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

    ... VIDEOS REPORTS Related Links Recalls Safety Education Regulations, Laws & Standards Research & Statistics Business & Manufacturing Small Business Resources OnSafety Blogs International Newsroom ...

  3. 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.

  4. 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.

  5. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-24

    ... From the Federal Register Online via the Government Publishing Office ] Part III Consumer Product Safety Commission 16 CFR Part 1102 Publicly Available Consumer Product Safety Information Database...; ] CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1102 Publicly Available Consumer Product Safety...

  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. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. Microbial bioinformatics for food safety and production

    PubMed Central

    Alkema, Wynand; Boekhorst, Jos; Wels, Michiel

    2016-01-01

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

  13. 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.

  14. 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.

  15. 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...

  16. 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...

  17. Achieving Product Qualities Through Software Architecture Practices

    DTIC Science & Technology

    2016-06-14

    information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and...University page 9 Business Goals High quality Quick time to market Effective use of limited resources Product alignment Low cost production Low cost... time , build time , design time System: user interface, platform, environment, system that interoperates with target system © 2004 by Carnegie Mellon

  18. 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.

  19. 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…

  20. 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.

  1. 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...

  2. 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...

  3. 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...

  4. 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…

  5. 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.

  6. 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…

  7. 44 CFR 321.4 - Achieving production readiness.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 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...

  8. 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...

  9. 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...

  10. 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

  11. 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…

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. 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…

  17. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... operating rules, and operating speeds; (3) An operational concepts document, including a complete... the safety assurance concepts used in the product design, including an explanation of the design... not compromised as a result of any such change. (Software changes involving safety...

  18. 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.

  19. 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

  20. 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)

  1. 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.

  2. 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)...

  3. 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.

  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. 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.

  6. 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:

  7. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Findings Under the Consumer Product Safety Act Appendix to Part 1213 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... Part 1213—Findings Under the Consumer Product Safety Act The Consumer Product Safety Act requires...

  8. 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.

  9. 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...

  10. 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

  11. 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.

  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. 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.

  14. 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.…

  15. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... description of the specific procedures and test equipment necessary to ensure the safe and proper installation... description of the safety assessment and verification and validation processes applied to the product and the... equipment manufacturer's recommendations; (14) An analysis of the applicability of the requirements...

  16. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... operating rules, and operating speeds; (3) An operational concepts document, including a complete... description of the safety assessment and verification and validation processes applied to the product and the results of these processes, describing how subject areas covered in appendix C to this part are...

  17. 49 CFR 236.907 - Product Safety Plan (PSP).

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... operating rules, and operating speeds; (3) An operational concepts document, including a complete... description of the safety assessment and verification and validation processes applied to the product and the results of these processes, describing how subject areas covered in appendix C to this part are...

  18. 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...

  19. 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.

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

    ERIC Educational Resources Information Center

    Blake, Robert R; Mouton, Jane S.

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

  1. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

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

  3. 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)...

  4. 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)...

  5. [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.

  6. 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.

  7. 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

  8. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    PubMed Central

    Vlachojannis, Christian

    2015-01-01

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

  9. 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…

  10. 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…

  11. 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.

  12. [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.

  13. 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.

  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. 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…

  16. 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.

  17. 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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-25

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

  19. 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

  20. 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.

  1. 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.

  2. 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...

  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...

  4. 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...

  5. 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...

  6. 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...

  7. 75 FR 18825 - Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-13

    ... Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC AGENCY: Department of Energy... intent to grant to: Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC, of... enhanced. Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC, of...

  8. 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.

  9. 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.…

  10. 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.

  11. 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.

  12. 77 FR 58567 - Information Collection Activities: Well Control and Production Safety Training, Submitted for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-21

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

  13. 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.

  14. 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).

  15. 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

  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. 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).

  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. 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...

  1. 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)

  2. 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)

  3. 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...

  4. 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.

  5. 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...

  6. 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…

  7. 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.

  8. 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.

  9. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-31

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

  10. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... research. (i) Disclosure of patient safety work product to persons carrying out research, evaluation or... Secretary, for the purpose of conducting research. (ii) If the patient safety work product disclosed... permitted under the HIPAA Privacy Rule. (7) Disclosure to the Food and Drug Administration (FDA)...

  11. 42 CFR 3.206 - Confidentiality of patient safety work product.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... research. (i) Disclosure of patient safety work product to persons carrying out research, evaluation or... Secretary, for the purpose of conducting research. (ii) If the patient safety work product disclosed... permitted under the HIPAA Privacy Rule. (7) Disclosure to the Food and Drug Administration (FDA)...

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

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... research. (i) Disclosure of patient safety work product to persons carrying out research, evaluation or... Secretary, for the purpose of conducting research. (ii) If the patient safety work product disclosed... permitted under the HIPAA Privacy Rule. (7) Disclosure to the Food and Drug Administration (FDA)...

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

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... research. (i) Disclosure of patient safety work product to persons carrying out research, evaluation or... Secretary, for the purpose of conducting research. (ii) If the patient safety work product disclosed... permitted under the HIPAA Privacy Rule. (7) Disclosure to the Food and Drug Administration (FDA)...

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

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... research. (i) Disclosure of patient safety work product to persons carrying out research, evaluation or... Secretary, for the purpose of conducting research. (ii) If the patient safety work product disclosed... permitted under the HIPAA Privacy Rule. (7) Disclosure to the Food and Drug Administration (FDA)...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-10

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

  16. 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,...

  17. 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.

  18. 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.

  19. 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.

  20. 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,"…

  1. 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…

  2. 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…

  3. 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.

  4. 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.

  5. 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.

  6. 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

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

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... production-safety systems. 250.802 Section 250.802 Mineral Resources MINERALS MANAGEMENT SERVICE, DEPARTMENT... Analysis Checklists are included in API RP 14C you must utilize the analysis technique and documentation...., type cable, conduit, or wire). (ii) Elementary electrical schematic of any platform safety...

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

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... software upgrades, patches, or revisions for their processor-based system, sub-system, or component, and... procedures for action upon notification of a safety-critical upgrade, patch, or revision for this processor-based system, sub-system, or component, and until the upgrade, patch, or revision has been...

  9. 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.

  10. 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....

  11. 76 FR 50748 - Information Collection Activity: Production Safety Systems, Revision of a Collection; Submitted...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-16

    ... Bureau of Ocean Energy Management, Regulation and Enforcement Information Collection Activity: Production Safety Systems, Revision of a Collection; Submitted for Office of Management and Budget (OMB) Review; Comment Request AGENCY: Bureau of Ocean Energy Management, Regulation and Enforcement (BOEMRE),...

  12. 77 FR 35747 - Highway Safety Programs; Conforming Products List of Evidential Breath Alcohol Measurement Devices

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... Evidential Breath Alcohol Measurement Devices AGENCY: National Highway Traffic Safety Administration... Specifications for Evidential Breath Alcohol Measurement Devices dated, September 17, 1993 (58 FR 48705). DATES... Alcohol (38 FR 30459). A Qualified Products List of Evidential Breath Measurement Devices comprised...

  13. 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)

  14. 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

  15. 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…

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... reflect the information that was available to the Consumer Product Safety Commission (“CPSC” or..., and the probable effect of the rule on the utility, cost, or availability of such products to meet.... Manufacturers would have to devote some resources to the development or modification of technology to...

  2. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    .... Unblinding G. Information Sufficient to Consider Product Administration Changes--Proposed Sec. 312.32(c)(1... product administration changes,'' Make it clear that safety reports of overall findings or data in the... of this document) and other revisions, including editorial changes to clarify provisions and...

  3. 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…

  4. 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...

  5. 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.

  6. 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.

  7. 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.

  8. 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.

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  10. 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.

  11. 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.

  12. [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.

  13. [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.

  14. 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.

  15. 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.

  16. 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

  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. 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.

  19. 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.

  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. 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...

  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. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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…

  8. 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…

  9. 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

  10. 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…

  11. [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.

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... 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...

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

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... for igniting cigarettes, cigars, and pipes, whether or not such devices are subject to the requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... substitute products, such as matches. However, as with child-resistant cigarette lighters, the...

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

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... for igniting cigarettes, cigars, and pipes, whether or not such devices are subject to the requirements of the Safety Standard for Cigarette Lighters (16 CFR part 1210); devices that contain more than... substitute products, such as matches. However, as with child-resistant cigarette lighters, the...

  15. 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...

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  1. 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.

  2. 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...

  3. [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.

  4. Achievement of the POSITIVE (Participation-Oriented Safety Improvement by Trade Union InitiatiVE) activities in the Philippines.

    PubMed

    Tachi, Norihide; Itani, Toru; Takeyama, Hidemaro; Yoshikawa, Toru; Suzuki, Koji; Castro, Ariel B

    2006-01-01

    The POSITIVE (Participation-oriented safety improvement by trade union initiative) programme was introduced into the Philippines in 1995. The monitoring of activities was carried out in 2004 among core trainers who had been trained before. The results of the questionnaire survey showed that the core trainers evaluated their activities satisfactory in general, and particularly the training activities were considered excellent. Also, the union workers who had been trained by the POSITIVE programme implemented improvements at the rate of around 5 examples a year on average. It was of note that the installation ratio (the number of installations/that of plans) was higher in small- and medium-sized enterprises than in larger companies, although the numbers of plans and installations of improvements were greater in large enterprises. Together with the previous findings, the present results suggest that the POSITIVE-style participatory training program is effective and efficient for workers to take actions for the OSH in not only larger enterprises but also small enterprises.

  5. 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.

  6. 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.

  7. 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)

  8. 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

  9. 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'.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  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. 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.

  17. 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

  18. 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

  19. [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.

  20. 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

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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…

  6. 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…

  7. 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

  8. 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...

  9. [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.

  10. 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.

  11. 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.

  12. 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...

  13. 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...

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

    Code of Federal Regulations, 2010 CFR

    2010-04-01

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

  15. 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...

  16. 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...

  17. 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.

  18. 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.

  19. 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

  20. 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

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  10. 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.

  11. 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

  12. 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

  13. 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.

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. 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.

  19. 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

  20. 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.

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. Made in China: Policy Analysis and Prescriptions to Improve China’s Consumer Product Safety Regulatory Regime

    DTIC Science & Technology

    2008-12-01

    or products such as rice protein concentrate and wheat gluten used to manufacture pet food and animal feed) from China believed to have caused the...People’s Republic of China on Animal and Plant Entry and Exit Quarantine Administrative Regulations of the People’s Republic of China of Veterinary ... products coming into the United States meet the standards of safety and quality that Americans expect. These products include food and animal feed, human

  15. 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.

  16. 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

  17. 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

  18. 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.

  19. 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.

  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. 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

  2. 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

  3. 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.)

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY...

  11. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug products withdrawn or removed from the market for reasons of safety or effectiveness. 216.24 Section 216.24 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL PHARMACY...

  12. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Global Quality Systems--An Integrated Approach To Improving... ``Global Quality Systems--An Integrated Approach to Improving Medical Product Safety.'' This 2-day...

  13. 14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 14 Aeronautics and Space 4 2013-01-01 2013-01-01 false Flight Safety Analysis Methodologies and... Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown With a Wind Weighting... analysis required for the launch of an unguided suborbital launch vehicle flown with a wind...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 14 Aeronautics and Space 4 2014-01-01 2014-01-01 false Flight Safety Analysis Methodologies and... Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown With a Wind Weighting... analysis required for the launch of an unguided suborbital launch vehicle flown with a wind...

  15. 14 CFR Appendix C to Part 417 - Flight Safety Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 14 Aeronautics and Space 4 2012-01-01 2012-01-01 false Flight Safety Analysis Methodologies and... Analysis Methodologies and Products for an Unguided Suborbital Launch Vehicle Flown With a Wind Weighting... analysis required for the launch of an unguided suborbital launch vehicle flown with a wind...

  16. 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.

  17. 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

  18. 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

  19. 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.

  20. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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.

  5. 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

  6. 30 CFR 250.802 - Design, installation, and operation of surface production-safety systems.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ..., Recommended Practice for Installation, Maintenance, and Repair of Surface Safety Valves and Underwater Safety..., storage tanks, compressors, pipeline pumps, metering devices, and other hydrocarbon-handling vessels. (2.... (6) The design and schematics of the installation and maintenance of all fire- and...

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

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ..., Recommended Practice for Installation, Maintenance, and Repair of Surface Safety Valves and Underwater Safety..., storage tanks, compressors, pipeline pumps, metering devices, and other hydrocarbon-handling vessels. (2.... (6) The design and schematics of the installation and maintenance of all fire- and...

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

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ..., Recommended Practice for Installation, Maintenance, and Repair of Surface Safety Valves and Underwater Safety..., storage tanks, compressors, pipeline pumps, metering devices, and other hydrocarbon-handling vessels. (2.... (6) The design and schematics of the installation and maintenance of all fire- and...

  9. 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.

  10. 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.

  11. 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)

  12. 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

  13. Hand Safety

    MedlinePlus

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

  14. 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.

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

    PubMed

    Fruijtier-Pölloth, Claudia

    2005-10-15

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

  16. 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...

  17. 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

  18. 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.

  19. 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

  20. 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…

  1. 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

  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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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…

  11. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... structure is large enough so a child can slip his or her body through it, it must be large enough that the... entities will always present a compliance problem, because new manufacturers can enter the marketplace... at the point of purchase and make their purchase decisions with this safety information in mind....

  12. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... structure is large enough so a child can slip his or her body through it, it must be large enough that the... entities will always present a compliance problem, because new manufacturers can enter the marketplace... at the point of purchase and make their purchase decisions with this safety information in mind....

  13. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... structure is large enough so a child can slip his or her body through it, it must be large enough that the... entities will always present a compliance problem, because new manufacturers can enter the marketplace... at the point of purchase and make their purchase decisions with this safety information in mind....

  14. 16 CFR Appendix to Part 1213 - Findings Under the Consumer Product Safety Act

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... structure is large enough so a child can slip his or her body through it, it must be large enough that the... entities will always present a compliance problem, because new manufacturers can enter the marketplace... at the point of purchase and make their purchase decisions with this safety information in mind....

  15. 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

    ... fuel cell detector and is battery powered. (2) The ``Alcotest 9510'' manufactured by Draeger Safety.... It uses a fuel cell detector and is battery powered. (4) The ``Evidenzer'' manufactured by Nanopuls..., Fredericksburg, Virginia. This is a hand-held instrument that uses a fuel cell detector and is battery...

  16. 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

  17. 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.

  18. 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.

  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. 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.

  1. 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.

  2. 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.

  3. 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

  4. 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…

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

    ERIC Educational Resources Information Center

    Rotem, Avital; Henik, Avishai

    2015-01-01

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

  7. 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.

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

  13. 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.

  14. [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.

  15. 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.

  16. 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...

  17. 78 FR 76443 - Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ...The Food and Drug Administration (FDA) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use with water (referred to throughout as consumer antiseptic washes) are......

  18. 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.

  19. 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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

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

    Technology Transfer Automated Retrieval System (TEKTRAN)

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

  3. 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.

  4. 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.

  5. 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.

  6. 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.

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

    SciTech Connect

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

    1992-07-01

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

  8. 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.

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

    SciTech Connect

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

    1992-07-01

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

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

    SciTech Connect

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

    1980-03-01

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

  11. 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.

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

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... and surrogate lighters for preliminary child panel testing; • Retooling and other production equipment... surrogate lighters; conducting child panel tests; and issuing and maintaining records for each model. The largest component of these costs is believed to be building surrogates and conducting child panel...

  13. [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.

  14. [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.

  15. 76 FR 78929 - Establishing Timeframes for Implementation of Product Safety Labeling Changes; Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-20

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

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

    PubMed

    Dirks, Michael

    2015-01-01

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

  17. Quality and safety aspects of infant nutrition.

    PubMed

    Koletzko, Berthold; Shamir, Raanan; Ashwell, Margaret

    2012-01-01

    Quality and safety aspects of infant nutrition are of key importance for child health, but oftentimes they do not get much attention by health care professionals whose interest tends to focus on functional benefits of early nutrition. Unbalanced diets and harmful food components induce particularly high risks for untoward effects in infants because of their rapid growth, high nutrient needs, and their typical dependence on only one or few foods during the first months of life. The concepts, standards and practices that relate to infant food quality and safety were discussed at a scientific workshop organized by the Child Health Foundation and the Early Nutrition Academy jointly with the European Society for Paediatric Gastroenterology, Hepatology and Nutrition, and a summary is provided here. The participants reviewed past and current issues on quality and safety, the role of different stakeholders, and recommendations to avert future issues. It was concluded that a high level of quality and safety is currently achieved, but this is no reason for complacency. The food industry carries the primary responsibility for the safety and suitability of their products, including the quality of composition, raw materials and production processes. Introduction of new or modified products should be preceded by a thorough science based review of suitability and safety by an independent authority. Food safety events should be managed on an international basis. Global collaboration of food producers, food-safety authorities, paediatricians and scientists is needed to efficiently exchange information and to best protect public health.

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

    SciTech Connect

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

    2014-12-01

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

  19. An overview of food safety and bacterial foodborne zoonoses in food production animals in the Caribbean region.

    PubMed

    Guerra, Maria Manuela Mendes; de Almeida, Andre M; Willingham, Arve Lee

    2016-08-01

    Foodborne diseases (FBDs) in the Caribbean have a high economic burden. Public health and tourism concerns rise along with the increasing number of cases and outbreaks registered over the last 20 years. Salmonella spp., Shigella spp., and Campylobacter spp. are the main bacteria associated with these incidents. In spite of undertaking limited surveillance on FBD in the region, records related to bacterial foodborne zoonoses in food-producing animals and their associated epidemiologic significance are poorly documented, giving rise to concerns about the importance of the livestock, food animal product sectors, and consumption patterns. In this review, we report the available published literature over the last 20 years on selected bacterial foodborne zoonoses in the Caribbean region and also address other food safety-related aspects (e.g., FBD food attribution, importance, surveillance), mainly aiming at recognizing data gaps and identifying possible research approaches in the animal health sector.

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

    PubMed

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

    2015-04-01

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

  1. Computer analyses for the design, operation and safety of new isotope production reactors: A technology status review

    SciTech Connect

    Wulff, W.

