewage sludge (SS) disposal and greenhouse gas (GHG) emission in China, we proposed an integrated method for the first time to simultaneously deal with these two problems. The hot slags below 920 °C could act as a good heat carrier for sludge gasification and the increasing CO2 concentration in CO2/O2 atmospheres enhanced the production of CO and H2 at 400-800 °C. Three stages of syngas release were clearly identified by Gaussian fittings, i.e., volatile release, char transformation and fixed carbon reaction. Additionally, the effect of sulfur retention of slags and the synergy effect of the stabilization of toxic elements in the solid residuals were discovered in this study. Furthermore, a novel prototype of multiple industrial and urban systems was put forward, in which the produced CO + H2 could be utilized for direct reduced iron (DRI) production and the solid residuals of sludge ash and glassy slags would be applied as cementitious materials. For a steel plant with an annual production of crude steel of 10 million tons in China, the total annual energy saving and GHG emission reduction achieved are 3.31*10(5) tons of standard coal and 1.74*10(6) tons of CO2, respectively. PMID:26074060

  2. Achieving waste to energy through sewage sludge gasification using hot slags: syngas production

    PubMed Central

    Sun, Yongqi; Nakano, Jinichiro; Liu, Lili; Wang, Xidong; Zhang, Zuotai

    2015-01-01

    To relieve the environmental issues of sewage sludge (SS) disposal and greenhouse gas (GHG) emission in China, we proposed an integrated method for the first time to simultaneously deal with these two problems. The hot slags below 920 °C could act as a good heat carrier for sludge gasification and the increasing CO2 concentration in CO2/O2 atmospheres enhanced the production of CO and H2 at 400–800 °C. Three stages of syngas release were clearly identified by Gaussian fittings, i.e., volatile release, char transformation and fixed carbon reaction. Additionally, the effect of sulfur retention of slags and the synergy effect of the stabilization of toxic elements in the solid residuals were discovered in this study. Furthermore, a novel prototype of multiple industrial and urban systems was put forward, in which the produced CO + H2 could be utilized for direct reduced iron (DRI) production and the solid residuals of sludge ash and glassy slags would be applied as cementitious materials. For a steel plant with an annual production of crude steel of 10 million tons in China, the total annual energy saving and GHG emission reduction achieved are 3.31*105 tons of standard coal and 1.74*106 tons of CO2, respectively. PMID:26074060

  3. [Assessment of rice achievable productivity and its application in rice production management division: a case study in Fuyang County of Zhejiang Province, East China].

    PubMed

    Wu, Hao-Xiang; Jiang, Yu-Gen; Chen, Jian-Ming; Dai, Yong-Yi; He, Xu-Hua; Qiu, Xi-Ya

    2011-11-01

    Rice productivity is the key factor affecting rice production and its sustainable development. Based on the gradation of cultivated land quality at county-level, this paper evaluated the rice productivity in Fuyang County of Zhejiang Province, and, through selected sampling field investigation and according to the land productivity index of paddy field quality, a model for assessing rice achievable productivity was established, aimed to analyze the regional rice productivity and its achievable productivity. In the study area, there was a positive correlation between the land productivity index and rice yield. For single cropping rice, its achievable productivity was 1.70 x 10(5) t, being 1.6 times of its realistic productivity (1.04 x 10(5) t). In 2009, the realistic rice productivity per unit area was 7676 kg x hm(-2), and the achievable productivity was 8831 kg x hm(-2), with a production potentiality of +15%, a big potential of rice production capacity in the county. Through the analyses of rice productivity, relative superiority of rice production scale, and its growth potential index in the villages and towns, the rice production of Fuyang County was divided into three regions, i. e., key enhancement region, optimization construction region, and development protection region. PMID:22303662

  4. Is it possible to "achieve a balance" and meet the "safety net"? Paediatric Advisory Subcommittee to the North West Thames Regional Health Authority.

    PubMed

    Jones, S A; Kovar, I; Williams, M; Bentley, D

    1989-09-30

    The government's document Hospital Medical Staffing--Achieving a Balance--Plan for Action introduced the concept of a "safety net"--that is, a minimum safe level of staffing--of junior doctors in the acute specialties. The North West Thames Paediatric Advisory Group has therefore reviewed the implications and consequences of implementing the safety net in respect of children's services. The group found that if a reasonable safety net was to be provided that enabled the services to stay within the projected junior staffing levels, maintain a balance, meet training needs, and reduce junior doctors' hours of work, then changes in the organisation of the services would be required. Examining the options available showed that to achieve a safety net within the projected numbers of junior staff at least six paediatric units in the region would have to close. It is doubtful if there is the political will to support the very radical changes that would be needed in the distribution of services if the government's recommendations in Achieving a Balance were to be implemented. The profession, the Department of Health, and the public must be made aware that the proposed changes in medical staffing will cause a fundamental change in the traditional pattern of delivery of health care. PMID:2510851

  5. The moderating effects of task complexity on the relationship between regulatory foci and safety and production performance.

    PubMed

    Wallace, J Craig; Little, Laura M; Shull, Amanda

    2008-04-01

    Regulatory foci of promotion and prevention have been shown to relate differentially to occupational safety and production. This research proposes that task complexity can help explain the differences reported between these 2 self-regulatory processes and safety and productivity performance. Results revealed that promotion is positively related to production and prevention is positively related to safety regardless of task complexity. However, when task complexity is high, promotion negatively relates to safety and prevention negatively relates production. Implications for work motivation theory and research, as well as avenues for future research, are discussed. Practical implications for managerial interventions to optimize both safety and productivity are also presented. PMID:18393579

  6. Postharvest intervention technologies for safety enhancement of meat and meat based products; a critical review.

    PubMed

    Sohaib, Muhammad; Anjum, Faqir Muhammad; Arshad, Muhammad Sajid; Rahman, Ubaid Ur

    2016-01-01

    Globally, the demand for safe, healthy and nutritious meat and allied products possesses improved taste with extended shelf life is mounting. Microbial safety is among the imperative challenges that prevails in meat products because they provide an ideal medium for the growth of microorganisms particularly pathogenic bacteria. The incidence of these microbes can result quality deterioration of products leading towards food borne diseases when consumed by peoples. Several preservation technologies like chemical and biological interventions are effective to retard or inactivate the growth of micro-organisms most commonly related to food-borne diseases. Despite these, innovative approaches like hydrostatic pressure processing, active packaging, pulse electric field, hurdle approach and use of natural antimicrobials can be deployed to enhance the safety of meat and meat products. The objective of review is to describe the current approaches and developing technologies for enhancing safety of meat and allied meat products. PMID:26787929

  7. Safety.

    ERIC Educational Resources Information Center

    Education in Science, 1996

    1996-01-01

    Discusses safety issues in science, including: allergic reactions to peanuts used in experiments; explosions in lead/acid batteries; and inspection of pressure vessels, such as pressure cookers or model steam engines. (MKR)

  8. 78 FR 10181 - Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-13

    ... Medical Product Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... ``Global Quality Systems--An Integrated Approach to Improving Medical Product Safety.'' This 2-day public... Safety of our Drugs and Devices--the Complex Reality. Nanotechnology. Drug and Medical Device...

  9. 76 FR 48941 - Notification of Petition for Approval; Product Safety Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-09

    ... Railroad Administration (FRA) approval of a Product Safety Plan (PSP) submitted pursuant to 49 CFR part 236... approval of a PSP for the Railsoft TrackAccess System. The TrackAccess System is a processor- based... productivity. Marquette asserts the PSP demonstrates that the TrackAccess System has been designed in a...

  10. Dangerous Products, Dangerous Places: An AARP Report on Home Safety and Older Consumers.

    ERIC Educational Resources Information Center

    Fise, Mary Ellen R.

    This report was written to identify the safety problems confronting older persons and to educate readers about product and home hazards and appropriate preventive measures. It was written for older consumers, their families, policymakers, and manufacturers. Information on the incidence of home accidents and consumer product accidents among the…

  11. Special report. New products that improve officer performance, safety.

    PubMed

    1991-12-01

    The need for products that improve performance of security officers is counterbalanced these days by budgetary constraints. While this may limit major investments in security systems and personnel, less costly improvements or innovations might be worth considering. In this report, we will discuss four advances that may be valuable not only in hospital security, but in other industries as well. One of them, a smoke filter, was originally developed for the hotel industry. Another, a drug detection device, may replace the use of undercover agents or drug-sniffing' dogs in certain circumstances. The third new product is an economical patrol vehicle for parking facilities which might replace more costly vehicles such as golf carts or cars. The fourth product, a roving CCTV camera, is actually being tested at a Midwest medical center and may allow you to monitor areas of parking garages with cameras instead of officers on patrol. PMID:10116406

  12. Genetic improvement of drought tolerance for productivity and food safety

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Production losses in agriculture during extended or severe drought episodes can be significant. Among a number of important food crops in the U.S. and many regions of the world, peanut is an important legume that is a rich source for oil, proteins, and vitamins. Drought can negatively affect yield...

  13. Safety evaluation of a natural eggshell membrane-derived product.

    PubMed

    Ruff, Kevin J; Endres, John R; Clewell, Amy E; Szabo, James R; Schauss, Alexander G

    2012-03-01

    Natural Eggshell Membrane (NEM®) is a novel dietary ingredient that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. NEM® was evaluated for safety via in vitro and in vivo toxicological studies. This included testing for cytotoxicity, genotoxicity, acute oral toxicity, and 90-day repeated-dose oral toxicity. NEM® did not exhibit any cytotoxic effects at a dose of 100 μg in an in vitro human cell viability assay after incubation for up to 20 h. NEM® did not exhibit any genotoxic effects in an in vitro assay of four strains of histidine-dependent Salmonella typhimurium and one strain of tryptophan-dependent Escherichia coli at a dose of up to 5000 μg/plate. NEM® did not exhibit any signs of acute toxicity in rats at a single oral dose of up to 2000 mg/kg body weight, nor signs of toxicity (via urinalysis, hematology, clinical chemistry, or histopathological evaluation) in rats at a repeated oral dose of up to 2000 mg/kg body weight per day for 90 days. The results of these studies suggest that NEM® may be safe for human consumption. PMID:22245377

  14. Draft safety review plan for accelerator production of tritium (APT) project

    SciTech Connect

    1997-07-01

    The purpose of this ``living`` Safety Review Plan (SRP) is to describe the products and processes that will be followed to conduct a systematic review of the Accelerator Production of Tritium (APT) Facility Preliminary Safety Analysis Report (PSAR), and subsequently to prepare a draft Safety Evaluation Report (SER) on the PSAR. This plan is prepared for and will be implemented by the APT Independent Safety Review Committee (ISRC) over the period July 1, 1997 through September 30, 1998, in accordance with provisions established in DOE-STD-1104-96. A core team of DOE, INEEL, and AMPARO Corporation engineers and scientists will prepare the initial draft SER with assistance from other ISRC team members on an as needed basis. Guidelines for preparing the draft SER are presented in Section 7 of this SRP. The PSAR reviews will focus exclusively on safety. The ever-present two-part question will be: Does the subject matter have safety significance? If so, does the APT structural, system, component, and/or process engineering design ensure an acceptable margin of safety? The APT mission, efficiency, and cost are not considerations of this plan. A more detailed discussion of the review philosophy is presented in Section 5 of this SRP.

  15. The safety and regulation of natural products used as foods and food ingredients.

    PubMed

    Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

    2011-10-01

    The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements. PMID:21821733

  16. [Universal implementation of pathogen inactivation in labile blood products is a major step towards transfusion safety].

    PubMed

    Cazenave, Jean-Pierre

    2010-12-01

    Transfusion of labile blood products (red cell concentrates, platelet concentrates and plasma) is vital in the absence of alternatives. Patients and doctors have always feared infections transmitted by blood, blood components and blood-derived drugs. It is potentially dangerous to delay implementation of pathogen inactivation in labile blood products pending a perfect process. Universal implementation of pathogen inactivation in labile blood products is a major step towards transfusion safety. PMID:22043595

  17. Handover--Enabling Learning in Communication for Safety (HELiCS): a report on achievements at two hospital sites.

    PubMed

    Iedema, Rick; Merrick, Eamon T; Kerridge, Ross; Herkes, Robert; Lee, Bonne; Anscombe, Mike; Rajbhandari, Dorrilyn; Lucey, Mark; White, Les

    2009-06-01

    Clinical handover is an area of critical concern, because deficiencies in handover pose a patient safety risk. Redesign of handover must allow for input from frontline staff to ensure that designs fit into existing practices and settings. The HELiCS (Handover--Enabling Learning in Communication for Safety) tool uses a "video-reflexive" technique: handover encounters are videotaped and played back to the practitioners involved for analysis and discussion. Using the video-reflexive process, staff of an emergency department and an intensive care unit at two different tertiary hospitals redesigned their handover processes. The HELiCS study gave staff greater insight into previously unrecognised clinical and operational problems, enhanced coordination and efficiency of care, and strengthened junior-senior communication and teaching. Our study showed that reflexive and "bottom-up" handover redesign can produce outcomes that harbour local fit, practitioner ownership and (to date) sustainability. PMID:19485862

  18. Investigational new drug safety reporting requirements for human drug and biological products and safety reporting requirements for bioavailability and bioequivalence studies in humans. Final rule.

    PubMed

    2010-09-29

    The Food and Drug Administration (FDA) is amending its regulations governing safety reporting requirements for human drug and biological products subject to an investigational new drug application (IND). The final rule codifies the agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implements internationally harmonized definitions and reporting standards. The revisions will improve the utility of IND safety reports, reduce the number of reports that do not contribute in a meaningful way to the developing safety profile of the drug, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, subject bioavailability and bioequivalence studies to safety reporting requirements, promote a consistent approach to safety reporting internationally, and enable the agency to better protect and promote public health. PMID:20879180

  19. Solving a product safety problem using a recycled high density polyethylene container

    NASA Technical Reports Server (NTRS)

    Liu, Ping; Waskom, T. L.

    1993-01-01

    The objectives are to introduce basic problem-solving techniques for product safety including problem identification, definition, solution criteria, test process and design, and data analysis. The students are given a recycled milk jug made of high density polyethylene (HDPE) by blow molding. The objectives are to design and perform proper material test(s) so they can evaluate the product safety if the milk jug is used in a certain way which is specified in the description of the procedure for this investigation.

  20. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid.

    PubMed

    Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D

    2015-12-01

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids and other potential carcinogens can contaminate these products. As herbal and food supplement producers are left to their own means to determine the safety and purity of their products prior to marketing, disturbingly often good marketing practices currently in place are ignored and content is largely undocumented. Historical examples of poisoning and health issues relating to plant material containing dehydopyrrolizidine alkaloids and aristolochic acids were used as examples to demonstrate the risk and potential toxicity of herbal products, food supplements, or traditional medicines. More work is needed to educate consumers of the potential risk and require the industry to be more responsible to verify the content and insure the safety of their products. PMID:26152912

  1. Comparing Occupational Health and Safety Management System Programming with Injury Rates in Poultry Production.

    PubMed

    Autenrieth, Daniel A; Brazile, William J; Douphrate, David I; Román-Muñiz, Ivette N; Reynolds, Stephen J

    2016-01-01

    Effective methods to reduce work-related injuries and illnesses in animal production agriculture are sorely needed. One approach that may be helpful for agriculture producers is the adoption of occupational health and safety management systems. In this replication study, the authors compared the injury rates on 32 poultry growing operations with the level of occupational health and safety management system programming at each farm. Overall correlations between injury rates and programming level were determined, as were correlations between individual management system subcomponents to ascertain which parts might be the most useful for poultry producers. It was found that, in general, higher levels of occupational health and safety management system programming were associated with lower rates of workplace injuries and illnesses, and that Management Leadership was the system subcomponent with the strongest correlation. The strength and significance of the observed associations were greater on poultry farms with more complete management system assessments. These findings are similar to those from a previous study of the dairy production industry, suggesting that occupational health and safety management systems may hold promise as a comprehensive way for producers to improve occupational health and safety performance. Further research is needed to determine the effectiveness of such systems to reduce farm work injuries and illnesses. These results are timely given the increasing focus on occupational safety and health management systems. PMID:27409413

  2. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG... Compounded Drug Products § 216.24 Drug products withdrawn or removed from the market for reasons of safety or..., and Cosmetic Act: Adenosine phosphate: All drug products containing adenosine phosphate....

  3. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG... Compounded Drug Products § 216.24 Drug products withdrawn or removed from the market for reasons of safety or..., and Cosmetic Act: Adenosine phosphate: All drug products containing adenosine phosphate....

  4. Establishment and implementation of common product assurance and safety requirements for the contractors of the Columbus programme

    NASA Astrophysics Data System (ADS)

    Wessels, H.; Stephan, H. J.

    1991-08-01

    When establishing the Columbus Product Assurance (PA)/safety requirements, the international environment of the Space Station Freedom program has to be taken into account. Considerations given to multiple ways of requirement definition and stages within the European Space Agency (ESA) Procedures, Specifications, and Standards (PSS-01) series of documents and the NASA Space Station requirements are discussed. A series of adaptations introduced by way of tailoring the basic ESA and NASA requirement sets to the Columbus program's needs are described. For the implementation of these tailored requirements, a scheme is developed, which recognizes the PA/safety approach within the European industries by way of various company handbooks and manuals. The changes introduced in the PSS-01 series and the applicable NASA Space Station requirements in recent years, has coincided with the establishment of Columbus PA/safety requirements. To achieve the necessary level of cooperation between ESA and the Columbus industries, a PA Working Group (PAWG) is established. The PAWG supervises the establishement of the Common PA/Safety Plan and the Standards to be used. Due to the high number of European industries participating in the Columbus program, a positive influence on the evolution of the industrial approaches in PA/safety can be expected. Cooperation in the PAWG has brought issues to light which are related to the ESA PSS-01 series and its requirements. Due to the rapid changes of recent years, basic company documentation has not followed the development, specifically as various recent ESA projects use different project specifc issues of the evolving PSS-01 documents.

  5. Shelf life and safety concerns of bakery products--a review.

    PubMed

    Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

    2004-01-01

    Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail. PMID:15077880

  6. The Achievement Productivity of Psychological Variables: A Replication and Extension in Rajasthan, India.

    ERIC Educational Resources Information Center

    Walberg, Herbert J.; And Others

    1984-01-01

    Analysis of achievement test scores of 439 tenth-grade students found the hypothesized variables of IQ, socioeconomic status (SES), self-rated motivation, peer-rated studiousness, peer-group status, and parent-rated home environment contributed uniquely to achievement variance; SES, sex, and language medium of instruction were superfluous in the…

  7. Construction of Traceability System for Quality Safety of Cereal and Oil Products

    NASA Astrophysics Data System (ADS)

    Zheng, Huoguo; Liu, Shihong; Meng, Hong; Hu, Haiyan

    After several significant food safety incident, global food industry and governments in many countries are putting increasing emphasis on establishment of food traceability systems. Food traceability has become an effective way in food quality and safety management. The traceability system for quality safety of cereal and oil products was designed and implemented with HACCP and FMECA method, encoding, information processing, and hardware R&D technology etc, according to the whole supply chain of cereal and oil products. Results indicated that the system provide not only the management in origin, processing, circulating and consuming for enterprise, but also tracing service for customers and supervisor by means of telephone, internet, SMS, touch machine and mobile terminal.

  8. It's No Accident: A Consumer Product Safety Education Curriculum Resource Guide for Teachers of Grades 3 through 6.

    ERIC Educational Resources Information Center

    Consumer Product Safety Commission, Washington, DC.

    This guide for teachers contains product safety information appropriate for young children and suggests learning activities for third through sixth graders. Activities encourage children to examine their home environments for safety hazards and to share this information with family and friends. Unit 1 introduces five basic safety concepts upon…

  9. The European space suit, a design for productivity and crew safety.

    PubMed

    Skoog, A I; Berthier, S; Ollivier, Y

    1991-01-01

    In order to fulfill the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today--and will be for several years--a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: easy donning/doffing thru rear entry, suit ergonomy optimisation, display of operational information in alpha-numerical and graphical form, and voice processing for operations and safety critical information. Concerning crew safety the major design features are: a lower R-factor for emergency EVA operations thru increased suit pressure, zero prebreath conditions for normal operations, visual and voice processing of all safety critical functions, and an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System. PMID:11537126

  10. 77 FR 64374 - Notification of Petition for Approval; Port Authority Trans-Hudson Product Safety Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-19

    ... a Product Safety Plan (PSP). FRA assigned the petition Docket Number FRA-2012-0075. PATH is... maintenance costs. PATH asserts that the PSP demonstrates that Digicode has been designed in a highly safe... Train Control Systems. The PSP itself provides the detailed description of the Digicode track...

  11. 21 CFR 14.120 - Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). 14.120 Section 14.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE Technical Electronic...

  12. 76 FR 1137 - Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... site. In the Federal Register of December 9, 2010 (75 FR 76832), we published a final rule to establish... COMMISSION Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences... Commission (``Commission,'' ``CPSC,'' or ``we'') is announcing two Web conferences to demonstrate...

  13. 76 FR 14643 - Hazardous Materials: Safety Requirements for External Product Piping on Cargo Tanks Transporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-17

    ... April 11, 2000 (65 FR 19477) or you may visit http://www.regulations.gov . SUPPLEMENTARY INFORMATION: I. Background On January 27, 2011, PHMSA published a notice of proposed rulemaking (NPRM) (HM-213D; 76 FR 4847...: Safety Requirements for External Product Piping on Cargo Tanks Transporting Flammable Liquids...

  14. 77 FR 8818 - Public Availability of Consumer Product Safety Commission FY 2011 Service Contract Inventory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-15

    ... COMMISSION Public Availability of Consumer Product Safety Commission FY 2011 Service Contract Inventory... contract inventory for fiscal year (``FY'') 2011. This inventory provides information on service contract..., MD 20814. Telephone: 301-504-7009; email dhutton@cpsc.gov . SUPPLEMENTARY INFORMATION: On December...

  15. 78 FR 33392 - Public Availability of Consumer Product Safety Commission FY 2012 Service Contract Inventory

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-04

    ... COMMISSION Public Availability of Consumer Product Safety Commission FY 2012 Service Contract Inventory... contract inventory for fiscal year (FY) 2012. This inventory provides information on service contract..., MD 20814. Telephone: 301-504-7009; email: dhutton@cpsc.gov . SUPPLEMENTARY INFORMATION: On...

  16. Design of Complex Systems to Achieve Passive Safety: Natural Circulation Cooling of Liquid Salt Pebble Bed Reactors

    NASA Astrophysics Data System (ADS)

    Scarlat, Raluca Olga

    This dissertation treats system design, modeling of transient system response, and characterization of individual phenomena and demonstrates a framework for integration of these three activities early in the design process of a complex engineered system. A system analysis framework for prioritization of experiments, modeling, and development of detailed design is proposed. Two fundamental topics in thermal-hydraulics are discussed, which illustrate the integration of modeling and experimentation with nuclear reactor design and safety analysis: thermal-hydraulic modeling of heat generating pebble bed cores, and scaled experiments for natural circulation heat removal with Boussinesq liquids. The case studies used in this dissertation are derived from the design and safety analysis of a pebble bed fluoride salt cooled high temperature nuclear reactor (PB-FHR), currently under development in the United States at the university and national laboratories level. In the context of the phenomena identification and ranking table (PIRT) methodology, new tools and approaches are proposed and demonstrated here, which are specifically relevant to technology in the early stages of development, and to analysis of passive safety features. A system decomposition approach is proposed. Definition of system functional requirements complements identification and compilation of the current knowledge base for the behavior of the system. Two new graphical tools are developed for ranking of phenomena importance: a phenomena ranking map, and a phenomena identification and ranking matrix (PIRM). The functional requirements established through this methodology were used for the design and optimization of the reactor core, and for the transient analysis and design of the passive natural circulation driven decay heat removal system for the PB-FHR. A numerical modeling approach for heat-generating porous media, with multi-dimensional fluid flow is presented. The application of this modeling

  17. Assessing the dermal safety of products intended for genital mucosal exposure.

    PubMed

    Farage, Miranda A; Scheffler, Heike

    2011-01-01

    Manufacturers employ a stepwise approach to ensure the skin safety and compatibility of consumer products that are intended for contact with mucosal skin. The properties of the ingredients are evaluated fully, along with any available safety and skin compatibility information, to eliminate any chemicals that may be strong contact sensitizers or irritants. Contact sensitization potential is evaluated by applying a quantitative exposure assessment to each ingredient or component to determine if the extent of the expected exposure is likely to pose any risk of contact sensitization. Likely exposures are calculated using the manufacturer's unique knowledge of the intended product matrix, consumer usage patterns and measurements of particular exposure variables. If adequate safety assurance cannot be provided, further testing may be conducted. The skin compatibility and irritation potential of each ingredient is evaluated using existing test data, and experience from other products containing the same or a structurally similar ingredient. Once a finished product or formulation is developed, another round of assessments is conducted to ensure that no unexpected matrix effects negatively impact the skin compatibility profile. This may include clinical testing protocols involving single and multiple patch tests, and extended use testing, with visual and/or instrumental assessments. This approach to ensuring the skin safety of products has been used successfully for many decades, and adverse skin reactions to modern products are rare. The challenge for the future is to develop test protocols that will discriminate between products that are very similar in their favorable skin compatibility profile. Options to meet this challenge include testing protocols that will: (1) further exaggerate exposure conditions, such as the behind-the-knee protocol, (2) increase the sensitivity of scoring for irritant effects, such as with the use of instrumentation, and (3) quantitatively

  18. Human ergology that promotes participatory approach to improving safety, health and working conditions at grassroots workplaces: achievements and actions.

    PubMed

    Kawakami, Tsuyoshi

    2011-12-01

    Participatory approaches are increasingly applied to improve safety, health and working conditions of grassroots workplaces in Asia. The core concepts and methods in human ergology research such as promoting real work life studies, relying on positive efforts of local people (daily life-technology), promoting active participation of local people to identify practical solutions, and learning from local human networks to reach grassroots workplaces, have provided useful viewpoints to devise such participatory training programmes. This study was aimed to study and analyze how human ergology approaches were applied in the actual development and application of three typical participatory training programmes: WISH (Work Improvement for Safe Home) with home workers in Cambodia, WISCON (Work Improvement in Small Construction Sites) with construction workers in Thailand, and WARM (Work Adjustment for Recycling and Managing Waste) with waste collectors in Fiji. The results revealed that all the three programmes, in the course of their developments, commonly applied direct observation methods of the work of target workers before devising the training programmes, learned from existing local good examples and efforts, and emphasized local human networks for cooperation. These methods and approaches were repeatedly applied in grassroots workplaces by taking advantage of their the sustainability and impacts. It was concluded that human ergology approaches largely contributed to the developments and expansion of participatory training programmes and could continue to support the self-help initiatives of local people for promoting human-centred work. PMID:25665213

  19. Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

    PubMed

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

    Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market. PMID:23794245

  20. Relating safety, productivity and company type for motor-manual logging operations in the Italian Alps.

    PubMed

    Montorselli, Niccolò Brachetti; Lombardini, Carolina; Magagnotti, Natascia; Marchi, Enrico; Neri, Francesco; Picchi, Gianni; Spinelli, Raffaele

    2010-11-01

    The study compared the performance of four different logging crews with respect to productivity, organization and safety. To this purpose, the authors developed a data collection method capable of providing a quantitative analysis of risk-taking behavior. Four crews were tested under the same working conditions, representative of close-to-nature alpine forestry. Motor-manual working methods were applied, since these methods are still prevalent in the specific study area, despite the growing popularity of mechanical processors. Crews from public companies showed a significantly lower frequency of risk-taking behavior. The best safety performance was offered by the only (public) crew that had been administered formal safety training. The study seems to deny the common prejudice that safety practice is inversely proportional to productivity. Instead, productivity is increased by introducing more efficient working methods and equipment. The quantitative analysis of risk-taking behavior developed in this study can be applied to a number of industrial fields besides forestry. Characterizing risk-taking behavior for a given case may eventually lead to the development of custom-made training programmes, which may address problem areas while avoiding that the message is weakened by the inclusion of redundant information. In the specific case of logging crews in the central Alps, the study suggests that current training courses may be weak on ergonomics, and advocates a staged training programme, focusing first on accident reduction and then expanding to the prevention of chronic illness. PMID:20728656

  1. [Efficacy and safety in the new regulation of pharmaceutical products in Peru].

    PubMed

    Vásquez, Hans; Salas, Sofía; Figueroa, Linder; Gutiérrez, Sonia

    2012-01-01

    Internationally, pharmaceutical products (FP) are authorized after their risk-benefit profile has been assessed, taking into account efficacy, safety and quality parameters. In 2009, it was established in Peru that all pharmaceutical products to be commercialized should show proof of their efficacy and safety. According to the new regulation, in effect as of 2012, the pharmaceutical specialties (FS) have been grouped into three categories: category 1, if included in the National List of Essential Medicines; category 2, if authorized in countries with high health surveillance; and category 3, if not included in categories 1 or 2. The scientific documentation to be submitted for the registration or re-registration of the product in the regulatory entity will depend on its FS category. PMID:23338643

  2. Design of Complex Systems to Achieve Passive Safety: Natural Circulation Cooling of Liquid Salt Pebble Bed Reactors

    NASA Astrophysics Data System (ADS)

    Scarlat, Raluca Olga

    This dissertation treats system design, modeling of transient system response, and characterization of individual phenomena and demonstrates a framework for integration of these three activities early in the design process of a complex engineered system. A system analysis framework for prioritization of experiments, modeling, and development of detailed design is proposed. Two fundamental topics in thermal-hydraulics are discussed, which illustrate the integration of modeling and experimentation with nuclear reactor design and safety analysis: thermal-hydraulic modeling of heat generating pebble bed cores, and scaled experiments for natural circulation heat removal with Boussinesq liquids. The case studies used in this dissertation are derived from the design and safety analysis of a pebble bed fluoride salt cooled high temperature nuclear reactor (PB-FHR), currently under development in the United States at the university and national laboratories level. In the context of the phenomena identification and ranking table (PIRT) methodology, new tools and approaches are proposed and demonstrated here, which are specifically relevant to technology in the early stages of development, and to analysis of passive safety features. A system decomposition approach is proposed. Definition of system functional requirements complements identification and compilation of the current knowledge base for the behavior of the system. Two new graphical tools are developed for ranking of phenomena importance: a phenomena ranking map, and a phenomena identification and ranking matrix (PIRM). The functional requirements established through this methodology were used for the design and optimization of the reactor core, and for the transient analysis and design of the passive natural circulation driven decay heat removal system for the PB-FHR. A numerical modeling approach for heat-generating porous media, with multi-dimensional fluid flow is presented. The application of this modeling

  3. The Development of Product Parity Sensitivity in Children with Mathematics Learning Disability and in Typical Achievers

    ERIC Educational Resources Information Center

    Rotem, Avital; Henik, Avishai

    2013-01-01

    Parity helps us determine whether an arithmetic equation is true or false. The current research examines the development of sensitivity to parity cues in multiplication in typically achieving (TA) children (grades 2, 3, 4 and 6) and in children with mathematics learning disabilities (MLD, grades 6 and 8), via a verification task. In TA children…

  4. School Quality and Cognitive Achievement Production: A Case Study of Rural Pakistan.

    ERIC Educational Resources Information Center

    Behrman, Jere R.; And Others

    1997-01-01

    Examines determinants of cognitive achievement in rural Pakistan, controlling for cognitive ability, family background, various school quality measures, and educational attainment. Estimates indicate substantial variation in school effectiveness. Investments that improve teacher quality and increase student exposure to teachers are likely to have…

  5. Teacher Quality in Educational Production. Tracking, Decay, and Student Achievement. NBER Working Paper No. 14442

    ERIC Educational Resources Information Center

    Rothstein, Jesse

    2008-01-01

    Growing concerns over the achievement of U.S. students have led to proposals to reward good teachers and penalize (or fire) bad ones. The leading method for assessing teacher quality is "value added" modeling (VAM), which decomposes students' test scores into components attributed to student heterogeneity and to teacher quality. Implicit in the…

  6. A Thorough and Efficient Education: School Funding, Student Achievement and Productivity

    ERIC Educational Resources Information Center

    Ahlgrim, Richard W.

    2010-01-01

    Many school districts are facing stagnant or reduced funding (input) concurrent with demands for improved student achievement (output). In other words, there is pressure for all schools, even those schools with student populations of low socioeconomic status, to improve academic results (accountability for output) without a directly proportionate…

  7. Biotechnological production of polyamines by bacteria: recent achievements and future perspectives.

    PubMed

    Schneider, Jens; Wendisch, Volker F

    2011-07-01

    In Bacteria, the pathways of polyamine biosynthesis start with the amino acids L-lysine, L-ornithine, L-arginine, or L-aspartic acid. Some of these polyamines are of special interest due to their use in the production of engineering plastics (e.g., polyamides) or as curing agents in polymer applications. At present, the polyamines for industrial use are mainly synthesized on chemical routes. However, since a commercial market for polyamines as well as an industry for the fermentative production of amino acid exist, and since bacterial strains overproducing the polyamine precursors L-lysine, L-ornithine, and L-arginine are known, it was envisioned to engineer these amino acid-producing strains for polyamine production. Only recently, researchers have investigated the potential of amino acid-producing strains of Corynebacterium glutamicum and Escherichia coli for polyamine production. This mini-review illustrates the current knowledge of polyamine metabolism in Bacteria, including anabolism, catabolism, uptake, and excretion. The recent advances in engineering the industrial model bacteria C. glutamicum and E. coli for efficient production of the most promising polyamines, putrescine (1,4-diaminobutane), and cadaverine (1,5-diaminopentane), are discussed in more detail. PMID:21552989

  8. Proposal of Scope of Clinical Assays of Safety and Effectiveness of Cosmetic Products

    NASA Astrophysics Data System (ADS)

    Almeida, L. S.

    2015-01-01

    The demand for accreditation for clinical assays involving cosmetic products has led the Division of Laboratory Accreditation (Dicla) to study the possibility of implementing the General Coordination for Accreditation (Cgcre) which is a specific accreditation program for Good Clinical Practice (GCP). This work represents the very beginning of such a study thus conveying a proposed model of scope for clinical assays on safety and effectiveness.

  9. The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery

    PubMed Central

    Toomey, Paul G.; Ross, Sharona B.; Choung, Edward; Donn, Natalie; Vice, Michelle; Luberice, Kenneth; Albrink, Michael

    2015-01-01

    Background and Objectives: As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. Methods: LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. Results: Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0–20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. Conclusion: In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in

  10. RFID in the blood supply chain--increasing productivity, quality and patient safety.

    PubMed

    Briggs, Lynne; Davis, Rodeina; Gutierrez, Alfonso; Kopetsky, Matthew; Young, Kassandra; Veeramani, Raj

    2009-01-01

    As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions. PMID:19894488

  11. 78 FR 54417 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-04

    ... Operations on the Outer Continental Shelf--Oil and Gas Production Safety Systems Correction In proposed rule....802 Design, installation, Sec. 250.819 Specification and operation of surface production- for surface... features. Sec. 250.803 Additional production Sec. 250.850 Production system requirements....

