Science.gov

Sample records for achieve product safety

  1. Achieving acoustical performance with fire safe products

    NASA Astrophysics Data System (ADS)

    Fritz, Thomas

    2005-09-01

    Recent serious fires in North and South America have pointed out potential problems with attempts to improve acoustical performance in building spaces at the expense of using acoustical treatments that may have poor performance in fire situations. Foam plastic products, sometimes not designed for exposed use in buildings, can ignite quickly and spread fire rapidly throughout a building space, resulting in fire victims being trapped within the building or not being afforded the needed safe egress time. There are ways of achieving equivalent and even superior acoustical performance without sacrificing fire safety. Acoustical products are available which can add comparable or superior acoustical treatment without the fire hazard associated with exposed foam plastic materials. This presentation is a review of the U.S. code requirements of interior finish materials, the various types of fire tests that are applied to these products, and a discussion of the achievable fire and acoustical performance.

  2. Consumer Product Safety Commission

    MedlinePlus

    ... Centers Neighborhood Safety Network Community Outreach Resource Center Toy Recall Statistics CO Poster Contest Pool Safely Business & ... to Shock and Fire Hazards October 5, 2017 Toys “R” Us Recalls Infant Wiggle Balls Due to ...

  3. Hydrocracking to achieve product flexibility

    SciTech Connect

    George, S.E. ); Boardman, S.R. ); Foley, R.M. )

    1994-01-01

    Hydrocracking has demonstrated a broad diversity in upgrading a wide range of feedstocks ranging from atmospheric gas oil through heavy vacuum gas oil; conversion products from cat crackers and cokers; and product streams from lube plants and deasphalters. The 90's bring many challenges to the refining industry with more stringent environmental specifications on fuels and a general trend for conversion units such as hydrocrackers to process more difficult/low value feedstocks at higher throughputs. These changes are making hydrogen availability and catalyst stability a limiting factor in many refineries. There is an ever increasing incentive to develop catalyst technology to meet the challenges of the 1990's. The formation of Zeolyst International combined Shell's considerable hydrocracking catalyst technology with the zeolite powder R D and manufacturing expertise of PQ Corporation. Shell utilizes this catalyst technology in all 12 of their advised hydrocrackers world-wide, including 7 units in North America. This level of utilization exceeds the internal use of most process licensors. Criterion Catalyst Co. manufacturers and markets Zeolyst International zeolitic hydrocracking catalyst product line worldwide. This paper discusses the wide range of applications of Criterion/Zeolyst hydrocracking catalyst systems under a variety of feedstocks, operating conditions, and unit configurations with multiple product performance targets. Commercial feedback customers on the performance of Criterion/Zeolyst hydrocracking catalysts discussed in this paper demonstrates the flexibility and value added benefits of the systems.

  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. Intensive swine production and pork safety.

    PubMed

    Davies, Peter R

    2011-02-01

    Major structural changes in livestock production in developed countries, particularly intensive confinement production and increases in herd and flock sizes, have raised several societal concerns about the future directions and implications of livestock food production, including the safety of meat products. This review of the major parasitic and bacterial foodborne pathogens associated with pork production indicates that pork safety in the United States has improved demonstrably over recent decades. Most notably, changes in swine production methods have been associated with virtual elimination of risk of the foodborne parasites Taenia solium, Trichinella spiralis, and Toxoplasma gondii from pigs reared on modern intensive farms. This represents a substantial public health achievement that has gone largely unheralded. Regulatory changes have led to demonstrably lower prevalence of Salmonella on pork carcasses, but control of bacterial foodborne pathogens on farms remains a significant challenge. Available evidence does not support the hypothesis that intensive pork production has increased risk for the major bacterial foodborne pathogens that are common commensals of the pig (Salmonella, Campylobacter, Listeria, and Yersinia enterocolitica), or that pigs produced in alternative systems are at reduced risk of colonization with these organisms. However, pigs raised in outdoor systems inherently confront higher risks of exposure to foodborne parasites, particularly T. gondii.

  6. Monitoring product safety in the postmarketing environment.

    PubMed

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    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.

  7. Automation ensures safety, extends production

    SciTech Connect

    Perdue, J.M.

    1996-06-01

    This paper reviews some current improvements in offshore platform safety as a result of new regulations. In response to Norwegian Petroleum Directorate regulations limiting personnel on the rig floor, Weatherford Norway has developed a casing modem with remote-controlled power tongs. This paper reviews the various automated systems for handling drill pipes and joints on offshore platforms and how they work.

  8. 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.

  9. 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

  10. Microbial bioinformatics for food safety and production.

    PubMed

    Alkema, Wynand; Boekhorst, Jos; Wels, Michiel; van Hijum, Sacha A F T

    2016-03-01

    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.

  11. Overcoming dysfunctional momentum: Organizational safety as a social achievement

    Treesearch

    Michelle A. Barton; Kathleen M. Sutcliffe

    2009-01-01

    Research on organizational safety and reliability largely has emphasized system-level structures and processes neglecting the more micro-level, social processes necessary to enact organizational safety. In this qualitative study we remedy this gap by exploring these processes in the context of wildland fire management. In particular, using interview data gathered from...

  12. 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.

  13. 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.

  14. 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.

  15. Skin safety evaluation of laundry detergent products.

    PubMed

    Kwon, Seok; Holland, Daniela; Kern, Petra

    2009-01-01

    The conduct of a scientifically sound safety assessment of new ingredients and finished products is essential prior to their introduction into the marketplace. Such assessments are based on a risk assessment paradigm established by the National Academy of Science (NAS, 1983) that consists of a four-step process: hazard identification, dose-response assessment, exposure assessment, and risk characterization. This risk assessment paradigm has been (1) used as a framework for estimating an adverse health risk posed by environmental chemicals, and (2) applied to systemic toxicological endpoints. The general principles of risk assessment may be applied to skin safety evaluation of consumer products, considering that dermal toxicity is also a threshold phenomenon. This study describes a risk assessment-based approach for skin safety evaluation of laundry detergent products.

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 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 COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains...

  17. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 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 COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains several...

  18. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 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 COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains several...

  19. 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...

  20. Achieving a safer health service: Part 1. Making safety a way of life.

    PubMed

    Woodward, Suzette

    2004-01-01

    Patient safety incidents are a major problem in the health service and it is acknowledged that blaming and reprimanding staff for actual or potential mistakes does not encourage an open and safe culture in which to work. In the first paper in a three-part series the National Patient Safety Agency's seven key to steps to achieving patient safety are discussed.

  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.

  2. 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…

  3. 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.

  4. Consensus achievement of leadership, organisational and individual factors that influence safety climate: Implications for nursing management.

    PubMed

    Fischer, Shelly A; Jones, Jacqueline; Verran, Joyce A

    2017-09-21

    To validate a framework of factors that influence the relationship of transformational leadership and safety climate, and to enable testing of safety chain factors by generating hypotheses regarding their mediating and moderating effects. Understanding the patient safety chain and mechanisms by which leaders affect a strong climate of safety is essential to transformational leadership practice, education, and research. A systematic review of leadership and safety literature was used to develop an organising framework of factors proposed to influence the climate of safety. A panel of 25 international experts in leadership and safety engaged a three-round modified Delphi study with Likert-scored surveys. Eighty per cent of participating experts from six countries were retained to the final survey round. Consensus (>66% agreement) was achieved on 40 factors believed to influence safety climate in the acute care setting. Consensus regarding specific factors that play important roles in an organisation's climate of safety can be reached. Generally, the demonstration of leadership commitment to safety is key to cultivating a culture of patient safety. Transformational nurse leaders should consider and employ all three categories of factors in daily leadership activities and decision-making to drive a strong climate of patient safety. © 2017 John Wiley & Sons Ltd.

  5. 78 FR 51064 - Safety Zone; Motion Picture Production; Chicago, IL

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-20

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago, IL... temporary safety zones on waterways near Chicago, IL. These safety zones are intended to restrict vessels from portions of Chicago waterways due to the filming of a motion picture. These temporary safety zones...

  6. 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.

  7. 78 FR 57570 - Safety Zone; Motion Picture Production; Chicago, Illinois

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-19

    ... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago... will enforce the temporary safety zone for motion picture filming in Calumet Harbor, Chicago, IL from 9... Safety Zone; Motion Picture Production; Chicago, IL (78 FR 20241, August 20, 2013). This updated schedule...

  8. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., DEPARTMENT OF ENERGY, MARITIME ADMINISTRATION) § 321.4 Achieving production readiness. (a) In order to... plants, or arrangements for alternative supply lines where increased inventories are not feasible. (ii) A capability to carry on urgent production without dependence on additional personnel, external sources...

  9. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., DEPARTMENT OF ENERGY, MARITIME ADMINISTRATION) § 321.4 Achieving production readiness. (a) In order to... plants, or arrangements for alternative supply lines where increased inventories are not feasible. (ii) A capability to carry on urgent production without dependence on additional personnel, external sources of...

  10. 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.

  11. Activation product safety in the ARIES-I reactor design

    SciTech Connect

    Herring, J.S. ); Sze, D.K. ); Wong, C.; Cheng, E.T. ); Grotz, S.P. )

    1990-01-01

    The ARIES design effort has sought to maximize the environmental and safety advantages of fusion through careful selection of materials and careful design. Three goals are that the reactor achieve inherent or passive safety, that no public evacuation plan be necessary and that the waste be disposable as 10CFR61 Class C waste. The ARIES-I reactor consists of a SiC composite structure for the first wall and blanket, cooled by 10 MPa He. The breeder is Li{sub 2}ZrO{sub 3}, although Li{sub 2}O and Li{sub 4}SiO{sub 4} were also considered. The divertor consists of SiC composite tubes coated with 2 mm of tungsten. Due to the minimal afterheat of this blanket design, LOCA calculations indicate maximum temperatures will not cause damage if the plasma is promptly extinguished. Two primary safety issues are the zirconium in the breeder and tungsten on the divertor. Li{sub 2}ZrO{sub 3} was chosen because of its demonstrated high-temperature stability. The other breeders have lower afterheat and activation. Use of zirconium in the breeder will necessitate isotopic tailoring to remove {sup 90}Zr and {sup 94}Zr. The 5.8 tonnes of W on the divertor would also have to be tailored to remove {sup 186}W and/or to concentrate {sup 183}W. Thus the ARIES-I design achieves the passive safety and low-level waste disposal criteria with respect to activation products. Development of low activation materials to replace zirconium and tungsten is needed to avoid requiring an evacuation plan.

  12. 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…

  13. 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…

  14. 75 FR 76831 - Publicly Available Consumer Product Safety Information Database

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-09

    ...The Consumer Product Safety Commission (``Commission,'' ``CPSC,'' or ``we'') is issuing a final rule 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 maintain a publicly available, searchable database on the safety of consumer products, and other products or substances regulated by the Commission. The final rule interprets various statutory requirements pertaining to the information to be included in the Database and also establishes provisions regarding submitting reports of harm; providing notice of reports of harm to manufacturers; publishing reports of harm and manufacturer comments in the Database; and dealing with confidential and materially inaccurate information.

  15. Climate Change and Food Safety: Beyond Production

    NASA Astrophysics Data System (ADS)

    Ziska, L. H.; Crimmins, A. R.

    2016-12-01

    There is merited interest in determining the extent of climate disruption on agricultural production and food security. However, additional aspects of food security, including food safety, nutrition and distribution have, overall, received less attention. Beginning in 2013, the U.S. Global Change Research Program as part of the ongoing National Climate Assessment, began a directed effort to evaluate the vulnerability of climate change to these under-represented aspects of food security for developed countries. Based on this extensive review of current science, several key findings were developed: (a) Climate change, including rising temperatures and changes in weather extremes, is expected to increase the exposure of food to certain pathogens and toxins; (b) Climate change will increase human exposure to chemical contaminants in food through several pathways; (c) The nutritional value of agriculturally important food crops, including cereals, will decrease in response to the ongoing increase in atmospheric carbon dioxide; (d) Increases in the frequency or intensity of extreme weather events associated with climate change may disrupt food distribution. These findings will be presented as a means to describe the state of the science and expand on food security research in the broader context of public health and climate change.

  16. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Achieving production readiness. 321.4 Section 321.4 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS MAINTENANCE OF THE MOBILIZATION BASE (DEPARTMENT OF...

  17. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 44 Emergency Management and Assistance 1 2011-10-01 2011-10-01 false Achieving production readiness. 321.4 Section 321.4 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS MAINTENANCE OF THE MOBILIZATION BASE (DEPARTMENT OF...

  18. 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…

  19. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Achieving production readiness. 321.4 Section 321.4 Emergency Management and Assistance FEDERAL EMERGENCY MANAGEMENT AGENCY, DEPARTMENT OF HOMELAND SECURITY PREPAREDNESS MAINTENANCE OF THE MOBILIZATION BASE (DEPARTMENT OF DEFENSE...

  20. 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…

  1. 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…

  2. 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

  3. Intraoperative radiation safety in orthopaedics: a review of the ALARA (As low as reasonably achievable) principle.

    PubMed

    Kaplan, Daniel J; Patel, Jay N; Liporace, Frank A; Yoon, Richard S

    2016-01-01

    The use of fluoroscopy has become commonplace in many orthopaedic surgery procedures. The benefits of fluoroscopy are not without risk of radiation to patient, surgeon, and operating room staff. There is a paucity of knowledge by the average orthopaedic resident in terms proper usage and safety. Personal protective equipment, proper positioning, effective communication with the radiology technician are just of few of the ways outlined in this article to decrease the amount of radiation exposure in the operating room. This knowledge ensures that the amount of radiation exposure is as low as reasonably achievable. Currently, in the United States, guidelines for teaching radiation safety in orthopaedic surgery residency training is non-existent. In Europe, studies have also exhibited a lack of standardized teaching on the basics of radiation safety in the operating room. This review article will outline the basics of fluoroscopy and educate the reader on how to safe fluoroscopic image utilization.

  4. 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.

  5. Report From the Night Shift: How Administrative Supervisors Achieve Nurse and Patient Safety.

    PubMed

    Weaver, Susan H; Lindgren, Teri G; Cadmus, Edna; Flynn, Linda; Thomas-Hawkins, Charlotte

    The administrative supervisor role (the nurse leader on the evening or night shift) has been present in hospitals for more than 100 years, but research is just commencing regarding how this leader achieves nurse and patient safety. This focused ethnographic study was conducted in 2 parts. The first part consisted of focus groups with night-shift staff nurses, held at 7 hospitals in the mid-Atlantic region of the United States, with the objective of obtaining the staff nurses' perception of the supervisors' role. The second part consisted of interviews with 30 administrative supervisors, recruited nationally from 20 different states, to explore the supervisors' perspective on practices used to enhance safety. The focus group and interview transcripts were thematically analyzed, using an iterative, comparative method to identify codes and sort for patterns. The findings reveal that administrative supervisors "make it (whatever needs to be done) work" and achieve nurse and patient safety by building trust with the staff, doing rounds, educating, and providing support to the front line team. These shift leaders foster a culture of safety with their relationship-oriented leadership style. By gaining further understanding about the administrative supervisor role, new workflow processes can be explored; specific continuing education programs can be developed; and additional research can be conducted.

  6. 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.

  7. 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…

  8. 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.

  9. Cost Benefit Analysis of Consumer Product Safety Standards

    ERIC Educational Resources Information Center

    Smith, Betty F.; Dardis, Rachel

    1977-01-01

    This paper investigates the role of cost-benefit analysis in evaluating consumer product safety standards and applys such analysis to an evaluation of flammability standards for children's sleepwear. (Editor)

  10. Viral safety of human plasma-derived medicinal products: impact of regulation requirements.

    PubMed

    Velthove, Karin J; Over, Jan; Abbink, Kristiena; Janssen, Mart P

    2013-07-01

    The viral safety of plasma-derived medicinal products is of paramount importance. This article aims to provide insight into the relative impact of different safety measures on achieving viral safety of finished products, derived from human plasma. Virus removal and/or inactivation during the production process is the most important safety measure, and model-based risk estimates show that with current safety measures, the risk of transmission of known blood-borne pathogens to plasma product recipients is extremely low. However, because the residual risk of virus transmissions is also influenced by the incidence rate of infection in the donor population, it makes sense to control these incidence rates, as well. The current measures are aiming in the right direction, but integration of guidelines is required to adequately address their common goal: controlling the risk of infectious disease transmission by plasma-derived medicinal products. By integration of guidelines, the combination of various types of safety measures to prevent virus transmission-donor selection, donation screening, quarantining, and virus removal and/or inactivation during production-may be consistently interpreted and adequately assessed.

  11. 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)...

  12. 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.

  13. 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.

  14. 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

  15. Safety in the wood products industry

    Treesearch

    Judd H. Michael; Janice K. Wiedenbeck; Janice K. Wiedenbeck

    2004-01-01

    The wood products industry has historically been considered to be one of the most dangerous for manufacturing employees. Workers are exposed to hazards ranging from falling trees to debarkers to saws to nail guns, while often working under pressures for high productivity. Compounding the danger from these hazards are the mentally and physically challenging working...

  16. 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.

  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. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  18. 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:

  19. Offshore Production and Safety Act of 2011

    THOMAS, 112th Congress

    Sen. McConnell, Mitch [R-KY

    2011-05-11

    Senate - 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. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  20. 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

  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... product components and their physical relationship in the subsystem or system; (2) A description of the...

  2. Danish initiatives to improve the safety of meat products.

    PubMed

    Wegener, Henrik C

    2010-02-01

    During the last two decades the major food safety problems in Denmark, as determined by the number of human patients, has been associated with bacterial infections stemming from meat products and eggs. The bacterial pathogens causing the majority of human infections has been Salmonella and Campylobacter, and to a lesser extent Yersinia, Escherichiacoli O157 and Listeria. Danish initiatives to improve the safety of meat products have focused on the entire production chain from the farm to the consumer, with a special emphasis on the pre-harvest stage of production. The control of bacterial pathogens which are resistant to antibiotics has been a new area of attention in the recent decade, and recently, the increasing globalization of the domestic food supply has called for a complete rethinking of the national food safety strategies. The implementations of a "case-by-case" risk assessment system, as well as increased international collaboration on surveillance, are both elements in this new strategy.

  3. Production of carotenoids by microalgae: achievements and challenges.

    PubMed

    Varela, João C; Pereira, Hugo; Vila, Marta; León, Rosa

    2015-09-01

    Carotenoids are a wide group of lipophylic isoprenoids synthesized by all photosynthetic organisms and also by some non-photosynthetic bacteria and fungi. Animals, which cannot synthesize carotenoids de novo, must include them in their diet to fulfil essential provitamin, antioxidant, or colouring requirements. Carotenoids are indispensable in light harvesting and energy transfer during photosynthesis and in the protection of the photosynthetic apparatus against photooxidative damage. In this review, we outline the factors inducing carotenoid accumulation in microalgae, the knowledge acquired on the metabolic pathways responsible for their biosynthesis, and the recent achievements in the genetic engineering of this pathway. Despite the considerable progress achieved in understanding and engineering algal carotenogenesis, many aspects remain to be elucidated. The increasing number of sequenced microalgal genomes and the data generated by high-throughput technologies will enable a better understanding of carotenoid biosynthesis in microalgae. Moreover, the growing number of industrial microalgal species genetically modified will allow the production of novel strains with enhanced carotenoid contents.

  4. 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 expenditure…

  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 expenditure…

  6. 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...

  7. Health and safety risks in production agriculture.

    PubMed

    Von Essen, S G; McCurdy, S A

    1998-10-01

    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.

  8. 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

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 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 COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains several...

  10. Family violence intervention within an emergency department: achieving change requires multifaceted processes to maximize safety.

    PubMed

    Ritchie, Miranda; Nelson, Katherine; Wills, Russell

    2009-04-01

    Family violence is common with significant long-term negative health effects. Health professionals are recognised as key providers of family violence intervention. In 2002, the Hawke's Bay District Health Board launched a Family Violence Intervention Programme in its emergency department. The intervention programme involved staff training, the development of resources and routine questioning for partner abuse within the social history for all women 16 years and over. The aim was to identify the barriers and enablers to routine questioning one year after the programme was launched to inform programme improvements. Evaluation research using semi-structured interviews; eleven staff participated in either a single or a group interview. Content and thematic analysis, with triangulation of findings was used. The interviews revealed that routine questioning for partner abuse is difficult in the emergency department. Some staff screened routinely while others only offered intervention when overt abuse was identified. Barriers, enablers and solutions revealed by participants were either personal or organisational; all had the common theme of safety. Routine questioning for partner abuse is challenging and its introduction into practice requires a systems approach to achieve change. Barriers to questioning exist and by simultaneously addressing these and implementing enablers, at an organisational and personal level, barriers are eliminated or at least minimised. A link was evident between nurses' level of comfort and their rate of questioning. A multifaceted approach focusing on safety of all concerned can support change resulting in implementation of family violence intervention in the health sector.

  11. How is success achieved by individuals innovating for patient safety and quality in the NHS?

    PubMed

    Sheard, Laura; Jackson, Cath; Lawton, Rebecca

    2017-09-11

    Innovation in healthcare is said to be notoriously difficult to achieve and sustain yet simultaneously the health service is under intense pressure to innovate given the ever increasing demands placed upon it. Whilst many studies have looked at diffusion of innovation from an organisational perspective, few have sought to understand how individuals working in healthcare innovate successfully. We took a positive deviance approach to understand how innovations are achieved by individuals working in the NHS. We conducted in depth interviews in 2015 with 15 individuals who had received a national award for being a successful UK innovator in healthcare. We invited only those people who were currently (or had recently) worked in the NHS and whose innovation focused on improving patient safety or quality. Thematic analysis was used. Four themes emerged from the data: personal determination, the ability to broker relationships and make connections, the ways in which innovators were able to navigate organisational culture to their advantage and their ability to use evidence to influence others. Determination, focus and persistence were important personal characteristics of innovators as were skills in being able to challenge the status quo. Innovators were able to connect sometimes disparate teams and people, being the broker between them in negotiating collaborative working. The culture of the organisation these participants resided in was important with some being able to use this (and the current patient safety agenda) to their advantage. Gathering robust data to demonstrate their innovation had a positive impact and was seen as essential to its progression. This paper reveals a number of factors which are important to the success of innovators in healthcare. We have uncovered that innovators have particular personal traits which encourage a propensity towards change and action. Yet, for fruitful innovation to take place, it is important for relational networks and

  12. Underbalanced completions improve well safety and productivity

    SciTech Connect

    Walker, T.; Hopmann, M.

    1995-11-01

    Recent advances in completion technology, especially the use of and advances in coiled tubing technology, have presented the petroleum industry with methods that were previously unknown or considered too risky. Specifically, coiled tubing drilling and underbalanced drilling have both proven to be effective and acceptable methods in industry today. Several methods have been presented that will allow for the well to be completed underbalanced. By utilizing these methods, the completion process can be carried out while experiencing the same benefits offered by underbalanced drilling. the well can be completed with minimal fluid loss, which will result in reduced formation damage and improved well productivity. This new approach to the completion process provides additional opportunities both for completing new wells and for reentering existing wells.

  13. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 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 in...

  14. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 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 in...

  15. 33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 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 in...

  16. Geologic mapping can boost productivity, safety underground

    SciTech Connect

    Ledvina, C.T.

    1986-04-01

    Geologic mapping in hardrock mines is old hat, but in the coal industry it's a relatively new management tool, Only during the past eight to 10 years have some of the larger coal operators been convinced that mapping of macro- and micro-structures in their mines may help to make the mines more productive, more profitable and more safe. In most underground coal mines, roof conditions-indeed, mining conditions in general-are dependent upon geologic factors. Of special significance are the roof falls, almost always a function of roof geology. Unfortunately, many important geologic factors that may provide clues to areas prone to roof falls are frequently too small or too local to be detected by drilling programs and go undected until mining reveals them. By applying basic techniques of geologic mapping, using simple tools and little time, many important relationships between geologic factors and actual roof and mining conditions can be more easily understood. And by understanding these relationships, mining and roof control plans can be adjusted to accommodate or avoid poor conditions, often in advance of mining. Mapping thus benefits not only operating mines but supplements exploration or pre-mining investigation.

  17. Evaluation of additional cooking procedures to achieve lethality microbiological performance standards for large, intact meat products.

    PubMed

    Haneklaus, A N; Harris, K B; Cuervo, M P; Ilhak, O I; Lucia, L M; Castillo, A; Hardin, M D; Osburn, W N; Savell, J W

    2011-10-01

    The U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) has a specific lethality performance standard for ready-to-eat products. To assist meat processing establishments in meeting the performance standard, USDA-FSIS developed Appendix A, which provides guidelines for cooking temperatures, times, and relative humidity. This project determined whether the USDA-FSIS performance standards for lethality were met when using parameters other than those identified in Appendix A to cook large hams and beef inside rounds. The effects of alternative lethality parameters on the reduction of Salmonella Typhimurium and coliforms and on the toxin production of Staphylococcus aureus were evaluated. Large (9- to 12-kg) cured bone-in hams (n = 80) and large (8- to 13-kg) uncured beef inside rounds (n = 80) were used in this study. The products were subjected to 1 of 10 treatments defined by combinations of final internal product temperatures (48.9, 54.4, 60.0, 65.6, or 71.1°C) and batch oven relative humidities (50 or 90 % ). For all treatments, at least a 6.5-log reduction in Salmonella Typhimurium was achieved. The coliform counts were also substantially reduced for both hams and rounds. Across all treatments for both products, S. aureus toxin production was not detected. The relative humidity did not alter the lethality effectiveness for any of the treatments. The final internal temperatures and relative humidity combinations used in this project achieved the lethality performance standard established by USDA-FSIS for fully cooked, ready-to-eat products.

  18. Quality and Safety Aspects of Cereals (Wheat) and Their Products.

    PubMed

    Varzakas, Theo

    2016-11-17

    Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

  19. Safety in the Marketplace: A Program for the Improvement of Consumer Product Safety.

    ERIC Educational Resources Information Center

    National Business Council for Consumer Affairs, Washington, DC.

    Prepared under the auspices of the National Business Council for Consumer Affairs by its Sub-Council on Product Safety, this report is part of a program to advise the federal government on voluntary activities by the business community which would help consumers. Contents include analysis, conclusions and recommendations relating to manufacturers,…

  20. 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.…

  1. Decisions about Product Safety. A Multidisciplinary Teaching Unit.

    ERIC Educational Resources Information Center

    Procter and Gamble Educational Services, Cincinnati, OH.

    A multidisciplinary educational unit featuring product safety decisions made by businesses and consumers is presented. teach critical thinking and decision making while supplementing the science, home economics, social studies, and economics curricula. The activities rely extensively, though not exclusively, on Procter & Gamble's experiences…

  2. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... description of the safety assessment and verification and validation processes applied to the product and the... using an alternative method, and a complete explanation of the manner in which those requirements are...: (i) All post-implementation testing (validation) and monitoring procedures, including the intervals...

  3. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... description of the safety assessment and verification and validation processes applied to the product and the... using an alternative method, and a complete explanation of the manner in which those requirements are...: (i) All post-implementation testing (validation) and monitoring procedures, including the intervals...

  4. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... description of the safety assessment and verification and validation processes applied to the product and the... using an alternative method, and a complete explanation of the manner in which those requirements are...: (i) All post-implementation testing (validation) and monitoring procedures, including the intervals...

  5. On the Safety of Machine Learning: Cyber-Physical Systems, Decision Sciences, and Data Products.

    PubMed

    Varshney, Kush R; Alemzadeh, Homa

    2017-09-01

    Machine learning algorithms increasingly influence our decisions and interact with us in all parts of our daily lives. Therefore, just as we consider the safety of power plants, highways, and a variety of other engineered socio-technical systems, we must also take into account the safety of systems involving machine learning. Heretofore, the definition of safety has not been formalized in a machine learning context. In this article, we do so by defining machine learning safety in terms of risk, epistemic uncertainty, and the harm incurred by unwanted outcomes. We then use this definition to examine safety in all sorts of applications in cyber-physical systems, decision sciences, and data products. We find that the foundational principle of modern statistical machine learning, empirical risk minimization, is not always a sufficient objective. We discuss how four different categories of strategies for achieving safety in engineering, including inherently safe design, safety reserves, safe fail, and procedural safeguards can be mapped to a machine learning context. We then discuss example techniques that can be adopted in each category, such as considering interpretability and causality of predictive models, objective functions beyond expected prediction accuracy, human involvement for labeling difficult or rare examples, and user experience design of software and open data.

  6. 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. 250.804 Section 250.804 Mineral Resources BUREAU OF SAFETY AND ENVIRONMENTAL ENFORCEMENT, DEPARTMENT... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a)...

  7. 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... Gas Production Safety Systems § 250.804 Production safety-system testing and records. (a)...

  8. 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...

  9. A public-private consortium advances cardiac safety evaluation: achievements of the HESI Cardiac Safety Technical Committee.

    PubMed

    Pierson, Jennifer B; Berridge, Brian R; Brooks, Marjory B; Dreher, Kevin; Koerner, John; Schultze, A Eric; Sarazan, R Dustan; Valentin, Jean-Pierre; Vargas, Hugo M; Pettit, Syril D

    2013-01-01

    The evaluation of cardiovascular side-effects is a critical element in the development of all new drugs and chemicals. Cardiac safety issues are a major cause of attrition and withdrawal due to adverse drug reactions (ADRs) in pharmaceutical drug development. The evolution of the HESI Technical Committee on Cardiac Safety from 2000-2013 is presented as an example of an effective international consortium of academic, government, and industry scientists working to improve cardiac safety. The HESI Technical Committee Working Groups facilitated the development of a variety of platforms for resource sharing and communication among experts that led to innovative strategies for improved drug safety. The positive impacts arising from these Working Groups are described in this article. Copyright © 2013 Elsevier Inc. All rights reserved.

  10. [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.

  11. 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

  12. 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

  13. 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…

  14. 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...

  15. Ethylene Production Maximum Achievable Control Technology (MACT) Compliance Manual

    EPA Pesticide Factsheets

    This July 2006 document is intended to help owners and operators of ethylene processes understand and comply with EPA's maximum achievable control technology standards promulgated on July 12, 2002, as amended on April 13, 2005 and April 20, 2006.

  16. 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...

  17. 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. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. An overview of food safety issues relative to animal products.

    PubMed

    Baile, C A

    1990-06-01

    Presently, strategies for discovering new factors for enhancing animal productivity allow for greater assurance of food safety. A high degree of assurance of food safety is provided by the use of natural growth factors. This is especially true when these factors are proteins which, when ingested, are digested to inactive peptides and amino acids and are, in addition, inactive in human tissues. Knowing the mechanisms of activity of such factors also allows for the assurance that known mediators of the growth factors can also be shown to be inactivated by intestinal barriers. The design of nonpeptide molecules with highly selective activity will be possible with the large amount of progress expected in understanding the structure of the active components of natural molecules and the availability of specific receptor systems. Food safety concerns may be met by the demonstration that these molecules are inactive in comparable human receptor systems. These drug discovery strategies can ensure with a high degree of confidence the development of new productivity enhancers that meet food safety requirements.

  19. 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…

  20. 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…

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

    PubMed

    Dutto, Moreno; Alfonzo, Santo; Rubbiani, Maristella

    2012-01-01

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

  2. 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...

  3. 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...

  4. 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.

  5. Quality and safety requirements for sustainable phage therapy products.

    PubMed

    Pirnay, Jean-Paul; Blasdel, Bob G; Bretaudeau, Laurent; Buckling, Angus; Chanishvili, Nina; Clark, Jason R; Corte-Real, Sofia; Debarbieux, Laurent; Dublanchet, Alain; De Vos, Daniel; Gabard, Jérôme; Garcia, Miguel; Goderdzishvili, Marina; Górski, Andrzej; Hardcastle, John; Huys, Isabelle; Kutter, Elizabeth; Lavigne, Rob; Merabishvili, Maia; Olchawa, Ewa; Parikka, Kaarle J; Patey, Olivier; Pouilot, Flavie; Resch, Gregory; Rohde, Christine; Scheres, Jacques; Skurnik, Mikael; Vaneechoutte, Mario; Van Parys, Luc; Verbeken, Gilbert; Zizi, Martin; Van den Eede, Guy

    2015-07-01

    The worldwide antibiotic crisis has led to a renewed interest in phage therapy. Since time immemorial phages control bacterial populations on Earth. Potent lytic phages against bacterial pathogens can be isolated from the environment or selected from a collection in a matter of days. In addition, phages have the capacity to rapidly overcome bacterial resistances, which will inevitably emerge. To maximally exploit these advantage phages have over conventional drugs such as antibiotics, it is important that sustainable phage products are not submitted to the conventional long medicinal product development and licensing pathway. There is a need for an adapted framework, including realistic production and quality and safety requirements, that allows a timely supplying of phage therapy products for 'personalized therapy' or for public health or medical emergencies. This paper enumerates all phage therapy product related quality and safety risks known to the authors, as well as the tests that can be performed to minimize these risks, only to the extent needed to protect the patients and to allow and advance responsible phage therapy and research.