    1990-01-01

    A review is presented on the currently available technologies for nuclear reactor analyses by computer. The important distinction is made between traditional computer calculation and advanced computer simulation. Simulation needs are defined to support the design, operation, maintenance and safety of isotope production reactors. Existing methods of computer analyses are categorized in accordance with the type of computer involved in their execution: micro, mini, mainframe and supercomputers. Both general and special-purpose computers are discussed. Major computer codes are described, with regard for their use in analyzing isotope production reactors. It has been determined in this review that conventional systems codes (TRAC, RELAP5, RETRAN, etc.) cannot meet four essential conditions for viable reactor simulation: simulation fidelity, on-line interactive operation with convenient graphics, high simulation speed, and at low cost. These conditions can be met by special-purpose computers (such as the AD100 of ADI), which are specifically designed for high-speed simulation of complex systems. The greatest shortcoming of existing systems codes (TRAC, RELAP5) is their mismatch between very high computational efforts and low simulation fidelity. The drift flux formulation (HIPA) is the viable alternative to the complicated two-fluid model. No existing computer code has the capability of accommodating all important processes in the core geometry of isotope production reactors. Experiments are needed (heat transfer measurements) to provide necessary correlations. It is important for the nuclear community, both in government, industry and universities, to begin to take advantage of modern simulation technologies and equipment. 41 refs.

  2. Identifying behaviour patterns of construction safety using system archetypes.

    PubMed

    Guo, Brian H W; Yiu, Tak Wing; González, Vicente A

    2015-07-01

    Construction safety management involves complex issues (e.g., different trades, multi-organizational project structure, constantly changing work environment, and transient workforce). Systems thinking is widely considered as an effective approach to understanding and managing the complexity. This paper aims to better understand dynamic complexity of construction safety management by exploring archetypes of construction safety. To achieve this, this paper adopted the ground theory method (GTM) and 22 interviews were conducted with participants in various positions (government safety inspector, client, health and safety manager, safety consultant, safety auditor, and safety researcher). Eight archetypes were emerged from the collected data: (1) safety regulations, (2) incentive programs, (3) procurement and safety, (4) safety management in small businesses (5) production and safety, (6) workers' conflicting goals, (7) blame on workers, and (8) reactive and proactive learning. These archetypes capture the interactions between a wide range of factors within various hierarchical levels and subsystems. As a free-standing tool, they advance the understanding of dynamic complexity of construction safety management and provide systemic insights into dealing with the complexity. They also can facilitate system dynamics modelling of construction safety process.

  3. Frozen, Fully-Cooked Products and Botulism--Food Safety Advisory

    MedlinePlus

    ... Administrative Forms Standard Forms Skip Navigation Z7_0Q0619C0JGR010IFST1G5B10H1 Web Content Viewer (JSR 286) Actions ${title} Loading... / Topics / ... Frozen Fully-cooked Products and Botulism Z7_0Q0619C0JGR010IFST1G5B10H3 Web Content Viewer (JSR 286) Actions ${title} Loading... Z7_ ...

  4. Development of a convenience and safety chilled sous vide fish dish: Diversification of aquacultural products.

    PubMed

    Espinosa, M C; López, G; Díaz, P; Linares, M B; Garrido, M D

    2016-04-01

    The dynamic expansion of the ready-to-eat seabream sector in its adaptation to new lifestyles has led to the search for new presentation formats in seabream (Sparus aurata). Green sauce (olive oil, wine vinegar, garlic, fresh parsley, black pepper, basil and salt) and 60 ℃ of cooking temperature were chosen by the panellists for the sous vide cooking process. Seabream fillet and sauce were packaged in polypropylene trays, cooked, chilled and stored at 2 ℃. Microbiological (total viable counts,Enterobacteriaceae,lactic acid bacteria, anaerobic psychrotrophic, moulds and yeasts, Salmonella and Listeria monocytogenes), chemical (pH and TBARs) and sensory parameters were determined at 0, 7, 17, 34, 48 and 62 days. In the conditions used, the microbiological counts remained stable, and Salmonella and Listeria monocytogenes were absent. The acidic sauce had a positive effect on the pH of the product, and low TBARs were obtained throughout storage. The processing conditions used in the present study allowed a chilled ready-to-eat seabream product of consistently high quality up to 62 days of storage to be obtained, representing an expansion of the products offered by the aquacultural industry.

  5. Product reformulation in the food system to improve food safety. Evaluation of policy interventions.

    PubMed

    Marotta, Giuseppe; Simeone, Mariarosaria; Nazzaro, Concetta

    2014-03-01

    The objective of this study is to understand the level of attention that the consumer awards to a balanced diet and to product ingredients, with a twofold purpose: to understand whether food product reformulation can generate a competitive advantage for companies that practice it and to evaluate the most appropriate policy interventions to promote a healthy diet. Reformulation strategy, in the absence of binding rules, could be generated by consumers. Results from qualitative research and from empirical analysis have shown that the question of health is a latent demand influenced by two main factors: a general lack of information, and the marketing strategies adopted by companies which bring about an increase in the information asymmetry between producers and consumers. In the absence of binding rules, it is therefore necessary that the government implement information campaigns (food education) aimed at increasing knowledge regarding the effects of unhealthy ingredients, in order to inform and improve consumer choice. It is only by means of widespread information campaigns that food product reformulation can become a strategic variable and allow companies to gain a competitive advantage. This may lead to virtuous results in terms of reducing the social costs related to an unhealthy diet.

  6. Food safety in raw milk production: risk factors associated to bacterial DNA contamination.

    PubMed

    Cerva, Cristine; Bremm, Carolina; Reis, Emily Marques dos; Bezerra, André Vinícius Andrade; Loiko, Márcia Regina; Cruz, Cláudio Estêvão Farias da; Cenci, Alexander; Mayer, Fabiana Quoos

    2014-06-01

    While human illness from milkborne pathogens may be linked to contamination of the product after pasteurization or improper pasteurization, such diseases are usually associated with consumption of raw milk or its by-products. Molecular biology tools were applied to investigate contamination by Listeria monocytogenes, Salmonella spp., some pathogenic strains of Escherichia coli, and Campylobacter jejuni in 548 raw milk samples from 125 dairy farms established in two regions from southern Brazil. Moreover, 15 variables were evaluated for their association with raw milk contamination levels, and the risk factors were determined by multiple regression analysis. Salmonella spp. were more frequently detected, followed by pathogenic E. coli. There was difference in contamination index between the regions, in which risk factors such as temporary cattle confinement, low milk production, low milking machine cleaning frequency, and milk storage area without tile walls were identified. The risk factors were specific to each region studied. Nevertheless, the data can be used to improve milk quality of dairy farms/herds with similar management practices.

  7. Robustness of nanofiltration for increasing the viral safety margin of biological products.

    PubMed

    Caballero, Santiago; Diez, José M; Belda, Francisco J; Otegui, Magdalena; Herring, Steven; Roth, Nathan J; Lee, Douglas; Gajardo, Rodrigo; Jorquera, Juan I

    2014-03-01

    In this study, the virus-removal capacity of nanofiltration was assessed using validated laboratory scale models on a wide range of viruses (pseudorabies virus; human immunodeficiency virus; bovine viral diarrhea virus; West Nile virus; hepatitis A virus; murine encephalomyocarditis virus; and porcine parvovirus) with sizes from 18 nm to 200 nm and applying the different process conditions existing in a number of Grifols' plasma-derived manufacturing processes (thrombin, α1-proteinase inhibitor, Factor IX, antithrombin, plasmin, intravenous immunoglobulin, and fibrinogen). Spiking experiments (n = 133) were performed in process intermediate products, and removal was subsequently determined by infectivity titration. Reduction Factor (RF) was calculated by comparing the virus load before and after nanofiltration under each product purification condition. In all experiments, the RFs were close to or greater than 4 log10 (>99.99% of virus elimination). RF values were not significantly affected by the process conditions within the limits assayed (pH, ionic strength, temperature, filtration ratio, and protein concentration). The virus-removal capacity of nanofiltration correlated only with the size of the removed agent. In conclusion, nanofiltration, as used in the manufacturing of several Grifols' products, is consistent, robust, and not significantly affected by process conditions.

  8. [Mercury pollution in selected food products in Poland in the context of their health safety].

    PubMed

    Kiedrowski, Mirosław; Tarasiuk, Katarzyna; Gajewska, Danuta; Włodarek, Dariusz

    2014-10-01

    Mercury is a silvery-white chemically active transition metal without known physiological role. It is also a toxin accumulated in living organisms--especially in the aquatic creatures (fish and shellfish). Mercury compounds are involved in biogeochemical cycles (especially atmospheric and hydrobiologic), and thus they become contaminants of food. Such process is facilitated by the increasing environmental chemization. Toxic effects of mercury compounds result from their high affinity to sulfur (sulfhydryl groups of amino acids), accumulation in parenchymal organs, metallic mercury lipophilicity as well as long biological half-life period. In Poland the major sources of mercury exposure in diet are fish products and mushrooms. The role of mercury in human toxicology was presented in the work, along with a review of the literature concerning mercury content in selected food products in Poland. In general, most of foods do not pose a threat to consumers' health. Some restrictions in the amount of predatory fish and mushrooms consumed by pregnant and breastfeeding women as well as small children should be however recommended.

  9. Nuclear safety

    NASA Technical Reports Server (NTRS)

    Buden, D.

    1991-01-01

    Topics dealing with nuclear safety are addressed which include the following: general safety requirements; safety design requirements; terrestrial safety; SP-100 Flight System key safety requirements; potential mission accidents and hazards; key safety features; ground operations; launch operations; flight operations; disposal; safety concerns; licensing; the nuclear engine for rocket vehicle application (NERVA) design philosophy; the NERVA flight safety program; and the NERVA safety plan.

  10. 78 FR 52239 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-22

    ... are necessary to bolster human safety, environmental protection, and regulatory oversight of critical... August 22, 2013 Part II Department of the Interior Bureau of Safety and Environmental Enforcement 30 CFR... / Proposed Rules#0;#0; ] DEPARTMENT OF THE INTERIOR Bureau of Safety and Environmental Enforcement 30...

  11. [Development of an magnetic resonance imaging safety management system for metallic biomedical products using an magnetic resonance compatibility database and inquiry-based patient records].

    PubMed

    Fujiwara, Yasuhiro; Kata, Tomomi; Fujimoto, Shinichi; Yachida, Takuya; Kanamoto, Masayuki; Nanbu, Yousuke; Seki, Kouichirou; Kosaka, Nobuyuki; Kimura, Hirohiko; Adachi, Toshiki

    2014-12-01

    Several incidents involving magnetic resonance imaging (MRI) examinations of patients with unchecked MR-unsafe metallic products have been reported. To improve patient safety, we developed a new MRI safety management system for metallic biomedical products and evaluated its efficiency in clinical practice. Our system was integrated into the picture archiving and communication system (PACS) and comprised an MR compatibility database and inquiry-based patient records of internal metallic biomedical products, enabling hospital staff to check MR compatibility by product name. A total of 6,637 biomedical implants and devices were listed in this system, including product names and their MR compatibilities. Furthermore, MRI histories for each patient at our hospital were also recorded. Using this system, it was possible to confirm the MR compatibility of the patients' metallic biomedical products effectively and to reduce the number of unchecked internal products through systematic patient inquiry. In conclusion, our new system enhanced metallic biomedical product checking procedures, and improved patient safety during clinical MRI examinations.

  12. A congressional counterpoint: challenging the Reagan Administration on the safety of blood and blood products.

    PubMed

    Robbins, Anthony

    2012-08-01

    When the US Centers for Disease Control met a hard wall of political restraint in attempting a full response to the emergency of AIDS in the early 1980s, it was possible to move toward protection of blood and blood products from the legislative branch of government instead - despite resistance from the Red Cross, blood banks, and the Reagan Administration. A Congressional creation, the Office of Technology Assessment (OTA), received a request from the author, made on behalf of his employer, the Chairman of a Congressional Committee and a Member of the OTA Congressional Board. He asked the OTA to assess US blood policy in light of scientific and technological developments - most importantly the new disease, AIDS. The OTA issued its report in January 1985. In 1995, a new Republican majority in both legislative chambers eliminated the OTA - and thus a valuable source of policy analysis of scientific issues independent of the executive branch.

  13. A critical assessment of the scientific basis, and implementation, of regulations for the safety assessment and marketing of innovative tobacco-related products.

    PubMed

    Combes, Robert D; Balls, Michael

    2015-09-01

    Our scientific, logistical, ethical and animal welfare-related concerns about the latest US Food and Drug Administration (FDA) regulations for existing and so-called 'new' tobacco products, aimed at reducing harmful exposures, are explained. Such claims for sales in the USA now have to be based on a wide range of information, a key part of which will increasingly be data on safety and risk. One of the pathways to achieve marketing authorisation is to demonstrate substantial equivalence (SE) with benchmark products, called predicates. However, the regulations are insufficiently transparent with regard to: a) a rationale for the cut-off date for 'old' and 'new' products, and for exempting the former from regulation; b) the scientific validity and operation of SE; c) options for product labelling to circumvent SE; d) the experimental data required to support, and criteria to judge, a claim; and e) a strategy for risk assessment/management. Scientific problems related to the traditional animal methods used in respiratory disease and inhalation toxicology, and the use of quantitative comparators of toxicity, such as the No Observed Adverse Effect Level, are discussed. We review the advantages of relevant in vitro, mechanism-based, target tissue-oriented technologies, which an advisory report of the Institute of Medicine of the US National Academy of Sciences largely overlooked. These benefits include: a) the availability, for every major site in the respiratory tract, of organotypic human cell-based tissue culture systems, many of which are already being used by the industry; b) the accurate determination of concentrations of test materials received by target cells; c) methods for exposure to particulate and vapour phases of smoke, separately or combined; d) the ability to study tissue-specific biotransformation; and e) the use of modern, human-focused methodologies, unaffected by species differences. How data extrapolation, for risk assessment, from tissue culture to

  14. Ping-pong amplification of a retroviral vector achieves high-level gene expression: human growth hormone production.

    PubMed Central

    Kozak, S L; Kabat, D

    1990-01-01

    Retroviral vectors offer major advantages for gene transfer studies but have not been useful for producing proteins in large quantities. This deficiency has resulted in part from interference to superinfection, which limits the numbers of active proviruses in cells. Recently, we found that these vectors amplify when they are added as calcium phosphate precipitates to cocultures of cells that package retroviruses into ecotropic and amphotropic host range envelopes. Helper-free virions from either cell type can infect the other without interference, resulting in theoretically limitless back-and-forth (ping-pong) vector replication. In initial studies, however, amplifications of a vector that contained the human growth hormone gene ceased when the hormone produced was 0.3% or less of cellular protein synthesis. This limit was caused by two factors. First, recombinant shutoff viruses that are replication defective and encode envelope glycoproteins form at a low probability during any round of the vector replication cycle and these spread in cocultures, thereby establishing interference. Single cells in shutoff cocultures therefore synthesize both ecotropic and amphotropic envelope glycoproteins, and they release promiscuous (presumably hybrid) virions. The probability of forming shutoff viruses before the vector had amplified to a high multiplicity was reduced by using small cocultures. Second, cells with large numbers of proviruses are unhealthy and their proviral expression can be unstable. Stable expresser cell clones were obtained by selection. Thereby, cell lines were readily obtained that stably produce human growth hormone as 4 to 6% of the total protein synthesis. A ping-pong retroviral vector can be used for high-level protein production in vertebrate cells. Images PMID:2352330

  15. Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions

    PubMed Central

    Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R

    2005-01-01

    Background: Until recently, the preparation of paediatric parenteral nutrition formulations in our institution included re-transcription and manual compounding of the mixture. Although no significant clinical problems have occurred, re-engineering of this high risk activity was undertaken to improve its safety. Several changes have been implemented including new prescription software, direct recording on a server, automatic printing of the labels, and creation of a file used to pilot a BAXA MM 12 automatic compounder. The objectives of this study were to compare the risks associated with the old and new processes, to quantify the improved safety with the new process, and to identify the major residual risks. Methods: A failure modes, effects, and criticality analysis (FMECA) was performed by a multidisciplinary team. A cause-effect diagram was built, the failure modes were defined, and the criticality index (CI) was determined for each of them on the basis of the likelihood of occurrence, the severity of the potential effect, and the detection probability. The CIs for each failure mode were compared for the old and new processes and the risk reduction was quantified. Results: The sum of the CIs of all 18 identified failure modes was 3415 for the old process and 1397 for the new (reduction of 59%). The new process reduced the CIs of the different failure modes by a mean factor of 7. The CI was smaller with the new process for 15 failure modes, unchanged for two, and slightly increased for one. The greatest reduction (by a factor of 36) concerned re-transcription errors, followed by readability problems (by a factor of 30) and chemical cross contamination (by a factor of 10). The most critical steps in the new process were labelling mistakes (CI 315, maximum 810), failure to detect a dosage or product mistake (CI 288), failure to detect a typing error during the prescription (CI 175), and microbial contamination (CI 126). Conclusions: Modification of the process

  16. 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.

  17. Use of a Closed Culture System to Improve the Safety of Lentiviral Vector Production.

    PubMed

    Wu, Tao; Bour, Gaëtan; Durand, Sarah; Lindner, Véronique; Gossé, Francine; Zona, Laetitia; Certoux, Jean-Marie; Diana, Michele; Baumert, Thomas F; Marescaux, Jacques; Mutter, Didier; Pessaux, Patrick; Robinet, Eric

    2015-12-01

    We evaluated the possibility of introducing a combination of six oncogenes into primary porcine hepatocytes (PPH) using a lentiviral vector (LV)-mediated gene transfer in order to develop a porcine hepatocellular carcinoma model based on autologous transplantation of ex vivo-transformed hepatocytes. The six oncogenes were introduced into three plasmids, hence enabling the production of LVs encoding a luciferase reporter gene and hTERT+p53(DD), cyclinD1+CDK4(R24C), and c-myc(T58A)+HRas(G21V) genes, respectively. In order to improve the protection of the laboratory personnel manipulating such LVs, we used a compact cell culture cassette (CliniCell(®) device) as a closed cell culture system. We demonstrated that the CliniCell device allows to produce LVs, through plasmid transfection of 293T cells, and, after transfer to a second cassette, to transduce PPH with a similar efficacy as conventional open cell culture systems such as flasks or Petri dishes. Additionally, it is possible to cryopreserve at -80°C the transduced cells, directly in the CliniCell device used for the transduction. In conclusion, the use of a closed culture system for the safe handling of oncogene-encoding LVs lays the foundation for the development of porcine tumor models based on the autologous transplantation of ex vivo-transformed primary cells.