  12. Fermentative production of lactic acid from renewable materials: recent achievements, prospects, and limits.

    PubMed

    Wang, Ying; Tashiro, Yukihiro; Sonomoto, Kenji

    2015-01-01

    The development and implementation of renewable materials for the production of versatile chemical resources have gained considerable attention recently, as this offers an alternative to the environmental problems caused by the petroleum industry and the limited supply of fossil resources. Therefore, the concept of utilizing biomass or wastes from agricultural and industrial residues to produce useful chemical products has been widely accepted. Lactic acid plays an important role due to its versatile application in the food, medical, and cosmetics industries and as a potential raw material for the manufacture of biodegradable plastics. Currently, the fermentative production of optically pure lactic acid has increased because of the prospects of environmental friendliness and cost-effectiveness. In order to produce lactic acid with high yield and optical purity, many studies focus on wild microorganisms and metabolically engineered strains. This article reviews the most recent advances in the biotechnological production of lactic acid mainly by lactic acid bacteria, and discusses the feasibility and potential of various processes. PMID:25077706

  13. Organic Broccoli Production can be Optimized to Achieve High Yield and More Efficient Water Use

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Organic farming is a viable agronomic option in central and north coastal California. Organic agriculture is dependent upon the application of organic amendments for providing nutrients and water management for sustaining successful organic production on a multitude of crops. Our multi-year field ...

  14. Integrated crop–livestock systems: Strategies to achieve synergy between agricultural production and environmental quality

    Technology Transfer Automated Retrieval System (TEKTRAN)

    A need to increase agricultural production across the world for food security appears to be at odds with the urgency to reduce agriculture’s negative environmental impacts. We suggest that a cause of this dichotomy is loss of diversity within agricultural systems at field, farm and landscape scales....

  15. Measurement and standardization of eye safety for optical radiation of LED products

    NASA Astrophysics Data System (ADS)

    Mou, Tongsheng; Peng, Zhenjian

    2013-06-01

    The blue light hazard (BLH) to human eye's retina is now a new issue emerging in applications of artificial light sources. Especially for solid state lighting sources based on the blue chip-LED(GaN), the photons with their energy more than 2.4 eV show photochemical effects on the retina significantly, raising damage both in photoreceptors and retinal pigment epithelium. The photobiological safety of artificial light sources emitting optical radiation has gained more and more attention worldwide and addressed by international standards IEC 62471-2006(CIE S009/E: 2002). Meanwhile, it is involved in IEC safety specifications of LED lighting products and covered by European Directive 2006/25/EC on the minimum health and safety requirements regarding the exposure of the workers to artificial optical radiation. In practical applications of the safety standards, the measuring methods of optical radiation from LED products to eyes are important in establishment of executable methods in the industry. In 2011, a new project to develop the international standard of IEC TR62471-4,that is "Measuring methods of optical radiation related to photobiological safety", was approved and are now under way. This paper presents the concerned methods for the assessment of optical radiation hazards in the standards. Furthermore, a retina radiance meter simulating eye's optical geometry is also described, which is a potential tool for blue light hazard assessment of retinal exposure to optical radiation. The spectroradiometric method integrated with charge-coupled device(CCD) imaging system is introduced to provide more reliable results.

  16. Study designs for the nonclinical safety testing of new vaccine products.

    PubMed

    Forster, Roy

    2012-07-01

    During the development of a new vaccine, the purpose of nonclinical studies is to provide safety information to support the clinical development and licensure of the product. In this article the study designs currently accepted for the nonclinical safety testing of new vaccines are described for single dose, local tolerance, repeat dose toxicity and safety pharmacology studies; these studies together form the basis of a typical nonclinical safety evaluation dossier. The detailed design of the preclinical package must take account of the intended clinical use, patient population, route of administration, formulation, dose level and immunisation schedule. The test item that is used for these studies must be adequately representative of the intended clinical formulation. The animal model used for these studies must be selected on criteria of relevance. Single dose toxicity studies provide information on acute actions or the potential effect of accidental overdose, but this information is often available from the repeat dose toxicity study, obviating the need for the acute study. Local tolerance studies provide information on tissue reactions at the site of administration. Evaluation of the findings must distinguish between normal tissue responses to injected material and findings indicative of undesirable pathological changes. The repeated dose toxicity studies are the principal studies that support the safety profile of the vaccines. The design of these studies must take full account of the features of the vaccine in the choice of treatment regime, dose levels, pharmacodynamic monitoring and timing of investigations and sacrifice. Safety pharmacology studies are performed to evaluate the potential for undesirable secondary pharmacological actions of vaccines if there is data to suggest that such studies are needed; this evaluation is made on a case by case basis. In the absence of specific guidance the design of studies for therapeutic vaccines follows the same

  17. Dust control products at Hagerman National Wildlife Refuge, Texas: environmental safety and performance

    USGS Publications Warehouse

    Kunz, Bethany K.; Little, Edward E.

    2015-01-01

    Controlling fugitive dust while protecting natural resources is a challenge faced by all managers of unpaved roads. Unfortunately, road managers choosing between dust control products often have little objective environmental information to aid their decisions. To address this information gap, the U.S. Geological Survey and the U.S. Fish and Wildlife Service collaborated on a field test of three dust control products with the objectives of (a) evaluating product performance under real-world conditions, (b) verifying the environmental safety of products identified as practically nontoxic in laboratory tests, and (c) testing the feasibility of several environmental monitoring techniques for use in dust control tests. In cooperation with refuge staff and product vendors, three products (one magnesium chloride plus binder, one cellulose, and one synthetic fluid plus binder) were applied in July 2012 to replicated road sections at the Hagerman National Wildlife Refuge in Texas. These sections were monitored periodically for 12 months after application. Product performance was assessed by mobile-mounted particulate-matter meters measuring production of fugitive dust and by observations of road conditions. Environmental safety was evaluated through on-site biological observations and leaching tests with samples of treated aggregate. All products reduced dust and improved surface condition during those 12 months. Planned environmental measurements were not always compatible with day-to-day refuge management actions; this incompatibility highlighted the need for flexible biological monitoring plans. As one of the first field tests of dust suppressants that explicitly incorporated biological endpoints, this effort provides valuable information for improving field tests and for developing laboratory or semifield alternatives.

  18. Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

    SciTech Connect

    Jordan, Scott A.; Cunningham, David G.; Marles, Robin J.

    2010-03-01

    Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantity and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.

  19. Safety assessment of personal care products/cosmetics and their ingredients

    SciTech Connect

    Nohynek, Gerhard J.; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO{sub 2} and ZnO in sunscreens

  20. Safety assessment of personal care products/cosmetics and their ingredients.

    PubMed

    Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

  1. [Concentrations and safety evaluation of heavy metals in aquatic products of Yancheng, Jiangsu Province].

    PubMed

    Liu, Yang; Fu, Qiang; Gao, Jun; Xu, Wang-Gu; Yin, Bo; Cao, Ya-Qiao; Qin, Wei-Hua

    2013-10-01

    Current status and intake risk of heavy metal pollution in aquatic products were studied in Yancheng, Jiangsu Province. Twenty-two kinds of aquatic products were sampled in May 2012, and the concentrations of Cd, Cu, Zn, Pb and Cr in muscles were measured using atomic absorption spectroscopy. Single factor pollution index (Pg) and metal pollution index (MPI) were used to evaluate the degree of pollution, and provisional tolerable weekly intake (PTWI) and carcinogenic risks were used to assess the edible safety and health risk, respectively. We found all the aquatic products were contaminated, and the pollutions by Cd, Pb and Cr were more serious, with the exceeding rates of 31.8% , 31.8% and 40.9% , respectively. Pi indices indicated the contents of Cd, Pb and Cr exceeded the allowable criteria of " Light Pollution", while Cd and Pb in freshwater fish, Pb and Cr in shellfish, and Cr in cephalopoda reached the criteria of " Heavy Pollution". The MPI results showed that heavy metal pollution in shellfish was the most severe, followed by crustacean, freshwater fish, and cephalopoda, while it was slight in marine fish. At present, the edible safety of heavy metals in aquatic products was acceptable in Yancheng, but the Cr intake of shellfish and cephalopoda was approaching PTWI and that of a minority of marine fishes even exceeded the PTWI value. The model estimation for health risk indicated that the health risk value of heavy metal ingestion was still below the maximal acceptable level (5.0 x 10(-5) a-1), recommended by International Commission on Radiation Protection (ICRP) , but the values of Cr for shellfish and cephalopoda were approaching the criterion. In summary, heavy metal pollution in aquatic products in Yancheng is rather severe, especially for Cr pollution, and more attention should be paid to the pollution status, edible safety and health risk. PMID:24364334

  2. Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

    DOE PAGESBeta

    Collin, Blaise P.; Petti, David A.; Demkowicz, Paul A.; Maki, John T.

    2016-04-07

    Safety tests were conducted on fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800 °C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during 15 of these safety tests. Comparisons between PARFUME predictions and post-irradiation examination results of the safety tests were conducted on two types of AGR-1 compacts: compactsmore » containing only intact particles and compacts containing one or more particles whose SiC layers failed during safety testing. In both cases, PARFUME globally over-predicted the experimental release fractions by several orders of magnitude: more than three (intact) and two (failed SiC) orders of magnitude for silver, more than three and up to two orders of magnitude for strontium, and up to two and more than one orders of magnitude for krypton. The release of cesium from intact particles was also largely over-predicted (by up to five orders of magnitude) but its release from particles with failed SiC was only over-predicted by a factor of about 3. These over-predictions can be largely attributed to an over-estimation of the diffusivities used in the modeling of fission product transport in TRISO-coated particles. The integral release nature of the data makes it difficult to estimate the individual over-estimations in the kernel or each coating layer. Nevertheless, a tentative assessment of correction factors to these diffusivities was performed to enable a better match between the modeling predictions and the safety testing results. The method could only be successfully applied to silver and cesium. In the case of strontium, correction factors could not be assessed

  3. Safety of Switching Factor VIII Products in the Era of Evolving Concentrates: Myths and Facts.

    PubMed

    Coppola, Antonio; Marrone, Emiliana; Conca, Paolo; Cimino, Ernesto; Mormile, Rosaria; Baldacci, Erminia; Santoro, Cristina

    2016-07-01

    Recent advances in the development of factor VIII (FVIII) concentrates offer patients with hemophilia the opportunity to switch to products considered safer or with improved properties. In some cases, product switch occurs due to side effects, convenience issues, or economic reasons affecting clinical choices. Reluctance to change FVIII concentrates is shown by patients and also by their physicians, because of concerns in particular about the risk of inhibitor development. A literature review was performed to retrieve the best evidence regarding safety issues of switching FVIII concentrate in patients with severe hemophilia A. Product switch was not associated with an increased inhibitor risk in four studies in patients during the first 50 to 75 exposure days, or in three studies reporting national switches in Canada and United Kingdom. The latter, the only available study comparing switcher and nonswitcher patients, showed an inhibitor incidence similar to that historically reported in the United Kingdom. In 16 phase III clinical trials and 6 postmarketing studies of FVIII concentrates, few de novo inhibitors were detected in previously treated patients, mostly transient and low-titer, with some additional recurrent inhibitors in patients with previous positive testing. On the whole, although rigorous controlled studies are lacking, literature data do not support increased risk of inhibitor development or other safety issues related to product switch. Therefore, in the presence of clinical needs, the advantages of switching FVIII products should not be missed because of perceived more than evidence-based challenges, in particular in this era of products with improved properties recently introduced or available in few years. Caution, however, is suggested in patients with high inhibitor risk, including in those in concomitance with surgery or intensive treatment. A careful inhibitor testing prior to and after product switch is always needed, to identify real de

  4. 14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown With a Wind Weighting Safety System C Appendix C to Part 417 Aeronautics and Space COMMERCIAL SPACE TRANSPORTATION, FEDERAL AVIATION ADMINISTRATION, DEPARTMENT OF TRANSPORTATION LICENSING...

  5. Identification and analysis of labor productivity components based on ACHIEVE model (case study: staff of Kermanshah University of Medical Sciences).

    PubMed

    Ziapour, Arash; Khatony, Alireza; Kianipour, Neda; Jafary, Faranak

    2015-01-01

    Identification and analysis of the components of labor productivity based on ACHIEVE model was performed among employees in different parts of Kermanshah University of Medical Sciences in 2014. This was a descriptive correlational study in which the population consisted of 270 working personnel in different administrative groups (contractual, fixed- term and regular) at Kermanshah University of Medical Sciences (872 people) that were selected among 872 people through stratified random sampling method based on Krejcie and Morgan sampling table. The survey tool included labor productivity questionnaire of ACHIEVE. Questionnaires were confirmed in terms of content and face validity, and their reliability was calculated using Cronbach's alpha coefficient. The data were analyzed by SPSS-18 software using descriptive and inferential statistics. The mean scores for labor productivity dimensions of the employees, including environment (environmental fit), evaluation (training and performance feedback), validity (valid and legal exercise of personnel), incentive (motivation or desire), help (organizational support), clarity (role perception or understanding), ability (knowledge and skills) variables and total labor productivity were 4.10±0.630, 3.99±0.568, 3.97±0.607, 3.76±0.701, 3.63±0.746, 3.59±0.777, 3.49±0.882 and 26.54±4.347, respectively. Also, the results indicated that the seven factors of environment, performance assessment, validity, motivation, organizational support, clarity, and ability were effective in increasing labor productivity. The analysis of the current status of university staff in the employees' viewpoint suggested that the two factors of environment and evaluation, which had the greatest impact on labor productivity in the viewpoint of the staff, were in a favorable condition and needed to be further taken into consideration by authorities. PMID:25560364

  6. Identification and Analysis of Labor Productivity Components Based on ACHIEVE Model (Case Study: Staff of Kermanshah University of Medical Sciences)

    PubMed Central

    Ziapour, Arash; Khatony, Alireza; Kianipour, Neda; Jafary, Faranak

    2015-01-01

    Identification and analysis of the components of labor productivity based on ACHIEVE model was performed among employees in different parts of Kermanshah University of Medical Sciences in 2014. This was a descriptive correlational study in which the population consisted of 270 working personnel in different administrative groups (contractual, fixed- term and regular) at Kermanshah University of Medical Sciences (872 people) that were selected among 872 people through stratified random sampling method based on Krejcie and Morgan sampling table. The survey tool included labor productivity questionnaire of ACHIEVE. Questionnaires were confirmed in terms of content and face validity, and their reliability was calculated using Cronbach’s alpha coefficient. The data were analyzed by SPSS-18 software using descriptive and inferential statistics. The mean scores for labor productivity dimensions of the employees, including environment (environmental fit), evaluation (training and performance feedback), validity (valid and legal exercise of personnel), incentive (motivation or desire), help (organizational support), clarity (role perception or understanding), ability (knowledge and skills) variables and total labor productivity were 4.10±0.630, 3.99±0.568, 3.97±0.607, 3.76±0.701, 3.63±0.746, 3.59±0.777, 3.49±0.882 and 26.54±4.347, respectively. Also, the results indicated that the seven factors of environment, performance assessment, validity, motivation, organizational support, clarity, and ability were effective in increasing labor productivity. The analysis of the current status of university staff in the employees’ viewpoint suggested that the two factors of environment and evaluation, which had the greatest impact on labor productivity in the viewpoint of the staff, were in a favorable condition and needed to be further taken into consideration by authorities. PMID:25560364

  7. Yeasts in foods and beverages: impact on product quality and safety.

    PubMed

    Fleet, Graham H

    2007-04-01

    The role of yeasts in food and beverage production extends beyond the well-known bread, beer and wine fermentations. Molecular analytical technologies have led to a major revision of yeast taxonomy, and have facilitated the ecological study of yeasts in many other products. The mechanisms by which yeasts grow in these ecosystems and impact on product quality can now be studied at the level of gene expression. Their growth and metabolic activities are moderated by a network of strain and species interactions, including interactions with bacteria and other fungi. Some yeasts have been developed as agents for the biocontrol of food spoilage fungi, and others are being considered as novel probiotic organisms. The association of yeasts with opportunistic infections and other adverse responses in humans raises new issues in the field of food safety. PMID:17275276

  8. Achieving production-level use of HEP software at the Argonne Leadership Computing Facility

    NASA Astrophysics Data System (ADS)

    Uram, T. D.; Childers, J. T.; LeCompte, T. J.; Papka, M. E.; Benjamin, D.

    2015-12-01

    HEP's demand for computing resources has grown beyond the capacity of the Grid, and these demands will accelerate with the higher energy and luminosity planned for Run II. Mira, the ten petaFLOPs supercomputer at the Argonne Leadership Computing Facility, is a potentially significant compute resource for HEP research. Through an award of fifty million hours on Mira, we have delivered millions of events to LHC experiments by establishing the means of marshaling jobs through serial stages on local clusters, and parallel stages on Mira. We are running several HEP applications, including Alpgen, Pythia, Sherpa, and Geant4. Event generators, such as Sherpa, typically have a split workload: a small scale integration phase, and a second, more scalable, event-generation phase. To accommodate this workload on Mira we have developed two Python-based Django applications, Balsam and ARGO. Balsam is a generalized scheduler interface which uses a plugin system for interacting with scheduler software such as HTCondor, Cobalt, and TORQUE. ARGO is a workflow manager that submits jobs to instances of Balsam. Through these mechanisms, the serial and parallel tasks within jobs are executed on the appropriate resources. This approach and its integration with the PanDA production system will be discussed.

  9. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables.

    PubMed

    Jenke, Dennis

    2007-10-01

    A review is provided on the general topic of the compatibility of plastic materials with pharmaceutical products, with specific emphasis on the safety aspects associated with extractables and leachables related to such plastic materials. PMID:17701994

  10. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  11. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  12. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  13. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  14. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  15. Safety assessment of Maillard reaction products of chicken bone hydrolysate using Sprague-Dawley rats

    PubMed Central

    Wang, Jin-Zhi; Sun, Hong-Mei; Zhang, Chun-Hui; Hu, Li; Li, Xia; Wu, Xiao-Wei

    2016-01-01

    Background The Maillard reaction products of chicken bone hydrolysate (MRPB) containing 38% protein, which is a derived product from chicken bone, is usually used as a flavor enhancer or food ingredient. In the face of a paucity of reported data regarding the safety profile of controversial Maillard reaction products, the potential health effects of MRPB were evaluated in a subchronic rodent feeding study. Methods Sprague–Dawley rats (SD, 5/sex/group) were administered diets containing 9, 3, 1, or 0% of MRPB derived from chicken bone for 13 weeks. Results During the 13-week treatment period, no mortality occurred, and no remarkable changes in general condition and behavior were observed. The consumption of MRPB did not have any effect on body weight or feed and water consumption. At the same time, there was no significant increase in the weights of the heart, liver, lung, kidney, spleen, small intestine, and thymus in groups for both sexes. Serological examination showed serum alanine aminotransferase in both sexes was decreased significantly, indicating liver cell protection. No treatment-related histopathological differences were observed between the control and test groups. Conclusion Based on the results of this study, the addition of 9% MRPB in the diet had no adverse effect on both male and female SD rats during the 90-day observation. Those results would provide useful information on the safety of a meaty flavor enhancer from bone residue as a byproduct of meat industry. PMID:27016175

  16. A field test and calibration system for production safety monitoring systems

    NASA Astrophysics Data System (ADS)

    Liu, Yang; Xing, Weiwei; Fan, Shangchun

    2008-10-01

    This paper introduces a field testing and calibrating system that serves the national industrial standards of production safety. The system supervises the monitoring systems of hazardous sources by measuring and evaluating them in the field. The system is designed as a cabinet that can be carried by an automobile. The front end parts of the system are designed as intrinsically safe handset instruments, so that they can be moved into Zone 0 independently and measure the supervised devices as close as possible. Measurement accuracy of the instruments is guaranteed by design. The system also provides a calibration interface with upper standard devices to facilitate periodically automatic calibration itself.

  17. Regulation of toxin production by Bacillus cereus and its food safety implications.

    PubMed

    Ceuppens, Siele; Rajkovic, Andreja; Heyndrickx, Marc; Tsilia, Varvara; Van De Wiele, Tom; Boon, Nico; Uyttendaele, Mieke

    2011-08-01

    Toxin expression is of utmost importance for the food-borne pathogen B. cereus, both in food poisoning and non-gastrointestinal host infections as well as in interbacterial competition. Therefore it is no surprise that the toxin gene expression is tightly regulated by various internal and environmental signals. An overview of the current knowledge regarding emetic and diarrheal toxin transcription and expression is presented in this review. The food safety aspects and management tools such as temperature control, food preservatives and modified atmosphere packaging are discussed specifically for B. cereus emetic and diarrheal toxin production. PMID:21417966

  18. Control of Listeria species food safety at a poultry food production facility.

    PubMed

    Fox, Edward M; Wall, Patrick G; Fanning, Séamus

    2015-10-01

    Surveillance and control of food-borne human pathogens, such as Listeria monocytogenes, is a critical aspect of modern food safety programs at food production facilities. This study evaluated contamination patterns of Listeria species at a poultry food production facility, and evaluated the efficacy of procedures to control the contamination and transfer of the bacteria throughout the plant. The presence of Listeria species was studied along the production chain, including raw ingredients, food-contact, non-food-contact surfaces, and finished product. All isolates were sub-typed by pulsed-field gel electrophoresis (PFGE) to identify possible entry points for Listeria species into the production chain, as well as identifying possible transfer routes through the facility. The efficacy of selected in-house sanitizers against a sub-set of the isolates was evaluated. Of the 77 different PFGE-types identified, 10 were found among two or more of the five categories/areas (ingredients, food preparation, cooking and packing, bulk packing, and product), indicating potential transfer routes at the facility. One of the six sanitizers used was identified as unsuitable for control of Listeria species. Combining PFGE data, together with information on isolate location and timeframe, facilitated identification of a persistent Listeria species contamination that had colonized the facility, along with others that were transient. PMID:26187831

  19. Approach for validating actinide and fission product compositions for burnup credit criticality safety analyses

    SciTech Connect

    Radulescu, Georgeta; Gauld, Ian C.; Ilas, Germina; Wagner, John C.

    2014-11-01

    This paper describes a depletion code validation approach for criticality safety analysis using burnup credit for actinide and fission product nuclides in spent nuclear fuel (SNF) compositions. The technical basis for determining the uncertainties in the calculated nuclide concentrations is comparison of calculations to available measurements obtained from destructive radiochemical assay of SNF samples. Probability distributions developed for the uncertainties in the calculated nuclide concentrations were applied to the SNF compositions of a criticality safety analysis model by the use of a Monte Carlo uncertainty sampling method to determine bias and bias uncertainty in effective neutron multiplication factor. Application of the Monte Carlo uncertainty sampling approach is demonstrated for representative criticality safety analysis models of pressurized water reactor spent fuel pool storage racks and transportation packages using burnup-dependent nuclide concentrations calculated with SCALE 6.1 and the ENDF/B-VII nuclear data. Furthermore, the validation approach and results support a recent revision of the U.S. Nuclear Regulatory Commission Interim Staff Guidance 8.

  20. Approach for validating actinide and fission product compositions for burnup credit criticality safety analyses

    DOE PAGESBeta

    Radulescu, Georgeta; Gauld, Ian C.; Ilas, Germina; Wagner, John C.

    2014-11-01

    This paper describes a depletion code validation approach for criticality safety analysis using burnup credit for actinide and fission product nuclides in spent nuclear fuel (SNF) compositions. The technical basis for determining the uncertainties in the calculated nuclide concentrations is comparison of calculations to available measurements obtained from destructive radiochemical assay of SNF samples. Probability distributions developed for the uncertainties in the calculated nuclide concentrations were applied to the SNF compositions of a criticality safety analysis model by the use of a Monte Carlo uncertainty sampling method to determine bias and bias uncertainty in effective neutron multiplication factor. Application ofmore » the Monte Carlo uncertainty sampling approach is demonstrated for representative criticality safety analysis models of pressurized water reactor spent fuel pool storage racks and transportation packages using burnup-dependent nuclide concentrations calculated with SCALE 6.1 and the ENDF/B-VII nuclear data. Furthermore, the validation approach and results support a recent revision of the U.S. Nuclear Regulatory Commission Interim Staff Guidance 8.« less

  1. Effects of an onion by-product on bioactivity and safety markers in healthy rats.

    PubMed

    Roldán-Marín, Eduvigis; Krath, Britta N; Poulsen, Morten; Binderup, Mona-Lise; Nielsen, Tom H; Hansen, Max; Barri, Thaer; Langkilde, Søren; Cano, M Pilar; Sánchez-Moreno, Concepción; Dragsted, Lars O

    2009-12-01

    Onions are excellent sources of bioactive compounds including fructo-oligosaccharides (FOS) and polyphenols. An onion by-product was characterised in order to be developed as a potentially bioactive food ingredient. Our main aim was to investigate whether the potential health and safety effects of this onion by-product were shared by either of two derived fractions, an extract containing the onion FOS and polyphenols and a residue fraction containing mainly cell wall materials. We report here on the effects of feeding these products on markers of potential toxicity, protective enzymes and gut environment in healthy rats. Rats were fed during 4 weeks with a diet containing the products or a control feed balanced in carbohydrate. The onion by-product and the extract caused anaemia as expected in rodents for Allium products. No other toxicity was observed, including genotoxicity. Glutathione reductase (GR) and glutathione peroxidase (GPx1) activities in erythrocytes increased when rats were fed with the onion extract. Hepatic gene expression of Gr, Gpx1, catalase, 5-aminolevulinate synthase and NAD(P)H:quinone oxidoreductase was not altered in any group of the onion fed rats. By contrast, gamma-glutamate cysteine ligase catalytic subunit gene expression was upregulated but only in rats given the onion residue. The onion by-products as well as the soluble and insoluble fractions had prebiotic effects as evidenced by decreased pH, increased butyrate production and altered gut microbiota enzyme activities. In conclusion, the onion by-products have no in vivo genotoxicity, may support in vivo antioxidative defence and alter the functionality of the rat gut microbiota. PMID:19682402

  2. System safety education focused on flight safety

    NASA Technical Reports Server (NTRS)

    Holt, E.

    1971-01-01

    The measures necessary for achieving higher levels of system safety are analyzed with an eye toward maintaining the combat capability of the Air Force. Several education courses were provided for personnel involved in safety management. Data include: (1) Flight Safety Officer Course, (2) Advanced Safety Program Management, (3) Fundamentals of System Safety, and (4) Quantitative Methods of Safety Analysis.

  3. Safety and Efficacy of Epithelium-On Corneal Collagen Cross-Linking Using a Multifactorial Approach to Achieve Proper Stromal Riboflavin Saturation

    PubMed Central

    Stojanovic, Aleksandar; Chen, Xiangjun; Jin, Nan; Zhang, Ting; Stojanovic, Filip; Raeder, Sten; Utheim, Tor Paaske

    2012-01-01

    Purpose. To evaluate the efficacy and safety of epithelium-on corneal collagen cross-linking (CXL) using a multifactorial approach to achieve proper stromal riboflavin saturation. Methods. This non-randomized retrospective study comprised 61 eyes with progressive keratoconus treated with epithelium-on CXL. Chemical epithelial penetration enhancement (benzalkonium chloride-containing local medication and hypotonic riboflavin solution), mechanical disruption of the superficial epithelium, and prolongation of the riboflavin-induction time until verification of stromal saturation were used before the UVA irradiation. Uncorrected and corrected distance visual acuity (UDVA, CDVA), refraction, corneal topography, and aberrometry were evaluated at baseline and at 1, 3, 6, and 12 months postoperative. Results. At 12-month, UDVA and CDVA improved significantly. None of the eyes lost lines of CDVA, while 27.4% of the eyes gained 2 or more lines. Mean spherical equivalent decreased by 0.74 D, and mean cylindrical reduction was 1.15 D. Irregularity index and asymmetry from Scheimpflug-based topography and Max-K at the location of cone from Placido-based topography showed a significant decrease. Higher-order-aberration data demonstrated a slight reduction in odd-order aberrations S 3, 5,7 (P = 0.04). Postoperative pain without other complications was recorded. Conclusion. Epithelium-on CXL with our novel protocol appeared to be safe and effective in the treatment of progressive keratoconus. PMID:22900147

  4. The safety of herbal medicinal products derived from Echinacea species: a systematic review.

    PubMed

    Huntley, Alyson L; Thompson Coon, Joanna; Ernst, Edzard

    2005-01-01

    Echinacea spp. are native to North America and were traditionally used by the Indian tribes for a variety of ailments, including mouth sores, colds and snake-bites. The three most commonly used Echinacea spp. are E. angustifolia, E. pallida and E. purpurea. Systematic literature searches were conducted in six electronic databases and the reference lists of all of the papers located were checked for further relevant publications. Information was also sought from the spontaneous reporting programmes of the WHO and national drug safety bodies. Twenty-three manufacturers of echinacea were contacted and asked for data held on file. Finally our own departmental files were searched. No language restrictions were imposed. Combination products and homeopathic preparations were excluded. Data from clinical studies and spontaneous reporting programmes suggest that adverse events with echinacea are not commonly reported. Gastrointestinal upsets and rashes occur most frequently. However, in rare cases, echinacea can be associated with allergic reactions that may be severe. Although there is a large amount of data that investigates the efficacy of echinacea, safety issues and the monitoring of adverse events have not been focused on. Short-term use of echinacea is associated with a relatively good safety profile, with a slight risk of transient, reversible, adverse events. The association of echinacea with allergic reactions is supported by the present evaluation. While these reactions are likely to be rare, patients with allergy or asthma should carefully consider their use of echinacea. The use of echinacea products during pregnancy and lactation would appear to be ill-advised in light of the paucity of data in this area. PMID:15853441

  5. Processing, food applications and safety of aloe vera products: a review.

    PubMed

    Ahlawat, Kulveer Singh; Khatkar, Bhupender Singh

    2011-10-01

    Aloe vera is used for vigor, wellness and medicinal purposes since rigvedic times. Health benefits of aloe vera include its application in wound healing, treating burns, minimizing frost bite damage, protection against skin damage from x-rays, lung cancer, intestinal problems, increasing high density lipoprotein (HDL), reducing low density lipoprotein (LDL), reducing blood sugar in diabetics, fighting acquired immune deficiency syndrome (AIDS), allergies and improving immune system. Phytochemistry of aloe vera gel has revealed the presence of more than 200 bioactive chemicals. Aloe vera gel is extracted from its leaves and appropriate processing techniques are needed for stabilization as well as preparation of the end products. The industries involved in processing of aloe vera need Government surveillance to ensure that the aloe vera products have beneficial bio-active chemicals as per claims of the manufacturers. Regulatory bodies also need to look into the safety and toxicological aspects of aloe vera products for food applications. The claims made for medicinal value of aloe products should be supported by authentic and approved clinical trial data. It is presumptive to mention that nutraceutical claims of aloe products made by the manufacturers are numerous. However, approved clinical evidences are available only for lowering LDL, increasing HDL, decreasing blood glucose level, treating genital herpes and psoriases. PMID:23572784

  6. Progress achieved in restricting the marketing of high-fat, sugary and salty food and beverage products to children

    PubMed Central

    Vandevijvere, Stefanie; Sacks, Gary; Brinsden, Hannah; Hawkes, Corinna; Barquera, Simón; Lobstein, Tim; Swinburn, Boyd A

    2016-01-01

    Abstract In May 2010, 192 Member States endorsed Resolution WHA63.14 to restrict the marketing of food and non-alcoholic beverage products high in saturated fats, trans fatty acids, free sugars and/or salt to children and adolescents globally. We examined the actions taken between 2010 and early 2016 – by civil society groups, the World Health Organization (WHO) and its regional offices, other United Nations (UN) organizations, philanthropic institutions and transnational industries – to help decrease the prevalence of obesity and diet-related noncommunicable diseases among young people. By providing relevant technical and policy guidance and tools to Member States, WHO and other UN organizations have helped protect young people from the marketing of branded food and beverage products that are high in fat, sugar and/or salt. The progress achieved by the other actors we investigated appears variable and generally less robust. We suggest that the progress being made towards the full implementation of Resolution WHA63.14 would be accelerated by further restrictions on the marketing of unhealthy food and beverage products and by investing in the promotion of nutrient-dense products. This should help young people meet government-recommended dietary targets. Any effective strategies and actions should align with the goal of WHO to reduce premature mortality from noncommunicable diseases by 25% by 2025 and the aim of the UN to ensure healthy lives for all by 2030. PMID:27429493

  7. Progress achieved in restricting the marketing of high-fat, sugary and salty food and beverage products to children.

    PubMed

    Kraak, Vivica I; Vandevijvere, Stefanie; Sacks, Gary; Brinsden, Hannah; Hawkes, Corinna; Barquera, Simón; Lobstein, Tim; Swinburn, Boyd A

    2016-07-01

    In May 2010, 192 Member States endorsed Resolution WHA63.14 to restrict the marketing of food and non-alcoholic beverage products high in saturated fats, trans fatty acids, free sugars and/or salt to children and adolescents globally. We examined the actions taken between 2010 and early 2016 - by civil society groups, the World Health Organization (WHO) and its regional offices, other United Nations (UN) organizations, philanthropic institutions and transnational industries - to help decrease the prevalence of obesity and diet-related noncommunicable diseases among young people. By providing relevant technical and policy guidance and tools to Member States, WHO and other UN organizations have helped protect young people from the marketing of branded food and beverage products that are high in fat, sugar and/or salt. The progress achieved by the other actors we investigated appears variable and generally less robust. We suggest that the progress being made towards the full implementation of Resolution WHA63.14 would be accelerated by further restrictions on the marketing of unhealthy food and beverage products and by investing in the promotion of nutrient-dense products. This should help young people meet government-recommended dietary targets. Any effective strategies and actions should align with the goal of WHO to reduce premature mortality from noncommunicable diseases by 25% by 2025 and the aim of the UN to ensure healthy lives for all by 2030. PMID:27429493

  8. Three-color mixing for classifying agricultural products for safety and quality

    NASA Astrophysics Data System (ADS)

    Ding, Fujian; Chen, Yud-Ren; Chao, Kuanglin; Kim, Moon S.

    2006-05-01

    A three-color mixing application for food safety inspection is presented. It is shown that the chromaticness of the visual signal resulting from the three-color mixing achieved through our device is directly related to the three-band ratio of light intensity at three selected wavebands. An optical visual device using three-color mixing to implement the three-band ratio criterion is presented. Inspection through human vision assisted by an optical device that implements the three-band ratio criterion would offer flexibility and significant cost savings as compared to inspection with a multispectral machine vision system that implements the same criterion. Example applications of this optical three-color mixing technique are given for the inspection of chicken carcasses with various diseases and for apples with fecal contamination. With proper selection of the three narrow wavebands, discrimination by chromaticness that has a direct relation with the three-band ratio can work very well. In particular, compared with the previously presented two-color mixing application, the conditions of chicken carcasses were more easily identified using the three-color mixing application. The novel three-color mixing technique for visual inspection can be implemented on visual devices for a variety of applications, ranging from target detection to food safety inspection.

  9. Occupational health and safety aspects of animal handling in dairy production.

    PubMed

    Lindahl, Cecilia; Lundqvist, Peter; Hagevoort, G Robert; Lunner Kolstrup, Christina; Douphrate, David I; Pinzke, Stefan; Grandin, Temple

    2013-01-01

    Livestock handling in dairy production is associated with a number of health and safety issues. A large number of fatal and nonfatal injuries still occur when handling livestock. The many animal handling tasks on a dairy farm include moving cattle between different locations, vaccination, administration of medication, hoof care, artificial insemination, ear tagging, milking, and loading onto trucks. There are particular problems with bulls, which continue to cause considerable numbers of injuries and fatalities in dairy production. In order to reduce the number of injuries during animal handling on dairy farms, it is important to understand the key factors in human-animal interactions. These include handler attitudes and behavior, animal behavior, and fear in cows. Care when in close proximity to the animal is the key for safe handling, including knowledge of the flight zone, and use of the right types of tools and suitable restraint equipment. Thus, in order to create safe working conditions during livestock handling, it is important to provide handlers with adequate training and to establish sound safety management procedures on the farm. PMID:23844794

  10. Survey of commercial Rhodiola products revealed species diversity and potential safety issues.

    PubMed

    Xin, Tianyi; Li, Xiaojin; Yao, Hui; Lin, Yulin; Ma, Xiaochong; Cheng, Ruiyang; Song, Jingyuan; Ni, Lianghong; Fan, Congzhao; Chen, Shilin

    2015-01-01

    The adulteration of herbal products is a threat to consumer safety. Here we surveyed the species composition of commercial Rhodiola products using DNA barcoding as a supervisory method. A Rhodiola dietary supplement DNA barcode database was successfully constructed using 82 voucher samples from 10 Rhodiola species. Based on the DNA barcoding standard operating procedure (SOP), we used this database to identify 100 Rhodiolae Crenulatae Radix et Rhizoma decoction piece samples that were purchased from drug stores and hospitals. The results showed that only 36 decoction piece sequences (40%) were authentic R. crenulata, which is recorded in Chinese Pharmacopeia, whereas the other samples were all adulterants and may indicate a potential safety issue. Among the adulterants, 35 sequences (38.9%) were authenticated as R. serrata, nine sequences (10%) were authenticated as R. rosea, which is documented in the United States Pharmacopeia, and the remaining samples were authenticated as other three Rhodiola species. This result indicates decoction pieces that are available in the market have complex origins and DNA barcoding is a convenient tool for market supervision. PMID:25661009

  11. 42 CFR 3.304 - Principles for achieving compliance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Principles for achieving compliance. 3.304 Section 3.304 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Enforcement Program §...