  6. 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…

  7. 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…

  8. Productivity and safety in worker cooperatives and conventional firms.

    PubMed

    Grunberg, L; Everard, J; O'Toole, M

    1984-01-01

    This paper examines the relationship between productivity and workers' safety in firms characterized by very different types of relations in production. Arguments are developed to explain why worker cooperatives are expected to have higher productivity and lower accident rates than conventional capitalist firms. Workers who own and control their firms are expected to have a greater incentive to be efficient and a greater ability to safeguard their health than workers employed under hierarchical and alienating conditions. The hypotheses are tested by comparing carefully matched conventional and cooperative plywood companies. Preliminary results suggest that while cooperatives may be more productive they are not safer, indicating the limits of the isolated cooperative form in capitalist market economies.

  9. 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...

  10. The Occupational Safety and Health Act: Its Goals and Its Achievements. Evaluative Studies Series.

    ERIC Educational Resources Information Center

    Smith, Robert Stewart

    The safety and health mandate of the Occupational Safety and Health Act of 1970 is examined in reference to its effectiveness in reducing injuries and its consistency with the goal of promoting general welfare. Chapter 1 describes the essential features of the act and its administration to date, and analyzes the mandate as revealed by legislative…

  11. 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…

  12. 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…

  13. 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…

  14. 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…

  15. Evolution of approaches to viral safety issues for biological products.

    PubMed

    Lubiniecki, Anthony S

    2011-01-01

    CONFERENCE PROCEEDING Proceedings of the PDA/FDA Adventitious Viruses in Biologics: Detection and Mitigation Strategies Workshop in Bethesda, MD, USA; December 1-3, 2010 Guest Editors: Arifa Khan (Bethesda, MD), Patricia Hughes (Bethesda, MD) and Michael Wiebe (San Francisco, CA) Approaches to viral safety issues for biological products have evolved during the past 50+ years. The first cell culture products (viral vaccines) relied largely on the use of in vitro and in vivo virus screening assays that were based upon infectivity of adventitious viral agents. The use of Cohn fractionation and pasteurization by manufacturers of plasma derivatives introduced the concepts that purification and treatment with physical and chemical agents could greatly reduce the risk of viral contamination of human albumin and immunoglobulin products. But the limitations of such approaches became clear for thermolabile products that were removed early in fractionation such as antihemophilic factors, which transmitted hepatitis viruses and HIV-1 to some product recipients. These successes and limitations were taken into account by the early developers of recombinant DNA (rDNA)-derived cell culture products and by regulatory agencies, leading to the utilization of cloning technology to reduce/eliminate contamination due to human viruses and purification technologies to physically remove and inactivate adventitious and endogenous viruses, along with cell banking and cell bank characterization for adventitious and endogenous viruses, viral screening of biological raw materials, and testing of cell culture harvests, to ensure virus safety. Later development and incorporation of nanofiltration technology in the manufacturing process provided additional assurance of viral clearance for safety of biotechnology products. These measures have proven very effective at preventing iatrogenic infection of recipients of biotechnology products; however, viral contamination of production cell cultures has

  16. Alternatives to animal testing in the safety evaluation of products.

    PubMed

    Knight, Derek J; Breheny, Damien

    2002-01-01

    The conventional method for assessing the safety of products, ranging from pharmaceuticals to agrochemicals, biocides and industrial and household chemicals - including cosmetics - involves determining their toxicological properties by using experimental animals. The aim is to identify any possible adverse effects in humans by using these animal models. Providing safe products is undoubtedly of the utmost importance but, over the last decade or so, this aim has come into conflict with strong public opinion, especially in Europe, against animal testing. Industry, academia and the regulators have worked in partnership to find other ways of evaluating the safety of products, by non-animal testing, or at least by reducing the numbers of animals required and the severity of the tests in which they are used. There is a long way to go before products can be evaluated without any animal studies, and it may be that this laudable aim is an impossible dream. Nevertheless, considerable progress has been made by using a combination of in vitro tests and the prediction of properties based on chemical structure. The aim of this review is to describe these important and worthwhile developments in various areas of toxicological testing, with a focus on the European regulatory framework for general industrial and household chemicals.

  17. Microbiological quality and safety assessment of lettuce production in Brazil.

    PubMed

    Ceuppens, Siele; Hessel, Claudia Titze; de Quadros Rodrigues, Rochele; Bartz, Sabrina; Tondo, Eduardo César; Uyttendaele, Mieke

    2014-07-02

    The microbiological quality and safety of lettuce during primary production in Brazil were determined by enumeration of hygiene indicators Escherichia coli, coliforms and enterococci and detection of enteric pathogens Salmonella and E. coli O157:H7 in organic fertilizers, soil, irrigation water, lettuce crops, harvest boxes and worker's hands taken from six different lettuce farms throughout the crop growth cycle. Generic E. coli was a suitable indicator for the presence of Salmonella and E. coli O157:H7, while coliforms and enterococci were not. Few pathogens were detected: 5 salmonellae and 2 E. coli O157:H7 from 260 samples, of which only one was lettuce and the others were manure, soil and water. Most (5/7) pathogens were isolated from the same farm and all were from organic production. Statistical analysis revealed the following environmental and agro-technical risk factors for increased microbial load and pathogen prevalence in lettuce production: high temperature, flooding of lettuce fields, application of contaminated organic fertilizer, irrigation with water of inferior quality and large distances between the field and toilets. Control of the composting process of organic fertilizers and the irrigation water quality appear most crucial to improve and/or maintain the microbiological quality and safety during the primary production of lettuce. Copyright © 2014 Elsevier B.V. All rights reserved.

  18. SAW with multiple electrodes achieves high production rates

    SciTech Connect

    Tusek, J.

    1996-08-01

    Increased demands for higher productivity in the production of welded structures dictate the use of new higher-performance welding procedures. Submerged arc welding (SAW) is already one of the highest performing arc welding processes, but with certain improved variants, its performance can be increased. These variants are multiple-head welding, double electrode welding and submerged arc welding with metal powder addition. These three variations of submerged arc welding have been put into practice and are extensively treated in the welding literature. The application of welding with more than three wires in a joint contact tube is rare, however, and rarely mentioned. The purpose of this article is to show the basic characteristics and eventual applications of SAW using multiple electrodes.

  19. Microbial Gas Production Used to Achieve Autonomous Buoyancy Control

    DTIC Science & Technology

    2010-09-01

    counter weight. The microbe used is cultured in the Erlenmeyer flask. Clostridium acetobutylicum for micro1bial ballast In order to utilize microbial...34 20 0 --100% 0 20 40 60 80 Time(hr) Figure 6. Gas production by different S()lid-phase agar cultures of C. acetobutvlicum. Clostridium ... acetobutylicum as our model microbe; a gram-positive anaerobic bacterium known for its ability to produce hydrogen gas 4,5 To determine if there

  20. 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 Radiation...

  1. 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 Radiation...

  2. 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 Radiation...

  3. 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 Radiation...

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

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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 Radiation...

  5. 2011 John M. Eisenberg Patient Safety and Quality Awards. Individual Achievement. Interview by Eric J. Thomas.

    PubMed

    Shine, Kenneth

    2012-07-01

    Dr. Shine, who, as president, led the Institute of Medicine's focus on quality and patient safety, describes initiatives at the University of Texas System, including quality improvement training, systems engineering, assessment of projects' economic impact, and dissemination of good practices.

  6. Medical product safety surveillance: how many databases to use?

    PubMed

    Maro, Judith C; Brown, Jeffrey S; Kulldorff, Martin

    2013-09-01

    Large linked database networks, like the US Food and Drug Administration's Sentinel System, are being built for medical product surveillance. One use of these networks is for "near real-time" sequential database surveillance of prespecified medical product-adverse event pairs, which may result in a "safety signal" when a statistical excess risk is detected. Sequential database surveillance requires the investigator to manage surveillance in both information time (ie, how sample size accrues) and calendar time. Calendar time is important because people external to the surveillance population may be affected by the speed with which a safety signal is detected or ruled out. Optimal design and analysis aspects of sequential database surveillance are not well developed, but are gaining in importance as observational database networks grow. Using information time concepts, we show how to calculate sample sizes when performing sequential database surveillance, illustrating the relationships between statistical power, the time to detect a signal, and the maximum sample size for various true effect sizes. Then, using a vaccine example, we demonstrate a four-step planning process that allows investigators to translate information time into calendar time. Given the calendar time for surveillance, the process focuses on choosing observational database configurations consistent with the investigator's preferences for timeliness and statistical power. Although the planning process emphasizes sample size considerations, the influence of secondary database attributes such as delay times, measurement error, and cost are also discussed. Appropriate planning allows the most efficient use of public health dollars dedicated to medical product surveillance efforts.

  7. Safety assessment of chromium by exposure from cosmetic products.

    PubMed

    Hwang, Myungsil; Yoon, Eun Kyung; Kim, Ja Young; Son, Bo Kyung; Yang, Seong Jun; Yun, Mi Ok; Choi, Sang Sook; Jang, Dong Deuk; Yoo, Tae Moo

    2009-02-01

    Low level impurities often reside in cosmetic products. The aim of the present study was to estimate the human exposure to chromium from cosmetic products purchased at a local market in South Korea, and to assess the risk on public health. Hexavalent chromium is an impurity substance that contaminates cosmetic products during manufacture. The potential for chromium to induce and elicit allergic contact dermatitis, as well as the degree of chromium exposure from cosmetic products, were assessed. Chromium exposure was estimated using the chromium concentrations found in cosmetic samples taken from the local market along with the expected user pattern data that was taken from the literature. Of the cosmetics we tested and available for purchase on the Korean market, seven had chromium contents above the detection limit of 0.1 ppm (0.1 microg/mL), ranging from 0.2 to 3.15 ppm. In risk assessment, scientifically defensible dose-response relationships must be established for the end points of concern. In the case of chromium contaminated cosmetic products, this includes conducting dose-response assessments for allergic contact dermatitis following dermal exposure. This dose-response information can then be integrated with site-specific exposure assessments to regulate consumer safety by use of these products. We found that dermal exposure to chromium concentrations ranging from 0.0002 to 0.003 microg/cm(2) does not appear to cause concern for eliciting allergic contact dermatitis.

  8. Productivity, Syntax, and Ideation in the Written Expression of Remedial and Achieving Readers.

    ERIC Educational Resources Information Center

    Anderson, Peggy L.

    1989-01-01

    The study compared the written expression of 56 fourth to fifth grade remedial readers and achieving readers. Significant differences favoring the achieving readers were found in three areas: productivity, syntax, and level of ideation. Remedial readers tended toward the same kinds of errors as achieving readers but with an increased frequency.…

  9. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

    ... Production Safety Training, Submitted for Office of Management and Budget (OMB) Review; Comment Request... Safety Training.'' This notice also provides the public a second opportunity to comment on the revised... 250, Subpart O, Well Control and Production Safety Training. OMB Control Number: 1014-0008. Abstract...

  10. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety... 30 Mineral Resources 1 2011-07-01 2011-07-01 false MSHA acceptance of equivalent non-MSHA product...

  11. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS TESTING AND EVALUATION BY INDEPENDENT LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA acceptance of equivalent non-MSHA product...

  12. 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.

  13. Product-based Safety Certification for Medical Devices Embedded Software.

    PubMed

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

  14. 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

  15. Safety studies on products from whole coffee fruit.

    PubMed

    Heimbach, J T; Marone, P A; Hunter, J M; Nemzer, B V; Stanley, S M; Kennepohl, E

    2010-01-01

    The fruit of the coffee plant, Coffea arabica, has high phenolic antioxidant and phytonutrient content and could be a beneficial food ingredient. However, the fruit has historically been discarded for the favored harvesting of the coffee bean alone. CoffeeBerry products are derived from the whole fruit and include a ground whole powder, a water extract, and a more recently developed water-ethanol extract. The safety of CoffeeBerry products was evaluated in three genotoxicity studies, three short-term oral toxicity studies, and a 90-day dietary toxicity study. Bacterial mutagenicity studies and a micronucleus test using murine peripheral cells demonstrated that none of the three products showed mutagenic or genotoxic potential. In the short-term studies, despite palatability issues, female rats showed a tolerance for whole powder and ethanol extract at doses up to 8800 mg/kg bw/day. Male rats also exhibited palatability issues and tolerated lower doses of approximately 4000 mg/kg bw/day ethanol extract via gavage and approximately 2100 mg/kg bw/day whole powder or water extract in the diet. When fed in the diet to Sprague-Dawley rats for 90 days, ethanol extract showed no adverse effects at dietary concentrations of up to 5% (approximately 3446 and 4087 mg/kg bw/day for male and female rats, respectively).

  16. 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.

  17. 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...

  18. Food safety objective approach for controlling Clostridium botulinum growth and toxin production in commercially sterile foods.

    PubMed

    Anderson, N M; Larkin, J W; Cole, M B; Skinner, G E; Whiting, R C; Gorris, L G M; Rodriguez, A; Buchanan, R; Stewart, C M; Hanlin, J H; Keener, L; Hall, P A

    2011-11-01

    As existing technologies are refined and novel microbial inactivation technologies are developed, there is a growing need for a metric that can be used to judge equivalent levels of hazard control stringency to ensure food safety of commercially sterile foods. A food safety objective (FSO) is an output-oriented metric that designates the maximum level of a hazard (e.g., the pathogenic microorganism or toxin) tolerated in a food at the end of the food supply chain at the moment of consumption without specifying by which measures the hazard level is controlled. Using a risk-based approach, when the total outcome of controlling initial levels (H(0)), reducing levels (ΣR), and preventing an increase in levels (ΣI) is less than or equal to the target FSO, the product is considered safe. A cross-disciplinary international consortium of specialists from industry, academia, and government was organized with the objective of developing a document to illustrate the FSO approach for controlling Clostridium botulinum toxin in commercially sterile foods. This article outlines the general principles of an FSO risk management framework for controlling C. botulinum growth and toxin production in commercially sterile foods. Topics include historical approaches to establishing commercial sterility; a perspective on the establishment of an appropriate target FSO; a discussion of control of initial levels, reduction of levels, and prevention of an increase in levels of the hazard; and deterministic and stochastic examples that illustrate the impact that various control measure combinations have on the safety of well-established commercially sterile products and the ways in which variability all levels of control can heavily influence estimates in the FSO risk management framework. This risk-based framework should encourage development of innovative technologies that result in microbial safety levels equivalent to those achieved with traditional processing methods.

  19. 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.

  20. An education-service partnership to achieve safety and quality improvement competencies in nursing.

    PubMed

    Fater, Kerry H; Ready, Robert

    2011-12-01

    The Institute of Medicine recommends that educational and service organizations develop partnerships to promote and prioritize competency development for nurses. This article describes a collaborative project between a college of nursing and a regional health care system. The project's aim was to foster the development of safety and quality by creating a curriculum based on the 10 core competencies identified by the Massachusetts Department of Higher Education Nurse of the Future Competency Committee. To accomplish this goal, learning experiences were created to address competency development. Competency-based education will help ensure that nursing graduates are adequately prepared to meet the current and future health care needs of our population.

  1. 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.

  2. 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)

  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. Viral safety of solvent/detergent-treated blood products.

    PubMed

    Horowitz, B; Prince, A M; Hamman, J; Watklevicz, C

    1994-12-01

    Laboratory research that began in 1982 led to the licensing in the USA of a solvent/detergent (SD)-treated factor VIII concentrate in 1985. The licence was granted on the basis of several factors. First, studies had demonstrated the inactivation of several marker viruses (vesicular stomatitis virus, Sindbis virus, Sendai virus) and other viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and non-A, non-B hepatitis virus (NANBHV; now known principally to be hepatitis C virus) added to the factor VIII concentrate just before treatment. Secondly, it had been realized that the relevant viruses in transfusion (e.g. HIV, HBV, NANBHV) all had lipid envelopes. Finally, laboratory, preclinical and clinical evidence indicated that factor VIII and other proteins present in the preparation were unaffected by SD treatment. The applicability of the SD method to a wide range of products and preparations, high process recoveries and a growing body of viral safety information linked with the failure of several other virus-inactivation methods to eliminate hepatitis transmission fostered the adoption of SD technology by more than 50 organizations worldwide. SD mixtures are now used in the preparation of a diverse array of products. Numerous laboratory and clinical studies suggest that coagulation-factor concentrates and other SD-treated products prepared from plasma pools are now safer than the individual units from which they were derived. Also, a large body of evidence indicates that hepatitis A virus (HAV) is not typically transmitted by blood and blood products.(ABSTRACT TRUNCATED AT 250 WORDS)

  5. 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

    ... product design. A copy of the petition, as well as any written communications concerning the petition, is... Product Safety Plan In accordance with Part 236 of Title 49 Code of Federal Regulations (CFR) and 49 U.S.C... a Product Safety Plan (PSP). FRA assigned the petition Docket Number FRA-2012-0075. PATH...

  6. Viral safety of solvent-detergent treated blood products.

    PubMed

    Horowitz, B; Prince, A M; Horowitz, M S; Watklevicz, C

    1993-01-01

    Laboratory research commencing in 1982 led to licensing in the United States in 1985 of a solvent/detergent (SD)-treated anti-haemophilic factor (AHF) concentrate. Licensing was based on (a) studies demonstrating the inactivation of several marker viruses [vesicular stomatitis virus (VSV), Sindbis virus, Sendai virus], human immunodeficiency virus (HIV), hepatitis B virus (HBV), and non-A, non-B hepatitis virus [NANBHV; now known to be principally hepatitis C virus (HCV)] added to AHF just before treatment, (b) the realization that the principal viruses of concern in a transfusion setting (e.g. HIV, HBV, NANBHV) were all lipid-enveloped, and (c) laboratory, preclinical and clinical evidence indicating that AHF and other proteins present in the preparation were unaffected. The applicability of the SD method to a wide range of products and preparations, high process recoveries, and a growing body of viral safety information linked with the failure of several other virus inactivation methods to eliminate hepatitis transmission fostered the adoption of SD technology by more than 50 organizations world-wide. SD mixtures are now used in the preparation of products as diverse as intermediate purity and monoclonal antibody purified AHF and other coagulation factor concentrates, fibrin glue, normal and hyperimmune IgG and IgM preparations including those derived from tissue culture, plasma for transfusion, and various diagnostic controls. Over four million doses of SD-treated products have been administered, and numerous laboratory and clinical studies designed to assess virus safety have been conducted. SD treatment has been shown to inactivate > or = 10(9.2) tissue culture infectious doses (TCID50) of VSV, > or = 10(8.8) TCID50 of Sindbis virus, > or = 10(6.0) TCID50 of Sendai virus, > or = 10(7.3) duck infectious doses of duck HBV, > or = 10(11.0) degrees TCID50 of HIV-1, > or = 10(6.0) TCID50 of HIV-2, > or = 10(6.0) chimpanzee infectious doses (CID50) of HBV, > or = 10

  7. Review of health safety aspects of nanotechnologies in food production.

    PubMed

    Bouwmeester, Hans; Dekkers, Susan; Noordam, Maryvon Y; Hagens, Werner I; Bulder, Astrid S; de Heer, Cees; ten Voorde, Sandra E C G; Wijnhoven, Susan W P; Marvin, Hans J P; Sips, Adriënne J A M

    2009-02-01

    Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. Estimate the consumer exposure to nanoparticles.

  8. 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

    ...: Safety Requirements for External Product Piping on Cargo Tanks Transporting Flammable Liquids AGENCY...) seeking public comment on a proposal to prohibit the transportation of flammable liquids in...

  9. Active safety monitoring of new medical products using electronic healthcare data: Selecting alerting rules

    PubMed Central

    Gagne, Joshua J.; Rassen, Jeremy A.; Walker, Alexander M.; Glynn, Robert J.; Schneeweiss, Sebastian

    2012-01-01

    BACKGROUND Active medical-product-safety surveillance systems are being developed to monitor many products and outcomes simultaneously in routinely collected longitudinal electronic healthcare data. These systems will rely on algorithms to generate alerts about potential safety concerns. METHODS We compared the performance of five classes of algorithms in simulated data using a sequential matched-cohort framework, and applied the results to two electronic healthcare databases to replicate monitoring of cerivastatin-induced rhabdomyolysis. We generated 600,000 simulated scenarios with varying expected event frequency in the unexposed, alerting threshold, and outcome risk in the exposed, and compared the alerting algorithms in each scenario type using an event-based performance metric. RESULTS We observed substantial variation in algorithm performance across the groups of scenarios. Relative performance varied by the event frequency and by user-defined preferences for sensitivity versus specificity. Type I error-based statistical testing procedures achieved higher event-based performance than other approaches in scenarios with few events, whereas statistical process control and disproportionality measures performed relatively better with frequent events. In the empirical data, we observed 6 cases of rhabdomyolysis among 4,294 person-years of follow-up, with all events occurring among cerivastatin-treated patients. All selected algorithms generated alerts before the drug was withdrawn from the market. CONCLUSION For active medical-product-safety monitoring in a sequential matched cohort framework, no single algorithm performed best in all scenarios. Alerting algorithm selection should be tailored to particular features of a product-outcome pair, including the expected event frequencies and trade-offs between false-positive and false-negative alerting. PMID:22266893

  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.

  11. National Culture, Creativity, and Productivity: What's the Relationship with Student Achievement?

    ERIC Educational Resources Information Center

    Fang, Zheng; Xu, Xianxuan; Grant, Leslie W.; Stronge, James H.; Ward, Thomas J.

    2016-01-01

    Using Hofstede's culture dimensions and World Values Survey (WVS) dimensions, the study uses a series of multiple regressions to explore the relationship among national culture, creativity as measured by patents, economic productivity as measured by gross domestic product per capita, and student achievement as measured by Trends in International…

  12. National Culture, Creativity, and Productivity: What's the Relationship with Student Achievement?

    ERIC Educational Resources Information Center

    Fang, Zheng; Xu, Xianxuan; Grant, Leslie W.; Stronge, James H.; Ward, Thomas J.

    2016-01-01

    Using Hofstede's culture dimensions and World Values Survey (WVS) dimensions, the study uses a series of multiple regressions to explore the relationship among national culture, creativity as measured by patents, economic productivity as measured by gross domestic product per capita, and student achievement as measured by Trends in International…

  13. Nanoscale sensors for assuring the safety of food products.

    PubMed

    Wang, Yun; Duncan, Timothy V

    2017-04-01

    As far as chemical analysis is concerned, foods are among the most difficult matrices to work with because they are complex, heterogeneous substances with a high degree of variety. Assaying foods for trace levels of chemical and microbiological substances is a challenge that often requires the application of time-consuming, expensive analytical instrumentation in dedicated facilities populated by highly trained personnel. Therefore there is a continued demand for new analytical technologies that can detect small concentrations of chemicals or microbes in a more cost- and time-effective manner, preferably in the field, on the production line, and/or non-destructively, with little to no sample pre-treatment, and possibly by individuals with scant scientific training. In the last decade, nanotechnology - a branch of science that takes advantage of the unique chemical and physical properties of matter on the nanoscale - has created new opportunities for both qualitative and quantitative detection of vapors/gasses, small molecules, biopolymers, and even living microbes in a fraction of the time and expense of traditional analytical techniques. This article offers a focused review of recent progress in nanotechnology-enabled biosensing as applied to foods and related matrices, paying particular attention to trends in the field, recent breakthroughs, and current areas of need. Special focus is paid to two primary categories of nanobiosensors - optical and electrochemical - and the discussion includes a comparison of their various strengths and weaknesses as they pertain ensuring the safety of the food supply.

  14. Safety of blood and blood products in Scandinavia today.

    PubMed

    Lindholm, A

    1988-01-01

    The safety of blood and blood products in Scandinavia today is high. An absolutely safe blood supply is, however, an unattainable goal. The dominating risk is transmission of non-A, non-B virus (NANBV). The calculated per blood unit risk is 1:200. The incidence of cirrhosis due to post-transfusion hepatitis NANB is calculated to at most 0.1% among recipients of blood components from about 5 donors. Other risk factors are transmission of hepatitis B virus (HBV), human immunodeficiency virus (HIV-1) and cytomegalovirus (CMV). The prevalence of HBsAg among first time donors is about 0.05% (Sweden). In Scandinavia, anti-HIV-1 has been found in 0.001% of donations from start of screening in 1985 to December 1987. The prevalence was higher in Denmark, lower in Finland (and perhaps Iceland). The prevalence has declined during the last years. As of June 1988, 117 patients in the Scandinavian countries have been infected by blood components, all but 2 before screening was introduced. Besides these, 226 haemophiliacs have been infected by, in almost all cases, imported clotting factor concentrates before heat treatment was introduced. Most of the infected patients are still asymptomatic. About 70% of blood donors have anti-CMV, a few percent of which will transmit CMV-infection, with severe symptoms, to immunosuppressed patients without anti-CMV.

  15. [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.

  16. Design considerations in an active medical product safety monitoring system.

    PubMed

    Gagne, Joshua J; Fireman, Bruce; Ryan, Patrick B; Maclure, Malcolm; Gerhard, Tobias; Toh, Sengwee; Rassen, Jeremy A; Nelson, Jennifer C; Schneeweiss, Sebastian

    2012-01-01

    Active medical product monitoring systems, such as the Sentinel System, will utilize electronic healthcare data captured during routine health care. Safety signals that arise from these data may be spurious because of chance or bias, particularly confounding bias, given the observational nature of the data. Applying appropriate monitoring designs can filter out many false-positive and false-negative associations from the outset. Designs can be classified by whether they produce estimates based on between-person or within-person comparisons. In deciding which approach is more suitable for a given monitoring scenario, stakeholders must consider the characteristics of the monitored product, characteristics of the health outcome of interest (HOI), and characteristics of the potential link between these. Specifically, three factors drive design decisions: (i) strength of within-person and between-person confounding; (ii) whether circumstances exist that may predispose to misclassification of exposure or misclassification of the timing of the HOI; and (iii) whether the exposure of interest is predominantly transient or sustained. Additional design considerations include whether to focus on new users, the availability of appropriate active comparators, the presence of an exposure time trend, and the measure of association of interest. When the key assumptions of self-controlled designs are fulfilled (i.e., lack of within-person, time-varying confounding; abrupt HOI onset; and transient exposure), within-person comparisons are preferred because they inherently avoid confounding by fixed factors. The cohort approach generally is preferred in other situations and particularly when timing of exposure or outcome is uncertain because cohort approaches are less vulnerable to biases resulting from misclassification.

  17. The role of production and teamwork practices in construction safety: a cognitive model and an empirical case study.

    PubMed

    Mitropoulos, Panagiotis Takis; Cupido, Gerardo

    2009-01-01

    In construction, the challenge for researchers and practitioners is to develop work systems (production processes and teams) that can achieve high productivity and high safety at the same time. However, construction accident causation models ignore the role of work practices and teamwork. This study investigates the mechanisms by which production and teamwork practices affect the likelihood of accidents. The paper synthesizes a new model for construction safety based on the cognitive perspective (Fuller's Task-Demand-Capability Interface model, 2005) and then presents an exploratory case study. The case study investigates and compares the work practices of two residential framing crews: a 'High Reliability Crew' (HRC)--that is, a crew with exceptional productivity and safety over several years, and an average performing crew from the same company. The model explains how the production and teamwork practices generate the work situations that workers face (the task demands) and affect the workers ability to cope (capabilities). The case study indicates that the work practices of the HRC directly influence the task demands and match them with the applied capabilities. These practices were guided by the 'principle' of avoiding errors and rework and included work planning and preparation, work distribution, managing the production pressures, and quality and behavior monitoring. The Task Demand-Capability model links construction research to a cognitive model of accident causation and provides a new way to conceptualize safety as an emergent property of the production practices and teamwork processes. The empirical evidence indicates that the crews' work practices and team processes strongly affect the task demands, the applied capabilities, and the match between demands and capabilities. The proposed model and the exploratory case study will guide further discovery of work practices and teamwork processes that can increase both productivity and safety in construction

  18. 77 FR 22602 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-16

    ... Production Safety Training, Submitted for Office of Management and Budget (OMB) Review; Comment Request... inviting comments on a collection of information that we will submit to the Office of Management and Budget... paperwork requirements in the regulations under Subpart O, ``Well Control and Production Safety Training...

  19. 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 ``5...

  20. 77 FR 51912 - Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Tom Lyons Productions Fireworks, Long.... 165.T01-0618 to read as follows: Sec. 165.T01-0618 Safety Zone; Tom Lyons Productions Fireworks, Long...

  1. 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.

  2. Efficacy and safety of olmesartan medoxomil in patients with stage 1 hypertension: blood pressure lowering and goal achievement.

    PubMed

    Wilford Germino, F

    2010-11-01

    Hypertension is a known risk factor for cardiovascular events and mortality. The risk of cardiovascular events increases with age and is linear above 115/75 mm Hg. It also doubles for every 20/10-mm Hg elevation beyond this level and at every age level. Although guidelines vary somewhat by country, the seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure recommends a blood pressure (BP) goal of < 140/90 mm Hg for patients with uncomplicated hypertension and < 130/80 mm Hg for patients with type 2 diabetes mellitus (T2DM) or renal disease. Based on clinical evidence, patients with stage 1 hypertension (seated cuff systolic BP of 140-159 mm Hg or diastolic BP of 90-99 mm Hg) should be treated to targeted BP levels to reduce cardiovascular morbidity and mortality. The angiotensin II receptor blockers (ARBs) are well tolerated and demonstrate significant BP reduction. Olmesartan medoxomil (OM), an ARB, has been well studied and achieves significant BP lowering and goal achievement with good tolerability. Moreover, combination therapy comprising OM plus hydrochlorothiazide can significantly increase BP goal achievement without significantly increasing adverse events. This review evaluates clinical efficacy and safety data from 5 OM-based studies: 4 dose-titration studies and 1 factorial study. Study results demonstrate that OM ± hydrochlorothiazide is highly effective in reducing BP while enabling a majority of patients with stage 1 hypertension to achieve BP goal. In addition, OM tolerability data showed that the high achievement of BP goals was not attained at the expense of increased adverse events. This treatment is associated with low discontinuation rates, even in elderly patients and individuals with T2DM. The clinical data presented in this review support OM-based therapy as a rational and safe therapeutic option for patients with stage 1 hypertension.

  3. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

    PubMed

    2014-06-10

    The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

  4. Expert Consensus Statement on achieving self-sufficiency in safe blood and blood products, based on voluntary non-remunerated blood donation (VNRBD).

    PubMed

    2012-11-01

    All countries face challenges in making sufficient supplies of blood and blood products available and sustainable, while also ensuring the quality and safety of these products in the face of known and emerging threats to public health. Since 1975, the World Health Assembly (WHA) has highlighted the global need for blood safety and availability. WHA resolutions 63·12, 58·13 and 28·72, The Melbourne Declaration on 100% Voluntary Non-Remunerated Donation of Blood and Blood Components and WHO Global Blood Safety Network recommendations have reaffirmed the achievement of 'Self-sufficiency in blood and blood products based on voluntary non-remunerated blood donation (VNRBD)' as the important national policy direction for ensuring a safe, secure and sufficient supply of blood and blood products, including labile blood components and plasma-derived medicinal products. Despite some successes, self-sufficiency is not yet a reality in many countries. A consultation of experts, convened by the World Health Organization (WHO) in September 2011 in Geneva, Switzerland, addressed the urgent need to establish strategies and mechanisms for achieving self-sufficiency. Information on the current situation, and country perspectives and experiences were shared. Factors influencing the global implementation of self-sufficiency, including safety, ethics, security and sustainability of supply, trade and its potential impact on public health, availability and access for patients, were analysed to define strategies and mechanisms and provide practical guidance on achieving self-sufficiency. Experts developed a consensus statement outlining the rationale and definition of self-sufficiency in safe blood and blood products based on VNRBD and made recommendations to national health authorities and WHO. © 2012 World Health Organization. Vox Sanguinis © 2012 International Society of Blood Transfusion.

  5. 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.

  6. Achievement of thermal stability by varying metabolic heat production in flying honeybees.

    PubMed

    Harrison, J F; Fewell, J H; Roberts, S P; Hall, H G

    1996-10-04

    Thermoregulation of the thorax allows endothermic insects to achieve power outputs during flight that are among the highest in the animal kingdom. Flying endothermic insects, including the honeybee Apis mellifera, are believed to thermoregulate almost exclusively by varying heat loss. Here it is shown that a rise in air temperature from 20 degrees to 40 degrees C causes large decreases in metabolic heat production and wing-beat frequency in honeybees during hovering, agitated, or loaded flight. Thus, variation in heat production may be the primary mechanism for achieving thermal stability in flying honeybees, and this mechanism may occur commonly in endothermic insects.