  18. Factors affecting yield and safety of protein production from cassava by Cephalosporium eichhorniae

    SciTech Connect

    Mikami, Y.; Gregory, K.F.; Levadoux, W.L.; Balagopalan, C.; Whitwill, S.T.

    1982-01-01

    The properties of C. eichhorniae 152 (ATCC 38255) affecting protein production from cassava carbohydrate, for use as an animal feed, were studied. This strain is a true thermophile, showing optimum growth at 45-47 degrees, maximum protein yield at 45 degrees, and no growth at 25 degrees. It has an optimum pH of approximately 3.8 and is obligately acidophilic, being unable to sustain growth at pH of more than or equal to 6.0 in a liquid medium, or pH of more than or equal to 7.0 on solid media. The optimum growth conditions of pH 3.8 and 45 degrees were strongly inhibitive to potential contaminants. It rapidly hydrolyzed cassava starch. It did not utilize sucrose, but approximately 16% of the small sucrose component of cassava was chemically hydrolyzed during the process. Growth with cassava meal (50 g/l) was complete in approximately 20 h, yielding 22.5 g/l (dry biomass), containing 41% crude protein (48-50% crude protein in the mycelium) and 31% true protein (7.0 g/l). Resting and germinating spores (10 to the power of 6 - 10 to the power of 8 per animal) injected by various routes into normal and gamma-irradiated 6-week-old mice and 7-day-old chickens failed to initiate infections.

  19. Effects of extended work shifts and shift work on patient safety, productivity, and employee health.

    PubMed

    Keller, Simone M

    2009-12-01

    It is estimated 1.3 million health care errors occur each year and of those errors 48,000 to 98,000 result in the deaths of patients (Barger et al., 2006). Errors occur for a variety of reasons, including the effects of extended work hours and shift work. The need for around-the-clock staff coverage has resulted in creative ways to maintain quality patient care, keep health care errors or adverse events to a minimum, and still meet the needs of the organization. One way organizations have attempted to alleviate staff shortages is to create extended work shifts. Instead of the standard 8-hour shift, workers are now working 10, 12, 16, or more hours to provide continuous patient care. Although literature does support these staffing patterns, it cannot be denied that shifts beyond the traditional 8 hours increase staff fatigue, health care errors, and adverse events and outcomes and decrease alertness and productivity. This article includes a review of current literature on shift work, the definition of shift work, error rates and adverse outcomes related to shift work, health effects on shift workers, shift work effects on older workers, recommended optimal shift length, positive and negative effects of shift work on the shift worker, hazards associated with driving after extended shifts, and implications for occupational health nurses.

  20. African fermented dairy products - Overview of predominant technologically important microorganisms focusing on African Streptococcus infantarius variants and potential future applications for enhanced food safety and security.

    PubMed

    Jans, Christoph; Meile, Leo; Kaindi, Dasel Wambua Mulwa; Kogi-Makau, Wambui; Lamuka, Peter; Renault, Pierre; Kreikemeyer, Bernd; Lacroix, Christophe; Hattendorf, Jan; Zinsstag, Jakob; Schelling, Esther; Fokou, Gilbert; Bonfoh, Bassirou

    2017-03-21

    Milk is a major source of nutrients, but can also be a vehicle for zoonotic foodborne diseases, especially when raw milk is consumed. In Africa, poor processing and storage conditions contribute to contamination, outgrowth and transmission of pathogens, which lead to spoilage, reduced food safety and security. Fermentation helps mitigate the impact of poor handling and storage conditions by enhancing shelf life and food safety. Traditionally-fermented sour milk products are culturally accepted and widely distributed in Africa, and rely on product-specific microbiota responsible for aroma, flavor and texture. Knowledge of microbiota and predominant, technologically important microorganisms is critical in developing products with enhanced quality and safety, as well as sustainable interventions for these products, including Africa-specific starter culture development. This narrative review summarizes current knowledge of technologically-important microorganisms of African fermented dairy products (FDP) and raw milk, taking into consideration novel findings and taxonomy when re-analyzing data of 29 publications covering 25 products from 17 African countries. Technologically-important lactic acid bacteria such as Lactococcus lactis and Streptococcus infantarius subsp. infantarius (Sii), Lactobacillus spp. and yeasts predominated in raw milk and FDP across Africa. Re-analysis of data also suggests a much wider distribution of Sii and thus a potentially longer history of use than previously expected. Therefore, evaluating the role and safety of African Sii lineages is important when developing interventions and starter cultures for FDP in Africa to enhance food safety and food security. In-depth functional genomics, epidemiologic investigations and latest identification approaches coupled with stakeholder involvement will be required to evaluate the possibility of African Sii lineages as novel food-grade Streptococcus lineage.

  1. Fisheries and aquaculture industries involvement to control product health and quality safety to satisfy consumer-driven objectives on retail markets in Europe.

    PubMed

    Roth, Eva; Rosenthal, Harald

    2006-01-01

    Over the past years the export of agricultural and fishery products from developing countries has substantially increased to markets within the OECD. Retailers and importers are expanding their international operations to meet consumer demands for year-round delivery of products. Moreover, consumers have become increasingly concerned about the safety of food, including those derived from aquatic resources [FAO/NACA/WHO Joint Study Group, 1999. Report food safety issues associated with products from aquaculture. WHO Technical Report Series No 883: VII, pp. 1-55]. Governments and leading businesses are responding by imposing new safety regulations and standards to the international food system (e.g. HACCP, EUREP-GAP), product liability and labeling [Reilly, A., Howgate, P., Käferstein, F., 1997. Safety hazards and the application of HACCP in aquaculture. In: Proceedings of the Second International Conference on Fish Inspection and Quality Control: A Global Focus, Arlington, VA, 19-24 May 1996. Technomic Publishing, Lancaster, PA, pp. 353-373]. Initial concerns for imports of aquacultural products from developing to industrialized countries focussed on bacterial contamination [Buras, N. 1993. Microbial safety of produce from wastewater-fed aquaculture. In: Pullin, R.V.C., Rosenthal, H., MacLean, J.L.(Eds.), Proceedings of ICLARM Conferences, vol. 31, pp. 285-295]. Today, if trade opportunities are to be maintained, these countries must adapt to a full array of regulations and standards. This paper describes four scenarios in aquaculture and fishing product trade between developing countries and countries in the European Union.

  2. 75 FR 51178 - Safety Standard for Infant Walkers; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-19

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1216 Safety Standard for Infant Walkers; Correction AGENCY: Consumer Product Safety Commission. ACTION: Final rule; correction. SUMMARY: The United States Consumer Product Safety...

  3. Composition, labelling, and safety of food supplements based on bee products in the legislative framework of the European Union - Croatian experiences.

    PubMed

    Vujić, Mario; Pollak, Lea

    2015-12-01

    The European Union market is overflown by food supplements and an increasing number of consumers prefer those where bee products play an important part in their composition. This paper deals with complex European Union legislation concerning food supplements based on bee products, placing a special emphasis on their composition, labelling, and safety. Correct labelling of food supplements also represents a great challenge since, in spite of legal regulations in force, there are still open issues regarding the statements on the amount of propolis, which is not clearly defined by the legal framework. One of the key issues are the labels containing health claims from the EU positive list approved by the European Food Safety Authority. Emphasis will also be placed on informing consumers about food, as statements which imply the healing properties of food supplements and their capacity to cure diseases are forbidden. One of the key elements of product safety is HACCP based on the EU Regulations EC 178/02 and 852/2004. Health safety analyses of food supplements with bee products used as raw materials, which are standardised by legal regulations will also be discussed. In the future, attention should also be paid to establishing the European Union "nutrivigilance" system. Croatian experiences in addressing challenges faced by producers, supervisory entities, and regulatory and inspection bodies may serve as an example to countries aspiring to become part of the large European family.

  4. An Approach for Validating Actinide and Fission Product Burnup Credit Criticality Safety Analyses-Isotopic Composition Predictions

    SciTech Connect

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

    2011-01-01

    The expanded use of burnup credit in the United States (U.S.) for storage and transport casks, particularly in the acceptance of credit for fission products, has been constrained by the availability of experimental fission product data to support code validation. The U.S. Nuclear Regulatory Commission (NRC) staff has noted that the rationale for restricting the Interim Staff Guidance on burnup credit for storage and transportation casks (ISG-8) to actinide-only is based largely on the lack of clear, definitive experiments that can be used to estimate the bias and uncertainty for computational analyses associated with using burnup credit. To address the issues of burnup credit criticality validation, the NRC initiated a project with the Oak Ridge National Laboratory to (1) develop and establish a technically sound validation approach for commercial spent nuclear fuel (SNF) criticality safety evaluations based on best-available data and methods and (2) apply the approach for representative SNF storage and transport configurations/conditions to demonstrate its usage and applicability, as well as to provide reference bias results. The purpose of this paper is to describe the isotopic composition (depletion) validation approach and resulting observations and recommendations. Validation of the criticality calculations is addressed in a companion paper at this conference. For isotopic composition validation, the approach is to determine burnup-dependent bias and uncertainty in the effective neutron multiplication factor (keff) due to bias and uncertainty in isotopic predictions, via comparisons of isotopic composition predictions (calculated) and measured isotopic compositions from destructive radiochemical assay utilizing as much assay data as is available, and a best-estimate Monte Carlo based method. This paper (1) provides a detailed description of the burnup credit isotopic validation approach and its technical bases, (2) describes the application of the approach for

  5. Consumer assessment of safety and date labeling statements on ready-to-eat meat and poultry products designed to minimize risk of listeriosis.

    PubMed

    Lenhart, Jenna; Kendall, Patricia; Medeiros, Lydia; Doorn, Jessica; Schroeder, Mary; Sofos, John

    2008-01-01

    Point-of-purchase safety-based labeling guidance on the proper storage and handling of refrigerated ready-to-eat (RTE) meat and poultry products could help reduce the risk of listeriosis. Seniors and pregnant women are two population groups at increased risk of listeriosis due to suppressed or compromised immune systems. We conducted 11 focus groups with senior-aged women and women of childbearing age in Colorado and Ohio to assess consumer awareness of Listeria, storage practices of RTE meat products, perceptions regarding the acceptability and usefulness of common date and potential food safety labeling statements on RTE meat and poultry products, and food safety information needs. Storage times for opened and unopened RTE products varied widely, with opened products often being stored longer than recommended. Women in both age groups paid attention to date labels on packages but varied highly in their interpretation of the statements. "Use by" statements were considered clearer and more helpful than "Sell by" or "Best if used by" labels. Proposed food safety-based labeling statements listing "antilisterial" agents used in RTE products were not well received. However, labels giving consumers instructions on how long they could keep RTE products and when to discard them after opening were considered helpful and well received. Participants indicated the need for further information about Listeria and its control. Educational information at point-of-purchase and where seniors and pregnant women congregate are suggested. Manufacturers are encouraged to provide more complete information on the safe storage and use of ready-to-eat meat and poultry products on package labels.

  6. Risk assessment strategies for Europe: integrated safety strategy or final product control: Example of Listeria monocytogenes in processed products from pork meat industry.

    PubMed

    Salvat, G; Fravalo, P

    2004-08-01

    The European regulation 2160/2003 of November 17th, 2003 clearly shows the European strategy of zoonosis monitoring and control as an integrated approach, including the entire food production chain with a first application to Salmonella control in different animal species. This regulation is the consequence of a risk assessment performed with a "farm to fork" philosophy. European strategy is scarcely different from the American strategy, despite the fact that both were achieved by a quantitative risk assessment, as for instance, in the USA the control of Salmonella in eggs is supposed to be completed by refrigeration. Nevertheless, the EU will still have a final product control approach towards future regulations on microbiological criteria for foodstuffs. The final production monitoring and control with HACCP (93/43/EC) and microbiological criteria is the only one available for L. monocytogenes in foodstuffs. The purpose of this paper is to discuss alternative control strategies for L. monocytogenes in pig production including integrated risk assessment. In France, most of the food-borne outbreaks associated with L. monocytogenes in delicatessen were due to one particular group of strains belonging to serovar 4b and presenting a particular RFLP/PFGE (Restriction Fragment Length Polymorphism/Pulsed Field Gel Electrophoresis) profile. The outbreak itself is always associated with the initial contamination of a RTE ("ready to eat") product and re-contamination by inappropriate handling after cooking. Consequently, in most cases the RTE product is subject to inadequate refrigeration during an excessive shelf-life. The responsibility of the food industry and the consumer is clearly engaged during this scenario of foodborne diseases. The question is how to avoid the introduction of this particular strain of L. monocytogenes in the food chain. In a study we tried to evaluate the risk of pig carcass contamination at slaughterhouse level and to identify the main risk

  7. Development of design and simulation model and safety study of large-scale hydrogen production using nuclear power.

    SciTech Connect

    Gelbard, Fred; Oh, Seungmin; Rodriguez, Salvador B.; Revankar, Shripad T.; Gauntt, Randall O.; Cole, Randall K., Jr.; Espinosa, Flor; Drennen, Thomas E.; Tournier, Jean-Michel; Hogan, Kevin; Archuleta, Louis; Malczynski, Leonard A.; Vierow, Karen; McFadden, Katherine Letizia; Martin, William Joseph; El-Genk, Mohamed S.; Louie, David L. Y.

    2007-10-01

    Before this LDRD research, no single tool could simulate a very high temperature reactor (VHTR) that is coupled to a secondary system and the sulfur iodine (SI) thermochemistry. Furthermore, the SI chemistry could only be modeled in steady state, typically via flow sheets. Additionally, the MELCOR nuclear reactor analysis code was suitable only for the modeling of light water reactors, not gas-cooled reactors. We extended MELCOR in order to address the above deficiencies. In particular, we developed three VHTR input models, added generalized, modular secondary system components, developed reactor point kinetics, included transient thermochemistry for the most important cycles [SI and the Westinghouse hybrid sulfur], and developed an interactive graphical user interface for full plant visualization. The new tool is called MELCOR-H2, and it allows users to maximize hydrogen and electrical production, as well as enhance overall plant safety. We conducted validation and verification studies on the key models, and showed that the MELCOR-H2 results typically compared to within less than 5% from experimental data, code-to-code comparisons, and/or analytical solutions.

  8. The Archveyor{trademark} mining system: Automated high wall mining, a precursor to improved safety, productivity, and cost underground

    SciTech Connect

    Sawarynski, T.J.

    1996-12-31

    Arch Mineral Corporation has an automated high wall miner called the Archveyor {trademark}. In production since 1992, it uses just two employees to operate the system. They consistently produce 91 metric tons per eight-hour employer-shift with peaks nearing 226 metric tons. The system uses a modified Joy 12CM miner cutting 3.7 meters. That loads into a 219 meter long continuous haulage Archveyor{trademark}. It discharges into a loadout vehicle that elevates the coal to load haul trucks. This technology can be adapted to mine over 305 meters into the high wall. Any continuous miner can be used to suit conditions. It is programmed to sump, shear down, sump, and shear up in a continuous cycle. It advances a set distance before the Archveyor{trademark} moves up behind it. The Archveyor{trademark} has a flight conveyor 838 mm wide used to tram and convey. Lift cylinders raise it off the ground to convey. To tram, the cylinders retract, dropping the Archveyor{trademark} to the ground. That places the full length of the return side or bottom of the flight conveyor in contract with the floor to tram in either direction. Programmable logic controllers are used with a gyroscope, gamma detectors, and inclinometers to keep on-heading and in-seam. Critical system functions are monitored and displayed for the operator. Safety, lower costs, and higher productivity drive the effort to use the Archveyor{trademark} technology underground. Arch Technology is assembling and preparing to install an underground system in the third quarter of 1996.

  9. Manufacture of Immunoglobulin Products for Patients with Primary Antibody Deficiencies – The Effect of Processing Conditions on Product Safety and Efficacy

    PubMed Central

    Farrugia, Albert; Quinti, Isabella

    2014-01-01

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

  10. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... altitude where wind no longer affects the launch vehicle. (g) Trajectory analysis products. The products of... as a function of altitude for the air space regions from the Earth's surface to 100,000 feet in altitude for the area intersected by the launch vehicle trajectory. Altitude intervals must not exceed...

  11. 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

    ... altitude where wind no longer affects the launch vehicle. (g) Trajectory analysis products. The products of... as a function of altitude for the air space regions from the Earth's surface to 100,000 feet in altitude for the area intersected by the launch vehicle trajectory. Altitude intervals must not exceed...

  12. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... altitude where wind no longer affects the launch vehicle. (g) Trajectory analysis products. The products of... as a function of altitude for the air space regions from the Earth's surface to 100,000 feet in altitude for the area intersected by the launch vehicle trajectory. Altitude intervals must not exceed...

  13. 14 CFR Appendix A to Part 417 - Flight Safety Analysis Methodologies and Products for a Launch Vehicle Flown With a Flight Safety...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... altitude where wind no longer affects the launch vehicle. (g) Trajectory analysis products. The products of... as a function of altitude for the air space regions from the Earth's surface to 100,000 feet in altitude for the area intersected by the launch vehicle trajectory. Altitude intervals must not exceed...

  14. 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

    ....852 Flowlines/ Headers. Sec. 250.853 Safety sensors. Sec. 250.855 Emergency shutdown (ESD) system. Sec.... Sec. 250.868 Non-metallic piping. Sec. 250.870 Time delays on pressure safety low (PSL) sensors. Sec..., including the electrical power supply and also including the type, location, and number of detection...

  15. Diesels boost productivity, safety

    SciTech Connect

    Jackson, D.

    1984-02-01

    In the US, the use of diesel equipment in underground coal mines is increasing, despite the controversy over the harmful effects of the emissions. The pros and cons of using diesels are discussed, and British experience is quoted. A list of manufacturers in the US, West Germany and the UK is given.

  16. In vitro study of beneficial properties and safety of lactic acid bacteria isolated from Portuguese fermented meat products.