  12. Safety assessments and public concern for genetically modified food products: the American view.

    PubMed

    Harlander, Susan K

    2002-01-01

    In the relatively short time since their commercial introduction in 1996, genetically modified (GM) crops have been rapidly adopted in the United States GM crops are regulated through a coordinated framework developed in 1992 and administered by three agencies-the US Department of Agriculture (USDA) that ensures the products are safe to grow, the Environmental Protection Agency (EPA) that ensures the products are safe for the environment, and the Food and Drug Administration (FDA) that ensures the products are safe to eat. Rigorous food and environmental safety assessments must be completed before GM crops can be commercialized. Fifty-one products have been reviewed by the FDA, including several varieties of corn, soybeans, canola, cotton, rice, sugar beets, potatoes, tomatoes, squash, papaya, and flax. Because FDA considers these crops "substantially equivalent" to their conventional counterparts, no special labeling is required for GM crops in the United States and they are managed as commodities with no segregation or identity preservation. GM crops have thus made their way through commodity distribution channels into thousands of ingredients used in processed foods. It has been estimated that 70% to 85% of processed foods on supermarket shelves in the United States today contain one or more ingredients potentially derived from GM crops. The food industry and retail industry have been monitoring the opinions of their consumers on the GM issue for the past several years. Numerous independent groups have also surveyed consumer concerns about GM foods. The results of these surveys are shared and discussed here. PMID:11890465

  13. [Current concept for the microbiological safety of cell-based medicinal products].

    PubMed

    Schurig, Utta; Karo, Jan-Oliver; Sicker, U; Spindler-Raffel, E; Häckel, L; Spreitzer, I; Bekeredjian-Ding, I

    2015-11-01

    Ensuring microbiological safety in advanced-therapy medicinal products is still a big challenge for manufacturers. There are fundamental problems, especially in cell-based medicinal products, regarding sterility of source materials, short shelf-life of final products, and the selection of suitable microbiological methods. Different from classical medicinal products, there is the need to evaluate a large number of possible risks and to calculate the risk-benefit balance. Depending on the source material, the presence of micro-organisms with specific growth requirements has to be considered. They cannot be detected by conventional testing methods, but may replicate after the application of the preparation in the recipient. Mycoplasmas are the primary representatives of these contaminants and specific testing procedures are required. Additionally, depending on the source and processing of the biological material, specific testing methods for mycobacteria and other contaminants should be included. Alternative microbiological methods (e.g. NAT, flow cytometry) should be applied in order to reduce the time to detection and to provide reliable results before application of a preparation, but should be also assessed for their possible use for the detection of conventionally undetectable micro-organisms. PMID:26369764

  14. Microbiological Food Safety Status of Commercially Produced Tomatoes from Production to Marketing.

    PubMed

    van Dyk, Brigitte N; de Bruin, Willeke; du Plessis, Erika M; Korsten, Lise

    2016-03-01

    Tomatoes have been implicated in various microbial disease outbreaks and are considered a potential vehicle for foodborne pathogens. Traceback studies mostly implicate contamination during production and/or processing. The microbiological quality of commercially produced tomatoes was thus investigated from the farm to market, focusing on the impact of contaminated irrigation and washing water, facility sanitation, and personal hygiene. A total of 905 samples were collected from three largescale commercial farms from 2012 through 2014. The farms differed in water sources used (surface versus well) and production methods (open field versus tunnel). Levels of total coliforms and Escherichia coli and prevalence of E. coli O157:H7 and Salmonella Typhimurium were determined. Dominant coliforms were identified using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. No pathogens or E. coli were detected on any of the tomatoes tested throughout the study despite the high levels of coliforms (4.2 to 6.2 log CFU/g) present on the tomatoes at the market. The dominant species associated with tomatoes belonged to the genera Enterobacter, Klebsiella, and Citrobacter. Water used on the farm for irrigation considered not fit for purpose according to national agricultural irrigation standards, with high E. coli levels resulting from either a highly contaminated source water (river water at 3.19 log most probable number [MPN]/100 ml) or improper storage of source water (stored well water at 1.72 log MPN/100 ml). Salmonella Typhimurium was detected on two occasions on a contact surface in the processing facility of the first farm in 2012. Contact surface coliform counts were 2.9 to 4.8 log CFU/cm(2). Risk areas identified in this study were water used for irrigation and poor sanitation practices in the processing facility. Implementation of effective food safety management systems in the fresh produce industry is of the utmost importance to ensure product

  15. Overall requirements for an advanced underground coal extraction system. [environment effects, miner health and safety, production cost, and coal conservation

    NASA Technical Reports Server (NTRS)

    Goldsmith, M.; Lavin, M. L.

    1980-01-01

    Underground mining systems suitable for coal seams expoitable in the year 2000 are examined with particular relevance to the resources of Central Appalachia. Requirements for such systems may be summarized as follows: (1) production cost; (2)miner safety; (3) miner health; (4) environmental impact; and (5) coal conservation. No significant trade offs between production cost and other performance indices were found.

  16. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING Compounded Drug Products § 216.24 Drug...

  17. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY COMPOUNDING Compounded Drug Products § 216.24 Drug...

  18. 77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ... HUMAN SERVICES Food and Drug Administration Clinical Studies of Safety and Effectiveness of Orphan... of FDA's Office of Orphan Products Development (OPD) grant program. The goal of FDA's OPD grant... Needleman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire...

  19. Hazardous organic compounds in biogas plant end products--soil burden and risk to food safety.

    PubMed

    Suominen, K; Verta, M; Marttinen, S

    2014-09-01

    The end products (digestate, solid fraction of the digestate, liquid fraction of the digestate) of ten biogas production lines in Finland were analyzed for ten hazardous organic compounds or compound groups: polychlorinated dibenzo-p-dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCB(7)), polyaromatic hydrocarbons (PAH(16)), bis-(2-ethylhexyl) phthalate (DEHP), perfluorinated alkyl compounds (PFCs), linear alkylbenzene sulfonates (LASs), nonylphenols and nonylphenol ethoxylates (NP+NPEOs), polybrominated diphenyl ethers (PBDEs), hexabromocyclododecane (HBCD) and tetrabromobisphenol A (TBBPA). Biogas plant feedstocks were divided into six groups: municipal sewage sludge, municipal biowaste, fat, food industry by-products, animal manure and others (consisting of milling by-products (husk) and raw former foodstuffs of animal origin from the retail trade). There was no clear connection between the origin of the feedstocks of a plant and the concentrations of hazardous organic compounds in the digestate. For PCDD/Fs and for DEHP, the median soil burden of the compound after a single addition of digestate was similar to the annual atmospheric deposition of the compound or compound group in Finland or other Nordic countries. For PFCs, the median soil burden was somewhat lower than the atmospheric deposition in Finland or Sweden. For NP+NPEOs, the soil burden was somewhat higher than the atmospheric deposition in Denmark. The median soil burden of PBDEs was 400 to 1000 times higher than the PBDE air deposition in Finland or in Sweden. With PBDEs, PFCs and HBCD, the impact of the use of end products should be a focus of further research. Highly persistent compounds, such as PBDE- and PFC-compounds may accumulate in agricultural soil after repeated use of organic fertilizers containing these compounds. For other compounds included in this study, agricultural use of biogas plant end products is unlikely to cause risk to food safety in Finland. PMID:24593894

  20. Assessing Natural Product-Drug Interactions: An End-to-End Safety Framework.

    PubMed

    Roe, Amy L; Paine, Mary F; Gurley, Bill J; Brouwer, Kenneth R; Jordan, Scott; Griffiths, James C

    2016-04-01

    The use of natural products (NPs), including herbal medicines and other dietary supplements, by North Americans continues to increase across all age groups. This population has access to conventional medications, with significant polypharmacy observed in older adults. Thus, the safety of the interactions between multi-ingredient NPs and drugs is a topic of paramount importance. Considerations such as history of safe use, literature data from animal toxicity and human clinical studies, and NP constituent characterization would provide guidance on whether to assess NP-drug interactions experimentally. The literature is replete with reports of various NP extracts and constituents as potent inhibitors of drug metabolizing enzymes, and transporters. However, without standard methods for NP characterization or in vitro testing, extrapolating these reports to clinically-relevant NP-drug interactions is difficult. This lack of a clear definition of risk precludes clinicians and consumers from making informed decisions about the safety of taking NPs with conventional medications. A framework is needed that describes an integrated robust approach for assessing NP-drug interactions; and, translation of the data into formulation alterations, dose adjustment, labelling, and/or post-marketing surveillance strategies. A session was held at the 41st Annual Summer Meeting of the Toxicology Forum in Colorado Springs, CO, to highlight the challenges and critical components that should be included in a framework approach. PMID:26776752

  1. Standardization as situation-specific achievement: regulatory diversity and the production of value in intercontinental collaborations in stem cell medicine.

    PubMed

    Rosemann, Achim

    2014-12-01

    The article examines the role and challenges of scientific self-governance and standardization in inter-continental clinical research partnerships in stem cell medicine. The paper shows that - due to a high level of regulatory diversity - the enactment of internationally recognized standards in multi-country stem cell trials is a complex and highly situation-specific achievement. Standardization is imposed on a background of regulatory, institutional and epistemic-cultural heterogeneity, and implemented exclusively in the context of select clinical projects. Based on ethnographic data from the first trans-continental clinical trial infrastructure in stem cell medicine between China and the USA, the article demonstrates that locally evolved and international forms of experimental clinical research practices often co-exist in the same medical institutions. Researchers switch back and forth between these schemas, depending on the purposes of their research, the partners they work with, the geographic scale of research projects, and the contrasting demands for regulatory review, that result from these differences. Drawing on Birch's analysis of the role of standardization in international forms of capital production in the biosciences, the article argues that the integration of local knowledge institutions into the global bioeconomy does not necessarily result in the shutting down of localized forms of value production. In emerging fields of medical research, that are regulated in highly divergent ways across geographical regions, the coexistence of distinct modes of clinical translation allows also for the production of multiple forms of economic value, at varying spatial scales. This is especially so in countries with lenient regulations. As this paper shows, the long-standing absence of a regulatory framework for clinical stem cell applications in China, permits the situation-specific adoption of internationally recognized standards in some contexts, while enabling

  2. Environment, safety and health compliance assessment, Feed Materials Production Center, Fernald, Ohio

    SciTech Connect

    Not Available

    1989-09-01

    The Secretary of Energy established independent Tiger Teams to conduct environment, safety, and health (ES H) compliance assessments at US Department of Energy (DOE) facilities. This report presents the assessment of the Feed Materials Production Center (FMPC) at Fernald, Ohio. The purpose of the assessment at FMPC is to provide the Secretary with information regarding current ES H compliance status, specific ES H noncompliance items, evaluation of the adequacy of the ES H organizations and resources (DOE and contractor), and root causes for noncompliance items. Areas reviewed included performance under Federal, state, and local agreements and permits; compliance with Federal, state and DOE orders and requirements; adequacy of operations and other site activities, such as training, procedures, document control, quality assurance, and emergency preparedness; and management and staff, including resources, planning, and interactions with outside agencies.

  3. Efficacy and Safety of Medicinal Plants or Related Natural Products for Fibromyalgia: A Systematic Review

    PubMed Central

    de Souza Nascimento, Simone; DeSantana, Josimari Melo; Ribeiro, Êurica Adélia Nogueira; da Silva, Daniel Lira; Araújo-Júnior, João Xavier; da Silva Almeida, Jackson Roberto Guedes; Bonjardim, Leonardo Rigoldi; de Souza Araújo, Adriano Antunes; Quintans-Júnior, Lucindo José

    2013-01-01

    To assess the effects of medicinal plants (MPs) or related natural products (RNPs) on fibromyalgia (FM) patients, we evaluate the possible benefits and advantages of MP or RNP for the treatment of FM based on eight randomized placebo-controlled trials (RCTs) involving 475 patients. The methodological quality of all studies included was determined according to JADAD and “Risk of Bias” with the criteria in the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0. Evidence suggests significant benefits of MP or RNP in sleep disruption, pain, depression, joint stiffness, anxiety, physical function, and quality of life. Our results demonstrated that MP or RNP had significant effects on improving the symptoms of FM compared to conventional drug or placebo; longer tests are required to determine the duration of the treatment and characterize the long-term safety of using MP, thus suggesting effective alternative therapies in the treatment of pain with minimized side effects. PMID:23861696

  4. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses: Criticality (keff) Predictions

    DOE PAGESBeta

    Scaglione, John M.; Mueller, Don E.; Wagner, John C.

    2014-12-01

    One of the most important remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation—in particular, the availability and use of applicable measured data to support validation, especially for fission products (FPs). Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. In this study, this paper describes a validation approach for commercial spent nuclear fuel (SNF) criticality safety (keff) evaluations based on best-available data and methodsmore » and applies the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The criticality validation approach utilizes not only available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion program to support validation of the principal actinides but also calculated sensitivities, nuclear data uncertainties, and limited available FP LCE data to predict and verify individual biases for relevant minor actinides and FPs. The results demonstrate that (a) sufficient critical experiment data exist to adequately validate keff calculations via conventional validation approaches for the primary actinides, (b) sensitivity-based critical experiment selection is more appropriate for generating accurate application model bias and uncertainty, and (c) calculated sensitivities and nuclear data uncertainties can be used for generating conservative estimates of bias for minor actinides and FPs. Results based on the SCALE 6.1 and the ENDF/B-VII.0 cross-section libraries indicate that a conservative estimate of the bias for the minor actinides and FPs is 1.5% of their worth within the

  5. Consumer product safety: Risk assessment of exposure to asbestos emissions from hand-held hair dryers

    NASA Astrophysics Data System (ADS)

    Hallenbeck, William H.

    1981-01-01

    The United States Consumer Product Safety Commission (CPSC) is concerned that consumer exposure to asbestos from consumer products may present an unreasonable risk of injury. Recently, CPSC has obtained agreement by industry to cease production and distribution of hair dryers containing asbestos heat insulation. CPSC intends to broaden its investigation by selecting consumer products containing asbestos for “priority attention.” The Commission does not intend to make quantitative estimates of cancer risks posed by exposure to asbestos fibers in making regulatory decisions. This position may lead to a serious waste of resources for the Commission, industry, and society. The Commission should focus its initial attention on those products for which the release of asbestos is significant enough to cause an unreasonable health risk. To make a risk assessment for a particular use of asbestos, CPSC must acquire or request data on asbestos emissions and define “unreasonable risk to health.” In an attempt to give some meaning to the phrase “risk assessment,” the primary goal of this paper is to present a detailed risk assessment of exposure to asbestos from hand-held hair dryers. Several scenarios of use are presented using various assumptions regarding time of operation, mixing of fibers in a small room, rate of fiber emission, and time of exposure. The worst case analysis of the health risk of exposure to hair dryer emissions is based on several conservative assumptions and shows that the increased number of deaths per year due to respiratory cancer is 4 for the entire United States population. A more representative case analysis shows the increased number of deaths to be on the order of 0.15 per year.

  6. HTR 2014 Paper - Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

    SciTech Connect

    Blaise P. Collin

    2001-10-01

    Safety tests were conducted on fourteen fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800°C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during the safety tests, and the predicted values were compared with experimental results. Preliminary comparisons between PARFUME predictions and post-irradiation examination (PIE) results of the safety tests show an overall over-prediction of the fractional release of these fission products, which is largely attributed to an over-estimation of the diffusivities used in the modeling of fission product transport in TRISO-coated particles. Correction factors to these diffusivities were assessed for silver and cesium in order to enable a better match between the modeling predictions and the safety testing results. In the case of strontium, correction factors could not be assessed because potential release during the safety tests could not be distinguished from matrix content released during irradiation. In the case of krypton, all the coating layers are partly retentive and the available data did not allow to determine their respective retention powers, hence preventing to derive any correction factors.

  7. Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

    SciTech Connect

    Blaise Collin

    2014-09-01

    Safety tests were conducted on fourteen fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800°C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during the safety tests, and the predicted values were compared with experimental results. Preliminary comparisons between PARFUME predictions and post-irradiation examination (PIE) results of the safety tests show different trends in the prediction of the fractional release depending on the species, and it leads to different conclusions regarding the diffusivities used in the modeling of fission product transport in TRISO-coated particles: • For silver, the diffusivity in silicon carbide (SiC) might be over-estimated by a factor of at least 102 to 103 at 1600°C and 1700°C, and at least 10 to 102 at 1800°C. The diffusivity of silver in uranium oxy-carbide (UCO) might also be over-estimated, but the available data are insufficient to allow definitive conclusions to be drawn. • For cesium, the diffusivity in UCO might be over-estimated by a factor of at least 102 to 103 at 1600°C, 105 at 1700°C, and 103 at 1800°C. The diffusivity of cesium in SiC might also over-estimated, by a factor of 10 at 1600°C and 103 at 1700°C, based upon the comparisons between calculated and measured release fractions from intact particles. There is no available estimate at 1800°C since all the compacts heated up at 1800°C contain particles with failed SiC layers whose release dominates the release from intact particles. • For strontium, the diffusivity in SiC might be over-estimated by a factor of 10 to 102 at 1600 and 1700°C, and 102 to 103 at 1800°C. These

  8. Manufacture of immunoglobulin products for patients with primary antibody deficiencies - the effect of processing conditions on product safety and efficacy.

    PubMed

    Farrugia, Albert; Quinti, Isabella

    2014-01-01

    Early preparations of immunoglobulin (Ig) manufactured from human plasma by ethanol (Cohn) fractionation were limited in their usefulness for substitution therapy in patients with primary antibody deficiencies (PAD), as Ig aggregates formed during manufacture resulted in severe systemic reactions in patients when given intravenously. Developments in manufacturing technology obviated this problem through the capacity to produce concentrated solutions of intact monomeric Ig, revolutionizing PAD treatment and improving patient life expectancy and quality of life. As the need for Ig has grown, manufacturers have refined further manufacturing technologies to improve yield from plasma and produce therapies, which are easier and less expensive to deliver. This has led to the substitution, partly or wholly, of ethanol precipitation by other techniques such as chromatography, and has also stimulated the production of highly concentrated solutions capable of rapid infusion. Ig products have been associated, since their inception, with certain adverse events, including infectious disease transmission, hemolysis, and thromboembolism. The introduction of standardized manufacturing processes and dedicated pathogen elimination steps has removed the risk of infectious disease, and the focus of attention has shifted to other problems, which appear to have increased over the past 5 years. These include hemolysis and thromboembolism, both the cause for substantial concern and the subject of recent regulatory scrutiny and actions. We review the development of manufacturing technology and the emerging evidence that changes for the optimization of yield and convenience has contributed to the recent incidents in certain adverse events. Industry measures under development will be discussed in terms of their potential to improve safety and optimize care for patients with PAD. PMID:25566269

  9. Two-color mixing for classifying agricultural products for safety and quality

    NASA Astrophysics Data System (ADS)

    Ding, Fujian; Chen, Yud-Ren; Chao, Kuanglin; Chan, Diane E.

    2006-02-01

    We show that the chromaticness of the visual signal that results from the two-color mixing achieved through an optically enhanced binocular device is directly related to the band ratio of light intensity at the two selected wavebands. A technique that implements the band-ratio criterion in a visual device by using two-color mixing is presented here. The device will allow inspectors to identify targets visually in accordance with a two-wavelength band ratio. It is a method of inspection by human vision assisted by an optical device, which offers greater flexibility and better cost savings than a multispectral machine vision system that implements the band-ratio criterion. With proper selection of the two narrow wavebands, discrimination by chromaticness that is directly related to the band ratio can work well. An example application of this technique for the inspection of carcasses chickens of afficted with various diseases is given. An optimal pair of wavelengths of 454 and 578 nm was selected to optimize differences in saturation and hue in CIE LUV color space among different types of target. Another example application, for the detection of chilling injury in cucumbers, is given, here the selected wavelength pair was 504 and 652 nm. The novel two-color mixing technique for visual inspection can be included in visual devices for various applications, ranging from target detection to food safety inspection.

  10. Needs and opportunities for improving the health, safety, and productivity of medical research facilities.

    PubMed Central

    Hodgson, M; Brodt, W; Henderson, D; Loftness, V; Rosenfeld, A; Woods, J; Wright, R

    2000-01-01

    Medical research facilities, indeed all the nation's constructed facilities, must be designed, operated, and maintained in a manner that supports the health, safety, and productivity of the occupants. The National Construction Goals, established by the National Science and Technology Council, envision substantial improvements in occupant health and worker productivity. The existing research and best practices case studies support this conclusion, but too frequently building industry professionals lack the knowledge to design, construct, operate, and maintain facilities at these optimum levels. There is a need for more research and more collaborative efforts between medical and facilities engineering researchers and practitioners in order to attain the National Construction Goals. Such collaborative efforts will simultaneously support attainment of the National Health Goals. This article is the summary report of the Healthy Buildings Committee for the Leadership Conference: Biomedical Facilities and the Environment sponsored by the National Institutes of Health, the National Association of Physicians for the Environment, and the Association of Higher Education Facilities Officers on 1--2 November 1999 in Bethesda, Maryland, USA. PMID:11124125

  11. Genetically modified feeds in poultry diet: safety, performance, and product quality.

    PubMed

    Tufarelli, V; Selvaggi, M; Dario, C; Laudadio, V

    2015-01-01

    Concerns have been expressed regarding the safety of using biotechnology derived feeds in diets of livestock animals and in regard to human consumption of products from species fed transgenic crops. As a consequence, a large number of poultry nutrition studies have been conducted to evaluate the wholesomeness of transgenic crops by examining performances of animals during growth or egg laying. Studies also evaluated whether foreign DNA and proteins could be detected in meat, egg, and tissue samples from broiler chickens and laying hens fed diets containing transgenic feeds. In all studies, the conclusions were in agreement that the transgenic crops provided comparable performance, carcass and egg yields, and meat and egg composition, when compared with conventional grains. Moreover, it was demonstrated that transgenic proteins and DNA present in livestock feeds are not detectable in food products derived from these animals, using the most sensitive detection methods available, confirming that they are rapidly degraded by normal digestive processes. The lack of significant differences were a result of the similarity in nutrient composition of the genetically modified feeds and lack of differences in intake and digestibility, while there were no evidences that the differences reported for performance response variables and carcass measurements between treatment groups were attributable to the presence of the transgenic gene and protein in the biotechnology derived plants. Results demonstrated that genetically modified feeds are substantially equivalent and they result as safe as existing conventional feeds. PMID:24915369

  12. Applicability of biological time temperature integrators as quality and safety indicators for meat products.

    PubMed

    Ellouze, M; Augustin, J-C

    2010-03-31

    The objective of this study was to evaluate (eO), a biological time temperature integrator (TTI) as a quality and safety indicator for ground beef packed under modified atmosphere and spiced cooked chicken slices packed under modified atmosphere. Storage trials and challenge tests were thus performed on several batches of the studied food to monitor and model the behavior of Listeria monocytogenes, Salmonella, Staphylococcus aureus and the indigenous food flora. Then, two different prototypes of the TTI (eO) were set and manufactured according to the studied products shelf lives. The TTI evolution with time at static and dynamic temperatures was monitored and modeled. Finally, exposure assessment models were set and used under several realistic storage profiles to assess the distributions of the concentration of the indigenous food flora and the distributions of the increase in the pathogens populations obtained at the end of the product shelf life or at the end point of the TTI, taking into account the TTIs batch variability. Results showed that in case of poor storage conditions, TTI can reduce the consumer exposure to altered or hazardous foods. PMID:20074826

  13. The effect of globalization of drug manufacturing, production, and sourcing and challenges for American drug safety.

    PubMed

    Woo, J; Wolfgang, S; Batista, H

    2008-03-01

    Americans benefit from one of the safest drug supplies and one of the highest standards of consumer protection in the world. Over the past decade, though, a general trend toward globalization of the supply chains for finished pharmaceutical products and active pharmaceutical ingredients has created new challenges for the Food and Drug Administration (FDA) in ensuring the safety and quality of the drug supply. Explosive growth in pharmaceutical manufacturing for the US market is particularly evident in the developing regions of Asia. Manufacturing sites in China and India now comprise approximately 40% of all FDA-registered foreign sites, having increased from 30% in 2002. (In 2001, when legislation first went into effect requiring registration of all foreign drug manufacturing sites, 140 registered sites in China listed 797 drug items for potential importation; as of 1 October 2007, that number had grown to 815 registered sites and well over 3,000 listed items.) In total in 2006, the United States received >145,000 line entries of imported drug products from >160 countries, up from only 1,300 line entries in 2000. FDA regulatory oversight resources (e.g., those allocated to inspection and testing of imports) are being challenged to keep up with the explosive growth of imported drugs. (In 2006, the FDA performed inspections at 212 foreign drug firms. This number has remained relatively consistent over the past 6 years, starting at 249 in 2001 and ranging from 190 to 260 on an annual basis.) PMID:18253142

  14. Microorganisms in fresh ground meats: the relative safety of products with low versus high numbers.

    PubMed

    Jay, J M

    1996-01-01

    The two outbreaks of haemorrhagic colitis (HC) that were traced to ground beef in 1982 were the first foodborne cases known to be caused by Escherichia coli 0157:H7. The 1993 outbreak in the U.S. Pacific Northwest is the largest foodborne disease outbreak ever traced to ground beef. Why these events occurred continues to be a matter of speculation and debate. It is the thesis of this review that HC-causing strains of E. coli, which could have been in the meat supply as early as the mid-1950s, can persist in meats that contain too few of the background bacterial biota. The antagonistic effect of background organisms against pathogenic bacteria (microbial interference) is well established. Fresh ground meats that contain 10(5)-10(6)/g of background organisms are inherently safer than those that contain, say, 10(3)/g. Although the production of fresh ground meats with as few microorganisms as possible would seem to be the ideal, there is little or no evidence to support the superior safety of such products. It is suggested that when pathogen-reduction strategies are applied to animal carcasses, the carcasses should be 'protected' against subsequent colonization by pathogens by actually adding appropriate mixtures of harmless bacteria. PMID:22060641

  15. Plasmid DNA Vaccine vector design: impact on efficacy, safety and upstream production

    PubMed Central

    Williams, James A; Carnes, Aaron E; Hodgson, Clague P

    2009-01-01

    Critical molecular and cellular biological factors impacting design of licensable DNA vaccine vectors that combine high yield and integrity during bacterial production with increased expression in mammalian cells are reviewed. Food and Drug Administration (FDA), World Health Organization (WHO) and European Medical Agencies (EMEA) regulatory guidance’s are discussed, as they relate to vector design and plasmid fermentation. While all new vectors will require extensive preclinical testing to validate safety and performance prior to clinical use, regulatory testing burden for follow-on products can be reduced by combining carefully designed synthetic genes with existing validated vector backbones. A flowchart for creation of new synthetic genes, combining rationale design with bioinformatics, is presented. The biology of plasmid replication is reviewed, and process engineering strategies that reduce metabolic burden discussed. Utilizing recently developed low metabolic burden seed stock and fermentation strategies, optimized vectors can now be manufactured in high yields exceeding 2 g/L, with specific plasmid yields of 5% total dry cell weight. PMID:19233255

  16. Health, safety, and environmental risk assessment of steel production complex in central Iran using TOPSIS.

    PubMed

    Jozi, S A; Majd, N Moradi

    2014-10-01

    This research was carried out with the aim of presenting an environmental management plan for steel production complex (SPC) in central Iran. Following precise identification of the plant activities as well as the study area, possible sources of environmental pollution and adverse impacts on the air quality, water, soil, biological environment, socioeconomic and cultural environment, and health and safety of the employees were determined considering the work processes of the steel complex. Afterwards, noise, wastewater, and air pollution sources were measured. Subsequently, factors polluting the steel complex were identified by TOPSIS and then prioritized using Excel Software. Based on the obtained results, the operation of the furnaces in hot rolling process with the score 1, effluent derived from hot rolling process with the score 0.565, nonprincipal disposal and dumping of waste at the plant enclosure with the score 0.335, walking beam process with the score 1.483 respectively allocated themselves the highest priority in terms of air, water, soil and noise pollution. In terms of habitats, land cover and socioeconomic and cultural environment, closeness to the forest area and the existence of four groups of wildlife with the score 1.106 and proximity of villages and residential areas to the plant with the score 3.771 respectively enjoyed the highest priorities while impressibility and occupational accidents with the score 2.725 and cutting and welding operations with score 2.134 had the highest priority among health and safety criteria. Finally, strategies for the control of pollution sources were identified and Training, Monitoring and environmental management plan of the SPC was prepared. PMID:25049141

  17. Development of Product Relatedness and Distance Effects in Typical Achievers and in Children With Mathematics Learning Disabilities.

    PubMed

    Rotem, Avital; Henik, Avishai

    2015-01-01

    The current study examined the development of two effects that have been found in single-digit multiplication errors: relatedness and distance. Typically achieving (TA) second, fourth, and sixth graders and adults, and sixth and eighth graders with a mathematics learning disability (MLD) performed a verification task. Relatedness was defined by a slow and inaccurate response to false results that were related to one of the operands via a shared multiplication row (e.g., 3 × 4 = 16). Distance was defined by a slow and inaccurate response to false results that were close in magnitude to the true result (e.g., 6 × 8 = 49). The presence of these effects indicates that participants are sensitive to numerical features of products. TA children demonstrated sensitivity to relatedness and distance from second grade onward. With age their sensitivity expanded from easy problems (e.g., 2 × 3) to difficult ones (e.g., 8 × 9). Children with MLD were sensitive to relatedness on easy problems. Their sensitivity to distance differed from the pattern seen in sixth grade and was partial in eighth grade. The presence of numerical sensitivity in children with MLD calls for instructional methods that would further develop their number sense. PMID:24509566

  18. An Effect of Levels of Learning Ability and Types of Feedback in Electronic Portfolio on Learning Achievement of Students in Electronic Media Production for Education Subject

    ERIC Educational Resources Information Center

    Koraneekij, Prakob

    2008-01-01

    The purpose of this research was to study an effect of levels of learning ability and types of feedback in an electronic portfolio on learning achievement of students in electronic media production for education subject. The samples were 113 students registered in Electronic Media Production for Education Subject divided into 6 groups : 3 control…

  19. Food Safety Knowledge, Behavior, and Attitudes of Vendors of Poultry Products Sold at Pennsylvania Farmers' Markets

    ERIC Educational Resources Information Center

    Scheinberg, Joshua; Radhakrishna, Rama; Cutter, Catherine N.

    2013-01-01

    A needs assessment survey was developed to assess the knowledge and attitudes of poultry vendors at farmers' markets in Pennsylvania, on food safety, regulation, and poultry production. Vendors were administered a 32-question paper survey, in person, during market hours. The results revealed critical vendor practices and identified important…

  20. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... HUMAN SERVICES Food and Drug Administration Clinical Studies of Safety and Effectiveness of Orphan... of FDA's Office of Orphan Products Development (OPD) grant program. The goal of FDA's OPD grant... Background and Significance section documentation to support the estimated prevalence of the orphan...

  1. Genotypic characterization and safety assessment of lactic acid bacteria from indigenous African fermented food products

    PubMed Central

    2012-01-01

    Background Indigenous fermented food products play an essential role in the diet of millions of Africans. Lactic acid bacteria (LAB) are among the predominant microbial species in African indigenous fermented food products and are used for different applications in the food and biotechnology industries. Numerous studies have described antimicrobial susceptibility profiles of LAB from different parts of the world. However, there is limited information on antimicrobial resistance profiles of LAB from Africa. The aim of this study was to characterize 33 LAB previously isolated from three different African indigenous fermented food products using (GTG)5-based rep-PCR, sequencing of the 16S rRNA gene and species-specific PCR techniques for differentiation of closely related species and further evaluate their antibiotic resistance profiles by the broth microdilution method and their haemolytic activity on sheep blood agar plates as indicators of safety traits among these bacteria. Results Using molecular biology based methods and selected phenotypic tests such as catalase reaction, CO2 production from glucose, colonies and cells morphology, the isolates were identified as Lactobacillus delbrueckii, Lactobacillus fermentum, Lactobacillus ghanensis, Lactobacillus plantarum, Lactobacillus salivarius, Leuconostoc pseudomesenteroides, Pediococcus acidilactici, Pediococcus pentosaceus and Weissella confusa. The bacteria were susceptible to ampicillin, chloramphenicol, clindamycin and erythromycin but resistant to vancomycin, kanamycin and streptomycin. Variable sensitivity profiles to tetracycline and gentamicin was observed among the isolates with Lb. plantarum, Lb. salivarius, W. confusa (except strain SK9-5) and Lb. fermentum strains being susceptible to tetracycline whereas Pediococcus strains and Lb. ghanensis strains were resistant. For gentamicin, Leuc. pseudomesenteroides, Lb. ghanensis and Ped. acidilactici strains were resistant to 64 mg/L whereas some W. confusa

  2. Safety analysis for the use of hazardous production materials in photovoltaic applications

    SciTech Connect

    Moskowitz, P.D.; Fthenakis, V.M.; Crandall, R.S.; Nelson, B.P.

    1993-12-31

    A wide range of hazardous production materials (HPMs) are used in industrial and university facilities engaged in research and development (R&D) related to semiconductor and photovoltaic devices. Because of the nature of R&D facilities where research activities are constantly changing, it is important for facility managers to pro-actively control the storage, distribution, use and disposal of these HPMs. As part of this control process, facility managers must determine the magnitude of the risk presented by their operations and the protection afforded by the administrative, engineering and personnel controls that have been implemented to reduce risks to life and property to acceptable levels. Facility auditing combined with process hazard analysis (PHA), provides a mechanism for identifying these risks and evaluating their magnitude. In this paper, the methods and results of a PHA for a photovoltaic R&D facility handling HPMs are presented. Of the 30 potential accidents identified, none present High or even Moderate Risks; 18 present Low Risks; and, 12 present Routine Risks. Administrative, engineering and personal safety controls associated with each accident are discussed. 15 refs., 2 figs., 6 tabs.

  3. Safety analysis for the use of hazardous production materials in photovoltaic applications

    SciTech Connect

    Moskowitz, P.D.; Fthenakis, V.M.; Crandall, R.S.; Nelson, B.P.

    1993-11-01

    A wide range of hazardous production materials (HPMs) are used in industrial and university facilities engaged in research and development (R and D) related to semiconductor and photovoltaic devices. Because of the nature of R and D facilities where research activities are constantly changing, it is important for facility managers to pro-actively control the storage, distribution, use and disposal of these HPMs. As part of this control process, facility managers must determine the magnitude of the risk presented by their operations and the protection afforded by the administrative, engineering and personnel controls that have been implemented to reduce risks to life and property to acceptable levels. Facility auditing combined with process hazard analysis (PHA), provides a mechanism for identifying these risks and evaluating their magnitude. In this paper, the methods and results of a PHA for a photovoltaic R and D facility handling HPMs are presented. Of the 30 potential accidents identified, none present High or even Moderate Risks; 18 present Low Risks; and, 12 present Routine Risks. Administrative, engineering and personal safety controls associated with each accident are discussed.