  7. 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,"…

  8. Safety of the production process of SURFACEN(®) to inactivate and remove virus.

    PubMed

    Sánchez, Yordank; Noa, Enrique; Alfonso, Wilma; Dubed, Marta; Alvarez, Giselle; Navea, Leonor; Montes de Oca, Nivian; Lobaina, Leonor; Díaz, Elaine

    2013-07-01

    SURFACEN(®) is a biological product produced from pig lungs. Since these animals can be potential sources of microbial pathogens such as viruses, the manufacturing process of this product should guarantee safety from health hazards. The SURFACEN(®) production procedure is capable of effective viral clearance (inactivation/removal) by involving two stages of organic solvent extraction followed by acetone precipitation and heat treatment. In this study, we evaluated the clearance capacity of these four stages for a wide range of viruses by performing spiking experiments. Residual contamination was assessed using a Tissue Culture Infectious Dose assay (log10 TCID50). The validation study demonstrated that, for all viruses tested, the TCID50 titers were reduced by more than 2 log10 in each stage. Total log reduction values achieved were between ≥17.82 log10 and ≥27.93 log10, depending on the virus physical properties, titer, and the number of processing stages applied. Results indicated that the production procedure of SURFACEN(®) can inactivate or remove contaminant viruses from the raw material.

  9. Three studies testing the effects of role models on product users' safety behavior.

    PubMed

    deTurck, M A; Chih, I H; Hsu, Y P

    1999-09-01

    Three studies were conducted to determine the effect of a role model's safety behavior on observers' safety behavior. In Studies 1 and 2, role models (confederates) used a cleaning product requiring them to wear safety gloves. Study 1 examined observers' safety behavior after they witnessed a friendly (unfriendly) role model's safety behavior in one of four conditions: 1) wearing rubber gloves, 2) not wearing rubber gloves and experiencing no chemical burn, 3) not wearing rubber gloves and experiencing a mild chemical burn, and 4) not wearing rubber gloves and experiencing a severe chemical burn. In Study 2, participants tested a cleaning product with a warning message (low hazard vs. high hazard) after observing a role model first test the cleaning product in one of the four conditions specified above. As predicted, in Studies 1 and 2, observers were influenced by the role model's safety behavior. However, the friendliness of the role model (Study 1) and level of hazard (Study 2) communicated in the warning message did not influence participants' safety behavior. Using an over-the-counter pain reliever, Study 3 tested the joint effects of: 1) the level of hazard communicated in the warning, 2) observers' outcome-relevant involvement, and 3) role model's compliance. Although the level of hazard communicated in the warning exerted no impact on observers' safety compliance, the role model's safety behavior and level of involvement jointly influenced observers' safety behavior. The implications of the findings and future research directions are discussed. Actual or potential applications of the research include, but are not limited to, using role models in warning messages and safety training programs to demonstrate the proper use of safety gear so as to enhance product users' compliance with safety recommendations.

  10. 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…

  11. 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…

  12. Safety Parameter Management in Astrium Based on Ranking of Product Characteristics Process

    NASA Astrophysics Data System (ADS)

    Meredith, Laurence; Magnin, Cedric

    2013-09-01

    Economic constraints are one of the major drivers in systems development. Because safety is a major constraint that cannot be neglected, industries must find a way to build safe designs without overdesign or superfluous activities and costs.The purpose is to provide sufficient effort on actual safety critical items and not to waste effort (time and money).Via its multi-systems experience in space transportation, space vehicles and satellites, ASTRIUM has developed dedicated processes to optimize safety costs without decreasing the level of safety of its systems.The process is based on an iterative and exhaustive identification of items involved in systems safety thanks to risk analysis right from the beginning of the projects. Safety critical items and their parameters/characteristics that contribute to potential safety issues are ranked depending on the criticality of their failures and their probability of occurrence and these are then treated through the dedicated safety process. Referred to as Ranking Of Product Characteristics (ROPC) in ASTRIUM SPACE TRANSPORTATION or safety Critical Items management in ASTRIUM SA TELLITE, the different terms reflect primarily the divergence between types of safety critical items present on a space vehicle or on a satellite.Each identified safety parameter of a given element of a system is earmarked as such throughout the design, manufacturing, supply, assembly, anomaly control... and end usage and maintenance of the systems. Safety characteristics are controlled and monitored at each step of the development through dedicated checks, keypoints and tests until its last possible test and maintenance plan. The process also deals with systems evolutions and safety non regression. It ensures safety of a system through analysis but also actually verifies that the design is compliant to specified safety parameters: safety built as specified without extra costs due to emphasis put on non-critical parameters.

  13. 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

  14. [Demonstration of quality, safety and efficacy of biological products subject to changes in their manufacturing process].

    PubMed

    Vasil'ev, A N; Gavrishina, E V; Niiazov, R R; Snegireva, A A; Adonin, V K

    2013-01-01

    Ensuring quality, safety and efficacy of the medicinal products placed on the market of the Russian Federation constitutes the area that requires strict regulation. When changes are made to the manufacturing process, the manufacturer generally needs to evaluate the relevant quality attributes of the product to demonstrate that modifications did not occur that would adversely impact the safety and efficacy of the drug. Where there is the lack of a sound legal basis, there is a need in harmonization of current Russian legislation with international and European rules governing medicinal product for human use to ensure quality, safety and efficacy thereof.

  15. Relevance of UV filter/sunscreen product photostability to human safety.

    PubMed

    Nash, J Frank; Tanner, Paul R

    2014-01-01

    Photostability or photo-instability of sunscreen products is most often discussed in undesirable terms with respect to human safety. The health risks, specifically associated with sunscreens, photostable or photo-unstable, include phototoxic/photoirritation or photoallergic responses and, longer-term, an increased risk of skin cancers or photoageing. The aims of this paper are to define photostability/photo-instability and objectively assess the acute and chronic toxicological consequences from the human exposure to UV filter/sunscreens and any probable photo-degradation products. The reported prevalence of photoirritation and photoallergic responses to sunscreens is rare compared with adverse events, for example, skin irritation or sensitization, produced by cosmetics or topically applied drugs and do not directly implicate potential photo-degradation products of UV filters. Moreover, for at least one photo-unstable combination, octyl methoxycinnamate and avobenzone, the long-term benefits to humans, i.e., reduction in skin cancers, seem to outweigh any potential adverse consequences attributed to photo-degradation. Sunscreen products are formulated to achieve maximum efficacy which, by necessity and design, incorporate measures to support and promote photostability since all organic UV filters have the potential to photo-degrade. Current performance measures, in vivo SPF and in vitro UVA, conducted under standardized conditions, in part account for photostability. The concerns expressed when considering human exposure to potential photo-unstable UV filters or sunscreen products may not manifest as health risks under conditions of use. Still, improvement in sunscreen product photostability continues to be a key strategic objective for manufacturers. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  16. 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.

  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, 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. A...

  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, 2010 CFR

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 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. A...

  19. Design of agricultural product quality safety retrospective supervision system of Jiangsu province

    NASA Astrophysics Data System (ADS)

    Wang, Kun

    2017-08-01

    In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

  20. Production of particulates from transducer erosion: implications on food safety.

    PubMed

    Mawson, Raymond; Rout, Manoj; Ripoll, Gabriela; Swiergon, Piotr; Singh, Tanoj; Knoerzer, Kai; Juliano, Pablo

    2014-11-01

    The formation of metallic particulates from erosion was investigated by running a series of transducers at various frequencies in water. Two low frequency transducer sonotrodes were run for 7.5h at 18kHz and 20kHz. Three high frequency plates operating at megasonic frequencies of 0.4MHz, 1MHz, and 2MHz were run over a 7days period. Electrical conductivity and pH of the solution were measured before and after each run. A portion of the non-sonicated and treated water was partially evaporated to achieve an 80-fold concentration of particles and then sieved through nano-filters of 0.1μm, 0.05μm, and 0.01μm. An aliquot of the evaporated liquid was also completely dried on strips of carbon tape to determine the presence of finer particles post sieving. An aliquot was analyzed for detection of 11 trace elements by Inductively Coupled Plasma Mass Spectroscopy (ICPMS). The filters and carbon tapes were analyzed by FE-SEM imaging to track the presence of metals by EDS (Energy Dispersive Spectroscopy) and measure the particle size and approximate composition of individual particles detected. Light microscopy visualization was used to calculate the area occupied by the particles present in each filter and high resolution photography was used for visualization of sonotrode surfaces. The roughness of all transducers before and after sonication was tested through profilometry. No evidence of formation of nano-particles was found at any tested frequency. High amounts of metallic micron-sized particles at 18kHz and 20kHz formed within a day, while after 7day runs only a few metallic micro particles were detected above 0.4MHz. Erosion was corroborated by an increase in roughness in the 20kHz tip after ultrasound. The elemental analysis showed that metal leach occurred but values remained below accepted drinking water limits, even after excessively long exposure to ultrasound. With the proviso that the particles measured here were only characterized in two dimensions and could be

  1. Feasibility and safety of temporary subcutaneous venous figure-of-eight suture to achieve haemostasis after ablation of atrial fibrillation.

    PubMed

    Traullé, Sarah; Kubala, Maciej; Doucy, Alexandre; Quenum, Serge; Hermida, Jean-Sylvain

    2016-06-01

    This prospective study was carried out to assess the feasibility and safety of venous figure-of-eight suture to achieve haemostasis after atrial fibrillation (AF) ablation. Consecutive patients who underwent catheter ablation of AF were prospectively enrolled from February 2012 to September 2013. At the end of the procedure, a temporary subcutaneous 'Figure-of-eight' suture technique was used to achieve haemostasis. Anticoagulation strategy evolved during the study. Initially, vitamin K antagonists (VKAs) were stopped and replaced by administration of low-molecular-weight heparin. It was subsequently decided to perform these procedures without stopping VKA. With the arrival of direct oral anticoagulants (DOACs), it was decided to miss the evening dose before the procedure. One hundred and twenty-four patients were included. Seventy-three per cent of patients were male, and the mean age was 58 ± 10 years old. One hundred and twelve patients (90%) experienced paroxysmal AF and were treated by cryotherapy with the use of a 15 Fr outer diameter Flexcath Advance sheath. The 'Figure-of-eight' suture technique was able to be performed in all patients and was sufficient in 114 patients. Mechanical external compression was required for 10 patients. Three patients developed a haematoma. The overall incidence of haematoma was therefore 2.4%. Figure-of-eight suture is a fast closure technique that can be used as an efficient alternative to usual compression methods to prevent bleeding during high-intensity anticoagulation and the use of large-diameter venous sheaths and multiple femoral venous accesses. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  2. 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…

  3. 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.

  4. Using high-dimensional propensity scores to automate confounding control in a distributed medical product safety surveillance system.

    PubMed

    Rassen, Jeremy A; Schneeweiss, Sebastian

    2012-01-01

    Distributed medical product safety monitoring systems such as the Sentinel System, to be developed as a part of Food and Drug Administration's Sentinel Initiative, will require automation of large parts of the safety evaluation process to achieve the necessary speed and scale at reasonable cost without sacrificing validity. Although certain functions will require investigator intervention, confounding control is one area that can largely be automated. The high-dimensional propensity score (hd-PS) algorithm is one option for automated confounding control in longitudinal healthcare databases. In this article, we discuss the use of hd-PS for automating confounding control in sequential database cohort studies, as applied to safety monitoring systems. In particular, we discuss the robustness of the covariate selection process, the potential for over- or under-selection of variables including the possibilities of M-bias and Z-bias, the computation requirements, the practical considerations in a federated database network, and the cases where automated confounding adjustment may not function optimally. We also outline recent improvements to the algorithm and show how the algorithm has performed in several published studies. We conclude that despite certain limitations, hd-PS offers substantial advantages over non-automated alternatives in active product safety monitoring systems.

  5. 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.

  6. 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)

  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. 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.

  9. 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.

  10. Preclinical safety testing for cell-based products using animals.

    PubMed

    McBlane, James W

    2015-09-01

    The objectives of preclinical testing include to show why there might be therapeutic benefit in patients and to provide information on the product's toxicity. For cell-based products, given even once, there may be long term exposure and this could imply, unlike for conventional drugs, that all preclinical studies may be needed prior to first human use. The duration of exposure to cells should be studied in animals to guide toxicity assessments. Distribution of cells after administration by a route resembling that intended in humans should be studied to understand potential risks. Risk of tumour formation with the product may also need to be characterised. To the extent that this information can be generated by in vitro testing, studies in animals may not be needed and limitations on the capability of preclinical data to predict human toxicity are recognised: species-specificity make some cell products act only in humans and a human cell-product might be expected to be rejected by immunocompetent animals. Does this suggest testing in immunosuppressed animals or of development of an animal-cell product supposedly similar to the human cell product? No single answer seems to fit every situation. Copyright © 2015.

  11. Managing occupational safety and health in aluminum production: case study of aluminum production factory, Mostar, Bosnia and Herzegovina.

    PubMed

    Doko Jelinic, Jagoda; Mustajbegovic, Jadranka; Zuskin, Eugenija; Lukic, Jela; Cavar, Velimir; Ivankovic, Ante

    2005-10-01

    To assess the effect of modernization of the aluminium production on physical and chemical health hazards at work environment in the Aluminium Mostar factory. The modernization included introduction of automatic equipment, computerized management, and rationalized coke manipulation in Anoda, Electrolysis, and Cast House plants. Periodical measurements of chemical (gas concentrations and aerosols) and physical (microclimatic factors, noise, and illumination) factors were performed at the same workplaces by the same methods of measurements before (1982-1988) and after the modernization (2004). The measured values were compared with the recommended Occupational Safety and Health Standards of Bosnia and Herzegovina. The number of workplaces with a high noise level was reduced from 65.0% (89/137) in 1982-1988 to 28.7% (51/178) in 2004. The best results were achieved in Cast House plant. The illumination of the workplace was partly improved. Values of microclimatic factors did not considerably change; they deviated from the recommended values at nearly all the workplaces in the factory. The concentrations of chemical agents were above the recommended standards in 56.3% (196/348) of the samples in 1982-1988, and in only 15.4% (99/645) of the samples tested in 2004. High concentrations of hydrogen fluoride have remained the primary pollutant in Electrolysis plant. The modernization of the factory has considerably reduced the amount of harmful substances at work environment in the Aluminum Mostar. However, the exposure to unfavorable physical factors has been only partly reduced.

  12. High Performing Schools in High Risk Environments: A Study on Leadership, School Safety, and Student Achievement at Two Urban Middle Schools in Los Angeles County

    ERIC Educational Resources Information Center

    Frias, Gus

    2010-01-01

    In the United States of America, all students and staff have a constitutional right to attend schools that are safe, secure, and successful. Despite this right, at many public schools, education leaders have failed to ensure the safety and high academic achievement of all students. The purpose of this research study is to expand knowledge about…

  13. High Performing Schools in High Risk Environments: A Study on Leadership, School Safety, and Student Achievement at Two Urban Middle Schools in Los Angeles County

    ERIC Educational Resources Information Center

    Frias, Gus

    2010-01-01

    In the United States of America, all students and staff have a constitutional right to attend schools that are safe, secure, and successful. Despite this right, at many public schools, education leaders have failed to ensure the safety and high academic achievement of all students. The purpose of this research study is to expand knowledge about…

  14. [Product safety analysis of somatic cell cloned bovine].

    PubMed

    Hua, Song; Lan, Jie; Song, Yongli; Lu, Chenglong; Zhang, Yong

    2010-05-01

    Somatic cell cloning (nuclear transfer) is a technique through which the nucleus (DNA) of a somatic cell is transferred into an enucleated oocyte for the generation of a new individual, genetically identical to the somatic cell donor. It could be applied for the enhancement of reproduction rate and the improvement of food products involving quality, yield and nutrition. In recent years, the United States, Japan and Europe as well as other countries announced that meat and milk products made from cloned cattle are safe for human consumption. Yet, cloned animals are faced with a wide range of health problems, with a high death rate and a high incidence of disease. The precise causal mechanisms for the low efficiency of cloning remain unclear. Is it safe that any products from cloned animals were allowed into the food supply? This review focuses on the security of meat, milk and products from cloned cattle based on the available data.

  15. 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. Copyright © 2013 Elsevier Ltd. All rights reserved.

  16. Technique of an Assessment of Industrial Safety of Paint and Varnish Productions

    NASA Astrophysics Data System (ADS)

    Omelchenko, E. V.; Trushkova, E. A.; Pushenko, S. L.; Sitnik, S. V.; Firsov, V. A.

    2017-05-01

    In article the technique of an assessment and the analysis of industrial safety of paint and varnish productions is described, the main measures of prevention, the main reasons for traumatism and action for decrease in risks of influence of dangerous and harmful production factors on workers are given.

  17. 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…

  18. 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…

  19. 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...

  20. Safety testing of cell-based medicinal products: opportunities for the monocyte activation test for pyrogens.

    PubMed

    Montag, Thomas; Spreitzer, Ingo; Löschner, Bettina; Unkelbach, Uwe; Flory, Egbert; Sanzenbacher, Ralf; Schwanig, Michael; Schneider, Christian K

    2007-01-01

    The European Partnership for Alternative Approaches to Animal Testing (EPAA) pointed out the need to involve authorities throughout the process of validation and legal acceptance of alternatives to animal experiments. The Paul-Ehrlich-Institute (PEI), Federal Agency for Sera and Vaccines, is the national competent authority in Germany which is responsible for the quality and safety of biologicals including blood and cell-based products. This paper is intended to contribute to the discussion concerning the use of alternative methods in safety testing of medicinal products and considers the scientific work of the PEI in this field. From a regulator's perspective, adequate demonstration of safety and quality of medicinal products are of major interest. Additionally, the availability of the products to the patient has to be taken into consideration. It has to be carefully explored whether the respective in vitro method for demonstration of non-clinical safety as part of the non-clinical development programme is able to guarantee safety level comparable to the corresponding experiment in animals. The topics cited above shall be discussed in this paper using the example of the Alternative Pyrogen Test or also called Monocyte Activation Test. The Alternative Pyrogen Test could serve as paradigm to exemplify how an alternative test can provide at least a comparable level of safety estimation in comparison with a conventional animal test. Furthermore, this alternative test creates additional information which cannot be obtained from the animal experiment, and might also open further scientific insight into the mechanisms of pyrogenicity and acute pro-inflammatory reactions in patients. This test method allows the definition of pyrogen limits for medicinal products. Due to its use of relevant cell systems this in vitro test might contribute significantly to safety assessments of advanced medicinal products during the pre-clinical phase.

  1. 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.

  2. Systems metabolic engineering of microorganisms to achieve large-scale production of flavonoid scaffolds.

    PubMed

    Wu, Junjun; Du, Guocheng; Zhou, Jingwen; Chen, Jian

    2014-10-20

    Flavonoids possess pharmaceutical potential due to their health-promoting activities. The complex structures of these products make extraction from plants difficult, and chemical synthesis is limited because of the use of many toxic solvents. Microbial production offers an alternate way to produce these compounds on an industrial scale in a more economical and environment-friendly manner. However, at present microbial production has been achieved only on a laboratory scale and improvements and scale-up of these processes remain challenging. Naringenin and pinocembrin, which are flavonoid scaffolds and precursors for most of the flavonoids, are the model molecules that are key to solving the current issues restricting industrial production of these chemicals. The emergence of systems metabolic engineering, which combines systems biology with synthetic biology and evolutionary engineering at the systems level, offers new perspectives on strain and process optimization. In this review, current challenges in large-scale fermentation processes involving flavonoid scaffolds and the strategies and tools of systems metabolic engineering used to overcome these challenges are summarized. This will offer insights into overcoming the limitations and challenges of large-scale microbial production of these important pharmaceutical compounds.

  3. 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.

  4. Analysis the Changes of the NGL Product Pipe Safety in the Process of Operation

    NASA Astrophysics Data System (ADS)

    Berg, V. I.; Petryakov, V. A.; Brand, A. E.

    2017-01-01

    The paper presents to analyze the changes of the NGL product pipe safety in the process of operation. In the article the analysis and to mathematically calculated the margin of safety and durability according to change thickness of pipeline. The study of analysis the accident conditions risks during the pipeline operation have shown that such measure as the pipe wall thickness increase is appropriate. The proposed conditions on the application of the obtained results.

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

    USDA-ARS?s Scientific Manuscript database

    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...

  6. 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.

  7. The First Global Patient Safety Challenge "Clean Care is Safer Care": from launch to current progress and achievements.

    PubMed

    Allegranzi, Benedetta; Storr, Julie; Dziekan, Gerald; Leotsakos, Agnès; Donaldson, Liam; Pittet, Didier

    2007-06-01

    Healthcare-associated infection is a major safety issue affecting the quality of care of hundreds of millions of patients every year in both developed and developing countries. To meet the goal of ensuring patient safety across healthcare settings around the globe, the World Health Organization launched the World Alliance for Patient Safety in October 2004. Healthcare-associated infections were identified as a fundamental work priority and selected as the topic of the First Global Patient Safety Challenge launched by the Alliance. Under the banner "Clean Care is Safer Care", the Challenge aims at implementing several actions to reduce healthcare-associated infections worldwide, regardless of the level of development of healthcare systems and the availability of resources. Implementation strategies include the integration of multiple interventions in the areas of blood safety, injection safety, clinical procedure safety, and water, sanitation and waste management, with the promotion of hand hygiene in healthcare as the cornerstone. Several initiatives have been undertaken to raise global awareness and to obtain country commitment to support action on this issue. The new Guidelines on Hand Hygiene in Health Care, including the most consistent scientific evidence available, have been issued in an advanced draft form. An implementation strategy is proposed therein to provide solutions to overcome obstacles to improvement in compliance with hand hygiene practices, together with a range of practical tools for use in healthcare settings. The latter are currently undergoing testing in several pilot sites to evaluate feasibility, acceptability and sustainability.

  8. Patient information on drug therapy. A problem of medical malpractice law: between product safety and user safety.

    PubMed

    Hart, Dieter

    2007-04-01

    Medicinal products are associated with risks as well as potential therapeutic benefits. This is reflected by the legal requirements for patient information on drug therapy which can be differentiated into general product information, regulated by pharmaceutical (i. e. product safety) law, and individual patient information on the treatment with the product, which is subject to medical malpractice law. The physician's duty to inform the patient comprises therapeutic information as well as information required for informed consent. Therapeutic information intends to empower the patient to comply with the requirements of treatment and to protect him/her against preventable danger and risk; it is part of the medical treatment, aimed at the individual patient and his/her personal situation. Information required for informed consent enables the patient to a self-determined decision on the treatment offered; it can be divided into information on the course of treatment and risk information. Product information and treatment information complement each other; the former should be the basis of individual information on the concrete treatment, provided by the physician in a mandatory oral conversation with the patient. Product information cannot replace the physician's individual information about the treatment.

  9. [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.

  10. Safety pharmacology in the nonclinical assessment of new medicinal products: definition, place, interest and difficulties.

    PubMed

    Claude, Jean-Roger

    2002-04-01

    Until the year 2000 there was no internationally-accepted definition for the terms used in nonclinical pharmacology (primary, secondary pharmacodynamics, discovery, safety pharmacology, etc). Now, after ICH5 (San Diego, November 2000), a harmonisation of the nomenclature is adopted: safety pharmacology is defined as the studies that investigate the potential undesirable pharmacodynamic effects of a medicinal product on physiological functions in relationship to exposure. Consequently, safety pharmacology studies are a part of the safety assessment for a new product, in the same way than toxicological studies, and a basic battery of tests (core battery) has to be conducted prior to the first administration to humans. Safety pharmacology studies are of peculiar interest: they show a good predictive potential for humans, they do not require a large number of laboratory animals, long-term studies, large amount of products and they are more dynamic and more flexible than toxicological studies. Nevertheless, many difficulties occur for the implementation in industry, related to practical and/or scientific problems: location of the studies, routine activity for the pharmacologists, sometimes difficulties in the relationship between toxicologists and pharmacologists, adaptation to the GLP requirements, elaboration of an early relevant scientific programme, necessity to go to contract-labs or to academic research for unusual or for up to date methods, etc. To conclude, a retrospective timetable of the regulatory evolution for the last 10 years will be provided, as an illustration of the worldwide progress in the concept of 'harmonisation' for the assessment of new medicinal products.

  11. [Application of Raman Spectroscopy Technique to Agricultural Products Quality and Safety Determination].

    PubMed

    Liu, Yan-de; Jin, Tan-tan

    2015-09-01

    The quality and safety of agricultural products and people health are inseparable. Using the conventional chemical methods which have so many defects, such as sample pretreatment, complicated operation process and destroying the samples. Raman spectroscopy as a powerful tool of analysing and testing molecular structure, can implement samples quickly without damage, qualitative and quantitative detection analysis. With the continuous improvement and the scope of the application of Raman spectroscopy technology gradually widen, Raman spectroscopy technique plays an important role in agricultural products quality and safety determination, and has wide application prospects. There have been a lot of related research reports based on Raman spectroscopy detection on agricultural product quality safety at present. For the understanding of the principle of detection and the current development situation of Raman spectroscopy, as well as tracking the latest research progress both at home and abroad, the basic principles and the development of Raman spectroscopy as well as the detection device were introduced briefly. The latest research progress of quality and safety determination in fruits and vegetables, livestock and grain by Raman spectroscopy technique were reviewed deeply. Its technical problems for agricultural products quality and safety determination were pointed out. In addition, the text also briefly introduces some information of Raman spectrometer and the application for patent of the portable Raman spectrometer, prospects the future research and application.

  12. 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.

  13. Evaluating Product-Related Hazards at the Consumer Product Safety Commission: The Case of All-Terrain Vehicles.

    ERIC Educational Resources Information Center

    Rodgers, Gregory B.

    1990-01-01

    Application of multivariate qualitative response models, such as logit regression models, to analysis of risks of all-terrain vehicles is discussed. Data are from national exposure and injury surveys and records of fatalities of the Consumer Product Safety Commission. Suggestions are made for further applications of the method. (SLD)

  14. 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.

  15. Safety aspects of the production of foods and food ingredients from insects.

    PubMed

    Schlüter, Oliver; Rumpold, Birgit; Holzhauser, Thomas; Roth, Angelika; Vogel, Rudi F; Quasigroch, Walter; Vogel, Stephanie; Heinz, Volker; Jäger, Henry; Bandick, Nils; Kulling, Sabine; Knorr, Dietrich; Steinberg, Pablo; Engel, Karl-Heinz

    2017-06-01

    At present, insects are rarely used by the European food industry, but they are a subject of growing interest as an alternative source of raw materials. The risks associated with the use of insects in the production of foods and food ingredients have not been sufficiently investigated. There is a lack of scientifically based knowledge of insect processing to ensure food safety, especially when these processes are carried out on an industrial scale. This review focuses on the safety aspects that need to be considered regarding the fractionation of insects for the production of foods and food ingredients. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  16. Survey among agricultural workers about interpretation of plant protection product labels and safety data sheets.

    PubMed

    Rubbiani, Maristella

    2010-01-01

    The objective of this work was to examine the effectiveness of risk communication in agriculture through examination and interpretation of safety data sheets and product labels for agriculture products classified as hazardous. Labels and safety data sheets were shown to the users inviting them to report their own interpretation of hazard, risk and the need of preventive measures. One area sample was identified in a cluster of wine companies, chosen in a range of medium to large sizes throughout the country, where 100 subjects were interviewed by telephone or direct interview. Participants were surveyed through questions relating to demographic information, education and perception of risk.

  17. 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.

  18. 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.

  19. 76 FR 6765 - Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... (``Bicycles and Related Products'') designed or intended primarily for children 12 years of age or younger. 74... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION Consumer Product Safety Act: Notice of Commission Action on the Stay of Enforcement of Testing...

  20. 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

    ... August 14, 2009, products designed or intended primarily for children 12 and younger cannot contain more... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section 1500.88 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES...

  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.

  2. Benchmarking road safety of U.S. states: a DEA-based Malmquist productivity index approach.

    PubMed

    Egilmez, Gokhan; McAvoy, Deborah

    2013-04-01

    In this study, a DEA based Malmquist index model was developed to assess the relative efficiency and productivity of U.S. states in decreasing the number of road fatalities. Even though the national trend in fatal crashes has reached to the lowest level since 1949 (Traffic Safety Annual Assessment Highlights, 2010), a state-by-state analysis and comparison has not been studied considering other characteristics of the holistic national road safety assessment problem in any work in the literature or organizational reports. In this study, a DEA based Malmquist index model was developed to assess the relative efficiency and productivity of 50 U.S. states in reducing the number of fatal crashes. The single output, fatal crashes, and five inputs were aggregated into single road safety score and utilized in the DEA-based Malmquist index mathematical model. The period of 2002-2008 was considered due to data availability for the inputs and the output considered. According to the results, there is a slight negative productivity (an average of -0.2 percent productivity) observed in the U.S. on minimizing the number of fatal crashes along with an average of 2.1 percent efficiency decline and 1.8 percent technological improvement. The productivity in reducing the fatal crashes can only be attributed to the technological growth since there is a negative efficiency growth is occurred. It can be concluded that even though there is a declining trend observed in the fatality rates, the efficiency of states in utilizing societal and economical resources towards the goal of zero fatality is not still efficient. More effective policy making towards increasing safety belt usage and better utilization of safety expenditures to improve road condition are derived as the key areas to focus on for state highway safety agencies from the scope of current research.

  3. 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.

  4. 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

  5. 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.

  6. Tracking the Market Performance of Companies That Integrate a Culture of Health and Safety: An Assessment of Corporate Health Achievement Award Applicants.

    PubMed

    Fabius, Raymond; Loeppke, Ronald R; Hohn, Todd; Fabius, Dan; Eisenberg, Barry; Konicki, Doris L; Larson, Paul

    2016-01-01

    The aim of this study was to assess the hypothesis that stock market performance of companies achieving high scores on either health or safety in the Corporate Health Achievement Award (CHAA) process will be superior to average index performance. The stock market performance of portfolios of CHAA winners was examined under six different scenarios using simulation and past market performance in tests of association framed to inform the investor community. CHAA portfolios out-performed the S&P average on all tests. This study adds to the growing evidence that a healthy and safe workforce correlates with a company's performance and its ability to provide positive returns to shareholders. It advances the idea that a proven set of health and safety metrics based on the CHAA evaluation process merits inclusion with existing measures for market valuation.

  7. The content of the message matters: The differential effects of promotive and prohibitive team voice on team productivity and safety performance gains.

    PubMed

    Li, Alex Ning; Liao, Hui; Tangirala, Subrahmaniam; Firth, Brady M

    2017-08-01

    We propose that it is important to take the content of team voice into account when examining its impact on team processes and outcomes. Drawing on regulatory focus theory (Higgins, 1997), we argue that promotive team voice and prohibitive team voice help teams achieve distinct collective outcomes-that is, team productivity performance gains and team safety performance gains, respectively. Further, we identify mechanisms through which promotive and prohibitive team voices uniquely influence team outcomes as well as boundary conditions for such influences. In data collected from 88 production teams, we found that promotive team voice had a positive association with team productivity performance gains. By contrast, prohibitive team voice had a positive association with team safety performance gains. The relationship between promotive team voice and team productivity performance gains was mediated by team innovation, and the relationship between prohibitive team voice and team safety performance gains was mediated by team monitoring. In addition, the indirect effect of prohibitive team voice on team safety performance gains via team monitoring was stronger when prior team safety performance was lower. We discuss the theoretical and practical implications of these findings. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  8. 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.

  9. 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…

  10. The development of product parity sensitivity in children with mathematics learning disability and in typical achievers.

    PubMed

    Rotem, Avital; Henik, Avishai

    2013-02-01

    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 the onset of parity sensitivity was observed at the beginning of 3rd grade, whereas in children with MLD it was documented only in 8th grade. These results suggest that children with MLD develop parity aspects of number sense, though later than TA children. To check the plausibility of equations, children used mainly the multiplication parity rule rather than familiarity with even products. Similar to observations in adults, parity sensitivity was largest for problems with two even operands, moderate for problems with one even and one odd operand, and smallest for problems with two odd operands. Copyright © 2012 Elsevier Ltd. All rights reserved.

  11. Device for controlling a safety valve disposed below an activation pump in a hydrocarbon production well

    SciTech Connect

    Lefebvre, H. M.; Helderle, P. M.

    1985-05-21

    In a hydrocarbon production well in which the effluent is activated by an activation pump installed in a production pipe, a safety valve is disposed in the production pipe below the pump, the safety valve being operated by lowering of an operating member by a controlling device. The controlling device comprises a piston and cylinder system, and connection means connecting the piston to the operating member during the downward movement of the piston. The cylinder and piston system is provided at the level of the pump, and is advantageously constituted by the production pipe and pump respectively, so that pressurized fluid present at the level of the pump will cause downward movement of the piston.