    PubMed

    Todorov, S D; Franco, B D G M; Wiid, I J

    2014-09-01

    Many lactic acid bacteria produce bacteriocins with a rather broad spectrum of inhibition, which could offer potential applications in food preservation. Bacteriocin production by starter cultures may bring advantage to these strains in competitive interactions with pathogenic bacteria from the food matrix. The objective of this study was to determine the safety of beneficial strains (Lactobacillus plantarum ST202Ch and ST216Ch, Enterococcus faecium ST211Ch, and Lactobacillus sakei ST22Ch, ST153Ch and ST154Ch) previously isolated from fermented meat products and characterised as bacteriocin producers. Auto-aggregation was strain-specific, and values of 28.97, 27.86 and 28.56% were recorded for L. sakei ST22Ch, ST153Ch and ST154Ch, respectively, 16.95 and 14.58% for L. plantarum ST202Ch and ST216Ch, respectively, and 12.77% for E. faecium ST211Ch. Various degrees of co-aggregation between 28.85 and 44.76% for Listeria monocytogenes 211 and 409, and between 23.60 to 34.96% for E. faecium ATCC 19443 were observed. According to the results of the diffusion method, the studied strains demonstrated susceptibility to penicillin G, ampicillin, amoxicillin, amoxicillin/clavulonic acid, imipenem, linezolid, and tetracycline. In addition, the susceptibility of the six strains to various non-antibiotic commercial drugs was examined. Production of β-galactosidase by L. sakei ST22Ch, ST153Ch and ST154Ch, L. plantarum ST202Ch and ST216Ch, and E. faecium ST211Ch was confirmed by employing sterile filter paper discs impregnated with o-nitrophenyl-β-D-galactopyranose. A statistically significant (P<0.001) inhibition of Mycobacterium tuberculosis growth by bacteriocins produced by L. plantarum ST202Ch (38.3%) and ST216Ch (48.6%), L. sakei ST153Ch (16.2%) and ST154Ch (16.1%), and E. faecium ST211Ch (21.7%) was observed. As determined by the polymerase chain reaction, the tested strains showed a low virulence gene profile.

  17. Applying SE Methods Achieves Project Success to Evaluate Hammer and Fixed Cutter Grinders Using Multiple Varieties and Moistures of Biomass Feedstock for Ethanol Production

    SciTech Connect

    Larry R. Zirker; Christopher T. Wright, PhD; R. Douglas Hamelin

    2008-06-01

    Applying basic systems engineering (SE) tools to the mission analysis phases of a 2.5-million dollar biomass pre-processing project for the U.S. Department of Energy directly assisted the project principal investigator understand the complexity and identify the gaps of a moving-target project and capture the undefined technical/functional requirements and deliverables from the project team and industrial partners. A creative application of various SE tools by non-aerospace systems engineers developed an innovative “big picture” product that combined aspects of mission analysis with a project functional flow block diagram, providing immediate understanding of the depth and breath of the biomass preprocessing effort for all team members, customers, and industrial partners. The “big picture” diagram became the blue print to write the project test plan, and provided direction to bring the project back on track and achieve project success.

  18. Productivity Techniques and Quality Aspects in the Criticality Safety Evaluation of Y-12 Type-B Fissile Material Packages

    SciTech Connect

    DeClue, J. F.

    2011-06-28

    The inventory of certified Type-B fissile material packages consists of ten performance-based packages for offsite transportation purposes, serving transportation programs at the Y-12 National Security Complex. The containment vessels range from 5 to 19 in. in diameter and from 17 to 58 in. in height. The drum assembly external to the containment vessel ranges from 18 to 34 in. in diameter and from 26 to 71 in. in height. The weight of the packaging (drum assembly and containment vessel) ranges from 239 to 1550 lb. The older DT-nn series of Cellotex-based packages are being phased-out and replaced by a new generation of Kaolite-based ('Y-12 patented insulation') packages capable of withstanding the dynamic crush test 10 CFR 71.73(c)(2). Three replacement packages are in various stages of development; two are in use. The U.S. Department of Transportation (DOT) 6M specification package, which does not conform to the U.S. Nuclear Regulatory Commission requirements for Type-B packages, is no longer authorized for service on public roads. The ES-3100 shipping package is an example of a Kaolite-based Type-B fissile material package developed as a replacement package for the DOT 6M. With expanded utility, the ES-3100 is designed and licensed for transporting highly enriched uranium and plutonium materials on public roads. The ES-3100 provides added capability for air transport of up to 7-kg quantities of uranium material. This paper presents the productivity techniques and quality aspects in the criticality safety evaluation of Y-12 packages using the ES-3100 as an example.

  19. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan. Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated...

  20. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan. Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated...

  1. 21 CFR 216.24 - Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... fenfluramine hydrochloride. Flosequinan: All drug products containing flosequinan. Gelatin: All intravenous drug products containing gelatin. Glycerol, iodinated: All drug products containing iodinated...

  2. Methanol production from eucalyptus wood chips. Attachment IV. Health and safety aspects of the eucalypt biomass to methanol energy system

    SciTech Connect

    Fishkind, H.H.

    1982-06-01

    The basic eucalyptus-to-methanol energy process is described and possible health and safety risks are identified at all steps of the process. The toxicology and treatment for exposure to these substances are described and mitigating measures are proposed. The health and safety impacts and risks of the wood gasification/methanol synthesis system are compared to those of the coal liquefaction and conversion system. The scope of this report includes the health and safety risks of workers (1) in the laboratory and greenhouse, where eucalyptus seedlings are developed, (2) at the biomass plantation, where these seedlings are planted and mature trees harvested, (3) transporting these logs and chips to the refinery, (4) in the hammermill, where the logs and chips will be reduced to small particles, (5) in the methanol synthesis plant, where the wood particles will be converted to methanol, and (6) transporting and dispensing the methanol. Finally, the health and safety risks of consumers using methanol is discussed.

  3. Safety of isotropic flywheels

    SciTech Connect

    Schwartz, M.W.

    1981-04-30

    A probabilistic safety criterion for isotropic flywheel rotors is established based on the tolerated noncontainment failure rates of commercial aircraft turbojet engine rotors. A technique is developed combining reliability with fracture mechanics, and a sample calculation provided, to show the energy-storage levels that isotropic flywheel rotors could achieve within the constraints of this safety criterion.

  4. Exploration on the safety assessment of nanomaterials in China

    PubMed Central

    Shi, Xin-Li; Wang, Qiangbin; Hu, Kun; Wang, Xiu-Mei

    2012-01-01

    More and more applications of nanomaterials have been achieved in the biomedicine field. Numerous nanomedical devices, such as bone grafts with nano-hydroxyapatite and the silver-based anti-bacteria products, have been developed and have been trying to enter into the Chinese market. The State Food and Drug Administration of China (SFDA) is facing a critical challenge of how to explore and supervise the safety assessment of the nanomedical products. This paper briefly introduces the approval status of nanomedical products and the current advances of the safety assessment of nanomaterials in China. PMID:23741614

  5. Farm Safety

    PubMed Central

    Wilson, G. S.

    1966-01-01

    Accident and safety are related terms; the higher the accident rate in any industry, the greater is the need for safety measures designed to prevent accidents. This article discusses the accident and safety problems in agriculture, which includes horticulture and forestry. There is still a tendency among townspeople to think of the countryside as peaceful and tranquil, a place where nothing happens very quickly and far removed from violent death or crippling injury. This pleasant rustic picture has undergone a striking change in the last 30 years owing to considerable agricultural mechanization and the development of chemical pesticides, which have brought new dangers to those who live and work on the land. Although men have readily adapted themselves to new machines and methods, they have not proved as able to recognize new dangers and learn how to guard against them. In consequence, accidents have increased to such an extent that the whole industry has realized the need for positive preventive measures. In this country, it is generally accepted that an employer of labour has a responsibility to provide safe working conditions for those he employs. Farm safety legislation goes a little further and usually requires an employer to provide necessary safeguards, with the added requirement on a worker to make use of them. It is a feature of accident prevention work that it never reaches a stage when it can be regarded as complete. Even when a reduction in accidents has been achieved, the effort must be sustained or the trend will be quickly reversed. Images PMID:5904095

  6. Opinion of the Scientific Committee on Consumer Safety (SCCS) - Final version of the opinion on Phenoxyethanol in cosmetic products.

    PubMed

    Lilienblum, Werner

    2016-12-01

    The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided. The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults. This Opinion does not take into account exposure from sources other than cosmetics.

  7. Process safety improvement--quality and target zero.

    PubMed

    Van Scyoc, Karl

    2008-11-15

    Process safety practitioners have adopted quality management principles in design of process safety management systems with positive effect, yet achieving safety objectives sometimes remain a distant target. Companies regularly apply tools and methods which have roots in quality and productivity improvement. The "plan, do, check, act" improvement loop, statistical analysis of incidents (non-conformities), and performance trending popularized by Dr. Deming are now commonly used in the context of process safety. Significant advancements in HSE performance are reported after applying methods viewed as fundamental for quality management. In pursuit of continual process safety improvement, the paper examines various quality improvement methods, and explores how methods intended for product quality can be additionally applied to continual improvement of process safety. Methods such as Kaizen, Poke yoke, and TRIZ, while long established for quality improvement, are quite unfamiliar in the process safety arena. These methods are discussed for application in improving both process safety leadership and field work team performance. Practical ways to advance process safety, based on the methods, are given.

  8. Don't let safety happen by accident.

    PubMed

    Blaco, C E

    1992-02-01

    Get ready to update and improve your company's safety program. On pages 24-38, you'll find a comprehensive guide to safe industry practices to enhance your operation and help you stay in compliance with OSHA regulations such as the General Duty Clause and the Right-to-Know law. Achieving a safe, healthy, productive, and profitable business doesn't happen by accident. It takes upper-management commitment to improve equipment, procedures, and employee training. Managers have a personal and a legal responsibility for employees' safety on the job. Don't delay safety improvements!

  9. 75 FR 7606 - Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-22

    ... applications (TEAs). We are currently evaluating the safety and effectiveness of these ingredients. DATES... found eligible for possible addition to an OTC drug monograph via the TEA process described in 21 CFR... inclusion in an OTC drug monograph under the TEA process on the basis of foreign marketing...

  10. Behavioral Self-Monitoring of Safety and Productivity in the Workplace: A Methodological Primer and Quantitative Literature Review

    ERIC Educational Resources Information Center

    Olson, Ryan; Winchester, Jamey

    2008-01-01

    Workplace applications of behavioral self-monitoring (BSM) methods have been studied periodically for over 35 years, yet the literature has never been systematically reviewed. Recent occupational safety interventions including BSM resulted in relatively large behavior changes. Moreover, BSM methods are functional for addressing a broad range of…

  11. 77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-06

    ... Products Research Project Grant (R01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... substantially contribute to, market approval of these products. Applicants must include in the application's... either help support product approval or provide essential data needed for product development....

  12. Safety Evaluation of Sous Vide-Processed Products with Respect to Nonproteolytic Clostridium botulinum by Use of Challenge Studies and Predictive Microbiological Models

    PubMed Central

    Hyytiä-Trees, Eija; Skyttä, Eija; Mokkila, Mirja; Kinnunen, Arvo; Lindström, Miia; Lähteenmäki, Liisa; Ahvenainen, Raija; Korkeala, Hannu

    2000-01-01

    Sixteen different types of sous vide-processed products were evaluated for safety with respect to nonproteolytic group II Clostridium botulinum by using challenge tests with low (2.0-log-CFU/kg) and high (5.3-log-CFU/kg) inocula and two currently available predictive microbiological models, Food MicroModel (FMM) and Pathogen Modeling Program (PMP). After thermal processing, the products were stored at 4 and 8°C and examined for the presence of botulinal spores and neurotoxin on the sell-by date and 7 days after the sell-by date. Most of the thermal processes were found to be inadequate for eliminating spores, even in low-inoculum samples. Only 2 of the 16 products were found to be negative for botulinal spores and neurotoxin at both sampling times. Two products at the high inoculum level showed toxigenesis during storage at 8°C, one of them at the sell-by date. The predictions generated by both the FMM thermal death model and the FMM and PMP growth models were found to be inconsistent with the observed results in a majority of the challenges. The inaccurate predictions were caused by the limited number and range of the controlling factors in the models. Based on this study, it was concluded that the safety of sous vide products needs to be carefully evaluated product by product. Time-temperature combinations used in thermal treatments should be reevaluated to increase the efficiency of processing, and the use of additional antibotulinal hurdles, such as biopreservatives, should be assessed. PMID:10618228

  13. Impact of biomarker development on drug safety assessment

    SciTech Connect

    Marrer, Estelle; Dieterle, Frank

    2010-03-01

    Drug safety has always been a key aspect of drug development. Recently, the Vioxx case and several cases of serious adverse events being linked to high-profile products have increased the importance of drug safety, especially in the eyes of drug development companies and global regulatory agencies. Safety biomarkers are increasingly being seen as helping to provide the clarity, predictability, and certainty needed to gain confidence in decision making: early-stage projects can be stopped quicker, late-stage projects become less risky. Public and private organizations are investing heavily in terms of time, money and manpower on safety biomarker development. An illustrative and 'door opening' safety biomarker success story is the recent recognition of kidney safety biomarkers for pre-clinical and limited translational contexts by FDA and EMEA. This milestone achieved for kidney biomarkers and the 'know how' acquired is being transferred to other organ toxicities, namely liver, heart, vascular system. New technologies and molecular-based approaches, i.e., molecular pathology as a complement to the classical toolbox, allow promising discoveries in the safety biomarker field. This review will focus on the utility and use of safety biomarkers all along drug development, highlighting the present gaps and opportunities identified in organ toxicity monitoring. A last part will be dedicated to safety biomarker development in general, from identification to diagnostic tests, using the kidney safety biomarkers success as an illustrative example.

  14. Safety of magnetic fusion facilities: Requirements

    SciTech Connect

    1996-05-01

    This Standard identifies safety requirements for magnetic fusion facilities. Safety functions are used to define outcomes that must be achieved to ensure that exposures to radiation, hazardous materials, or other hazards are maintained within acceptable limits. Requirements applicable to magnetic fusion facilities have been derived from Federal law, policy, and other documents. In addition to specific safety requirements, broad direction is given in the form of safety principles that are to be implemented and within which safety can be achieved.

  15. Thermal reactor safety

    SciTech Connect

    Not Available

    1980-06-01

    Information is presented concerning new trends in licensing; seismic considerations and system structural behavior; TMI-2 risk assessment and thermal hydraulics; statistical assessment of potential accidents and verification of computational methods; issues with respect to improved safety; human factors in nuclear power plant operation; diagnostics and activities in support of recovery; LOCA transient analysis; unresolved safety issues and other safety considerations; and fission product transport.

  16. Drug Safety

    MedlinePlus

    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  17. Vaccine Safety

    MedlinePlus

    ... FAQs about Vaccine Safety Research Publications HDM Reports ISO Scientific Agenda Ensuring Safety History Understanding Side Effects ... Datalink Publications Emergency Preparedness Vaccine Safety Partners About ISO File Formats Help: How do I view different ...

  18. Factors associated with regulatory action involving investigation of illnesses associated with Shiga toxin-producing Escherichia coli in products regulated by the Food Safety and Inspection Service.

    PubMed

    Green, Alice L; Seys, Scott; Douris, Aphrodite; Levine, Jeoff; Robertson, Kis

    2014-07-01

    We described characteristics of the Escherichia coli O157 and Escherichia coli non-O157 illness investigations conducted by the United States Department of Agriculture's Food Safety and Inspection Service (FSIS) during the 5-year period from 2006 through 2010. We created a multivariable logistic regression model to determine characteristics of these investigations that were associated with FSIS regulatory action, which was defined as having occurred if a product recall occurred or if FSIS personnel performed an environmental health assessment (Food Safety Assessment) at the implicated establishment. During this period, FSIS took regulatory action in 38 of 88 (43%) investigations. Illness investigations in which FoodNet states were involved were more likely to result in regulatory action. Illness investigations in which state and local traceback, or FSIS traceback occurred were more likely to result in regulatory action. Reasons for lack of action included evidence of cross-contamination after the product left a regulated establishment, delayed notification, lack of epidemiological information, and insufficient product information.

  19. Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.

    PubMed

    Kesselheim, Aaron S; Gagne, Joshua J

    2015-10-01

    Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalence studies were not relevant; and (2) cases of complex molecules that may require specially tailored pharmaceutical equivalence studies. Examples include venlafaxine extended release, acarbose, vancomycin capsules, sodium ferric gluconate, salmon calcitonin nasal spray, and enoxaparin. Product-specific approaches to demonstrating therapeutic equivalence are essential to avoid delays in low-cost generic drug availability but can have important clinical implications; yet, currently, there is no formal process in place to monitor the safety and effectiveness of generic drugs approved using modified regulatory pathways. Several strategies can be used to monitor the safety and effectiveness of generic drugs approved via product-specific determinations of therapeutic equivalence.

  20. Chemical Products in the Home, Workshop and Garden. Proceed with Caution; Consumer Safety in the Home, II.

    ERIC Educational Resources Information Center

    Saskatchewan Consumer and Commercial Affairs, Regina.

    The average home has chemical products to clean floors, kill insects, clean ovens, thin paint, remove grease, and perform countless other chores. Many consumers remain unaware of the dangers these products bring into the home. This booklet provides information on the safe use, storage, and disposal of these products. The compounds found in…

  1. 75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-06

    ... Products Research Project Grant (R01) AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY... substantially contribute to, market approval of these products. Applicants must include in the application's... proposed study will either help support product approval or provide essential data needed for...

  2. Review of the US Consumer Product Safety Commission's health effects and exposure assessment documents on nitrogen dioxide. Report of the Clean Air Scientific Advisory Committee. Final report

    SciTech Connect

    Not Available

    1988-05-09

    At the request of the Consumer Product Safety Commission, the Clean Air Scientific Advisory Committee conducted a review on the potential health hazards associated with exposure to 0.1 to 1.0 ppm nitrogen dioxide generated by unvented indoor combustion sources. The committee concluded that: (1) repeated peak exposures at concentrations of 0.3 ppm of nitrogen dioxide may cause health effects in some individuals; (2) the population groups that appear most sensitive to nitrogen dioxide exposure include children, chronic bronchitics, asthmatics, and individuals with emphysema; and (3) the most direct evidence regarding lung damage associated with nitrogen dioxide is obtained from animal studies.

  3. Practicing Fireworks Safety

    MedlinePlus

    ... recent fireworks injury report (PDF) from the U.S. Consumer Product Safety Commission, fireworks injuries in the in ... to help. For those who decide to purchase consumer fireworks because they live in states where they ...

  4. Rodent Control Pesticide Safety Review

    EPA Pesticide Factsheets

    EPA completed a safety review in 2008 of rat and mouse poison products. Many companies' products have our safety measures that reduce risks to humans, pets, and non-target wildlife. Products must be sold with bait stations that securely contain the poison.