  4. The conception of fashion products for children: reflections on safety parameters.

    PubMed

    Prete, Lígia Gomes Pereira; Emidio, Lucimar de Fátima Bilmaia; Martins, Suzana Barreto

    2012-01-01

    The purpose of this study is to reflect on safety requirements for children's clothing, based on the standardization proposed by the ABNT (Technical Standardization Brazilian Association). Bibliographic research and case studies were considered on writing this work. We also discuss the importance of adding other safety requirements to the current standardization, as well as the increasing of the actual age range specified by the ABNT, following the children's clothing safety standardizations in Portugal and the United States, also stated here. PMID:22316891

  5. Microbiological Status and Food Safety Compliance of Commercial Basil Production Systems.

    PubMed

    de Bruin, Willeke; Otto, Denise; Korsten, Lise

    2016-01-01

    Basil has been implicated in a number of microbe-associated foodborne illnesses across the world, and the source of contamination has often been traced back to the production and/or processing stages of the supply chain. The aim of this study was to evaluate the microbiological quality of fresh basil from the point of production to the retail outlet in the Gauteng and Northwest Provinces of South Africa. A total of 463 samples were collected over a 3-month period from two large-scale commercial herb producing and processing companies and three retail outlets. The microbiological quality of the samples was assessed based on the presence or absence of Escherichia coli O157:H7 and Salmonella Typhimurium and the levels of the indicator bacteria E. coli and total coliforms. Salmonella Typhimurium was detected on four basil samples (0.9%) arriving at the processing facility and at dispatch, but no E. coli O157:H7 was detected throughout the study. Total coliform counts were 0.4 to 4.1 CFU/g for basil, 1.9 to 3.4 log CFU/ml for water, and 0.2 to 1.7 log CFU/cm(2) for contact surfaces, whereas E. coli was detected in the water samples and only once on basil. The Colilert-18 and membrane filter methods were used to analyze water samples, and a comparison of results revealed that the Colilert-18 method was more sensitive. Strong evidence suggests that high numbers of coliforms do not necessarily indicate the presence of Salmonella Typhimurium. The study results highlight the importance of effective implementation of food safety management systems in the fresh produce industry. PMID:26735028

  6. Production and evaluation of children's dietary life safety index data on metropolitan cities and provinces in Korea

    PubMed Central

    Choi, Young-Sun; Lee, Jung-Sug; Kim, Hye-Young; Kwak, Tong-Kyung; Chung, Hae Rang; Kwon, Sehyug; Choi, Youn-Ju; Lee, Soon-Kyu

    2012-01-01

    This pilot study was performed to produce data of the Children's Dietary Life Safety (CDLS) Index which is required by the Special Act on Safety Management of Children's Dietary Life and to evaluate the CDLS Index for 7 metropolitan cities and 9 provinces in Korea. To calculate the CDLS Index score, data regarding the evaluation indicators in the children's food safety domain and children's nutrition safety domain were collected from the local governments in 2009. For data regarding the indicators in the children's perception & practice domain, a survey was conducted on 2,400 5th grade children selected by stratified sampling in 16 local areas. Relative scores of indicators in each domain were calculated using the data provided by local governments and the survey, the weights are applied on relative scores, and then the CDLS Index scores of local governments were produced by adding scores of the 3 domains. The national average scores of the food safety domain, the nutrition safety domain and the perception and practice domain were 23.74 (14.67-26.50 on a 40-point scale), 16.65 (12.25-19.60 on a 40-point scale), and 14.88 (14.16-15.30 on a 20-point scale), respectively. The national average score of the CDLS Index which was produced by adding the scores of the three domains was 55.27 ranging 46.44-58.94 among local governments. The CDLS Index scores produced in this study may provide the motivation for comparing relative accomplishment and for actively achieving the goals through establishment of the target value by local governments. Also, it can be used as useful data for the establishment and improvement of children's dietary life safety policy at the national level. PMID:23346305

  7. Aerospace Safety Advisory Panel

    NASA Technical Reports Server (NTRS)

    1984-01-01

    An assessment of NASA's safety performance for 1983 affirms that NASA Headquarters and Center management teams continue to hold the safety of manned flight to be their prime concern, and that essential effort and resources are allocated for maintaining safety in all of the development and operational programs. Those conclusions most worthy of NASA management concentration are given along with recommendations for action concerning; product quality and utility; space shuttle main engine; landing gear; logistics and management; orbiter structural loads, landing speed, and pitch control; the shuttle processing contractor; and the safety of flight operations. It appears that much needs to be done before the Space Transportation System can achieve the reliability necessary for safe, high rate, low cost operations.

  8. How Close We Are to Achieving Commercially Viable Large-Scale Photobiological Hydrogen Production by Cyanobacteria: A Review of the Biological Aspects

    PubMed Central

    Sakurai, Hidehiro; Masukawa, Hajime; Kitashima, Masaharu; Inoue, Kazuhito

    2015-01-01

    Photobiological production of H2 by cyanobacteria is considered to be an ideal source of renewable energy because the inputs, water and sunlight, are abundant. The products of photobiological systems are H2 and O2; the H2 can be used as the energy source of fuel cells, etc., which generate electricity at high efficiencies and minimal pollution, as the waste product is H2O. Overall, production of commercially viable algal fuels in any form, including biomass and biodiesel, is challenging, and the very few systems that are operational have yet to be evaluated. In this paper we will: briefly review some of the necessary conditions for economical production, summarize the reports of photobiological H2 production by cyanobacteria, present our schemes for future production, and discuss the necessity for further progress in the research needed to achieve commercially viable large-scale H2 production. PMID:25793279

  9. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... Safety Standard for Cigarette Lighters, 16 CFR part 1210. In developing that standard, the Commission... number of features from the cigarette lighter standard, 16 CFR part 1210, in order to minimize...

  10. Social protection for all ages? Impacts of Ethiopia's Productive Safety Net Program on child nutrition.

    PubMed

    Porter, Catherine; Goyal, Radhika

    2016-06-01

    We investigate the impact of a large-scale social protection scheme, the Productive Safety Net Program (PSNP) in Ethiopia, on child nutritional outcomes. Children living in households that receive cash transfers should experience improved child nutrition. However, in the case of the PSNP, which for the majority of participants is a public works program, there are several potential threats to finding effects: first, without conditionality on child inputs, increased household income may not be translated into improved child nutrition. Second, the work requirement may impact on parental time, child time use and calories burned. Third, if there is a critical period for child human capital investment that closes before the age of 5 then children above this age may not see any improvement in medium-term nutritional outcomes, measured here as height-for-age. Using a cohort study that collected data both pre-and post-program implementation in 2002, 2006 and 2009, we exploit several novel aspects of the survey design to find estimates that can deal with non-random program placement. We present both matching and difference-in-differences estimates for the index children, as well as sibling-differences. Our estimates show an important positive medium-term nutritional impact of the program for children aged 5-15 that are comparable in size to Conditional Cash Transfer program impacts for much younger children. We show indicative evidence that the program impact on improved nutrition is associated with improved food security and reduced child working hours. Our robustness checks restrict the comparison group, by including only households who were shortlisted, but never received PSNP, and also exclude those who never received aid, thus identifying impact based on timing alone. We cannot rule out that the nutritional impact of the program is the same for younger and older children. PMID:27176466

  11. Respiratory symptoms and pulmonary function tests in security and safety products plant workers

    PubMed Central

    Balbay, Ege Gulec; Toru, Umran; Arbak, Peri; Balbay, Oner; Suner, Kezban Ozmen; Annakkaya, Ali Nihat

    2014-01-01

    Objective: Lock and key factory workers are under the risk of metal pneumoconiosis and occupational asthma. In this cross-sectional study, it’s aimed to evaluate the relationship between metal dust exposure and respiratory symptoms, pulmonary function tests of workers in different section of lock and key factory. Methods: 54 male workers (mean age, 32.8 ± 5.4) in a security and safety products plant were evaluated for respiratory symptoms, pulmonary function tests and smoking habits. Results have been interpreted by comparison of the painting (28/54) and grinding group workers (26/54). Results: There was no significant difference between painting (32.1 ± 4.8) and grinding (33.6 ± 6.1) groups regarding mean age (P > 0.05). Smokers were in significantly higher in grinding group (18/26). Cough and sputum were reported 14.3% (4/28) in painting and 3.8% (1/26) in grinding workers (P > 0.05). Chest tightness was seen in 7.1% and 7.7% of painting and grinding workers, respectively (P > 0.05). But no chest tightness was reported in both groups when they were away work. Breathlessness was seen in 10.7% and 7.7% of painting and grinding workers, respectively (P > 0.05). Breathlessness was similar in both groups (7.1% vs. 3.8%) when they were away work. When comparing painting and grinding workers respiratory functions no significant difference observed. Chest radiography in painting and grinding workers showed hyperlucency (3.6% vs.11.4%), respectively. Conclusion: Painting groups in lock and key factory workers had more but statistically insignificantrespiratory complaints. Interestingly, chest tightness was only observed when both groups were at work. It was thought that ventilation and using personal protective equipment in factory could provide significant benefits. PMID:25126195

  12. Sensemaking and the co-production of safety: a qualitative study of primary medical care patients.

    PubMed

    Rhodes, Penny; McDonald, Ruth; Campbell, Stephen; Daker-White, Gavin; Sanders, Caroline

    2016-02-01

    This study explores the ways in which patients make sense of 'safety' in the context of primary medical care. Drawing on qualitative interviews with primary care patients, we reveal patients' conceptualisation of safety as fluid, contingent, multi-dimensional, and negotiated. Participant accounts drew attention to a largely invisible and inaccessible (but taken for granted) architecture of safety, the importance of psycho-social as well as physical dimensions and the interactions between them, informal strategies for negotiating safety, and the moral dimension of safety. Participants reported being proactive in taking action to protect themselves from potential harm. The somewhat routinised and predictable nature of the primary medical care consultation, which is very different from 'one off' inpatient spells, meant that patients were not passive recipients of care. Instead they had a stock of accumulated knowledge and experience to inform their actions. In addition to highlighting the differences and similarities between hospital and primary care settings, the study suggests that a broad conceptualisation of patient safety is required, which encompasses the safety concerns of patients in primary care settings. PMID:26547907

  13. A Model-Based Product Evaluation Protocol for Comparison of Safety-Engineered Protection Mechanisms of Winged Blood Collection Needles.

    PubMed

    Haupt, C; Spaeth, J; Ahne, T; Goebel, U; Steinmann, D

    2016-05-01

    OBJECTIVE To evaluate differences in product characteristics and user preferences of safety-engineered protection mechanisms of winged blood collection needles. DESIGN Randomized model-based simulation study. SETTING University medical center. PARTICIPANTS A total of 33 third-year medical students. METHODS Venipuncture was performed using winged blood collection needles with 4 different safety mechanisms: (a) Venofix Safety, (b) BD Vacutainer Push Button, (c) Safety-Multifly, and (d) Surshield Surflo. Each needle type was used in 3 consecutive tries: there was an uninstructed first handling, then instructions were given according to the operating manual; subsequently, a first trial and second trial were conducted. Study end points included successful activation, activation time, single-handed activation, correct activation, possible risk of needlestick injury, possibility of deactivation, and preferred safety mechanism. RESULTS The overall successful activation rate during the second trial was equal for all 4 devices (94%-100%). Median activation time was (a) 7 s, (b) 2 s, (c) 9 s, and (d) 7 s. Single-handed activation during the second trial was (a) 18%, (b) 82%, (c) 15%, and (d) 45%. Correct activation during the second trial was (a) 3%, (b) 64%, (c) 15%, and (d) 39%. Possible risk of needlestick injury during the second trial was highest with (d). Possibility of deactivation was (a) 0%, (b) 12%, (c) 9%, and (d) 18%. Individual preferences for each system were (a) 11, (b) 17, (c) 5, and (d) 0. The main reason for preference was the comprehensive safety mechanism. CONCLUSION Significant differences exist between safety mechanisms of winged blood collection needles. Infect Control Hosp Epidemiol 2016;37:505-511. PMID:26868306

  14. Safety in the Workplace.

    ERIC Educational Resources Information Center

    Shaw, Richard

    1999-01-01

    Addresses workplace safety needs and tips for helping an organization achieve a high level of safety. Tips include showing administration commitment, establishing retribution-free reporting of safety problems and violations, rewarding excellent safety effort, and allowing no compromises in following safety procedures. (GR)

  15. Safety assessment on polyethylene glycols (PEGs) and their derivatives as used in cosmetic products.

    PubMed

    Fruijtier-Pölloth, Claudia

    2005-10-15

    This assessment focusses on polyethylene glycols (PEGs) and on anionic or nonionic PEG derivatives, which are currently used in cosmetics in Europe. These compounds are used in a great variety of cosmetic applications because of their solubility and viscosity properties, and because of their low toxicity. The PEGs, their ethers, and their fatty acid esters produce little or no ocular or dermal irritation and have extremely low acute and chronic toxicities. They do not readily penetrate intact skin, and in view of the wide use of preparations containing PEG and PEG derivatives, only few case reports on sensitisation reactions have been published, mainly involving patients with exposure to PEGs in medicines or following exposure to injured or chronically inflamed skin. On healthy skin, the sensitising potential of these compounds appears to be negligible. For some representative substances of this class, information was available on reproductive and developmental toxicity, on genotoxicty and carcinogenic properties. Taking into consideration all available information from related compounds, as well as the mode and mechanism of action, no safety concern with regard to these endpoints could be identified. Based on the available data it is therefore concluded that PEGs of a wide molecular weight range (200 to over 10,000), their ethers (laureths. ceteths, ceteareths, steareths, and oleths), and fatty acid esters (laurates, dilaurates, stearates, distearates) are safe for use in cosmetics. Limited data were available for PEG sorbitan/sorbitol fatty acid esters, PEG sorbitan beeswax and PEG soy sterols. Taking into account all the information available for closely related compounds, it can be assumed that these compounds as presently used in cosmetic preparations will not present a risk for human health. PEG castor oils and PEG hydrogenated castor oils have caused anaphylactic reactions when used in intravenous medicinal products. Their topical use in cosmetics is

  16. Quality and safety of herbal medical products: regulation and the need for quality assurance along the value chains

    PubMed Central

    Heinrich, Michael

    2015-01-01

    Herbal medicines and products derived from them are a diverse group of products for which different (and often limited) levels of evidence are available. As importantly, such products generally vary in their composition and are at the end of an often poorly understood value chain, which often links producers in biodiversity rich countries with the large markets in the North. This paper discusses the current regulatory framework of such herbal medical products (with a focus on the UK) and using examples from our own metabolomic research on Curcumal longa L. (turmeric, Zingiberaceae) how value chains impact on the composition and quality (and thus the safety) of such products. Overall, our recent research demonstrates the need for studying the links between producers and consumers of commodities produced in provider countries and that plant metabolomics offer a novel way of assessing the chemical variability along a value chain. PMID:25581270

  17. Parallel computation safety analysis irradiation targets fission product molybdenum in neutronic aspect using the successive over-relaxation algorithm

    NASA Astrophysics Data System (ADS)

    Susmikanti, Mike; Dewayatna, Winter; Sulistyo, Yos

    2014-09-01

    One of the research activities in support of commercial radioisotope production program is a safety research on target FPM (Fission Product Molybdenum) irradiation. FPM targets form a tube made of stainless steel which contains nuclear-grade high-enrichment uranium. The FPM irradiation tube is intended to obtain fission products. Fission materials such as Mo99 used widely the form of kits in the medical world. The neutronics problem is solved using first-order perturbation theory derived from the diffusion equation for four groups. In contrast, Mo isotopes have longer half-lives, about 3 days (66 hours), so the delivery of radioisotopes to consumer centers and storage is possible though still limited. The production of this isotope potentially gives significant economic value. The criticality and flux in multigroup diffusion model was calculated for various irradiation positions and uranium contents. This model involves complex computation, with large and sparse matrix system. Several parallel algorithms have been developed for the sparse and large matrix solution. In this paper, a successive over-relaxation (SOR) algorithm was implemented for the calculation of reactivity coefficients which can be done in parallel. Previous works performed reactivity calculations serially with Gauss-Seidel iteratives. The parallel method can be used to solve multigroup diffusion equation system and calculate the criticality and reactivity coefficients. In this research a computer code was developed to exploit parallel processing to perform reactivity calculations which were to be used in safety analysis. The parallel processing in the multicore computer system allows the calculation to be performed more quickly. This code was applied for the safety limits calculation of irradiated FPM targets containing highly enriched uranium. The results of calculations neutron show that for uranium contents of 1.7676 g and 6.1866 g (× 106 cm-1) in a tube, their delta reactivities are the still

  18. Review of PGDP assessment of criticality safety problems in increasing product assay to 5 wt % /sup 235/U

    SciTech Connect

    Petrie, L.M.; Turner, J.C.; Stewart, G.B.

    1985-02-01

    Paducah Gaseous Diffusion Plant (PGDP) performed an evaluation of the PGDP facilities to determine the feasibility of increasing product assay from 2.0 wt % to 5.0 wt % /sup 235/U and to determine the impact of this increase on plant criticality safety; their conclusions are reported in KY-710. This report critiques the methods used and conclusions reached in KY-710. 4 figures, 5 tables.

  19. Medical Device Safety

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Medical Devices Home Medical Devices Medical Device Safety Medical Device Safety Share Tweet Linkedin Pin it More sharing ...

  20. The Determinants of School Achievement in Developing Countries: The Educational Production Function. International Bank for Reconstruction and Development Staff Working Paper No. 201.

    ERIC Educational Resources Information Center

    Alexander, Leigh; Simmons, John

    A number of studies are reviewed in an attempt to identify those schooling inputs that affect schooling outcomes, specifically cognitive achievement of students, in developing countries. Part 1 of the paper outlines the nature of the major tool of analysis, the educational production function (EPF), and the problems associated with its use as a…

  1. Triclosan: a critical review of the experimental data and development of margins of safety for consumer products.

    PubMed

    Rodricks, Joseph V; Swenberg, James A; Borzelleca, Joseph F; Maronpot, Robert R; Shipp, Annette M

    2010-05-01

    Triclosan (2,4,4'-trichloro-2'-hydroxy-diphenyl ether) is an antibacterial compound that has been used in consumer products for about 40 years. The tolerability and safety of triclosan has been evaluated in human volunteers with little indication of toxicity or sensitization. Although information in humans from chronic usage of personal care products is not available, triclosan has been extensively studied in laboratory animals. When evaluated in chronic oncogenicity studies in mice, rats, and hamsters, treatment-related tumors were found only in the liver of male and female mice. Application of the Human Relevance Framework suggested that these tumors arose by way of peroxisome proliferator-activated receptor alpha (PPARalpha) activation, a mode of action not considered to be relevant to humans. Consequently, a Benchmark Dose (BMDL(10)) of 47 mg/kg/day was developed based on kidney toxicity in the hamster. Estimates of the amount of intake from in the use of representative personal care products for men, women, and children were derived in two ways: (1) using known or assumed triclosan levels in various consumer products and assumed usage patterns (product-based estimates); and (2) using upper bound measured urinary triclosan levels from human volunteers (biomonitoring-based estimates) using data from the Centers for Disease Control and Prevention. For the product-based estimates, the margin of safety (MOS) for the combined exposure estimates of intake from the use of all triclosan-containing products considered were approximately 1000, 730, and 630 for men, women, and children, respectively. The MOS calculated from the biomonitoring-based estimated intakes were 5200, 6700, and 11,750 for men, women, and children, respectively. Based on these results, exposure to triclosan in consumer products is not expected to cause adverse health effects in children or adults who use these products as intended. PMID:20377306

  2. Natural Product-Derived Treatments for Attention-Deficit/Hyperactivity Disorder: Safety, Efficacy, and Therapeutic Potential of Combination Therapy

    PubMed Central

    Ahn, James; Ahn, Hyung Seok; Cheong, Jae Hoon; dela Peña, Ike

    2016-01-01

    Typical treatment plans for attention-deficit/hyperactivity disorder (ADHD) utilize nonpharmacological (behavioral/psychosocial) and/or pharmacological interventions. Limited accessibility to behavioral therapies and concerns over adverse effects of pharmacological treatments prompted research for alternative ADHD therapies such as natural product-derived treatments and nutritional supplements. In this study, we reviewed the herbal preparations and nutritional supplements evaluated in clinical studies as potential ADHD treatments and discussed their performance with regard to safety and efficacy in clinical trials. We also discussed some evidence suggesting that adjunct treatment of these agents (with another botanical agent or pharmacological ADHD treatments) may be a promising approach to treat ADHD. The analysis indicated mixed findings with regard to efficacy of natural product-derived ADHD interventions. Nevertheless, these treatments were considered as a “safer” approach than conventional ADHD medications. More comprehensive and appropriately controlled clinical studies are required to fully ascertain efficacy and safety of natural product-derived ADHD treatments. Studies that replicate encouraging findings on the efficacy of combining botanical agents and nutritional supplements with other natural product-derived therapies and widely used ADHD medications are also warranted. In conclusion, the risk-benefit balance of natural product-derived ADHD treatments should be carefully monitored when used as standalone treatment or when combined with other conventional ADHD treatments. PMID:26966583

  3. Is There a "Consensus" on School Choice and Achievement?: Advocacy Research and the Emerging Political Economy of Knowledge Production

    ERIC Educational Resources Information Center

    Lubienski, Christopher; Weitzel, Peter; Lubienski, Sarah Theule

    2009-01-01

    A number of school choice advocates claim that there is a research consensus indicating that vouchers for private schools lead to higher academic achievement. The authors review and critique these local studies of voucher programs, contrasting them with findings from larger-scale analyses of nationally representative samples of public and private…

  4. Largest Producer of Steel Products in the United States Achieves Significant Energy Savings at its Minntac Plant

    SciTech Connect

    2008-09-01

    The U. S. Steel Minntac plant in Mt. Iron, MN, achieved annual savings of $760,000 and 95,000 MMBtu after receiving a DOE Save Energy Now energy assessment and implementing recommendations to improve the efficiency of its process heating system.

  5. Largest Producer of Steel Products in the United States Achieves Significant Energy Savings at its Minntac Plant

    SciTech Connect

    Not Available

    2008-09-01

    This case study describes how the U. S. Steel Minntac plant in Mt. Iron, Minnesota, achieved annual savings of $760,000 and 95,000 MMBtu after receiving a DOE Save Energy Now energy assessment and implementing recommendations to improve the efficiency of its process heating system.

  6. Development of Product Relatedness and Distance Effects in Typical Achievers and in Children with Mathematics Learning Disabilities

    ERIC Educational Resources Information Center

    Rotem, Avital; Henik, Avishai

    2015-01-01

    The current study examined the development of two effects that have been found in single-digit multiplication errors: relatedness and distance. Typically achieving (TA) second, fourth, and sixth graders and adults, and sixth and eighth graders with a mathematics learning disability (MLD) performed a verification task. Relatedness was defined by a…

  7. The Use of Courseware Teams for Achieving Content Objectives in Television Production. Satellite Technology Demonstration, Technical Report No. 0505.

    ERIC Educational Resources Information Center

    Linder, Gene; Lonsdale, Helen C.

    The Satellite Technology Demonstration (STD) adopted a coordinated approach called the "courseware team concept" to effectively merge content and video production expertise in television programing. To encourage involvement and participation by the entire staff in the production of a television series, a system was designed to avoid an…

  8. Health, safety, and environmental risks from energy production: A year-long reality check

    SciTech Connect

    Oldenburg, C.M.

    2011-04-01

    Large-scale carbon dioxide capture and storage (CCS) offers the benefit of reducing CO{sub 2} emissions and thereby mitigating climate change risk, but it will also bring its own health, safety, and environmental risks. Curtis M. Oldenburg, Editor-in-Chief, considers these risks in the context of the broader picture of energy production. Over the last year, there have been major acute health, safety, and environmental (HSE) consequences related to accidents involving energy production from every major primary energy source. These are, in chronological order: (i) the Upper Big Branch (coal) Mine disaster, (ii) the Gulf of Mexico Macondo (oil) well blowout, (iii) the San Bruno (natural gas) pipeline leak and explosion, and (iv) the Fukushima (nuclear) reactor radioactivity releases. Briefly, the Upper Big Branch Mine disaster occurred in West Virginia on April 5, 2010, when natural methane in the mine ignited, causing the deaths of 29 miners, the worst coal mine disaster in the USA since 1970. Fifteen days later, the Macondo oil well in the Gulf of Mexico suffered a blowout, with a gas explosion and fire on the floating drilling platform that killed 11 people. The oil and gas continued to flow out of the well at the seafloor until July 15, 2010, spilling a total of approximately 5 million barrels of oil into the sea. On September 9, 2010, a 30-inch (76-cm) buried, steel, natural gas pipeline in San Bruno, California, leaked gas and exploded in a residential neighborhood, killing 8 people in their homes and burning a total of 38 homes. Flames were up to 1000 ft (300 m) high, and the initial explosion itself reportedly measured 1.1 on the Richter scale. Finally, on March 11, 2011, a magnitude 9.0 earthquake off the coast of Japan's main island, Honshu, caused a tsunami that crippled the backup power and associated cooling systems for six reactor cores and their spent fuel storage tanks at the Fukushima nuclear power plant. At time of writing, workers trying to bring

  9. Verification and Implementation of Operations Safety Controls for Flight Missions

    NASA Technical Reports Server (NTRS)

    Smalls, James R.; Jones, Cheryl L.; Carrier, Alicia S.

    2010-01-01

    There are several engineering disciplines, such as reliability, supportability, quality assurance, human factors, risk management, safety, etc. Safety is an extremely important engineering specialty within NASA, and the consequence involving a loss of crew is considered a catastrophic event. Safety is not difficult to achieve when properly integrated at the beginning of each space systems project/start of mission planning. The key is to ensure proper handling of safety verification throughout each flight/mission phase. Today, Safety and Mission Assurance (S&MA) operations engineers continue to conduct these flight product reviews across all open flight products. As such, these reviews help ensure that each mission is accomplished with safety requirements along with controls heavily embedded in applicable flight products. Most importantly, the S&MA operations engineers are required to look for important design and operations controls so that safety is strictly adhered to as well as reflected in the final flight product.

  10. 76 FR 4847 - Hazardous Materials: Safety Requirements for External Product Piping on Cargo Tanks Transporting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-27

    ... CFR Part 173 Hazardous materials transportation, Packaging and containers, Radioactive materials... amounts of hazardous materials as adopted at 54 FR 24982, 25005 (June 12, 1989) and 55 FR 37028, 37049... Pipeline and Hazardous Materials Safety Administration 49 CFR Part 173 RIN 2137-AE53 Hazardous...

  11. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The..., Electrical Safety Division, Approval and Certification Center, 765 Technology Drive, Triadelphia, WV 26059... sealing rings (grommets). If plugs and mating receptacles are mounted to an enclosure wall, they shall...

  12. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR 160.103 and contains protected health information as defined by the HIPAA Privacy Rule at 45 CFR 160.103,...

  13. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR 160.103 and contains protected health information as defined by the HIPAA Privacy Rule at 45 CFR 160.103,...

  14. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR 160.103 and contains protected health information as defined by the HIPAA Privacy Rule at 45 CFR 160.103,...

  15. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work... pursuant to paragraph (b)(6)(i) of this section is by a HIPAA covered entity as defined at 45 CFR 160.103 and contains protected health information as defined by the HIPAA Privacy Rule at 45 CFR 160.103,...

  16. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland.

    PubMed

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

  17. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland

    PubMed Central

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

  18. [Roundtables of SFTS Congress 2013: Needs, indications and safety of blood products; self-sufficiency in blood products].

    PubMed

    Hermine, O; Lassale, B; Morel, P; Samama, C M; Folléa, G; Monsellier, M; Noël, S; Tissot, J-D; Lefrère, J-J

    2014-06-01

    The current issues debate brings together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products are confronted. PMID:24906893

  19. Preliminary scoping safety analyses of the limiting design basis protected accidents for the Fast Flux Test Facility tritium production core

    SciTech Connect

    Heard, F.J.

    1997-11-19

    The SAS4A/SASSYS-l computer code is used to perform a series of analyses for the limiting protected design basis transient events given a representative tritium and medical isotope production core design proposed for the Fast Flux Test Facility. The FFTF tritium and isotope production mission will require a different core loading which features higher enrichment fuel, tritium targets, and medical isotope production assemblies. Changes in several key core parameters, such as the Doppler coefficient and delayed neutron fraction will affect the transient response of the reactor. Both reactivity insertion and reduction of heat removal events were analyzed. The analysis methods and modeling assumptions are described. Results of the analyses and comparison against fuel pin performance criteria are presented to provide quantification that the plant protection system is adequate to maintain the necessary safety margins and assure cladding integrity.

  20. Inhibition of growth of nonproteolytic Clostridium botulinum type B in sous vide cooked meat products is achieved by using thermal processing but not nisin.

    PubMed

    Lindström, M; Mokkila, M; Skyttä, E; Hyytiä-Trees, E; Lähteenmäki, L; Hielm, S; Ahvenainen, R; Korkeala, H

    2001-06-01

    The safety of refrigerated processed foods of extended durability (REPFEDs) with respect to nonproteolytic Clostridium botulinum is under continuous evaluation. In the present study, mild (P7.0(85.0) values 0 to 2 min [P, pasteurization value; z-value 7.0 degrees C; reference temperature 85.0 degrees C]) and increased (P7.0(85.0) values 67 to 515 min) heat treatments were evaluated in relation to survival of nonproteolytic C. botulinum type B spores in sous vide processed ground beef and pork cubes. The use of two concentrations of nisin in inhibition of growth and toxin production by nonproteolytic C. botulinum in the same products was also evaluated. A total of 96 samples were heat processed and analyzed for C. botulinum by BoNT/B gene-specific polmerase chain reaction and for botulinum toxin by a mouse bioassay after storage of 14 to 28 days at 4 and 8 degrees C. Predictably, after mild processing all samples of both products showed botulinal growth, and one ground beef sample became toxic at 8 degrees C. The increased heat processing, equivalent to 67 min at 85 degrees C. resulted in growth but not toxin production of C. botulinum in one ground beef sample in 21 days at 8 degrees C: in the pork cube samples no growth was detected. The increased heating of both products resulted in higher sensory quality than the milder heat treatment. Nisin did not inhibit the growth of nonproteolytic C. botulinum in either product; growth was detected in both products at 4 and 8 degrees C, and ground beef became toxic with all nisin levels within 21 to 28 days at 8 degrees C. Aerobic and lactic acid bacterial counts were reduced by the addition of nisin at 4 degrees C. The study demonstrates that the mild processing temperatures commonly employed in sous vide technology do not eliminate nonproteolytic C. botulinum type B spores. The intensity of each heat treatment needs to be carefully evaluated individually for each product to ensure product safety in relation to

  1. Achieving a production goal of 1 million B/D of coal liquids by 1990. [Impediments and constraints

    SciTech Connect

    Miller, Charles; LaRosa, Dr., P. J.; Coles, E. T.; Fein, H. L.; Petros, J. J.; Iyer, R. S.; Merritt, R. T.

    1980-03-01

    Under this contract, Bechtel analyzed the resource requirements and reviewed major obstacles to the daily production of several million barrels of synthetic coal liquids. Further, the study sought to identify the industry infrastructure needed to support the commercial readiness of the coal liquefaction process. A selected list of critical resource items and their domestic/international availability was developed and examined, and the impact of their supply on the various synthetic coal liquids programs was evaluated. The study approach was to develop representative, or generic, direct and indirect coal liquefaction conceptual designs from available technology and costs data. The generic processes were to employ technology that would be considered commercial by the mid- or late-1980s. The size of the generic construction mobilization was considered reasonable at the outset of the program. The product slate was directed toward unrefined liquid fuels rather than diesel oil or gasoline. The generic processes were to use a wide range of coals to permit siting in most coal-producing regions across the country. Because of the dearth of conceptual design data in the literature, Bechtel developed generic plant designs by using in-house design expertise. Bechtel assumed that because it is first generation technology, the indirect process will be used at the outset of the liquids program, and the direct process will be introduced two to four years later as a second generation technology. The products of either of these processes will be limited to boiler fuels and/or other liquid products which require further upgrading. Cost estimates were developed from equipment lists, as well as material and labor estimates, which enabled the determination of an order-of-magnitude cost estimate and target plant construction schedule for both processes.

  2. Parallel computation safety analysis irradiation targets fission product molybdenum in neutronic aspect using the successive over-relaxation algorithm

    SciTech Connect

    Susmikanti, Mike; Dewayatna, Winter; Sulistyo, Yos

    2014-09-30

    One of the research activities in support of commercial radioisotope production program is a safety research on target FPM (Fission Product Molybdenum) irradiation. FPM targets form a tube made of stainless steel which contains nuclear-grade high-enrichment uranium. The FPM irradiation tube is intended to obtain fission products. Fission materials such as Mo{sup 99} used widely the form of kits in the medical world. The neutronics problem is solved using first-order perturbation theory derived from the diffusion equation for four groups. In contrast, Mo isotopes have longer half-lives, about 3 days (66 hours), so the delivery of radioisotopes to consumer centers and storage is possible though still limited. The production of this isotope potentially gives significant economic value. The criticality and flux in multigroup diffusion model was calculated for various irradiation positions and uranium contents. This model involves complex computation, with large and sparse matrix system. Several parallel algorithms have been developed for the sparse and large matrix solution. In this paper, a successive over-relaxation (SOR) algorithm was implemented for the calculation of reactivity coefficients which can be done in parallel. Previous works performed reactivity calculations serially with Gauss-Seidel iteratives. The parallel method can be used to solve multigroup diffusion equation system and calculate the criticality and reactivity coefficients. In this research a computer code was developed to exploit parallel processing to perform reactivity calculations which were to be used in safety analysis. The parallel processing in the multicore computer system allows the calculation to be performed more quickly. This code was applied for the safety limits calculation of irradiated FPM targets containing highly enriched uranium. The results of calculations neutron show that for uranium contents of 1.7676 g and 6.1866 g (× 10{sup 6} cm{sup −1}) in a tube, their delta

  3. Risk assessment of low-level chemical exposures from consumer products under the U.S. Consumer Product Safety Commission chronic hazard guidelines.