  12. Quality and safety aspects of meat products as affected by various physical manipulations of packaging materials.

    PubMed

    Lee, Keun Taik

    2010-09-01

    This article explores the effects of physically manipulated packaging materials on the quality and safety of meat products. Recently, innovative measures for improving quality and extending the shelf-life of packaged meat products have been developed, utilizing technologies including barrier film, active packaging, nanotechnology, microperforation, irradiation, plasma and far-infrared ray (FIR) treatments. Despite these developments, each technology has peculiar drawbacks which will need to be addressed by meat scientists in the future. To develop successful meat packaging systems, key product characteristics affecting stability, environmental conditions during storage until consumption, and consumers' packaging expectations must all be taken into consideration. Furthermore, the safety issues related to packaging materials must also be taken into account when processing, packaging and storing meat products.

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

    NASA Astrophysics Data System (ADS)

    Skoog, A. Ingemar; Berthier, S.; Ollivier, Y.

    In order to fulfil 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 from, 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 incressed 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.

  14. The National Shipbuilding Research Program. 1997 Ship Production Symposium, Paper Number 7: Physiological Factors Affecting Quality and Safety in Production Environment

    DTIC Science & Technology

    1997-04-01

    1997 Ship Production Symposium Paper No. 7: Physiological Factors Affecting Quality And Safety In Production Environment U.S. DEPARTMENT OF THE NAVY...Research Program 1997 Ship Production Symposium, Paper No. 7: Physiological Factors Affecting Quality And Safety in Production Environment 5a...Paper presented at the 1997 Ship Production Symposium, April 21-23, 1997 New Orleans Hilton Hotel, New Orleans, Louisiana Physiological Factors

  15. 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…

  16. 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... system in lieu of a water system. BSEE may require additional information be submitted to maintain approval. The information is used to determine if the chemical-only system provides the...

  17. 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

    ... 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 to...''). The Web conferences will be webcast live from the Commission's headquarters in Bethesda, MD via the...

  18. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... ENFORCEMENT, DEPARTMENT OF THE INTERIOR OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production Safety Systems § 250.802 Design, installation, and operation of surface... installation features shall be maintained by the lessee at the lessee's offshore field office nearest the OCS...

  19. 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

    ... of Calibrating Units for Breath Alcohol Testers AGENCY: National Highway Traffic Safety... conform to the Model Specifications for Calibrating Units for Breath Alcohol Tester (CUs) dated, June 25...) published a standard for Calibrating Units for Breath Alcohol Testers. A Qualified Products List of...

  20. [Specific aspects for virus safety of raw materials for cellular-based medicinal products].

    PubMed

    Stühler, Albert; Blümel, J

    2015-11-01

    Virus safety of cell-based medicinal products is a particular challenge. These products are frequently manufactured using various human- or animal-derived starting and raw materials (serum and feeder-cells) in cell culture, which are possible sources for viral contamination. For living or proliferating cells, no methods for virus inactivation (such as heat or chemical treatment) can be used and the options for testing these medicinal products for all possible viral contaminations are very limited. As a consequence, other safety measures, in particular careful selection and testing of starting and raw materials, are very important. For raw materials, attention should be paid to cell-culture additives of biological origin, such as human and bovine serum and porcine trypsin. Whenever possible, manufacturing steps for inactivation and removal of viruses should be introduced as an additional safety measure. In addition, recombinant products from animal cell cultures (such as growth factors, monoclonal antibodies for cell sorting, viral vectors) are used and have to be tested for virus safety.

  1. 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

    ...The Consumer Product Safety Commission (CPSC or we), in accordance with section 743(c) of Division C of the Consolidated Appropriations Act, 2010 (Pub. L. 111-117, 123 Stat. 3034, 3216), is announcing the availability of CPSC's service contract inventory for fiscal year (FY) 2012. This inventory provides information on service contract actions over $25,000 that CPSC made in FY 2012.

  2. Investigating the Chemical Safety of Household Products. Teacher's Guide [and] Student Materials.

    ERIC Educational Resources Information Center

    Davison, Phil J.

    This document provides teaching guidelines and student material for a unit intended for use in high school science or consumer programs. Time allotment is from four to six hours of classroom time. The objective of this capsule is to investigate the chemical safety of household products by teaching students how to form a hypothesis through the…

  3. Impact of Investment in Education and Training on Performance in Production, Quality and Safety.

    ERIC Educational Resources Information Center

    Williams, J. Fred; Robinson-Horne, Jacquelyn P.

    This paper reports on a study that sought to determine the relationships between investment in education and training and performance in production, quality, and safety in manufacturing companies in northeast Alabama and northwest Georgia. The study also examined whether company size was a factor in predicting the ratio of the investment. One…

  4. Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2008-01-24

    Such shipments will be detained until they are proven to be free of contaminants . The National Highway Traffic Safety Administration (NHTSA) in June...in March 2007 issued warnings and announced voluntary recalls on certain pet foods (or products such as rice protein concentrate and wheat gluten

  5. 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…

  6. Clinical efficacy and safety of achieving very low LDL-cholesterol concentrations with the PCSK9 inhibitor evolocumab: a prespecified secondary analysis of the FOURIER trial.

    PubMed

    Giugliano, Robert P; Pedersen, Terje R; Park, Jeong-Gun; De Ferrari, Gaetano M; Gaciong, Zbigniew A; Ceska, Richard; Toth, Kalman; Gouni-Berthold, Ioanna; Lopez-Miranda, Jose; Schiele, François; Mach, François; Ott, Brian R; Kanevsky, Estella; Pineda, Armando Lira; Somaratne, Ransi; Wasserman, Scott M; Keech, Anthony C; Sever, Peter S; Sabatine, Marc S

    2017-08-25

    LDL cholesterol is a well established risk factor for atherosclerotic cardiovascular disease. How much one should or safely can lower this risk factor remains debated. We aimed to explore the relationship between progressively lower LDL-cholesterol concentrations achieved at 4 weeks and clinical efficacy and safety in the FOURIER trial of evolocumab, a monoclonal antibody to proprotein convertase subtilisin-kexin type 9 (PCSK9). In this prespecified secondary analysis of 25 982 patients from the randomised FOURIER trial, the relationship between achieved LDL-cholesterol concentration at 4 weeks and subsequent cardiovascular outcomes (primary endpoint was the composite of cardiovascular death, myocardial infarction, stroke, coronary revascularisation, or unstable angina; key secondary endpoint was the composite of cardiovascular death, myocardial infarction, or stroke) and ten prespecified safety events of interest was examined over a median of 2·2 years of follow-up. We used multivariable modelling to adjust for baseline factors associated with achieved LDL cholesterol. This trial is registered with ClinicalTrials.gov, number NCT01764633. Between Feb 8, 2013, and June 5, 2015, 27 564 patients were randomly assigned a treatment in the FOURIER study. 1025 (4%) patients did not have an LDL cholesterol measured at 4 weeks and 557 (2%) had already had a primary endpoint event or one of the ten prespecified safety events before the week-4 visit. From the remaining 25 982 patients (94% of those randomly assigned) 13 013 were assigned evolocumab and 12 969 were assigned placebo. 2669 (10%) of 25 982 patients achieved LDL-cholesterol concentrations of less than 0·5 mmol/L, 8003 (31%) patients achieved concentrations between 0·5 and less than 1·3 mmol/L, 3444 (13%) patients achieved concentrations between 1·3 and less than 1·8 mmol/L, 7471 (29%) patients achieved concentrations between 1·8 to less than 2·6 mmol/L, and 4395 (17%) patients achieved

  7. Evaluation of Facebook and Twitter Monitoring to Detect Safety Signals for Medical Products: An Analysis of Recent FDA Safety Alerts.

    PubMed

    Pierce, Carrie E; Bouri, Khaled; Pamer, Carol; Proestel, Scott; Rodriguez, Harold W; Van Le, Hoa; Freifeld, Clark C; Brownstein, John S; Walderhaug, Mark; Edwards, I Ralph; Dasgupta, Nabarun

    2017-04-01

    The rapid expansion of the Internet and computing power in recent years has opened up the possibility of using social media for pharmacovigilance. While this general concept has been proposed by many, central questions remain as to whether social media can provide earlier warnings for rare and serious events than traditional signal detection from spontaneous report data. Our objective was to examine whether specific product-adverse event pairs were reported via social media before being reported to the US FDA Adverse Event Reporting System (FAERS). A retrospective analysis of public Facebook and Twitter data was conducted for 10 recent FDA postmarketing safety signals at the drug-event pair level with six negative controls. Social media data corresponding to two years prior to signal detection of each product-event pair were compiled. Automated classifiers were used to identify each 'post with resemblance to an adverse event' (Proto-AE), among English language posts. A custom dictionary was used to translate Internet vernacular into Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms. Drug safety physicians conducted a manual review to determine causality using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) assessment criteria. Cases were also compared with those reported in FAERS. A total of 935,246 posts were harvested from Facebook and Twitter, from March 2009 through October 2014. The automated classifier identified 98,252 Proto-AEs. Of these, 13 posts were selected for causality assessment of product-event pairs. Clinical assessment revealed that posts had sufficient information to warrant further investigation for two possible product-event associations: dronedarone-vasculitis and Banana Boat Sunscreen--skin burns. No product-event associations were found among the negative controls. In one of the positive cases, the first report occurred in social media prior to signal detection from FAERS, whereas the other case

  8. Efficacy and safety of recombinant factor VIII products in patients with hemophilia A.

    PubMed

    Musso, Robert

    2008-10-01

    The introduction of recombinant factor VIII (rFVIII) clotting factor concentrates nearly 20 years ago represented a significant advance in the treatment of hemophilia A. The major advantage of rFVIII products compared with plasma-derived FVIII products is related to product safety, with rFVIII products virtually eliminating bloodborne pathogen transmission. The most challenging aspect of hemophilia A management today is the development of FVIII inhibitors; previously untreated patients are at the highest risk for inhibitor formation. Presented in this article are results of clinical trials in previously treated and untreated patients and postmarketing surveillance studies for the four commercially available rFVIII products (Recombinate, ReFacto, Kogenate FS/Kogenate Bayer and Advate). Recombinant FVIII therapies are highly efficacious when used ondemand and prophylactically, and they have excellent safety profiles; there have been no reports of viral- or prion-based disease transmission associated with rFVIII administration. The incidence rate of inhibitors in previously untreated patients ranges from 15% to approximately 30%. Because rFVIII concentrates have proven efficacy and safety profiles, a number of hemophilia treatment groups recommend rFVIII products as first-line therapy in the management of hemophilia A.

  9. A Survey of Cognitive Style in Maryland Ninth-Graders: I. Achievement Motivation, Productivity. Report No. 60.

    ERIC Educational Resources Information Center

    Antwisle, Doris R.; Greenberger, Ellen

    In a survey of ninth graders in and around Baltimore, Maryland, in the spring of 1968, several cognitive style variables were measured. The sample of students was divided by sex, IQ level, and residential locus. This report discusses achievement motivation and productivity (the number of words written in achievement motivation stories). The…

  10. 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.

  11. [Quality control of gene therapy products: approach of the French Agency for the Safety of Health Products].

    PubMed

    Chenivesse, Xavier; Ridoux, Valérie; Tissier, Marie-Hélène

    2003-04-01

    Gene therapy is a new therapeutic strategy which can constitute in some diseases a true alternative or a complement to the "classical treatments". Regarding the innovative features, the complexity and the extreme diversity of the gene therapy products (naked DNA, synthetic vectors, viral vectors, genetically modified cells), these new products presently in clinical trials have to be precisely evaluated and controlled for their medicine quality as well as their biological origin and/or their specific characteristics of genetically modified organisms. The French Agency for the Safety of Health Products engaged an in-depth scientific review concerning the control of this very heterogeneous class of potential therapeutics through the creation of a working group. The objectives of this group were to determine the testings to be performed by a national authority for each type of gene therapy products and to select the appropriate techniques or methods to be developed. Controls considered as essential are listed and include the verification of the identity, the purity, the transfer and expression efficiency as well as the microbiological and viral safety of the products. This implies the development of diverse techniques of molecular biology, cellular biology, physico-chemistry, animal testing, histology and microbiology. Finally, in order to define the basis of testings of these emerging products, the marketing of which should be effective for some of them in the next years, it appears extremely important to harmonize the quality, efficiency and safety criteria, to develop specific references and standards and to create specific guidelines for the control of gene therapy products.

  12. Understanding safety and production risks in rail engineering planning and protection.

    PubMed

    Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

    2009-07-01

    Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

  13. 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.

  14. Safety and health in biomass production, transportation, and storage: a commentary based on the biomass and biofuels session at the 2013 North American Agricultural Safety Summit.

    PubMed

    Yoder, Aaron M; Schwab, Charles; Gunderson, Paul; Murphy, Dennis

    2014-01-01

    There is significant interest in biomass production ranging from government agencies to the private sector, both inside and outside of the traditional production agricultural setting. This interest has led to an increase in the development and production of biomass crops. Much of this effort has focused on specific segments of the process, and more specifically on the mechanics of these individual segments. From a review of scientific literature, it is seen that little effort has been put into identifying, classifying and preventing safety hazards in on-farm biomass production systems. This commentary describes the current status of the knowledge pertaining to health and safety factors of biomass production and storage in the US and identifies areas of standards development that the biomass industry needs from the agricultural safety and health community.

  15. 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

    ... FDA's Office of Orphan Products Development (OPD) grant program. The document was published with an.... FDA-2010-N-0394] Clinical Studies of Safety and Effectiveness of Orphan Products Research...

  16. Safety aspects of "sous vide" products and prevention of microbial risks.

    PubMed

    Martens, T

    1995-03-01

    The diversity and quantities of vacuum packed and vacuum cooked prepared meals and menu components are rapidly growing on the European market. Because of the minimal heat processing, high water activity, absence of preservatives, and the use of many different often exotic ingredients, these products have a high risk potential. For this reason, Anglo-Saxon governments and industries are very sceptical about the safety of "sous vide" products. Industrial practice, as well as parallel tests and recent studies on inoculated packs have shown that, in many cases, it is more a potential than a real risk. Quality is the primary concern for "sous vide" products, and safety must be guaranteed by the application of the Hazard Analysis Critical Control Point (HACCP) concept, along with an adequate combination of different inhibitory factors (temperature of heating and cooling, pH, incorporation of starter cultures, bacteriocins and some particular enzymes).

  17. 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

    ... ``Global Quality Systems--An Integrated Approach to Improving Medical Product Safety.'' This 2-day public... HUMAN SERVICES Food and Drug Administration Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of...

  18. Attitudes and knowledge toward natural products safety in the pharmacy setting: an Italian study.

    PubMed

    Cuzzolin, Laura; Benoni, Giuseppina

    2009-07-01

    The lack of a professional supervision may expose consumers of natural products to risks; pharmacists play an important role in giving information about these substances. A survey was designed to investigate the attitudes and knowledge of consumers and pharmacists toward the safety of natural products. Twenty-three pharmacies participated in the project. On the basis of a pre-structured 17-item questionnaire, face-to-face interviews were conducted with consumers buying a natural product over a 6-month period. A further 8 items had to be compiled by pharmacists about the purchased product. During the study period, 1420 interviews were carried out. The most frequently purchased products were echinacea, propolis, garlic, guggul, ginkgo, liquorice, ginseng, glucomannan, guarana, valerian, and passionflower; 71.8% of consumers reported to have been taking conventional medicines along with natural products. Some (3.9%) referred to adverse effects in the last year: allergic reactions after cartilage of shark, propolis and thyme; anxiety after hypericum; hypotension and tachycardia after a mix containing chamomile, valerian and melissa; pyrosis and stomach-ache after laxative-depurative herbs. Pharmacists referred to some adverse effects observed in the past in relation to the products bought by consumers involved in this study. Findings from this study demonstrate that in general consumers need information on herbal safety and pharmacists are more likely to answer correctly about the use of herbs rather than about cautions, adverse effects and interactions.

  19. Students' corner: using Te Tiriti O Waitangi to identify and address racism, and achieve cultural safety in nursing.

    PubMed

    Oda, Keiko; Rameka, Maria

    2012-12-01

    Racism is an idea and belief that some races are superior to others (Harris et al., 2006a). This belief justifies institutional and individual practices that create and reinforce oppressive systems, inequality among racial or ethnic groups, and this creates racial hierarchy in society (Harris et al., 2006a). Recent studies have emphasised the impact of racism on ethnic health inequality (Harris et al., 2006a). In this article we analyse and discuss how nurses can challenge and reduce racism at interpersonal and institutional levels, and improve Māori health outcomes by understanding and using cultural safety in nursing practice and understanding Te Tiriti O Waitangi.

  20. Moclobemide safety: monitoring a newly developed product in the 1990s.

    PubMed

    Hilton, S; Jaber, B; Ruch, R

    1995-08-01

    Moclobemide is a reversible and selective inhibitor of monoamine oxidase subtype A with a wide spectrum of antidepressant activity. To fully evaluate product safety, Roche Drug Safety has collected data on adverse events (AEs), regardless of causality, from all sources worldwide through the product development phase and after launch. This effort has included analyses of reports from clinical trials, regulatory authorities, the literature, observational studies, and the marketplace. Roche Drug Safety has also carefully examined all cases where moclobemide was taken in overdose, whether with or without other substances. This article presents the safety profile of the product after 3 years on world markets. In clinical trials, moclobemide appeared only slightly less well tolerated than placebo. In comparative trials, moclobemide was largely devoid of the anticholinergic effects associated with tricyclic antidepressants. To the end of June 1993, with an estimated 780,000 subjects exposed, AEs had been reported by less than 0.2% of users. The most frequently reported AEs were psychiatric, neurologic, and gastrointestinal disorders. Hepatobiliary AEs were rare, suggesting that moclobemide is largely devoid of hepatotoxic potential. Cardiovascular AEs reflected the prevalence of cardiovascular disease in the population treated. This safety profile is largely unchanged from those observed at 1 and 2 years postlaunch, when the estimated exposed populations were 168,000 and 328,000, respectively. It is of great significance that the fatal toxicity index of moclobemide is zero. A review of single-drug intoxications with moclobemide at doses of up to 20.55 g revealed no deaths due solely to moclobemide overdose. All patients recovered fully within 1 to 7 days without residual hepatic or cardiovascular toxicity.(ABSTRACT TRUNCATED AT 250 WORDS)

  1. Understanding of definition and safety of oral health products among patients, physicians and pharmacists.

    PubMed

    Asahina, Yasuko; Hori, Satoko; Sawada, Yasufumi

    2010-07-01

    Our objective was to clarify the current understanding of the definition and safety of oral health products among patients and health professionals, and patients' perception about their communication with physicians and pharmacists regarding those products. Self-administered questionnaires were completed by patients at 17 community pharmacies in 14 prefectures of Japan. For health professionals, we sent a questionnaire to pharmacists and physicians who were registered as members of the Internet-based Medical Doctor's and Pharmacist's Information-Sharing System. The respondents were 242 patients, 158 physicians and 407 pharmacists. Some patients did not categorize dietary supplements as health products, while they did so categorize conventional foods (e.g., fermented soybeans, yogurt). Their understanding of the definition of health products was different from that of health professionals. Less than half of the patients considered that health products might potentiate or attenuate the effects of concomitant drugs, and this view was especially common among the elderly. The percentage of patients who reported that they rarely or never asked for advice from a pharmacist about their use of health products was significantly higher among those who had an incorrect understanding about health products. In conclusion, some patients' recognition of oral health products was different from that of health professionals, and most patients do not discuss their use of such products unless they are asked. Therefore, it is important for health professionals to check a patient's use of health products and be sure what he or she means when using the term 'health product'.

  2. Evaluation of Hygiene and Safety Criteria in the Production of a Traditional Piedmont Cheese

    PubMed Central

    Bellio, Alberto; Adriano, Daniela; Bianchi, Daniela Manila; Gallina, Silvia; Gorlier, Alessandra; Gramaglia, Monica; Lombardi, Giampiero; Macori, Guerrino; Zuccon, Fabio; Decastelli, Lucia

    2014-01-01

    Traditional products and related processes must be safe to protect consumers’ health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B). Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (Aw)] were performed as well. Shiga-toxin Escherichia coli, aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae, E.coli and coagulase-positive staphylococci (CPS) were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and Aw values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and Aw are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products. PMID:27800354

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

    PubMed

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

    2015-01-01

    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. 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. 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. 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 performing a more difficult technique to obtain better

  4. Evaluation of Hygiene and Safety Criteria in the Production of a Traditional Piedmont Cheese.

    PubMed

    Astegiano, Sara; Bellio, Alberto; Adriano, Daniela; Bianchi, Daniela Manila; Gallina, Silvia; Gorlier, Alessandra; Gramaglia, Monica; Lombardi, Giampiero; Macori, Guerrino; Zuccon, Fabio; Decastelli, Lucia

    2014-08-28

    Traditional products and related processes must be safe to protect consumers' health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B). Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (Aw)] were performed as well. Shiga-toxin Escherichia coli, aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae, E.coli and coagulase-positive staphylococci (CPS) were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and Aw values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and Aw are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  5. 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.

  6. The emerging role of simulation education to achieve patient safety: translating deliberate practice and debriefing to save lives.

    PubMed

    Griswold, Sharon; Ponnuru, Srikala; Nishisaki, Akira; Szyld, Demian; Davenport, Moira; Deutsch, Ellen S; Nadkarni, Vinay

    2012-12-01

    Simulation-based educational processes are emerging as key tools for assessing and improving patient safety. Multidisciplinary or interprofessional simulation training can be used to optimize crew resource management and safe communication principles. There is good evidence that simulation training improves self-confidence, knowledge, and individual and team performance on manikins. Emerging evidence supports that procedural simulation, deliberate practice, and debriefing can also improve operational performance in clinical settings and can result in safer patient and population/system outcomes in selected settings. This article highlights emerging evidence that shows how simulation-based interventions and education contribute to safer, more efficient systems of care that save lives. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Sanitation safety planning as a tool for achieving safely managed sanitation systems and safe use of wastewater.

    PubMed

    Winkler, Mirko S; Jackson, Darryl; Sutherland, David; Lim, Jose Marie U; Srikantaiah, Vishwanath; Fuhrimann, Samuel; Medlicott, Kate

    2017-09-01

    Increasing water stress and growing urbanization force a greater number of people to use wastewater as an alternative water supply, especially for irrigation. Although wastewater irrigation in agriculture has a long history and substantial benefits, without adequate treatment and protective measures on farms and in markets, use of wastewater poses risks to human health and the environment. Against this background, the World Health Organization (WHO) published Guidelines for the safe use of wastewater, excreta and greywater in agriculture and aquaculture, in 2006. The Sanitation safety planning: manual for safe use and disposal of wastewater, greywater and excreta - a step-by-step risk-based management tool for sanitation systems - was published by WHO in 2016 to put these guidelines into practice. Sanitation safety planning (SSP) can be applied to all sanitation systems, to ensure the systems are managed to meet health objectives. This paper summarizes the pilot-testing of the SSP manual in India, Peru, Portugal, Philippines, Uganda and Viet Nam. Also reviewed are some of the key components of the manual and training, and an overview of SSP training and dissemination efforts and opportunities for implementation in the WHO South-East Asia Region. Lessons learnt during the piloting phase show how reducing health risks can be surprisingly easy, even in a low-income setting, especially when combining many smaller measures. The SSP approach can make an important contribution towards Sustainable Development Goal target 6.3, by reducing pollution, eliminating dumping and minimizing the release of hazardous chemicals and materials, thereby halving the proportion of untreated wastewater and substantially increasing recycling and safe reuse globally.

  8. Preclinical safety and efficacy of a new recombinant FIX drug product for treatment of hemophilia B.

    PubMed

    Dietrich, Barbara; Schiviz, Alexandra; Hoellriegl, Werner; Horling, Frank; Benamara, Karima; Rottensteiner, Hanspeter; Turecek, Peter L; Schwarz, Hans Peter; Scheiflinger, Friedrich; Muchitsch, Eva-Maria

    2013-11-01

    Baxter has developed a new recombinant factor IX (rFIX) drug product (BAX326) for treating patients with hemophilia B, or congenital FIX deficiency. An extensive preclinical program evaluated the pharmacokinetics, efficacy, and safety of BAX326 in different species. The efficacy of BAX326 was tested in three mouse models of primary pharmacodynamics: tail-tip bleeding, carotid occlusion, and thrombelastography. The pharmacokinetics was evaluated after a single intravenous bolus injection in mice, rats, and macaques. Toxicity was assessed in rats and macaques, safety pharmacology in rabbits and macaques, and immunogenicity in mice. BAX326 was shown to be efficacious in all three primary pharmacodynamic studies (P ≤ 0.0076). Hemostatic efficacy was dose related and similar for the three lots tested. Pharmacokinetic results showed that rFIX activity and rFIX antigen concentrations declined in a bi-phasic manner, similar to a previously licensed rFIX product. BAX326 was well tolerated in rabbits and macaques at all dose levels; no thrombogenic events and no adverse clinical, respiratory, or cardiovascular effects occurred. BAX326 was also shown to have a similar immunogenicity profile to the comparator rFIX product in mice. These results demonstrate that BAX326 has a favorable preclinical safety and efficacy profile, predictive of a comparable effect to that of the previously licensed rFIX in humans.

  9. 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.

  10. Recent achievements in Tc-99m radiopharmaceutical direct production by medical cyclotrons.

    PubMed

    Boschi, Alessandra; Martini, Petra; Pasquali, Micol; Uccelli, Licia

    2017-09-01

    (99m)Tc is the most commonly used radionuclide in the field of diagnostic imaging, a noninvasive method intended to diagnose a disease, assess the disease state and monitor the effects of treatments. Annually, the use of (99m)Tc, covers about 85% of nuclear medicine applications. This isotope releases gamma rays at about the same wavelength as conventional X-ray diagnostic equipment, and owing to its short half-life (t½ = 6 h) is ideal for diagnostic nuclear imaging. A patient can be injected with a small amount of (99m)Tc and within 24 h almost 94% of the injected radionuclide would have decayed and left the body, limiting the patient's radiation exposure. (99m)Tc is usually supplied to hospitals through a (99)Mo/(99m)Tc radionuclide generator system where it is produced from the β decay of the parent nuclide (99)Mo (t½ = 66 h), which is produced in nuclear reactors via neutron fission. Recently, the interruption of the global supply chain of reactor-produced (99)Mo, has forced the scientific community to investigate alternative production routes for (99m)Tc. One solution was to consider cyclotron-based methods as potential replacement of reactor-based technology and the nuclear reaction (100)Mo(p,2n)(99m)Tc emerged as the most worthwhile approach. This review reports some achievements about (99m)Tc produced by medical cyclotrons. In particular, the available technologies for target design, the most efficient extraction and separation procedure developed for the purification of (99m)Tc from the irradiated targets, the preparation of high purity (99m)Tc radiopharmaceuticals and the first clinical studies carried out with cyclotron produced (99m)Tc are described.

  11. Dermal safety assessment of Arm & Hammer laundry products formulated for sensitive skin.

    PubMed

    Frederick, Douglas M; Vorwerk, Linda; Gupta, Archana; Ghassemi, Annahita

    2017-09-01

    The prevalence of sensitive skin among the general population in industrialized countries is reported to be over 50%. Sensitive skin subjects often report significant reactions to contact with cosmetics, soaps and other consumer products. This paper describes the overall skin compatibility and mildness program for a newly developed, lightly fragranced, colorant free laundry product (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent), specially formulated for individuals with sensitive skin. The skin mildness of the product was compared to Arm & Hammer™ Free & Clear liquid laundry detergent with no fragrance or colorant, and an established history of safe use by sensitive skin consumers. The test material was a liquid laundry product with a light scent formulated for sensitive skin consumers (Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent). The product was compared to commercially marketed products for sensitive skin with a history of skin safety in the marketplace, including: a very similar product formulation (Arm & Hammer™ Free & Clear with no fragrance), and several selected competitors' products. Studies were conducted among individuals with self-assessed sensitive skin (based on a questionnaire) using standard protocols for the Human Repeat Insult Patch Test (HRIPT), 10-Day Cumulative Irritation, the Wrist Band Wear test, and the Safety In-Use testing. Responses in all protocols were evaluated by visual scoring of potential dermatologic reactions, and recording any sensory effects at the time of the examination. In addition, sensory effects collected from panelists' daily diaries were also evaluated. The HRIPT confirmed that neither the fragrance alone, nor the product formulation with fragrance, induced contact sensitization in sensitive skin subjects. The 10-Day cumulative irritation study conducted using sensitive skin subjects showed highly favorable skin compatibility, and the test product was comparable to the control

  12. 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

  13. 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.

  14. Quality and safety aspects of food products addressing the needs of pregnant women and infants.

    PubMed

    Hoeft, Birgit; Eggersdorfer, Manfred; Heck, Stephan

    2014-01-01

    Food safety is a primary concern for pregnant women and infants as the immune system is weakened during pregnancy and not developed enough in infants, which makes them especially vulnerable to suffering from the negative effects of nonquality food products. However, food contaminations not only affect an individual's health but also a country's economic development, social harmony, food trade and even politics, as seen during the Chinese infant formula crisis in 2008. Thus, quality control is crucial in the production processes in order to have safe food products on the market. But quality control alone is not enough: manufacturers must embrace quality beyond classic in-process parameters and perform a final microbiological analysis at the end of the production process. This requires a clear and trustworthy approach to quality and safety and the involvement of all stakeholders from industry, government and academia over policy makers to consumers. This paper provides an introductory context for current quality management systems and gives real-life examples of challenges that manufacturers face during quality management and control throughout the production process. © 2014 S. Karger AG, Basel.

  15. 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.

  16. 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

  17. 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

  18. [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.

  19. A chief safety officer as the driver and guardian of a great safety rating.

    PubMed

    Steck, Oliver; Zenker, Daniel; Beatty, Tom

    2013-02-01

    If the Pharmaceutical Industry were to align to broad metrics that objectively state each product's "Safety Rating" two things would happen. First, Life Sciences companies would refocus dramatically on safety (followed by outcomes). Second, companies that have the highest aggregate "Safety Rating" would enjoy a significant competitive advantage. To achieve and maintain a high safety rating, the role of Safety officer needs to be elevated to the C-Suite.

  20. 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.

  1. Putting an end to Black Wednesday: improving patient safety by achieving comprehensive trust induction and mandatory training by day 1.

    PubMed

    Gaskell, Natalie; Hinton, Richard; Page, Tristan; Elvins, Tracy; Malin, Adam

    2016-04-01

    The term 'Black Wednesday' has been used to describe the August national changeover day, a day when a new cohort of inexperienced doctors start work, many of whom are absent from patient care to attend organisational induction and mandatory training. In this paper, we report on the development and implementation of a novel, interactive e-learning programme for induction and mandatory training for junior doctors in a district general hospital in south-west England from August 2013. This comprehensive mandatory-training programme with summative assessment saved 19.5 hours of trust time per trainee. Since the programme's inception, the completion rate has been 100% (n = 370). Subgroup analysis of starters from August 2013 (n = 141) showed that 85.7% completed by day 1 (mean time of completion 3.0 days before day 1, standard deviation 14.2 days). Importantly, 90 minutes of induction was freed on Black Wednesday, enabling earlier, ward-based clinical orientation, thereby enhancing patient safety. We believe that this is the first programme to combine induction with fully assessed, comprehensive mandatory training in a single package. Such an approach is suitable for widespread application and is to be implemented regionally. © 2016 Royal College of Physicians.

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

    DOE PAGES

    Collin, Blaise P.; Petti, David A.; Demkowicz, Paul A.; ...