  5. A randomised, crossover study on an electronic vapour product, a nicotine inhalator and a conventional cigarette. Part B: Safety and subjective effects.

    PubMed

    Walele, Tanvir; Sharma, Girish; Savioz, Rebecca; Martin, Claire; Williams, Josie

    2016-02-01

    An Electronic Vapour Product (EVP) has been evaluated for short-term safety parameters and subjective effects in a 2-part study, in smokers. Part 1 compared the EVP with unflavoured (UF) and flavoured (FL) e-liquid at 2.0% nicotine to a conventional cigarette (CC; JPS Silver King Size, 0.6 mg) and a licensed nicotine inhalator (Nicorette(®), 15 mg). Part 2 assessed the effect of increasing concentrations of nicotine in the e-liquid used with the EVP (0%, 0.4%, 0.9%, 2.0%). The study was designed as a randomised, controlled, crossover trial. Outcomes included adverse events (AEs), vital signs, exhaled carbon monoxide (CO), clinical laboratory parameters, smoking urges and withdrawal symptoms. In both study parts, only mild non-serious AEs were reported. No major differences were observed in AEs between the EVPs and Nicorette(®). Exhaled CO levels only increased for CC. All products appeared to decrease smoking urges and nicotine withdrawal symptom scores to a similar extent. The EVP had a similar short-term safety profile to Nicorette(®) and relieved smoking urges and nicotine withdrawal symptoms to a similar extent as Nicorette(®) and CC. Unlike nicotine replacement therapies, the EVP may offer an alternative for those finding it difficult to quit the behavioural and sensorial aspects of smoking.

  6. Product Failures in Respirators and Consumables: Analysis of Field Safety Notices of 2005-2013 Publicized by the Federal Institute for Drugs and Medical Devices in Germany.

    PubMed

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system governed by the three EC directives 93/42/EEC (Medical Device Directive), 98/79/EC (In-Vitro Diagnostic Directive) and 90/385/EEC (Active Implantable Medical Device Directive) regulates marketing and post-market surveillance of medical devices in the European Economic Area (EEA). In cases of incidents raising the field safety corrective actions (FSCA), manufacturers have to inform the responsible Competent Authority (CA; in Germany this is the Federal Institute for Drugs and Medical Devices, BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of respirators and consumables directly required for their function, whereas devices for anesthesia and gas delivery were excluded. FSCA and FSN of 2005-2013 publicized by BfArM for the included products were analyzed with respect to the MEDDEV 2.12-1 rev. 8. In total, 60 FSCA were publicized. German and English FSN were found in 59/53 cases, respectively. FSN were clearly characterized as FSN in 44/38 cases and declaration of the type of action in 45/44 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/7 and 43/40 cases, respectively. Detailed information regarding FSCA and product malfunction was found in all cases. Information on product related risks with previous use of affected devices was provided in 42/38 cases. In 53/53 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness in the organization were found in 27/24 cases. Contact data were provided in 53/48 cases, respectively. Confirmation that a CA was informed was found in 28/26 cases and in 19/15 cases a customer confirmation was included. The identified risks were: total loss of function (19/16), short circuit (1/1) and burn (3/3), and inhalation of foreign particles (1/1) which might cause severe risk to patients and users. The most frequent

  7. [Design of a Hazard Analysis and Critical Control Points (HACCP) plan to assure the safety of a bologna product produced by a meat processing plant].

    PubMed

    Bou Rached, Lizet; Ascanio, Norelis; Hernández, Pilar

    2004-03-01

    The Hazard Analysis and Critical Control Point (HACCP) is a systematic integral program used to identify and estimate the hazards (microbiological, chemical and physical) and the risks generated during the primary production, processing, storage, distribution, expense and consumption of foods. To establish a program of HACCP has advantages, being some of them: to emphasize more in the prevention than in the detection, to diminish the costs, to minimize the risk of manufacturing faulty products, to allow bigger trust to the management, to strengthen the national and international competitiveness, among others. The present work is a proposal based on the design of an HACCP program to guarantee the safety of the Bologna Special Type elaborated by a meat products industry, through the determination of hazards (microbiological, chemical or physical), the identification of critical control points (CCP), the establishment of critical limits, plan corrective actions and the establishment of documentation and verification procedures. The used methodology was based in the application of the seven basic principles settled down by the Codex Alimentarius, obtaining the design of this program. In view of the fact that recently the meat products are linked with pathogens like E. coli O157:H7 and Listeria monocytogenes, these were contemplated as microbiological hazard for the establishment of the HACCP plan whose application will guarantee the obtaining of a safe product.

  8. Safety of plant-made pharmaceuticals: product development and regulatory considerations based on case studies of two autologous human cancer vaccines.

    PubMed

    Tusé, Daniel

    2011-03-01

    Guidelines issued by regulatory agencies for the development of plant-made pharmaceutical (PMP) products provide criteria for product manufacturing and characterization, safety determination, containment and mitigation of environmental risks. Features of plant-made products do not always enable an easy fit within the criteria subscribed to by regulators. The unconventional nature of plant-based manufacturing processes and peculiarities of plant biology relative to that of traditional biological production systems have led to special considerations in the regulatory scrutiny of PMP. Presented in this review are case studies of two plant-made autologous (patient-specific) cancer vaccines, the nature of which introduced challenges to conventional and standardized development and preclinical evaluation routes. The rationale presented to FDA by the sponsors of each vaccine to build consensus and obtain variances to existing guidelines is discussed. While development of many plant-made biologics can be accomplished within the existing regulatory framework, the development of specialized products can be defended with rational arguments based on strong science.

  9. Addressing Uniqueness and Unison of Reliability and Safety for a Better Integration

    NASA Technical Reports Server (NTRS)

    Huang, Zhaofeng; Safie, Fayssal

    2016-01-01

    Over time, it has been observed that Safety and Reliability have not been clearly differentiated, which leads to confusion, inefficiency, and, sometimes, counter-productive practices in executing each of these two disciplines. It is imperative to address this situation to help Reliability and Safety disciplines improve their effectiveness and efficiency. The paper poses an important question to address, "Safety and Reliability - Are they unique or unisonous?" To answer the question, the paper reviewed several most commonly used analyses from each of the disciplines, namely, FMEA, reliability allocation and prediction, reliability design involvement, system safety hazard analysis, Fault Tree Analysis, and Probabilistic Risk Assessment. The paper pointed out uniqueness and unison of Safety and Reliability in their respective roles, requirements, approaches, and tools, and presented some suggestions for enhancing and improving the individual disciplines, as well as promoting the integration of the two. The paper concludes that Safety and Reliability are unique, but compensating each other in many aspects, and need to be integrated. Particularly, the individual roles of Safety and Reliability need to be differentiated, that is, Safety is to ensure and assure the product meets safety requirements, goals, or desires, and Reliability is to ensure and assure maximum achievability of intended design functions. With the integration of Safety and Reliability, personnel can be shared, tools and analyses have to be integrated, and skill sets can be possessed by the same person with the purpose of providing the best value to a product development.

  10. Playground Safety. The Long Trail.

    ERIC Educational Resources Information Center

    Wallach, Frances

    1995-01-01

    This paper describes the evolution of playground safety, discussing the Consumer Product Safety Commission (CPSC) "Handbook for Public Playground Safety" and examining the direction in which CPSC guidelines are moving. The paper notes the importance of certification of playground equipment, reviews pertinent questions to address, and…

  11. The Mechanics of Human Achievement.

    PubMed

    Duckworth, Angela L; Eichstaedt, Johannes C; Ungar, Lyle H

    2015-07-01

    Countless studies have addressed why some individuals achieve more than others. Nevertheless, the psychology of achievement lacks a unifying conceptual framework for synthesizing these empirical insights. We propose organizing achievement-related traits by two possible mechanisms of action: Traits that determine the rate at which an individual learns a skill are talent variables and can be distinguished conceptually from traits that determine the effort an individual puts forth. This approach takes inspiration from Newtonian mechanics: achievement is akin to distance traveled, effort to time, skill to speed, and talent to acceleration. A novel prediction from this model is that individual differences in effort (but not talent) influence achievement (but not skill) more substantially over longer (rather than shorter) time intervals. Conceptualizing skill as the multiplicative product of talent and effort, and achievement as the multiplicative product of skill and effort, advances similar, but less formal, propositions by several important earlier thinkers.

  12. The Mechanics of Human Achievement

    PubMed Central

    Duckworth, Angela L.; Eichstaedt, Johannes C.; Ungar, Lyle H.

    2015-01-01

    Countless studies have addressed why some individuals achieve more than others. Nevertheless, the psychology of achievement lacks a unifying conceptual framework for synthesizing these empirical insights. We propose organizing achievement-related traits by two possible mechanisms of action: Traits that determine the rate at which an individual learns a skill are talent variables and can be distinguished conceptually from traits that determine the effort an individual puts forth. This approach takes inspiration from Newtonian mechanics: achievement is akin to distance traveled, effort to time, skill to speed, and talent to acceleration. A novel prediction from this model is that individual differences in effort (but not talent) influence achievement (but not skill) more substantially over longer (rather than shorter) time intervals. Conceptualizing skill as the multiplicative product of talent and effort, and achievement as the multiplicative product of skill and effort, advances similar, but less formal, propositions by several important earlier thinkers. PMID:26236393

  13. A review of Thimerosal (Merthiolate) and its ethylmercury breakdown product: specific historical considerations regarding safety and effectiveness.

    PubMed

    Geier, David A; Sykes, Lisa K; Geier, Mark R

    2007-12-01

    Thimerosal (Merthiolate) is an ethylmercury-containing pharmaceutical compound that is 49.55% mercury and that was developed in 1927. Thimerosal has been marketed as an antimicrobial agent in a range of products, including topical antiseptic solutions and antiseptic ointments for treating cuts, nasal sprays, eye solutions, vaginal spermicides, diaper rash treatments, and perhaps most importantly as a preservative in vaccines and other injectable biological products, including Rho(D)-immune globulin preparations, despite evidence, dating to the early 1930s, indicating Thimerosal to be potentially hazardous to humans and ineffective as an antimicrobial agent. Despite this, Thimerosal was not scrutinized as part of U.S. pharmaceutical products until the 1980s, when the U.S. Food and Drug Administration finally recognized its demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and began to eliminate it from these. Ironically, while Thimerosal was being eliminated from topicals, it was becoming more and more ubiquitous in the recommended immunization schedule for infants and pregnant women. Furthermore, Thimerosal continues to be administered, as part of mandated immunizations and other pharmaceutical products, in the United States and globally. The ubiquitous and largely unchecked place of Thimerosal in pharmaceuticals, therefore, represents a medical crisis.

  14. Safety analysis report for the use of hazardous production materials in photovoltaic applications at the National Renewable Energy Laboratory. Volume 2, Appendices

    SciTech Connect

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

    1992-07-01

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

  15. Predicting Student Achievement with the Education Production-Function and Per-Pupil Expenditure: Synthesizing Regression Models from 1968-1994

    ERIC Educational Resources Information Center

    Pigott, Therese D.; Williams, Ryan T.; Polanin, Joshua R.; Wu-Bohanon, Meng-Jia

    2012-01-01

    The purpose of this research to investigate the heterogeneity of per-pupil expenditure (PPE) slope estimates in predicting student achievement. The research question guiding this project is: how does the measured relationship between per-pupil expenditure vary across studies that use different models? In concert with SREE's 2012 conference mission…

  16. The Effect of Block Scheduling High School Mathematics Courses on Student Achievement and Teachers' Use of Time: Implications for Educational Productivity.

    ERIC Educational Resources Information Center

    Rice, Jennifer King; Croninger, Robert G.; Roellke, Christopher F.

    2002-01-01

    Draws on data from 1988 National Education Longitudinal Study to estimate the impact of block-scheduled mathematics course on 10th-grade student achievement and teachers' use of class time. Findings suggest that while block scheduling is positively associated with teachers' use of multiple instructional methods and more individualized instruction,…

  17. Project LEAP: The Labor Education Achievement Program. A Program To Improve the Literacy Level and Productivity of the Workforce. Final Project Report. April 1, 1990-June 30, 1991.

    ERIC Educational Resources Information Center

    Metropolitan Baltimore Council of AFL-CIO Unions, MD.

    The Labor Education Achievement Program (LEAP) exceeded its recruitment and enrollment goal for April 1990 to June 1991. The number of union workers receiving services was 697 in 59 classes at 20 sites. Recruitment success was made possible by the use of the communication networks of the Baltimore AFL-CIO Metropolitan Council of Unions and public…

  18. Worker health is good for the economy: union density and psychosocial safety climate as determinants of country differences in worker health and productivity in 31 European countries.

    PubMed

    Dollard, Maureen F; Neser, Daniel Y

    2013-09-01

    Work stress is recognized globally as a social determinant of worker health. Therefore we explored whether work stress related factors explained national differences in health and productivity (gross domestic product (GDP)). We proposed a national worker health productivity model whereby macro market power factors (i.e. union density), influence national worker health and GDP via work psychosocial factors and income inequality. We combined five different data sets canvasing 31 wealthy European countries. Aggregated worker self-reported health accounted for 13 per cent of the variance in national life expectancy and in national gross domestic product (GDP). The most important factors explaining worker self-reported health and GDP between nations were two levels of labor protection, macro-level (union density), and organizational-level (psychosocial safety climate, PSC, i.e. the extent of management concern for worker psychological health). The majority of countries with the highest levels of union density and PSC (i.e., workplace protections) were Social Democratic in nature (i.e., Sweden, Finland, Denmark, Norway). Results support a type of society explanation that social and economic factors (e.g., welfare regimes, work related policies) in concert with political power agents at a national level explain in part national differences in workplace protection (PSC) that are important for worker health and productivity. Attention should be given across all countries, to national policies to improve worker health, by bolstering national and local democratic processes and representation to address and implement policies for psychosocial risk factors for work stress, bullying and violence. Results suggest worker health is good for the economy, and should be considered in national health and productivity accounting. Eroding unionism may not be good for worker health or the economy either.

  19. Salmonella Enteritidis in meat, poultry, and pasteurized egg products regulated by the U.S. Food Safety and Inspection Service, 1998 through 2003.

    PubMed

    White, Patricia L; Naugle, Alecia L; Jackson, Charlene R; Fedorka-Cray, Paula J; Rose, Bonnie E; Pritchard, Katrine M; Levine, Priscilla; Saini, Parmesh K; Schroeder, Carl M; Dreyfuss, Moshe S; Tan, Regina; Holt, Kristin G; Harman, Jane; Buchanan, Stephanie

    2007-03-01

    The U.S. Food Safety and Inspection Service (FSIS) tests for Salmonella in meat, poultry, and egg products through three regulatory testing programs: the Pathogen Reduction-Hazard Analysis and Critical Control Point (PR-HACCP) program, the ready-to-eat program for meat and poultry products, and the pasteurized egg products program. From 1998 through 2003, 293,938 samples collected for these testing programs were analyzed for the presence of Salmonella enterica serotypes. Of these samples, 12,699 (4.3%) were positive for Salmonella, and 167 (1.3%) of the positive samples (0.06% of all samples) contained Salmonella Enteritidis. The highest incidence of Salmonella Enteritidis was observed in ground chicken PR-HACCP samples (8 of 1,722 samples, 0.46%), and the lowest was found in steer-heifer PR-HACCP samples (0 of 12,835 samples). Salmonella Enteritidis isolates were characterized by phage type, pulsed-field gel electrophoretic pattern, and antimicrobial susceptibility. Phage typing of 94 Salmonella Enteritidis isolates identified PT13 (39 isolates) and PT8 (36 isolates) as the most common types. One isolate from a ready-to-eat ham product was characterized as PT4. Electrophoretic analysis of 148 Salmonella Enteritidis isolates indicated genetic diversity among the isolates, with 28 unique XbaI electrophoretic patterns identified. Of these 148 isolates, 136 (92%) were susceptible to each of 16 antimicrobials tested. Two isolates were resistant to ampicillin alone, and 10 isolates were resistant to two or more antimicrobials. Isolation of Salmonella Enteritidis from FSIS-regulated products emphasizes the need for continued consumer education on proper food handling and cooking practices and continued work to decrease the prevalence of Salmonella in meat, poultry, and pasteurized egg products.

  20. Total safety management: An approach to improving safety culture

    SciTech Connect

    Blush, S.M. )

    1993-01-01

    A little over 4 yr ago, Admiral James D. Watkins became Secretary of Energy. President Bush, who had appointed him, informed Watkins that his principal task would be to clean up the nuclear weapons complex and put the US Department of Energy (DOE) back in the business of producing tritium for the nation's nuclear deterrent. Watkins recognized that in order to achieve these objectives, he would have to substantially improve the DOE's safety culture. Safety culture is a relatively new term. The International Atomic Energy Agency (IAEA) used it in a 1986 report on the root causes of the Chernobyl nuclear accident. In 1990, the IAEA's International Nuclear Safety Advisory Group issued a document focusing directly on safety culture. It provides guidelines to the international nuclear community for measuring the effectiveness of safety culture in nuclear organizations. Safety culture has two principal aspects: an organizational framework conducive to safety and the necessary organizational and individual attitudes that promote safety. These obviously go hand in hand. An organization must create the right framework to foster the right attitudes, but individuals must have the right attitudes to create the organizational framework that will support a good safety culture. The difficulty in developing such a synergistic relationship suggests that achieving and sustaining a strong safety culture is not easy, particularly in an organization whose safety culture is in serious disrepair.

  1. Auto Safety

    MedlinePlus

    ... kids by following simple safety measures and by teaching some basic rules. Importance of Child Safety Seats ... your child correctly — a small child in a large seat may not be the best option. Models ...

  2. Water Safety

    MedlinePlus

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety A A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  3. Water Safety

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Water Safety KidsHealth > For Teens > Water Safety A A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  4. Food Safety

    MedlinePlus

    ... the safety of fish caught in your local lakes, rivers, and coastal areas. Advisories may recommend that ... Charts Picky Eating Physical Activity Food Safety Resources Kids Students Adults Families Professionals Multiple Languages MyPlate, MyWins ...

  5. Water Safety

    MedlinePlus

    ... Old Feeding Your 1- to 2-Year-Old Water Safety KidsHealth > For Parents > Water Safety Print A ... best measure of protection. previous continue Making Kids Water Wise It's important to teach your kids proper ...