    PubMed Central

    Babich, M A

    1998-01-01

    The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency that was created in 1973. The CPSC has jurisdiction over more the 15,000 types of consumer products used in and around the home or by children, except items such as food, drugs, cosmetics, medical devices, pesticides, certain radioactive materials, products that emit radiation (e.g., microwave ovens), and automobiles. The CPSC has investigated many low-level exposures from consumer products, including formaldehyde emissions from urea-formaldehyde foam insulation and pressed wood products, CO and NO2 emmissions from combustion appliances, and dioxin in paper products. Many chemical hazards are addressed under the Federal Hazardous Substances Act (FHSA), which applies to acute and chronic health effects resulting from high- or low-level exposures. In 1992 the Commission issued guidelines for assessing chronic hazards under the FHSA, including carcinogenicity, neurotoxicity, reproductive/developmental toxicity, exposure, bioavailability, risk assessment, and acceptable risk. The chronic hazard guidelines describe a series of default assumptions, which are used in the absence of evidence to the contrary. However, the guidelines are intended to be sufficiently flexible to incorporate the latest scientific information. The use of alternative procedures is permissible, on a case-by-case basis, provided that the procedures used are scientifically defensible and supported by appropriate data. The application of the chronic hazard guidelines in assessing the risks from low-level exposures is discussed. PMID:9539035

  4. Accuracy of reported flash point values on material safety data sheets and the impact on product classification.

    PubMed

    Radnoff, Diane

    2013-01-01

    Material Safety Data Sheets (MSDSs) are the foundation of worker right-to-know legislation for chemical hazards. Suppliers can use product test data to determine a product's classification. Alternatively, they may use evaluation and professional judgment based on test results for the product or a product, material, or substance with similar properties. While the criteria for classifying products under the new Globally Harmonized System of Classification and Labeling of Chemicals (GHS) are different, a similar process is followed. Neither the current Workplace Hazardous Materials Information System (WHMIS) nor GHS require suppliers to test their products to classify them. In this project 83 samples of products classified as flammable or combustible, representing a variety of industry sectors and product types, were collected. Flash points were measured and compared to the reported values on the MSDSs. The classifications of the products were then compared using the WHMIS and GHS criteria. The results of the study indicated that there were significant variations between the disclosed and measured flash point values. Overall, more than one-third of the products had flash points lower than that disclosed on the MSDS. In some cases, the measured values were more than 20°C lower than the disclosed values. This could potentially result in an underestimation regarding the flammability of the product so it is important for employers to understand the limitations in the information provided on MSDSs when developing safe work procedures and training programs in the workplace. Nearly one-fifth of the products were misclassified under the WHMIS system as combustible when the measured flash point indicated that they should be classified as flammable when laboratory measurement error was taken into account. While a similar number of products were misclassified using GHS criteria, the tendency appeared to be to "over-classify" (provide a hazard class that was more conservative

  5. A comparison of commercial/industry and nuclear weapons safety concepts

    SciTech Connect

    Bennett, R.R.; Summers, D.A.

    1996-07-01

    In this paper the authors identify factors which influence the safety philosophy used in the US commercial/industrial sector and compare them against those factors which influence nuclear weapons safety. Commercial/industrial safety is guided by private and public safety standards. Generally, private safety standards tend to emphasize product reliability issues while public (i.e., government) safety standards tend to emphasize human factors issues. Safety in the nuclear weapons arena is driven by federal requirements and memoranda of understanding (MOUs) between the Departments of Defense and Energy. Safety is achieved through passive design features integrated into the nuclear weapon. Though the common strand between commercial/industrial and nuclear weapons safety is the minimization of risk posed to the general population (i.e., public safety), the authors found that each sector tends to employ a different safety approach to view and resolve high-consequence safety issues.

  6. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses--Criticality (keff) Predictions

    SciTech Connect

    Scaglione, John M; Mueller, Don; Wagner, John C

    2011-01-01

    One of the most significant remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation - in particular, the availability and use of applicable measured data to support validation, especially for fission products. Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. U.S. Nuclear Regulatory Commission (NRC) staff have noted that the rationale for restricting their Interim Staff Guidance on burnup credit (ISG-8) to actinide-only is based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address the issue of validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach (both depletion and criticality) for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the criticality (k{sub eff}) validation approach, and resulting observations and recommendations. Validation of the isotopic composition (depletion) calculations is addressed in a companion paper at this conference. For criticality validation, the approach is to utilize (1) available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion (HTC) program to support validation of the principal actinides and (2) calculated sensitivities, nuclear data uncertainties, and the limited available fission

  7. Feeder layer- and animal product-free culture of neonatal foreskin keratinocytes: improved performance, usability, quality and safety.

    PubMed

    De Corte, Peter; Verween, Gunther; Verbeken, Gilbert; Rose, Thomas; Jennes, Serge; De Coninck, Arlette; Roseeuw, Diane; Vanderkelen, Alain; Kets, Eric; Haddow, David; Pirnay, Jean-Paul

    2012-03-01

    Since 1987, keratinocytes have been cultured at the Queen Astrid Military Hospital. These keratinocytes have been used routinely as auto and allografts on more than 1,000 patients, primarily to accelerate the healing of burns and chronic wounds. Initially the method of Rheinwald and Green was used to prepare cultured epithelial autografts, starting from skin samples from burn patients and using animal-derived feeder layers and media containing animal-derived products. More recently we systematically optimised our production system to accommodate scientific advances and legal changes. An important step was the removal of the mouse fibroblast feeder layer from the cell culture system. Thereafter we introduced neonatal foreskin keratinocytes (NFK) as source of cultured epithelial allografts, which significantly increased the consistency and the reliability of our cell production. NFK master and working cell banks were established, which were extensively screened and characterised. An ISO 9001 certified Quality Management System (QMS) governs all aspects of testing, validation and traceability. Finally, as far as possible, animal components were systematically removed from the cell culture environment. Today, quality controlled allograft production batches are routine and, due to efficient cryopreservation, stocks are created for off-the-shelf use. These optimisations have significantly increased the performance, usability, quality and safety of our allografts. This paper describes, in detail, our current cryopreserved allograft production process. PMID:21394485

  8. Safety and toxicological evaluation of Aflapin: a novel Boswellia-derived anti-inflammatory product.

    PubMed

    Krishnaraju, A V; Sundararaju, D; Vamsikrishna, U; Suryachandra, R; Machiraju, G; Sengupta, K; Trimurtulu, G

    2010-11-01

    Boswellia serrata gum resin has been used for treatment of various ailments in different cultures for thousands of years. Aflapin(®) is a novel synergistic composition derived from B. serrata gum resin (Indian Patent Application No. 2229/CHE/2008). Aflapin is significantly better as an anti-inflammatory agent compared to the Boswellia extracts presently available in the market. To assess the safety of Aflapin, a battery of acute and sub-acute toxicity studies were conducted in various animal models according to the OECD test guidelines. The acute oral LD50 of Aflapin was greater than 5000 mg/kg in female Sprague Dawley (SD) rats. Acute dermal LD50 of Aflapin was greater than 2000 mg/kg in SD rats. A primary dermal irritation study conducted using New Zealand White rabbits indicated that Aflapin is non-irritating to skin. Aflapin caused minimal ocular irritation in a primary eye irritation test conducted on New Zealand Albino rabbits. A repeat dose 28-day sub-acute oral toxicity study in SD rats demonstrated no significant signs of toxicity. Various evaluations including hematology, clinical chemistry, gross necropsy, and histopathology did not show any significant adverse changes. The NOAEL of Aflapin was found to be greater than 2500 mg/kg body weight. These studies demonstrate broad spectrum safety of Aflapin in animal models. PMID:20874664

  9. Application of color mixing for safety and quality inspection of agricultural products

    NASA Astrophysics Data System (ADS)

    Ding, Fujian; Chen, Yud-Ren; Chao, Kuanglin

    2005-11-01

    In this paper, color-mixing applications for food safety and quality was studied, including two-color mixing and three-color mixing. It was shown that the chromaticness of the visual signal resulting from two- or three-color mixing is directly related to the band ratio of light intensity at the two or three selected wavebands. An optical visual device using color mixing to implement the band ratio criterion was presented. Inspection through human vision assisted by an optical device that implements the band ratio criterion would offer flexibility and significant cost savings as compared to inspection with a multispectral machine vision system that implements the same criterion. Example applications of this optical color mixing technique were given for the inspection of chicken carcasses with various diseases and for the detection of chilling injury in cucumbers. Simulation results showed that discrimination by chromaticness that has a direct relation with band ratio can work very well with proper selection of the two or three narrow wavebands. This novel color mixing technique for visual inspection can be implemented on visual devices for a variety of applications, ranging from target detection to food safety inspection.

  10. [PAHs concentrations in aquatic products and food safety evaluation in the coupled mangrove planting-aquaculture ecological system].

    PubMed

    Chen, Guan-Qiu; Li, Yao-Chu; Huang, Jin-Mu; Nan, Yan; Lin, Mao-Hong

    2012-06-01

    In order to know about the PAHs concentration in aquatic products from mangrove planting-aquaculture ecological system and to make sure of food quality and food safety, HPLC was used to determine concentrations of 13 polycyclic aromatic hydrocarbons (PAHs) in the Tilapia mossambica, Mugil cephalu and Concha ostreae from coupled mangrove planting-aquaculture ponds, food safety in aquatic products was also evaluated. The 13 PAHs were Fluorene (Flu), Phenanthrene (Phe), Anthracene (Ant), Fluoranthene (Fla), Pyrene (Pyr), Benz[a] anthraces (BaA), Chrysene (Chr), Benzo[b] fluoranthene (BbF), Benzo[k] fluoranthene (BkF), Benzo[a] Pyrene (BaP), Dibenzo [a, h] anthercene (DahA), Benzo [g, h, i] perylene (BghiP) and Indeno [1,2,3-c, d] pyrene (InP). Concentrations of PAHs were the highest in Concha ostreae which were in the range of 89.79-98.49 microg x kg(-1) dry weight, while those were in the range of 25.97-34.64 microg x kg(-1) in Mugil cephalu and 12.31-14.41 microg x kg(-1) in Tilapia mossambica. The content of fat affected the levels of PAHs content in different aquatic products. The individual composition of PAHs was characterized by 3 rings in samples with the range of 41.58% - 83.35%. Comparing with other areas, PAHs pollution of aquatic products in the studied area was in the mild level. Values of the total BaP(eq) concentration ranged from 0.0689 microg x kg(-1) to 1.0373 microg x kg(-1), which were lower than the maximum level set by European Union. PMID:22946164

  11. Hand Safety

    MedlinePlus

    ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ... en gatillo See More... Hand Anatomy Hand Safety Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening ...

  12. Hand Safety

    MedlinePlus

    ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ... Fireworks Safety Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Español Artritis ...

  13. Use of plant-derived antimicrobials for improving the safety of poultry products

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Salmonella Enteritidis and Campylobacter jejuni are the two major foodborne pathogens transmitted through poultry products. Chickens are the reservoir hosts of these pathogens, with their intestinal colonization being the most significant factor causing contamination of meat and eggs. Effective pre-...

  14. 76 FR 50748 - Information Collection Activity: Production Safety Systems, Revision of a Collection; Submitted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Bureau of Ocean Energy Management, Regulation and Enforcement Information Collection Activity: Production...; Comment Request AGENCY: Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE), Interior... of Ocean Energy Management, Regulation and Enforcement; Attention: Cheryl Blundon; 381 Elden...

  15. Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydropyrrolizidine alkaloids and aristolochic acid

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids ...

  16. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately... they are not put to sleep in them. ix. Bunk beds are products that can be made relatively easily...

  17. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately... they are not put to sleep in them. ix. Bunk beds are products that can be made relatively easily...

  18. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately... they are not put to sleep in them. ix. Bunk beds are products that can be made relatively easily...

  19. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... population at risk, and the risk of injury. See 16 CFR 1009.8. These and other factors also appropriately... they are not put to sleep in them. ix. Bunk beds are products that can be made relatively easily...

  20. Safety concerns of herbal products and traditional Chinese herbal medicines: Dehydopyrrolizidine alkaloids and aristolochic acid

    Technology Transfer Automated Retrieval System (TEKTRAN)

    In many countries, including the United States, herbal supplements, tisanes and vegetable products including traditional Chinese medicines are largely unregulated and their content is not registered, monitored or verified. Consequently potent plant toxins including dehydopyrrolizidine alkaloids and...

  1. Safety issues of high-concentrated hydrogen peroxide production used as rocket propellant

    NASA Astrophysics Data System (ADS)

    Romantsova, O. V.; Ulybin, V. B.

    2015-04-01

    The article dwells on the possibility of production of high-concentrated hydrogen peroxide with the Russian technology of isopropyl alcohol autoxidation. Analysis of fire/explosion hazards and reasons of insufficient quality is conducted for the technology. Modified technology is shown. Non-standard fire/explosion characteristics required for integrated fire/explosion hazards rating for modified hydrogen peroxide production based on the autoxidation of isopropyl alcohol are defined.

  2. Guide for preparing annual reports on radiation-safety testing of electronic products (general)

    SciTech Connect

    Not Available

    1987-10-01

    For manufacturers of electronic products other than those for which a specific guide has been issued, the guide replaces the Guide for the Filing of Annual Reports (21 CFR Subchapter J, Section 1002.11), HHS Publication FDA 82-8127. The electronic product (general) annual reporting guide is applicable to the following products: products intended to produce x radiation (accelerators, analytical devices, therapy x-ray machines); microwave diathermy machines; cold-cathode discharge tubes; and vacuum switches and tubes operating at or above 15,000 volts. To carry out its responsibilities under Public Law 90-602, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has issued a series of regulations contained in Title 21 of the Code of Federal Regulations (CFR). Part 1002 of 21 CFR deals with records and reports. Section 1002.61 categorizes electronic products into Groups A through C. Section 1002.30 requires manufacturers of products in Groups B and C to establish and maintain certain records, while Section 1002.11 requires such manufacturers to submit an Annual Report summarizing the contents of the required records. Section 1002.7 requires that reports conform to reporting guides issued by CDRH unless an acceptable justification for an alternate format is provided.

  3. Workplace Safety and Health Topics: Safety & Prevention

    MedlinePlus

    ... message, please visit this page: About CDC.gov . Workplace Safety and Health Topics Industries & Occupations Hazards & Exposures Diseases & ... Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health Topics Publications and Products Programs Contact NIOSH ...

  4. Tritium production, management and its impact on safety for a D- sup 3 He fusion reactor

    SciTech Connect

    Sze, D.K. ); Herring, S. ); Sawan, M. )

    1991-11-01

    About three percent of the fusion energy produced by a D-{sup 3}He reactor is in the form of neutrons. Those neutrons are generated by D-D and D-T reactions, with the tritium produced by the D-D fusion. The neutrons will react with structural steel, deuterium, {sup 3}He and shielding material to produce tritium. About half of the tritium generated by the D-D reaction will not burn in the plasma and will exit as a part of the plasma exhaust. Thus, there is enough tritium produced in a D-{sup 3}He reactor and careful management will be required. The tritium produced in the shield and plasma can be managed with an acceptable effect on cost and safety. 3 refs., 2 figs., 3 tabs.

  5. The availability and validity of safety information of over the counter herbal products for use in diabetes in Sri Lanka: A cross sectional study

    PubMed Central

    Medagama, Arjuna Bandara; Widanapahirana, Heshan; Prasanga, Tharindu

    2015-01-01

    Aims: There is an increase of over-the-counter (OTC) herbal products for use in diabetes mellitus. The aim of this study is to evaluate the safety information provided with OTC herbal remedies intended for diabetic patients in Sri Lanka and to assess the completeness of the information provided. Methods: Inclusion criteria consisted of OTC herbal remedies meant for use in diabetes. They were bought from local Sri Lankan supermarkets and non-ayurvedic pharmacies and product information regarding the risk of hypoglycemia, precautions for use, adverse events, dose, and interactions were assessed using a scoring system. The accuracy of the information was then compared against published data. Results: 11 products fulfilled the inclusion criteria. Five products contained a single constituent and five contained more than one. None had complete and accurate safety information according to our criteria. None specifically warned against the risk of hypoglycemia. 9 out of 11 products (81.8%) carried ≤3 items of the five essential factual information we expected. Hypoglycemic coma, gastrointestinal symptoms, hepatotoxicity, carcinogenesis, and interactions causing elevated drug levels of Carbamazepine were some of the safety information that was missing. Conclusions: Key safety information was absent in most products. Regulation of sale, provision of key safety information and adverse event reporting should be a priority. PMID:26649230

  6. Comparative in vitro tests on the efficacy and safety of 13 anti-head-lice products.

    PubMed

    Abdel-Ghaffar, Fathy; Semmler, Margit; Al-Rasheid, Khaled; Klimpel, Sven; Mehlhorn, Heinz

    2010-01-01

    Head lice are an emerging social problem, not only in economically poor countries but also in practically all other societies. Several of the common anti-louse products have lost--at least in part--their efficacy due to increasing resistance of lice against insecticides such as permethrin or allethrin. Other compounds, like lindan, were redrawn or banned due to high toxicity. Some recently developed products are based on dimethicones or cyclomethicones and turned out to be easily inflammable. Other styled medicinal products are based on plant extracts-some were proven of high efficacy-others of ineffectivity. The present study investigated in in vitro tests the anti-head louse efficacy of 13 products, the contents of which are used worldwide: Aesculo-Gel L, EtoPril, Goldgeist Forte, InfectoPedicul, Jacutin Pedicul Fluid, K.Laus, Liberalice, Licatack, Mosquito Läuse-Shampoo, Nyda, Paranix, Picksan Louse Stop, and Wash Away Louse. It turned out that several of them are easily inflammable, and therefore, they endanger users (InfectoPedicul, Paranix, EtoPril, Nyda, Goldgeist Forte, and K.Laus, see Table 1). Others have to remain for many hours on the hair in order to reach efficacy (Table 4). During such long periods, highly dosed oils may become inhaled and thus may become dangerous for the user's lung epithelia by covering them. When incubating the lice for 3 or 10 min in vitro, only the following products killed all lice exposed to these products: InfectoPedicul, Paranix, Jacutin Pedicul Fluid, Nyda, K.Laus, Picksan Louse Stop, Licatack, and Wash Away Louse. When evaluating the possible dangers for the users, the last three products, especially, derived from plant extracts, are safe and highly effective at the same time. Furthermore, they had been tested dermatologically as "very good". PMID:19908068

  7. Salmonella Enteritidis in Meat, Poultry, and Pasteurized Egg Products Regulated by the U.S. Food Safety and Inspection Service, 1998 through 2003

    Technology Transfer Automated Retrieval System (TEKTRAN)

    The Food Safety and Inspection Service (FSIS) tests for Salmonella in meat, poultry, and egg products through three regulatory testing programs: the Pathogen Reduction/Hazard Analysis and Critical Control Point (PR/HACCP) program, the ready-to-eat (RTE) program for meat and poultry products, and the...

  8. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-22

    ... ASTM F963-11 standard titled, Standard Consumer Safety Specifications for Toy Safety. Pursuant to... 110-314, made the provisions of ASTM F963-07, Standard Consumer Safety Specifications for Toy Safety... toy chests). The requirements of ASTM F963-08 became effective on August 16, 2009, except for...

  9. Safety analysis report for the use of hazardous production materials in photovoltaic applications at the National Renewable Energy Laboratory

    SciTech Connect

    Crandall, R.S.; Nelson, B.P.; Moskowitz, P.D.; Fthenakis, V.M.

    1992-07-01

    To ensure the continued safety of SERI's employees, the community, and the environment, NREL commissioned an internal audit of its photovoltaic operations that used hazardous production materials (HPMS). As a result of this audit, NREL management voluntarily suspended all operations using toxic and/or pyrophoric gases. This suspension affected seven laboratories and ten individual deposition systems. These activities are located in Building 16, which has a permitted occupancy of Group B, Division 2 (B-2). NREL management decided to do the following. (1) Exclude from this SAR all operations which conformed, or could easily be made to conform, to B-2 Occupancy requirements. (2) Include in this SAR all operations that could be made to conform to B-2 Occupancy requirements with special administrative and engineering controls. (3) Move all operations that could not practically be made to conform to B-2 occupancy requirements to alternate locations. In addition to the layered set of administrative and engineering controls set forth in this SAR, a semiquantitative risk analysis was performed on 30 various accident scenarios. Twelve presented only routine risks, while 18 presented low risks. Considering the demonstrated safe operating history of NREL in general and these systems specifically, the nature of the risks identified, and the layered set of administrative and engineering controls, it is clear that this facility falls within the DOE Low Hazard Class. Each operation can restart only after it has passed an Operational Readiness Review, comparing it to the requirements of this SAR, while subsequent safety inspections will ensure future compliance. This document contains the appendices to the NREL safety analysis report.

  10. Making innovative tattoo ink products with improved safety: possible and impossible ingredients in practical usage.

    PubMed

    Dirks, Michael

    2015-01-01

    Today's tattoo inks are no longer just simple solids in liquid suspension. Nowadays, these inks are high-tech dispersions made from finely spread pigments in a binder-solvent mixture. These so-called colour dispersions must follow the modern standards of tattooing, which are increasing every year. They must be rich in chromophoric pigments and yet fluid, they must not dry rapidly, and there should be no occurrence of any sedimentation, even during longer tattoo seasons. An innovative tattoo ink should enable long-lasting, brilliant tattoos without a negative impact on the artist's workflow and of course without endangering the consumer. The high standard in tattoos, regarding the motives and techniques, that is witnessed today could not be achieved by the artists without quality tools and modern tattoo ink. This article will give the reader a brief overview of the different ingredients of tattoo ink and of the function of binding agents and solvents in modern tattoo ink as well as describe what additives are used to achieve the desired behaviour during application. Furthermore, the article will take a look into the pigments that are used in tattoo ink and show why certain pigments are not suited for tattoo ink. The differences, advantages and disadvantages of organic and inorganic pigments will be explained. PMID:25833633

  11. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Parts 312 and 320 (formerly Docket No. 00N-1484) RIN...: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA... products: Janet Norden, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

  12. 76 FR 78929 - Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

    ... packaging, and printing labels and other labeling; (2) supply chain issues; and, (3) other issues. FDA may... of different types of revised product labeling? B. Supply Chain Issues 3. What are the supply chain...? Please relate this timeframe to the optimal point in the supply chain (e.g., newly manufactured...

  13. 77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ...) published in the Federal Register on March 11, 2010 (75 FR 11624) for instruments that conform to the Model Specifications for Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES... Alcohol (38 FR 30459). A Qualified Products List of Evidential Breath Measurement Devices comprised...

  14. Productivity, job satisfaction, and health and safety in the coal industry: the participatory alternative

    SciTech Connect

    Not Available

    1982-01-01

    This is a conference which presents results and ideas on workplace participation in the coal industry. It discusses the theory of the quality circle groups for developing their own production rates and design goals. It presents the results of different coal company participation in this idea and how to implement this option. Individual topics are entered into the Data Base as separate items.

  15. 77 FR 64588 - Highway Safety Programs; Conforming Products List of Calibrating Units for Breath Alcohol Testers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... calibrating units for breath alcohol testers to Model Specifications for such devices (49 FR 48865) and to... found to conform to the 1994 amended Model Specifications (59 FR 67377) when tested at alcohol... Products List (CPL) published in the Federal Register on June 25, 2007 (72 FR 34747) for devices...

  16. Public health and the safety of milk and milk products from sheep and goats.

    PubMed

    Klinger, I; Rosenthal, I

    1997-08-01

    Goats and sheep rank third and fourth in terms of global milk production from different species, but unlike cow milk, which has stringent hygiene and quality regulations, microbiological standards for the production and distribution of goat milk and sheep milk are more relaxed. Difficulties in managing the sanitary quality of sheep and goat milk derive from a series of factors including the low level of production per head, the milking system, the difficulty involved in machine milking, the conditions under which the herds or flocks are raised, adverse climatic conditions and the spread of production over a wide geographic area. Fresh goat milk is consumed by infants and others with allergies to cow milk and is also used for on-farm manufactured cheese, with or without thermal treatment. The high fat content and peculiar taste of cheeses made from ewe milk are also very popular. These cheese varieties, which are mostly still of 'artisan-type', are not covered by regulatory definitions and the dispute over the use of raw versus pasteurised milk is still alive. However, in documented intoxications recorded after the consumption of cheese, there has always been evidence of incorrect temperature control during pasteurisation, the deliberate addition of raw milk, or contamination during storage. Compositional differences between the milk from cows, ewes and goats (chemical composition of lipids, phosphatase level, freezing point, natural bacterial inhibitor levels, somatic cell count, etc.) preclude the nondiscriminatory use of bovine standards for regulatory purposes. Quality standards adjusted for the specifics of ewe/goat milk should be considered. The production of safe cheese is linked to a series of conditions which ensure consumer health, primarily pasteurisation. In the absence of pasteurisation, all cheeses made from raw milk should be subjected to strict periodic controls. PMID:9501361

  17. Improving the safety of Staphylococcus aureus polyvalent phages by their production on a Staphylococcus xylosus strain.

    PubMed

    El Haddad, Lynn; Ben Abdallah, Nour; Plante, Pier-Luc; Dumaresq, Jeannot; Katsarava, Ramaz; Labrie, Steve; Corbeil, Jacques; St-Gelais, Daniel; Moineau, Sylvain

    2014-01-01

    Team1 (vB_SauM_Team1) is a polyvalent staphylococcal phage belonging to the Myoviridae family. Phage Team1 was propagated on a Staphylococcus aureus strain and a non-pathogenic Staphylococcus xylosus strain used in industrial meat fermentation. The two Team1 preparations were compared with respect to their microbiological and genomic properties. The burst sizes, latent periods, and host ranges of the two derivatives were identical as were their genome sequences. Phage Team1 has 140,903 bp of double stranded DNA encoding for 217 open reading frames and 4 tRNAs. Comparative genomic analysis revealed similarities to staphylococcal phages ISP (97%) and G1 (97%). The host range of Team1 was compared to the well-known polyvalent staphylococcal phages phi812 and K using a panel of 57 S. aureus strains collected from various sources. These bacterial strains were found to represent 18 sequence types (MLST) and 14 clonal complexes (eBURST). Altogether, the three phages propagated on S. xylosus lysed 52 out of 57 distinct strains of S. aureus. The identification of phage-insensitive strains underlines the importance of designing phage cocktails with broadly varying and overlapping host ranges. Taken altogether, our study suggests that some staphylococcal phages can be propagated on food-grade bacteria for biocontrol and safety purposes. PMID:25061757

  18. Improving the Safety of Staphylococcus aureus Polyvalent Phages by Their Production on a Staphylococcus xylosus Strain

    PubMed Central

    El Haddad, Lynn; Ben Abdallah, Nour; Plante, Pier-Luc; Dumaresq, Jeannot; Katsarava, Ramaz; Labrie, Steve; Corbeil, Jacques; St-Gelais, Daniel; Moineau, Sylvain

    2014-01-01

    Team1 (vB_SauM_Team1) is a polyvalent staphylococcal phage belonging to the Myoviridae family. Phage Team1 was propagated on a Staphylococcus aureus strain and a non-pathogenic Staphylococcus xylosus strain used in industrial meat fermentation. The two Team1 preparations were compared with respect to their microbiological and genomic properties. The burst sizes, latent periods, and host ranges of the two derivatives were identical as were their genome sequences. Phage Team1 has 140,903 bp of double stranded DNA encoding for 217 open reading frames and 4 tRNAs. Comparative genomic analysis revealed similarities to staphylococcal phages ISP (97%) and G1 (97%). The host range of Team1 was compared to the well-known polyvalent staphylococcal phages phi812 and K using a panel of 57 S. aureus strains collected from various sources. These bacterial strains were found to represent 18 sequence types (MLST) and 14 clonal complexes (eBURST). Altogether, the three phages propagated on S. xylosus lysed 52 out of 57 distinct strains of S. aureus. The identification of phage-insensitive strains underlines the importance of designing phage cocktails with broadly varying and overlapping host ranges. Taken altogether, our study suggests that some staphylococcal phages can be propagated on food-grade bacteria for biocontrol and safety purposes. PMID:25061757

  19. Safety Analysis Report for the use of hazardous production materials in photovoltaic applications at the National Renewable Energy Laboratory

    SciTech Connect

    Crandall, R.S.; Nelson, B.P. ); Moskowitz, P.D.; Fthenakis, V.M. )

    1992-07-01

    To ensure the continued safety of SERI's employees, the community, and the environment, NREL commissioned an internal audit of its photovoltaic operations that used hazardous production materials (HPMs). As a result of this audit, NREL management voluntarily suspended all operations using toxic and/or pyrophoric gases. This suspension affected seven laboratories and ten individual deposition systems. These activities are located in Building 16, which has a permitted occupancy of Group B, Division 2 (B-2). NREL management decided to do the following. (1) Exclude from this SAR all operations which conformed, or could easily be made to conform, to B-2 Occupancy requirements. (2) Include in this SAR all operations that could be made to conform to B-2 Occupancy requirements with special administrative and engineering controls. (3) Move all operations that could not practically be made to conform to B-2 Occupancy requirements to alternate locations. In addition to the layered set of administrative and engineering controls set forth in this SAR, a semiquantitative risk analysis was performed on 30 various accident scenarios. Twelve presented only routine risks, while 18 presented low risks. Considering the demonstrated safe operating history of NREL in general and these systems specifically, the nature of the risks identified, and the layered set of administrative and engineering controls, it is clear that this facility falls within the DOE Low Hazard Class. Each operation can restart only after it has passed an Operational Readiness Review, comparing it to the requirements of this SAR, while subsequent safety inspections will ensure future compliance.

  20. Human food safety and environmental hazards associated with the use of methyltestosterone and other steroids in production of all-male tilapia.

    PubMed

    Mlalila, Nichrous; Mahika, Charles; Kalombo, Lonji; Swai, Hulda; Hilonga, Askwar

    2015-04-01

    In recent years, all-male cultures of Nile tilapia (Oreochromis niloticus) have been the most preferred mode of production in aquaculture industry. All-male individuals achieve higher somatic growth rate and shut high energy losses associated with gonadal development and reproduction. The economic advantages of culturing all-male tilapia have led to the development of procedures for producing unisex cultures, using 17α-methyltestosterone (MT). Despite widespread use of the MT in tilapia farming, the implications of hormone treatment in relation to human health and the environment have raised a number of concerns in the scientific community. In this review, the hormonal application processes, economic and ecological significance of MT, food safety and residual MT, comparative uses of steroids in aquaculture, animal husbandry, and medicine have been briefly reviewed for regulatory guidelines, and finally, future research perspectives have been addressed. The review can be used as policy-making guidelines in aquaculture framework development as can be emphasized in African continent, among others. The most important conclusion to draw is that the quantity of MT used in conventional practice is large compared to the actual dose required for sex reversal, fish produced are safe for human consumptions, and the environmental hazards should be further emphasized. PMID:25639247

  1. Concentration-triggered fission product release from zirconia: consequences for nuclear safety

    NASA Astrophysics Data System (ADS)

    Gentils, A.; Thomé, L.; Jagielski, J.; Garrido, F.

    2002-02-01

    Crystalline oxide ceramics, more particularly zirconia and spinel, are promising matrices for plutonium and minor actinide transmutation. An important issue concerning these materials is the investigation of their ability to confine radiotoxic elements resulting from the fission of actinides. This letter reports the study of the release, upon annealing or irradiation at high temperature, of one of the most toxic fission product (Cs) in zirconia. The foreign species are introduced by ion implantation and the release is studied by Rutherford backscattering experiments. The results emphasize the decisive influence of the fission product concentration on the release properties. The Cs mobility in zirconia is strongly increased when the impurity concentration exceeds a threshold of the order of a few atomic per cent. Irradiation with medium-energy heavy ions is shown to enhance Cs outdiffusion with respect to annealing at the same temperature.

  2. Product identification and safety evaluation of aflatoxin B1 decontaminated by electrolyzed oxidizing water.

    PubMed

    Xiong, Ke; Liu, Hai jie; Li, Li te

    2012-09-26

    In this study with aflatoxin-contaminated peanuts, the effectiveness of electrolyzed oxidizing water (EOW) in the decontamination of aflatoxin B(1) was investigated. The aflatoxin B(1) content was markedly reduced upon treatment with EOW, particularly with neutral electrolyzed oxidizing water (NEW). The conversion product of EOW treatment was isolated and identified as 8-chloro-9-hydroxy aflatoxin B(1) (compound 1), which is an amphiphilic molecule, in contrast to fat-soluble aflatoxin B(1). A mutagenic response study revealed that the number of revertants per plate after treatment of bacterial strains TA-97, TA-98, TA-100, and TA-102 with NEW was within the standard value range. The HepG2 cell viability assay yielded an IC(50) value of compound 1 approximately 150 mM. This study indicates that EOW had the ability to decontaminate aflatoxin B(1), and the conversion product, compound 1, did not exhibit mutagenic activity or cytotoxic effects. PMID:22950859

  3. Frozen, Fully-Cooked Products and Botulism--Food Safety Advisory

    MedlinePlus

    ... Administrative Forms Standard Forms Skip Navigation Z7_0Q0619C0JGR010IFST1G5B10H1 Web Content Viewer (JSR 286) Actions ${title} Loading... / Topics / ... Frozen Fully-cooked Products and Botulism Z7_0Q0619C0JGR010IFST1G5B10H3 Web Content Viewer (JSR 286) Actions ${title} Loading... Z7_ ...

  4. Labelling Of Textile Products From The Perspective Of Quality, Maintenance, Safety And Environment

    NASA Astrophysics Data System (ADS)

    Draxlerová, Mária; Rusko, Miroslav; Kuracina, Marcel

    2015-06-01

    Fundamental right of all consumers is the availability of necessary information to protect their own health. Information should be obtained from the marks referred to the product which they come into contact with. Marks are integral parts of everyone's life. We can see various types of marks at home, in stores and everywhere around us. Symbols indicate to the consumer the importance assigned to them in an opinion system (labelling scheme).

  5. An overview of food safety and bacterial foodborne zoonoses in food production animals in the Caribbean region.

    PubMed

    Guerra, Maria Manuela Mendes; de Almeida, Andre M; Willingham, Arve Lee

    2016-08-01

    Foodborne diseases (FBDs) in the Caribbean have a high economic burden. Public health and tourism concerns rise along with the increasing number of cases and outbreaks registered over the last 20 years. Salmonella spp., Shigella spp., and Campylobacter spp. are the main bacteria associated with these incidents. In spite of undertaking limited surveillance on FBD in the region, records related to bacterial foodborne zoonoses in food-producing animals and their associated epidemiologic significance are poorly documented, giving rise to concerns about the importance of the livestock, food animal product sectors, and consumption patterns. In this review, we report the available published literature over the last 20 years on selected bacterial foodborne zoonoses in the Caribbean region and also address other food safety-related aspects (e.g., FBD food attribution, importance, surveillance), mainly aiming at recognizing data gaps and identifying possible research approaches in the animal health sector. PMID:27215411

  6. Validation of the safety of MDCK cells as a substrate for the production of a cell-derived influenza vaccine.

    PubMed

    Onions, David; Egan, William; Jarrett, Ruth; Novicki, Deborah; Gregersen, Jens-Peter

    2010-09-01

    Cell culture-based production methods may assist in meeting increasing demand for seasonal influenza vaccines and developing production flexibility required for addressing influenza pandemics. MDCK-33016PF cells are used in propagation of a cell-based seasonal influenza vaccine (Optaflu); but, like most continuous cell lines, can grow in immunocompromised mice to produce tumors. It is, therefore, essential that no residual cells remain within the vaccine, that cell lysates or DNA are not oncogenic, and that the cell substrate does not contain oncogenic viruses or oncogenic DNA. Multiple, redundant processes ensure the safety of influenza vaccines produced in MDCK-33016PF cells. The probability of a residual cell being present in a dose of vaccine is approximately 1 in 10(34). Residual MDCK-DNA is < or =10 ng per dose and the ss-propiolactone used to inactivate influenza virus results in reduction of detectable DNA to less than 200 base pairs (bp). Degenerate PCR and specific PCR confirm exclusion of oncogenic viruses. The manufacturing process has been validated for its capacity to remove and inactivate viruses. We conclude that the theoretical risks arising from manufacturing seasonal influenza vaccine using MDCK-33016PF cells are reduced to levels that are effectively zero by the multiple, orthogonal processes used during production. PMID:20537553

  7. Computer analyses for the design, operation and safety of new isotope production reactors: A technology status review

    SciTech Connect

    Wulff, W.