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

    SciTech Connect

    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: compacts 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 because

  4. Thermal Safety Analyses for the Production of Plutonium-238 at the High Flux Isotope Reactor

    SciTech Connect

    Hurt, Christopher J.; Freels, James D.; Hobbs, Randy W.; Jain, Prashant K.; Maldonado, G. Ivan

    2016-08-01

    There has been a considerable effort over the previous few years to demonstrate and optimize the production of plutonium-238 (238Pu) at the High Flux Isotope Reactor (HFIR). This effort has involved resources from multiple divisions and facilities at the Oak Ridge National Laboratory (ORNL) to demonstrate the fabrication, irradiation, and chemical processing of targets containing neptunium-237 (237Np) dioxide (NpO2)/aluminum (Al) cermet pellets. A critical preliminary step to irradiation at the HFIR is to demonstrate the safety of the target under irradiation via documented experiment safety analyses. The steady-state thermal safety analyses of the target are simulated in a finite element model with the COMSOL Multiphysics code that determines, among other crucial parameters, the limiting maximum temperature in the target. Safety analysis efforts for this model discussed in the present report include: (1) initial modeling of single and reduced-length pellet capsules in order to generate an experimental knowledge base that incorporate initial non-linear contact heat transfer and fission gas equations, (2) modeling efforts for prototypical designs of partially loaded and fully loaded targets using limited available knowledge of fabrication and irradiation characteristics, and (3) the most recent and comprehensive modeling effort of a fully coupled thermo-mechanical approach over the entire fully loaded target domain incorporating burn-up dependent irradiation behavior and measured target and pellet properties, hereafter referred to as the production model. These models are used to conservatively determine several important steady-state parameters including target stresses and temperatures, the limiting condition of which is the maximum temperature with respect to the melting point. The single pellet model results provide a basis for the safety of the irradiations, followed by parametric analyses in the initial prototypical designs that were necessary due to the

  5. Safety and treatment volumes achieved following new developments of the magnetic resonance-guided focused ultrasound system in the treatment of uterine fibroids: a cohort study

    PubMed Central

    2013-01-01

    Background This research investigates whether modifications to the magnetic resonance-guided focused ultrasound ablation of uterine fibroid (MRgFUS) system used resulted in improved treatment volumes of uterine fibroids, while maintaining safety. Methods This study is a prospective cohort analysis of 34 women undergoing the ExAblate 2100 MRgFUS treatment for their uterine fibroids. Results The percentage of non-perfused volume (NPV) achieved with the ExAblate 2100 system was 54.92% compared with 50.49 % with the ExAblate 2000 system over the preceding year (p = 0.543). The ExAblate 2100 system resulted in a greater NPV in hyper-intense fibroids compared with the ExAblate 200 system (43.20% versus 36.33%, p = 0.005). There have been no recorded hospital admissions, no skins burns, and no reported major adverse events since the introduction of this new system. Conclusion Overall, the new system has thus far shown an encouraging safety record and an improvement in non-perfused volumes achieved, especially in hyper-intense fibroids. PMID:25512863

  6. Feed Materials Production Center environmental, safety and health management plan: (Revision to NLCO-2037 preliminary)

    SciTech Connect

    Loudin, D.J.

    1986-09-01

    The Feed Materials Production Center (FMPC) produces uranium metal for DOE defense programs at the Washington and South Carolina reactor sites, and DOE facilities elsewhere. Since the FMPC produces uranium metal products in support of various DOE defense programs, it is important that the FMPC maintain high standards of operation in a safe and environmentally compatible manner. This Environmental, Safety and Health (ES and H) Management Plan is a vital initial step to bring together all of the ES and H programs as an integrated plan which meets site ES and H concerns, and supports continued operations to fulfill FMPC mission requirements. The ES and H Management Plan report explains the FMPC mission and history, describes the site and surrounding area, and details the purpose and organization of the report; describes Air Pollution Control, Water Pollution Control, Solid Waste Management, and the Remedial Action Plan at the FMPC; describes the Safety Analyses program, Health Physics/Radiation Protection, Nuclear Criticality Prevention, Industrial Hygiene, and Safety/Fire Protection programs; and describes the FMPC Emergency Preparedness Plan.

  7. 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

  8. [Problems in microbial safety of advanced therapy medicinal products. Squaring the circle].

    PubMed

    Montag-Lessing, T; Störmer, M; Schurig, U; Brachert, J; Bubenzer, M; Sicker, U; Beshir, R; Spreitzer, I; Löschner, B; Bache, C; Becker, B; Schneider, C K

    2010-01-01

    Today, sterility of parenteral drugs is practically guaranteed. Well-defined procedures in the pharmaceutical industry enable effective protection against contamination by bacteria and fungi. In contrast, problems regarding microbial safety of advanced therapy medicinal products (ATMPs), especially of cell therapeutics, are at best only partially solved. The latter should be understood as a challenge for manufacturers, regulators, and physicians. Many of the manufacturing principles mentioned above are not applicable in production of cell therapeutics. Sterility of source materials cannot be guaranteed and the hitherto known procedures for sterilization are, as a rule, not feasible. Thus, the sterility of the final product cannot be guaranteed. Considering the extremely short shelf life of many cell therapeutics, sometimes only a few hours, the results from established methods for sterility testing are often available too late. Furthermore, the sterility of a test sample does not indicate sterility of the whole product. In most cases, conventional methods for pyrogen testing are not applicable for ATMPs. This paper demonstrates relevant limitations regarding microbial safety and pyrogenicity. Possibilities to overcome these problems are discussed and some novel solutions are proposed.

  9. Safety evaluation of perfluoropolyethers, liquid polymers used in barrier creams and other skin-care products.

    PubMed

    Malinverno, G; Pantini, G; Bootman, J

    1996-07-01

    Fomblin HC products are a 'family' of high-purity perfluoropolyethers manufactured for barrier cream and other personal care applications which involve direct application to the skin. To confirm the safety of such use, representative Fomblin HC products were tested in experimental animals for acute toxicity, primary and repeated insult irritancy, sensitization and photosensitization, subacute oral toxicity and comedogenicity; mutagenicity was examined in vitro, and irritancy or sensitization was also investigated on human skin (in patch tests with volunteers). A high molecular weight Fomblin HC only was tested in rats for subacute oral toxicity and in man for dermal effects. Single oral doses of 15 g/kg body weight were without evident toxicity to rats, as were single dermal applications or an ip injection at 5 g/kg. No primary irritant action was seen in rabbits or man, and similarly there was no evidence of skin sensitization or photosensitization in guinea pigs, or sensitization in man. No mutagenic action on Salmonella strains of tester bacteria was seen. In repeat dose irritancy or oral toxicity tests in rabbits or rats, no adverse effects of Fomblin HC products were noted; in particular, daily oral administration (1000 mg/kg/day) to rats over 28 days produced no significant reaction. No comedogenic action was found. From the known chemistry of the perfluoropolyethers, the test programme reported here and the limited published data, it is concluded that the intended use of Fomblin HC products in formulations applied to human skin has a high margin of safety.

  10. Safe two-plasmid production for the first clinical lentivirus vector that achieves >99% transduction in primary cells using a one-step protocol.

    PubMed

    Lu, Xiaobin; Humeau, Laurent; Slepushkin, Vladimir; Binder, Gwendolyn; Yu, Qiao; Slepushkina, Tatiana; Chen, Ziping; Merling, Randall; Davis, Brian; Chang, Yung-Nien; Dropulic, Boro

    2004-09-01

    We report the design of a unique two-plasmid production system for the first lentiviral vector to be evaluated in humans, VRX496. VRX496 is an optimized VSV-G pseudotyped vector derived from HIV-1 that expresses antisense to the HIV envelope gene. We found that a two-plasmid approach to production resulted in higher vector production titers when compared with a three-plasmid approach, which is particularly important for vector production at the large scale. Therefore, we carefully designed a single packaging construct, VIRPAC, for safety by reducing its homology with VRX496 and by insertion of functionally validated genetic elements designed to reduce the risk of generation of a replication-competent lentivirus (RCL). A native cis-acting ribozyme is used to prevent read through into the envelope gene from the upstream gag-pol genes in the packaging vector, thus preventing RNAs containing gag-pol and env together for comparable safety to a three-plasmid system. We demonstrate that there is no significant in vivo vector mobilization using a primary SCID-hu mouse transplantation model, which correlates with the presence of an anti-HIV payload and suggests that inclusion of antisense may be a useful tool to restrict mobilization in other vector constructs. Gene transfer is achieved using a one-step transduction procedure that is simple and clinically translatable, which reaches stable transduction efficiencies of >99% in CD4+ T lymphocytes within 3 days of culture initiation. Copyright 2004 John Wiley & Sons, Ltd.

  11. Mapping medical marijuana: state laws regulating patients, product safety, supply chains and dispensaries, 2017.

    PubMed

    Klieger, Sarah B; Gutman, Abraham; Allen, Leslie; Pacula, Rosalie Liccardo; Ibrahim, Jennifer K; Burris, Scott

    2017-07-11

    (1) To describe open source legal data sets, created for research use, that capture the key provisions of US state medical marijuana laws. The data document how state lawmakers have regulated a medicine that remains, under federal law, a Schedule I illegal drug with no legitimate medical use. (2) To demonstrate the variability that exists across states in rules governing patient access, product safety and dispensary practice. Two legal researchers collected and coded state laws governing marijuana patients, product safety and dispensaries in effect on 1 February 2017, creating three empirical legal data sets. We used summary tables to identify the variation in specific statutory provisions specified in each state's medical marijuana law as it existed on 1 February 2017. We compared aspects of these laws to the traditional Federal approach to regulating medicine. Full data sets, codebooks and protocols are available through the Prescription Drug Abuse Policy System (http://www.pdaps.org/; Archived at http://www.webcitation.org/6qv5CZNaZ on 2 June 2017). Twenty-eight states (including the District of Columbia) have authorized medical marijuana. Twenty-seven specify qualifying diseases, which differ across states. All states protect patient privacy; only 14 protect patients against discrimination. Eighteen states have mandatory product safety testing before any sale. While the majority have package/label regulations, states have a wide range of specific requirements. Most regulate dispensaries (25 states), with considerable variation in specific provisions such as permitted product supply sources number of dispensaries per state and restricting proximity to various types of location. The federal ban in the United States on marijuana has resulted in a patchwork of regulatory strategies that are not uniformly consistent with the approach usually taken by the Federal government and whose effectiveness remains unknown. © 2017 Society for the Study of Addiction.

  12. Assessment of the microbial safety and quality of cooked chilled foods and their production process.

    PubMed

    Daelman, Jeff; Jacxsens, Liesbeth; Lahou, Evy; Devlieghere, Frank; Uyttendaele, Mieke

    2013-01-01

    Refrigerated processed foods of extended durability (REPFEDs) are a heterogeneous group of food products. This study assesses the microbial safety and quality along the production process in five REPFED companies. Samples were taken of raw materials (n=123), intermediate products (n=123), end products at production day (n=45) and at end of shelf life (n=90), food contact surfaces (n=226) and worker's hands/gloves (n=92). Samples are analysed for total psychrotrophic aerobic count, aerobic spore count, sulphite reducing Clostridia, Bacillus cereus and Listeria monocytogenes. Both L. monocytogenes and B. cereus were detected on the raw materials. Nine of 72 raw materials tested were positive (in 25g) for L. monocytogenes and all but one of these raw materials were raw or minimally processed animal products. Three of 123 raw materials contained high counts (>4log CFU/g) of B. cereus, all of these samples were dried herbs. During production both food contact surfaces (90/226) and gloves (43/92) contained increased levels of total psychrotrophic aerobic counts (≥3log CFU/25cm(2)). This points out a potential source of bacterial recontamination. However, only a four and six of 223 food contact surfaces were positive (per 25cm(2)) for L. monocytogenes and B. cereus respectively. None of the gloves sampled contained L. monocytogenes and only 2 sets of gloves were positive for B. cereus. Of the 123 intermediate products tested twelve tested positive for L. monocytogenes (in 25g) and 5 showed elevated counts of B. cereus (ca. 2.5log CFU/g). Despite the presence of L. monocytogenes in the raw materials, the production area and in some of the intermediate products, none of the end products were positive for L. monocytogenes and only 9 of 135 samples (6.7%) showed to have low numbers of B. cereus (<2.7log CFU/g). This results show that the current pasteurization processes and the food safety management system are adequate to guarantee the production of microbiologically safe

  13. Agency perspectives on food safety for the products of animal biotechnology.

    PubMed

    Howard, H J; Jones, K M; Rudenko, L

    2012-08-01

    Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals. © 2012 Blackwell Verlag GmbH.

  14. [Pathogen inactivation in labile blood products: transfusion safety and economic impact].

    PubMed

    Cazenave, Jean-Pierre

    2006-01-01

    The safety of labile blood products (red blood cell concentrates, platelet concentrates and plasma) is currently ensured by medical and biological donor selection measures. Nonetheless, in addition to the residual risk of bacterial injection of platelet concentrates and parasitic infection of red cell concentrates, there is the emerging danger associated with new viruses. Pathogen inactivation based on chemical or photochemical genomic modifications is a broad-spectrum approach. These techniques are already used to inactivate plasma, and are being developed or application to platelet and erythrocyte concentrates. Universal inactivation of all labile blood products should be possible in a few years' time, but clinical and hemovigilance studies must first show that the biological properties and therapeutic efficacy of these products are not markedly affected, and that the methods used do not lead to long-term toxicity.

  15. Life cycle assessment of a road safety product made with virgin and recycled HDPE.

    PubMed

    Simões, Carla L; Xará, Susana M; Bernardo, C A

    2011-04-01

    The present study aims at evaluating the potential environmental impact of using recycled high-density polyethylene (HDPE) in the production of an anti-glare lamella (AGL), a road safety device currently manufactured from virgin (not recycled) polymer. The impact was evaluated using the life cycle assessment (LCA) technique and comparing two alternative systems: current AGL, manufactured from virgin HDPE, and optional AGL, made with recycled HDPE obtained from post-consumer packages. The AGL manufacturing phase was found to be responsible for most of the impacts in both systems, with the production of the raw material being the largest contributor for that phase. The present study makes a contribution to the problem of developing value-added products made from post-consumer polymeric recyclates.

  16. [Official experimental testing of biomedical products. Regulatory frame and importance of for quality, safety and efficacy].

    PubMed

    Vieths, S; Seitz, R

    2014-10-01

    The official experimental testing of biomedicinal products provides a very significant contribution to ensuring quality, safety and efficacy of these indispensable medicines. Already in the prelicensing phase or to elucidate clusters of increased adverse effects, official medicinal control laboratories are committed to perform experimental testing. The official batch release can be seen as external quality control of the manufacturer's release testing. For proficient performance in these tasks, scientific research is required, in particular on the development and refinement of test methods, and considering the continuous development of innovative biomedicinal products. This article is aimed at introducing the present thematic issue and in particular the regulatory basis of experimental product testing, and illustrates by means of several examples its great importance for the sake of the patients.

  17. Consumption Safety of Pastries, Confectioneries, and Potato Products as Related to Fat Content.

    PubMed

    Żbikowska, Anna; Rutkowska, Jarosława; Kowalska, Małgorzata

    2015-01-01

    To determine the content of the main groups of fatty acids in pastries, confectionery, and potato products, paying special attention to trans fatty acids and the products of fat oxidation and hydrolysis, as factors affecting the safety of consumption. A total of 157 products were collected in Poland in 2009-2010. In fats extracted from samples, products of oxidation and hydrolysis were assayed using peroxide (PV), anisidine (AnV), and acid (AV) values. The fatty acid (FA) composition, especially the trans FAs (TFAs) content, was determined by gas chromatography. When assessing the TFA intake, Household Budget Surveys were considered. Highest content of fat was found for wafers with filling and crisps (32.3% and 29.3%, respectively). In 4 out of 9 groups of pastry and confectionery products studied, the quality of fat was decreased due to an excessive oxidation, as evidenced by a substantial content of secondary products of fat oxidation. The extracted fat was rich in SFA (on average, 50 g SFA/100 g FA) except fries and mixes. A great diversity of TFA content in fat of the products was found (0.1-24.8 g TFA/100 g FA). Wafers were characterized by the highest average content of TFA in the group of pastries (1.94 g TFA/100 g of product). Products of natural origin supplied 0.496 g of TFA per day, and those of industrial origin supplied about 1.5 g. The average TFA consumption, about 2 g/day, does not seem to affect health. However, an excessive consumption of pastry and confectionery products may present a risk, due not only to TFA but also to a high consumption of toxic secondary oxidation lipid products. Moreover, because 75% of TFAs in the diet were isomers of industrial origin, their further limitation and monitoring of their level in food seems highly recommendable.

  18. 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

    ... comments to the Department of the Interior (DOI); Bureau of Safety and Environmental Enforcement; Attention... operating dry tree and subsea tree production systems on the Outer Continental Shelf (OCS) and divide...

  19. Report: EPA Should Assess Needs and Implement Management Controls to Ensure Effective Incorporation of Chemical Safety Research Products

    EPA Pesticide Factsheets

    Report #17-P-0294, June 23, 2017. With management controls that ensure the collaborative development of research products and prioritize chemical safety research needs, the EPA would be better able to conduct faster chemical risk assessments.

  20. Development of a Safety Monitoring and Assurance System for chilled food products.

    PubMed

    Koutsoumanis, K; Taoukis, P S; Nychas, G J E

    2005-04-15

    The principles of a novel chill chain management policy, coded Safety Monitoring and Assurance System (SMAS) for the optimisation of the distribution of chilled food products within the chill chain are developed. In this system, a new approach based on actual risk evaluation at important points of the chill chain is used in order to promote products to the next stage of distribution. This evaluation based on product's time-temperature history, variation in product's characteristics (e.g. a(w), pH, etc.), and the use of predictive models for the growth of food pathogens, allows to give priority to products in such a way that risk at consumption time is minimized. The effectiveness of SMAS was evaluated against the First In First Out (FIFO) approach, the current method for food distribution, in a case study on the risk of listeriosis of cooked ham using the Monte Carlo simulation technique. Furthermore, the two approaches were compared for their effect on the quality of the products in terms of remaining shelf life at the time of consumption. The results showed that following the SMAS approach the risk of listerisosis is significantly lower while the spoiled products at the time of consumption are significantly reduced compared to FIFO approach.

  1. 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 been...

  2. 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 been...

  3. 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 been...

  4. 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 been...

  5. 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 been...

  6. Explaining the Relationship between Resources and Student Achievement: A Methodological Comparison of Production Functions and Canonical Analysis

    ERIC Educational Resources Information Center

    Knoeppel, Robert C.; Rinehart, James S.

    2008-01-01

    The purpose of this study was to compare multiple regression with canonical analysis in order to introduce a new, policy relevant methodology to the literature on production functions. Findings from this study confirmed the results of past inquiries that found a relationship between the inputs to schooling and measures of student achievement. A…

  7. 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

  8. Active surveillance of postmarket medical product safety in the Federal Partners' Collaboration.

    PubMed

    Robb, Melissa A; Racoosin, Judith A; Worrall, Chris; Chapman, Summer; Coster, Trinka; Cunningham, Francesca E

    2012-11-01

    After half a century of monitoring voluntary reports of medical product adverse events, the Food and Drug Administration (FDA) has launched a long-term project to build an adverse events monitoring system, the Sentinel System, which can access and evaluate electronic health care data to help monitor the safety of regulated medical products once they are marketed. On the basis of experience gathered through a number of collaborative efforts, the Federal Partners' Collaboration pilot project, involving FDA, the Centers for Medicare & Medicaid Services, the Department of Veteran Affairs, and the Department of Defense, is already enabling FDA to leverage the power of large public health care databases to assess, in near real time, the utility of analytical tools and methodologies that are being developed for use in the Sentinel System. Active medical product safety surveillance is enhanced by use of these large public health databases because specific populations of exposed patients can be identified and analyzed, and can be further stratified by key variables such as age, sex, race, socioeconomic status, and basis for eligibility to examine important subgroups.

  9. Development of requirements on safety cases of machine industry products for power engineering

    NASA Astrophysics Data System (ADS)

    Aronson, K. E.; Brezgin, V. I.; Brodov, Yu. M.; Gorodnova, N. V.; Kultyshev, A. Yu.; Tolmachev, V. V.; Shablova, E. G.

    2016-12-01

    This article considers security assurance for power engineering machinery in the design and production phases. The Federal Law "On Technical Regulation" and the Customs Union Technical Regulations "On Safety of Machinery and Equipment" are analyzed in the legal, technical, and economic aspect with regard to power engineering machine industry products. From the legal standpoint, it is noted that the practical enforcement of most norms of the Law "On Technical Regulation" makes it necessary to adopt subordinate statutory instruments currently unavailable; moreover, the current level of adoption of technical regulations leaves much to be desired. The intensive integration processes observed in the Eurasian Region in recent years have made it a more pressing task to harmonize the laws of the region's countries, including their technical regulation framework. The technical aspect of analyzing the technical regulation of the Customs Union has been appraised by the IDEF0 functional modeling method. The object of research is a steam turbine plant produced at the turbine works. When developing the described model, we considered the elaboration of safety case (SC) requirements from the standpoint of the chief designer of the turbine works as the person generally responsible for the elaboration of the SC document. The economic context relies on risk analysis and appraisal methods. In their respect, these are determined by the purposes and objectives of analysis, complexity of considered objects, availability of required data, and expertise of specialists hired to conduct the analysis. The article proposes the description of all sources of hazard and scenarios of their actualization in all production phases of machinery life cycle for safety assurance purposes. The detection of risks and hazards allows forming the list of unwanted events. It describes the sources of hazard, various risk factors, conditions for their rise and development, tentative risk appraisals, and

  10. 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…

  11. 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…

  12. 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. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    DOE PAGES

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

    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

  14. 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.

  15. Application of lentiviral vectors for development of production cell lines and safety testing of lentiviral-derived cells or products.

    PubMed

    Plewa, Cherylene

    2010-01-01

    Lentiviral vectors (LVs) are frequently used to engineer cell lines for preclinical research purposes including assay development and target validation. Development of production cell lines for manufacturing recombinant protein therapeutics may also benefit from the use of LVs because they may reduce timelines and generate more uniform or higher expressing stable pools and clones. In addition, LVs could be advantageous for engineering new, alternative host cell substrates due to their ability to efficiently transduce most cell types. We demonstrate here that NS0 mouse myeloma cells, a host cell frequently used for protein production, can be transduced with LVs to greater than 80% efficiency and with no cytotoxic effects. The use of LVs for engineering of production cell lines will require additional testing procedures. Since LVs have previously been used in human gene therapy clinical trials, safety testing assays and procedures have been developed that could easily be applied to the development process for manufacturing cell lines to ensure the absence of unwanted viral material in cell banks and biologic products.

  16. 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.

  17. 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.

  18. Current achievements in the production of complex biopharmaceuticals with moss bioreactors.

    PubMed

    Decker, Eva L; Reski, Ralf

    2008-01-01

    Transgenic plants are promising alternatives for the low-cost and safe pathogen-free production of complex recombinant pharmaceutical proteins (molecular farming). Plants as higher eukaryotes perform posttranslational modifications similar to those of mammalian cells. However, plant-specific protein N-glycosylation was shown to be immunogenic, a fact that represents a drawback for many plant systems in biopharmaceutical production. The moss Physcomitrella patens offers unique properties as a contained system for protein production. It is grown in the predominant haploid gametophytic stage as tissue suspension cultures in photobioreactors. Efficient secretory signals and a transient transfection system allow the secretion of freshly synthesized proteins to the surrounding medium. The key advantage of Physcomitrella compared to other plant systems is the feasibility of targeted gene replacements. By this means, moss strains with non-immunogenic humanized glycan patterns were created. Here we present an overview of the relevant aspects for establishing moss as a production system for recombinant biopharmaceuticals.

  19. Predicting Product Adherence in a Topical Microbicide Safety Trial in Pune, India

    PubMed Central

    Tolley, Elizabeth E.; Tsui, Sharon; Mehendale, Sanjay; Weaver, Mark A.; Kohli, Rewa

    2012-01-01

    The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples’ ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction. PMID:21877203

  20. Predicting product adherence in a topical microbicide safety trial in Pune, India.

    PubMed

    Tolley, Elizabeth E; Tsui, Sharon; Mehendale, Sanjay; Weaver, Mark A; Kohli, Rewa

    2012-10-01

    The inconclusive results of past trials and recent findings of partial protection of Tenofovir 1% gel underscore the need to better understand product adherence in microbicide trials. This study aimed to identify factors predicting couples' ability to sustain topical gel and condom use during clinical trial participation. We enrolled 100 Indian participants of a randomized, controlled safety trial of Tenofovir 1% gel (CT cohort) and 100 similar women who were ineligible or declined trial participation (NCT cohort). Compared to the NCT cohort, CT women reported higher baseline condom use, more positive attitudes towards condoms and higher levels of protection efficacy. While NCT condom use remained low, CT condom use increased dramatically during the study. Reported gel consistency was higher than condom consistency. Individual and couple-related factors predicted condom consistency and interest in future gel use, but not gel consistency. Findings could inform trial recruitment strategies and product introduction.

  1. Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

    PubMed

    Baldziki, Mike; Brown, Jeff; Chan, Hungching; Cheetham, T Craig; Conn, Thomas; Daniel, Gregory W; Hendrickson, Mark; Hilbrich, Lutz; Johnson, Ayanna; Miller, Steven B; Moore, Tom; Motheral, Brenda; Priddy, Sarah A; Raebel, Marsha A; Randhawa, Gurvaneet; Surratt, Penny; Walraven, Cheryl; White, T Jeff; Bruns, Kevin; Carden, Mary Jo; Dragovich, Charlie; Eichelberger, Bernadette; Rosato, Edith; Sega, Todd

    2015-01-01

    The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.

  2. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which 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 medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

  3. 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.

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

    PubMed Central

    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

  5. 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.

  6. Biotechnological production of enantiomeric pure lactic acid from renewable resources: recent achievements, perspectives, and limits.

    PubMed

    Okano, Kenji; Tanaka, Tsutomu; Ogino, Chiaki; Fukuda, Hideki; Kondo, Akihiko

    2010-01-01

    Lactic acid (LA) is an important and versatile chemical that can be produced from renewable resources such as biomass. LA is used in the food, pharmaceutical, and polymers industries and is produced by microorganism fermentation; however, most microorganisms cannot directly utilize biomass such as starchy materials and cellulose. Here, we summarize LA production using several kinds of genetically modified microorganisms, such as LA bacteria, Escherichia coli, Corynebacterium glutamicum, and yeast. Using gene manipulation and metabolic engineering, the yield and optical purity of LA produced from biomass has been significantly improved. In this review, the drawbacks as well as improvements of LA production by fermentation is discussed.

  7. Current products and practices: curriculum development in orthodontic specialist registrar training: can orthodontics achieve constructive alignment?

    PubMed

    Chadwick, S M

    2004-09-01

    This paper aims to encourage a debate on the learning outcomes that have been developed for orthodontic specialist education. In outcome-based education the learning outcomes are clearly defined. They determine curriculum content and its organization, the teaching and learning approaches, the assessment techniques and hope to focus the minds of the students on ensuring all the learning outcomes are met. In Orthodontic Specialist Registrar training, whether constructive alignment can be achieved depends on the relationship between these aspects of the education process and the various bodies responsible for their delivery in the UK.

  8. Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

    PubMed Central

    2013-01-01

    Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug

  9. Microbiological performance of dairy processing plants is influenced by scale of production and the implemented food safety management system: a case study.

    PubMed

    Opiyo, Beatrice Atieno; Wangoh, John; Njage, Patrick Murigu Kamau

    2013-06-01

    The effects of existing food safety management systems and size of the production facility on microbiological quality in the dairy industry in Kenya were studied. A microbial assessment scheme was used to evaluate 14 dairies in Nairobi and its environs, and their performance was compared based on their size and on whether they were implementing hazard analysis critical control point (HACCP) systems and International Organization for Standardization (ISO) 22000 recommendations. Environmental samples from critical sampling locations, i.e., workers' hands and food contact surfaces, and from end products were analyzed for microbial quality, including hygiene indicators and pathogens. Microbial safety level profiles (MSLPs) were constructed from the microbiological data to obtain an overview of contamination. The maximum MSLP score for environmental samples was 18 (six microbiological parameters, each with a maximum MSLP score of 3) and that for end products was 15 (five microbiological parameters). Three dairies (two large scale and one medium scale; 21% of total) achieved the maximum MSLP scores of 18 for environmental samples and 15 for the end product. Escherichia coli was detected on food contact surfaces in three dairies, all of which were small scale dairies, and the microorganism was also present in end product samples from two of these dairies, an indication of cross-contamination. Microbial quality was poorest in small scale dairies. Most operations in these dairies were manual, with minimal system documentation. Noncompliance with hygienic practices such as hand washing and cleaning and disinfection procedures, which is common in small dairies, directly affects the microbial quality of the end products. Dairies implementing HACCP systems or ISO 22000 recommendations achieved maximum MSLP scores and hence produced safer products.

  10. Achieving ethanol-type fermentation for hydrogen production in a granular sludge system by aeration.

    PubMed

    Zhang, Song; Liu, Min; Chen, Ying; Pan, Yu-Ting

    2017-01-01

    To investigate the effects of aeration on hydrogen-producing granular system, experiments were performed in two laboratory-scale anaerobic internal circulation hydrogen production (AICHP) reactors. The preliminary experiment of Reactor 1 showed that direct aeration was beneficial to enhancing hydrogen production. After the direct aeration was implied in Reactor 2, hydrogen production rate (HPR) and hydrogen content were increased by 100% and 60%, respectively. In addition, mixed-acid fermentation was transformed into typical ethanol-type fermentation (ETF). Illumina MiSeq sequencing shows that the direct aeration did not change the species of hydrogen-producing bacteria but altered their abundance. Hydrogen-producing bacteria and ethanol-type fermentative bacteria were increased by 24.5% and 146.3%, respectively. Ethanoligenens sp. sharply increased by 162.2% and turned into predominant bacteria in the system. These findings indicated that appropriate direct aeration might be a novel and promising way to obtain ETF and enhance hydrogen production in practical use.

  11. 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. Copyright © 2014 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

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

    USDA-ARS?s Scientific Manuscript database

    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....

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

    USDA-ARS?s Scientific Manuscript database

    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. Food safety issues associated with products from aquaculture. Report of a Joint FAO/NACA/WHO Study Group.

    PubMed

    1999-01-01

    The past decade has seen rapid expansion in aquaculture production. In the fisheries sector, as in animal production, farming is replacing hunting as the primary food production strategy. In future, farmed fish will be an even more important source of protein foods than they are today, and the safety for human consumption of products from aquaculture is of public health significance. This is the report of a Study Group that considered food safety issues associated with farmed finfish and crustaceans. The principal conclusion was that an integrated approach--involving close collaboration between the aquaculture, agriculture, food safety, health and education sectors--is needed to identify and control hazards associated with products from aquaculture. Food safety assurance should be included in fish farm management and form an integral part of the farm-to-table food safety continuum. Where appropriate, measures should be based on Hazard Analysis and Critical Control Point (HACCP) methods; however, difficulties in applying HACCP principles to small-scale farming systems were recognized. Food safety hazards associated with products from aquaculture differ according to region, habitat and environmental conditions, as well as methods of production and management. Lack of awareness of hazards can hinder risk assessment and the application of risk management strategies to aquaculture production, and education is therefore needed. Chemical and biological hazards that should to be taken into account in public health policies concerning products from aquaculture are discussed in this report, which should be of use to policy-makers and public health officials. The report will also assist fish farmers to identify hazards and develop appropriate hazard-control strategies.

  15. Efficacy and safety of biphasic insulin aspart 70/30 versus exenatide in subjects with type 2 diabetes failing to achieve glycemic control with metformin and a sulfonylurea.

    PubMed

    Bergenstal, Richard; Lewin, Andrew; Bailey, Timothy; Chang, Denise; Gylvin, Titus; Roberts, Victor

    2009-01-01

    To compare safety and efficacy of biphasic insulin aspart 70/30 (BIAsp 30) with exenatide in subjects with type 2 diabetes mellitus (T2DM) not achieving glycemic targets with metformin and sulfonylurea in a randomized, open-label, 24-week trial. Subjects (N = 372, T2DM > 6 months, age > or = 18 and < or = 80 years, HbA1c > or = 8%, insulin naive not achieving glycaemic targets, receiving metformin and sulfonylurea) were randomized 1: 1: 1 to receive either BIAsp 30 QD (12 U before supper); BIAsp 30 BID (12 U divided equally between pre-breakfast and pre-supper); or exenatide (5 microg BID for 4 weeks and 10 microg BID thereafter). Efficacy (HbA1c, fasting plasma glucose [FPG]) and safety (adverse events and hypoglycemic episodes) were assessed. Glycemic control achieved with both BIAsp 30 BID and BIAsp 30 QD was superior to that with exenatide (BIAsp 30 BID-exenatide: HbA1c difference -0.91% [95% CI: -1.23 to -0.59%] and BIAsp 30 QD-exenatide: difference: -0.67% [95% CI: -0.99 to -0.34%]). At the end of the study, more subjects achieved HbA1c < 7% and < or = 6.5% in the BIAsp 30 BID group than in the exenatide group (HbA1c < 7%: 37% vs. 20%, p = 0.0060; HbA1c < or = 6.5%: 25% vs. 8%, p = 0.0004, respectively). Combined hypoglycemic episodes (major, minor, symptoms only) were reported by 56%, 61%, and 29% of the subjects in the BIAsp 30 QD, BIAsp 30 BID, and exenatide groups, respectively. Weight gain was observed in the BIAsp 30 group (BIAsp 30 QD: 2.85 kg, BIAsp 30 BID: 4.08 kg) and weight loss was observed in the exenatide group (-1.96 kg). Nausea or vomiting was responsible for discontinuation of seven subjects in the exenatide group and one subject in the BIAsp 30 BID group. Significantly more T2DM patients (poorly controlled with combination metformin/sulfonylurea) achieved glycemic goals when treated with BIAsp 30 than with exenatide. The high baseline HbA1c values (approximately 10.2%) and the long duration of diabetes (approximately 9 years) suggests that

  16. 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.