  6. Water Safety

    MedlinePlus

    ... Loss Surgery? A Week of Healthy Breakfasts Shyness Water Safety KidsHealth > For Teens > Water Safety Print A ... tied to alcohol use. previous continue At the Water Park OK, so you do more splashing than ...

  7. [Registry of the Italian Institute for Occupational Prevention and Safety of local productive units: methodology and structure].

    PubMed

    Scarselli, A; Leva, A; Campo, G; Marconi, M; Nesti, M; Erba, P

    2005-01-01

    The Italian Institute for Occupational Prevention and Safety (ISPESL) carried out a register of enterprises operating in industry, services and agriculture sector to provide information on their location, economical activity and occupational data. This database has been built merging administrative files from the National Institute of Social Security (INPS) and the Computer Science Society of Italian Chambers of Commerce (InfoCamere). Enterprises have been classified by economic sector - in accordance with ISTAT (National Statistics Institute) "Ateco91" classification--and by accuracy level of the record linkage. In details, three different subsystems have been set up: (A) enterprises satisfying linkage; (B) enterprises in InfoCamere file not linked with INPS file; (C) enterprises in INPS file not linked with InfoCamere file. In the whole, 6.026.676 factories have been collected, of which 1.188.784 in group A, 4.543.091 in group B and 294.801 in group C. Establishing a database of information on industries may be useful to improve preventive programs and to plan health care surveillance systems.

  8. Industrial-grade silicone injections causing intermittent bilateral malar swelling: review of safety and efficacy of techniques and products available.

    PubMed

    Seward, Austin C; Meara, Daniel J

    2013-07-01

    Silicone and other fillers have become a popular aid to increase soft tissue density, decrease static skin rhytids, and treat muscle wasting, particularly in the face. As a result, injectable silicone has become popular in patients with the human immunodeficiency virus (HIV). It has been postulated that highly active antiretroviral therapy detrimentally induces the physiologic process of fat atrophy of the temporal and buccal fat pads of the face and regional fat wasting of the arms, legs, and buttocks and that HIV protease inhibitors may induce fat atrophy by binding and inhibiting homologous human proteins that are involved in fat metabolism. The classic hollowed-out facial appearance linked to HIV positivity can have detrimental social implications in infected patients who are otherwise very functional. In consequence, facial implantation, fat transplantation, and dermal and subcutaneous fillers have been used to aid in the restoration of facial appearance. This report describes the case of a patient who underwent multiple rounds of silicone injections and complained of intermittent facial swelling and pain long after the injections. The authors report on the safety of specific medical-grade injectable fillers and techniques found to be safely effective, especially in the HIV-positive population.

  9. Assessment of the microbiological safety of dried spices and herbs from production and retail premises in the United Kingdom.

    PubMed

    Sagoo, S K; Little, C L; Greenwood, M; Mithani, V; Grant, K A; McLauchlin, J; de Pinna, E; Threlfall, E J

    2009-02-01

    A study of dried spices and herbs from retail and production premises to determine the microbiological status of such products was undertaken in the UK during 2004. According to EC Recommendation 2004/24/EC and European Spice Association specifications, 96% of 2833 retail samples and 92% of 132 production batches were of satisfactory/acceptable quality. Salmonella spp. were detected in 1.5% and 1.1% of dried spices and herbs sampled at production and retail, respectively. Overall, 3.0% of herbs and spices contained high counts of Bacillus cereus (1%, > or =10(5) cfu g(-1)), Clostridium perfringens (0.4%, > or =10(3) cfu g(-1)) and/or Escherichia coli (2.1%, > or =10(2) cfu g(-1)). Ninety percent of samples examined were recorded as being 'ready-to-use', 96% of which were of satisfactory/acceptable quality. The potential public health risk of using spices and herbs as an addition to ready-to-eat foods that potentially undergo no further processing is therefore highlighted in this study. Prevention of microbial contamination in dried herbs and spices lies in the application of good hygiene practices during growing, harvesting and processing from farm to fork, and effective decontamination. In addition, the importance of correct food handling practices and usage of herbs and spices by end users cannot be overemphasised.

  10. Food safety and organic meats.

    PubMed

    Van Loo, Ellen J; Alali, Walid; Ricke, Steven C

    2012-01-01

    The organic meat industry in the United States has grown substantially in the past decade in response to consumer demand for nonconventionally produced products. Consumers are often not aware that the United States Department of Agriculture (USDA) organic standards are based only on the methods used for production and processing of the product and not on the product's safety. Food safety hazards associated with organic meats remain unclear because of the limited research conducted to determine the safety of organic meat from farm-to-fork. The objective of this review is to provide an overview of the published results on the microbiological safety of organic meats. In addition, antimicrobial resistance of microbes in organic food animal production is addressed. Determining the food safety risks associated with organic meat production requires systematic longitudinal studies that quantify the risks of microbial and nonmicrobial hazards from farm-to-fork.

  11. Safety Handbook.

    ERIC Educational Resources Information Center

    Montgomery County Public Schools, Rockville, MD.

    Safety policies, procedures, and related information are presented in this manual to assist school personnel in a continuing program of accident prevention. Chapter 1 discusses safety education and accident prevention in general. Chapter 2 covers traffic regulations relating to school safety patrols, school bus transportation, bicycles, and…

  12. An investigation into drug products withdrawn from the EU market between 2002 and 2011 for safety reasons and the evidence used to support the decision-making

    PubMed Central

    McNaughton, Rhian; Huet, Gwenaël; Shakir, Saad

    2014-01-01

    Objectives The objective of this study was to determine the nature of evidence used to support the withdrawal of marketing authorisations of drug products for safety reasons throughout the European Union (EU) between 2002 and 2011. Setting Products withdrawn, either by a medicines agency or a marketing authorisation holder, during the period 2002–2011 were identified by conducting detailed searches of the WHO, the European Medicines Agency (EMA) and national medicines agency websites throughout the EU plus Norway, Iceland and Liechtenstein. The scientific evidence used to support the decision was identified from a search within PubMed, the EMA and national medicines agencies websites. Information about spontaneous case reports entered into EudraVigilance and unavailable on the EMA website was received by email from the EMA. Results 19 drugs were withdrawn from the market, throughout the EU, for safety reasons from 2002 to 2011. Case reports were cited in 95% of withdrawals (18/19) and case–control studies (4/19), cohort studies (4/19), randomised controlled trials (RCTs) (12/19) or meta-analysis (5/19) were cited in 63% of withdrawals (12/19). Cardiovascular events or disorders were the main reason for withdrawal (9/19), followed by hepatic disorders (4/19) and neurological or psychiatric disorders (4/19). Conclusions This study has shown that the level of evidence used to support drug withdrawal has improved during the past 10 years, with an increased use of case–control studies, cohort studies, RCTs and meta-analyses. This research has demonstrated that such studies have contributed to decision-making in almost two-thirds of cases. PMID:24435895

  13. Lactobacillus plantarum with broad antifungal activity: A promising approach to increase safety and shelf-life of cereal-based products.

    PubMed

    Russo, Pasquale; Arena, Mattia Pia; Fiocco, Daniela; Capozzi, Vittorio; Drider, Djamel; Spano, Giuseppe

    2016-05-06

    Cereal-based fermented products are worldwide diffused staple food resources and cereal-based beverages represent a promising innovative field in the food market. Contamination and development of spoilage filamentous fungi can result in loss of cereal-based food products and it is a critical safety concern due to their potential ability to produce mycotoxins. Lactic Acid Bacteria (LAB) have been proposed as green strategy for the control of the moulds in the food industry due to their ability to produce antifungal metabolites. In this work, eighty-eight Lactobacillus plantarum strains were screened for their antifungal activity against Aspergillus niger, Aspergillus flavus, Fusarium culmorum, Penicillium roqueforti, Penicillium expansum, Penicillium chrysogenum, and Cladosporium spp. The overlayed method was used for a preliminary discrimination of the strains as no, mild and strong inhibitors. L. plantarum isolates that displayed broad antifungal spectrum activity were further screened based on the antifungal properties of their cell-free supernatant (CFS). CFSs from L. plantarum UFG 108 and L. plantarum UFG 121, in reason of their antifungal potential, were characterized and analyzed by HPLC. Results indicated that lactic acid was produced at high concentration during the growth phase, suggesting that this metabolic aptitude, associated with the low pH, contributed to explain the highlighted antifungal phenotype. Production of phenyllactic acid was also observed. Finally, a new oat-based beverage was obtained by fermentation with the strongest antifungal strain L. plantarum UFG 121. This product was submitted or not to a thermal stabilization and artificially contaminated with F. culmorum. Samples containing L. plantarum UFG 121 showed the best biopreservative effects, since that no differences were observed in terms of some qualitative features between not or contaminated samples with F. culmorum. Here we demonstrate, for the first time, the suitability of LAB

  14. Graded Achievement, Tested Achievement, and Validity

    ERIC Educational Resources Information Center

    Brookhart, Susan M.

    2015-01-01

    Twenty-eight studies of grades, over a century, were reviewed using the argument-based approach to validity suggested by Kane as a theoretical framework. The review draws conclusions about the meaning of graded achievement, its relation to tested achievement, and changes in the construct of graded achievement over time. "Graded…

  15. Elaborating the Role of Natural Products-Induced Autophagy in Cancer Treatment: Achievements and Artifacts in the State of the Art

    PubMed Central

    2015-01-01

    Autophagy is a homeostatic process that is highly conserved across different types of mammalian cells. Autophagy is able to relieve tumor cell from nutrient and oxidative stress during the rapid expansion of cancer. Excessive and sustained autophagy may lead to cell death and tumor shrinkage. It was shown in literature that many anticancer natural compounds and extracts could initiate autophagy in tumor cells. As summarized in this review, the tumor suppressive action of natural products-induced autophagy may lead to cell senescence, provoke apoptosis-independent cell death, and complement apoptotic cell death by robust or target-specific mechanisms. In some cases, natural products-induced autophagy could protect tumor cells from apoptotic death. Technical variations in detecting autophagy affect data quality, and study focus should be made on elaborating the role of autophagy in deciding cell fate. In vivo study monitoring of autophagy in cancer treatment is expected to be the future direction. The clinical-relevant action of autophagy-inducing natural products should be highlighted in future study. As natural products are an important resource in discovery of lead compound of anticancer drug, study on the role of autophagy in tumor suppressive effect of natural products continues to be necessary and emerging. PMID:25821829

  16. The Safety of Crowds

    ERIC Educational Resources Information Center

    Dron, Jon

    2007-01-01

    If we assume that learning is best achieved in a social setting, then a vital aspect of any learning environment is its ability to support the development of trust. Trust takes many forms, from helping to identify the validity or the effectiveness of a learning resource to feelings of safety and reliance on support from fellow learners and…

  17. Estimates of occupational safety and health impacts resulting from large-scale production of major photovoltaic technologies

    SciTech Connect

    Owens, T.; Ungers, L.; Briggs, T.

    1980-08-01

    The purpose of this study is to estimate both quantitatively and qualitatively, the worker and societal risks attributable to four photovoltaic cell (solar cell) production processes. Quantitative risk values were determined by use of statistics from the California semiconductor industry. The qualitative risk assessment was performed using a variety of both governmental and private sources of data. The occupational health statistics derived from the semiconductor industry were used to predict injury and fatality levels associated with photovoltaic cell manufacturing. The use of these statistics to characterize the two silicon processes described herein is defensible from the standpoint that many of the same process steps and materials are used in both the semiconductor and photovoltaic industries. These health statistics are less applicable to the gallium arsenide and cadmium sulfide manufacturing processes, primarily because of differences in the materials utilized. Although such differences tend to discourage any absolute comparisons among the four photovoltaic cell production processes, certain relative comparisons are warranted. To facilitate a risk comparison of the four processes, the number and severity of process-related chemical hazards were assessed. This qualitative hazard assessment addresses both the relative toxicity and the exposure potential of substances in the workplace. In addition to the worker-related hazards, estimates of process-related emissions and wastes are also provided.

  18. Moving forward with safety culture.

    PubMed

    Weber, Michael

    2012-04-01

    Radiation safety and protection of people are shared goals of the Health Physics Society (HPS) and the U.S. Nuclear Regulatory Commission (NRC). A positive safety culture contributes to achieving radiation safety and protection of people, which are important to both the HPS and the NRC. Through unprecedented collaboration and engagement with diverse stakeholders, the NRC and the stakeholders developed a Safety Culture Policy Statement. The policy statement defines safety culture and describes the traits of a positive safety culture. Consideration of both safety and security issues and the interface of safety and security are underlying principles that support the policy. Examination of significant events, both within the nuclear industry and in society at large, illustrates how weaknesses in these traits can contribute to the occurrence and consequences of safety incidents, including serious injury and loss of life. With the policy statement in place, the NRC is moving forward with outreach and education about safety culture. Health physicists and other radiation safety specialists play an essential role in enhancing safety culture.

  19. In vitro safety and efficacy evaluations of a complex botanical mixture of Eugenia dysenterica DC. (Myrtaceae): Prospects for developing a new dermocosmetic product.

    PubMed

    Moreira, Larissa Cleres; de Ávila, Renato Ivan; Veloso, Danillo Fabrini Maciel Costa; Pedrosa, Tatiana Nascimento; Lima, Emerson Silva; do Couto, Renê Oliveira; Lima, Eliana Martins; Batista, Aline Carvalho; de Paula, José Realino; Valadares, Marize Campos

    2017-04-04

    In the context of developing a new natural product-based cosmetic, the in vitro efficacy and safety evaluations of a complex botanical mixture based on Eugenia dysenterica leaf hydroalcoholic extract (EDE) (2.5-1000μg/mL) were carried out. Chromatographic analysis demonstrated the presence of the tannin (ellagic acid) and flavonoids (quercetin and gallic acid) which characterize the EDE as a polyphenol-rich mixture. Using HFF-1 fibroblasts, it was shown that EDE promoted cell regeneration after UVA exposure. It also led to the inhibition of the collagenase, elastase and tyrosinase enzymes, which are involved in skin-related disorders. In terms of toxicological evaluation, the EDE was classified as non-phototoxic through the 3T3 Neutral Red Uptake Phototoxicity Test (OECD N° 432, 2004) and non-eye irritant by Bovine Corneal Opacity and Permeability (OECD N° 437, 2013) assay, in conjunction with corneal histomorphometric analysis. Furthermore, the EDE has no skin sensitization potential as demonstrated by a two-out-of-three prediction model [protein-binding/haptenization (OECD N° 442C, 2015), keratinocyte and dendritic cell activations]. In addition, it was shown that the EDE seems to be non-genotoxic through the cytokinesis-block micronucleus assay (OECD N° 487, 2014) using HepG2 cells. When considered together, these findings support the use of EDE botanical mixture in cosmetic/pharmaceutical products.

  20. Neutronics Simulations of 237Np Targets to Support Safety-Basis and 238Pu Production Assessment Efforts at the High Flux Isotope Reactor

    SciTech Connect

    Chandler, David; Ellis, Ronald James

    2015-01-01

    Fueled by two highly enriched uranium-bearing fuel elements surrounded by a large concentric ring of beryllium reflector, the High Flux Isotope Reactor (HFIR) provides one of the highest neutron fluxes in the world and is used to produce unique isotopes like plutonium-238. The National Aeronautics and Space Administration use radioisotope thermoelectric generators powered by 238Pu for deep-space missions. As part of the US Department of Energy s task to reestablish the domestic production of 238Pu, a technology demonstration sub-project has been initiated to establish a new 238Pu supply chain. HFIR safety-basis neutronics calculations are being performed to ensure the target irradiations have no adverse impacts on reactor performance and to calculate data required as input to follow-on thermal-structural, thermal-hydraulic and radionuclide/dose analyses. Plutonium-238 production assessments are being performed to estimate the amount of 238Pu that can be produced in HFIR s permanent beryllium reflector. It is estimated that a total of 0.96 1.12 kg 238Pu (~1.28 1.49 kg PuO2 at 85% 238Pu/Pu purity) could be produced per year in HFIR s permanent beryllium reflector irradiation facilities if they are all utilized.

  1. Multiplex liquid chromatography-tandem mass spectrometry for the detection of wheat, oat, barley and rye prolamins towards the assessment of gluten-free product safety.

    PubMed

    Manfredi, Anita; Mattarozzi, Monica; Giannetto, Marco; Careri, Maria

    2015-10-01

    Celiac patients should feel confident in the safety of foods labelled or expected to be gluten-free. In this context, a targeted proteomic approach based on liquid chromatography-electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) technique was proposed to assess the presence of celiotoxic cereals, namely wheat, oats, barley and rye, in raw and processed food products. To this aim, unique marker peptides were properly selected in order to distinguish between the different cereal types. A revised cocktail solution based on reducing and denaturing agents was exploited for prolamin extraction from raw and processed food; in addition, defatting with hexane was carried out for sample clean-up, allowing to largely reduce problems related to matrix effect. Method validation on fortified rice flour showed good analytical performance in terms of sensitivity (limits of detection in the 2-18 mg kg(-1) range). However, poor trueness was calculated for self-made incurred bread (between 3 and 30% depending on the peptide), probably due to baking processes, which reduce gluten extractability. Thus, it is evident that in the case of processed foods further insights into sample treatment efficiency and reference materials for protein calibration are required to obtain accurate gluten determination. Finally, the developed method was applied for the analysis of market food products, offering the possibility to discriminate among cereals, with good agreement with labelled ingredients for gluten-containing foodstuffs.

  2. Material recycling of post-consumer polyolefin bulk plastics: Influences on waste sorting and treatment processes in consideration of product qualities achievable.

    PubMed

    Pfeisinger, Christian

    2017-02-01

    Material recycling of post-consumer bulk plastics made up of polyolefins is well developed. In this article, it is examined which effects on waste sorting and treatment processes influence the qualities of polyolefin-recyclats. It is shown that the properties and their changes during the product life-cycle of a polyolefin are defined by its way of polymerisation, its nature as a thermoplast, additives, other compound and composite materials, but also by the mechanical treatments during the production, its use where contact to foreign materials is possible and the waste sorting and treatment processes. Because of the sum of the effects influencing the quality of polyolefin-recyclats, conclusions are drawn for the material recycling of polyolefins to reach high qualities of their recyclats. Also, legal requirements like the EU regulation 1907/2006 concerning the registration, evaluation, authorisation and restrictions on chemicals are considered.