    1990-01-01

    A review is presented on the currently available technologies for nuclear reactor analyses by computer. The important distinction is made between traditional computer calculation and advanced computer simulation. Simulation needs are defined to support the design, operation, maintenance and safety of isotope production reactors. Existing methods of computer analyses are categorized in accordance with the type of computer involved in their execution: micro, mini, mainframe and supercomputers. Both general and special-purpose computers are discussed. Major computer codes are described, with regard for their use in analyzing isotope production reactors. It has been determined in this review that conventional systems codes (TRAC, RELAP5, RETRAN, etc.) cannot meet four essential conditions for viable reactor simulation: simulation fidelity, on-line interactive operation with convenient graphics, high simulation speed, and at low cost. These conditions can be met by special-purpose computers (such as the AD100 of ADI), which are specifically designed for high-speed simulation of complex systems. The greatest shortcoming of existing systems codes (TRAC, RELAP5) is their mismatch between very high computational efforts and low simulation fidelity. The drift flux formulation (HIPA) is the viable alternative to the complicated two-fluid model. No existing computer code has the capability of accommodating all important processes in the core geometry of isotope production reactors. Experiments are needed (heat transfer measurements) to provide necessary correlations. It is important for the nuclear community, both in government, industry and universities, to begin to take advantage of modern simulation technologies and equipment. 41 refs.

  8. Robustness of nanofiltration for increasing the viral safety margin of biological products.

    PubMed

    Caballero, Santiago; Diez, José M; Belda, Francisco J; Otegui, Magdalena; Herring, Steven; Roth, Nathan J; Lee, Douglas; Gajardo, Rodrigo; Jorquera, Juan I

    2014-03-01

    In this study, the virus-removal capacity of nanofiltration was assessed using validated laboratory scale models on a wide range of viruses (pseudorabies virus; human immunodeficiency virus; bovine viral diarrhea virus; West Nile virus; hepatitis A virus; murine encephalomyocarditis virus; and porcine parvovirus) with sizes from 18 nm to 200 nm and applying the different process conditions existing in a number of Grifols' plasma-derived manufacturing processes (thrombin, α1-proteinase inhibitor, Factor IX, antithrombin, plasmin, intravenous immunoglobulin, and fibrinogen). Spiking experiments (n = 133) were performed in process intermediate products, and removal was subsequently determined by infectivity titration. Reduction Factor (RF) was calculated by comparing the virus load before and after nanofiltration under each product purification condition. In all experiments, the RFs were close to or greater than 4 log10 (>99.99% of virus elimination). RF values were not significantly affected by the process conditions within the limits assayed (pH, ionic strength, temperature, filtration ratio, and protein concentration). The virus-removal capacity of nanofiltration correlated only with the size of the removed agent. In conclusion, nanofiltration, as used in the manufacturing of several Grifols' products, is consistent, robust, and not significantly affected by process conditions. PMID:24485384

  9. Development of a convenience and safety chilled sous vide fish dish: Diversification of aquacultural products.

    PubMed

    Espinosa, M C; López, G; Díaz, P; Linares, M B; Garrido, M D

    2016-04-01

    The dynamic expansion of the ready-to-eat seabream sector in its adaptation to new lifestyles has led to the search for new presentation formats in seabream (Sparus aurata). Green sauce (olive oil, wine vinegar, garlic, fresh parsley, black pepper, basil and salt) and 60 ℃ of cooking temperature were chosen by the panellists for the sous vide cooking process. Seabream fillet and sauce were packaged in polypropylene trays, cooked, chilled and stored at 2 ℃. Microbiological (total viable counts,Enterobacteriaceae,lactic acid bacteria, anaerobic psychrotrophic, moulds and yeasts, Salmonella and Listeria monocytogenes), chemical (pH and TBARs) and sensory parameters were determined at 0, 7, 17, 34, 48 and 62 days. In the conditions used, the microbiological counts remained stable, and Salmonella and Listeria monocytogenes were absent. The acidic sauce had a positive effect on the pH of the product, and low TBARs were obtained throughout storage. The processing conditions used in the present study allowed a chilled ready-to-eat seabream product of consistently high quality up to 62 days of storage to be obtained, representing an expansion of the products offered by the aquacultural industry. PMID:25941212

  10. Product reformulation in the food system to improve food safety. Evaluation of policy interventions.

    PubMed

    Marotta, Giuseppe; Simeone, Mariarosaria; Nazzaro, Concetta

    2014-03-01

    The objective of this study is to understand the level of attention that the consumer awards to a balanced diet and to product ingredients, with a twofold purpose: to understand whether food product reformulation can generate a competitive advantage for companies that practice it and to evaluate the most appropriate policy interventions to promote a healthy diet. Reformulation strategy, in the absence of binding rules, could be generated by consumers. Results from qualitative research and from empirical analysis have shown that the question of health is a latent demand influenced by two main factors: a general lack of information, and the marketing strategies adopted by companies which bring about an increase in the information asymmetry between producers and consumers. In the absence of binding rules, it is therefore necessary that the government implement information campaigns (food education) aimed at increasing knowledge regarding the effects of unhealthy ingredients, in order to inform and improve consumer choice. It is only by means of widespread information campaigns that food product reformulation can become a strategic variable and allow companies to gain a competitive advantage. This may lead to virtuous results in terms of reducing the social costs related to an unhealthy diet. PMID:24355908

  11. Food safety in raw milk production: risk factors associated to bacterial DNA contamination.

    PubMed

    Cerva, Cristine; Bremm, Carolina; Reis, Emily Marques dos; Bezerra, André Vinícius Andrade; Loiko, Márcia Regina; Cruz, Cláudio Estêvão Farias da; Cenci, Alexander; Mayer, Fabiana Quoos

    2014-06-01

    While human illness from milkborne pathogens may be linked to contamination of the product after pasteurization or improper pasteurization, such diseases are usually associated with consumption of raw milk or its by-products. Molecular biology tools were applied to investigate contamination by Listeria monocytogenes, Salmonella spp., some pathogenic strains of Escherichia coli, and Campylobacter jejuni in 548 raw milk samples from 125 dairy farms established in two regions from southern Brazil. Moreover, 15 variables were evaluated for their association with raw milk contamination levels, and the risk factors were determined by multiple regression analysis. Salmonella spp. were more frequently detected, followed by pathogenic E. coli. There was difference in contamination index between the regions, in which risk factors such as temporary cattle confinement, low milk production, low milking machine cleaning frequency, and milk storage area without tile walls were identified. The risk factors were specific to each region studied. Nevertheless, the data can be used to improve milk quality of dairy farms/herds with similar management practices. PMID:24715203

  12. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses: Criticality (keff) Predictions

    SciTech Connect

    Scaglione, John M.; Mueller, Don E.; Wagner, John C.

    2014-12-01

    One of the most important remaining challenges associated with expanded implementation of burnup credit in the United States is the validation of depletion and criticality calculations used in the safety evaluation—in particular, the availability and use of applicable measured data to support validation, especially for fission products (FPs). Applicants and regulatory reviewers have been constrained by both a scarcity of data and a lack of clear technical basis or approach for use of the data. In this study, this paper describes a validation approach for commercial spent nuclear fuel (SNF) criticality safety (keff) evaluations based on best-available data and methods and applies the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The criticality validation approach utilizes not only available laboratory critical experiment (LCE) data from the International Handbook of Evaluated Criticality Safety Benchmark Experiments and the French Haut Taux de Combustion program to support validation of the principal actinides but also calculated sensitivities, nuclear data uncertainties, and limited available FP LCE data to predict and verify individual biases for relevant minor actinides and FPs. The results demonstrate that (a) sufficient critical experiment data exist to adequately validate keff calculations via conventional validation approaches for the primary actinides, (b) sensitivity-based critical experiment selection is more appropriate for generating accurate application model bias and uncertainty, and (c) calculated sensitivities and nuclear data uncertainties can be used for generating conservative estimates of bias for minor actinides and FPs. Results based on the SCALE 6.1 and the ENDF/B-VII.0 cross-section libraries indicate that a conservative estimate of the bias for the minor actinides and FPs is 1.5% of their worth

  13. Volcanic Ash Image Products from MODIS for Aviation Safety and Natural Hazard Mitigation

    NASA Astrophysics Data System (ADS)

    Stephens, G.; Ellrod, G. P.; Im, J.

    2003-12-01

    Multi-spectral volcanic ash image products have been developed using Moderate Resolution Imaging Spectroradiometer (MODIS) data from the NASA Terra spacecraft (Ellrod and Im 2003). Efforts are now underway to integrate these new products into the MODIS Data Retrieval System at NESDIS, for use in the operational Hazard Mapping System (HMS). The images will be used at the Washington Volcanic Ash Advisory Center (W-VAAC) in the issuance of volcanic ash advisory statements to aircraft. In addition, the images will be made available to users in the global volcano and emergency management community via the World Wide Web. During the development process, good results (high detection rate with low ­false alarms­") were obtained from a tri-spectral combination of MODIS Infrared (IR) bands centered near 8.6, 11.0 and 12.0 ŸYm (Bands 29, 31, and 32). Optimum Red-Green-Blue false color composite images were developed to provide information on ash cloud location, as well as cloud phase and surface characteristics, to aid in interpretation both day and night. Information on volcanic ash derived from the tri-spectral product was displayed using the red color gun. This information was combined with visible (0.6 ŸYm) and near-IR (1.6 ŸYm) data for green and blue, respectively, during daylight periods. At night, the 8.6 ­V 11.0 ŸYm combination and 11.0 ŸYm band were used for the green and blue colors in the RGB product. Currently, raw MODIS data in five minute ­granules­" are processed for the following regions: (1) southern Alaska, (2) Mexico, Central America and the Caribbean, and (3) northern Andes region of South America. Image products are converted to Geo-spatial Information System (GIS) compatible formats for use in the HMS, and to Man-Computer Interactive Data Access System (McIDAS) ­Area File­" format for use in currently configured W-VAAC display systems. The installation of a high speed, fiber optic line from NASA Goddard Space Flight Center to the World

  14. Artisanal alcohol production in Mayan Guatemala: chemical safety evaluation with special regard to acetaldehyde contamination.

    PubMed

    Kanteres, Fotis; Rehm, Jürgen; Lachenmeier, Dirk W

    2009-11-01

    There is a lack of knowledge regarding the composition, production, distribution, and consumption of artisanal alcohol, particularly in the developing world. In Nahualá, an indigenous Mayan municipality located in highland Guatemala, heavy alcohol consumption appears to have had a significant negative impact on health, a major role in cases of violence and domestic abuse, and a link to street habitation. Cuxa, an artisanally, as well as commercially produced sugarcane alcohol, is widely consumed by heavy drinkers in this community. Cuxa samples from all distribution points in the community were obtained and chemically analyzed for health-relevant constituents and contaminants including methanol, acetaldehyde, higher alcohols, and metals. From those, only acetaldehyde was confirmed to be present in unusually high levels (up to 126 g/hl of pure alcohol), particularly in samples that were produced clandestinely. Acetaldehyde has been evaluated as "possibly carcinogenic" and has also been identified as having significant human exposure in a recent risk assessment. This study explores the reasons for the elevated levels of acetaldehyde, through both sampling and analyses of raw and intermediary products of cuxa production, as well as interviews from producers of the clandestine alcohol. For further insight, we experimentally produced this alcohol in our laboratory, based on the directions provided by the producers, as well as materials from the town itself. Based on these data, the origin of the acetaldehyde contamination appears to be due to chemical changes induced during processing, with the major causative factors consisting of poor hygiene, aerobic working conditions, and inadequate yeast strains, compounded by flawed distillation methodology that neglects separation of the first fractions of the distillate. These results indicate a preventable public health concern for consumers, which can be overcome through education about good manufacturing practices, as well

  15. The effect of spiked boots on logger safety, productivity and workload.

    PubMed

    Kirk, P; Parker, R

    1994-04-01

    Analysis of 1657 lost-time logging accidents in the New Zealand logging industry (1985-1991) indicates that 17.5% were as a result of slips, trips and falls and a total of 2870 days were lost. Most (56%) of these slipping, tripping and falling accidents occurred in the felling and delimbing phase of the logging operation, where 37% of the workforce are employed. In an attempt to reduce the number of slipping injuries to loggers employed in felling and delimbing, a study of the effectiveness of spike-soled (caulk) boots was undertaken. Four loggers were intensively observed at work, by continuous time-study methods, while wearing their conventional rubber-soled boots and then spike-soled boots. The number of slips, work methods used, physiological workload and productivity were compared for loggers wearing the two footwear types. Results indicated that spike-soled boots were associated with a significant reduction in the frequency of slips and had no adverse effect on work methods, physiological workload or productivity. Spike-soled boots are now being promoted for use by loggers in New Zealand as a simple method to reduce slipping, tripping and falling accidents. PMID:15676957

  16. Efficacy and safety of Dr Michaels® (Soratinex®) product family for the topical treatment of psoriasis: a monitored status study.

    PubMed

    França, K; Novotny, F; Hercogovấ, J; Fioranelli, M; Gianfaldoni, S; Chokoeva, A A; Tchernev, G; Wollina, U; Tirant, M; Roccia, M G; Lotti, T

    2016-01-01

    The aim of the study was to investigate the efficacy and safety of Michaels® (Soratinex®) remedies in patients suffering from chronic plaque psoriasis in a Czech population. Seventy-five (34 female/41 male) patients, aged 18-72 years old (mean age: 38.5 years) with mild to severe plaque psoriasis participated in the study. The products, including cleansing gel, ointment and skin conditioner, containing fruit acid complex, herbal oils and emulsifiers, were used twice daily and in the same manner for all the skin lesions. The study period was eight weeks. Histologic variables and various blood picture parameters, including FW, glucose, cholesterol, triacylglyceroles, bilirubin, GMT, ALT, AST, creatinine, uric acid and urea in blood were monitored, before and after therapy with Michaels® (Soratinex®) treatment. Assessment, using the Psoriasis Activity Severity Index (PASI) scores and photographic analysis, was done at time 0, and after 2, 4, 6 and 8 weeks. Patient’s improvement was determined by the percentage reduction of the PASI scores. Side effects and tolerability were also evaluated. After 8 weeks using Dr Michaels® (Soratinex®) treatment course, 5 patients had a moderate improvement, with the resolution of 25-50% of skin lesions; 11 patients showed a good improvement, with the resolution of 51-75% of lesions. Another 50 patients had an outstanding improvement, with the regression of 76-100% of lesions. Only 4 patients did not achieve an improvement of psoriasis. Six patients experienced folliculitis, which resolved without cessation of treatment. Three patients worsened and discontinued treatment. Six patients dropped out because of non-compliance. The blood results and histologic findings were all normal. Our investigation shows that Dr Michaels® (Soratinex®) products can be safely and successfully used in the treatment of chronic plaque psoriasis. PMID:27498668

  17. Quality and safety aspects of infant nutrition.

    PubMed

    Koletzko, Berthold; Shamir, Raanan; Ashwell, Margaret

    2012-01-01

    Quality and safety aspects of infant nutrition are of key importance for child health, but oftentimes they do not get much attention by health care professionals whose interest tends to focus on functional benefits of early nutrition. Unbalanced diets and harmful food components induce particularly high risks for untoward effects in infants because of their rapid growth, high nutrient needs, and their typical dependence on only one or few foods during the first months of life. The concepts, standards and practices that relate to infant food quality and safety were discussed at a scientific workshop organized by the Child Health Foundation and the Early Nutrition Academy jointly with the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, and a summary is provided here. The participants reviewed past and current issues on quality and safety, the role of different stakeholders, and recommendations to avert future issues. It was concluded that a high level of quality and safety is currently achieved, but this is no reason for complacency. The food industry carries the primary responsibility for the safety and suitability of their products, including the quality of composition, raw materials and production processes. Introduction of new or modified products should be preceded by a thorough science based review of suitability and safety by an independent authority. Food safety events should be managed on an international basis. Global collaboration of food producers, food-safety authorities, paediatricians and scientists is needed to efficiently exchange information and to best protect public health. PMID:22699763

  18. A critical assessment of the scientific basis, and implementation, of regulations for the safety assessment and marketing of innovative tobacco-related products.

    PubMed

    Combes, Robert D; Balls, Michael

    2015-09-01

    Our scientific, logistical, ethical and animal welfare-related concerns about the latest US Food and Drug Administration (FDA) regulations for existing and so-called 'new' tobacco products, aimed at reducing harmful exposures, are explained. Such claims for sales in the USA now have to be based on a wide range of information, a key part of which will increasingly be data on safety and risk. One of the pathways to achieve marketing authorisation is to demonstrate substantial equivalence (SE) with benchmark products, called predicates. However, the regulations are insufficiently transparent with regard to: a) a rationale for the cut-off date for 'old' and 'new' products, and for exempting the former from regulation; b) the scientific validity and operation of SE; c) options for product labelling to circumvent SE; d) the experimental data required to support, and criteria to judge, a claim; and e) a strategy for risk assessment/management. Scientific problems related to the traditional animal methods used in respiratory disease and inhalation toxicology, and the use of quantitative comparators of toxicity, such as the No Observed Adverse Effect Level, are discussed. We review the advantages of relevant in vitro, mechanism-based, target tissue-oriented technologies, which an advisory report of the Institute of Medicine of the US National Academy of Sciences largely overlooked. These benefits include: a) the availability, for every major site in the respiratory tract, of organotypic human cell-based tissue culture systems, many of which are already being used by the industry; b) the accurate determination of concentrations of test materials received by target cells; c) methods for exposure to particulate and vapour phases of smoke, separately or combined; d) the ability to study tissue-specific biotransformation; and e) the use of modern, human-focused methodologies, unaffected by species differences. How data extrapolation, for risk assessment, from tissue culture to

  19. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... sample calculations for at least one flight hazard area malfunction start time and one downrange... seconds after the flight hazard area malfunction start time or at the time of nominal thrust termination... establishing flight safety limits and hazard areas and performing debris risk, toxic, and blast analyses....

  20. Identifying behaviour patterns of construction safety using system archetypes.

    PubMed

    Guo, Brian H W; Yiu, Tak Wing; González, Vicente A

    2015-07-01

    Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process. PMID:25909389

  1. Safety evaluation of petroleum products using an in vitro eye irritation test battery.

    PubMed

    Martin, S A; Roy, T A; Saladdin, K A; Fleming, B A; Mackerer, C R

    1994-08-01

    An in vitro eye irritation test battery (IVEye) composed of the EYTEX and Modified Agarose Diffusion Method (MADM) assays was evaluated for use as a predictive, economical screen and/or adjunct for the Draize eye test. EYTEX mimics corneal opacification using a synthetic matrix of proteins that is intended to produce measurable opacity on exposure to chemical irritants in proportion to their ocular irritation potential. MADM is a cytotoxicity-based assay consisting of NCTC clone 929 mouse fibroblasts overlayed with 1% agarose in culture medium. Potential eye irritation is measured macroscopically as the area of decolorization (neutral red release) around the area of chemical application and microscopically as the percentage of cell lysis resulting from chemical application. Of the 70 materials tested in the IVEye for which Draize eye test data also exist, the battery correctly identified 38 materials as non-irritants and 30 as irritants, with two false positives and no false negatives. Non-parametric analysis of the data show the battery to have a sensitivity of 100%, a specificity of 95% and a predictive value of 94%. The irritation class correlation (equivalence; irritation ranking) between EYTEX alone and the Draize data was 85%. These data support the use of IVEye as an accurate, reproducible and cost-effective in vitro method for identifying the eye irritation potential of petroleum products. PMID:20692994

  2. Use of a Closed Culture System to Improve the Safety of Lentiviral Vector Production.

    PubMed

    Wu, Tao; Bour, Gaëtan; Durand, Sarah; Lindner, Véronique; Gossé, Francine; Zona, Laetitia; Certoux, Jean-Marie; Diana, Michele; Baumert, Thomas F; Marescaux, Jacques; Mutter, Didier; Pessaux, Patrick; Robinet, Eric

    2015-12-01

    We evaluated the possibility of introducing a combination of six oncogenes into primary porcine hepatocytes (PPH) using a lentiviral vector (LV)-mediated gene transfer in order to develop a porcine hepatocellular carcinoma model based on autologous transplantation of ex vivo-transformed hepatocytes. The six oncogenes were introduced into three plasmids, hence enabling the production of LVs encoding a luciferase reporter gene and hTERT+p53(DD), cyclinD1+CDK4(R24C), and c-myc(T58A)+HRas(G21V) genes, respectively. In order to improve the protection of the laboratory personnel manipulating such LVs, we used a compact cell culture cassette (CliniCell(®) device) as a closed cell culture system. We demonstrated that the CliniCell device allows to produce LVs, through plasmid transfection of 293T cells, and, after transfer to a second cassette, to transduce PPH with a similar efficacy as conventional open cell culture systems such as flasks or Petri dishes. Additionally, it is possible to cryopreserve at -80°C the transduced cells, directly in the CliniCell device used for the transduction. In conclusion, the use of a closed culture system for the safe handling of oncogene-encoding LVs lays the foundation for the development of porcine tumor models based on the autologous transplantation of ex vivo-transformed primary cells. PMID:26467420

  3. Effects of extended work shifts and shift work on patient safety, productivity, and employee health.

    PubMed

    Keller, Simone M

    2009-12-01

    It is estimated 1.3 million health care errors occur each year and of those errors 48,000 to 98,000 result in the deaths of patients (Barger et al., 2006). Errors occur for a variety of reasons, including the effects of extended work hours and shift work. The need for around-the-clock staff coverage has resulted in creative ways to maintain quality patient care, keep health care errors or adverse events to a minimum, and still meet the needs of the organization. One way organizations have attempted to alleviate staff shortages is to create extended work shifts. Instead of the standard 8-hour shift, workers are now working 10, 12, 16, or more hours to provide continuous patient care. Although literature does support these staffing patterns, it cannot be denied that shifts beyond the traditional 8 hours increase staff fatigue, health care errors, and adverse events and outcomes and decrease alertness and productivity. This article includes a review of current literature on shift work, the definition of shift work, error rates and adverse outcomes related to shift work, health effects on shift workers, shift work effects on older workers, recommended optimal shift length, positive and negative effects of shift work on the shift worker, hazards associated with driving after extended shifts, and implications for occupational health nurses. PMID:20043622

  4. Factors affecting yield and safety of protein production from cassava by Cephalosporium eichhorniae

    SciTech Connect

    Mikami, Y.; Gregory, K.F.; Levadoux, W.L.; Balagopalan, C.; Whitwill, S.T.

    1982-01-01

    The properties of C. eichhorniae 152 (ATCC 38255) affecting protein production from cassava carbohydrate, for use as an animal feed, were studied. This strain is a true thermophile, showing optimum growth at 45-47 degrees, maximum protein yield at 45 degrees, and no growth at 25 degrees. It has an optimum pH of approximately 3.8 and is obligately acidophilic, being unable to sustain growth at pH of more than or equal to 6.0 in a liquid medium, or pH of more than or equal to 7.0 on solid media. The optimum growth conditions of pH 3.8 and 45 degrees were strongly inhibitive to potential contaminants. It rapidly hydrolyzed cassava starch. It did not utilize sucrose, but approximately 16% of the small sucrose component of cassava was chemically hydrolyzed during the process. Growth with cassava meal (50 g/l) was complete in approximately 20 h, yielding 22.5 g/l (dry biomass), containing 41% crude protein (48-50% crude protein in the mycelium) and 31% true protein (7.0 g/l). Resting and germinating spores (10 to the power of 6 - 10 to the power of 8 per animal) injected by various routes into normal and gamma-irradiated 6-week-old mice and 7-day-old chickens failed to initiate infections.

  5. How does the efficacy and safety of Oralair(®) compare to other products on the market?

    PubMed

    Larenas-Linnemann, Désirée

    2016-01-01

    Due to differences between allergen immunotherapy (AIT) trials in patient populations, trial design (including primary efficacy variables), the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair(®) and Grazax(®)/Grastek(®), should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair(®) is effective in a pre (2-months)-coseasonal schedule to reduce symptoms and medication use, and improve a patients' quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months)-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair(®) is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax(®)/Grastek(®) showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available), and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. PMID:27313458

  6. Safety of Herbal Medicinal Products: Echinacea and Selected Alkylamides Do Not Induce CYP3A4 mRNA Expression.

    PubMed

    Modarai, Maryam; Silva, Elisabete; Suter, Andy; Heinrich, Michael; Kortenkamp, Andreas

    2011-01-01

    A major safety concern with the use of herbal medicinal products (HMP) is their interactions with conventional medicines, which are often mediated via the cytochrome P450 (CYP) system. Echinacea is a widely used over-the-counter HMP, with proven immunomodulatory properties. Its increasing use makes research into its safety an urgent concern. Previously, we showed that Echinacea extracts and its alkylamides (thought to be important for Echinacea's immunomodulatory activity) mildly inhibit the enzymatic activity of the main drug metabolising CYP isoforms, but to this date, there is insufficient work on its ability to alter CYP expression levels. We now report for the first time the effect of a commercial Echinacea extract (Echinaforce) and four Echinacea alkylamides on the transcription of the major drug metabolizing enzyme CYP3A4. HepG2 cells were exposed for 96 h to clinically relevant concentrations of Echinaforce (22, 11.6 and 1.16 μg mL(-1)) or the alkylamides (1.62 and 44 nM). CYP3A4 mRNA levels were quantified using real-time reverse transcription polymerase chain reaction (RT-PCR). Neither Echinaforce nor the alkylamides produced any significant changes in the steady-state CYP3A4 mRNA levels, under these conditions. In contrast, treatment with 50 μM rifampicin resulted in a 3.8-fold up-regulation over the vehicle control. We conclude that Echinaforce is unlikely to affect CYP3A4 transcriptional levels, even at concentrations which can inhibit the enzymatic activity of CYP3A4. Overall, our data provides further evidence for the lack of interactions between Echinacea and conventional drugs. PMID:19906827

  7. Safety Analysis Report for the use of hazardous production materials in photovoltaic applications at the National Renewable Energy Laboratory

    SciTech Connect

    Crandall, R.S.; Nelson, B.P.; Moskowitz, P.D.; Fthenakis, V.M.

    1992-07-01

    To ensure the continued safety of SERI`s employees, the community, and the environment, NREL commissioned an internal audit of its photovoltaic operations that used hazardous production materials (HPMs). As a result of this audit, NREL management voluntarily suspended all operations using toxic and/or pyrophoric gases. This suspension affected seven laboratories and ten individual deposition systems. These activities are located in Building 16, which has a permitted occupancy of Group B, Division 2 (B-2). NREL management decided to do the following. (1) Exclude from this SAR all operations which conformed, or could easily be made to conform, to B-2 Occupancy requirements. (2) Include in this SAR all operations that could be made to conform to B-2 Occupancy requirements with special administrative and engineering controls. (3) Move all operations that could not practically be made to conform to B-2 Occupancy requirements to alternate locations. In addition to the layered set of administrative and engineering controls set forth in this SAR, a semiquantitative risk analysis was performed on 30 various accident scenarios. Twelve presented only routine risks, while 18 presented low risks. Considering the demonstrated safe operating history of NREL in general and these systems specifically, the nature of the risks identified, and the layered set of administrative and engineering controls, it is clear that this facility falls within the DOE Low Hazard Class. Each operation can restart only after it has passed an Operational Readiness Review, comparing it to the requirements of this SAR, while subsequent safety inspections will ensure future compliance.

  8. How does the efficacy and safety of Oralair® compare to other products on the market?

    PubMed Central

    Larenas-Linnemann, Désirée

    2016-01-01

    Due to differences between allergen immunotherapy (AIT) trials in patient populations, trial design (including primary efficacy variables), the definition of a pollen season, data analysis, and comparisons between AIT products with existing data, is not possible nor valid. The efficacy of two grass pollen AIT tablets, Oralair® and Grazax®/Grastek®, should not be compared by looking at the percentage of score improvement in their respective trials. However, the evidence available concerning the efficacy and safety in trials can be compared by paying close attention to the scientific quality of the trials, details in the administration schedules, and safety issues. It can be concluded due to the high level of evidence available, that Oralair® is effective in a pre (2-months)-coseasonal schedule to reduce symptoms and medication use, and improve a patients’ quality of life during the treatment season. For the long-term, where the quality of efficacy evidence is moderate at 2-year posttreatment due to a high dropout rate, the pre (4-months)-coseasonal schedule should be used. No clinical efficacy data exists for starting treatment in-season, but the clinical onset of action of Oralair® is detectable after only 1 month of treatment. In the pivotal trials in Europe and the USA, no tablet-related epinephrine was needed, though some rare severe local reactions have been reported. Research for Grazax®/Grastek® showed that the long-term efficacy needs a continuous 3-year administration (moderate-low quality evidence available), and in two patients, tablet-related epinephrine was given. Further details on the comparative efficacy of both tablets would only be possible if both were evaluated in the same, adequately powered trial. PMID:27313458

  9. Applying SE Methods Achieves Project Success to Evaluate Hammer and Fixed Cutter Grinders Using Multiple Varieties and Moistures of Biomass Feedstock for Ethanol Production

    SciTech Connect

    Larry R. Zirker; Christopher T. Wright, PhD; R. Douglas Hamelin

    2008-06-01

    Applying basic systems engineering (SE) tools to the mission analysis phases of a 2.5-million dollar biomass pre-processing project for the U.S. Department of Energy directly assisted the project principal investigator understand the complexity and identify the gaps of a moving-target project and capture the undefined technical/functional requirements and deliverables from the project team and industrial partners. A creative application of various SE tools by non-aerospace systems engineers developed an innovative “big picture” product that combined aspects of mission analysis with a project functional flow block diagram, providing immediate understanding of the depth and breath of the biomass preprocessing effort for all team members, customers, and industrial partners. The “big picture” diagram became the blue print to write the project test plan, and provided direction to bring the project back on track and achieve project success.

  10. Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe.

    PubMed

    Roth, Eva; Rosenthal, Harald

    2006-01-01

    Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union. PMID:17070860

  11. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses-Isotopic Composition Predictions

    SciTech Connect

    Radulescu, Georgeta; Gauld, Ian C; Ilas, Germina; Wagner, John C

    2011-01-01

    The expanded use of burnup credit in the United States (U.S.) for storage and transport casks, particularly in the acceptance of credit for fission products, has been constrained by the availability of experimental fission product data to support code validation. The U.S. Nuclear Regulatory Commission (NRC) staff has noted that the rationale for restricting the Interim Staff Guidance on burnup credit for storage and transportation casks (ISG-8) to actinide-only is based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address the issues of burnup credit criticality validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the isotopic composition (depletion) validation approach and resulting observations and recommendations. Validation of the criticality calculations is addressed in a companion paper at this conference. For isotopic composition validation, the approach is to determine burnup-dependent bias and uncertainty in the effective neutron multiplication factor (keff) due to bias and uncertainty in isotopic predictions, via comparisons of isotopic composition predictions (calculated) and measured isotopic compositions from destructive radiochemical assay utilizing as much assay data as is available, and a best-estimate Monte Carlo based method. This paper (1) provides a detailed description of the burnup credit isotopic validation approach and its technical bases, (2) describes the application of the approach for

  12. Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

    PubMed

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family. PMID:26751855

  13. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  14. Potential health and safety hazards associated with the production of cadmium telluride, copper indium diselenide, and zinc phosphide photovoltaic cells

    SciTech Connect

    Moskowitz, P.D.; Fthenakis, V.M.; Lee, J.C.

    1985-04-01

    In large-scale manufacture of cadmium telluride, copper indium diselenide, and zinc phosphide photovoltaic cells, the materials and equipment used may present potential health and safety hazards to workers and the public. These hazards were identified by reviewing data on process materials, availability of control technology, biomedical effects, and health and environmental standards. Quantitative estimates of material inputs and outputs, and control technology costs for selected processes were based on preliminary engineering designs for hypothetical 10-MWp/yr photovoltaic cell production facilities. In the fabrication of these devices, unusually large quantities of some toxic gases may be used; large demands for phosphine and hydrogen selenide are of special concern. Because projected usage of these materials is much larger than the current one, a thorough evaluation of engineering controls will be needed before the technologies are commercialized. These materials could also present occupational health hazards. Some management options to reduce occupational exposures to these materials are presented. Although specific federal and state regulations have not been promulgated for emissions from the photovoltaic industry, prudent engineering practice should be applied to all waste streams - solid, atmospheric, or liquid - containing toxic pollutants to limit discharges of these materials. Control costs for most atmospheric waste streams should not be large (<0.01 cent per watt); for phosphine, however, costs are potentially much larger (4.4 cents per watt). Some processes may also produce large quantities of solid waste defined as toxic or hazardous under US Environmental Protection Agency guidelines. Disposal costs for these materials are presented.

  15. Development of design and simulation model and safety study of large-scale hydrogen production using nuclear power.

    SciTech Connect

    Gelbard, Fred; Oh, Seungmin; Rodriguez, Salvador B.; Revankar, Shripad T.; Gauntt, Randall O.; Cole, Randall K., Jr.; Espinosa, Flor; Drennen, Thomas E.; Tournier, Jean-Michel; Hogan, Kevin; Archuleta, Louis; Malczynski, Leonard A.; Vierow, Karen; McFadden, Katherine Letizia; Martin, William Joseph; El-Genk, Mohamed S.; Louie, David L. Y.

    2007-10-01

    Before this LDRD research, no single tool could simulate a very high temperature reactor (VHTR) that is coupled to a secondary system and the sulfur iodine (SI) thermochemistry. Furthermore, the SI chemistry could only be modeled in steady state, typically via flow sheets. Additionally, the MELCOR nuclear reactor analysis code was suitable only for the modeling of light water reactors, not gas-cooled reactors. We extended MELCOR in order to address the above deficiencies. In particular, we developed three VHTR input models, added generalized, modular secondary system components, developed reactor point kinetics, included transient thermochemistry for the most important cycles [SI and the Westinghouse hybrid sulfur], and developed an interactive graphical user interface for full plant visualization. The new tool is called MELCOR-H2, and it allows users to maximize hydrogen and electrical production, as well as enhance overall plant safety. We conducted validation and verification studies on the key models, and showed that the MELCOR-H2 results typically compared to within less than 5% from experimental data, code-to-code comparisons, and/or analytical solutions.

  16. Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies – The Effect of Processing Conditions on Product Safety and Efficacy

    PubMed Central

    Farrugia, Albert; Quinti, Isabella

    2014-01-01

    Early preparations of immunoglobulin (Ig) manufactured from human plasma by ethanol (Cohn) fractionation were limited in their usefulness for substitution therapy in patients with primary antibody deficiencies (PAD), as Ig aggregates formed during manufacture resulted in severe systemic reactions in patients when given intravenously. Developments in manufacturing technology obviated this problem through the capacity to produce concentrated solutions of intact monomeric Ig, revolutionizing PAD treatment and improving patient life expectancy and quality of life. As the need for Ig has grown, manufacturers have refined further manufacturing technologies to improve yield from plasma and produce therapies, which are easier and less expensive to deliver. This has led to the substitution, partly or wholly, of ethanol precipitation by other techniques such as chromatography, and has also stimulated the production of highly concentrated solutions capable of rapid infusion. Ig products have been associated, since their inception, with certain adverse events, including infectious disease transmission, hemolysis, and thromboembolism. The introduction of standardized manufacturing processes and dedicated pathogen elimination steps has removed the risk of infectious disease, and the focus of attention has shifted to other problems, which appear to have increased over the past 5 years. These include hemolysis and thromboembolism, both the cause for substantial concern and the subject of recent regulatory scrutiny and actions. We review the development of manufacturing technology and the emerging evidence that changes for the optimization of yield and convenience has contributed to the recent incidents in certain adverse events. Industry measures under development will be discussed in terms of their potential to improve safety and optimize care for patients with PAD. PMID:25566269

  17. Consumer Product Safety Commission

    MedlinePlus

    ... Recall Updates via E-mail CPSC RSS Feeds Business Education Get Started Testing and Certification Business Guidance ... only gone for a moment... View More Videos BUSINESS EDUCATION Businesses, Do You Know Your Requirements? REPORTS ...

  18. In vitro study of beneficial properties and safety of lactic acid bacteria isolated from Portuguese fermented meat products.