  17. 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.

  18. Safety and quality of some chicken meat products in Al-Ahsa markets-Saudi Arabia

    PubMed Central

    AL-Dughaym, A.M.; Altabari, G.F.

    2009-01-01

    One hundred samples of 10 poultry meat products were collected from AL-Ahsa markets (Kingdom of Saudi Arabia). The samples were ranked from carcass cuts (chilled, frozen, fillet and thigh) to minced meat or further processed products as burger, nuggets, frankfurter and meat paste loaf. Samples were collected in triplicate for sensory, chemical and microbiological analysis to assure their quality and safety. The obtained results revealed variation in chemical composition; some products with high fat percentage had a high thiobarbituric acid value, which resulted in the appearance of an unacceptable flavor. Bacteriological analysis revealed that the mean total bacterial count was ranged from 2.7 × 104 cfu/g for nuggetsA to 3.3 × 107 cfu/g for burgerB and the other products in the range of 105–106 cfu/g. While Staphylococcus aureus mean count ranged from less than 102 cfu/g for all samples, accept 104 and 106 cfu/g for minceB and frankfurter samples, respectively. Escherichia coli isolated from 70% of the samples and Salmonella arizona was isolated at once from thigh samples. Thirty percentages of samples not comply with Saudi Standards due to sensory unacceptability and 21% of samples nonconforming with bacteriological specifications. PMID:23961056

  19. Safety and quality of some chicken meat products in Al-Ahsa markets-Saudi Arabia.

    PubMed

    Al-Dughaym, A M; Altabari, G F

    2010-01-01

    One hundred samples of 10 poultry meat products were collected from AL-Ahsa markets (Kingdom of Saudi Arabia). The samples were ranked from carcass cuts (chilled, frozen, fillet and thigh) to minced meat or further processed products as burger, nuggets, frankfurter and meat paste loaf. Samples were collected in triplicate for sensory, chemical and microbiological analysis to assure their quality and safety. The obtained results revealed variation in chemical composition; some products with high fat percentage had a high thiobarbituric acid value, which resulted in the appearance of an unacceptable flavor. Bacteriological analysis revealed that the mean total bacterial count was ranged from 2.7 × 10(4) cfu/g for nuggets(A) to 3.3 × 10(7) cfu/g for burger(B) and the other products in the range of 10(5)-10(6) cfu/g. While Staphylococcus aureus mean count ranged from less than 10(2) cfu/g for all samples, accept 10(4) and 10(6) cfu/g for mince(B) and frankfurter samples, respectively. Escherichia coli isolated from 70% of the samples and Salmonella arizona was isolated at once from thigh samples. Thirty percentages of samples not comply with Saudi Standards due to sensory unacceptability and 21% of samples nonconforming with bacteriological specifications.

  20. Preparation, Phytochemical Investigation, and Safety Evaluation of Chlorogenic Acid Products from Eupatorium adenophorum.

    PubMed

    Liu, Boyan; Cao, Lili; Zhang, Lijun; Yuan, Xiaofan; Zhao, Bing

    2016-12-31

    Eupatorium adenophorum is widely distributed throughout the world's tropical and temperate regions. It has become a harmful weed of crops and natural environments. Its leaves contain bioactive compounds such as chlorogenic acid and may be used as feed additives. In this study, chlorogenic acid was extracted and separated from leaves of E. adenophorum. Three chlorogenic acid products were prepared with different purities of 6.11%, 22.17%, and 96.03%. Phytochemical analysis demonstrated that the main toxins of sesquiterpenes were almost completely removed in sample preparation procedure. The three products were evaluated for safety via in vitro and in vivo toxicological studies. All the products exhibited no cytotoxic effects at a dose of 400 μg/mL in an in vitro cell viability assay. When administered in vivo at a single dose up to 1.5 g/kg bw, all three products caused no signs or symptoms of toxicity in mice. These results encourage further exploration of extracts from E. adenophorum in feed additive application.

  1. Next-generation sequencing: the future of molecular genetics in poultry production and food safety.

    PubMed

    Diaz-Sanchez, S; Hanning, I; Pendleton, Sean; D'Souza, Doris

    2013-02-01

    The era of molecular biology and automation of the Sanger chain-terminator sequencing method has led to discovery and advances in diagnostics and biotechnology. The Sanger methodology dominated research for over 2 decades, leading to significant accomplishments and technological improvements in DNA sequencing. Next-generation high-throughput sequencing (HT-NGS) technologies were developed subsequently to overcome the limitations of this first generation technology that include higher speed, less labor, and lowered cost. Various platforms developed include sequencing-by-synthesis 454 Life Sciences, Illumina (Solexa) sequencing, SOLiD sequencing (among others), and the Ion Torrent semiconductor sequencing technologies that use different detection principles. As technology advances, progress made toward third generation sequencing technologies are being reported, which include Nanopore Sequencing and real-time monitoring of PCR activity through fluorescent resonant energy transfer. The advantages of these technologies include scalability, simplicity, with increasing DNA polymerase performance and yields, being less error prone, and even more economically feasible with the eventual goal of obtaining real-time results. These technologies can be directly applied to improve poultry production and enhance food safety. For example, sequence-based (determination of the gut microbial community, genes for metabolic pathways, or presence of plasmids) and function-based (screening for function such as antibiotic resistance, or vitamin production) metagenomic analysis can be carried out. Gut microbialflora/communities of poultry can be sequenced to determine the changes that affect health and disease along with efficacy of methods to control pathogenic growth. Thus, the purpose of this review is to provide an overview of the principles of these current technologies and their potential application to improve poultry production and food safety as well as public health.

  2. 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

  3. Pharmacy compounding of high-risk level products and patient safety.

    PubMed

    Mullarkey, Tamira

    2009-09-01

    Issues surrounding pharmacy compounding as well as patient safety concerns surrounding compounding of high-risk level products are discussed. The practice of traditional pharmacy compounding is an established activity of pharmacists that serves a vital function to meet the prescribed medical needs of individual patients. However, legal and regulatory debate concerning the oversight of pharmacy compounding has arisen in recent decades, driven mostly by patient harm that has occurred as a result of compounding errors or deceptive practices. Federal and state government agencies and professional organizations have reported errors in pharmacy compounding, including subpotent and contaminated products that have caused patient harm. The United States Pharmacopeia (USP) chapter 797 serves to protect patients by requiring best practice and quality standards for the safe preparation and handling of compounded sterile preparations (CSPs). High-risk level CSPs pose the greatest risk to patients since non-sterile ingredients or containers are used, which mandates final product sterilization prior to dispensing. Pharmacists should understand and comply with federal, state, and USP chapter 797 requirements when preparing CSPs, particularly high-risk level CSPs. Professional pharmacy organizations, such as the American Society of Health-System Pharmacists (ASHP) and the National Association of Boards of Pharmacy (NABP), continue to support the practice of traditional pharmacy compounding through their guidelines, with patient safety as a central theme. Until the regulatory debate is resolved, pharmacists engaged in pharmacy compounding, particularly in the preparation of high-risk level CSPs, should remain competent in their skills and practice in accordance with federal, state, and USP chapter 797 requirements and, thereby, protect patients and the professionalism of pharmacy.

  4. Protein production from the structural genomics perspective: achievements and future needs

    PubMed Central

    Almo, Steven C; Garforth, Scott J; Hillerich, Brandan S; Love, James D; Seidel, Ronald D; Burley, Stephen K

    2014-01-01

    Despite a multitude of recent technical breakthroughs speeding high-resolution structural analysis of biological macromolecules, production of sufficient quantities of well-behaved, active protein continues to represent the rate-limiting step in many structure determination efforts. These challenges are only amplified when considered in the context of ongoing structural genomics efforts, which are now contending with multi-domain eukaryotic proteins, secreted proteins, and ever-larger macromolecular assemblies. Exciting new developments in eukaryotic expression platforms, including insect and mammalian-based systems, promise enhanced opportunities for structural approaches to some of the most important biological problems. Development and implementation of automated eukaryotic expression techniques promises to significantly improve production of materials for structural, functional, and biomedical research applications. PMID:23642905

  5. ACHIEVING THE REQUIRED COOLANT FLOW DISTRIBUTION FOR THE ACCELERATOR PRODUCTION OF TRITIUM (APT) TUNGSTEN NEUTRON SOURCE

    SciTech Connect

    D. SIEBE; K. PASAMEHMETOGLU

    2000-11-01

    The Accelerator Production of Tritium neutron source consists of clad tungsten targets, which are concentric cylinders with a center rod. These targets are arranged in a matrix of tubes, producing a large number of parallel coolant paths. The coolant flow required to meet thermal-hydraulic design criteria varies with location. This paper describes the work performed to ensure an adequate coolant flow for each target for normal operation and residual heat-removal conditions.

  6. Improving production of 11C to achieve high specific labelled radiopharmaceuticals

    NASA Astrophysics Data System (ADS)

    Savio, E.; García, O.; Trindade, V.; Buccino, P.; Giglio, J.; Balter, H.; Engler, H.

    2012-12-01

    Molecular imaging is usually based on the recognition by the radiopharmaceuticals of specific sites which are present in limited number or density in the cells or biological tissues. Thus is of high importance to label the radiopharmaceuticals with high specific activity to be able to achieve a high target to non target ratio. The presence of carbon dioxide (CO2) from the air containing 98,88% of 12C and 1,12% 13C compete with 11CO2 produced at the cyclotron. In order to minimize the presence of these isotopes along the process of irradiation, transferring and synthesis of radiopharmaceuticals labelled with 11C, we applied this method: previous to the irradiation the target was 3-4 times flushed with He (5.7) as a cold cleaning, followed by a similar conditioning of the line, from the target up to the module, and finally a hot cleaning in order to desorb 12CO2 and 13CO2, this was performed by irradiation during 1 min at 5 uA (3 times). In addition, with the aim of improving quality of gases in the target and in the modules, water traps (Agilent) were incorporated in the inlet lines of the target and modules. Target conditioning process (cold and hot flushings) as well as line cleaning, allowing the desorption of unlabelled CO2, together with the increasing of gas purity in the irradiation and in the synthesis, were critical parameters that enable to achieve 11C-radiopharamaceuticals with high specific activity, mainly in the case of 11C-PIB.

  7. 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. Copyright © 2014

  8. Herbal products containing Hibiscus sabdariffa L., Crataegus spp., and Panax spp.: Labeling and safety concerns.

    PubMed

    Nunes, Maria Antónia; Rodrigues, Francisca; Alves, Rita C; Oliveira, Maria Beatriz P P

    2017-10-01

    Herbs have been used from ancient times for infusion preparation based on their potential health effects. In particular, the consumption of Hibiscus sabdariffa L., Crataegus spp. and Panax spp. has been largely associated to cardiovascular benefits. In this work, the label information of 52 herbal products for infusion preparation containing the referred herbs was analyzed and discussed, taking into consideration the European Union regulation for herbal products, which intends to protect public health and harmonize the legal framework in Member States. Details about the cardiovascular-related statements and warning notifications about consumption were considered. Also, regulatory issues and possible herb-drug interactions were explored and discussed. A total of 14 of the 52 herbal products selected presented health claims/statements on the label. Hibiscus was present in the majority of the products and, in some cases, it was mentioned only in the ingredients list and not on the product front-of-pack. Despite the promising outcomes of these plants to modulate cardiovascular risk markers, consumers with some sort of cardiovascular dysfunction and/or under medication treatments should be aware to carefully analyze the labels and consult additional information related to these herbal products. Manufacturers have also a huge responsibility to inform consumers by presenting awareness statements. Lastly, health professionals must advise and alert their patients about possible interactions that could occur between the concomitant consumption of drugs and herbs. Overall, there is still a real need of additional studies and clinical trials to better understand herbs effects and establish a science-based guidance to assess their safety. Copyright © 2017 Elsevier Ltd. All rights reserved.

  9. Prescribing patterns and safety monitoring of duloxetine using the Danish Register of Medicinal Product Statistics as a source.

    PubMed

    Johansen, Anja Nygaard; Stenzhorn, Annette Aalykke; Rosenzweig, Mary; Thirstrup, Steffen; Gazerani, Parisa

    2013-12-01

    The safety and pattern of use of a medicinal product cannot be fully studied prior to its marketing. In Denmark, the Danish Health and Medicines Authority (DHMA) monitors marketed drugs. An available source is the Register of Medicinal Product Statistics (RMPS), which can possibly be used for these purposes. To investigate utilisation and potential safety issues of relatively new antidepressants containing the active ingredient duloxetine (Cymbalta(®) and Xeristar(®)) by using dispensing data available in the RMPS. A retrospective study using dispensing data was designed to estimate the size and composition of the user population and patterns of use of the antidepressants Cymbalta(®) and Xeristar(®) (active ingredient: duloxetine) in the period from 1 January 2005 to 31 December 2010. Data were retrieved from Epikur, a register subset of the RMPS. Both women and men in different age groups used duloxetine for depression. Some users switched to another antidepressant. Prescription of the drug for persons below the age of 18 years revealed a potential safety issue. Concomitant treatment with Cymbalta(®) or Xeristar(®) and fluvoxamine, isocarboxazid, Yentreve(®), or ciprofloxacin also revealed potential safety issues. The present study indicated that the RMPS is applicable in monitoring the pattern of use and potential safety issues related to duloxetine when it is prescribed for depression. Switching to other antidepressants could reflect some potential safety issues. Use of duloxetine for persons below the age of 18 years and its concomitant use with contraindicated drugs also indicated potential safety issues.

  10. Acetaminophen (paracetamol) inhibits myeloperoxidase-catalyzed oxidant production and biological damage at therapeutically achievable concentrations.

    PubMed

    Koelsch, Maud; Mallak, Roger; Graham, Garry G; Kajer, Tracey; Milligan, Marian K; Nguyen, Ly Q; Newsham, Dawn W; Keh, Jeremy S; Kettle, Anthony J; Scott, Kieran F; Ziegler, John B; Pattison, David I; Fu, Shanlin; Hawkins, Clare L; Rees, Martin D; Davies, Michael J

    2010-04-15

    The heme peroxidase enzyme myeloperoxidase (MPO) is released by activated neutrophils and monocytes, where it uses hydrogen peroxide (H(2)O(2)) to catalyze the production of the potent oxidants hypochlorous acid (HOCl), hypobromous acid (HOBr) and hypothiocyanous acid (HOSCN) from halide and pseudohalide (SCN(-)) ions. These oxidants have been implicated as key mediators of tissue damage in many human inflammatory diseases including atherosclerosis, asthma, rheumatoid arthritis, cystic fibrosis and some cancers. It is shown here that acetaminophen (paracetamol), a phenol-based drug with analgesic and antipyretic actions, is an efficient inhibitor of HOCl and HOBr generation by isolated MPO-H(2)O(2)-halide systems. With physiological halide concentrations, acetaminophen concentrations required for 50% inhibition of oxidant formation (IC(50)) were 77+/-6microM (100mMCl(-)) and 92+/-2microM (100mMCl(-) plus 100microMBr(-)), as measured by trapping of oxidants with taurine. The IC(50) for inhibition of HOCl generation by human neutrophils was ca. 100microM. These values are lower than the maximal therapeutic plasma concentrations of acetaminophen (< or =150microM) resulting from typical dosing regimes. Acetaminophen did not diminish superoxide generation by neutrophils, as measured by lucigenin-dependent chemiluminescence. Inhibition of HOCl production was associated with the generation of fluorescent acetaminophen oxidation products, consistent with acetaminophen acting as a competitive substrate of MPO. Inhibition by acetaminophen was maintained in the presence of heparan sulfate and extracellular matrix, materials implicated in the sequestration of MPO at sites of inflammation in vivo. Overall, these data indicate that acetaminophen may be an important modulator of MPO activity in vivo. 2009 Elsevier Inc. All rights reserved.

  11. Safety of tomatillos and products containing tomatillos canned by the water-bath canning method.

    PubMed

    McKee, L H; Remmenga, M D; Bock, M A

    1998-01-01

    Three studies were conducted to evaluate the safety of tomatillos and products containing tomatillos canned by the water-bath processing method. In the first study, plain tomatillos were processed for 25, 37.5, 50 and 62.5 min. In the second study, five tomatillo/onion combinations were prepared while five tomatillo/green chile combinations were prepared in the third study. pH evaluations were conducted to determine safety in all studies using pH 4.2 as the cut-off value. No differences in the pH of plain tomatillos were detected due to processing time. All jars of plain tomatillos had pH values below 4.1. All combinations of tomatillos/onions and tomatillos/green chile containing more than 50% tomatillo had pH values below the 4.2 cut-off value. Results of the three studies indicate (1) acidification of plain tomatillos is probably unnecessary for canning by the water-bath processing method and (2) combinations of acidic tomatillos and low-acid onions or green chile must contain more than 50% tomatillos to have a pH low enough for safe water-bath processing.

  12. Applying Toyota production system techniques for medication delivery: improving hospital safety and efficiency.

    PubMed

    Newell, Terry L; Steinmetz-Malato, Laura L; Van Dyke, Deborah L

    2011-01-01

    The inpatient medication delivery system used at a large regional acute care hospital in the Midwest had become antiquated and inefficient. The existing 24-hr medication cart-fill exchange process with delivery to the patients' bedside did not always provide ordered medications to the nursing units when they were needed. In 2007 the principles of the Toyota Production System (TPS) were applied to the system. Project objectives were to improve medication safety and reduce the time needed for nurses to retrieve patient medications. A multidisciplinary team was formed that included representatives from nursing, pharmacy, informatics, quality, and various operational support departments. Team members were educated and trained in the tools and techniques of TPS, and then designed and implemented a new pull system benchmarking the TPS Ideal State model. The newly installed process, providing just-in-time medication availability, has measurably improved delivery processes as well as patient safety and satisfaction. Other positive outcomes have included improved nursing satisfaction, reduced nursing wait time for delivered medications, and improved efficiency in the pharmacy. After a successful pilot on two nursing units, the system is being extended to the rest of the hospital.

  13. 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. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Safety assessment and public concern for genetically modified food products: the European view.

    PubMed

    Moseley, Bevan E B

    2002-01-01

    The safety assessment for marketing purposes of genetically modified (GM) foods in the 15 Member States of the European Union (EU) is based on the Novel Foods and Novel Food Ingredients Regulation adopted in May 1997. Before a GM food can be approved under the Regulation, it must satisfy three criteria: Gm food must be safe, it must not mislead the consumer and it must be nutritionally adequate. The EU Scientific Committee on Food has published a set of guidelines describing the type of information expected from a company in support of an application for approval of a GM food or food ingredient. Despite this rigorous procedure and there being no evidence of harm resulting from the consumption of GM foods worldwide, there is essentially no market in the EU for such products at present. Possible reasons for this are discussed and the view put forward that the market for GM foods will change only when there are more clearly perceived consumer benefits.

  15. 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.

  16. Ugba, the fermented African oilbean seeds; its production, chemical composition, preservation, safety and health benefits.

    PubMed

    Ogueke, C C; Nwosu, J N; Owuamanam, C I; Iwouno, J N

    2010-05-15

    Ugba is the Ibo name of the fermented African Oilbean seeds (Pentaclethra macrophylla, Benth). It is a traditional food condiment generally produced by natural (local) fermentation in homes as a small family business. It is an important and cheap source of protein for people whose staple foods are deficient in proteins. It is also eaten as a delicacy and used as flavouring for soup. This write up aims to review all published studies on ugba in the direction of the various methods used in the production, the chemical composition of the seeds, the microorganisms involved and the biochemical changes that occur during fermentation and optimization of the fermentation. The nutritional and food values, toxicological properties, health promoting potentials, microbiological safety as well as the storage and preservation have also been highlighted.

  17. 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

  18. 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

  19. 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

    2014-12-15

    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.

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

    DOE PAGES

    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

  1. One manufacturer's approach to using nucleic acid testing for enhanced plasma-product safety.

    PubMed

    Liss, A

    2001-04-01

    Source plasma must contain the lowest possible pathogen bioburden so as to minimize the stress placed on subsequent viral reduction steps. Differences exist between European and US criteria for developing assays used to detect these viral pathogens. The approach used by 1 plasma-product manufacturer is described here. By adding polymerase chain reaction (PCR) detection techniques for various viral pathogens (including human immunodeficiency virus-1, hepatitis C virus, and hepatitis B virus) to the plasma screening process, this manufacturer maximizes the use of cutting-edge technology for plasma product safety while satisfying both European and US criteria and requirements for this process. The protocol begins with maxipool testing and eventually identifies any specific donor plasma that might be positive in the contributing minipools. The goal is to identify reactive donors for possible periodic monitoring and to use only nonreactive donations to continue producing a particular plasma product. Controversy surrounding the use of PCR to screen emerging organisms of questionable pathogenicity or known organisms that are of minimal pathogenicity for most of the population is also discussed, and possible solutions to this debate are provided.

  2. Costs and benefits of communicating product safety information to the public via the Internet.

    PubMed

    Saoutert, Erwan; Andreasen, Ina

    2006-04-01

    Procter & Gamble (P&G) developed Science-in-the-Box (SIB; www.scienceinthebox.com) after discussions with their stakeholders as to how the consumer products company could better communicate key environmental performance and safety information to the public. A series of workshops enabled P&G to understand that consumers and other key business decision makers wanted meaningful information about the science behind P&G products. In addition, it was clear that making such information available would produce business benefits by encouraging long-term relationships with decision makers ranging from consumers and retailers to policy makers and nongovernmental organizations. These benefits were not necessarily quantifiable in the short term, but they still had to be balanced by the costs in terms of resource commitment and potential intellectual property issues. Since its inception in September 2002, SIB has successfully reached key target audiences and built improved credibility and confidence in P&G products and approaches. The website is now available in English, French, Spanish, German, and Italian and is used by consumers, journalists, teachers, scientists, and policy makers. Several user surveys carried out during the initial developmental period, together with unsolicited e-mail feedback, have demonstrated that SIB has successfully created a platform for continuous dialogue with consumers and other interested parties.

  3. Technology and safety assessment for lactic acid bacteria isolated from traditional Bulgarian fermented meat product "lukanka".

    PubMed

    Todorov, Svetoslav Dimitrov; Stojanovski, Saso; Iliev, Ilia; Moncheva, Penka; Nero, Luis Augusto; Ivanova, Iskra Vitanova

    The present work discusses the technological and new selection criteria that should be included for selecting lactic acid bacteria for production of fermented meat. Lactic acid bacteria isolated from Bulgarian traditional fermented "lulanka" salami was studied regarding some positive technological parameters (growth at different temperature, pH, and proteolytic activity). The presence of genes related to the virulence factors, production of biogenic amines, and vancomycin resistance were presented in low frequency in the studied lactic acid bacteria. On the other hand, production of antimicrobial peptides and high spread of bacteriocin genes were broadly presented. Very strong activity against L. monocytogenes was detected in some of the studied lactic acid bacteria. In addition, the studied strains did not present any antimicrobial activity against tested closely related bacteria such as Lactobacillus spp., Lactococcus spp., Enterococcus spp. or Pediococcus spp. To our knowledge this is the first study on the safety and antimicrobial properties of lactic acid bacteria isolated from Bulgarian lukanka obtained by spontaneous fermentation. Copyright © 2017 Sociedade Brasileira de Microbiologia. Published by Elsevier Editora Ltda. All rights reserved.

  4. 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.

  5. Occupational health and safety assessment of exposure to jet fuel combustion products in air medical transport.

    PubMed

    MacDonald, Russell D; Thomas, Laura; Rusk, Frederick C; Marques, Shauna D; McGuire, Dan

    2010-01-01

    Transport medicine personnel are potentially exposed to jet fuel combustion products. Setting-specific data are required to determine whether this poses a risk. This study assessed exposure to jet fuel combustion products, compared various engine ignition scenarios, and determined methods to minimize exposure. The Beechcraft King Air B200 turboprop aircraft equipped with twin turbine engines, using a kerosene-based jet fuel (Jet A-1), was used to measure products of combustion during boarding, engine startup, and flight in three separate engine start scenarios ("shielded": internal engine start, door closed; "exposed": ground power unit start, door open; and "minimized": ground power unit right engine start, door open). Real-time continuous monitoring equipment was used for oxygen, carbon dioxide, carbon monoxide, nitrogen dioxide, hydrogen sulfide, sulfur dioxide, volatile organic compounds, and particulate matter. Integrated methods were used for aldehydes, polycyclic aromatic hydrocarbons, volatile organic compounds, and aliphatic hydrocarbons. Samples were taken in the paramedic breathing zone for approximately 60 minutes, starting just before the paramedics boarded the aircraft. Data were compared against regulated time-weighted exposure thresholds to determine the presence of potentially harmful products of combustion. Polycyclic aromatic hydrocarbons, aldehydes, volatile organic compounds, and aliphatic hydrocarbons were found at very low concentrations or beneath the limits of detection. There were significant differences in exposures to particulates, carbon monoxide, and total volatile organic compound between the "exposed" and "minimized" scenarios. Elevated concentrations of carbon monoxide and total volatile organic compounds were present during the ground power unit-assisted dual-engine start. There were no appreciable exposures during the "minimized" or "shielded" scenarios. Air medical personnel exposures to jet fuel combustion products were

  6. Achieving partnership: the contribution of nursing education to the production of a flexible workforce.

    PubMed

    Flanagan, J

    1998-05-01

    This paper examines education's contribution to labour force reform in the nursing profession within the United Kingdom. In a globalized society there is increasing demand for more flexible forms of working. Nursing faces radical change in its employment characteristics if it is to continue to meet the health care needs of the population in the new century. ORIGINS OF INFORMATION AND DATA ANALYSIS: Key sociological texts and contemporary analysis of nursing skill have been analysed and synthesized to identify the dynamic of change in nursing and nursing education's contribution to these changes. Patterns of upskilling and multiskilling are leading to the breakdown of professional role boundaries in the broader workforce. These patterns can also be seen in nursing. Upskilling is associated with increased stress and 'risk' for the individual, therefore achievement of flexibility is not without cost. Changes in the skill level in nursing lead many to conclude that the profession will become divided into a core and periphery distinction. This simplistic analysis does not account for the complexities of nursing and nursing skill although there is clearly a growing need for a 'knowledge and technical elite'. The core-periphery distinction is too simplistic to analyse nursing skills and the dynamic of change in the workforce. A radical perspective of nursing characterized by workers with a range of skills and competencies is less likely to lead to rigid professional boundaries. There is a clear need for multiskilled and knowledgeable workers; the 'technical and knowledge elite'. These nurses may be recognized as advanced practice nurses. High quality education is required to prepare these practitioners. Adaptation of nursing to the postmodern world needs to be facilitated by changes in current educational policy and practice.

  7. 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.

  8. 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

  9. 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

  10. Oxidation and volatilization of a niobium alloy. Fusion Safety Program/Activation Products Task

    SciTech Connect

    Smolik, G.R.; McCarthy, K.A.

    1992-07-01

    This report presents the findings from a preliminary investigation into oxidation and volatilization characteristics of a niobium alloy. Niobium is a candidate alloy for use in plasma facing components (PFCS) in experimental fusion reactors like the Intemational Thermonuclear Experimental Reactor (ITER). An experimental alloy was tailored to simulate small changes in chemistry which could result from transmutations from irradiation. The alloy was exposed in air and steam between 800{degree}C and 1200{degree}C. Volatilized products and hydrogen were collected and measured. Post-test examinations were also performed on the samples to determine the amount of material loss during the exposures. The obtained measurements of volatilization flux (g/m{sup 2}-s), hydrogen generation rates (liters/m{sup 2}-s), and recession rates (mm/s) are data which can be used for safety analyses and material performance to predict consequences which may result from an accident involving the ingress of air or steam into the plasma chamber of fusion reactor. In our volatility tests, only molybdenum and niobium were found at release levels above the detection limit. Although molybdenum is present at only 0.12 wt%, the quantities of this element volatilized in air are nearly comparable to the quantities of niobium released. The niobium release in steam is only three to four times higher than that of molybdenum in steam. The hydrogen production of the niobium alloy is compared with other PFC materials that we have tested, specifically, beryllium, graphite, and a tunesten alloy. At high temperatures, the hydrogen production rate of the niobium alloy is among the lowest of these materials, significantly lower than beryllium. To understand what this means in an accident situation, modeling is necessary to predict temperatures, and therefore total hydrogen production. The INEL is currently doing this modeling.

  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.

  12. 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

  13. Effect of fermented soybean products intake on the overall immune safety and function in mice

    PubMed Central

    Lee, Jae Hee; Paek, Se Hee; Shin, Hye Won; Lee, Seung Yeon; Moon, Byoung Seok; Park, Jung Eun; Lim, Gyeong Dong; Kim, Chang Yul

    2017-01-01

    Various functional activities have been reported for the fermented soybean products doenjang (DJ) and cheonggukjang (CGJ), although no systemic investigations of their immune functions have been conducted to date. We examined the effects of an experimental diet of DJ, CGJ, or a mixture of unfermented raw material for 4 weeks on overall immunity and immune safety in mice. No significant alterations were observed in peripheral or splenic immune cells among groups. Enhanced splenic natural killer cell activity was observed in the DJ and CGJ groups compared with the plain diet group. T helper type-1 (Th1)-mediated immune responses were enhanced in the DJ and CGJ groups with an upregulated production ratio of IFN-γ vs. IL-4 and IgG2a vs. IgG1 in stimulated splenic T and B cells, respectively. Resistance to Listeria monocytogenes infection was observed in the DJ and CGJ groups. Overall, the results of this study suggest that DJ and CGJ intake consolidates humoral and cellular immunity to Th1 responses. PMID:27030201

  14. 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.)

  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. Fire safety

    Treesearch

    Robert H. White; Mark A. Dietenberger

    1999-01-01

    Fire safety is an important concern in all types of construction. The high level of national concern for fire safety is reflected in limitations and design requirements in building codes. These code requirements are discussed in the context of fire safety design and evaluation in the initial section of this chapter. Since basic data on fire behavior of wood products...

  17. 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.

  18. 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.

  19. Former food products safety: microbiological quality and computer vision evaluation of packaging remnants contamination.

    PubMed

    Tretola, M; Di Rosa, A R; Tirloni, E; Ottoboni, M; Giromini, C; Leone, F; Bernardi, C E M; Dell'Orto, V; Chiofalo, V; Pinotti, L

    2017-08-01

    The use of alternative feed ingredients in farm animal's diets can be an interesting choice from several standpoints, including safety. In this respect, this study investigated the safety features of selected former food products (FFPs) intended for animal nutrition produced in the framework of the IZS PLV 06/14 RC project by an FFP processing plant. Six FFP samples, both mash and pelleted, were analysed for the enumeration of total viable count (TVC) (ISO 4833), Enterobacteriaceae (ISO 21528-1), Escherichia coli (ISO 16649-1), coagulase-positive Staphylococci (CPS) (ISO 6888), presumptive Bacillus cereus and its spores (ISO 7932), sulphite-reducing Clostridia (ISO 7937), yeasts and moulds (ISO 21527-1), and the presence in 25 g of Salmonella spp. (ISO 6579). On the same samples, the presence of undesired ingredients, which can be identified as remnants of packaging materials, was evaluated by two different methods: stereomicroscopy according to published methods; and stereomicroscopy coupled with a computer vision system (IRIS Visual Analyzer VA400). All FFPs analysed were safe from a microbiological point of view. TVC was limited and Salmonella was always absent. When remnants of packaging materials were considered, the contamination level was below 0.08% (w/w). Of note, packaging remnants were found mainly from the 1-mm sieve mesh fractions. Finally, the innovative computer vision system demonstrated the possibility of rapid detection for the presence of packaging remnants in FFPs when combined with a stereomicroscope. In conclusion, the FFPs analysed in the present study can be considered safe, even though some improvements in FFP processing in the feeding plant can be useful in further reducing their microbial loads and impurity.

  20. [Historical and Hygienic Aspects on Roles of Quality Requirements for Antibiotic Products in Japan: Part 2--Achievements of Domestic Production of Penicillin and Streptomycin].