  3. Safety Evaluation of the Coagulase-Negative Staphylococci Microbiota of Salami: Superantigenic Toxin Production and Antimicrobial Resistance.

    PubMed

    Soares Casaes Nunes, Raquel; Mere Del Aguila, Eduardo; Paschoalin, Vânia Margaret Flosi

    2015-01-01

    The risks of contracting staphylococci food poisoning by the consumption of improperly manufactured salami and the possibility of this food being reservoirs for antibiotic resistance were evaluated. Nineteen coagulase-negative staphylococci (CNS) strains were found in commercial and artisanal salami. The species in commercial salami were S. saprophyticus, S. sciuri, S. xylosus, and S. carnosus. Artisanal salami showed S. succinus, S. epidermidis, and S. hominis but no S. carnosus. Phylogenetic analyses grouped the strains into three major staphylococcal species groups, comprised of 4 refined clusters with similarities superior to 90%. Fifteen strains harbored multiple enterotoxin genes, with high incidence of seb/sec and sea, 57% and 50%, respectively, intermediate incidence of sed/seh/selm and sei/seln/tst-H, 33% and 27%, correspondingly, and low incidence of see/selj/selo and seg, of respectively 13% and 1%. Real time RT-PCR and enzyme-linked-immunosorbent assays confirmed the enterotoxigenicity of the strains, which expressed and produced enterotoxins in vitro. The CNS strains showed multiresistance to several antimicrobials of therapeutic importance in both human and veterinarian medicine, such as β-lactams, vancomycin, and linezolid. The effective control of undue staphylococci in fermented meat products should be adopted to prevent or limit the risk of food poisoning and the spread of antimicrobial-resistant strains.

  4. Safety Evaluation of the Coagulase-Negative Staphylococci Microbiota of Salami: Superantigenic Toxin Production and Antimicrobial Resistance

    PubMed Central

    Soares Casaes Nunes, Raquel; Mere Del Aguila, Eduardo; Paschoalin, Vânia Margaret Flosi

    2015-01-01

    The risks of contracting staphylococci food poisoning by the consumption of improperly manufactured salami and the possibility of this food being reservoirs for antibiotic resistance were evaluated. Nineteen coagulase-negative staphylococci (CNS) strains were found in commercial and artisanal salami. The species in commercial salami were S. saprophyticus, S. sciuri, S. xylosus, and S. carnosus. Artisanal salami showed S. succinus, S. epidermidis, and S. hominis but no S. carnosus. Phylogenetic analyses grouped the strains into three major staphylococcal species groups, comprised of 4 refined clusters with similarities superior to 90%. Fifteen strains harbored multiple enterotoxin genes, with high incidence of seb/sec and sea, 57% and 50%, respectively, intermediate incidence of sed/seh/selm and sei/seln/tst-H, 33% and 27%, correspondingly, and low incidence of see/selj/selo and seg, of respectively 13% and 1%. Real time RT-PCR and enzyme-linked-immunosorbent assays confirmed the enterotoxigenicity of the strains, which expressed and produced enterotoxins in vitro. The CNS strains showed multiresistance to several antimicrobials of therapeutic importance in both human and veterinarian medicine, such as β-lactams, vancomycin, and linezolid. The effective control of undue staphylococci in fermented meat products should be adopted to prevent or limit the risk of food poisoning and the spread of antimicrobial-resistant strains. PMID:26697486

  5. Safety evaluations under the proposed US Safe Cosmetics and Personal Care Products Act of 2013: animal use and cost estimates.

    PubMed

    Knight, Jean; Rovida, Costanca

    2014-01-01

    The proposed Safe Cosmetics and Personal Care Products Act of 2013 calls for a new evaluation program for cosmetic ingredients in the US, with the new assessments initially dependent on expanded animal testing. This paper considers possible testing scenarios under the proposed Act and estimates the number of test animals and cost under each scenario. It focuses on the impact for the first 10 years of testing, the period of greatest impact on animals and costs. The analysis suggests the first 10 years of testing under the Act could evaluate, at most, about 50% of ingredients used in cosmetics. Testing during this period would cost about $ 1.7-$ 9 billion and 1-11.5 million animals. By test year 10, alternative, high-throughput test methods under development are expected to be available, replacing animal testing and allowing rapid evaluation of all ingredients. Given the high cost in dollars and animal lives of the first 10 years for only about half of ingredients, a better choice may be to accelerate development of high-throughput methods. This would allow evaluation of 100% of cosmetic ingredients before year 10 at lower cost and without animal testing.

  6. Medication safety.

    PubMed

    Keohane, Carol A; Bates, David W

    2008-03-01

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

  7. 75 FR 51177 - Safety Standard for Infant Bath Seats; Correction

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-19

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Part 1215 Safety Standard for Infant Bath Seats; Correction AGENCY: Consumer Product Safety Commission. ACTION: Final rule; correction. ] SUMMARY: The United States Consumer Product Safety...

  8. Decontamination method using heat and relative humidity for radish seeds achieves a 7-log reduction of Escherichia coli O157:H7 without affecting product quality.

    PubMed

    Kim, Y B; Kim, H W; Song, M K; Rhee, M S

    2015-05-18

    We developed a novel decontamination method to inactivate Escherichia coli O157:H7 on radish seeds without adversely affecting seed germination or product quality. The use of heat (55, 60, and 65 °C) combined with relative humidity (RH; 25, 45, 65, 85, and 100%) for 24h was evaluated for effective microbial reduction and preservation of seed germination rates. A significant two-way interaction of heat and RH was observed for both microbial reduction and germination rate (P<0.0001). Increases in heat and RH were associated with corresponding reductions in E. coli O157:H7 and in germination rate (P<0.05). The order of lethality for the different treatments was generally as follows: no treatment <55 °C/25-65% RH ≒60 °C/25-45% RH ≒65 °C/25% RH <55 °C/85% RH =60 °C/65% RH <55 °C/100% RH =60 °C/85-100% RH =65 °C/45-100% RH. The most effective condition, 65 °C/45% RH, completely inactivated E. coli O157:H7 on the seeds (7.0 log CFU/g reduction) and had no significant effect on the germination rate (85.4%; P>0.05) or product quality. The method uses only heat and relative humidity without chemicals, and is thus applicable as a general decontamination procedure in spout producing plants where the use of growth chambers is the norm.

  9. Solidifying Safety

    NASA Technical Reports Server (NTRS)

    Covault, Craig

    2003-01-01

    Contents include the following: 1. Solidifying Safety: NASA s new safety organization spools up, as the 1SS program grapples with long-term risk. 2. Earth to Orbit O'Keefe telling skeptical lawmakers Orbital Space Plan (OSP) will cover exploration vision. China's rapid pace.

  10. Safety Systems

    ERIC Educational Resources Information Center

    Halligan, Tom

    2009-01-01

    Colleges across the country are rising to the task by implementing safety programs, response strategies, and technologies intended to create a secure environment for teachers and students. Whether it is preparing and responding to a natural disaster, health emergency, or act of violence, more schools are making campus safety a top priority. At…

  11. Lab Safety.

    ERIC Educational Resources Information Center

    West, Sandra S.

    1991-01-01

    In response to the Texas Hazardous Communication Act (THCA) of 1986 which raised many new health and liability issues regarding students in science laboratories, a laboratory safety survey was generated for use in evaluating laboratory safety. This article contains the easy-to-use survey. (ZWH)

  12. Safety First

    ERIC Educational Resources Information Center

    Taft, Darryl

    2011-01-01

    Ned Miller does not take security lightly. As director of campus safety and emergency management at the Des Moines Area Community College (DMACC), any threat requires serious consideration. As community college administrators adopt a more proactive approach to campus safety, many institutions are experimenting with emerging technologies, including…

  13. The social aspects of safety management: trust and safety climate.

    PubMed

    Luria, Gil

    2010-07-01

    This study tested the contribution of trust between leaders and subordinates to safety. It is suggested that leaders who create a relationship of trust with their subordinates are more likely to create a safe working environment, and to achieve higher and stronger safety-climate perceptions among their subordinates. Hence, trust should be negatively related to injuries and positively related to safety climate. Questionnaires distributed among 2524 soldiers in three army brigades tested for trust and safety-climate variables and were then crossed with injury rate according to medical records at the platoon level of analysis (N=105). Trust was found to be negatively related to injuries and positively related both to level and strength of safety climate. Furthermore, safety-climate level was found to mediate the relationship between trust and injury rates. Theoretical and practical implications are discussed.

  14. Incongruity and Provisional Safety: Thinking through Humor

    ERIC Educational Resources Information Center

    Mayo, Cris

    2010-01-01

    The aim of this paper is to reconceive safety as a form of relation embedded in particular ways of speaking, listening and thinking. Moving away from safety as a relation that is achieved once and for all and afterwards remains safe avoids some of the disappointments of discourses of safety that seem to promise once a risk is taken or a gap is…

  15. Assessing the status of food safety management systems for fresh produce production in East Africa: evidence from certified green bean farms in Kenya and noncertified hot pepper farms in Uganda.

    PubMed

    Nanyunja, J; Jacxsens, L; Kirezieva, K; Kaaya, A N; Uyttendaele, M; Luning, P A

    2015-06-01

    The farms of fresh produce farmers are major sources of food contamination by microbiological organisms and chemical pesticides. In view of their choice for farming practices, producers are influenced by food safety requirements. This study analyzes the role of food safety standard certification toward the maturity of food safety management systems (FSMS) in the primary production of fresh produce. Kenya and Uganda are two East African countries that export green beans and hot peppers, respectively, to the European Union but have contrasting features in terms of agricultural practices and certification status. In the fresh produce chain, a diagnostic instrument for primary production was used to assess context factors, core control and assurance activities, and system output to measure the performance of FSMS for certified green bean farms in Kenya and noncertified hot pepper farms in Uganda. Overall, our findings show that in Uganda, noncertified hot pepper farms revealed only a "basic level of control and assurance" activities in their FSMS, which was not satisfactory, because no insight into potential pesticide microbial contamination was presented by these farmers. On the other hand, certified green bean farms in Kenya had an "average level of control and assurance," providing insight into the delivered food safety and quality by the farmers. Farm size did not impact the maturity level of FSMS. This study confirms the role played by food safety standard certification toward the maturity of FSMS implemented in developing countries and demonstrates the possibility of Ugandan farms to upgrade agricultural practices in the fresh produce sector.

  16. Evolved strains of Scheffersomyces stipitis achieving high ethanol productivity on acid- and base-pretreated biomass hydrolyzate at high solids loading

    DOE PAGES

    Slininger, Patricia J.; Shea-Andersh, Maureen A.; Thompson, Stephanie R.; ...

    2015-04-09

    Lignocellulosic biomass is an abundant, renewable feedstock useful for the production of fuel-grade ethanol via the processing steps of pretreatment, enzyme hydrolysis, and microbial fermentation. Traditional industrial yeasts do not ferment xylose and are not able to grow, survive, or ferment in concentrated hydrolyzates that contain enough sugar to support economical ethanol recovery since they are laden with toxic byproducts generated during pretreatment. Repetitive culturing in two types of concentrated hydrolyzates was applied along with ethanol challenged xylose-fed continuous culture to force targeted evolution of the native pentose fermenting yeast Scheffersomyces (Pichia) stipitis strain NRRL Y-7124 maintained in the ARSmore » Culture Collection, Peoria, IL. Isolates collected from various enriched populations were screened and ranked based on relative xylose uptake rate and ethanol yield. Ranking on hydrolyzates with and without nutritional supplementation was used to identify those isolates with best performance across diverse conditions. Robust S. stipitis strains adapted to perform very well in enzyme hydrolyzates of high solids loading ammonia fiber expansion-pretreated corn stover (18% weight per volume solids) and dilute sulfuric acid-pretreated switchgrass (20% w/v solids) were obtained. Improved features include reduced initial lag phase preceding growth, significantly enhanced fermentation rates, improved ethanol tolerance and yield, reduced diauxic lag during glucose-xylose transition, and ability to accumulate >40 g/L ethanol in <167 h when fermenting hydrolyzate at low initial cell density of 0.5 absorbance units and pH 5 to 6.« less

  17. [The external quality assessment schemes for lead in blood organized by the French national agency for medicine and health product safety: a synthesis of 15 years of activity].

    PubMed

    Pineau, Alain; Otz, Jocelyne; Guillard, Olivier; Fauconneau, Bernard; Dumont, Gilles; François-Burg, Elisabeth

    2014-01-01

    In 1992, at the request of the French labor ministry following questions on the ability of medical biology laboratories to satisfactorily measure blood lead level (PbB), a national PbB quality control came into being. Only in 1996 did this external quality control include a number of laboratories sufficient to allow for a significant retrospective evaluation. After fifteen years (1996-2011), The French National Agency for Medicines and Health Products Safety wished to exploit the database collected. The number of participating laboratories went down from 73 to 41. On the other hand, the key finding pertained to the highly improved performance of the laboratories, which was associated with a spread decrease of the results over the entire range of tested PbBs (9 to 700 μg/L). Since 2006, we have observed increasing use of the inductively coupled plasma with mass spectrometry and decreasing use of electrothermal atomic absorption spectrometry. Provided that they rely on identical metrology expertise, the two analytical techniques lead to results on all the tested concentrations that are not statistically different.

  18. A Comparative Randomized Controlled Clinical Trial on the Effectiveness, Safety, and Tolerability of a Homeopathic Medicinal Product in Children with Sleep Disorders and Restlessness

    PubMed Central

    Jong, Miek C.; Ilyenko, Lydia; Kholodova, Irina; Verwer, Cynthia; Burkart, Julia; Weber, Stephan; Keller, Thomas; Klement, Petra

    2016-01-01

    A prospective, multicenter, randomized, open-label, controlled clinical trial was performed to evaluate the effectiveness and safety of the homeopathic product ZinCyp-3-02 in children with sleep disorders for ≥ one month compared to glycine. Children ≤ six years old received either ZinCyp-3-02 (N = 89) or comparator glycine (N = 90). After treatment for 28 days, total sleep-disorder-associated complaints severity scores decreased in both groups from median 7.0 (out of maximum 11.0) points to 2.0 (ZinCyp-3-02) and 4.0 (glycine) points, respectively, with overall higher odds of showing improvement for ZinCyp-3-02 (odds ratio: 4.45 (95% CI: 2.77–7.14), p < 0.0001, POM overall treatment related effect). Absence of individual complaints (time to sleep onset, difficulties maintaining sleep, sleep duration, troubled sleep (somniloquism), physical inactivity after awakening, restlessness for unknown reason, and sleep disorders frequency) at study end were significantly higher with ZinCyp-3-02 (all p values < 0.05). More children with ZinCyp-3-02 were totally free of complaints (p = 0.0258). Treatment effectiveness (p < 0.0001) and satisfaction assessments (p < 0.0001) were more favorable for ZinCyp-3-02. Few nonserious adverse drug reactions were reported (ZinCyp-3-02: N = 2, glycine: N = 1) and both treatments were well tolerated. Treatment with the homeopathic product ZinCyp-3-02 was found to be safe and superior to the comparator glycine in the treatment of sleep disorders in children. PMID:27242915

  19. Effect of the product type, of the amount of applied sunscreen product and the level of protection in the UVB range on the level of protection achieved in the UVA range.

    PubMed

    Couteau, C; Diarra, H; Coiffard, L

    2016-03-16

    Using a topical product is part of the overall strategy for skin cancer prevention. The level of protection attainable when using commercial products is indicated by the Sun Protection Factor (SPF) value, in use everywhere. This value reflects the level of protection primarily in the UVB range. However, UVA radiation also has deleterious effects on the skin, and it is essential to prevent it, which is why products must offer a wide spectrum of protection. Tests conducted in vivo, before any marketing, are done by applying the studied product at a rate of 2.0 mg cm(-2), while users, in practice, only use 1.0-1.5 mg cm(-2). We now know that this reduction in the amount of applied product greatly affects the SPF. To complete the state of knowledge in this area, we sought to evaluate the effect of a decrease in the amount of applied sunscreen product by studying sunscreen creams and oils on the level of protection attainable in the UVA range. We have shown that the PF-UVA is divided by a factor of 2.2, on average, when the amount of applied product is reduced by half, with differences depending on the product type under consideration (cream or oil) and depending on the SPF of the preparation.

  20. Evolved strains of Scheffersomyces stipitis achieving high ethanol productivity on acid- and base-pretreated biomass hydrolyzate at high solids loading

    SciTech Connect

    Slininger, Patricia J.; Shea-Andersh, Maureen A.; Thompson, Stephanie R.; Dien, Bruce S.; Kurtzman, Cletus P.; Balan, Venkatesh; da Costa Sousa, Leonardo; Uppugundla, Nirmal; Dale, Bruce E; Cotta, Michael A

    2015-04-09

    Lignocellulosic biomass is an abundant, renewable feedstock useful for the production of fuel-grade ethanol via the processing steps of pretreatment, enzyme hydrolysis, and microbial fermentation. Traditional industrial yeasts do not ferment xylose and are not able to grow, survive, or ferment in concentrated hydrolyzates that contain enough sugar to support economical ethanol recovery since they are laden with toxic byproducts generated during pretreatment. Repetitive culturing in two types of concentrated hydrolyzates was applied along with ethanol challenged xylose-fed continuous culture to force targeted evolution of the native pentose fermenting yeast Scheffersomyces (Pichia) stipitis strain NRRL Y-7124 maintained in the ARS Culture Collection, Peoria, IL. Isolates collected from various enriched populations were screened and ranked based on relative xylose uptake rate and ethanol yield. Ranking on hydrolyzates with and without nutritional supplementation was used to identify those isolates with best performance across diverse conditions. Robust S. stipitis strains adapted to perform very well in enzyme hydrolyzates of high solids loading ammonia fiber expansion-pretreated corn stover (18% weight per volume solids) and dilute sulfuric acid-pretreated switchgrass (20% w/v solids) were obtained. Improved features include reduced initial lag phase preceding growth, significantly enhanced fermentation rates, improved ethanol tolerance and yield, reduced diauxic lag during glucose-xylose transition, and ability to accumulate >40 g/L ethanol in <167 h when fermenting hydrolyzate at low initial cell density of 0.5 absorbance units and pH 5 to 6.