    PubMed

    Todorov, S D; Franco, B D G M; Wiid, I J

    2014-09-01

    Many lactic acid bacteria produce bacteriocins with a rather broad spectrum of inhibition, which could offer potential applications in food preservation. Bacteriocin production by starter cultures may bring advantage to these strains in competitive interactions with pathogenic bacteria from the food matrix. The objective of this study was to determine the safety of beneficial strains (Lactobacillus plantarum ST202Ch and ST216Ch, Enterococcus faecium ST211Ch, and Lactobacillus sakei ST22Ch, ST153Ch and ST154Ch) previously isolated from fermented meat products and characterised as bacteriocin producers. Auto-aggregation was strain-specific, and values of 28.97, 27.86 and 28.56% were recorded for L. sakei ST22Ch, ST153Ch and ST154Ch, respectively, 16.95 and 14.58% for L. plantarum ST202Ch and ST216Ch, respectively, and 12.77% for E. faecium ST211Ch. Various degrees of co-aggregation between 28.85 and 44.76% for Listeria monocytogenes 211 and 409, and between 23.60 to 34.96% for E. faecium ATCC 19443 were observed. According to the results of the diffusion method, the studied strains demonstrated susceptibility to penicillin G, ampicillin, amoxicillin, amoxicillin/clavulonic acid, imipenem, linezolid, and tetracycline. In addition, the susceptibility of the six strains to various non-antibiotic commercial drugs was examined. Production of β-galactosidase by L. sakei ST22Ch, ST153Ch and ST154Ch, L. plantarum ST202Ch and ST216Ch, and E. faecium ST211Ch was confirmed by employing sterile filter paper discs impregnated with o-nitrophenyl-β-D-galactopyranose. A statistically significant (P<0.001) inhibition of Mycobacterium tuberculosis growth by bacteriocins produced by L. plantarum ST202Ch (38.3%) and ST216Ch (48.6%), L. sakei ST153Ch (16.2%) and ST154Ch (16.1%), and E. faecium ST211Ch (21.7%) was observed. As determined by the polymerase chain reaction, the tested strains showed a low virulence gene profile. PMID:24463204

  19. Productivity Techniques and Quality Aspects in the Criticality Safety Evaluation of Y-12 Type-B Fissile Material Packages

    SciTech Connect

    DeClue, J. F.

    2011-06-28

    The inventory of certified Type-B fissile material packages consists of ten performance-based packages for offsite transportation purposes, serving transportation programs at the Y-12 National Security Complex. The containment vessels range from 5 to 19 in. in diameter and from 17 to 58 in. in height. The drum assembly external to the containment vessel ranges from 18 to 34 in. in diameter and from 26 to 71 in. in height. The weight of the packaging (drum assembly and containment vessel) ranges from 239 to 1550 lb. The older DT-nn series of Cellotex-based packages are being phased-out and replaced by a new generation of Kaolite-based ('Y-12 patented insulation') packages capable of withstanding the dynamic crush test 10 CFR 71.73(c)(2). Three replacement packages are in various stages of development; two are in use. The U.S. Department of Transportation (DOT) 6M specification package, which does not conform to the U.S. Nuclear Regulatory Commission requirements for Type-B packages, is no longer authorized for service on public roads. The ES-3100 shipping package is an example of a Kaolite-based Type-B fissile material package developed as a replacement package for the DOT 6M. With expanded utility, the ES-3100 is designed and licensed for transporting highly enriched uranium and plutonium materials on public roads. The ES-3100 provides added capability for air transport of up to 7-kg quantities of uranium material. This paper presents the productivity techniques and quality aspects in the criticality safety evaluation of Y-12 packages using the ES-3100 as an example.

  20. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    .... Bromfenac sodium: All drug products containing bromfenac sodium. Butamben: All parenteral drug products... more of diethylstilbestrol per unit dose. Dihydrostreptomycin sulfate: All drug products containing dihydrostreptomycin sulfate. Dipyrone: All drug products containing dipyrone. Encainide hydrochloride: All...

  1. Methanol production from eucalyptus wood chips. Attachment IV. Health and safety aspects of the eucalypt biomass to methanol energy system

    SciTech Connect

    Fishkind, H.H.

    1982-06-01

    The basic eucalyptus-to-methanol energy process is described and possible health and safety risks are identified at all steps of the process. The toxicology and treatment for exposure to these substances are described and mitigating measures are proposed. The health and safety impacts and risks of the wood gasification/methanol synthesis system are compared to those of the coal liquefaction and conversion system. The scope of this report includes the health and safety risks of workers (1) in the laboratory and greenhouse, where eucalyptus seedlings are developed, (2) at the biomass plantation, where these seedlings are planted and mature trees harvested, (3) transporting these logs and chips to the refinery, (4) in the hammermill, where the logs and chips will be reduced to small particles, (5) in the methanol synthesis plant, where the wood particles will be converted to methanol, and (6) transporting and dispensing the methanol. Finally, the health and safety risks of consumers using methanol is discussed.

  2. Safety features of subcritical fluid fueled systems

    SciTech Connect

    Bell, Charles R.

    1995-09-15

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitative in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved is very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.

  3. Safety features of subcritical fluid fueled systems

    SciTech Connect

    Bell, C.R.

    1994-09-01

    Accelerator-driven transmutation technology has been under study at Los Alamos for several years for application to nuclear waste treatment, tritium production, energy generation, and recently, to the disposition of excess weapons plutonium. Studies and evaluations performed to date at Los Alamos have led to a current focus on a fluid-fuel, fission system operating in a neutron source-supported subcritical mode, using molten salt reactor technology and accelerator-driven proton-neutron spallation. In this paper, the safety features and characteristics of such systems are explored from the perspective of the fundamental nuclear safety objectives that any reactor-type system should address. This exploration is qualitative in nature and uses current vintage solid-fueled reactors as a baseline for comparison. Based on the safety perspectives presented, such systems should be capable of meeting the fundamental nuclear safety objectives. In addition, they should be able to provide the safety robustness desired for advanced reactors. However, the manner in which safety objectives and robustness are achieved in very different from that associated with conventional reactors. Also, there are a number of safety design and operational challenges that will have to be addressed for the safety potential of such systems to be credible.

  4. Exploration on the safety assessment of nanomaterials in China

    PubMed Central

    Shi, Xin-Li; Wang, Qiangbin; Hu, Kun; Wang, Xiu-Mei

    2012-01-01

    More and more applications of nanomaterials have been achieved in the biomedicine field. Numerous nanomedical devices, such as bone grafts with nano-hydroxyapatite and the silver-based anti-bacteria products, have been developed and have been trying to enter into the Chinese market. The State Food and Drug Administration of China (SFDA) is facing a critical challenge of how to explore and supervise the safety assessment of the nanomedical products. This paper briefly introduces the approval status of nanomedical products and the current advances of the safety assessment of nanomaterials in China. PMID:23741614

  5. Exploration on the safety assessment of nanomaterials in China.

    PubMed

    Shi, Xin-Li; Wang, Qiangbin; Hu, Kun; Wang, Xiu-Mei

    2012-06-01

    More and more applications of nanomaterials have been achieved in the biomedicine field. Numerous nanomedical devices, such as bone grafts with nano-hydroxyapatite and the silver-based anti-bacteria products, have been developed and have been trying to enter into the Chinese market. The State Food and Drug Administration of China (SFDA) is facing a critical challenge of how to explore and supervise the safety assessment of the nanomedical products. This paper briefly introduces the approval status of nanomedical products and the current advances of the safety assessment of nanomaterials in China. PMID:23741614

  6. Behavioral Self-Monitoring of Safety and Productivity in the Workplace: A Methodological Primer and Quantitative Literature Review

    ERIC Educational Resources Information Center

    Olson, Ryan; Winchester, Jamey

    2008-01-01

    Workplace applications of behavioral self-monitoring (BSM) methods have been studied periodically for over 35 years, yet the literature has never been systematically reviewed. Recent occupational safety interventions including BSM resulted in relatively large behavior changes. Moreover, BSM methods are functional for addressing a broad range of…

  7. 14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... safety system, except for the hazard area analysis required by § 417.107, which is covered in appendix B... establishing hazard areas and performing debris risk and toxic analyses. A launch operator's debris model must... periods sufficient to meet the requirements for smooth and continuous contours used to define hazard...

  8. 75 FR 53701 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-01

    ... Federal Register of August 6, 2010 (75 FR 47602). The document announced the availability of grant funds...-7177, email: vieda.hubbard@fda.hhs.gov . SUPPLEMENTARY INFORMATION: In FR Doc. 2010-19354, appearing on... HUMAN SERVICES Food and Drug Administration Clinical Studies of Safety and Effectiveness of...

  9. Safety Evaluation of Sous Vide-Processed Products with Respect to Nonproteolytic Clostridium botulinum by Use of Challenge Studies and Predictive Microbiological Models

    PubMed Central

    Hyytiä-Trees, Eija; Skyttä, Eija; Mokkila, Mirja; Kinnunen, Arvo; Lindström, Miia; Lähteenmäki, Liisa; Ahvenainen, Raija; Korkeala, Hannu

    2000-01-01

    Sixteen different types of sous vide-processed products were evaluated for safety with respect to nonproteolytic group II Clostridium botulinum by using challenge tests with low (2.0-log-CFU/kg) and high (5.3-log-CFU/kg) inocula and two currently available predictive microbiological models, Food MicroModel (FMM) and Pathogen Modeling Program (PMP). After thermal processing, the products were stored at 4 and 8°C and examined for the presence of botulinal spores and neurotoxin on the sell-by date and 7 days after the sell-by date. Most of the thermal processes were found to be inadequate for eliminating spores, even in low-inoculum samples. Only 2 of the 16 products were found to be negative for botulinal spores and neurotoxin at both sampling times. Two products at the high inoculum level showed toxigenesis during storage at 8°C, one of them at the sell-by date. The predictions generated by both the FMM thermal death model and the FMM and PMP growth models were found to be inconsistent with the observed results in a majority of the challenges. The inaccurate predictions were caused by the limited number and range of the controlling factors in the models. Based on this study, it was concluded that the safety of sous vide products needs to be carefully evaluated product by product. Time-temperature combinations used in thermal treatments should be reevaluated to increase the efficiency of processing, and the use of additional antibotulinal hurdles, such as biopreservatives, should be assessed. PMID:10618228

  10. Farm Safety

    PubMed Central

    Wilson, G. S.

    1966-01-01

    Accident and safety are related terms; the higher the accident rate in any industry, the greater is the need for safety measures designed to prevent accidents. This article discusses the accident and safety problems in agriculture, which includes horticulture and forestry. There is still a tendency among townspeople to think of the countryside as peaceful and tranquil, a place where nothing happens very quickly and far removed from violent death or crippling injury. This pleasant rustic picture has undergone a striking change in the last 30 years owing to considerable agricultural mechanization and the development of chemical pesticides, which have brought new dangers to those who live and work on the land. Although men have readily adapted themselves to new machines and methods, they have not proved as able to recognize new dangers and learn how to guard against them. In consequence, accidents have increased to such an extent that the whole industry has realized the need for positive preventive measures. In this country, it is generally accepted that an employer of labour has a responsibility to provide safe working conditions for those he employs. Farm safety legislation goes a little further and usually requires an employer to provide necessary safeguards, with the added requirement on a worker to make use of them. It is a feature of accident prevention work that it never reaches a stage when it can be regarded as complete. Even when a reduction in accidents has been achieved, the effort must be sustained or the trend will be quickly reversed. Images PMID:5904095

  11. The Mechanics of Human Achievement

    PubMed Central

    Duckworth, Angela L.; Eichstaedt, Johannes C.; Ungar, Lyle H.

    2015-01-01

    Countless studies have addressed why some individuals achieve more than others. Nevertheless, the psychology of achievement lacks a unifying conceptual framework for synthesizing these empirical insights. We propose organizing achievement-related traits by two possible mechanisms of action: Traits that determine the rate at which an individual learns a skill are talent variables and can be distinguished conceptually from traits that determine the effort an individual puts forth. This approach takes inspiration from Newtonian mechanics: achievement is akin to distance traveled, effort to time, skill to speed, and talent to acceleration. A novel prediction from this model is that individual differences in effort (but not talent) influence achievement (but not skill) more substantially over longer (rather than shorter) time intervals. Conceptualizing skill as the multiplicative product of talent and effort, and achievement as the multiplicative product of skill and effort, advances similar, but less formal, propositions by several important earlier thinkers. PMID:26236393

  12. Process safety improvement--quality and target zero.

    PubMed

    Van Scyoc, Karl

    2008-11-15

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given. PMID:18374483

  13. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain...

  14. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain...

  15. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain...

  16. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... in children's products. Section 101(a) of the CPSIA provides that by February 10, 2009, products designed or intended primarily for children 12 and younger may not contain more than 600 ppm of lead. After August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain...

  17. Chemical Products in the Home, Workshop and Garden. Proceed with Caution; Consumer Safety in the Home, II.

    ERIC Educational Resources Information Center

    Saskatchewan Consumer and Commercial Affairs, Regina.

    The average home has chemical products to clean floors, kill insects, clean ovens, thin paint, remove grease, and perform countless other chores. Many consumers remain unaware of the dangers these products bring into the home. This booklet provides information on the safe use, storage, and disposal of these products. The compounds found in…

  18. Factors associated with regulatory action involving investigation of illnesses associated with Shiga toxin-producing Escherichia coli in products regulated by the Food Safety and Inspection Service.

    PubMed

    Green, Alice L; Seys, Scott; Douris, Aphrodite; Levine, Jeoff; Robertson, Kis

    2014-07-01

    We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information. PMID:24826872

  19. Project LEAP: The Labor Education Achievement Program. A Program To Improve the Literacy Level and Productivity of the Workforce. Final Project Report. April 1, 1991-September 30, 1992.

    ERIC Educational Resources Information Center

    Metropolitan Baltimore Council of AFL-CIO Unions, MD.

    Maryland's Labor Education Achievement Program (LEAP) worked with a wide diversity of union workers in multiple industries and within numerous private companies and public agencies over a dispersed geographic area. Staff development included a workshop for local coordinators and a teacher inservice training session. LEAP provided…

  20. Predicting Student Achievement with the Education Production-Function and Per-Pupil Expenditure: Synthesizing Regression Models from 1968-1994

    ERIC Educational Resources Information Center

    Pigott, Therese D.; Williams, Ryan T.; Polanin, Joshua R.; Wu-Bohanon, Meng-Jia

    2012-01-01

    The purpose of this research to investigate the heterogeneity of per-pupil expenditure (PPE) slope estimates in predicting student achievement. The research question guiding this project is: how does the measured relationship between per-pupil expenditure vary across studies that use different models? In concert with SREE's 2012 conference mission…

  1. Delivering safety

    SciTech Connect

    Baldwin, N.D.; Spooner, K.G.; Walkden, P.

    2007-07-01

    In the United Kingdom there have been significant recent changes to the management of civil nuclear liabilities. With the formation in April 2005 of the Nuclear Decommissioning Authority (NDA), ownership of the civil nuclear licensed sites in the UK, including the Magnox Reactor Stations, passed to this new organisation. The NDAs mission is to seek acceleration of the nuclear clean up programme and deliver increased value for money and, consequently, are driving their contractors to seek more innovative ways of performing work. British Nuclear Group manages the UK Magnox stations under contract to the NDA. This paper summarises the approach being taken within its Reactor Sites business to work with suppliers to enhance working arrangements at sites, improve the delivery of decommissioning programmes and deliver improvements in safety and environmental performance. The UK Magnox stations are 1. generation gas-graphite reactors, constructed in the 1950's and 1960's. Two stations are currently still operating, three are shut-down undergoing defueling and the other five are being decommissioned. Despite the distractions of industry restructuring, an uncompromising policy of demanding improved performance in conjunction with improved safety and environmental standards has been adopted. Over the past 5 years, this policy has resulted in step-changes in performance at Reactor Sites, with increased electrical output and accelerated defueling and decommissioning. The improvements in performance have been mirrored by improvements in safety (DACR of 0 at 5 sites); environmental standards (reductions in energy and water consumption, increased waste recycling) and the overall health of the workforce (20% reduction in sickness absence). These achievements have, in turn, been recognised by external bodies, resulting in several awards, including: the world's first ISRS and IERS level 10 awards (Sizewell, 2006), the NUMEX plant maintenance award (Bradwell, 2006), numerous Ro

  2. Impact of biomarker development on drug safety assessment

    SciTech Connect

    Marrer, Estelle; Dieterle, Frank

    2010-03-01

    Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.

  3. Impact of biomarker development on drug safety assessment.

    PubMed

    Marrer, Estelle; Dieterle, Frank

    2010-03-01

    Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and "door opening" safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the "know how" acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example. PMID:20036272

  4. Review of the US Consumer Product Safety Commission's health effects and exposure assessment documents on nitrogen dioxide. Report of the Clean Air Scientific Advisory Committee. Final report

    SciTech Connect

    Not Available

    1988-05-09

    At the request of the Consumer Product Safety Commission, the Clean Air Scientific Advisory Committee conducted a review on the potential health hazards associated with exposure to 0.1 to 1.0 ppm nitrogen dioxide generated by unvented indoor combustion sources. The committee concluded that: (1) repeated peak exposures at concentrations of 0.3 ppm of nitrogen dioxide may cause health effects in some individuals; (2) the population groups that appear most sensitive to nitrogen dioxide exposure include children, chronic bronchitics, asthmatics, and individuals with emphysema; and (3) the most direct evidence regarding lung damage associated with nitrogen dioxide is obtained from animal studies.

  5. Safety Training in Reed International

    ERIC Educational Resources Information Center

    Ridley, J.

    1974-01-01

    The safety training provided within Reed International Limited and its relationship to production operations are outlined, demonstrating that safety works when management is committed to it on both humanitarian and economic grounds. (MW)

  6. Workplace Safety: Indoor Environmental Quality

    MedlinePlus

    ... message, please visit this page: About CDC.gov . Workplace Safety & Health Topics Indoor Environmental Quality Health Hazard Evaluation ... Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health Topics Publications and Products Programs Contact NIOSH ...

  7. Thermal reactor safety

    SciTech Connect

    Not Available

    1980-06-01

    Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

  8. Graded Achievement, Tested Achievement, and Validity

    ERIC Educational Resources Information Center

    Brookhart, Susan M.

    2015-01-01

    Twenty-eight studies of grades, over a century, were reviewed using the argument-based approach to validity suggested by Kane as a theoretical framework. The review draws conclusions about the meaning of graded achievement, its relation to tested achievement, and changes in the construct of graded achievement over time. "Graded…

  9. Summertime Safety

    MedlinePlus

    ... Violence & Safety Life Stages & Populations Travelers' Health Workplace Safety & Health Features Media Sign up for Features Get Email Updates ... Submit What's this? Submit Button Past Emails CDC Features Summertime Safety Recommend on Facebook Tweet Share Compartir The feature ...

  10. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  11. Safety Education.

    ERIC Educational Resources Information Center

    Daniels, James H.; And Others

    1980-01-01

    Five articles in this issue focus on safety education in agricultural laboratories. Topics discussed include teacher liability; elements of a safety instruction program; state and federal safety standards; ground fault current protection; and eye protection requirements and equipment. (SK)

  12. 78 FR 52239 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... current regulations were originally published on April 1, 1988 (53 FR 10690). Since that time, various..., well completions associated with offshore production platforms are characterized as either dry tree... a well casinghead used to control the production and flow of oil or gas. Dry tree completions...

  13. Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

  14. Binding and cleavage (BINACLE) assay for the functional in vitro detection of tetanus toxin: applicability as alternative method for the safety testing of tetanus toxoids during vaccine production.

    PubMed

    Behrensdorf-Nicol, Heike A; Bonifas, Ursula; Hanschmann, Kay-Martin; Krämer, Beate; Weißer, Karin

    2013-12-16

    Tetanus toxoids (i.e. chemically inactivated preparations of tetanus neurotoxin) are used for the production of tetanus vaccines. In order to exclude the risk of residual toxicity or of a "reversion to toxicity", each batch of tetanus toxoid is subject to strict safety testing. Up to now, these prescribed safety tests have to be performed as in vivo toxicity tests in guinea pigs. However, as animal tests are generally slow, costly and ethically disputable, a replacement by an in vitro method would be desirable. A suitable alternative method would have to be able to sensitively detect already low concentrations of active tetanus neurotoxin in matrices containing large amounts of inactivated toxoid molecules. We have developed a method which detects active tetanus neurotoxin molecules based on their specific receptor-binding capacity as well as their proteolytic activity. By taking into account two relevant functional characteristics, this combined "BINding And CLEavage" (BINACLE) assay more reliably discriminates between toxic and detoxified molecules than other in vitro assays which solely rely on one single toxin function (e.g. endopeptidase assays). Data from an in-house validation show that the BINACLE assay is able to detect active tetanus neurotoxin with a detection limit comparable to the in vivo test. The sensitive detection of active toxin which has been spiked into toxoid samples from different manufacturers could also be demonstrated. Specificity and precision of the method have been shown to be satisfactory. The presented data indicate that for toxoid batches from some of the most relevant European vaccine manufacturers, the BINACLE assay may represent a potential alternative to the prescribed animal safety tests. In addition, this novel method may also provide a convenient tool for monitoring batch-to-batch consistency during toxoid production. PMID:24156922

  15. Elaborating the role of natural products-induced autophagy in cancer treatment: achievements and artifacts in the state of the art.

    PubMed

    Wang, Ning; Feng, Yibin

    2015-01-01

    Autophagy is a homeostatic process that is highly conserved across different types of mammalian cells. Autophagy is able to relieve tumor cell from nutrient and oxidative stress during the rapid expansion of cancer. Excessive and sustained autophagy may lead to cell death and tumor shrinkage. It was shown in literature that many anticancer natural compounds and extracts could initiate autophagy in tumor cells. As summarized in this review, the tumor suppressive action of natural products-induced autophagy may lead to cell senescence, provoke apoptosis-independent cell death, and complement apoptotic cell death by robust or target-specific mechanisms. In some cases, natural products-induced autophagy could protect tumor cells from apoptotic death. Technical variations in detecting autophagy affect data quality, and study focus should be made on elaborating the role of autophagy in deciding cell fate. In vivo study monitoring of autophagy in cancer treatment is expected to be the future direction. The clinical-relevant action of autophagy-inducing natural products should be highlighted in future study. As natural products are an important resource in discovery of lead compound of anticancer drug, study on the role of autophagy in tumor suppressive effect of natural products continues to be necessary and emerging. PMID:25821829

  16. Elaborating the Role of Natural Products-Induced Autophagy in Cancer Treatment: Achievements and Artifacts in the State of the Art

    PubMed Central

    2015-01-01

    Autophagy is a homeostatic process that is highly conserved across different types of mammalian cells. Autophagy is able to relieve tumor cell from nutrient and oxidative stress during the rapid expansion of cancer. Excessive and sustained autophagy may lead to cell death and tumor shrinkage. It was shown in literature that many anticancer natural compounds and extracts could initiate autophagy in tumor cells. As summarized in this review, the tumor suppressive action of natural products-induced autophagy may lead to cell senescence, provoke apoptosis-independent cell death, and complement apoptotic cell death by robust or target-specific mechanisms. In some cases, natural products-induced autophagy could protect tumor cells from apoptotic death. Technical variations in detecting autophagy affect data quality, and study focus should be made on elaborating the role of autophagy in deciding cell fate. In vivo study monitoring of autophagy in cancer treatment is expected to be the future direction. The clinical-relevant action of autophagy-inducing natural products should be highlighted in future study. As natural products are an important resource in discovery of lead compound of anticancer drug, study on the role of autophagy in tumor suppressive effect of natural products continues to be necessary and emerging. PMID:25821829

  17. A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: Safety and subjective effects.

    PubMed

    Walele, Tanvir; Sharma, Girish; Savioz, Rebecca; Martin, Claire; Williams, Josie

    2016-02-01

    An Electronic Vapour Product (EVP) has been evaluated for short-term safety parameters and subjective effects in a 2-part study, in smokers. Part 1 compared the EVP with unflavoured (UF) and flavoured (FL) e-liquid at 2.0% nicotine to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette(®), 15 mg). Part 2 assessed the effect of increasing concentrations of nicotine in the e-liquid used with the EVP (0%, 0.4%, 0.9%, 2.0%). The study was designed as a randomised, controlled, crossover trial. Outcomes included adverse events (AEs), vital signs, exhaled carbon monoxide (CO), clinical laboratory parameters, smoking urges and withdrawal symptoms. In both study parts, only mild non-serious AEs were reported. No major differences were observed in AEs between the EVPs and Nicorette(®). Exhaled CO levels only increased for CC. All products appeared to decrease smoking urges and nicotine withdrawal symptom scores to a similar extent. The EVP had a similar short-term safety profile to Nicorette(®) and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette(®) and CC. Unlike nicotine replacement therapies, the EVP may offer an alternative for those finding it difficult to quit the behavioural and sensorial aspects of smoking. PMID:26702788

  18. Safety's impact on an alternative energy source

    SciTech Connect

    Denton, D.K.

    1983-01-01

    Our ability to make underground mines a safe place to work will be a major concern to those seeking to use coal as an energy source. Increased production will stimulate a heightened concern for making mining a more effective energy resource. This effectiveness means that unless safe performance is achieved, the cost of poor safety, such as loss of lives and costly delays due to breakdowns and other failures, will greatly reduce productivity of underground mining operations. As such, coal companies and miners must be prepared to safely manage their operation before underground mining makes a significant effect on energy independence.

  19. Tritium production, management and its impact on safety for a D-{sup 3}He fusion reactor

    SciTech Connect

    Sze, D.K.; Herring, S.; Sawan, M.

    1991-11-01

    About three percent of the fusion energy produced by a D-{sup 3}He reactor is in the form of neutrons. Those neutrons are generated by D-D and D-T reactions, with the tritium produced by the D-D fusion. The neutrons will react with structural steel, deuterium, {sup 3}He and shielding material to produce tritium. About half of the tritium generated by the D-D reaction will not burn in the plasma and will exit as a part of the plasma exhaust. Thus, there is enough tritium produced in a D-{sup 3}He reactor and careful management will be required. The tritium produced in the shield and plasma can be managed with an acceptable effect on cost and safety. 3 refs., 2 figs., 3 tabs.

  20. Analytical criteria for performance characteristics of IgE binding methods for evaluating safety of biotech food products.

    PubMed

    Holzhauser, Thomas; Ree, Ronald van; Poulsen, Lars K; Bannon, Gary A

    2008-10-01

    There is detailed guidance on how to perform bioinformatic analyses and enzymatic degradation studies for genetically modified crops under consideration for approval by regulatory agencies; however, there is no consensus in the scientific community on the details of how to perform IgE serum studies. IgE serum studies are an important safety component to acceptance of genetically modified crops when the introduced protein is novel, the introduced protein is similar to known allergens, or the crop is allergenic. In this manuscript, we describe the characteristics of the reagents, validation of assay performance, and data analysis necessary to optimize the information obtained from serum testing of novel proteins and genetically modified (GM) crops and to make results more accurate and comparable between different investigations. PMID:18727951

  1. Towards a Three-Dimensional Near-Real Time Cloud Product for Aviation Safety and Weather Diagnoses

    NASA Technical Reports Server (NTRS)

    Minnis, Patrick; Nguyen, Louis; Palikonda, Rabindra; Spangeberg, Douglas; Nordeen, Michele L.; Yi, Yu-Hong; Ayers, J. Kirk

    2004-01-01

    Satellite data have long been used for determining the extent of cloud cover and for estimating the properties at the cloud tops. The derived properties can also be used to estimate aircraft icing potential to improve the safety of air traffic in the region. Currently, cloud properties and icing potential are derived in near-real time over the United States of America (USA) from the Geostationary Operational Environmental Satellite GOES) imagers at 75 W and 135 W. Traditionally, the results have been given in two dimensions because of the lack of knowledge about the vertical extent of clouds and the occurrence of overlapping clouds. Aircraft fly in a three-dimensional space and require vertical as well as horizontal information about clouds, their intensity, and their potential for icing. To improve the vertical component of the derived cloud and icing parameters, this paper explores various methods and datasets for filling in the three-dimensional space over the USA with cloud water.

  2. Overview of current meat hygiene and safety risks and summary of recent studies on biofilms, and control of Escherichia coli O157:H7 in nonintact, and Listeria monocytogenes in ready-to-eat, meat products.

    PubMed

    Sofos, John N; Geornaras, Ifigenia

    2010-09-01

    As meat consumption is increasing around the world, so do concerns and challenges to meat hygiene and safety. These concerns are mostly of a biological nature and include bacterial pathogens, such as Escherichia coli O157:H7, Salmonella and Campylobacter in raw meat and poultry, and Listeria monocytogenes in ready-to-eat processed products, while viral pathogens are of major concern at foodservice. A major goal of scientists, industry, public health and regulatory authorities is to control pathogenic microorganisms and improve meat product hygiene and safety within a country and internationally. This paper is not a comprehensive or critical review of the scientific literature on the broad area of meat hygiene and safety, but it provides an overview of major current meat hygiene and safety issues, and then a summary of studies on biofilm formation by pathogens, control of E. coli O157:H7 in nonintact meat products, and control of L. monocytogenes in ready-to-eat meat products, conducted at the Center for Meat Safety & Quality and Food Safety Cluster of Colorado State University in recent years. PMID:20510532

  3. Addressing Uniqueness and Unison of Reliability and Safety for a Better Integration

    NASA Technical Reports Server (NTRS)

    Huang, Zhaofeng; Safie, Fayssal

    2016-01-01

    Over time, it has been observed that Safety and Reliability have not been clearly differentiated, which leads to confusion, inefficiency, and, sometimes, counter-productive practices in executing each of these two disciplines. It is imperative to address this situation to help Reliability and Safety disciplines improve their effectiveness and efficiency. The paper poses an important question to address, "Safety and Reliability - Are they unique or unisonous?" To answer the question, the paper reviewed several most commonly used analyses from each of the disciplines, namely, FMEA, reliability allocation and prediction, reliability design involvement, system safety hazard analysis, Fault Tree Analysis, and Probabilistic Risk Assessment. The paper pointed out uniqueness and unison of Safety and Reliability in their respective roles, requirements, approaches, and tools, and presented some suggestions for enhancing and improving the individual disciplines, as well as promoting the integration of the two. The paper concludes that Safety and Reliability are unique, but compensating each other in many aspects, and need to be integrated. Particularly, the individual roles of Safety and Reliability need to be differentiated, that is, Safety is to ensure and assure the product meets safety requirements, goals, or desires, and Reliability is to ensure and assure maximum achievability of intended design functions. With the integration of Safety and Reliability, personnel can be shared, tools and analyses have to be integrated, and skill sets can be possessed by the same person with the purpose of providing the best value to a product development.

  4. Worker health is good for the economy: union density and psychosocial safety climate as determinants of country differences in worker health and productivity in 31 European countries.

    PubMed

    Dollard, Maureen F; Neser, Daniel Y

    2013-09-01

    Work stress is recognized globally as a social determinant of worker health. Therefore we explored whether work stress related factors explained national differences in health and productivity (gross domestic product (GDP)). We proposed a national worker health productivity model whereby macro market power factors (i.e. union density), influence national worker health and GDP via work psychosocial factors and income inequality. We combined five different data sets canvasing 31 wealthy European countries. Aggregated worker self-reported health accounted for 13 per cent of the variance in national life expectancy and in national gross domestic product (GDP). The most important factors explaining worker self-reported health and GDP between nations were two levels of labor protection, macro-level (union density), and organizational-level (psychosocial safety climate, PSC, i.e. the extent of management concern for worker psychological health). The majority of countries with the highest levels of union density and PSC (i.e., workplace protections) were Social Democratic in nature (i.e., Sweden, Finland, Denmark, Norway). Results support a type of society explanation that social and economic factors (e.g., welfare regimes, work related policies) in concert with political power agents at a national level explain in part national differences in workplace protection (PSC) that are important for worker health and productivity. Attention should be given across all countries, to national policies to improve worker health, by bolstering national and local democratic processes and representation to address and implement policies for psychosocial risk factors for work stress, bullying and violence. Results suggest worker health is good for the economy, and should be considered in national health and productivity accounting. Eroding unionism may not be good for worker health or the economy either. PMID:23849285

  5. 78 FR 29279 - Safety Standard for Carriages and Strollers

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-20

    ...The Danny Keysar Child Product Safety Notification Act, Section 104 of the Consumer Product Safety Improvement Act of 2008 (CPSIA), requires the United States Consumer Product Safety Commission (Commission or CPSC) to promulgate consumer product safety standards for durable infant or toddler products. These standards are to be ``substantially the same as'' applicable voluntary standards or......

  6. Safety analysis report for the use of hazardous production materials in photovoltaic applications at the National Renewable Energy Laboratory. Volume 2, Appendices

    SciTech Connect

    Crandall, R.S.; Nelson, B.P.; Moskowitz, P.D.; Fthenakis, V.M.

    1992-07-01

    To ensure the continued safety of SERI`s employees, the community, and the environment, NREL commissioned an internal audit of its photovoltaic operations that used hazardous production materials (HPMS). As a result of this audit, NREL management voluntarily suspended all operations using toxic and/or pyrophoric gases. This suspension affected seven laboratories and ten individual deposition systems. These activities are located in Building 16, which has a permitted occupancy of Group B, Division 2 (B-2). NREL management decided to do the following. (1) Exclude from this SAR all operations which conformed, or could easily be made to conform, to B-2 Occupancy requirements. (2) Include in this SAR all operations that could be made to conform to B-2 Occupancy requirements with special administrative and engineering controls. (3) Move all operations that could not practically be made to conform to B-2 occupancy requirements to alternate locations. In addition to the layered set of administrative and engineering controls set forth in this SAR, a semiquantitative risk analysis was performed on 30 various accident scenarios. Twelve presented only routine risks, while 18 presented low risks. Considering the demonstrated safe operating history of NREL in general and these systems specifically, the nature of the risks identified, and the layered set of administrative and engineering controls, it is clear that this facility falls within the DOE Low Hazard Class. Each operation can restart only after it has passed an Operational Readiness Review, comparing it to the requirements of this SAR, while subsequent safety inspections will ensure future compliance. This document contains the appendices to the NREL safety analysis report.

  7. 75 FR 34360 - Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... a notice of requirements that appeared in the Federal Register on September 2, 2009. 74 FR 45428. On... testing and certification requirements for many products, including bicycles. 74 FR 6396. The Commission... of the CPSIA and their applicability.'' 74 FR 6396, 6398. On December 28, 2009, the...

  8. Eye Safety for Emergency Response and Disaster Recovery

    MedlinePlus

    ... message, please visit this page: About CDC.gov . Workplace Safety & Health Topics Eye Safety Eye Safety for Emergency ... Pinterest Twitter YouTube NIOSH Homepage NIOSH A-Z Workplace Safety & Health Topics Publications and Products Programs Contact NIOSH ...

  9. Pathogen safety of intravenous Rh immunoglobulin liquid and other immune globulin products: enhanced nanofiltration and manufacturing process overview.