    PubMed

    Yagisawa, Morimasa; Foster, Patrick J; Kurokawa, Tatsuo

    2015-01-01

    Domestic production of penicillin was initiated in 1946 and that of streptomycin in 1950. In the early days, however, the quality of products was considerably lower and the capacity of production small. Surprisingly, there was a sufficient amount of penicillin preparations, with a purity of 85% or more, satisfying domestic demand within three years (1949). In the case of streptomycin, within three years (1953), preparations with a purity two-fold higher than initially available were produced in amounts sufficient to meet both domestic demand and create a surplus availability for exporting purposes. Such increases in quality and production were considered to be made possible by strict quality control of penicillin and streptomycin preparations, based on "Minimum Requirements for Penicillin" established in May 1947 and "Minimum Requirements for Streptomycin" established in December 1949. These requirements were also amended over time in order to provide even higher quality standards in response to the evolving improvements in production processes. Life-threatening diseases such as septicemia and pneumonia were controlled by the sufficient supply of high-quality penicillin preparations and the mortality rate of tuberculosis, regarded as a national disease at the time, markedly decreased by that of streptomycin preparations. Achievements of domestic production of penicillin and streptomycin were considered important factors that contributed greatly to the maintenance of public health in Japan.

  1. Achieving high lipid productivity of a thermotolerant microalga Desmodesmus sp. F2 by optimizing environmental factors and nutrient conditions.

    PubMed

    Ho, Shih-Hsin; Chang, Jo-Shu; Lai, Yen-Ying; Chen, Ching-Nen Nathan

    2014-03-01

    The optimal conditions for cultivating the thermotolerant lipid-rich microalga Desmodesmus sp. F2 to achieve maximal lipid productivity were determined in this study. The conditions were light intensity, 700μmol/m(2)s; temperature, 35°C; cultivation nitrogen source, nitrate; initial nitrogen level, 6.6mM nitrogen. Carbon dioxide (2.5%, 0.2 vvm) was pumped into the cultures continuously. In the pre-optimized conditions, the maximal lipid productivity of this microalga was 113mg/L/d, which was raised to 263mg/L/d in the optimized conditions. This level of lipid productivity of microalgae is the highest ever reported in the literature. Fatty acid composition of the lipid produced by Desmodesmus sp. F2 in the optimal conditions was determined, in which C16 and C18 species accounted for 95% of the fatty acids. Saturated, monounsaturated and polyunsaturated fatty acids accounted for 38.9%, 33.1% and 22.6%, respectively. Based on the analysis, this lipid quality makes it a good feedstock for biodiesel production.

  2. 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

  3. 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.

  4. International trade standards for commodities and products derived from animals: the need for a system that integrates food safety and animal disease risk management.

    PubMed

    Thomson, G R; Penrith, M-L; Atkinson, M W; Thalwitzer, S; Mancuso, A; Atkinson, S J; Osofsky, S A

    2013-12-01

    A case is made for greater emphasis to be placed on value chain management as an alternative to geographically based disease risk mitigation for trade in commodities and products derived from animals. The geographic approach is dependent upon achievement of freedom in countries or zones from infectious agents that cause so-called transboundary animal diseases, while value chain-based risk management depends upon mitigation of animal disease hazards potentially associated with specific commodities or products irrespective of the locality of production. This commodity-specific approach is founded on the same principles upon which international food safety standards are based, viz. hazard analysis critical control points (HACCP). Broader acceptance of a value chain approach enables animal disease risk management to be combined with food safety management by the integration of commodity-based trade and HACCP methodologies and thereby facilitates 'farm to fork' quality assurance. The latter is increasingly recognized as indispensable to food safety assurance and is therefore a pre-condition to safe trade. The biological principles upon which HACCP and commodity-based trade are based are essentially identical, potentially simplifying sanitary control in contrast to current separate international sanitary standards for food safety and animal disease risks that are difficult to reconcile. A value chain approach would not only enable more effective integration of food safety and animal disease risk management of foodstuffs derived from animals but would also ameliorate adverse environmental and associated socio-economic consequences of current sanitary standards based on the geographic distribution of animal infections. This is especially the case where vast veterinary cordon fencing systems are relied upon to separate livestock and wildlife as is the case in much of southern Africa. A value chain approach would thus be particularly beneficial to under-developed regions of

  5. 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... Firefighting systems. Sec. 250.862 Fire and gas- detection systems. Sec. 250.863 Electrical equipment. Sec. 250... the fire and gas- showing a functional block diagram detection systems. of the detection...

  6. Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2009-01-13

    businesses. • On July 4, 2007, the China Daily reported that the government had finished making amendments to all food safety standards and had...established an emergency response mechanism among several ministries to deal with major problems regarding food safety . • On August 9, 2007, China Daily...reported that the government had pledged to spend $1 billion by 2010 to improve drug and food safety . • On August 15, 2007, a spokesperson from the

  7. Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2008-09-22

    152,000 unlicensed food businesses. ! On July 4, 2007, the China Daily reported that the government had finished making amendments to all food safety standards...and had established an emergency response mechanism among several ministries to deal with major problems regarding food safety . ! On August 9...2007, China Daily reported that the government had pledged to spend $1 billion by 2010 to improve drug and food safety . ! On August 15, 2007, a

  8. 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.

  9. 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

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

    PubMed

    Adimpong, David B; Nielsen, Dennis S; Sørensen, Kim I; Derkx, Patrick M F; Jespersen, Lene

    2012-05-17

    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. 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 and Lb. plantarum

  11. Exploring the potential of Product Service Systems to achieve household waste prevention on new housing developments in the UK.

    PubMed

    Gottberg, Annika; Longhurst, Philip J; Cook, Matthew B

    2010-03-01

    Product service systems (PSS) are cleaner product concepts which have been developed to achieve improvements in resource productivity which may be realized from modern trends in service delivery. However, there is a paucity of research on the waste prevention performance of PSS in UK household markets. This paper reports the findings of exploratory research which begins to address this gap in knowledge. An exploratory waste prevention assessment was completed on four experimental PSS which were developed in conjunction with a major UK house-builder for delivery on their new housing developments. The results of the assessment show that the selected PSS concepts have potential to prevent high value and harmful Waste Electrical and Electronic Equipment (WEEE) arising in UK household waste streams. Consistent with the canon of exploratory research, the assessment also identifies a number of factors which are thought to influence PSS waste prevention performance. It is recognized that further research is needed to gain an in-depth understanding of these factors as well as to define policy measures which enable the conditions in which PSS prevent household waste on new housing developments in the UK to be created.

  12. Product, not process! Explaining a basic concept in agricultural biotechnologies and food safety.

    PubMed

    Tagliabue, Giovanni

    2017-12-01

    Most life scientists have relentlessly recommended any evaluative approach of agri-food products to be based on examination of the phenotype, i.e. the actual characteristics of the food, feed and fiber varieties: the effects of any new cultivar (or micro-organism, animal) on our health are not dependent on the process(es), the techniques used to obtain it.The so-called "genetically modified organisms" ("GMOs"), on the other hand, are commonly framed as a group with special properties - most frequently seen as dubious, or even harmful.Some social scientists still believe that considering the process is a correct background for science-based understanding and regulation. To show that such an approach is utterly wrong, and to invite scientists, teachers and science communicators to explain this mistake to students, policy-makers and the public at large, we imagined a dialogue between a social scientist, who has a positive opinion about a certain weight that a process-based orientation should have in the risk assessment, and a few experts who offer plenty of arguments against that view. The discussion focuses on new food safety.

  13. Safety of L-proline as a stabilizer for immunoglobulin products.

    PubMed

    Hagan, John B; Wasserman, Richard L; Baggish, Jeffrey S; Spycher, Martin O; Berger, Melvin; Shashi, Vandana; Lohrmann, Emanuel; Sullivan, Kathleen E

    2012-02-01

    Privigen(®) (immune globulin intravenous [human], 10% liquid) and Hizentra(®) (immune globulin subcutaneous [human], 20% liquid) are stabilized by proline. The clinical implications of administering proline-containing immunoglobulin products to patients with defects of proline metabolism have not been addressed; Privigen and Hizentra are contraindicated in these patients. Some patients with chromosome 22q11.2 deletion syndrome have elevated proline levels; however, only 3-4% of patients also have an immunodeficiency that requires IgG therapy. This review summarizes the evidence related to the safety and pharmacokinetics of proline assessed in Privigen and Hizentra preclinical and clinical studies, and subsequent implications for patients with defects in proline metabolism. Clinical data indicate that proline does not accumulate after Privigen or Hizentra treatment and is not associated with adverse events. There is no evidence to suggest that patients with defects of proline metabolism would be affected by transient elevations in plasma proline following Privigen and/or Hizentra treatment.

  14. 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.

  15. Animal production food safety: priority pathogens for standard setting by the World Organisation for Animal Health.

    PubMed

    Knight-Jones, T J D; Mylrea, G E; Kahn, S

    2010-12-01

    In this short study, expert opinion and a literature review were used to identify the pathogens that should be prioritised by the World Organisation for Animal Health (OIE) for the development of future standards for animal production food safety. Prioritisation was based on a pathogen's impact on human health and amenability to control using on-farm measures. As the OIE mandate includes alleviation of global poverty, the study focused on developing countries and those with 'in-transition' economies. The regions considered were Eastern Europe, Asia, the Middle East, Africa and South America. Salmonella (from species other than poultry) and pathogenic Escherichia coli were considered to be top priorities. Brucella spp., Echinococcus granulosus and Staphylococcus aureus were also mentioned by experts. As Salmonella, and to a lesser extent pathogenic E. coli, can be controlled by on-farm measures, these pathogens should be considered for prioritisation in future standard setting. On-farm control measures for Brucella spp. will be addressed in 2010-2011 in a review of the OLE Terrestrial Animal/Health Code chapter on brucellosis. In Africa, E. granulosus, the causative agent of hydatidosis, was estimated to have the greatest impact of all pathogens that could potentially be transmitted by food (i.e. via contamination). It was also listed for the Middle East and thought to be of importance by both South American experts consulted. Taenia saginata was thought to be of importance in South America and Africa and by one expert in the Middle East.

  16. Uptake of health insurance and the productive safety net program in rural Ethiopia.

    PubMed

    Shigute, Zemzem; Mebratie, Anagaw D; Sparrow, Robert; Yilma, Zelalem; Alemu, Getnet; Bedi, Arjun S

    2017-03-01

    Due to lack of well-developed insurance and credit markets, rural families in Ethiopia are exposed to a range of covariate and idiosyncratic risks. In 2005, to deal with the consequences of covariate risks, the government implemented the Productive Safety Net Program (PSNP), and in 2011, to mitigate the financial consequences of ill-health, the government introduced a pilot Community Based Health Insurance (CBHI) Scheme. This paper explores whether scheme uptake and retention is affected by access to the PSNP. Based on household panel data and qualitative information, the analysis shows that participating in the PSNP increases the probability of CBHI uptake by 24 percentage points and enhances scheme retention by 10 percentage points. A large proportion of this effect may be attributed to explicit and implicit pressure applied by government officials on PSNP beneficiaries. Whether this is a desirable approach is debatable. Nevertheless, the results suggest that membership in existing social protection programs may be leveraged to spread new schemes and potentially accelerate poverty reduction efforts. Copyright © 2017 Elsevier Ltd. All rights reserved.

  17. 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.

  18. 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.

  19. A risk-based, product-level approach for assuring aquatic environmental safety of cleaning products in the context of sustainability: The Environmental Safety Check (ESC) scheme of the A.I.S.E. Charter for Sustainable Cleaning.

    PubMed

    Pickup, John Alexander; Dewaele, Joost; Furmanski, Nicola L; Kowalczyk, Agnieszka; Luijkx, Gerard Ca; Mathieu, Sophie; Stelter, Norbert

    2017-01-01

    Cleaning products have long been a focus of efforts to improve sustainability and assure safety for the aquatic environment when disposed of after use. The latter is addressed at ingredient level through environmental risk assessment, including in formal frameworks such as REACH. Nevertheless, in the context of programs to improve overall sustainability, stakeholders demand both environmental safety assurance and progress at product level. Current product-level approaches for aquatic toxicity (e.g., USEtox™, Critical Dilution Volume) can be seen as predominantly hazard-based. The more logical approach would be risk-based, because ecotoxicity is generally threshold-dependent and hazard-based assessment produces conflicts with risk-based learnings. The development of a risk-based approach to assess formulated products is described: the International Association for Soaps, Detergents and Maintenance Products (A.I.S.E.) Charter Environmental Safety Check (ESC), which is consistent with the scientific principles underlying REACH. This is implemented through a simple spreadsheet tool and internal database of ingredient parameters including predicted no-effect concentration (PNEC) and removal rate. A novel feature is applying market volume information for both product types and ingredients to permit a risk-based calculation. To pass the ESC check, the projected environmental safety ratio (PESR) for each ingredient as formulated and dosed (unless cleared by a published risk assessment or exempted as inherently low risk) must be less than 1. The advantages of a risk-based approach are discussed. The strengths and limitations of various possible approaches to standard-setting, product-ranking and driving continuous improvement in respect of potential ecotoxic impacts on the aquatic environment are considered. It is proposed that as ecotoxicity is generally accepted to be threshold-dependent, with no effect below the threshold, the most constructive approach to continuous

  20. Factors that contribute to the botulinal safety of reduced-fat and fat-free process chesse products.

    PubMed

    Glass, Kathleen A; Johnson, Eric A

    2004-08-01

    The effects of fat, type of natural cheese, and adjunct process cheese ingredients were evaluated to determine factors that contribute to the botulinal safety of reduced-fat (RF) process cheese products stored at 30 degrees C. In the first set of experiments, pasteurized process cheese products (PPCPs) were formulated using full-fat (FF) Cheddar, 30% RF Cheddar, or skim milk (SM) cheese as cheese-base types and were standardized to 59% moisture, pH 5.75, 2.8 or 3.2% total salts, and 15 to 19% fat. Subsequent trials evaluated the effect of fat levels and adjunct ingredients in PPCPs made with SM, RF, and FF cheese (final fat levels, less than 1, 13, and 24%, respectively). When fat levels of PPCPs were comparable (15.1, 19.1, and 16.2 for product manufactured with SC, RE and FF cheese, respectively), botulinal toxin production was delayed for up to 2 days in PPCPs formulated with SM compared with RF or FF cheese; however, the effect was not statistically significant. When fat levels were reduced to less than 1% in SM PPCPs, toxin production was delayed 2 weeks in products made with SM compared with RF or FF cheese manufactured with 13 or 24% fat, respectively. The antibotulinal effect of adjunct ingredients varied among the products manufactured with different fat levels. Sodium lactate significantly delayed toxin production (P < 0.05) for all fat levels tested, whereas beta-glucan fat replacer did not delay toxin production. An enzyme-modified cheese used as a flavor enhancer significantly delayed toxin production (P < 0.05) in SM (less than 1% fat) products but had little to no inhibitory effect in RF (13% fat) and FF (24% fat) cheese products. Similarly, monolaurin increased the time to detectable toxin in SM products but was ineffective in RF or FF cheese products. These results verify that RF PPCPs exhibit greater safety than FF products and that safety may be enhanced by using certain adjunct ingredients as antimicrobials.

  1. Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product.

    PubMed

    Abdalla, Abuelmagd; Byrne, Niamh; Conway, Richard; Walsh, Thomas; Mannion, Geraldine; Hanly, Michael; O'Sullivan, Miriam; Curran, Ann Maria; Carey, John J

    2017-01-01

    To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab. Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost.

  2. Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System.

    PubMed

    Jenke, Dennis

    2012-01-01

    An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered. Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

  3. Comparative safety profile of hyaluronic acid products for knee osteoarthritis: a systematic review and network meta-analysis.

    PubMed

    Bannuru, R R; Osani, M; Vaysbrot, E E; McAlindon, T E

    2016-12-01

    Intra-articular (IA) hyaluronic acid (HA) is considered a safer alternative to oral Non-Steroidal Antiinflammatory Drugs (NSAIDs) and opioids for knee osteoarthritis (OA). A recent review raised potential safety concerns about HA, warranting further review of safety outcomes. We examined the risks of HA compared with IA placebo and investigated whether the risks vary among individual HA preparations. We searched all relevant databases from inception to October 2015 and sought unpublished data. We included all knee OA trials which compared any of the 18 HA products and reported on adverse events (AEs) and withdrawals. We calculated odds ratios for safety data reported at the longest follow-up. Network meta-analysis was performed using a Bayesian hierarchical random effects model for mixed multiple treatment comparisons. We identified 74 studies involving 13,032 participants aged between 45 and 75 years. The proportion of women ranged from 28% to 100%. The overall incidence of local reactions reported across all products was 8.5%. Commonly reported AEs were transient local reactions, such as pain, swelling and arthralgia, which subsided rapidly. None of the HA products were statistically significantly different from IA placebo or from each other with regard to incidence of AEs. Three treatment-related serious adverse events (SAEs) were reported among 9214 participants. Given the very low incidence of any particular AEs, we conclude that HA products are relatively well tolerated. These products have a similar safety profile compared to each other. This information along with the comparative effectiveness profile and relative cost would be helpful for clinicians in delivering individualized patient care. Copyright © 2016 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  4. Safety risk categorization of organic extractables associated with polymers used in packaging, delivery and manufacturing systems for parenteral drug products.

    PubMed

    Jenke, Dennis

    2015-03-01

    To develop and justify a Risk Evaluation Matrix for estimating the safety risk associated with extractables from plastic materials used in pharmaceutical applications and to apply that matrix to approximately 510 extractables to assess the risk that they would accumulate in drug products at levels sufficiently high to affect patient safety. The Risk Evaluation Matrix considers toxicological, availability and solubility characteristics of extractables. Safety Risk categories were established based on certain scaled values for these characteristics, Total Risk Scores were calculated for each extractable and the extractables were categorized with respect to their safety risk based on these calculations. The Total Risk Scores were normally distributed around a value of 20 to 23, corresponding to safety risk categories of moderate and intermediate risk. The range in Risk Scores defined by the mean ± one standard deviation encompassed the entire region of moderate and intermediate risk. Approximately 15% of the extractables were categorized as lowest risk while 3% of the extractables were categorized as highest risk. Categorization of extractables could facilitate the selection of materials for use in pharmaceutical systems, the analytical testing of extracts and the selection of target extractables.

  5. 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.

  6. 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. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. 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

  8. Opinion of the Scientific Committee on Consumer safety (SCCS) - Opinion on the safety of the use of Methylisothiazolinone (MI) (P94), in cosmetic products (sensitisation only).

    PubMed

    Scientific Committee Of Consumer Safety-Sccs; Giménez-Arnau, A M

    2016-04-01

    The information provided does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy. For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy. The information provided does not support the safe use of MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy. The concerns and opinions raised in SCCS Opinion SCCS/1521/13 (12 December 2013 with revision 27 March 2014) remain. The results of the recent Scandinavian study do not support safety of MI in rinse-off products at either 100 ppm or at 50 ppm for elicitation or induction. Copyright © 2016. Published by Elsevier Inc.

  9. 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

  10. 60th Anniversary of electricity production from light water reactors: Historical review of the contribution of materials science to the safety of the pressure vessel

    NASA Astrophysics Data System (ADS)

    van Duysen, J. C.; Meric de Bellefon, G.

    2017-02-01

    The first light water nuclear reactor dedicated to electricity production was commissioned in Shippingport, Pennsylvania in the United States in 1957. Sixty years after the event, it is clear that this type of reactor will be a major source of electricity and one of the key solutions to limit climate change in the 21st century. This article pays homage to the teams that contributed to this achievement by their involvement in research and development and their determination to push back the frontiers of knowledge. Via a few examples of scientific or technological milestones, it describes the evolution of ideas, models, and techniques during the last 60 years, and gives the current state-of-the-art in areas related to the safety of the reactor pressure vessel. Among other topics, it focuses on vessel manufacturing, steel fracture mechanics analysis, and understanding of irradiation-induced damage.

  11. Animal Drug Safety FAQs

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  12. Final report of the safety assessment of methacrylate ester monomers used in nail enhancement products.

    PubMed

    2005-01-01

    Methacrylate ester monomers are used in as artificial nail builders in nail enhancement products. They undergo rapid polymerization to form a hard material on the nail that is then shaped. While Ethyl Methacrylate is the primary monomer used in nail enhancement products, other methacrylate esters are also used. This safety assessment addresses 22 other methacrylate esters reported by industry to be present in small percentages as artificial nail builders in cosmetic products. They function to speed up polymerization and/or form cross-links. Only Tetrahydrofurfuryl Methacrylate was reported to the FDA to be in current use. The polymerization rates of these methacrylate esters are within the same range as Ethyl Methacrylate. While data are not available on all of these methacrylate esters, the available data demonstrated little acute oral, dermal, or i.p. toxicity. In a 28-day inhalation study on rats, Butyl Methacrylate caused upper airway irritation; the NOAEL was 1801 mg/m3. In a 28-day oral toxicity study on rats, t-Butyl Methacrylate had a NOAEL of 20 mg/kg/day. Beagle dogs dosed with 0.2 to 2.0 g/kg/day of C12 to C18 methacrylate monomers for 13 weeks exhibited effects only in the highest dose group: weight loss, emesis, diarrhea, mucoid feces, or salivation were observed. Butyl Methacrylate (0.1 M) and Isobutyl Methacrylate (0.1 M) are mildly irritating to the rabbit eye. HEMA is corrosive when instilled in the rabbit eye, while PEG-4 Dimethacrylate and Trimethylolpropane Trimethacrylate are minimally irritating to the eye. Dermal irritation caused by methacrylates is documented in guinea pigs and rabbits. In guinea pigs, HEMA, Isopropylidenediphenyl Bisglycidyl Methacrylate, Lauryl Methacrylate, and Trimethylolpropane Trimethacrylate are strong sensitizers; Butyl Methacrylate, Cyclohexyl Methacrylate, Hexyl Methacrylate, and Urethane Methacrylate are moderate sensitizers; Hydroxypropyl Methacrylate is a weak sensitizer; and PEG-4 Dimethacrylate and

  13. 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

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

    PubMed

    Heinrich, Michael

    2015-07-01

    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.

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

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... which Safety Analysis Checklists are included in API RP 14C you must utilize the analysis technique and... the type of decking, ceiling, walls (e.g., grating or solid) and firewalls; and (B) Location...

  16. A randomised controlled trial of the efficacy and safety of allopurinol dose escalation to achieve target serum urate in people with gout.

    PubMed

    Stamp, Lisa K; Chapman, Peter T; Barclay, Murray L; Horne, Anne; Frampton, Christopher; Tan, Paul; Drake, Jill; Dalbeth, Nicola

    2017-09-01

    To determine the efficacy and safety of allopurinol dose escalation using a treat-to-target serum urate (SU) approach. A randomised, controlled, parallel-group, comparative clinical trial was undertaken. People with gout receiving at least creatinine clearance (CrCL)-based allopurinol dose for ≥1 month and SU ≥6 mg/dL were recruited. Participants were randomised to continue current dose (control) or allopurinol dose escalation for 12 months. In the dose escalation group, allopurinol was increased monthly until SU was <6 mg/dL. The primary endpoints were reduction in SU and adverse events (AEs). 183 participants (93 control, 90 dose escalation) were recruited. At baseline, mean (SD) urate was 7.15 (1.6) mg/dL and allopurinol dose 269 mg/day. 52% had CrCL<60 mL/min. Mean changes in SU at the final visit were -0.34 mg/dL in the control group and -1.5 mg/dL in the dose escalation group (p<0.001) with a mean difference of 1.2 mg/dL (95% CI 0.67 to 1.5, p<0.001). At month 12, 32% of controls and 69% in the dose escalation had SU <6 mg/dL. There were 43 serious AEs in 25 controls and 35 events in 22 dose escalation participants. Only one was considered probably related to allopurinol. Five control and five dose escalation participants died; none was considered allopurinol related. Mild elevations in LFTs were common in both groups, a few moderate increases in gamma glutamyl transferase (GGT) were noted. There was no difference in renal function changes between randomised groups. Higher than CrCL-based doses of allopurinol can effectively lower SU to treatment target in most people with gout. Allopurinol dose escalation is well tolerated. ANZCTR12611000845932; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  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. [HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals].

    PubMed

    Gyalrong-Steur, Miriam; Kellermann, Anita; Bernard, Rudolf; Berndt, Georg; Bindemann, Meike; Nusser-Rothermundt, Elfriede; Amann, Steffen; Brakebusch, Myga; Brüggmann, Jörg; Tydecks, Eva; Müller, Markus; Dörje, Frank; Kochs, Eberhard; Riedel, Rainer

    2017-04-01

    In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands

  19. 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…

  20. 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

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

    PubMed

    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.

  2. There's No Place Like Home: Achieving Safety, Permanency, and Well-Being for Lesbian and Gay Adolescents in Out-of-Home Care Settings.

    ERIC Educational Resources Information Center

    Mallon, Gerald P.; Aledort, Nina; Ferrera, Michael

    2002-01-01

    Examined what challenges are presented in ensuring permanency, safety, and well-being for gay and lesbian youth in a gay-affirming child welfare environment. Found that the need remains to develop practice principles and guidelines specific to working toward permanency for these youth and to be more sensitive to their unique needs. (Author/SD)

  3. 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.

  4. 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

  5. Twenty-Two Years of U.S. Meat and Poultry Product Recalls: Implications for Food Safety and Food Waste.

    PubMed

    Gorton, Acton; Stasiewicz, Matthew J

    2017-04-01

    The U.S. Department of Agriculture, Food Safety and Inspection Service maintains a recall case archive of meat and poultry product recalls from 1994 to the present. In this study, we collected all recall records from 1994 to 2015 and extracted the recall date, meat or poultry species implicated, reason for recall, recall class, and pounds of product recalled and recovered. Of a total of 1,515 records analyzed, the top three reasons for recall were contamination with Listeria, undeclared allergens, and Shiga toxin-producing Escherichia coli . Class I recalls (due to a hazard with a reasonable probability of causing adverse health consequences or death) represented 71% (1,075 of 1,515) of the total recalls. The amounts of product recalled and recovered per event were approximately lognormally distributed. The mean amount of product recalled and recovered was 6,800 and 1,000 lb (3,087 and 454 kg), respectively (standard deviation, 1.23 and 1.56 log lb, respectively). The total amount of product recalled in the 22-year evaluation period was 690 million lb (313 million kg), and the largest single recall involved 140 million lb (64 million kg) (21% of the total). In every data category subset, the largest recall represented >10% of the total product recalled in the set. The amount of product recovered was known for only 944 recalls. In 12% of those recalls (110 of 944), no product was recovered. In the remaining recalls, the median recovery was 29% of the product. The number of recalls per year was 24 to 150. Recall counts and amounts of product recalled over the 22-year evaluation period did not regularly increase by year, in contrast to the regular increase in U.S. meat and poultry production over the same time period. Overall, these data suggest that (i) meat and poultry recalls were heavily skewed toward class I recalls, suggesting recalls were focused on improving food safety, (ii) numbers of products and amounts of each product recalled were highly variable but did

  6. 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.

  7. 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

  8. Safety Requirements for Home Playground Equipment. (Voluntary Product Standard PS 66-75).

    ERIC Educational Resources Information Center

    American National Standards Inst., Inc., New York, NY.

    This document presents the National Bureau of Standards safety requirements for home playground equipment intended for use by children 2 through 10 years old. The requirements are concerned with the design and performance of the units and their components, the structural integrity of the units and their components during and after exposure to…

  9. 75 FR 11624 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-11

    ... Evidential Breath Alcohol Measurement Devices AGENCY: National Highway Traffic Safety Administration, DOT... Evidential Breath Alcohol Measurement Devices (58 FR 48705). DATES: Effective Date: March 11, 2010. FOR... Administration (NHTSA) published the Standards for Devices to Measure Breath Alcohol (38 FR 30459). A Qualified...

  10. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) and underwater safety valves (USV). All wellhead SSV's, USV's, and their actuators which are installed...). (4) Electrical system information including the following: (i) A plan for each platform deck... Locations for Electrical Installations at Petroleum Facilities Classified as Class I, Division 1 and...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... Manufacturers would have to devote some resources to the development or modification of technology to produce... • Lost revenue if sales are adversely affected. 3. Industry sources have not been able to provide firm... goes into effect. D. Impact on consumers. Aside from increased safety, the rule is likely to affect...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    .... Manufacturers would have to devote some resources to the development or modification of technology to produce... • Lost revenue if sales are adversely affected. 3. Industry sources have not been able to provide firm... goes into effect. D. Impact on consumers. Aside from increased safety, the rule is likely to affect...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... Manufacturers would have to devote some resources to the development or modification of technology to produce... • Lost revenue if sales are adversely affected. 3. Industry sources have not been able to provide firm... goes into effect. D. Impact on consumers. Aside from increased safety, the rule is likely to affect...

  14. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    .... Manufacturers would have to devote some resources to the development or modification of technology to produce... • Lost revenue if sales are adversely affected. 3. Industry sources have not been able to provide firm... goes into effect. D. Impact on consumers. Aside from increased safety, the rule is likely to affect...

  15. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... Manufacturers would have to devote some resources to the development or modification of technology to produce... • Lost revenue if sales are adversely affected. 3. Industry sources have not been able to provide firm... goes into effect. D. Impact on consumers. Aside from increased safety, the rule is likely to affect...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., Electrical Safety Division, Approval and Certification Center, 765 Technology Drive, Triadelphia, WV 26059..., sectionalizing terminals, or other isolating parts are sequentially removed from the common wall between the... barriers, sectionalizing terminals, or other isolating parts be maintained in order to insure the explosion...

  17. 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

  18. How close we are to achieving commercially viable large-scale photobiological hydrogen production by cyanobacteria: a review of the biological aspects.

    PubMed

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

    2015-03-18

    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.

  19. Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product

    PubMed Central

    Abdalla, Abuelmagd; Byrne, Niamh; Conway, Richard; Walsh, Thomas; Mannion, Geraldine; Hanly, Michael; O’Sullivan, Miriam; Curran, Ann Maria; Carey, John J

    2017-01-01

    Purpose To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. Patients and methods In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Results Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab. Conclusion Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. PMID:28331376

  20. High-pressure processing of berry and other fruit products: implications for bioactive compounds and food safety.

    PubMed

    Tadapaneni, Ravi Kiran; Daryaei, Hossein; Krishnamurthy, Kathiravan; Edirisinghe, Indika; Burton-Freeman, Britt M

    2014-05-07

    Fruits contain a variety of nutrients and polyphenols that are associated with health benefits. Year-round availability of fresh fruits is limited due to perishability. Processing fruits extends shelf life. Individual quick-frozen fruit is the most common for fruits, but nowadays, processing fruits into beverages offers extended shelf life and new market opportunities. Conventional thermal processing is an effective method for producing safe, extended shelf life, and shelf-stable products, including beverages. However, the high temperatures negatively affect nutritive quality by destroying essential nutrients and biologically active "non-essential" components such as polyphenols. Therefore, novel technologies that can preserve nutrient quality while ensuring food safety are warranted. In this review, the application of high-pressure processing (HPP) for preserving nutrients and phytochemicals while ensuring microbiological safety in beverages and other foods containing fruits is discussed.

  1. A perspective on the safety of cosmetic products: a position paper of the American Council on Science and Health.

    PubMed

    Ross, Gilbert

    2006-01-01

    Over the years, some activist groups have targeted cosmetics as possible human health threats, claiming that cosmetic ingredients are not adequately tested for safety and may pose risks to consumers. The groups allege that industry practices related to safety testing are flawed, that there is little government oversight, and that cosmetics contain cancer-causing chemicals and other toxicants. A critical review of the scientific data related to these claims indicates the following: (1) Industry has the primary responsibility to ensure that all ingredients, preservatives, and coformulants used in products are safe for their intended uses. (2) The U.S. Food and Drug Administration (FDA) has regulatory oversight of the cosmetic industry. Its authority includes the banning or restriction of ingredients for safety reasons. (3) The Cosmetic Ingredient Review (CIR), an independent, scientific review board, critically evaluates chemical ingredients used in cosmetics and publishes the results of its findings in the peer-reviewed literature. (4) Health-related allegations about cosmetic ingredients are generally based on the results of high-dose laboratory testing in animals and have little relevance for humans. As true now as when Paracelsus said it in the 16th century, "It is the dose that makes the poison." (5) The health-related allegations involving specific chemicals (e.g., phthalates, parabens, and 1,3-butadiene) fail to consider important scientific studies and recent regulatory conclusions about these chemicals, which have found that they are not hazardous. (6) Animal and human physiology differ in crucial ways, further invalidating simplistic attempts to extrapolate rodent testing to human health risks. The cosmetic industry should be encouraged to publish more of its toxicity studies and safety evaluations, which would aid in dispelling the uncertainty that some consumers have about cosmetic safety.

  2. Safety assessment of food and feed from biotechnology-derived crops employing RNA-mediated gene regulation to achieve desired traits: a scientific review.