  1. Bromine Safety

    SciTech Connect

    Meyers, B

    2001-04-09

    The production and handling in 1999 of about 200 million kilograms of bromine plus substantial derivatives thereof by Great Lakes Chemical Corp. and Albemarle Corporation in their southern Arkansas refineries gave OSHA Occupational Injury/Illness Rates (OIIR) in the range of 0.74 to 1.60 reportable OIIRs per 200,000 man hours. OIIRs for similar industries and a wide selection of other U.S. industries range from 1.6 to 23.9 in the most recent OSHA report. Occupational fatalities for the two companies in 1999 were zero compared to a range in the U.S.of zero for all computer manufacturing to 0.0445 percent for all of agriculture, forestry and fishing in the most recent OSHA report. These results show that bromine and its compounds can be considered as safe chemicals as a result of the bromine safety standards and practices at the two companies. The use of hydrobromic acid as an electrical energy storage medium in reversible PEM fuel cells is discussed. A study in 1979 of 20 megawatt halogen working fluid power plants by Oronzio de Nora Group found such energy to cost 2 to 2.5 times the prevailing base rate at that time. New conditions may reduce this relative cost. The energy storage aspect allows energy delivery at maximum demand times where the energy commands premium rates. The study also found marginal cost and performance advantages for hydrobromic acid over hydrochloric acid working fluid. Separate studies in the late 70s by General Electric also showed marginal performance advantages for hydrobromic acid.

  2. Software safety

    NASA Technical Reports Server (NTRS)

    Leveson, Nancy

    1987-01-01

    Software safety and its relationship to other qualities are discussed. It is shown that standard reliability and fault tolerance techniques will not solve the safety problem for the present. A new attitude requires: looking at what you do NOT want software to do along with what you want it to do; and assuming things will go wrong. New procedures and changes to entire software development process are necessary: special software safety analysis techniques are needed; and design techniques, especially eliminating complexity, can be very helpful.

  3. System safety approach in the VLT Project

    NASA Astrophysics Data System (ADS)

    Ansorge, Wolfgang

    1997-03-01

    Safety, like quality and reliability, has to be designed into a product and respected during all project phases from the concept definition to the operation and maintenance phases. The VLT approach towards occupational safety and health and equipment safety starts with the definition of realistic safety requirements and applicability of ECC directives and national laws of the ESO Member States. The approach continues with preliminary safety analyses during the early project phases, with hazard analysis and safety verifications during the developmental phases, the training for safe operation, maintenance, and later material disposal. System safety is an integral part of the VLT project.

  4. Postmarket Drug Safety Information for Patients and Providers

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Drugs Home Drugs Drug Safety and Availability Postmarket Drug Safety Information for Patients and Providers Postmarket Drug Safety Information for Patients and Providers Share Tweet ...

  5. U.S. Coast Guard, Office of Boating Safety

    MedlinePlus

    ... Product Assurance Branch Boating Safety Circulars Beacon Alerts Marine Safety Alerts Multimedia PSA's Image Library News Videos ... National Nonprofit Organization Funding Opportunity Application Deadline Announced MARINE SAFETY ALERT ISSUED FOR INFLATABLE LIFE JACKETS MARINE ...

  6. Sun Safety

    MedlinePlus

    ... Links Buttons and Badges Stay Informed Cancer Home Sun Safety Language: English Español (Spanish) Recommend on Facebook Tweet Share Compartir The sun’s ultraviolet (UV) rays can damage your skin in ...

  7. Food safety.

    PubMed

    Borchers, Andrea; Teuber, Suzanne S; Keen, Carl L; Gershwin, M Eric

    2010-10-01

    Food can never be entirely safe. Food safety is threatened by numerous pathogens that cause a variety of foodborne diseases, algal toxins that cause mostly acute disease, and fungal toxins that may be acutely toxic but may also have chronic sequelae, such as teratogenic, immunotoxic, nephrotoxic, and estrogenic effects. Perhaps more worrisome, the industrial activities of the last century and more have resulted in massive increases in our exposure to toxic metals such as lead, cadmium, mercury, and arsenic, which now are present in the entire food chain and exhibit various toxicities. Industrial processes also released chemicals that, although banned a long time ago, persist in the environment and contaminate our food. These include organochlorine compounds, such as 1,1,1-trichloro-2,2-bis(p-chlorophenyl)ethane (dichlorodiphenyl dichloroethene) (DDT), other pesticides, dioxins, and dioxin-like compounds. DDT and its breakdown product dichlorophenyl dichloroethylene affect the developing male and female reproductive organs. In addition, there is increasing evidence that they exhibit neurodevelopmental toxicities in human infants and children. They share this characteristic with the dioxins and dioxin-like compounds. Other food contaminants can arise from the treatment of animals with veterinary drugs or the spraying of food crops, which may leave residues. Among the pesticides applied to food crops, the organophosphates have been the focus of much regulatory attention because there is growing evidence that they, too, affect the developing brain. Numerous chemical contaminants are formed during the processing and cooking of foods. Many of them are known or suspected carcinogens. Other food contaminants leach from the packaging or storage containers. Examples that have garnered increasing attention in recent years are phthalates, which have been shown to induce malformations in the male reproductive system in laboratory animals, and bisphenol A, which negatively

  8. Biological safety cabinetry.

    PubMed Central

    Kruse, R H; Puckett, W H; Richardson, J H

    1991-01-01

    The biological safety cabinet is the one piece of laboratory and pharmacy equipment that provides protection for personnel, the product, and the environment. Through the history of laboratory-acquired infections from the earliest published case to the emergence of hepatitis B and AIDS, the need for health care worker protection is described. A brief description with design, construction, function, and production capabilities is provided for class I and class III safety cabinets. The development of the high-efficiency particulate air filter provided the impetus for clean room technology, from which evolved the class II laminar flow biological safety cabinet. The clean room concept was advanced when the horizontal airflow clean bench was manufactured; it became popular in pharmacies for preparing intravenous solutions because the product was protected. However, as with infectious microorganisms and laboratory workers, individual sensitization to antibiotics and the advent of hazardous antineoplastic agents changed the thinking of pharmacists and nurses, and they began to use the class II safety cabinet to prevent adverse personnel reactions to the drugs. How the class II safety cabinet became the mainstay in laboratories and pharmacies is described, and insight is provided into the formulation of National Sanitation Foundation standard number 49 and its revisions. The working operations of a class II cabinet are described, as are the variations of the four types with regard to design, function, air velocity profiles, and the use of toxins. The main certification procedures are explained, with examples of improper or incorrect certifications. The required levels of containment for microorganisms are given. Instructions for decontaminating the class II biological safety cabinet of infectious agents are provided; unfortunately, there is no method for decontaminating the cabinet of antineoplastic agents. Images PMID:2070345

  9. Human aspects of mission safety

    NASA Technical Reports Server (NTRS)

    Connors, Mary M.

    1989-01-01

    Recent discussions of psychology's involvement in spaceflight have emphasized its role in enhancing space living conditions and incresing crew productivity. While these goals are central to space missions, behavioral scientists should not lose sight of a more basic flight requirement - that of crew safety. This paper examines some of the processes employed in the American space program in support of crew safety and suggests that behavioral scientists could contribute to flight safety, both through these formal processes and through less formal methods. Various safety areas of relevance to behavioral scientists are discussed.

  10. Comparing Science Achievement Constructs: Targeted and Achieved

    ERIC Educational Resources Information Center

    Ferrara, Steve; Duncan, Teresa

    2011-01-01

    This article illustrates how test specifications based solely on academic content standards, without attention to other cognitive skills and item response demands, can fall short of their targeted constructs. First, the authors inductively describe the science achievement construct represented by a statewide sixth-grade science proficiency test.…

  11. [Diagnosis and treatment of community-acquired urinary tract infections in adults: what has changed. Comments on the 2008 guidelines of the French Health Products Safety Agency (AFSSAPS)].

    PubMed

    Caron, François

    2010-01-01

    This article comments on the new recommendations for the diagnosis and treatment of adult patients with community-acquired urinary tract infections (UTIs), issued in 2008 by the French Health Products Safety Agency (AFSSAPS). The terms uncomplicated and complicated UTIs have been retained ; complicated UTIs are those with risk factor for complication (rather than with established complications). In women, age (>or= 65 years) is no longer considered itself a risk factor for complications. In men, cystitis must be treated as prostatitis. The bacterial levels defining UTIs have been revised, but levels below the threshold cannot be used to rule out UTI in the presence of symptoms. For uncomplicated cystitis, only fosfomycin-trometamol is recommended as a first-line treatment, essentially because of its ecological advantages (resistance uncommon, no cross resistance with other antibiotic classes, specific class, sparing others). For recurrent cystitis, prophylactic antibiotic treatment must be limited to cases when other preventive measures are impossible. For complicated cystitis, the principle is to delay antibiotic therapy until the resistance profile results are available, when possible (because of the high risk of resistance). Delay must be avoided during pregnancy, however, because of maternal-fetal risks. The strategy for uncomplicated pyelonephritis has been simplified : no plain abdominal radiography, antibiotic therapy shortened to 10-14 days (even 7 days for regimen or relay including fluoroquinolone), and no routine verification by urine culture. For prostatitis, PSA testing is not recommended during the acute phase of prostatitis, and a 14-day antibiotic regimen is enough for the easiest-to-treat infections.

  12. Efficacy and safety of a vaginal medicinal product containing three strains of probiotic bacteria: a multicenter, randomized, double-blind, and placebo-controlled trial

    PubMed Central

    Tomusiak, Anna; Strus, Magdalena; Heczko, Piotr B; Adamski, Paweł; Stefański, Grzegorz; Mikołajczyk-Cichońska, Aleksandra; Suda-Szczurek, Magdalena

    2015-01-01

    Objective The main objective of this study was to evaluate whether vaginal administration of probiotic Lactobacillus results in their colonization and persistence in the vagina and whether Lactobacillus colonization promotes normalization and maintenance of pH and Nugent score. Patients and methods The study was a multicenter, randomized, double-blind, and placebo-controlled trial. Altogether, 376 women were assessed for eligibility, and signed informed consent. One hundred and sixty eligible women with abnormal, also called intermediate, vaginal microflora, as indicated by a Nugent score of 4–6 and pH >4.5 and zero or low Lactobacillus count, were randomized. Each participant was examined four times during the study. Women were randomly allocated to receive either the probiotic preparation inVag®, or a placebo (one capsule for seven consecutive days vaginally). The product inVag includes the probiotic strains Lactobacillus fermentum 57A, Lactobacillus plantarum 57B, and Lactobacillus gasseri 57C. We took vaginal swabs during visits I, III, and IV to determine the presence and abundance of bacteria from the Lactobacillus genus, measure the pH, and estimate the Nugent score. Drug safety evaluation was based on analysis of the types and occurrence of adverse events. Results Administration of inVag contributed to a significant decrease (between visits) in both vaginal pH (P<0.05) and Nugent score (P<0.05), and a significant increase in the abundance of Lactobacillus between visit I and visits III and IV (P<0.05). Molecular typing revealed the presence of Lactobacillus strains originating from inVag in 82% of women taking the drug at visit III, and 47.5% at visit IV. There was no serious adverse event related to inVag administration during the study. Conclusion The probiotic inVag is safe for administration to sustainably restore the healthy vaginal microbiota, as demonstrated by predominance of the Lactobacillus bacteria in vaginal microbiota. PMID:26451088

  13. Which Achievement Gap?

    ERIC Educational Resources Information Center

    Anderson, Sharon; Medrich, Elliott; Fowler, Donna

    2007-01-01

    From the halls of Congress to the local elementary school, conversations on education reform have tossed around the term "achievement gap" as though people all know precisely what that means. As it's commonly used, "achievement gap" refers to the differences in scores on state or national achievement tests between various…

  14. Fire safety. Explosion safety - Handbook

    NASA Astrophysics Data System (ADS)

    Baratov, Anatolii Nikolaevich

    The physicochemical principles underlying combustion and explosion processes are examined, and the main fire and explosion safety characteristics of materials are reviewed with particular reference to the ignition limits of combustible mixtures, the minimal oxygen content that constitutes an explosion hazard, and the flash point and ignition temperatures. Fire-fighting and explosion suppression methods and equipment are described. The discussion also covers the efficiency of fire prevention measures and safety engineering in fire fighting.

  15. INTEGRATED SAFETY MANAGEMENT SYSTEM SAFETY CULTURE IMPROVEMENT INITIATIVE

    SciTech Connect

    MCDONALD JA JR

    2009-01-16

    In 2007, the Department of Energy (DOE) identified safety culture as one of their top Integrated Safety Management System (ISMS) related priorities. A team was formed to address this issue. The team identified a consensus set of safety culture principles, along with implementation practices that could be used by DOE, NNSA, and their contractors. Documented improvement tools were identified and communicated to contractors participating in a year long pilot project. After a year, lessons learned will be collected and a path forward determined. The goal of this effort was to achieve improved safety and mission performance through ISMS continuous improvement. The focus of ISMS improvement was safety culture improvement building on operating experience from similar industries such as the domestic and international commercial nuclear and chemical industry.

  16. Module Safety Issues (Presentation)

    SciTech Connect

    Wohlgemuth, J.

    2012-02-01

    Description of how to make PV modules so that they are less likely to turn into safety hazards. Making modules inherently safer with minimum additional cost is the preferred approach for PV. Safety starts with module design to ensure redundancy within the electrical circuitry to minimize open circuits and proper mounting instructions to prevent installation related ground faults. Module manufacturers must control the raw materials and processes to ensure that that every module is built like those qualified through the safety tests. This is the reason behind the QA task force effort to develop a 'Guideline for PV Module Manufacturing QA'. Periodic accelerated stress testing of production products is critical to validate the safety of the product. Combining safer PV modules with better systems designs is the ultimate goal. This should be especially true for PV arrays on buildings. Use of lower voltage dc circuits - AC modules, DC-DC converters. Use of arc detectors and interrupters to detect arcs and open the circuits to extinguish the arcs.

  17. Impacts of soil and water pollution on food safety and health risks in China.

    PubMed

    Lu, Yonglong; Song, Shuai; Wang, Ruoshi; Liu, Zhaoyang; Meng, Jing; Sweetman, Andrew J; Jenkins, Alan; Ferrier, Robert C; Li, Hong; Luo, Wei; Wang, Tieyu

    2015-04-01

    Environmental pollution and food safety are two of the most important issues of our time. Soil and water pollution, in particular, have historically impacted on food safety which represents an important threat to human health. Nowhere has that situation been more complex and challenging than in China, where a combination of pollution and an increasing food safety risk have affected a large part of the population. Water scarcity, pesticide over-application, and chemical pollutants are considered to be the most important factors impacting on food safety in China. Inadequate quantity and quality of surface water resources in China have led to the long-term use of waste-water irrigation to fulfill the water requirements for agricultural production. In some regions this has caused serious agricultural land and food pollution, especially for heavy metals. It is important, therefore, that issues threatening food safety such as combined pesticide residues and heavy metal pollution are addressed to reduce risks to human health. The increasing negative effects on food safety from water and soil pollution have put more people at risk of carcinogenic diseases, potentially contributing to 'cancer villages' which appear to correlate strongly with the main food producing areas. Currently in China, food safety policies are not integrated with soil and water pollution management policies. Here, a comprehensive map of both soil and water pollution threats to food safety in China is presented and integrated policies addressing soil and water pollution for achieving food safety are suggested to provide a holistic approach.

  18. Final amended report on the safety assessment of Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben as used in cosmetic products.

    PubMed

    2008-01-01

    , demonstrate a low order of parabens' toxicity at concentrations that would be used in cosmetics. Parabens are rarely irritating or sensitizing to normal human skin at concentrations used in cosmetics. Although parabens do penetrate the stratum corneum, metabolism of parabens takes place within viable skin, which is likely to result in only 1% unmetabolized parabens available for absorption into the body. The Expert Panel did consider data in the category of endocrine disruption, including male reproductive toxicity and various estrogenic activity studies. The CIR Expert Panel compared exposures to parabens resulting from use of cosmetic products to a no observed adverse effect level (NOAEL) of 1000 mg/kg day(- 1) based on the most statistically powerful and well-conducted study of the effects of Butylparabens on the male reproductive system. The CIR Expert Panel considered exposures to cosmetic products containing a single parabens preservative (use level of 0.4%) separately from products containing multiple parabens (use level of 0.8%) and infant exposures separately from adult exposures in determining margins of safety (MOS). The MOS for infants ranged from approximately 6000 for single paraben products to approximately 3000 for multiple paraben products. The MOS for adults ranged from 1690 for single paraben products to 840 for multiple paraben products. The Expert Panel considers that these MOS determinations are conservative and likely represent an overestimate of the possibility of an adverse effect (e.g., use concentrations may be lower, penetration may be less) and support the safety of cosmetic products in which parabens preservatives are used.

  19. 16 CFR 1203.53 - Interim safety standards.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Interim safety standards. 1203.53 Section 1203.53 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS..., Through March 10, 1999 § 1203.53 Interim safety standards. (a) Bicycle helmets must comply with one...

  20. NASA System Safety Handbook. Volume 1; System Safety Framework and Concepts for Implementation

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Smith, Curtis; Stamatelatos, Michael; Youngblood, Robert

    2011-01-01

    unrtainties represents a method of probabilistic thinking wherein the analyst and decision makers recognize possible outcomes other than the outcome perceived to be "most likely." Without this type of analysis, it is not possible to determine the worth of an analysis product as a basis for making decisions related to safety and mission success. In line with these considerations the handbook does not take a hazard-analysis-centric approach to system safety. Hazard analysis remains a useful tool to facilitate brainstorming but does not substitute for a more holistic approach geared to a comprehensive identification and understanding of individual risk issues and their contributions to aggregate safety risks. The handbook strives to emphasize the importance of identifying the most critical scenarios that contribute to the risk of not meeting the agreed-upon safety objectives and requirements using all appropriate tools (including but not limited to hazard analysis). Thereafter, emphasis shifts to identifying the risk drivers that cause these scenarios to be critical and ensuring that there are controls directed toward preventing or mitigating the risk drivers. To address these and other areas, the handbook advocates a proactive, analytic-deliberative, risk-informed approach to system safety, enabling the integration of system safety activities with systems engineering and risk management processes. It emphasizes how one can systematically provide the necessary evidence to substantiate the claim that a system is safe to within an acceptable risk tolerance, and that safety has been achieved in a cost-effective manner. The methodology discussed in this handbook is part of a systems engineering process and is intended to be integral to the system safety practices being conducted by the NASA safety and mission assurance and systems engineering organizations. The handbook posits that to conclude that a system is adequately safe, it is necessary to consider a set of safety claims that