    PubMed

    Soluk, Lori; Price, Hugh; Sinclair, Chris; Atalla-Mikhail, Dina; Genereux, Maurice

    2008-01-01

    Plasma products for therapeutic use pose specific challenges in manufacturing to ensure products maintain biologic activity and are safe with respect to contamination and transmission of disease-causing agents. Various processes have demonstrated effectiveness in eliminating, reducing, or inactivating viral contaminants. Recently, the possibility of transmitting variant Creutzfeld-Jakob disease (vCJD) or transmissible spongiform encephalopathies (TSE) through blood-based products has become a concern. The present study involves the validation of a hyperimmune immunoglobulin manufacturing process incorporating a nanofiltration step with a nominal pore size of 20 nm for removal of viral contaminants and other adventitious agents. Processing intermediates during the manufacture of IV Rh IgG (WinRho SDF/WinRho SDF Liquid, Cangene Corporation, Manitoba, Canada) were spiked with model viruses and processed in scaled-down procedures to validate the viral reduction capacity of each step. Anion-exchange chromatography and solvent/detergent steps are known to contribute to virus removal and inactivation. The Planova 20 N nanofiltration step was effective in reducing model viruses representing a wide range of viral morphologies with varying degrees of resistance to physicochemical inactivation. All in-process and final batch testing met current standards for production of IV Rh IgG manufactured with the previously licensed filter, which had a larger nominal pore size of 35 nm. The manufacturing process, employing a Planova 35 N filtration step, has been proactively improved by the change to a smaller-pore 20 N filter. Replacement of the 35 N filter with the 20 N filter produces a similar product while enhancing the capability for removal of smaller viruses and prions. PMID:18806519

  10. Industrial-grade silicone injections causing intermittent bilateral malar swelling: review of safety and efficacy of techniques and products available.

    PubMed

    Seward, Austin C; Meara, Daniel J

    2013-07-01

    Silicone and other fillers have become a popular aid to increase soft tissue density, decrease static skin rhytids, and treat muscle wasting, particularly in the face. As a result, injectable silicone has become popular in patients with the human immunodeficiency virus (HIV). It has been postulated that highly active antiretroviral therapy detrimentally induces the physiologic process of fat atrophy of the temporal and buccal fat pads of the face and regional fat wasting of the arms, legs, and buttocks and that HIV protease inhibitors may induce fat atrophy by binding and inhibiting homologous human proteins that are involved in fat metabolism. The classic hollowed-out facial appearance linked to HIV positivity can have detrimental social implications in infected patients who are otherwise very functional. In consequence, facial implantation, fat transplantation, and dermal and subcutaneous fillers have been used to aid in the restoration of facial appearance. This report describes the case of a patient who underwent multiple rounds of silicone injections and complained of intermittent facial swelling and pain long after the injections. The authors report on the safety of specific medical-grade injectable fillers and techniques found to be safely effective, especially in the HIV-positive population. PMID:23522770

  11. Occupational Safety and Health Professionals

    ERIC Educational Resources Information Center

    Wash, Pat

    1975-01-01

    The growing concern for safety in both the workplace and in consumer products will create many new jobs through the mid-1980's--especially in private industry. The largest number of safety professionals are safety engineers; others include fire protection engineers, industrial hygienists, loss control and occupational health consultants, and…

  12. Safety in the Science Classroom.

    ERIC Educational Resources Information Center

    Science Teacher, 1997

    1997-01-01

    Presents a checklist as a guide for preparing a set of safety rules that has been adapted from the U.S. Consumer Products Safety Commission's publication titled "School Science Laboratories: A Guide to Some Hazardous Substances". Addresses work habits; safety wear; facilities and equipment; purchasing, use, and disposal of chemicals; and…

  13. Decontamination method using heat and relative humidity for radish seeds achieves a 7-log reduction of Escherichia coli O157:H7 without affecting product quality.

    PubMed

    Kim, Y B; Kim, H W; Song, M K; Rhee, M S

    2015-05-18

    We developed a novel decontamination method to inactivate Escherichia coli O157:H7 on radish seeds without adversely affecting seed germination or product quality. The use of heat (55, 60, and 65 °C) combined with relative humidity (RH; 25, 45, 65, 85, and 100%) for 24h was evaluated for effective microbial reduction and preservation of seed germination rates. A significant two-way interaction of heat and RH was observed for both microbial reduction and germination rate (P<0.0001). Increases in heat and RH were associated with corresponding reductions in E. coli O157:H7 and in germination rate (P<0.05). The order of lethality for the different treatments was generally as follows: no treatment <55 °C/25-65% RH ≒60 °C/25-45% RH ≒65 °C/25% RH <55 °C/85% RH =60 °C/65% RH <55 °C/100% RH =60 °C/85-100% RH =65 °C/45-100% RH. The most effective condition, 65 °C/45% RH, completely inactivated E. coli O157:H7 on the seeds (7.0 log CFU/g reduction) and had no significant effect on the germination rate (85.4%; P>0.05) or product quality. The method uses only heat and relative humidity without chemicals, and is thus applicable as a general decontamination procedure in spout producing plants where the use of growth chambers is the norm. PMID:25732001

  14. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making

    PubMed Central

    McNaughton, Rhian; Huet, Gwenaël; Shakir, Saad

    2014-01-01

    Objectives The objective of this study was to determine the nature of evidence used to support the withdrawal of marketing authorisations of drug products for safety reasons throughout the European Union (EU) between 2002 and 2011. Setting Products withdrawn, either by a medicines agency or a marketing authorisation holder, during the period 2002–2011 were identified by conducting detailed searches of the WHO, the European Medicines Agency (EMA) and national medicines agency websites throughout the EU plus Norway, Iceland and Liechtenstein. The scientific evidence used to support the decision was identified from a search within PubMed, the EMA and national medicines agencies websites. Information about spontaneous case reports entered into EudraVigilance and unavailable on the EMA website was received by email from the EMA. Results 19 drugs were withdrawn from the market, throughout the EU, for safety reasons from 2002 to 2011. Case reports were cited in 95% of withdrawals (18/19) and case–control studies (4/19), cohort studies (4/19), randomised controlled trials (RCTs) (12/19) or meta-analysis (5/19) were cited in 63% of withdrawals (12/19). Cardiovascular events or disorders were the main reason for withdrawal (9/19), followed by hepatic disorders (4/19) and neurological or psychiatric disorders (4/19). Conclusions This study has shown that the level of evidence used to support drug withdrawal has improved during the past 10 years, with an increased use of case–control studies, cohort studies, RCTs and meta-analyses. This research has demonstrated that such studies have contributed to decision-making in almost two-thirds of cases. PMID:24435895

  15. Evolved strains of Scheffersomyces stipitis achieving high ethanol productivity on acid- and base-pretreated biomass hydrolyzate at high solids loading

    DOE PAGESBeta

    Slininger, Patricia J.; Shea-Andersh, Maureen A.; Thompson, Stephanie R.; Dien, Bruce S.; Kurtzman, Cletus P.; Balan, Venkatesh; da Costa Sousa, Leonardo; Uppugundla, Nirmal; Dale, Bruce E; Cotta, Michael A

    2015-04-09

    Lignocellulosic biomass is an abundant, renewable feedstock useful for the production of fuel-grade ethanol via the processing steps of pretreatment, enzyme hydrolysis, and microbial fermentation. Traditional industrial yeasts do not ferment xylose and are not able to grow, survive, or ferment in concentrated hydrolyzates that contain enough sugar to support economical ethanol recovery since they are laden with toxic byproducts generated during pretreatment. Repetitive culturing in two types of concentrated hydrolyzates was applied along with ethanol challenged xylose-fed continuous culture to force targeted evolution of the native pentose fermenting yeast Scheffersomyces (Pichia) stipitis strain NRRL Y-7124 maintained in the ARSmore » Culture Collection, Peoria, IL. Isolates collected from various enriched populations were screened and ranked based on relative xylose uptake rate and ethanol yield. Ranking on hydrolyzates with and without nutritional supplementation was used to identify those isolates with best performance across diverse conditions. Robust S. stipitis strains adapted to perform very well in enzyme hydrolyzates of high solids loading ammonia fiber expansion-pretreated corn stover (18% weight per volume solids) and dilute sulfuric acid-pretreated switchgrass (20% w/v solids) were obtained. Improved features include reduced initial lag phase preceding growth, significantly enhanced fermentation rates, improved ethanol tolerance and yield, reduced diauxic lag during glucose-xylose transition, and ability to accumulate >40 g/L ethanol in <167 h when fermenting hydrolyzate at low initial cell density of 0.5 absorbance units and pH 5 to 6.« less

  16. Safety valve apparatus and method

    SciTech Connect

    Hynes, J. H.; Morrill, Ch.

    1984-10-16

    A safety valve for controlling flow in a flow line is disclosed which is especially adapted for use in emergency control of a producing well. The apparatus includes means for securing a punch out tube in series with the flow line and ramming means for ramming the punch out tube and displacing at least a portion of it from the flow path of the flow line and sealing the flow line. The punch out tube comprises top, bottom and middle cylindrical members stacked end to end with an elastomeric seal provided in channels resulting from cooperating grooves formed in the end surfaces of the members. When the middle member is rammed, while the bottom and top members are fixed within the valve body, the middle member is displaced to a valve recess and the ram covers and seals the outlet flow path of the valve. The valve is adapted to be attached between production casing of a production wellhead and a production tree. The production tubing is supported within the valve body. Production flow path is achieved by coupling of the punch out tube to the production tubing and the flow path of an annular packoff. The production tree or a tubular extension to the tree is attached to the top of the valve body. A method and means for accomplishing the method are provided for replacing the punch out tube without removing the production tree from the valve body. A method for installing the valve between a production wellhead and a production tree is also provided.

  17. Estimates of occupational safety and health impacts resulting from large-scale production of major photovoltaic technologies

    SciTech Connect

    Owens, T.; Ungers, L.; Briggs, T.

    1980-08-01

    The purpose of this study is to estimate both quantitatively and qualitatively, the worker and societal risks attributable to four photovoltaic cell (solar cell) production processes. Quantitative risk values were determined by use of statistics from the California semiconductor industry. The qualitative risk assessment was performed using a variety of both governmental and private sources of data. The occupational health statistics derived from the semiconductor industry were used to predict injury and fatality levels associated with photovoltaic cell manufacturing. The use of these statistics to characterize the two silicon processes described herein is defensible from the standpoint that many of the same process steps and materials are used in both the semiconductor and photovoltaic industries. These health statistics are less applicable to the gallium arsenide and cadmium sulfide manufacturing processes, primarily because of differences in the materials utilized. Although such differences tend to discourage any absolute comparisons among the four photovoltaic cell production processes, certain relative comparisons are warranted. To facilitate a risk comparison of the four processes, the number and severity of process-related chemical hazards were assessed. This qualitative hazard assessment addresses both the relative toxicity and the exposure potential of substances in the workplace. In addition to the worker-related hazards, estimates of process-related emissions and wastes are also provided.

  18. Crosslinked, polymerized, and PEG-conjugated hemoglobin-based oxygen carriers: clinical safety and efficacy of recent and current products.

    PubMed

    Jahr, Jonathan S; Akha, Arezou Sadighi; Holtby, Randall J

    2012-09-01

    Blood substitutes, especially hemoglobin based oxygen carriers (HBOC) have been widely studied and reviewed over the past 30 years. The development of HBOCs was highlighted by crosslinking to minimize adverse effects. However, even early attempts at single crosslinking using alpha-alpha crosslinks or diaspirin crosslinking failed clinical trials due to renal morbidity and increased mortality. In fact, preclinical trials may have predicted failure of this first generation product, DCLHb (diaspirin-crosslinked Hb) (HemAssist ®, Baxter). In the 1980's, three small biopharmaceutical companies developed "second generation" HBOCs, the first being Hemosol with their raffinose crosslinked HBOC, hemoglobin- raffimer. The other two development programs modified the HBOC using glutaraldehyde polymerization, in an attempt to further alleviate the toxicities of the "first" generation HBOCs. This paper will review the definitive clinical trials of the two polymerized HBOCs, Biopure's hemoglobin glutamer-250 (bovine) and Northfield's polymerized human Hb, pegylated HBOC and Sangart's peg-conjugated HBOC, with an introductory brief review of Hemosol's hemoglobinraffimer. The paper will then introduce the newest polymerized hemoglobin, zero-linked hemoglobin polymer, which has not yet undergone clinical trials but has undergone some preclinical work that will be discussed in a section on this product. As a new generation HBOC, zero-linked hemoglobin polymer may begin to address the issues presented by the first two generations of HBOCs, and may hold promise as a universally applicable HBOC. PMID:21745179

  19. Evolved strains of Scheffersomyces stipitis achieving high ethanol productivity on acid- and base-pretreated biomass hydrolyzate at high solids loading

    SciTech Connect

    Slininger, Patricia J.; Shea-Andersh, Maureen A.; Thompson, Stephanie R.; Dien, Bruce S.; Kurtzman, Cletus P.; Balan, Venkatesh; da Costa Sousa, Leonardo; Uppugundla, Nirmal; Dale, Bruce E; Cotta, Michael A

    2015-04-09

    Lignocellulosic biomass is an abundant, renewable feedstock useful for the production of fuel-grade ethanol via the processing steps of pretreatment, enzyme hydrolysis, and microbial fermentation. Traditional industrial yeasts do not ferment xylose and are not able to grow, survive, or ferment in concentrated hydrolyzates that contain enough sugar to support economical ethanol recovery since they are laden with toxic byproducts generated during pretreatment. Repetitive culturing in two types of concentrated hydrolyzates was applied along with ethanol challenged xylose-fed continuous culture to force targeted evolution of the native pentose fermenting yeast Scheffersomyces (Pichia) stipitis strain NRRL Y-7124 maintained in the ARS Culture Collection, Peoria, IL. Isolates collected from various enriched populations were screened and ranked based on relative xylose uptake rate and ethanol yield. Ranking on hydrolyzates with and without nutritional supplementation was used to identify those isolates with best performance across diverse conditions. Robust S. stipitis strains adapted to perform very well in enzyme hydrolyzates of high solids loading ammonia fiber expansion-pretreated corn stover (18% weight per volume solids) and dilute sulfuric acid-pretreated switchgrass (20% w/v solids) were obtained. Improved features include reduced initial lag phase preceding growth, significantly enhanced fermentation rates, improved ethanol tolerance and yield, reduced diauxic lag during glucose-xylose transition, and ability to accumulate >40 g/L ethanol in <167 h when fermenting hydrolyzate at low initial cell density of 0.5 absorbance units and pH 5 to 6.

  20. Effect of the product type, of the amount of applied sunscreen product and the level of protection in the UVB range on the level of protection achieved in the UVA range.

    PubMed

    Couteau, C; Diarra, H; Coiffard, L

    2016-03-16

    Using a topical product is part of the overall strategy for skin cancer prevention. The level of protection attainable when using commercial products is indicated by the Sun Protection Factor (SPF) value, in use everywhere. This value reflects the level of protection primarily in the UVB range. However, UVA radiation also has deleterious effects on the skin, and it is essential to prevent it, which is why products must offer a wide spectrum of protection. Tests conducted in vivo, before any marketing, are done by applying the studied product at a rate of 2.0 mg cm(-2), while users, in practice, only use 1.0-1.5 mg cm(-2). We now know that this reduction in the amount of applied product greatly affects the SPF. To complete the state of knowledge in this area, we sought to evaluate the effect of a decrease in the amount of applied sunscreen product by studying sunscreen creams and oils on the level of protection attainable in the UVA range. We have shown that the PF-UVA is divided by a factor of 2.2, on average, when the amount of applied product is reduced by half, with differences depending on the product type under consideration (cream or oil) and depending on the SPF of the preparation. PMID:26806467

  1. Vaccine Safety

    MedlinePlus

    ... During Pregnancy Frequently Asked Questions about Vaccine Recalls Historical Vaccine Safety Concerns FAQs about GBS and Menactra ... CISA Resources for Healthcare Professionals Evaluation Current Studies Historical Background 2001-12 Publications Technical Reports Vaccine Safety ...

  2. Towards an advanced therapy medicinal product based on mesenchymal stromal cells isolated from the umbilical cord tissue: quality and safety data

    PubMed Central

    2014-01-01

    -free cryoprotectant medium with approximately 100% recovery and 98% viability post-thaw. Additionally, UCX®-ATMP were genetically stable upon expansion (up to P15) and maintained their immunomodulatory properties. Conclusions We have successfully adapted a method to consistently isolate, expand and cryopreserve a well-characterized population of human umbilical cord tissue-derived MSCs (UCX®), in order to obtain a cell product that is compliant with cell therapy. Here, we present quality and safety data that support the use of the UCX® as an ATMP, according to existing international guidelines. PMID:24438697

  3. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

    Safety policies, procedures, and related information are presented in this manual to assist school personnel in a continuing program of accident prevention. Chapter 1 discusses safety education and accident prevention in general. Chapter 2 covers traffic regulations relating to school safety patrols, school bus transportation, bicycles, and…

  4. The Safety of Crowds

    ERIC Educational Resources Information Center

    Dron, Jon

    2007-01-01

    If we assume that learning is best achieved in a social setting, then a vital aspect of any learning environment is its ability to support the development of trust. Trust takes many forms, from helping to identify the validity or the effectiveness of a learning resource to feelings of safety and reliance on support from fellow learners and…

  5. Traffic Safety Education Guide.

    ERIC Educational Resources Information Center

    New York State Education Dept., Albany. Bureau of Curriculum Development.

    This guide, intended for administrators, curriculum developers, and teachers, provides outlines and suggestions for strategies and materials needed to achieve the goals and objectives of the safety education program. The guide covers the following topics: a broad examination of the highway system; the responsibilities highway users have toward…

  6. Multiplex liquid chromatography-tandem mass spectrometry for the detection of wheat, oat, barley and rye prolamins towards the assessment of gluten-free product safety.

    PubMed

    Manfredi, Anita; Mattarozzi, Monica; Giannetto, Marco; Careri, Maria

    2015-10-01

    Celiac patients should feel confident in the safety of foods labelled or expected to be gluten-free. In this context, a targeted proteomic approach based on liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) technique was proposed to assess the presence of celiotoxic cereals, namely wheat, oats, barley and rye, in raw and processed food products. To this aim, unique marker peptides were properly selected in order to distinguish between the different cereal types. A revised cocktail solution based on reducing and denaturing agents was exploited for prolamin extraction from raw and processed food; in addition, defatting with hexane was carried out for sample clean-up, allowing to largely reduce problems related to matrix effect. Method validation on fortified rice flour showed good analytical performance in terms of sensitivity (limits of detection in the 2-18 mg kg(-1) range). However, poor trueness was calculated for self-made incurred bread (between 3 and 30% depending on the peptide), probably due to baking processes, which reduce gluten extractability. Thus, it is evident that in the case of processed foods further insights into sample treatment efficiency and reference materials for protein calibration are required to obtain accurate gluten determination. Finally, the developed method was applied for the analysis of market food products, offering the possibility to discriminate among cereals, with good agreement with labelled ingredients for gluten-containing foodstuffs. PMID:26454460

  7. Neutronics Simulations of 237Np Targets to Support Safety-Basis and 238Pu Production Assessment Efforts at the High Flux Isotope Reactor

    SciTech Connect

    Chandler, David; Ellis, Ronald James

    2015-01-01

    Fueled by two highly enriched uranium-bearing fuel elements surrounded by a large concentric ring of beryllium reflector, the High Flux Isotope Reactor (HFIR) provides one of the highest neutron fluxes in the world and is used to produce unique isotopes like plutonium-238. The National Aeronautics and Space Administration use radioisotope thermoelectric generators powered by 238Pu for deep-space missions. As part of the US Department of Energy s task to reestablish the domestic production of 238Pu, a technology demonstration sub-project has been initiated to establish a new 238Pu supply chain. HFIR safety-basis neutronics calculations are being performed to ensure the target irradiations have no adverse impacts on reactor performance and to calculate data required as input to follow-on thermal-structural, thermal-hydraulic and radionuclide/dose analyses. Plutonium-238 production assessments are being performed to estimate the amount of 238Pu that can be produced in HFIR s permanent beryllium reflector. It is estimated that a total of 0.96 1.12 kg 238Pu (~1.28 1.49 kg PuO2 at 85% 238Pu/Pu purity) could be produced per year in HFIR s permanent beryllium reflector irradiation facilities if they are all utilized.

  8. 75 FR 12167 - Virginia Graeme Baker Pool and Spa Safety Act; Public Accommodation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-15

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY...: Consumer Product Safety Commission. ACTION: Proposed interpretive rule. SUMMARY: The Consumer Product... of the Secretary, Consumer Product Safety Commission, Room 502, 4330 East West Highway, Bethesda,...

  9. Safety Evaluation of the Coagulase-Negative Staphylococci Microbiota of Salami: Superantigenic Toxin Production and Antimicrobial Resistance

    PubMed Central

    Soares Casaes Nunes, Raquel; Mere Del Aguila, Eduardo; Paschoalin, Vânia Margaret Flosi

    2015-01-01

    The risks of contracting staphylococci food poisoning by the consumption of improperly manufactured salami and the possibility of this food being reservoirs for antibiotic resistance were evaluated. Nineteen coagulase-negative staphylococci (CNS) strains were found in commercial and artisanal salami. The species in commercial salami were S. saprophyticus, S. sciuri, S. xylosus, and S. carnosus. Artisanal salami showed S. succinus, S. epidermidis, and S. hominis but no S. carnosus. Phylogenetic analyses grouped the strains into three major staphylococcal species groups, comprised of 4 refined clusters with similarities superior to 90%. Fifteen strains harbored multiple enterotoxin genes, with high incidence of seb/sec and sea, 57% and 50%, respectively, intermediate incidence of sed/seh/selm and sei/seln/tst-H, 33% and 27%, correspondingly, and low incidence of see/selj/selo and seg, of respectively 13% and 1%. Real time RT-PCR and enzyme-linked-immunosorbent assays confirmed the enterotoxigenicity of the strains, which expressed and produced enterotoxins in vitro. The CNS strains showed multiresistance to several antimicrobials of therapeutic importance in both human and veterinarian medicine, such as β-lactams, vancomycin, and linezolid. The effective control of undue staphylococci in fermented meat products should be adopted to prevent or limit the risk of food poisoning and the spread of antimicrobial-resistant strains. PMID:26697486

  10. Safety evaluations under the proposed US Safe Cosmetics and Personal Care Products Act of 2013: animal use and cost estimates.

    PubMed

    Knight, Jean; Rovida, Costanca

    2014-01-01

    The proposed Safe Cosmetics and Personal Care Products Act of 2013 calls for a new evaluation program for cosmetic ingredients in the US, with the new assessments initially dependent on expanded animal testing. This paper considers possible testing scenarios under the proposed Act and estimates the number of test animals and cost under each scenario. It focuses on the impact for the first 10 years of testing, the period of greatest impact on animals and costs. The analysis suggests the first 10 years of testing under the Act could evaluate, at most, about 50% of ingredients used in cosmetics. Testing during this period would cost about $ 1.7-$ 9 billion and 1-11.5 million animals. By test year 10, alternative, high-throughput test methods under development are expected to be available, replacing animal testing and allowing rapid evaluation of all ingredients. Given the high cost in dollars and animal lives of the first 10 years for only about half of ingredients, a better choice may be to accelerate development of high-throughput methods. This would allow evaluation of 100% of cosmetic ingredients before year 10 at lower cost and without animal testing. PMID:24468774

  11. Nuclear regulation and safety

    SciTech Connect

    Hendrie, J.M.

    1982-01-01

    Nuclear regulation and safety are discussed from the standpoint of a hypothetical country that is in the process of introducing a nuclear power industry and setting up a regulatory system. The national policy is assumed to be in favor of nuclear power. The regulators will have responsibility for economic, reliable electric production as well as for safety. Reactor safety is divided into three parts: shut it down, keep it covered, take out the afterheat. Emergency plans also have to be provided. Ways of keeping the core covered with water are discussed. (DLC)

  12. Comparing Science Achievement Constructs: Targeted and Achieved

    ERIC Educational Resources Information Center

    Ferrara, Steve; Duncan, Teresa

    2011-01-01

    This article illustrates how test specifications based solely on academic content standards, without attention to other cognitive skills and item response demands, can fall short of their targeted constructs. First, the authors inductively describe the science achievement construct represented by a statewide sixth-grade science proficiency test.…

  13. Varieties of Achievement Motivation.

    ERIC Educational Resources Information Center

    Kukla, Andre; Scher, Hal

    1986-01-01

    A recent article by Nicholls on achievement motivation is criticized on three points: (1) definitions of achievement motives are ambiguous; (2) behavioral consequences predicted do not follow from explicit theoretical assumptions; and (3) Nicholls's account of the relation between his theory and other achievement theories is factually incorrect.…

  14. Motivation and School Achievement.

    ERIC Educational Resources Information Center

    Maehr, Martin L.; Archer, Jennifer

    Addressing the question, "What can be done to promote school achievement?", this paper summarizes the literature on motivation relating to classroom achievement and school effectiveness. Particular attention is given to how values, ideology, and various cultural patterns impinge on classroom performance and serve to enhance motivation to achieve.…

  15. Mobility and Reading Achievement.

    ERIC Educational Resources Information Center

    Waters, Theresa Z.

    A study examined the effect of geographic mobility on elementary school students' achievement. Although such mobility, which requires students to make multiple moves among schools, can have a negative impact on academic achievement, the hypothesis for the study was that it was not a determining factor in reading achievement test scores. Subjects…

  16. PASS and Reading Achievement.

    ERIC Educational Resources Information Center

    Kirby, John R.

    Two studies examined the effectiveness of the PASS (Planning, Attention, Simultaneous, and Successive cognitive processes) theory of intelligence in predicting reading achievement scores of normally achieving children and distinguishing children with reading disabilities from normally achieving children. The first study dealt with predicting…

  17. National Safety Council

    MedlinePlus

    ... Introduction Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ... Safety Safety Management Systems Workplace Safety Consulting Employee Perception Surveys Research Journey to Safety Excellence Join the ...

  18. Assessing the status of food safety management systems for fresh produce production in East Africa: evidence from certified green bean farms in Kenya and noncertified hot pepper farms in Uganda.

    PubMed

    Nanyunja, J; Jacxsens, L; Kirezieva, K; Kaaya, A N; Uyttendaele, M; Luning, P A

    2015-06-01

    The farms of fresh produce farmers are major sources of food contamination by microbiological organisms and chemical pesticides. In view of their choice for farming practices, producers are influenced by food safety requirements. This study analyzes the role of food safety standard certification toward the maturity of food safety management systems (FSMS) in the primary production of fresh produce. Kenya and Uganda are two East African countries that export green beans and hot peppers, respectively, to the European Union but have contrasting features in terms of agricultural practices and certification status. In the fresh produce chain, a diagnostic instrument for primary production was used to assess context factors, core control and assurance activities, and system output to measure the performance of FSMS for certified green bean farms in Kenya and noncertified hot pepper farms in Uganda. Overall, our findings show that in Uganda, noncertified hot pepper farms revealed only a "basic level of control and assurance" activities in their FSMS, which was not satisfactory, because no insight into potential pesticide microbial contamination was presented by these farmers. On the other hand, certified green bean farms in Kenya had an "average level of control and assurance," providing insight into the delivered food safety and quality by the farmers. Farm size did not impact the maturity level of FSMS. This study confirms the role played by food safety standard certification toward the maturity of FSMS implemented in developing countries and demonstrates the possibility of Ugandan farms to upgrade agricultural practices in the fresh produce sector. PMID:26038896

  19. A comparison of the oral application and injection routes using the onderstepoort biological products fowl typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens.

    PubMed

    Purchase, C; Picard, J; McDonald, R; Bisschop, S P R

    2008-03-01

    This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft) vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks postvaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA) test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %,by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05) in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine. PMID:18678191

  20. A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness.

    PubMed

    Jong, Miek C; Ilyenko, Lydia; Kholodova, Irina; Verwer, Cynthia; Burkart, Julia; Weber, Stephan; Keller, Thomas; Klement, Petra

    2016-01-01

    A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 (N = 89) or comparator glycine (N = 90). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77-7.14), p < 0.0001, POM overall treatment related effect). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all p values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (p = 0.0258). Treatment effectiveness (p < 0.0001) and satisfaction assessments (p < 0.0001) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: N = 2, glycine: N = 1) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children. PMID:27242915

  1. A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness

    PubMed Central

    Jong, Miek C.; Ilyenko, Lydia; Kholodova, Irina; Verwer, Cynthia; Burkart, Julia; Weber, Stephan; Keller, Thomas; Klement, Petra

    2016-01-01

    A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 (N = 89) or comparator glycine (N = 90). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77–7.14), p < 0.0001, POM overall treatment related effect). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all p values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (p = 0.0258). Treatment effectiveness (p < 0.0001) and satisfaction assessments (p < 0.0001) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: N = 2, glycine: N = 1) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children. PMID:27242915

  2. The development of regulatory expectations for computer-based safety systems for the UK nuclear programme

    SciTech Connect

    Hughes, P. J.; Westwood, R.N; Mark, R. T.; Tapping, K.

    2006-07-01

    The Nuclear Installations Inspectorate (NII) of the UK's Health and Safety Executive (HSE) has completed a review of their Safety Assessment Principles (SAPs) for Nuclear Installations recently. During the period of the SAPs review in 2004-2005 the designers of future UK naval reactor plant were optioneering the control and protection systems that might be implemented. Because there was insufficient regulatory guidance available in the naval sector to support this activity the Defence Nuclear Safety Regulator (DNSR) invited the NII to collaborate with the production of a guidance document that provides clarity of regulatory expectations for the production of safety cases for computer based safety systems. A key part of producing regulatory expectations was identifying the relevant extant standards and sector guidance that reflect good practice. The three principal sources of such good practice were: IAEA Safety Guide NS-G-1.1 (Software for Computer Based Systems Important to Safety in Nuclear Power Plants), European Commission consensus document (Common Position of European Nuclear Regulators for the Licensing of Safety Critical Software for Nuclear Reactors) and IEC nuclear sector standards such as IEC60880. A common understanding has been achieved between the NII and DNSR and regulatory guidance developed which will be used by both NII and DNSR in the assessment of computer-based safety systems and in the further development of more detailed joint technical assessment guidance for both regulatory organisations. (authors)

  3. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  4. Solidifying Safety

    NASA Technical Reports Server (NTRS)

    Covault, Craig

    2003-01-01

    Contents include the following: 1. Solidifying Safety: NASA s new safety organization spools up, as the 1SS program grapples with long-term risk. 2. Earth to Orbit O'Keefe telling skeptical lawmakers Orbital Space Plan (OSP) will cover exploration vision. China's rapid pace.

  5. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

    Ned Miller does not take security lightly. As director of campus safety and emergency management at the Des Moines Area Community College (DMACC), any threat requires serious consideration. As community college administrators adopt a more proactive approach to campus safety, many institutions are experimenting with emerging technologies, including…

  6. Safety and quality parameters of ready-to-cook minced pork meat products supplemented with Helianthus tuberosus L. tubers fermented by BLIS producing lactic acid bacteria.

    PubMed

    Stimbirys, Arturas; Bartkiene, Elena; Siugzdaite, Jurate; Augeniene, Dovile; Vidmantiene, Daiva; Juodeikiene, Grazina; Maruska, Audrius; Stankevicius, Mantas; Cizeikiene, Dalia

    2015-07-01

    The aim of this study was to evaluate the influence of additives of Jerusalem artichoke (JA), fermented with P. acidilactici KTU05-7, P. pentosaceus KTU05-9, L. sakei KTU05-6, on the quality and safety parameters of ready - to cook - minced pork (RCMP). Fermented JA additives reduced pH of the meat products and decreased water holding capacity (WHC) from 2.01 till 2.93 %. Concentrations of biogenic amines in RCMP with additives of the lactic acid bacteria (LAB) - fermented JA were significantly lower comparing with control sample. The number of pathogenic bacteria in artificially contaminated meat samples was significantly reduced in case of LAB-fermented JA additives. The highest antimicrobial activity was obtained using P. acidilactici fermented JA additives. The amounts of microbial pathogens E. coli and Ent. faecalis, S. aureus and Streptococcus spp. were determined 3.41, 3.38, 3,96 and 4.74 log CFU/g correspondingly, whereas without LAB-fermented JA additives were 8.94, 7.75, 8.82 and 8.58 log CFU/g, correspondingly. A possibility to improve sensory properties (flavor) of RCMP using LAB fermented JA additives was investigated. The composition of volatile compounds of RCMP without additive and with LAB-fermented JA additives was analyzed using gas chromatography-mass spectrometry (GC-MS). The results of sensory evaluation of meat products supplemented with fermented JA additives revealed specific odor, which is pleasant and acceptable for consumers might be explainable that LAB-fermented JA additives have shown considerable differences mainly due to the accumulation of volatiles such as toluene, ethylbenzene, decane, undecane, 2 methyl undecane. N-morpholinomethyl-isopropyl-sulfide, 6-undecilamine and N,N-dimethyl-1-pentadecanamine were not determined in RCMP with LAB-fermented JA additives. The results obtained show, that P. acidilactici fermented JA 5 % additive is most suitable for the RCMP processing in order to prevent microbiological spoilage, increase

  7. Heritability of Creative Achievement

    ERIC Educational Resources Information Center

    Piffer, Davide; Hur, Yoon-Mi

    2014-01-01

    Although creative achievement is a subject of much attention to lay people, the origin of individual differences in creative accomplishments remain poorly understood. This study examined genetic and environmental influences on creative achievement in an adult sample of 338 twins (mean age = 26.3 years; SD = 6.6 years). Twins completed the Creative…

  8. Confronting the Achievement Gap

    ERIC Educational Resources Information Center

    Gardner, David

    2007-01-01

    This article talks about the large achievement gap between children of color and their white peers. The reasons for the achievement gap are varied. First, many urban minorities come from a background of poverty. One of the detrimental effects of growing up in poverty is receiving inadequate nourishment at a time when bodies and brains are rapidly…

  9. States Address Achievement Gaps.

    ERIC Educational Resources Information Center

    Christie, Kathy

    2002-01-01

    Summarizes 2 state initiatives to address the achievement gap: North Carolina's report by the Advisory Commission on Raising Achievement and Closing Gaps, containing an 11-point strategy, and Kentucky's legislation putting in place 10 specific processes. The North Carolina report is available at www.dpi.state.nc.us.closingthegap; Kentucky's…

  10. Wechsler Individual Achievement Test.

    ERIC Educational Resources Information Center

    Taylor, Ronald L.

    1999-01-01

    This article describes the Wechsler Individual Achievement Test, a comprehensive measure of achievement for individuals in grades K-12. Eight subtests assess mathematics reasoning, spelling, reading comprehension, numerical operations, listening comprehension, oral expression, and written expression. Its administration, standardization,…

  11. Inverting the Achievement Pyramid

    ERIC Educational Resources Information Center

    White-Hood, Marian; Shindel, Melissa

    2006-01-01

    Attempting to invert the pyramid to improve student achievement and increase all students' chances for success is not a new endeavor. For decades, educators have strategized, formed think tanks, and developed school improvement teams to find better ways to improve the achievement of all students. Currently, the No Child Left Behind Act (NCLB) is…

  12. Achievement Test Program.

    ERIC Educational Resources Information Center

    Ohio State Dept. of Education, Columbus. Trade and Industrial Education Service.

    The Ohio Trade and Industrial Education Achievement Test battery is comprised of seven basic achievement tests: Machine Trades, Automotive Mechanics, Basic Electricity, Basic Electronics, Mechanical Drafting, Printing, and Sheet Metal. The tests were developed by subject matter committees and specialists in testing and research. The Ohio Trade and…

  13. General Achievement Trends: Maryland

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  14. General Achievement Trends: Arkansas

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  15. General Achievement Trends: Idaho

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  16. General Achievement Trends: Nebraska

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  17. General Achievement Trends: Colorado

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  18. General Achievement Trends: Iowa

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  19. General Achievement Trends: Hawaii

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…

  20. General Achievement Trends: Kentucky

    ERIC Educational Resources Information Center

    Center on Education Policy, 2009

    2009-01-01

    This general achievement trends profile includes information that the Center on Education Policy (CEP) and the Human Resources Research Organization (HumRRO) obtained from states from fall 2008 through April 2009. Included herein are: (1) Bullet points summarizing key findings about achievement trends in that state at three performance…