    PubMed

    Petrick, Jay S; Brower-Toland, Brent; Jackson, Aimee L; Kier, Larry D

    2013-07-01

    Gene expression can be modulated in plants to produce desired traits through agricultural biotechnology. Currently, biotechnology-derived crops are compared to their conventional counterparts, with safety assessments conducted on the genetic modification and the intended and unintended differences. This review proposes that this comparative safety assessment paradigm is appropriate for plants modified to express mediators of RNA-mediated gene regulation, including RNA interference (RNAi), a gene suppression mechanism that naturally occurs in plants and animals. The molecular mediators of RNAi, including long double-stranded RNAs (dsRNA), small interfering RNAs (siRNA), and microRNAs (miRNA), occur naturally in foods; therefore, there is an extensive history of safe consumption. Systemic exposure following consumption of plants containing dsRNAs that mediate RNAi is limited in higher organisms by extensive degradation of ingested nucleic acids and by biological barriers to uptake and efficacy of exogenous nucleic acids. A number of mammalian RNAi studies support the concept that a large margin of safety will exist for any small fraction of RNAs that might be absorbed following consumption of foods from biotechnology-derived plants that employ RNA-mediated gene regulation. Food and feed derived from these crops utilizing RNA-based mechanisms is therefore expected to be as safe as food and feed derived through conventional plant breeding. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. Are safety data sheets for cleaning products used in Norway a factor contributing to the risk of workers exposure to chemicals?

    PubMed

    Suleiman, Abdulqadir M; Svendsen, Kristin V H

    2014-10-01

    Cleaning products are considered less hazardous than those used in other sectors. Suppliers and distributors are less conscientious when it comes to informing users on health risks. The aim of the study was to elaborate on the usefulness and clarity of information in the safety data sheets (SDS) for cleaning products, and considering if the use of these SDSs can be seen as a risk factor towards occupational exposure to hazardous chemicals in the sector. Safety data sheets were selected based on the risk level of the product assigned in an industrial sector scheme. 320 SDSs for cleaning products were reviewed. Constituent components found in the products over a given threshold were listed and available information thereof used to assess the perceived non-hazard consideration of the chemicals. The contents of the SDSs was generic and mostly incomplete. Safety measures and health information lacked sufficient specificity despite varying compositions and concentrations of components. There is generally incompatibility between mentioned sections on the suggested non-hazardous nature of the products and health effects. Not all substances used in these products have harmonized classifications, which makes them open to various classification of the products and the suggested safety measures. This results in different companies classifying similar products differently. Risk management measures and suggested personal protective equipment (PPEs) are given haphazardly. Physical properties relevant to risk assessment are not included. The safety data sheets are ambiguous, and they lack relevant and important information. Inadequate information and risk assessment concerning the products can lead to workers being exposed to hazardous chemicals. Underestimation of the hazard contribution of the components of the products and the insufficient, non-objective mention of appropriate control and protective measures are the major contributing elements. There is a need to test the

  4. Health and Safety Concerns over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2007-08-28

    importers. They further counter that some imported U.S. products (such as soybeans, meats , and fruit) have failed to meet Chinese standards. However...the food production industry had found that a variety of dangerous industrial raw materials had been used in the production of flour , candy, pickles

  5. Processing, quality and safety of irradiation - and high pressure processed meat and seafood products

    USDA-ARS?s Scientific Manuscript database

    In the past two decades, worldwide demands for meat and seafood products have increased dramatically due to the improved economical condition in many countries. To meet the demand, the producers have increased the production of meat and seafood products as well as applied new processing techniques t...

  6. Microbiological Safety and Food Handling Practices of Seed Sprout Products in the Australian State of Victoria.

    PubMed

    Symes, Sally; Goldsmith, Paul; Haines, Heather

    2015-07-01

    Seed sprouts have been implicated as vehicles for numerous foodborne outbreaks worldwide. Seed sprouts pose a unique food safety concern because of the ease of microbiological seed contamination, the inherent ability of the sprouting process to support microbial growth, and their consumption either raw or lightly cooked. To examine seed sprout safety in the Australian state of Victoria, a survey was conducted to detect specific microbes in seed sprout samples and to investigate food handling practices relating to seed sprouts. A total of 298 seed sprout samples were collected from across 33 local council areas. Escherichia coli was detected in 14.8%, Listeria spp. in 12.3%, and Listeria monocytogenes in 1.3% of samples analyzed. Salmonella spp. were not detected in any of the samples. A range of seed sprout handling practices were identified as potential food safety issues in some food businesses, including temperature control, washing practices, length of storage, and storage in proximity to unpackaged ready-to-eat potentially hazardous foods.

  7. 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

  8. Methods of analysis for toxic elements in food products. 3. Limit of determination of methods for assuring safety

    SciTech Connect

    Skurikhin, I.M.

    1989-03-01

    To evaluate the suitability of the analytical methods used in determining food safety, a new metrological characteristic ''MQS'' is suggested. MQS is defined as the absolute minimum quantity in micrograms of a substance that can be determined in a test solution (solubilized test portion). MQS accounts for 2 factors: (a) the necessity for a reliable determination of ML (maximum permitted level, i.e., regulatory tolerance), and (b) the optimum quantity of test portion of a food product to be analyzed, and thus assists in evaluating the suitability of a method to assure food safety. The MQS of 8 toxic elements in any food are As, 3; Cd, 0.5; Cu, 20; Fe, 50; Hg, 0.2; Pb, 4; Sn, 200; Zn, 100 micrograms. To characterize the applicability of any given method, the specific minimum limit of determination, MQSM, must be established for each method. The method in question may be used to control food safety only if MQSM is less than MQS. MQSM values are given for the common polarographic and colorimetric methods for determining these elements.

  9. 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.

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

    PubMed

    Babich, M A

    1998-02-01

    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.

  11. 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

  12. Safety of herbal products in Thailand: an analysis of reports in the thai health product vigilance center database from 2000 to 2008.

    PubMed

    Saokaew, Surasak; Suwankesawong, Wimon; Permsuwan, Unchalee; Chaiyakunapruk, Nathorn

    2011-04-01

    The use of herbal products continues to expand rapidly across the world and concerns regarding the safety of these products have been raised. In Thailand, Thai Vigibase, developed by the Health Product Vigilance Center (HPVC) under the Thai Food and Drug Administration, is the national database that collates reports from health product surveillance systems and programmes. Thai Vigibase can be used to identify signals of adverse events in patients receiving herbal products. The purpose of the study was to describe the characteristics of reported adverse events in patients receiving herbal products in Thailand. Thai Vigibase data from February 2000 to December 2008 involving adverse events reported in association with herbal products were used. This database includes case reports submitted through the spontaneous reporting system and intensive monitoring programmes. Under the spontaneous reporting system, adverse event reports are collected nationwide via a national network of 22 regional centres covering more than 800 public and private hospitals, and health service centres. An intensive monitoring programme was also conducted to monitor the five single herbal products listed in the Thai National List of Essential Medicines (NLEM), while another intensive monitoring programme was developed to monitor the four single herbal products that were under consideration for inclusion in the NLEM. The database contained patient demographics, adverse events associated with herbal products, and details on seriousness, causality and quality of reports. Descriptive statistics were used for data analyses. A total of 593 reports with 1868 adverse events involving 24 different products were made during the study period. The age range of individuals was 1-86 years (mean 47 years). Most case reports were obtained from the intensive monitoring programme. Of the reports, 72% involved females. The herbal products for which adverse events were frequently reported were products containing

  13. Consistent use of a combination product versus a single product in a safety trial of the diaphragm and microbicide in Harare, Zimbabwe.

    PubMed

    van der Straten, Ariane; Moore, Jie; Napierala, Sue; Clouse, Kate; Mauck, Christine; Hammond, Nii; Padian, Nancy

    2008-06-01

    We examined the use and acceptability of a combination product (diaphragm and gel) compared to a single product (gel) during a 6-month safety trial in Zimbabwe. Women were randomized to the use of a diaphragm with gel or the use of gel alone, in addition to male condoms. Ever use and use of study product on the last act of sexual intercourse were assessed monthly by Audio Computer-Assisted Self-Interviewing. Acceptability, correct use and consistent use (use at every sexual act during the previous 3 months) were measured on the last visit by face-to-face interview. Predictors of consistent use were examined using multivariate logistic regression analyses. In this sample of 117 sexually active, monogamous, contracepting women, rates of consistent use were similar in both groups (59.7% for combination method vs. 56.4% for gel alone). Product acceptability was high, but was not independently associated with consistent use. Independent predictors of consistent use included age [adjusted odds ratio (AOR)=1.08; 95% confidence interval (95% CI)=1.01-1.16], consistent condom use (AOR=3.85; 95% CI=1.54-9.63) and having a partner who approves of product use (AOR=2.66; 95% CI=1.10-6.39). Despite high reported acceptability and few problems with the products, the participants reported only moderate product adherence levels. Consistent use of condoms and consistent use of products were strongly associated. If observed in other studies, this may bias the estimation of product effectiveness in future trials of female-controlled methods.

  14. Safety-catch linker strategies for the production of radiopharmaceuticals labeled with positron-emitting isotopes.

    PubMed

    Maclean, Derek; Zhu, Jiang; Chen, Mingying; Hale, Ron; Satymurthy, Nagichettiar; Barrio, Jorge R

    2003-08-27

    A novel synthetic stratetegy for compounds labeled with the positron-emitting isotope carbon-11 is described. The use of precursors attached to a solid support via safety-catch linkers allows selective release of radiolabeled material, leaving unreacted precursor attached to the support. Two different linkers demonstrate the application to the preparation of radiolabeled N-alkyl tertiary amines and N-alkylsulfonamides. This technique is expected to lead to more widespread use of positron emission tomography for the in vivo analysis of compound behavior.

  15. 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

  16. Quantifying Faculty Productivity in Japan: Development and Application of the Achievement-Motivated Key Performance Indicator. Research & Occasional Paper Series: CSHE.8.16

    ERIC Educational Resources Information Center

    Aida, Misako; Watanabe, Satoshi P.

    2016-01-01

    Universities throughout the world are trending toward more performance based methods to capture their strengths, weaknesses and productivity. Hiroshima University has developed an integrated objective measure for quantifying multifaceted faculty activities, namely the "Achievement-Motivated Key Performance Indicator" (A-KPI), in order to…

  17. 75 FR 81236 - Consumer Product Safety Act: Notice of Commission Action Lifting Stay of Enforcement of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ...-children's products subject to CPSC regulations pertaining to vinyl plastic film, carpets and rugs, and... expires for non-children's products subject to CPSC regulations pertaining to vinyl plastic film, carpets... 28, 2009 notice included: Carpets and rugs (16 CFR parts 1630 and 1631); Vinyl plastic film (16...

  18. 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.

  19. 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.

  20. Dermatotoxicology: Safety Evaluation of Topical Products in Minipigs: Study Designs and Practical Considerations.

    PubMed

    Willard-Mack, Cynthia; Ramani, Thulasi; Auletta, Carol

    2016-04-01

    The minipig has long been identified as the nonrodent animal of choice for preclinical safety evaluation of topically applied materials. This article reviews types of topical applications, study designs, and practical considerations. Dermal administration to the minipig presents multiple challenges. Issues to be considered are the area of exposure, the nature of the test article, the need for covering of the dose site, preparation of the dose site, and procedures for administration. The potential for cross-contamination (exposure of control animals to test article) is very high in topical studies and appropriate safeguards to prevent this are discussed. Topical administration to the intact skin is the most commonly utilized form of safety evaluation, but procedures have also been developed for intradermal administration and for the use of nonintact/wounded skin; these will be discussed. Evaluation of local (topical) effects is critical and can become complicated. Considerations in evaluations of the skin are interobserver variability, use of different scoring systems and discrepancies betweenin vivoobservations, necropsy observations, and microscopic pathology findings. Causes for apparent discrepancies and suggestions for practical resolution through appropriate procedures are discussed. Practical issues in necropsy and histotechnology procedures and techniques to optimize preservation of skin are also discussed. © The Author(s) 2016.

  1. 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.

  2. [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.

  3. An innovative approach to the safety evaluation of natural products: cranberry (Vaccinium macrocarpon Aiton) leaf aqueous extract as a case study.

    PubMed

    Booth, Nancy L; Kruger, Claire L; Wallace Hayes, A; Clemens, Roger

    2012-09-01

    Assessment of safety for a food or dietary ingredient requires determination of a safe level of ingestion compared to the estimated daily intake from its proposed uses. The nature of the assessment may require the use of different approaches, determined on a case-by-case basis. Natural products are chemically complex and challenging to characterize for the purpose of carrying out a safety evaluation. For example, a botanical extract contains numerous compounds, many of which vary across batches due to changes in environmental conditions and handling. Key components integral to the safety evaluation must be identified and their variability established to assure that specifications are representative of a commercial product over time and protective of the consumer; one can then extrapolate the results of safety studies on a single batch of product to other batches that are produced under similar conditions. Safety of a well-characterized extract may be established based on the safety of its various components. When sufficient information is available from the public literature, additional toxicology testing is not necessary for a safety determination on the food or dietary ingredient. This approach is demonstrated in a case study of an aqueous extract of cranberry (Vaccinium macrocarpon Aiton) leaves. Copyright © 2012. Published by Elsevier Ltd.

  4. Smokers' beliefs about the relative safety of other tobacco products: findings from the ITC collaboration.

    PubMed

    O'Connor, Richard J; McNeill, Ann; Borland, Ron; Hammond, David; King, Bill; Boudreau, Christian; Cummings, K Michael

    2007-10-01

    Most tobacco control efforts in western countries focus on the factory-made, mass-produced (FM) cigarette, whereas other tobacco products receive relatively little attention. Noncombusted tobacco products (i.e., referred to as smokeless tobacco), particularly Swedish-style snus, carry lower disease risks, compared with combusted tobacco products such as cigarettes. In this context, it is important to know what tobacco users believe about the relative harmfulness of various types of tobacco products. Data for this study came from random-digit-dialed telephone surveys of current smokers aged 18 or older in Australia, Canada, the United Kingdom, and the United States. Three waves of data, totaling 13,322 individuals, were assessed. Items assessed use of and beliefs about the relative harms of cigars, pipes, smokeless tobacco, and FM and roll-your-own cigarettes, as well as sociodemographics and smoking behaviors. Cigars (2.8%-12.7%) were the other tobacco products most commonly used by current cigarette smokers, followed by pipes (0.3%-2.1%) and smokeless tobacco (0.0%-2.3%). A significant minority of smokers (12%-21%) used roll-your-own cigarettes at least some of the time. About one-quarter of smokers believed that pipes, cigars, or roll-your-own cigarettes were safer than FM cigarettes, whereas only about 13% responded correctly that smokeless tobacco was less hazardous than cigarettes. Multivariate analyses showed that use of other tobacco products was most strongly related to beliefs about the reduced harm of these other products. Use of other tobacco products was low but may be growing among smokers in the four countries studied. Smokers are confused about the relative harms of tobacco products. Health education efforts are needed to correct smoker misperceptions.

  5. Instructional Variables and Student Achievement in Reading and Mathematics: A Synthesis of Recent Process-Product Research.

    ERIC Educational Resources Information Center

    Ruff, Frances K.

    The findings of eight reviews of process-product studies are synthesized. Results are organized under the main headings of time, instructional organization, monitoring, management, instruction, and environment. The paper begins with a brief history of research on teacher effectiveness, a description of the process-product paradigm, and a…

  6. Leader as achiever.

    PubMed

    Dienemann, Jacqueline

    2002-01-01

    This article examines one outcome of leadership: productive achievement. Without achievement one is judged to not truly be a leader. Thus, the ideal leader must be a visionary, a critical thinker, an expert, a communicator, a mentor, and an achiever of organizational goals. This article explores the organizational context that supports achievement, measures of quality nursing care, fiscal accountability, leadership development, rewards and punishments, and the educational content and teaching strategies to prepare graduates to be achievers.

  7. Achieving excellence.

    PubMed

    Williams, R B

    1986-03-01

    The concept of achieving excellence in pharmacy through development of effective leadership is discussed. The majority of hospital pharmacy directors have had very little education and training in management and effective leadership. Yet, excellent leadership skills will be needed to transform pharmacy more completely into a health profession. The management style most likely to be effective in this era of change is one that encompasses a high regard for both people and production through shared responsibility, high participation, involvement, and commitment. The following recommendations are offered to help achieve excellence through effective leadership: the ethic of self-development must be instilled in aspiring managers; courses in human behavior, leadership, and management should be added to undergraduate pharmacy curricula; pharmacy technicians should be educated in college-based programs that focus on drug distribution; Master of Science programs in hospital pharmacy should be deleted or restructured to focus on leadership and management; regional "centers for excellence" in leadership education should be developed; general residency training should be incorporated in undergraduate education so that more advanced residencies can be offered to graduates; high-level, self-study programs in management and leadership need to be developed, and substantial research funds need to be dedicated to the study of hospital pharmacy management.

  8. 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

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

    USDA-ARS?s Scientific Manuscript database

    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-...

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

    USDA-ARS?s Scientific Manuscript database

    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...

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

    USDA-ARS?s Scientific Manuscript database

    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 ...

  12. 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…

  13. 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…

  14. 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.

  15. 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.

  16. Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2008-05-08

    inspection of the food production industry had found that a variety of dangerous industrial raw materials had been used in the production of flour, candy...pickles, biscuits , black fungus, melon seeds, bean curd, and seafood. As a result, the government reportedly closed 180 food factories found to be...persist. For example in January 2008, dozens of people in Japan reportedly became ill from eating dumplings imported from China that contained

  17. Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2008-07-29

    inspection of the food production industry had found that a variety of dangerous industrial raw materials had been used in the production of flour, candy...pickles, biscuits , black fungus, melon seeds, bean curd, and seafood. As a result, the government reportedly closed 180 food factories found to be...persist. For example in January 2008, dozens of people in Japan reportedly became ill from eating dumplings imported from China that contained

  18. Health and Safety Concerns Over U.S. Imports of Chinese Products: An Overview

    DTIC Science & Technology

    2008-03-20

    inspection of the food production industry had found that a variety of dangerous industrial raw materials had been used in the production of flour, candy...pickles, biscuits , black fungus, melon seeds, bean curd, and seafood. As a result, the government reportedly closed 180 food factories found to be...persist. For example in January 2008, dozens of people in Japan reportedly became ill from eating dumplings imported from China that contained

  19. Quality and safety assessment of food and agricultural products by hyperspectral fluorescence imaging.

    PubMed

    Zhang, Ruoyu; Ying, Yibin; Rao, Xiuqin; Li, Jiangbo

    2012-09-01

    Hyperspectral fluorescence imaging (HSFI) is potentially useful for assessing food and agricultural products, because it combines the merits of both hyperspectral imaging and fluorescence spectroscopy. This paper provides an introduction to HSFI: the principle and components of HSFI, calibration and image processing are described. In addition, recent advances in the application of HSFI to food and agricultural product assessment are reviewed, such as contaminant detection, constituent analysis and quality evaluation. Finally, current limitations and likely future development trends are discussed.

  20. Improving health IT through understanding the cultural production of safety in clinical settings.

    PubMed

    Novak, Laurie Lovett

    2010-01-01

    Health IT is said to have the potential to improve the safety and effectiveness of care. However, it is known that the implementation of health IT can introduce new risks into the environment of care as a result of design failures, implementation failures, and unintended consequences. The design and implementation of health IT systems reflect explicit or implicit assumptions about what constitutes safe practice. These assumptions may clash with those held by patients and clinicians who are the intended users and subjects of the technology. Current perspectives on risk are discussed and an anthropological approach to understanding the construction of safe practices in the clinical setting is explored using research in barcode medication administration.

  1. [Comparison of Preparation Efficiency and Therapeutic Safety between Generic Products of Gemcitabine].

    PubMed

    Sato, Yuhki; Ono, Hiroyuki; Amada, Kohei; Nakahara, Ryosuke; Itoh, Hiroki

    2017-04-01

    Because generic medicines reduce the financialburden on patients and medicalinsurance providers, they have become increasingly popular. However, there are only a few reports that have analyzed the efficacy and safety of generic medicines, especially in terms of their characteristics and side effects. Gemcitabine is an antineoplastic drug that is frequently used with good results in the treatment of lung cancer, pancreatic cancer, breast cancer, ovarian cancer, and malignant lymphoma. However, its fat solubility is high, and several adverse events, such as myelosuppression, are known to develop during its use. We investigated the efficacy, characteristics, and the incidence of adverse events for the generic versions of gemcitabine. We found differences between the generic versions in terms of the characteristics and preparation time; however, the incidence of adverse events was not significantly different, suggesting that the generic versions could be a reasonable substitute.

  2. Recommendation for a test battery for the ecotoxicological evaluation of the environmental safety of construction products.

    PubMed

    Gartiser, Stefan; Heisterkamp, Ines; Schoknecht, Ute; Bandow, Nicole; Burkhardt, N Michael; Ratte, Monika; Ilvonen, Outi

    2017-03-01

    The European Construction Products Regulation allows Member States to adopt rules for evaluating the environmental impact of their buildings. The aim of the project was to develop recommendations for a test battery for the ecotoxicological assessment of the environmental impact of construction products for outdoor use and contribute to the European harmonization of test methods. From a shortlist of 39 products 20 products were included in the ecotoxicological testing program. Monolithic and plate-like construction products were eluted in the Dynamic Surface Leaching test (DSLT) in accordance with CEN/TS 16637-2, granular products were eluted in a one stage batch test in accordance with DIN EN 12457-1. The eluates were examined in four aquatic toxicity tests (algae, daphnia, luminescent bacteria, fish eggs), a genotoxicity test (umu test) and in the respirometer test (OECD 301 F). Here, low to very high ecotoxicity was observed (up to a dilution factor of 1536). Six out of 8 eluates, whose TOC exceeded 10 mg L(-1) showed a good biodegradability above 75%. The intra-laboratory repeatability of the Lowest Ineffective Dilution (LID) usually was within ±1 dilution steps (ecotoxicity tests) and ±2 dilution steps (leaching and ecotoxicity tests). This is acceptable, when considering that the overall variability of sample preparation, leaching test, and bioassays add up. The conclusions lead to practical recommendations for a suitable combination of leaching and ecotoxicity tests. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Safety assessment of biotechnology products for potential risk of food allergy: implications of new research.

    PubMed

    Selgrade, MaryJane K; Bowman, Christal C; Ladics, Gregory S; Privalle, Laura; Laessig, Susan A

    2009-07-01

    Food allergy is a potential risk associated with use of transgenic proteins in crops. Currently, safety assessment involves consideration of the source of the introduced protein, in silico amino acid sequence homology comparisons to known allergens, physicochemical properties, protein abundance in the crop, and, when appropriate, specific immunoglobulin E binding studies. Recently conducted research presented at an International Life Sciences Institute/Health and Environmental Sciences Institute-hosted workshop adds to the scientific foundation for safety assessment of transgenic proteins in five areas: structure/activity, serum screening, animal models, quantitative proteomics, and basic mechanisms. A web-based tool is now available that integrates a database of allergenic proteins with a variety of computational tools which could be used to improve our ability to predict allergenicity based on structural analysis. A comprehensive strategy and model protocols have been developed for conducting meaningful serum screening, an extremely challenging process. Several animal models using oral sensitization with adjuvant and one dermal sensitization model have been developed and appear to distinguish allergenic from non-allergenic food extracts. Data presented using a mouse model suggest that pepsin resistance is indicative of allergenicity. Certain questions remain to be addressed before considering animal model validation. Gel-free mass spectrometry is a viable alternative to more labor-intensive approaches to quantitative proteomics. Proteomic data presented on four nontransgenic varieties of soy suggested that if known allergen expression in genetically modified crops falls within the range of natural variability among commercial varieties, there appears to be no need to test further. Finally, basic research continues to elucidate the etiology of food allergy.

  4. 21 CFR 1000.15 - Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Radiation Control for Health and Safety Act of 1968. 1000.15 Section 1000.15 Food and Drugs FOOD AND DRUG... Policy and Interpretation § 1000.15 Examples of electronic products subject to the Radiation Control for... illustrative examples of sources of electronic product radiation to which the regulations of this part...

  5. 21 CFR 1000.15 - Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Radiation Control for Health and Safety Act of 1968. 1000.15 Section 1000.15 Food and Drugs FOOD AND DRUG... Policy and Interpretation § 1000.15 Examples of electronic products subject to the Radiation Control for... illustrative examples of sources of electronic product radiation to which the regulations of this part...

  6. 21 CFR 1000.15 - Examples of electronic products subject to the Radiation Control for Health and Safety Act of 1968.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Radiation Control for Health and Safety Act of 1968. 1000.15 Section 1000.15 Food and Drugs FOOD AND DRUG... Policy and Interpretation § 1000.15 Examples of electronic products subject to the Radiation Control for... illustrative examples of sources of electronic product radiation to which the regulations of this part...

  7. Current Status of the Preharvest Application of Pro- and Prebiotics to Farm Animals to Enhance the Microbial Safety of Animal Products.

    PubMed

    Joerger, Rolf D; Ganguly, Arpeeta

    2017-01-01

    The selection of microorganisms that act as probiotics and feed additives that act as prebiotics is an ongoing research effort, but a sizable range of commercial pro-, pre- and synbiotic (combining pro- and prebiotics) products are already available and being used on farms. A survey of the composition of commercial products available in the United States revealed that Lactobacillus acidophilus, Enterococcus faecium, and Bacillus subtilis were the three most common species in probiotic products. Of the nearly 130 probiotic products (also called direct-fed microbials) for which information was available, about 50 also contained yeasts or molds. The focus on these particular bacteria and eukaryotes is due to long-standing ideas about the benefits of such strains, research data on effectiveness primarily in laboratory or research farm settings, and regulations that dictate which microorganisms or feed additives can be administered to farm animals. Of the direct-fed microbials, only six made a claim relating to food safety or competitive exclusion of pathogens. None of the approximately 50 prebiotic products mentioned food safety in their descriptions. The remainder emphasized enhancement of animal performance such as weight gain or overall animal health. The reason why so few products carry food safety-related claims is the difficulties in establishing unambiguous cause and effect relationships between the application of such products in varied and constantly changing farm environments and improved food safety of the end product.

  8. Automatic polymerase chain reaction product detection system for food safety monitoring using zinc finger protein fused to luciferase.

    PubMed

    Yoshida, Wataru; Kezuka, Aki; Murakami, Yoshiyuki; Lee, Jinhee; Abe, Koichi; Motoki, Hiroaki; Matsuo, Takafumi; Shimura, Nobuaki; Noda, Mamoru; Igimi, Shizunobu; Ikebukuro, Kazunori

    2013-11-01

    An automatic polymerase chain reaction (PCR) product detection system for food safety monitoring using zinc finger (ZF) protein fused to luciferase was developed. ZF protein fused to luciferase specifically binds to target double stranded DNA sequence and has luciferase enzymatic activity. Therefore, PCR products that comprise ZF protein recognition sequence can be detected by measuring the luciferase activity of the fusion protein. We previously reported that PCR products from Legionella pneumophila and Escherichia coli (E. coli) O157 genomic DNA were detected by Zif268, a natural ZF protein, fused to luciferase. In this study, Zif268-luciferase was applied to detect the presence of Salmonella and coliforms. Moreover, an artificial zinc finger protein (B2) fused to luciferase was constructed for a Norovirus detection system. In the luciferase activity detection assay, several bound/free separation process is required. Therefore, an analyzer that automatically performed the bound/free separation process was developed to detect PCR products using the ZF-luciferase fusion protein. By means of the automatic analyzer with ZF-luciferase fusion protein, target pathogenic genomes were specifically detected in the presence of other pathogenic genomes. Moreover, we succeeded in the detection of 10 copies of E. coli BL21 without extraction of genomic DNA by the automatic analyzer and E. coli was detected with a logarithmic dependency in the range of 1.0×10 to 1.0×10(6) copies.

  9. Risk management in primary apicultural production. Part 2: a Hazard Analysis Critical Control Point approach to assuring the safety of unprocessed honey.

    PubMed

    Formato, Giovanni; Zilli, Romano; Condoleo, Roberto; Marozzi, Selene; Davis, Ivor; Smulders, Frans J M

    2011-06-01

    In managing risks associated with the human consumption of honey, all sectors of the production chain must be considered, including the primary production phase. Although the introduction of the Hazard Analysis Critical Control Point (HACCP) system has not been made compulsory for purposes of quality and safety control in farming operations, European legislation makes many references to the key role of primary production in food safety management and the HACCP system has been indicated as the preferred tool to ensure that consumers are provided with safe foods. This article describes a systematic HACCP-based approach to identifying, preventing and controlling food safety hazards occurring in primary apicultural production. This approach serves as a useful tool for beekeepers, food business operators, veterinary advisors, and for Food and Veterinary Official Control Bodies in their planning and conducting of audits and for establishing priorities for the evaluation of training programmes in the apicultural sector.

  10. 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 section...

  11. Nuclear Safety

    SciTech Connect

    Silver, E G

    1989-01-01

    This document is a review journal that covers significant developments in the field of nuclear safety. Its scope includes the analysis and control of hazards associated with nuclear energy, operations involving fissionable materials, and the products of nuclear fission and their effects on the environment. Primary emphasis is on safety in reactor design, construction, and operation; however, the safety aspects of the entire fuel cycle, including fuel fabrication, spent-fuel processing, nuclear waste disposal, handling of radioisotopes, and environmental effects of these operations, are also treated.

  12. Patient safety with blood products administration using wireless and bar-code technology.

    PubMed

    Porcella, Aleta; Walker, Kristy

    2005-01-01

    Supported by a grant from the Agency for Healthcare Research and Quality, a University of Iowa Hospitals and Clinics interdisciplinary research team created an online data-capture-response tool utilizing wireless mobile devices and bar code technology to track and improve blood products administration process. The tool captures 1) sample collection, 2) sample arrival in the blood bank, 3) blood product dispense from blood bank, and 4) administration. At each step, the scanned patient wristband ID bar code is automatically compared to scanned identification barcode on requisition, sample, and/or product, and the system presents either a confirmation or an error message to the user. Following an eight-month, 5 unit, staged pilot, a 'big bang,' hospital-wide implementation occurred on February 7, 2005. Preliminary results from pilot data indicate that the new barcode process captures errors 3 to 10 times better than the old manual process.

  13. 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.

  14. 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

  15. [Methods of identification and assessment of safety of genetically modified microorganisms in manufacture food production].

    PubMed

    Khovaev, A A; Nesterenko, L N; Naroditskiĭ, B S

    2011-01-01

    Methods of identification of genetically modified microorganisms (GMM), used in manufacture food on control probes are presented. Results of microbiological and molecular and genetic analyses of food products and their components important in microbiological and genetic expert examination of GMM in foods are considered. Examination of biosafety of GMM are indicated.

  16. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... Production Platform Piping Systems (as incorporated by reference in § 250.198). (4) Electrical system... classified according to API RP 500, Recommended Practice for Classification of Locations for Electrical..., Recommended Practice for Classification of Locations for Electrical Installations at Petroleum Facilities...

  17. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Production Platform Piping Systems (as incorporated by reference in § 250.198). (4) Electrical system... classified according to API RP 500, Recommended Practice for Classification of Locations for Electrical..., Recommended Practice for Classification of Locations for Electrical Installations at Petroleum Facilities...

  18. Level of use and safety of botanical products for itching vulvar dermatoses. Are patch tests useful?

    PubMed

    Corazza, Monica; Virgili, Annarosa; Toni, Giulia; Minghetti, Sara; Tiengo, Silvia; Borghi, Alessandro

    2016-05-01

    Topical remedies based on botanical ingredients are popular. To assess: (i) the usage of botanical substances in subjects affected with itching and chronic vulvar complaints; (ii) the incidence of side-effects associated with their use and the frequency of contact allergy; (iii) the diagnostic usefulness of patch testing. Sixty-six patients were provided with a questionnaire to assess the prevalence and type of topical botanical preparations used and the occurrence of adverse reactions. Patients were patch tested with (i) the Italian baseline series, (ii) a topical medicament series, and (iii) a botanical series. Forty-two patients (63.6%) reported the use of natural topical products on the vulva. Seven (16.7%) noted adverse reactions; 27 showed positive reactions with the baseline series; 14 (21.2%) had at least one relevant reaction, mainly to allergens in topical products and cosmetics; and 2 (3%) showed positive reactions to the botanical series. Of the 7 patients complaining of adverse effects of botanical products, 3 (42.8%) showed relevant sensitization. The use of natural topical products is widespread among women affected with itching vulvar diseases. Contact dermatitis is a possible adverse effect. Botanical series are of questionable usefulness, owing to the wide variety of botanical ingredients. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  19. 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.

  20. [The problems of radioecology and radiation safety of the former uranium production in Kyrgyzstan].

    PubMed

    Dzhenbaev, B M; Kaldybaev, B K; Zholboldiev, B T

    2013-01-01

    The article summarizes the history and problems of the former uranium production (tailing and waste dumps), the current status and their possible impact on the environment. Also given are the priority radio-ecological and radiobiogeohemichal problems for the medium term, as well as legal and regulatory framework.